Biosimilar contract manufacturing market seen reaching $51.4B by 2035

Market Research Future projects the biosimilar contract manufacturing market will grow from $12.82 billion in 2025 to $51.42 billion by 2035, driven by biologic patent expiries, payer cost pressure and faster, more efficient manufacturing methods. The report says large capacity additions by Samsung Biologics, Lonza and Fujifilm Diosynth are helping reshape where biosimilars are made.

Why it matters: - The market is expanding as more blockbuster biologics lose exclusivity and sponsors outsource production instead of building their own plants. - Contract manufacturing is becoming central to biosimilar access because payer pressure is pushing down drug prices while manufacturing costs remain high. - The shift could reshape where biologics are made, how quickly biosimilars launch and how much they cost.

What happened: - Market Research Future projected the global biosimilar contract manufacturing market will rise from $12.82 billion in 2025 to $51.42 billion by 2035. - The report put the forecast period CAGR at 14.9% from 2026 to 2035. - The market opens the forecast window at $14.73 billion in 2026. - The report was published Sept. 23, 2026.

The details: - The demand outlook is tied to about $180 billion in annual biologic sales losing exclusivity between 2026 and 2032. - Many sponsors targeting those medicines do not have commercial-scale bioreactor capacity. - The report cited payer cost-containment measures, including the U.S. Inflation Reduction Act negotiation list and Europe’s tender-driven procurement, as pressure points on reference-product pricing. - The report said single-use intensified perfusion lines and high-density fed-batch processes have increased typical monoclonal antibody titres from 2–3 g/L to 6–9 g/L. - The report said capital intensity per gram has fallen by almost 40%. - Mammalian expression systems held 74.5% of the market in 2025. - Recombinant glycosylated proteins were the largest product segment at $6.34 billion in 2025. - Oncology was the largest application segment at 42.8% share in 2025. - Upstream processing was the dominant service segment at 35.2% share in 2025. - North America led the market with 41.5% of global revenue in 2025, or about $5.32 billion. - Europe ranked second at $3.46 billion in 2025, equal to a 27.0% share. - Asia-Pacific accounted for 22.8% of the global market and was the fastest-growing region at 17.6% CAGR.

Between the lines: - The report points to a structural change in biosimilar production: fewer sponsors want to own expensive manufacturing assets when contract manufacturers can offer lower costs and faster scale-up. - Better process yields are changing the economics of outsourced production, not just the volume available. - Regulatory streamlining is also shifting work to CDMOs, because sponsors still need analytical and comparability data even when clinical trial requirements are reduced. - The concentration of new capacity among a few large manufacturers suggests the market is rewarding scale, speed and platform breadth.

What happened in the industry: - Samsung Biologics completed Plant 5 in Songdo in April 2025, adding 180,000 litres and lifting total capacity above 780,000 litres. - Lonza closed its acquisition of Roche’s Vacaville, California biologics site for about $1.2 billion, adding 330,000 litres of U.S. mammalian capacity. - Fujifilm Diosynth opened its Holly Springs, North Carolina facility after a $3.2 billion commitment, with eight 20,000-litre bioreactors. - Samsung Biologics, Lonza and WuXi Biologics have together committed more than $12 billion to new capacity since 2023. - The report said much of that investment is intended for biosimilar manufacture rather than innovative biologics. - Boehringer Ingelheim BioXcellence committed EUR 500 million to expand its Biberach site. - Celltrion announced a $1.9 billion multi-year capital plan covering a fourth plant and more fill-finish capacity.

What's next: - The report expects growth to continue as more biosimilar programs move to external manufacturing. - New demand is likely to come from subcutaneous and high-concentration formulations, analytics-as-a-service, integrated cell-line-to-fill-finish programs and digital bioprocessing tools. - Sustainability could become a procurement requirement, with carbon intensity per gram emerging as a competitive factor. - Contract manufacturers that can combine capacity, analytics and lower-cost production are positioned to capture the next wave of outsourced biosimilar work.

The bottom line: - Biosimilar contract manufacturing is moving from a niche outsourcing segment to a core part of the biologics supply chain, and the next decade looks set for rapid capacity buildout and more outsourcing.