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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 - Product Image

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

  • ID: 2175921
  • July 2012
  • Region: Europe, United States
  • 141 Pages
  • GBI Research

FEATURED COMPANIES

  • 3SBio
  • Biocon
  • Celltrion
  • Dr Reddy’s Laboratories
  • Hospira
  • Intas Pharma
  • MORE

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 READ MORE >

Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • 3SBio
  • Biocon
  • Celltrion
  • Dr Reddy’s Laboratories
  • Hospira
  • Intas Pharma
  • MORE

1.1 List of Tables
1.2 List of Figures

2 Introduction

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

4 Biosimilars in Developed Countries- Geographic Landscape
4.1 Introduction
4.2 Global Biosimilar Market
4.2.1 Market Size and Forecast
4.2.2 Drivers and Barriers
4.3 US Biosimilar Market
4.3.1 Market Size and Forecast
4.3.2 Regulatory Landscape
4.3.3 Objectives of Biosimilar Legislation and Regulatory Frameworks
4.3.4 Regulatory Framework for Biopharmaceutical Industry
4.3.5 Evolution of Regulatory Pathways for Biosimilars
4.3.6 BPCI Act and the Pathway for Approval of Biosimilar Products
4.3.7 Drivers and Barriers
4.4 Top Five European Markets- Biosimilar Market Size and Forecast
4.4.1 Introduction
4.4.2 Market Size and Forecast
4.4.3 Regulatory Framework for Biopharmaceutical Industry
4.4.4 Evolution of Regulatory Pathways for Biosimilars
4.4.5 Current Position on Biosimilars
4.4.6 The Bolar Type Provision
4.4.7 The Comparability Exercise
4.4.8 Biosimilars Approvals and Applications
4.4.9 EMA Guidelines for Biosimilar mAb
4.4.10 European Biosimilars Industry- Issues
4.4.11 Drivers and Barriers
4.4.12 Country Analysis – The UK
4.4.13 Country Analysis – Germany
4.4.14 Country Analysis – France
4.4.15 Country Analysis – Spain
4.4.16 Country Analysis – Italy
4.5 Japan Biosimilars Market Size and Forecasts
4.5.1 Market Size and Forecast
4.6 Regulatory Landscape in Japan
4.6.1 Regulatory Framework for Biopharmaceutical Industry
4.6.2 Evolution of Regulatory Pathways for Biosimilars
4.6.3 Current Position on Biosimilars
4.6.4 Drivers and Barriers

5 Biosimilars in Developed Countries – Market Characterization
5.1 Human Growth Hormone Biosimilars Market
5.1.1 Pipeline molecules
5.1.2 Drivers and barriers
5.2 Erythropoietin (EPO) Biosimilars Market
5.2.1 Pipeline molecules
5.2.2 Drivers and barriers
5.3 Granulocyte-Colony Stimulating Factor (G-CSF) Biosimilars Market
5.3.1 Pipeline molecules
5.3.2 Drivers and barriers
5.4 Interferon alpha Biosimilars Market
5.4.1 Pipeline molecules
5.5 Interferon beta Biosimilars Market
5.5.1 Pipeline molecules
5.5.2 Interferon alpha and Interferon beta Drivers and Barriers
5.6 Insulin and Insulin Analogs Biosimilars Market
5.6.1 Pipeline molecules
5.6.2 Drivers and barriers
5.7 TNF-alpha Inhibitor Biosimilars Market
5.7.1 Pipeline molecules
5.7.2 Drivers and barriers
5.8 Biosimilars Market for Monoclonal Antibodies against Cancer
5.8.1 Pipeline molecules
5.8.2 Drivers and barriers

6 Biosimilars in Developed Countries- Case Study
6.1 Market Share of Biosimilars in Top Five European Markets
6.1.1 Market Share – Filgrastim
6.1.2 Market Share- Somatropin
6.1.3 Market Share- EPO
6.2 Pricing of Biosimilars in Top Five European Markets
6.3 Strategies Adopted By Branded Biologic Companies to Beat Generic Competition
6.3.1 Introduction
6.3.2 Second Generation Biologics
6.3.3 New Formulation
6.3.4 Combination Products
6.3.5 New Approved Indications
6.3.6 Caps
6.4 Industry Dynamics- Strategies to Be Adopted by Companies to Enter the Biosimilar Market
6.4.1 Product
6.4.2 Price
6.4.3 Place
6.4.4 Promotion
6.4.5 People

