Emergence of Immuno-Oncology and Its Applications
Immuno-oncology, also known as cancer immunotherapy, leverages the body's own immune system to fight cancer. It involves modifying or enhancing parts of the immune system, like T-cells, to recognize and destroy cancer cells. The approach differs from traditional cancer treatments like chemotherapy, radiation therapy and surgery that directly kill cancer cells. Instead, it trains the immune system to eradicate tumors on its own. Recent breakthroughs in understanding the interaction between cancer and the immune system have enabled new targeted therapies called "checkpoint inhibitors" that unleash the immune system by blocking certain checkpoints that normally inhibit immune responses. Checkpoint inhibitors against molecules like PD-1, PD-L1 and CTLA-4 have shown durable responses against various cancers like lung cancer, melanoma and renal cell carcinoma. With their ability to induce long-lasting remissions, immuno-oncology drugs are revolutionizing cancer treatment.
Opportunities in India's Growing Cancer Burden
With its large treatment-naïve patient population and significant budget constraints in providing cancer care, India provides opportunities for affordable Immuno-Oncology Drugs therapies. Global pharmaceutical companies are recognizing India's massive potential as incomes rise and more patients opt for novel targeted treatments. Innovative pricing models and partnerships with domestic players can help make immuno-oncology accessible for Indian patients.
Domestic Capabilities Expanding in Drug Development
India is strengthening its drug development capabilities to address the growing demand. Indian biotechs are gaining experience in conducting early phase clinical trials of international drug candidates. Major biopharma companies like Biocon, Dr. Reddy’s, Natco and Zydus Cadila have built robust manufacturing infrastructure as well as research functions for biosimilars. Some local players are also developing novel biologicals through research collaborations. The government's flagship 'Make in India' and 'Startup India' programs aim to boost the life sciences industry and encourage localized R&D. Initiatives like setting up genomic data centers and expanding the network of cancer centers will help build clinical trial expertise. As technical capabilities increase, Indian firms are envisioning self-reliance in developing indigenous immuno-oncology drugs either through importing technologies or in-licensing candidates. Their strong focus on affordability will expand treatment access for millions within the country.
Immuno-Therapy Drug Approvals and Launches
Key immuno-oncology launches in India include MSD's anti-PD-1 drug Keytruda, which was approved in 2017 for various cancers like melanoma, lung cancer and head & neck cancer. Bristol Myers Squibb's anti-CTLA4 drug Yervoy received approval in 2014, making it the first immuno-oncology therapy available in India. Roche/Genentech's Tecentriq was launched in 2019, while Merck KGaA's Bavencio got regulatory approval in 2020. These multi-national corporations have set up expanded access programs and community outreach initiatives to improve availability. Domestic pharma major Biocon also launched its anti-PD-L1 biosimilar, which it co-developed with Mylan, in 2019 at a fraction of originator drug prices. In 2021, Dr Reddy's launched a generic version of Merck's anti-PD-1 drug Keytruda. These launches represent India's growing acceptance and adoption of the novel cancer treatment approach. With continued medical education efforts and demonstration of real-world outcomes, oncology experts predict immuno-oncology therapies could account for 30-50% of new cancer treatments in India in the coming years.
Government Support Boosting Indigenous Capability
The Government of India recognizes the need to bolster indigenous medical innovation through public-private partnerships. Significant funding has been committed towards vaccine and biopharma R&D through initiatives such as the 'Medicine from the Sky' program and Budget allocation of INR 500 crores per year to the Biotechnology Industry Research Assistance Council (BIRAC). BIRAC's partnership with the Bill & Melinda Gates Foundation to fund projects in vaccines, drugs and diagnostics will support development of affordable healthcare solutions tailored for India. The Department of Biotechnology's 1000 Crore INR grant for establishing pre-clinical test facilities and assay development will also foster immuno-oncology research. Schemes like the BIRAC Regional Bio-Innovation Centers and National Biopharma Mission aim to encourage commercialization of affordable biologics and attract investment into biosimilars and novel biologicals development. With strong government backing to scale up infrastructure and workforce, India is on track to emerge as a top outsourcing destination and innovation hub for global immuno-oncology research.
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