Miltenyi Biotec sees big India opportunity as it advances Made‑for‑India CAR‑T therapies

Miltenyi is preparing to bring its pipeline of cancer and autoimmune‑targeted therapies to India

• Miltenyi Biotec, CMC Vellore to develop CAR-T therapies in India
• CD19 CAR-T trial shows safety, early efficacy in Indian patients
• Hospital-based manufacturing aims to cut CAR-T therapy costs

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Miltenyi Biotec, the German cell and gene therapy (CGT) specialist that quietly powers much of the world’s CAR‑T manufacturing ecosystem, is preparing a major push into India—not just as an equipment supplier, but as a developer of home‑grown CAR‑T therapies.

“After 30 years, cell and gene therapy has finally reached the moment where it can become real medicine,” says Stefan Miltenyi, founder of Miltenyi Biotec in an interview to Moneycontrol on  the sidelines of BioAsia 2026 in Hyderabad.

Miltenyi is preparing to bring its pipeline of cancer and autoimmune‑targeted therapies to India. The company is working with Christian Medical College (CMC) Vellore on a CD19‑directed CAR‑T program for blood cancers, and plans deeper collaborations with healthcare institutions as it looks to tap the country’s growing CGT ecosystem.

CAR-T therapy (Chimeric Antigen Receptor T-cell therapy) is a groundbreaking, personalized cancer treatment that uses patient's living cells to treat the diseases such as cancers and autoimmune disorders.

The company’s CD19 CAR‑T candidate has completed a Phase 1 trial at CMC Vellore, led by hematologist Dr. Vikram Matthews. The study demonstrated safety and early efficacy in Indian patients with non‑Hodgkin lymphoma and leukemia. Miltenyi and CMC have submitted the data to Indian regulators to pave the way for a Phase 2 registration trial.

“This is co‑invented in Germany, made in India, for India,” said Dr. Toon Overstijns, Managing Director of Miltenyi Biomedicine and Board Member, Germany. He added that the therapy could eventually extend beyond oncology to autoimmune diseases, including lupus, ulcerative colitis and other B‑cell–driven conditions.

Hospital‑based manufacturing to cut costs

Affordability remains the biggest hurdle in India’s CAR‑T landscape, where commercial therapies can cost more than Rs.50 lakh. Miltenyi says it intends to change that by enabling CAR‑T manufacturing inside or near hospitals, eliminating the need for complex central manufacturing and international cold‑chain logistics.

The company has developed equipment that allows fresh‑to‑fresh cell processing—no freezing cycles, shorter turnaround times and lower costs. Treatment cycles could shrink to 1–2 weeks, a crucial advantage for fast‑progressing cancers.

“You’re at the right address when it comes to cost efficiency,” Miltenyi said, noting that the company manufactures all components in‑house, from viral vectors and cytokines to media, plastics and software. “It’s a one‑stop solution, and that gives us cost control.”

Still, he cautioned that CAR‑T is inherently labour‑intensive: “It’s individualized medicine. Like a tailor‑made suit, it will always involve more effort than a standard product.”

Expanding India footprint

Miltenyi is ramping up hiring in India to support both its equipment business—which supplies research institutes and emerging therapy developers—and its future therapy commercialization. While open to partnerships with Indian drugmakers, the company believes CGT requires specialized capabilities that it is best positioned to manage itself.

“This is not a classical pharma business where you sell pills,” Overstijns said. “We feel we can do this better ourselves, but remain open to collaborations.”

Global pipeline, local ambition

Alongside its India plans, Miltenyi is preparing to file for European approval of Zamtocabtagene, a dual‑target (CD19/CD20) CAR‑T therapy that has completed clinical trials in Europe and the US, executives expect the therapy to reach India as well, though the local commercialization model is still undecided.

For now, the near‑term focus is clear, accelerating the Indian registration study of the CD19 therapy.

“We want to reach Indian patients as quickly as possible,” Overstijns said. “If expedited pathways exist, we will take them.”