中东医疗器械市场分析到2025年的预测

MARKET ESTIMATES & TREND ANALYSIS
Middle East Medical Devices Market

Market, by product (In Vitro Diagnostics(IVD), Cardiology, Orthopedics, Diagnostic
imaging, Ophthalmic, General and plastic surgery, Drug delivery, Endoscopy, Dental,
Wound management, Diabetic care, Nephrology, Ear, Nose and Throat, General hospital
and Healthcare, Neurology, Skin Care & Aesthetics)
Market, by FDA classification (Class I, II, III)
Market, by end user (Hospitals, Clinics, Laboratories, Blood Banks, Pharmacies, Stand
Alone Clinics, Dermatology Clinics & Cosmetic Centers)
Market, by region (Saudi Arabia, UAE, Qatar, Kuwait, Oman, Bahrain, Egypt, Iran, Iraq,
Israel, Cyprus, Jordan, Turkey, Lebanon, Palestine)
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Middle East medical devices Market Analysis and Segment Forecast to 2025
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Back to Table of Contents
©Grand View Research, Inc., USA. All Rights Reserved.

Middle East Medical Devices Market Analysis and Segment Forecast to 2025
Table of Contents
Chapter 1 Research Methodology ................................................... 12

1.1 Information procurement ........................................................................................... 14
1.2 Information or Data Analysis ...................................................................................... 17
1.3 Market Formulation & Validation ............................................................................... 21
1.4 Region Wise Market Calculation ................................................................................. 21
1.4.1 Region Wise Market: Base Estimates ................................................................. 21
1.4.2 Middle East Market: CAGR Calculation .............................................................. 22
1.5 Region based segment share calculation ..................................................................... 22
Chapter 2 Executive Summary ........................................................ 26

2.1 Market Snapshot ........................................................................................................ 28
Chapter 3 Middle East Medical Device Market Variables,

Trends & Scope ............................................................... 29
3.1 Market segmentation & scope .................................................................................... 30
3.1.1 Market Driver Analysis...................................................................................... 31
3.1.1.1 Supportive reimbursement pathways: .......................... 31
3.1.1.2 Technological advancements: ...................................... 32
3.1.1.3 Rising incidence of conventional diseases: ..................... 32
3.1.1.4 Mergers and acquisitions: ........................................... 32
3.1.2 Market Restraint Analysis ................................................................................. 33
3.1.2.1 Product pricing pressures: .......................................... 33
3.1.2.2 Stringent regulatory affairs: ........................................ 34
3.2 Penetration & growth prospect mapping .................................................................... 35
3.3 Middle East Medical Devices– SWOT Analysis, By Factor (political & legal,
economic and technological) ...................................................................................... 36
3.3.1 Political and legal ............................................................................................. 37
3.3.2 Economic ......................................................................................................... 38
3.3.3 Technology ....................................................................................................... 39
3.4 Industry Analysis – Porter’s ........................................................................................ 41
3.4.1 Bargaining power of supplier (Moderate): ......................................................... 42
3.4.2 Bargaining power of buyer (High): ..................................................................... 42
3.4.3 Competitive rivalry (High): ................................................................................ 43
3.4.4 Threat of substitutes (Low): .............................................................................. 43

3
3.4.5 Threat of new entrants (higher): ....................................................................... 44

3.5 Middle East medical devices: Regulation analysis ........................................................ 45
3.5.1 Document Legalization: .................................................................................... 45
3.5.1.1 Apostille countries: .................................................... 45
3.5.1.2 Non-Apostille ............................................................ 45
3.5.2 Region-wise regulatory framework: .................................................................. 46
3.6 Middle East medical devices: Reimbursement pathway ............................................... 49
3.6.1 Region-wise reimbursement pathway: .............................................................. 51
3.6.1.1 Kuwait: .................................................................... 51
3.6.1.2 Saudi Arabia: ............................................................ 52
3.6.1.3 Qatar: ..................................................................... 53
3.6.1.4 U.A.E. ...................................................................... 54
3.6.1.5 Bahrain:................................................................... 55
3.6.1.6 Oman ...................................................................... 55
3.6.1.7 Egypt....................................................................... 56
3.6.1.8 Iran ......................................................................... 56
3.6.1.9 Israel: ..................................................................... 57
3.6.1.10 Cyprus:.................................................................... 58
3.6.1.11 Turkey ..................................................................... 58
3.6.1.12 Lebanon ................................................................... 58
Chapter 4 Middle East medical devices Market: Product

Estimates & Trend Analysis ........................................... 59
4.1 Middle East medical devices market: Product movement analysis ............................... 61
4.1.1 In-Vitro Diagnostics(IVDs): ................................................................................ 61
4.1.1.1 In-Vitro Diagnostics(IVDs) market, 2014–2025 (USD
Million) .................................................................... 61
4.1.2 Cardiovascular: ................................................................................................. 62
4.1.2.1 Cardiovascular market, 2014–2025 (USD Million) ........... 63
4.1.3 Orthopedics ............................................................. Error! Bookmark not defined.
4.1.3.1 Orthopedics market, 2014–2025 (USD Million)............... 64
4.1.4 Diagnostic imaging ........................................................................................... 64
4.1.4.1 Diagnostic imaging market, 2014–2025 (USD
Million) .................................................................... 65
4.1.5 Ophthalmic ...................................................................................................... 65
4.1.5.1 Ophthalmic market, 2014–2025 (USD Million) ............... 66
4.1.6 General and plastic surgery .................................................................

4
4.1.6.1 General and plastic surgery market, 2014–2025

(USD Million) ............................................................ 67
4.1.7 Drug Delivery ................................................................................................... 67
4.1.7.1 Drug Delivery market, 2014–2025 (USD Million) ............ 68
4.1.8 Endoscopy ........................................................................................................ 68
4.1.8.1 Endoscopy market, 2014–2025 (USD Million) ................ 69
4.1.9 Dental .............................................................................................................. 69
4.1.9.1 Dental market, 2014–2025 (USD Million) ...................... 70
4.1.10 Wound care management ................................................................................. 70
4.1.10.1 Wound care management market, 2014–2025 (USD
Million) .................................................................... 71
4.1.11 Diabetes ........................................................................................................... 71
4.1.11.1 Diabetes market, 2014–2025 (USD Million) ................... 72
4.1.12 Nephrology ...................................................................................................... 72
4.1.12.1 Nephrology market, 2014–2025 (USD Million) ............... 73
4.1.13 Ear, Nose and Throat (ENT) ............................................................................... 73
4.1.13.1 Ear, Nose and Throat (ENT) market, 2014–2025
(USD Million) ............................................................ 74
4.1.14 General hospital and Healthcare ....................................................................... 75
4.1.14.1 General hospital and Healthcare, 2014–2025 (USD
Million) .................................................................... 75
4.1.15 Neurology ........................................................................................................ 76
4.1.15.1 Neurology market, 2014–2025 (USD Million) ................. 76
4.1.16 Skin Care & Aesthetics ...................................................................................... 77
4.1.16.1 Skin Care & Aesthetics, 2014–2025 (USD Million) .......... 77
4.1.17 Others .............................................................................................................. 78
4.1.17.1 Others market, 2014–2025 (USD Million) ...................... 78
Chapter 5 Middle East Medical Devices Market: U.S. FDA

Classification Estimates & Trend Analysis ................... 80
5.1 Middle East Medical Devices market: U.S. FDA classification movement analysis ......... 81
5.2 Market Size & Forecasts and Trend Analyses, 2014 to 2025 for the following
classes: .............................................................................. Error! Bookmark not defined.
5.2.1 Class I devices (general controls): ...................................................................... 82
5.2.1.1 Class I devices market, 2014–2025 (USD Million)........... 82
5.2.2 Class II devices (general & special controls)........................................................ 83
5.2.2.1 Class II devices market, 2014–2025 (USD Million) ......... 83

5
5.2.3 Class III devices (general/special controls and premarket approval) .................... 84
5.2.3.1 Class III devices market, 2014–2025 (USD Million) ........ 84
Chapter 6 Middle East Medical Devices Market: End-use

6.1 End-use Movement Analysis & Market Share, 2014 & 2025 ......................................... 87
6.2 Market Size & Forecasts and Trend Analyses, 2014 to 2025 for the following
classes: .............................................................................. Error! Bookmark not defined.
6.2.1 Hospitals: ......................................................................................................... 88
6.2.1.1 Hospitals market, 2014–2025 (USD Million) .................. 88
6.2.2 Clinics: ............................................................................................................. 89
6.2.2.1 Clinics market, 2014–2025 (USD Million) ...................... 89
6.2.3 Laboratories ..................................................................................................... 90
6.2.3.1 Laboratories market, 2014–2025 (USD Million) .............. 90
6.2.4 Blood Banks: .................................................................................................... 91
6.2.4.1 Blood Banks market, 2014–2025 (USD Million) .............. 91
6.2.5 Pharmacies:...................................................................................................... 92
6.2.5.1 Pharmacies market, 2014–2025 (USD Million) ............... 92
6.2.6 Stand-alone clinics: ........................................................................................... 93
6.2.6.1 Stand-alone clinics market, 2014–2025 (USD
Million) .................................................................... 93
6.2.7 Dermatology clinics and cosmetic centre: .......................................................... 94
6.2.7.1 Dermatology clinics and cosmetic center market,
2014–2025 (USD Million) ............................................ 94
6.2.8 Others: ............................................................................................................. 95
6.2.8.1 Others market, 2014–2025 (USD Million) ...................... 95
Chapter 7 Middle East Medical Device Market: Regional

7.1 Middle East medical devices market share by region, 2016 & 2025 .............................. 98
7.2 Saudi Arabia ............................................................................................................... 99
7.2.1 U.A.E. ............................................................................................................. 100
7.2.2 Qatar ............................................................................................................. 101
7.2.3 Kuwait ........................................................................................................... 102
7.2.4 Oman ............................................................................................................. 103
7.2.5 Bahrain .......................................................................................................... 104
7.2.6 Egypt.............................................................................................................. 105

6
7.2.7 Iran ................................................................................................................ 106

7.2.8 Iraq ................................................................................................................ 107
7.2.9 Israel .............................................................................................................. 108
7.2.10 Cyprus ............................................................................................................ 109
7.2.11 Jordan ............................................................................................................ 110
7.2.12 Turkey ............................................................................................................ 111
7.2.13 Lebanon ......................................................................................................... 112
7.2.14 Palestine ........................................................................................................ 113
Chapter 8 Competitive Landscape ................................................ 115

8.1 Strategy framework.................................................................................................. 115
8.2 Company Profiles ..................................................................................................... 121
8.2.1 Medtronic ...................................................................................................... 121
8.2.1.1 Company overview .................................................. 121
8.2.1.2 Financial performance .............................................. 122
8.2.1.3 Product benchmarking.............................................. 122
8.2.1.4 Strategic initiatives .................................................. 131
8.2.2 Johnson & Johnson ......................................................................................... 132
8.2.3 Siemens AG .................................................................................................... 134
8.2.4 Roche ............................................................................................................. 138
8.2.5 Becton Dickinson ............................................................................................ 140
8.2.5.2 Financial Performance .............................................. 140

7

8.2.6 Abbot Laboratories ......................................................................................... 143
8.2.7 Novartis ......................................................................................................... 145
8.2.8 Olympus Corporation ..................................................................................... 147
8.2.9 General Electric Healthcare ............................................................................. 150
8.2.10 Biomerica Inc.................................................................................................. 153
8.2.11 Baxter International ....................................................................................... 156
8.2.12 Smith & Nephew ............................................................................................ 159

8
8.2.13 BioMérieux .................................................................................................... 161

8.2.14 Zimmer Biomet............................................................................................... 163
8.2.15 Philips ............................................................................................................ 164

9
List of Figures
FIG. 1 Market research process 13

FIG. 2 Information Procurement 14
FIG. 3 Primary research pattern 16
FIG. 4 Market research approaches 18
FIG. 5 Value chain based sizing & forecasting 18
FIG. 6 QFD modelling for market share assessment 20
FIG. 7 Market summary (USD Million), 2016 28
FIG. 8 Market trends & outlook 29
FIG. 9 Market segmentation & scope 30
FIG. 10 Market driver relevance analysis (Current & future impact) 31
FIG. 11 Market restraint relevance analysis (Current & future impact) 33
FIG. 12 Penetration & growth prospect mapping 35
FIG. 13 SWOT Analysis, By Factor (political & legal, economic and technological) 36
FIG. 14 Porter’s Five Forces Analysis 41
FIG. 15 Middle East medical devices: Regulation analysis. 45
FIG. 16 Middle East medical device market: Product outlook key takeaways 59
FIG. 17 Middle East medical devices market: Product outlook key takeaways 60
FIG. 18 In-Vitro Diagnostics(IVDs) market, 2014 – 2025 (USD Million) 62
FIG. 19 Cardiovascular market, 2014 – 2025 (USD Million) 63
FIG. 20 Orthopedics market, 2014 – 2025 (USD Million) 64
FIG. 21 Diagnostic imaging market, 2014 – 2025 (USD Million) 65
FIG. 22 Ophthalmic market, 2014 – 2025 (USD Million) 66
FIG. 23 General and plastic surgery market, 2014 – 2025 (USD Million) 67
FIG. 24 Drug Delivery market, 2014 – 2025 (USD Million) 68
FIG. 25 Endoscopy market, 2014 – 2025 (USD Million) 69
FIG. 26 Dental market, 2014 – 2025 (USD Million) 70
FIG. 27 Wound care management market, 2014 – 2025 (USD Million) 71
FIG. 28 Diabetes market, 2014 – 2025 (USD Million) 72
FIG. 29 Nephrology market, 2014 – 2025 (USD Million) 73
FIG. 30 Ear, Nose and Throat (ENT) market, 2014 – 2025 (USD Million) 75
FIG. 31 General hospital and Healthcare, 2014 – 2025 (USD Million) 76
FIG. 32 Neurology market, 2014 – 2025 (USD Million) 77
FIG. 33 Skin Care & Aesthetics, 2014 – 2025 (USD Million) 78
FIG. 34 Others market, 2014 – 2025 (USD Million) 79
FIG. 35 Middle East medical devices market: FDA Classification outlook key takeaways 80
FIG. 36 Middle East medical device market: U.S. FDA classification movement analysis 81

10
FIG. 37 Class I devices market, 2014 – 2025 (USD Million) 83

FIG. 38 Class II devices market, 2014 – 2025 (USD Million) 84
FIG. 39 Class III devices market, 2014 – 2025 (USD Million) 85
FIG. 40 Middle East medical devices market: End-use outlook key takeaways 86
FIG. 41 Middle East medical devices market: End-user movement analysis 87
FIG. 42 Hospitals market, 2014 – 2025 (USD Million) 89
FIG. 43 Clinics market, 2014 – 2025 (USD Million) 90
FIG. 44 Laboratories market, 2014 – 2025 (USD Million) 91
FIG. 45 Blood Banks market, 2014 – 2025 (USD Million) 92
FIG. 46 Pharmacies market, 2014 – 2025 (USD Million) 93
FIG. 47 Stand-alone clinics market, 2014 – 2025 (USD Million) 94
FIG. 48 Dermatology clinics and cosmetic centre market, 2014 – 2025 (USD Million) 95
FIG. 49 Others market, 2014 – 2025 (USD Million) 96
FIG. 50 Regional market place: Key takeaways 97
FIG. 51 Regional outlook, 2016 & 2025 98
FIG. 52 Saudi Arabia Medical Devices market, 2014 – 2025 (USD Million) 100
FIG. 53 U.A.E. Medical Devices market, 2014 – 2025 (USD Million) 101
FIG. 54 Qatar Medical Devices market, 2014 – 2025 (USD Million) 102
FIG. 55 Kuwait Medical Devices market, 2014 – 2025 (USD Million) 103
FIG. 56 Oman Medical Devices market, 2014 – 2025 (USD Million) 104
FIG. 57 Bahrain Medical Devices market, 2014 – 2025 (USD Million) 105
FIG. 58 Egypt Medical Devices market, 2014 – 2025 (USD Million) 106
FIG. 59 Iran Medical Devices market, 2014 – 2025 (USD Million) 107
FIG. 60 Iraq Medical Devices market, 2014 – 2025 (USD Million) 108
FIG. 61 Israel Medical Devices market, 2014 – 2025 (USD Million) 109
FIG. 62 Cyprus Medical Devices market, 2014 – 2025 (USD Million) 110
FIG. 63 Jordan Medical Devices market, 2014 – 2025 (USD Million) 111
FIG. 64 Turkey Medical Devices market, 2014 – 2025 (USD Million) 112
FIG. 65 Lebanon Medical Devices market, 2014 – 2025 (USD Million) 113
FIG. 66 Palestine Medical Devices market, 2014 – 2025 (USD Million) 114
FIG. 67 Strategy framework 115

11
Chapter 1 Research Methodology
Our research methodology entails an ideal mixture of primary and secondary initiatives. Key
steps involves in the process are listed below:
 Information procurement
The stage involves the procurement of market data or related information via different
sources & methodologies.
 Information analysis
This step involves the analysis & mapping of all the information procured from the
previous step. It also encompasses the analysis of data discrepancies observed across
various data sources.
 Market formulation
The final step entails the placement of data points at appropriate market spaces in an
attempt to deduce viable conclusions. Analyst perspective & subject matter expert based
heuristic form of market sizing also plays an integral role in this step.
 Validation & publishing
Validation is the most important step in the process. Validation & re-validation via an
intricately designed process helps us finalize data-points to be used for final calculations.
The movement from step – 1 and step – 2 is bi-directional in nature. The process follows a to &
fro from both the ends. This is an integral data filtration technique used by GVR. The validation
& market formulation steps are also reversible in nature. They are run parallel to ensure data
accuracy and process flexibility.
The process of market sizing & data point identification runs throughout the report schedule.
The process moves from Step 1&2 to Step 3&4, while keeping the steps 1&2 and 3&4
reversible. The cycle of market sizing & variable identification also keeps repeating until every
data point is duly validated and is fit for publishing.

12
FIG. 1 Market research process
Information procurement Information analysis Market formulation

Validation & publishing
The stage involves the This step involves the The final step entails the
Validation is the most
procurement of market analysis & mapping of all placement of data points
important step in the
data or related the information procured at appropriate market
process. Validation & re-
information via different from the previous step. It spaces in an attempt to
validation via an
sources & methodologies. also encompasses the deduce viable conclusions.
intricately designed
analysis of data Analyst perspective &
process helps us finalize
discrepancies observed subject matter expert
data-points to be used for
across various data based heuristic form of
final calculations.
sources. market sizing also plays an
integral role in this step.
The movement from step – 1 and step – 2 is bi-directional in The validation & market formulation steps are also reversible in
nature. The process follows a to & fro from both the ends. This is nature. They are run parallel to ensure data accuracy and process
an integral data filtration technique used by GVR. flexibility.
The process of market sizing & data point identification runs throughout the report schedule. The process moves from Step 1&2
to Step 3&4, while keeping the steps 1&2 and 3&4 reversible. The cycle of market sizing & variable identification also keeps
repeating until every data point is duly validated and is fit for publishing.
©Grand View Research, Inc., USA. All Rights Reserved. 13

1.1 Information procurement
FIG. 2 Information Procurement
Information Procurement
The stage involves the procurement of market data or related information via different sources &
methodologies.
GVR’s Internal Database

Includes historic market
databases, pertinent
Purchased Database studies, internal audit
We buy access to paid reports & archives. We
databases such as have a dedicated team of
Hoover’s & Factiva to gain analysts updating &
access to company maintaining these
financials, industry databases.
information, white
papers, industry journals,
SME journals etc.
Primary Research Secondary Sources & Third Party Perspectives

Secondary sources includes government statistics
Primary interviews with published by organizations like WHO, NGOs,
in-house industry experts, World Bank etc., KoL publications, Company
freelance consultants, filings, Investor documents etc.
manufacturers, users &
distributors. Interviews Third party perspectives includes the analysis of
are largely based on investor analyst reports, broker reports, academic
brainstorming, tele- commentary, government quotes & wealth
interviews, online surveys management publications.
etc
©Grand View Research, Inc., USA. All Rights Reserved. 14

Information procurement is one of the most extensive stages in our research process. As
illustrated in the figure above, the techniques can broadly be categorized into five sections, as
stated below:
Purchased database:
 Includes company databases such as Hoover’s: This helps us identify financial

information, industry competitive landscape, structure of the market participants. Also, it
serves as an important step in market sizing, especially, in case of commodity-flow
techniques.
 Industry databases, e.g. Factiva. Helps us gain access to industry statistics, and KoL
opinions & formulate conclusions.
 Other sources include SME journals, pertinent databases from third-party vendors to gain
insights into:
o Usage rates
o Procedure statistics
o Potential market related statistics
o Information on unmet needs
o Regional expenditure pattern
o Investment information or opportunity based statistics
GVR’s Internal Database
 Includes our internal database of data points, collected as a result of previous research &
studies and information made available via our database management team
 Also includes internal audit reports & archives
Secondary sources:
 A list of secondary sources along with the information extracted from them will be available
in the final deliverable
 Notable examples include white papers, government statistics published by organizations
like WHO, NGOs, World Bank etc., KoL publications, company filings, investor documents
etc.
Third Party Perspective:
15

 This section includes market derivation through investor analyst reports, broker reports,
academic commentary, government quotes & wealth management publications.
Primary Research:
FIG. 3 Primary research pattern
The primary interviews & surveys derive directions from extensive secondary research. Secondary
research is a continuous process & is conducted at each level along the value chain
Interview with
Interview with market
Interviews with raw manufacturers,
players, industry
material suppliers & distributors, researchers,
experts, & independent
manufacturers & representatives of
consultants
regulatory bodies
Interview scope
Research tool: Questionnaire based research & telephonic discussions
Database: Paid vendors, Hoovers, LinkedIn, Factiva, Sources extracted from previous pertinent
studies
Regional scope: All countries within the scope of the studies. Interview of KoLs from non-English
speaking countries are conducted via our vendors and questionnaire

16
1.2 Information or Data Analysis
Information procured from secondary and primary initiatives are then, analyzed by using
the following tools/models: (a partial list)
 Identifying variables and establishing market impact

 Establishing market trends
 Analyzing future opportunities and market penetration rates by understanding
product commercialization, regional expansion etc.
 Analyzing reimbursement/regulatory trends and changes in market dynamics to
establish future growth
 Analyzing sustainability strategies adhered by market participants in an attempt to
determine future course of the market
 Analyzing historical market trends and super-imposing them on the current and
future variables to determine year-on-year trends
 Understanding consumer base, procedure trends and regulatory framework
 Keeping a track of technological advancements in individual segments
 Base numbers are established by analyzing the following:
- Company revenues and market share (this list generally includes the analysis of
revenue published by publicly listed manufacturers)
- Derivation of market estimates via analyzing parent and ancillary markets
The following techniques outline our research methodology:
 Model selection: demand based bottom up approach, usage rates based approach and
mixed approach (top down and bottom up)

17
FIG. 4 Market research approaches
Bottom-up demand approach
Total • Demand estimation of each product across countries/regions summed

market to form the total market
• Variable analysis for demand forecasting
Product A • Demand estimation via analyzing paid databases, company financials
Product B1 either via annual reports or paid databases
Product B • Primary interviews for data revalidation and insight collection
Product B Product B2
Top-down approach
Derived via commodity flow & • Used extensively for new product forecasting or analyzing penetration
Overall market demand/consumption models levels
• Tools used involve product flow & penetration models
• Use of regression multi-variate analyses for forecasting
Regional market • Involves extensive use of paid and public databases
Demand at a sub- • Primary interviews & vendor-based primary research for variable
Regional category level impact analysis
Sub-category market
market Demand at a
country level
Combined approach
Derived via commodity flow &
Total Overall market demand/consumption models
market
Product A Regional market

Demand at a sub-
Product B1 Regional category level
Product B Product B Sub-category market
market Demand at a
Product B2 country level
FIG. 5 Value chain based sizing & forecasting
Value-chain-based sizing & forecasting
Supply Demand
Side Side
estimates Estimates
•Identifying parent markets and

•Company revenue estimation via
ancillary markets
referring to annual reports, investor
•Segment penetration analysis to
presentations and Hoover‘s > obtain pertinent revenue/volume
•Segment revenue determination via
•Procedure volumes, usage rates to
variable analysis and penetration
derive market size
modeling
•Heuristic forecasting with the help of
•Competitive benchmarking to
identify market leaders and their
collective revenue shares
•Forecasting via analyzing
> subject matter experts
•Forecasting via variable analysis
commercialization rates, pipeline,

market initiatives, distribution
networks etc

18
 Penetration modeling for products

o Determining and forecasting penetration via analyzing product features,
proposed pricing, availability of internal and external substitutes etc.
o Heuristic estimation of year-on-year sales by conducting primary interviews with:
 Healthcare practitioners
 Industry experts & KoLs
 Distributors
o Product sizing and forecasting by following a diffusion model based on S-curve
growth
 Analysis of current usage rates and patterns to determine substitution rates

 Regression and variable analysis
o Identifying variables and assigning impact to determine growth)
o QFD modeling for market share assessment (an example cited in the figure
below)
o Referring to historic data to establish base estimates
o Using exponential smoothing for forecasting
 User size based penetration
o Analyzing current needs and determining penetration to estimate market size or
sales
o Using unmet needs and capitalization rates to determine growth
 Trend analysis (based on year on year trending models)

19
FIG. 6 QFD modelling for market share assessment
Scores derived Price Efficacy rates Current Future Consumer

via QFD penetration prospects preference
index
Product A 10 9 7 9 6
Product B 8 9 4 6 5
Product C 10 7 1 7 9
Product D 4 8 10 9 4
Product E 8 6 6 3 1
Weightage in terms of % Market shares as calculated for initial research purposes
Average score Relative market share
Price 25%
Product A 8.3 24.48%
Efficacy rates 25%

Product B 6.6 19.47%
Current penetration 25% Product C 6.6 19.32%
Future prospects 10% Product D 7.0 20.65%
Consumer preference index 15% Product E 5.5 16.08%
100% 33.9
Note: The above illustrated figure is for representation purposes only. attribute selection and score rendering is an extensive process
involving rigorous primary and secondary research

20
1.3 Market Formulation & Validation
Step 2: Data
Analysis
• This step involves the finalization of market numbers. This step on an internal level is
designed to manage outputs from the Data Analysis step.
• Data normalization
Market
• The final market estimates & forecasts are then aligned and sent to industry experts,
Formulation
in-panel quality control managers for validation
• This step also entails the finalization of the report scope and data representation
pattern
The process entails multiple levels of

validation. All these steps are run in parallel
Multi-level Data Validation
and the study is forwarded for publishing

only if all three levels render validated
Level 1: In-panel QC team results.
validation
Wait for Move to
Validated complete
Level 2: Validation by validation Publishing
industry experts & KoLs Output
Level 3: Validation by Partial Validation Move to Step 2

multiple data analysis Post-launch
models (triangulation) Market
Monitoring
1.4 Region Wise Market Calculation
1.4.1 Region Wise Market : Base Estimates
Approach 1: Commodity flow and bottom up market estimation

 Objective: Calculating base estimates for Middle East medical device market by
analyzing product demand, penetration, and regional presence.
 Tools: Primary interviews, analyst perspective, and secondary research.
 Investor documents published by Medtronic, Philips Healthcare, GE Healthcare, J&J,
Abbott, Roche, Siemens Healthineers, Zimmer Biomet, Olympus corporation, Biomerica
and others.
 Conclusion: Gained insights on demand, application, and frequency of purchase,
regional penetration, and R&D innovation.
Approach 2: Region wise market estimation using bottom up approach

 Objective: Calculating base estimates for Middle East medical device market by

21
estimating the country-based market in all the regions.

