The Future of Biosimilars - Market Forecasts to 2015, Opportunity

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The Future of Biosimilars - Market Forecasts to 2015, Opportunity
Analysis and Regulatory Pathways

Description:    “The Future of Biosimilars - Market Forecasts to 2015, Opportunity Analysis and Regulatory
                Pathways” 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 a 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
Contents:   1 TOC
            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

List of Figures:

Figure   1: Biosimilars Market, Global, Top 25 Biologics By Therapeutic Class, 2008
Figure   2: Biosimilars Market, Global, Top 25 Biologics By Production System, 2008
Figure   3: Biosimilars Market, Global, Biologics Under Development by Therapeutic Class, Global,
2008
Figure   4: Biosimilars Market, Global, Biologics Under Development by Disease Category, Global,
2008
Figure 5: Biosimilars Market, Global, Comparison of Biosimilars With Generics, 2008
Figure 6: Biosimilars Market, Global, Development Costs and Timelines for a Biosimilar, 2008
Figure 7: Biosimilars Market, Global, Challenges in Biopharmaceutical Manufacturing, 2008
Figure 8: Biosimilars Market, Global, Solutions to Challenges Faced in Biopharmaceutical
Manufacturing, 2008
Figure 9: Biosimilars Market, Global, Revenue Forecasts ($m), 2008-2015
Figure 10: Biosimilars Market, The US, Revenue Forecasts ($m), 2008-2015
Figure 11: Biosimilars Market, Europe, Revenue Forecasts ($m), 2008-2015
Figure 12: Biosimilars Market, Japan, Revenue Forecasts ($m), 2008-2015
Figure 13: hGH Biosimilars Market, Global, Revenue Forecasts ($m), 2008-2015
Figure 14: EPO Biosimilars Market, Global, Revenue Forecasts ($m), 2008-2015
Figure 15: G-CSF Biosimilars Market, Global, Revenue Forecasts ($m), 2008-2015
Figure 16: Biosimilars Market, Global, Interferon-alpha Opportunity Analysis ($m), 2008-2015
Figure 17: Biosimilars Market, Global, Interferon-beta Opportunity Analysis ($m), 2008-2015
Figure 18: Biosimilars Market, Global, Insulin and Insulin Analogs Opportunity Analysis ($m), 2008-
2015
Figure 19: Biosimilars Market, Global, Revenue Estimates of Biologics Going Off Patent ($bn), 2010
-2015
Figure 20: Biosimilars Market, The US, Regulatory Bodies for Biologics, November 2009
Figure 21: Biosimilars Market, The US, Drug Development and Approval Process, November 2009
Figure 22: Biosimilars Market, The US, Evolution of Regulatory Pathway, November 2009
Figure 23: Biosimilars Market, The US, Impact of Data Exclusivity Period on Biosimilars
Development, November 2009
Figure 24: Biosimilars Market, The US, Impact of Eshoo Proposal on Biosimilars Industry, November
2009
Figure 25: Biosimilars Market, The US, Impact of Waxman Proposal on Biosimilars Industry,
November 2009
Figure 26: Biosimilars Market, The US, Drivers and Barriers for the Biosimilars Market, 2008-2015
Figure 27: Biosimilars Market, Europe, Drug Approval Process, November 2009
Figure 28: Biosimilars Market, Europe, Evolution of Regulatory Pathway for Approval of Biosimilars,
November 2009
Figure 29: Biosimilars Market, Europe, General and Product Specific Guidelines for Biosimilars,
November 2009
Figure 30: Biosimilars Market, Europe, Approval Process for Biosimilars, November 2009
Figure 31: Biosimilars Market, Europe, Data and Market Exclusivity Periods, November 2009
Figure 32: Biosimilars Market, Europe, Comparability Exercises, November 2009
Figure 33: Biosimilars Market, Europe, Number of Biosimilar Applications, 2004-2009
Figure 34: Biosimilars Market, Europe, Key Issues Facing Biosimilars Market, November 09
Figure 35: Biosimilars Market, Europe, Drivers and Barriers for the Biosimilars Market, 2008-2015
Figure 36: Biosimilars Market, The UK, Drivers and Barriers for the Biosimilars Market, 2008-2015
Figure 37: Biosimilars Market, Germany, Drivers and Barriers for the Biosimilars Market, 2008-2015
Figure 38: Biosimilars Market, France, Drivers and Barriers for the Biosimilars Market, 2008-2015
Figure 39: Biosimilars Market, Spain, Drivers and Barriers for the Biosimilars Market, 2008-2015
Figure 40: Biosimilars Market, Italy, Drivers and Barriers for the Biosimilars Market, 2008-2015
Figure 41: Biosimilars Market, Japan, Evolution of Regulatory Pathway, November 2009
Figure 42: Biosimilars Market, Japan, Drivers and Barriers for the Biosimilars Market, 2008-2015
Figure 43: Biosimilars Market, Global, Costs of Development, Manufacturing and Approval of
Biosimilars By Cell Culture Type, 2008
Figure 44: Biosimilars Market, Global, Percentage Split of Biosimilars Players Based on Company
Size, 2008
Figure 45: Biosimilars Market, Global, Strategic Positioning in Biosimilars Market, 2008
Figure 46: Biosimilars Market, Global, Avenues for Cost Reduction in Biosimilars Development,
2008
Figure 47: Biosimilars Market, Global, Teva Pharmaceuticals Ltd, November 2009
Figure 48: Biosimilars Market, Global, Dr. Reddy’s Laboratories, November 2009
Figure 49: Biosimilars Market, Global, Phage Biotechnology Corporation, November 2009
Figure 50: Biosimilars Market, Global, Cangene Corporation, November 2009
Figure 51: Biosimilars Market, Global, Biopartners, November 2009
Figure 52: Biosimilars Market, Global, BioCon Ltd, November 2009
Figure 53: Biosimilars Market, Global, BioGenerix AG, November 2009
Figure 54: Biosimilars Market, Global, Apotex Inc, November 2009
Figure 55: Biosimilars Market, Global, Sandoz Inc, November 2009
            Figure   56:   Biosimilars Market, Global, Hospira Inc, November 2009
            Figure   57:   Biosimilars Market, Global, Watson Pharmaceuticals, November 2009
            Figure   58:   Biosimilars Market, Global, STADA Arzneimittel AG, November 2009
            Figure   59:   Biosimilars Market, Global, ANALIZA INC, November 2009
            Figure   60:   Biosimilars Market, Global, Reliance GeneMedix Plc, November 2009
            Figure   61:   Biosimilars Market, Global, Momenta Pharmaceuticals, November 2009
            Figure   62:   Biosimilars Market, Global, Microbix Biosystems Inc, November 2009
            Figure   63:   Biosimilars Market, Global, Dragon Pharmaceuticals, November 2009
            Figure   64:   GBI Research Methodology



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