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Biosimilars: Global Markets

  • January 2015
  • -
  • BCC Research
  • -
  • 136 pages


Table of Contents


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.

This report provides:

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.


Biosimilars are an affordable alternative to well-established therapeutic interventions. Biosimilars are similar to but not identical copies of the already approved biologics. BCC Research’s goal in conducting this study is to provide an overview of the current and future characteristics of the market for biosimilars. The key objective is to present
a comprehensive analysis and future direction of biosimilars. Present and future approaches within the biosimilars market are investigated in this report. For the purpose of this report, the biosimilars market is categorized into, erythropoietins, human growth hormone (HGH), granulocyte colony-stimulating factors (G-CSF), low-molecular-weight heparins (LMWH) and other biosimilars. The improvisations of the market, and the setbacks and the needs of the market are discussed in this report. Current market trends for biosimilars are also reported. A thorough analysis of the structure of the biosimilar industry is provided. Revenues are broken down by region. Sales figures are estimated for the five-year period from 2014 through 2019. The report also covers significant patents and their allotments in each category.


In recent years, significant changes in the regulatory aspects of biosimilars plus their cost effectiveness are driving new energy in the biosimilars market. Even though the market is in its infancy, opportunities are set to expand as patents expire on leading biologics. This is pointing the way for accelerated market growth. An increasingly aging population, growth in chronic illness and expanding need for healthcare worldwide will help drive the growth of biosimilars over the next few years, especially due to their affordability.
Acquisition strategies and collaborations by companies are also covered in this report. This study also discusses the strength and weaknesses of each type/market in light of new technologies, growing competition and changing customer needs.


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.

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