Biosimilars market seen hitting $193.2B by 2035

Market Research Future projects the global biosimilars market will rise from $40.2 billion in 2025 to $193.2 billion by 2035, driven by patent expirations, regulatory expansion and demand for lower-cost biologics. The report points to oncology, Europe and Asia-Pacific as key engines of growth.

Why it matters: - The biosimilars market is moving into a period of rapid expansion as healthcare systems look for lower-cost alternatives to expensive biologic drugs. - Market Research Future projects the global market will grow from USD 40.2 billion in 2025 to USD 193.2 billion by 2035, a 17.0% compound annual growth rate. - The shift could broaden access to biologic therapies while reducing pressure on payer budgets.

What happened: - Market Research Future released a forecast saying the biosimilars market will surge through 2035. - The report ties the outlook to patent expirations for blockbuster biologics, stronger regulatory pathways and rising demand for cost-effective biologic treatments. - The report says the FDA approved 18 biosimilars in 2025 alone across oncology, immunology, endocrinology and ophthalmology. - The report says the FDA had approved 96 biosimilars by the end of 2025, including 25 interchangeable products. - Europe remains the market leader, while Asia-Pacific is the fastest-growing region.

The details: - More than USD 200 billion worth of innovator biologics are expected to lose patent protection by 2030. - Keytruda, or pembrolizumab, is highlighted as a major upcoming opportunity, with more than USD 31 billion in 2025 sales and a patent expiry expected in 2028. - Interchangeable biosimilars can be substituted at the pharmacy level where state law allows. - The FDA has shifted toward greater use of analytical characterization, which the report says can lower development costs and shorten time to market. - Biosimilars are typically priced 40% to 50% below originator biologics. - Bevacizumab biosimilars held 93% of the biologic volume share in Europe in 2024. - In oncology, bevacizumab and trastuzumab biosimilars reached 82% and 78% volume market shares, respectively, within three years of U.S. launch. - Monoclonal antibodies are the largest product segment. - Recombinant non-glycosylated proteins are the fastest-growing product segment. - Oncology is the largest therapeutic area. - Autoimmune and inflammatory diseases are the fastest-growing therapeutic area. - Ophthalmology is projected to post strong growth through 2035. - Europe leads adoption because of early regulation, coordinated procurement and gain-sharing schemes in some EU countries. - North America has the largest absolute revenue potential, supported by FDA approvals and reimbursement changes tied to the Inflation Reduction Act. - The report says projected U.S. savings from IRA-driven biosimilar adoption could reach USD 181 billion over five years. - Asia-Pacific is being lifted by manufacturers in South Korea, China and India. - South Korea has more than 70 approved biosimilars as of 2024. - China has approved more than 20 domestically developed biosimilars. - India has more than 100 approved biosimilars and more than 100 biopharma companies working on biosimilar platforms. - Biocon Biologics has built strong positions in several emerging markets, including 58% share for bevacizumab in South Africa, 85% for rh-insulin in Mexico and 40% for trastuzumab in Brazil. - Key companies in the market include Celltrion, Samsung Bioepis, Biocon Biologics, Sandoz Group AG, Pfizer, Amgen, Dr. Reddy's Laboratories, Cipla and Zydus Lifesciences. - Samsung Bioepis is developing SB27, a pembrolizumab biosimilar, and started global Phase 3 trials in April 2024. - Cipla in September 2026 in-licensed exclusive U.S. rights to Qilu Pharmaceutical's QL2107, a Keytruda biosimilar. - Zydus Lifesciences partnered with Formycon AG to market a Keytruda biosimilar. - The report also points to GLP-1 biosimilars as a future opportunity, with semaglutide patents expected to expire in China by 2026 and globally by 2031.

Between the lines: - The forecast suggests the next growth wave will come from large biologics nearing patent expiry, especially high-revenue oncology drugs. - Regulatory modernization matters because it lowers the cost and complexity of biosimilar development. - The regional split shows a mature adoption story in Europe, a reimbursement-driven opportunity in the U.S. and a manufacturing-led growth story in Asia-Pacific. - Emerging markets may become a larger commercial outlet as governments push for more affordable access to biologic medicines.

What's next: - Biosimilar makers are likely to keep targeting big-brand biologics with the largest sales potential. - Additional launches are expected around pembrolizumab and later GLP-1 therapies if patent timelines open the door. - Market share gains will likely depend on manufacturing scale, regulatory timing and payer incentives. - The market's growth through 2035 will hinge on how quickly biosimilars can convert patent expirations into commercial adoption.