BIOTECHNOLOGY

December 2023
For updated information, please visit www.ibef.org
Table of Contents

Executive Summary 3

Advantage India 5

Market Overview 7

Recent Trends and Strategies 11

Growth Drivers 18

Opportunities 22

Key Industry Contacts 28

Appendix 31

2
Executive summary
2. STRONG START-UP ECOSYSTEM
• India has a strong start-up ecosystem, originating from gradual
improvements in the ease of doing business, proof-of-concept
funds for start-ups, and favourable government policies.
• The biotechnology industry in India comprises 760 core biotech
companies, 100 biotech incubators and 6,000 biotech start-ups,
which are estimated to reach 10,000 by 2025.
1. GLOBAL POSITION
• India is among the top 12
biotechnology destinations in the world
and the third-largest in the Asia-Pacific
region. The country holds ~3% of the
global biotechnology industry pie. The
country is also the world’s third-largest
producer of recombinant Hepatitis B
vaccine and second-largest producer
of BT cotton.
• The country is one of the world’s
leading suppliers of DPT, BCG &
measles vaccines, contributing 70% to
WHO’s vaccines.
• India was one of the first countries to
establish a Biotechnology Department.
• India’s bio-economy industry has
grown from US$ 8 billion in 2014 to
US$ 100 billion in the last 8 years in
2022. Moreover, it is expected to
1 4
reach US$ 150 billion by 2025 and
US$ 300 billion by 2030.
3. STRONG GROWTH IN BIOPHARMACEUTICALS
• In the Indian bio-economy market, bio-pharmaceuticals and medical devices
industry are the two largest segments, accounting for for nearly 62% of the total
contribution.
• The Indian biotechnology industry growth is driven by vaccines and recombinant
therapeutics. By 2025, the vaccination market in India is projected to be worth
US$ 3.04 billion (Rs. 252 billion).
• In January 2022, BIRAC made a major contribution to developing the world's
first Intranasal vaccine for Covid through Bharat Biotech International Limited
(BBIL).
• In December 2022, the world's first COVID-19 intranasal vaccine, iNCOVACC was
launched which has been developed by Bharat Biotech.
4. LEADING DESTINATION
FOR CLINICAL TRIALS
• The New Drugs and Clinical Trials Rules,
2019 were developed to create a
streamlined legal framework for the
biopharmaceutical market to reduce costs,
02 03 approval timelines and cut bureaucratic
2 3 •
red tape.
In October 2021, drug firm AstraZeneca
launched a clinical data and insights
division in Bengaluru, India, for data-
related management of its clinical trials.
• In November 2021, US-based Akston
Biosciences announced that it will start
clinical trials of its second-generation
Covid-19 vaccine ‘AKS-452’ in India soon.

Notes: BT Cotton: Genetically modified pest resistant plant cotton, DPT: diphtheria, pertussis, tetanus, BCG: Bacille Calmette-Guerin
Source: Global Bio-India 2019, Biotechnology Industry Research Assistance Council, FDI India

3
Key Statistics: Department of Biotechnology

International
Ongoing Projects Projects Research
Collaborative
as of December Sanctioned as of Personnel as of
Projects as of
2023 December 2023 December 2023
December 2023

1,484 5,462 10 48,502

Technology Patents Scientists

Publications as of
Generated as of Filed as of Supported as of
December 2023
December 2023 December 2023 December 2023

1,020 1,171 22,128 22,708

Source: Department of Biotechnology

4
Advantage India

5
Advantage India
1. Skilled human capital
► With a total population of 1.4 billion, 47%
being under the age of 25, India has a large
pool of young and skilled workforce.
► India has a large reservoir of scientific human
resources including scientists and engineers.
► Biotechnology has emerged as a trending
career option among the youth. According to
a survey of Class 12th students in Delhi,
Biotechnology was ranked as the preferred
stream at No.4/5.
2. Infrastructure facilities
► 9 DBT-supported biotech parks and 60
BIRAC-supported bio-incubators.
► In the Union Budget 2023-24, the
Department of Biotechnology (DBT) was
allotted US$ 162.7 million (Rs. 1,345 crore).
► Dr. Jitendra Singh inaugurates the
Northeast's first International Biotech
Conclave.
► In February 2023, Serum Institute of India
announces centre of excellence in
Hyderabad to tackle future pandemics.
► Dr. Jitendra Singh, inaugurated a new
Biotechnology Centre for Northeast tribals in
the remote area of Kimin (Arunachal
Pradesh).
► In July 2023, 15 companies sign MoUs
worth Rs. 2,000 crore (US$ 239.99 million),
in a day, for investments in biotech sector.
Source: Department of Biotechnology, FDI India
6
4. Epidemiological factors
► Patient pool expected to increase over
20% in the next 10 years, mainly due
to rise in population.
► New diseases & lifestyle changes to
boost demand for drugs and devices.
3. Policy support
► National Biopharma Mission is
1 4 supporting 101 projects including more
than 150 organizations and 30 MSMEs. It
has increased employment opportunities
and engaged 1,065 manpower including
304 scientists/ researchers.
ADVANTAGE
INDIA ► While 74% is permitted under automatic
2 3 route for brownfield projects, 100% under
government route is permitted for
brownfield investments.
► Mission COVID Suraksha was announced
by the Government of India to accelerate
the development and production of
indigenous COVID vaccines.
► The National Biotechnology
Development Strategy 2020-25, provides
the government with a platform to
strengthen skill development, resource
and innovation converging into one
strong ecosystem for knowledge sharing.
Market Overview

