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Published by: Kalorama Information
Published: Apr. 1, 2008 - 153 Pages
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
Market Size and Growth
CHAPTER FOUR: BIOGENERIC PHARMACEUTICALS FOR FUTURE EXPIRED BIOLOGIC PATENTS
- Market Size and Growth
- World Market
- Non-U.S. Market
CHAPTER FIVE: ISSUES AND TRENDS
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
CHAPTER SIX: MARKET SUMMARY
Total Market Size and Forecast
Competitor Analysis
CHAPTER SEVEN: CORPORATE PROFILES
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.
LIST OF EXHIBITS
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
INTRODUCTION AND OVERVIEW
Table 2-1: Scientific Differences of Pharmaceuticals and Biopharmaceuticals
CHAPTER THREE: BIOGENERIC PHARMACEUTICALS FOR EXPIRED BIOLOGIC PATENTS
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 Patents
Table 3-5: Total Non-U.S. Biogenerics Market Potential 2006-2012, Products
with Expired Patents
CHAPTER FOUR: BIOGENERIC PHARMACEUTICALS FOR FUTURE EXPIRED BIOLOGIC 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
CHAPTER FIVE: ISSUES AND TRENDS
Table 5-1: Estimates of Treatment Cost Per Patient of Selected
Biopharmaceuticals
CHAPTER SIX: MARKET ANALYSIS
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
Abstract In one sense, the opportunity for follow-on proteins is as good as ever. 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. But there are also regulatory challenges to marketing follow-on biologics in the U.S. that companies will need to navigate to prosper. In this report, Biogenerics: The World Market for Biosimilars Kalorama has identified key biologic products that are off patent and are either facing development of a generic competitor or are likely in Kalorama's estimate to face biogeneric competition in the future.
Since Kalorama Information last visited the market for synthetic or recombinant versions of natural biologic substances, including proteins such as enzymes or antibodies four years ago, there has been much more worldwide involvement in the development of the biogeneric arena.
Kalorama Information's survey includes as part of its market analysis a breakdown of generic replacements for:
- Drugs with Active patents
- Drugs with Expired patents
with this geographic breakdown:
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.
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