What it will take for India to lead global biotech manufacturing value chain

This article is authored by Dhananjay Singh, managing director, Merck Life Science & head, Discovery Solutions, India.

India’s pharmaceutical industry is widely recognised as the backbone of the global health care system. It accounts for nearly 20% of the world’s generic drugs by volume. It is also responsible for providing 55-60% of the vaccines procured by UNICEF, further cementing its status as the ‘pharmacy of the world.’

Biotech

This is reflected in the economic size of the industry. The Indian pharmaceutical market is estimated at $ 55-60 billion in 2025, which is expected to expand to $ 120-130 billion by 2030. However, the economic size of the biotechnology sector has crossed $ 165 billion in the national bioeconomy and is expected to expand to $ 300 billion by 2030.

Scale is not the only factor that makes an industry or sector a leader in the modern biotechnology landscape. For instance, in the world biotechnology landscape, the value chain is gradually moving away from the high-scale production of generic drugs towards high-precision manufacturing of biologics and biosimilars. However, the next decade will be crucial for India to build on its strength as a cost-effective generic drug manufacturer while also emerging as a leading hub for biotech manufacturing.

Indian generics manufacturers gained their competitive edge from efficient process innovation, effective manufacturing facility structure, increasing capabilities for contract development and manufacturing organizations, and a large reservoir of scientific knowledge.

On the other hand, biologics manufacturing is a much more complicated and highly-regulated environment that needs high levels of scientific knowledge and engineering accuracy at each step. These include upstream processing, fermentation and cell culture, downstream processing, formulation, and filling. Biologics manufacturing also requires the constant application of advanced engineering methods.

At this point in time, India is considered to be in the transition from where it currently is to developing into a leader in biologics manufacturing; to achieve that, India will require deeper investment in all aspects of the biotechnology value chain.

In addition, the health of the Indian population is changing; therefore, developing a strong domestic biopharmaceutical industry will aid the country's ability to export and be resilient when it comes to its healthcare. India is experiencing a steadily growing incidence and prevalence of non-communicable diseases such as diabetes, heart disease, stroke and cancer. Biologics and advanced therapies are now available to treat such illnesses.

Fortunately, India has begun to develop policies that will enhance the manufacturing and research capabilities of its biotechnology sector. The introduction of the Production Linked Incentive (PLI) Scheme, the BioE3 Policy, and the Research Driven Innovation (RDI) Programme, along with the introduction of the forthcoming Biopharma SHAKTI Programme, demonstrates a strategic transformation to an innovation-driven method of growth. India’s policy advancement in pharmaceuticals and biotechnology aligns with global precedence, where the EU is in advanced stage of drafting Biotech Act I and II, China’s listing of biomanufacturing as one of six future industries in its 15th Five Year Plan, and the US pharma Section 232 tariffs enforcement on patented pharma imports.

Policymaking alone is insufficient for establishing a globally competitive biotech ecosystem. One major area of difference between India and mature biotech markets, the US and western European economies, is that industry financing has been a central component of funding the early stages of research and translational development through R&D funding sources. In comparison, academic institutions and government remain responsible for the majority of R&D financing in India.

If India is to take a leadership role in the biotech manufacturing value chain, then the industry-academia ecosystem must transition from ad-hoc collaborations to well-integrated research networks. New start-up companies developing innovative molecules, academic laboratories making early-stage discoveries, and large-scale manufacturers will need to work together as part of a fully coordinated innovation pipeline.

India possesses many structural advantages that enable it to be successful within the biotechnology manufacturing ecosystem. These advantages include a large and skilled scientific workforce; a growing biomanufacturing infrastructure; and an increased global demand for cost-effective biologics and biosimilars. Together, these advantages create a solid foundation for India to expand its business model from simply being a manufacturing location to becoming a significant participant in the global biotechnology value chain.

To facilitate further advancement, investments must be made specifically into upstream bioprocess technologies, advanced analytical capabilities, and globally compliant manufacturing inputs. Additionally, supplier ecosystems (including high-quality reagents, cell culture media, and advanced bioprocess technologies) play a critical role in enhancing the capabilities of biotechnology manufacturers. These inputs enable researchers and manufacturers to reduce their development timelines and adhere to regulatory compliance regulations.

Global life science partners and technology providers can play an important and significant role in providing state-of-the-art research tools, reliable materials, and scalable process technologies, which are essential for assisting Indian researchers and manufacturers with fulfilling the rapidly growing global requirements for producing modern biologics.

Biotechnology manufacturing of the future will be defined not only by scale and economically viable manufacturing but also by innovation acceleration, regulatory agility, collaboration, and partnerships.

The opportunity for India lies in creating a new manufacturing model that leverages its existing strengths in manufacturing, while creating new capacities and capabilities for research, digital technologies, and global partnerships. Rather than simply copying previous biotechnology hub examples, India has an opportunity to create a new model that combines manufacturing efficiencies with affordable, innovative products.

India could become a major global biopharmaceutical hub within the next several decades if the integration of policies, industry, academia, and technology ecosystems continues to develop along a common pathway.

(The views expressed are personal)

This article is authored by Dhananjay Singh, managing director, Merck Life Science & head, Discovery Solutions, India.