7
Biotechnology market

▪ The biotechnology sector in India is witnessing a strong growth trajectory

and has proved to be highly inventive. Indian biotechnology industry valuation (US$ billion)
▪ The biotechnology sector, mainly due to its multidisciplinary approach,
160 150
holds the potential to provide an array of solutions for challenges in CAGR 16.4%
various sectors such as health, agriculture, environment, energy, and 140
industrial processes.
120
▪ India is among the top 12 biotechnology destinations in the world and the 100
100
third-largest in the Asia-Pacific region. The Indian biotech industry holds
3-5% of the global market share. 80
63
▪ The Indian bioeconomy grew from US$ 70.2 billion in 2020 to US$ 100 60 51
44
billion in 2022, growing at a CAGR of 19.35%. There are a total of 6,000 40
biotech startups in India in 2023.
20
▪ India’s bio-economy industry has grown from US$ 10 billion in 2015 to
US$ 80 billion in the last 8 years in 2023. 0
FY17 FY18 FY19 FY23 FY25
▪ The Indian biotechnology industry is likely to reach US$ 150 billion by
2025 and has the potential to reach US$ 270-300 billion by the year 2030.
▪ By 2025, the contribution of the Indian biotechnology industry in the
global biotechnology market is expected to increase to ~19%.
Indian bioeconomy at a glance (2023)

▪ India has 665 FDA-approved plants outside of the US, which is the
highest in the world. India also has a 44% share of the global abbreviated
new drug applications (ANDA) and >1400 manufacturing plants which
US$ 12 billion 1 million
India’s Biotech India’s Biotech
comply with WHO requirements.
Industry Revenue Workforce
▪ HempStreet became the first medicinal cannabis firm to win BIRAC grant
in India in July 2021.
6,000+ 15,500+
▪ As of 2020, biopharmaceuticals contributed 62% to the Indian Biotech Companies Biotech Graduates
bioeconomy, followed by bio-agriculture (16%), bio-services (15%) and in India Every Year
bio-industrial (7%).

Notes: FDA: Food and Drug Administration

Source: DPT-BIRAC, Association of Biotechnology Led Enterprises (ABLE)

8
Indian biotechnology sector is divided into five segments

Biotechnology

Biopharma Bio-Services Bio-Agri

• Biosimilars
• Vaccines
• Hybrid seeds
• Insulin
• Contract manufacturing • Bio-fertilisers
• Regenerative medicines
• Clinical research • Bio-pesticides
• Medical devices

Bioindustrial Bio-IT

• Biofuels • Bio-infomatics
• Industrial enzymes • Big data
• Bio-polymers • Precision medicine

Source: Association of Biotechnology Led Enterprises (ABLE)

9
Key players

Indian pharmaceutical company based in Bangalore that manufactures generic active pharmaceutical
Biocon
ingredients.

Serum Institute of Manufacturer of immuno-biologicals, which include Diphtheria, Tetanus, Pertussis, Hib, BCG, r-
India Hepatitis B, Measles, Mumps and Rubella vaccines.

Panacea Biotec Innovation-driven biotechnology company, undertaking research and development, manufacturing,
Limited sales, distribution and marketing of pharmaceuticals, vaccines and biosimilars.

Dr Reddy’s
Integrated pharmaceutical company, providing affordable and innovative medicines.
Laboratory Limited

Global pharmaceutical and biotechnology organisation, manufacturing pharmaceuticals,

Wockhardt
biopharmaceutical formulations and active pharmaceutical ingredients.

Jubilant Life Sciences Integrated global pharmaceutical and life sciences company, engaged in pharmaceuticals, life science
Co ingredients, drug discovery solutions and India-branded pharmaceuticals.

AstraZeneca Pharma Indian biopharmaceutical company based in Bengaluru that manufactures cardiovascular, renal and
India Ltd. metabolic diseases, oncology, and respiratory medicines.

Bharat Serums and Indian pharmaceutical company based in Mumbai that manufactures plasma derivatives, monoclonals,
Vaccines Ltd fertility hormones, antitoxins, antifungals, anaesthetics, cardiovascular drugs and diagnostic products.

Indian Indian biopharmaceutical company based in Hyderabad that manufactures animal and human vaccine
Immunologicals Ltd including rabies, Hepatitis B, Diptheria and Influenza vaccines.

Indian biotechnology company based in Hyderabad that engages in drug discovery, drug development
Bharat Biotech
as well as manufactures vaccines, bio-therapeutics, pharmaceuticals and health care products.

