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BIOPHARMACEUTICAL
INDUSTRY
Why Thailand for
the Biopharmaceutical
Industry?
	 Following North America and EU,
Southeast and East Asia is ranked 3rd the
highest projected pharmaceutical sales in
2024 with the value of USD 232 billion1. As
part of the region, Thailand’s pharmaceutical
industry has grown and has been considered
one of the top biopharma clusters regarding
its public R&D spending, number of patents,
initial public offerings, number of companies,
and jobs2.
Source: 1Statista and 2Genetic Engineering and
Biotechnology News (2019)
Roadmap to Become
a Pharmaceutical Hub
	 Recently, Thailand has already activated
the policy for a sustainable recovery from
Covid-19, the so-called Bio-Circular-Green
Economy Model (BCG). This model is initially
proposed by the Ministry of Higher Education,
Science, Research, and Innovation (MHESI)
as a new growth engine. The implementation
under the BCG model is projected to span
from 2021 to 2026, with an aim to generate
THB 4.9 trillion at the end of the period. The
total investment is forecasted to be THB
750 billion in 20261. It focuses on 4 s-curve
industries, including medical and wellness.
BCG sets up the mission to reduce the import
value of pharmaceuticals and vaccines worth
approximately THB 100 billion per year.
Source: 1Bangkok Post
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
Antibodies are needed to treat diseases.
	 Apart from internal factors, the global
pandemic has underlined the necessity of the
biopharma industry. The demand for vaccines
has risen sharply. Thailand embraces these
opportunities and leverages the potential to
become a production base for vaccines, rapid
tests, and genomic products. It successfully
attracted investors such as AstraZeneca,
KinGen Biotech, and Apsalagen.
Source: 1UN World Population Prospects
Healthcare Destination
	 Due to robust healthcare infrastructure,
state-of-the-art medical facilities, highly skilled
professionals, and affordable costs, Thailand
is undoubtedly the destination for patients
from abroad. Approximately 3.5 million tourists
visited Thailand in 2019 and spent USD 726
million on healthcare services, accounting for
9% of the global total. It is the only country in
Southeast Asia placed in the top 151. As of
July 2021, there are 61 Thai medical institutes
across every region of the country that are
Joint Commission International-Accredited,
ensuring the world-class status of medical
facilities. Thailand not only offers the opportunities
of the market, but it also accommodates
investors with a comprehensive supply chain
from upstream to downstream industries.
Manufacturers can access essential raw
materials,clinicaltrialcentersfortestingdrugs,
and manufacturing facilities for production.
Source: 1IMF
Fully Integrated R&D Hub
	 The existence of the following infrastructure
and facilities has made Thailand a prime hub
for biotechnology research and development.
	
	 	 ThailandSciencePark:Thiscountry’s
first science and technology park offers facilities,
business space, and a range of services to
promoteinnovationdevelopmentintheprivate
sector. It is also a home for 110 firms and
national research institutions and laboratories
such as BIOTEC, TCELS CPU, and GMP
Production Unit for Cell and Gene Therapy
(CPU).
	 	 Biopolis: The area established in the
EasternEconomicCorridorofInnovation(EECi)
exists as an innovation center and industrial
cluster for life sciences and biotechnology.
It provides long-term land leases, laboratory
spaces, testbeds, and incentives for investors
to scale up their research activities to mass
commercialization.
	 	 Center for Medical Genomics (CMG):
The institution is under the control of the
Faculty of Medicine Ramathibodi Hospital,
Mahidol University. It positions itself as a
platform to advance the region’s genomic
toolkit. Since 2014, CMG has joined forces
with TCELS on pharmacogenomics research
to increase Thailand’s competitiveness in
genomic medicine.
Notable Manufacturing Plants
in Thailand
	 Biopharmaceutical manufacturers companies
can be divided into 3 categories: international
companies establishing manufacturing facilities
in Thailand, a joint venture between government
agencies and international companies, and
Thai manufacturers. The example of them is
as follows.
