What is the Europe Biosimilar Market size in 2025?

Europe Biosimilar Market Summary 2025

Market Size in 2024: USD 13,864 Million
Market Forecast in 2033: USD 59,733.3 Million
Market Growth Rate 2025-2033: 17.1%

The Europe biosimilar market was valued at USD 13,864 million in 2024 and is expected to reach USD 59,733.3 million by 2033, expanding at a CAGR of 17.1%. Patent cliffs of blockbuster biologics, rising chronic-disease prevalence, and supportive EMA pathways are converging to create one of the fastest-growing segments in European healthcare.

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Growth Drivers Accelerating the European Biosimilar Market

Blockbuster Patent Expiry Cliff and Launch Tsunami

Between 2024 and 2027, patents protecting EUR 28 billion worth of originator biologics are set to expire in Europe, including those for adalimumab, trastuzumab, and rituximab. The European Medicines Agency approved a record 19 denosumab biosimilars in April 2025 alone, offering hospitals instant multi-source competition and average list-price discounts of 35%. Germany's AMNOG process automatically assigns a lower reference price once three interchangeable biosimilars are available, accelerating payer substitution. As originator companies shift their promotional spend to next-generation biologics, prescribers gain confidence in adopting biosimilars as the standard of care, turning patent loss into volume gain for manufacturers that secure a first-mover advantage.

Chronic-Disease Burden and Cost-Containment Mandates

The European Union reports that 50 million citizens live with diabetes and 3.5 million with inflammatory bowel disease, conditions are long-term conditions managed with biological therapy. Italy's National Health Service saved EUR 1.2 billion in 2024, compulsory for naive patients, compulsory by the use of biosimilar first-line, is now a policy that is now repeated in France and Spain. England's NHS saved GBP 747 million through biosimiller switching programs between 2019 and 2024, reinvesting in funding innovative drugs. These real-world savings resonate with the finance ministries, which induce quota-based tenders that guarantee 70% of the biosphere market share within 24 months of launch, forcing a policy-powered bridge-throat that offers the doctor inertia.

Regulatory Streamlining and Real-World Evidence

The new "biosimilars 2.0" guideline of EMA allows comparative efficacy data to increase additionally in signals after a decisive study, cutting the time of development up to 18 months. EU-Pearl initiative pools real-world data from 18 countries, which enables post-marketing monitoring that supports label expansion without additional tests. In May 2025, Sandose launched Pizchiva, the first Ustekinumab Biosimilar Autoinjector, which was cleared under the fast-track route and rolled out in Spain within 60 days. Regulatory certainty plus strong pharmacovigilance reduces the alleged risk for prescribers and payments, accelerates adoption curves and widens the patient pool in oncology, dermatology, and rheumatology.

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Europe Biosimilar Market Segmentation

Analysis by Molecule

• Infliximab
• Insulin Glargine
• Epoetin Alfa
• Etanercept
• Filgrastim
• Somatropin
• Rituximab
• Follitropin Alfa
• Adalimumab
• Others

Analysis by Indication:

• Auto-Immune Diseases
• Blood Disorder
• Diabetes
• Oncology
• Growth Deficiency
• Female Infertility

Analysis by Type of Manufacturing

• In-house
• Contract

Analysis by Country

• Italy
• Germany
• United Kingdom
• France
• Spain
• Rest of Europe

Top European Biosimilar Companies:

• Novartis
• Pfizer
• Teva
• Celltrion
• Merck Sharp & Dohme
• Samsung Bioepis
• Eli Lilly
• Accord Healthcare Ltd.
• Amgen
• Boehringer Ingelheim
• Hexal Ag
• Apotex
• Stada Arzneimittel Ag
• Ratiopharm
• Mylan

Europe Biosimilar Market News

• March 2025: The EMA recommended approval of Biocon's bevacizumab biosimilar Bmab, expanding oncology treatment options across 27 member states.
• February 2025: Fresenius Kabi and mAbxience announced a strategic license to co-develop a denosumab biosimilar for Italy, targeting osteoporosis and oncology indications.
• January 2025: NHS England reported that switching patients to adalimumab biosimilars saved GBP 100 million in 2024, funds redirected to innovative cancer therapies.
• December 2024: Samsung Bioepis and Sandoz expanded their ustekinumab biosimilar rollout to Germany and France, offering both prefilled syringe and autoinjector formats.

Key highlights of the Report:

• Market Performance (2019-2024)
• Market Outlook (2025-2033)
• COVID-19 Impact on the Market
• Porter's Five Forces Analysis
• Strategic Recommendations
• Historical, Current and Future Market Trends
• Market Drivers and Success Factors
• SWOT Analysis
• Structure of the Market
• Value Chain Analysis
• Comprehensive Mapping of the Competitive Landscape

Note: If you need specific information that is not currently within the scope of the report, we can provide it to you as part of the customization.

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