Note: News Articles

10
Recent Trends and Strategies

11
National and international partnerships
Two PSUs ink pact
with Covaxin maker
Bharat Biotech to
manufacture COVID
vaccines
In May 2021, Indian
Immunologicals Limited
(IIL) and Bharat
Immunologicals and
Biologicals Corporation
(BIBCOL) signed
technology transfer
pacts with Bharat
Biotech to develop the
vaccine locally to boost
India's vaccination drive.
IIL started supplying the
vaccines to Bharat
Biotech in August 2021,
while BIBCOL plans to
finish production of the
trial batch of Covaxin in
February 2022.
Notes: BIRAC: Biotechnology Industry Research Assistance Council
Source: Company Website, News Articles
12
Serum Institute of
INOVIO’s Partnership
India to
INNOVATE Phase 3 between Mylab
manufacture WHO issued EUL One Health
Trial for Covid-19 Solutions &
Novavax's Covid for COVAXIN Consortium
DNA Vaccine in Shilpa
vaccine for the US
India Biologicals
market
In June 2022, Serum In November 2021, In November 2021, In October 2021, the In February 2022,
Institute of India the World Health INOVIO announced Department of Pune-based Mylab
partnered with US Organization (WHO) that it has received Biotechnology Discovery Solutions
company Novavax to issued an emergency authorisation from launched a ‘One entered into a
manufacture their use listing (EUL) for India's Central Drugs Health’ consortium strategic
Covid vaccine (NVX- Bharat Biotech’s Standard Control that will survey partnership with
CoV2373) for the US Covid-19 vaccine Organization’s important bacterial, Shilpa Biologicals,
market. COVAXIN. It was (CDSCO) Drug viral and parasitic a subsidiary of
found to have 78% Controller General of infections of Shilpa Medicare, to
efficacy against Covid- India (DCGI) to zoonotic as well as manufacture
19 virus of any proceed with the transboundary vaccines and
severity. Phase 3 segment of pathogens in the therapeutics,
INNOVATE (INOVIO country. The starting with the
INO-4800 Vaccine consortium consists Covid-19 vaccine.
Trial for Efficacy) in of 27 organisations,
In February 2022,
India. INOVIO is and is led by the
DBT inked a five-
partnering with DBT-National
year MoU with the
Advaccine Institute of Animal
Indian Council of
Biopharmaceuticals Biotechnology,
Medical Research
Suzhou Co., Ltd. Hyderabad.
(ICMR) and IAVI.
(Advaccine) to
conduct the trials.
Recent Developments
India allows 100% FDI under the automatic route (a non-resident or Indian company will not require any approval from the government) for greenfield
pharmaceuticals and manufacturing medical devices.

2023-24
• In December 2023, the Gujarat Chief Minister also inaugurated the ‘Start-Up Product Launch’ which included innovative products developed by startups
such as Bioscan, SynerSense, Iota, and STRUmed Solutions during the 10th Vibrant Gujarat Global Summit. The Pre-Summit also witnessed the
signing of a Memorandum of Understanding (MoU) between Indus Setu Global Foundation and Gujarat State Biotechnology Mission.
• In November 2023, Bharat Biotech signs MoU with University of Sydney Infectious Diseases Institute (Sydney ID) to collaborate on vaccine research
initiatives and strengthen academic-industry partnerships.
• In October 2023, the Uttarakhand government signed several MoUs worth Rs. 5,450 crore (US$ 653.97 million) with industrial bodies in Dubai.
• In August 2023, CSIR- National Institute of Science Communication and Policy Research (NIScPR) published a special issue of the Indian Journal of
Biochemistry and Biophysics (IJBB) on Biological Electron Microscopy and Nanobiotechnology.
• In August 2023, the Department of Biotechnology (DBT) and the United States-National Science Foundation (US-NSF) announced to build bilateral
collaborations between India and the USA through this Implementation Arrangement.
• In August 2023, the Technology Development Board (TDB) and the Department of Science & Technology (DST) partnered with Chemlife Innovations
for the Innovative Bio-Trace Minerals Project to enhance livestock productivity, optimize feed and fodder resources and infuse technology into livestock
management.
▪ In July 2023, National Biopharma Mission is supporting 101 projects including more than 150 organizations and 30 MSMEs. It has increased
employment opportunities and engaged 1,065 manpower including 304 scientists/ researchers.
▪ In July 2023, Aurigene Pharmaceutical Services to set up US$ 40 million facility in Hyderabad.
▪ In July 2023, India and Argentina agreed to a bilateral exchange of young researchers and Startups, particularly in the field of Biotechnology and
Agriculture.
▪ In April 2023, under the Biotech-KISAN scheme, 160,000 farmers received benefits during the last one-year (January-December 2022).
▪ In February 2023, in the Union Budget 2023-24, the Department of Biotechnology (DBT) was allotted US$ 162.7 million (Rs. 1,345 crore) to
promote research and development, agriculture biotechnology, etc.

