Europe Biosimilars Market Forecasted for 15.4% CAGR Growth Through 2031: Persistence Market Research

The Europe biosimilars market is poised for robust growth, driven by the increasing adoption of biosimilars across various therapeutic areas, rising healthcare costs, and the expiration of biologic patents. With a projected Compound Annual Growth Rate (CAGR) of 15.4% from 2024 to 2031, the market is expected to expand from USD 12.3 billion in 2024 to USD 33.5 billion by 2031. This surge is fueled by the growing demand for affordable biologic alternatives and the positive regulatory environment in Europe, which is accelerating biosimilar approval processes and fostering market entry.

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Market Size and Trends Analysis

The European biosimilars market has witnessed significant growth in recent years and is set to continue this trend over the next decade. The increasing adoption of biosimilars, particularly in oncology, reflects broader efforts to control escalating healthcare costs while ensuring high-quality treatment options. Biologic drugs, which were once seen as cutting-edge treatments, are now becoming more accessible due to the introduction of biosimilars-nearly identical copies of these biologic drugs once their patents expire. The biosimilar market is transforming the healthcare landscape by offering the same efficacy and safety profiles at a fraction of the cost, thus enabling broader patient access.

The European market is benefiting from growing regulatory support, particularly from the European Medicines Agency (EMA), which has streamlined the approval process for biosimilars. The competition among biosimilar manufacturers is intensifying as new players enter the market, driving down prices and offering innovative treatment alternatives for a range of conditions such as cancer, autoimmune diseases, and chronic conditions like diabetes.

Key Industry Highlights

Patent Expiry of Biologics: With many blockbuster biologics nearing the end of their patent exclusivity, the demand for biosimilars has surged. This trend is particularly pronounced in oncology and immunology, where the biologics market is substantial, and the expiration of patents opens doors for affordable alternatives.

Rising Healthcare Costs: As healthcare systems across Europe strive to manage rising drug costs, biosimilars provide an effective solution. These drugs offer similar therapeutic outcomes to branded biologics at significantly reduced prices, making them a compelling choice for healthcare providers and patients alike.

Regulatory Support: The European Union (EU) has been instrumental in creating a conducive regulatory environment for biosimilars. The EMA's clear guidelines for biosimilar approval have made Europe one of the most active regions for biosimilar development, providing a level of regulatory certainty that is attractive to both investors and manufacturers.

Market Dynamics

Drivers

Cost-Effectiveness: The primary driver behind the growth of the biosimilars market is their affordability compared to originator biologics. Healthcare systems across Europe are under significant pressure to reduce expenditures, and biosimilars offer a way to cut costs without compromising on treatment quality.

Expiring Biologic Patents: As the patents for blockbuster biologics in areas like oncology, immunology, and diabetes expire, biosimilar manufacturers are able to introduce cheaper alternatives, capturing a share of the market.

Government Support and Reimbursement: Many European countries are actively promoting biosimilars through favorable reimbursement policies, which have encouraged the broader use of these drugs in healthcare systems.

Restraints

Intellectual Property (IP) Challenges: Patent litigation remains one of the key barriers to the widespread adoption of biosimilars. Some originator biologic manufacturers employ "evergreening" strategies to extend the life of their products through minor modifications and new patents, which can delay the market entry of biosimilars.

Slow Adoption in Certain Regions: While countries like Germany and the UK have rapidly embraced biosimilars, other European countries have been slower to adopt them. Factors such as physicians' concerns about switching from originator biologics and the lack of adequate pricing regulation can hinder growth in some markets.

Opportunities

Biosimilar Interchangeability: The approval of biosimilars as interchangeable with originator biologics in certain therapeutic areas presents a significant growth opportunity. Interchangeability could allow patients to switch to biosimilars without requiring a new prescription or additional medical evaluation.

Expansion into Non-Oncology Areas: While oncology remains the largest segment for biosimilars, there is significant potential for expansion into other therapeutic areas such as autoimmune diseases, diabetes, and chronic inflammatory conditions. These diseases present large patient populations and significant market opportunities for biosimilar developers.

Long-Term Cost Savings: With predictions that biosimilars will save over EUR 50 billion across Europe by 2030, these cost savings represent a compelling case for their adoption. Increased savings can be reinvested into healthcare systems to improve patient access to treatment.

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Category-Wise Analysis

Oncology Diseases

Oncology is the largest and fastest-growing therapeutic category for biosimilars in Europe. The increasing prevalence of cancer, combined with the high costs of biologic treatments, has made biosimilars a viable option for patients and healthcare providers alike. The oncology biosimilars segment is expected to grow at a CAGR of 13.7% through 2031, driven by the availability of affordable alternatives for biologic cancer treatments.

Distribution Channel - Hospital Pharmacies

The hospital pharmacies segment is another major driver of the biosimilars market in Europe. Hospital pharmacies are crucial in the administration of biosimilars, particularly in oncology. The segment is expected to witness a CAGR of 14.2% from 2024 to 2031, reflecting the growing role of hospital-based distribution in providing cost-effective biosimilars to patients.

Regional Insights

Germany is expected to dominate the European biosimilars market, with a projected CAGR of 15% through 2031. This is attributed to its progressive healthcare policies, including the automatic substitution of biologics with biosimilars in pharmacies. The country has a well-established reimbursement framework, which supports the widespread use of biosimilars. Other key markets in Europe include the UK, France, and Italy, where favorable policies are facilitating the adoption of biosimilars.

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Competitive Landscape

The competitive landscape for biosimilars in Europe is highly fragmented, with several established players competing alongside emerging companies. Key players in the market include:

Sandoz AG
Amgen Inc.
Biogen Inc.
Celltrion, Inc.
Samsung Bioepis Co. Ltd.
Pfizer Inc.

These companies are focusing on expanding their portfolios across a range of therapeutic areas, including oncology, immunology, and rheumatology. Research and development (R&D) remain crucial for market differentiation, with manufacturers increasingly investing in innovation to offer better and more effective biosimilars.

Recent Developments

In July 2024, the European Medicines Agency (EMA) recommended several new biosimilars for approval, including Samsung Bioepis's EKSUNBI (ustekinumab) and Fresenius Kabi's OTULFI (ustekinumab). These approvals reflect the growing number of biosimilars entering the market, contributing to increased competition and broader patient access to affordable treatments.

Additionally, the strategic partnerships between major players, such as Apotex's collaboration with Coherus Biosciences to license toripalimab, highlight the increasing investment in biosimilars, particularly in oncology.

Market Segmentation

By Indication: Oncology, Immunology, Rheumatology, Endocrinology, and others.

By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, and Others.

By Country: Germany, the UK, France, Italy, Spain, and others.

Future Outlook

The future of the Europe biosimilars market looks promising, with continued growth expected across various therapeutic areas. Increased awareness, improved regulatory frameworks, and expanded reimbursement policies will likely fuel the widespread adoption of biosimilars. The market is expected to benefit from the ongoing expiration of biologic patents, the increasing preference for cost-effective treatment options, and the potential for biosimilars to replace originator biologics in many chronic disease treatments.

As more biosimilar options become available and physician confidence in their safety and efficacy grows, the Europe biosimilars market will continue to expand, offering significant opportunities for both existing players and new entrants.

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