India BioEconomy Report 2023
India BioEconomy Report 2023
BIOECONOMY
REPORT
DECEMBER 2023
©BIRAC
This report has been prepared for “Make In India Facilitation Cell for
Biotechnology” of Biotechnology Industry Research Assistance Coun-
cil (BIRAC) by Association of Biotechnology Led Enterprises (ABLE).
The report is written by Narayanan Suresh, Chie Operating Ocer
of ABLE and Srinivas Rao Chandan, Editorial Consultant for ABLE
under the able guidance of Mr G S Krishnan, President, ABLE
02 | IBER 2023
CONTENTS
Bioeconomy Brilliance 04
Revised India Bioeconomy Estimates For 2020 And 2021 07
Foreword: Dr Jitendra Singh, Minister of State (Independent Charge)
of the Ministry of Science and Technology. 08
From DBT Secretary’s Desk: Dr Rajesh Gokhale, Secretary,
Department of Biotechnology (DBT) and Chairman, BIRAC 10
IBER 2023 Research Methodology 12
Executive Summary 18
Key Highlights Of India’s Bioeconomy 19
Regional & Sectoral Analysis 20
Startups 22
Biotech Investment Landscape 23
BioEconomy Projections 2030 28
Overview 33
India’s BioEconomy Booms 34
Key Segments & Subsegments 38
Regional Overview 42
Future Forecast 43
Startup Ecosystem 45
Biotech New Startups in 2022 46
Top states for New Startups 50
Analysis of Cumulative Startups 52
Regional & Sectoral Analysis of Cumulative Startup Base 53
BIRAC’s Initiatives 55
Biotech Investments 57
Key Insight 58
PE Investments by State 62
Top Deals 64
Innovation Ecosystem 69
Empowering Emerging Biotech Enterprises 70
Dynamic Landscape of Bioincubators 74
New BioClusters 80
New Product Releases in 2022 86
Policy Framework 97
Regulatory Developments 98
BioMedical Policy 100
BioIndustrial Policies 101
Biotech Policies in Various States 102
Key Biotech Developments in 2022 110
Forecast & Recommendations 115
Outlook and Conclusions 116
Leader’s Insights 120
Acknowledgements and Sources 122
03 | IBER 2023
01
$28 MILLION DAILY IN BIOAGRI BIOECONOMY
The cotton crop production for the year stands at 34.2
02
million bales, making a substantial contribution to the
BioAgricultural bioeconomy valued at $10.23 billion. On
a daily basis, this translates to approximately $28.05
million, showcasing the consistent economic output of Bt
cotton within the BioAgri sector. Monthly, the cotton crop
production reaches around 2.85 million bales, contributing
$30 MILLION BIOECONOMY FROM
significantly to the monthly BioEconomy of the BioAgri
DAILY DIAGNOSTICS TESTS:
sector, which amounted to $852 million.
In 2022, the diagnostic market
in India witnessed robust
growth, buoyed by favorable
BIOECONOMY
macroeconomic conditions.
The total bioeconomic value
of Diagnostics, excluding
medical devices, surged to
BRILLIANCE
$10.8 billion. India conducted
approximately 600-700 million
diagnostics tests annually,
with a notable daily average
of almost 2 million tests. The
A Glance at India’s monthly value of diagnostics
within the BioEconomy reached
Top 10 Triumphs in 2022 $0.9 billion, marking a 1.5-fold
increase from 2018. Including
03
medical devices, the daily value
of the diagnostics BioEconomy
amounted to $52.60 million,
equivalent to a monthly value
of $1.6 billion.
$38 MILLION DAILY VACCINES BIOECONOMY
The BioPharma Vaccines (non-Covid alone) market
makes a significant daily contribution of approximately
$38 million, underscoring its substantial impact on the
biopharmaceutical sector. On a monthly basis, this market
adds around $1.16 billion, highlighting its critical role in
public health and reinforcing India’s position as a key player
in vaccine development and distribution. India notably
leads global vaccine supply by volume, producing nearly 2
billion doses annually.
04 | IBER 2023
034
$46 MILLION DAILY IN BIOTHERAPEUTICS
BIOECONOMY
06 $73 MILLION DAILY IN THE BIOETHANOL ECONOMY
India’s ethanol production capacity has surged
to 947 crore liters, more than doubling from the
2020 level of 427 crore liters, marking a growth
of 2.22 times. The government’s objective is to
achieve a 20% blending of ethanol with petrol by
The BioPharma - Therapeutics segment 2025 through the Ethanol Blended Petrol (EBP)
commands an annual value of $16.8 Program. The comprehensive Bioeconomy value,
billion, showcasing its strong presence in encompassing Biofuels, Potable alcohol, and
the broader biopharmaceutical industry. alcoholic beverages, amounted to $26.4 billion.
On a daily basis, this sector generates The monthly average for the Bioethanol economy
approximately $46.03 million in the alone stands at $2.2 billion.
BioEconomy. Monthly, the BioPharma -
Therapeutics segment contributes around
$1.4 billion, emphasizing its substantial
role in shaping the industry.
07 5 SECTORS GENERATE $1 BILLION MONTHLY BIOECONOMY
Bioethanol Economy ($2.2 Billion Monthly)
Diagnostics BioEconomy ($1.6 Billion Monthly)
Biotherapeutics BioEconomy ($1.4 Billion
Monthly)
Enzymes (Poultry and Aqua) BioEconomy ($1.47
Billion Monthly)
Vaccines BioEconomy ($1.16 Billion Monthly)
05
Venture Capital (VC) investments, reaching a
record-breaking $938.8 million—an outstanding
19% growth in private equity investments
compared to the previous year.
05 | IBER 2023
BIOECONOMY BRILLIANCE
1,391
New Biotech 50+
Startups in New Products
2022 Unveiled
06 | IBER 2023
BIOECONOMY BRILLIANCE
07 | IBER 2023
FOREWORD
BIOECONOMY IS
years. In 2014, our bioeconomy stood at
$10 billion; today, it has grown to $137
UNLEASHING INNOVATION,
billion, and is expected to achieve $300
billion by 2030.
‘AMRIT KAAL’”
increasing from just about 50 in 2014 to
over 6,756 in 2022. I am happy to see that
08 | IBER 2023
in 2022, a total of 1,391 biotech startups Biotechnology has emerged as a trend-
were incorporated in the country. This ing career option among our youth, with
means on an average, every day in 2022, tools like Synthetic Technology, Genome
four biotech startups were formed in the Editing, Microbial Bioresources, and Met-
country. abolic Engineering gaining increased
attention.
As our industry friendly policies perco-
late to all sectors, biotechnology too has Hon’ble Prime Minister Modi ji’s vision
beneted immensely. Nearly a billion o Atmanirbhar Bharat has signicantly
dollar was invested in the industry in infuenced our vaccine strategy, exempli-
the country. As the national progresses ed by Mission Suraksha, ostering col-
towards the “Zero carbon” state, we pro- laboration among pharma, industry, and
duced a record 443 crore litres of biofu- academia. Our scientic achievements,
els in 2022, enabling to reach the 10% including Chandrayaan-3 and the devel-
blending target, and thus saving nearly $ opment of DNA vaccines, have elevated
8 billion in foreign exchange. We are con- our scientic raternity recognition to a
dent o achieving the 20% blending tar- global level. India is now acknowledged
get by 2030 as the industry delivers with as the vaccination hub of the world.
increased production capacities using
indigenous technologies and raw materi- It is time for broader synergy among all
als. professions to achieve the “Amrit Kaal”
goals over the next 25 years. Our col-
Biotechnology, being the technology of lective efforts and advancements in the
tomorrow, can leverage our wealth of biotechnology sector underscore India’s
bioresources, unique biodiversity in the potential as a global player in the eld.
Himalayas, and a vast 7,500 km-long
coast line. Initiatives like Samudrayaan, I am very happy to note the signicant
exploring biodiversity beneath the seas, achievements of the national BioEco-
highlight our commitment to harness- nomy has been recorded in the India
ing our bioresources. The Department BioEconomy Report 2023, brought out
of Biotechnology (DBT) supports R&D by the Make in India cell of the DBT-Bio-
innovations and Bio-manufacturing in technology Industry Research Assistance
Advanced Biofuels and ‘Waste to Energy’ Council (BIRAC) in association with the
technologies, foreseeing a green and sus- Association of Biotechnology Led Enter-
tainable future. prises (ABLE).
09 | IBER 2023
FROM DBT SECRETARY’S DESK
10 | IBER 2023
impact on the environments. network with 75 bio-incubators across 21
states/UTs, supporting 1,800+ incubates.
As the word ‘BioEconomy’ gained atten- Funding initiatives like the ‘Biotech Igni-
tion in many large bio-based economies, tion Grant-in-aid, Equity Fund, SBIRI,
the impact of biotech-based products and BIPP and investment through Fund of
services has become evident. The rst Funds-AcE Fund further bolster biotech
India BioEconomy Report (IBER) was innovation in the country.
brought out in 2016 and since then updat-
ed annual versions have been released to This year’s India BioEconomy Report
capture the tremendous transformation. (IBER, 2023) has given insights revealing
the brilliance of India’s BioEconomy. This
The Department of Biotechnology since its annual report has been prepared by the
inception has been providing an enabling Make in India Facilitation Cell of BIRAC
ecosystem to promote biotechnology with research support from the Associ-
research and improve capacity building ation of Biotechnology Led Enterprises
across the country. The emphasis has (ABLE).
been on fostering cutting edge-research
and innovation, with strong emphasis on An attempt has been made to accurately
translation research. Through its various capture some of the key economic activ-
initiatives towards promoting innovative ities that rely signicantly on biotech
research, empowering people, building products such as enzymes and other
world class infrastructure and supporting bio-based materials in this edition of the
public-private partnership, the Depart- report. Inclusion of a big chunk of bio-
ment has made a huge impact on Indi- based product segments in this report
an agriculture, healthcare, industry, and that was not covered in previous editions
environment on one hand, while raising has accounted for more than $ 40 billion
global standing of India in the sphere of in value.
biotechnology on the other.
The overall BioEconomy has surged to
For example, under the National BioPhar- an impressive $137.2 billion in 2022. It
ma Mission, 15 vaccine candidates and 4 is gratifying to note that the report incor-
related technologies for various diseases porates segments such as Aqua, Poultry,
are underway. Additionally, 21 Biosimilar Ethanol, and Food Enzymes, besides oth-
products for diseases like Diabetes and er emerging areas, to derive the gures.
Cancer, along with 29 Medical Devices & This alignment with BioEconomy deni-
Diagnostics, have received support. tions signies a positive trend towards
data harmonization. It is our vision that
The government, through BIRAC, cham- India’s BioEconomy reaches $300 Billion
pions biotech innovation, supporting over by 2030 and accounts for 5-6% share of
4,800 startups and entrepreneurs. It has India’s GDP. I congratulate team for this
established a robust biotech innovation timely report.
