Despite its status as the “pharmacy of the world,” India’s deep life sciences roots have traditionally been based in manufacturing and replication. Now, a string of recent wins on the frontiers of novel drug development could mean that a homegrown innovation industry is within reach.
The country has “had a very successful pharma story just playing the generics game,” Ajay Mahipal, co-founder and general partner of India-focused healthcare fund HealthKois, said in an interview with Fierce.
These days, however, as the upper echelon of Indian drugmakers raise their market caps into the $40 billion to $50 billion range, it “makes so much more sense to get into the discovery game,” Mahipal explained, citing a confluence of local regulatory developments and government support.
India ranks as the third largest pharma producer in the world by volume and serves some 40% of the U.S. demand for generic medicines specifically, with that number working out to 20% on a global scale. The country’s share of global vaccine production is even higher at 60%, according to a new report (PDF) from HealthKois and Boston Consulting Group (BCG), which Mahipal co-authored and highlights India’s opportunity to seize on its recent innovative R&D victories.
What the report dubs “green shoots” of innovation have emerged over the past decade, during which time more than 10 novel assets have been advanced by internal drugmakers. Some of these have already yielded approvals overseas or high-value out-licensing pacts for well-known Indian firms like Wockhardt and Glenmark, respectively.
That sum of novel assets coming out of India is “not a large number,” Priyanka Aggarwal, managing director and senior partner at BCG, who also helped author the report, told Fierce, “but it’s substantially better than before.”
While various Indian firms have tried their hands at innovative drug development in recent decades, the “deep pockets that are needed” for that work, coupled with the “smaller domestic size of the Indian market,” created a sort of chicken-and-egg scenario, explained Aggarwal.
“The belief that this is kind of a worthwhile endeavor wasn’t there,” she said. “I think now with some successes, it creates the inspiration for everyone to say, ‘Listen, Glenmark has done it, Zydus can do it—you know, we from India can do it.’”
A decade in the clinic
Not all of the novel drugs reflected in the report are approved, though each has earned a mark of distinction, either within the domestic healthcare market for India or in the form of big deals and regulatory validation from outside the country.
In one notable example, AbbVie last summer agreed to pay $700 million upfront to Ichnos Glenmark Innovation for rights to a trispecific antibody targeting CD38, BCMA and CD3. The asset, if eventually approved, is being positioned to take on Johnson & Johnson’s Tecvayli in multiple myeloma.
Meanwhile, ImmunoAct scored an approval in India for its NexCAR19, the country’s first locally developed CAR-T therapy, way back in the fall of 2023. The HealthKois and BCG report noted that the lymphoma and lymphoblastic leukemia med is roughly 10-times cheaper than imported therapies in its class.
More recently, Mumbai’s Wockhardt scored (PDF) an FDA green light for Zaynich, a novel intravenous antibiotic for complicated urinary tract infections caused by susceptible Gram-negative pathogens.
Still, India’s annual pharma R&D spend continues to be dwarfed by that of other countries, clocking in at $2 billion to $3 billion, according to the report, versus China, Europe and the U.S., where this spend ranges from $15 billion to $20 billion, $55 billion to $60 billion, and $70 billion to $75 billion, respectively.
That low amount of domestic innovation spending could also be due, in part, to the fact that India’s total pharma market is hovering around $60 billion, with roughly half of that accounting for generic consumption and the other half exported as generics around the world, Aggarwal pointed out.
That’s multiple times smaller than the domestic market in China, for instance, Aggarwal said. India is “still a volume market where prices are very low,” and where roughly two-thirds of prescriptions are paid for out of pocket, given local insurance policies, he noted.
Across the broader R&D landscape, HealthKois and BCG’s report also tracked around 1.5-times growth in the innovation pipeline of Indian firms over the past 10 years.
With regards to therapeutic areas of interest, “we’re seeing a lot of traction in oncology,” Mahipal noted, adding that infectious disease and immunology have also proven popular targets, alongside specific modalities like cell and gene therapy. Breaking the numbers down further, Indian drugmakers are now propelling 16 late-stage cancer assets through the clinic, with another 14 currently engaged in phase 2 development.
Make-or-break moment
The success of pharma majors like Wockhardt and Glenmark doesn’t tell the entire story, however, as increasing support for biopharma from the Indian government and integration with local academia in recent years, plus regulatory reform, lay the groundwork for an enduring innovation ecosystem.
In particular, the report points to some $5 billion in funding put forward by the Indian government to nurture startups and emerging technologies, as well as translational research and infrastructure buildout, much of which is currently concentrated around manufacturing. India is also contributing funds to talent and research.
The local regulatory environment is becoming more hospitable, too, as India’s Central Drugs Standard Control Organisation (CDSCO) adopts new technologies to make its work more efficient, and as drug development timelines and licensing rules for non-commercial manufacturing have been relaxed.
India is also aiming to create a framework to fast-track breakthrough therapies, and the country has forged a plan to create a scientific cadre of around 1,500 members to strengthen internal subject matter expertise, in part to reduce dependence on external knowledge for regulatory decision-making, among other measures.
As for how the Indian innovation industry must continue to grow, even with more early government funding now available in the form of grants, and an uptick in private capital, “there is still more needed,” Aggarwal said. He noted that innovation efforts take ample capital given that “it’s a long game, [a] risky game, and there’s always the risk of scientific failure.”
On the talent side, “we’ve always had chemistry talent,” Aggarwal explained. “Obviously, the whole industry is built on reverse engineering.”
Biology talent, meanwhile, “is also coming into place, but Aggarwal admitted that “perhaps more strengthening of that ecosystem is still required.”
Meanwhile, even as private capital has “doubled in the last five years, it’s still small,” Mahipal explained, flagging the need for “much more long-term patient capital to essentially fuel some of this life sciences innovation.”
To seize on the present moment and ensure India’s innovation opportunity doesn’t stall, the report's authors propose several initiatives, including a push to build the country’s “first generation of specialist biotech capital.”
In particular, they argue for targeted government schemes and tax incentives to bolster R&D investments from the industry, plus increases in direct public funding for early-stage and translational research. Nurturing industry-academia collaborations will also be key, they argue, as will the creation of fast-track regulatory pathways for novel drugs. This would likely require the buildout of specialized regulatory review teams for advanced modalities like mRNA and cell and gene therapy.
India should also lean on its established manufacturing muscle, with the report's authors calling for investments in domestic production of research-grade materials to reduce R&D lead times.
Looking at the roughly 10 novel drugs India has advanced so far, Mahipal estimated that, over the next two decades, “we could see 10- to 20-times growth from here in terms of new discoveries and what we launch in the market.”