Luton, Bedfordshire, United Kingdom, June 23, 2025 (GLOBE NEWSWIRE) — Biosimilars Market Report: 2024–2025 Overview
Foreword
Biosimilars have emerged as a powerful tool in the global healthcare arsenal, delivering cost-effective alternatives to high-priced biologics and expanding patient access. As policymakers, payers, providers, and manufacturers align incentives around value, biosimilars are reshaping therapeutic landscapes and fueling generics-style competition in biologics.
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The biosimilars market is anticipated to reach a valuation of approximately $25 billion in 2024, driven by increasing demand for cost-effective biologic therapies and a growing prevalence of chronic diseases. The market is projected to expand significantly, with an estimated value of $60 billion by 2034, reflecting a robust Compound Annual Growth Rate (CAGR) of around 9% during the forecast period from 2025 to 2034.
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As one health policy expert remarked during a POLITICO Focus roundtable: > “Experts explored the pivotal role that biosimilars play in strengthening the nation’s health care system…”
Scientific and regulatory leaders also emphasize mitigating biases and reinforcing confidence. Professor Schellekens notes: > “Biosimilars often have even a higher quality than the reference products.”
Additional insights from industry leaders underline the ongoing transformation: – Sarah Yim (FDA): “Both biosimilars and interchangeable biosimilars meet the same high standard of biosimilarity for FDA approval and both are as safe and effective as the reference product.” – Adam Fein (Drug Channels): “For 2025, the three largest pharmacy benefit managers… have again each excluded hundreds of drugs from their standard formularies… creating an increasingly confusing and crowded biosimilar marketplace.” – Alex Brill (Matrix Global Advisors): “Is the biosimilar market a failure with respect to these pharmacy benefit drugs like Humira? Maybe in March it was, but in April it’s starting to look functional again.” – Jon Martin (Organon): “That’s what gives us some optimism,” referring to expectations that biosimilars can gain ~50% share over time, as seen with Remicade. – AMCP 2025 Reports: “High adherence rates, comparable clinical effectiveness, and cost savings have marked the early adoption of adalimumab biosimilars in the US.” – Sandoz Spokesperson: “Misaligned incentives across the US healthcare system have led to meaningful delays and barriers to biosimilar adoption, resulting in significant missed opportunities for healthcare savings.”
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Market Size & Segmentation
- Global Valuation & Growth:
- USD 18.65 billion (2024), rising to 21.95 billion in 2025. Estimated CAGR: 17.7% to USD 42.16 billion by 2029.
- Other projections suggest growth from USD 40.4 billion (2025) to USD 176 billion by 2034 at 17.8% CAGR.
- Segmentation:
- By Therapeutic Area: Oncology, autoimmune diseases, metabolic disorders.
- By Molecule Type: Monoclonal antibodies, G-CSF, insulin, epoetins.
- By Application: Chronic and acute care.
- By Region: North America, Europe, Asia-Pacific, Latin America, Middle East & Africa.
Key Players
- Established Leaders: Amgen, Novartis/Sandoz, Samsung Bioepis, Pfizer, Celltrion, Biogen, Coherus, Merck & Co., Dr. Reddy’s, Biocon, Intas.
- Emerging Names: CVS/Cordavis, Alvotech, Kashiv BioSciences, Fresenius Kabi.
Key Market Events (2024–2025)
- FDA Approvals: Over 60 biosimilars approved in the U.S. as of late 2024.
- Ustekinumab Biosimilars Launch: Products like Wezlana, Pyzchiva, and Imuldosa began sales in Q1 2025.
- CVS Cordavis x Sandoz: Hyrimoz launched as a private-label biosimilar for Humira in the U.S. (Apr 2024).
- Humira Dynamics: Despite biosimilar competition, Humira retained over 80% U.S. market share in 2024 due to PBM rebates.
- India Rule Overhaul: Indian regulators revised biosimilar manufacturing and …