Biosimilars: Global Markets

Report Highlights

The global biosimilars market was valued at $1.8 billion in 2013 and nearly $2.0 billion in 2014. The market is expected to reach nearly $4.0 billion by 2019, with a compound annual growth rate (CAGR) of 15% from 2014 through 2019.

Report Includes

• An overview of the global market for biosimilars.
• Analyses of global market trends, with data from 2012 through 2014, and projections of CAGRs through 2019.
• A look at biosimilar product classes in various regions worldwide, as well as the worldwide pipeline for biosimilars.
• Detailed analysis of the emerging regulatory framework in regulated markets as well as comparisons of biosimilar guidelines in Europe, the U.S., Japan, Canada, and the guidelines developed by WHO.
• Technology trends and patent analysis.
• Comprehensive profiles of key players in the market.

Report Scope

The scope of this study encompasses biosimilars in pharmaceutical and biotechnology markets. BCC Research analyzes each market and its applications, regulatory environment, technology, market projections, and market shares.

In semi- and unregulated markets, various copies of biologics were sold for many years before the establishment of biosimilar guidelines by the European Medicines Agency (EMA). The regulatory processes are considerably less stringent in less regulated markets as compared to that of EMA; hence, a number of biosimilars are available in these regions. However, manufacturers are now targeting regulated markets, and are adopting various strategies to enter highly regulated markets such as Europe and the U.S. Therefore, the report includes all the products for which EMA has already published guidelines for market authorization or for which guidelines are under development.

This report includes product segments such as somatropin, erythropoietin, colony-stimulating factors (CSFs), interferons, interleukins, insulin and insulin analogues, follicle-stimulating hormones (FSHs), monoclonal antibodies (MAbs) and low-molecular-weight heparins (LMWHs). This report is a comprehensive study on the demand for biosimilar drugs that have entered the market worldwide. Technological issues include the latest trends and developments.

The emerging markets for biosimilars include countries such as India, China, Japan, Korea, Taiwan, Canada, Africa, Australia and New Zealand.

Analyst Credentials

Shalini Shahani Dewan focuses on pharmaceuticals and biotechnology and has been a BCC Research contributor since 2002 as both an analyst and project manager. She has explored a wide range of topics and companies, including working for Johnson & Johnson doing market surveillance. She has an undergraduate degree in pharmacy and master's degree in medicinal chemistry. She resides in the Bay Area.