Plants
Thai Red Cross
Plasma Fractionation
Centre
Geo-Merieux
Biological Products
GPO Influenza
Vaccine Plant
Bionet-Asia
Siam Bioscience
Austrianova
About
	Transferredtechnologyfrom
	 KoreanGreenCross
	Onlyplasmaproduct
	 manufacturingfacility
	 inSoutheastAsia
	JointventurebetweenGPO,
	 SanofiandCPBEquity
	Egg-basedfluvaccinefacility
	Thai-Frenchprivatelyheld
	 biotechcompany
	Focusingonre-emerging
	diseases
	ThefirstThaibiopharmaceutical
	manufacturer
	2subsidiaries:Abinisand
	 InnoBiocosmed
	Biotechcompanybased
	 inSingapore
	Expertincellbiologyand
	 encapsulationoflivingcells
	Isolator-basedmanufacturing
	processes
Main Products
	Albumin
	IVIG
	FactorVIII
	Fluvaccine
	JEvaccine
	Rabiesvaccine
	HepatitisBvaccine
	Seasonalfluvaccine
	Pentavalentvaccine
	Erythropoietin
	Filgrastim
	Fullservicefor
	 cell-basedproducts
Source: TCELS, Bionet-Asia, Siam Bioscience
Table1:ExistingBiopharmaceuticalPlantsinThailand
Overview of
Pharmaceutical
Industry
	 Driven by prominent factors including
demographic shift, the prevalence of chronic
diseases and the Covid-19 outbreak, the
global pharmaceutical market is expected to
grow from USD 405.52 billion in 2020 to USD
486.62 billion in 2021 at approximately 20%
year-over-year growth1.
Source: 1Acumen Research and Consulting
Overall Pharmaceutical Market
	 In 2018, the sales value of pharmaceuticals
in Thailand was USD 5.47 Billion. It is expected
to reach USD 6.9 billion in 2024, which accounts
for 1.1% of gross domestic product (GDP)1.
The market size of Thailand has been the
second largest in Southeast Asia, after Indonesia.
The growing demand for medicines and treatment
leads to the expansion of the domestic market
by an annual average rate of 4.5%2.
Source: 1Fitch Solution and 2Krungsri Research
Production
	 The manufacturers in Thailand usually
import active ingredients such as aluminum
hydroxide, aspirin, sodium bicarbonate, or
deferiprone to mix and produce the finished
generic drugs in-house. As of August 2021,
148 domestic pharmaceuticals producers were
accredited with Good Manufacturing Practice
(GMP) standard1. In 2020, investments in a
pharmaceutical and chemical market were
worth a value of THB 16.32 billion which the
top contributors are from Thailand, Japan,
India,Switzerland,andCuba.Thespending 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
pharmaceuticalsarefromAlimentaryTractand
Metabolism, General Anti-infective-systemic,
Cardiovascular system, Dermatological, and
Hospital Solutions3.
Source: 1Thai FDA, 2Statista (2020) and 3Statista (2018)
Distribution
	 Duetotheexpansionofnationaluniversal
healthcare coverage, there is a surge in
demand for medicines from the domestic
market. Approximately 90% of pharmaceutical
output is distributed within the country, leaving
10%tradedinaninternationalmarket.In2020,
Thailand exported around THB 17.73 billion,
with 3.34% CAGR growth over 5 years. The
large share of export went to Asian countries.
The top 5 destination took 58% of total value
including Vietnam, Myanmar, Cambodia, Japan,
and the Philippines. However, Thailand still
needed to import some high-value products
that were unable to produce domestically to
satisfy the domestic demand. The value of
imports was worth THB 77.83 billion in 2020,
while the CAGR growth over 5 years was
2.16%. The main partners are Germany, the
USA, France, India, and Japan1. This gap opens
opportunities for investors to enter the market
with strong potential for growth.
	 The main destination for the domestic
market is hospitals, where government and
private hospitals share 60% and 20% of total
output. Most of the medicines distributed
through this channel are prescription drugs.
Therestbecomesover-the-countermedicines
sold by pharmacists, which have represented
astableshareoveryears2.In2019,therewere
20,516 registered pharmacies nationwide
while the number of pharmacists constantly
rised from 7,690 in 2009 to 15,040 in 20193.