Note: CSIR-CMERI - Council of Scientific & Industrial Research-Central Mechanical Engineering Research Institute
Source: News Articles, ABLE India

13
Recent Developments
2022-23
▪ In December 2022, Union Health Minister Dr. Mansukh Mandaviya and the Minister of State, Ministry of Science and Technology, Earth Science,
Personnel, Public Grievances, Pensions, Space and Atomic Energy Minister, Dr. Jitendra Singh launched the world's first COVID-19 intranasal
vaccine, iNCOVACC, which has been developed by Bharat Biotech.
▪ In December 2022, Bengaluru-headquartered Centre for Cellular and Molecular Platforms (C-CAMP), an initiative supported by the Department of
Biotechnology, announced a next-generation Indo-Dutch bilateral collaboration to address challenges posed by Antimicrobial Resistance (AMR).
▪ In December 2022, the Department of Biotechnology has financed 51 Biotech-Kisan centres, of which 44 are operational. These centres are
spread across 15 agro-climatic regions of the nation and operate in 169 districts.
▪ In November 2022, Yara India, which is part of the Oslo-based, Norwegian multinational Yara International, has tied up with a Bengaluru-based
start-up and ABLE Member Sea6 Energy, to market and distribute its bio-stimulant AG Boost in India.
▪ On November 14th, 2022, India and Finland agreed to advance bilateral collaboration and expand cooperation in sectors like digital education,
future mobile technologies, biotechnology, and the digital partnership in ICT.
▪ In FY22, India’s pharmaceutical exports touched Rs. 1.8 trillion (US$ 23.04 billion). Formulations and biologicals account for 73.31% of the country's
total exports, followed by bulk drugs and drug intermediates.
▪ In February 2022, Genova Biopharmaceuticals, who were conducting phase 2 and 3 trials of India’s first indigenous mRNA vaccine on humans,
finished those trials. The data is currently being reviewed by the Drug Controller General of India (DCGI).
▪ In February 2022, American biotech company Vaxart announced plans to start phase II clinical trials of its oral tablet-based Covid-19 vaccine in
India soon.
▪ In February 2022, India administered the world’s first DNA vaccine – ZYCOV-D in Patna, which was developed by Ahmedabad-based vaccine
manufacturer Zydus Cadila.
▪ In February 2022, the Malaysian Drug Control Authority (DCA) approved Bharat Biotech’s Covaxin to be used in Malaysia.
▪ In February 2022, DCGA of India granted restricted emergency use authorisation to Biological E's Covid-19 vaccine Corbevax for kids in the 12-18
years age bracket.
▪ In February 2022, Union Minister Dr. Jitendra Singh inaugurates the Northeast's first International Biotech Conclave.
▪ In February 2022, the Indian government has accepted to announce a new initiative to encourage pharmaceutical research and development (R&D)
in the Union Budget for 2023-24.

Note: CSIR-CMERI - Council of Scientific & Industrial Research-Central Mechanical Engineering Research Institute
Source: News Articles, ABLE India

14
National Biopharma Mission

Developing Specific Products

Vaccines Biosimilars Medical devices

GCLP lab for clinical GLP lab for biologics, cell EMI/EMC testing facility,
Facilities immunogenicity, cell line line repository, PDL+GMP large animal testing facility,
repository, PDL+GMP prototyping facilities

Viral repositories Raw materials

Traditional
High throughput assays Novel biologics
Strengthening Ecosystem

research consortia Animal models

Animal models Novel cell lines development Core technology

Technology
Novel assays Indigenous manufacturing development
platforms techniques

Field site capacities for Hospital based clinical trial Hospital based clinical trial
Enhancing clinical
clinical trials networks networks
trial capacity

The mission engaged Biotech Consortium India Limited (BCIL) to organise a series of lecture-based
Skill development workshops to facilitate skill development to build next-generation interdisciplinary skills for product
innovations across the country

Technology
Established ‘Technology Transfer Offices’ to support technology transfer and entrepreneurship
transfer offices

Affordable Products
Notes: GCLP: Good clinical laboratory practice, GLP: Good laboratory practice, EMI: Electromagnetic interference, EMC: electromagnetic compatibility, PDL: preferred drug list,
GMP: Good manufacturing practices
Source: Department of Biotechnology

15
Atal Jai Anusandhan Biotech Mission

• Atal Jai Anusandhan Biotech Mission is implemented by Department of Biotechnology (DBT), Ministry of Science and
Technology.

• The purpose of this mission is to address the challenges of maternal and child health, antimicrobial resistance, vaccines for
infectious disease, food and nutrition, and clean technologies.

