India's biotechnology sector has surged to become a global powerhouse, boasting a value of USD 92 billion in 2023 with a 15% growth, fuelled by its leadership in vaccines and recombinant therapeutics. The industry is a key player in the global market, supplying 70% of WHO's vaccine needs and pioneering innovations like the world's first intranasal COVID-19 vaccine. India's favourable policies, robust start-up ecosystem, and strategic collaborations have propelled its biotech landscape, positioning it for continued growth and innovation, with forecasts predicting a market value of USD 150 billion by 2025 and USD 300 billion by 2030.
Market Insight
India's biotechnology sector is thriving, ranking among the top global destinations and standing third in the Asia-Pacific region, with a 3% share of the global market. Rapid growth is evident, with the industry surging from USD 70.2 billion to USD 80.12 billion in 2021, marked by the launch of 1,128 biotech start-ups. Projections suggest further expansion, with estimates reaching USD 150 billion by 2025 and an impressive USD 270-300 billion by 2030, driven by domestic initiatives like Aatmanirbhar Bharat and international demand for Indian vaccines and biopharmaceuticals. India's multidisciplinary approach addresses sectors from health to agriculture, while its commitment to sustainable agriculture and innovative initiatives, like the GOBARdhan scheme, underscore its leading role in the global biotechnology landscape.
Growth Drivers
India's biotechnology sector is thriving due to several key factors. A skilled workforce of over a million professionals, supported by initiatives like the Pan India Star College Mentorship Program, forms the industry's backbone. The country has established 74 bio-incubation centres and four industry clusters, fostering robust infrastructure. Government initiatives such as 'Make in India,' 'Start-up India,' and 'Atmanirbhar Bharat Abhiyan' boost domestic manufacturing, complemented by policies like the Draft R&D Policy 2021 and Production-Linked Incentive schemes. India's demographic and epidemiological landscape fuels demand for healthcare solutions, while the sector's investment climate, including favourable foreign direct investment policies, drives substantial investments. Strategic initiatives like Bio-Tech Parks bridge the gap between research and applications, while a vibrant start-up ecosystem, supported by entities like BIRAC and international collaborations, propels innovation, leading the biotechnology sector toward a promising future.
Recent Developments
India's biotechnology sector is rapidly advancing, marked by key achievements and initiatives. It leads globally in biosimilars, aiming for a USD 12 billion industry by 2025, with a 22% growth rate. India's infrastructure includes nine Biotech Parks, fostering a conducive environment. As a leading vaccine manufacturer, it exports vaccines to 150+ countries, supported by initiatives like Mission Indradhanush. The National Biopharma Mission, backed by USD 250 million, focuses on biopharmaceutical innovation. India is emerging in Bio-IT and Bio-Services, with 19% growth. FDI liberalization, financial allocations, collaborative efforts, and advancements like the world's first COVID-19 intranasal vaccine and the inauguration of the 'Indian Biological Data Centre' showcase India's progress. Notably, pharmaceutical exports reached INR 1.8 trillion in FY22.
Why Invest in India?
India's biotechnology sector is flourishing due to its abundant human capital, including a young and skilled workforce, and support from initiatives like the Biotech-KISAN program benefiting thousands of farmers. Epidemiological trends point to a 20% patient population growth, driven by population expansion and lifestyle shifts, increasing demand for pharmaceuticals and medical devices. Robust policy support, such as 100% FDI for greenfield projects and proactive initiatives like Mission COVID Suraksha, accelerates domestic vaccine development. Significant developments include the establishment of biotech parks and bio-incubators, backed by a substantial USD 162.7 million allocation in the 2023-24 Union Budget. Initiatives like the International Biotech Conclave and the creation of a centre of excellence in Hyderabad further enhance India's biotechnology landscape, fostering innovation and addressing future pandemics.
