Biosimilar Market in Europe

Market Overview:

The biosimilar market in Europe size reached US$ 11,849.5 Million in 2023. Looking forward, IMARC Group expects the market to reach US$ 53,222.9 Million by 2032, exhibiting a growth rate (CAGR) of 17.6% during 2024-2032. The implementation of favorable reimbursement policies to encourage the use of biosimilars, the expansion of production facilities to ensure a consistent supply of the products, and technological advancements are among the key factors driving the market growth.

Biosimilars are biological products designed to have similar safety, efficacy, and therapeutic characteristics as an already approved biological product, known as the reference product. While they aren't identical, due to the complex nature of biological products, they match closely in terms of their function, administration, and intended use. The goal of a biosimilar is to provide an equivalent treatment option that can be marketed at a potentially lower cost once the original product's patent expires. The development of biosimilars undergoes a rigorous process, involving multiple phases of trials to demonstrate their comparability to the reference product. The key focus lies in achieving "biosimilarity" that assures no clinically meaningful differences from the reference product in terms of safety and effectiveness. Therefore, biosimilars play a significant role in increasing access to life-changing biological treatments by offering cost-effective alternatives.

Europe has one of the highest proportions of elderly people globally. Aging is often associated with an increased prevalence of chronic diseases, many of which require biological treatments. Biosimilars, offering affordable options for biologic drugs, therefore cater to this demographic and the associated increased demand for therapeutics. Along with this, European countries are implementing favorable reimbursement policies to encourage the use of biosimilars. Such policies, for instance in Germany and France, facilitate better access to biosimilars for patients and help to reduce the financial burden on healthcare systems. In addition, the rising manufacturing capacities for biosimilars in Europe are also positively influencing the market. Several biosimilar companies are investing in expanding their production facilities to ensure a consistent supply of these products, which in turn supports market growth. Apart from this, the escalating educational initiatives for healthcare professionals and patients, and measures to incentivize prescription is contributing to the market. Furthermore, innovations in bioprocessing and analytical methods to reduce the time and cost of biosimilar production and development are creating a positive market outlook.

Biosimilar Market in Europe Market Trends/Drivers:

Patent Expiries and Cost Containment

One of the most prominent market drivers for the biosimilars industry in Europe is the expiry of patents for a host of high-revenue biologic drugs. These patent expiries create lucrative opportunities for biosimilar manufacturers to introduce less costly alternatives in the market, which in turn accelerates the adoption of biosimilars. As European countries grapple with rising healthcare costs, cost containment has become a crucial aspect. In addition, biosimilars typically enter the market at a significantly reduced price compared to their reference biologic, contributing to savings in healthcare expenditure. Several European healthcare systems are encouraging the use of biosimilars as a cost-effective strategy. For instance, government organizations are introducing policies to incentivize the prescription of biosimilars. As a result, cost containment strategies coupled with patent expirations are fostering the growth of the biosimilars market in Europe.

Increased Adoption due to Awareness and Acceptance

The growing level of awareness and acceptance of biosimilars among healthcare providers and patients in Europe is positively influencing the market. This can be supported by the educational initiatives of regulatory bodies and industry groups, which aim to dispel misconceptions about biosimilars and highlight their comparable safety and efficacy to reference biologics. Such initiatives have led to increased trust and wider acceptance of biosimilars. In confluence with this, successful case studies, such as the introduction and usage of biosimilar infliximab in several European countries, have showcased potential cost savings without compromising patient outcomes. This increased acceptance and trust in biosimilars, supported by positive real-world evidence, is a significant driver for the growth of the biosimilars industry in Europe.

Biosimilar Market in Europe Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the biosimilar market in Europe report, along with forecasts at the regional and country levels from 2024-2032. Our report has categorized the market based on molecule, indication and manufacturing type.

Breakup by Country:

• Italy
• Germany
• United Kingdom
• France
• Spain
• Rest of Europe

Italy exhibits a clear dominance, accounting for the largest biosimilar market share in Europe

The report has also provided a comprehensive analysis of all the major regional markets, which includes Italy, Germany, France, the United Kingdom, Spain, and the rest of Europe. According to the report, Italy accounted for the largest market share.