7 Biosimilars in Developed Countries-Competitive Landscape
7.1 Celltrion
7.1.1 Company Profile
7.1.2 SWOT Analysis
7.2 Dr Reddy’s Laboratories
7.2.1 Company Profile
7.2.2 SWOT Analysis
7.3 Hospira
7.3.1 Company Profile
7.3.2 SWOT Analysis
7.4 Biocon
7.4.1 Company Profile
7.4.2 SWOT Analysis
7.5 Teva Pharmaceuticals Ltd
7.5.1 Company Profile
7.5.2 SWOT Analysis
7.6 Sandoz
7.6.1 Company Profile
7.6.2 SWOT Analysis
7.7 3SBio
7.7.1 Company Profile
7.7.2 SWOT Analysis
7.8 Intas Pharma
7.8.1 Company Profile
7.8.2 SWOT Analysis
7.9 Samsung Biologics
7.9.1 Company Profile
7.9.2 SWOT Analysis

8 Biosimilars in Developed Countries- Strategic Consolidations
8.1 Deals by Type
8.2 Mergers & Acquisitions (M&A)
8.2.1 M&A Deals by Year
8.2.2 M&A Deals by Value
8.2.3 M&A Deals by Geography
8.2.4 M&A Deals in 2011
8.3 Licensing Agreements in the Biosimilars Market
8.3.1 Licensing Agreements By Year
8.3.2 Licensing Agreements By Value
8.3.3 Licensing Agreements By Geography
8.3.4 Licensing Agreement Deals
8.4 Co- Development Deals
8.4.1 Co-Development Deals By Year
8.4.2 Co-Development Deals By Value
8.4.3 Co-Development Deals By Geography
8.4.4 Co-Development Deals

9 Biosimilars in Developed Countries- Appendix
9.1 Market Definitions
9.2 Abbreviations
9.3 Bibliography
9.4 Research Methodology
9.4.1 Market Overview
9.4.2 Geographic Landscape
9.4.3 Market Characterization
9.4.4 Case Study
9.4.5 Competitive Landscape
9.4.6 Strategic Consolidations
9.5 Contact Us
9.6 Disclaimer