Source: 1Ministry of Commerce, 2Krungsri Research
and 3Statista
Investment
Opportunities
	 Biotechnologyissetasaprioritysectorto
promote a post-Covid 19 recovery. In the first
quarter of 2021, BOI approved new projects
in this field worth around THB 2.4 million. This
reflects investors’ confidence in the sector’s
capabilities and opportunities from much
broader and more diverse activities. Medical
biotechnologies such as vaccines, genomics,
and biopharmaceuticals are now under the
spotlight and attract multiple manufacturers to
launch and scale up their businesses.
Vaccines
	 Thailand has established itself as the
leading developer of vaccines in ASEAN
due to its high caliber of researchers and
vaccine developers. Some of the remarkable
vaccines developed by Thai manufacturers
and laboratories are:
	 	 Cocktail Vaccine (5-in-1), developed
		 by NSTDA and BIO-NET Asia
	 	 Haemophilus influenzae type b (Hib)
		 Vaccine, developed by BIO-NET Asia
	 	 DengueVaccine,developedbyNSTDA
	 	 HIVVaccine,developedbytheVaccine
		 Trial Centre from Mahidol University
	 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
production. The money was allocated to fund
many projects from both private companies
and public agencies. Several organizations
and companies are in promising progress of
Covid-19 vaccine development.
	
	 	 Siam Bioscience: The company is
selectedbyAstraZenecatolicenseitsvaccine
and currently supplies doses to Thailand and
other countries in the region
	 	 GPO Saraburi: The vaccine facility
in Saraburi with the assistance from Texas
University, is currently in Phase 1 of developing
egg-based Covid-19 vaccine from its influenza
technology
	 	 Baiya Phytopharm: The Thai startup
has developed its vaccine from plant leaves
and has already passed a laboratory animal
test.
	 	 BioNet-Asia: Phase 1 of the vaccine,
so-called COVIGEN, has been already approved
by the University of Sydney
	 	 Chulalongkorn University: The Chula
Vaccine Research Center, in collaboration
with Pennsylvania University, has developed
an mRNA vaccine, ChulaCov19. The vaccine
has already been tested on humans in June
2021.
Source: Thailand Board of Investment, The Chemical
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
useasatherapyforchronicdiseasessuchascancer,andgeneticdisorderssuchasHemophilia
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.
Biopharma Product
Insulin
Erythropoietin
Interferon α
Factor VIII
Therapeutic Antibodies
GCSF
Application
Diabetes
Anemia
Hepatitis
Hemophilia
Cancer
White Blood Cell
Manufacturers/Distributors
EliLily,NovoNordisk
Amgen,Johnson&Johnson
Roche
Bayer
GSK,Amgen
Amgen,Sankyo
Source: Advances in Industrial Biotechnology by Ram S. Singh and companies’ website
Table 2 Example of Product, Application, and manufacturers/distributor in Thailand
Government
and BOI Support
	
	 Thefollowingagenciesarekeystakeholders
inThailand’sbiopharmaceuticalindustry.They
support industries both in terms of academic
successes and promotion of business
establishment.
BIOTEC
	 TheNationalCenterforGeneticEngineering
and Biotechnology (BIOTEC) is operated under
theNationalScienceandTechnologyDevelopment
Agency (NSTDA) control. It is located in Thailand
Science Park and functions as a research
institute for agricultural, biomedical, and
environmental science. The key research
prioritization in the medical biotechnology
sector is tropical and emerging diseases such
as malaria, tuberculosis, dengue fever, and
influenza. Apart from providing biotechnology
infrastructure such as laboratories, it also
acts as a policy accelerator that supports the
linkage between academia and industries.
TCELS
	 The Thailand Center of Excellence for
Life Sciences (TCELS) is established with
the core intention to support, develop, and
facilitate life sciences industries. In partnership
with domestic and international institutions,
it acts as a focal point for all life sciences
stakeholders and creates the central link
between innovation and investment. The
current focus areas of TCELS include
pharmaceutical and biotechnology, natural
products, biomedical engineering, and medical
services. TCELS has partnered with NSTDA,
KMUTT, U Mahidol University, Thai Red Cross
Society, and NVI to research 4 biopharma
products: Erythropoietin, Growth Hormone,
Trastuzumab, and Antibody against EV71.
