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Bharat Biotech, a Hyderabad-based vaccine maker, is charting a new course into cell and gene therapy, a move that could reshape access to advanced treatments in India and beyond. The company, known for its pivotal role during the Covid pandemic with its indigenous jab, Covaxin, is leveraging its expertise in virus production to develop novel therapies for cancers and genetic disorders.

In an exclusive conversation with Moneycontrol, Raches Ella, Chief Development Officer (CDO) of Bharat Biotech, said this is a similar set of skills the company has honed over the years to build vaccines at scale against various viral diseases.

Ella wants to put those skills in developing CAR-T, and gene therapies at a fraction of the cost, aspiring to be a critical part of the cell and gene therapy value chain.

“We missed the bus on monoclonal antibodies, jumping straight into biosimilars. But with gene therapy, we intend to be a frontrunner rather than a follower,” Ella said.

The company is making a substantial investment of $75 million in a state-of-the-art, vertically integrated cell and gene therapy and viral production facility located at Genome Valley in Hyderabad.

“We have been analysing this space not from the perspective of who else is entering, but from our core philosophy of ensuring efficacy, safety, equity, and accessibility,” he said.

Viruses, or viral vectors, are used as delivery vehicles, carrying healthy genes to target cells to repair or replace faulty genes in gene therapy, and in cell therapy like CAR-T therapy they deliver genetic code for chimeric antigen receptors (CARs) into a patient's T cells. The vectors commonly used in cell and gene therapy are lentiviruses, retroviruses and adenoviruses or adeno-associated viruses (AAVs), which are manipulated to lose their ability to cause disease while retaining their ability to infect cells.

Bridging the cost gap 

The market for CAR-T cell therapies—an innovative cancer treatment that modifies a patient’s own immune cells to attack cancer—has seen significant progress in the West but remains largely inaccessible in India due to exorbitant costs. Existing CAR-T therapies can range from Rs 40 lakh to Rs 50 lakh per patient, a price tag beyond the reach of most Indians.

“Our focus is not just on introducing these therapies but on making them more affordable. A major cost driver in CAR-T treatment is the viral vectors required for genetic modifications, which alone can cost approximately $8,000 to $12,000 per vial,” Ella said. “Since Bharat Biotech specialises in virus production (at scale), we believe we can significantly reduce this dependency on imported materials.”

Bharat Biotech’s foray into cell therapy will initially focus on autologous treatments—where a patient’s own cells are modified and reinfused. However, the company sees the future in allogeneic therapies, where cells from a universal donor can be engineered, stored, and used as needed, similar to off-the-shelf vaccines. “This shift would reduce costs and improve accessibility, but it remains an industry-wide challenge that requires more R&D,” he noted.

A hybrid R&D model

The company is employing a dual strategy—developing therapies in-house while also collaborating with global experts. Bharat Biotech has enlisted two leading Indian-American scientists, Dr Krishnendu Roy from Vanderbilt University and Prof Krishanu Saha from the University of Wisconsin, Madison, on its scientific advisory board.

“We are not just licensing technologies but developing core capabilities within India,” Ella said. “Around 60 percent of our R&D is internal, and 40 percent comes from strategic collaborations.”

Bharat Biotech has committed $75 million over the next three to five years toward cell and gene therapy, with 50 percent of this investment already deployed in building laboratories and acquiring equipment. “Unlike large pharmaceutical firms that spend just 6 percent of revenue on R&D, we are investing several times that amount, because we believe innovation is the key to solving India’s healthcare challenges,” he said.

The company remains self-funded, relying on internal accruals rather than external investors. While acknowledging the importance of partnerships, Bharat Biotech is keen on retaining control over its innovations. “We have always been strategic in seeking non-dilutive funding for vaccines, but cell and gene therapy currently lacks similar funding mechanisms. However, we are seeing encouraging signals from the Indian government in this space,” he added.

Funding the foray into cell and gene therapy isn’t a problem, as the company has a healthy balance sheet.  According to rating agency India Ratings and Research, Bharat Biotech, on a consolidated level, reported a revenue of Rs 1,300 crore in FY24.

“Despite decline in revenue in FY2024 compared to FY2022 and FY2023, the company has a strong financial profile with a robust capital structure as the company continued to be debt-free throughout the year and as on March 31, 2024. Further, the company has sizeable cash reserves in addition to large bonds/equity investments indicating a strong liquidity position,” according to rating agency ICRA.

An executive who follows Bharat Biotech, who didn’t want to be named, said during Covid the company has built huge capacities given the demand. But with the pandemic ending, it could probably be utilising a part of those capacities for cell and gene therapies.

Beyond vaccines

While details remain under wraps, Bharat Biotech is developing multiple CAR-T programs targeting leukaemia and lymphoma, with plans to enter clinical trials in early 2025. The company is also exploring gene therapy approaches, particularly in vivo gene editing, where a corrected gene is delivered directly to affected organs.

While vaccines remain the company’s core business, Bharat Biotech sees this expansion as an adjacent opportunity rather than a deviation. “Our expertise lies in working with viruses and cells—whether for vaccines or gene therapy. This is a natural extension of our capabilities,” he added.

The company has also begun developing CRISPR-based gene editing therapies, which could provide a non-viral alternative to traditional CAR-T cell modification. “The industry is slowly moving towards CRISPR as a more precise and scalable solution, and we are committed to being at the forefront of that transition,” he said.

The road ahead

As Bharat Biotech embarks on this ambitious journey, the company acknowledges the challenges ahead—be it high manufacturing costs, regulatory hurdles, or the need for a skilled workforce. Yet, it remains steadfast in its mission to democratise access to advanced healthcare.

“For India to truly innovate, we need to reward innovation rather than just cost competitiveness. The global market is evolving, and we are positioning Bharat Biotech to be a leader in this next wave of medical breakthroughs,” Ella said.

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