 Tools: Variable analysis by using parameters such as usage rate, patient volume, rising
healthcare expenditure, and allotment of hospital budgets towards such equipment (a
partial list).
 Conclusion: The market estimates for the region was estimated and MEA market was
calculated by using a bottom up approach.
 These percentages were assigned to the regions by studying other related markets.
Along with this, we also conducted variable analysis and considered factors such as
healthcare spending, market penetration, and target population to conclude on the
above-mentioned shares.
Approach 3: Associated Market Analysis

 Objective: Calculating the base estimates for the Medical devices market by studying
the ancillary markets such In-vitro diagnostics, cardiology, ophthalmic devices market.
 Tools: Primary interviews, analyst perspective, and secondary research
 Conclusion: Gained insights on demand, regional penetration, and application of the
related markets
1.4.2 Middle East Market : C AGR Calculation
 The CAGR for this market is calculated on the basis of following factors:
o Growth in revenue (of products)
o Growth rate of ancillary market
o Growth in end-user market
o Growth in technological innovations
1.5 Region based segment share calculation
 Market penetration, usage pattern, and expected market consumers were studied to
understand market growth
 The trends observed were applied to the market segments individually. The sum of
different products was taken to obtain the market estimate for 2016
 The product segment was divided into the following segments:

22
o In Vitro Diagnostics(IVD)
o Cardiology
o Orthopedics
o Diagnostic imaging
o Ophthalmic
o General and plastic surgery
o Drug delivery
o Endoscopy
o Dental
o Wound management
o Diabetic care
o Nephrology
o Ear, Nose and Throat
o General hospital and Healthcare
o Neurology
o Skin Care & Aesthetics.
 Through primary interviews and annual reports analysis, it was validated that in-vitro
diagnostics held higher market share of 60% in 2016. Data mining through industry
journals and white papers by leading market players helped in finalizing the estimates.
 Product penetration, product availability in the market, key advantages offered, and
future pipeline products along with strategies implemented by market players were
studied to estimate the market share of each segment
 In product segmentation, market shares were allotted by studying the product
penetration in different regions and applying the weighted average calculation to these.
Along with prices, factors such as applications, usability ratio, and penetration rate of
products were also studied and analyzed.
 The share for product segment was calculated based on the following factors:
o Price
o Awareness
o Cost efficiency
o Reliability

23
o Usage rate (depending on the efficacy of the product)

o Penetration (depending on the product availability)
Note: Segment share for each region was calculated using variable analysis method. All
the indicated variables were assigned weights after studying the market and these
shares were decided.
TABLE 1 List of Secondary Sources

Source Information Extracted
Total population
The World Health Organization (WHO) Regional population

Healthcare expenditure per capita of countries
Chronic disease prevalence
U.S. Centers of Disease Control (CDC) Surgical volume
Geriatric population
The Organization for Economic Co-operation and Development
Economic growth of developing regions
(OECD) Total number hospital beds
Information regarding government initiatives and
National Health Services regulation
Country wise breakdown of population, number of
Eurostat hospitals and diseases in European countries
World Bank Population in various countries
Country-wise population
United Nations Population Network
Geriatric population breakdown
Trends being followed in the industry
Journals Currently used products and their performance

portfolio
Financial data
Hoover’s Company profile
Revenue data
Bloomberg Strategic initiatives
Healthcare reforms
UNICEF Current status of chronic conditions by geography
Technical aspects of devices
Prices
Product Brochures Country-wise availability

Product profiling and advantages
Launch and strategic initiatives
U.S. Food and drug administration Cardiovascular device classification as per U.S. FDA.
Annual Ortho Summit, 2017 List of orthopedic medical devices.

24
Medical Expo e-magazine New innovations driving orthopedic device market.
Information on world conference on thoracic imaging

World Congress of Thoracic Imaging, 2017
devices.
Information on technology introduced by Philips on

Health Imaging
diagnostic imaging.
The Telegraph Information on Ophthalmic Devices.
Information on general and plastic surgery devices in

The National
Dubai.
Innovation technology introduced in drug delivery

Bostinno
device market.
Omnics international- 11th world drug delivery summit Information on drug delivery technologies.
Conference series Nephrology devices growth trends.
Index U.A.E. Information on clinics in U.A.E.

25
Chapter 2 Executive Summary
The Middle East medical devices market was valued at USD 19,610
The World Nephrology
Conference 2017, states million in 2016 and is expected to grow with CAGR of 5.5% over the
that around 19.0% of forecast period. Increasing demand for medical devices in Middle East
the UAE population is
is anticipated to be a result of increasing geriatric population,
estimated to suffer
from diabetes,17.0% increasing incidences of conventional diseases such as diabetes due
from hypertension and to sedentary lifestyle and lack of exercise. Other major drivers include
40.0% of these patients
technological innovations and increasing demand and acceptance of
are expected to develop
some form of chronic such technologies in Middle Eastern countries majorly in UAE, Saudi
kidney disease Arabia and Qatar. Limited number of market players in Middle East
and an increase in unmet demand has resulted in extravagant
opportunity for the medical devices in this region.
The World Nephrology Conference 2017, states that around 19.0% of

the UAE population is estimated to suffer from diabetes,17.0% from
hypertension and 40.0% of these patients are expected to develop
some form of chronic kidney disease. Diabetes being an important
segment, shows massive potential for Medical Device companies for
further growth in the market. Current research comprises of
implantable insulin pumps, disruption of fat metabolism, artificial
pancreas, invasive and non-invasive glucose sensors, new insulin
delivery systems including transdermal, inhaled, and implantable
devices, insulin delivering pens, conventional therapeutic approaches
and bariatric surgery.
The U.S. FDA classifies

medical devices into The U.S. FDA classifies medical devices into class I, II and III. Class I
class I, II and III medical devices pose minimal harm to the patients and are simpler in
depending upon the
potential risk and design. 47.0% of medical devices fall under Class I category out of
intricacy of the device which 95.0% are exempted from the regulatory processes. This class
design
includes higher risk devices which require greater regulatory controls
as compared to Class I devices. 43.0% of medical devices fall under

26
this category. This class includes devices with the highest risk and
hence, are subject to the highest level of regulatory control. 10.0% of
medical devices fall under this category.
UAE, Saudi Arabia and Qatar held a substantial share in medical

devices market in Middle East 2016. The World Health Organization
UAE, Saudi Arabia
and Qatar have high (WHO) stated that one third of adults in the U.A.E. are obese while
opportunity for medical one out of five people are diabetic. An increase in incidences of
devices in middle east.
lifestyle diseases are witnessed along with higher spending capacity
They have stringent
regulatory framework to which demands greater quality of healthcare. To maintain the quality,
ensure quality, efficacy efficacy and safety of the medical devices with a basic agenda to
and safety of medical
protect the citizens, Middle Eastern countries have stringent
devices, majorly being
imported into the regulatory bodies in place. Every country has a different country-
country. specific regulation for the medical devices.

27
2.1 Market Snapshot
FIG. 7 Market summary (USD Million), 2016
Total Market By U.S. FDA Segment Key facts

classification
Owning to the increasing availability of
Product: Neurology sophisticated equipment to monitor and track
Devices brain and nerve activity, this segment is expected
to dominate the market.
Rising technological innovations catering to the
U.S. FDA classification: unmet needs is a major driver for the lucrative
Class II (Fastest) growth of this segment.
End-user: Dermatology Growing awareness for aesthetic procedures

clinics and cosmetic among consumers coupled with rising disposable
centers income are expected to support the growth.
Supportive reimbursement pathways and

12,528.8
Region: Qatar (Fastest) regulations are expected to significantly

contribute to the regional growth.
Oligopolistic market nature with major players

Competitive Landscape
having similar share.
19,610.0
Drivers Restraint
1,572.8
5,508.4
• Supportive reimbursement • Product pricing pressures

pathways • Stringent regulatory affairs
• Technological advancements
• Rising incidence of
conventional diseases
• Mergers and acquisitions
Total Market Class II Class I Class III
Source: WHO, U.S. CDC, FDA, Investor Presentations, Primary Interviews, Grand View Research
28

Chapter 3 Middle East Medical Device Market Variables, Trends & Scope
FIG. 8 Market trends & outlook
Supportive reimbursement pathways Technological advancements Rising incidence of conventional Mergers and Acquisitions
diseases
The GCC countries have adopted Technological breakthroughs Middle East has a higher incidence Recent mergers and acquisitions in
Growth Factor reimbursement systems such as concentrating on increasing efficiency rate of conventional diseases majorly 2017 include Roche- ForSight Labs,
(Impact low to high Medical Coding systems including and accuracy are expected to occur due to sedentary lifestyle, consumption Abbott- St. Jude Medical, Olympus
along the arrow) International Classification of Diseases during the forecast period. Middle of unhealthy food and lack of physical Corporation - Image Stream Medical,
(ICD) codes, Current Procedural Eastern countries especially UAE, exercise. Major conventional diseases GE Healthcare- Monica Healthcare
Terminology (CPT) codes and Saudi Arabia and Kuwait are the include diabetes, cardiovascular and a few more. Mergers and
Diagnosis-related group (DRG) codes. innovators and early adaptors, diseases and obesity. Increased acquisitions benefit the companies in
Other pathways include national health embracing technological amount of disposable income is also a various ways such as entering a new
insurance program and private advancements. Major technological major contributing factor for the rising market, adding products to a pre-set
healthcare reimbursement featuring advancements include prime injector, incidence of conventional disease in product portfolio and many more.
public–private partnership model. dental devices used for sleep apnea the Middle East.
such as mandibular advancement
devices and others.
Product Pricing Pressures Stringent regulatory affairs
Restraining factor Overcrowding of the market with The regulatory bodies are put in place to
(Impact low to high competitors result in increased pricing ensure quality, safety, efficacy and
along the arrow) pressures on the companies. Price drop of authenticity of the Medical Devices majorly
a single product in the market will result in being imported into the countries. Every
a substantial price drop of all the country has a separate regulatory body
subsequent products of the same type. with different requirements for import of
The government setting ceiling prices of medical devices. Hence, it is a task for the
the medical devices and healthcare Medical device companies to abide by all
products also limits the potential of the the different regulatory requirements of the
companies to offer more innovative Middle Eastern countries
products.
Source: WHO, U.S. CDC, FDA, Investor Presentations, Annual reports, Primary Interviews, Grand View Research
29

3.1 Market segmentation & scope
FIG. 9 Market segmentation & scope
Middle East Medical Device Market
Product U.S. FDA End-user Regional
 In Vitro Diagnostics (IVD)  Class I  Hospital  Saudi Arabia
 Cardiology  Class II  Clinics  UAE
 Orthopaedics  Class III  Laboratories  Qatar
 Diagnostic imaging  Blood Banks  Kuwait
 Ophthalmic  Pharmacies  Oman
 General and plastic  Stand-alone Clinics  Bahrain

surgery
 Dermatology Clinics  Egypt
 Drug delivery & Cosmetic Centers
 Iran
 Endoscopy  Others
 Iraq
 Dental
 Israel
 Wound management
 Cyprus
 Diabetic care
 Jordan
 Nephrology
 Turkey
 Ear, Nose and Throat
 Lebanon
 General hospital and
Healthcare  Palestine
 Neurology
 Skin Care & Aesthetics
 Others
Attribute Details
Base year used for market estimation 2016
Historic analysis Actual data from 2014 to 2016
Forecast 2017 to 2025
30

3.1.1 Market Dri ver Anal ysis
FIG. 10 Market driver relevance analysis (Current & future impact)

High
Supportive
reimbursement
pathways
Technological
advancements
Medium
Rising incidence
of conventional
diseases
Low
Mergers and
Acquisitions
Current impact Short-term impact Long-term impact
3.1.1.1 Supportive reimbursement pathways:
A major factor resulting in increased growth and demand of medical devices in the Middle East
market are the supportive reimbursement pathways adopted by the countries. The GCC
countries have adopted reimbursement systems such as medical coding systems including
International Classification of Diseases (ICD) codes, Current Procedural Terminology (CPT)
codes and Diagnosis-Related Group (DRG) codes. Other pathways include national health
insurance program and private healthcare reimbursement featuring public–private partnership
model. Majority of the countries have either free public healthcare facilities or devices are
available at a subsidized rate. This takes place either by setting a ceiling price for the medical
devices or tender system. Majorly, reimbursement is regulated by the Ministry of Health (MoH)
of the respective countries. The medical device companies must make sure that their product is
meeting all the requirements to be a part of the reimbursement pathway. This is important, as
majority of the population prefers devices which they will be reimbursed for.

31
3.1.1.2 Technological advancements:
Middle eastern countries especially UAE, Saudi Arabia and Kuwait are the innovators and early
adaptors, embracing technological advancements and hence, are the most important customers
for the medical device market undergoing extensive technological innovations. Technological
breakthroughs concentrating on increasing efficiency and accuracy are expected to occur during
the forecast period. Growing market penetration of technologically advanced products, such as
drug delivery devices introduced by Portal Instruments by inventing PRIME injector. The injector
is a handheld device enabling chronic disease sufferers to self-administer a full dose of drug in
half a second without a needle or syringe, are leading to advancements of medical devices in
the Middle East markets. In 2017, BiPS Health won the Israeli innovation competition held at the
Israel Export institute. The featured product was a wearable medical device which is to be worn
on the wrist and it monitors the vitals such as blood pressure, heart and respiration rate and
blood oxygen saturation. All these factors are contributing to increased demand of medical
devices in the Middle East market.
3.1.1.3 Rising incidence of conventional di seases:
Along with being a hub for technology, Middle East also witnesses a higher incidence rate of
conventional diseases. These majorly include diabetes, cardiovascular diseases, obesity and a
few others. The WHO, estimated a total of 422.0 million people suffering from diabetes
worldwide out of which 43 million are estimated to be from the Middle Eastern region. Among
these, Saudi Arabia, Kuwait, Qatar, Bahrain, UAE and Oman have highest prevalence of
diabetes. Moreover, sedentary lifestyle due to desk jobs and lack of exercise and an increased
amount of disposable income has resulted in higher incidence of cardiovascular diseases and
obesity. All these factors are creating opportunities for the medical device market growth in the
Middle East.
3.1.1.4 Mergers and acquisitions:
The Middle East medical devices market is extremely dynamic with overcrowding of market
players. Mergers and acquisition is an important strategy implied by the companies to sustain in
such a dynamic market. Recent mergers and acquisitions in 2017 include Roche- ForSight

32
Labs, Abbott- St. Jude Medical, Olympus Corporation - Image Stream Medical, GE Healthcare-
Monica Healthcare and a few more. Mergers and acquisitions benefit the companies in various
ways such as entering a new market, adding products to a pre-set product portfolio and many
more. Higher demand of medical devices in Middle East will spur opportunistic M&A across
GCC countries.
3.1.2 Market Restraint Anal ysis
FIG. 11 Market restraint relevance analysis (Current & future impact)

High
Product
pricing
pressures
Medium
Stringent
regulatory
affairs
Low
Current impact Short-term impact Long-term impact

3.1.2.1 Product pricing pressures:
The major restraint for the medical device companies is the pricing pressures in the middle
eastern market because of the vast number of market players offering similar products. The
pricing of the product must be decided in such a way that it is not a low-price rendering less or
no profit to the company, nor should it be exorbitantly priced, making it out of budget for the
customers. The companies must make sure that their product prices are in-line with the
competitor’s product prices. Drop of price of a single product will result in the drop of prices of all

33
the other products, to sustain in the market. Another restrain is government setting ceiling prices
of the medical devices and healthcare products which limits the potential of the companies to
offer more innovative products.
3.1.2.2 Stringent regulatory affairs:
The Middle Eastern market includes various countries following different regulations for the
healthcare and medical device industry. A few of the regulatory bodies include Ministry of
Health (MoH) – Registration and Drug Control Department, Saudi Food and Drug Authority
(SFDA), Ministry of Economy and Commerce (MEC). Moreover, some Middle Eastern countries,
participate in the Asian Harmonization Working Party (AHWP) for medical devices with a goal of
harmonizing medical device regulations in the Asian regions. This causes coordination with the
Global Harmonization Task Force and other related international organizations, to establish
harmonized clinical evidence requirements, procedures and standards. Various requirements
are mandatory to be followed in order to import a medical device inside any country. A few of
them include compulsory CE mark, having a local authorized representative to get import
license and others. These regulations are put in place to ensure quality, safety and efficacy of
the products. The companies must abide by these regulations for getting an import license.

34
3.2 Penetration & growth prospect mapping
FIG. 12 Penetration & growth prospect mapping
Uncharted territories Segment spearhead

Future growth prospects (Low to High along the axis)
Class I
Class II
Class III
The no go zone Mature
Penetration (Low to High along the axis)
On the basis of products, the Middle East machines. Introduction of advanced devices
medical devices market is segmented into and availability of reimbursement is
Class I, II and III. Class II includes higher anticipated to foster their usage over the
risk devices which require greater regulatory forecast period. Class I devices were
controls to provide assurance of safety and predomiant in the initial years. Over
effectiveness of the devices. Class II include saturation of the market with devices and
wheelchairs, pregnancy test kits, market players along with limited scope for
acupuncture needles, infusion pumps, air innovation has resulted in hindered growth
purifiers and surgical drapes, X-ray of this segment.

35
3.3 Middle East Medical Devices– SWOT Analysis, By Factor (political & legal, economic and technological)
FIG. 13 SWOT Analysis, By Factor (political & legal, economic and technological)
Strength: Presence of supportive reimbursement policies through Ministry of Health (MoH), Health Insurance Organization (HIO) and
National Organization for Drug Control and Research (NODCAR) are expected to nurture the market growth of Medical devices.
Weakness: Stringent regulatory pathways are a task for the companies to adhere to and fulfil all the requirements in order to export the
medical devices into Middle East.
Political & Legal
Opportunity: Implication of compulsory health insurance and Multiple government initiatives are the contributing factors for the future
growth of Middle East medical device market.
Threat: Stringent ethical and legal laws catering to issues such as irresponsible advertising. In 2017, the biggest political crisis hit Middle
East when Qatar faced a diplomatic freeze by key allies and neighbor countries including Saudi Arabia and UAE.
Strength: Rising economic development in the developing countries, such as Saudi Arabia, UAE, Qatar, Kuwait and Oman is expected to
increase healthcare spending or spending on Medical devices, resulting in high growth potential in Middle East.
Weakness: Fall in the GDP by 15% of the oil-exporting countries, between 2014 and 2016 is anticipated to hinder the market growth
potential.
Economic Opportunity: Compulsory health insurance and rising per capita income levels are expected to significantly improve the market penetration
rates.
Threat: High prices of the medical devices and surgery costs along with limited reimbursement policies are expected to hinder the market
growth.
Strength: Technological breakthroughs concentrating on increasing efficiency and accuracy are expected to take during the forecast period.
Growing market penetration of technologically advanced products such as prime injector, dental devices used for sleep apnea and many
more .
Weakness: High cost of research and production along with technical complexity might restrict middle east medical device market demand
Technological
Opportunity: Development of advanced technologies such as mandibular advanced devices for sleep apnea are anticipated to support the
market growth.
Threat: Recently trending technologies could become obsolete soon, and hence investing millions upon the research and development of
such technologies could be risky for the Medical device companies.
36

3.3.1 Political and legal
 Strength:
Presence of supporting regulations and reimbursement pathways facilitate the demand of
medical devices in Middle East. The Ministry of Health and Population (MoHP), Health
Insurance Organization (HIO) and National Organization for Drug Control and Research
(NODCAR) are the regulatory and reimbursement bodies in the Middle East, responsible
for supervising and sanctioning reimbursement
 Weakness:
It is difficult for the medical device companies to maintain a track of all the regulations
and regulatory bodies present in different countries in Middle East. Although the
reimbursement pathway facilitates the demand of medical devices in the Middle East but
the regulations are stringent, and it becomes a tough task for the companies to adhere
and fulfil all the requirements. Partnership with a local representative to export the
devices in the Middle East market is a must, which is anticipated to limit the reach of the
companies into the market.
 Opportunity:
Implication of compulsory health insurance in majority of the counties could be an
opportunity for the Middle East medical device market. Multiple government initiatives
contributing to awareness of the diseases along with creating a need for the devices in
this market, although being a secondary outcome.
 Threat:
Stringent ethical and legal laws catering to issues such as irresponsible advertising,
bribing healthcare professionals in order to get business are a threat to the medical
device market in the Middle East market. In 2017, the biggest political crisis hit Middle
East when Qatar faced a diplomatic freeze by key allies and neighbor countries.
Countries such as Saudi Arabia and UAE alleged claimed that Qatar is involved in some
unethical practices and hence, abandoned the country. Qatar is an integral source of oil
and these crises may lead to a hike in the oil prices. Qatar is dependent on Saudi Arabia
for food import. This could negatively impact the medical device market as the overall
health expenditure could decline.
37

3.3.2 Economic
 Strength:
Increased healthcare expenditure is witnessed due to increasing disposable income
rendering higher demand for medical devices in the Middle East. The ever-increasing
cost of oil has resulted in betterment of overall lifestyle of the citizens and caused an
increase in middle class population. Rising GDP growth from 2.4% in 2017 to a growth of
3.3% in 2018, which is anticipated to increase the demand for medical devices in the
Middle East market.
 Weakness:
Middle Eastern oil-exporting countries’ revenues faced a fall by more than one-third or 15
of GDP of the countries, between 2014 and 2016. This is anticipated to impact the overall
expenditure spent on healthcare, thus declining the demand for high ended medical
devices.
 Opportunity:
Increased healthcare spending by the government including the incorporation of
compulsory health insurance in many countries are anticipated to increase the ease of
penetration of global medical device companies. Rising per capita income levels is
expected to significantly improve the market penetration rate of medical device
companies as well.
 Threat:
High prices of the medical devices and surgery costs along with limited reimbursement
policies in a few counties of Middle East are expected to hinder the market growth and
demand of medical devices.

38
3.3.3 Technolog y
 Strength:
Technological breakthroughs concentrating on increasing efficiency and accuracy are
expected to occur during the forecast period. Growing market penetration of
technologically advanced products, such as drug delivery devices introduced by the
Portal Instruments by inventing PRIME injector. This is a handheld device enabling
chronic disease sufferers to self-administer a full dose of the drug in half a second without
a needle or syringe are leading to advancements of medical devices in the Middle East
market. In 2017, BiPS Health won the Israeli innovation competition held at the Israel
Export institute. The featured product was a wearable medical device which is to be worn
on the wrist which constantly monitors the vitals such as blood pressure, heart and
respiration rate and blood oxygen saturation. All these factors are contributing to
increased demand of medical devices in the Middle East market.
 Weakness:
It is hard to prevent the misuse of non-licensed technology with the growing occurrence
of technology piracy in medical device market. This is a major weakness for medical
device industry, which also holds true for the Middle East market. High cost of research
and production along with technical complexity might restrict the Middle East medical
device market demand. As much as technological advancement is a boom to the medical
device industry, it also seems to have a negative effect on the overall healthcare industry.
Over dependence on technology results in over analysis and over thinking of any
symptom. This could cause misinterpretation and misdiagnosis of the disease and
eventually may pose threat to the patient’s life.
 Opportunity:
Development of advanced technologies products for sleep apnea including mandibular
advancement devices and combination Continuous Positive Airway Pressure (CPAP)
/dental sleep device therapy are beneficial for the medical device market in the Middle
East. Various minimally invasive devices are the trending innovations contributing to
increased demand for medical devices market in the Middle East.
 Threat:
Technological advancement is an ongoing process and there are innovations being
discovered every second in the world. This is anticipated to be the greatest threat to the

39
medical device market. There are high chances of the technology being trending in the
market currently to become obsolete in not less than a few months. Investing huge capital
in the R&D of such technologies could be a threat to the companies. Another threat could
be the level of compatibility and usability of the technologies in various sectors of the
Middle East. Increasing amount is incurred in the training and development of personnel
who are using the technology. Highly trained individuals are required to handle the high-
end medical devices, as a single shortcoming could be life-threatening to the patient.