11 | IBER 2023
RESEARCH METHODOLOGY
US BIOECONOMY DEFINITIONS
U.S. BIOECONOMY
Economic activity that is driven by research and innovation in the life
sciences and biotechnology, and that is enabled by technological advances
in engineering and in computing and information sciences
EXAMPLES
Genetically modified
crops/animals,
precision agriculture
EXAMPLES
Life sciences or biotechnology-related software and
databases, specialized equipment or instruments for use in
the bioeconomy (e.g., pipetting robots, mass spectrometers,
DNA sequencing and synthesizers), bioscience patent lawyers
Sources: Adapted from Figure 2-2, National Academies of Sciences, Engineering, and Medicine Safeguarding the Bioeconomy
12 | IBER 2023
RESEARCH METHODOLOGY
13 | IBER 2023
RESEARCH METHODOLOGY
14 | IBER 2023
RESEARCH METHODOLOGY
ed for blending with petrol and other BioEconomy Calculations are also
purposes, stands at approximately 947 based on various reports by Econo-
crore liters, comprising 619 crore liters mists to measure the true economic
of molasses-based production capac- value of any product.
ity and 328 crore liters of grain-based
production capacity. Nearly 46 percent For example, take an SUV that a buy-
of this capacity is allocated for blended er gets it from, say Hyundai, for Rs
ethanol. 20 lakh
Potable & Industrial Alcohol contrib- Of this price, the actual invoice from
utes $14.52 billion to the BioEconomy. Hyundai will be just about Rs 10
The calculation considers a total of 432 lakh. That is the price realized by
crore liters of ethanol, based on estimates Hyundai and this further includes
of the total ethanol production capacity. excise duty etc.
The BioEconomy value is determined at
40 percent of the average price per liter The balance 10 lakh is various state
and central taxes, insurance, regis-
BIOECONOMIC VALUE OF BIOSERVICES: tration charges etc. So if one adds
The BioServices segment, including Con- only the revenues of all automobile
tract Research Services (CRO) and BioIT, manufacturers and importers, it will
is conservatively valued by considering give only half the actual picture.
the revenues of the CROs and IT compa-
nies with life science practices. Various estimates indicate that
the lifetime value creation of a car
BIOECONOMY VALUATION OF BIOPHARMA bought for Rs 20 lakh will be at least
Vaccines: The BioEconomic value of 3X or Rs 60 lakh over an assumed
vaccines, encompassing both human and lifetime of 10 years. The manufac-
animal categories, is calculated by multi- turer captures only about 16.6 % of
plying the overall vaccine supplies with the value created by a car. Rest of it
the weighted average price per dose. is garnered by fuel makers, acces-
sories, local governments as taxes,
Therapeutics, biosimilars, etc.: This insurance, tourism and other sec-
is measured based on the data insights of tors beneted by the mobility given
EY & IQVIA, import and export data. to the owner, infrastructure provid-
ers like road construction compa-
MedTech BioEconomy Calculations: nies, toll collection agencies, and so
The MedTech BioEconomy is valued at on.
tests and the medical devices’ revenue
size. Similar attempts are made to capture
the full economic value of various
biotech products. It is an evolving
eld.
15 | IBER 2023
EXECUTIVE
SUMMARY
EXECUTIVE
SUMMARY
India’s BioEconomy - A Powerhouse
of Innovation and Growth
18 | IBER 2023
EXECUTIVE SUMMARY
19 | IBER 2023
EXECUTIVE SUMMARY
27.71
16.74 16.41
11.02 10.32 10.08
7.5
MAHARASHTRA KARNATAKA TELANGANA GUJARAT UTTAR PRADESH DELHI ANDHRA PRADESH OTHERS
These leading states underscore the collaborative nature of India’s BioEconomy, each
bringing unique strengths to the table. The distributed contributions from Maharashtra’s
diverse sectors, Karnataka’s prowess in biotechnology, and Telangana’s innovation in
pharmaceuticals collectively shape the dynamic landscape of the national BioEconomy.
The comprehensive overview serves as a guide or stakeholders, showcasing the signi-
cant regional players and their distinct contributions to India’s fourishing BioEconomy.
20 | IBER 2023
EXECUTIVE SUMMARY
MAHARASHTRA KARNATAKA TELANGANA DELHI UTTAR GUJARAT TAMIL NADU WEST ANDHRA ODISHA
PRADESH BENGAL PRADESH
Source: ABLE Analysis
The “Others” category, encompassing various states, contributed 26% to the overall startup count. In 2022, a
total o 1391 startups were registered, refecting a substantial 23% growth rom the previous year’s count o
1128. This overview provides valuable insights into the diverse and expanding startup ecosystem, empha-
sizing the prominent role o specic states in driving entrepreneurial growth.
21 | IBER 2023
EXECUTIVE SUMMARY
197 182
MAHARASHTRA KARNATAKA DELHI TELANGANA UTTAR GUJARAT TAMIL NADU WEST ODISHA
PRADESH BENGAL
Source: ABLE Analysis
22 | IBER 2023
EXECUTIVE SUMMARY
23 | IBER 2023
EXECUTIVE SUMMARY
REGIONAL BREAKDOWN
1. SOUTH (46%) 3. NORTH (17%)
Led by Karnataka and Telangana, the Southern states The northern states, including Delhi, Haryana, and Uttar
dominate with a substantial 46% share, showcasing Pradesh, collectively contribute 17%, showcasing a
diverse biotech hubs and a proactive investment climate. noteworthy presence in the evolving biotech sector.
2. WEST (29%) 4. OTHERS (8%)
Gujarat and Maharashtra jointly contribute 29%, States beyond major regions contribute 8%, highlighting
underscoring the region’s significance in fostering emerging players and unique biotech narratives outside
biotech innovation. primary focus areas
TOP STATES
Karnataka consistently emerges as a ments (13%) and a leading cumulative base
leader across all three data tables, com- of biotech startups (1162). Moreover, Maha-
manding a substantial share in biotech rashtra holds a leading position in BioEcono-
investments (30%), having a signicant my contributions ($37.46 Billion).
cumulative base of biotech startups (852),
and making a substantial contribution to Gujarat stands out with a signicant
the BioEconomy (20% share). share in biotech investments (14%) and
contributing substantially to the BioEco-
Maharashtra, fueled by the Mumbai-Pune nomy ($11.02 Billion). The state’s proac-
biotech axis, is a consistent player, boasting tive approach is evident in shaping the
a considerable share in both biotech invest- nation’s biotech future.
UNICORN STATUS
In a groundbreaking achievement, billion, showcasing an 8X increase
Molbio Diagnostics achieved unicorn from its previous valuation of $182.7
status following a remarkable funding million. This milestone positioned
round led by Temasek, which raised Molbio Diagnostics as the second uni-
an impressive $85 million. This signif- corn to emerge from India in Septem-
icant investment catapulted the com- ber 2022 after Tata1MG.
pany’s valuation to a staggering $1.53
24 | IBER 2023
EXECUTIVE SUMMARY
25 | IBER 2023
26 | IBER 2023
27 | IBER 2023
EXECUTIVE SUMMARY
PROJECTIONS
28 | IBER 2023
EXECUTIVE SUMMARY
350
300
241.3
250 224.6
181.4 209.1
168.9 194.7 25.8
157.6 22.7
200 147 15.5 20
137.1 17.6
13.6
12 97.5
150 10.6 86 91.6
9.3 80.8
75.8
71.2
100 59 66.9 20.9 22.7
62.8 19.2
16.2 17.6
12.5 13.6 14.8
11.5
50 95.3
57.3 61.1 65.1 69.3 73.9 78.7 83.9 89.4
0
2022 2023 2024 2025 2026 2027 2028 2029 2030
350 330.7
295.2 42.4
300
263.7 35.1
236
250 29
211.2 121
189.4 24 110.6
169.9
200 19.9
152.6 16.4 101.1
137.1 13.6 92.5
11.2
150 9.3 84.5
77.3 39.3
64.6 70.6 33.7
28.9
100 59 21.2 24.8
18.2
13.4 15.6 115.8 128
11.5 94.7 104.7
50 77.5 85.6
57.3 63.4 70.1
0
2022 2023 2024 2025 2026 2027 2028 2029 2030
NOTES ON SEGMENTS
BioMedical: Biopharmaceuticals, diagnostics, medical devices
BioAgriculture: Bt Crops, Animal biotech, Biomass, Pesticides, Fertilizers
BioIndustrial: Aqua - Shrimp industry, Food and Beverage industry, Industrial sector, Laundry and Cleaning industry,
Paper and Pulp, Poultry Industry, Textile Industry, Vegetable Oils industry
BioServices: BioIT, Platforms, Contract Research, Drug Discovery, Patent Services, etc.
29 | IBER 2023
EXECUTIVE SUMMARY
30 | IBER 2023
EXECUTIVE SUMMARY
31 | IBER 2023
32 | IBER 2023
OVERVIEW
33 | IBER 2023
OVERVIEW
I N D I A’ S B I O E C O N O M Y
A POWERHOUSE
OF INNOVATION
AND GROWTH
India’s BioEconomy Booms,
Registers 29% Growth in 2022,
Valued at $137.24 Billion
34 | IBER 2023
OVERVIEW
BIOECONOMY (2020-2022)
$137.2
$106.3 Billion
CY 2022
$86 Billion
CY 2021
Billion
CY 2020
35 | IBER 2023
OVERVIEW
36 | IBER 2023
OVERVIEW
11.47
BIOAGRI
BIOECONOMY
$137.24 BILLION 9.29
BIOIT RESEARCH
CY 2022 ($ Billion) SERVICES
1. BIOINDUSTRIAL: 3. BIOAGRI:
Market Size: $58.97 billion Market Size: $11.47 billion
Percentage Share: 43% Percentage Share: 8%
37 | IBER 2023
OVERVIEW
The BioAgri segment was the third larg- 1. BIOAGRI THRIVES WITH SUSTAINABLE PRACTICES
est segment, accounting for 8% of the BioAgri Resilience (2020-2022): The
total BioEconomy. This segment includes BioAgri sub-segment showcased resil-
activities such as the production of Bt ience, maintaining consistent growth
Cotton, biofertilizers, biopesticides, and from $11.1 billion in 2020 to $11.47 bil-
bio-based agricultural products. lion in 2022. This stability was driven by
advancements in biotechnology-driven
The BIOITresearch segment accounted for agriculture, increased adoption of Bt Cot-
7% of the total BioEconomy. This segment ton, and a growing focus on sustainable
includes activities such as the development and circular agriculture practices.
of bioinformatics tools, the conduct of bio-
based research, clinical research, and the BioAgri Sub-segments:
provision of bio-based consulting services. BioPesticides, Biofertilizers, BioStim-
38 | IBER 2023
OVERVIEW
ulants: With a notable 1% share, this and more ecient industrial processes.
