Europe Biosimilars Market Development, Leading Players and Forecast | Persistence Market Research

The Europe biosimilars market is poised for substantial growth, with Persistence Market Research projecting a compound annual growth rate (CAGR) of 15.4% from 2024 to 2031. Valued at US$ 12.3 billion in 2024, the market is forecast to reach an impressive US$ 33.5 billion by 2031. This growth trajectory is underpinned by the expiration of patents for major biologics, increasing acceptance of biosimilars by healthcare professionals, and the push towards value-based healthcare models.

A key growth catalyst is the rising prevalence of chronic diseases like cancer, autoimmune disorders, and diabetes, which require long-term treatment with biologics. As a cost-effective alternative, biosimilars are seeing increased adoption, especially in oncology, which leads the market in terms of therapeutic application. Germany dominates the regional landscape, largely due to its robust regulatory framework, high healthcare spending, and early embrace of biosimilar substitution policies.

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Key Highlights from the Report

• Europe biosimilars market to grow at a CAGR of 15.4% between 2024 and 2031.
• Oncology remains the top therapeutic segment, expected to grow at a CAGR of 13.7%.
• Hospital pharmacies are the dominant distribution channel, with a CAGR projection of 14.2%.
• Germany leads the regional market with a 15% CAGR, driven by strong regulatory support.
• Patent expirations of high-cost biologics continue to open market opportunities for biosimilars.
• Digital transformation by biosimilar manufacturers is expanding consumer reach and access.

Market Segmentation

The Europe biosimilars market is segmented by product type, therapeutic application, and distribution channel. Among therapeutic applications, oncology dominates, driven by the high cost of cancer treatments and the availability of biosimilar alternatives for drugs like trastuzumab and rituximab. Non-oncology areas such as immunology, endocrinology, and rheumatology are also witnessing increased biosimilar adoption, propelled by chronic disease burden and improved physician awareness.

In terms of distribution channels, hospital pharmacies are leading due to their centralized role in administering complex biologic treatments. Their prominence is expected to continue, as they offer a structured environment for biosimilar use and ensure proper storage and administration. Meanwhile, retail pharmacies and online distribution platforms are beginning to play a growing role, especially with the increasing digitalization of pharmaceutical supply chains.

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Regional Insights

Germany stands as the powerhouse of the Europe biosimilars market, backed by a well-structured reimbursement model and early implementation of biosimilar substitution laws. The 2019 GSAV law allowing automatic substitution of biologics has significantly enhanced biosimilar uptake across hospitals and pharmacies.

In contrast, Southern and Eastern European countries are experiencing a slower rate of biosimilar adoption. Factors such as limited awareness among healthcare professionals, lack of regulatory incentives, and minimal price differentiation between biosimilars and originator biologics contribute to this discrepancy.

Market Drivers
1. Increasing Reimbursement Support and Pricing Flexibility

European governments have recognized the economic advantage of biosimilars, resulting in wider reimbursement coverage and pricing models that promote their use. Public health systems now incentivize physicians to prescribe biosimilars through cost-sharing programs, making these drugs more accessible to a broader patient population. These financial enablers have not only spurred market growth but also made treatments more affordable.

2. Regulatory Backing from EMA and National Bodies

The European Medicines Agency (EMA) has been instrumental in setting clear and efficient pathways for biosimilar approvals. With over 100 biosimilars approved by 2024, the EMA ensures stringent quality, efficacy, and safety benchmarks. National governments, like those in Germany and the UK, have aligned policies to further support biosimilar adoption, including educational programs and prescribing guidelines for healthcare professionals.

3. Cost Pressure on Healthcare Systems

The rising cost of healthcare across Europe is pushing stakeholders to explore more sustainable alternatives. Biosimilars offer significant cost savings-studies indicate that biosimilars have helped save over €50 billion across Europe since 2006, with €10 billion saved in 2023 alone. This economic benefit is a powerful driver encouraging hospitals, payers, and clinicians to transition toward biosimilar-based treatments.