The biosimilar market in Italy is driven by the rising prevalence of chronic diseases in the country, such as autoimmune disorders, cancer, and diabetes, which has led to an increased demand for cost-effective treatment options. Biosimilars offer significant cost savings compared to their originator counterparts, making them a compelling choice for healthcare providers and patients alike. Along with this, the Italian government is implementing policies and incentives to encourage the adoption of biosimilars, recognizing their potential to improve patient access to essential therapies while reducing healthcare expenditures. The country's well-established regulatory framework and robust guidelines for biosimilar approval have instilled confidence in these products, further fostering their acceptance and utilization in the Italian market. Additionally, collaborations between biosimilar manufacturers and Italian healthcare organizations have played a crucial role in driving market growth, as they work together to raise awareness, educate stakeholders, and establish best practices for biosimilar integration into the healthcare system.

Breakup by Molecule:

• Infliximab
• Insulin Glargine
• Epoetin Alfa
• Etanercept
• Filgrastim
• Somatropin
• Rituximab
• Follitropin Alfa
• Adalimumab
   

The report has provided a detailed breakup and analysis of the market based on the molecule. This includes infliximab, insulin glargine, epoetin alfa, etanercept, filgrastim, somatropin, rituximab, follitropin alfa, and adalimumab.

In the Europe biosimilar market, Infliximab has emerged as a prominent product with significant market drivers. Infliximab, a monoclonal antibody used to treat various autoimmune diseases, has witnessed growing demand due to its efficacy and cost-effectiveness. Along with this, the rising prevalence of chronic conditions, such as rheumatoid arthritis, Crohn's disease, and psoriasis, has propelled the demand for Infliximab biosimilars in recent years. Additionally, the expiry of patents on originator biologic products has opened opportunities for biosimilar manufacturers to enter the market, further intensifying competition. Furthermore, healthcare systems in Europe's cost-containment measures and the emphasis on providing access to affordable treatments have fueled the adoption of Infliximab biosimilars.

On the contrary, insulin glargine, a long-acting insulin analog, is widely used to manage diabetes, a chronic condition affecting a substantial population in Europe. the increasing prevalence of diabetes, coupled with the growing need for cost-effective treatment options, has fueled the demand for insulin glargine biosimilars. As the patents for originator insulin products have expired, it has created an opportunity for biosimilar manufacturers to enter the market and offer more affordable alternatives. in addition, the rising pressure on healthcare systems to optimize expenditure on diabetes care has also accelerated the adoption of insulin glargine biosimilars. these factors, along with the Europe medicines agency's stringent regulatory framework for biosimilars, contribute to the market's growth, positioning insulin glargine biosimilars as key drivers in the expanding landscape of biosimilar utilization in Europe.

Breakup by Indication:

• Auto-Immune Diseases
• Blood Disorder
• Diabetes
• Oncology
• Growth Deficiency
• Female Infertility

A detailed breakup and analysis of the market based on the indication has also been provided in the report. This includes auto-immune diseases, blood disorder, diabetes, oncology, growth deficiency, and female infertility.

In the region, the indication for auto-immune diseases has emerged as a significant driver for growth. Auto-immune diseases, encompassing a wide range of conditions like rheumatoid arthritis, psoriasis, and inflammatory bowel disease, affect a substantial number of patients across the region. In confluence with this, the growing prevalence of these chronic disorders has driven the demand for cost-effective and accessible treatment options. Biosimilars, as comparable alternatives to originator biologics, offer the potential for significant cost savings, making them an attractive choice for healthcare systems aiming to manage expenditure while ensuring quality care for patients. Moreover, the expiry of patents on several originator biologics has created opportunities for biosimilar developers to enter the market, fostering competition and promoting innovation. As regulatory agencies in Europe, such as the European Medicines Agency, continue to establish robust guidelines for biosimilar approval, the confidence in the safety and efficacy of these products grows, further supporting their adoption.

