BIOPHARMACEUTICAL

INDUSTRY
 Global and Local Demand
Thailand’s healthcare sector is one of
the fast-growing sectors driven by soaring
domestic demand. Like many other countries
in Asia, Thailand is heading towards an aging
society. In 2020, the proportion of citizens
aged over 65 was 13%, and it is expected to
increase to 30% in 20501. The rise of the aging
population is associated with the demand for
medical services in the decades ahead. As
the number of elderly increases, they tend to
develop certain conditions ranging from
heart disease to blood clots, diabetes, and
cancer. Biopharma products such as Tissue
Plasminogen Activator, Insulin, and Therapeutic
Why Thailand for Antibodies are needed to treat diseases.
the Biopharmaceutical Apart from internal factors, the global
Industry? pandemic has underlined the necessity of the
biopharma industry. The demand for vaccines
Following North America and EU, has risen sharply. Thailand embraces these
Southeast and East Asia is ranked 3rd the opportunities and leverages the potential to
highest projected pharmaceutical sales in become a production base for vaccines, rapid
2024 with the value of USD 232 billion1. As tests, and genomic products. It successfully
part of the region, Thailand’s pharmaceutical attracted investors such as AstraZeneca,
industry has grown and has been considered KinGen Biotech, and Apsalagen.
one of the top biopharma clusters regarding Source: 1 UN World Population Prospects
its public R&D spending, number of patents,
initial public offerings, number of companies, Healthcare Destination
and jobs2. Due to robust healthcare infrastructure,
Source: 1 Statista and 2 Genetic Engineering and state-of-the-art medical facilities, highly skilled
Biotechnology News (2019) professionals, and affordable costs, Thailand
is undoubtedly the destination for patients
Roadmap to Become from abroad. Approximately 3.5 million tourists
a Pharmaceutical Hub visited Thailand in 2019 and spent USD 726
Recently, Thailand has already activated million on healthcare services, accounting for
the policy for a sustainable recovery from 9% of the global total. It is the only country in
Covid-19, the so-called Bio-Circular-Green Southeast Asia placed in the top 151. As of
Economy Model (BCG). This model is initially July 2021, there are 61 Thai medical institutes
proposed by the Ministry of Higher Education, across every region of the country that are
Science, Research, and Innovation (MHESI) Joint Commission International-Accredited,
as a new growth engine. The implementation ensuring the world-class status of medical
under the BCG model is projected to span facilities. Thailand not only offers the opportunities
from 2021 to 2026, with an aim to generate of the market, but it also accommodates
THB 4.9 trillion at the end of the period. The investors with a comprehensive supply chain
total investment is forecasted to be THB from upstream to downstream industries.
750 billion in 20261. It focuses on 4 s-curve Manufacturers can access essential raw
industries, including medical and wellness. materials, clinical trial centers for testing drugs,
BCG sets up the mission to reduce the import and manufacturing facilities for production.
value of pharmaceuticals and vaccines worth Source: 1IMF
approximately THB 100 billion per year.
Source: 1Bangkok Post
Fully Integrated R&D Hub Center for Medical Genomics (CMG):
The existence of the following infrastructure The institution is under the control of the
and facilities has made Thailand a prime hub Faculty of Medicine Ramathibodi Hospital,
for biotechnology research and development. Mahidol University. It positions itself as a
platform to advance the region’s genomic
Thailand Science Park: This country’s toolkit. Since 2014, CMG has joined forces
first science and technology park offers facilities, with TCELS on pharmacogenomics research
business space, and a range of services to to increase Thailand’s competitiveness in
promote innovation development in the private genomic medicine.
sector. It is also a home for 110 firms and
national research institutions and laboratories Notable Manufacturing Plants
such as BIOTEC, TCELS CPU, and GMP in Thailand
Production Unit for Cell and Gene Therapy Biopharmaceutical manufacturers companies
(CPU). can be divided into 3 categories: international
Biopolis: The area established in the companies establishing manufacturing facilities
Eastern Economic Corridor of Innovation (EECi) in Thailand, a joint venture between government
exists as an innovation center and industrial agencies and international companies, and
cluster for life sciences and biotechnology. Thai manufacturers. The example of them is
It provides long-term land leases, laboratory as follows.
spaces, testbeds, and incentives for investors
to scale up their research activities to mass
commercialization.
Table 1: Existing Biopharmaceutical Plants in Thailand

