GLP-1 Drugs Demand Surge Brings Manufacturing Capacity Issues in India
GLP-1 Drugs and Their Impact on India's Pharmaceutical Landscape
As GLP-1 drugs such as semaglutide surge in demand, India's contract development and manufacturing organisations (CDMOs) face unprecedented challenges. Following the expiration of semaglutide patents, a flood of generic manufacturers seeks to secure capacity, resulting in significant supply bottlenecks.
Manufacturing and Regulatory Constraints
Industry leaders, including Neeraj Sharma from OneSource Specialty Pharma, highlight that supply constraints will overshadow demand issues over the next two years. Various obstacles, like peptide active pharmaceutical ingredient (API) shortages and regulatory hurdles, contribute to the capacity limitations. The regulatory pathway for entering competitive markets, especially the US and Europe, can take up to 24 months.
Future Manufacturing Slot Reservations
As demand remains promising, Indian firms like HAB Pharma actively reserve future manufacturing slots prior to receiving regulatory approvals. Export interest is surging from markets in Africa and West Asia, driven by global shortages.
Innovations in Drug-Device Combinations
As semaglutide becomes a benchmark in obesity therapy, the emphasis on the ability to produce complex injectable drug-device combinations intensifies. This shift signifies that success in the future marketplace will hinge on compliance, manufacturing scale, and innovativeness.
This article was prepared using information from open sources in accordance with the principles of Ethical Policy. The editorial team is not responsible for absolute accuracy, as it relies on data from the sources referenced.