Introduction
For most of human history, a cancer diagnosis in a low-income or middle-income country meant one of two things: treatment with whatever the public health system could afford, or no treatment at all. The world's most advanced cancer therapies — the ones that could put terminal patients into complete remission — existed only in American and European hospitals, at price tags that put them beyond the reach of 90 percent of the world's cancer patients.
That equation began to change in October 2023, when India's Central Drugs Standard Control Organisation approved NexCAR19 — the country's first indigenous CAR-T cell therapy, developed by ImmunoACT, a spinoff from the Indian Institute of Technology Bombay in collaboration with the Tata Memorial Centre in Mumbai. It changed further when the therapy entered commercial use in April 2024. And it changed decisively when the numbers from that first year of commercial operations came in: over 350 patients treated across 70 hospitals, revenue of Rs 62 crore, and a profit before tax of Rs 12 crore in FY25 — marking rare profitability for an Indian biotech startup in its first full year of operations.
A therapy that costs $400,000 in the United States. The same category of therapy, built entirely in India, costing Rs 30 lakh — approximately $36,000 — and falling. This is not incremental progress. This is a structural disruption of one of the most expensive categories of medicine ever created.
What CAR-T Cell Therapy Actually Is
Before understanding why NexCAR19 matters, it helps to understand what CAR-T therapy is and why it has been so transformative — and so inaccessible.
CAR-T stands for Chimeric Antigen Receptor T-cell therapy. It is a form of immunotherapy that does not use drugs in the conventional sense. Instead, it reprograms the patient's own immune system to become the weapon.
The process works as follows. A sample of T-cells — the immune system's primary fighters — is extracted from the patient's blood. These cells are then genetically engineered in a laboratory to express a Chimeric Antigen Receptor on their surface, a specially designed protein that enables them to recognise and bind to a specific marker on cancer cells. The modified cells are then multiplied into tens of millions and reinfused into the patient's body, where they seek out and destroy cancer cells bearing that marker with a precision that conventional chemotherapy cannot approach.
CAR-T therapy is not a treatment that reduces tumour size. In many cases, it eliminates tumours entirely. For patients with relapsed or refractory blood cancers — patients who have already failed multiple rounds of chemotherapy and have essentially run out of conventional options — it has produced complete remission rates that were previously considered impossible.
The problem is the cost. Every step of the process — extracting T-cells, engineering them, manufacturing the viral vectors used to introduce the new genetic instructions, multiplying the cells under sterile conditions, quality-testing the final product, and infusing it — requires specialised equipment, expertise, and infrastructure that, until recently, existed only in a handful of countries.
The Journey: A Decade from Research Lab to Patient
ImmunoACT was established in 2018 as a spinoff from IIT Bombay's Biosciences and Bioengineering department, built on research that began in 2013. That five-year gap between research and company formation is itself a story. ImmunoACT was founded by immunologist Dr. Rahul Purwar following his research experience in the United States and Germany.
Dr. Alka Dwivedi, along with her colleague Rahul Purwar and Gaurav Narula, sought guidance from the National Cancer Institute in Bethesda, Maryland, to advance their research. Through collaboration with leading experts at NCI's Center for Cancer Research, including Dr. Nirali Shah, the team gained valuable insights and training in designing an effective CAR-T cell therapy suitable for the Indian healthcare system.
The collaboration with Tata Memorial Centre — India's premier cancer hospital — gave the research its clinical backbone. The CAR-T cell therapy was developed by Prof. Rahul Purwar and his team, with clinical investigations and translational studies led by Dr. Hasmukh Jain and Dr. Gaurav Narula and their teams at Tata Memorial Hospital.
Atharva Karulkar, Alka Dwivedi and the team led by Rahul Purwar, IIT Bombay associate professor, designed and developed NexCAR19, which subsequently underwent integrative process development and manufacturing under current Good Manufacturing Practice, or cGMP, at ImmunoACT.