sub-segment highlighted the growing
importance of sustainable agricultural Enzymes - Alcohol, Beer, Wine Mak-
practices, contributing to pest manage- ing: The category of BioIndustrial
ment and soil health. Enzymes played a pivotal role, contrib-
uting signicantly to the production o
Bt Cotton: Emerging as a dominant Potable & Industrial Alcohol (10.58%),
force with a 7.45% share, Bt Cotton Beer (3.64%), and Wine (0.12%).
rearmed India’s prowess in bio-
tech-enhanced crops, showcasing 3. BIOIT AND RESEARCH SERVICES FUEL
technological advancements and con- TECHNOLOGICAL ADVANCEMENTS
tributing signicantly to the agricultur- BioITResearch Services Growth (2020-
al sector’s economic footprint. 2022): The BIOITResearch Services
sub-segment demonstrated steady growth,
2. BIOINDUSTRIAL BOOM with value increasing to $9.3 billion in
BioIndustrial Growth (2020-2022): 2022. Large IT companies with dedicated
The BioIndustrial sub-segment, includ- biotechhealthcare practices signicantly
ing Enzymes and Biofuels, experienced contributed to this growth, aligning with
substantial growth, surging from $20.92 the increasing integration of technology in
billion in 2020 to an impressive $59.04 biotechnology research and development.
billion in 2022. Increased emphasis on
sustainable industrial practices, support- BioIT Research Services Sub-segment:
ed by the Indian Government’s amend- With a 6.77% share, this sub-segment
ments to the National Policy on Biofuels, refected the increasing reliance on bio-
played a crucial role in driving this growth. technology for research and technolog-
ical advancements. The growth signaled
BIOINDUSTRIAL INNOVATIONS: a synergy between biotechnology and
Aqua (Shrimp): The BioIndustrial information technology, driving innova-
sector demonstrated versatility with tions in healthcare and life sciences.
notable contributions in aquaculture
contributing over 5.32% to the BioEco- 4. BIOPHARMA CONTINUES TO LEAD THE WAY
nomy. Biopharma Growth (2020-2022): The
Biopharma sub-segment stood out as a
Biofuels: Positioned at 4.88%, the Bio- dominant force, experiencing consistent
fuels sub-segment highlighted India’s growth from $38 billion in 2020 to $49.79
commitment to sustainable energy billion in 2022, demonstrating resilience
solutions, aligning with the nation’s and robustness. Factors contributing
focus on reducing carbon footprints. to this growth included the increasing
acceptance of India-made biosimilars in
Poultry Feed: Poultry Feed accounted developed markets.
for 7.51%) across various sectors
Vaccines Sub-segment: The Vaccines
Baking Industry (Biscuits & Breads), sub-segment exhibited interesting fuc-
Textile, Dishwashing Enzymes: Con- tuations, experiencing a dip from $12.5
tributions from Textile (5.03%), Dish- billion in 2020 to $8.67 billion in 2021,
washing Enzymes (0.05%), and Baking followed by a notable rebound to $13.96
industry (2.33%) showcased the wide- billion in 2022. This volatility refect-
spread infuence o BioIndustrial appli- ed the sector’s responsiveness to global
cations. The shift is towards greener health challenges, with the resurgence in
39 | IBER 2023
OVERVIEW
2022 aligning with intensied global vac- testing demand and a subsequent decline
cination campaigns. in 2022 as the emphasis shifts towards
recovery and post-pandemic strategies.
Therapeutics Sub-segment: The Thera-
peutics sub-segment showcased steady Combined Contributions (Therapeutics,
growth, doubling its nancial contribu- Diagnostics, Vaccines, Covid Testing,
tion from $7.5 billion in 2020 to $16.81 Covid Vaccines): The BioPharma sec-
billion in 2022. This indicated a rising tor collectively contributed over 41.8%,
demand for therapeutic solutions and with contributions from Therapeutics
underscored advancements in biotech- (12.24%), Diagnostics (13.86%), Vaccines
nological research, aligning with the (10.17%), Covid Testing (1.40%), and
increasing focus on precision medicine, Covid Vaccines (4.18%). These collective-
personalized treatments, and innovative ly demonstrated the sector’s resilience
BioPharmaceuticals. and strategic importance, particularly in
the context of global health challenges.
Diagnostics Sub-segment: Diagnostics
witness a mixed performance, reaching a The diverse contributions from BioAg-
peak of $20.4 billion in 2021, followed by ri, BioIndustrial, BioIT, and BioPharma
a slight decrease to $19.0 billion in 2022. showcased India’s prowess in harness-
This fuctuation may be attributed to the ing biotechnology across various sectors.
evolving landscape of diagnostic tech- This data underscored not only economic
nologies and the impact of the COVID-19 growth but also the nation’s commitment
pandemic. The COVID Economy sub-seg- to sustainable and innovative practices
ment refects the pandemic’s infuence, in agriculture, industry, healthcare, and
with a spike in 2021 driven by increased research.
40 | IBER 2023
OVERVIEW
19.02 14.52
Diagnostics Potable & Industrial
Alcohol
10.23 6.7 5.74
Bt Cotton Biofuels Covid 1.24
Vaccines BioPesticides,
Biofertilizers,
BioStimulants
2.6 1.92
Baking Covid 0.72
Industry Testing Vegetable Oil
(Breads) (Rice Bran)*
0.9
16.8 16.8 9.29 5 Cheese 0.6
Therapeutics Vaccines BIOIT Research Beer 2.1 Baking Industry
Services making Laundry (Biscuits)
41 | IBER 2023
OVERVIEW
FUTURE FORECAST
2025 Projection: The cumulative impact of the discussed trends and drivers positions the Indian
biotechnology sector for significant growth, with the BioEconomy projected to reach the ambitious
$150 billion mark by 2025. Continued focus on innovation, global market penetration, and
sustainable practices will be pivotal in achieving this milestone.
2030 Vision: Looking ahead to 2030, the forecast suggests a BioEconomy worth $270-300 billion,
accounting for 3.3-3.5% of India’s GDP. Key contributors include a robust Biopharma sector, a
thriving BioIndustrial segment, and a flourishing BioServices sector. Achieving this vision will require
sustained government initiatives, strategic collaborations, and a commitment to technological
advancements. The sector’s ability to navigate challenges, capitalize on global opportunities, and
embrace innovation positions it as a key driver of India’s economic growth. Strategic planning,
regulatory support, and continuous collaboration will be paramount in realizing the full potential of
the Indian biotechnology sector.
43 | IBER 2023
44 | IBER 2023
STARTUP
ECOSYSTEM
45 | IBER 2023
STARTUP ECOSYSTEM
46 | IBER 2023
STARTUP ECOSYSTEM
YEARLY OVERVIEW
Startup Count Trends: In 2020, the mar- positive trend signals continued growth
ket saw the emergence of 840 startups, and innovation within the startup sector,
and this number experienced a signif- emphasizing its pivotal role in driving
icant surge to 1128 in 2021, boasting a economic development and fostering a
substantial growth rate of 34.3%. The culture of entrepreneurship.
upward trajectory persisted in 2022, with
1391 startups and a growth rate of 23.3%. Quarterly Dynamics: In 2022, the start-
up landscape maintained its growth
Yearly Growth Comparison: Compar- momentum, with the second quarter
ing growth percentages reveals a note- (Q2) witnessing the highest number of
worthy expansion from 2020 to 2021, startups. Despite occasional declines in
with a substantial 20 percentage point specic quarters, the overall trend show-
increase. Although the growth rate slight- cased the resilience and adaptability of
ly decreased by 11 percentage points in the startup ecosystem, demonstrating its
2022, the absolute number of startups ability to rebound and thrive.
continued to rise, indicating a sustained
positive trend in the entrepreneurial sec- Average Quarterly Registrations: The
tor. average quarterly registrations in 2022
reached approximately 348 startups, sur-
Exceptional Performance in 2022: The passing the 2021 average of 282 startups.
exceptional performance of startups This suggests a higher rate of startup reg-
in 2022, characterized by a signicant istrations per quarter in 2022. The aver-
increase in both quantity and growth rate, age quarterly registrations growth from
underscores the resilience and vibrancy 2021 to 2022 is estimated at approxi-
of the entrepreneurial ecosystem. This mately 23.32%.
1391
NEW STARTUPS 2022
2020-2222
1128
2021
840
2020
47 | IBER 2023
STARTUP ECOSYSTEM
MONTHLY AVERAGES
2022: The monthly average for startup registrations in 2022 was approximately 116. In 2021,
the monthly average for startup registrations was approximately 94. This average highlighted the
sustained and vibrant nature of entrepreneurial activities throughout the year.
100
80
60 2021
Source: ABLE Analysis
40
20
JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC
48 | IBER 2023
STARTUP ECOSYSTEM
CATEGORIZATION OF STARTUPS
The startup registrations were widely distributed across nature of activities. This highlighted the
dynamic and multifaceted nature of startup activities. The concentration in health, manufacturing,
and business services indicated a robust entrepreneurial ecosystem that contributed to various
sectors, fostering overall economic development.
Health and Social Work (32%): The viding diverse professional services.
largest segment, comprising 32%,
signified a substantial focus on Trading (9%): Trading activities con-
health-related services and social tributed 9%, indicating the crucial role
initiatives. This underscored a grow- startups played in facilitating com-
ing emphasis on well-being and com- merce and trade. This segment refect-
munity welfare within the startup ed a diverse range of startups offering
ecosystem. products and services.
24%
16%
10%
ACTIVITY
DESCRIPTION 7%
32%
6% 2%
1%
HEALTH AND MANUFACTURING (CHEMICALS
SOCIAL WORK AND PRODUCTS THEREOF)
49 | IBER 2023
STARTUP ECOSYSTEM
122 startups, experiencing a growth growth rate of 20%. The state contrib-
rate of 36% and holding a 9% share in uted 3% to the overall startup ecosys-
the overall startup count. tem.
Uttar Pradesh (115 Startups): Uttar Andhra Pradesh (40 Startups): Andhra
Pradesh emerged as a signicant play- Pradesh showcased growth with 40
er with 115 startups, marking a growth startups, marking a 33% increase. The
rate of 24%. The state contributed 8% state held a 3% share in the total start-
to the total startup ecosystem. up count.
Gujarat (97 Startups): Gujarat eatured Odisha (33 Startups): Odisha eatured
prominently with 97 startups, showcas- in the top 10 with 33 startups, exhibit-
ing a growth rate of 29%. The state con- ing a growth rate of 32% and holding a
tributed 7% to the total startup count. 2% share in the total startup count.
Tamil Nadu (82 Startups): Tamil Nadu Other States and Grand Total: The
registered 82 startups, exhibiting a “Others” category encompassed var-
growth rate of 26% and holding a 6% ious states, contributing 26% to the
share in the overall startup landscape. overall startup count. In 2022, there
were a total o 1391 startups, refecting
West Bengal (48 Startups): West Ben- a 23% growth from the previous year’s
gal recorded 48 startups, refecting a count of 1128.