40
3.4 Industry Analysis – Porter’s
FIG. 14 Porter’s Five Forces Analysis
Threat of new entrants: Moderate

Despite the investment required to establish new
companies in this space being high, there has been
constant rise in the number of players operating in this
market. Although, stringent government regulations and
reimbursement pathways limit the entry of new players,
high demand for advanced minimally invasive medical
devices with enhanced features and innovative
technologies are raising the barriers for new market
entrants in Middle east. Therefore, the threat of new
entrants is anticipated to be at a moderate level during the
forecast period.
Bargaining power of suppliers: Moderate Competitive rivalry: High Bargaining power of buyers: High
The raw materials required to produce medical Devices are Companies have adopted strategies such as new product The medical device market is witnessing overcrowding of
the various polymers, polyether’s, vast technologies and launch, partnership, merger & acquisition, competitive market players offering the same devices and
many more materials forming an integral part of any advantage. Furthermore, the manufacturers are more technologies. This results in more number of alternatives
medical device. There is an increase the number of focused on the development of technologically advanced offered to the buyers. Incidence of innovative technologies,
suppliers for the raw materials in the market. However, due products, which offer improved accuracy and efficiency. start-ups and new entrants, increasing collaborations
to stringent regulations for medical devices in Middle east, Entry of new players is posing a threat to the existing between companies to provide products catering to niche
it is a challenging task for the companies to trust and rely market players, thereby maintaining competitive rivalry on customer needs are factors contributing to increasing
on suppliers. As a result, supplier power is expected to the higher side. competition in Middle East. Thus, the bargaining power of
remain moderate. buyers is anticipated to be at a high level throughout the
forecast period.
Threat of substitutes: Low

Physiotherapy, homeopathy, Ayurveda and other
conventional therapies could contribute as substitutes but
at a lower percentage. The current devices form the new
products and there are no direct substitutes except generic
products. Therefore, the threat of substitutes is assessed
to be at a lower level.
41

3.4.1 Bargaining pow er of supplier (Moderate):
The basic raw materials required to produce medical devices are polymers, polyether’s, vast
technologies and many more materials forming an integral part of any medical device. Many
regulatory bodies are established to ensure the quality, safety and efficacy of the medical
devices as any shortcomings in the same may be life-threatening. Increasing population,
disease prevalence, geriatric population, healthcare expenditure and many such similar drivers
are responsible for an increase in the demand for medical devices in the Middle East. Due to
this reason, there is an increase in the number of suppliers for the raw materials. However, due
to stringent regulations for medical devices in Middle East, it is a challenging task for the
companies to trust and rely on suppliers. Due to this, many companies believe in maintaining
loyal relationships with one or two suppliers. However, it is suggested to keep a back-up
supplier, in case the supplier is unable to provide the promised raw materials in time thus,
hindering production and sales.
Increased cost-effectiveness in healthcare delivery has caused many companies to join Group
Purchasing Organizations (GPOs), or have formed Integrated Delivery Networks (IDNs) thus,
enhancing their purchasing power. GPOs and IDNs negotiate with manufacturers and
distributors and make pricing arrangements which are made available to the members of GPO
and IDN. An example of this is Baxter, which has purchasing agreements with several major
GPOs. GPOs may have agreements with more than one supplier for certain products.
Due to the regulatory constraints, it is difficult to establish additional or replacement sources for
some materials or components. An interruption or reduction in supply, and an inability to
develop alternative sources for the same, could adversely affect product sales. As a result, the
anticipated bargaining power of suppliers is assessed on a moderate level over the forecast
period.
3.4.2 Bargaining pow er of buyer (High):
In case of the medical device market in Middle East, the buyers include hospital, clinics,
laboratories, blood banks, pharmacies, stand-alone clinics, dermatology & cosmetic centers and
others. The medical device market is witnessing overcrowding of market players offering the
same devices and technologies, thus resulting in a ‘Red Ocean’. Incidence of innovative
technologies, start-ups and new entrants, increasing collaborations by companies to provide
products catering to niche customer needs are a few drivers resulting in increasing competition
42

of medical devices in Middle East market. This results in more number of alternatives offered to
the buyers causing an increased bargaining power of the buyers.
Middle East has stringent regulatory and reimbursement pathways which affect the buying
behaviour of the end-users. Therefore, the company must make sure that the offered product is
aligned with the regulatory and reimbursement pathways of the respective country. To be a
leading player in the market, the company must be able to offer innovative technologies and
products, thus applying ‘Blue Ocean strategy’ and creating a benchmark in the market. The
medical devices and technologies must be adequately priced in such a manner that it is neither
too high nor too low as compared to the competitor’s product. Therefore, the anticipated
bargaining power of buyers is higher for medical device market in the Middle East.
3.4.3 Competiti ve ri valry (High):
The medical device market in the Middle East is overcrowded due to multiple players offering
the same or similar product, thus resulting in higher competitive rivalry. To overcome this, the
companies have adopted strategies including new product launch, partnership and strategic
alliances, merger & acquisition, increasing investments in R&D and many other strategies.
Moreover, the manufacturers are focusing on development of technologically advanced
products, to cater a niche customer need. New entrants are also posing a threat to the existing
market players, thus elevating competitive rivalry. Patented medical devices also result in an
increased competitive rivalry. Innovations such as minimally invasive devices, dental devices
such as mandibular advancement devices and Continuous Positive Airway Pressure (CPAP)
used for sleep apnea, along with many other innovations are increasing the competitive rivalry
in the medical device market in the Middle East. Other factors contributing to competitive rivalry
are high brand loyalty among the end users for a particular brand and increased brand recall
resulting in decreased sales. Ethical marketing procedures must be adopted by all the
companies to sell the products in the market. Therefore, the anticipated completive rivalry is
assessed on a higher side for the medical device market in the Middle East.
3.4.4 Threat of substitutes (Low ):
Medical devices, that offer minimally invasive form of treatment unlike the former ones which
were invasive, are a substitute to those devices used in the past. Therefore, they form the new
products and no products are substituting them except generic products.

43
Drugs prescribed to a patient instead of surgical intervention also acts as a substitute for the
medical device market globally. This situation is also true for Middle East market. Although,
these substitutes don’t match the standards and efficacy offered by the medical devices,
however this may happen in future owing to continuous technological advancements.
External factors including high costs for the insurance companies could replace medical devices
in future. There is a potential risk which is anticipated to occur in future but not perceivable now.
Physiotherapy, homeopathy, Ayurveda and other conventional therapies could contribute as
substitutes; however, medical devices are a must in case of any surgical intervention.
Therefore, the anticipated threat of substitute is low for the medical device market in the Middle
East.
3.4.5 Threat of new entrants (higher):
The Middle East is a growing market providing vast opportunities for medical devices. The rising
demand for medical devices and the lack of market participant’s presence to cater the same
attracts avenues for establishment of new companies. Despite the substantial investment
required to establish new companies in this market, there has been a drastic rise in the number
of new entrant’s due to vast demand. Although, stringent government regulations and
reimbursement pathways limit the entry of new players, high demand for advanced minimally
invasive medical devices with enhanced features and innovative technologies are raising the
barriers for new market entrants in the Middle East market. Therefore, the threat of new entrants
is anticipated to be at a higher level during the forecast period.

44
3.5 Middle East medical devices: Regulation analysis
FIG. 15 Middle East medical devices: Regulation analysis.
3.5.1 Document Legalizat ion:
Any company that wishes to market its products in the Middle East requires assurance that the
product is effective, safe and in alignment with the current Good Manufacturing Practices
(GMP). The Health ministers require copies of the companies U.S. FDA approval certificates/
ISO certification/Free Sales Certificate (FSC) to document defect-free products. The products
must be certified, authenticated, legalized or apostilled depending on the National Health
Ministry’s requirements, to prove the documentation.
3.5.1.1 Apostille countries
Oman and Israel are the only countries under this segment and the mentioned certificates
require only Apostille legalization.
3.5.1.2 N o n- Ap o st ille
For the rest of the countries the documents must be sent to respective embassy and the
chamber of commerce for consular legalization.

45
3.5.2 Region-w ise regulatory framew ork:
Country Regulatory Bodies Features
1. Kingdom of Saudi Arabia  The Saudi Arabian Food and  Medical Devices authorized by
(KSA) Drug authority (SFDA) one of the founding IMDRF
members have access to the
 Asian Harmonization Working KSA market.
Party (AHWP)
 MDIR consists of an electronic
 International Medical Device system to facilitate efficient
Regulators Forum (IMDRF) communication between the
 Global Harmonization Task SFDA and manufacturers,
Force (GHTF) Importers, Authorized
Representatives, Distributors,
 Medical Devices Interim and other parties
Regulations (MDIR) system
 Requires local representative
2. United Arab Emirates (UAE)  Ministry of Health (MOH)  Follow regulations and
guidelines, mainly of:
 Global Harmonization Task
Force (GHTF)  The IMDRF for Medical
Devices,
 The US Food and Drug
Administration’s Devices
Regulation,
 The EU Medical Devices
Directive 93/42/EEC,
 The EU in Vitro Diagnostic
Devices Directive (IVDD)
98/79/EC and
 The EU Active Implantable
Medical Devices Directive
(AIMDD) 90/385/EEC.
 Requires local representative
3. Qatar  Ministry of Public Health  In June 2011, a law stated that
(MOPH) only Qatar MEC-authorized
medical Devices can be used
 Ministry of Economy and within Qatar.
Commerce (MEC)
 Global Harmonization Task
 Ministry of Municipal Affairs Force (GHTF) authorized
and Agriculture (MMAA) devices can apply for a MEC
 Global Harmonization Task marketing authorization.
Force (GHTF)  Requires local representative
4. Kuwait  Asian Harmonization Working  Requires local representative

Party (AHWP).
 Documents must be legalized
 Ministry of Health (MOH) by the Arab Chamber of
Commerce and the Kuwait
 Kuwait Embassy Embassy

46
5. Oman  Ministry of Health (MOH)  The medical Devices are

organized in a form of tender
system.
 Accepts all medical Devices
classification systems
6. Bahrain  Ministry of Health (MOH)  Comply with one of the
international standards
 Pharmaceutical Product including CE mark or USA
Regulatory Office (PPRO) of FDA standards.
National Health Regulatory
Authority (NHRA)  Approved through the NHRA
Medical Devices engineering
department.
7. Egypt  Egyptian Ministry of Health  The DPPC controls and sets
(MOH) the strategic rules for drug
policy but it also regulates the
 Drug Policy and Planning importation and manufacture
Center (DPPC) of medical Devices and
 Central Administration of instruments.
Pharmaceutical Affairs (CAPA)
8. Iran  Central Office for Medical  Regulatory requirements are
Equipment (COME) outlined in the Medical Cure
and Medical Education Act.
 The Institute of Standards &
Industrial Research of Iran
(ISIRI)- sole organization to
develop and designate official
standards for the medical
devices.
9. Iraq  Technical Affairs Directorate  The sole Iraqi company named
within the MOH the State Company for
Marketing Drugs and Medical
Appliances (KIMADIA) is
specialized for importing,
storing and distributing
medical devices and
equipment’s public healthcare
facilities.
10. Israel  Israel’s Ministry of Health  AMAR unit under IMOH
(IMOH). certifies all the activities
concerning import, export and
 Division of Medical Devices sale of medical device
and Accessories
11. Cyprus  Cyprus Medical Devices  Devices not meeting the
Competent Authority (CyMDA) essential requirements of the
country such as not having aa
 Cyprus Customs Authority and CE mark are confiscated by
Department of Pharmaceutical the Customs Authority of
Services of the MOH Cyprus.

47
12. Jordan  Jordan Food and Drug  The device must at least
Administration (JFDA) have one of the following
 Medical Devices Importation  FDA Certificate (Certificate to
Regulations. Foreign Government)
 CE Certificate and
 FSC

13. Turkey  The General Directorate of  The Turkish Medical Devices
Pharmaceuticals. Directive regulates the devices
by using the EU Medical
 Pharmacy Department of Devices Directive (MDD)
Medical Device Services framework.
14. Lebanon  Ministry of Public Health  All Medical Devices would
(MOPH) require a CE certificate or a
FDA certificate
15. Palestine  Ministry of Health (MOH).  Product registration is not
required.
 General Administration of
Pharmacy and the Drug  Import license is mandatory.
Registration Department.
Source: Ministry of Health, Regulatory requirements of Medical Devices in MENA countries
The stringent regulatory framework is put in place by the middle eastern countries ensuring
safety, efficacy and authenticity of the medical devices imported into the country. Abiding by
these regulations and fulfilling all the set requirements for import, could be a restrain for the
medical device market players. The regulations in many countries are not well-established yet,
but are under development and are expected to be rooted in near future. These regulations are
anticipated to have a pessimistic impact on the medical device market in Middle East in the near
future.

48
3.6 Middle East medical devices: Reimbursement pathway
Sr. No. Country Reimbursement pathway
1. GCC countries Medical Coding systems:
Saudi Arabia International Classification of Diseases (ICD) codes used to describe

procedures and diagnoses provided in facilities.
The United Arab
Emirates Current Procedural Terminology (CPT) codes: used to describe services
and procedures provided by medical professionals
Bahrain
Diagnosis-related group (DRG) codes: used to capture procedures and
Kuwait diagnoses performed as the basis for inpatient facility payments.
Oman National health insurance:
Qatar Qatar: Qatari national population and expatriates have full public
coverage of health care costs.
Saudi Arabia: Mandatory health insurance program.
Private health care:
Public–private partnership model: - Private players such as international

institutions are appointed as managers of publicly funded health facilities
to improve infrastructure and provide cost-effective delivery of services
Example: SEHA, The Abu Dhabi Health Services Company in Abu

Dhabi, has eight health systems managed under one umbrella
organization. The private partners include Johns Hopkins and the
Cleveland Clinic, United States.
2. Egypt The reimbursement process is specified by the Egyptian Ministry of

Health and Population (MoHP), health insurance organization (HIO) and
National Organization for Drug Control and Research (NODCAR). They
have separate rules for management of benefits and payment of
premiums. Medical device tender list is given to the hospitals and other
users where a ceiling price is fixed for the mentioned medical devices.

49
3. Iran Reimbursement is regulated by government-controlled health insurance

schemes including:
 Public Health Insurance Scheme

 Military Health Insurance Scheme.
 Social Health Insurance Scheme
Included under the High Council for Health Insurance jurisdiction.
Medical Services Insurance Organization (MSIO) cover insurance of the

services that are not included in the primary healthcare network.
The social security organization (SSO) Scheme provides additional

health care benefits including retirement pensions, benefits for disabled,
survivors, work-injured, marriage grant, unemployment maternity, and
other benefits.
4. Iraq No reimbursement policy for medical devices
5. Israel The National Health Insurance (NHI) Law, 1995 ensures medical
insurance for every citizen of Israel with the help of Health Maintenance
Organizations (HMO). The HMOs are funded by an income-based,
progressive health tax. The government further distributes the collected
NHI funds to the Israeli citizens thus, providing healthcare services. The
National Health Basket Committee under the National Health Insurance
Law includes all the services, supplies, medications, and equipment’s
that the insured is entitled to receiving.
6. Cyprus Around 80% of the population has access to free of charge public
healthcare that is state-financed, while others rely on the private
healthcare sector. Ministry of Health centrally procure the Medical
devices that are funded by the state via tender and further supply them
through the public sector. Other products are supplied by private
sectors, abiding by the Ministry of Health regulations.
7. Jordan No reimbursement policy for medical devices
8. Turkey Social Security Institution (SGK) establishes reimbursement schemes

with a settled reimbursement price for all medical devices. An
application by all medical devices must be made to SGK for
reimbursement. The reimbursed price depends on the tender price of
the state hospital. The SGK considers the lowest tender prices of the
state hospital from the last year. The class of the device is also
considered for the reimbursement price. If a similar product is already
present in the market, the reimbursement margin of that product is set
for the product in question.

50
9. Lebanon Reimbursement of medical devices is handled by National Social

Security Fund (NSSF) providing insurance coverage for sickness,
maternity care, family allowances, work related accidents and a few
other segments.
10. Palestine Reimbursement policy regulated by Palestine Ministry of Health (MoH)
3.6.1 Region-w ise reimbursement pathw ay
3.6.1.1 Kuwait
Kuwait’s population enjoys standardized level of health as the government is involved in

providing many health amenities and education to its citizens. The medical facilities provided in
the country are considered to be at par with the other western nations such as the U.S. and
Europe. Over 76.0% deaths in Kuwait are caused due to non-communicable diseases such as
cardiovascular conditions, road accidents, and cancer. However, the conditions arising due to
changing lifestyles such as obesity, dyslipidemia, and diabetes are also appearing as major risk
conditions, demanding healthcare sector intervention.
To overcome these issues, Kuwait healthcare system plans a shift from curative medicine to
preventive medicines. This reform in the healthcare system is anticipated to address all the
challenges occurring due to non-communicable conditions. With adequate number of healthcare
institutions equipped with skilled staff and dedicated to providing effective healthcare services,
Kuwait is the most modern healthcare infrastructure in the region.
The healthcare system in the country is a mix of both public and private, wherein public sector is
present with larger share, whereas private sector is a growing one.
Public Healthcare System:
There are three distinct levels in the public healthcare system in Kuwait, primary, secondary,
and tertiary. Over 100 primary healthcare centers are currently functional in the country. These
centers primarily focus on non-communicable conditions along with mental health. This
healthcare system also encompasses preventive measures and control of communicable
diseases such as HIV and tuberculosis. Disease control, health promotion, and emergency
responses are the most worked on categories under the healthcare system.
Private Healthcare System:
The private healthcare system in Kuwait has minimum autonomy and is majorly regulated and

51
monitored by the Ministry of Health (MoH) in terms of pricing the services. The system is
generally involved in providing high standard curative health services, thereby allowing the
government to concentrate on preventive measures. Private players do not accept local
insurance cover inclusive of the expatriate insurance law, which was introduced in April 2000.
This leads to out-of-pocket payment by individuals.
3.6.1.2 Sau di Arab ia:
Saudi Arabia represents the largest healthcare system in the region, with huge amounts of
government funding on healthcare system; the country is outperforming in terms of health care
resources and delivery. The healthcare system in Saudi Arabia is structured to provide a basic
platform of healthcare services with advanced facilities at private and public hospitals.
The below mentioned health indicators illustrates that their healthcare system offers the best
provisions:
• The life expectancy in Saudi Arabia is 75 years, which exceeds the regional average by
seven years
• Death rate per 1,000 people is 3.8, which is lower than the regional rate and half of global
rate
• Infant mortality rate per 1,000 people is eight, which is 63% less than regional rate and 56%
less than global rate
The Saudi Arabia has implemented mandatory health coverage for all expatriates. It is expected
that Saudi government is planning to implement the same rule for nationals increasing the
demand for private health services.
The public healthcare system in Saudi Arabia is governed by Ministry of Health (MoH), the
department is responsible for enforcing regulations to give necessary standards for practicing
medicine. The department is also responsible for healthcare resource management in which
they build hospitals and manage healthcare professionals. The hospitals in Mexico are divided
into various sectors, which include ministry of health, private sector and other governmental
hospitals.

52
Ministry of Health dominated with 60.2% of hospitals, private sector accounted for 30.6% of
hospitals and other governmental hospitals accounted for 9.2%. Out of 445 hospitals all over,
there were 307 public hospitals. Additionally, major projects to develop the hospitals such as
King Khaled Medical City, King Faisel Medical City, and King Abdullah Medical City are
projected to deploy additional 5,500 hospital beds.
The private health facilities in Saudi Arabia include hospitals, dispensaries, laboratories, and
pharmacies. Significant Investment opportunities in manufacturing medical devices and drugs
are assisting the growth of private healthcare sector in Saudi Arabia. Moreover, availability of
skilled healthcare professionals in Saudi Arabia is opening up the opportunities in the private
sector.
3.6.1.3 Qatar:
The supportive government initiatives resulted in improvised healthcare system in Qatar. The
rate of child mortality has declined over a couple of decades. As per the World Health
Organization (WHO), Qatar has the highest per capita health expenditure among the Gulf
Cooperative Council (GCC) countries. Qatar spent USD 4.7 billion on healthcare in 2014, which
was highest in Middle East. In 2013, as per the World Bank statistics the infant mortality rate
was seven in every thousand live births while life expectancy was 79 years. The organizations
primarily focused on quality and evaluation of existing healthcare system in Qatar. The system
has several challenges such as import of medical professional’s due to the dearth of Qatari
healthcare providers. However, long-term investments in medical education system resulted in
many local health professionals working in the system. Another challenge includes high
intolerance to drugs and adverse outcomes, which is discouraging medical professionals to
resort to complex procedures.
The Supreme Council of Health controls the healthcare activities in country. There are various
departments of supreme council, which include e-health department, department of research,
department of public health, emergency preparedness & diseases control, immunization &
vaccine control and surveillance & outbreaks section. Supreme Council also formulates the
regulations and protocols for private players.

53
The private healthcare players dominate Qatar with almost 65% of shares. The proportion of
healthcare spending by the private sector is increasing; this reflects the government’s
encouragement of private players. The major private hospitals operating include Al emadi
hospital, Doha clinic and Al Ahil Hospital, Sidra clinic, and Aspetar
3.6.1.4 U . A.E.
The healthcare standard in U.A.E. is high, reflecting high levels of healthcare spending ever
since oil boom. The healthcare sector is expected to witness an exponential growth driven by
the gap between demand and supply. The U.A.E.’s 2021 vision states that the government will
continually invest to build world-class healthcare infrastructure, services and expertise to fulfil
the growing needs and expectations of the citizens. The major regulators in U.A.E. are:
 The Ministry of Health (MoH)
 Health Authority Abu Dhabi (HAAD)
 Dubai Health Authority (DHA)
 Dubai Healthcare City Free Zone.
The drivers for the increasing demand of medical devices in U.A.E is rising population due to
high birth rates and longer life expectancy. The percentage of citizens above 60 years of age
are anticipated to rise from 5.2% in 2016 to 11% by 2032, thus increasing the demand for
healthcare devices. U.A.E. produces limited number of medical devices and hence offer
extensive opportunities for international market players.
Public healthcare system:
The government of Dubai regulates the medical devices by its own department of Health and
Medical services (DOHMS), independent of federal U.A.E. Ministry of Health. Seeing the current
scenario, curative services have been paid special attention to by the U.A.E. government.
These services are developed by well-planned strategies thus supporting the modern
equipment’s. The MoH has established an extensive network of healthcare centres, hospitals
and clinics to make the service available to everyone.

54
This helps meet the rising population needs and be in-line with the new technological
advancements.
Private healthcare system:
The private healthcare sector in U.A.E. is developed to provide comprehensive healthcare to the
U.A.E. citizens along with supporting the public healthcare system. Most of the private
healthcare institutions are based in the urban areas and major cities. They carry intensive
proportion of healthcare provisions which in turn reduces the burden of the facilities offered by
the Ministry of Health.
3.6.1.5 Bahrain
The healthcare spending in Bahrain is the lowest, owning to a small population base.
Nevertheless, the Bahrain government is putting in efforts to provide necessary healthcare
infrastructure to their residents. An increase in the number of expatriates have resulted in rising
need for private medical facilities. Like the other GCC countries, the government of Bahrain is
the chief provider of healthcare services to the citizens of Bahrain. The National Healthcare
Regulatory Authority are responsible for regulation of the healthcare system. To improve the
efficiency of te healthcare system, the MoH has decentralized the services. Bahrain has
mandatory health insurance services for the citizens within the country and for the expatriates.
The National Health and Health Improvement Strategies cater to the country’s health planning
cycle. The health insurance provided under this strategy covers both public and private sectors.
An executive committee is established for a national health insurance programme.
3.6.1.6 Oman
The overall healthcare spending in Oman has inclined drastically over the past years owing to
the ever-rising population along with the government’s determination to provide solutions for the
rising lifestyle related diseases. Oman’s healthcare system is recognised by the World Health
Organisation (WHO) for its rapid and cost-effective development. Oman is committed to
upgrading its facilities and diagnostic capabilities as per healthcare devices is concerned, thus
offering solid prospects for the innovative technologies to penetrate in the market. The Omani
Ministry of Health (MoH) has expressed interest in the U.S. healthcare technologies to
standardize their operations and establish interconnectivity among the hospitals and clinics in
Oman. The 2016 budget allocates USD 1.6 billion to the healthcare

55
expenditure thus, opening gates for innovative technologies in the medical device market.
Several private and semi-private healthcare facilities are also present within the country. The
MoH has also been announcing 5 year plans focusing on enhanced service delivery,
decentralized services and preventive care facilities. The Ministry is also considering
introduction of medical insurance policy as a reimbursement mechanism for Omani citizens.
3.6.1.7 Egypt
The reimbursement process is specified by the Egyptian Ministry of Health and Population
(MoHP), health insurance organization (HIO) and National Organization for Drug Control and
Research (NODCAR). They have separate rules for management of benefits and payment of
premiums. Medical device tender list is given to the hospitals and other users where a ceiling
price is fixed for the mentioned medical devices. The Health Insurance Organization (HIO)
administers a set of social health insurance programs with separate rules for the payment of
premium along with management of healthcare benefits like inpatient care, treatment abroad
with low copayment rates and plastic surgeries at subsidized rates. For reimbursement, each
public entity operates and owns a large network of hospitals and outpatient facilities. A separate
set of regulations and negotiations are available for the private sectors. A procurement
department is appointed which is responsible for publishing the tender list for medical devices.
The MoHP is the final decision maker for reimbursement based on the procurement technical
committee recommendation for the public sector. The device must be safe, effective and
efficient to be listed in the tender list.
3.6.1.8 Iran
Reimbursement is regulated by government-controlled health insurance schemes including:
• Public Health Insurance Scheme
• Military Health Insurance Scheme.
• Social Health Insurance Scheme
included under the High Council for Health Insurance jurisdiction.
Medical Services Insurance Organization (MSIO) cover insurance of the services that are not
included in the primary healthcare network.

56
The social security organization (SSO) Scheme provides additional health care benefits
including retirement pensions, benefits for disabled, survivors, work-injured, marriage grant,
unemployment maternity, and other benefits.
Public Health Care system:
At the national level, the Ministry of Health exercises policy making, governance, planning,
steering and financing of the healthcare programs. At provincial level, the Universities of
Medical Sciences and Health Services (UMSHS) are the significant institutes. Other than this,
the peripheral units such as health houses and rural health centers present within the premises
of medical science universities offer free of charge health services.
The private healthcare system is mostly concentrated in the allopathic system of medicine.
There are many non-government organizations (NGOs) and charities providing healthcare
services at subsidized rates. There are also NGOs operated and funded by the government
such as Imam Khomeini Relief Committee (IKRF) or Committee Emdad which are large
government organizations working for welfare and relief of people in need.
3.6.1.9 Israel:
The National Health Insurance (NHI) Law, 1995 ensures medical insurance for every citizen of
Israel with the help of Health Maintenance Organizations (HMO). The HMOs are funded by an
income-based, progressive health tax. The government further distributes the collected NHI
funds to the Israeli citizens thus, providing healthcare services. The National Health Basket
Committee under the National Health Insurance Law includes all the services, supplies,
medications, and equipment’s that the insured is entitled to receiving.
The National Health Insurance (NHI) law was established based on the following principles:
 Application to residents: this states that every Israeli resident is entitle to all the health
services under this law
 Provision of service is not connected to the ability to pay: according to NHI law, the
residents can pay for the health insurance according to their means. The treatment
provided is irrespective of the amount paid by the citizen. The state is responsible for the
funding, while the health fund in which the citizen is insured is responsible for providing

57
the service.
 Choice of a fund without limitations
 Other provisions include maintaining dignity and privacy, freedom to switch health funds,
selection of service provider, authority to compliant in case of any issue and application
to the court in which the citizen is entitled to claim an application to the Regional Labor
Court.
3.6.1.10 Cyprus
Around 80% of the population has access to free of charge public healthcare that is state-
financed, while others rely on the private healthcare sector. Ministry of Health centrally procure
the Medical devices that are funded by the state via tender and further supply them through the
public sector. Other products are supplied by private sectors, abiding by the Ministry of Health
regulations.
3.6.1.11 Turkey
Social Security Institution (SGK) establishes reimbursement schemes with a settled

reimbursement price for all medical devices. An application by all medical devices must be
made to SGK for reimbursement. The reimbursed price depends on the tender price of the state
hospital. The SGK considers the lowest tender prices of the state hospital from the last year.
The class of the device is also considered for the reimbursement price. If a similar product is
already present in the market, the reimbursement margin of that product is set for the product in
question.
3.6.1.12 Lebanon
Reimbursement of medical devices is handled by National Social Security Fund (NSSF)

providing insurance coverage for sickness, maternity care, family allowances, work related
accidents and a few other segments. The major providers of for-profit services are private
hospitals, healthcare centers, clinics and many others. the non-profit organizations include
majorly non-government healthcare centers, nursing homes and rehabilitations institutes.