GARBH-Ini for mental and child Bifortified and protein rich wheat Global Antimicrobial Resistance
healt for Poshan Abhiyan Research and Development Hub
for affordable health

Ind-CEPI – vaccinies for endemic UNATI Mission Clean Technologies

preparedess for Swachh Bharat

Atal Jai Anusandhan Biotech Mission

Source: Department of Biotechnology

16
State-specific policies
Andhra Pradesh
Biotechnology Policy 2015-2020
Karnataka
Biotechnology Policy 2017-2022
Telangana
Life Sciences Policy 2015-2020
Uttarakhand
Biotechnology Policy 2018-2023
Himachal Pradesh
Biotechnology Policy 2014
Rajasthan
Biotechnology Policy 2015
Gujarat
Biotechnology Policy 2022-27
Assam
Biotechnology Policy 2018-2022
Odisha
Biotechnology Policy 2018
Madhya Pradesh
Biotechnology Policy 2003
Source: State Government Website
17
South
Development of several infrastructure projects and industrial parks.
Strengthening the ecosystem required for boosting start-ups, accessing funds for R&D and product development,
developing attractive incentives for investors and providing mentorship for growth.
Development of suitable infrastructure to attract life science companies and become a leading investment
destination in the sector.
North
Aims to attract new investments worth US$ 709 million in the sector; generate employment opportunities for 5000
people by 2023.
Aims to make Himachal a globally competitive destination for development of biotechnology products, processes
and services.
West
Aims to establish world-class research institutes and biomanufacturing infrastructure.
To make Gujarat a preferred and globally competitive destination for development of biotechnology products and
services.
East
Development of the biotechnology industry in Assam, following the growth of bio-agri segment in the state.
Aims to make Odisha one of the top biotech investment and innovation destinations in the country.
Central
Conservation and sustainable utilisation of bio-resources to promote socioeconomic growth in the state.
Growth Drivers

18
Strong demand and policy support driving investments

Growing demand Policy support Increasing investment

100% FDI under Expanding

Rising demand for
automatic route for production and
agriculture-based
greenfield projects distribution facilities
products
in India

100% FDI under

Growing incidence government route for Increasing
Inviting Resulting in
of chronic ailments brownfield R&D activities
investments

Demand for 74% FDI under

Providing support to
personalised automatic route for
global projects
medicines and brownfield
biosimilars investments

Establishing LSSSDC
under NSDC to promote
skill development in the
life sciences sector

Notes: LSSSDC: Life Sciences Sector Skill Development Council, NSDC: National Skill Development Corporation, R&D - Research and Development
Source: Department of Biotechnology, Association of Biotechnology Led Enterprises (ABLE)

19
Ecosystem for start-ups
▪ The start-up ecosystem in India is strongly supported on the back of gradual improvements in the ease of doing business, proof-of-concept funds for start-ups
and favorable government policies.

▪ BIRAC, a public sector undertaking of DBT, partnered with innovative foundations and universities to focus on ‘Make
Visakhapatnam in India’(million
port traffic and ‘Start-up India’ programmes.
tonnes)
▪ The overall number of biotech startups increased from 4,237 in 2020 to 6,000 in 2023. There are more than a 1,000 startups supported by BIRAC funding.

▪ BIRAC established several industry-focussed schemes such as SBIRI, BIPP Biotechnology Ignition Grant, BioNEST, SITARE, PACE, SIIP, SEED, LEAP
and Fund of Funds-AcE. BIRAC has supported 60 bio-incubators for potential entrepreneurs.

▪ In July 2023, India and Argentina agreed to a bilateral exchange of young researchers and Startups, particularly in the field of Biotechnology and Agriculture.

▪ In May 2023, India and Israel will strengthen their connection in areas such as innovation and start-ups, ushering in a new period of deeper bilateral
cooperation.

▪ The Department of Biotechnology (DBT) of the Ministry of Science and Technology in India, and UNESCO-TWAS established a fellowship programme for
foreign scholars from developing countries who wish to pursue research towards a PhD/post-doctoral research in biotechnology.

Vertical-wise distribution of start-ups, FY21 (%) BIRAC (Bio-Incubator) (As of

December, 2023)
Herbal Tissue Incubators supported 74
Culture/
Micropropagation Amount committed for BioNEST US$ 44.85 million
12%
Food Nutrition / Incubation area supported 7,13,132 sq. ft.
29% Bio Fertilisers
12% Incubatees supported 3,500+
Diagnostic / Total products/technologies
Biomedical 600
supported
Device
Fermentation Total employment generated 32,474
23%
Academic Institutes Supported 344
24%
Molecular Biology Total IPs generated 1,250
Total trainings/workshops
1,000
conducted
Source: BIRAC, DBT

20
Biotech parks
South India North India

Golden Jubilee Biotech Park for Women

Location: Tharamani, Chennai
Tamil Nadu Biotech Park
Tidco Centre for Life Sciences (TICEL) Uttar Pradesh
Location: Jankipuram, Lucknow
Biotech Park
Location: Navalur, south suburban, Chennai
Jammu & Industrial Biotechnology Parks
Biotechnology Incubation Centre Kashmir Location: Kathua district
Telangana
Location: Habsiguda, Hyderabad

Biotechnology Incubation Centre Chhattisgarh Chhattisgarh Biotech Park

Kerala Location: Indira Gandhi Agricultural University
Location: Kalamassery, Kochi

Karnataka Biotechnology Park Biotech Park Technology Incubation

Location: Chandapura, Bengaluru Assam Centre
Location: Guwahati

▪ Biotechnology parks and incubators are established across the country by the Department of
Biotechnology (DBT), under the Ministry of Science and Technology, to translate research into products
and services by providing necessary infrastructure support.

