Biosimilars: Global Markets

Report Code: BIO090A

Publish Date: May 2012

Publisher: BCC Publishing

Category: Cell Biology

Customize This Report

Single User License: $2500

Member Price: FREE

EXPLORE OFFERS

Explore Our Services

Already a member? Login to access this report free.

Report Highlights

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%.

Report Scope

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.

Analyst Credentials

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.

Need a custom data table, graph, region, segment, companies or complete report? CUSTOMIZE NOW
Let us assist you! Our analysts are ready to tailor this report to your specific need. Talk to Our Analyst

Table of Contents

All reports provided in PDF format. For shared licensing options (5+ Users), please call a representative at (+1) 781-489-7301 or contact us at info@bccresearch.com
Title/Chapter NamePagesMember Price
Full Report: Biosimilars: Global Markets289Free
Chapter- 1: INTRODUCTION6Free
Chapter- 2: SUMMARY3Free
Chapter- 3: MARKET OVERVIEW51Free
Chapter- 4: BIOSIMILAR MARKETS IN EUROPE53Free
Chapter- 5: BIOSIMILAR MARKETS IN THE U.S.23Free
Chapter- 6: BIOSIMILAR MARKETS IN THE ASIA-PACIFIC REGION58Free
Chapter- 7: REST OF THE WORLD (ROW) MARKETS12Free
Chapter- 8: TECHNOLOGY TRENDS12Free
Chapter- 9: PATENT ANALYSIS4Free
Chapter- 10: C. CRAMER & CO. GMBH64Free
Chapter- 11: APPENDIX3Free

Related Reports

Antibody Drugs: Technologies and Global Markets

Published - Feb 2012 | Publisher - Esther Bosklopper | Code - BIO016H

The global market for therapeutic monoclonal antibodies (mAbs) was estimated at $44.6 billion in 2011.  With the rollout of at least eight new therapeutic mAb products and expanded indications for existing products expected during the forecast period, the global mAb market is expected to rise at a compound annual growth rate (CAGR) of 5.3% to nearly $58 billion in 2016.

2011 Biotechnology Research Review

Published - Jan 2012 | Publisher - Various Analysts | Code - BIO069C

Highlights from various reports on biotechnology markets published by BCC Research in 2011.

Therapeutics for Immune System Disorders

Published - Jan 2011 | Publisher - Syamala Ariyanchira | Code - BIO025D

In 2010, the global market for drugs for the treatment of immune disease was estimated to be approximately $72.2 billion.  The market size is forecast to grow at a compound annual growth rate (CAGR) of 2.6% to reach $82.2 billion by 2015.

Biologic Therapeutic Drugs: Technologies and Global Markets

Published - Jan 2011 | Publisher - Jackson Highsmith | Code - BIO079A

The global biologics market is valued at an estimated $149 billion in 2010 and is expected to reach $239 billion by 2015, a compound annual growth rate (CAGR) of 9.9% from 2010-2015. Driving this growth is the need for a more extensive drug pipeline, attractive targets against challenging diseases, a push to pursue biosimilars, and enabling manufacturing technologies that reduce the cost to produce profitable products.

Recent Reports

Artificial Intelligence (AI) in Cancer

Published - Nov 2024 | Publisher - BCC Publishing | Code - BIO196B

The global market for artificial intelligence (AI) in cancer is estimated to increase from $2.2 billion in 2024 to reach $6.3 billion by 2029, at a compound annual growth rate (CAGR) of 23.1% from 2024 through 2029.

Cell and Gene Therapy Tools, and Reagents: Global Markets

Published - Nov 2024 | Publisher - BCC Publishing | Code - BIO208C

The global market for Cell and Gene Therapy (CGT) Tools and Reagents is estimated to increase from $10.0 billion in 2024 to reach $16.7 billion by 2029, at a compound annual growth rate (CAGR) of 10.8% from 2024 through 2029.