National
Biopharmaceutical
Facility
	 NationalBiopharmaceuticalFacility(NPF)
isthefirststate-ownedcontractmanufacturing
facility under the collaboration between the
King Mongkut’s University of Technology
Thonburi and BIOTEC. The facility can be
divided into 2 units: Microbial Fermentation
and Cell Culture. NBF provides a variety of
services to biopharmaceutical manufacturers
ranging from process development, GMP
production for a clinical trial, technology
transfer, and training and consultancy.
Chulabphorn
Research Institute
	 Chulabphorn Research Institute is a
biomedical and chemistry research institute
operatedbyanindependentfundfromtheThai
government. The institute’s research activities
consist of 9 areas, including natural products,
medicinal chemistry, organic synthesis,
biochemistry, chemical carcinogenesis,
immunology, pharmacology, environmental
toxicology, and biotechnology. In support of
the progress towards the development of the
biopharmaceutical industry, the institute aims
to build up capabilities in producing high-
quality but less expensive alternative drugs
sold in Thailand.
BOI
	 TheBoardofInvestment(BOI)offeredtax
andnon-taxincentivesforbiopharmaceutical-
related activities. The number of years for CIT
exemption depends on activities, as shown in
the tables.
Active
Pharmaceutical
Ingredients
Manufacturing
of Targeted
Medicines
Manufacturing
of Conventional
And Traditional
Medicines
Research and
development (R&D)
activity and/or
manufacturing of
biopharmaceutical
agent using
biotechnology
8-year CIT exemption
*	Must be for production of active or raw materials of active pharmaceutical
	 ingredients (APIs)
8-year CIT exemption
*	Must engage in the manufacturing of targeted medicines as announced by
	 the Ministry of Public Health
*	Must be GMP certified in accordance with PIC/S guidelines
5-year CIT exemption
*Must be GMP certified in accordance with PIC/S guidelines
8-year CIT exemption (no cap)
*	Shall be granted import tax incentives on goods imported for research and
	 development and all related experimentation for a period of one year on each
	occasion
* Project located in a science and technology park will receive an additional 50
	percent reduction of corporate income tax for 5 years after the end of its
	 corporate tax exemption period
Incentives
Incentives
Type of Activities
Type of Activities
Table 2: BOI Corporate Income Tax Incentives for Pharmaceuticals
Table3:BOICorporateIncomeTaxIncentivesforBiotechnologyResearchandDevelopment
Source: Thailand Board of Investment
Source: Thailand Board of Investment
Apply for
BOI incentives
Register
your
entity
Get the certificate
of investment promotion
Submit the application for investment
promotion from Board of Investment
RegisteryourbusinessattheDepartment
of Business Development, Ministry of
Commerce
Obtain the certificate of investment
incentive from the BOI
Establishment of a Manufacturing Site Approval of Drug
Manufacturing
Building Permit and Occupancy
Permit: apply at the Civil Works
department of the area of your
establishment
At the Thai Food
and Drug Administration
Pre-marketing Control
License Application
	Reviewmanufacturingplantlayout
	 before construction
	Apply for premise to manufacture,
	 sell or import medicine
Drug Registration
Applyfordrugregistrationcertificates
based on the ASEAN Harmonization
guideline
Dealing with
Construction
Permits
Telephone:connectwiththeTOT
Public Company Limited
Water: apply at the Provincial or
Metropolitan Waterworks Authority
depending on your location
Connect with the Metropolitan
Electricity Authority or the Provincial
Electricity Authority depending on
your location
Getting
Electricity
Submit your documents at the
LandOffice,DepartmentofLands.
Obtain foreign business license
if required
	Authorization to Use Land
	Authorization for New Factory
	 Construction or Rental Factory
	Renovations
	Authorization to begin factory
Understand Thai labor laws and
business incentives for skill
upgrading / training
e-Custom system
Foreign Business
License
Import and
Export License
Registering
Property
Manufacturing
License
Recruitment
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.
Post-marketing Control
GMDP Inspection
Inspect to verify compliance of IMPs,
APIs, and finished products
Process
Dealing With Construction Permits
Getting Electricity
Registering Property
Recruitment
Manufacturing License
Import And Export License
Foreign Business License/Certificate
Details and Contact Point
	 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
	 Connect with the Metropolitan Electricity
	 AuthorityortheProvincialElectricityAuthority
	 depending on your location
	 Submit your documents at the Land Office,
	 Department of Lands.