▪ The Department of Biotechnology (DBT) has supported 11 Biotechnology Parks in various States. “These parks are successfully accelerating
the commercialisation of new technologies,
▪ These biotechnology parks offer facilities to scientists, and small and medium sized enterprises (SMEs) nurturing and maintaining emerging
for technology incubation, technology demonstration and pilot plant studies to accelerate commercial ventures and assisting new enterprises to
development of biotechnology. forge appropriate linkages with other
stakeholders of biotechnology sector
▪ The government, at present, supports nine biotechnology parks in various states, with the bulk being in including academia and the government.”
the southern region. - Secretary, DBT

▪ In October 2023, the Uttar Pradesh government is planning to establish a Biotech Park in Pilibhit.

Source: Association of Biotechnology Led Enterprises (ABLE), News Articles

21
 Opportunities

OPPORTUNITIES

22
Opportunities in various segments
In the Union Budget 2023-24, the Department of Biotechnology (DBT) was allotted US$ 162.7 million (Rs. 1,345 crore) for research and development.
Bio-Services
• India has potential for
clinical trials due to a
large and low-cost
market.
• Clinical trials in India are
regulated by the Central
Drug Standard Control
Organisation, which has
reduced approval time
to about 30-60 days,
giving opportunity for
market growth.
• The country also has the
advantage of English-
speaking researchers
and required medical
infrastructure to conduct
medical research.
Source: Association of Biotechnology Led Enterprises (ABLE), Institute for Competitiveness
23
Bioindustrials
• Biofuels and bioenergy
are considered
alternative resources
and are gaining
popularity in India.
• Rise in energy demand
is leading to an increase
in dependence on fossil
fuel imports.
• As a result, companies
can develop a strategy
to reduce import
dependence through
biofuels and bioenergy.
Biopharma
• The Indian biologics market •
is expected to register a
CAGR of 22% from 2019 to
2025, to reach US$ 12
billion by 2025.
• Growth of biologics
provides opportunity for • This increased the
biosimilars in the market.
Bio-Agri Bio-IT
India’s Union budget • Biotechnology has
2021-22 stated the immense growth
government’s plan to potential in the Bio-IT
enhance farm segment, given the
productivity and focus rising need for
on food security. technology to transform
data generated by R&D
importance of bio- institutes, clinics,
agriculture, which will hospitals, etc., into a
enhance efficient food defined format.
production. • India’s IT industry is
witnessing substantial
growth and has the
requisite IT
infrastructure to cater to
the needs of the global
Bio-IT industry.
Key investment opportunities
▪ India is among the preferred destinations for clinical trials owing to a large patient
pool, transformation of the healthcare market, well-educated physicians and cost Clinical trials market in India (US$ billion)
competitiveness.
▪ The Union Ministry for Health and Family Welfare had introduced new Drugs and 5 CAGR 8.8%
Clinical Trials Rules in 2019, which changed the regulatory landscape for approval
of new drugs and conducting clinical trials in the country. 4
3.2
2.9
▪ The Indian medical devices industry is expected to reach US$ 50 billion by 2025 3 2.4 2.7
2.1 2.2
from US$ 10.36 billion (Rs. 75,611 crore ) in 2020. 1.9
2
• In August 2023, the Department of Biotechnology (DBT) and the United States-
National Science Foundation (US-NSF) announced to build bilateral collaborations 1
between India and the USA through this Implementation Arrangement.
0
• In August 2023, Technology Development Board (TDB) and the Department of FY19 FY20 FY21 FY22 FY23 FY24 FY25

Science & Technology (DST) partnered with Chemlife Innovations for the Innovative
Bio-Trace Minerals Project to enhance livestock productivity, optimize feed and
fodder resources and infuse technology into livestock management.
Medical devices market in India (US$ billion)
▪ In July 2023, Aurigene Pharmaceutical Services to set up US$ 40 million facility in
Hyderabad. 70 CAGR 37.0%

▪ In July 2023, India and Argentina agreed to a bilateral exchange of young 60

researchers and Startups, particularly in the field of Biotechnology and Agriculture. 50
40
▪ In February 2023, Bristol-Myers Squibb intends to invest US$ 96.69 million (Rs. 800
crore) in establishing a cutting-edge centre in Telegana to boost its global medical
30
50
development and IT capabilities. 20
10
▪ In February 2023, CrisprBits, a biotechnology startup and one of the first Indian 10
0
companies using CRISPR, raised US$ 250,000 in the pre-seed funding from a US-
2020 2025
based VJ Group, for product development, team expansion, and for research and
development.
Note: US FDA - United States Food and Drug Administration, EMA - European Medicines Agency, UK MHRA – United Kingdom Medicines and Healthcare products Regulatory Agency,
PMDA - Pharmaceuticals and Medical Devices Agency, Japan, News Articles
Source: News Articles

