Global forecast for the $35+ billion biosimilars market, encompassing monoclonal antibodies, granulocyte colony-stimulating factor, insulin, anticoagulants, rhGH, teriparatide, and GLP-1, up until 2035

Global forecast for the $35+ billion biosimilars market, encompassing monoclonal antibodies, granulocyte colony-stimulating factor, insulin, anticoagulants, rhGH, teriparatide, and GLP-1, up until 2035 – provided by ResearchAndMarkets.com

Global Biosimilars Market Set to Grow Rapidly, Reaching USD 205.65 Billion by 2035

The biosimilars market is expected to experience strong growth from 2025 to 2035, with a compound annual growth rate (CAGR) ranging roughly from 14% to 17.6%, reaching valuations between USD 188 billion to USD 205 billion by 2035. This growth is driven by several key opportunities and factors, as detailed in the recently published report, "Biosimilars Market by Drug Class, Indication, Competitive Landscape, Region - Global Forecast to 2035," now available on ResearchAndMarkets.com.

Market Size & Growth

The global biosimilars market, valued at approximately USD 34.61 billion in 2024, is expected to reach USD 205.65 billion by 2035, growing at a CAGR of 17.6%. Another forecast estimates the market to grow from USD 43.8 billion in 2024 to USD 188.7 billion by 2035, at a CAGR of 14.2%.

Monoclonal Antibodies Segment

The monoclonal antibodies segment dominates this market due to its widespread use in oncology and autoimmune diseases. Patent expirations on key drugs like Humira and Herceptin are opening significant market opportunities. Technological advances and regulatory approvals have accelerated biosimilar introductions for these complex molecules.

Oncology Biosimilars Market

The oncology biosimilars market is estimated at USD 10.9 billion in 2025 and projected to grow to USD 24 billion by 2035 globally, at approximately an 8.1% CAGR. The US oncology biosimilars market in particular is expected to grow faster, at around 9.5% CAGR, motivated by reimbursement policies and active R&D.

US Market Focus

The US market is critical, given its high cancer incidence (~1.9 million new cases annually) and autoimmune disease prevalence (over 50 million Americans affected). FDA approval of multiple biosimilars in recent years and ongoing innovation in manufacturing technologies support market expansion. Strong insurance and government reimbursement policies incentivize biosimilar adoption.

Key Trends

Increasing regulatory support and clinician acceptance are reducing market entry barriers. Advanced manufacturing processes (e.g., single-use bioreactors, AI-driven optimization) improve production matching innovator biologics in quality and consistency. Digital pharmacovigilance and immunogenicity analytics accelerate regulatory approval and safety monitoring.

Key Challenges

Key challenges for the market growth include regulatory complexities and intellectual property issues. Manufacturing complexities and high cost of biosimilars, intense competition and pricing pressure among market players are other restraints.

Report Details

The report covers a forecast period of 2025 - 2035 and has a total of 392 pages. It includes a section on key technologies, which includes advanced bioprocessing & manufacturing technologies, analytical & characterization techniques, AI & ML, lab automation & robotics, microbial fermentation, D bioprinting & high-density cell culture, and trends/disruptions impacting customers' businesses.

The report also covers the role in ecosystem, patent analysis, and a list of key patents. It provides market leaders and new entrants with the closest approximations of the revenue numbers for the overall biosimilars market and its subsegments.

Companies featured in the report include Sandoz Group Ag, Pfizer Inc., Amgen Inc., Celltrion Inc., Biocon, Dr. Reddy's Laboratories Ltd., Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., Fresenius Kabi Ag, Stada Arzneimittel Ag, Boehringer Ingelheim International GmbH, Samsung Biologics, Amneal Pharmaceuticals LLC, Coherus Biosciences, Bio Thera Solutions, Aprogen, Shanghai Henlinus Biotech, Inc., Alvotech, Amega Biotech, Biocad, Probiomed S.A. De C.V., Fujifilm Kyowa Kirin Biologics Co. Ltd., Polpharma Biologics Group, Neuclone, Xentria, Yl Biologics, Kashiv Biosciences, LLC, Nanogen Pharmaceutical Biotechnology Jsc, Synermore Biologics (Suzhou) Co. Ltd., Curateq Biologics Pvt. Ltd.

For more information about this report, contact Laura Wood, Senior Press Manager at [email protected] or call 1-917-300-0470 (EST Office Hours), 1-800-526-8630 (US/CAN Toll Free), or +353-1-416-8900 (GMT Office Hours). The report is available for more information at https://www.researchandmarkets.com/r/o8xspv.