Key Opportunities
India's biotechnology sectors are rapidly advancing: bio-services benefit from streamlined approval processes, biopharma anticipates a 22% CAGR, bio-industrials focus on biofuels for energy independence, Bio-IT thrives due to data demands, and bio-agri gains importance for enhanced food security, all contributing to India's burgeoning biotech landscape.
Investment Opportunities
India's biotech landscape is thriving, attracting substantial investments and global attention. The country's appeal for clinical trials is bolstered by its vast patient pool and competitive costs. Regulatory changes in drug approvals have reshaped the clinical trial landscape. The medical devices industry is set to grow to USD 50 billion by 2025. Key investments include Bristol-Myers Squibb's USD 96.69 million centre and start-ups like CrisprBits and Eyestem securing funds for research and product development. Hospitals like Yashoda Super Specialty plan significant investments, while biotech startups, including Zaara Biotech, are receiving substantial funding, propelling India's bioeconomy to new heights with a 400% increase in investments since 2014.
Opportunities in Bio-Pharma
India's biotech industry is making significant global impacts across various sectors. The country is a key player in the vaccine market, covering a substantial portion of WHO's demand and expected to grow from USD 2 billion to USD 5 billion, with the domestic vaccination market predicted to reach USD 3.04 billion by 2025. India is also addressing the diabetes challenge, with over 100 million potential patients by 2030, offering opportunities for insulin market growth. Regenerative medicine is on the rise, with research institutions exploring stem cell applications in areas like cardiology and ophthalmology. Additionally, India is making strides in biosimilars, with over 125 approved products and a market set to reach USD 2.2 billion by 2025, leveraging generics to provide cost-effective healthcare solutions globally.
India : Emerging Hub for Biosimilar and Biologics
India's pharmaceutical industry is at the forefront of the global shift from traditional chemical drugs to biologics and biosimilars. India's early adoption of biosimilars, with approvals dating back to 2000, has positioned the country as a leader in this sector. With approximately 127 approved biosimilars, India is poised for significant growth, with a potential bioeconomic value of USD 15 billion by 2025. The biologics economy is also thriving, expected to reach USD 12 billion by 2025 with a remarkable CAGR of 22%. Key players like Biocon Ltd., along with companies such as Dr. Reddy's Laboratories, Intas Pharmaceuticals, Zydus Cadila, and Lupin, highlight India's influential role in the global biopharmaceutical market, providing innovative and cost-effective healthcare solutions worldwide.
National Biopharma Mission
The National Biopharma Mission (NBM) is a collaborative initiative between India's biopharmaceutical industry and academia, launched in 2017 with a budget of Rs 1500 crore, 50% of which is funded by the World Bank. Administered by the Biotechnology Industry Research Assistance Council (BIRAC), under the Department of Biotechnology, NBM focuses on accelerating biopharmaceutical development in India. It operates through the Innovate in India (i3) program, targeting critical products like vaccines and biosimilars, enhancing infrastructure, developing skilled professionals, and establishing technology transfer offices. NBM and i3 play a pivotal role in fostering innovation, research, and self-reliance in India's biopharmaceutical sector.
Atal Jai Anusudhan Biotech Mission
The Atal Jai Anusandhan Biotech Mission - UNaTI, unveiled in 2019 by the Department of Biotechnology, is a transformative initiative spanning five years with a focus on Health, Agriculture, and Energy sectors. It includes programs like GARBH-ini for maternal and child health, IndCEPI for developing vaccines, biofortified wheat research, Anti-Microbial Resistance (AMR) initiatives, and Clean Energy interventions. UNaTI demonstrates India's dedication to advancing these sectors through innovative biotechnological research, aiming to reduce maternal mortality, enhance vaccine development, improve nutrition, combat AMR, and contribute to clean energy solutions.