51 | IBER 2023
STARTUP ECOSYSTEM
52 | IBER 2023
STARTUP ECOSYSTEM
showing a steady upward trajectory of 28%. While these projections are based on the
2025 to 2026: A 26% percent increase is provided data, several external factors could
forecast, with the cumulative startups influence the actual growth of startups,
reaching 12523. such as economic conditions, government
2026 to 2027: If the growth trend con policies, technological advancements, and
tinues, India is expected to have 16713 global events. It’s essential to consider these
cumulative startups. variables and regularly update predictions to
2027 to 2030: The cumulative startups account for changing circumstances in the
base is forecast to further increase to entrepreneurial landscape.
31223, based on consistent upward
trajectory.
BIRAC’S INITIATIVES:
STRATEGIC COLLABORATIONS AND PARTNERSHIPS
BIRAC’s programs, schemes, and policy initiatives were supplemented through strategic
collaborations and public-private partnerships with national and international bodies, government
departments, states, industry, investors, mentors, experts, philanthropic organizations, and NGOs.
Central Enabler and Impact on the Biotech Innovation Ecosystem: BIRAC, as a central enabler,
played a crucial role in nurturing the biotech innovation ecosystem in India, aiming to develop
globally competitive and affordable products to address the unmet needs of society.
Entrepreneurship and Start-up Support: BIRAC fostered a culture of biotech entrepreneurship,
creating a pipeline of over 11,000 aspiring entrepreneurs and 6300+ biotech startups. Recognizing
that the biotech innovation ecosystem is largely driven by startups, BIRAC supported 4800+
startups, entrepreneurs, and other beneficiaries.
Biotech Innovation Network: BIRAC established a vibrant biotech innovation network, including
75 bio-incubators across 21 statesUTs supporting 1800+ incubatees. This network also included
four regional centers for mentoring and handholding, seven technology transfer offices, and twelve
daughter funds under the Fund of Funds initiative.
Regulatory Information Facilitation Centre and IP Impact: BIRAC supported about 800 regulatory
queries from startups, entrepreneurs, and innovators through the BIRAC Regulatory Information
Facilitation Centre platform. BIRAC’s efforts led to the filing of over 1300 intellectual property (IP)
applications, with over 800 biotech productstechnologies reaching the market.
Biotechnology Innovation Fund-Accelerating Entrepreneurs (AcE) Fund: The Biotechnology
Innovation Fund-Accelerating Entrepreneurs (AcE) Fund, a ‘Fund of Funds,’ was launched to invest
equity in startups, providing the risk capital for innovation, research, and product development. AcE
mobilized over $120 million, with BIRACDBT committing $15 million in biotech startups and small
to medium-sized enterprises (SMEs).
Funding Support to Startups: Out of 11,000+ new innovative ideas, BIRAC supported:
950+ startups under the ‘Biotech Ignition Grant.’
159 startups provided equity investment through SEED and LEAP Fund.
77 companies provided investment through Fund of Funds-AcE Fund.
55 | IBER 2023
56 | IBER 2023
BIOTECH
INVESTMENTS
57 | IBER 2023
BIOTECH INVESTMENTS
ital health, consumer health, self-care, Ignition Grant (BIG), equity invest-
medical devices, platform technology, ment through SEED and LEAP Fund,
point-of-care devices, animal health, and investments through Accelerat-
drug discovery, and biotech. ing Entrepreneurs (AcE), a fund under
Biotechnology Innovation Fund, and
This transformation has been driven the fostering of high-performance bio-
by two main actors: rstly, the impact manufacturing.
of the coronavirus pandemic, and sec-
ondly, favorable government policies The disruptions in the global supply
such as the Ayushman Bharat health chains due to COVID-19 prompted
insurance scheme introduced in 2019, major pharmaceutical companies to
the National Digital Health Mission reconsider their strategies, leading to
(NDHM) initiated in 2021, the Arti- a diversication o sourcing. India is
cial Intelligence (AI) initiative, BIRAC’s expected to benet signicantly rom
programs to nurture the biotech inno- this trend.
vation ecosystem through Biotech
495.13
438.61 417.90
362.62
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Source: ABLE Analysis
DISCLAIMER
• The life sciences sector, • Various investment tracking within the realms of Biotech
encompassing healthcare, pharma, reports, such as Ernst & Young and bioinformatics, diagnostic
and biotech, stands out as one of the (EY) analysis of VC Edge data, Bain services, drug discovery in
most exciting and promising areas for reports, Tracxn Reports, or Venture biotech, biopharmaceuticals,
private equity (PE) investment. This Intelligence Lifesciences Reports, biomanufacturing, medical devices,
sector benefits from several favorable indicate that the overall life sciences agritech companies, alternate fuels,
trends, including aging populations, sector deals fall within the range of etc. It intentionally excludes sectors
an increase in chronic diseases, $4.1-4.5 billion. This figure represents such as hospitals, pharma distribution
and advancements in technology. the total PEVC investments e-commerce companies, pure-play
Consequently, PE firms have been across the life segments, including pharma companies, etc.
making substantial investments in pharmaceuticals and healthcare. • The analysis has been conducted
these sectors, placing their bets on • However, this IBER report based on data sourced from Venture
the long-term growth potential. specifically focuses on deals Intelligence, Tracxn, and EY Reports.
59 | IBER 2023
BIOTECH INVESTMENTS
60 | IBER 2023
BIOTECH INVESTMENTS
150 SERIES A ($ M)
SEED ($M)
100
ANGEL ($M)
50
0
2014 2015 2016 2017 2018 2019 2020 2021 2022 Source: ABLE Analysis
61 | IBER 2023
BIOTECH INVESTMENTS
PE INVESTMENTS BY STATE
Biotech Investment Deals Analysis (2013-2022) - Regional Distribution.
Analysis of biotech investments by region ments in the South and West regions of
and state in India from 2013 to 2022 India could be attributed to several fac-
showed that the South and West regions tors, including:
dominated biotech investments, with a
combined share of 73%. The total size of The presence of leading biotech com-
investments during the period was $4.87 panies and research institutions in
billion. these regions.
Karnataka and Gujarat were the top-rank- The proactive approach of state gov-
ing states, with shares of 30% and 14%, ernments in promoting biotech invest-
respectively. Maharashtra, Telangana, ments.
and Delhi also made signicant contri-
butions to the biotech investment land- A strong entrepreneurial ecosystem.
scape. The Rest of the States category
accounted for 8% of the total biotech REGIONAL BREAKDOWN:
investment share. North (17%): The northern states col-
lectively contributed 17% to the total
The concentration of biotech invest- biotech investment deals. This region,
62 | IBER 2023
BIOTECH INVESTMENTS
comprising Delhi, Haryana, and Uttar state and its role in shaping the nation’s
Pradesh, showcased a noteworthy biotech future.
presence in the evolving biotech sector.
Maharashtra Momentum (13%):
South (46%): The Southern states, led Mumbai-Pune Biotech Axis: Maha-
by Karnataka and Telangana, emerged rashtra followed closely, boasting a
as the powerhouse, commanding a 13% share fueled by the Mumbai-Pune
substantial 46% share. The region’s biotech axis. It was a bustling biotech
prominence was evident in its diverse corridor o the nancial and cultural
biotech hubs and proactive investment hub of India.
climate.
Delhi Drift: The Capital’s 8% Biotech
West (29%): Gujarat and Maharashtra Share: The national capital secured
in the West jointly contributed 29%, the th spot with an 8% share. Delhi’s
underlining the region’s signicance in infuence reverberated in the biotech
fostering biotech innovation. Mumbai landscape, blending politics and inno-
and Pune played pivotal roles in this vation.
vibrant ecosystem.
Haryana Hustle: A 6% Slice of Biotech
Others (8%): States beyond the major Glory: Haryana, the rising star in the
regions and the listed states collec- north, snatched a 6% share. The stra-
tively contributed 8%, showcasing a tegic location positioned Haryana as a
mosaic of innovation. This catego- noteworthy contender in the biotech
ry highlighted emerging players and race.
unique biotech narratives outside the
primary focus areas. Uttar Pradesh Unleashed: Breaking
Biotech Barriers (3%): Uttar Pradesh
TOP STATES broke barriers with a 3% share, mark-
Karnataka Occupied Biotech Throne ing its presence in the evolving biotech
(30%): Karnataka emerged as the narrative of the north.
undisputed king, commanding a whop-
ping 30% share of biotech investments. Southern Flourish: Tamil Nadu’s 3%
The top-ranking state, Karnataka, Biotech Symphony: Tamil Nadu played
attracted investments totaling $1.45 a melodious tune with a 3% share, add-
Billion. Bangalore’s magnetic pull for ing a southern fourish to India’s bio-
biotech innovators and investors drove tech symphony.
the deals.
Goa’s Biotech Beachhead (2%): Small
Telangana Triumph: Hyderabad’s State, Big Impact: Goa, though small,
Biotech Power Play (14%): Hyder- made a big impact with a 2% share.
abad’s rise in the biotech realm pro-
pelled Telangana to a commendable Rising Stars: The Collective Force of
second place with a 14% share. “Rest o the States” (8%): In the biotech
constellation, the “Rest of the States”
Gujarat’s Biotech Blitz (14%): A West- shone bright, contributing a collective
ern Dynamo Gujarat, a western dyna- force of 8%. Witness how these ris-
mo, claimed a signicant 14% share in ing stars added diversity and depth to
India’s biotech bonanza. The success India’s biotech investment galaxy.
came from the proactiveness of the
63 | IBER 2023
BIOTECH INVESTMENTS
a quarter of the total funding that was rounds showed substantial investments of
raised by companies in the healthcare $91.3 million and $150.37 million, respec-
industry. This suggested that the Medical tively. This balanced distribution suggest-
Devices sector was also a very attractive ed investor condence in both early-stage
sector for investors. development and subsequent scaling.
65 | IBER 2023
BIOTECH INVESTMENTS
66 | IBER 2023
BIOTECH INVESTMENTS
Company Post Money Value Total Equity Funding Lead Investors Include
Biocon Biologics $6B $632M Serum Life Sciences
Molbio Diagnostics $2B $117M Temasek Holdings
Source: ABLE Analysis
67 | IBER 2023
68 | IBER 2023
INNOVATION
ECOSYSTEM
69 | IBER 2023
INNOVATION ECOSYSTEM
EMPOWERING
EMERGING
BIOTECH
ENTERPRISES
Over the past decade, BIRAC has played a signicant role in
fostering the growth of the biotech ecosystem.
