|
Published by: GBI Research
Published: Dec. 31, 2009 - 97 Pages
Table of Contents
- 1 Table of Contents
- 1.1 List of Tables
- 1.2 List of Figures
- 2 Introduction
- 2.1 GBI Research Report Guidance
- 3 The Future of Biosimilars - Market Overview
- 3.1 Overview of the Biopharmaceutical Industry
- 3.2 Comparison of Biosimilars with Generics
- 3.3 Biopharmaceutical Manufacturing Process
- 4 The Future of Biosimilars - Market Characterization
- 4.1 Global Biosimilars Market Size and Forecasts
- 4.2 The US Biosimilars Market Size and Forecasts
- 4.3 Europe Biosimilars Market Size and Forecasts
- 4.4 Japan Biosimilars Size and Market Forecasts
- 4.5 Market Forecasts for Biosimilars
- 4.5.1 Human Growth Hormone Biosimilars Markets
- 4.5.2 Erythropoietin (EPO) Biosimilars Markets
- 4.5.3 Granulocyte - Colony Stimulating Factor (G-CSF) Biosimilars Markets
- 4.6 Opportunity Analysis
- 4.6.1 Interferon-alpha Biosimilars
- 4.6.2 Interferon-beta Biosimilars
- 4.6.3 Insulin and Insulin Analogs Biosimilars
- 4.6.4 Monoclonal Antibodies
- 4.7 Unmet Needs in the Biopharmaceutical Market
- 5 The Future of Biosimilars - Regulatory Landscape
- 5.1 Regulatory Landscape in the US
- 5.1.1 Regulatory Framework for Biopharmaceutical Industry
- 5.1.2 Evolution of Regulatory Pathways for Biosimilars
- 5.1.3 Current Position on Biosimilars
- 5.1.4 Drivers and Barriers
- 5.2 Regulatory Landscape in Europe
- 5.2.1 Regulatory Framework for Biopharmaceutical Industry
- 5.2.2 Evolution of Regulatory Pathways for Biosimilars
- 5.2.3 Current Position on Biosimilars
- 5.2.4 The ‘Bolar’ Type Provision
- 5.2.5 The Comparability Exercise
- 5.2.6 Biosimilars Approvals and Applications
- 5.2.7 Issues Facing the European Biosimilars Industry
- 5.2.8 Drivers for the European Biosimilars Market
- 5.2.9 Barriers for the European Biosimilars Market
- 5.2.10 Country Analysis - The United Kingdom
- 5.2.11 Country Analysis - Germany
- 5.2.12 Country Analysis - France
- 5.2.13 Country Analysis - Spain
- 5.2.14 Country Analysis - Italy
- 5.3 The Regulatory Landscape in Japan
- 5.3.1 The Regulatory Framework for the Biopharmaceutical Industry
- 5.3.2 Evolution of Regulatory Pathways for Biosimilars
- 5.3.3 Current Position on Biosimilars
- 5.3.4 Drivers and Barriers
- 6 The Future of Biosimilars - Competitive Landscape
- 6.1 The Costs of Biosimilar Development Are Higher Than That of Generics
- 6.2 High Initial Investments Favors Growth of Biosimilars Players with Financial Strength
- 6.3 Technical Expertise in Biopharmaceutical Development and Manufacturing Determines Strategic Positioning
- 6.4 Leading Biosimilars Players
- 6.4.1 Teva Pharmaceuticals Ltd
- 6.4.2 Dr. Reddy’s Laboratories
- 6.4.3 Phage Biotechnology Corporation
- 6.4.4 Cangene Corporation
- 6.4.5 Biopartners
- 6.4.6 BioCon Ltd
- 6.4.7 BioGenerix AG
- 6.4.8 Apotex Inc
- 6.4.9 Sandoz
- 6.4.10 Hospira Inc
- 6.4.11 Watson Pharmaceuticals
- 6.4.12 STADA Arzneimittel AG
- 6.4.13 ANALIZA, INC
- 6.4.14 Reliance GeneMedix Plc
- 6.4.15 Momenta Pharmaceuticals
- 6.4.16 Microbix Biosystems Inc
- 6.4.17 Dragon Pharmaceuticals
- 7 The Future of Biosimilars - Strategic Consolidations
- 7.1 Mergers & Acquisitions
- 7.1.1 Merck Acquires Insmed’s Follow-On Biologics for $130m
- 7.1.2 Teva and Lonza Joint Venture Targets Biosimilars
- 7.1.3 GTC Enters a Follow-On-Biologic Founder Development Collaboration With Ag Research
- 7.2 Licensing Deals
- 7.2.1 Innogene Seals Deal With CIMAB To Market Biosimilars
- 7.2.2 Abraxis Licenses Rights To Biosimilar From Indian Firm Biocon
- 8 Appendix
- 8.1 Market Definitions
- 8.2 Abbreviations
- 8.3 Research Methodology
- 8.3.1 Coverage
- 8.3.2 Secondary Research
- 8.3.3 Primary Research
- 8.3.4 Expert Panel Validation
- 8.4 Contact Us
- 8.5 Disclaimer
- List of Tables
- Table 1: Biosimilars Market, Global, Revenue Forecasts ($m), 2008-2015
- Table 2: Biosimilars Market, The US, Revenue Forecasts ($m), 2008-2015
