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Biogenerics: The World Market for Biosimilars

Kalorama Information
April 1, 2008
153 Pages - SKU: KLI1399521

Attention: There is an updated edition available for this report.

Abstract Table of Contents Search inside this report Related Reports

Countries covered: Global

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:

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

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
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

Non-U.S. Market

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

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