Biosimilars: Global Markets
The global market for biosimilars reached $1.7 billion in 2010 and $2.5 billion in 2011. The market is expected to reach $3.6 billion by 2016, a compound annual growth rate (CAGR) of 7.7%.
The market definition is important to consider in this report. There are several copies of biologic drugs sold for many years in semi- and unregulated markets before the establishment of biosimilar guidelines by the European Medicines Agency (EMA). The regulatory processes in these regions for the approval of these products are considerably less stringent compared to that of EMA. However, these companies are targeting regulated markets, and are adopting various strategies to enter highly regulated markets such as Europe and the U.S. Hence, the approach taken for this report is to include all the products for which EMA has already published guidelines for market authorization or for which guidelines are under development. The scope of this report includes the 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 (LMWH). It is often argued that LMWH is not essentially a biosimilar product since it is derived from dead tissues. However, considering the complexity of LMWH, EMA has developed specific guidelines for LMWH; hence, this is included as one of the product segment in this report. The global market size estimation includes the above mentioned product segments.
Both EMA and World Health Organization (WHO) exclude vaccines from consideration as biosimilars. The EMA guideline says: “Due to complexity and the likelihood that they cannot be thoroughly characterized at the molecular level, vaccines must be considered on a case-by-case basis.” Besides vaccines, plasma-derived products and their recombinant analogues are also excluded from biosimilar guidelines by EMA due to their complex and variable physicochemical, biological and functional characteristics. Therefore, vaccines and blood products are not included as product segments in this report. Other biologic drug segments excluded in the market estimation of this report include streptokinase, hyaluronidase, etc., since biosimilar guidelines neither exist at present nor under development by EMA.
This report contains:
- An overview of biosimilar product classes in various regions worldwide.
- Biosimilar products approved by EMA.
- A look at the biosimilar pipeline worldwide.
- Detailed analysis of the emerging regulatory framework in regulated markets.
- Comparison of biosimilar guidelines in Europe, the U.S., Japan, Canada, and the guidelines developed by WHO.
- Detailed analysis of the market and key players in Europe and country-by-country analysis of key markets in Europe and the market forecasts for the region for various product classes
- Detailed analysis of U.S. market regulation, key players and emerging trends.
- Detailed analysis of the APAC market with analysis of key national markets (including Australia, Singapore, Korea, India, China and Japan), local players, investment trends and regulatory developments.
- Detailed analysis of the rest of world (ROW) market size, trends, country analysis of promising markets (including Brazil, Russia, and Canada), regional players, and emerging regulatory and market trends.
- Technology trends and patent analysis.
- Profiles of over 70 key players.
- Global and regional sales projections through 2016 for various product classes and regions.
Syamala Ariyanchira is actively involved in technology assessment, strategic planning, competitor analysis, due diligence, and market analysis. She combines her technical background with current business sector issues with ease. Her clients include investment firms, government agencies, and chemical and pharmaceutical companies. She holds a Ph.D. from Indian Institute of Science, Bangalore, India, and has over sixteen years of experience in the industry.