- Table 3: Biosimilars Market, Europe, Revenue Forecasts ($m), 2008-2015
- Table 4: Biosimilars Market, Japan, Revenue Forecasts ($m), 2008-2015
- Table 5: hGH Biosimilars Market, Global, Revenue Forecasts ($m), 2008-2015
- Table 6: EPO Biosimilars Market, Global, Revenue Forecasts ($m), 2008-2015
- Table 7: G-CSF Biosimilars Market, Global, Revenue Forecasts ($m), 2008-2015
- Table 8: Biosimilars Market, Global, Interferon-alpha Opportunity Analysis ($m), 08-2015
- Table 9: Biosimilars Market, Global, Interferon-beta Opportunity Analysis ($m), 2008-2015
- Table 10: Biosimilars Market, Global, Insulin and Insulin Analogs Opportunity Analysis ($m), 2008-2015
- Table 11: Biosimilars Market, Global, Biologics Off-Patent in the US , 2008
- Table 12: Biosimilars Market, The US, Comparison of Waxman and Eshoo Proposals, November 2009
- Table 13: Biosimilars Market, Europe, Existing Guidelines for Biosimilars, November 2009
- Table 14: Biosimilars Market, Europe, Biosimilar Approvals, November 2009
- Table 15: Biosimilars Market, Europe, Applications Rejected or Withdrawn, November 2009
AbstractSummary
GBI Research, the leading business intelligence provider, has released its latest research “The Future of Biosimilars - Market Forecasts to 2015, Opportunity Analysis and Regulatory Pathways”. The report provides insights on the biosimilars market revenues and growth until 2015. Further, the distribution of revenues across key geographies such as the US, the top five countries in Europe and Japan are provided in the report. The report discusses the latest developments in the regulatory landscape and the evolving biosimilars approval pathways in Europe, the US and Japan. In-depth analysis into the individual segments of biosimilars market, their market forecasts and potential are also provided. The study analyzes the competitive landscape including benchmarking of the leading companies in the biosimilars market. Finally, a key trends analysis of mergers and acquisitions and licensing agreements involving biosimilars, is also provided.
This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts.
Scope
The scope of this report includes:
- Analysis on the regulations for biosimilars market in the leading geographies of the world - the US, the UK, Germany, France, Italy, Spain, and Japan
- Market forecasts and potential for the biosimilars market from 2008 to 2015. The key biologics classes included are human growth hormones, granulocyte colony stimulating factors, insulins, interferons and erythropoietins
- Market characterization data for biosimilars including market size, market share and market potential
- Key drivers and restraints that have a significant impact on the market
- Competitive landscape of global biosimilars market including benchmarking of the leading companies. The key companies discussed in this report are Teva, Sandoz, Hospira Inc, STADA Arzneimittel AG, Ratiopharm, Dr.Reddy’s Laboratories and Biocon Ltd
- Key M&A activities, licensing agreements, that have taken place between 2008 and 2009 in the global biosimilars market
Reasons to buy
The report will enable business development and marketing executives strategizing their product launches to
- Build effective strategies to launch pipeline products by identifying the latest regulatory developments in the US, Europe and Japan
- Develop market-entry and market expansion strategies by identifying the geographic markets poised for strong growth
- Exploit in-licensing and out-licensing opportunities by identifying products that could fill their portfolio gaps
- Develop key strategic initiatives by studying the key strategies of top competitors
- Reinforce R&D pipelines by identifying licensing strategies for acquiring new delivery mechanisms that have more efficiency and better safety
Get Full Details About This Report >>
|
|
US: 800.298.5699
Int'l: +1.240.747.3093
|
|
|