	 Allcorporatedocumentsusedinthisprocess
	 must be certified copies.
	 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
	 ApplyforAuthorizationtoUseLand,Authorization
	 for New Factory Construction or Rental Factory
	 Renovations,andAuthorizationtobeginfactory
	 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
	 Use of e-Custom system for importing and
	exporting
	 Obtain foreign business license if required
	 per business type
Source: BOI OSOS Investment Center
	 Peraboveillustration,apartfromobtainingtheBOIincentivesandcertificates,allowtheBOI
to assist you on the following processes.
Head Office, Office Of The Board Of Investment
555Vibhavadi-RangsitRoad.,Chatuchak,Bangkok10900,Thailand
Tel: (+66) 2553 8111 Fax: (+66) 2553 8315 Email: head@boi.go.th
www.boi.go.th

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Biopharmaceutical Industry

  • 2.
  • 3. Why Thailand for the Biopharmaceutical Industry? Following North America and EU, Southeast and East Asia is ranked 3rd the highest projected pharmaceutical sales in 2024 with the value of USD 232 billion1. As part of the region, Thailand’s pharmaceutical industry has grown and has been considered one of the top biopharma clusters regarding its public R&D spending, number of patents, initial public offerings, number of companies, and jobs2. Source: 1Statista and 2Genetic Engineering and Biotechnology News (2019) Roadmap to Become a Pharmaceutical Hub Recently, Thailand has already activated the policy for a sustainable recovery from Covid-19, the so-called Bio-Circular-Green Economy Model (BCG). This model is initially proposed by the Ministry of Higher Education, Science, Research, and Innovation (MHESI) as a new growth engine. The implementation under the BCG model is projected to span from 2021 to 2026, with an aim to generate THB 4.9 trillion at the end of the period. The total investment is forecasted to be THB 750 billion in 20261. It focuses on 4 s-curve industries, including medical and wellness. BCG sets up the mission to reduce the import value of pharmaceuticals and vaccines worth approximately THB 100 billion per year. Source: 1Bangkok Post 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 Antibodies are needed to treat diseases. Apart from internal factors, the global pandemic has underlined the necessity of the biopharma industry. The demand for vaccines has risen sharply. Thailand embraces these opportunities and leverages the potential to become a production base for vaccines, rapid tests, and genomic products. It successfully attracted investors such as AstraZeneca, KinGen Biotech, and Apsalagen. Source: 1UN World Population Prospects Healthcare Destination Due to robust healthcare infrastructure, state-of-the-art medical facilities, highly skilled professionals, and affordable costs, Thailand is undoubtedly the destination for patients from abroad. Approximately 3.5 million tourists visited Thailand in 2019 and spent USD 726 million on healthcare services, accounting for 9% of the global total. It is the only country in Southeast Asia placed in the top 151. As of July 2021, there are 61 Thai medical institutes across every region of the country that are Joint Commission International-Accredited, ensuring the world-class status of medical facilities. Thailand not only offers the opportunities of the market, but it also accommodates investors with a comprehensive supply chain from upstream to downstream industries. Manufacturers can access essential raw materials,clinicaltrialcentersfortestingdrugs, and manufacturing facilities for production. Source: 1IMF
  • 4. Fully Integrated R&D Hub The existence of the following infrastructure and facilities has made Thailand a prime hub for biotechnology research and development. ThailandSciencePark:Thiscountry’s first science and technology park offers facilities, business space, and a range of services to promoteinnovationdevelopmentintheprivate sector. It is also a home for 110 firms and national research institutions and laboratories such as BIOTEC, TCELS CPU, and GMP Production Unit for Cell and Gene Therapy (CPU). Biopolis: The area established in the EasternEconomicCorridorofInnovation(EECi) exists as an innovation center and industrial cluster for life sciences and biotechnology. It provides long-term land leases, laboratory spaces, testbeds, and incentives for investors to scale up their research activities to mass commercialization. Center for Medical Genomics (CMG): The institution is under the control of the Faculty of Medicine Ramathibodi Hospital, Mahidol University. It positions itself as a platform to advance the region’s genomic toolkit. Since 2014, CMG has joined forces with TCELS on pharmacogenomics research to increase Thailand’s competitiveness in genomic medicine. Notable Manufacturing Plants in Thailand Biopharmaceutical manufacturers companies can be divided into 3 categories: international companies establishing manufacturing facilities in Thailand, a joint venture between government agencies and international companies, and Thai manufacturers. The example of them is as follows.
