Ajay Mahipal of India-focused healthcare impact and venture capital investment platform HealthKois argues that India’s life-sciences ecosystem is approaching an inflection point. Having built its reputation on manufacturing scale, the country now has a narrow window to build the clinical-development capabilities needed to originate and test novel therapies itself. India still conducts only around four percent of the world’s clinical trials despite carrying roughly 15 percent of the global disease burden; how well the country bridges that gap will define whether Indian innovation and clinical development can have a truly global impact.
India’s life-sciences story has, for decades, been defined by scale: the ability to manufacture at cost, deliver generics efficiently and serve some of the world’s largest pharmaceutical markets. That foundation remains important. But the more interesting question now is what India can build on top of it.
A new generation of Indian companies is beginning to push further upstream, working on novel molecules, biologics, cell and gene therapies and AI-enabled drug candidates. For the first time, there are credible signs of an ecosystem that can do more than manufacture and deliver medicines. It can originate them, develop them and, potentially, take them to global markets.
Clinical development will be central to whether that promise becomes reality.
The opportunity, therefore, is not simply to increase India’s share of global clinical trials. It is to develop the scientific, clinical and institutional capabilities that allow India to play a meaningful role in bringing the next generation of medicines to patients.
The HealthKois–BCG report, Built on Scale, Turning to Science, points to the foundations of this transition. More than ten novel drug assets have originated from India over the past decade, while biotech start-ups, patent activity and the innovation pipeline have expanded. Private capital flowing into healthcare innovation has also increased significantly. Yet India continues to conduct only around four percent of global clinical trials despite accounting for approximately 15 percent of the global disease burden.
The numbers suggest an ecosystem with considerable potential, but one that is still early in converting its underlying strengths into clinical-development depth.
The Next Advantage Is Not Cost Alone
India’s traditional proposition in clinical research has rested on a compelling combination of patient diversity, scientific talent and cost efficiency. Those advantages remain real. But they are increasingly becoming the starting point rather than the destination.
The greater opportunity lies in bringing these strengths together with capabilities in early-stage development, specialised clinical research, translational science and data.
This becomes particularly important as Indian innovation moves beyond established generics and biosimilars. A novel therapy originating in India needs an ecosystem that can support it from discovery through first-in-human studies, proof of concept and global development. The same applies to global pharmaceutical and biotechnology companies looking for partners capable of working on increasingly complex modalities.
Building the Early-Phase Engine
One of the most significant opportunities lies in strengthening Phase I and Phase II capabilities.
India has historically been more visible in later-stage, recruitment-led trials than in early-stage development. The report highlights under-penetration in Phase I and II trials, shortages of trained investigators and trial-management professionals, and resource constraints at trial sites, particularly in government hospitals. At the same time, dedicated Phase I infrastructure is beginning to emerge through the Indian Council of Medical Research (ICMR), while the BioShakti Mission is building towards a network of 1,000 accredited clinical-trial sites.
This is not simply an infrastructure challenge. Early-stage capability determines where value is created.
The ability to design and execute first-in-human studies, work with biomarkers, identify appropriate patient populations and generate high-quality evidence brings India much closer to the centre of drug development. It also creates a stronger bridge between the country’s growing scientific innovation and the global pharmaceutical ecosystem.
This is where some of the most consequential opportunities may emerge: in building the specialised infrastructure, technology and talent that make complex clinical development not just possible, but repeatable.
CROs Have an Opportunity to Move Up the Value Chain
The CRO sector will be an important part of this evolution.
India has already built a strong base in clinical-research services. The next phase should be about moving beyond execution and participating more deeply in development.
As trials become more complex, CROs can increasingly contribute across patient identification, site intelligence, protocol optimisation, decentralised and technology-enabled trials, data management, biomarkers, pharmacovigilance and early-phase development. The competitive advantage will increasingly belong to organisations that can combine operational scale with scientific and technological depth.
There is a broader pattern here. India’s CRDMO market was estimated at around USD eight billion in 2024 and is growing faster than the global market. The opportunity is not simply to capture more outsourcing. It is to see more sophisticated research and development activities being performed in India.
That creates a multiplier effect across the ecosystem. Better CRO capabilities can make complex trials more executable. Stronger trial infrastructure can make innovative companies more investable. A deeper clinical-development ecosystem can make India more attractive for global partnerships.
Regulation Will Determine the Speed of the Transition
India has been moving towards a more streamlined and internationally aligned clinical-development framework, with greater digitisation and reforms intended to reduce procedural burden and timelines. The regulatory system is also becoming more explicit about the accountability of CROs and increasingly aligned with international clinical-research standards.
The next priority should be predictability, particularly for novel modalities.
Traditional regulatory pathways benefit from precedent. Cell and gene therapies, novel biologics and emerging technology-enabled approaches often have little of it. As India seeks to attract and originate more such programmes, regulatory capability will need to develop alongside scientific capability.
A predictable regulatory environment does more than accelerate an individual trial. It allows companies, researchers and capital providers to make better decisions around development risk. For an ecosystem trying to move into higher-value, more complex science, that predictability can be a significant competitive advantage.
Data Could Become an Underappreciated Advantage
There is another opportunity that deserves greater attention: data.
India’s expanding digital-health infrastructure, initiatives such as GenomeIndia and the development of real-world patient datasets could, over time, give researchers a much richer understanding of disease patterns and patient populations. The HealthKois–BCG report identifies the convergence of data, infrastructure and scientific capability as an important part of building a more complete innovation ecosystem.
The significance of this will only grow as drug development becomes more data-intensive.
The ability to connect clinical-trial evidence with real-world evidence could help India develop a model that is not simply an imitation of established clinical-research markets. It could become a differentiator in its own right.
The opportunity is not to replicate how other markets conduct clinical trials. It is to build around the characteristics that make India distinctive.
Turning Momentum into a Durable Advantage
This is ultimately where India’s next phase of clinical development will be decided.
The country has many of the ingredients required: scale, scientific talent, disease diversity, growing innovation, expanding infrastructure and increasing capital. What remains is to connect these capabilities more deeply.
The transition described in the HealthKois–BCG report is broader than clinical trials alone: from replication to origination, from process excellence to scientific discovery, and from serving global supply chains to building globally relevant pipelines.
Clinical development sits at the heart of that transition. Innovation cannot become globally consequential without the ability to test, validate and develop it at scale.
There is an equally important capital dimension. Healthcare innovation rarely follows short investment cycles. The companies and infrastructure capable of transforming clinical development require time, specialised expertise and capital willing to support capability-building through periods of scientific and regulatory uncertainty. The report identifies access to patient capital as one of the structural gaps that will influence India’s ability to scale innovation.
Capital, however, cannot solve this in isolation. Science, infrastructure, regulation, talent and capital need to reinforce one another. That is why India’s clinical-trial opportunity should be understood as part of a much larger transformation in the country’s life-sciences landscape.
The ambition should not be limited to conducting more trials, or even becoming a larger destination for global clinical research. It should be to build an ecosystem in which globally relevant therapies can be conceived, tested, developed and scaled, with India participating meaningfully across that value chain.
That is the real shift from scale to science.
And if the capabilities now being built become sufficiently deep, connected and repeatable, India’s next clinical-trial advantage may not be measured by how much of the world’s research it hosts, but by how much of the world’s next generation of therapies it helps bring to life.
