Europe Biosimilars Market: Size, Trend and Forecast (2025-2034)

Market Overview

The Europe biosimilars market has been expanding rapidly due to the growing demand for affordable alternatives to expensive biologic drugs. Biosimilars, which are biologic medical products highly similar to approved reference products, are used for the treatment of various chronic conditions. These conditions, including autoimmune diseases, diabetes, and oncology, require long-term management and often involve high costs for treatment. The increasing application of biosimilars in managing these conditions has significantly contributed to the growth of the market in Europe. With the increasing adoption of biosimilars by healthcare systems across Europe, the biosimilars market is poised to expand even further in the coming years.

Market Size and Share

The European biosimilars market was valued at USD 10.13 billion in 2024. This significant value is attributed to the growing recognition of biosimilars as cost-effective treatment options for patients suffering from chronic conditions, as well as the increasing pressure on healthcare systems to provide affordable alternatives to expensive biologic therapies. The market is expected to grow at a compound annual growth rate (CAGR) of 12.80% from 2025 to 2034, reaching an estimated USD 33.78 billion by 2034. This growth is fueled by factors such as the expiration of patents for key biologics, the increasing number of approved biosimilars, and the growing adoption of these products in European healthcare systems.

Market Trends

Expansion in Chronic Disease Management The increasing application of biosimilars for managing chronic diseases is one of the primary trends driving the market. Conditions such as rheumatoid arthritis, Crohn’s disease, and cancer often require biologic therapies, which are expensive. Biosimilars offer a more affordable alternative, increasing their adoption across Europe. The growing prevalence of chronic diseases and the need for long-term treatment options is fueling the market growth.
Regulatory Advancements and Approvals Europe has been a global leader in the approval and regulation of biosimilars. Regulatory bodies such as the European Medicines Agency (EMA) have streamlined the approval process for biosimilars, ensuring their safety and efficacy. This has accelerated the entry of new biosimilars into the European market, making them more accessible to patients. As regulatory processes continue to evolve, more biosimilars are expected to be approved in the coming years.
Cost Savings for Healthcare Systems The increasing pressure on healthcare systems to reduce costs has led to a growing focus on biosimilars as a cost-effective solution. By offering similar therapeutic benefits to their reference biologics at a fraction of the cost, biosimilars help reduce the financial burden on healthcare systems. This trend is expected to continue as European governments and healthcare providers look for ways to optimize healthcare spending without compromising patient care.
Focus on High-Value Therapeutic Areas Biosimilars are increasingly being developed for high-value therapeutic areas such as oncology, autoimmune diseases, and diabetes. These therapeutic areas account for a significant portion of healthcare costs in Europe. The focus on these areas is expected to drive market growth as more biosimilars targeting these conditions are introduced to the market. Additionally, as more biosimilars become available, their uptake in these critical areas is likely to increase.

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Market Analysis

Molecule Segmentation The biosimilars market in Europe is segmented by the type of molecules. Major molecules in the market include Infliximab, Insulin Glargine, Epoetin Alfa, Etanercept, Filgrastim, Somatropin, Rituximab, and Follitropin Alfa. Infliximab and insulin glargine are among the most widely used biosimilars due to their importance in managing autoimmune diseases and diabetes. The demand for these biosimilars is expected to grow as the prevalence of these conditions increases across Europe.
Manufacturing Type The market is also segmented by manufacturing type, with in-house manufacturing and contract manufacturing being the two key categories. In-house manufacturing refers to biosimilars produced by the same company that holds the patent for the original biologic. Contract manufacturing involves outsourcing the production of biosimilars to third-party manufacturers. As the biosimilars market expands, the demand for contract manufacturing services is also expected to increase, as more companies enter the biosimilars production space.
Indication Segmentation Biosimilars in Europe are used to treat a variety of indications, including autoimmune diseases, blood disorders, diabetes, oncology, growth deficiency, and female infertility. Autoimmune diseases such as rheumatoid arthritis and Crohn’s disease represent a major indication area for biosimilars, as biologic therapies are widely used to treat these conditions. The oncology and diabetes sectors are also seeing an increase in the use of biosimilars, as these diseases have a significant treatment burden and cost.
Regional Insights The European biosimilars market is geographically diversified, with major contributions from the United Kingdom, Germany, France, and Italy. The United Kingdom is a key market due to its advanced healthcare infrastructure and strong focus on cost-effective treatment options. Germany, with its well-established healthcare system, is another significant contributor. France and Italy also represent important markets, with growing healthcare expenditures and an increasing focus on affordable biologic therapies.

