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
Published on December 2009

                                                                                                                          Report Summary

Summary


The author 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




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                                                                                                                           Table of Content

1 Table of Contents
1 Executive Summary
1.1 Escalating Healthcare Expenditures Increase the Need for Low Cost Biosimilars
1.2 Differences Between the Branded and Generics Industries in the US is Reflected in the Legislative Proposals
1.3 Lack of Interchangeability Between Biosimilars and Reference Products Slows Down Uptake of Biosimilars
1.4 High Costs of Development and Manufacturing Coupled with the Need for Technical Expertise in Biologics Act as Entry Barriers
for Smaller Players and Favors Larger Players
2 Table of Contents
2.1 List of Tables
2.2 List of Figures
3 Introduction
3.1 GBI Research Report Guidance
4 The Future of Biosimilars ' Market Overview
4.1 Overview of the Biopharmaceutical Industry
4.2 Comparison of Biosimilars with Generics
4.3 Biopharmaceutical Manufacturing Process
5 The Future of Biosimilars ' Market Characterization
5.1 Global Market Size and Forecasts
5.2 The US Biosimilars Market Size and Forecasts
5.3 Europe Biosimilars Market Size and Forecasts
5.4 Japan Biosimilars Size and Market Forecasts
5.5 Market Forecasts for Biosimilars
5.5.1 Human Growth Hormone Biosimilars Markets
5.5.2 Erythropoietin (EPO) Biosimilars Markets
5.5.3 Granulocyte ' Colony Stimulating Factor (G-CSF) Biosimilars Markets
5.6 Opportunity Analysis
5.6.1 Interferon-alpha Biosimilars
5.6.2 Interferon-beta Biosimilars
5.6.3 Insulin and Insulin Analogs Biosimilars
5.6.4 Monoclonal Antibodies
5.7 Unmet Needs in the Biopharmaceutical Market
6 The Future of Biosimilars ' Regulatory Landscape
6.1 Regulatory Landscape in the US
6.1.1 Regulatory Framework for Biopharmaceutical Industry
6.1.2 Evolution of Regulatory Pathways for Biosimilars
6.1.3 Current Position on Biosimilars
6.1.3.1 Comparison of Eshoo Barton with Waxman Legislative Proposals
6.1.3.2 Approval of Omnitrope
6.1.4 Drivers and Barriers
6.2 Regulatory Landscape in Europe
6.2.1 Regulatory Framework for Biopharmaceutical Industry
6.2.2 Evolution of Regulatory Pathways for Biosimilars
6.2.3 Current Position on Biosimilars
6.2.3.1 Overarching Guidelines
6.2.3.2 Quality Guidelines
6.2.3.3 Non Clinical and Clinical Guidelines


