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Achieving biopharma self-reliance
This article is authored by Tony Acciarito and Srinath Venkatesh.
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India has already earned global recognition as the world's pharmacy. The next phase of growth is even more ambitious: becoming a global leader in biopharmaceutical innovation. Achieving that vision will require more than manufacturing excellence. It will demand sustained investment in research, infrastructure, talent and collaboration across the public and private sectors.
India sits at the midpoint of a period stretching from the signing of the Trade Related Intellectual Property Rights (TRIPS) agreement in 2005, and the realisation of the vision of Viksit Bharat in 2047. The first set the stage for Indian companies to boost their drug discovery capabilities; the second will witness the emergence of India as a developed country with the health and research ecosystem representative of that status.
Over the last 21 years, Indian companies have made significant strides in biopharma. Bengaluru-based Biocon, for example, has developed and commercialised biosimilar monoclonal antibodies for breast cancer. Serum Institute, known primarily as the world’s largest vaccine producer, has expanded into therapeutic antibodies, in partnership with global organisations.
Beyond these industry leaders, a growing number of Indian companies are expanding their capabilities across the biopharmaceutical value chain. They are investing in advanced mammalian cell culture platforms, developing recombinant monoclonal antibodies for oncology and inflammatory diseases, and researching novel recombinant proteins for infectious diseases, immunology and other therapeutic areas. Together, they reflect a rapidly maturing ecosystem that is broadening both its scientific capabilities and global ambitions.
The government continues to play a significant role in this evolution of biopharma. In 2012, the Biopharma Industry Research Assistance Council (BIRAC) was launched under the aegis of the Department of Biotechnology (DBT) to fund and nurture biotech start-ups.
With the World Bank, the government launched the National Biopharma Mission, a $250 million programme to Innovate in India. This was followed by the BioE3 Policy in 2024, targeting high performance biomanufacturing. In February this year, the government launched Biopharma SHAKTI, a national strategy aimed at building an end-to-end self-reliant ecosystem for the domestic production of advanced biologics, biosimilars and clinical trial networks.
These initiatives have laid a strong foundation for biopharmaceutical innovation. The next phase will require sustained public and private investment in research and development to accelerate India's emergence as a global biopharmaceutical hub.
The numbers tell a compelling story. In 2006, India’s biotech industry was valued at approximately $1.1 billion, of which biopharma accounted for $800-836 million. Compare that to a global biopharma market of $50 billion in that same year. About 400–500 drugs were under clinical development at that time.
In 2025, India’s biopharma market is estimated to be at about $8.95 billion. Compare that to a global market value estimate of $484.4 billion for the same year. There are an estimated 8,684 investigative drugs under active development, almost 20 times the number under development 21 years ago.
A robust biopharma industry is characterised by three key attributes: high-intensity R&D, strict regulatory oversight and advanced technical infrastructure. These may seem to be distinct qualities; in reality, they reinforce and strengthen each other and are the mainstays of the biopharma innovation ecosystem.
Looking out 21 years into the future – to 2047, to be exact – India has set three clear goals: Develop 100 biologics, have an industry worth $450 billion in revenues and progress from being the ‘pharmacy to the world’ for generic drugs to becoming the global biopharmaceutical industry’s hub.
Today, hundreds of Indian companies and specialised start-ups are developing biopharmaceuticals across the value chain. Many have USFDA-approved biosimilars on the market or in development, while Reports suggest that there are over 200 biopharmaceutical entities currently under development. Together, they reflect the depth and growing sophistication of India's biopharmaceutical ecosystem.
Challenges remain, however. While there is a lot of innovation going on, building an innovation system that can accelerate the development timeframe from discovery to market is still moving too slowly.
A BCG study found Innovation also depends on strong linkages between institutions that generate knowledge and those capable of translating it into products and patient solutions Strong industry-academia collaboration develops skilled talent and accelerates translational research that can feed an innovation ecosystem. That partnership includes giving researchers access to advanced technology platforms to test their concepts.
The National Biopharma Mission and PRIP programme are strengthening academia-industry collaboration. Technology Transfer Offices and Centres of Excellence are becoming formal pathways to translate research into clinical development and commercialisation.
NexCAR19, India’s first indigenous CAR-T therapy is a notable example of this model. Developed jointly by ImmunoACT (incubated at IIT Bombay) and Tata Memorial Center, Mumbai, it showcases how academic research can evolve into a globally competitive therapy with support from BIRAC’s BioNest.
The BIRSA 101, an indigenous CRISPR-based therapeutic developed by CSIR-IGIB and advanced through a partnership with Serum Institute of India illustrates how public-private partnerships are enabling this journey.
An important, even critical, component for government support is setting policy frameworks that facilitate rapid discovery and development. Take regulatory pathways. When it comes to new and novel therapies like cell and gene therapy, faster regulatory approvals can go a long way to creating faster access to these novel therapies.
Last, but no less important than the preceding two areas, is addressing the challenge of shortening the path from discovery to clinical development and manufacturing. The use of advanced technologies for analytical characterisation and productivity optimisation for precise and repeatable results is key.
Many Indian companies may be using these technologies. Given the goal of Viksit Bharat, they must be acquired and adopted aggressively. They are part of critical R&D and manufacturing infrastructure.
The ambition set out in Viksit Bharat is both bold and achievable. India has the scientific talent, entrepreneurial spirit and policy momentum needed to become a leader in biopharmaceutical innovation. The next chapter will be written through sustained investment in research, enabling technologies and partnerships that accelerate discovery and bring new therapies to patients faster.
The foundations are in place. Now is the time to build on them.
(The views expressed are personal)
This article is authored by Tony Acciarito, president, Asia Pacific, Middle East and Africa (APMEA) and Srinath Venkatesh, managing director, India and South Asia, Thermo Fisher Scientific.