  • 5. Plants Thai Red Cross Plasma Fractionation Centre Geo-Merieux Biological Products GPO Influenza Vaccine Plant Bionet-Asia Siam Bioscience Austrianova About Transferredtechnologyfrom KoreanGreenCross Onlyplasmaproduct manufacturingfacility inSoutheastAsia JointventurebetweenGPO, SanofiandCPBEquity Egg-basedfluvaccinefacility Thai-Frenchprivatelyheld biotechcompany Focusingonre-emerging diseases ThefirstThaibiopharmaceutical manufacturer 2subsidiaries:Abinisand InnoBiocosmed Biotechcompanybased inSingapore Expertincellbiologyand encapsulationoflivingcells Isolator-basedmanufacturing processes Main Products Albumin IVIG FactorVIII Fluvaccine JEvaccine Rabiesvaccine HepatitisBvaccine Seasonalfluvaccine Pentavalentvaccine Erythropoietin Filgrastim Fullservicefor cell-basedproducts Source: TCELS, Bionet-Asia, Siam Bioscience Table1:ExistingBiopharmaceuticalPlantsinThailand
  • 6. Overview of Pharmaceutical Industry Driven by prominent factors including demographic shift, the prevalence of chronic diseases and the Covid-19 outbreak, the global pharmaceutical market is expected to grow from USD 405.52 billion in 2020 to USD 486.62 billion in 2021 at approximately 20% year-over-year growth1. Source: 1Acumen Research and Consulting Overall Pharmaceutical Market In 2018, the sales value of pharmaceuticals in Thailand was USD 5.47 Billion. It is expected to reach USD 6.9 billion in 2024, which accounts for 1.1% of gross domestic product (GDP)1. The market size of Thailand has been the second largest in Southeast Asia, after Indonesia. The growing demand for medicines and treatment leads to the expansion of the domestic market by an annual average rate of 4.5%2. Source: 1Fitch Solution and 2Krungsri Research Production The manufacturers in Thailand usually import active ingredients such as aluminum hydroxide, aspirin, sodium bicarbonate, or deferiprone to mix and produce the finished generic drugs in-house. As of August 2021, 148 domestic pharmaceuticals producers were accredited with Good Manufacturing Practice (GMP) standard1. In 2020, investments in a pharmaceutical and chemical market were worth a value of THB 16.32 billion which the top contributors are from Thailand, Japan, India,Switzerland,andCuba.Thespending 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 pharmaceuticalsarefromAlimentaryTractand Metabolism, General Anti-infective-systemic, Cardiovascular system, Dermatological, and Hospital Solutions3. Source: 1Thai FDA, 2Statista (2020) and 3Statista (2018) Distribution Duetotheexpansionofnationaluniversal healthcare coverage, there is a surge in demand for medicines from the domestic market. Approximately 90% of pharmaceutical output is distributed within the country, leaving 10%tradedinaninternationalmarket.In2020, Thailand exported around THB 17.73 billion, with 3.34% CAGR growth over 5 years. The large share of export went to Asian countries. The top 5 destination took 58% of total value including Vietnam, Myanmar, Cambodia, Japan, and the Philippines. However, Thailand still needed to import some high-value products that were unable to produce domestically to satisfy the domestic demand. The value of imports was worth THB 77.83 billion in 2020, while the CAGR growth over 5 years was 2.16%. The main partners are Germany, the USA, France, India, and Japan1. This gap opens opportunities for investors to enter the market with strong potential for growth. The main destination for the domestic market is hospitals, where government and private hospitals share 60% and 20% of total output. Most of the medicines distributed through this channel are prescription drugs. Therestbecomesover-the-countermedicines sold by pharmacists, which have represented astableshareoveryears2.In2019,therewere 20,516 registered pharmacies nationwide while the number of pharmacists constantly rised from 7,690 in 2009 to 15,040 in 20193. Source: 1Ministry of Commerce, 2Krungsri Research and 3Statista
  • 7. Investment Opportunities Biotechnologyissetasaprioritysectorto promote a post-Covid 19 recovery. In the first quarter of 2021, BOI approved new projects in this field worth around THB 2.4 million. This reflects investors’ confidence in the sector’s capabilities and opportunities from much broader and more diverse activities. Medical biotechnologies such as vaccines, genomics, and biopharmaceuticals are now under the spotlight and attract multiple manufacturers to launch and scale up their businesses. Vaccines Thailand has established itself as the leading developer of vaccines in ASEAN due to its high caliber of researchers and vaccine developers. Some of the remarkable vaccines developed by Thai manufacturers and laboratories are: Cocktail Vaccine (5-in-1), developed by NSTDA and