58
Chapter 4 Middle East Medical Devices Market: Product Estimates & Trend
Analysis
FIG. 16 Middle East medical device market: Product outlook key takeaways
8,000.0
7,000.0
6,000.0
5,000.0
4,000.0
3,000.0
2,000.0
1,000.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
In Vitro Diagnostics(IVD) Cardiology Orthopedics
Diagnostic imaging Ophthalmic General and plastic surgery
Drug delivery Endoscopy Dental
Wound management Diabetic care Nephrology
Ear, Nose and Throat General hospital and Healthcare Neurology
Skin Care & Aesthetics Others
59

FIG. 17 Middle East medical devices market: Product outlook key takeaways
• Market growth from $3,522mn • Market growth from $545.5mn

In-vitro diagnostics • Market growth from $589.7mn
in 2016 to $5,334mn in 2025 Nephrology in 2016 to $1,080mn in 2025
(IVD)
• CAGR 4.7% from 2017 - 2025 Drug Delivery in 2016 to $957.9mn in 2025
• CAGR 7.9% from 2017 - 2025
• CAGR 5.6% from 2017 - 2025
• Market growth from $1,666.7

• Market growth from $286.3mn
Cardiovascular
mn in 2016 to $2,950.7mn in Ear, Nose and in 2016 to $604.3mn in 2025
2025 • Market growth from $1,030.3 Throat (ENT)
mn in 2016 to $1,746.2 mn in • CAGR 8.6% from 2017 - 2025
• CAGR 6.6% from 2017 - 2025 Endoscopy 2025
• CAGR 6.1% from 2017 - 2025
Orthopedic
mn in 2016 to $1,654.9 mn in General hospital in 2016 to $380.2mn in 2025
2025 and healthcare • CAGR 3.6% from 2017 - 2025
• CAGR 4.9% from 2017 - 2025 • Market growth from $476.3
mn in 2016 to $793.8 mn in
Dental 2025
• Market growth from $1,011.7 • CAGR 5.9% from 2017 - 2025
mn in 2016 to $1,450.9 mn in
Diagnostic imaging 2025 Neurology in 2016 to $963.8mn in 2025
• CAGR 14.2% from 2017 - 2025
• CAGR 4.1% from 2017 - 2025
• Market growth from $494.3 mn
Wound care in 2016 to $888.9 mn in 2025
• Market growth from $830mn in management • CAGR 6.8% from 2017 - 2025 • Market growth from $532mn in
Ophthalmic 2016 to $1,350.4 mn in 2025
Skin Care & 2016 to $1,196.6mn in 2025
• CAGR 5.6% from 2017 - 2025 Aesthetics • CAGR 9.4% from 2017 - 2025

• Market growth from
• Market growth from $636 mn in mn in 2016 to $2,353.0 mn in
General and plastic Diabetes 2025 $5,070.3mn in 2016 to
surgery
2016 to $1,180 mn in 2025 Others $6,800.0mn in 2025
• CAGR 7.1% from 2017 - 2025 • CAGR 7.0% from 2017 - 2025
• CAGR 3.3% from 2017 - 2025
60

4.1 Middle East medical devices market: Product movement analysis
The Middle East medical market, based on the products, is

In-vitro segmented into in-vitro diagnostics, cardiovascular, orthopaedic,
diagnostics
opthalmic and others. In-vitro diagnostics (IVD) held lucrative share
spearheaded the
product segment in 2016. This segment is inclusive of a wide range of devices used
in 2016. to conduct tests on urine, blood and tissues samples to detect,
diagnose and prevent any form of disease condition. Neurology
devices are anticipated to gain significant market share over the forecast period. Introduction of
technological advanced products is likely to help this segment’s growth.
4.1.1 In-Vitro Diagnostics(IVDs)
IVDs include devices and accessories which are used to conduct tests on urine, blood and
tissues samples to detect, diagnose and prevent any form of disease condition. IVDs have large
market potential in the Middle East despite the presence of many market players. This is due to
increasing growth rate and healthcare spending which is anticipated to positively impact the
Middle East market over the forecast period. The sedentary lifestyle in Middle East due to
higher income thus, increasing intake of convenient food with high levels of sugar and capacity
to buy a self-owned car resulting in reduced exercise are increasing the prevalence of western
diseases such as diabetes thus, resulting in higher demand for IVDs. The other trends include
rising incidence of chronic diseases along with aging populations which generally demands
Point of Care (PoC) testing. The major market players for IVD in Middle East are Siemens
Healthcare, Roche Diagnostics, Becton Dickinson, Johnson and Johnson, Abbott Laboratories
and others. Saudi Arabia, Egypt, Turkey and United Arab Emirates (UAE) are anticipated to be
the major markets for IVDs in Middle East.
4.1.1.1 In-Vitro Diagnostics (IVDs) market, 2014–2025 (USD Million)
The in-vitro diagnostics (IVDs) was valued at USD 3,522 million in 2016 and is expected to grow
at a CAGR of 4.7% during the forecast period, to reach an expected value of USD 5,334 million
in 2025.
61

FIG. 18 In-Vitro Diagnostics (IVDs) market, 2014 – 2025 (USD Million)
6,000.0
5,000.0
5,334.0
5,086.8
4,852.9
4,631.0
4,421.6
4,000.0
4,223.2
4,034.7
3,855.6
3,685.0
3,522.0
3,353.2
3,000.0
3,234.5
2,000.0
1,000.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
4.1.2 Cardiovascular
Cardiovascular devices include wide range of medical devices and accessories which are used
to diagnose, treat, mitigate and prevent any heart related problems. Cardiovascular devices are
divided into the following types according to the Code of Federal Regulations, Title 21 of the
U.S. FDA:
• Cardiovascular Diagnostic Devices
• Cardiovascular Monitoring Devices
• Cardiovascular Prosthetic Devices
• Cardiovascular Surgical Devices
• Cardiovascular Therapeutic Devices
The key players in cardiovascular devices are Abbott Laboratories, Medtronic plc, Boston
Scientific Corporation, St. Jude Medical, and Cardinal Health in the Middle East market.

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4.1.2.1 Cardiovascular market, 2014–2025 (USD Million)
The cardiovascular market was valued at USD 1,666.7 million in 2016 and is expected to grow
at a CAGR of 6.6% during the forecast period, to reach an expected value of USD 2.950.7
million in 2025.
FIG. 19 Cardiovascular market, 2014 – 2025 (USD Million)
3,500.0
3,000.0
2,950.7
2,765.1
2,500.0
2,592.3
2,431.3
2,281.3
2,000.0
2,141.4
2,010.9
1,888.7
1,774.1
1,500.0
1,666.7
1,559.6
1,478.3
1,000.0
500.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
4.1.3 Orthopaedi cs
Orthopedic medical devices include wide range of products for reducing pain, restoring mobility
and improving the quality of life of patients worldwide. The orthopedic device list includes:
Cervical & Lumbar Plates, Facet, Pedicel and Bone Screw Systems, Hip Stems, System
Implants, Wrist Plates and many more. There are various system additions to this range
including robotics, Computer Navigated Devices and 3D Printing that adds value to the
healthcare industry. The orthopedic medical device market constituted about 11.0% of the
global medical device market in 2016. Factors such as aging population, rising prevalence of
osteoarthritis and osteoporosis along with the rising demand for minimally invasive surgery,
increasing incidence of sports injuries and accidents and development of robotics is likely to
drive the growth of orthopedic devices in Middle East.

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4.1.3.1 Orthopedics market, 2014–2025 (USD Million)
The orthopedics market was valued at USD 1,074.5 million in 2016 and is expected to grow at a
CAGR of 4.9% during the forecast period, to reach an expected value of USD 1,654.9 million in
2025
FIG. 20 Orthopaedics market, 2014 – 2025 (USD Million)
1,800.0
1,600.0
1,654.9
1,576.2
1,400.0
1,500.9
1,429.7
1,362.4
1,200.0
1,298.6
1,238.3
1,180.8
1,126.6
1,000.0
1,074.5
1,020.7
982.4
800.0
600.0
400.0
200.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
4.1.4 Diagnostic imaging
Imaging is a technique used to create visual representation of the internal body to analyze any
medical intervention. According to the WHO, diagnostic imaging includes medical imaging,
imaging modalities and medical radiation exposure with professionals including radiologists,
sonographers, physicist and engineers. The devices image the human body for diagnostic and
treatment purposes thus, playing an important role in improving public health. In June 2017 at
the 4th Annual World Congress of Thoracic Imaging (WCTI), Konica Minolta Healthcare
showcased advancements in Dynamic Chest Radiography which is their under-development
technology. Recently Philips announced their molecular imaging solutions at the Society of
Nuclear Medicine and Molecular Imaging (SNMMI), 2017 annual meeting which highlighted
Philips’ commitment to innovation and personalized care. Philips made a lasting impact by
providing innovations such as Time-of-Flight PET and digital PET/CT thus, adding value to

64
healthcare industry in Middle East.
4.1.4.1 Diagnostic imaging market, 2014–2025 (USD Million)
The diagnostic imaging market was valued at USD 1,011.7 million in 2016 and is expected to
grow at a CAGR of 4.1% during the forecast period, to reach an expected value of USD 1,450.9
million in 2025.
FIG. 21 Diagnostic imaging market, 2014 – 2025 (USD Million)
1,600.0
1,400.0
1,450.9
1,396.6
1,343.0
1,200.0
1,291.0
1,241.2
1,192.4
1,145.1
1,099.2
1,000.0
1,055.0
1,011.7
965.8
933.6
800.0
600.0
400.0
200.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
4.1.5 Ophthalmic
Ophthalmic medical devices encompass a wide range of surgical devices including glasses,
contact lenses, implants, intraocular lenses, diagnostics, solutions, lasers, and surgical
instruments used for treatment, diagnosis, prevention and mitigation of any retinal diseases
including glaucoma and vision-impairing afflictions. Increasing awareness, rising retinal health
conditions, advancements in technology and increasing healthcare expenditure are few driving
factors for the growth of ophthalmic devices in Middle East. Increasing geriatric population is a
key driver influencing the ophthalmic device market in Middle East as they are most susceptible
to developing eye related problems like glaucoma, dry eye and many other disorders. Johnson

65
& Johnson, Abbott Medical Optics Inc, and Ziemer Ophthalmic System are a few market players
in ophthalmic devices in Middle East.
4.1.5.1 Ophthalmic market, 2014–2025 (USD Million)
The ophthalmic market was valued at USD 830.2 million in 2016 and is expected to grow at a
2025.
FIG. 22 Ophthalmic market, 2014 – 2025 (USD Million)
1,600.0
1,400.0
1,350.4
1,200.0
1,277.5
1,208.5
1,143.8
1,000.0
1,083.1
1,026.2
973.3
922.9
800.0
875.2
830.2
784.6
751.3
600.0
400.0
200.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
4.1.6 General and plastic surgery
General surgery includes knowledge related to anatomy, physiology, immunology, metabolism,

nutrition, pathology, shock and resuscitation, wound healing, intensive care, and neoplasia.
Plastic surgery devices include a wide range of surgical devices and accessories for
reconstruction, alteration or restoration of the body by cosmetic/aesthetic surgery, craniofacial
surgery, hand surgery, treatment of burns and microsurgery. Middle East is a booming market
for general and plastic surgery due to increasing awareness, increasing healthcare expenditure,
lifestyle changes and increasing amount of disposable income. Non-invasive cosmetic surgeries
which reduce the sign of ageing, Botox, dermal fillers and laser are a few surgeries majorly
conducted in Middle East. Stem cells used for rejuvenation treatment is estimated to be the

66
latest technology which is soon anticipated to gain popularity in Middle East. UAE is the hub of
general and surgical treatments with Dubai contributing majorly to this market.
4.1.6.1 General and plastic surgery market, 2014–2025 (USD Million)
The general and plastic surgery market was valued at USD 636.4 million in 2016 and is
expected to grow at a CAGR of 7.1% during the forecast period, to reach an expected value of
USD 1,179.5 million in 2025.
FIG. 23 General and plastic surgery market, 2014 – 2025 (USD Million)
1,400.0
1,200.0
1,179.5
1,100.5
1,000.0
1,027.1
958.2
894.9
800.0
835.4
780.6
728.9
681.1
600.0
636.4
591.8
557.9
400.0
200.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
4.1.7 Drug Deli very
The other segment includes patient positioning devices lifting slings, hoop-shaped mobility aids,
electric motor vehicles, and wearable robotic exoskeletons, which aid in mobility of patients.
Medical slings are used to transfer users or amputees from a bed to a wheelchair, shower chair,
or toilet, or from the floor to the bed. Medical lifting slings are of various types such as nylon,
padded, mesh, canvas, cotton, and polypropylene. The other segment is expected to witness
positive linear growth over the forecast period.
Patient positioning devices are used during robotic, gynecological, urological, laparoscopic, and
other surgeries. These devices assist in patient positioning in

67
operating rooms and protect against complications such as nerve damage and pressure ulcers.
The products include foam positioner, positioning straps, and gel positioners.
4.1.7.1 Drug Delivery market, 2014–2025 (USD Million)
The drug delivery market was valued at USD 589.7 million in 2016 and is expected to grow at a
CAGR of 5.6% during the forecast period, to reach an expected value of USD 957.9 million in
2025.
FIG. 24 Drug Delivery market, 2014 – 2025 (USD Million)
1,200.0
1,000.0
957.9
906.1
800.0
857.6
811.4
768.8
728.3
690.8
600.0
655.0
621.7
589.7
557.8
534.2
400.0
200.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
4.1.8 Endoscopy
Endoscopy devices are minimally invasive diagnostic instruments used to examine interior
surfaces of the body. It comprises of a wide range of products including flexible and rigid
endoscopes, capsule endoscopes, endoscopy fluid management systems, endoscopic
reprocessors, endoscopy visualization systems and other aids which has tremendous potential
in the Middle east market. Ageing population, growing preference for minimally invasive surgery,
increasing rate of surgical operations, anatomical observations and internal diagnosis are the
factors increasing the demand of endoscopy devices in Middle East. Increasing incidence of
chronic diseases such as cancer, gastrointestinal diseases and other diseases related to

68
obesity and lifestyle related factors majorly contribute to the increasing demand for endoscopy
devices in Middle East. Improvement in diagnosis and visualization technology, along with
higher awareness of advantages among medical professionals, is also driving the growth of
endoscopy devices in Middle East.
4.1.8.1 Endoscopy market, 2014–2025 (USD Million)
The endoscopy devices market was valued at USD 1,030.3 million in 2016 and is expected to
million in 2025.
FIG. 25 Endoscopy market, 2014 – 2025 (USD Million)
2,000.0
1,800.0
1,746.2
1,600.0
1,643.8
1,548.2
1,400.0
1,458.9
1,375.4
1,200.0
1,297.3
1,224.3
1,155.6
1,000.0
1,091.0
1,030.3
969.1
923.3
800.0
600.0
400.0
200.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
4.1.9 Dental
Dental devices are tools used to examine, treat, manipulate, remove and restore teeth and
surrounding oral tissues. These instruments include retractors, headpieces, mirrors, probes,
burs, periodontal scalers, orthodontic instruments and many more. Dental devices have
tremendous opportunities in the Middle Eastern market. Some factors attributing to this growth
are increasing economic growth, increasing tourism in Middle East, increasing geriatric
population, rising demand for cosmetic surgery, increasing number of dental clinics and

69
practitioners providing tremendous of dental care. Products for sleep apnea such as mandibular
advancement devices and combination continuous positive airway pressure (CPAP) /dental
sleep device therapy along with various minimally invasive devices are the recent innovations
contributing to increased demand for dental devices in Middle East.
4.1.9.1 Dental market, 2014–2025 (USD Million)
The dental market was valued at USD 476.3 million in 2016 and is expected to grow at a CAGR
of 5.9% during the forecast period, to reach an expected value of USD 793.8 million in 2025.
FIG. 26 Dental market, 2014 – 2025 (USD Million)
900.0
800.0
793.8
700.0
748.5
706.2
666.7
600.0
629.1
594.6
562.4
500.0
532.1
503.1
476.3
400.0
449.3
429.0
300.0
200.0
100.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
4.1.10 Wound care management
Wound care management devices are used to treat acute and chronic wounds. Traditional and
advanced wound care and closure products are analyzed under this segment. Advanced wound
care has emerged to be a standard solution for treating chronic wounds as they are expensive
to treat and take more time to heal. Middle East offers tremendous opportunities for wound care
management devices because of increasing funding, rising geriatric population, increasing
surgeries, impetus growth of disorders extensive technological advancements in advanced
wound care and closure, and growth and investment opportunities. Middle East is anticipated to
witness highest growth in wound care management devices. Baxter International Inc. and Smith

70
& Nephew are among the prominent players in wound care management devices in Middle
East.
4.1.10.1 Wound care management market, 2014–2025 (USD Million)
The wound care management market was valued at USD 494.3 million in 2016 and is expected
to grow at a CAGR of 6.8% during the forecast period, to reach an expected value of USD 888.9
million in 2025.
FIG. 27 Wound care management market, 2014 – 2025 (USD Million)
1,000.0
900.0
888.9
800.0
831.7
778.4
700.0
729.0
682.3
600.0
639.5
599.6
562.3
500.0
526.9
494.3
461.9
400.0
436.9
300.0
200.0
100.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
4.1.11 Diabetes
Diabetic devices include surgical devices and accessories which are used to diagnose, prevent,
treat and mitigate any form of diabetes related healthcare problems in patients. Insulin delivery
devices, diabetes control solutions and monitoring devices are the various segments under his
category. Current research comprises of implantable insulin pumps, disruption of fat
metabolism, artificial pancreas, invasive and non-invasive glucose sensors, new insulin delivery
systems including transdermal, inhaled, and implantable devices, insulin delivering pens,
conventional therapeutic approaches and bariatric surgery. Traditional approaches such as
herbal medications and acupuncture play a vital role in treatment and risk factors related to
obesity and diabetes. Tremendous patient pool suffering from diabetes, improving treatment

71
and diagnosis rates, increasing R&D expenses, new technology innovation and increasing
awareness are the major factors attributing for increasing demand for diabetic disorders in
Middle East.
4.1.11.1 Diabetes market, 2014–2025 (USD Million)
The diabetes devices market was valued at USD 1,285.1 million in 2016 and is expected to
million in 2025.
FIG. 28 Diabetes market, 2014 – 2025 (USD Million)
2,500.0
2,353.0
2,197.5
2,000.0
2,052.3
1,918.2
1,792.8
1,676.8
1,500.0
1,568.4
1,467.7
1,373.0
1,285.1
1,197.4
1,000.0
1,130.5
500.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
4.1.12 Nephrolog y
Nephology devices include surgical devices and accessories which are used to diagnose,
prevent, treat and mitigate any form of kidney related healthcare problems.
The World Nephrology Conference 2017, states that around 19.0% of the UAE population is
estimated to suffer from diabetes,17.0% from hypertension and 40.0% of these patients are
expected to develop some form of chronic kidney disease. 1 in 10 of the general population has
some degree of chronic kidney disease as per International Federation of Kidney
Foundation(IFKF). Rising occurrence of chronic kidney diseases, increasing healthcare
expenditure and growing geriatric population are few factors favoring the market growth of

72
nephrology devices in Middle East.
4.1.12.1 Nephrology market, 2014–2025 (USD Million)
The nephology devices market was valued at USD 545.5 million in 2016 and is expected to
million in 2025.
FIG. 29 Nephrology market, 2014 – 2025 (USD Million)
1,200.0
1,079.6
1,000.0
1,001.0
927.6
800.0
859.6
797.4
739.1
685.2
600.0
635.6
588.9
545.5
503.1
470.4
400.0
200.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
4.1.13 Ear, Nose and Throat (ENT)
ENT devices are equipment or accessories used for diagnosis, treatment, prevention or surgery
of any disorder related to ear, nose and throat thus, correcting any problems related to snoring,
hearing, smelling or speaking. They include endoscopes, hearing aids and implants, CO2
lasers, image-guided surgery systems and other devices. Middle East is a high potential market
for ENT devices due to various reason including increasing prevalence of chronic sinusitis,
rising geriatric population, increasing demand for minimally invasive ENT devices, increasing
number of market players and technological advancements. The growing demand for
instruments and techniques that are minimally invasive and highly accurate than various

73
conventional methods are the key market trends that are diving ENT devices market in Middle
East.
4.1.13.1 Ear, Nose and Throat (ENT) market, 2014–2025 (USD Million)
The ENT market was valued at USD 286.3 million in 2016 and is expected to grow at a CAGR

74
FIG. 30 Ear, Nose and Throat (ENT) market, 2014 – 2025 (USD Million)
700.0
600.0
604.3
556.9
500.0
513.1
472.6
400.0
435.3
400.7
368.8
300.0
339.2
311.8
286.3
261.6
242.0
200.0
100.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
4.1.14 General hospital and Healthcare
General hospitals are non-specialized hospital and healthcare providers, who treat patients with
all type of ailments and medical conditions. Growth is anticipated in this segment, though
considerably lower as compared to the other segments, which is driven by increasing population
and rising incidences of conventional diseases.
4.1.14.1 General hospital and Healthcare, 2014 –2025 (USD Million)
The general hospital and healthcare market was valued at USD 276.0 million in 2016 and is
expected to grow at a CAGR of 3.6% during the forecast period, to reach an expected value of
USD 380.2 million in 2025.

75
FIG. 31 General hospital and Healthcare, 2014 – 2025 (USD Million)
400.0
380.2
350.0
368.1
355.5
343.2
331.2
300.0
319.5
308.7
297.5
286.6
276.0
250.0
264.6
256.9
200.0
150.0
100.0
50.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
4.1.15 Neurology
Neurology devices include surgical devices and accessories which are used to diagnose and
treat any condition related to the central and peripheral nervous system. The factors driving the
demand for neurology devices in Middle East include neurological research and medicine
advancements, increasing availability of sophisticated equipment to monitor and track brain and
nerve activity to facilitate better diagnostics and treatments to patients. Other factors include
increasing incidence of neurological disorders such as epilepsy, Alzheimer’s, Parkinson’s and
other neurodegenerative disorders, availability of treatments for many disorders such as nerve
regeneration and repair and rising geriatric population. Interventional neurology devices include
non-surgical specialty of minimally invasive equipment for diagnosis and treatment of diseases
related to neck, brain and spine.
4.1.15.1 Neurology market, 2014–2025 (USD Million)
The neurology market was valued at USD 282.5 million in 2016 and is expected to grow at a

76
2025.
FIG. 32 Neurology market, 2014 – 2025 (USD Million)
1,200.0
1,000.0
963.8
800.0
858.9
762.2
674.4
600.0
593.5
520.0
400.0
452.3
390.8
334.0
282.5
200.0
233.9
192.8
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
4.1.16 Skin Care & Aesthetics
Medical aesthetic devices cater to body contouring, dermal tightening and resurfacing, acne
prevention, hair removal, reduction of skin pigmentation and blemishes and reduction of age
related dermal or vascular lesions. Facial and body contouring devices have a major share in
the market revenue of medical aesthetic devices in Middle East. This increasing demand is due
to beauty consciousness, rising awareness among consumers and product innovations
4.1.16.1 Skin C are & Aest h et ics , 2014 – 2025 ( U SD M illio n)
The skin care & aesthetics market was valued at USD 532.1 million in 2016 and is expected to
million in 2025.

77
FIG. 33 Skin Care & Aesthetics, 2014 – 2025 (USD Million)
1,400.0
1,200.0
1,196.6
1,097.0
1,000.0
1,005.2
920.6
800.0
842.4
770.3
703.7
600.0
642.0
585.0
532.1
400.0
480.8
439.6
200.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
4.1.17 Others
Other device segments include devices used for respiratory care, gynecology stem cell therapy,
tissue engineering, urogenital and other untapped segments. Respiratory devices include
airway management and therapeutic devices such as tracheostomy tubes, arterial blood gas
systems, lung expansion products, bronchial hygiene, active nebulization and humidification
systems, closed and open suction catheters, and many more.
4.1.17.1 Others market, 2014–2025 (USD Million)
The others market was valued at USD 5,070.3 million in 2016 and is expected to grow at a
2025.

78
FIG. 34 Others market, 2014 – 2025 (USD Million)
8,000.0
7,000.0
6,800.0
6,000.0
6,368.9
6,349.9
6,143.4
5,945.4
5,756.3
5,574.9
5,000.0
5,400.1
5,232.2
5,070.3
4,894.8
4,789.1
4,000.0
3,000.0
2,000.0
1,000.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025

79
Chapter 5 Middle East Medical Devices Market: U.S. FDA Classification

Estimates & Trend Analysis
FIG. 35 Middle East medical devices market: FDA Classification outlook key takeaways
Key site segments Key segment trends
25,000.0
$5,508.4 mn in 2016 to
Class I $8,487.9 mn in 2025
20,000.0
• CAGR 4.9% from 2017
- 2025
15,000.0
• Market growth from 10,000.0

$12,528.8 mn in 2016
Class II to $20,771.7 mn in
2025
• CAGR 5.8% from 2017 5,000.0
- 2025
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025

$1,572.8 mn in 2016 to
Class III $2,425.1 mn in 2025
• CAGR 4.9% from 2017 Class I Class II Class III
- 2025
80

5.1 Middle East Medical Devices market: U.S. FDA classification movement analysis
Class II The Middle East medical devices market, based on the U.S. FDA
spearheaded the classification, is segmented into Class I, II and III. Class II held
product segment lucrative share in 2016. This is attributed to the technological
in 2016.
adavcenments and innovations to cater to the unmet needs.
FIG. 36 Middle East medical device market: U.S. FDA classification movement analysis
High
2016 5,508.4 12,528.8 1,572.8 Class II: Share growth by 1.7%

Medium
Low
Low
2025 8,487.9 20,771.7 2,425.1
Class III: Share decline by 0.4%
Medium
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Class I: Share decline by 1.3%
Class I Class II Class III High
Source: WHO, U.S. CDC, FDA, NIH Journals, Investor Presentations, Primary Interviews, Grand View Research
81

5.1.1 Class I devi ces (general controls)
According to the U.S. FDA, medical devices that poses minimal harm to the patients and are
simpler in design, are included under the class I category. Class I devices are low on risk and
hence, are subjected to least regulatory controls. The products under this category are
subjected to general regulatory controls and are with or without exemptions. Most of the class I
devices are expected to abide by the good manufacturing practices and FDA notification
regulations. Examples include enema kits and elastic bandages. 47.0% of medical devices fall
under Class I category out of which 95.0% are exempted from the regulatory processes.
The U.S. FDA released a list of class I devices in April 2017, which are exempted from the
premarket notification requirement 510(k)*, including enzyme controls, tonometer’s,
parallelometers, irrigating dental syringes, finger cots, and protective restraints for patients.
Class I devices are divided into sterile devices and measuring devices. Class I sterile device
manufactures must implement ISO 13485, certification and GMP controls. All class I devices
can affix CE Mark by self-declaration. Examples of class I measuring device are: body
temperature measuring non-active device, pacifier including a non-active temperature display,
non-invasive and non-active device for measuring blood pressure and intra-ocular pressure,
volume or flow of liquid or gases removed from or delivered to the human body, liquid delivering
devices such as medicine spoons, droppers, cups, without graduation or scale, physiological
parameters displaying devices including urine drainage bags without graduation or scale and
calipers for obesity, charts for eye-testing and others.
*Note: Section 510(k) of the Food, Drug and Cosmetic Act requires those device manufacturers
who must register to notify FDA their intent to market a medical device. This is known as
Premarket Notification (PMN) or 510(k).
5.1.1.1 Class I devices market, 2014–2025 (USD Million)
The class I devices market was valued at USD 5,508.4 million in 2016 and is expected to grow
at a CAGR of 4.9% during the forecast period, to reach an expected value of USD 8,487.9
million in 2025.
82

FIG. 37 Class I devices market, 2014 – 2025 (USD Million)
9,000.0
8,000.0
8,487.9
8,062.2
7,675.1
7,000.0
7,308.7
6,965.3
6,639.9
6,000.0
6,334.7
6,043.7
5,769.1
5,000.0
5,508.4
5,238.2
5,065.6
4,000.0
3,000.0
2,000.0
1,000.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
5.1.2 Class II devi ces (general & special controls)
This class includes higher risk devices which require greater regulatory controls as compared to
Class I devices to provide assurance of safety and effectiveness of the devices. General and
special control are implied to this class. These products are critical as compared to class I
devices and hence, self-declaration is illegal. QMS implementation and design review should be
verified along with clinical investigation documents and technical files. Before affixing CE mark,
conformity assessment by a Notified Body is mandatory. 43.0% of medical devices fall under
this category. Examples of Class II devices include powered wheelchairs, pregnancy test kits,
acupuncture needles, infusion pumps, air purifiers and surgical drapes, X-ray machines. Few of
the devices are exempted from the premarket notification. Special controls include mandatory
performance standards, special labeling requirements and post market surveillance.
5.1.2.1 Class II devices market, 2014–2025 (USD Million)
The class II market was valued at USD 12,528.8 million in 2016 and is expected to grow at a
CAGR of 5.8% during the forecast period, to reach an expected value of USD 20,771.7 million
in 2025.

