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

This publication has been discontinued on September 9, 2011.

Introduction

Abstract

The global biologics market was valued at approximately $XX billion in 2008 and is growing at a rapid rate of XX% a year. The top 25 biologics account for XX% of the revenues of the global biologics market. Of the top 25 biologics, XX products generate revenues of more than $XX billion a year. Biologics such as Remicade, Enbrel and Humira are also approved for multiple indications as part of expansion strategies. However, the global biologics market accounts for only XX% of the global pharmaceutical industry a share that is expected to increase with the increasing number of approvals and indications that they treat. The XX top selling drugs in the global pharmaceutical industry includes four biologics and one low molecular weight heparin (Lovenox).Biologics are expected to dominate the list of the highest selling products due to the patent expiries facing some of the top selling small molecule products such as Lipitor, Plavix, Nexium and Seretide.

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 Strength66
• 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

1.1 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

1.2 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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