The World Market for Biosimilars and the Potential for US Follow-on Biologics.pdf
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1、 The World Market for Biosimilars Rures adquireret umbraculi, etiam tremulus matrimonii libere senesceret app August 2009 Kalorama Information A division of MarketR 38 East 29th Street Sixth Floor New York, New York 10016 212.807 .2660 t 800.298.5603 t 212.807 .2676 f Copyright 2009 Kalorama Inform
2、ation Reproduction without prior written permission, in any media now in existence or hereafter developed, whole or in any part, is strictly prohibited THE WORLD MARKET FOR BIOSIMILARS AND THE FUTURE OF FOLLOW-ON BIOLOGICS A KALORAMA INFORMATION MARKET INTELLIGENCE REPORT World Market for Biosimilar
3、s has been prepared by Kalorama Information. We serve business and industrial clients worldwide with a complete line of information services and research publications. Kalorama Information Market Intelligence Reports are specifically designed to aid the action-oriented executive by providing a thoro
4、ugh presentation of essential data and concise analysis. Editor Steven Heffner Author: Mary Anne Crandall Publication Date: August 2009 641 Avenue of the Americas New York, New York 10011-2002 (800) 298-5699 Outside the U.S. (212) 807-2657 FAX: (212) 807-2676 http:/www.KaloramaI E-MAIL: KLI2402283
5、Copyright 2009 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, whole or in any part, is strictly prohibited TABLE OF CONTENTS CHAPTER ONE: EXECUTIVE SUMMARY1 Introduction.1 Scope and Methodology2 Size and Growth of the Market
6、.3 Table 1-1: Total World Biosimilar Market Potential 2006-2013, Products with Currently Expired Patents5 Figure 1-1: Total World Biosimilar Market Potential 2006-2013, Products with Currently Expired Patents.6 Trends Affecting the Market .7 Biosimilars in the U.S. 9 Figure 1-2: Projected Biosimilar
7、s Market in the U.S. to-2015 (millions).11 Market Outlook.11 INTRODUCTION AND OVERVIEW15 Biogenerics Overview .15 Table 2-1: Scientific Differences of Pharmaceuticals and Biopharmaceuticals .17 Biopharmaceutical Industry and Approval Process18 Genetic Engineering .19 Patent Approval20 Regulations fo
8、r Biopharmaceuticals .22 History of the Prescription Generic Pharmaceuticals Industry .24 History of the Generic Approval Process26 Regulation of Prescription Generic Pharmaceuticals28 Biopharmaceuticals.29 Areas of Treatment for Biopharmaceuticals31 CHAPTER THREE: BIOGENERIC PHARMACEUTICALS FOR EXP
9、IRED BIOLOGIC PATENTS .35 Table 3-1: Select Marketed Biopharmaceuticals with Expired Patents41 CHAPTER FOUR: BIOGENERIC PHARMACEUTICALS FOR FUTURE EXPIRED BIOLOGIC PATENTS 43 Table 4-1: Select Marketed Biopharmaceuticals with Active Patents57 vi World Market for Biosimilars Copyright 2009 Kalorama I
10、nformation Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. vi CHAPTER FIVE: ISSUES AND TRENDS 63 Overview63 Worldwide Regulatory and Legislative Issues .64 Europe.64 Table 5-1: Biosimilars Approved
11、in EU.67 Biosimilars Approved in EU 68 United States.69 Pathway for Biosimilars Act75 Promoting Innovation and Access to Life-Saving Medicine Act75 Japan.75 Rest of World76 Asia and Biogenerics.77 Scientific Issues81 Immunogenicity81 Patent Issues82 Pricing Issues.82 Table 5-2: Estimates of Treatmen
12、t Cost Per Patient of Selected Biopharmaceuticals.83 Barriers to Entry.84 Innovator Companies and Follow-on Biologics86 Innovator Strategies and Challenges.87 Bulk Suppliers and Contract Manufacturing.88 Bioequivalence Issues89 International Issues.91 Low Cost Branded HGH94 Biogenerics and Health-Ca
13、re Spending94 Intellectual Property.95 CHAPTER SIX: MARKET SUMMARY97 Market Size and Growth97 Table 6-1: Total World Biosimilar Market Potential 2006-2013, Products with Currently Expired Patents .98 Figure 6-1: World Biosimilar Market Potential by Region 2006-2013, Products with Expired Patents .99
14、 Regional Market Analysis 100 Table 6-2: World Biosimilar Market Potential by Region 2006-2013, Products with Currently Expired Patents101 Figure 6-2: World Biosimilar Market Potential by Region 2006-2013, Products with Currently Expired Patents.102 Table of Contents vii Copyright 2009 Kalorama Info
15、rmation Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. Biologic Class Market Analysis .103 Table 6-3: The World Market Potential for Biosimilars by Biological Class (EPO, G-CSF, HGH, Insulin, Inter
16、fereon alpha, Others) 2006-2013* 104 Figure 6-3: The World Market Potential for Biosimilars by Biological Class Market Share 2009.105 Figure 6-4 The World Market Potential for Biosimilars by Biological Class Market Share 2013.106 Table 6-4: Market Share of Biosimilar Sales in Comparison to Brand Sal
17、es107 Market Potential108 U.S. Market108 Non-U.S. Market108 Competitor Analysis .109 Potential War between Brand and Generic109 Table 6-5: Market Share of Early Leaders in the World Biosimilar Market, 2009 110 CHAPTER SEVEN: CORPORATE PROFILES.111 Apotex, Inc.113 Biocon Ltd .115 Biogenerix Ag117 Bio
18、Partners GmbH.119 Cangene Corporation .121 Dr. Reddys Laboratories Limited.123 Dragon Pharmaceuticals, Inc.125 GeneMedix PLC127 Hospira, Inc.129 Merck Bioventures130 Microbix Biosystems, Inc. 132 Momenta Pharmaceuticals Inc134 Phage Biotechnology Corp.135 Ranbaxy Laboratories Limited.136 Sandoz138 S
19、TADA Arzneimittel AG.141 TEVA Pharmaceutical Industries, Ltd.143 Watson Pharmaceuticals, Inc.148 APPENDIX A: COMPANY DIRECTORY151 Copyright 2009 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, whole or in any part, is strictly
20、 prohibited CHAPTER ONE Executive Summary INTRODUCTION Worldwide interest in biogenerics, biosimilars or whatever name is attached to follow-on proteins is gaining momentum. Kalorama Information last visited this topic in 2006. Since that time there has been increasing worldwide involvement in the d
21、evelopment of the biogeneric arena; however, the United States is still lagging due to regulatory stumbling blocks. Some of the biggest-selling biological drugs developed during the first phase of the biotechnology revolution in the 1980s, including human growth hormone (hGH) and insulin, have lost
22、patent protection. This opens up the market currently worth $40 billion and growing at over 20% per year if the regulatory hurdles can be overcome. Biopharmaceuticals are synthetic or recombinant versions of natural biologic substances, including proteins such as enzymes or antibodies, and nucleic a
23、cids such as DNA or RNA. Generic products are non-patented chemical and therapeutic equivalents of brand name drugs. However, biogenerics are not generic biologics because there can be no generic form of biologics due to the complex process of creating biologics. Industry participants are struggling
24、 with what to call these hybrid forms of biologics that will be created by the generic companies. 2 World Market for Biosimilars Copyright 2009 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, whole or in any part, is strictly
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