Biosimilar Market in Europe

Biosimilar Market in Europe:

The biosimilar market in Europe size reached USD 13,864 Million in 2024. Looking forward, IMARC Group expects the market to reach USD 59,733.3 Million by 2033, exhibiting a growth rate (CAGR) of 17.1% during 2025-2033. 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 continuous technological advancements are among the key factors driving the growth market.

Biosimilar Market in Europe Analysis:

• Major Market Drivers: The increasing prevalence of chronic diseases, such as respiratory disorders, diabetes, cancer, etc., is primarily driving the growth of the market. Moreover, the rising geriatric population in the region, who are more susceptible to ailments, is also creating a positive outlook for the overall market.
• Key Market Trends: Ongoing innovations in bioprocessing and analytical methods to reduce the time and cost of biosimilar production and development are significantly catalyzing the growth of the market. Furthermore, the government authorities of Europe are introducing favorable reimbursement policies to encourage the use of biosimilars, which is also contributing to the market growth. 
• Competitive Landscape: Some of the leading biosimilar companies in Europe are Novartis, Pfizer, Teva, Celltrion, Samsung Bioepis, Amgen, Apotex, Ratiopharm, Mylan, Merck Sharp & Dohme, Eli Lilly, Accord Healthcare Ltd, Boehringer Ingelheim, Hexal Ag, and Stada Arzneimittel Ag, among others. 
• Geographical Trends: According to the report, Italy accounted for the largest market share. The biosimilar market 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.
• Challenges and Opportunities: Challenges in Europe's biosimilar market include regulatory hurdles, patent litigation, and physician/patient acceptance. However, opportunities arise from the growing demand for cost-effective biologics, expanding healthcare access, and favorable government policies encouraging biosimilar adoption. Strategic partnerships, innovation in manufacturing processes, and market education can unlock the market's potential for biosimilar growth in Europe.

Biosimilar Market in Europe Trends:

Patent Expiries and Cost Containment

One of the most prominent market drivers for the biosimilar industry in Europe is the expiry of patents for a host of high-revenue biologic drugs. Moreover, as European countries are grappling with rising healthcare costs, cost containment is becoming a crucial aspect. In response to this, 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. Additionally, according to a data report, as of August 2020, the European Medicines Agency, which evaluates biosimilars, approved a total of 72 entities since 2006, compared to 28 biosimilars approved by the US Food and Drug Administration. Furthermore, the rising healthcare costs in Europe are prompting patients to opt for biosimilars. For instance, health-related expenditure averaged almost €6,000 per inhabitant in 2019. In Germany, a consultation with a general practitioner costs around €75 for non-residents. As a result, the increasing cost and rising patent expirations of biological products are propelling the demand for biosimilars in Europe.

Increasing Prevalence of Chronic Diseases

The rising cases of various chronic diseases, such as COPD, asthma, cancer, diabetes, etc., are further catalyzing the growth of the biosimilar market in Europe. For instance, more than one-third (36.1%) of people in the EU reported having a long-standing (chronic) health problem in 2022. Moreover, non-communicable diseases (NCDs), including cardiovascular diseases, diabetes, chronic respiratory diseases, mental disorders, neurological disorders, and cancer, are responsible for 80% of the disease burden in the EU countries and are the leading causes of avoidable premature deaths. Additionally, the growing burden of cancer and increasing deaths due to it are creating the need for affordable treatment and thus boosting the growth of the biosimilar market. For instance, over 4 million new cancer cases and 1.9 million cancer-related deaths were estimated in Europe in 2020. Additionally, in 2022, the highest cancer rate for men and women among European countries was in Denmark, with 728.5 cancer cases per 100,000 population. Ireland and the Netherlands followed, with 641.6 and 641.4 people diagnosed with cancer per 100,000 population, respectively. The increasing incidence of cancer is expected to drive the need for advanced and affordable cancer drugs for the effective treatment of patients. This, in turn, is anticipated to significantly propel the biosimilar market share in Europe in the coming years.

