While India has mastered the production of small-molecule generics, the future lies in emerging therapeutics. India boasts an impressive portfolio of over 98 approved biosimilars, and with the biosimilar market pegged at $12 billion, India must capture a larger share of this high-margin sector.

A breakthrough came in last year when India approved its first Indigenous CAR-T cell therapy, signalling its ability to compete in next-generation biologics. The CGT market is on track for exponential growth, presenting opportunities for India to strengthen its presence in next-gen biologics1. With the right mix of investment and regulatory efficiency, India can become a leading hub for advanced biologics manufacturing.

Meanwhile, the global mRNA therapeutics market is emerging as a promising $10 billion frontier, with significant potential for India to build on its vaccine expertise. Provided it develops flexible biomanufacturing infrastructure and integrates single-use bioprocessing technologies (SUTs) for scalable production.

Despite its pharmaceutical dominance, India remains highly dependent on imports for biologic raw materials, with import reliance ranging from 20% to 90%, depending on the class of biosimilars and intended markets. In 2023-24, 60-65% of India’s API needs were met through imports2, with China alone catering to a majority of it.

This over-reliance inflates costs by 30% due to additional import duties and logistical delays, making domestic raw material production a strategic necessity. India must accelerate indigenisation of key bioprocessing inputs such as single use consumables, critical raw materials, buffers, packaging materials, and sterilisers, which can cut import dependence by 30% over the next five years and reduce overall production costs by 3-4% and promote just-in-time logistics model for better resource utilisation.

The recent passage of the Bio-E3 policy and the Bio-Ride programme has ensured India that it has the potential to leverage a combination of regulatory improvement, translational research, and PLI programmes to drive domestic manufacturing and research capabilities through bio-manufacturing and bio-AI hubs and capitalise on the upcoming opportunities in biologics, biosimilars, and vaccine development.

India’s regulatory environment has evolved significantly, continued regulatory facilitation will be key to accelerating the biopharma growth. The Central Drugs Standard Control Organisation (CDSCO) has waived local clinical trial requirements for drugs already approved in major global markets under Rule 101 of the New Drugs and Clinical Trials Rules, 2019. This is a step in the right direction and must be leveraged aggressively to attract international biotech companies while expediting domestic approvals for breakthrough therapies.

On the investment front, foreign direct investment (FDI) inflows into India’s pharmaceutical sector reached ₹2,814 crore in FY 2022-23, demonstrating global confidence in India’s biopharma potential. Additionally, government-led initiatives such as the PLI scheme ( ₹15,000 crore financial outlay), Bio-RIDE, PRIP, and Bio-E3 are incentivising high-value biologic production. However, private sector collaboration in high-risk, high-reward biotech will be instrumental, for Indian pharma companies allocate just 8.4% of their sales value towards R&D compared to 10-11% by global peers. Additionally, expanding R&D expenditure will further strengthen India’s position in global biopharma innovation.

A coordinated approach across regulatory agencies could further enhance efficiency in approvals. Enhancing regulatory expertise through continued collaboration with global best practices will support the evolving needs of the biopharma sector. Additionally, targeted strategies, brand-building initiatives, and market promotion activities must be undertaken to expand the market share of identified export products.

One of the most significant opportunities for Indian biopharma will unfold this fiscal, when about 25 high-revenue blockbuster drug patents expire, creating a patent cliff. This presents an unprecedented chance for Indian firms to rapidly develop biosimilars and affordable alternatives, strengthening their already dominant position in generics while expanding into higher-margin biologics. If India can successfully navigate this transition from volume-driven generics to value-driven biopharma, it will solidify its standing as a global leader in the future of health care innovation. The path ahead demands strategic investment, policy foresight, and industry collaboration, but if executed well, India’s $300 billion bio-economy vision will not just be realised—it will redefine the global biopharmaceutical landscape.

This article is authored by Dr YK Gupta, president, AIIMS, Jammu and Ankush Kapoor, founder & CEO, Pharma NXT Biotech.