The Europe biosimilars market is poised for substantial growth, driven by increasing demand for cost-effective therapeutic solutions, robust regulatory frameworks, and expanding awareness among healthcare providers and patients. With a growing shift toward value-based healthcare models and heightened pressure on healthcare budgets, biosimilars are becoming a pivotal component in the region’s therapeutic Analysis. The Europe biosimilars market is projected to grow from US$ 15.32 Bn in 2025 to US$ 43.4 Bn by 2032, reflecting a CAGR of 16.03% over the forecast period.
The growing demand for biosimilar drugs is reshaping healthcare delivery across Europe. Biosimilars are being widely adopted for their ability to offer high-quality, affordable alternatives to expensive biologics, especially in chronic and life-threatening disease treatments such as oncology, rheumatology, and immunology.
A cumulative savings of over €50 billion has been achieved in Europe since the introduction of biosimilars, with significant savings realized in 2023 alone. This demonstrates their growing role in ensuring sustainability in national healthcare systems.
Cost containment is a top priority for many European nations, and biosimilars play a critical role in achieving this goal. Governments and healthcare institutions are promoting biosimilars through price incentives, reimbursement policies, and prescription quotas to encourage their adoption.
Wider reimbursement coverage and pricing approvals across Europe also contribute to market expansion. National healthcare systems are increasingly including biosimilars in public programs, improving affordability and accessibility.
Additionally, the expansion of biosimilars into non-oncology therapeutic areas such as autoimmune diseases, diabetes, and inflammatory disorders is expected to drive further market growth. These segments present vast patient populations in need of long-term treatment, making affordability a key concern that biosimilars can address.
With an estimated loss of exclusivity for approximately 10 biological medicines between 2030 and 2032, worth nearly €30 billion, manufacturers have a golden opportunity to capitalize on these gaps by introducing new biosimilars.
France, the U.K., Italy, and Spain also play significant roles in shaping the regional biosimilars market, with government initiatives aimed at promoting biosimilar usage. However, some countries continue to show slower adoption due to conservative prescribing habits, limited awareness, and inconsistent pricing policies.
Additionally, adoption rates remain inconsistent across European countries due to cultural, regulatory, and educational barriers. Physicians in certain regions remain hesitant to prescribe biosimilars despite comparable safety and efficacy, often due to lack of familiarity or minimal pricing differences.
Also in July 2024, the Committee for Medicine Products for Human Use (CHMP) of the EMA recommended approval for 14 new medicines. Among these were several biosimilars including Samsung Bioepis’s EKSUNBI, Formycon AG’s FYMSKINA, Fresenius Kabi’s OTULFI, and Prestige Biopharma’s TUZNUE.
This product will be delivered within 1-3 business days.
Market Insights
Europe’s biosimilars market is evolving rapidly, supported by favorable policies and a proactive stance on pharmaceutical innovation. Regulatory bodies such as the European Medicines Agency (EMA) have streamlined approval processes for biosimilars, enabling faster market entry while maintaining strict standards for safety, efficacy, and quality.The growing demand for biosimilar drugs is reshaping healthcare delivery across Europe. Biosimilars are being widely adopted for their ability to offer high-quality, affordable alternatives to expensive biologics, especially in chronic and life-threatening disease treatments such as oncology, rheumatology, and immunology.
A cumulative savings of over €50 billion has been achieved in Europe since the introduction of biosimilars, with significant savings realized in 2023 alone. This demonstrates their growing role in ensuring sustainability in national healthcare systems.
Market Drivers
One of the primary growth drivers is the increasing number of patent expiries of originator biologics. The expiration of exclusivity rights opens the market to biosimilars, which can then be introduced at more affordable prices, leading to higher uptake among healthcare providers and patients.Cost containment is a top priority for many European nations, and biosimilars play a critical role in achieving this goal. Governments and healthcare institutions are promoting biosimilars through price incentives, reimbursement policies, and prescription quotas to encourage their adoption.
Wider reimbursement coverage and pricing approvals across Europe also contribute to market expansion. National healthcare systems are increasingly including biosimilars in public programs, improving affordability and accessibility.
Business Opportunities
The Europe biosimilars market presents strong opportunities for manufacturers in multiple therapeutic areas. A particularly promising avenue is the switch from reference biologics to biosimilars. As physician confidence grows and real-world data continues to support biosimilar efficacy, switching programs are gaining traction, helping to reduce healthcare costs significantly.Additionally, the expansion of biosimilars into non-oncology therapeutic areas such as autoimmune diseases, diabetes, and inflammatory disorders is expected to drive further market growth. These segments present vast patient populations in need of long-term treatment, making affordability a key concern that biosimilars can address.
With an estimated loss of exclusivity for approximately 10 biological medicines between 2030 and 2032, worth nearly €30 billion, manufacturers have a golden opportunity to capitalize on these gaps by introducing new biosimilars.
Regional Analysis
Germany is positioned at the forefront of the Europe biosimilars market, with a proactive regulatory environment and a well-developed reimbursement framework. The implementation of automatic substitution laws and physician prescribing guidance has supported biosimilar uptake across therapeutic categories including oncology, immunology, and rheumatology.France, the U.K., Italy, and Spain also play significant roles in shaping the regional biosimilars market, with government initiatives aimed at promoting biosimilar usage. However, some countries continue to show slower adoption due to conservative prescribing habits, limited awareness, and inconsistent pricing policies.
Challenges and Restraints
Despite the strong market momentum, certain challenges persist. Intellectual property and patent litigation continue to delay market entry for many biosimilars. Complex patent portfolios and "evergreening" strategies by originator companies often lead to legal battles that deter smaller biosimilar manufacturers.Additionally, adoption rates remain inconsistent across European countries due to cultural, regulatory, and educational barriers. Physicians in certain regions remain hesitant to prescribe biosimilars despite comparable safety and efficacy, often due to lack of familiarity or minimal pricing differences.
Key Players
The competitive Analysis is becoming increasingly dynamic with the involvement of major pharmaceutical companies and specialized biosimilar developers. Prominent players in the Europe biosimilars market 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.
Recent Developments
In July 2024, Apotex Inc. entered into an agreement with Coherus Biosciences to license toripalimab for the Canadian market, marking a significant move in oncology biosimilars.Also in July 2024, the Committee for Medicine Products for Human Use (CHMP) of the EMA recommended approval for 14 new medicines. Among these were several biosimilars including Samsung Bioepis’s EKSUNBI, Formycon AG’s FYMSKINA, Fresenius Kabi’s OTULFI, and Prestige Biopharma’s TUZNUE.
Europe Biosimilars 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
This product will be delivered within 1-3 business days.
Table of Contents
1. Executive Summary
2. Market Overview
3. Europe Biosimilars Market Outlook, 2019-2032
4. Competitive Landscape
5. Appendix
Companies Mentioned
- 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.
Methodology
LOADING...
