World Market for Biosimilars and the Potential for US Follow-on Biologics, The

Publication Date	August 2009
Publisher	Kalorama Information
Product Type	Report
Pages	150
ISBN Number	not applicable
Product Code	KAL00178

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Summary

Biosimilars, or generic biologic drugs, are marketed around the world but still restricted in the U.S. This may soon change, and Kalorama Information has released this timely study of the market in Europe and other areas in the world and the possibility of a U.S. Market in the near future. As part of its research, this Kalormaa Information report provides the following

Current market size and forecasts for biogenerics in Europe and Rest of World Markets
Review of Marketed Biological Drugs with Expired Patents
Review of Marketed Biological Drugs with Active Patents
Profiles of the Major Competitors in biogenerics
Discussion of FDA and EMEA regulatory activity
Pending U.S. Legislation and Projections for US Markets
Coverage of Patent Trends, Pricing Trends, Healthcare Spending, IP and ohter Relevant Issues and Trends

For purposes of study, Kalorama has focused on the market for products which have lost patent in key markets. Projections were made based on the progress that is occurring within the generic arena in terms of capabilities, capital, interest, and development of biopharmaceuticals.
Kalorama has identified the biopharmaceuticals that have lost patent protection and are likely to be the first products that will be attempted by generic companies. Some of these products are relatively simple in structure (by biotech complexity) such as the insulins and human growth hormones, while others are extremely difficult to process.
There are a number of biopharmaceuticals that are identified as potential targets for generic development. Many of these biopharmaceutical patents have expired. Many of these products sport manufacturer sales of over $10 billion, presenting a ripe opportunity for generic manufacturers. However, because many of these products demonstrate sales of over $1 billion per year, it is anticipated that there will considerable resistance from the biotech innovator companies in allowing generic capitalization and consequently approvals.
The information and analysis presented in this report are based on an extensive survey of senior management in the biogeneric drug industry. Background information was obtained from a comprehensive search of published literature and reports obtained from various government, business, medical trade, and international journals.

Key information from published literature was used to conduct interviews with over 42 industry executives and product managers to validate and obtain expert opinion on current and future trends in the psychotherapeutic industry. Interviews were also used to confirm and/or adjust market size, as well as in formulating market projections.

All market data pertains to the world market at the manufacturers' level. Data are expressed in current U.S. dollars. The geographic scope of the study is worldwide with particular emphasis on the United States and Europe.

Content

CHAPTER ONE: EXECUTIVE SUMMARY
- Introduction
- Scope and Methodology
- Size and Growth of the Market
- List of Tables
- Table 1-1: Total World Biosimilar Market Potential 2006-2013, Products with Currently Expired Patents
- List of Figures
- 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
- List of Tables
- 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
- List of Tables
- Table 3-1: Select Marketed Biopharmaceuticals with Expired Patents
- Select Marketed Biopharmaceuticals with Expired Patents
CHAPTER FOUR: BIOGENERIC PHARMACEUTICALS FOR FUTURE EXPIRED BIOLOGIC PATENTS
- List of Tables
- Table 4-: Select Marketed Biopharmaceuticals with Active Patents
CHAPTER FIVE: ISSUES AND TRENDS
- Overview
- Worldwide Regulatory and Legislative Issues
- Europe
- List of Tables
- 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
- List of Tables
- 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
- List of Tables
- Table 6-: Total World Biosimilar Market Potential 2006-2013, Products with Currently Expired Patents
- List of Figures
- Figure 6-: World Biosimilar Market Potential by Region 2006-2013, Products with Currently Expired Patents
- Regional Market Analysis
- List of Tables
- Table 6-2: World Biosimilar Market Potential by Region 2006-2013, Products with Currently Expired Patents
- List of Figures
- Figure 6-2: World Biosimilar Market Potential by Region 2006-2013, Products with Currently Expired Patents
- Biologic Class Market Analysis
- List of Tables
- Table 6-3: The World Market Potential for Biosimilars by Biological Class (EPO, G-CSF, HGH, Insulin, Interfereon alpha, Others) 2006-2013*
- List of Figures
- 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
- List of Tables
- 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
- List of Tables
- 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.
- COMPANY DIRECTORY