Press release
Europe Biosimilars Market Set to Hit USD 33.5 Billion by 2031 - Persistence Market Research
Overview of the MarketBiosimilars are biologic products that are highly similar to already-approved originator biologics but are generally more affordable. The Europe biosimilars market is thriving due to the increasing adoption of these drugs, driven by rising healthcare costs and the expiring patents of several biologics. As healthcare providers, patients, and payers seek more cost-effective alternatives, biosimilars are becoming increasingly attractive. In 2024, the European biosimilars market size stands at $12.3 billion, and it is expected to grow significantly, reaching $33.5 billion by 2031.
The adoption of biosimilars has been particularly strong in oncology, where cancer treatments are often prohibitively expensive. However, biosimilars are also gaining ground in other therapeutic areas like immunology, autoimmune diseases, and diabetes. Germany stands out as the leading country in this market due to its proactive regulatory environment and strong healthcare system. The country's favorable stance on biosimilars, along with the German government's policies aimed at encouraging biosimilar adoption, positions it as a key growth region.
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Key Highlights from the Report:
• The Europe biosimilars market is projected to grow at a CAGR of 15.4% from 2024 to 2031.
• Rising patent expirations of biologics across multiple therapeutic areas are driving the biosimilars market.
• Oncology is the leading therapeutic area for biosimilars, with a projected CAGR of 13.7% through 2031.
• Hospital pharmacies are the leading distribution channel, projected to grow at a CAGR of 14.2%.
• Germany is expected to dominate the Europe biosimilars market with a CAGR of 15% due to its strong healthcare system and regulatory environment.
• The increasing adoption of biosimilars in chronic disease management is expanding the market.
Market Segmentation
The Europe biosimilars market is segmented based on product type, therapeutic indication, distribution channel, and geography. By product type, the market includes monoclonal antibodies, insulin, growth hormones, and other biosimilars. The monoclonal antibody segment is expected to continue its dominance due to its application in treating cancers and autoimmune diseases.
Therapeutically, oncology leads the market, with cancer treatment making up a significant portion of biosimilars sales. Other notable therapeutic areas include immunology, dermatology, and endocrinology, which are also witnessing increased adoption of biosimilars. Regarding distribution channels, hospital pharmacies are projected to lead, driven by their central role in administering complex treatments, including cancer therapies.
Regional Insights
Germany stands as the largest market for biosimilars in Europe, driven by a favorable regulatory environment and significant investments in the biosimilars sector. The country has implemented proactive measures to boost biosimilar adoption, such as the Act for Greater Safety in the Supply of Medicines, which mandates automatic substitution of biologics with biosimilars.
In addition to Germany, the United Kingdom and France also have robust biosimilars markets, supported by strong healthcare infrastructure and growing demand for affordable biologic therapies. In particular, the UK has established effective reimbursement policies for biosimilars, encouraging their widespread use.
Market Drivers
The biosimilars market in Europe is primarily driven by the need for cost-effective alternatives to expensive biologic therapies. As patents for blockbuster biologic drugs expire, biosimilars present an opportunity to reduce healthcare costs significantly. With the rising burden of chronic diseases and oncology conditions, healthcare systems are increasingly seeking ways to manage the economic impact of biologic treatments. Biosimilars offer a solution, providing the same clinical efficacy as branded biologics at a lower cost.
Another key driver is the growing acceptance of biosimilars among healthcare providers and patients. Supported by rigorous regulatory frameworks, including the European Medicines Agency (EMA), biosimilars are proving to be just as effective and safe as their reference biologics, driving their adoption across various therapeutic areas.
Market Restraints
Despite the positive outlook, the biosimilars market faces several challenges. Intellectual property (IP) issues and patent litigation are significant obstacles. Originator biologics often have complex patent portfolios, which can delay the entry of biosimilars into the market due to ongoing legal disputes. Additionally, the "evergreening" practices of patent holders, where new patents are filed for biologics to extend market exclusivity, can hinder biosimilar competition.
Slow adoption in some European countries also presents a challenge. While biosimilars are gaining traction in countries like Germany and the UK, other regions are slower to embrace these therapies. Conservative prescribing practices, lack of awareness, and concerns over the clinical efficacy of biosimilars contribute to this hesitancy.
Market Opportunities
The expansion of biosimilars into non-oncology therapeutic areas presents a significant opportunity for market growth. Although oncology is currently the leading area, there is increasing development of biosimilars for autoimmune diseases, diabetes, and inflammatory conditions. These therapeutic areas represent large patient populations where biologic treatments are often expensive, creating a high demand for affordable alternatives.
Additionally, biosimilar-reference biologic switching offers a unique opportunity for cost savings. As healthcare systems shift towards value-based care models, switching patients from originator biologics to biosimilars can provide long-term cost benefits. The regulatory support for such switching, along with increasing physician confidence in biosimilar efficacy, will drive broader adoption of biosimilars in Europe.
Reasons to Buy the Report
✔ Gain a comprehensive understanding of the market dynamics and growth trends in the Europe biosimilars market.
✔ Access detailed information about market segmentation and growth opportunities in various therapeutic areas.
✔ Understand the impact of regulatory frameworks and government policies on biosimilar adoption in Europe.
✔ Get insights into the competitive landscape and key players shaping the market.
✔ Forecast future market trends and estimate market size, growth rate, and potential risks.
Frequently Asked Questions (FAQs)
1. How Big is the Europe Biosimilars Market?
2. Who are the Key Players in the Europe Biosimilars Market?
3. What is the Projected Growth Rate of the Europe Biosimilars Market?
4. What is the Market Forecast for Europe Biosimilars by 2031?
5. Which Region is Estimated to Dominate the Europe Biosimilars Market through 2031?
Company Insights
Several key players are currently dominating the Europe biosimilars market. These companies include:
• Sandoz (Novartis)
• Amgen Inc.
• Samsung Biologics
• Biogen
• Celltrion, Inc.
• Pfizer Inc.
• Biocon
• Viatris (Mylan Pharmaceuticals Inc.)
• Coherus BioSciences, Inc.
• Boehringer Ingelheim Pharmaceuticals, Inc.
Recent Developments
1. July 2024: Apotex Inc. entered into an exclusive agreement with Coherus Biosciences to license toripalimab, marking a significant step into the oncology biosimilars market.
2. July 2024: The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended 14 biosimilars for marketing approval, which includes products from companies like Samsung Bioepis, Formycon AG, and Fresenius Kabi.
Conclusion
The Europe biosimilars market is on a strong growth trajectory, driven by the need for affordable biologic alternatives, regulatory support, and the expiration of key biologic patents. With increasing adoption in oncology and beyond, biosimilars are set to transform the healthcare landscape in Europe. The market offers substantial growth potential, but challenges such as intellectual property disputes and slow adoption in some regions must be addressed. As the market continues to evolve, opportunities in non-oncology therapeutic areas and switching programs will be critical in sustaining growth.
About Persistence Market Research:
At Persistence Market Research, we specialize in creating research studies that serve as strategic tools for driving business growth. Established as a proprietary firm in 2012, we have evolved into a registered company in England and Wales in 2023 under the name Persistence Research & Consultancy Services Ltd. With a solid foundation, we have completed over 3600 custom and syndicate market research projects, and delivered more than 2700 projects for other leading market research companies' clients.
Our approach combines traditional market research methods with modern tools to offer comprehensive research solutions. With a decade of experience, we pride ourselves on deriving actionable insights from data to help businesses stay ahead of the competition. Our client base spans multinational corporations, leading consulting firms, investment funds, and government departments. A significant portion of our sales comes from repeat clients, a testament to the value and trust we've built over the years.
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