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Biosimilars in Developed Countries - Launch of Biosimilar mAbs in Europe and New Regulatory Pathways in the US to Spur Market Growth

Executive Summary

Only FDA Approval Pathway Complications are Holding Back the US Biosimilars Flood.

New guidelines laid out by the US Food and Drug Administration (FDA) lack clarity and specificity, meaning that a wealth of biosimilars are currently restricted from the world's biggest pharmaceutical market, states a new report from healthcare industry analysts GBI Research.

The report* says that ambiguity within the healthcare authority's approval pathway procedure suggests decisions will be made on a case-by-case basis, hindering the flow of biosimilars into the US market.

As biosimilars require high investments and long periods of development compared to generics, companies need to know in advance what US regulators will require when they submit their applications for the approval of a new product.

GBI Research expects the first biosimilar to be approved in the US by the end of this year, followed by products by Sandoz and Hospira in early 2013. Once these medications have broken through, and a clearer approval pathway is established, an abundance of biosimilars is expected to follow and take advantage of the highly lucrative US pharmaceutical market.

Europe has already approved 14 biosimilars - the highest of any region - with a range of products belonging to the erythropoietin (EPO) and granulocyte colony stimulating factors (G-CSF) and human growth hormones (HGH) groups. Japan launched its first biosimilar in October 2009.

The reduction of healthcare expenditure is at the top of the agenda for national healthcare authorities around the globe, and as biologics are among the highest priced therapies in the world, establishing governing regulations is a key focus.

GBI Research predicts that the value of the worldwide biologics market will rocket from $450m in 2011 to $7.5 billion in 2018, climbing at a highly impressive Compound Annual Growth Rate (CAGR) of 49.6%. This staggering jump is attributed to the entrance of the US into the global biologics market.

Biosimilars in Developed Countries - Launch of Biosimilar mAbs in Europe and New Regulatory Pathways in the US to Spur Market Growth

This report provides key data, information and analysis of the major trends and issues affecting the biosimilar market in developed countries covering the US, the top five European markets and Japan

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research's team of industry experts.

Abstract

Biosimilars in Developed Countries - Launch of Biosimilar mAbs in Europe and New Regulatory Pathways in the US to Spur Market Growth

Summary

GBI Research, the leading business intelligence provider, has released its latest report, "Biosimilars in Developed Countries - Launch of Biosimilar mAbs in Europe and New Regulatory Pathways in the US to Spur Market Growth" that provides key data, information and analysis of the major trends and issues affecting the biosimilar market in developed countries covering the US, the top five European markets and Japan. The report provides a comprehensive insight into the biosimilar market, and offers market forecasts by geography as well as biosimilar categories. It also provides the drivers and restraints affecting the biosimilars market, as well as the business environment and the key success factors in the global biosimilar industry. In addition, the report describes the regulatory environment in the US, top five European markets and Japan with respect to biosimilars. Finally, the report looks into the competitive landscape of the biosimilar industry by offering profiles of key players in the industry and the analysis of major deals that have taken place.

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.

The global biosimilars industry has grown significantly over the past few years and has a great scope for future growth due to the expiry of patents for major biological drugs, pressure on the governments of developed nations to cut healthcare costs and the savings in treatment costs offered by biosimilars. The global biosimilar industry was valued at $450m in 2011 and is expected to increase to $7.5billion in 2018 at a compound annual growth rate (CAGR) of 49.6%. Access to the US market after the issuance of draft guidelines by the US Food and Drug Administration (FDA) will offer a major boost to the growth of the global biosimilar market. The establishment of guidelines for the approval of biosimilar interferons in the European Union will also drive global biosimilar market growth.