83
FIG. 38 Class II devices market, 2014 – 2025 (USD Million)
25,000.0
20,000.0
20,771.7
19,597.8
18,501.0
17,475.5
16,515.2
15,000.0
15,616.3
14,773.7
13,979.7
13,233.3
12,528.8
11,817.3
10,000.0
11,294.4
5,000.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
5.1.3 Class III devices (general/special cont rols and premarket approval)
This class includes devices with the highest risk and hence, are subject to the highest level of
regulatory control. It is mandatory to get Class III devices approved by FDA before being
marketed. These devices usually support or sustain life, are implanted, or poses unreasonable
potential of risk of illness or injury. Examples of Class III devices include implantable
pacemakers, breast implants, replacement heart valves, implanted cerebral simulators, HIV
diagnostic tests, and endosseous implants, automated external defibrillators and various other
devices. 10.0% of medical devices fall under this category. These devices have intricate design
and have the strictest guidelines due to greatest risk possession. It is mandatory for Class III
medical devices to follow Class I & II guidelines along with pre-market approval by the FDA and
a scientific review of the device before marketing.
5.1.3.1 Class III devices market, 2014–2025 (USD Million)

84
The class III device market was valued at USD 1,572.8 million in 2016 and is expected to grow
at a CAGR of 4.9% during the forecast period, to reach an expected value of USD 2,425.1
million in 2025.
FIG. 39 Class III devices market, 2014 – 2025 (USD Million)
3,000.0
2,500.0
2,425.1
2,318.9
2,204.7
2,000.0
2,098.6
1,997.4
1,903.3
1,813.5
1,730.4
1,500.0
1,648.8
1,572.8
1,494.5
1,422.6
1,000.0
500.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025

85
Chapter 6 Middle East Medical Devices Market: End-use Estimates & Trend
Analysis
FIG. 40 Middle East medical devices market: End-use outlook key takeaways
Key site segments Key segment trends
• Market growth from $12,241 mn in 25,000.0

Hospitals 2016 to $19,926 mn in 2025
• CAGR 5.6% from 2017 - 2025
• Market growth from $2,875.2 mn

Clinics in 2016 to $4,823.9 mn in 2025 20,000.0
• CAGR 5.9% from 2017 - 2025
• Market growth from $1,044.2 mn

Laboratories in 2016 to $1,743.6 mn in 2025 15,000.0
• CAGR 5.9% from 2017 - 2025
• Market growth from $532.9 mn in

Blood banks 2016 to $719.7mn in 2025 10,000.0
• CAGR 3.4% from 2017 - 2025
• Market growth from $777mn in

Pharmacies 2016 to $1,100mn in 2025
• CAGR 4.0% from 2017 - 2025 5,000.0

Stand-alone clinics 2016 to $841mn in 2025
• CAGR 2.9% from 2017 - 2025 -
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
• Market growth from $1,089.0mn in
Dermatology clinics 2016 to $1,993.7 mn in 2025 Hospitals Clinics
and cosmetic centre • CAGR 7.0% from 2017 - 2025 Laboratories Blood Banks
Pharmacies Stand Alone Clinics
2016 to $537mn in 2025 Dermatology Clinics & Cosmetic Others
Others
• CAGR 3.3% from 2017 - 2025
86

6.1 End-use Movement Analysis & Market Share, 2014 & 2025
The Middle East medical devices market, based on the end-use, is

Hospitals segmented into hospitals, clinics, pharmacies and other segments.
spearheaded the
Hospitals held lucrative share in 2016. This is attributed to the large
product segment
in 2016. volume of patient vising hospitals across the globe for diagnosis
and treatment.
FIG. 41 Middle East medical devices market: End-user movement analysis
High
Dermatology Clinics & Cosmetic:
Share growth by 0.7%
Clinics: Share growth by 0.6%

532.9 650.4
2016 12,241.1 2,875.2 1,044.2 1,089.0
777.0
400.2
Medium
Hospitals: Share growth by 0.5%
Laboratories: Share growth by

0.2%
Low
719.7 841.3
2025 19,925.9 4,823.9 1,743.6 1,993.7
1,100.1 Low
536.7
Others: Share decline by 0.3%
0% 20% 40% 60% 80% 100% Blood banks: Share decline by 0.4%
Medium
Hospitals Clinics
Pharmacies: Share decline by 0.5%
Laboratories Blood Banks
Pharmacies Stand Alone Clinics
Dermatology Clinics & Cosmetic Others Stand alone clinics: Share decline by
0.7%
High
87

6.1.1 Hospitals:
The hospital segment is sub-divided into public and private market segments. The public
healthcare expenditure accounts for over 70.0% of the GCC region and the rest 30.0% is
accounted by the private segment. Saudi Arabia and UAE are the leading markets in the public-
private partnerships, owing to increasing number of international hospitals emerging over the
years. The government is offering financial incentives and infrastructure help such as support
offered by the Dubai Healthcare City thus, attracting private players to the healthcare sector.
Saudi Arabia and the UAE are the largest markets accounting for 80% and 77% of the total
number of hospitals and hospital beds, respectively. Saudi Arabia alone is equipped with 268
hospitals. The Joint Commission International (JCI) accreditation provides credibility to
international partnerships in the healthcare sector to boost medical tourism in the Middle East.
In 2016 budget, the Middle East government allocated USD 27.7 billion towards further
development of the sector. Rising geriatric population, increasing prevalence of lifestyle
associated diseases, focusing on mandatory health insurance and medical tourism, digital
transformation, innovative technologies and PPP are the key drivers for the growth of hospital
sector in Middle East, which further facilitates the medical devices market in this region.
6.1.1.1 Hospitals market, 2014–2025 (USD Million)
The hospitals market was valued at USD 12,241.1 million in 2016 and is expected to grow at a
CAGR of 5.6% during the forecast period, to reach an expected value of USD 19,925.9 million
in 2025.

88
FIG. 42 Hospitals market, 2014 – 2025 (USD Million)
25,000.0
20,000.0
19,925.9
18,838.4
17,820.0
16,865.9
15,000.0
15,971.4
15,132.5
14,345.2
13,602.7
12,902.1
12,241.1
11,569.2
10,000.0
11,080.7
5,000.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
6.1.2 Clinics
The medical device market has evolved eventually in the Middle Eastern countries due to vast
technological innovations. Steady economic recovery and healthcare infrastructure’s
development are contributing factors towards the growth of multiple clinics in the Middle East.
Rise of medical equipment costs and increased competition for qualified professionals caused
an increase in the overall amount charged by the hospitals and clinics. Dubai has around 202
clinics, including private clinics and polyclinics. Saudi Arabia has a total of 192 private clinics
with 73.0% of them present in Riyadh and Jeddah health regions only. Some government
agencies such as the National Guard and the Ministries of Education and Defense have their
own clinics. In Saudi Arabia, services such as vaccinations and basic medical care in remote
rural areas are delivered by mobile clinics.
6.1.2.1 Clinics market, 2014–2025 (USD Million)
The clinics market was valued at USD 2,875.2 million in 2016 and is expected to grow at a
2025.

89
FIG. 43 Clinics market, 2014 – 2025 (USD Million)
6,000.0
5,000.0
4,823.9
4,545.0
4,000.0
4,284.6
4,041.5
3,814.3
3,601.8
3,403.0
3,000.0 3,216.2
3,040.4
2,875.2
2,708.5
2,585.7
2,000.0
1,000.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
6.1.3 Laboratories
The Middle East has witnessed a steady growth over the past few years in the economic
segment. However, this economic growth has led to a decline in the overall health of the
population majorly due to the sedentary lifestyle and higher income. An increase in the intake of
convenient food with high levels of sugar and capacity to buy a self-owned car is resulting in
reduced physical exercise and are increasing the prevalence of western diseases such as
diabetes, obesity and cardiovascular diseases. All these factors, along with advancements in
technology and increasing healthcare expenditure have resulted in an increasing need for
laboratories in the Middle East market for appropriate and timely diagnosis of the diseases,
hence resulting in driving the demand for medical devices.
6.1.3.1 Laboratories market, 2014–2025 (USD Million)
The laboratories market was valued at USD 1,044.2 million in 2016 and is expected to grow at a
2025.

90
FIG. 44 Laboratories market, 2014 – 2025 (USD Million)
2,000.0
1,800.0
1,743.6
1,600.0
1,642.8
1,548.9
1,400.0
1,461.5
1,379.8
1,200.0
1,303.6
1,232.5
1,000.0 1,165.8
1,103.1
1,044.2
984.9
941.5
800.0
600.0
400.0
200.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
6.1.4 Blood Banks:
The transfusion of blood and blood products help save millions of lives such as patients
suffering from thalassemia, during and post-operation blood loss, blood loss after an accident
and many other reasons. However, transfusion of infectious and noncompatible blood is the
biggest threat during transfusion. Catering to this issue, in September 2016, at the 34th
International Conference of International Society for Blood Transfusion (ISBT) in Dubai, Roche
Diagnostics gave a cutting-edge solution to the blood banks in the Middle East which is a high-
sensitivity blood screening solution to secure blood supplies. The risk of contaminated blood is
significantly reduced with the aid of these tools. The portfolio of Nucleic Acid Testing (NAT)
technologies and advanced serology screening, delivers reliability and workflow efficiency for
blood centers. The Dubai Blood Donation Center (DBDC) of the Dubai Health Authority is the
major and only blood bank of the UAE that provides a safe and adequate supply of blood.
6.1.4.1 Blood Banks market, 2014–2025 (USD Million)
The blood banks market was valued at USD 532.9 million in 2016 and is expected to grow at a

91
2025.
FIG. 45 Blood Banks market, 2014 – 2025 (USD Million)
800.0
700.0
719.7
695.8
672.8
650.6
600.0
629.3
608.7
588.8
569.6
551.0
500.0
532.9
513.3
500.9
400.0
300.0
200.0
100.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
6.1.5 Pharmacies
Pharmacy segment in the Middle East is rapidly advancing due to increasing population and
increasing healthcare expenditure. Wide range of medical devices are available at the
pharmacies. These include low risk devices such as first aid bandages, thermometers, syringes,
tongue depressors and gloves to higher risk device categories such as pregnancy related kits,
contraceptive devices, blood glucose monitoring systems, ophthalmic irrigation solutions and
many others. The prime legislation that regulates pharmacy in UAE is the UAE Federal Law
number 4 for Pharmaceutical Professions and Institutions.
6.1.5.1 Pharmacies market, 2014–2025 (USD Million)
The pharmacies market was valued at USD 777.0 million in 2016 and is expected to grow at a
2025.

92
FIG. 46 Pharmacies market, 2014 – 2025 (USD Million)
1,200.0
1,100.1
1,000.0
1,057.1
1,016.1
977.1
939.9
904.4
870.6
800.0
838.1
806.9
777.0
745.2
724.1
600.0
400.0
200.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
6.1.6 Stand- alone clinics
Stand-alone clinics have emerged over the past couple of years in the Middle East due to
increasing medical insurance coverage which entails the stand-alone clinics, increasing
healthcare expenditure, increasing geriatric population and other reasons. Initially there was a
lack of mature referral network between hospital based clinical laboratories and stand-alone
clinics. This gap has been filled by the stand-alone clinical laboratories which are operating
independently. Bourn Hall is the only stand-alone Fertility clinic in the Middle East to receive the
Joint Commission International (JCI) Accreditation.
6.1.6.1 Stand-alone clinics market, 2014–2025 (USD Million)
The stand-alone clinics market was valued at USD 650.4 million in 2016 and is expected to
grow at a CAGR of 2.9% during the forecast period, to reach an expected value of USD 841.3
million in 2025.

93
FIG. 47 Stand-alone clinics market, 2014 – 2025 (USD Million)
900.0
800.0
841.3
818.5
796.1
774.1
752.4
700.0
731.3
710.6
690.1
670.1
600.0
650.4
628.5
615.1
500.0
400.0
300.0
200.0
100.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
6.1.7 Dermatology clinics and cosmetic centre:
Dermatology clinics cater specifically to ailments and disorders of hair, nail and skin.
Cosmetology clinics offer beauty treatment services with an intention of enhancing the overall
aesthetic look. Skin conditions such as, eczema, rosacea cell carcinoma, psoriasis, acne,
pruritus, dermatitis, and others have resulted in the uptake of dermatology diagnostic devices in
the Middle East market. Rising demand for non-invasive dermatological and cosmeceutical
procedures along with increasing aesthetic awareness have accelerated the adoption of
dermatology and cosmetology centers in Middle East. In November 2016, 11th Global
Dermatologists Congress was organized at Dubai, UAE themed "Global Tuning of Innovative
Therapies" which touched upon various topics such as dermatological oncology, dermatological
diseases, pediatric dermatology, surgical dermatology, aesthetic and cosmetic dermatology,
technological innovation in dermatology, dermatopathology and clinical and medical
dermatology.
6.1.7.1 Dermatology clinics and cosmetic center market, 2014–2025 (USD

Million)

94
The dermatology clinics and cosmetic center market was valued at USD 1,089.0 million in 2016
and is expected to grow at a CAGR of 7.0% during the forecast period, to reach an expected
value of USD 1,993.7 million in 2025.
FIG. 48 Dermatology clinics and cosmetic centre market, 2014 – 2025 (USD Million)
2,500.0
2,000.0
1,993.7
1,861.0
1,738.0
1,500.0
1,623.9
1,518.0
1,419.6
1,328.2
1,242.9
1,163.3
1,000.0
1,089.0
1,015.5
959.5
500.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
6.1.8 Others:
The others market basically shall include nursing homes, home healthcare and other end-user
segments which are anticipated to have minimal effect on the Middle East medical device
market as compared to the aforementioned segments. Nursing homes can offer an extensive
care in a non-hospital setting. Home health monitoring platform utilize medical devices to treat
patients with severe chronic conditions from the comfort of their homes and communicate the
same information via electronic means to the respective healthcare practitioners
6.1.8.1 Others market, 2014–2025 (USD Million)
The others market was valued at USD 400.2 million in 2016 and is expected to grow at a CAGR

95
FIG. 49 Others market, 2014 – 2025 (USD Million)
600.0
536.7
500.0
520.3
504.2
488.4
472.9
457.8
443.0
400.0
428.4
414.2
400.2
384.9
375.0
300.0
200.0
100.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025

96
Chapter 7 Middle East Medical Device Market: Regional Estimates & Trend
Analysis
FIG. 50 Regional market place: Key takeaways
Saudi Arabia
Revenue in 2016: $ 4,924.1mn
Revenue in 2025: $ 8,158.8 mn
CAGR: 5.8%
ROMEA
Revenue in 2016: $10,719mn
Revenue in 2025: $15,770 mn
U.A.E. CAGR: 5.2%
Notable markets: Oman,
Revenue in 2016: $ 2,069.2mn Bahrain, Egypt, Iran, Iraq, Israel
Revenue in 2025: $ 4,990.3 mn Cyprus, Jordan, Turkey, Lebanon
CAGR: 8.8% Palestine.
Qatar Kuwait
Revenue in 2016: $ 410.8mn Revenue in 2016: $876 mn
Revenue in 2025: $ 1,314.9mn Revenue in 2025: $ 1,451.2mn
CAGR: 11.2% CAGR: 5.3%
97

7.1 Middle East medical devices market share by region, 2016 & 2025
Saudi Arabia dominated the Middle East medical devices market. However, Qatar region is
expected to grow at the fastest rate owing to rapid introduction of technologically advanced
systems during the forecast period. Qatar is expected to register the highest CAGR of 11.2%
during the forecast period. Large presence of untapped opportunities in emerging markets such
as Iraq and Oman and constantly improving infrastructure in these markets are some of the
attributes accounting for an increasing CAGR.
FIG. 51 Regional outlook, 2016 & 2025
High
Saudi Arabia: Share growth

1,314.9 U.A.E.: Share growth by 3.9%
by 0.6%
2025 8,158.8 15,770
4,990.3
1,451.2
Medium
Qatar: Share growth by 1.6%
Low
500.1
Low
2016 4,924.1 2,331.6 10,719
913.8
Kuwait: Share decline by 0.1%
Medium
0% 20% 40% 60% 80% 100%
Saudi Arabia UAE Qatar Kuwait ROMEA
High
98

7.2 Saudi Arabia
The Saudi Food and Drug Authority (SFDA) is the body that regulates medical devices and In-
vitro Diagnostics (IVDs) that are sold and distributed in Saudi Arabia. SFDA has launched this
marketing authorization program to safeguard public health with respect to medical devices. The
program comprises of two steps:
• To establish an overall profile of the medical devices currently in the Kingdom of Saudi
Arabia (KSA) market.
• Development, adoption and application of Medical Devices Interim Regulation to ensure

legal certainty that medical devices been authorized by one of the founding members of
the Global Harmonization Task Force (GHTF) have access to the KSA market.
Abiding by their rules, the manufacturers must receive Medical Device Marketing Authorization
(MDMA) before launching a product in the market. Prior approval in one of the following
reference markets is mandatory to register the device in Kingdom of Saudi Arabia (KSA),
namely: Australia, Europe, Canada, Japan, or the USA. The device classification in the
reference market will determine its classification by SFDA. A KSA authorized representative
(AR) must be appointed to manage the medical device registration in Saudi Arabia.
The Saudi Arabia market was valued at USD 4,924.1 million in 2016 and is expected to grow at
a CAGR of 5.8% during the forecast period, to reach an expected value of USD 8,158.8 million
in 2025.

99
FIG. 52 Saudi Arabia Medical Devices market, 2014 – 2025 (USD Million)
9,000.0
8,000.0
8,158.8
7,698.6
7,000.0
7,268.3
6,865.9
6,000.0
6,489.2
6,134.1
5,803.8
5,000.0
5,492.8
5,200.0
4,924.1
4,644.9
4,000.0
3,000.0
2,000.0
1,000.0
-
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
7.2.1 U. A.E.
U.A.E. healthcare market is observed to be one of the fastest growing markets worldwide. Being
an import driven market, they have an extremely stringent regulatory system at both Federal
and Emirate level. The World Health Organization (WHO) stated that one third of adults in the
U.A.E. are obese while one out of five people are diabetic. With an increase in incidences of
lifestyle diseases, U.A.E. residents with higher spending capacity demand greater quality of
healthcare. U.A.E. government recently launched a new health insurance program in Dubai
providing complete health insurance that will be tied to the issuance and renewal of their U.A.E.
residence visas. Although U.A.E. is a zero-tax country, the government is anticipated to
implement 5.0% value added tax (VAT) in 2018. The control and regulation of medical devices
in U.A.E. is supervised and directed by the Ministry of Health (MoH) – Registration and Drug
Control Department. These regulations are based upon EU, U.S. (FDA) and Australian TGA
regulations and the products must have EU, Australian, U.S. and Canadian approval to be
eligible for registration process in the U.A.E. GE Healthcare, Siemens Healthineers and Philips
Medical Systems are the leading players in this market. Orthopedic devices are anticipated to
witness highest growth in near future due to increasing geriatric population.
The U.A.E. Medical Devices market was valued at USD 2,331.6 million in 2016 and is expected

100
to grow at a CAGR of 8.8% during the forecast period, to reach an expected value of USD
4,990.3 million in 2025.
FIG. 53 U.A.E. Medical Devices market, 2014 – 2025 (USD Million)
6,000.0
5,000.0
4,990.3
4,592.8
4,000.0
4,225.9
3,887.3
3,574.6
3,000.0
3,288.1
3,021.1
2,773.6
2,544.2
2,000.0
2,331.6
2,125.8
1,000.0
-
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
7.2.2 Qatar
Medical Devices registration in Qatar is conducted by the Ministry of Economy and Commerce
(MEC). Post registration, an application request is sent to the Ministry of Municipal Affairs and
Agriculture (MMAA) to conduct inspection of the premises, as business activities cannot be
performed in certain prohibited areas. An import permit is mandatory, which is obtained by a
local authorized representative. Moreover, the devices must be authorized by one of the
founding members of Global Harmonization Task Force (GHTF) to obtain market access. The
devices must also require a Qatar MEC (Ministry of Economy and Commerce) Marketing
Authorization to facilitate distribution and sale of the devices within the country. Increasing
urbanization, expanding health insurance market, growing population, and tremendous
healthcare developments are the major trends responsible for increasing demand of medical
devices in Qatar.
The Qatar market was valued at USD 500.1 million in 2016 and is expected to grow at a CAGR
of 11.2% during the forecast period, to reach an expected value of USD 1,314.9 million in 2025.

101
FIG. 54 Qatar Medical Devices market, 2014 – 2025 (USD Million)
1,400.0
1,314.9
1,200.0
1,190.2
1,000.0
1,075.6
973.2
800.0
876.4
787.6
706.0
600.0
633.0
563.8
500.1
400.0
439.6
389.4
200.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
7.2.3 Kuw ait
Ministry of Health’s Department for Unclassified and Medical Devices regulate the medical and
in vitro diagnostic (IVD) devices in Kuwait. The country follows EU model of medical device
classification i.e. Classes I, IIa, IIb and III and requires an authorized representative to register
products within the country. Import of pre-owned medical devices is strictly prohibited into
Kuwait, as the public health institutions refrain from buying refurbished or used medical devices.
Kuwait is fully dependent on imports for medical devices, which is an advantage for the U.S.
suppliers. The European suppliers are gaining market share majorly due to their proximity and
high level of customer support perception.
The Kuwait market was valued at USD 913.8 million in 2016 and is expected to grow at a CAGR

102
FIG. 55 Kuwait Medical Devices market, 2014 – 2025 (USD Million)
1,600.0
1,400.0
1,451.2
1,376.0
1,305.5
1,200.0
1,239.3
1,174.5
1,116.2
1,000.0
1,061.3
1,009.4
960.3
800.0 913.8
864.4
830.4
600.0
400.0
200.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
7.2.4 Oman
Oman’s medical devices market is regulated by the Directorate General of Pharmaceutical

affairs/Ministry of Health (MoH). It is majorly dependent on import devices due to limited in-
house production. Licenses held by local importers are valid for a period of 5 years. Over the
past 30 years, Oman has created a modern hospital system by investing heavily in the
healthcare sector. Oman has no restrictions on the import of refurbished or used medical
devices, though the MOH does not purchase them. The Ministry of Health is the main buyer
ensuring safety, quality and efficacy of the devices. The increasing population and rising cost of
treatment are the primary factors aiding the growth of medical device market in Oman.
The Oman market was valued at USD 351.0 million in 2016 and is expected to grow at a CAGR

103
FIG. 56 Oman Medical Devices market, 2014 – 2025 (USD Million)
800.0
700.0
684.4
600.0
635.6
590.3
548.4
500.0
507.0
471.1
400.0
437.8
406.8
377.9
351.0
300.0
322.8
302.3
200.0
100.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
7.2.5 Bahrain
Fast growing economy and being one of the most advanced healthcare systems, the Kingdom
of Bahrain provides tremendous opportunities for medicinal products and devices. The country
follows EU model of medical device classification i.e. Classes I, IIa, IIb and III. Medical devices
in Bahrain are regulated by Pharmaceutical Product Regulatory Office (PPRO) of the National
Health Regulatory Authority (NHRA). Approval from NHRA is possible only if the medical
equipment complies with one of the international standards such as the U.S. FDA standards or
CE mark. The license to approval expires after 2 years.
The Bahrain market was valued at USD 184.3 million in 2016 and is expected to grow at a
2025.

104
FIG. 57 Bahrain Medical Devices market, 2014 – 2025 (USD Million)
350.0
300.0
301.0
284.8
250.0
269.6
255.4
242.0
229.5
200.0
217.8
206.7
194.1
184.3
174.4
150.0
167.2
100.0
50.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
7.2.6 Egypt
The Egyptian Ministry of Health (MOH) regulates the medical device market in Egypt by
standardizing and coordinating the registration, approval, import and manufacturing of medical
Devices within the country. This is done under the guidance of Drug Policy and Planning Center
(DPPC) and the Central Administration of Pharmaceutical
Affairs (CAPA). The DPPC sets and controls drug policy by setting strategic rules along with
regulating the import and manufacturing of medical devices and instruments within Egypt. A
separate committee is appointed to review the medical device before approving the import and
manufacturing of the devices within the country. The country follows EU model of medical
device classification i.e. Classes I, IIa, IIb and III. Import of pre-owned medical devices is strictly
banned without any prior approval of MoH.
The Egypt market was valued at USD 619.7 million in 2016 and is expected to grow at a CAGR

105
FIG. 58 Egypt Medical Devices market, 2014 – 2025 (USD Million)
1,200.0
1,000.0
1,007.6
953.3
902.5
800.0
852.2
807.7
765.9
726.6
687.4
600.0
652.6
619.7
586.2
560.2
400.0
200.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
7.2.7 Iran
The department of Medical Equipment within the Ministry of Health & Medical Education
(MOHME) is accountable for regulating imports of medical devices into Iran. The Central Office
for Medical Equipment (COME) is the prime regulatory authority for medical devices in Iran.
Though the private sector handles the actual importation and distribution of medical devices in
Iran, there are a few local productions for basic medical devices. Euro being the preferred
currency, few U.S. companies use their European subsidiaries for money retrieval from Iran. In
2016, a Final Rule amending the Iranian Transactions and Sanctions Regulations, 31 C.F.R.
Part 560 (ITSR) was issued by the U.S. Department of the Treasury’s Office of Foreign Assets
Control (OFAC) to broaden the scope of permissible exports of medical devices to Iran.
Importation of refurbished and used devices is strictly prohibited in Iran.
The Iran market was valued at USD 804.0 million in 2016 and is expected to grow at a CAGR of
4.6% during the forecast period, to reach an expected value of USD 1,204.0 million in 2025.