24
Upcoming biotechnology projects in India

Upcoming Biotechnology Projects State Presence Cost of the Project (US$ million)

The Genome India Project Bangalore 2.15

Mangalapuram Bio 360 Life Sciences Park Project - Phase II Kerala 56.56

Kupwara Biotechnology Jammu & Kashmir 4.5

Source: News Articles

25
India: Emerging hub for biologics and biosimilars

The global life sciences industry is shifting from chemical-based drug to biologics and biosimilars; India approved its first biosimilar as
early as 2000.
Visakhapatnam port traffic (million tonnes)
Number of biologics and biosimilars approved in India
▪ India’s first biosimilar was approved in 2000 for
hepatitis B. In 2021, there were approximately 50
Biologics Biosimilars 42
127 approved biosimilars.
40
▪ In July 2023, Biocon Biologics launched a 28
30 24
biosimilar version of AbbVie's top-selling biologic 23
17 18
Humira (generically called adalimumab) in the 20 15
12
US market under the brand name HULIO. 8
10 5
3
1
▪ With the help of recombinant and biosimilar
0
products, the therapeutics sector is predicted to FY14 FY15 FY16 FY17 FY18 FY19
generate US$ 15 billion in bioeconomic activity
by 2025.

▪ Biologics economy in India is forecasted to

First
reach US$ 12 billion by 2025, growing at a Drug name Originator company Active companies
launched
CAGR of 22%.
NuPTH Cadila Pharmaceuticals Cadila Pharmaceuticals 02-Oct-20
▪ In India, the biologics segment is led by Biocon bevacizumab Dr Reddy's Laboratories Ltd. Dr Reddy's Laboratories Ltd 19-Aug-19
Ltd., who has commercialised the biosimilars
trastuzumab Dr Reddy's Laboratories Ltd Dr Reddy's Laboratories Ltd 26-Jul-18
Trastuzumab and Pegfilgrastim, among others,
pegfilgrastim Lupin Ltd Lupin Ltd 25-Jul-18
in partnership with Mylan.
pegfilgrastim Biocon Ltd Biocon Ltd; Mylan NV 30-Jun-18
▪ Other players in the space include Dr Reddy’s
adalimumab Hetero Group Hetero Group 03-Jan-18
Laboratories, Intas Pharmaceuticals, Zydus
Cadila and Lupin. bevacizumab Biocon Ltd Biocon Ltd; Mylan NV 23-Nov-17

Source: Biologics Division, CDSCO, Association of Biotechnology Led Enterprises (ABLE)

26
Opportunity in Biopharma
2. VACCINES
• India exports vaccines to about 150 countries.
3. REGENERATIVE MEDICINE
• The country covers 40-70% of the World Health Organisation’s (WHO) • Several research institutes in India are investigating the use of stem cells
demand for DPT (diphtheria, pertussis or whooping cough, and tetanus) to regenerate nerve, heart and adult muscle cells, and repair damaged
and BCG (Bacille Calmette-guérin) vaccines against tuberculosis, followed bone tissues.
by ~90% of its demand for the measles vaccine. • Rise in chronic disease incidents is driving the demand for regenerative
• By 2025, the vaccination market in India is projected to be worth US$ 3.04 medicine.
billion (Rs. 252 billion). • The Indian Council of Medical Research has issued the National Guideline
• In July 2022, India’s 1st indigenously developed quadrivalent Human for Stem Cell Research to promote clinical applications of stem cell
Papilloma Virus (qHPV) vaccine against cervical cancer supported by DBT research in ophthalmology, cardiology and spinal cord repair.
and BIRAC received market authorization from DCGI • The first phase I clinical trial on gene therapy for haemophilia, enhancing
the quality and shelf life of stored blood, potential therapy for psoriasis,
testing over 3 lakh samples for COVID-19, novel nanobody inhibiting
SARS-COV2 entry, germicidal masks and many more.
1. BIOSIMILARS
• India has >125 approved biosimilar
products and the market is expected to 4. INSULIN
reach US$ 2.2 billion by 2025.
• India is likely to witness >100 million
• Expiry of ~US$ 70 billion biologics drugs diabetics by 2030. With the rising
patent in 2020 provided export number of patients, ~50% are
opportunities. undiagnosed, providing domestic
• Global companies are leveraging market opportunity to the country.
generics to contain healthcare costs and
Indian companies such as Biocon are
2 3 • Indian players are also creating
opportunities in the international
positioning themselves to deliver market. For example, Biologics and
affordable access to innovative and its partner Mylan N.V. launched their
inclusive healthcare solutions. insulin glargine injection under the
• In July 2023, Biocon Biologics launched brand name Semglee in the US.
a biosimilar version of AbbVie's top- 1 4
selling biologic Humira (generically
called adalimumab) in the US market
under the brand name HULIO.

