2025-11-19

India’s journey as the “pharmacy of the world” has so far been defined by its strength in generics and affordable vaccines. However, as the global biopharmaceutical sector pivots toward personalised therapies, namely cell therapy, gene therapy, and mRNA platforms, India must reimagine its role. This new era in medicine is infrastructure- and innovation-intensive, demanding bold investments, regulatory foresight, and world-class talent.

The next wave of biopharma innovation is centered on advanced modalities like CAR-T cell therapy, gene editing (CRISPR/Cas9), antisense oligonucleotides, and mRNA platforms that offer curative potential for cancers, rare diseases, and chronic conditions. The global cell and gene therapy market is projected to grow to over USD 76 billion by 2030, with a 44% CAGR. Meanwhile, the mRNA therapeutics market, riding on pandemic-era breakthroughs, is expected to cross USD 30 billion by 2030, growing at a CAGR of 17.05%, expanding into oncology and autoimmune areas.

These therapies are defining the future of medicine. They’re also reshaping supply chains, regulatory frameworks, and the very definition of what a pharmaceutical ecosystem looks like. For India, the stakes are high, to adopt and eventually lead in innovation, scale, and global delivery.

Pockets of Promise

India’s current standing in advanced biopharma is nascent but promising. While Indian companies have made early forays into CAR-T and gene therapies, most are either in early-phase trials or technology-licensing modes rather than homegrown innovation or global commercialisation. North America hosts over 500 commercial gene therapy developers and China has over 400 gene and cell therapy clinical trials underway, which makes up 50% of the total global trials. India, by contrast, has just a handful of trials and limited academic-industry collaboration in this space.

There are three major reasons for this lag:

Firstly, manufacturing advanced biologics like CAR-T cells or viral vectors requires Good Manufacturing Practices (GMP)-grade cleanrooms, automated closed systems, and cold chain capabilities that are still in the developing stage in India. Secondly, unlike the US FDA or EMA, India’s CDSCO lacks a dedicated framework for fast-track approvals of novel therapies, leading to slower trial pipelines.

And lastly, there are talent and R&D bottlenecks in India, as it spends just 0.64% of GDP on R&D, substantially below the global average of around 2%. Additionally, very few institutions offer specialised training in cell biology, synthetic genomics, or regulatory science for biopharma.

Yet, we would say, India is uniquely positioned in one regard: its ability to democratise access. If India can do for advanced therapies what it did for vaccines, that is, develop high-quality, lower-cost alternatives, it could become the launch pad for global south innovation. However, this would require deliberate strategy, rather than incrementalism.

What Must India Do? A Five-Point Agenda for Breakthrough Leadership

To truly capture the next biopharma wave and emerge as a global hub, India needs to focus on five interlinked strategies:

• Firstly, we need to build advanced infrastructure. This can be done by establishing regional GMP-compliant biomanufacturing hubs dedicated to gene and cell therapy production, supported by plug-and-play biotech parks and public-private investment models.
• Secondly, there should be a dedicated fast-track regulatory cell within CDSCO for advanced therapies, mirroring the US FDA’s Office of Tissues and Advanced Therapies (OTAT). This will provide speed, transparency, and investor confidence.
• Thirdly, we should consider promoting R&D through Academic-Industry Synergy. This can be done by encouraging translational research through targeted grants, technology-transfer incentives, and joint IP ownership models between academic institutions and private firms.
• Fourthly, upskilling our workforce is a must. The authorities can consider launching national fellowships and skilling programmes focused on bioprocessing, genomics, bioinformatics, and regulatory science.
• Last but not least, we should actively pursue partnerships with multinationals and biotech startups for tech transfer, CRDMO opportunities, and co-development models. India must not be a back-end factory but a front-end innovation partner.

As the global biopharmaceutical landscape transforms, India has a unique window to define its role, not just as the “pharmacy of the world,” but as the innovation hub of the global south. Advanced therapies are a frontier of national health security, economic opportunity, and scientific leadership. As Bill Gates once said, “Innovation is moving at a scarily fast pace.” Nations that fail to keep up risk being left behind. If India plays its cards right, the next global breakthrough could have its origins in Bengaluru rather than Boston or Beijing.