The pharmaceutical and biopharmaceutical sectors are undergoing transformative shifts driven by geopolitical tensions and regulatory changes. Among these changes, the BIOSECURE Act and the 2032 decoupling deadline from Chinese CDMOs stand out, prompting companies to reassess and revamp their supply chain strategies. Chloe Euripides of the International Biopharmaceutical Industry Journal recently interviewed three key representatives from leading Indian CDMOs: Alex Del Priore of Syngene International Ltd., Ramesh Subramanian of Aragen Life Sciences, and Himanshu Gadgil of Enzene Biosciences. Their responses provide a comprehensive view of how these companies are adapting to the new landscape and positioning themselves as competitive alternatives to Chinese CDMOs.
The BIOSECURE Act and Strategic Shifts
The BIOSECURE Act and the 2032 decoupling deadline are significantly shaping Enzene’s strategic planning. Himanshu Gadgil, CEO, highlights that the shift has driven Western companies to explore alternatives to Chinese CDMOs, resulting in increased interest and customer visits to Enzene’s facilities. To leverage these opportunities Enzene is expanding its operations, including launching a new drug discovery division and investing in innovative technologies like EnzeneX™. This expansion aims to provide end-to-end solutions and meet the evolving demands of their clients.
Ramesh Subramanian, Chief Commercial Officer, notes that the BIOSECURE Act is prompting Western pharma companies to reconsider their strategies. Aragen is preparing for these strategic shifts by investing USD 250 million to expand its R&D and manufacturing facilities in Hyderabad. This includes adding biologics manufacturing capabilities and expanding their footprint in small molecules, peptides, oligonucleotides, and ADCs. Unlike the rapid shifts during the COVID-19 pandemic, Subramanian observes a more deliberate approach as companies plan for long-term changes.
Alex Del Priore, Senior Vice President of Manufacturing Services, explains that Syngene is strategically positioned to capitalise on the supply chain shifts accelerated by the BIOSECURE Act. The company has experienced a surge in interest from biopharma companies seeking to reduce reliance on China. Syngene’s strategy involves leveraging its dual growth engines – CRO services and CDMO services – while offering flexible supply chain options to cater to clients’ needs for both China-based and China-independent sourcing.
Unique Strengths of Indian CDMOs
Enzene’s unique strengths in the global CDMO market include their proprietary EnzeneX™ technology, which offers significantly greater productivity and cost-efficiency compared to traditional methods. With operations in India and a planned US site, Enzene focuses on innovation, quality and customer[1]centricity, making it an attractive alternative to Chinese CDMOs.
Aragen’s strengths lie in its skilled English-speaking workforce, strong track record of quality compliance, and experience with Western regulatory guidelines. These factors, combined with rich experience in the West, position Aragen as a reliable partner for Western clients seeking high-quality CDMO services.
Syngene’s integrated services from discovery to commercial scale manufacturing, coupled with their investment in next-generation technologies and a large pool of skilled scientists, make them a strong competitor in the global CDMO market. Their flexible R&D services and long-term strategic collaborations further enhance their attractiveness as an alternative to Chinese CDMOs.