Market Restraints
1. Patent Litigation and Intellectual Property Challenges

The biosimilars market faces significant delays due to complex patent landscapes of originator biologics. Evergreening strategies-where biologic manufacturers extend their market exclusivity by securing new patents-stall the entry of biosimilars. Legal battles not only drain financial resources but also create uncertainty that can deter investments in biosimilar development.

2. Low Adoption in Certain European Regions

Adoption remains uneven across Europe. Countries in Eastern and Southern Europe often lag behind due to conservative prescribing habits, insufficient incentives, and minimal educational outreach to clinicians. In some markets, the cost differential between biosimilars and branded biologics is too small to justify switching, dampening enthusiasm for adoption.

3. Hesitation Among Healthcare Professionals

Despite regulatory endorsements, some healthcare providers remain skeptical about the interchangeability and therapeutic equivalence of biosimilars. This hesitance, rooted in limited experience and educational gaps, can slow down the transition from branded biologics to biosimilar alternatives, particularly in high-risk therapeutic areas like oncology.

Market Opportunities
1. Switching Programs and Interchangeability

There is a significant opportunity in switching patients from originator biologics to biosimilars, especially in chronic care settings. As regulatory bodies begin to endorse interchangeability, healthcare systems can implement switching programs that facilitate smoother transitions. With an estimated €30 billion opportunity opening from 2030 to 2032 due to patent expirations, the potential for biosimilar adoption through switching is immense.

2. Expansion into Non-Oncology Therapeutic Segments

While oncology leads in biosimilar uptake, other segments like autoimmune diseases, diabetes, and nephrology are showing strong growth potential. These areas represent large patient bases with continuous treatment needs, making cost-effective options highly desirable. Continued research, clinical trials, and regulatory approvals in these areas are expected to diversify the biosimilar portfolio.

3. Digital Transformation and Strategic Partnerships

Biosimilar manufacturers are increasingly leveraging digital platforms to reach wider audiences and streamline supply chains. Digital marketing, e-detailing for physicians, and e-commerce channels for hospitals are becoming integral to distribution strategies. Strategic partnerships, like the Apotex-Coherus agreement for oncology biologics in Canada, are likely to expand in Europe, enhancing product pipelines and regional presence.

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Reasons to Buy the Report

• In-depth market analysis with 2024-2031 forecasts, covering market size, growth drivers, and trends.
• Detailed segmentation insights by product type, therapeutic application, and distribution channel.
• Comprehensive regional analysis highlighting leading and lagging European markets.
• Profiles of top companies along with recent strategic developments and partnerships.
• Evaluation of market risks, challenges, and opportunities to inform strategic planning.

Frequently Asked Questions (FAQs)

• How Big is the Europe Biosimilars Market in 2024?
• What is the Projected Growth Rate of the Europe Biosimilars Market?
• Who are the Key Players in the Global Market for Biosimilars?
• What is the Market Forecast for Europe Biosimilars through 2031?
• Which Region is Estimated to Dominate the Industry through the Forecast Period?

Company Insights

The competitive landscape in the Europe biosimilars market is marked by the presence of several prominent players competing on innovation, pricing, and regional expansion strategies. These companies include:

• Sandoz AG
• Biogen Inc.
• Amgen Inc.
• Samsung Bioepis Co., Ltd.
• Celltrion, Inc.
• Pfizer Inc.
• Fresenius Kabi
• Viatris (Mylan Pharmaceuticals Inc.)
• Coherus BioSciences, Inc.
• Eli Lilly and Company
• Bio-Thera Solutions, Ltd.
• Biocon

Recent Developments

• In July 2024, Apotex Inc. partnered with Coherus Biosciences to distribute toripalimab in Canada upon regulatory approval-marking its entry into oncology biologics.
• Also in July 2024, the CHMP of the EMA recommended 14 biosimilars for marketing authorization, including products from Samsung Bioepis, Fresenius Kabi, and Formycon AG.

The Europe biosimilars market is set to play a transformative role in reshaping healthcare economics and improving patient access to high-quality treatments. With strong regulatory frameworks, a maturing competitive landscape, and growing trust among healthcare providers, biosimilars are becoming a central pillar in Europe's biopharmaceutical industry.

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