70 | IBER 2023
INNOVATION ECOSYSTEM
71 | IBER 2023
INNOVATION ECOSYSTEM
NO OF STARTUPS
SUPPORTED INVESTED IN BIOTECH
49 STARTUPS
400+ `349 Cr
1,250 Academic
IPs Generated Institutes
Supported
during the entire journey, from idea mat- received for funding support, a rising
uration to product commercialization. count of startups, national and inter-
national recognition of Indian startups,
Over the past decade, BIRAC has sig- and the successful commercialization of
nicantly contributed to the growth o Made-in-India products.
the biotech ecosystem, evident in the
increasing numbers of applications BIRAC has supported over 4800 ben-
72 | IBER 2023
INNOVATION ECOSYSTEM
73 | IBER 2023
INNOVATION ECOSYSTEM
THE DYNAMIC
LANDSCAPE OF
BIOINCUBATORS
IN INDIA
74 | IBER 2023
INNOVATION ECOSYSTEM
75 | IBER 2023
INNOVATION ECOSYSTEM
76 | IBER 2023
INNOVATION ECOSYSTEM
IKP 2.0: Mission revisited in 2019, focus- Awards: Received various awards,
ing on advancing deep tech and co-creat- including Top Innovation Enabler and
ing solutions. Top Bio-incubator.
78 | IBER 2023
INNOVATION ECOSYSTEM
GOLDEN JUBILEE BIOTECH PARK FOR WOMEN KIIT TECHNOLOGY BUSINESS INCUBATOR (TBI):
SOCIETY: Formation: Established in 2009 at KIIT
Inauguration: Established in 2001 in University, Odisha, supported by various
Siruseri, Chennai, with a commitment to government bodies and industries.
empowering women entrepreneurs.
Nurturing: Enabled the creation of over
Leadership: Governed by a commercial 5,000 technical jobs, on-boarded 50+
team led by Prof. PM Murali, with 150 industries, and promoted 200+ manufac-
years of cumulative corporate experience. turing startups.
79 | IBER 2023
INNOVATION ECOSYSTEM
NEW BIOCLUSTERS
The Department of Biotechnology in India
has implemented a strategic initiative to
enhance collaboration and networking in the
biotech sector through the establishment of
Bioclusters. Currently, four Bioclusters are
operational in India -- Faridabad (Haryana),
Bangalore (Karnataka), Kalyani (West Bengal),
and Pune (Maharashtra). Under this program,
TCG INTERNATIONAL BIOTECH PARK (TCG IBP): notable achievements include the creation of
Location: Situated on the Mumbai-Pune
advanced facilities like the National Structural
knowledge corridor, incorporated in 2003
Biology Facility with an Electron Cryo-
as a public-private partnership.
microscope, an Advanced Technology Platform
Focus Areas: Dedicated to the Life Sci- Centre with a Bioincubator, and a system
ences industry, particularly in R&D, with medicine platform for generating biological
thrust areas in biotechnology and phar- and medical evidence.
maceuticals.
NCR Biotech Science Cluster in Farid-
Integrated Biotech Park: Spans 80 acres, abad: The NCR Biotech Science Cluster
providing space for R&D and including in Faridabad, an ambitious project span-
residential, commercial, and hotel facil- ning 200 acres, aims to position Farid-
ities. abad as a global biotechnology hub. It
is a collaborative eort involving ve
Notable Tenants: Hosts companies like partner institutions of national impor-
Emcure Pharmaceuticals, Gennova Bio- tance, including the National Institute
pharmaceuticals, Hikal Ltd, Omni Active of Immunology (NII), Regional Centre
Technologies, and more. for Biotechnology (RCB), Translational
Health Sciences and Technology Insti-
Infrastructure: Offers premises ready tute (C), National Brain Research Centre
or t-outs, lab spaces, and biotech land. (NBRC), and National Institute for Plant
Infrastructure includes wide roads, an Genome Research (NIPGR). The cluster
electrical substation, 100% power back- features shared facilities such as labo-
up, and efuent treatment plants. ratories, pilot facilities, clinical research
and data management centers, animal
houses, instrumentation facilities, and
an incubation center for innovative start-
ups. The Oce o Connectivity has been
conceptualized as the cluster oce or
the NCR Biotech Science Cluster and is
responsible to establish a governance
structure for the management and utili-
zation of common facilities.
80 | IBER 2023
INNOVATION ECOSYSTEM
81 | IBER 2023
INNOVATION ECOSYSTEM
forms (C-CAMP), The Institute for Stem create a supportive environment for the
Cell Science and Regenerative Medicine growth of biotechnology startups. The
(InStem), and The National Centre for Bangalore Biocluster has made signi-
Biological Sciences (NCBS). The objec- cant contributions to the growth of the
tives of the Bangalore Biocluster are to biotechnology sector in India. Some of
promote collaboration and networking its key achievements include incubation
among researchers in the biotechnology of over 100 biotechnology startups and
sector, facilitate the translation of basic raising of over Rs 500 crore ($60 million)
research into commercial products, and in funding for biotechnology startups.
BIOTECHNOLOGY PARKS
The DBT has established 11 Biotechnology ParksIncubators across India to translate research
into commercial products and services. These parks support scientists and Small & Medium-sized
Enterprises (SMEs) in technology incubation, demonstration, and pilot plant studies. Notable
parks include Biotech Park in Lucknow, Guwahati Biotech Park, KRIBS BioNest in Kochi, Industrial
Biotechnology Parks in Jammu & Kashmir, Chhattisgarh Biotech Park, and Biopharma Growth
Phase Park in Hyderabad.
BIOTECH PARKS
Biotech Park, Lucknow, Uttar Pradesh Biotechnology Park, Bangalore,
Biotechnology Incubation Centre, Karnataka
Hyderabad, Telangana Two Industrial Biotechnology Parks
Tidco Centre For Life Sciences (TICEL) (IBTPs), Jammu & Kashmir
Biotech Park, Chennai, Tamil Nadu Chhattisgarh Biotech Park, Naya
The Golden Jubilee Biotech Park For Raipur, Chhattisgarh
Women, Chennai, Tamil Nadu Biopharma Growth Phase park and
Biotech Park Technology Incubation a common Scale up manufacturing
Centre, Guwahati, Assam facility with training provision in
Biotechnology Incubation Centre, Genome Valley, Hyderabad
Cochin, Kerala KRIBS BioNest, Kochi, Kerala
82 | IBER 2023
INNOVATION ECOSYSTEM
83 | IBER 2023
84 | IBER 2023
BIOTECH
PRODUCTS
85 | IBER 2023
BIOTECH PRODUCTS
PRODUCTS LAUNCHED
IN 2022
The year witnessed the
introduction of nearly
50 products in the
broad life sciences
and healthcare
segment.
86 | IBER 2023
BIOTECH PRODUCTS
87 | IBER 2023
BIOTECH PRODUCTS
88 | IBER 2023
BIOTECH PRODUCTS
carry payloads and maintain tempera- MEDTRONIC'S TRUCLEAR & HYSTEROLUX SYSTEM
ture control throughout the transporta- FOR HYSTEROSCOPY:
tion supply chain. DATE: NOVEMBER 2, 2022
Summary: Medtronic launched the Tru-
FREUDENBERG MEDICAL'S HELIXFLEX TPE TUBING: Clear system for diagnostic and operative
DATE: NOVEMBER 30, 2022 hysteroscopy, addressing intrauterine
Summary: Freudenberg Medical abnormalities causing abnormal uterine
launched HelixFlex, a high-purity TPE bleeding. The system is designed to be
tubing or biopharmaceutical fuid trans- safe and effective for treating conditions
fer applications. It offers advantages like like broids and polyps.
easy welding to existing tubing lines,
heat-sealing or ast fuid transport, var- EVER PHARMA'S APOMORPHINE THERAPY DEVICES
ious sterilization options, and environ- FOR PARKINSON'S:
mental friendliness compared to silicone. DATE: MARCH 5, 2022
Summary: Celera Neuro Sciences
LUMIRADX'S CRP POINT OF launched advanced apomorphine pumps
CARE ANTIGEN TEST: and pens for Parkinson's patients in
DATE: NOVEMBER 25, 2022 India. The third-generation D-mine apo-
Summary: LumiraDX morphine pumps offer self-handling
Healthcare introduced capability and electronic control for safe
a CRP point-of-care antigen test in India and convenient administration.
to aid in reducing unnecessary antibiot-
ic prescribing and combat antimicrobial MANKIND PHARMA'S RAPID
resistance. The test provides results with- TESTING PREGNANCY DEVICE:
in four minutes, contributing to World DATE: APRIL 13, 2022
Antimicrobial Awareness Week. Summary: Prega News,
Mankind Pharma's preg-
AVAY BIOSCIENCES' MITO PLUS BIO 3D PRINTER: nancy test kit brand, launched Prega
DATE: NOVEMBER 19, 2022 News Advance, a single-step pregnancy
Summary: Indian startup Avay Biosci- test device for home use. The device is
ences launched 'Mito Plus,' an advanced easy to use, requiring no dropper, and
Bio 3D Printer capable of printing human provides results in just three minutes.
tissues. Developed in collaboration with
the Indian Institute of Science, it utilizes CADILA PHARMACEUTICALS'
bioprinting technology with engineered THREE-DOSE RABIES VACCINE
bioinks. THRABIS:
DATE: APRIL 8, 2022
ROCHE DIAGNOSTICS' AUTOMATED CEREBROSPINAL Summary: Cadila Phar-
FLUID-BASED TEST FOR ALZHEIMER'S: maceuticals launched ThRabis, a novel
DATE: NOVEMBER 16, 2022 three-dose rabies vaccine using Virus-
Summary: Roche Diagnostics India intro- Like Particle technology. The vaccine
duced Elecsys AD CSF assays for auto- aims to prevent rabies by generating
mated cerebrospinal fuid-based tests to antibodies against the rabies G protein.
aid in the early diagnosis and risk assess-
ment of Alzheimer's disease. The assays
are available at top neurological insti-
tutes in India.
89 | IBER 2023
BIOTECH PRODUCTS
ROCHE PHARMA'S PHESGO FOR layer. These masks are highly breathable,
HER-2 POSITIVE BREAST washable, and reusable, offering a unique
CANCER: solution for the Indian healthcare mar-
DATE: MAY 12, 2022 ket.
Summary: Roche Pharma
introduced PHESGO, a xed-dose ormu- GODREJ INSULICOOL FOR
lation combining Perjeta and Herceptin INSULIN STORAGE:
monoclonal antibodies with hyaluroni- DATE: JULY 12, 2022
dase for subcutaneous administration. Summary: Godrej Appli-
The therapy targets early and metastatic ances launched Insuli-
HER2-positive breast cancer. Cool, an innovative cooling solution for
insulin storage. The product maintains
ZYDUS LIFESCIENCES' BEMDAC FOR UNCONTROLLED recommended temperatures, addressing
LDL-CHOLESTEROL: challenges faced by diabetic patients, and
DATE: MAY 16, 2022 has broader applications for storing tem-
Summary: Zydus Liesciences launched perature-sensitive medical items.