Role of Technology in the Industry
The role of technology in India's biotech industry is pivotal, driving scientific advancements in drug discovery, healthcare solutions, and agricultural innovation. It enhances global competitiveness, fosters economic growth, and aids disease management through vaccines and therapies. Moreover, technology promotes environmental sustainability, supports cutting-edge research, and ensures regulatory compliance, enabling India to contribute to global health initiatives. Investment in technology education is vital for developing a skilled workforce, and technology innovations also lead to intellectual property rights, enhancing the industry's global presence. Additionally, technology facilitates the establishment of biobanks and research repositories, crucial for scientific research and innovation.
Available Technological Support in India
India's biotechnology industry showcases diverse expertise across multiple sectors. In healthcare, the country excels in vaccine development, biosimilars, stem cell research, and medical diagnostics. In agriculture, India pioneers genetically modified crops, biological pest control, and bioprocessing technologies. The nation also leads in bioinformatics, bioremediation, tissue engineering, DNA sequencing, and genomics research. India's robust biotechnology education and research institutions, such as IITs and IISERs, contribute significantly. The country's biotech landscape includes biobanks, startups, and incubators, emphasizing innovation and entrepreneurship. Additionally, research in plant and animal biotechnology further strengthens India's position in the global biotech arena.
Regulatory Framework
India's biotechnology regulatory framework is comprehensive and multi-faceted, overseen by key entities such as the Department of Biotechnology (DBT), Genetic Engineering Appraisal Committee (GEAC), Central Drugs Standard Control Organization (CDSCO), Food Safety and Standards Authority of India (FSSAI), Ministry of Agriculture and Farmers Welfare, Indian Council of Medical Research (ICMR), Department of Science and Technology (DST), National Biodiversity Authority (NBA), and State Biotechnology Coordination Committees. These bodies collectively ensure the safety, ethical conduct, and compliance of biotech research, development, and commercialization activities, covering areas like genetically modified organisms, biopharmaceuticals, food safety, biodiversity, and intellectual property rights. The regulatory landscape also involves legal acts such as the Environment Protection Act 1986, safeguarding against environmental implications of biotech endeavors.
Approvals and Licenses
In India, engaging in biotechnology activities necessitates obtaining various licenses and approvals from regulatory bodies. This includes Genetic Engineering Approval Committee (GEAC) approval for genetically modified organisms, Central Drugs Standard Control Organization (CDSCO) clearance for clinical trials, licenses from Directorate General of Foreign Trade (DGFT) for import/export, environmental clearance from Ministry of Environment, Forest and Climate Change (MoEFCC) for environmentally impactful projects, State Drug Control Authorities' license for drug manufacturing, Institutional Ethics Committee approval for ethical human/animal research, and Biological Diversity Access and Benefit-Sharing (ABS) approval from National Biodiversity Authority (NBA) for projects involving biological resources. Additionally, Food Safety and Standards Authority of India (FSSAI) licenses are needed for biotech-related foods, and protecting intellectual property via patents, copyrights, or trademarks is crucial. Exporters might also require registration with Export Promotion Councils (EPC) for incentives. These measures ensure compliance with regulatory standards and ethical considerations in biotechnology ventures.
Key Industry Players
- Serum Institute of India
- Panacea Biotech Ltd.
- Biocon Ltd.
- AstraZeneca plc
- Bayer AG
- GlaxoSmithKline plc
- Novozymes A/S
Conclusion
India's biotechnology industry is experiencing significant growth, driven by key sectors like vaccines, recombinant therapeutics, monoclonal antibodies, stem cell therapies, and growth factors. The country's large population makes it a major market for vaccines, offering research and production opportunities. Investment in protein and antibody production, diagnostic protein chips, stem cell research, and cell-based therapeutics promises advancements in disease diagnosis and treatment. India also has potential in transgenic crops and genetically modified vegetables, enhancing agricultural productivity and sustainability. Additionally, areas like medicinal plants, animal biotechnology, aquaculture, marine biotechnology, and biofuels offer diverse research and commercialization opportunities. With a focus on research, collaboration, and investment, India is poised to shape the future of biotechnology, addressing healthcare, agricultural challenges, and contributing to sustainable development.
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