Currently, the global biosimilar market is at nascent stage. Major pharmaceutical companies including Teva Pharmaceuticals, Sandoz and Hospira have made a strong position for themselves in the European biosimilar market. However, the markets in the US and Japan have not been explored fully. Companies such as Pfizer, Mylan and Merck have shown interest in the opportunities offered by the global biosimilar market and have taken initiatives enter into it. Players such as Biocon and Celltrion from the emerging economies are collaborating with these global pharmaceutical companies to develop and market biosimilars. The market is expected to witness a large amount of strategic consolidation between these players in near future.

Scope

  • Data and analysis on the biosimilar market in the leading geographies of the world - the US, the UK, Germany, France, Italy, Spain, and Japan.
  • Market forecast for global biosimilar market from 2011 to 2018, by geography as well as product category.
  • Key drivers and restraints that have had a significant impact on the market globally as well as at national level.
  • The regulatory environment for biosimilars in the US, the EU and in Japan.
  • Analysis of competitive environment in the industry and profiles of key players in the biosimilar market. The companies studied in this report are Sandoz, Teva Pharmaceuticals, Hospira, Dr. Reddy's, Biocon, Intas, Celltrion and 3S Bio.
  • Key M&A activities and Licensing Agreements that took place between 2009 up until February 2012 in the global biosimilar market.

Reasons to buy

  • Make more informed business decisions from the insightful and in-depth analysis of the global biosimilar market and the factors shaping it.
  • Identify the key areas of deal making through a thorough understanding of the deals landscape in the global biosimilar market.
  • Build effective strategies to launch pipeline products by identifying potential geographies.
  • Identify the companies from emerging nations for collaborations along with their key capabilities.
  • Exploit in-licensing and out-licensing opportunities by identifying products that might fill your portfolio gaps.

TOC

1 Table of Contents

1 Table of Contents 5

  • 1.1 List of Tables 8
  • 1.2 List of Figures 10

2 Introduction 13

3 Biosimilars in Developed Countries- Market Overview 14

  • 3.1 Introduction 14
  • 3.2 Biologics and Small Molecules 15
    • 3.2.1 Structural Differences between Biologics and Small Molecules 15
  • 3.3 Market Size and Patent Expiries of Branded Biologics 16
    • 3.3.1 Market Size of Branded Biologics & Sales by Major Drug Classes in 2010 16
    • 3.3.2 Top Ten Biologics in 2010 17
    • 3.3.3 Patent Expiry of Leading Biologics, 2011-2018 18
  • 3.4 Approved Biosimilars in Europe until December 2011 19
  • 3.5 Biopharmaceutical and Biosimilars Manufacturing and Development Process 20
    • 3.5.1 Manufacturing Process 20
    • 3.5.2 Setting up a new biosimilar manufacturing facility 21
    • 3.5.3 Development Process & Cost 21

4 Biosimilars in Developed Countries- Geographic Landscape 22

  • 4.1 Introduction 22
  • 4.2 Global Biosimilar Market 23
    • 4.2.1 Market Size and Forecast 23
    • 4.2.2 Drivers and Barriers 25
  • 4.3 US Biosimilar Market 26
    • 4.3.1 Market Size and Forecast 26
    • 4.3.2 Regulatory Landscape 28
    • 4.3.3 Objectives of Biosimilar Legislation and Regulatory Frameworks 29
    • 4.3.4 Regulatory Framework for Biopharmaceutical Industry 30
    • 4.3.5 Evolution of Regulatory Pathways for Biosimilars 33
    • 4.3.6 BPCI Act and the Pathway for Approval of Biosimilar Products 36
    • 4.3.7 Drivers and Barriers 42
  • 4.4 Top Five European Markets- Biosimilar Market Size and Forecast 43
    • 4.4.1 Introduction 43
    • 4.4.2 Market Size and Forecast 43
    • 4.4.3 Regulatory Framework for Biopharmaceutical Industry 45
    • 4.4.4 Evolution of Regulatory Pathways for Biosimilars 46
    • 4.4.5 Current Position on Biosimilars 47
    • 4.4.6 The Bolar Type Provision 50
    • 4.4.7 The Comparability Exercise 50
    • 4.4.8 Biosimilars Approvals and Applications 52
    • 4.4.9 EMA Guidelines for Biosimilar mAb 54
    • 4.4.10 European Biosimilars Industry- Issues 54
    • 4.4.11 Drivers and Barriers 56
    • 4.4.12 Country Analysis - The UK 57
    • 4.4.13 Country Analysis - Germany 58
    • 4.4.14 Country Analysis - France 60
    • 4.4.15 Country Analysis - Spain 62
    • 4.4.16 Country Analysis - Italy 64
  • 4.5 Japan Biosimilars Market Size and Forecasts 65
    • 4.5.1 Market Size and Forecast 65
  • 4.6 Regulatory Landscape in Japan 66
    • 4.6.1 Regulatory Framework for Biopharmaceutical Industry 66
    • 4.6.2 Evolution of Regulatory Pathways for Biosimilars 67
    • 4.6.3 Current Position on Biosimilars 68
    • 4.6.4 Drivers and Barriers 69

