Table of Contents
CHAPTER ONE: EXECUTIVE SUMMARY
- Introduction
- Scope and Methodology
- Size and Growth of the Market
- Table 1-1: Total World Biosimilar Market Potential 2006-2013, Products
with Currently Expired Patents
- Figure 1-1: Total World Biosimilar Market Potential 2006-2013, Products
with Currently Expired Patents
- Trends Affecting the Market
- Market Outlook
CHAPTER TWO: INTRODUCTION AND OVERVIEW
- Biogenerics Overview
- Table 2-1: Scientific Differences of Pharmaceuticals and Biopharmaceuticals
- Biopharmaceutical Industry and Approval Process
- Genetic Engineering
- Patent Approval
- Regulations for Biopharmaceuticals
- History of the Prescription Generic Pharmaceuticals Industry
- History of the Generic Approval Process
- Regulation of Prescription Generic Pharmaceuticals
- Biopharmaceuticals
- Areas of Treatment for Biopharmaceuticals
CHAPTER THREE: BIOGENERIC PHARMACEUTICALS FOR EXPIRED BIOLOGIC PATENTS
- Table 3-1: Select Marketed Biopharmaceuticals with Expired Patents
- Select Marketed Biopharmaceuticals with Expired Patents
CHAPTER FOUR: BIOGENERIC PHARMACEUTICALS FOR FUTURE EXPIRED BIOLOGIC PATENTS
- Table 4-: Select Marketed Biopharmaceuticals with Active Patents
CHAPTER FIVE: ISSUES AND TRENDS
- Overview
- Worldwide Regulatory and Legislative Issues
- Europe
- Table 5-1: Biosimilars Approved in EU
- Biosimilars Approved in EU
- United States
- Pathway for Biosimilars Act
- Promoting Innovation and Access to Life-Saving Medicine Act
- Japan
- Rest of World
- Asia and Biogenerics
- Scientific Issues
- Immunogenicity
- Patent Issues
- Pricing Issues
- Table 5-2: Estimates of Treatment Cost Per Patient of Selected
Biopharmaceuticals
- Barriers to Entry
- Innovator Companies and Follow-on Biologics
- Innovator Strategies and Challenges
- Bulk Suppliers and Contract Manufacturing
- Bioequivalence Issues
- International Issues
- Low Cost Branded HGH
- Biogenerics and Health-Care Spending
- Intellectual Property
CHAPTER SIX: MARKET SUMMARY
- Market Size and Growth
- Table 6-: Total World Biosimilar Market Potential 2006-2013, Products with
Currently Expired Patents
- Figure 6-: World Biosimilar Market Potential by Region 2006-2013, Products
with Currently Expired Patents
- Regional Market Analysis
- Table 6-2: World Biosimilar Market Potential by Region 2006-2013, Products
with Currently Expired Patents
- Figure 6-2: World Biosimilar Market Potential by Region 2006-2013,
Products with Currently Expired Patents
- Biologic Class Market Analysis
- Table 6-3: The World Market Potential for Biosimilars by Biological Class
(EPO, G-CSF, HGH, Insulin, Interfereon alpha, Others) 2006-2013*
- Figure 6-3: The World Market Potential for Biosimilars by Biological Class
2006-2013
- Figure 6-4: The World Market Potential for Biosimilars by Biological Class
Market Share 2009
- Figure 6-5: The World Market Potential for Biosimilars by Biological Class
Market Share 2013
- Key Biosimilar Markets and Comparison to Brand Market
- Table 6-4: Market Share of Biosimilar Sales in Comparison to Brand Sales,
2009 Estimates
- Market Potential
- U.S. Market
- Non-U.S. Market
- Competitor Analysis
- Potential ‘War' between Brand and Generic
- Table 6-5: Market Share of Early Leaders in the World Biosimilar Market,
2009
CHAPTER SEVEN: CORPORATE PROFILES
- Apotex, Inc.
- Biocon Ltd .
- Biogenerix Ag
- BioPartners GmbH
- Cangene Corporation
- Dr. Reddy' s Laboratories Limited
- Dragon Pharmaceuticals, Inc.
- GeneMedix PLC
- Hospira, Inc.
- Merck Bioventures
- Microbix Biosystems, Inc.
- Momenta Pharmaceuticals Inc
- Phage Biotechnology Corp
- Ranbaxy Laboratories Limited
- Sandoz
- STADA Arzneimittel AG
- TEVA Pharmaceutical Industries, Ltd.
- Watson Pharmaceuticals, Inc.
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