Expedited Approval of Drugs

The concerned authorities of Europe are expediting the approval of drugs in order to authorize promising treatments for urgent medical needs. The increasing burden of healthcare costs is prompting concerned government authorities in Europe to accelerate clinical trials and commercialize approved drugs. This, in turn, is positively impacting the biosimilar market outlook in Europe. For instance, in April 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended marketing authorization for two biosimilar medicines intended for the treatment of rheumatoid arthritis, COVID-19, polyarticular juvenile idiopathic arthritis, and systemic juvenile. Similarly, in January 2024, a pharmaceutical company, Sandoz, announced that the European Commission (EC) granted marketing authorization for Pyzchiva (biosimilar ustekinumab). Pyzchiva was developed and registered by Samsung Bioepis to match the reference medicine. It is approved for autoimmune disorders within disease areas such as gastroenterology and dermatology. The quickness in approving and marketing drugs by the concerned European authorities is anticipated to augment the biosimilar market’s recent price 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 for 2025-2033. Our report has categorized the market based on molecule, indication, and manufacturing type.

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 European biosimilar market, Infliximab have 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. Furthermore, Europe biosimilar market statistics by IMARC indicate that 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. 

Apart from this, insulin glargine, a long-acting insulin analog, is widely used to manage diabetes, a chronic condition affecting a substantial population in Europe. For instance, according to the IDF, the overall diabetes expenditure in Europe among the population aged 20-79 years was US$ 156 billion and is expected to increase to US$ 174 billion by 2040. These figures indicate that approximately 9% of the total healthcare expenditure is spent on diabetes in Europe. As a result, the increasing prevalence of diabetes, coupled with the growing need for cost-effective treatment options, is bolstering the demand for insulin glargine biosimilars.

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 rising cases of auto-immune diseases have 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 Europe. The growing prevalence of these chronic disorders is driving the demand for cost-effective and accessible treatment options. 

Similarly, blood disorders, including anemia, thrombocytopenia, and various hematologic malignancies, affect a considerable number of patients in the region. For instance, in the EU countries, malignant blood disorders cost €6·8 billion (12%) of the total healthcare expenditure on cancer (€57 billion), with this proportion being second only to breast cancer. As a result, the escalating prevalence of these conditions, coupled with the rising demand for cost-effective and efficient treatments, is stimulating the adoption of biosimilars as viable alternatives to originator biologics. 

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. 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. Moreover, it offers greater flexibility in responding to market demands and regulatory changes, enabling companies to adapt quickly to emerging opportunities and challenges.

On the other hand, contract manufacturing involves biosimilar companies outsourcing the production of their products to specialized manufacturing facilities. 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.

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 biosimilar market in Europe 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. For instance, chronic diseases (or non-communicable diseases) afflict about 24 million people in Italy. In 2021, around 23.7 million people in Italy suffered from at least one chronic disease. Such a massive rise in chronic disease cases in Italy is further augmenting the need for affordable biosimilars. Moreover, the overview of the biosimilar market in Europe by IMARC indicates that the Italian government is launching numerous policies and incentives to encourage the adoption of biosimilars, recognizing their potential to improve patient access to essential therapies while reducing healthcare expenditures. Besides this, 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.

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. 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
   

(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)

Biosimilar Market in Europe Recent Developments:

• January 2024: Partners STADA and Alvotech announced that the European Commission issued a marketing authorization for Uzpruvo (AVT04), a biosimilar candidate to Stelara (ustekinumab). The centralized marketing authorization for Europe’s first ustekinumab biosimilar is valid in all European Economic Area (EEA) countries, including the 27 European Union (EU) Member States as well as in Iceland, Liechtenstein, and Norway.
• October 2023: Samsung Bioepis, a biosimilar developer under Samsung Group, launched the hematology biosimilar, Epysqli, a biosimilar close to Soliris, in three European countries. This biosimilar is used in treating rare blood disease, paroxysmal nocturnal hemoglobinuria.
• September 2023: Celltrion Healthcare launched a new campaign to celebrate a decade of biosimilar innovation in Europe. The new campaign highlighted the positive impact of biosimilars on patients and healthcare systems. It also reflected on what the future could hold through continued innovation.

Biosimilar Market in Europe 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 2019-2033.
• 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.