106
FIG. 59 Iran Medical Devices market, 2014 – 2025 (USD Million)
1,400.0
1,200.0
1,204.0
1,148.2
1,098.3
1,000.0
1,048.4
1,001.3
959.1
916.9
800.0
878.9
840.5
804.0
768.0
741.5
600.0
400.0
200.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
7.2.8 Iraq
Regulation and importation of medical equipment within Iraq is through an operational arm of
the Ministry of Health known as ‘KIMADIA’, which is the state company for marketing drugs and
medical appliances and is the only Iraqi company being specialized for importing, storing and
distributing medical equipment’s for all public healthcare facilities. The market relies majorly on
imports as there are neither any regulations on the import of devices nor are there any dealer
qualifications necessary for import. A pre-shipment inspection of all the medical devices
imported into the country is required and is done primarily by KIMADIA. In December 2016, the
Office of Foreign Asset Control (OFAC) sanctioned a revised general license to export medical
devices (under EAR99 category) to Iran, which was sent to the U.S. medical device
manufacturers and their overseas subsidiaries.
The Iraq market was valued at USD 570.7 million in 2016 and is expected to grow at a CAGR of
8.2% during the forecast period, to reach an expected value of USD 1,156.6 million in 2025.

107
FIG. 60 Iraq Medical Devices market, 2014 – 2025 (USD Million)
1,400.0
1,200.0
1,156.5
1,000.0
1,070.2
987.7
914.0
800.0
845.9
782.8
722.0
600.0
667.8
617.5
570.7
523.1
487.2
400.0
200.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
7.2.9 Israel
The Division of Medical Devices and Accessories regulates the medical device market in Israel,
under Israel’s Ministry of Health (IMOH) by the "AMAR" unit. AMAR unit certifies all the activities
with respect to import, sale and export of medical devices in Israel.
The manufacturer must hold an AMAR registration to import or sell a Medical Device in Israel.
Prior approval in one of the founding Global Harmonization Task Force (GHTF) countries
including Australia, Europe, Canada, the United States or Japan is mandatory for registration in
Israel. The IMOH recognizes European Union CE Mark and Food and Drug Administration
(FDA) certification and approves such products without any further requirement. Israel being a
powerhouse in medical innovation also is a leader in patents per capita of medical device. In
2017, BiPS Health won the Israeli innovation competition held at the Israel Export institute. The
featured product was a wearable medical device which is to be worn on the wrist which
constantly monitors the vitals such as blood pressure, heart and respiration rate and blood
oxygen saturation. This device is anticipated to improve patient care and shall detect the
deterioration in patient health hours before it occurs.
The Israel market was valued at USD 1,064.8 million in 2016 and is expected to grow at a

108
2025.
FIG. 61 Israel Medical Devices market, 2014 – 2025 (USD Million)
2,000.0
1,800.0
1,749.0
1,600.0
1,651.8
1,560.9
1,400.0
1,475.9
1,396.2
1,321.5
1,200.0
1,251.5
1,185.6
1,123.4
1,000.0
1,064.8
1,007.3
963.8
800.0
600.0
400.0
200.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
7.2.10 Cyprus
Market surveillance of medical devices in Cyprus is regulated by the Cyprus Medical Devices
Competent Authority (CyMDA). The CyMDA also collaborates with the Cyprus Customs
Authority and Department of Pharmaceutical Services of the Ministry of Health dealing with
borderline devices and devices containing pharmaceuticals. Devices that do not meet the
essential requirements of the country and are entering the Cyprus market without a CE mark
are confiscated by the Customs Authority. Cyprus currently does not have any domestic medical
device manufacturing firm and is majorly dependent on imports, 90.0% of which is from EU
countries.
The Cyprus market was valued at USD 190.2 million in 2016 and is expected to grow at a
2025.

109
FIG. 62 Cyprus Medical Devices market, 2014 – 2025 (USD Million)
300.0
269.3
250.0
257.8
249.8
239.3
229.3
222.3
200.0
213.2
206.7
198.3
190.2
183.6
177.8
150.0
100.0
50.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
7.2.11 Jordan
Jordan is a member of the Asian Harmonization Working Party (AHWP)and the regulation of
medical devices is performed by the Medical Devices Importation Regulations. The Jordan Food
and Drug Administration (JFDA) is responsible for the approval and registration of devices in
Jordan. Used or refurbished medical devices are prohibited within Jordan. The sales of medical
devices in Jordan may be hindered due to increased VAT on the devices, although keeping the
market growth positive supported by a steady economic recovery and healthcare infrastructure
developments. Jordan medical device market relies entirely on the imports with U.S. being the
most important suppliers with an import market share of approximately 30.0%.
The Jordan market was valued at USD 229.4 million in 2016 and is expected to grow at a
2025.

110
FIG. 63 Jordan Medical Devices market, 2014 – 2025 (USD Million)
400.0
380.2
350.0
359.7
337.7
300.0
319.9
303.2
285.1
250.0
270.5
256.7
241.6
200.0 229.4
215.2
206.3
150.0
100.0
50.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
7.2.12 Turke y
The General Directorate of Pharmaceuticals and Pharmacy Department of Medical Device

Services governs medical devices in Turkey. The Turkish Medical Devices Directive regulates
the devices by using the EU Medical Devices Directive (MDD) framework. The IMOH
recognizes European Union CE Mark and Food and Drug Administration (FDA) certification and
approves such products without any further requirement. Importation of refurbished and used
devices is strictly prohibited in Turkey. A local representative is not mandatory to register
medical device with the Ministry of Health within Turkey.
The Turkey market was valued at USD 2,482.6 million in 2016 and is expected to grow at a
2025.

111
FIG. 64 Turkey Medical Devices market, 2014 – 2025 (USD Million)
4,500.0
4,000.0
4,198.2
3,951.2
3,500.0
3,723.6
3,508.2
3,309.6
3,000.0
3,121.4
2,947.8
2,782.3
2,500.0
2,628.9
2,482.6
2,337.3
2,000.0
2,228.2
1,500.0
1,000.0
500.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
7.2.13 Lebanon
Lebanon offers tremendous opportunities for the medical device market. Demographic boost
caused due to influx of Syrian refugees, medical tourism, increasing incidence of chronic
diseases, private healthcare predominance, stronger market regulation and import reliance are
the important factors causing growth of medical device market. All Medical Devices must have a
CE certificate or FDA certificate before being placed in Lebanon market.
The Lebanon market was valued at USD 243.0 million in 2016 and is expected to grow at a
2025.

112
FIG. 65 Lebanon Medical Devices market, 2014 – 2025 (USD Million)
400.0
350.0
364.4
347.8
332.1
300.0
317.2
303.2
289.9
277.4
250.0
265.4
254.0
243.2
231.9
224.1
200.0
150.0
100.0
50.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025
7.2.14 Palestine
The medical devices regulation in Palestine is governed by the General Administration of

Pharmacy and the Drug Registration Department which lies under the Ministry of Health (MOH).
There are no regulations particularly required for the manufacture or sale of medical devices
within the country yet as the MOH has not yet approved any regulations. Hence, there is no
need for any product registration in Palestine. However, an import license is mandatory for all
medical devices. The country is based on the U.S. FDA regulations and classifies devices
based on European model of classification.
The Palestine market was valued at USD 179.7 million in 2016 and is expected to grow at a
2025.

113
FIG. 66 Palestine Medical Devices market, 2014 – 2025 (USD Million)
300.0
250.0
253.5
242.8
232.7
223.1
200.0
214.0
205.4
194.8
187.1
179.7
172.6
150.0
165.1
160.0
100.0
50.0
-
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025

114
Chapter 8 Competitive Landscape

8.1 Strategy framework
FIG. 67 Strategy framework
Product Launch
Product Portfolio Expansion
Collaborations
M&A
Low Medium High

Strategy Spearheads
Medtronic, Johnson & Johnson, Becton Dickinson, Abbot Laboratories,
Novartis, Olympus Corporation, General Electric Healthcare, Smith &
M&A Nephew
Siemens AG, Becton Dickinson, Baxter International, BioMérieux, Zimmer
Collaboration Biomet
Product Launch Johnson & Johnson, Becton Dickinson, Siemens AG, Novartis, BioMérieux
Siemens AG, Novartis, Johnson & Johnson, Olympus Corporation, General
Product Portfolio Expansion Electric Healthcare
Source: Investor Documents, Primary Interviews, Secondary Research, Grand View Research

115
TABLE 2 Market players overview

Financial
Regional
Company Name Overview Performance Key brands Market position
presence
(USD Million)
Fujifilm Founded in 13,644 in Digital imaging, North Established

1934 2015 computed America, Asia player
Radiography, Pacific, MEA,
Headquarters Mammography. Europe, Latin
13,789.20 in
at Japan America
2016
Hitachi Founded in 90,371.46 in MRI systems, North Established

1910 2015 ultrasound America, Asia player +
consoles and Pacific, MEA, Innovator
Headquarters 90,368.71 in transducers Europe, Latin
at Japan 2016 America
Merz Pharma Founded in 1,358.02 in Aesthetics, North Established

1908 2015 neurotoxins and America, Asia player
other regional Pacific, MEA,
Headquarters 1,280 in 2016 devices Europe, Latin
in Germany America
Nestle Founded in 93,330 in Comapt range, North Established

1905 2015 Enfit connectors America, Asia player
and others Pacific, MEA,
Headquarters 94,040 in Europe, Latin
in Switzerland 2016 America
Mecomed Founded in Non-profit Diagnostic Middle East Established

2007 organization imaging and and North player
trading. Africa
Headquarters
in U.A.E.
Qiagen N.V. Founded in 1,280 in 2015 Molecular North Established

1984 diagnostics, America, Asia player
1,337 in 2016 bioinformatics, Pacific, MEA,
Headquarters human ID and Europe, Latin
in Germany forensics America

116
ZELTIQ Aesthetic Founded in 255 in 2015 Coolsculpting North Innovators

(acquired by Allergan 2005 cryolipolysis America, Asia
plc, 2017) 354 in 2016 Pacific, MEA,
Headquarters Europe, Latin
in U.S. America
Thermo Fischer Founded in 16,965 in Laboratory North New Entrant

Scientific 2006 2015 equipment’s, America, Asia
analytical Pacific, MEA,
Headquarters 18,270 in instruments Europe, Latin
in U.S. 2016 America
3M Healthcare Founded in 30,274 in Electronic North Established

1902 2015 monitoring, America, Asia player +
avagard hygiene Pacific, MEA, Innovator
Headquarters 30,109 in range Europe, Latin
Alliance healthcare Founded in 473 in 2015 Surgical Europe, MEA, Established

Inc. 1997 instruments, alvita North Player
505.5 in 2016 range of patient America.
Headquarters care products
in UK
Criticare Technologies, Founded in - Vital sign devices, North Established

Inc. 1984 patient and America, Asia Player
respiratory Pacific, MEA,
Headquartered monitoring Europe, Latin
in U.S. devices America
Carestream Health Founded in - Digital North Innovators

2007 radiography America, Asia
devices, medical Pacific, MEA,
Headquartered printing products. Europe, Latin
in U.S. America
Dameca Founded in - Anesthesia North Established

1947 machines, America, Asia Player
OR/ICU Pacific, MEA,
Headquartered equipment’s, and Europe, Latin
in Denmark hospital ward America
supplies

117
Down Surgical Founded in - Surgical Asia Pacific, New Entrant

International 1999 instruments and MEA
related devices
Headquartered
in Pakistan
Novocure Founded in 33,087 in Oncology devices North Innovators

2000 2015 America, Asia
Pacific, MEA,
Headquartered 82,888 in Europe, Latin
Edwards life sciences Founded in 2,493.7 in Heart valves, North Established

1958 2015 Cardiac surgery America, Asia Players
technology, Pacific, MEA,
Headquartered 2,963.7 in Critical care Europe, Latin
in U.S. 2016 technology America
Ethox International, Founded in - minimally invasive North Innovators

Inc. 1966 devices, America, Asia
biotechnology, Pacific, MEA,
Headquartered cardio vascular, Europe, Latin
in U.S. and interventional America
products
Fonar Corporation Founded in 1,820,979 in Upright North Innovator

1988 2015 multiposition MRI America, Asia
1,276,882 in device Pacific, MEA,
Headquartered 2016 Europe, Latin
in U.S. America
Gebrüder Martin Founded in - Plastic surgery North Established

GmbH & Co. KG 1923 and neurosurgical America, Asia Player
products Pacific, MEA,
Headquartered Europe, Latin
in Germany America
Ginevri Tecnologie Headquartered - Incubators, North Established

Biomediche in Rome ventilators, America, Asia Player
phonotherapy Pacific, MEA,
devices Europe, Latin
America

118
Hart Enterprises, Inc. Founded in - Biopsy, spinal North Innovators

1976 needles America, Asia
Pacific, MEA,
in U.S. America
HeartSine Founded in - Automated North Established

Technologies, Inc. 1998 external America, Asia Player
defibrillators Pacific, MEA,
Headquartered (AEDs) Europe, Latin
in U.S. America
Innervision medical Founded in - Acoustic based North New Entrant

technologies, Inc. 2000 imaging systems, America, Asia
flash Ultrasound Pacific, MEA,
in Canada America
Invacare corporation Founded in 1,142 in 2015 Wheelchairs, North Established

1885 1,047 in 2016 walkers mobility America, Asia player +
scooters, Pacific, MEA, innovator
Headquartered respiratory Europe, Latin
in U.S. products. America
Japan lifeline Founded in - Cardiac rhythm North Established

1981 management, America, Asia player +
ablation, Pacific, MEA, innovator
Headquartered cardiovascular Europe, Latin
in Japan and vascular America
surgery devices
Karl Storz GmbH & Founded in - Rigid and flexible North Innovator
Co. KG 1945 endoscopic America, Asia
instruments Pacific, MEA,
Europe, Latin
America
Meditechlab Headquartered - Dialyzers, North New Entrant

in France hemofilters and America, Asia
hemoconcentrator Pacific, MEA,
Europe, Latin
America
Laboratory Founded in - Gamma, wipe North Established

technologies, Inc. 1983 counter and multi- America, Asia Player
wiper Pacific, MEA,
in U.S. America

119
Labtech Ltd Founded in - ECG systems, North Established

1990 resting and stress America, Asia Player
systems Pacific, MEA,
in Uk America
Leisegang medical Founded in - Colposcopes North Innovator

1947 America, Asia
Pacific, MEA,
Europe, Latin
America
Maxim integrated Founded in 583 in 2015 Wearable North Established

1983 devices, America, Asia Player
566 in 2016 diagnostics and Pacific, MEA,
Headquartered therapy imaging Europe, Latin
in U.S. America
Nihon Kohden Founded in 1445.30 in EEGs, ECGs, North Established

1951 2015 EMG measuring America, Asia player
systems and Pacific, MEA,
Headquartered 1487.71 in patient monitors Europe, Latin
in Japan 2016 America

120
8.2 Company Profiles
8.2.1 Medtronic
8.2.1.1 Company overview
Medtronic plc, is among the world’s largest medical

technology, services and solutions companies which
is involved in serving hospitals, physicians,
Key Statistics
clinicians and patients in approximately 160 Establishment year: 1949
countries worldwide. Adapting innovation and
Headquarters: Dublin, Ireland.
demonstrating market leadership, the company has
Employee strength: 88,000+
pioneered advances in medical technology in all
their businesses. The company primarily follows Market relevance: High
three strategies, namely:
 Therapy innovation
 Globalization
 Providing economic value
Medtronic plc acquired Covidien plc, a public limited company on January 26, 2015 resulting in
increased financial strength and flexibility.
The company currently has four operating segments, as mentioned below:
 Cardiac and Vascular Group
 Minimally invasive therapies group
 Restorative therapies group
 Diabetes group
Medtronic employs more than 500 individuals, with main operations in Saudi Arabia, United
Arab Emirates, Jordan, Algeria, Lebanon, Morocco, and Egypt, thus penetrating the Middle
Eastern and North African market.
121

8.2.1.2 Financial performance
Financial (USD Millions) 2013 2014 2015 2016 Key contributing factors
Net Sales 16,590.00 17,005.00 20,261.00 28,833.00 There is an increase in the net
sales by 42 percent possibly
R&D spending 1,557.00 1,477.00 1,640.00 2,224.00 due to the acquisition of
Covidien plc in 2015
Net earnings 3,467.00 3,065.00 2,675.00 3,538.00
40,000.00
35,000.00
30,000.00
25,000.00
20,000.00
15,000.00
10,000.00
5,000.00
0.00
2013 2014 2015 2016
Net Sales R&D spending Net earnings
8.2.1.3 Product benchmarking
Product Application/Features
Advanced surgical technology
1. Ablation Systems
Advanced surgical technology provides strong value proposition to
2. Electrosurgical Hardware
patients, hospitals & surgeons through haemostatic sealing of soft
3. Electrosurgical Instruments
tissue and bone, reduced blood loss and improved surgeon
4. Smoke Evacuation
visualization.
5. Ultrasonic Dissection
6. Vessel Sealing

122
 RF Ablation Catheters, Cryoablation Catheter, Diagnostic

Catheters, Temporary Pacing Leads, Transseptal Sheaths
and Needles and Cardiac CryoAblation System are the
Cardiac rhythm
products in the company’s portfolio.
1. Ablation products for Arrhythmias &
 iRF Ablation & Argon-powered Cryoablation are the surgical
Atrial Fibrillation
products for ablation.
2. Surgical products for Ablation
 Cardioinsight workstation and mapping vest, CRT-Ds,
3. Cardiac diagnosis and monitoring, resynchronization therapy-pacemakers, tools to personalize
implantable electronic device (CIED) CRT are a few products included under this category.
stabilization, mapping products &
 Aquamantys Bipolar Sealers, Monopolar Sealers,
Cardiac resynchronization therapy
PlasmaBlade Soft Tissue Dissection Devices are the
(CRT) systems
electrosurgical products at Medtronic.
4. Electrosurgical products
 Various ICDs and defibrillation leads are available to treat
5. Implantable Cardioverter Defibrillator patients with tachyarrhythmia.
(ICD) Systems
 The company offers wide range of pacemaker leads with
6. Pacing systems
proven results for bradycardia therapy.
7. Managing your patients
 Provides tools to connect the doctors with the patients to
ensure extensive post-implant care and supervision.
Diagnostic Catheter

123
 iRF Ablation, Argon-powered Cryoablation are surgical

products for ablation
 Aortic Stent Grafts, Thoracic Stent Grafts are the

Cardiovascular products which creates stronger outcomes for the
patients
1. Surgical products for Ablation
 The company has a variety of blood Processing and
2. Aortic stent grafts
diagnostic products being used for blood related
3. Blood management and diagnostics
diagnosis
4. Cannulae
 Adult and pediatric cannulae are available in the product
5. Cardiopulmonary products & portfolio
cardiothoracic products
 The company has a vast variety of products catering to
6. Coronary balloons, catheters & stents the cardiopulmonary category right from oxygenators,
heart lung machine and hemoconcentrators.
7. Electrosurgical products
 Integrity Coronary Stent System is an innovative product
8. Embolic protection system
which is a revolution in coronary stent engineering
9. Surgical and transcatheter heart offering a unique continuous sinusoidal wire design.
valves
 Aquamantys Bipolar & monopolar Sealers, PlasmaBlade
10. Interventional guidewires and
Soft Tissue Dissection Devices are the products under
accessories
electrosurgical products
11. Pediatric perfusion products
 Occlusion and aspiration system is available for
12. Revascularization products(surgical) providing embolic protection
 Products for treatment of severe aortic stenosis and

RVOT conduct dysfunction are available
 Tissue Stabilizers, Heart Positioners, Retractors,
OPCAB Accessories are highly efficient revascularization

products

124
 Carelink is a web based therapy software to track blood

Diabetes
glucose and sensor glucose levels
1. CareLink Personal Therapy and Pro
 It’s a monitoring system in which the sensors are
Therapy Management Software
inserted under the skin and glucose levels are measured
2. Guardian REAL-Time Continuous every 5 minutes 24 hours a day.
Glucose Monitoring System
 Wide variety of products including MiniMed pro-set,
3. Infusion Sets quick-set, silhouette, sureT and mio are available under
this product portfolio.
4. Insulin Pumps with Continuous
Monitors  Consists of a device which has an insulin pump with
built-in CGM technology
5. iPro®2 Professional CGM
 iPro@ CGM comes with a recorder, sensor and serter
which does continuous glucose monitoring.
 It uses innovative visualization technology which helps

detect GI abnormalities, monitor disease activity, and
assess treatment efficacy.
 Improves clinical workflow.

Digestive & gastrointestinal
 Enterra II is the product under this category which
1. Capsule Endoscopy Products
generate mild electrical pulses for gastric electrical
2. Endoscopic Ultrasound Products stimulation
3. Gastric Electrical Stimulation  Medtronic offers Barrx system which is designed to

Systems remove the Barretts epithelium thus offering an
4. Gastrointestinal Radiofrequency alternative to watchful waiting for patients with intestinal
Ablation Products metaplasia
5. Motility Testing Products  High resolution manometry systems are available in the
product portfolio
6. Reflux Testing Products
 Bravo reflux testing system helps optimize reflux patient
7. Sacral Neuromodulation Systems
management with advanced pH monitoring.
 Interstim II neurostimulator, interstim neurostimulator,

verify evaluation system are available under Sacral
Neuromodulation Systems

125
 NuVent EM Balloon Sinus Dilation System is a pre-

calibrated targeted system.
 Bioresorbable nasal and ear packaging are included

under the product portfolio
 Sophono sysem offers more sound amplification that any

magnetic transcutaneous system.
 Ent surgical navigation systems and accessories are

Ear, nose & throat
available under this product portfolio
1. ENT Catalog
 Medtronic offers an award-winning powered hand piece
2. Balloon Sinus Dilation Products that drives many of the blades and burs with 360 degree
3. Biomaterials, Nasal Packing & Ear cutting ability
Packing  NIM Nerve Monitoring Systems, NIM EMG Endotracheal
4. Bone Conductive Hearing Device Tubes, APS Electrode, Probes and Other Accessories,
Stim Bur are available in the product portfolio.
5. Image-Guided Surgery Products
 Powered ENT Instruments, Integrated Power Console
6. Inferior Turbinate Surgical Products
(IPC System), Straightshot M4 Microdebrider, Indigo &
7. Nerve Monitoring Products Visao High-Speed Otologic Drill, Midas Rex Legend
Stylus High-Speed Surgical Drills, Hydrodebrider
8. Powered ENT Instruments
Endoscopic Sinus Irrigation System are the products
9. Sleep-Disordered Breathing Products
available under this category.
10. Thyroid and Parathyroid Surgery
 AIRvance System for Obstructive Sleep Apnea,
Products
Straightshot Inferior Turbinate Blades & M4
11. Tonsil & Adenoid Removal Products Microdebrider are the variety of products available in the
product portfolio.
 NIM Nerve Monitoring Systems, EMG Endotracheal

Tubes & Accessories are available under this category
 PEAK PlasmaBlade TNA Dissection Device, Straightshot

PITA Tonsil and Adenoid Blades & M4 Microdebrider,
IPC System are provided by Medtronic under this
category.

126
 Aquamantys Bipolar & Monopolar Sealers, PlasmaBlade

Soft Tissue Dissection Devices are available in the
product portfolio
 Veriset patch is the only product available under this

category
General surgery
 Hand instruments and litigation devices consists of highly
1. Electrosurgical Products engineered minimally invasive products
2. Haemostasis  Recent innovations under this category include Relia

tack, symbotex, progrip etc thus expanding the frontiers
3. Hand Instruments & Ligation Devices
of hernia repair
4. Hernia Repair
 Radialux lighted retractors are cordless illumination
5. Lighted Retractors
devices for breasts and abdominal procedures
6. OR Accessories, Safety & Suction
 Medtronic offers complete line of products and
7. Patient Positioning & Preparation accessories to help patients and keep them safe in
operating room
8. Surgical Set-Up Kits & Stapling
 Devon is the product available under this category.
9. Trocars & Access Instruments
 Medtronic packages all the components required in
10. Wound Closure
surgical setup kits
 Accommodates all the laproscopic devices for ease of

utilization.
 Various types of sutures, wound closure accessories and

devices are available under this category.

127
 INVISx Cranial Fixation System & TiMesh Cranial Plating

System are the products available under this category
 Duet & Becker External Drainage and Monitoring

Systems and various other systems are available under
this category.
Neurological
 Active OC, SC & RC neurostimulators are offered by
1. Cranial Repair Products Medtronic under this category
2. Critical Care Products
 SynchroMed II system comes with a pump and catheter
3. Deep Brain Stimulation Systems which are implanted under the skin to deliver the
documented precision and trusted performance
4. Drug Infusion Systems for Chronic
Pain & Severe Spasticity  Pipeline flex embolization device, axium detachable coils
are offered by Medtronic under this category
5. Hemorrhagic Stroke Products
 Visualase MRI-Guided Laser Ablation utilizes light
6. Laser Ablation Technology
energy to necrotize soft tissues in different procedures.
7. Powered Surgical Instruments
 Various products catering to orthopedic, spinal, ENT and
8. Revascularization Devices for Acute cranial procedures are available.
Ischemic Stroke
 Solitaire & mindframe capture LP revascularization
9. Shunts
device are available in the product portfolio
10. Spinal Cord Neurostimulation
 Ares Antibiotic Impregnated Catheters and various Strata
Systems
systems are available under this category
11. Surgical Imaging & Navigation
 Restore Sensor, Ultra, Advanced & PrimeAdvanced
Systems
SureScan MRI neurostimulator are available.
 O-arm offers multiple image protocols at 50% lower dose

to the patients as compared to standard dose mode
 HealthStation surgical navigation system is available

under this category

128
 Various types of antimicrobial, alginate, hydrogels and

hydrocolloids are available under this category.
 Monoject transfer and collection devices are available for

collecting blood cultures.
 Endodontic needles and syringes, dental supplies are

Patient care available under this portfolio
1. Advanced Wound Care  Acute, chronic and peritoneal dialysis catheters are
designed for advanced renal patient care.
2. Blood & Specimen Collection
 Salem sump system and kangaroo nutritional delivery
3. Dental Care
portfolio are available under this category
4. Dialysis Catheters
 Personal protective equipment (PPE) are offered by
5. Enteral Feeding Medtronic under this category
6. Hazardous Drug Protection  Medtronic offers a full line of products to facilitate

7. Incontinence incontinence care
8. Medication Delivery  Monoject and Magellan are a few safety products

available under this category
9. Needles & Syringes
 1 mL Luer Lock syringe is available which provides a
10. Obstetric & Neonatal
secure connection that reduces risk of leakage and
11. Sharps Disposal splatter
12. Vascular Compression  Labor & Delivery, neonatal and maternity care products
are available under this category
 Wide range of sharps and waste containers are available

under this category
 A-V Impulse, Kendall SCD and T.E.D. anti-embolism

systems are available under this category.