5 Biosimilars in Developed Countries - Market Characterization 70

  • 5.1 Human Growth Hormone Biosimilars Market 70
    • 5.1.1 Pipeline molecules 71
    • 5.1.2 Drivers and barriers 72
  • 5.2 Erythropoietin (EPO) Biosimilars Market 73
    • 5.2.1 Pipeline molecules 75
    • 5.2.2 Drivers and barriers 76
  • 5.3 Granulocyte-Colony Stimulating Factor (G-CSF) Biosimilars Market 77
    • 5.3.1 Pipeline molecules 79
    • 5.3.2 Drivers and barriers 80
  • 5.4 Interferon alpha Biosimilars Market 81
    • 5.4.1 Pipeline molecules 82
  • 5.5 Interferon beta Biosimilars Market 82
    • 5.5.1 Pipeline molecules 83
    • 5.5.2 Interferon alpha and Interferon beta Drivers and Barriers 84
  • 5.6 Insulin and Insulin Analogs Biosimilars Market 85
    • 5.6.1 Pipeline molecules 87
    • 5.6.2 Drivers and barriers 88
  • 5.7 TNF-alpha Inhibitor Biosimilars Market 89
    • 5.7.1 Pipeline molecules 91
    • 5.7.2 Drivers and barriers 92
  • 5.8 Biosimilars Market for Monoclonal Antibodies against Cancer 93
    • 5.8.1 Pipeline molecules 95
    • 5.8.2 Drivers and barriers 97

6 Biosimilars in Developed Countries- Case Study 98

  • 6.1 Market Share of Biosimilars in Top Five European Markets 98
    • 6.1.1 Market Share - Filgrastim 98
    • 6.1.2 Market Share- Somatropin 98
    • 6.1.3 Market Share- EPO 99
  • 6.2 Pricing of Biosimilars in Top Five European Markets 100
  • 6.3 Strategies Adopted By Branded Biologic Companies to Beat Generic Competition 102
    • 6.3.1 Introduction 102
    • 6.3.2 Second Generation Biologics 102
    • 6.3.3 New Formulation 103
    • 6.3.4 Combination Products 103
    • 6.3.5 New Approved Indications 104
    • 6.3.6 Caps 104
  • 6.4 Industry Dynamics- Strategies to Be Adopted by Companies to Enter the Biosimilar Market 105
    • 6.4.1 Product 106
    • 6.4.2 Price 106
    • 6.4.3 Place 107
    • 6.4.4 Promotion 107
    • 6.4.5 People 108