Scope of the Report

This report provides a comprehensive analysis of the European biosimilars market, including historical and forecast trends, market segmentation, and an analysis of key industry drivers and constraints. It also covers the market by molecule type, manufacturing type, indication, and region. The report highlights the potential for market growth across different therapeutic areas and discusses key factors influencing the market, including regulatory developments, market trends, and the competitive landscape.

Market Growth

The growth of the European biosimilars market is primarily driven by the increasing prevalence of chronic diseases and the demand for cost-effective alternatives to expensive biologic therapies. The expiration of patents for key biologic drugs, combined with the growing approval of new biosimilars, has created an opportunity for biosimilars to capture a larger share of the market. Additionally, regulatory support and cost-saving measures by healthcare systems are expected to further boost market expansion.

Recent Developments & Challenges

Regulatory Support for Biosimilars Regulatory bodies in Europe, including the EMA, have provided significant support for biosimilars through streamlined approval processes. This has helped accelerate the availability of biosimilars to patients and fostered greater competition in the market. However, challenges remain in ensuring the affordability and accessibility of these treatments for all patients across Europe.
Increasing Investment in Biosimilars Development Pharmaceutical companies are increasingly investing in the development of biosimilars, focusing on high-value therapeutic areas like oncology and autoimmune diseases. This investment is expected to result in more biosimilars entering the market, driving competition and further reducing healthcare costs.
Challenges in Market Penetration While the adoption of biosimilars is growing, there are still challenges related to physician and patient acceptance. Many patients and healthcare providers remain hesitant to switch from branded biologics to biosimilars. Overcoming these barriers through education and evidence of safety and efficacy will be critical to driving further market growth.
Pricing Pressures Biosimilars are generally more affordable than their reference biologics, but the market faces ongoing pressure to further reduce costs. Governments and healthcare providers are pushing for even lower prices to ensure affordability, which may affect the profitability of biosimilar manufacturers.

Key Players

Pfizer, Inc. Pfizer is one of the largest pharmaceutical companies in the world and a significant player in the biosimilars market. The company’s biosimilar portfolio includes products like Inflectra (Infliximab) and Retacrit (Epoetin Alfa), which are used to treat a variety of chronic conditions. Pfizer’s continued investment in the development of new biosimilars positions it as a leading force in the European market.

Celltrion Inc. Celltrion is a South Korean biopharmaceutical company that has made significant strides in the biosimilars market. The company’s biosimilar products include Remsima (Infliximab) and Truxima (Rituximab), which are widely used in the treatment of autoimmune diseases and cancers. Celltrion’s focus on biosimilars has made it one of the top players in the European biosimilars market.

Novartis AG Novartis, a global healthcare company, is a prominent player in the biosimilars market through its Sandoz division. Sandoz has a strong portfolio of biosimilars, including Zarxio (Filgrastim) and Erelzi (Etanercept). With its broad expertise in the pharmaceutical industry, Novartis continues to expand its biosimilar offerings across Europe.

Amgen Inc. Amgen is one of the leading innovators in the biopharmaceutical sector and has entered the biosimilars market with several key products. The company’s biosimilars portfolio includes Kanjinti (Trastuzumab) and Mvasi (Bevacizumab), which are used in oncology. Amgen’s strong presence in the European market is expected to grow as more biosimilars are introduced.

Other Companies Other key players in the European biosimilars market include Eli Lilly and Company, Samsung Bioepis, Sanofi SA, Dr. Reddy’s Laboratories Ltd., and Boehringer Ingelheim. These companies are contributing to the growth and expansion of the biosimilars sector by developing new products and expanding their portfolios.

FAQs

What are biosimilars? Biosimilars are biologic medical products that are highly similar to approved reference biologics, with no clinically meaningful differences in terms of safety, purity, and potency.
Why are biosimilars important? Biosimilars provide a more affordable alternative to expensive biologic therapies, making treatments accessible to a larger patient population and reducing the financial burden on healthcare systems.
What therapeutic areas are driving the growth of biosimilars? The growth of the biosimilars market is driven by their use in treating chronic diseases such as autoimmune disorders, diabetes, oncology, and blood disorders.
Which companies are leading the European biosimilars market? Leading companies in the European biosimilars market include Pfizer, Celltrion, Novartis, Amgen, and Eli Lilly, among others. These companies have established a strong presence with a diverse range of biosimilars.
What are the challenges in the biosimilars market? Challenges include regulatory hurdles, physician and patient acceptance, pricing pressures, and competition among biosimilar manufacturers. However, as biosimilars gain market acceptance, these challenges are expected to be addressed over time.

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