Europe Biosimilar Market: Growth Forecast, Trends, and Competitive Landscape (2025-2034)

The Europe biosimilar market is witnessing robust growth, driven by increased adoption of biosimilar therapies across a wide range of chronic diseases, rising healthcare expenditures, and the expiration of biologic drug patents. In 2024, the market achieved a valuation of USD 10.13 Billion and is expected to reach USD 33.78 Billion by 2034, growing at a CAGR of 12.80% during the forecast period.

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This article explores the size, share, key trends, growth drivers, opportunities, and challenges shaping the biosimilar landscape in Europe, along with insights into the competitive environment and frequently asked questions.

Europe Biosimilar Market Overview

Biosimilars are biologic medical products that are highly similar to approved reference biologics in terms of safety, purity, and efficacy. They are not generics but are developed using living organisms and must undergo rigorous comparative studies before gaining regulatory approval.

In Europe, biosimilars have gained wide acceptance due to their cost-effectiveness, clinical reliability, and strategic importance in reducing the financial burden of expensive biologic therapies. The region was the first to create a robust regulatory pathway for biosimilars (via the EMA), which has helped foster an established and mature biosimilar ecosystem.

Biosimilars are now widely used in managing chronic diseases such as:

Rheumatoid arthritis

Cancer

Inflammatory bowel disease (IBD)

Psoriasis

Diabetes

Chronic kidney disease

Europe Biosimilar Market Size and Share

The Europe biosimilar market reached a value of USD 10.13 Billion in 2024, making it one of the largest biosimilar markets globally. With the growing demand for cost-effective biologics and increased physician and patient confidence, the market is set to witness rapid expansion.

Forecast Period: 2025 to 2034

CAGR: 12.80%

Forecasted Market Size by 2034: USD 33.78 Billion

Regional Share Highlights:

Germany and the United Kingdom are among the top adopters due to strong regulatory compliance and national cost-containment initiatives.

France, Italy, and Spain are also contributing significantly to market expansion through active biosimilar switching policies and healthcare reforms.

Eastern Europe presents a rising opportunity for biosimilar adoption due to lower access to original biologics and high demand for affordable therapies.

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Market Dynamics and Emerging Trends

Patent Expirations of Biologic Drugs

One of the primary drivers of the European biosimilar market is the expiry of patents and exclusivity rights of blockbuster biologics such as:

Humira (adalimumab)

Herceptin (trastuzumab)

Enbrel (etanercept)

Avastin (bevacizumab)

Remicade (infliximab)

As originator drugs lose exclusivity, biosimilar manufacturers gain the opportunity to enter the market with more affordable alternatives.

Increasing Burden of Chronic Diseases

Europe is experiencing a surge in chronic illnesses such as cancer, autoimmune disorders, and diabetes. Biosimilars offer a more economical option for long-term treatment, making them highly attractive for national health systems.

Growing Physician and Patient Acceptance

The increasing availability of real-world evidence supporting biosimilar efficacy and safety is improving acceptance among healthcare professionals and patients. Educational campaigns and transparent substitution guidelines are also playing a role.

National Tendering and Pricing Policies

Several European countries have adopted competitive tendering and reference pricing models, driving the widespread adoption of biosimilars and fostering market competition.

Technological Advancements in Biologic Manufacturing

Improved cell-line engineering, upstream processing, and analytical techniques have enhanced biosimilar development efficiency and quality, encouraging more players to enter the market.

Market Growth and Contributing Factors

Cost Savings and Economic Incentives

Biosimilars are typically priced 20-40% lower than their reference biologics, generating significant savings for national healthcare systems. This cost-effectiveness is a major growth enabler, especially in publicly funded healthcare markets like the EU.

Policy Support from the European Medicines Agency (EMA)

The EMA has implemented standardized regulatory pathways for biosimilars since 2005, offering clear guidance for approval and fostering manufacturer confidence. This early leadership has helped Europe become a global pioneer in biosimilar adoption.

Increasing Clinical Trials and R&D Investments

Leading pharmaceutical companies and contract research organizations (CROs) are conducting head-to-head biosimilar trials across Europe, accelerating product development and regulatory submission.

Rise in Hospital and Pharmacy Substitution

With increasing substitution rights granted to hospital pharmacists and dispensers, biosimilars are replacing originator products in treatment protocols across multiple therapeutic areas.

Opportunities and Challenges in the Europe Biosimilar Market

Opportunities

Expansion into New Therapeutic Areas: The next wave of biosimilars will target diseases like asthma, osteoporosis, and ophthalmology, opening new markets.

Emerging Biosimilars for Insulin and Hormones: Demand for affordable insulin analogs and hormonal therapies is creating new opportunities.

Increased Uptake in Central and Eastern Europe: These regions present growth opportunities due to improving regulatory alignment and rising public health investments.

Partnerships and Licensing Deals: Collaborations between global biopharma firms and regional players can fast-track commercialization and localization efforts.

Challenges

Complex Manufacturing Processes: Unlike generics, biosimilars require highly sophisticated processes and stringent quality controls, raising entry barriers.