The result of that decade of work was an indigenously developed CD19-targeted CAR-T cell therapy — meaning it targets the CD19 protein on the surface of B-cells, which is the marker present on the cancer cells in B-cell lymphomas and leukemias.
The Clinical Trials: Results That Surprised the World
The multi-centre Phase I and Phase II pivotal clinical trial for NexCAR19 was led by Dr. Hasmukh Jain.
The trial was conducted with 60 patients of relapsed or refractory B-cell lymphomas and leukemia. The clinical data indicated approximately 70 percent overall response rate.
Clinical trials involving 64 patients with advanced lymphoma or leukemia showed promising results, with 67 percent experiencing significant cancer reduction and about half achieving complete remission.
But the headline clinical achievement was not just the efficacy. It was the safety profile. Unlike US-approved therapies that use mouse-derived antibody fragments, India's "humanised" CAR-T cells caused fewer severe side effects, with no reported neurologic complications and only 5 percent experiencing severe cytokine release syndrome.
This distinction requires explanation. Cytokine release syndrome — essentially an immune system overreaction triggered by the infusion of millions of activated CAR-T cells — is the most dangerous side effect of CAR-T therapy and has historically required intensive care unit admission for many patients in US-based treatments. Neurological toxicity has also been a documented concern. The safety profile in terms of cytokine release syndrome and absence of neurotoxicity indicates a significant improvement over other commercially approved CD19-directed CAR-T cell therapies.
Dr. Hasmukh Jain said: "NexCAR19 has shown an excellent balance of efficacy and low-toxicity, which is a significant advantage in clinical management of patients in our resource-constrained settings."
The humanised design of the CAR construct — using human antibody fragments rather than the mouse-derived sequences used in the original American CAR-T products — is believed to be a significant factor in the improved safety profile. Humanising the CAR probably contributed to the therapy's positive safety profile, says Rahul Purwar. Patients' costs are further reduced by the therapy's improved safety profile compared with some of the other FDA-approved products, because most patients did not need to spend time in intensive care units.
How They Made It Affordable: The Engineering of Affordability
The price gap between NexCAR19 and American CAR-T therapies is so large — roughly 90 percent lower — that it demands explanation. The answer is not a single shortcut. It is a systematic redesign of every expensive step in the manufacturing process.
To slash costs, the team developed, tested, and manufactured the product entirely in India, where labour is cheaper than in high-income countries. To introduce CARs to T-cells, researchers typically use lentiviruses, which are expensive. Purchasing enough lentiviral vector for a trial of 50 people can cost up to US$800,000 in the United States, says Steven Highfill, an immunologist at the US National Institutes of Health Clinical Center in Bethesda, who advised the Indian team. Scientists at ImmunoACT make this gene-delivery vehicle themselves. The Indian team also found a cheaper way to mass-produce the engineered cells, avoiding the need for expensive automated machinery.
The company's proprietary technology platform enables efficient CAR-T cell production with in-house lentiviral vector and plasmid manufacturing, giving them complete control over every aspect of creating an effective product.
The therapy's cost has decreased from Rs 42 lakh to Rs 30 lakh per dose, with further price reductions expected as production scales and demand increases. ImmunoACT's target is to bring the cost down to Rs 20 lakh per patient — approximately $24,000 — as production scales further.
NexCAR19 is priced significantly lower than international CAR-T cell therapies, costing approximately $50,000 in India compared to around $400,000 in the United States.
The traditional leukemia treatment in India — stem cell transplant, which is the standard of care for relapsed patients — costs between Rs 30 and 40 lakh, and carries its own risks and limitations. NexCAR19 is now competitive on price with the treatment it largely replaces, while offering significantly better response rates for the most difficult cases.
Commercial Launch and What Happened Next
NexCAR19 received CDSCO approval in October 2023. Commercial availability began in April 2024, following the official launch attended by President Droupadi Murmu. Director of Tata Memorial Centre Dr. Sudeep Gupta said at the launch: "The collaboration between IIT Bombay and Tata Memorial Centre to develop the first indigenous CAR-T cell therapy product has been extremely fruitful and satisfying. This CAR-T cell therapy product will save many lives at much lower cost compared to the cost of such products available outside India."