7 Biosimilars in Developed Countries-Competitive Landscape 109

  • 7.1 Celltrion 109
    • 7.1.1 Company Profile 109
    • 7.1.2 SWOT Analysis 109
  • 7.2 Dr Reddy's Laboratories 110
    • 7.2.1 Company Profile 110
    • 7.2.2 SWOT Analysis 110
  • 7.3 Hospira 111
    • 7.3.1 Company Profile 111
    • 7.3.2 SWOT Analysis 111
  • 7.4 Biocon 112
    • 7.4.1 Company Profile 112
    • 7.4.2 SWOT Analysis 112
  • 7.5 Teva Pharmaceuticals Ltd 113
    • 7.5.1 Company Profile 113
    • 7.5.2 SWOT Analysis 113
  • 7.6 Sandoz 114
    • 7.6.1 Company Profile 114
    • 7.6.2 SWOT Analysis 114
  • 7.7 3SBio 115
    • 7.7.1 Company Profile 115
    • 7.7.2 SWOT Analysis 115
  • 7.8 Intas Pharma 116
    • 7.8.1 Company Profile 116
    • 7.8.2 SWOT Analysis 116
  • 7.9 Samsung Biologics 117
    • 7.9.1 Company Profile 117
    • 7.9.2 SWOT Analysis 117

8 Biosimilars in Developed Countries- Strategic Consolidations 118

  • 8.1 Deals by Type 118
  • 8.2 Mergers & Acquisitions (M&A) 119
    • 8.2.1 M&A Deals by Year 119
    • 8.2.2 M&A Deals by Value 120
    • 8.2.3 M&A Deals by Geography 121
    • 8.2.4 M&A Deals in 2011 122
  • 8.3 Licensing Agreements in the Biosimilars Market 123
    • 8.3.1 Licensing Agreements By Year 123
    • 8.3.2 Licensing Agreements By Value 124
    • 8.3.3 Licensing Agreements By Geography 125
    • 8.3.4 Licensing Agreement Deals 126
  • 8.4 Co- Development Deals 128
    • 8.4.1 Co-Development Deals By Year 128
    • 8.4.2 Co-Development Deals By Value 129
    • 8.4.3 Co-Development Deals By Geography 130
    • 8.4.4 Co-Development Deals 131

9 Biosimilars in Developed Countries- Appendix 134

  • 9.1 Market Definitions 134
  • 9.2 Abbreviations 135
  • 9.3 Bibliography 137
  • 9.4 Research Methodology 139
    • 9.4.1 Market Overview 140
    • 9.4.2 Geographic Landscape 140
    • 9.4.3 Market Characterization 140
    • 9.4.4 Case Study 141
    • 9.4.5 Competitive Landscape 141
    • 9.4.6 Strategic Consolidations 141
  • 9.5 Contact Us 141
  • 9.6 Disclaimer 141

