Immuno-oncology or cancer immunotherapy has transformed the way cancer is treated over the past decade. With its promise to harness the power of the patient’s own immune system to fight cancer, this field has seen tremendous advances and many new drug approvals globally. India too is playing an increasingly important role in this exciting area of research and innovation.

Emergence of India as an Immuno-Oncology Hub

India has emerged as a major destination for clinical trials and research in immuno-oncology. Several global pharmaceutical companies have established R&D centers and infrastructure in India to conduct clinical trials for new immuno-oncology drug candidates. This is due to India's large patient population, cost effectiveness, experienced clinical research organizations and streamlined regulatory processes.

Indian pharmaceutical companies are also actively working to develop novel immuno-oncology therapies. Companies like Dr. Reddy’s, Biocon, Emcure Pharma and Natco Pharma already market biosimilars of blockbuster immuno-oncology drugs like Avastin, Herceptin and Opdivo in India and other markets. Startups like ImmunoAct and AdcImmune are developing new antibody drug conjugates for cancer treatment.

With the aim of promoting indigenous R&D in advanced therapies, the government has created fund of funds like BioCuBE and LifeScience Park in Hyderabad. Initiatives like these will boost India's capabilities in cell and gene therapy, immunology and other cutting edge areas of biomedical research.

India's Strength in Clinical Trials

India is rightly called the global capital for clinical trials due to numerous advantages it offers to pharmaceutical and biotech companies. According to industry estimates, about 10-15% of global clinical trials are currently being conducted in India.

Some key factors contributing to India's clinical trials expertise are: presence of qualified investigators, ability to rapidly enroll large number of patients, cost efficiencies of 60-70% compared to Western markets and simplified regulations. For immuno-oncology trials targeting cancers like head & neck or liver which are more prevalent in India, patient accrual is quite fast.

World-class clinical research organizations like IQVIA, Syneos Health and ICON have large operations in India managing global as well as local clinical programs. Presence of such experienced CROs further enhances the clinical trials ecosystem. As a result, India is playing a prominent role in evaluation of many novel immune checkpoint inhibitors, CAR-T therapies, cancer vaccines and combination regimens.

Growing Biosimilars Industry

Biosimilars provide affordable access to cutting-edge biologic medicines and have emerged as an important area for India's pharmacy industry. Many Indian pharmaceutical players have gained approvals and commercialized biosimilars of leading cancer drugs trastuzumab, bevacizumab, rituximab and cetuximab in Indian and global markets.

Biocon Biologics leads the industry with several immuno-oncology biosimilars approved and marketed. Dr. Reddy’s gained approval for a Pegfilgrastim biosimilar last year. Intas, Emcure and Mylan are some other companies with oncology biosimilar programs. It is estimated that the Indian biosimilars market will grow to $4-5 billion by 2025 driven by monoclonal antibodies and novel biologics.

Biosimilars are making cutting-edge cancer therapies available at affordable costs not just in India but around the world. This will play a major role in increasing accessibility of immunotherapies in developing and underdeveloped countries.

The Next Wave - Novel India's Immuno-Oncology

While clinical trials and biosimilars form the core of current activities, Indian companies are now working towards developing indigenous novel immuno-oncology therapies. Biocon and Dr. Reddy’s are conducting clinical trials of novel monoclonal antibodies in collaboration with global partners.

Among startups, ImmunoAct is developing an antibody against checkpoint molecule TIGIT for various cancers in partnership with Genentech. AdcImmune’s lead candidate ADCT-402 is an antibody drug conjugate targeting tumors through dual mechanisms of action in phase 1 studies. ImmunoGenomx is focused on individualized cancer immunotherapy using neoantigen profiling and artificial intelligence.

Governments and research institutes are also initiating large immuno-oncology programs. Department of Biotechnology’s Immunology Network is funding various academic research projects on development of next-gen cancer vaccines, multi-antigen T-cell therapies and tumor microenvironment modulation approaches.

With its strengths in low-cost manufacturing, clinical trials and a growing pool of scientific talent, India is poised to play an increasingly prominent role in the global immuno-oncology landscape. As new therapeutic strategies emerge from research, India will contribute by expediting clinical development, increasing access through biosimilars and potentially discovering novel homegrown drug candidates. These efforts will help realize the full promise of immunotherapy in providing cure to many more cancer patients worldwide.

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