1.1 List of Tables

Table 1: Biosimilars in Developed Countries, Patent Expiry of Leading Biologics 2011–2018
Table 2: Biosimilars in Developed Countries, European Union, Approved Biosimilars up to 2011
Table 3: Biosimilars in Developed Countries, Global, Market Forecasts ($m), 2011–2018
Table 4: Biosimilars in Developed Countries, US Biosimilars Market, Revenue Forecasts, ($m), 2011-2018
Table 5: Biosimilars in Developed Countries, European Biosimilars Market, Revenue Forecasts ($m), 2011–2018
Table 6: Biosimilars in Developed Countries, Biosimilar Approvals, Europe, 2011
Table 7: Biosimilars in Developed Countries, Japan Biosimilar Market, Revenue Forecasts ($m), 2011–2018
Table 8: Biosimilars in Developed Countries, Human Growth Hormone Biosimilars Market, Revenue Forecasts ($m), 2011–2018
Table 9: Biosimilars in Developed Countries, Human Growth Hormone Biosimilars Market, Pipeline Molecules, 2011
Table 10: Biosimilars in Developed Countries, Erythropoietin Biosimilars Market, Revenue Forecasts ($m), 2011–2018
Table 11: Biosimilars in Developed Countries, Erythropoietin Biosimilars Market, Pipeline Molecules Phase III , 2011
Table 12: Biosimilars in Developed Countries, Epoetin Alfa, Pipeline Molecules Phase I , 2011
Table 13: Biosimilars in Developed Countries, Erythropoietin Biosimilars Market, Pipeline Molecules Filed , 2011
Table 14: Biosimilars in Developed Countries, Erythropoietin Biosimilars Market, Pipeline Molecules Pre-Clinical , 2011
Table 15: Biosimilars in Developed Countries, Granulocyte-Colony Stimulating Factor Biosimilars Market, Revenue Forecasts ($m), 2011–2018
Table 16: Biosimilars in Developed Countries, Granulocyte-Colony Stimulating Factor Biosimilars Market, Pipeline Molecules Phase III , 2011
Table 17: Biosimilars in Developed Countries, Granulocyte-Colony Stimulating Factor Biosimilars Market, Pipeline Molecules Phase I , 2011
Table 18: Biosimilars in Developed Countries, Granulocyte-Colony Stimulating Factor Biosimilars Market, Pipeline Molecules Pre-clinical, 2011
Table 19: Biosimilars in Developed Countries, Granulocyte-Colony Stimulating Factor Biosimilars Market, Pipeline Molecules Filed, 2011
Table 20: Biosimilars in Developed Countries, Interferon alpha Biosimilars Market, Revenue Forecasts ($m), 2012–2018
Table 21: Biosimilars in Developed Countries, Interferon alpha Biosimilars Market, Pipeline Molecules, 2011
Table 22: Biosimilars in Developed Countries, Interferon beta Biosimilars Market, Revenue Forecasts ($m), 2012–2018
Table 23: Biosimilars in Developed Countries, Interferon beta Biosimilars Market, Pipeline Molecules, 2011
Table 24: Biosimilars in Developed Countries, Insulin and Insulin Analogs Biosimilars Market, Revenue Forecasts ($m), 2012–2018
Table 25: Biosimilars in Developed Countries, Insulin and Insulin Analogs Biosimilars Market, Pipeline Molecules, 2011
Table 26: Biosimilars in Developed Countries, TNF-alpha Inhibitor Biosimilars Market, Revenue Forecasts ($m), 2015–2018
Table 27: Biosimilars in Developed Countries, TNF-alpha Inhibitor Biosimilars Market, Pipeline Molecules, 2012
Table 28: Biosimilars in Developed Countries, Biosimilars Market for Monoclonal Antibodies Against Cancer, Revenue Forecasts ($m), 2014–2018
Table 29: Biosimilars in Developed Countries, Biosimilars Market for Monoclonal Antibodies Against Cancer, Pipeline Molecules, 2011
Table 30: Biosimilars in Developed Countries, Strategic Consolidations, Deals by Type, 2009–2012
Table 31: Biosimilars in Developed Countries, Strategic Consolidations, M&A Deals by Year, 2009–2011
Table 32: Biosimilars in Developed Countries, Strategic Consolidations, M&A Deals by Value*, 2009–2011
Table 33: Biosimilars in Developed Countries, Strategic Consolidations, M&A Deals by Geography, 2009–2011
Table 34: Biosimilars in Developed Countries, Strategic Consolidations, M&A Deals by Value, 2011
Table 35: Biosimilars in Developed Countries, Strategic Consolidations, Licensing Deals by Year, 2009–2011
Table 36: Biosimilars in Developed Countries, Strategic Consolidations, Licensing Deals by Value, 2009–2011
Table 37: Biosimilars in Developed Countries, Strategic Consolidations, Licensing Deals by Geography, 2009–2011
Table 38: Biosimilars in Developed Countries, Strategic Consolidations, Licensing Deals, 2011
Table 39: Biosimilars in Developed Countries, Strategic Consolidations, Co- Development Deals by Year, 2010–2011
Table 40: Biosimilars in Developed Countries, Strategic Consolidations, Co-Development Deals by Value, 2009–2012
Table 41: Biosimilars in Developed Countries, Strategic Consolidations, Co-Development Deals by Geography, 2009–2012
Table 42: Biosimilars in Developed Countries, Strategic Consolidations, Co-Development Deals, 2011–2012

1.2 List of Figures

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

Note: Product cover images may vary from those shown

- Celltrion
- Dr Reddy’s Laboratories
- Hospira
- Biocon
- Teva Pharmaceuticals Ltd
- Sandoz
- 3SBio
- Intas Pharma
- Samsung Biologics

Note: Product cover images may vary from those shown
Note: Product cover images may vary from those shown

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