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 BIS is the brain monitoring system featured by Medtronic

plc
 Microstream is the system which provides early warning

of respiratory compromise enabling capnography
Patient monitoring monitoring
1. Brain Monitoring  Various types of electrodes are available to cater to all

the clinical needs
2. Capnography Monitoring
 INVOS is the system featured under this category of
3. Cardiology Electrodes
Cerebral/Somatic Oximetry
4. Cerebral/Somatic Oximetry
 Vital sync system is used under this category
5. Health Informatics & Monitoring
 Nellcor, Microstream, INVOS and Bis systems are used
6. OEM Technology
for OEM monitoring solutions
7. Pulse Oximetry
 Nellcor system and its variants are available under this
8. Recording Chart Paper category
9. Temperature Management  Cardiology, kendall and digital imaging media papers are
available with consistent trace quality
10. Thermometry
 Mon-a-therm and warm touch thermometers are
available under this product portfolio
 Genius and Filac are the two systems featured under this
category by Medtronic
 Puritan Bennett is the trusted line of ventilation system
Respiratory which promotes more natural breathing
1. Acute Care Ventilation  Medtronic features TaperGuard Cuff technology which

exerts low pressure & impact on trachea
2. Intubation
 Consists of a variety of tip and valves styles for acute ad
3. Open Suction
long term care.
4. Portable Ventilation
 Newport portable ventilators are available to provide
5. Tracheostomy patients with life support.
6. Ventilator Filters  Standard & Puritan Bennett are the ventilator filters
available

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Spinal & orthopedic
1. Anterior Cervical Fusion Options

 Balloon kyphoplasty repair vertebral compression
2. Balloon Kyphoplasty
fractures
3. Bone Graft Options
 Midas system and spine shaver nucleus removal set are
4. Cervical Artificial Discs the tools featured by Medtronic
5. High-Speed Surgical Drills &
 Vertex Select Reconstruction System is featured by
Nucleus Removal Tools
Medtronic as reconstruction system
6. Laminoplasty Plate Fixation
 Products for sports related surgeries are available under
System
this product portfolio
7. Posterior Occipitocervical Upper-
 Kyphon V Premium Vertebroplasty is the sole product
Thoracic Reconstructive Systems
under this category
8. Sports Surgery
9. Tumor Management
10. Vertebroplasty
 NURO system is featured by Medtronic under this

Urological & urogynecological
category
1. Percutaneous Tibial Neuromodulation
System  Interstim and verify neurostimulator are the systems
under this category
2. Sacral Neuromodulation Systems
 Wide range of products addressing different types of
3. Urology Products
incontinence and meet a wide range of clinical needs
8.2.1.4 Strategic initiatives
 In January 2015, Medtronic plc successfully acquired Covidien plc, which marked a
significant milestone in the industry. The two companies bring together their extensive
and innovative capabilities for expanding access and improving clinical outcomes. The
acquisition resulted in a significant rise in the net sales of Medtronic in the year 2016
along with providing increased financial strength and flexibility.
 In February 2017, Medtronic announced a new professional development program named

as “Medtronic Impact” in Europe, Middle East and Africa regions to promote value-based
healthcare initiatives. This is anticipated to enable the firm to radically transform the design
and delivery training & education

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8.2.2 Johnson & Johnson
Johnson & Johnson is an American multinational

company engaged in R&D, manufacturing and
sales of a wide range of products in health care Key Statistics
field. The company is organized primarily in three
Establishment year: 1886
segments: consumer, pharmaceutical and medical
devices. Headquarters: New Brunswick,
New Jersey
J&J is present with more than 230 operating
Employee strength: 126,400
companies in over 60 counties, including the U.S.
The medical devices segment includes a wide Market relevance: High
range of products used in surgery, cardiovascular & orthopedic conditions, diabetes and vision
care. Their end users include nurses, hospitals eye care professionals, clinics and physicians.
To remain a market leader in healthcare, J&J strives to be a purpose driven organization and is
committed to developing global business leaders to achieve the objective.
It has been observed that the net
Net Sales 71,312.00 74,331.00 70,074.00 71,890.00 earning considerably increased
in 2016. This is believed to be a
result of the strategic
R&D expenses 8,183.00 8,494.00 9,046.00 9,095.00
acquisition of Abbott Medical
Optics, announced in
Net Earnings 13,831.00 16,323.00 15,409.00 16,540.00 September 2016.
120,000.00
100,000.00
80,000.00
60,000.00
40,000.00
20,000.00
0.00
2013 2014 2015 2016
Net Sales R&D expenses Net Earnings
Note: Conversion rate 1 CHF = 0.97 USD on 28th December 2016

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 Ethicon offers a variety of products to revolutionize surgery with minimal

invasion.
Surgery
 Offers advanced energy portfolio for open and laparoscopic procedures
1. Energy
 Endocutters along with full range surgical sapling option are provided
2. Endocutters
ensuring right solution for right procedures
3. Biosurgery
 Array of technologies to minimize intra and post-operative complications
4. Wound closure
 The wound closures help surgeons match specific need of healing tissue
to a specific device
 J&J offers advanced sterilization products to facilitate prevention of

healthcare associated infections
 J&J’s Acclarent business is dedicated to ENT segment delivering

Orthopedics, Cardiovascular
innovative technologies for more than a decade
Disease & Specialty
 Biosense Webster is a part of J&J family providing advanced diagnosis,
1. Infection Prevention
therapeutic and mapping tools for heart rhythm disorders
2. Ear Nose & Throat
 Codman Neuro and DePuy Synthes are the two companies catering to the
3. Arrhythmias orthopedic market
4. Orthopedics  Mentor Worldwide LLC, leading supplier of medical products for global
5. Breast Aesthetics market provides body and breast aesthetics.
6. Diabetes Care  Animas Corporation and LifeScan are a part of the J&J family catering to
the diabetic market. LifeScan is a company dedicated to improving quality
7. Vision Care
of life for the people through its OneTouch products
 ACUVUE company has repeatedly brought innovation and advancement

to the industry.
 In September 2016, J&J closed the USD 4.33 billion buyouts and acquired Abbott
Medical Optics from Abbott including its portfolio of ophthalmic products covering laser
refractive surgery, cataract surgery and consumer eye health. The total medical device
sales in 2016 was USD 25,119 million.
 In February 2017, J&J announced that they would continue the progress on

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reconstructing initiative in hospital medical device business to achieve USD 800.0

million-USD 1.0 billion by the end of 2018 as per the annual report, 2016
8.2.3 Siemens AG
The Siemens Group is a technology company,

which comprises of Siemens AG, a stock
corporation under Federal laws of Germany, as the
Key Statistics
parent company and its subsidiaries. The main
divisions of Siemens AG are power and gas, wind Establishment year: 1847
power and renewables, energy management, Headquarters: Munich,
Germany
building technologies, Mobility, Digital Factory,
Process Industries and Drives and Healthineers. Employee strength: 351,000
Over 12.0% of the company’s total sales is Market relevance: High
generated from the medical diagnostics equipment and health-care division. In June 2017,
Siemens Heathineers introduced a new type of 3D visualization i.e. cinematic rendering for
surgery which is a hyper realistic method to represent position of tumor tissue and blood
vessels which could be an important innovation in the history of medical devices.
An increase in revenue was
Revenue 82,780.59 81,061.75 85,236.45 89,756.80 observed, which is due to the
Income from continuing innovative technologies
operations 4,604.98 5,933.85 5,919.14 5,930.14 provided by Siemens
Healthineers (renamed in May
2016) to the entire heathcare
Net income 4,969.43 6,206.99 8,205.36 6,142.02 industry
120,000.00
100,000.00
80,000.00
60,000.00
40,000.00
20,000.00
0.00
2013 2014 2015 2016
Revenue Income from continuing operations Net income
Note: Conversion rate 1 Euro = 1.13 USD on 7th June 2017

134
 Artis interventional angiography, options and grades(Clinical Software

Applications and angiography system components), workplaces and
recording systems, cardiology, radiology, and surgical devices are
Medical imaging available under this product portfolio.
1. Angiography  Mobile c-arms set a benchmark with high precision, quality and operability
2. C-arms  Dual and single source CT scanner, clinical imaging solutions and options
and upgrades are available under this portfolio
3. Computed
Tomography  Remote and patient side controlled system are the products available
4. Fluoroscopy under this segment.
Equipment  Computed tomography, magnetic resonance and molecular imaging for
5. Imaging for radiation therapy along with software solutions are offered by Siemens
Radiation Therapy Heathineers under this category.
6. Magnetic  Magnetom MRI system is featured under this category providing
Resonance Imaging advanced human health.
7. Mammography  Various product ranges such as digital mammography to high definition

breast tomosynthesis are available with basic agenda to battle against
8. Molecular Imaging
breast cancer
9. Radiography
 Wide range of PET/CT products, pre-clinical imaging and others are
Systems
available under this category.
10. Robotic X-ray
 Digital, analogue, mobile X-ray devices are available under this category.
11. Ultrasound
 Twin robotic and robotic C-arm are available
Machines
 General imaging, cardiovascular, breast care, point if acre, elastography
12. Urology Equipment
and others are the range of products under this category.
 Dedicated systems such as X-ray and lithotripters are present for

applications such as TURP, PCNL and ESWL

135
Hearing aids
 Various systems such as Orion, Nitro, Siemens Life, Aquaris and Intuis
1. Receiver-in-canal are featured by siemens to facilitate profound hearing experience
(RIC), behind-the-
 Siemens Pockettio is a robust system, which helps correct hearing
ear (BTE), In-the-ear
impairment.
(ITE) hearing aids
2. Pocket hearing  A robust screw-on hook and baby-safe battery door are a few exclusive
instrument features in the instruments for kids and teens.
3. Instruments for kids  SecureEar system featured by Siemens has a robust elastic UV material
& teens to aid hearing.
4. Hearing protection  Echargers and batteries customized for Siemens hearing aids instruments
are available for trouble free hearing experience
5. Accessories
 Aptio automation and advanced robotic solution are featured under this
product portfolio
Laboratory Diagnosis
 ADVIA chemistry system is included under this category
1. Laboratory
 Viva drug testing system featured by Siemens Heathineers is available
automation
under this category
2. Clinical chemistry
 These systems give a first pass result for counting blood cells which is a
3. Drug testing fully automated process
solutions
 Atellica, Sysmex, Innovance and BFT II analyzer are the systems under
4. Hematology this product portfolio
5. Hemostasis  Advia and Immulite are the automated immunoassay platforms providing
6. Immunoassay comprehensive, disease-focused menu.
7. Infectious disease  Quadriga and BEP systems is available under this category
testing  Dimension EXL, Vista, Xpand and RxL systems are featured under this
8. Integrated chemistry category
9. Plasma proteins  Siemens provides a broad menu of dedicated plasma protein analyzer for
confident decision making
10. Urinalysis
 Clinitek system and its variations are featured under this system
11. Molecular diagnosis
 Atellica, versant are the systems under this category
12. Point-of-care testing
 Various categories catering to blood gas family, cardiac, urinalysis and
informatics are available under this portfolio

136
Accessories, OEM &

Electronics
 Various modalities and clinical applications are featured by Siemens such
1. Medical Imaging
as X-ray tubes and complex medical electronic solutions
Accessory Solutions
2. Medical Electronics
Others
 Siemens featured and Ecoline system for refurbished systems for medical
1. Refurbished
imagine and therapy
systems
 Products for various specialty areas such as cardiology, anemia, diabetes,
2. Clinical specialty &
organ transplant and others are available under this category
disease
 In May 2017, Siemens Healthineers joined forces with the U.S. based Imricor Medical
system which was a strategic partnership to improve procedures with MRI scan. This is
anticipated to develop an integrated solution for treating arrhythmia and improving
treatment outcomes. The direct impact of this strategy on the company could be an
increase in the total revenue of the company over the next fiscal year and an upper hand
in the treatment of arrhythmia disease segment.
 In October 2016, Siemens Healthineers highlighted technical innovations supporting

standardization of patient care by introducing expanded version of xSPECT Quant
technology. This technology is likely to elevate the overall sales of Siemens Healthineers
as it uses up to 3% of the traceable precision source according to National institute of
standards and technology(NIST) thus, giving Standardized Uptake Values (SUVs) for
disease detection and treatment facilities.
 In March 2016, Siemens Healthineers attended European Congress of Radiology (ECR),

where they introduced new applications, which will reduce the time required for MRI
neuro examinations and increases patient throughput and decreasing costs per scan.
This may result in increased overall sales of the company as it is the only technology
that acquires imaging slices simultaneously rather than sequentially, hence setting a
benchmark in the radiology segment.

137
8.2.4 Roche
F. Hoffmann-La Roche AG is a Swiss multinational

company (holding company-Roche holding AG)
operating in pharmaceuticals and diagnostics and it
Key Statistics
is the third largest pharma company worldwide.
Roche supports sustainable development goals Establishment year: 1896
(SDGs) which was unanimously adopted by United Headquarters: Switzerland

Nations General
Assembly in 2015 to end poverty and protect the Market relevance: High
planet and hence is a part of their CRM activity.
The diagnostics division introduced number of key instruments and tests such as Cobas
e801. It is a new module for clinical laboratories, which can carry out 300 immunological
test/hour.
Roche Diagnostics serves 16 markets in the Middle East with UAE being the frontrunner in
innovation approaches within the region.
An increase in the net sales and
Net sales 10,839 11,139 10,814 11,189 overall net income has been
observed, which is attributed to the
Net Income 11,767 9,865 12,247 13,128
increased penetration of Roche
Core operating profit 2,252 2,169 2,014 1,988 Diagnostics in the Middle East
Research and Development market.
expenses(loss) 1,052 1,073 1,240 1,373
30,000
25,000
20,000
15,000
10,000
5,000
0
2013 2014 2015 2016
Net sales Core operating profit Research and Development expenses Net Income
Note: Conversion rate 1 CHF = 1.03 USD on 7thJune 7, 2017
Data as per Diagnostics division income (core) results

138
 Roche provides extensive modular instrument solutions with

Clinical chemistry &
immunoassay and clinical chemistry assay for hospitals, labs and health
immunoassays
clinics
 Technologies catering to various segments such as virology, oncology,

Molecular diagnostics women’s health, microbiology and genomics are included under this
product profile
 Innovations and technologies used for standardizing and optimizing slide

Tissue diagnostics
staining process to deliver superior patient care.
 Instruments and IT solutions are introduced under this product segment to

Point of care diagnostics deliver quick, accurate and reliable result for clinicians and patient self-
monitoring. Example could be Accu-chek
 These systems are developed to simplify operations increase overall

Laboratory automation & IT
efficiency and reduce manual tasks.
 The platelet function testing technology combines medical and diagnostic

Hematology & hemostasis expertise with innovation to create a benchmark in the medical device
market
Urinalysis  Provides semi to fully automated systems under this product segment
 This segment is created for ongoing self-management of diabetes control

Patient self-testing
and prevention of blood clotting.
 Broad array of instruments with highly specific reagents and test kits are
Solutions for life science available under this category with a strong portfolio in genomics and
proteomics
 In January 2017, Roche acquired California based firm ForSight Labs with a product
range catering to vision impairment. There is an increasing rate of vision loss and
impairment worldwide and thus, this acquisition may be beneficial to the company in
long run. A wider range of products have been added to the eyecare segment which
could possibly increase the overall revenue of the company.
 In December 2016, Roche extended its partnership with Maryland based Senseonics
with an exclusive distribution agreement that provides Roche with the right to promote,

139
market and sell Eversense, a long-term implantable continuous glucose monitor worked
upon by Senseonics. This broadens the geographic foothold of Roche in most of
Europe, Middle East and Africa. Another benefit would be an increase in the product
range along with substantial increase in the revenue for the company.
 In September 2016, Roche Diagnostics introduced a powerful blood safety innovation at

a conference of the International Society of Blood Transfusion (ISBT) in Dubai, UAE.
The company’s comprehensive portfolio of nucleic acid testing and advancement in
serology testing technologies helps in delivering reliability and workflow efficiency for
blood centers. This may result in increased trust and loyalty among the end users, which
may eventually elevate the overall revenue of the company.
8.2.5 Becton Dicki nson
Becton Dickinson (BD) is a global medical technology

company with a basic agenda of advancing healthcare
industry by improving medial discovery, delivery of
care and diagnostics. Total revenue of the company is
Key Statistics
the year 2016 was USD 12.5 billion out of which USD Establishment year: 1897
8.7 billion was from the medical technology segment.
Headquarters: New Jersey
BD has a strong presence in the middle east market
Employee strength: 50000+
with technical & sales specialist, technical service and
application service for its products. The company also Market relevance: High
has a vast network of distributors in the middle east
region adding value to their products. The company basically has a vast product portfolio
comprising of medical devices, supplies, laboratory instruments, antibodies, diagnostic
products and reagents
8.2.5.2 Financial Performance

140
Revenue 8,054 8,446 10,282 12,483 An increase in net income and

R&D Expenses 494 550 632 828 revenue which may be the
result of acquisition of
Operating income 1,254 1,606 1,074 1,430
CareFusion Corporation in
2015, was observed
Net Income 1,293 1,185 695 976
18,000
16,000
14,000
12,000
10,000
8,000
6,000
4,000
2,000
0
2013 2014 2015 2016
Revenue R&D Expenses Operating income Net Income
Note: Conversion rate 1 CHF = 1.13 USD on 7th June, 2017
Research
Biosciences
1. Various technologies such as Accuri, FACSCelesta, LSRFortessa are
 Research available under this product portfolio
1. Cell Analyzers 2. FACS variations and influx system are featured by BD under this segment
2. Cell Sorters 3. Extensive catalogue of Medimachine system is available under this segment
3. Sample Prep Clinical
 Clinical 1. Variations of FACS systems are available under this product portfolio
1. Cell Analyzers 2. FACS lyse wash assistant and sample prep assistant is available under this
2. Sample Prep category
3. Software 3. Flow cytometry acquisition, LIS connectivity, data analysis and application
module software’s are provided by BD under this category

141
 Various systems are available under this category namely blood culture,
cervical cytology screening, collection and transport, data management
statistics and epidemiology, direct testing and serology, identification and
Diagnostics susceptibility testing, environmental, microbiological culture media, industrial
 Systems microbiology, molecular diagnostics and mycobacteria testing systems
 Preanalytical Systems  Preanalytical systems consists of blood collection systems, preservations and
standardization systems such as Advanced Scientific Products, Arterial Blood
Collection systems and accessories, tubes, ESR products. Microcollection and
sample acquisition products, urine collection and veterinary needles
 Anesthesia systems: Various products such as spinal, epidural and

combination anesthesia are available
 Infusion therapy systems: A variety of products are offered by BD such as fluid

management, IV and extended dwell catheters
Medical
 Injection systems: Various forms of specialty and prefilled syringes and
 Diabetes care
needles are available under this category.
 Surgical systems
 Insulin delivery devices: Innovative technologies are put forth together to
 Pharmaceutical systems provide devices improving comfort and convenience of the injection of insulin
 Needle safety: BD safe clip is available which will safely remove the used
needle from your syringe
 Sharp disposable systems and surgical scrubs: Available for safety purposes
 In December 2016, BD announced a research collaboration with a leading global

organization Juvenile Diabetes Research Foundation(JDRF) that would be funding BD’s
research for type 1 diabetes. This is anticipated to enable BD’s focus on enhancing
technology supporting extended wear insulin infusion set. This collaboration will
accelerate the innovation process resulting in elevated revenue along with a
benchmarked product in the market.
 In November 2016, BD launched the first syringe developed for people for administration
of Humulin R U-500 insulin in collaboration with Eli Lilly & Company, which
manufactures this type of insulin. This is likely to result in increased patient care owing to
the increasing prevalence of diabetes worldwide. As it is the sole product in the market,
there is no competition until now making BD the market leader in this segment.

142
 In October 2016, BD and Apax partners announced the launch of their joint venture
named Vyaire Medical, which would be a standalone firm for respiratory solutions. This
is anticipated to result in an increased expertise of BD in the respiratory segment, which
is further likely to result in an increase in the overall consolidated revenue. The company
would be focused on proving improved patient care and value to the customers through
this partnership.
8.2.6 Abbot Laboratories
Abbot laboratories is an American multinational

company, which offers broad range of products in
different segments such as generic pharmaceuticals,
diagnostics, medical devices, and nutrition products. The Key Statistics
company is a world leader in developing innovative Establishment year: 1888
technologies for medical devices, which has a significant
Headquarters: United States
impact on the end-user’s lives. Abbott has three basic
segments under medical devices worldwide, namely: Employee strength: 74,000+
vascular disease, diabetes care and vision car. Their Market relevance: Moderate
Absorb bio resorbable stent and Freestyle Libre Flash
glucose monitoring system were mentioned in the “Best of what’s new” category in Popular
Science magazine, 2016.
Abbott acquired St. Jude Medical, Inc. on January 2017, which is likely to result in expanded
opportunities for Abbot in the near future.

143
Financial (USD Millions) Key contributing factors

2013 2014 2015 2016
There is an increase in the net

Net Sales 19,657 20,247 20,405 20,853 sales but a drastic decrease in
the net earnings which could be
R&D Expenses 1,371 1,345 1,405 1,422 because of the cash used to
fund the St. Jude Medical
acquisition on January 4, 2017.
Net earnings 2,576 2,284 4,423 1,400
30,000
25,000
20,000
15,000
10,000
5,000
0
2013 2014 2015 2016
Net Sales R&D Expenses Net earnings
Note: Conversion rate 1 CHF = 0.97 USD on 7th June 12, 2017
 Abbot is an established global leader for drug eluting stents. The company
offers a variety of innovative products for cardiovascular care, such as
vessel closure, coronary artery disease, structural heart disease and
Vascular others. Furthermore, they have 20 more programs under development in
the above areas. Their featured products include: Xience, Omnilink Elite,
Trek, Rx Acculink and Rx Accunet, Armada 35 Ll, Perclose Proglide, Fox
catheters among others.
 The company is a global leader in blood glucose monitoring, providing an

improved glucose-testing experience. They are investing in the
Diabetes development of next-generation sensing technology for products, which
are affordable and easy to use. The products under this category are:
Freestyle Insulinx, Optium and Lite.
 The company has a long history in innovative development of market-

leading technologies for a wide range of vision impairments. The product
Vision
profile includes: Tecnis family of intraocular lenses and iFS femtosecond
laser.

144
 In January 2017, Abbot acquired St. Jude Medical, Inc., which is a global medical
device-manufacturing firm. The transaction is anticipated to provide an expanded level of
opportunity for Abbott’s future growth and is most likely to help develop a diverse and
strong portfolio of devices and other product segments. This will also help Abbott
compete in possibly every area of the USD 30.0 billion cardiovascular and
neuromodulation market.
 In September 2016, Abbott entered into an agreement to sell Abbott Medical Optics to
Johnson & Johnson for USD 4.3 billion in cash. This reflects the company’s proactive
shaping for its product portfolio to match with their strategic priorities.
 In January 2016, Abbot entered into an agreement to acquire Alere Inc., which is a
diagnostic device company. Due to some adverse developments, which have occurred
with respect to Alere, Abbot has filed a complaint in the Delaware Court of Chancery
asking for termination of the agreement.
8.2.7 Novartis
Novartis is a Swiss multinational pharmaceutical firm.

The business is divided into three operating divisions
namely: pharmaceuticals, Alcon (eyecare) and Sandoz Key Statistics
(generics). Novartis also holds 33.3% shares in Roche.
Alcon came up with the most recent innovation by
announcing launch of CyPass Micro-Stent surgical Headquarters: Switzerland
device for glaucoma in EU region, which is micro- Employee strength: 118,700 +
invasive and used to lower intraocular pressure in
Market relevance: Moderate
patients thus, reducing the dependence on topical
medicine for glaucoma.

145
Financial (USD
Key contributing factors
Millions) 2013 2014 2015 2016
There is a drastic decrease in

Net Sales 52,090 52,419 49,440 48,518 the net income which could
be due to Gleevec patent
R&D Expenses(loss) 9,071 9,086 8,935 9,039 expiry, investments in new
product launch and growth
plan of Alcon
Net Income 9,292 10,280 17,794 6,698
70000
60000
50000
40000
30000
20000
10000
0
2013 2014 2015 2016
Net Sales R&D Expenses Net Income
 The major system used under this category is Air Optix with various
innovations and specifications depending upon the end user needs. The
various products under this category are Air Optix Aqua, Aqua Multifocal,
for astigmatism, colors, night and day and hydraglyde contact lenses.
Contact Lenses
 Another system is Dailies Aquacomfort plus with various specifications
such as multifocal one day, toric and water gradient contact lenses
 Other types of systems are Focus Dailies and Freshlook system.
 Various surgical products include Acrysof Delivery Systems, Anterior

Chamber Lenses, Solutions for Eyecare, Cypass Micro-Stent, Ex-Press
Glaucoma Filtration Device, Kelman Multifle III Pmma Single-Piece
Surgical Products
Anterior Chamber Lenses, Lensx Laser, Monoflex Pmma Expand Single-
Piece Series IOLs, Single Piece Pmma IOLs and Wavelight Surgical
Suite.
 These are basically innovative eye drops intended for treatment of dry
Over-the-Counter Products
eyes, allergies, contact lens care, vitamins and hygiene products

146
 In December 2016, Novartis acquired Encore Vision, which was a private limited
company focused on development of treatment in presbyopia. This resulted in an
increased range of products in the eyecare portfolio along with specialization in the
extremely niche market of presbyopia.
 In October 2016, Alcon launched Cypass Micro-stent, which is a minimally invasive

glaucoma surgical device, at the American Academy of ophthalmology (AA) annual
meeting. This innovative technology is likely to help the company in establishing a
benchmark in the eyecare market and enhance patient care.
 In February 2016, Alcon acquired Transcend Medical, a med tech company that
develops minimally invasive surgical devices. Transend Medical developed Cypass
micro-stent which helped Alcon broaden the product portfolio and create a benchmark in
the glaucoma market segment
8.2.8 Ol ympus Corporati on
Olympus Corporation is a Japanese firm majorly into

optics and reprography. Their initial specialization was in
microscope and thermometer business, while currently
Key Statistics
they have a major share of gastro-intestinal endoscopes
in the world market. The company has three verticals,
namely: medical, scientific solutions and imaging Headquarters: Japan
business. The medical business segment approximately Employee strength: 39727+
generates 80.0% of the sales and holds a share of more
than 70.0% in global market. The company developed
the world’s first practical gastrocamera and thus, is established in the market as the sole
manufacturer to deal with both imaging equipment and energy devices. Olympus sold
medical devices worth USD 7.0 billion during 2006-2011.

