Indian Lifesciences Industry Going Ahead in its Innovation Journey While Navigating Challenges

While India is a hub for biosimilar manufacturing and continues to build its capabilities to manufacture these complex therapeutics, Indian biopharma companies are building R&D capabilities and establishing public-private collaborations and Centre of Excellences (CoEs) to develop innovative biologics and advanced therapeutic modalities like cell and gene therapy (CGT) and mRNA vaccines and therapies, biopharma sector remained robust in 2023, accounting for $53.8 billion (35 per cent of the BioEconomy). The growth was primarily driven by advances in biotechnology, personalised medicine innovations, and an expanding market for biosimilars in 2024.

- Ruplekha Choudhurie

India is a major supplier of vaccines, with more than 50 per cent of the world's vaccines coming from India. According to the WHO Global Vaccine Market Report, the vaccine major Serum Institute of India (SII) accounted for 24 per cent of the global vaccine market. SII joined the CEPI, (the Coalition for Epidemic Preparedness Innovations), network of vaccine producers, which will support rapid, agile responses to possible future infectious disease outbreaks. In addition to conventional vaccines, India has also emerged strong with two mRNA vaccines approved for the omicron variant. Innovations have also increased, with Indian Immunologicals Ltd (IIL), launching India's 'first' indigenously developed Hepatitis A vaccine, Havisure in February 2024.

Many Indian startups and academic organisations have been relentlessly working to advance affordable cell and gene therapies for oncology, rare diseases, and other indications. The push to develop more efficacious and accessible CAR-T therapies to millions of patients finally saw fruition, with the first indigenous CAR-T cell therapy receiving approval in 2023, making it the most affordable CAR-T therapy. The commercial launch of NexCAR19 in 2024 has helped India firmly establish its position in the advanced cell and gene therapy space. This launch has also sparked interest in investors and companies investing in cell and gene therapy developers. Other players like Cellogen Therapeutics are developing advanced CAR-T therapies by developing bi-specific CARS and adding immunostimulatory molecules. They received a $2 million investment from Natco Pharma in 2024 to support the R&D programmes. Immuneel Therapeutics also received $12 million in funding in 2024, which will help propel its CAR-T therapy manufacturing and development platform. Other notable developments included approving the country's first gene therapy clinical trial for Hemophilia A in February 2024.