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6.2.3.4 Annexes ' Product Specific Guidelines
6.2.3.5 Post Authorization Requirements
6.2.3.6 Data Exclusivity Period
6.2.3.7 What does this mean to the biosimilar industry'
6.2.4 The 'Bolar' Type Provision
6.2.5 The Comparability Exercise
6.2.6 Biosimilars Approvals and Applications
6.2.7 Issues Facing the European Biosimilars Industry
6.2.7.1 Naming
6.2.7.2 Labeling
6.2.7.3 Substitution / Interchangeability
6.2.7.4 Pharmacovigilance
6.2.8 Drivers for the European Biosimilars Market
6.2.8.1 Patent expiry of key biologic drugs will boost the market potential
6.2.8.2 Biosimilars will be widely accepted by payers as means to reduce rising healthcare costs
6.2.8.3 Leading pharma companies eye biosimilars as an area of growth
6.2.8.4 Biosimilar manufacturers from low cost emerging countries will drive market expansion
6.2.9 Barriers for the European Biosimilars Market
6.2.9.1 Substitution still remains a contentious issue in many European countries
6.2.9.2 Barriers to entry remain high due to a complex and high cost manufacturing process
6.2.9.3 Tradeoff between patient safety and healthcare costs will resist the acceptance of biosimilars
6.2.10 Country Analysis - The United Kingdom
6.2.10.1 Structure of the Healthcare System
6.2.10.2 Pricing and Reimbursement Mechanisms
6.2.10.3 Drivers and Barriers for Biosimilars
6.2.11 Country Analysis - Germany
6.2.11.1 Structure of the Healthcare System
6.2.11.2 Pricing and Reimbursement Mechanisms
6.2.11.3 Drivers and Barriers for Biosimilars
6.2.12 Country Analysis - France
6.2.12.1 Structure of the Healthcare System
6.2.12.2 Pricing and Reimbursement Mechanisms
6.2.12.3 Drivers and Barriers for Biosimilars
6.2.13 Country Analysis - Spain
6.2.13.1 Structure of the Healthcare System
6.2.13.2 Pricing and Reimbursement Mechanisms
6.2.13.3 Drivers and Barriers for Biosimilars
6.2.14 Country Analysis - Italy
6.2.14.1 Structure of the Healthcare System
6.2.14.2 Pricing and Reimbursement Mechanisms
6.2.14.3 Drivers and Barriers for Biosimilars
6.3 Regulatory Landscape in Japan
6.3.1 Regulatory Framework for Biopharmaceutical Industry
6.3.2 Evolution of Regulatory Pathways for Biosimilars
6.3.3 Current Position on Biosimilars
6.3.3.1 First Biosimilar Approved
6.3.4 Drivers and Barriers
7 The Future of Biosimilars ' Competitive Landscape
7.1 Costs of Biosimilar Development Are Higher Than That of Generics
7.2 High Initial Investments Favors Growth of Biosimilars Players with Financial Strength


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7.3 Technical Expertise in Biopharmaceutical Development and Manufacturing Determines Strategic Positioning
7.4 Leading Biosimilars Players
7.4.1 Teva Pharmaceuticals Ltd
7.4.1.1 Approved Biosimilars:
7.4.2 Dr. Reddy's Laboratories
7.4.2.1 Approved Biosimilars
7.4.3 Phage Biotechnology Corporation
7.4.3.1 Pipeline Biosimilar Products
7.4.4 Cangene Corporation
7.4.5 Biopartners
7.4.5.1 Approved Biosimilars
7.4.6 BioCon Ltd
7.4.6.1 Approved biosimilar products:
7.4.7 BioGenerix AG
7.4.7.1 Pipeline Biosimilar Products
7.4.8 Apotex Inc
7.4.9 Sandoz
7.4.9.1 Approved Biosimilar Products:
7.4.10 Hospira Inc
7.4.10.1 Approved Biosimilar Products:
7.4.11 Watson Pharmaceuticals
7.4.12 STADA Arzneimittel AG
7.4.13 ANALIZA, INC
7.4.14 Reliance GeneMedix Plc
7.4.14.1 Approved Biosimilar products
7.4.15 Momenta Pharmaceuticals
7.4.15.1 Pipeline Biosimilar products
7.4.16 Microbix Biosystems Inc
7.4.17 Dragon Pharmaceuticals
8 The Future of Biosimilars ' Strategic Consolidations
8.1 Mergers & Acquisitions
8.1.1 Merck Acquires Insmed Follow-On Biologics for $130m
8.1.2 Teva and Lonza JV Targets Biosimilars
8.1.3 GTC Enters Follow-On-Biologic Founder Development Collaboration With Ag Research
8.2 Licensing deals:
8.2.1 Innogene Seals Deal With CIMAB To Market Biosimilars
8.2.2 Abraxis Licenses Rights To Biosimilar From Indian Firm Biocon
9 Appendix
9.1 Market Definitions
9.2 Abbreviations
9.3 Research Methodology
9.3.1 Coverage
9.3.2 Secondary Research
9.3.3 Primary Research
9.3.4 Expert Panel Validation
9.4 Contact Us
9.5 Disclaimer



