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India's cell and gene therapy market has witnessed remarkable growth in recent years, positioning the country as a prominent player in the global biotechnology landscape. With its vast population and a growing pool of skilled scientists and researchers, India presents a fertile ground for advancements in this revolutionary field of medicine. According to BioIntel360, India’s cell and gene therapy market size is expected to record a compound annual growth rate (CAGR) of 23.2% during 2023-2027 to reach US$1,639.4 million by 2027, increasing from US$712.7 million in 2023. Over the last five years, the sector has recorded a CAGR of 24.8% to reach US$574.2 million in 2022.
Cell and gene therapies have emerged as a beacon of hope for patients suffering from previously untreatable or challenging-to-treat diseases. These therapies involve the use of a patient's cells or genetically modified cells to treat or cure conditions like cancer, genetic disorders, and certain autoimmune diseases. 3,689 therapies are in clinical development, ranging from preclinical through pre-registration, including 2,022 gene therapies and 813 non-genetically modified cell therapies (as of Apr 2023). The success stories and groundbreaking results of cell and gene therapies worldwide have sparked a surge in demand for such treatments in India.
In 2022, Yescarta and Breyanzi, both CAR-T therapies, received approvals as second-line treatments for large B cell lymphoma. These approvals not only showcase the therapeutic potential of CAR-T therapies but also provide patients with expanded treatment options and hope for improved outcomes. CAR-T (Chimeric Antigen Receptor T-cell) therapies, a revolutionary form of cell therapy, have made notable progress in India and are projected to experience significant growth with a CAGR of 25.3% from 2023 to 2027. This expansion is expected to elevate the market value to US$986.2 million by 2027, a substantial increase from US$400.0 million in 2023. Over the past five years, the sector has demonstrated remarkable progress, achieving a CAGR of 26.0%, culminating in a market size of US$319.1 million in 2022. These figures highlight the thriving potential and robust growth trajectory of the cell and gene therapy market in India, particularly in the CAR-T cell segment.
The sales of advanced therapies, excluding COVID vaccines, exhibited remarkable growth in 2022, reaching a market value of USD 8.1 billion. This surge in market value reflects the increasing adoption and acceptance of advanced therapies within the Indian healthcare system. Patients and healthcare providers alike are recognizing the transformative impact of these therapies on previously untreatable or challenging-to-treat diseases, driving the market's impressive expansion.
The Indian government has recognized the potential of cell and gene therapies in revolutionizing healthcare and has taken significant steps to support and regulate the sector. The National Biopharma Mission, launched by the government in collaboration with the World Bank, aims to foster innovation and promote entrepreneurship in the biopharmaceutical sector, including cell and gene therapies.
Furthermore, the Indian regulatory authority, the Central Drugs Standard Control Organization (CDSCO), has established guidelines for the development and approval of advanced therapies, providing a clear regulatory pathway for researchers and biotech companies. These regulatory advancements have instilled confidence in investors and researchers, leading to increased investments in cell and gene therapy research and development.
India boasts a robust research and development ecosystem, with numerous academic institutions, research centers, and biotechnology companies actively engaged in cell and gene therapy studies. Leading research institutes have been conducting clinical trials for cell and gene therapies, demonstrating the nation's commitment to advancing medical science and contributing to global knowledge.
India's cell and gene therapy market stands out for its cost-effectiveness compared to many Western countries. The relatively lower cost of conducting clinical trials and producing therapies attracts international pharmaceutical companies to collaborate with Indian research partners. This affordability factor not only benefits the domestic population but also positions India as a preferred destination for conducting multi-centric clinical trials.
While India's cell and gene therapy market shows immense promise, it also faces certain challenges. Intellectual property rights protection and complex regulatory procedures can present hurdles for researchers and companies seeking to bring new therapies to the market. Additionally, building the necessary infrastructure and expertise for large-scale commercialization of cell and gene therapies may require further investments and support.
India's cell and gene therapy market is experiencing a transformational phase, with accelerating research activities, government support, and growing industry interest. As the nation continues to make strides in this field, it holds the potential to become a significant contributor to the global cell and gene therapy market. By fostering collaboration between academia, industry, and regulatory bodies, India can build a robust ecosystem that nurtures innovation, ensures patient access to advanced therapies, and strengthens its position as a leader in cutting-edge medical advancements.
BioIntel360 suggests that it is essential for stakeholders in India's cell and gene therapy market to remain vigilant, adaptable, and committed to upholding the highest standards of research and patient care. With the right balance of innovation, regulation, and investment, India can pave the way for a brighter and healthier future through the transformative power of cell and gene therapies.