List of Tables

1.1 List of Tables

  • Table 1: Biosimilars in Developed Countries, Patent Expiry of Leading Biologics 2011-2018 18
  • Table 2: Biosimilars in Developed Countries, European Union, Approved Biosimilars up to 2011 19
  • Table 3: Biosimilars in Developed Countries, Global, Market Forecasts ($m), 2011-2018 24
  • Table 4: Biosimilars in Developed Countries, US Biosimilars Market, Revenue Forecasts, ($m), 2011-2018 27
  • Table 5: Biosimilars in Developed Countries, European Biosimilars Market, Revenue Forecasts ($m), 2011-2018 44
  • Table 6: Biosimilars in Developed Countries, Biosimilar Approvals, Europe, 2011 52
  • Table 7: Biosimilars in Developed Countries, Japan Biosimilar Market, Revenue Forecasts ($m), 2011-2018 65
  • Table 8: Biosimilars in Developed Countries, Human Growth Hormone Biosimilars Market, Revenue Forecasts ($m), 2011-2018 71
  • Table 9: Biosimilars in Developed Countries, Human Growth Hormone Biosimilars Market, Pipeline Molecules, 2011 71
  • Table 10: Biosimilars in Developed Countries, Erythropoietin Biosimilars Market, Revenue Forecasts ($m), 2011-2018 73
  • Table 11: Biosimilars in Developed Countries, Erythropoietin Biosimilars Market, Pipeline Molecules Phase III , 2011 75
  • Table 12: Biosimilars in Developed Countries, Epoetin Alfa, Pipeline Molecules Phase I , 2011 75
  • Table 13: Biosimilars in Developed Countries, Erythropoietin Biosimilars Market, Pipeline Molecules Filed , 2011 75
  • Table 14: Biosimilars in Developed Countries, Erythropoietin Biosimilars Market, Pipeline Molecules Pre-Clinical , 2011 75
  • Table 15: Biosimilars in Developed Countries, Granulocyte-Colony Stimulating Factor Biosimilars Market, Revenue Forecasts ($m), 2011-2018 77
  • Table 16: Biosimilars in Developed Countries, Granulocyte-Colony Stimulating Factor Biosimilars Market, Pipeline Molecules Phase III , 2011 79
  • Table 17: Biosimilars in Developed Countries, Granulocyte-Colony Stimulating Factor Biosimilars Market, Pipeline Molecules Phase I , 2011 79
  • Table 18: Biosimilars in Developed Countries, Granulocyte-Colony Stimulating Factor Biosimilars Market, Pipeline Molecules Pre-clinical, 2011 79
  • Table 19: Biosimilars in Developed Countries, Granulocyte-Colony Stimulating Factor Biosimilars Market, Pipeline Molecules Filed, 2011 79
  • Table 20: Biosimilars in Developed Countries, Interferon alpha Biosimilars Market, Revenue Forecasts ($m), 2012-2018 81
  • Table 21: Biosimilars in Developed Countries, Interferon alpha Biosimilars Market, Pipeline Molecules, 2011 82
  • Table 22: Biosimilars in Developed Countries, Interferon beta Biosimilars Market, Revenue Forecasts ($m), 2012-2018 83
  • Table 23: Biosimilars in Developed Countries, Interferon beta Biosimilars Market, Pipeline Molecules, 2011 83
  • Table 24: Biosimilars in Developed Countries, Insulin and Insulin Analogs Biosimilars Market, Revenue Forecasts ($m), 2012-2018 86
  • Table 25: Biosimilars in Developed Countries, Insulin and Insulin Analogs Biosimilars Market, Pipeline Molecules, 2011 87
  • Table 26: Biosimilars in Developed Countries, TNF-alpha Inhibitor Biosimilars Market, Revenue Forecasts ($m), 2015-2018 89
  • Table 27: Biosimilars in Developed Countries, TNF-alpha Inhibitor Biosimilars Market, Pipeline Molecules, 2012 91
  • Table 28: Biosimilars in Developed Countries, Biosimilars Market for Monoclonal Antibodies Against Cancer, Revenue Forecasts ($m), 2014-2018 93
  • Table 29: Biosimilars in Developed Countries, Biosimilars Market for Monoclonal Antibodies Against Cancer, Pipeline Molecules, 2011 95
  • Table 30: Biosimilars in Developed Countries, Strategic Consolidations, Deals by Type, 2009-2012 118
  • Table 31: Biosimilars in Developed Countries, Strategic Consolidations, M&A Deals by Year, 2009-2011 119
  • Table 32: Biosimilars in Developed Countries, Strategic Consolidations, M&A Deals by Value*, 2009-2011 120
  • Table 33: Biosimilars in Developed Countries, Strategic Consolidations, M&A Deals by Geography, 2009-2011 121
  • Table 34: Biosimilars in Developed Countries, Strategic Consolidations, M&A Deals by Value, 2011 122
  • Table 35: Biosimilars in Developed Countries, Strategic Consolidations, Licensing Deals by Year, 2009-2011 123
  • Table 36: Biosimilars in Developed Countries, Strategic Consolidations, Licensing Deals by Value, 2009-2011 124
  • Table 37: Biosimilars in Developed Countries, Strategic Consolidations, Licensing Deals by Geography, 2009-2011 125
  • Table 38: Biosimilars in Developed Countries, Strategic Consolidations, Licensing Deals, 2011 126
  • Table 39: Biosimilars in Developed Countries, Strategic Consolidations, Co- Development Deals by Year, 2010-2011 128
  • Table 40: Biosimilars in Developed Countries, Strategic Consolidations, Co-Development Deals by Value, 2009-2012 129
  • Table 41: Biosimilars in Developed Countries, Strategic Consolidations, Co-Development Deals by Geography, 2009-2012 130
  • Table 42: Biosimilars in Developed Countries, Strategic Consolidations, Co-Development Deals, 2011-2012 131

