Biogenerics - The World Market: Biosimilars and Biologics at a Crossroads
The biopharmaceutical market is at a crossroads. Some of the biggest-selling biologics developed during the first phase of the biotechnology revolution in the 1980s, including human growth hormone (hGH) and insulin, have lost patent protection or are set to lose patent protection in the US in 2007 and beyond. This opens up the market currently worth $40 billion and growing at over 20% per year if the regulatory hurdles can be overcome.
This report, Biogenerics, The World Market: Biosimilars and Biologics at a Crossroads identifies key biologic products that are off patent and are either facing development of a generic competitor or are likely to face biogeneric competition in the future.
The report includes a breakdown of generic replacements for:
- Drugs with Active patents
- Drugs with Expired patents
with this geographic breakdown:
- World
- US
- non-US
As part of overall market coverage of biogenerics, this report includes:
- Complete Overview
- Market Size Projections for Biogenerics Products
- Patent dates for Major Biopharmaceuticals
- Issues and Trends in the Industry
- Scientific Differences Between Biopharmaceuticals and Biogenerics
- Key Regulations Affecting this Market
- Company Profiles
The following critical trends occuring in biogenerics are discussed:
- Worldwide Regulatory and Legislative Issues
- Asia and Biogenerics
- Scientific Issues
- Patent Issues
- Pricing Issues
- Barriers to Entry
- Innovator Strategies and Challenges
- Bulk Suppliers and Contract Manufacturing
- Bioequivalence Issues
- International Issues
- Low Cost Branded HGH
- Biogenerics and Health-Care Spending
- Intellectual Property
As part of Kalorama Information\'s trusted information gathering process, this report is the result of both primary and secondary research. In addition to exhaustive research, Key executives at biogeneric companies were consulted to uncover key trends and develop models.
Table of Contents
TABLE OF CONTENTS
CHAPTER ONE: EXECUTIVE SUMMARY
- Introduction
- Scope and Methodology
- Size and Growth of the Market
- Trends Affecting the Market
- Market Outlook
CHAPTER TWO: INTRODUCTION AND OVERVIEW
- Biogenerics Overview
- 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
- Non-U.S. Market
- Market Size and Growth
- World Market
- Non-U.S. Market
- Overview
- Worldwide Regulatory and Legislative Issues
- Europe
- United States
- Rest of World
- Asia and Biogenerics
- Scientific Issues
- Patent Issues
- Pricing Issues
- Barriers to Entry
- Innovator Strategies and Challenges
- Bulk Suppliers and Contract Manufacturing
- Bioequivalence Issues
- International Issues
- Low Cost Branded HGH
- Biogenerics and Health-Care Spending
- Intellectual Property
- Total Market Size and Forecast
- Competitor Analysis
- Analiza, Inc
- Apotex, Inc.
- Barr Laboratories, Inc.
- Biogenerix Ag
- Biocon Ltd .
- BioPartners GmbH
- Cangene Corporation
- Dr. Reddy’s Laboratories Limited
- Dragon Pharmaceuticals, Inc.
- GeneMedix PLC
- Hospira, Inc.
- Microbix Biosystems, Inc.
- Momenta Pharmaceuticals Inc
- Phage Biotechnology Corp
- Sandoz
- Sicor, Inc.
- STADA Arzneimittel AG
- TEVA Pharmaceutical Industries, Ltd.
- Watson Pharmaceuticals, Inc.
CHAPTER ONE: EXECUTIVE SUMMARY
- Table 1-1: Total World Biogenerics Market Potential 2006-2012
- Figure 1-1: The World Market Potential for BioGeneric Drugs by Revenues 2006-2012
- Table 2-1: Scientific Differences of Pharmaceuticals and Biopharmaceuticals
- Table 3-2: Marketed Biopharmaceuticals with Expired Patents
- Table 3-3: Total World Biogenerics Market Potential 2006-2012, Products with Expired Patents
- Table 3-4: Total U.S. Biogenerics Market Potential 2006-2012, Products with Expired PatentsTable 3-5: Total Non-U.S. Biogenerics Market Potential 2006-2012, Productswith Expired Patents
- Table 4-1: Marketed Biopharmaceuticals with Active Patents
- Table 4-2: Total World Biogenerics Market Potential 2006-2012, Products with Active Patents
- Table 4-3: Total U.S. Biogenerics Market Potential 2006-2012, Products withActive Patents
- Table 4-4: Total Non-U.S. Biogenerics Market Potential 2006-2012, Products with Active Patents
- Table 5-1: Estimates of Treatment Cost Per Patient of Selected Biopharmaceuticals
- Table 6-1: Total World Biogenerics Market Potential 2006-2012
- Table 6-2: The World Market Potential for BioGeneric Drugs by Patent Segment 2006-2012
- Figure 6-1 Total World Biogenerics Market Potential 2006-2012 (Active, Expired)
- Figure 6-2 The World Market Potential for BioGeneric Drugs by Patent Segment (Active, Expired) 2006-2012
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