Physician Resistance in Some Regions: Although acceptance is improving, skepticism remains among a small segment of physicians, especially concerning switching stable patients.

Price Wars and Profitability Concerns: Intense pricing competition due to tendering may impact long-term profitability for manufacturers.

Patent Litigation and Legal Delays: Patent disputes with originator companies can delay biosimilar launch timelines.

Recent Developments in the Europe Biosimilar Market

Amgen launched Amgevita®, the biosimilar to Humira, across several European countries post-patent expiry of adalimumab.

Pfizer expanded its biosimilar portfolio in Europe with Zirabev® (biosimilar to Avastin) and Trazimera® (biosimilar to Herceptin).

Samsung Bioepis, in collaboration with Biogen, received EMA approval for Imraldi, Ontruzant, and Flixabi, strengthening its footprint in oncology and immunology biosimilars.

Celltrion has successfully rolled out Truxima (rituximab biosimilar) and Remsima across European markets, showing strong uptake in rheumatology.

Novartis (Sandoz) is investing in new manufacturing facilities in Austria and Slovenia to support European biosimilar production.

Dr. Reddy's Laboratories expanded its European reach through strategic licensing and partnerships with regional distributors.

Competitive Landscape: Key Players in the Europe Biosimilar Market

The biosimilar market in Europe is moderately consolidated, with global biopharmaceutical companies competing alongside local and regional manufacturers. These firms are focusing on pricing strategies, partnerships, and pipeline expansion to secure market share.

Pfizer, Inc.

Pfizer is one of the leading biosimilar manufacturers in Europe, offering a wide range of oncology and immunology biosimilars such as Zirabev, Trazimera, and Ruxience. It continues to invest in EU expansion and real-world data collection.

Celltrion Inc.

Based in South Korea, Celltrion has made significant inroads in the European market with biosimilars like Remsima (infliximab) and Truxima (rituximab). The company plans to launch subcutaneous biosimilars to enhance patient convenience.

Novartis AG

Through its Sandoz division, Novartis is one of the oldest players in the European biosimilar industry, offering multiple EMA-approved biosimilars and investing in manufacturing capabilities across Europe.

Amgen Inc.

Amgen's biosimilar portfolio includes key products such as Amgevita (adalimumab) and Mvasi (bevacizumab). The company is focusing on strategic launches and educational programs to support biosimilar uptake.

Eli Lilly and Company

Lilly is entering the biosimilar space through partnerships and pipeline development in immunology and endocrinology, aiming to expand its biosimilar presence across Europe.

Samsung Bioepis

Samsung Bioepis, a joint venture with Biogen, has launched several biosimilars in Europe, particularly in oncology and immunology, and is known for aggressive pricing and high-quality standards.

Sanofi SA

Sanofi is leveraging its expertise in biologics and strong European base to expand into biosimilars, especially in the insulin and oncology segments.

Dr. Reddy's Laboratories Ltd.

An Indian pharma giant, Dr. Reddy's is increasing its European biosimilar presence through collaborations, especially in oncology and nephrology biosimilars.

Boehringer Ingelheim

Boehringer developed Cyltezo, a biosimilar to Humira, and is investing in interchangeable biosimilar status in Europe to drive substitution and uptake.

Europe Biosimilar Market Segmentation

By Product

Monoclonal Antibodies (mAbs)

Insulin

Erythropoietin

Filgrastim and Pegfilgrastim

Human Growth Hormone

Others

By Application

Oncology

Autoimmune Diseases

Diabetes

Nephrology

Infectious Diseases

Others

By End User

Hospitals

Clinics

Retail Pharmacies

Academic and Research Institutes

By Country

Germany

France

United Kingdom

Italy

Spain

Rest of Europe

Europe Biosimilar Market FAQs

What is the current size of the Europe biosimilar market?
As of 2024, the Europe biosimilar market was valued at USD 10.13 Billion.

What is the forecasted size of the market by 2034?
The market is projected to reach USD 33.78 Billion by 2034, growing at a CAGR of 12.80%.

Which countries dominate the European biosimilar market?
Germany, the United Kingdom, and France are leading contributors to biosimilar adoption in Europe.

Which therapeutic areas are driving biosimilar demand?
Key therapeutic areas include oncology, autoimmune diseases, diabetes, and nephrology.

What are the top companies in the European biosimilar market?
Major players include Pfizer, Celltrion, Novartis (Sandoz), Amgen, Samsung Bioepis, and Sanofi.

Why is Europe leading in biosimilar adoption?
Europe has a well-established regulatory framework, strong healthcare systems, and policies supporting biosimilar substitution and price competition.

What are the biggest challenges in the biosimilar space?
Challenges include manufacturing complexity, physician resistance, legal disputes, and pricing pressure.

The Europe biosimilar market is positioned for strong, sustained growth over the next decade. Driven by cost savings, regulatory support, and increasing healthcare demand, biosimilars are becoming mainstream in chronic disease management across Europe.

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