Bemdac, a new drug for patients with
uncontrolled LDL-Cholesterol despite OMRON HEALTHCARE'S MEDICAL MOLECULAR SIEVE
liestyle modications and statin use. OXYGEN CONCENTRATOR:
The oral drug provides a new treatment DATE: JULY 6, 2022
option for managing dyslipidemia. Summary: OMRON Healthcare introduced
a portable oxygen concentrator based on
CADILA PHARMACEUTICALS' CHOLESTEROL DRUG medical molecular sieve technology. The
BELMORE: device provides a continuous supply of
DATE: MAY 25, 2022 high-purity oxygen, making it suitable for
Summary: Cadila Pharmaceuticals homecare providers managing patients
launched Belmore, a novel drug for with COPD and respiratory problems.
treating high LDL cholesterol. Bempe-
doic acid, the active ingredient, offers a
unique approach to managing bad cho-
lesterol levels.
90 | IBER 2023
BIOTECH PRODUCTS
and sleep pattern analysis. GOQii is also ing, addressing antimicrobial resistance.
moving towards a health metaverse with The rapid test provides results in four
blockchain tokens and gamication. minutes and aids in managing patient
compliance to mitigate the global burden
ROCHE PHARMA INDIA'S PATIENT SUPPORT APP - of drug-resistant pathogens.
THE BLUE TREE 2.0:
DATE: NOVEMBER 29, 2022 AVAY BIOSCIENCES - MITO PLUS BIO 3D PRINTER:
Summary: Roche Pharma India launched DATE: NOVEMBER 19, 2022
The Blue Tree 2.0 mobile app, enhancing Summary: Avay Biosciences launched
the patient support program experience. 'Mito Plus,' an indigenous Bio 3D Printer
The app facilitates easy access to patient capable of printing human tissues. The
support services, including enrollment printer utilizes bioprinting technology,
tracking, drug assistance requests, supporting tissue replication for applica-
and delivery services, improving over- tions in regenerative medicine and bio-
all patient and healthcare professional medical research.
experiences.
ROCHE DIAGNOSTICS - AUTOMATED CSF-BASED
APOLLO HOSPITALS' AUTOMATED RAPID-RESPONSE TEST FOR ALZHEIMER'S:
PATIENT MONITORING SYSTEM: DATE: NOVEMBER 16, 2022
DATE: OCTOBER 12, 2022 Summary: Roche Diagnostics India intro-
Summary: Apollo Hospitals introduced duced Elecsys assays for cerebrospinal
an indigenously developed automated fuid-based testing to aid in the early
patient monitoring system. The system, diagnosis of Alzheimer's disease. The
developed by HealthNet Global, uses tests are intended for patients with cogni-
advanced medical devices and wearables tive impairment and aim to improve the
to monitor patients continuously, provid- accuracy of AD diagnosis, enabling clini-
ing early warning alerts to ensure timely cians to evaluate disease progression.
intervention and improved patient out-
comes. Apollo is planning to expand this MEDTRONIC - TRUCLEAR & HYSTEROLUX SYSTEM:
system across its network of hospitals DATE: NOVEMBER 2, 2022
with a signicant investment. Summary: Medtronic launched the Tru-
Clear system, a mechanical hysteroscop-
FREUDENBERG MEDICAL - HELIXFLEX TPE TUBING: ic tissue removal system, for the safe and
DATE: NOVEMBER 30, 2022 effective treatment of intrauterine abnor-
Summary: Freudenberg Medical malities. The system addresses abnormal
launched HelixFlex, a high-purity ther- uterine bleeding, a symptom reported by
moplastic elastomer (TPE) tubing for bio- 9-14% of women in India.
pharmaceutical fuid transer. It oers
ast and sae fuid transport in biophar- EVER PHARMA - APOMORPHINE THERAPY DEVICES
ma processes and is an environmentally FOR PARKINSON'S:
friendly alternative to silicone, with vari- DATE: MARCH 5, 2022
ous sterilization options. Summary: German pharma company
Ever Pharma introduced advanced apo-
LUMIRADX - CRP POINT OF CARE ANTIGEN TEST: morphine pumps and pens for Parkin-
DATE: NOVEMBER 25, 2022 son's disease treatment in India. The
Summary: LumiraDX Healthcare devices offer a self-handling option for
launched a C-Reactive Protein (CRP) patients, providing continuous infusion
point-of-care antigen test in India to for rapid absorption.
reduce unnecessary antibiotic prescrib-
91 | IBER 2023
BIOTECH PRODUCTS
MANKIND PHARMA - RAPID TESTING PREGNANCY AVESTHAGEN - GENETIC TESTS FOR CANCERS WITH
DEVICE: WIPRO PARTNERSHIP:
DATE: APRIL 13, 2022 DATE: JUNE 20, 2022
Summary: Mankind Pharma launched Summary: Avesthagen partnered with
Prega News Advance, an advanced preg- Wipro to launch genetic testing for can-
nancy detection test kit. It offers a mid- cers, starting with the CALiBRxO 624
stream test device for direct urine stream gene panel. The collaboration aims to
testing, providing accurate results in offer genome-led medicine and expand
three minutes, enhancing convenience across South Asia, Southeast Asia, and
for users. the MENA region.
92 | IBER 2023
BIOTECH PRODUCTS
ROCHE PHARMA INDIA - THE BLUE TREE 2.0 MOBILE GENES2ME - NGS-BASED CLINICAL PANELS:
APP: DATE: MAY 23, 2022
DATE: NOVEMBER 29, 2022 Summary: Genes2Me launched next-gen-
Summary: Roche Pharma India launched eration sequencing (NGS)-based panels
The Blue Tree 2.0 mobile app, part of the for oncology, personalized medicine, and
Blue Tree patient support program. The hereditary diseases. The panels cover a
app enhances the patient experience, wide range of genes, enabling compre-
providing easy access to support services, hensive analysis and precise selection of
drug assistance, and delivery tracking. drugs for personalized treatment.
DR. MOHAN’S DIABETES - AI-ENABLED DIGITAL ROCHE DIABETES CARE INDIA - ACCU-FINE PEN
INNOVATIONS: NEEDLES:
DATE: OCTOBER 10, 2022 DATE: MAY 9, 2022
Summary: Dr. Mohan’s Diabetes Special- Summary: Roche Diabetes Care India
ities Centre launched AI-enabled digital launched ACCU-FINE pen needles to facil-
innovations under its digital transfor- itate painless insulin delivery for people
mation initiative, offering personal- with diabetes. The needles are designed
ized 247 online care. The 3D Initiative with features for gentle insertion, rapid
includes 'DIA' (AI-powered chatbot), 'DIA- insulin fow, and ease o use, contributing
LA' (patient-friendly mobile app), and to improved diabetes management.
'DIANA' (healthcare application for preci-
sion diabetes care). MEDGENOME - VARMINER AI-ENABLED VARIANT
INTERPRETATION SOFTWARE:
NIRAMAI - EASY LAUNCH KITS DATE: APRIL 11, 2022
FOR BREAST CANCER Summary: MedGenome Labs launched
SCREENING: VarMiner, an AI-enabled variant inter-
DATE: OCTOBER 3, 2022 pretation software suite. VarMiner aids
Summary: Bengalu- in detecting genetic variants for rare dis-
ru-based startup Niramai launched 'Easy eases and inherited cancers, providing
Launch Kits' for breast cancer screen- clinicians and geneticists with deeper
ing, providing affordable and accessi- insights and actionable information.
ble screening services. The initiative
involves partnerships with organizations,
hospitals, and diagnostic centers, aiming
to triage populations and identify high-
risk individuals.
93 | IBER 2023
BIOTECH PRODUCTS
J MITRA - 4TH GEN ELISA-BASED HCV TEST: The BD SARS-CoV-2Flu assay, for the BD
DATE: SEPTEMBER 29, 2022 COR™ System, is an automated multi-
Summary: J Mitra launched the 4th Gen- plexed real-time RT-PCR test designed to
eration Elisa-based HCV Test – the HCV detect and differentiate respiratory viral
Gen 4 Ag and Ab Microlisa. The test kit infections from a single nasal sample.
detects HCV core antigen and antibodies,
oering high sensitivity and specicity ABBOTT - HBSAG NEXT ASSAY FOR HEPATITIS B
for screening blood donations and clini- DETECTION:
cal diagnostic testing of Hepatitis C. DATE: MAY 9, 2022
Summary: Abbott launched the HBsAg
Next Qualitative solution in India to
enhance the detection of Hepatitis B virus
(HBV). The chemiluminescent micropar-
ticle immunoassay (CMIA) offers highly
sensitive and early detection of HBV in
human serum and plasma, supporting
patient care and blood safety.
94 | IBER 2023
95 | IBER 2023
96 | IBER 2023
POLICY
FRAMEWORK
97 | IBER 2023
POLICY FRAMEWORK
BIOTECHNOLOGY
REGULATORY DEVELOPMENTS AND ACHIEVEMENTS provides guidelines for regulatory pro-
IN BIOTECHNOLOGY - 2022-23 cesses, ensuring adherence to environ-
The regulatory landscape in biotechnol- mental safety standards. The committee
ogy during 2022-23 refects proactive meticulously reviews projects involving
measures, technological advancements, high-risk categories and controlled eld
and a commitment to environmental experiments, imposing restrictions when
safety. The achievements and initiatives necessary.
outlined in this report underscore the
continued growth and development of MAJOR ACHIEVEMENTS - 2022-23:
the biotechnology sector in India. RCGM Meetings: A total of 24 RCGM
meetings were conducted.
The focus was on the Rules for the Manu-
facture, Use, Import, Export, and Storage Biopharma Applications: The com-
of Hazardous micro-organismsGeneti- mittee considered 586 Biopharma
cally engineered organisms or cells (Rules applications.
1989), enacted under the Environment
(Protection) Act, 1986. Agriculture Applications: Evaluation
of 99 Agriculture applications.
Regulatory Framework: Enacted on
December 5, 1989, under the Environ- Awareness Sessions: 20 awareness
ment (Protection) Act, 1986, the Rules generation cum interactive sessions
1989 empower the Ministry of Envi- were conducted for researchers.
ronment, Forest and Climate Change
(MoEF&CC) to safeguard the environ- IBSC Registrations: The year saw the
ment, nature, and health concerning registration of 91 new Institutional
gene technology and micro-organisms. Biosafety Committees (IBSC).
To ensure nationwide implementation,
six competent authorities and roles have Guidelines for Genome Edited Plants: The
been established under these rules. Department of Biotechnology (DBT) took
signicant steps by notiying the Guide-
Review Committee on Genetic Manipu- lines for Safety Assessment of Genome
lation (RCGM): The Review Committee Edited Plants, 2022. These guidelines
on Genetic Manipulation (RCGM), oper- serve as a roadmap for the development
ating within the Department of Biotech- and sustainable use of Genome Editing
nology, plays a crucial role in monitoring Technologies for plants in India, address-
safety aspects of ongoing research proj- ing biosafety concerns and outlining reg-
ects involving genetically engineered ulatory pathways.
organismshazardous microorganisms. It
98 | IBER 2023
POLICY FRAMEWORK
Standard Operating Procedures (SOPs) for ers. Here are some of the initiatives that
Regulatory Review: To facilitate regulato- are being considered.
ry review for research and development
of genome-edited plants falling under Make in India 2.0 Plan: Policy, scal,
SDN-1 and SDN-2 categories, SOPs were and regulatory recommendations for
notied by DBT. These procedures are biotech subsectors have been collated
applicable only for research and develop- and submitted to the DPIIT-CII Nation-
ment conducted under contained condi- al Consultation Action Plan Committee.
tions.