List of Tables


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Table 1: The Future of Biosimilars, Global, Market Forecasts, 2008-2015
Table 2: The Future of Biosimilars, US, Market Forecasts, 2008-2015
Table 3: The Future of Biosimilars, Europe, Market Forecasts, 2008-2015
Table 4: The Future of Biosimilars, Japan, Market Forecasts, 2008-2015
Table 5: The Future of Biosimilars, Global, hGH Biosimilars Market Forecasts, 2008-2015
Table 6: The Future of Biosimilars, Global, EPO Biosimilars Market Forecasts, 2008-2015
Table 7: The Future of Biosimilars, Global, G-CSF Biosimilars Market Forecasts, 2008-2015
Table 8: The Future of Biosimilars, Global, Interferon-alpha Opportunity Analysis, 2008-2015
Table 9: The Future of Biosimilars, Global, Interferon-beta Opportunity Analysis, 2008-2015
Table 10: The Future of Biosimilars, Global, Insulin and Insulin Analogs Opportunity Analysis, 2008-2015
Table 11: The Future of Biosimilars, US, Biologics Off-Patent in the US, 2008
Table 12: The Future of Biosimilars, US, Comparison of Waxman and Eshoo Proposals, November 2009
Table 13: The Future of Biosimilars, Europe, Existing Guidelines for Biosimilars, November 2009
Table 14: The Future of Biosimilars, Europe, Biosimilar Approvals, November 2009
Table 15: The Future of Biosimilars, Europe, Applications Rejected or Withdrawn, November 2009


List of Figures
Figure 1: The Future of Biosimilars, Share of Top 25 Biologics By Therapeutic Class, 2008
Figure 2: The Future of Biosimilars, Share of Top 25 Biologics By Production System, 2008
Figure 3: The Future of Biosimilars, Biologics Under Development by Therapeutic Class, Global, 2008
Figure 4: The Future of Biosimilars, Biologics Under Development by Disease Category, Global, 2008
Figure 5: The Future of Biosimilars, Comparison of Biosimilars With Generics, 2008
Figure 6: The Future of Biosimilars, Development Costs and Timelines for a Biosimilar, 2008
Figure 7: The Future of Biosimilars, Challenges in Biopharmaceutical Manufacturing, 2008
Figure 8: The Future of Biosimilars, Solutions to Challenges Faced in Biopharmaceutical Manufacturing, 2008
Figure 9: The Future of Biosimilars, Global, Market Forecasts, 2008-2015
Figure 10: The Future of Biosimilars, US, Market Forecasts, 2008-2015
Figure 11: The Future of Biosimilars, Europe, Market Forecasts, 2008-2015
Figure 12: The Future of Biosimilars, Japan, Market Forecasts, 2008-2015
Figure 13: The Future of Biosimilars, Global, hGH Biosimilars Market Forecasts, 2008-2015
Figure 14: The Future of Biosimilars, Global, EPO Biosimilars Market Forecasts, 2008-2015
Figure 15: The Future of Biosimilars, Global, G-CSF Biosimilars Market Forecasts, 2008-2015
Figure 16: The Future of Biosimilars, Global, Interferon-alpha Opportunity Analysis, 2008-2015
Figure 17: The Future of Biosimilars, Global, Interferon-beta Opportunity Analysis, 2008-2015
Figure 18: The Future of Biosimilars, Global, Insulin and Insulin Analogs Opportunity Analysis, 2008-2015
Figure 19: The Future of Biosimilars, Biologics Going Off Patent, 2010-2015
Figure 20: The Future of Biosimilars, US, Regulatory Bodies for Biologics, November 2009
Figure 21: The Future of Biosimilars, US, Drug Development and Approval Process, November 2009
Figure 22: The Future of Biosimilars, US, Evolution of Regulatory Pathway, November 2009
Figure 23: The Future of Biosimilars, US, Impact of Data Exclusivity Period on Biosimilars Development, November 2009
Figure 24: The Future of Biosimilars, US, Impact of Eshoo Proposal on Biosimilars Industry, November 2009
Figure 25: The Future of Biosimilars, US, Impact of Waxman Proposal on Biosimilars Industry, November 2009
Figure 26: The Future of Biosimilars, US, Drivers and Barriers for the Biosimilars Market, 2008-2015
Figure 27: The Future of Biosimilars, Europe, Drug Approval Process, November 2009
Figure 28: The Future of Biosimilars, Europe, Evolution of Regulatory Pathway for Approval of Biosimilars, November 2009
Figure 29: The Future of Biosimilars, Europe, General and Product Specific Guidelines for Biosimilars, November 2009
Figure 30: The Future of Biosimilars, Europe, Approval Process for Biosimilars, November 2009
Figure 31: The Future of Biosimilars, Europe, Data and Market Exclusivity Periods, November 2009
Figure 32: The Future of Biosimilars, Europe, Comparability Exercises, November 2009
Figure 33: The Future of Biosimilars, Europe, Number of Biosimilar Applications, 2004-2009