By FY25, ImmunoACT had treated over 350 patients across 70 hospitals, generated revenue of Rs 62 crore, and recorded a profit before tax of Rs 12 crore — marking rare profitability for an Indian biotech startup in its first full year of operations.
NexCAR19 demonstrated progression-free survival benefits of 40 percent in B-cell non-Hodgkin lymphoma and 60 percent in B-cell acute lymphoblastic leukemia, representing significant improvements over standard of care treatments.
Hyderabad-based drug maker Laurus Labs holds approximately 34 percent equity stake in ImmunoACT. The investment from a major Indian pharmaceutical company signals that the industry regards ImmunoACT's commercial viability as credible, not speculative.
The therapy was also showcased at the Emerging Science, Technology and Innovation Conclave in Delhi, where Prime Minister Narendra Modi highlighted it as a humanised CAR-T therapy developed in India, stating: "This initiative demonstrates the potential of domestic biotechnology to address critical healthcare challenges while adhering to global safety and scientific standards."
The Global Significance: A Proof of Concept for the World
NexCAR19 is not merely an Indian achievement. It is a proof of concept for every low- and middle-income country that has watched advanced cancer therapies remain perpetually out of reach.
Rahul Purwar, the Founder and CEO of ImmunoACT, expressed the importance of this achievement for patients in India and other countries with limited resources, likening this development to a "moon shot" in terms of technical achievement and highlighting that it places India among select countries with access to CAR-T therapy.
ImmunoACT is planning to export the therapy to Mexico. Mexico, with a large cancer patient population and a healthcare system that cannot absorb American-level drug pricing, is a natural first export market — and a template for what the therapy's global trajectory could look like.
The ImmunoACT model demonstrates something that the global pharmaceutical industry has long treated as structurally impossible: that cutting-edge cell and gene therapy can be developed, manufactured, and commercialised in a developing country, at a fraction of Western costs, without sacrificing clinical efficacy or safety. The safety data is, in some respects, better than the American products it competes with.
What Comes Next
ImmunoACT is not standing still at NexCAR19. Ongoing research explores NexCAR19's potential for other cancers, including multiple myeloma. Multiple myeloma, a blood cancer with a large global patient population and limited treatment options in low-income settings, would represent a major expansion of the therapy's clinical reach.
Director of Tata Memorial Centre Dr. Sudeep Gupta said: "We hope that in years to come, our collaboration will lead to the development of other cell and gene therapy products that will help our patients with various cancers."
The broader Indian cell and gene therapy ecosystem is also developing around NexCAR19's success. Immuneel Therapeutics has announced India's first Phase II clinical trials for alternative CAR-T therapies. Eyestem Research is developing cell therapy for dry age-related macular degeneration. The regulatory and manufacturing infrastructure that ImmunoACT built to bring NexCAR19 to market is now available as a platform for the next generation of Indian cell and gene therapy products.
The Human Number That Defines It All
Three hundred and fifty patients. That is the number of people in India who received NexCAR19 in the therapy's first year of commercial operation. People who had relapsed after multiple rounds of chemotherapy. People who had been told, in the terminology of oncology, that they were refractory — meaning the cancer had stopped responding. People for whom the conventional toolkit had nothing more to offer.
Sixty percent of the B-ALL patients in that group achieved progression-free survival. Nearly half achieved complete remission.
Without NexCAR19, the vast majority of those patients would either have had no further treatment options in India or would have faced a cost of Rs 3 to 4 crore for an imported therapy that most could not access regardless. With it, they received a treatment that matches global standards of care at a price that, while still significant, is within the reach of an expanding pool of patients.
Rahul Purwar said at the time of approval: "This is like a dream come true and an incredible win for the patients in the country. Now our patients in India and countries with limited resources will have access to this life-saving drug at an affordable cost."
The dream has come true. It is now, measurably, saving lives.
