India’s Biotech Surge and Its Scaling Challenges
17.10.2025
- India’s Biotech Surge and Its Scaling Challenges
Context
India’s biotechnology sector has rapidly expanded—from about 500 startups in 2018 to over 10,000 by 2025—supported by policies like the BioE3 initiative and the government’s target of achieving a $300‑billion bioeconomy by 2030.
About the News
Background:
India’s biotech sector is transitioning from generic production to high-tech innovation, focusing on affordable R&D, digital integration, and global market expansion.
Growth Drivers:
- Startup Boom: A twentyfold rise in biotech ventures (2018–2025), backed by 90+ incubators across 25 states.
- Low‑Cost Research Advantage: India’s affordable R&D ecosystem and strong STEM base attract innovation.
- AI Integration: Startups use AI and data analytics for drug discovery and diagnostics.
- Global Vaccine Hub: India supplies around 60% of global immunisation doses, reinforcing its global leadership.
- BioE3 Policy (2025): Aims to integrate biomanufacturing, bio‑energy, and biopharma, aligning with sustainability and Atmanirbhar Bharat goals.
Key Government Initiatives
- BIRAC: Facilitates grants, incubation, and funding (BIG, SBIRI), supporting over 6,000 biotech startups.
- PLI for Biopharma: Promotes local production of raw materials and reduces import dependence.
- 100% FDI Policy: Encourages foreign investment and global R&D partnerships.
Major Challenges
- Funding Gaps in Scale‑Up Stage: Early funding is available, but later rounds (Series B/C) remain scarce, preventing market expansion.
- Fragmented Infrastructure: Most incubators lack shared GMP and pilot‑scale facilities; startups operate across multiple cities to complete one product cycle.
- Regulatory Lag: Outdated frameworks for gene editing, CRISPR, and AI‑based therapeutics delay global collaborations and IP protection.
- Talent Exodus: About 40% of biotech PhDs migrate abroad due to limited domestic opportunities and weak post‑doc funding.
- Limited Global Access: Misalignment with US and EU regulatory standards restricts high‑value biologics exports.
|
Area |
Proposed Reform |
|
Ecosystem Development |
Establish biotech clusters like “Bio Commons” in Genome Valley and Mumbai–Pune for shared facilities. |
|
Financing Mechanism |
Create a national bio‑venture fund using blended finance and venture debt models. |
|
Clinical Research |
Develop late‑phase clinical‑trial centres in AIIMS and major institutes with unified ethics committees. |
|
Talent Retention |
Launch tax‑incentivised reverse brain drain and micro‑credential training in CRISPR and AI‑biostatistics. |
|
Regulatory Modernisation |
Introduce adaptive, risk‑based systems inspired by EU and US frameworks for faster approvals. |
Way Forward
- Integrated Clusters: Consolidate infrastructure to reduce duplication and costs, encouraging collaboration.
- Dedicated Financing: Establish a National Biotech Fund combining equity, pension, and insurance capital.
- Adaptive Regulations: Align domestic rules with global standards to speed up innovation approval.
- Talent Strategies: Incentivise return of skilled professionals through direct grants and relocation support.
- Public–Private Partnerships: Strengthen R&D links between academia, industry, and government institutions to scale innovation.
Conclusion
India’s biotech ecosystem is witnessing rapid growth but faces scalability barriers in finance, regulation, and human capital. Building integrated clusters, reforming regulation, and deepening global linkages can transform India into the biotechnology hub of the Global South by 2030.