Plants About Main Products

Thai Red Cross Transferred technology from Albumin

Plasma Fractionation Korean Green Cross IVIG
Centre Only plasma product Factor VIII
manufacturing facility
in Southeast Asia

Geo-Merieux Joint venture between GPO, Flu vaccine

Biological Products Sanofi and CPB Equity JE vaccine
Rabies vaccine
Hepatitis B vaccine

GPO Influenza Egg-based flu vaccine facility Seasonal flu vaccine

Vaccine Plant

Bionet-Asia Thai-French privately held Pentavalent vaccine

biotech company
Focusing on re-emerging
diseases

Siam Bioscience The first Thai biopharmaceutical Erythropoietin

manufacturer Filgrastim
2 subsidiaries: Abinis and
Inno Biocosmed

Austrianova Biotech company based Full service for

in Singapore cell-based products
Expert in cell biology and
encapsulation of living cells
Isolator-based manufacturing
processes

Source: TCELS, Bionet-Asia, Siam Bioscience

Overview of Distribution
Pharmaceutical Due to the expansion of national universal
Industry healthcare coverage, there is a surge in
demand for medicines from the domestic
Driven by prominent factors including market. Approximately 90% of pharmaceutical
demographic shift, the prevalence of chronic output is distributed within the country, leaving
diseases and the Covid-19 outbreak, the 10% traded in an international market. In 2020,
global pharmaceutical market is expected to Thailand exported around THB 17.73 billion,
grow from USD 405.52 billion in 2020 to USD with 3.34% CAGR growth over 5 years. The
486.62 billion in 2021 at approximately 20% large share of export went to Asian countries.
year-over-year growth1. The top 5 destination took 58% of total value
Source: 1Acumen Research and Consulting including Vietnam, Myanmar, Cambodia, Japan,
and the Philippines. However, Thailand still
Overall Pharmaceutical Market needed to import some high-value products
In 2018, the sales value of pharmaceuticals that were unable to produce domestically to
in Thailand was USD 5.47 Billion. It is expected satisfy the domestic demand. The value of
to reach USD 6.9 billion in 2024, which accounts imports was worth THB 77.83 billion in 2020,
for 1.1% of gross domestic product (GDP)1. while the CAGR growth over 5 years was
The market size of Thailand has been the 2.16%. The main partners are Germany, the
second largest in Southeast Asia, after Indonesia. USA, France, India, and Japan1. This gap opens
The growing demand for medicines and treatment opportunities for investors to enter the market
leads to the expansion of the domestic market with strong potential for growth.
by an annual average rate of 4.5%2. The main destination for the domestic
Source: 1Fitch Solution and 2Krungsri Research market is hospitals, where government and
private hospitals share 60% and 20% of total
Production output. Most of the medicines distributed
The manufacturers in Thailand usually through this channel are prescription drugs.
import active ingredients such as aluminum The rest becomes over-the-counter medicines
hydroxide, aspirin, sodium bicarbonate, or sold by pharmacists, which have represented
deferiprone to mix and produce the finished a stable share over years2. In 2019, there were
generic drugs in-house. As of August 2021, 20,516 registered pharmacies nationwide
148 domestic pharmaceuticals producers were while the number of pharmacists constantly
accredited with Good Manufacturing Practice rised from 7,690 in 2009 to 15,040 in 20193.
(GMP) standard1. In 2020, investments in a Source: 1Ministry of Commerce, 2Krungsri Research
pharmaceutical and chemical market were and 3Statista
worth a value of THB 16.32 billion which the