BIO-NET Asia Haemophilus influenzae type b (Hib) Vaccine, developed by BIO-NET Asia DengueVaccine,developedbyNSTDA HIVVaccine,developedbytheVaccine Trial Centre from Mahidol University 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 production. The money was allocated to fund many projects from both private companies and public agencies. Several organizations and companies are in promising progress of Covid-19 vaccine development. Siam Bioscience: The company is selectedbyAstraZenecatolicenseitsvaccine and currently supplies doses to Thailand and other countries in the region GPO Saraburi: The vaccine facility in Saraburi with the assistance from Texas University, is currently in Phase 1 of developing egg-based Covid-19 vaccine from its influenza technology Baiya Phytopharm: The Thai startup has developed its vaccine from plant leaves and has already passed a laboratory animal test. BioNet-Asia: Phase 1 of the vaccine, so-called COVIGEN, has been already approved by the University of Sydney Chulalongkorn University: The Chula Vaccine Research Center, in collaboration with Pennsylvania University, has developed an mRNA vaccine, ChulaCov19. The vaccine has already been tested on humans in June 2021. Source: Thailand Board of Investment, The Chemical Engineer and Thai Publica
  • 8. 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 useasatherapyforchronicdiseasessuchascancer,andgeneticdisorderssuchasHemophilia 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. Biopharma Product Insulin Erythropoietin Interferon α Factor VIII Therapeutic Antibodies GCSF Application Diabetes Anemia Hepatitis Hemophilia Cancer White Blood Cell Manufacturers/Distributors EliLily,NovoNordisk Amgen,Johnson&Johnson Roche Bayer GSK,Amgen Amgen,Sankyo Source: Advances in Industrial Biotechnology by Ram S. Singh and companies’ website Table 2 Example of Product, Application, and manufacturers/distributor in Thailand
  • 9. Government and BOI Support Thefollowingagenciesarekeystakeholders inThailand’sbiopharmaceuticalindustry.They support industries both in terms of academic successes and promotion of business establishment. BIOTEC TheNationalCenterforGeneticEngineering and Biotechnology (BIOTEC) is operated under theNationalScienceandTechnologyDevelopment Agency (NSTDA) control. It is located in Thailand Science Park and functions as a research institute for agricultural, biomedical, and environmental science. The key research prioritization in the medical biotechnology sector is tropical and emerging diseases such as malaria, tuberculosis, dengue fever, and influenza. Apart from providing biotechnology infrastructure such as laboratories, it also acts as a policy accelerator that supports the linkage between academia and industries. TCELS The Thailand Center of Excellence for Life Sciences (TCELS) is established with the core intention to support, develop, and facilitate life sciences industries. In partnership with domestic and international institutions, it acts as a focal point for all life sciences stakeholders and creates the central link between innovation and investment. The current focus areas of TCELS include pharmaceutical and biotechnology, natural products, biomedical engineering, and medical services. TCELS has partnered with NSTDA, KMUTT, U Mahidol University, Thai Red Cross Society, and NVI to research 4 biopharma products: Erythropoietin, Growth Hormone, Trastuzumab, and Antibody against EV71. National Biopharmaceutical Facility NationalBiopharmaceuticalFacility(NPF) isthefirststate-ownedcontractmanufacturing facility under the collaboration between the King Mongkut’s University of Technology Thonburi and BIOTEC. The facility can be divided into 2 units: Microbial Fermentation and Cell Culture. NBF provides a variety of services to biopharmaceutical manufacturers ranging from process development, GMP production for a clinical trial, technology transfer, and training and consultancy. Chulabphorn Research Institute Chulabphorn Research Institute is a biomedical and chemistry research institute operatedbyanindependentfundfromtheThai government. The institute’s research activities consist of 9 areas, including natural products, medicinal chemistry, organic synthesis, biochemistry, chemical carcinogenesis, immunology, pharmacology, environmental toxicology, and biotechnology. In support of the progress towards the development of the biopharmaceutical industry, the institute aims to build up capabilities in producing high- quality but less expensive alternative drugs sold in Thailand. BOI TheBoardofInvestment(BOI)offeredtax andnon-taxincentivesforbiopharmaceutical- related activities. The number of years for CIT exemption depends on activities, as shown in the tables.