Single-use Technologies for Biopharmaceuticals: Global Markets

Published - Nov 2024 | Publisher - BCC Publishing | Code - BIO099F

The global market for single-use technologies for biopharmaceuticals is expected to grow from $6.5 billion in 2024 and is projected to reach $11.2 billion by the end of 2029, at a compound annual growth rate (CAGR) of 11.6% during the forecast period of 2024 to 2029.

Induced Pluripotent Stem Cells: Global Markets

Published - Nov 2024 | Publisher - BCC Publishing | Code - BIO135F

The global market for induced pluripotent stem cells (iPSCs) is expected to grow from $3.4 billion in 2023 to reach $5.2 billion by the end of 2028, at a compound annual growth rate (CAGR) of 9.1% from 2023 to 2028.

Commercial Amino Acids

Published - Nov 2024 | Publisher - BCC Publishing | Code - BIO007N

The global market for commercial amino acids was valued at $30.1 billion in 2023. It is expected to grow from $31.8 billion in 2024 to $42.8 billion by 2029, at a compound annual growth rate (CAGR) of 6.1% from 2024 through 2029.

Top Trending Reports

AI in Clinical and Molecular Diagnostics Market

Published - Oct 2024 | Publisher - BCC Publishing | Code - BIO261A

The global market for AI in clinical and molecular diagnostics is expected to grow from $2.6 billion in 2024 and is projected to reach $8.9 billion by the end of 2029, at a compound annual growth rate (CAGR) of 27.6% during the forecast period of 2024 to 2029.

Point-of-Care Diagnostics: Technologies and Global Markets

Published - Oct 2024 | Publisher - BCC Publishing | Code - HLC043H

The global market for point-of-care diagnostics was valued at $36.9 billion in 2023. It is expected to grow from $40.6 billion in 2024 to $65.9 billion by the end of 2029, at a compound annual growth rate (CAGR) of 10.2% from 2024 through 2029.

Medical Devices: Technologies and Global Markets

Published - Oct 2024 | Publisher - BCC Publishing | Code - HLC170F

The global market for medical devices reached $739.6 billion in 2023. It is expected to grow from $810.4 billion in 2024 to $1.3 trillion by the end of 2029, at a compound annual growth rate (CAGR) of 9.8% from 2024 through 2029.

Global Artificial Intelligence (AI) Market: Investments vs Potential

Published - Aug 2024 | Publisher - BCC Publishing | Code - IFT189C

The global market for artificial intelligence (AI) is estimated to increase from $148.8 billion in 2023 to reach $1.1 trillion by 2029, at a compound annual growth rate (CAGR) of 39.7% from 2024 through 2029.

CRISPR Technology: Global Markets

Published - Oct 2024 | Publisher - BCC Publishing | Code - HLC258C

The global market for CRISPR technology was valued at $3.4 billion in 2023. This market is expected to grow from $3.8 billion in 2024 to $7.5 billion by the end of 2029, at a compound annual growth rate (CAGR) of 14.4% from 2024 to 2029.

Become A Member

BCC Research offers a comprehensive library of reports, granting members unlimited access to data, insights, and market intelligence for informed business decisions, while actively supporting members in their evolving journeys and prioritizing high-quality, relevant topics based on continuous engagement with the research community.

Find Out More

Custom Consulting

BCC Research emphasizes the importance of organizations leveraging highly customized market insights aligned with specific strategic business objectives through direct engagement with primary sources and proprietary forecasting models for profitable decision-making in maximizing growth opportunities and minimizing risks.

Customize Now

Scorecard

The Venture Scorecard provides commercialization offices and decision makers with expert analysis, offering strategic insights crucial for aligning objectives with market realities at various stages of commercializing new products or evaluating investment opportunities, from opportunity assessment to growth planning.

Find Out More

Innovation Spotlight

Our industry experts offer strategic guidance to maximize the market potential of commercialized products, patents, and IP by providing insights into market trends, competitive dynamics, and effective positioning, using the Innovation Spotlight service for enhanced exposure to thought leaders and the wider community.

Find Out More
Biosimilars: Global Markets
Customize Report