top contributors are from Thailand, Japan,
India, Switzerland, and Cuba. The spending of
newly established pharmaceutical and medical
supply businesses was about THB 2.05
billion2.
Pfizer is ranked 1st in terms of revenue,
followed by GSK, MSD, Novartis, and Roche.
The top 5 production values of modern
pharmaceuticals are from Alimentary Tract and
Metabolism, General Anti-infective-systemic,
Cardiovascular system, Dermatological, and
Hospital Solutions3.
Source: 1Thai FDA, 2Statista (2020) and 3Statista (2018)
 As vaccines are the only long-term
solution to the current global pandemic,
Thailand is preparing itself as a regional
production hub supplying vaccines to other
countries in the region. The cabinet approved
the total THB 1.81 billion at the end of 2020
to support Covid-19 R&D and vaccine
Investment production. The money was allocated to fund
Opportunities many projects from both private companies
and public agencies. Several organizations
Biotechnology is set as a priority sector to and companies are in promising progress of
promote a post-Covid 19 recovery. In the first Covid-19 vaccine development.
quarter of 2021, BOI approved new projects
in this field worth around THB 2.4 million. This Siam Bioscience: The company is
reflects investors’ confidence in the sector’s selected by AstraZeneca to license its vaccine
capabilities and opportunities from much and currently supplies doses to Thailand and
broader and more diverse activities. Medical other countries in the region
biotechnologies such as vaccines, genomics, GPO Saraburi: The vaccine facility
and biopharmaceuticals are now under the in Saraburi with the assistance from Texas
spotlight and attract multiple manufacturers to University, is currently in Phase 1 of developing
launch and scale up their businesses. egg-based Covid-19 vaccine from its influenza
technology
Vaccines Baiya Phytopharm: The Thai startup
Thailand has established itself as the has developed its vaccine from plant leaves
leading developer of vaccines in ASEAN and has already passed a laboratory animal
due to its high caliber of researchers and test.
vaccine developers. Some of the remarkable BioNet-Asia: Phase 1 of the vaccine,
vaccines developed by Thai manufacturers so-called COVIGEN, has been already approved
and laboratories are: by the University of Sydney
Chulalongkorn University: The Chula
Cocktail Vaccine (5-in-1), developed Vaccine Research Center, in collaboration
by NSTDA and BIO-NET Asia with Pennsylvania University, has developed
Haemophilus influenzae type b (Hib) an mRNA vaccine, ChulaCov19. The vaccine
Vaccine, developed by BIO-NET Asia has already been tested on humans in June
Dengue Vaccine, developed by NSTDA 2021.
HIV Vaccine, developed by the Vaccine Source: Thailand Board of Investment, The Chemical
Trial Centre from Mahidol University Engineer and Thai Publica
Genomics
In parallel to a fast-growing global market, Thailand is in a race to advance its medical
services and R&D. Genomics is recognized as a significant technology to support the position of
Thailand as a medical hub. In 2019, The government announced the national strategic initiative
on precision medicine. The notable projects are as follows.

Genomics Thailand Initiative: The program constitutes a collaborative research network

running a flagship project to sequence the genomes of 50,000 Thai individuals and create a
public genome database enabling precision medicine.
National Biobank of Thailand (NBT): NBT is established with an aim to conserve bio-
resources in Thailand ranging from plant to human genome and convert these specimens into a
genetic database.