  • 10. Active Pharmaceutical Ingredients Manufacturing of Targeted Medicines Manufacturing of Conventional And Traditional Medicines Research and development (R&D) activity and/or manufacturing of biopharmaceutical agent using biotechnology 8-year CIT exemption * Must be for production of active or raw materials of active pharmaceutical ingredients (APIs) 8-year CIT exemption * Must engage in the manufacturing of targeted medicines as announced by the Ministry of Public Health * Must be GMP certified in accordance with PIC/S guidelines 5-year CIT exemption *Must be GMP certified in accordance with PIC/S guidelines 8-year CIT exemption (no cap) * Shall be granted import tax incentives on goods imported for research and development and all related experimentation for a period of one year on each occasion * Project located in a science and technology park will receive an additional 50 percent reduction of corporate income tax for 5 years after the end of its corporate tax exemption period Incentives Incentives Type of Activities Type of Activities Table 2: BOI Corporate Income Tax Incentives for Pharmaceuticals Table3:BOICorporateIncomeTaxIncentivesforBiotechnologyResearchandDevelopment Source: Thailand Board of Investment Source: Thailand Board of Investment
  • 11.
  • 12. Apply for BOI incentives Register your entity Get the certificate of investment promotion Submit the application for investment promotion from Board of Investment RegisteryourbusinessattheDepartment of Business Development, Ministry of Commerce Obtain the certificate of investment incentive from the BOI Establishment of a Manufacturing Site Approval of Drug Manufacturing Building Permit and Occupancy Permit: apply at the Civil Works department of the area of your establishment At the Thai Food and Drug Administration Pre-marketing Control License Application Reviewmanufacturingplantlayout before construction Apply for premise to manufacture, sell or import medicine Drug Registration Applyfordrugregistrationcertificates based on the ASEAN Harmonization guideline Dealing with Construction Permits Telephone:connectwiththeTOT Public Company Limited Water: apply at the Provincial or Metropolitan Waterworks Authority depending on your location Connect with the Metropolitan Electricity Authority or the Provincial Electricity Authority depending on your location Getting Electricity Submit your documents at the LandOffice,DepartmentofLands. Obtain foreign business license if required Authorization to Use Land Authorization for New Factory Construction or Rental Factory Renovations Authorization to begin factory Understand Thai labor laws and business incentives for skill upgrading / training e-Custom system Foreign Business License Import and Export License Registering Property Manufacturing License Recruitment 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. Post-marketing Control GMDP Inspection Inspect to verify compliance of IMPs, APIs, and finished products
  • 13. Process Dealing With Construction Permits Getting Electricity Registering Property Recruitment Manufacturing License Import And Export License Foreign Business License/Certificate Details and Contact Point 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 Connect with the Metropolitan Electricity AuthorityortheProvincialElectricityAuthority depending on your location Submit your documents at the Land Office, Department of Lands. Allcorporatedocumentsusedinthisprocess must be certified copies. 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 ApplyforAuthorizationtoUseLand,Authorization for New Factory Construction or Rental Factory Renovations,andAuthorizationtobeginfactory 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 Use of e-Custom system for importing and exporting Obtain foreign business license if required per business type Source: BOI OSOS Investment Center Peraboveillustration,apartfromobtainingtheBOIincentivesandcertificates,allowtheBOI to assist you on the following processes.
  • 14.
  • 15.
  • 16. Head Office, Office Of The Board Of Investment 555Vibhavadi-RangsitRoad.,Chatuchak,Bangkok10900,Thailand Tel: (+66) 2553 8111 Fax: (+66) 2553 8315 Email: head@boi.go.th www.boi.go.th