147

2013 2014 2015 2016
Net Sales 6,755.53 6,477.94 6,944.61 7,307.04 There is an extraordinary drop in

the net income(2015) due to the
funds invested in investigation
R&D Expenses 575.60 606.63 672.97 739.40 under U.S. Anti-kickback Act
and other related acts. The net
income elevated in 2016 due to
Operating Income 739.40 667.02 826.10 948.72
profound sales of the Medical
Business segment
Net Income 72.84 123.76 79.35 568.47
12,000.00
10,000.00
8,000.00
6,000.00
4,000.00
2,000.00
0.00
2013 2014 2015 2016
Net Sales R&D Expenses Operating Income Net Income
Note: Conversion rate 1 Japanese Yen = 0.0091 USD on 8th June 8, 2017

148
Medical Specialties: Includes a broad range of products in this segment consisting

of laparoscopes, endoscopes, video and imaging systems, surgical devices and a
wide range of endotherapy instruments.
Ear, nose, throat: Multiple products are available under this segment. Two
important technologies used are Narrow Band Imagine and 4K UHD (big screen
Medical Business surgery).
Gastroenterology: The most recent innovation under this segment is Endocapsule

 Medical Specialties
10 system. It is a comprehensive system for efficient, fast and precise examination
 Ear, Nose, Throat of the small intestine by delivering high quality images.
 Gastroenterology General Surgery: The systems used under this segment are Thunderbeat which is
 General Surgery world fully integrated ultrasonic and bipolar technology and PK technology which is
a bipolar energy solution
 Gynecology
Gynecology: Various technologies and procedure supporting laparoscopy,
 Pulmonology
hysterectomy and myoectomy are present under this section. Various systems
 Urology used are HiQ+Bipolar hand instruments; hysteroFlow/ balance are available along
with the above-mentioned systems.
Pulmonology: Systems such as EVIS EXERA III and CV-190 are available under
this section.
Urology: This segment includes plasma system, NBI urology portal and stone
management, URF-V2 superslim flexible video ureteroscope.
Advanced imaging solutions: Total internal reflection fluorescence (TIRF)

microscopy is the key technique used essentially in this category.
Life Science Solutions
Laser scanning microscopes: Confocal Laser Scanning Microscope and special
 Advanced imaging
multiphoton system are featured under this segment.
solutions
Microscopes: various types of microscopes are available under this section such as
 Laser scanning
inverted, upright, stereo, research macro zoom, disk confocal and virtual slide
microscopes
microscope
 Microscopes
Other categories: cell culture solutions, cameras, software’s and accessories are
 Other categories also developed and provided by Olympus.

149
 In April 2017, Olympus Corporation announced the acquisition of Image Stream Medical,
a healthcare systems integrator and operating room imaging systems integrator. this
collaboration is anticipated to increase the profitability and expand its presence within
the medical field.
 In November 2016, Olympus introduced cellSens software, which provides automatic

panoramic images on any kind of manual microscope. This is an innovative technology
and is anticipated to create a benchmark in the microscopic segment market
8.2.9 General Electric Healthcare
General Electric (GE) Healthcare is a subsidiary of

General Electric, an American medical device and
pharmaceutical company. This company provides
Key Statistics
information technologies and medical imaging, patient
monitoring systems, drug discovery, bio pharmaceutical Establishment year: 2004
manufacturing technologies, medical diagnostics and Headquarters: United States
services for performance solutions. GE Healthcare has
nine business units: detection and guidance solutions,
healthcare digital, life care solutions, life sciences, Market relevance: Moderate
magnetic resonance, molecular imaging & computed tomography, surgery, ultrasound and
global services. The company collaborated with CrossFit games in 2015, to provide mobile
imaging equipment to the athletes. Around 5.0% of the total revenue of GE healthcare is
generated by the Middle East and African market.

150

2013 2014 2015 2016
There is an increase in the
Net Revenue 113,245 117,184 117,386 123,693 revenue and net earnings
possibly due to higher volume in
Earnings from continuing the life sciences and healthcare
operations 7,618 9,535 1,663 9,128 system. A loss in net revenue in
2015 was witnessed which may
be attributed to inflation and
Net Earnings (loss in 2015) 13,057 15,233 -6,145 8,176 impact of stronger U.S. dollar
160,000
140,000
120,000
100,000
80,000
60,000
40,000
20,000
0
2013 2014 2015 2016
Net Revenue Earnings from continuing operations Net Earnings
 The segment is divided into anesthesia platform, delivery systems and

vaporizers. Platforms consists of ET control, advance CS2 with Ecoflow,
and Aspire View, which demonstrates GEs advanced technology. Delivery
Anesthesia Delivery
system consists of integrated and versatile workstations. Vaporizers
include devices used to deliver isoflurane, sevoflurane, desflurane
anesthetic agents
 Advanced visualization includes IDI Mammo Workstation, (T)EVAR Assist

Advanced visualization
Solutions and valve assist systems
 This category includes two major product groups namely quantitative

Bone health
ultrasound and DXA for bone health.
 Multiline sections of products are available under this segment such as

Clinical consumables Limb-O single limb breathing circuits and enflow fluid warmer which are
highly effective and economic
 Revolution EVO is featured under this category of GE’s innovative CT

Computed tomography
scan family

151
 It offers clinical, administrative and service IT solutions including

Healthcare IT enterprise & regional imaging solutions, HCIT cardiology, centricity high
acuity suite.
Interventional image guided  Includes a wide array of tested and trusted systems such as Innova IGS
systems 520, IGS for hybrid and interventional oncology
 Signa portfolio of intuitive and advanced redefine magnetic resonance

Magnetic resonance imaging
imaging
 Senographe Pristina and mobile mammography are the two systems

Mammography
available under this category
 Molecular imaging consists of nuclear medicine product Brivo based on

Molecular, surgical imaging
their Spect technology. Surgical imaging consists of OEC Brivo Plus.
 GE healthcare offers Carescape monitors which is technology which

Patient monitoring integrates monitors, wireless devices and integrated IT solutions to
provide a fluent system
 Fetal and Maternal Monitoring, combination environment, incubators and

Perinatal & Perioperative care warmers, infant resuscitation and phototherapy, Neonatal Intra-Hospital
Transportation, Perinatal Respiratory Support
 The products featured under this segment are fixed RAD systems, mobile
Surgical imagining
X-ray systems and advanced applications.
 Invenia Abus, voluson and Vscan family are a few products under this
Ultrasound
segment
 GE healthcare offers their latest technology classical R&F system with a

Fluoroscopy flat panel detector technology providing low dose, ease of use and optimal
image quality
 In March 2017, GE Healthcare acquired Monica Healthcare which resulted in expansion

of its Maternal-Infant Care business. Monica Healthcare is a monitoring technology
company, which is likely to help GE Healthcare enhance their digital and mobile offering
by providing innovative solutions for delivery, labor and homecare to patients and
clinicians. This is anticipated to help GE Healthcare gain specialization in the maternal
healthcare segment and create a benchmark for the same.

152
 In January 2017, GE Healthcare showcased its latest technologies which would

transform the Middle East healthcare market, at Arab Health 2017. The GCC healthcare
market is anticipated to grow from USD 40.3 billion to USD 71.3 billion from 2015 to
2020. Senographe Pristina system was one of the latest technologies launched for
tackling breast cancer. This is anticipated to cause advancement in the Middle East
healthcare market, improve patient care and establish geographic foothold of the
company in this region.
 In November 2016, GE Healthcare showcased innovative technologies and digital

solutions at Radiological Society of North America(RSNA) 201, thus focusing on
improving outcomes. The company launched the world’s first patient controlled
compression technology for mammography exam and showcased the latest MRI and CT
systems to increase productivity. This is anticipated to enable improved patient
experience and increased clinical confidence along with increased revenue for the
company in the next fiscal year.
8.2.10 Biomerica Inc.
Biomerica Inc is an American firm, which is, engaged

primarily in R&D, production and marketing of
diagnostic kits. These products are designed for early Key Statistics
detection and continuous monitoring of medical
conditions and chronic diseases. These kits are sold
in the following markets: clinical laboratories, Headquarters: The U.S.
physician's offices, over-the-counter i.e. in pharmacies Employee strength: 50+
and other markets. The company’s manufacturing
operations is regulated by the U.S. FDA good
manufacturing practices for medical devices. Out of the total sales by the company, 3.5%
sales are generated from the Middle East market, which is around USD 180,000 million.

153

2013 2014 2015 2016
There is a drastic decrease in the
Net Sales net earnings which is assumed
6,472,960 5,120,451 4,962,373 5,139,816
to be due to the royalty
Operating Income 1,913,853 2,115,802 2,212,401 2,350,994 expenses for two agreements to
obtain the right to manufacture
Net Earnings (loss) and market certain products
536,957 215,660 331,410 1,499,787 under that agreement
9,000,000
8,000,000
7,000,000
6,000,000
5,000,000
4,000,000
3,000,000
2,000,000
1,000,000
0
2013 2014 2015 2016
Net sales Operating expenses Net loss

154
Anemia: The basic system used in this segment is EPO Elisa which is a two-site in
vitro diagnostic ELISA which an advanced feature of direct label-2 site for capturing
antibody
Bone and Hormone: The technologies used under this segment is PTH, ACTH and
Clinical Lab Products
calcitonin ELISA.
1. Anemia
Cardiac: Biomerica features HS-CRP, Myoglobin and Troponin ELISA system
2. Bone and Hormone under this segment
3. Cardiac Celiac Disease: Transglutaminase, antigliadin, antigliadin IgA ELISA kits.
4. Celiac Disease Diabetes: Isletest GAD, ICA & IAA ELISA systems are featured under this
segment.
5. Diabetes
Food Intolerance: The ELISA system used under this section is intended for invitro
6. Food Intolerance
quantitative analysis of IgG antibodies.
7. Gastroenterology
Gastroenterology: Campylobacter, Verotoxin, E. coli O157, E. Histolytica Dispar &
8. Infectious Disease
Cryptosporidium are the products featured under this segment
9. Specialty Tests
Infectious Disease: It is a 1 hour 40 minutes ELISA test for detection is IgG, IgM &
IgA specific H. pylori.
Specialty Tests: IFA, TPMT (8-Patient Kit & 40-Patient Kit), Liver Kidney
Microsomal Type 1 are the products included under this category.
Tests to detect various infections caused due to Salmonella, Listeria, Shigella, C.

Physicians’ Office Products difficile GDH, Giardia Antigen, Campylobacter to see their presence and for
1. Infectious Disease diagnosis of the disease are included under this segment. In addition, test for
detection of H. pylori are availed under this segment.
Breast Care: Aware breast self-exam kit consisting of the Aware pad device for
routine examination
Home Diagnostic Tests
Diabetes: Fortel Microalbumin Screening-OTC is the product included under this
1. Breast Care
segment to detect elevated urine albumin in urine.
2. Diabetes
Drugs of Abuse: Multi-Drug Combo Test & Test Strip / Device uses lateral flow
3. Drugs of Abuse
chromatographic immunoassay.
4. Fecal Occult Blood
Fecal Occult Blood: EZ Detect Individual & OTC are featured under this segment.
5. Ovulation
Ovulation: it is a rapid cassette test used for the qualitative determination of
6. Pregnancy luteinizing hormone (LH) in human urine
7. Prostate-Specific Pregnancy: Fortel hCG Midstream and Bulk hCG is seen under this category
Antigen (PSA)
Prostate-Specific Antigen (PSA): PSA (Bulk)& Fortel PSA OTC are featured under
this category.

155
 In March 2016, Biomerica announced that International Search Authority (ISA) has
reviewed its international patent application for Irritable Bowel Syndrome (IBS) and
claimed it to be novel and non-obvious. Biomerica is developing professional use and
point-of-care versions of the novel product. This patent is anticipated to generate more
revenue for the company and add value to the customers and entire healthcare industry.
8.2.11 Baxter International
Baxter International, is an American medical

equipment company, which along with its subsidies
provides a broad portfolio of renal and hospital
Key Statistics
products. The company plays a critical role in
expanding access to healthcare in developing and Establishment year: 1931
emerging market. Baxter operates in 2 segments: Headquarters: Illinois

hospital and renal products. The company has
categorized its product portfolio in four strategic
Market relevance: Low
business groupings: core growth, core return on
capital, maintain/manage differently and strategic bets. In 2016, Baxter completed the
distribution and disposed of all the outstanding shares in Baxalta thus separating into two
individual firms.

156
Financial (USD Millions) 2014 2015 2016 Key contributing factors
Net sales 10,719.00 9,968.00 10,163.00 There is a drastic increase in the net
income which is anticipated to be due
R&D Expenses 610.00 603.00 647.00 to increase in the income from
Operating income 656.00 449.00 724.00 continuing operations and may also
be related to the Baxalta separation.
Net Income 2,497.00 968.00 4,965.00
18,000.00
16,000.00
14,000.00
12,000.00
10,000.00
8,000.00
6,000.00
4,000.00
2,000.00
0.00
2014 2015 2016
Net sales R&D Expenses Operating income Net Income
Infusion Pumps &  Baxter is a recognized market leader in IV medication delivery including a
Administration Sets wide range of product portfolio right from Large Volume Infusion pumps to
 Infusion Pumps Repeater pumps
 IV Connectors &  The product range consist of SIGMA Spectrum Infusion System and
Securement CLEARLINK Luer Activated Valve
Pharmacy Automation,
Software & Services  EXACTAMIX Automated Compounding System, ABACUS Calculation
Software, Repeater Pump and Enteral ENFIT Syringe and Accessory Line
 Compounding
are constituted under this category
Systems
 DoseEdge Pharmacy Workflow Manager is the product under this
 Workflow
category.
Management
 ICNet system is featured under this category.
 Software Systems
Surgical Care Products  Consists of technologies which facilitate hard tissue regeneration in
 Bio Surgery orthobiologics and soft tissue repair in a variety of surgical procedures.

157
Renal Care
 Amia Automated Pd System with Sharesource Connectivity Platform and
 Peritoneal Dialysis Homechoice & Homechoice Pro Automated Pd Systems are available
under this category.
 In-Center
Hemodialysis  Revaclear, Revaclear 300, Revaclear Max Dialyzers, Polyflux and Xenium
are the products featured under this category.
 Continuous Renal
Replacement  CRRT is used for critically ill patients who are hospitalized in the intensive
Therapy(CRRT) care unit with acute kidney injury (AKI). PRISMAFLEX System is majorly
used under this category.
 In May 2017, Baxter International Inc. announced a new research and development
collaboration with Mayo Clinic. This collaboration is anticipated to cause advanced
innovation across a spectrum of therapeutic areas thus catering to unmet needs of the
patient. This could also result in increased research and development which may result
in expansion of the product portfolio.
 In December 2016, Baxter announced the acquisition of Claris Lifesciences injectables

subsidiary, Claris Injectables, for USD 625 million. This is anticipated to increase the
overall revenue of the firm along with expansion in their product portfolio.

158
8.2.12 Smith & Nephew
Smith & Nephew is a British multinational medical

equipment manufacturing firm. Middle East is
included in the emerging market’s segment which Key Statistics
generates 15% of group revenue in 2016. The
company launched an Anthem Total Knee system
which is developed specifically to address patients Headquarters: United Kingdom
across Asia, the Middle East, Africa and Latin Employee strength: 15,000+
America. New innovations such as Lens and the
Werewolf Coblation System are important
components which are impacting the medical device industry.

2014 2015 2016
There is an increase in the revenue and R&D
Revenue 4,617.00 4,634.00 4,669.00 expenditure which is estimated to be due
to the acquisition of Blue Belt Technologies
Gross profit 3,455.00 3,491.00 3,397.00 Inc. for consideration in 2016. The
company continues to invest in innovative
technologies to differentiate themselves
R&D Expense (loss) 235.00 222.00 230.00 from the competitors.
9,000.00
8,000.00
7,000.00
6,000.00
5,000.00
4,000.00
3,000.00
2,000.00
1,000.00
0.00
2014 2015 2016
Revenue Gross profit R&D Expense

159
 A vast variety of products for the treatment of acute and chronic wounds,
Advanced Wound including diabetic and pressure ulcers, burns, and post-operative wounds.
Management A few products under this category are Acticoat, Allevyn, Cica-Care and
many more
 The various products under this segment cater to knee, hip, shoulder
joints as well as ancillary products such as bone cement. The acquisition
Orthopedic reconstruction
of Blue Belt Technologies added Navio surgical system to their product
portfolio.
 The sports medicine joint repair franchise offers minimally invasive

Sports medicine products for surgery of the joints, including repair of soft injuries and
degenerative conditions of hip, knee and shoulder
 Their key products include Taylor Spatial Frame, Circular Fixation System
Trauma and extremities
and Jet-X Bar Unilateral Fixator.
 In January 2016, Smith & Nephew acquired Blue Belt Technologies which secured their
leading position in the fast-growing orthopedic robotics assisted surgery market. This
acquisition is anticipated to broaden the product portfolio of Smith & Nephew with the
addition of Navio surgical system providing robotics assistance in partial knee
replacement surgery along with an increase in total revenue.
 In July 2016, Smith & Nephew extended its wound care academy to Saudi Arabia which
is anticipated to provide high level of education to Saudi Arabian healthcare
professionals for the first time and may also increase the goodwill of the company in that
area.
 In May 2014, Smith & Nephew acquired ArthroCare Corporation which added
technology and highly innovative products to their product portfolio under the sports
medicine category

160
8.2.13 BioMérieux
BioMérieux is the market leader in the field of in

vitro diagnostics and is present in over 50
countries through 42 subsidiaries and an extensive Key Statistics
network of distributors. The company provides Establishment year: 1878
diagnostic solutions to determine the source of the
Headquarters: France
disease and contamination to ensure consumer
safety and improve patient health. BioMérieux has Employee strength: 9,000+
5 main dedicated teams: Market relevance: Low
Food & water, biopharmaceutical, cosmetic &

personal care, advanced therapy & blood banks and veterinary diagnostics laboratories.
Their biopharmaceutical segment provides solutions entirely dedicated for biotechnology
and pharmaceutical industries

2014 2015 2016
There is an increase in the net sales
Net Sales 1,905.86 2,204.58 2,360.11
and net income which is anticipated
R&D Expenses (loss) 230.94 268.08 305.11 to be due to the robust growth of all
the product lines especially Vidas
Operating Income 228.47 218.71 317.01 immunoassay range showing
sustained growth in several Middle
Net Income 152.05 123.77 201.09 Eastern countries
3,000.00
2,500.00
2,000.00
1,500.00
1,000.00
500.00
0.00
2014 2015 2016
NET SALES R&D Expenses Operating Income Net Income
Note: Conversion rate 1 Euro = 1.12 USD on 12th June 12, 2017

161
Culture media preparation

APS One and Masterclave are the two systems featured under this category
and filling systems
Irradiated 3P Range, Air Ideal 3P Traceability, BioBall, Quantiswab, Labguard 3D,

Environmental monitoring
Incubators & Accessories are the innovative technologies featured under this
segment.
Rapid microbial detection & BacT/ALERT 3D Dual-T, ScanRDI, Media Fill 3P, Ready-to-Use Sterility Testing
sterility testing. Media, BioBall are the systems used for rapid microbial detection & sterility testing.
BacT/ALERT 3D Microbial Detection Systems, Dual-T and VIRTUO are the various
Blood bank / cellular products
product systems sunder this category
API/ID32, PREVI Color, VITEK 2 Compact & MS are the innovative methods used
Microbial identification
for microbial identification.
EviSight Compact total vision is a smart incubator and colony counter using highly
EVI sight
specified algorithms.
 In January 2017, BioMérieux and Banyan Biomarkers announced their partnership to

validate, develop and market the blood-based biomarkers for Traumatic Brain Injury.
This partnership is anticipated to add value to the company by obtaining the rights to
commercialize Banyan’s proprietary tests worldwide for use in invitro diagnostics, thus
increasing the total revenue of the company in the next fiscal year.
 In November 2016, BioMérieux launched eMAG which is a new generation automated

system for extraction of RNA and DNA. eMAG uses the BOOM technology which is the
gold standard in the field of molecular diagnostics. This technology is the first of its kind
and is anticipated to create a benchmark in the in vitro diagnostics field.

162
8.2.14 Zimmer Biomet
Zimmer Biomet is an American publicly traded medical

device firm. The company has operations in more
than 25 countries around the world and sells products
Key Statistics
in over 100 countries. The company develops,
manufactures, designs and markets orthopedic
products including hip, shoulder, foot and ankle and Headquarters: USA
various others. They have also been at the forefront of Employee strength: 17,500+
musculoskeletal innovation by eventually expanding
their portfolio of technologies, solutions and services.
The EMEA geographic segment is the company’s second largest operating segment with
Middle East being an integral part.

2014 2015 2016
Net sales 4,673.30 5,997.80 7,683.90 It has been observed that the net sales
and earnings have increased which
R&D Expenses 186.93 269.90 368.82 is anticipated to be driven primarily
by the Biomet Acquisition in 2016
Net earnings 1,098.00 1,310.50 1,610.80
12,000.00
10,000.00
8,000.00
6,000.00
4,000.00
2,000.00
0.00
2014 2015 2016
Net sales R&D Expenses net earnings

163
 Zimmer Persona Knee is a personalized knee replacement system for

Knees
arthroplasty
 Continuum Acetabular System is featured under this segment which

Hips allows the surgeon to choose the best technology catering to specific
patient needs
 Trabecular metal humeral stem and metal glenoid are the featured
Shoulders
products under this portfolio
 Coonrad/morrey total elbow is the system designed for post-traumatic and

Elbows
rheumatoid arthritis
 Trabecular metal total ankle is designed to reproduce the ankles natural

Foot and ankle
flexibility and motion
Dental  3i Dental system is featured under this segment
 Sequoia Thoracolumbar Pedicle Screw System with Tm Ardis Interbody

Spine
System is the product featured under this segment.
 Natural Nail system is a next-generation intramedullary nailing system to

Trauma
make surgery experience easier
 Chondrofix Osteochondral Allograft is a product used for repair of

Joint preservation
chondral and osteochondral lesions in diarthrodial joints.
Surgical and Operating Room

 Universal Power System is featured under this segment
Solutions
 In April 2017, Zimmer Biomet Dental announced its collaboration with Novabone
products for the distribution of their novabone dental putty & morsel devices in over 40
countries within the Middle East, Asia Pacific, Africa, Latin America and Europe. This
collaboration is anticipated to provide a new and advanced bone grafting solution to the
customers along with an increased revenue for Zimmer Biomet.
8.2.15 Philips

164
Philips is a Dutch technology company primarily

focused on electronics, lighting and healthcare
division. The company is a focused leader in the
Key Statistics
healthcare technology by innovating new
approaches catering to global heath challenges. Establishment year: 1891
The healthcare business adds up to 42% of the Headquarters: Netherlands

global sales revenue. In 2015, Philips acquired
Volcano Corporation to strengthen their position in
Market relevance: High
the non-invasive surgery and imaging segment.

2014 2015 2016
It has been observed that the net sales
Net Sales 23,939.63 27,132.55 27,436.96 and net income have increased
which is anticipated to be a result of
Income from continuining
247.33 463.33 1,203.08 the 5% growth in Personal
operations
Healthcare business and a 3%
growth in Diagnosis and Treatment
Net income 459.97 737.52 1,668.65 business sales.
35,000.00
30,000.00
25,000.00
20,000.00
15,000.00
10,000.00
5,000.00
0.00
2014 2015 2016
Net Sales Income from continuining operations Net income
Note: Conversion rate 1 Euro = 1.12 USD on 13th June 2017
 These products provide low dose molecular and hybrid imaging solutions
Molecular Imaging & Nuclear
to enhance lesion detectability with various innovations including Time-of-
Medicine Solutions
Flight PET, hybrid SPECT/CT and digital PET/CT

165
 The systems streamline management and analysis of patient data from

Clinical Informatics
patient monitors, imaging systems, and cardiac testing equipment
 Philips Healthcare has multiple innovations in CT product design, image

Computed Tomography
quality, radiation dose management and advanced clinical applications.
 Philips algorithms, cardiographs, monitors, and ECG data management

Diagnostic ECG
systems are available under this segment
Emergency Care and  Automated external defibrillators and Advanced life support solutions are
Resuscitation featured under this segment
 Philips Healthcare offers fluoroscopy room solutions and digital

Fluoroscopy
radiography under this segment
 Hospital respiratory ventilation and patient interfaces are available under

Hospital Respiratory Care
this category
Interventional devices,  Philips provides minimally invasive procedures for treatment of cardiology,
therapies & X-ray peripheral and advanced imaging systems.
 ScanWise Implant, MRI in-bore experience, Clinical applications selector,

Magnetic Resonance Coil Selector, Imaging Systems and other therapy systems are available
under this segment
 Ultrasound, Fetal and Maternal Monitoring, Tools for Jaundice

Mammography, Mother & Management, Breastfeeding and bottle feeding, infant Positioning &
child care solutions Soothing in the Hospital and other baby care devices are available under
this segment
 A range of IntelliVue and SureSigns patient monitors span care

Patient Monitoring
environments, patient acuity levels are available under this segment
 RTdrive MR prostate, Ingenia MR-R, CT Big Bore are the systems

Radiation oncology
featured under this segment.
 Consists of digital X-ray machines catering to everyday clinical and

Radiography
economic challenges.
 Philips features diamond Select program system which is an innovative

Refurbished Systems
refurbished imaging system giving high quality services
 Philips has a separate sector called Philips Respironics, a global leader in

Sleep and Respiratory Care
sleep and respiratory market providing personalized sleep and COPD
Solutions
therapies.
 Philips features Effica System under this category including Efficia CM

Value products
series and ECG100 in the product portfolio

166
 In December 2016, Philips Avent which is the company’s mother and childcare brand
launched and initiative in UAE to support breast pumping facilities. This initiative is
anticipated to improve patient care along with an increased trust and goodwill in the
company.
 In February 2015, Philips acquired Volcano Corporation and is consolidated as a part of

Philip’s Image-guide therapy. This is anticipated to increase the total revenue of the
company in the next fiscal year possibly due to addition of Volcano’s wide product range
to Philip’s Image-guide therapy product portfolio.

167
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MARKET ESTIMATES & TREND ANALYSIS

Middle East Medical Devices Market

Market, by FDA classification (Class I, II, III)

EMISPDF us-ucb from 128.32.10.230 on 2019-12-16 09:55:56 GMT. DownloadPDF.

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Chapter 1 Research Methodology ................................................... 12

Chapter 2 Executive Summary ........................................................ 26

Chapter 3 Middle East Medical Device Market Variables,

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3.4.5 Threat of new entrants (higher): ....................................................................... 44

Chapter 4 Middle East medical devices Market: Product

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4.1.6.1 General and plastic surgery market, 2014–2025

Chapter 5 Middle East Medical Devices Market: U.S. FDA

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Chapter 6 Middle East Medical Devices Market: End-use

Chapter 7 Middle East Medical Device Market: Regional

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7.2.7 Iran ................................................................................................................ 106

Chapter 8 Competitive Landscape ................................................ 115

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8.2.5.4 Strategic initiatives .................................................. 142

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8.2.13 BioMérieux .................................................................................................... 161

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FIG. 1 Market research process 13

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FIG. 37 Class I devices market, 2014 – 2025 (USD Million) 83

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Chapter 1 Research Methodology

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FIG. 1 Market research process

Information procurement Information analysis Market formulation

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1.1 Information procurement

FIG. 2 Information Procurement

GVR’s Internal Database

Primary Research Secondary Sources & Third Party Perspectives

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 Includes company databases such as Hoover’s: This helps us identify financial

GVR’s Internal Database

Third Party Perspective:

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FIG. 3 Primary research pattern