List of Figures

1.2 List of Figures

  • Figure 1: Biosimilars in Developed Countries, Size and Complexity- Small Molecule Drugs and Proteins, 2011 14
  • Figure 2: Biosimilars in Developed Countries, Size and Complexity- Small Molecule Drugs and Proteins, 2011 15
  • Figure 3: Biosimilars in Developed Countries, Global Biologics Market Size 2010-2018, Sales by Major Drug Classes in Developed Countries, 2010 16
  • Figure 4: Biosimilars in Developed Countries, Top 10 Biologics, 2010 17
  • Figure 5: Biosimilars in Developed Countries, Biopharmaceutical and Biosimilars Manufacturing, 2011 20
  • Figure 6: Biosimilars in Developed Countries, Market Overview, Cost and Timeline for Developing a Biosimilar, 2011 21
  • Figure 7: Biosimilars in Developed Countries, Global Biosimilars Market, Geographic Landscape, Regulatory Landscape, 2011 22
  • Figure 8: Biosimilars in Developed Countries, Global, Market Forecasts ($m), 2011-2018 23
  • Figure 9: Biosimilars in Developed Countries, Global Biosimilars Market , Geographic Landscape, Drivers and Barriers, 2011 25
  • Figure 10: Biosimilars in Developed Countries, US Biosimilars Market, Revenue Forecasts ($m), 2011-2018 26
  • Figure 11: Biosimilars in Developed Countries, Objectives of Biosimilar Legislation and Regulatory Frameworks, 2012 28
  • Figure 12: Biosimilars in Developed Countries, US, Regulatory Bodies for Biologics, 2012 30
  • Figure 13: Biosimilars in Developed Countries, US, Regulatory Bodies for Biologics, 2012 30
  • Figure 14: Biosimilars in Developed Countries, US, Drug Development and Approval Process, 2010 31
  • Figure 15: Biosimilars in Developed Countries, US, Evolution of Regulatory Pathway, 2012 33
  • Figure 16: Biosimilars in Developed Countries, US, Impact of Data Exclusivity Period on Biosimilars Development, 2010 34
  • Figure 17: Biosimilars in Developed Countries, US, Patent Litigation Provisions in BPCIA - Round 1, 2010 38
  • Figure 18: Biosimilars in Developed Countries, US, Patent Litigation Provisions in BPCIA - Round 2, 2010 40
  • Figure 19: Biosimilars in Developed Countries, US, Drivers and Barriers for the Biosimilars Market, 2011 42
  • Figure 20: Biosimilars in Developed Countries, Top Five European Biosimilars Market, Revenue Forecasts ($m), 2011-2018 43
  • Figure 21: Biosimilars in Developed Countries, Drug Approval Process, Europe, 2011 45
  • Figure 22: Biosimilars in Developed Countries, Evolution of Regulatory Pathway for Approval of Biosimilars, Europe, 2011 46
  • Figure 23: Biosimilars in Developed Countries, General and Product Specific Guidelines for Biosimilars, Europe, 2011 47
  • Figure 24: Biosimilars in Developed Countries, Approval Process for Biosimilars, Europe, 2011 48
  • Figure 25: Biosimilars in Developed Countries, Data and Market Exclusivity Periods, Europe, 2011 49
  • Figure 26: Biosimilars in Developed Countries, Comparability Exercises, Europe, 2011 51
  • Figure 27: Biosimilars in Developed Countries, Number of Biosimilar Applications, Europe, 2004-2009 53
  • Figure 28: Biosimilars in Developed Countries, Key Issues Facing Biosimilars Market, Europe, 2011 54
  • Figure 29: Biosimilars in Developed Countries, Drivers and Barriers for the Biosimilars Market, Europe, 2009-2016 56
