Market Overview

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, growing at a CAGR of 17.1% during 2025-2033. The market growth is driven by the increasing prevalence of chronic diseases, patent expirations of biologics, and supportive regulatory frameworks such as those from the European Medicines Agency (EMA). The rising acceptance among healthcare providers and patients further fuels market expansion.

Study Assumption Years

• Base Year: 2024
• Historical Year/Period: 2019-2024
• Forecast Year/Period: 2025-2033

Europe Biosimilar Market Key Takeaways

• The Europe biosimilar market size was USD 13,864 Million in 2024.
• The market is expected to grow at a CAGR of 17.1% during the forecast period 2025-2033.
• Italy holds the largest market share at 20.8% in 2024.
• Rising prevalence of chronic diseases such as diabetes, cancer, and autoimmune conditions fuels market demand.
• Supportive regulatory frameworks, especially by EMA, facilitate streamlined approvals.
• Patent expirations of major biologics open the market for biosimilar alternatives.

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Market Growth Factors

The Europe biosimilar market growth is driven by rising prevalence of chronic diseases including diabetes, cancer, and autoimmune diseases that fuel the need for developing affordable biologic medicines. As one of the regions with the largest aging population, Europe is characterized by high prevalence of chronic diseases. In Italy, chronic diseases affect around 24 million people, contributing to a strong demand for biosimilar products in the region.

Positive reimbursement policies such as the ones seen in Germany and France have been important growth facilitators by alleviating financial burdens on healthcare systems and improving patient access. Numerous patent expirations for blockbuster biologic drugs have set the stage for lower-cost biosimilar alternatives to enter the market and improve innovation and competition.

New bioprocessing and analytic technologies, allowing for decreasing production costs and higher-speed processes, a gradual uptake of these new drugs into the market, new production capabilities, and training programs for physicians and patients, are also expected to help improve market uptake. In May 2025, Alvotech announced a deal with Advanz Pharma to commercialize 3 additional European biosimilars.

Market Segmentation

By Molecule

• Infliximab: Largest molecule with 17.5% market share in 2024; used for autoimmune diseases such as rheumatoid arthritis and psoriasis, driven by increasing chronic disease prevalence.
• Insulin Glargine
• Epoetin Alfa
• Etanercept
• Filgrastim
• Somatropin
• Rituximab
• Follitropin Alfa
• Adalimumab

By Indication

• Auto-Immune Diseases: Leading segment with 38.2% market share in 2024, fueled by rising chronic autoimmune conditions such as rheumatoid arthritis and inflammatory bowel disease.
• Blood Disorder
• Diabetes
• Oncology
• Growth Deficiency
• Female Infertility

By Manufacturing Type

• In-house Manufacturing: Dominates with 80.3% market share in 2024; allows better quality control, reduced supply chain risks, and greater flexibility in production.
• Contract Manufacturing

By Country

• Italy: Largest market share of 20.8% in 2024; driven by rising chronic diseases, government incentives, and a robust regulatory framework.
• Germany
• United Kingdom
• France
• Spain
• Rest of Europe

Regional Insights

Italy dominates the Europe biosimilar market with a 20.8% share in 2024. The market growth in Italy is fueled by a high prevalence of chronic diseases, such as autoimmune disorders, cancer, and diabetes, affecting about 24 million people. The Italian government's supportive policies and strong regulatory framework encourage biosimilar adoption, enhancing patient access to affordable therapies while reducing healthcare expenditures.

Recent Developments & News

In May 2025, Sandoz launched Pyzchiva, the first ustekinumab biosimilar in Europe available as an autoinjector, starting with Spain. April 2025 saw Dong-A ST expand its Stelara biosimilar, Imuldosa, to the UK and Ireland after debuting in Germany, with further rollouts planned in France, Spain, and Italy.

In February 2025, Celltrion received EMA approval to start a Phase 3 clinical trial for CT-P55, a biosimilar to Cosentyx, targeting plaque psoriasis. Biocon launched liraglutide products in the UK, expanding biosimilar diabetes treatments after prior approvals.

In January 2025, Teva partnered to commercialize FYB203, a biosimilar to Eylea, across major European countries under the brand AHZANTIVE.

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Key Players

• 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

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