India as a $100 Bn Bio-Manufactur-
Biological Research Regulatory Approval ing Hub: Recommendations have been
Portal (BioRRAP) Launch: In line with the proposed to position India as a signi-
"One Nation, One Portal" initiative, the cant bio-manufacturing hub.
Biological Research Regulatory Approval
Portal (BioRRAP) ws launched on May 21, Covid-19 Fallout Recommendations:
2022. BioRRAP serves as a single nation- INR 100 Cr has been sanctioned from
al portal for biology researchers, stream- the Finance Ministry to address the
lining regulatory approvals for biological fallout of Covid-19 on startup suste-
research and development activities. This nance.
emphasizes both the "Ease of Science"
and the "Ease of Business." Establishing Technology Clusters:
Work is in progress to establish tech-
Foreign Trade: In-House R&D Recogni- nology clusters.
tion, and Other Issues: Recognizing the
indispensable role of trade in the coun- Research Linked Incentives Propos-
try's economy, the Department provided al: A draft proposal, based on stake-
comments on applications or xation o holder inputs, has been prepared to
IO norms and exportimport of restricted promote biotech innovations in moon-
items. Additionally, 25 R&D units in the shot areas.
biotechnology sector were recommended
for in-house R&D recognition. Digital Healthtech Innovations: The
Amrit Grand Innovation challenge,
Restructuring of DBT Institutions: DBT has JanCARE, has been launched to identi-
amalgamated its 14 Autonomous Institu- fy and support 75 innovations in digi-
tions into a single unied entity known tal health tech, telemedicine, mHealth
as the Biotechnology Research and Inno- using AI, ML, and blockchain.
vation Council (BRIC). This is to enhance
the scientic character and outcomes o REGULATORY FACILITATION INITIATIVES
the institutes, Foster research synergies FIRST HUB: Regulatory facilitation
and implement new education programs is provided to startups through FIRST
in line with the National Education Poli- HUB, where experts from various regu-
cy (NEP), and improve human resource latory bodies resolve queries. Over 750
structures. Aims to achieve "Minimum queries have been resolved.
Government, Maximum Governance."
Regulatory Facilitation Information
KEY STRATEGIC INPUTS AND REGULATORY Cell (RFIC): Established at BIRAC’s
FACILITATION IN BIOTECHNOLOGY Regional Centre in Pune, RFIC assists
Key Strategy Inputs through Stakeholder biotech startups throughout the year,
Consultation were sought by policy mak- facilitating 250+ startups, 11 ISO certi-
99 | IBER 2023
POLICY FRAMEWORK
BIOMEDICAL INDUSTRY
NATIONAL MEDICAL DEVICES POLICY sustained growth and development. The
The medical devices sector encompasses objective is to facilitate orderly growth,
electronic equipment, implants, consum- ensuring access, affordability, quality,
ables and disposables, surgical instru- and innovation in the medical device
ments, and in-vitro diagnostic reagents, sector. Aligning with the 'Atmanirbhar
urther classied into 24+1 sub-catego- Bharat' and 'Make in India' programs,
ries as per the Central Drugs Standard the policy aims to encourage domestic
Control Organization (CDSCO). The med- investments and production of medical
ical devices sector in India is a rapidly devices.
growing, sunrise industry, contributing
1.5% to the global medical device market. KEY HIGHLIGHTS OF MEDICAL DEVICE SECTOR PROMOTION
Factors driving this growth include a ris- STRATEGIES:
ing and aging population, increased per Regulatory Streamlining:
capita and disposable income, demand Introduction of a 'Single Window
for healthcare infrastructure, expanded Clearance System' for Medical
diagnostic services, and healthcare ser- Device Licensing.
vice dissemination. Additionally, the vet- Expansion of Indian Standards by
erinary sector is emerging as a vital and bodies like BIS for enhanced stan-
growing sector, necessitating the devel- dardization.
opment of affordable veterinary medi- Framework development for coher-
cal devices for both domestic and export ent pricing regulation aligned with
markets. DPCO.
Creation of a Guidance Framework
Role During COVID-19: The policy rec- for researchers, innovators, and
ognizes the signicant contribution o entrepreneurs.
the Indian medical devices sector during Institutional arrangement for align-
the COVID-19 pandemic. Through large- ing NMC Regulations and industry
scale production, it supported the domes- ethics.
tic and global battle against the virus by
manufacturing critical items such as ven- Enabling Infrastructure:
tilators, rapid antigen test kits, RT-PCR Establishment and strengthening of
kits, infrared thermometers, PPE kits, medical device parks and clusters.
and N-95 masks. Creation o testing and certication
facilities for medical devices.
The direction is to harness the potential Support for phased manufacturing
of the medical devices sector effective- of critical components for uninter-
ly. Despite various government schemes rupted supply.
and initiatives, a holistic policy is essen-
tial to provide a guiding framework for Facilitating R&D and Innovation:
BIOINDUSTRIAL POLICIES
MEASURES TO ENCOURAGE ETHANOL-BLENDED FUEL Ethanol Blending Program:
The Union Budget 2022-23 introduced
measures to promote the use of etha- Fuel Ethanol Demand:
nol-blended fuel in India, aligning with Projected increase in India's etha-
the nation's commitment to Sustainable nol requirement for petrol blending
Development Goals (SDGs) and clean from 173 crore litres (2019-20) to
energy. The budget proposes an addition- 1,016 crore litres (2025-26).
al differential excise duty of Rupees Two Suggested supply from surplus to
per liter on unblended fuel from October decit states or uniorm ethanol
1, 2022, to incentivize the blending of fuel blend availability.
and propel India towards energy security
and a low carbon economy. Ethanol Blending Roadmap:
Recommends notifying a plan for
E10 fuel (10% ethanol, 90% petrol) Encourages production from maize
availability by April 2022. and second-generation sources.
Proposes a phased rollout of E20 fuel
from April 2023, targeting availabili- Ethanol-Compatible Vehicles:
ty by 2025. Stresses holistic vehicle design for
Advocates beginning higher ethanol higher ethanol blends to prevent
blends in states with surplus pro- engine failure and low fuel economy.
duction. Recommends rolling out E20 mate-
rial compliant and E10 tuned engine
Regulatory Clearances: vehicles nationwide from April 2023.
Urges expedited regulatory clear- Proposes E20 tuned engine vehicles
ances for ethanol production. rollout from April 2025.
Recommends a single window sys-
tem by the Department for Promo- Unrestricted Movement of Ethanol:
tion of Industry and Internal Trade Highlights denatured ethanol's
for swift project clearances. use or blending, deemed unt or
human consumption.
Environmental Impact: Recommends central government
Emphasizes water conservation, control for unrestricted movement
suggesting incentives for ethanol across India, avoiding state-level
sourcing from less water-intensive restrictions.
crops.
Package 2 (Mega & Special Projects): 2027, or until the introduction of a new
Similar incentives as Package 1 but or revised policy.
with higher ceilings, along with facil-
itation support. TAMIL NADU HAS LIFE SCIENCES PROMOTION AND
RESEARCH AND DEVELOPMENT POLICY
Electricity Duty: 100% reimburse- Tamil Nadu recognizes the importance of
ment or ve years on the electricity the Life Sciences sector in achieving SDGs
duty paid. and is investing in drugs and medical
devices manufacturing, skill development,
Interest Subsidy on term loan: Quar- and lab construction. It announced a new
terly return at the rate of 7% against policy. This Policy is applicable for green-
interest paid on term loans of up to eld, or expansion projects engaged in the
Rs 100 crore ($12 million), with an following areas of Life Sciences, namely
annual ceiling of Rs. 7 crore ($0.84
million). Besides, quarterly return at Biotechnology and BioServices
the rate of 3% against interest paid
on term loans of above Rs.100 crore Pharmaceutical and Nutraceutical
($12 million), with an annual ceiling Industry
of Rs.20 crore
Medical Devices
POLICY IMPLEMENTATION:
Mission Director, GSBTM, will imple- Medical Textiles.
ment the policy in consultation with
the Department of Science and Tech- Research Ecosystem: Tamil Nadu has
nology. established TICEL Bio-Park to focus on
the application of advanced technology
Technical Advisory Committee (TAC) in microbiology and molecular biology,
will address ambiguity and provide supporting and amplifying the Life Sci-
inputs on emerging technologies. ences research ecosystem. It is home to
prestigious institutions such as Dr. M.G.R.
Units can choose incentives under this Medical University, Madras Medical Col-
policy or the Industrial Policy but not lege, IIT-Madras, Anna University, IIBAT,
both. Tamil Nadu Agricultural University, and
Tamil Nadu Veterinary and Animal Ser-
INVESTOR FACILITATION AND GUIDELINES: vices University.
Government acts as a facilitator, estab-
lishing a single-window clearance Investment and Job Generation Goals:
mechanism and a helpdesk. The government aims to attract Rs 20,000
crore ($2.5 Billion) of investment in the
Gujarat State Biotechnology Mission Life Sciences sector, with a parallel objec-
serves as a nodal agency, and detailed tive of generating 50,000 jobs.
implementation guidelines will be
issued. Sunrise Sectors: Medical electronics,
devices, equipment, biotechnology, phar-
POWER TO AMEND AND OPERATIVE PERIOD: maceuticals, bulk drugs, nutraceuticals,
The government reserves the right to and technical textiles, including medical
review and amend the policy. textiles, are recognized as sunrise sectors
under TNIP 2021. These sectors qualify
The policy is effective until March 31, for special incentives.
R&D Policy Objectives: The Research ized facilities will be developed based
and Development (R&D) policy targets on requirements through public-pri-
doubling the R&D expenditure in the state vate partnerships.
by 2030. It focuses on increasing inputs to
R&D, including the number of research- MEDICAL DEVICE PARKS:
ers and scientists, boosting innovation The government plans to develop a
outputs such as patents and publications, dedicated park for medical devices to
and developing a collaborative innovation enhance indigenous manufacturing,
ecosystem with research parks, centers, improve cost eciency, and achieve
hubs, and excellence centers. accelerated growth. SIPCOT is develop-
ing an exclusive greeneld industrial
Private Sector Promotion: The policy park at Oragadam, including common
emphasizes the promotion of R&D in the facilities and ensuring uninterrupted
private sector. water and electricity supply.
doubling the sectoral value to US$ 100 Bil- and strengthening the investment pro-
lion and adding 400,000 new jobs by 2030. motion body with a life sciences focus.