  • Figure 30: Biosimilars in Developed Countries, Drivers and Barriers for the Biosimilars Market, the UK, 2011 58
  • Figure 31: Biosimilars in Developed Countries, Drivers and Barriers for the Biosimilars Market, Germany, 2011 59
  • Figure 32: Biosimilars in Developed Countries, Drivers and Barriers for the Biosimilars Market, France, 2011 61
  • Figure 33: Biosimilars in Developed Countries, Drivers and Barriers for the Biosimilars Market, Spain, 2011 63
  • Figure 34: Biosimilars in Developed Countries, Drivers and Barriers for the Biosimilars Market, Italy, 2011 64
  • Figure 35: Biosimilars in Developed Countries, Japan Biosimilar Market, Revenue Forecasts ($m), 2011-2018 65
  • Figure 36: Biosimilars in Developed Countries, Evolution of Regulatory Pathway, Japan, November 2011 67
  • Figure 37: Biosimilars in Developed Countries, Drivers and Barriers for the Biosimilars Market, Japan, 2011 69
  • Figure 38: Biosimilars in Developed Countries, Human Growth Hormone Biosimilars Market, Revenue Forecasts ($m), 2011-2018 70
  • Figure 39: Biosimilars in Developed Countries, Erythropoietin Biosimilars Market, Drivers and Barriers, 2011 72
  • Figure 40: Biosimilars in Developed Countries, Erythropoietin Biosimilars Market, Revenue Forecasts ($m), 2011-2018 73
  • Figure 41: Biosimilars in Developed Countries, Erythropoietin Biosimilars Market, Marketed Products Outside the US and EU, 2011 74
  • Figure 42: Biosimilars in Developed Countries, Erythropoietin Biosimilars Market, Drivers and Barriers, 2011 76
  • Figure 43: Biosimilars in Developed Countries, Granulocyte-Colony Stimulating Factor Biosimilars Market, Revenue Forecasts ($m), 2011-2018 77
  • Figure 44: Biosimilars in Developed Countries, Granulocyte-Colony Stimulating Factor Biosimilars Market, Marketed Products Outside the US and EU, 2011 78
  • Figure 45: Biosimilars in Developed Countries, Granulocyte-Colony Stimulating Factor Biosimilars Market, Drivers and Barriers, 2011 80
  • Figure 46: Biosimilars in Developed Countries, Interferon alpha Biosimilars Market, Revenue Forecasts ($m), 2012-2018 81
  • Figure 47: Biosimilars in Developed Countries, Interferon alpha Biosimilars Market, Marketed Products Outside the US and the EU, 2011 82
  • Figure 48: Biosimilars in Developed Countries, Interferon beta Biosimilars Market, Revenue Forecasts ($m), 2012-2018 83
  • Figure 49: Biosimilars in Developed Countries, Interferon alpha and Interferon beta Biosimilars Market, Drivers and Barriers, 2011 84
  • Figure 50: Biosimilars in Developed Countries, Insulin and Insulin Analogs Biosimilars Market, Revenue Forecasts ($m), 2012-2018 86
  • Figure 51: Biosimilars in Developed Countries, Insulin and Insulin Analogs Biosimilars Market, Drivers and Barriers, 2011 88
  • Figure 52: Biosimilars in Developed Countries, TNF-alpha Inhibitor Biosimilars Market, Revenue Forecasts ($m), 2015-2018 89
  • Figure 53: Biosimilars in Developed Countries, TNF-alpha Inhibitor Biosimilars Market, Drivers and Barriers, 2011 92
  • Figure 54: Biosimilars in Developed Countries, Biosimilars Market for Monoclonal Antibodies Against Cancer, Revenue Forecasts ($m), 2014-2018 93