Source: BIRAC, CII

27
Key Industry Contacts

28
Key industry organisations

Agency Contact Information

Department of
6th-8th Floor, Block 2 CGO Complex, Lodhi Road New Delhi – 110 003.India
Biotechnology,
Phone: 91-11-2436 2950
Ministry of Science &
Website: www.dbtindia.gov.in
Technology

Department of Science & Technology, Technology Bhavan, New Mehrauli

Department of Science and Road, New Delhi-110 016
Technology, Ministry of Phone: +91-11-26562122/25/33/44, 26567373, 26962819
Science and Technology Fax +91-11-26863847, 26515637
Website: www.dst.gov.in

Biotechnology Industry 1st Floor ,MTNL Building ,9 , CGO Complex, Lodhi Road, New Delhi-110003
Research Website: www.birac.nic.in, E-mail address: birac.dbt@nic.in
Assistance Council Phone: + 91-11-24389600
(BIRAC) Fax: + 91-11-24389611
Council of Scientific and Industrial Research, Anusandhan Bhawan, 2 Rafi
Council of Scientific and
Ahmed Kidwai Marg, New Delhi - 110001
Industrial
Phone: +91-11-23737889
Research (CSIR)
Website: www.csir.res.in

# 123/C, 16th Main Road,5th Cross, 4th Block, Near Sony World showroom /
Association of Headstart school, Koramangala, Bangalore -560034, India
Biotechnology Led Phone: +91-80-41636853
Enterprises Fax: +91-80-25633853
Website: www.ableindia.in, E-mail address: info@ableindia.org.in

Biotechnology Division, NIIST, Industrial Estate P.O.,

The Biotech Research Trivandrum 695019
Society, India Phone: +91-471-251 5279
Website: https://www.brsi.in/

29
Departments concerning biotech approvals

Government of India

Ministry of Science & Ministry of Environment & Ministry of Chemicals & Ministry of Health & Family
Technology Forests Fertilisers Welfare

Department of Department of Environment, Department of Central Drug Standards

Biotechnology Forests & Wildlife Pharmaceuticals Control

Review Committee on Genetic Genetic Engineering Approval

Clinical Trials
Manipulation Committee

Recombination DNA Advisory

Committee

Institutional Biosafety
Committee

30
Appendix

31
Glossary

▪ CAGR: Compound Annual Growth Rate

▪ Capex: Capital Expenditure

▪ CENVAT: Central Value-added Tax

▪ EHTP: Electronic Hardware Technology Park

▪ EPCG: Export Promotion Capital Goods Scheme

▪ FDI: Foreign Direct Investment

▪ FY: Indian Financial Year (April to March); So, FY10 implies April 2009-March 2010

▪ LCD: Liquid Crystal Display

▪ R&D: Research and Development

▪ US$ : US Dollar

▪ Wherever applicable, numbers have been rounded off to the nearest whole number

32
Exchange rates

Exchange Rates (Fiscal Year) Exchange Rates (Calendar Year)

Year Rs. Equivalent of one US$ Year Rs. Equivalent of one US$
2004-05 44.95 2005 44.11
2005-06 44.28 2006 45.33
2006-07 45.29 2007 41.29
2007-08 40.24 2008 43.42
2008-09 45.91 2009 48.35
2009-10 47.42 2010 45.74
2010-11 45.58 2011 46.67
2011-12 47.95 2012 53.49
2012-13 54.45 2013 58.63
2013-14 60.50 2014 61.03
2014-15 61.15 2015 64.15
2015-16 65.46 2016 67.21
2016-17 67.09 2017 65.12
2017-18 64.45 2018 68.36
2018-19 69.89 2019 69.89
2019-20 70.49 2020 74.18
2020-21 73.20 2021 73.93
2021-22 74.42 2022 79.82
2022-23 78.60 2023* 83.40

Note: *- Until November 2023

Source: Foreign Exchange Dealers’ Association of India

33
Disclaimer

All rights reserved. All copyright in this presentation and related works is solely and exclusively owned by IBEF. The same may not be reproduced,
wholly or in part in any material form (including photocopying or storing it in any medium by electronic means and whether or not transiently or
incidentally to some other use of this presentation), modified or in any manner communicated to any third party except with the written approval of
IBEF.

This presentation is for information purposes only. While due care has been taken during the compilation of this presentation to ensure that the
information is accurate to the best of IBEF’s knowledge and belief, the content is not to be construed in any manner whatsoever as a substitute for
professional advice.

IBEF neither recommend nor endorse any specific products or services that may have been mentioned in this presentation and nor do they assume
any liability, damages or responsibility for the outcome of decisions taken as a result of any reliance placed on this presentation.

IBEF shall not be liable for any special, direct, indirect or consequential damages that may arise due to any act or omission on the part of the user
due to any reliance placed or guidance taken from any portion of this presentation.

34