The areas of focus identified under the strategic plan are cancer precision medicine, rare
and undiagnosed diseases, non-communicable diseases, non-invasive prenatal testing (NIPT),
newborn screening, pharmacogenomics for rational drug use (RDU), and precision health1.
In 2021, BOI already approved new incentives for the Genomics Thailand project to receive
additional incentives in the EEC area equivalent to other targeted industries2.
Source: 1Genomics Thailand and 2Bangkok Post

Biopharmaceuticals
Despite the high cost of products, biopharmaceuticals are a key partner in tackling non-
communicable diseases that traditional medicine struggles to compete with. It is acceptable to
use as a therapy for chronic diseases such as cancer, and genetic disorders such as Hemophilia
and Anemia. The move to an aging society and incremental changes in health concerns have
shone a bright light on biopharmaceuticals. Some of the products prevalently consumed are
shown in the table.
Table 2 Example of Product, Application, and manufacturers/distributor in Thailand

Biopharma Product Application Manufacturers/Distributors

Insulin Diabetes Eli Lily, Novo Nordisk

Erythropoietin Anemia Amgen, Johnson & Johnson

Interferon α Hepatitis Roche

Factor VIII Hemophilia Bayer

Therapeutic Antibodies Cancer GSK, Amgen

GCSF White Blood Cell Amgen, Sankyo

Source: Advances in Industrial Biotechnology by Ram S. Singh and companies’ website
Government National
and BOI Support Biopharmaceutical
Facility
The following agencies are key stakeholders National Biopharmaceutical Facility (NPF)
in Thailand’s biopharmaceutical industry. They is the first state-owned contract manufacturing
support industries both in terms of academic facility under the collaboration between the
successes and promotion of business King Mongkut’s University of Technology
establishment. Thonburi and BIOTEC. The facility can be
divided into 2 units: Microbial Fermentation
BIOTEC and Cell Culture. NBF provides a variety of
The National Center for Genetic Engineering services to biopharmaceutical manufacturers
and Biotechnology (BIOTEC) is operated under ranging from process development, GMP
the National Science and Technology Development production for a clinical trial, technology
Agency (NSTDA) control. It is located in Thailand transfer, and training and consultancy.
Science Park and functions as a research
institute for agricultural, biomedical, and Chulabphorn
environmental science. The key research Research Institute
prioritization in the medical biotechnology Chulabphorn Research Institute is a
sector is tropical and emerging diseases such biomedical and chemistry research institute
as malaria, tuberculosis, dengue fever, and operated by an independent fund from the Thai
influenza. Apart from providing biotechnology government. The institute’s research activities
infrastructure such as laboratories, it also consist of 9 areas, including natural products,
acts as a policy accelerator that supports the medicinal chemistry, organic synthesis,
linkage between academia and industries. biochemistry, chemical carcinogenesis,
immunology, pharmacology, environmental
TCELS toxicology, and biotechnology. In support of
The Thailand Center of Excellence for the progress towards the development of the
Life Sciences (TCELS) is established with biopharmaceutical industry, the institute aims
the core intention to support, develop, and to build up capabilities in producing high-
facilitate life sciences industries. In partnership quality but less expensive alternative drugs
with domestic and international institutions, sold in Thailand.
it acts as a focal point for all life sciences
stakeholders and creates the central link BOI
between innovation and investment. The The Board of Investment (BOI) offered tax
current focus areas of TCELS include and non-tax incentives for biopharmaceutical-
pharmaceutical and biotechnology, natural related activities. The number of years for CIT
products, biomedical engineering, and medical exemption depends on activities, as shown in
services. TCELS has partnered with NSTDA, the tables.
KMUTT, U Mahidol University, Thai Red Cross
Society, and NVI to research 4 biopharma
products: Erythropoietin, Growth Hormone,
Trastuzumab, and Antibody against EV71.
Table 2: BOI Corporate Income Tax Incentives for Pharmaceuticals
Type of Activities Incentives

Active 8-year CIT exemption

Pharmaceutical * Must be for production of active or raw materials of active pharmaceutical
Ingredients ingredients (APIs)

Manufacturing 8-year CIT exemption

of Targeted * Must engage in the manufacturing of targeted medicines as announced by
Medicines the Ministry of Public Health
* Must be GMP certified in accordance with PIC/S guidelines

