How India's biopharma industry is tackling the world's next health challenges

Hindustan Times

2 days ago

India has established itself as the pharmacy of the world. Supplying nearly 20% of the global generics market and 60% of the vaccine market, the country has established a strong foundation for affordable, large-scale pharmaceutical production. However, as global health challenges evolve, from infectious outbreaks to chronic lifestyle diseases, India's approach must also adapt. With non-communicable diseases like cardiovascular issues, diabetes, and others now making up over 70% of global deaths, the focus shifts from just volume to precision. If India wishes to maintain its global leadership and meet its ambitious goal of reaching a $300 billion biopharmaceutical industry by 2030, it must embrace next-generation therapies, such as gene therapies, antibody-drug conjugates (ADCs), and personalised medicine. Pharma(Pixabay/Representative)
Fortunately, India, with its scientific talent, robust infrastructure, and exceptional population diversity, might be the launchpad the world needs.
A significant milestone in India's biotech journey came in October 2023, when the CDSCO approved the country's first homegrown CAR-T cell therapy, NexCAR19. Developed entirely in India, this therapy for leukaemia and lymphoma showed response rates comparable to global CAR-T treatments. What sets it apart is the fact that it's being made available at a fraction of the typical price, making it a landmark in affordable, advanced immuno-oncology and India's first indigenously developed gene therapy.
India is also making strides in antibody-drug conjugates (ADCs), that is, targeted cancer drugs that combine antibodies with potent toxins. Human trials for the first India-developed ADC candidate began in 2024. Meanwhile, the private sector is investing heavily in ADC manufacturing infrastructure. This comes at the right time: the global ADC market is expected to hit $23 billion by 2030, and India is positioning itself as a competitive, low-cost developer in this high-growth space.
When it comes to precision medicine, India offers a uniquely rich landscape. With 1.4 billion people spanning diverse genetic, ethnic, and environmental backgrounds, it provides an ideal setting for testing and refining personalised therapies. The country also faces a dual burden of disease: persistent infectious threats like tuberculosis, accounting for 26–27% of global cases, alongside a rising tide of non-communicable diseases like diabetes and cardiovascular diseases. This diversity creates a robust, varied patient pool for clinical trials and real-world evidence studies. It's exactly what precision medicine needs: treatments that work not just in ideal conditions but in complex, real-world settings. Geographic and climatic variation, from the Himalayas to the coastal tropics, further adds to India's advantage.
Significant strides in these arenas have been made possible due to active policy impetus.
A cornerstone of India's biopharma push is the National Biopharma Mission, backed by ~$250 million from Indian and World Bank support. It enabled the country's first CAR-T trials and established a GMP-grade viral vector facility, fostering industry-academia collaboration and seeding a thriving biotech startup ecosystem.
The government's ₹15,000 crore PLI scheme for the pharmaceutical industry is driving domestic production of complex biologics, vaccines, and high-value drugs. Covering 68 biopharma products and 157 priority drugs, it has approved 55 projects and already catalyzed over ₹30,600 crore in investment and ₹1.83 lakh crore in output by September 2024. The initiative aims to reduce India's import dependence and position the country as a global hub for advanced pharmaceutical manufacturing.
The Ayushman Bharat Digital Mission is building a rich, anonymised health data backbone, enabling real-world evidence and post-market surveillance, and laying the foundation for precision medicine at a population scale.
As DBT notes, India's genomic diversity is as varied as its culture or cuisine. Leveraging this scientifically will help address diseases that disproportionately affect Indian and developing-country populations. To this end, India is already scaling its genomic science to the population level. The Genome India Project has already sequenced 10,000 genomes from 83 ethno-linguistic groups and, as of January 2025, made this dataset publicly available. The government now targets 10 million genomes, supported by allied programs like CSIR's IndiGen and ICMR's National Genomics Core, which together are building reference variants for Indian populations. This genomic trove, paired with extensive patient registries, positions the country as a future hub for precision medicine and pharmacogenomics tailored to its uniquely diverse population.
Despite strong momentum, India's biopharma industry must address a few critical roadblocks to realise its potential in advanced therapeutics fully.
First, the regulatory framework needs to be strengthened. While CDSCO has deep experience with generics and vaccines, clear pathways for novel biologics, gene therapies, and precision medicine are still evolving. To this end, India must develop science-led, globally aligned regulatory guidelines with dedicated review pathways for advanced therapies, similar to the US FDA's breakthrough designation.
Second, funding for innovation remains a bottleneck. Between 2013 and 2022, Indian biotech firms raised just $5 billion in venture capital, compared to $57 billion by U.S. biotech companies in 2023 alone. The government has tried to fill this gap through BIRAC grants and incubators and has recently proposed a Research-Linked Incentive (RLI) scheme to reward private R&D investments.
Third, there is a talent shortage in high-end biopharma R&D and biomanufacturing. India's biopharma talent resilience score dropped from 6.3 in 2021 to 5.6 in 2023, and nearly half of pharma executives report difficulty hiring for critical roles. There is an immediate need to invest in specialised skill development programs for biologics, data science, and regulatory science to bridge this gap.
Dr Tedros Adhanom Ghebreyesus, Director-General of the WHO, once said: 'Health is a human right. No one should get sick or die just because they are poor or because they cannot access the care they need.'
India has the potential to turn that principle into practice by making the next generation of therapies not only practical but also accessible and affordable. If it succeeds, India won't just lead the biopharma race; it will redefine who gets to benefit from the future of medicine.
This article is authored by Ankush Kapoor, co-founder and CEO, PharmNXT Biotech.