Europe Biosimilars Market Analysis, Growth Trends, and Forecasts 2025-2032: Streamlined Approvals and Value-Based Care Drive Surge in Demand, EMA-Backed Innovation and Policy Reform Fuel Expansion

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.


Dublin, May 14, 2025 (GLOBE NEWSWIRE) -- The "Europe Biosimilars Market - Industry Analysis, Size, Share, Growth, Trends, and Forecast 2032 - By Product, Technology, Grade, Application, End-user, Region: (Europe)" report has been added to ResearchAndMarkets.com's offering.

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%

The competitive Analysis is becoming increasingly dynamic with the involvement of major pharmaceutical companies and specialized biosimilar developers. 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.

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.

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.

Market Overview

  • Market Definitions and Segmentations
  • Market Dynamics
  • Drivers
  • Restraints
  • Market Opportunities
  • Value Chain Analysis
  • Porter's Five Forces Analysis
  • COVID-19 Impact Analysis
  • Supply
  • Demand
  • Impact of Ukraine-Russia Conflict
  • Economic Overview
  • World Economic Projections
  • PESTLE Analysis

Key Players

  • 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.

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

For more information about this report visit https://www.researchandmarkets.com/r/8f4avg

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