Europe Biosimilars Market - Industry Analysis, Size, Share, Growth, Trends, and Forecast 2032 - By Product, Technology, Grade, Application, End-user, Region: (Europe)

The biosimilars market in Europe is witnessing unprecedented growth, propelled by rising healthcare costs, increased patent expirations of biologics, and the growing need for accessible treatment options. As healthcare systems transition toward value-based care, biosimilars are gaining significant traction. The Europe biosimilars market is projected to rise from US$ 15.32 Bn in 2025 to US$ 43.4 Bn by 2032, growing at a robust CAGR of 16.03% during the forecast period.

Market Insights

Biosimilars are transforming the therapeutic Analysis in Europe. They are not only providing affordable alternatives to originator biologics but also enhancing access to treatment across diverse disease areas such as oncology, rheumatology, and immunology. Supportive regulatory mechanisms and favorable reimbursement policies are playing a pivotal role in boosting adoption across the region.

The European Medicines Agency (EMA) has streamlined the biosimilar approval process, helping to accelerate product launches without compromising safety or efficacy standards. This regulatory clarity has fostered greater confidence among prescribers and healthcare providers.

Key Market Drivers

The European biosimilars market is being driven by several interconnected factors:
• Patent Expirations: The expiration of patents for many blockbuster biologics is paving the way for biosimilars to enter the market, providing cost-effective therapeutic options.
• Healthcare Cost Pressures: As governments and institutions seek to control medical expenses, biosimilars offer substantial savings without sacrificing treatment quality.
• Policy Support: Reimbursement frameworks across Europe are increasingly including biosimilars, ensuring financial viability and broader usage.
• Regulatory Facilitation: EMA’s established biosimilar pathways and guidance documents have created a stable regulatory environment that encourages innovation and swift product approval.

Emerging Business Opportunities

There is growing opportunity in the transition from originator biologics to biosimilars, particularly in long-term therapy areas. Switching programs are becoming more common as real-world evidence supports the efficacy and safety of biosimilars. This is especially impactful in chronic disease areas like diabetes, inflammatory disorders, and autoimmune diseases.

Additionally, the biosimilars market is poised for expansion beyond oncology. As acceptance of biosimilars grows in other therapeutic areas, companies can target a broader range of conditions, tapping into underserved segments and large patient populations.

The loss of exclusivity for 10 biological drugs by 2032 offers a potential opportunity worth nearly €30 billion, paving the way for biosimilars to capture greater market share in the coming years.

Regional Analysis

Germany remains the frontrunner in biosimilars adoption in Europe, driven by a forward-thinking regulatory environment and robust healthcare infrastructure. The country’s policy of automatic substitution and physician prescribing guidelines has positioned it as a biosimilars hub.

Other major markets including France, the U.K., Italy, and Spain are also encouraging biosimilar use through national health policies, although adoption rates vary. In certain countries, slower uptake is observed due to limited awareness, conservative medical practices, or minimal pricing differentiation.

Challenges to Growth

While the market outlook is positive, there are key restraints that could hinder growth:
• Patent and IP Litigation: Legal challenges from originator companies remain a significant barrier, often delaying biosimilar launches and adding substantial costs.
• Uneven Adoption Across Countries: Some European countries show lower adoption rates due to physician hesitancy, lack of awareness, or insufficient pricing incentives.
• Market Fragmentation: Differing healthcare systems and regulatory interpretations across EU member states lead to inconsistent biosimilar uptake.

Competitive Analysis

The European biosimilars space is becoming increasingly competitive, featuring a mix of global pharmaceutical firms and specialized biosimilar developers. Key players include:
• Fresenius Kabi
• Biogen Inc.
• Celltrion, Inc.
• Pfizer Inc.
• Amgen Inc.
• Samsung Bioepis Co., Ltd.
• Biocon
• Viatris (Mylan Pharmaceuticals Inc.)
• Coherus BioSciences, Inc.
• Boehringer Ingelheim Pharmaceuticals, Inc.
• Eli Lilly and Company
• Bio-Thera Solutions, Ltd.

These companies are focused on expanding their portfolios, investing in R&D, and forging strategic alliances to strengthen their positions in the biosimilars sector.

Notable Developments
• In July 2024, Apotex Inc. partnered with Coherus Biosciences to license toripalimab, marking Apotex’s entry into innovative biologics in oncology.
• The same month, EMA’s CHMP recommended approval for 14 new medicines, including several biosimilars such as Samsung Bioepis’s EKSUNBI, Formycon AG’s FYMSKINA, Fresenius Kabi’s OTULFI, and Prestige Biopharma’s TUZNUE.

These developments highlight the momentum biosimilars are gaining and the commitment of companies to expand their offerings.

Market Segmentation

By Drug
• Adalimumab
• Bevacizumab
• Trastuzumab
• Rituximab
• Infliximab
• Etanercept
• Epoetin alfa
• Filgrastim
• Other Biosimilars

By Drug Class
• Antirheumatics
• TNF Alfa Inhibitors
• VEGF/VEGFR Inhibitors
• HER2 Inhibitors
• Selective Immunosuppressants
• Interleukin Inhibitors

By Indication
• Oncology Diseases
• Autoimmune Diseases
• Skin Disorders
• Inflammatory Bowel Disease (IBD)
• Rare Diseases
• Others

By Distribution Channel
• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Region
• Germany
• France
• U.K.
• Italy
• Spain
• Russia
• Rest of Europe

Please note: Delivery Timelines - 5 working days.