  • Figure 55: Biosimilars in Developed Countries, Biosimilars Market for Monoclonal Antibodies Against Cancer, Drivers and Barriers, 2011 97
  • Figure 56: Biosimilars in Developed Countries, Case Study, Biosimilars and Originator Sales in the EU Market ($m), 2007-2009 98
  • Figure 57: Biosimilars in Developed Countries, Case Study, Biosimilars and Originator's Eprex Market Share in Germany (%), 2007-2009 99
  • Figure 58: Biosimilars in Developed Countries, Case Study, Estimates of Generic Discount Offered in the US (%), 2005 100
  • Figure 59: Biosimilars in Developed Countries, Case Study, Discount on Biosimilars(%), 2007-2009 100
  • Figure 60: Biosimilars in Developed Countries, Market Overview, Eprex Branded vs. Generic Price Comparison (1000 I.E./0.5ml) ($), 2011 101
  • Figure 61: Biosimilars in Developed Countries, Industry Dynamics, Strategies Adopted By Branded Biologic Company to Beat Generic Competition, 2011 102
  • Figure 62: Biosimilars in Developed Countries, Industry Dynamics, Strategies To Be Adopted by Companies to Enter Biosimilar Market 105
  • Figure 63: Biosimilars in Developed Countries, Competitive Landscape, Celltrion SWOT Analysis, 2011 109
  • Figure 64: Biosimilars in Developed Countries, Competitive Landscape, Dr Reddy's Laboratories SWOT Analysis, 2011 110
  • Figure 65: Biosimilars in Developed Countries, Competitive Landscape, Hospira SWOT Analysis, 2011 111
  • Figure 66: Biosimilars in Developed Countries, Competitive Landscape, Biocon SWOT Analysis, 2011 112
  • Figure 67: Biosimilars in Developed Countries, Competitive Landscape, Teva Pharmaceuticals Ltd SWOT Analysis, 2011 113
  • Figure 68: Biosimilars in Developed Countries, Competitive Landscape, Sandoz SWOT Analysis, 2011 114
  • Figure 69: Biosimilars in Developed Countries, Competitive Landscape, 3SBio SWOT Analysis, 2011 115
  • Figure 70: Biosimilars in Developed Countries, Competitive Landscape, Intas Pharma SWOT Analysis, 2011 116
  • Figure 71: Biosimilars in Developed Countries, Competitive Landscape, Samsung Biologics SWOT Analysis, 2011 117
  • Figure 72: Biosimilars in Developed Countries, Strategic Consolidations, Deals by Type, 2009-2012 118
  • Figure 73: Biosimilars in Developed Countries, Strategic Consolidations, M&A Deals by Year, 2009-2011 119
  • Figure 74: Biosimilars in Developed Countries, Strategic Consolidations, M&A Deals by Value, 2009-2011 120
  • Figure 75: Biosimilars in Developed Countries, Strategic Consolidations, M&A Deals by Geography, 2009-2011 121
  • Figure 76: Biosimilars in Developed Countries, Strategic Consolidations, Licensing Deals by Year, 2009-2011 123
  • Figure 77: Biosimilars in Developed Countries, Strategic Consolidations, Licensing Deals by Value, 2009-2011 124
  • Figure 78: Biosimilars in Developed Countries, Strategic Consolidations, Licensing Deals by Geography, 2009-2011 125
  • Figure 79: Biosimilars in Developed Countries, Strategic Consolidations, Co-Development Deals by Year, 2010-2011 128
  • Figure 80: Biosimilars in Developed Countries, Strategic Consolidations, Co- Development Deals by Value, 2009-2012 129
  • Figure 81: Biosimilars in Developed Countries, Strategic Consolidations, Co-Development Deals by Geography, 2009-2012 130
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