Why history will remember 2025 as the year Indian drug innovation bets started paying off

In July 2025, Mumbai-headquartered Glenmark grabbed the spotlight when it signed what was one of the biggest out-licensing deals for an Indian drugmaker with Chicago-based Abbvie Inc. for an under-development cancer drug. The firm’s US-based unit, Ichnos Glenmark Innovation, signed a $700 million exclusive licensing agreement for its drug candidate to treat a rare blood cancer.

“We were always resilient in how we approached innovation. I think that's what finally rewarded us," a triumphant Glenn Saldanha, the firm’s managing director and CEO, had told Mint in an interview following the announcement.

Glenmark’s story is not the only one. Indian drugmakers, known for their chemistry and prowess in making generics—cheaper copies of innovative drugs—for the world, have noted that the next step is to pivot towards innovation if they want to remain competitive globally. Some, who took early bets (and have faced the ire of investors and shareholders), finally saw commercial success in 2025.

“This was a year where innovation moved from pipeline slides to balance sheets," independent pharma analyst Salil Kallianpur told Mint. “In fact, 2025 does stand out, but not because Indian pharma suddenly transformed into a discovery powerhouse. Rather, it marked a year where innovation began to show commercial and strategic validation, not just scientific intent," he said.

“Success attracts scientists, clinicians, and entrepreneurs who previously looked overseas strengthening the domestic innovation ecosystem. India desperately needs this to work like in China in the last three decades."

The wins

What made 2025 distinctive, said Kallianpur, was not the number of breakthroughs but the quality of outcomes, with late-stage clinical progress translating into global partnerships, and speciality, complex and differentiated products gaining regulatory approvals and market acceptance.

Saldanha called out the shift towards innovation. “The innovation successes we are seeing across the sector reflect a deeper structural shift from being known primarily for scale and affordability to being increasingly recognised for scientific depth, global relevance, and the ability to deliver differentiated innovation," he had told Mint.

Those who made early bets in innovative products are finally seeing success.

Wockhardt has been steadfast on its antibiotic drug discovery programme for over two decades, weathering financial storms and investor ire. In 2025, its antibiotic Miqnaf was launched in India, and another antibiotic—Zaynich, became the first new chemical entity (NCE) from India whose new drug abbreviation (NDA) was accepted by the US FDA. The company is looking at a regulatory approval followed by a launch in the US in mid-2026.

“The year 2025 was a very, very important year for us because all the efforts of research that we have done over the last 27-28 years culminated…I believe it has definitely put us in a global spotlight. Once we get a drug approval next year, it will also put India in the global spotlight," Wockhardt chairman Habil Khorakiwala told Mint.

Wockhardt’s antibiotic pipeline targets a growing global concern—antibiotic drug resistance (AMR) in which bacteria are increasingly growing resistant to existing treatments, increasing the risk of severe infections and sepsis.

Zaynich is aimed at treating multi-drug resistant infections and has already been used to save over 70 lives in compassionate use cases, including three in the US. The company sees an addressable market of $7 billion in the US and Europe alone.

For Sun Pharma, its innovative portfolio bet is paying off, with Q2 FY26 being the first time its innovative drug sales surpassed generics in the US.

Biocon’s unit Biocon Biologics launched and expanded market access of several key biosimilars during the year, including cinching the US FDA’s ‘interchangeable’ status for insulin aspart. A biosimilar is a biological medicine which is highly similar to an already approved original biologic drug. Unlike generic drugs, which are exact chemical copies, biosimilars are complex and demonstrate equivalence through rigorous studies, ensuring they work just as well as the original but with lower costs.

The stage for 2026

Several developments previous year set the stage for 2026.

“The US FDA’s draft guidance proposing the waiver of Phase III clinical trials for certain biosimilars, supported by strong CMC (chemistry, manufacturing and controls) and analytical evidence, is a game-changing development. It fundamentally reshapes biosimilar development economics," said Shreehas Tambe, CEO and managing director of Biocon Biologics, adding that Biocon’s long-standing investments allow it to leverage this shift.

Others like Cipla are increasing their focus on innovation going forward. “Our work this year (2025) ranged from next‑generation mRNA platforms targeting infectious diseases, to breakthroughs in treating urethral stricture, to transformational strides in stem‑cell science through our investee company Stempeutics product CiploStem," said Achin Gupta, the company’s global chief operating officer, who will take over as global CEO and managing director this year.

“The real impact of 2025 lies in what it enables next," said Kallianpur, the pharma analyst. “I believe with what happened in 2025, companies will no longer be satisfied with incremental complexity. The bar has moved toward platform innovation, not one-off successes. Boards and promoters now have evidence that patient capital in innovation can pay off."

The sector also saw a policy boost in 2025, with the department of pharmaceuticals inviting proposals for the Promotion of Research and Innovation in Pharma MedTech sector (Prip) scheme. The scheme, introduced in 2023, has a total outlay of ₹5,000 crore. The Centre also launched the Research, Development, and Innovation (RDI) scheme in 2025 with an outlay of ₹1 trillion, targeting sectors like energy, deeptech, AI, and biotech.

“Both signal a clear intent to catalyse private sector participation in R&D. These efforts, coupled with continued investment in research infrastructure and collaborative platforms, will help reduce structural friction in the innovation ecosystem," Glenmark's Saldanha said.

Need for regulatory reforms

Many have looked at China’s massive strides in biotech innovation, pivoting away from generics in decades, as an example of what India can achieve. Drugs originating from China are projected to account for 35% of approvals by the US FDA by 2040, up from only 5% now, according to a September Morgan Stanley report. “The industry’s progress stems from a decade of regulatory reform in China, cost optimization and increased financing," the report notes.

“India desperately needs this to work like in China in the last three decades," said Kallianpur. “Innovation momentum can stall if regulatory clarity lags, capital discipline weakens, and companies chase headlines rather than capabilities."

Wockhardt’s Khorakiwala believes that while government funding support is on the rise, and the private ecosystem is evolving, the regulatory mechanisms need to catch up significantly.

The next phase will require focus on regulatory predictability, more transparent clinical development pathways as well as better alignment with global standards. “A stable, forward-looking policy environment will be essential to attracting long-term global capital," said Saldanha.