Global Biosimilars Market Threats, Analysis, Key Players, Growth, and Forecast 2026

Europe accounts for largest revenue share in biosimilars market, followed by Asia Pacific with highest CAGR over next 10 years.

Biosimilar is a similar copy, but not identical, of the original biologic medical product that is manufactured by a different company, and is expected to possess similar clinical properties, safety, potency and purity as originally product licensed. Biosimilars can be made only when the patent for the original biologic medical product expires. Regulatory authorities approve biosimilars only after clinical trials.

Demand for biosimilars due to their cost-effectiveness is the key factor driving growth of the global biosimilars market. Biosimilars cost 10% to 30% less than original or parent products. Other major growth driving factors include increasing geriatric population, rising prevalence of various chronic diseases in developed and developing countries, high-cost of original medicines, growing pressure to curtail healthcare expenditure, and enhanced productivity and clinical trial activities for biosimilars. Rising government support and initiatives to develop and promote biosimilars coupled with expiry of patents of biologicals are also driving growth of this market.

However, developing a biosimilar product is not easy as manufacturers do not have access to the active drug substance, original molecular clone and original cell bank, nor access to details of the exact fermentation and purification process. The do however have access to the commercialized innovator product. As a result, high manufacturing cost and complexity of production, along with unclear regulatory policies in many countries are expected to be the major restraints for growth of the global biosimilar market during the forecast period.

Europe accounts for largest revenue share contribution to the global biosimilars market, followed by Asia Pacific with the highest CAGR during the forecast period. The US biosimilars market is still in its nascent stage; however, with a growing approval rate, scope for the biosimilars market in the country is expected to expand during the forecast period.

Global biosimilars market segmentation, by product:

 	
Anti-Inflammatory Agents (TNF inhibitors and others)
 	
Monoclonal Antibodies (Adalimumab, Infliximab, Rituximab, Trastuzumab, Bevacizumab and others)
 	
Immunomodulators (Interferon Alfa, Interferon Beta, and others)
 	
Recombinant Hormones (Insulin, Human Growth Hormone, Follicle Stimulating Hormone)
 	
Recombinant Growth Factors (Granulocyte Colony Stimulating Factor, Erythropoietin, and others)

Global biosimilars market segmentation, by application:

 	
Oncology
 	
Blood disorders
 	
Growth hormone deficiency diseases
 	
Chronic and autoimmune diseases

Global biosimilars market segmentation, by region:

 	
North America
 	
Europe
 	
Asia Pacific
 	
The Middle East & Africa
 	
Latin America

Key players profiles include:

 	
 Amgen Inc.
 	
 Biocon Ltd.
 	
 Celltrion Inc.
 	
 Dr. Reddy's Laboratories
 	
Hoffmann-La Roche Ltd.


 	
 Mylan Inc.
 	
 Pfizer Inc.
 	
 Samsung Bioepis
 	
 Sandoz International Gmbh (A Division of Novartis International Ag)
 	
 Teva Pharmaceutical Industries Ltd.

Report Structure:

In the first section of the report we offer a table of content, followed by a list of figures. The next section offers a definition and brief explanation of the various products and segmentation of the target market, along with research methodology and a list of acronyms and sources used to gather and analyze data and information.

The third section of the report entails a brief list of drivers, restraints, opportunities, and threats (DROTs) in the target market. The report also offers insights on various trends in regions, countries, and markets as per segmentation, as well as insights and crucial information obtained from various sources including primary and secondary, annual reports, the Internet and others.

The final section comprises detailed profiles of key players in the target market and a SWOT analysis of each company, apart from strategies, acquisitions and mergers.

Objective of Report:

Sections of the report are created and designed specifically to offer readers a clear, clean, and insights into historical, estimated, and revenue (US$ Mn/Bn) estimation and projection, Compounded Annual Growth Rate (CAGR %), and volume in measure as applicable to the target product/market. We offer illustrations, charts, tables, and figures to support our findings and analysis, in addition to key finding for markets in regions and countries. This report is valuable asset for the existing players, new entrants and the future investors.

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