MAJOR DEVELOPMENTS
Particulars Metrics
No. Molasses Based projects 263
Installed Capacity of Molasses based Production (in Crore liters p.a.) 619.4
No. Grain Based projects 123
Installed Capacity of Grain based Production (in Crore liters p.a.) 328.5
Total Installed Capacity of ethanol production (in Crore liters p.a.) 947.9
India's Share of Covid Vaccines (billion doses 2021) 2.46
India's Share of non-Covid Vaccines (billion doses 2021) 1.98
Cotton crop production for the (October-September) season in million 34.1
bales of 170 kg
PLI: Number of selected applicants 76
PLI: Total number of applications received under the PLI scheme 249
PLI: Number of products spread across the four Target categories for 55
domestic manufacturing scheme.
PLI: Total committed investment of Rs 4,138.41 crore $500 million
PLI: Expected employment generation of persons. 10,598
Note: The information on PLI encompasses details about the Source: ABLE Analysis
Production Linked Incentive (PLI) Scheme for Pharmaceuticals.
PLI SCHEME
Launched in 2021 under the Atmanirbharta initiative, the Product Linked Incentive (PLI) scheme
boasts a financial outlay of $1.8 billion (Rs. 15,000 crores) spread across six years. In its inaugural
production year (2022-2023), the scheme selected 55 applicants, including 20 MSMEs, with a
budgetary allocation of $83 million (Rs. 690 crores).
Incentives and Employment Impact: impact on production capacity is antici-
The Department of Pharmaceuticals pated in the coming years, there’s already
(DoP) disbursed the rst tranche o incen- a notable 4.54% reduction in India’s
tives, totaling $20 million (Rs. 166 crores), imports of bulk drugs and intermediates
beneting our selected applicants under globally.
the PLI scheme for pharmaceuticals.
This initiative generated employment Achievements in Medical Devices Sec-
for 23,000 individuals. The scheme also tor: Under the PLI scheme for Medical
offers incentives ranging from 10% to 3% Devices, with a $410 million (Rs. 3,420
based on incremental sales. The select- crores) outlay, an investment of $86 mil-
ed 55 applicants collectively reported lion (Rs. 714 crores) has been reported.
sales of approximately $4.3 billion, with a This marks a signicant milestone, as
total installed capacity exceeding 33,000 it has enabled the domestic production
tonnes. of high-end medical devices in India
or the rst time, creating employment
Impact on Bulk Drugs Production: The for about 2900 individuals. The scheme
PLI scheme for Bulk Drugs has seen an has approved 21 applicants with a com-
investment of $242 million (Rs. 2019 mitted investment of $127 million and
crores) and provided employment for an expected employment generation of
about 1900 individuals. While the full around 6,411 persons.
The Government has established an infows in the country. From April 2000
investor-friendly FDI policy to encourage to March 2023, FDI infows in Drugs &
investment in the pharmaceutical sector. Pharmaceuticals (Pharma) and Medtech
In Medical Devices, 100% foreign invest- Sectors reached $6.26 billion.
ment is permitted under the automatic
route. In pharmaceuticals, up to 100% The FDI infows in the pharmaceutical
FDI is allowed in greeneld projects, and sector, including both drugs & pharma-
up to 74% FDI in browneld projects is ceuticals and medtech activities, grew by
permitted under the automatic route. 6.7 times from $354 million in 2018. In
Government approval is required for for- the nancial year 2022-23, FDI infows
eign investment beyond 74% in brown- in the pharmaceutical sector amounted
eld projects. to $2 billion from drugs & pharmaceu-
ticals activities and $375 million from
The pharmaceutical sector contributes medtech activities, totaling $2.37 billion.
approximately 3.71% to the total FDI Additionally, between January 1, 2022,
Drugs &
2018-19 221 133 and November 30, 2022, the Department
Pharmaceuticals
of Pharmaceuticals approved 21 FDI pro-
Medtech posals or browneld projects, amount-
2019-20 438 264 ing to $560 million.
SOCIETAL IMPACT
Biotechnology-driven societal develop- On another front, the Biotech-Krishi
ment is on uplifting vulnerable segments, Innovation Science Application Network
particularly in Aspirational Districts. DBT (Biotech-KISAN) endeavors to enhance
has concentrated on such areas. Notable agricultural productivity for small farmers,
achievements in 2022-23 include sup- with success stories spanning grass pea
porting 32 projects that beneted over cultivation in Bihar to empowering wom-
5,000 individuals, with a strong empha- en farmers in the Sundarbans. Various hub
sis on empowering women (65% bene- activities and successes, such as the estab-
ciaries) and marginalized communities lishment of an organic farming hub in the
(56% from SC/ST groups). These initia- Northeast, underscore the multifaceted
tives, ranging from organic cultivation to impact of these biotechnological interven-
animal health camps, led to a commend- tions in fostering sustainable agricultural
able 30% average income increase. practices and economic development.
CONCLUSIONS
1,391 biotech startups, expanding the Paper and Pulp, Poultry Industry, Tex-
10-year base to 6,755. At this pace, pro- tile Industry, and Vegetable Oils industry.
jections indicate a thriving ecosystem BioMedical comprises Biopharmaceuti-
with 35,460 startups by 2030. Achieving cals, diagnostics, and medical devices.
this goal necessitates the incorporation BioAgriculture focuses on Bt Crops, Ani-
of an average of 3,590 new companies mal biotech, Biomass, Pesticides, and
annually between 2023 and 2030, mark- Fertilizers areas. BioServices encompass
ing a substantial increase rom ve start- BioIT, Platforms, Contract Research, Drug
ups a day in 2025 to 15 in 2030. Discovery, Patent Services, etc.
“India will make significant investment in R&D “With the rollout of iNCOVACC, we have
to develop a roadmap for design and delivery achieved our goal of establishing a novel
of vaccine development for future pandemic,” vaccine delivery platform for intranasal
DR JITENDRA SINGH delivery. It proves that India can innovate for
UNION MINISTER OF STATE (INDEPENDENT CHARGE) SCIENCE itself and for the world,”
& TECHNOLOGY DR KRISHNA ELLA
EXECUTIVE CHAIRMAN, BHARAT BIOTECH.
“Just like UPI revolutionized payment
transactions in India, Unified Health Interface “If India has to be at the cutting edge of
(UHI) will revolutionize digital health service innovation, our regulatory system also needs
delivery,” to undergo reforms. It needs to be reflecting
DR R S SHARMA the new kinds of work that goes on in this
CEO, NATIONAL HEALTH AUTHORITY. industry,”
MR SATISH REDDY
"A vision document is being prepared for India CHAIRMAN, DR REDDY'S LABORATORIES.
to become a developed economy of about USD
30 trillion by 2047, and it will be released by “India's pharmaceutical industry could surpass
Prime Minister Narendra Modi in January next USD 130 billion by 2030. The pharmaceutical
year. The draft 'Vision India @2047' document sector in India is expanding at a remarkable
will outline the institutional and structural rate, as demonstrated by the 8 per cent
changes/ reforms that will be needed for the year-to-date increase in exports and the
country to become a developed nation by noteworthy 29 per cent surge in October 2023
2047," alone. This growth is propelled by expanding
MR BVR SUBRAHMANYAM market opportunities, heightened demand in
CEO, NITI AAYOG. the USA, and critical shortages of medicines
in the US and Europe. Despite challenges in
"There was a lot of investment in health CIS countries, the global reception of Indian
systems made during the pandemic across pharmaceuticals remains positive,”
countries, and it will definitely keep us well MR VEERAMANI S. V.
prepared in case there are other outbreaks," CHAIRMAN, PHARMEXCIL (PHARMACEUTICALS EXPORT
MR ADAR POONAWALLA PROMOTION COUNCIL OF INDIA).
CEO, SERUM INSTITUTE OF INDIA (SII).
“There are more funding opportunities for “I think the timing is perfect right now for India
early-stage companies than 10 years ago. to utilize artificial intelligence and machine
Government organizations like Biotechnology learning, these fascinating new tools, to solve
Industry Research Assistance Council have impactful and meaningful problems. I work
pushed innovation across the board — in biotechnology, so we're trying to address
diagnostics, devices, new drugs, etc. They issues in agriculture, the environment, and
have provided seed funding to individuals and healthcare—large impact areas that affect
small companies that want to look at out-of- billions of people not just in India but all over
box ideas. The R&D ecosystem is developing the world. To be able to use technology to
due to push from innovators and pull from the make such meaningful contributions to India
government,” and the universe is a great opportunity for
MR SHRIDHAR NARAYANAN us. I request all young entrepreneurs who are
CHAIRMAN AND CEO OF FOUNDATION FOR NEGLECTED looking at AI and machine learning to work on
DISEASE RESEARCH, BENGALURU. impactful products. So, it is not Information
Technology anymore; it's impact technology,”
“On occasion of World Biofuels Day (10th DR ANAND ANANDKUMAR
Aug), Prime Minister Narendra Modi unveiled CEO AND MD, BUGWORKS RESEARCH
the first of its kind & Asia’s First 2G Ethanol
Bio-Refinery of Indian Oil Corporation “Technologies like artificial intelligence
Limited (IOCL) at Panipat Haryana. Praj is a and analytics can significantly improve
technology licensor and EPCM partner for efficiency in Indian agriculture. Indian farmers
this project, which is based on our proprietary are increasingly becoming open to new
technology processing rice straw as feedstock technologies and practices for enhancing
for production of Ethanol. We are very proud productivity and they can be our champions of
of our association with IOCL to set up this sustainability at the grassroot level. Also, the
coveted project. This plant is a huge milestone role of biotechnology in agriculture is pivotal,
in realizing our Prime Minister’s vision of particularly in precision breeding for climate-
energy independent India. We believe success resilient crops and genetic modification for
of this project reinforces India’s technology pest and disease resistance,”
leadership in global bioeconomy,” MR DEEPAK SOOD
DR. PRAMOD CHAUDHARI Secretary General, ASSOCHAM.
FOUNDER-CHAIRMAN, PRAJ INDUSTRIES.
“AI can play an important role in prevention
“Over the time that we’ve been here, in the and early detection of cancer. At the same
last seven-eight years, India has opened up to time, technological advancement will take
a lot more innovation-based solutions,” healthcare to people’s doorstep. There
MS EZHIL SUBBIAN won’t be a need for primary health centers
CO-FOUNDER AND CEO, STRING BIO. or big labs with hand-held devices and
miniaturization,”
“India is critical for Novozymes success. We’re DR VIJAY CHANDRU
going to continue to invest here. We produce in CO-FOUNDER & DIRECTOR STRAND LIFE SCIENCES
India for India, and we produce in India for the
globe. So, we look at our Indian operations as a “As the world grapples with the problems
global asset,” induced by climate change, helped by
MS ESTER BAIGET innovative government policies, ABLE
PRESIDENT AND CEO, NOVOZYMES. members will play even greater role as the
nation sets up more bio refineries to produce
enough biofuels to achieve the 20% blending
target by 2025,”
MR GS KRISHNAN
PRESIDENT, ABLE