Manufacturing 5-year CIT exemption

of Conventional *Must be GMP certified in accordance with PIC/S guidelines
And Traditional
Medicines

Source: Thailand Board of Investment

Table 3: BOI Corporate Income Tax Incentives for Biotechnology Research and Development
Type of Activities Incentives

Research and 8-year CIT exemption (no cap)

development (R&D) * Shall be granted import tax incentives on goods imported for research and
activity and/or development and all related experimentation for a period of one year on each
manufacturing of occasion
biopharmaceutical * Project located in a science and technology park will receive an additional 50
agent using percent reduction of corporate income tax for 5 years after the end of its
biotechnology corporate tax exemption period

Source: Thailand Board of Investment

Regulatory Process
The following illustration describes your investment journey in Thailand. The BOI stands
ready to provide investment facilitation services to ensure that you can fully comply with any
regulatory requirement.

Apply for Submit the application for investment

BOI incentives promotion from Board of Investment

Register Register your business at the Department

your of Business Development, Ministry of
entity Commerce

Get the certificate Obtain the certificate of investment

of investment promotion incentive from the BOI

Establishment of a Manufacturing Site Approval of Drug

Manufacturing
Building Permit and Occupancy At the Thai Food
Dealing with Permit: apply at the Civil Works and Drug Administration
Construction department of the area of your
Permits establishment
Telephone: connect with the TOT Pre-marketing Control
Public Company Limited
License Application
Water: apply at the Provincial or
Metropolitan Waterworks Authority Review manufacturing plant layout
depending on your location before construction
Apply for premise to manufacture,
Getting Connect with the Metropolitan sell or import medicine
Electricity Electricity Authority or the Provincial
Electricity Authority depending on Drug Registration
your location
Apply for drug registration certificates
Registering Submit your documents at the based on the ASEAN Harmonization
Property Land Office, Department of Lands. guideline

Recruitment Understand Thai labor laws and

business incentives for skill
upgrading / training Post-marketing Control

Manufacturing Authorization to Use Land GMDP Inspection

License Authorization for New Factory
Construction or Rental Factory Inspect to verify compliance of IMPs,
Renovations APIs, and finished products
Authorization to begin factory
Import and
Export License e-Custom system

Foreign Business Obtain foreign business license

License if required
 Per above illustration, apart from obtaining the BOI incentives and certificates, allow the BOI
to assist you on the following processes.

Process Details and Contact Point

Dealing With Construction Permits Building Permit and Occupancy Permit:

submit building permit application at the Civil
Works department of the area you are building
your establishment.
Telephone: TOT Public Company Limited
Water: connect with Provincial or Metropolitan
Waterworks Authority depending on your
location

Getting Electricity Connect with the Metropolitan Electricity

Authority or the Provincial Electricity Authority
depending on your location
Registering Property Submit your documents at the Land Office,
Department of Lands.
All corporate documents used in this process
must be certified copies.
Recruitment Key takeaways in understanding labor laws
in Thailand: protections, hours and holiday,
compensation, social security, cessation of
operation, termination, and minimum wage
Understand incentives for labor skill training

Manufacturing License Apply for Authorization to Use Land, Authorization

for New Factory Construction or Rental Factory
Renovations, and Authorization to begin factory
Connect with either the Industrial Estate
Authority of Thailand (IEAT) or the Ministry
of Industry (MOI) Provincial Offices (Dept. of
Industrial Works) depending on the location
of your establishment

Import And Export License Use of e-Custom system for importing and
exporting

Foreign Business License/Certificate Obtain foreign business license if required

per business type
Source: BOI OSOS Investment Center
 Head Office, Office Of The Board Of Investment
555 Vibhavadi-Rangsit Road., Chatuchak, Bangkok 10900, Thailand
Tel: (+66) 2553 8111 Fax: (+66) 2553 8315 Email: head@boi.go.th

www.boi.go.th