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Figure 34: The Future of Biosimilars, Europe, Key Issues Facing Biosimilars Market, November 2009
Figure 35: The Future of Biosimilars, Europe, Drivers and Barriers for the Biosimilars Market, 2008-2015
Figure 36: The Future of Biosimilars, The United Kingdom, Drivers and Barriers for the Biosimilars Market, 2008-2015
Figure 37: The Future of Biosimilars, Germany, Drivers and Barriers for the Biosimilars Market, 2008-2015
Figure 38: The Future of Biosimilars, France, Drivers and Barriers for the Biosimilars Market, 2008-2015
Figure 39: The Future of Biosimilars, Spain, Drivers and Barriers for the Biosimilars Market, 2008-2015
Figure 40: The Future of Biosimilars, Italy, Drivers and Barriers for the Biosimilars Market, 2008-2015
Figure 41: The Future of Biosimilars, Japan, Evolution of Regulatory Pathway, November 2009
Figure 42: The Future of Biosimilars, Japan, Drivers and Barriers for the Biosimilars Market, 2008-2015
Figure 43: The Future of Biosimilars, Costs of Development, Manufacturing and Approval of Biosimilars By Cell Culture Type, 2008
Figure 44: The Future of Biosimilars, Percentage Split of Biosimilars Players Based on Company Size, 2008
Figure 45: The Future of Biosimilars, Strategic Positioning in Biosimilars Market, 2008
Figure 46: The Future of Biosimilars, Avenues for Cost Reduction in Biosimilars Development, 2008
Figure 47: The Future of Biosimilars, Teva Pharmaceuticals Ltd
Figure 48: The Future of Biosimilars, Dr. Reddy's Laboratories
Figure 49: The Future of Biosimilars, Phage Biotechnology Corporation
Figure 50: The Future of Biosimilars, Cangene Corporation
Figure 51: The Future of Biosimilars, Biopartners
Figure 52: The Future of Biosimilars, BioCon Ltd
Figure 53: The Future of Biosimilars, BioGenerix AG
Figure 54: The Future of Biosimilars, Apotex Inc
Figure 55: The Future of Biosimilars, Sandoz Inc
Figure 56: The Future of Biosimilars, Hospira Inc
Figure 57: The Future of Biosimilars, Watson Pharmaceuticals
Figure 58: The Future of Biosimilars, STADA Arzneimittel AG
Figure 59: The Future of Biosimilars, ANALIZA, INC
Figure 60: The Future of Biosimilars, Reliance GeneMedix Plc
Figure 61: The Future of Biosimilars, Momenta Pharmaceuticals
Figure 62: The Future of Biosimilars, Microbix Biosystems Inc
Figure 63: The Future of Biosimilars, Dragon Pharmaceuticals
Figure 64: GBI Research Methodology



Companies mentioned
Teva Pharmaceuticals Ltd
Dr. Reddy's Laboratories
Phage Biotechnology Corporation
Cangene Corporation
Biopartners
BioCon Ltd
BioGenerix AG
Apotex Inc
Sandoz
Hospira Inc
Watson Pharmaceuticals
STADA Arzneimittel AG
ANALIZA, INC
Reliance GeneMedix Plc
Momenta Pharmaceuticals
Microbix Biosystems Inc


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Dragon Pharmaceuticals




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