Biosimilars Market Regulatory Landscape and Compliance

Kanesmith11104 Jun, 2025Health

The global biosimilars market size is expected to be worth around USD 34.4 billion by 2032 from USD 9.5 billion in 2022, growing at a CAGR of 14.1% during the forecast period from 2022 to 2032. The global biosimilars market is undergoing a transformation as healthcare systems worldwide seek affordable alternatives to expensive biologics. Biosimilars, which mirror the structure and function of original biologic drugs, are gaining traction in treating chronic conditions such as cancer, autoimmune diseases, and diabetes. As more blockbuster biologics lose patent protection, biosimilar manufacturers are scaling up to meet growing demand. Enhanced global regulatory harmonization and increased physician confidence are helping biosimilars secure greater market share.