India Emerging as Leader in Immuno-Oncology Drugs
India Emerging as Leader in Immuno-Oncology Drugs
Cancer has emerged as a leading cause of mortality in India with over 1 million new cases reported every year.

The rising prevalence of cancer and growing cost of cancer treatment has made immuno-oncology drugs an important area of focus. Immuno-oncology or immunotherapy works by boosting the body's natural defenses to fight cancer. It shows promise in treating cancer types that have been difficult to treat such as lung cancer and melanoma. The Indian government and private players have recognized immunotherapy as an important field that requires funding and development of indigenous capabilities.

Lung Cancer a Major Concern

Lung cancer accounts for a significant proportion of the cancer burden in India. It is estimated that over 1 lakh new cases of lung cancer are reported every year making it one of the most common cancer types. Unfortunately, most cases present at an advanced stage when treatment options are limited. Immuno-oncology drugs offer hope for improving outcomes in lung cancer patients. Several indigenous immuno-oncology drugs in clinical trials are focusing on treatments for lung cancer. As these drugs gain regulatory approval in the coming years, they will address an important unmet need.

Indian Industry Ramping up R&D

Indian pharmaceutical companies have made significant investments in setting up R&D centers focused on biologics and immuno-oncology over the last 5 years. Major players like Biocon, Dr. Reddy's, Sun Pharma and Zydus Cadila now have capabilities to develop monoclonal antibodies, cell therapies, cancer vaccines and other novel modalities. Biocon recently acquired Syncona portfolio company Kymab expanding its presence in immuno-oncology. Several Indian startups are also actively involved in developing innovative oncology drugs including immuno-oncology drugs for the global market. This level of investment and focus on a complex modality like immunotherapy demonstrates India's capabilities and ambition in this field.

First Drugs in Clinical Trials

India's first indigenous India's Immuno-Oncology BCD-100 developed by Biocon is currently in Phase 2 clinical trial for treatment of solid tumors. Other drugs that are in early to mid-stage clinical trials include Zybev by Zydus Cadila, an antibody drug conjugate for breast cancer, ADCETRIS biosimilar by Dr. Reddy's and Livatag by Panacea Biotech, a cancer vaccine for liver cancer. If these trials are successful, it will establish India's capabilities and result in the first set of approved indigenous immuno-oncology drugs in the next 2-3 years. This will be a milestone for the pharmaceutical industry in India.

Opportunities and Challenges

The rising incidence of cancer and emergence of targeted therapies has created opportunities for Indian companies to develop and commercialize affordable innovative therapeutics. India enjoys inherent advantages of a large patient pool for clinical trials, low cost of operations and a pool of scientific talent. However, developing complex biologics requires significant investments and technological capabilities. Scaling up manufacturing for these drugs is another challenge area. Further, most clinical trials are still done globally requiring higher costs and longer timelines to approval. For immuno-oncology to achieve its full potential in India, further policy reforms will be needed to address these challenges.

Policy Support Needed

While the government has launched initiatives like the Biotech Ignition Grant to boost R&D, more focussed support is required for immuno-oncology. Steps like setting up immuno-oncology centers of excellence, funding collaborative research with global institutes and tax incentives can help India emerge as a leader in this field. Regulatory reforms to enable local clinical trials, abbreviated approval pathways and schemes to reduce costs of capital equipment will reduce the entry barriers for domestic companies. With a dedicated policy push, India's low-cost advantage can be leveraged to make life-saving immuno-oncology therapies accessible globally in the coming decade.


The fast growing burden of cancer in India and availability of next-generation targeted therapies present a large opportunity for the pharmaceutical industry. Immuno-oncology is an area of strategic focus given its potential to treat difficult cancers. While initial progress has been promising, greater emphasis on incubating innovations, supporting infrastructure and regulatory facilitation is required. With a conducive policy environment and continued private investments, India can emerge as a leading destination for development and manufacture of affordable immuno-oncology drugs. This will ensure more cancer patients get access to life-extending treatments in the future.

 

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