On the contrary, blood disorders, including anemia, thrombocytopenia, and various hematologic malignancies, affect a considerable number of patients in the region. The escalating prevalence of these conditions, coupled with the rising demand for cost-effective and efficient treatments, has stimulated the adoption of biosimilars as viable alternatives to originator biologics. Biosimilars offer the potential for substantial cost savings, making them an attractive option for healthcare providers and systems striving to manage their budgets effectively. In addition, as patents for several originator biologics used in the treatment of blood disorders have expired or are nearing expiration, it has paved the way for biosimilar manufacturers to enter the market and introduce competitive products. Moreover, the growing confidence in the safety and efficacy of biosimilars, supported by the stringent regulatory framework established by agencies, has further boosted their acceptance and utilization.

Breakup by Manufacturing Type:

• In-house Manufacturing
• Contract Manufacturing
   

The report has provided a detailed breakup and analysis of the market based on the manufacturing type. This includes in-house manufacturing and contract manufacturing.

In-house manufacturing refers to the practice of biosimilar companies producing their products internally rather than outsourcing the manufacturing process. This trend has been fueled by several factors. Additionally, in-house manufacturing allows for better control over the entire production process, ensuring higher quality standards and reducing the risk of supply chain disruptions. In addition, it offers greater flexibility in responding to market demands and regulatory changes, enabling companies to adapt quickly to emerging opportunities and challenges. Apart from this, it often results in cost efficiencies, as it eliminates the need for third-party involvement and reduces transportation and logistics expenses. In confluence with this, companies can protect their intellectual property and maintain a competitive edge by safeguarding their manufacturing know-how. As biosimilar competition intensifies, in-house manufacturing provides companies with a means to differentiate their products and establish themselves as reliable and competent players in the European biosimilar market.

On the other hand, the utilization of contract manufacturing has emerged as a compelling market driver. Contract manufacturing involves biosimilar companies outsourcing the production of their products to specialized manufacturing facilities. This trend has been fueled by several key factors. Moreover, contract manufacturing offers cost advantages, allowing companies to leverage the expertise and economies of scale of established manufacturing facilities without significant capital investments. This enables them to focus on research, development, and commercialization aspects, ultimately expediting time-to-market for their biosimilars. Additionally, access to contract manufacturing facilities with cutting-edge technologies and regulatory compliance expertise ensures high-quality production, meeting the stringent standards required by regulatory authorities. Moreover, contract manufacturing allows biosimilar companies to maintain flexibility in their operations, scaling production up or down as market demands fluctuate.

Competitive Landscape:

The key players in the market are investing significantly in research and development to identify suitable reference biologics and develop biosimilar versions. This involved conducting pre-clinical and clinical studies to demonstrate similarity in efficacy, safety, and quality with the originator biologics. Along with this, the rising utilization of pricing and marketing initiatives to gain market share and compete with originator biologics effectively is significantly supporting the market. In addition, companies are managing their supply chains to ensure a consistent and reliable supply of biosimilar products to meet market demand, such as establishing partnerships with contract manufacturing organizations and distribution networks. Thus, it is positively influencing the market. With increasing competition in the biosimilar market, manufacturers are employing cost-effective pricing, and value-added services, and developing a strong brand reputation. Furthermore, negotiating reimbursement and formulary inclusion to ensure widespread adoption is contributing to the market.

The report has provided a comprehensive analysis of the competitive landscape in the biosimilar market in Europe market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

• Novartis
• Pfizer
• Teva 
• Celltrion 
• Merck Sharp & Dohme
• Samsung Bioepis 
• Eli Lilly
• Accord Healthcare Ltd.
• Amgen
• Boehringer Ingelheim
• Hexal Ag 
• Apotex 
• Stada Arzneimittel Ag
• Ratiopharm
• Mylan

Biosimilar Market in Europe Market Report Scope:

Key Benefits for Stakeholders:

• IMARC’s report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the biosimilar market in Europe from 2018-2032.
• The research study provides the latest information on the market drivers, challenges, and opportunities in the biosimilar market in Europe.
• Porter's five forces analysis assist stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the biosimilar market in Europe and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.