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

Published by	Kalorama Information
Published	August, 2009	Product code	96359
Content info	150 pages
Price	US $ 3700 PDF by E-mail (Single User License) US $ 4100 Hard Copy US $ 7400 PDF by E-mail (Global Site License)

Introduction
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The World Market for Biosimilars and the Potential for US Follow-on Biologics published by Kalorama Information in August, 2009. This report consists of 150 pages and the price starts from US $ 3700.

Introduction

Abstract

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 Kalorma 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.

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