The World Market for Orphan Drugs.pdf
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1、The World Market for Orphan Drugs 5th 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 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence o
2、r hereafter developed, in whole or in any part, is strictly prohibited. THE WORLDMARKET FOR ORPHAN DRUGS A KALORAMA INFORMATION MARKET INTELLIGENCE REPORT The World Market for Orphan Drugs has been prepared by Kalorama Information. We serve business and industrial clients in the United States and ab
3、road 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 thorough presentation of essential data and concise analysis. Author: Melissa Elder Publication
4、Date: July 2013 New York, New York (800) 298-5699 Outside the U.S. (212) 807-2657 FAX: (212) 807-2676 www.KaloramaI E-MAIL: Copyright 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly p
5、rohibited. Copyright 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. TABLE OF CONTENTS CHAPTER ONE: EXECUTIVE SUMMARY 1 Introduction . 1 Scope and Methodology 1 Market Segm
6、ents . 2 Issues and Trends 3 World Market Summary 3 Competitors 7 CHAPTER TWO: INTRODUCTION .9 Overview . 9 History of the U.S. Orphan Drug Market . 9 Pharmaceutical Research Lou Gehrigs disease), and muscular dystrophy, affect such small numbers of individuals in the United States, these diseases a
7、re considered rare under the Orphan Drug Act. There is general agreement that the total number of patients afflicted with rare diseases is significant. SCOPE AND METHODOLOGY For this market research report, market numbers discussed in this report are focused on the global market in brief with in-dep
8、th market coverage of the U.S. market. Additionally, there is select coverage for the European Union and Japanese market. All sales are displayed at the manufacturers level in U.S. dollars. Chapter One: Executive Summary 2 Copyright 2013 Kalorama Information Reproduction without prior written permis
9、sion, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. This report includes orphan drugs. In cases where sales are generated by indications for both orphan indications and non-orphan indications, we have attempted to extract just the orphan porti
10、on of sales. The base year is 2012, with forecasts provided for each year through 2017. The market was generated using estimates of individual product sales and compared with market data from a combination of other methods including disease prevalence trends, population trends, pricing trends, gover
11、nment regulations and reimbursements. Both primary and secondary sources were consulted in developing market estimates. Telephone interviews and email correspondence were the primary method of gathering information. For the purpose of this study Kalorama Information conducted interviews with more th
12、an 130 key industry officials, consultants, health care providers, and government personnel. These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Specific interviews with leading orphan drug developers represen
13、tatives including marketing directors, division managers, and product representatives, were consulted. Secondary sources such as company literature, databases, investment reports, and business journals were used to complement primary information. Market Segments As stated in the scope and methodolog
14、y outline, the report offers in-depth market data for the U.S. orphan drug industry. In this particular market, several segments are discussed, including: Oncology Hematology Musculoskeletal Neurology Endocrine Metabolic Others Chapter One: Executive Summary 3 Copyright 2013 Kalorama Information Rep
15、roduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. These segments are the most common areas of development and success for orphan drug developers/marketers which required providing detailed information ab
16、out these orphan drug market segments. ISSUES AND TRENDS The list of trends and factors affecting the orphan drug market remain lengthy. The orphan drug market is affected by both trends that affect the pharmaceutical industry as a whole and trends that specifically affect the orphan drug market. Th
17、e list below provides trends from both sides of the industry: Orphan drug pricing Aging of the population Increasing life expectancy Trends in birth rates Cost effectiveness Regulatory environments Orphan drug incentives Population demographics Product availability by country/region WORLD MARKET SUM
18、MARY The world orphan drug market is difficult to determine due to the variances in orphan drug status and requirements by country. Products may be available as an orphan drug on one country and be a traditional marketing approval for another country. In addition, some products gain orphan status, a
19、re granted approval and then removed from the orphan drug database at the request of the developer. There are a number of factors involved, including reimbursement by country, regulation by country, disease status by country and general development by country. The U.S. market is the largest orphan d
20、rug Chapter One: Executive Summary 4 Copyright 2013 Kalorama Information Reproduction without prior written permission, in any media now in existence or hereafter developed, in whole or in any part, is strictly prohibited. market worldwide with nearly 60% of sales, while the E.U. comes in at second
21、with less than half of U.S. sales. The U.S. is the most active and most lucrative market for orphan drugs. The world market for orphan drugs is valued at $61.1 billion for 2012, consisting largely of the $36.3 billion contribution from U.S. product sales. Sales will likely increase at a rate of 11.5
22、% throughout the forecast period, reaching a value of $105.2 billion by 2017. Leading contributors to the market will be global players such as Amgen, Roche and Novartis. Chapter One: Executive Summary 5 Copyright 2013 Kalorama Information Reproduction without prior written permission, in any media
23、now in existence or hereafter developed, in whole or in any part, is strictly prohibited. Table 1-1 World Orphan Drug Market 2007-2017 (in millions of dollars) Year Revenues Percent Change 2007 $30,910 2008 36,62018.5% 2009 40,38810.3% 2010 46,58315.3% 2011 53,09614.0% 2012 61,08515.0% 2013 68,60012
24、.3% 2014 77,44012.9% 2015 85,61310.6% 2016 94,79410.7% 2017 105,17511.0% Compound Annual Growth Rate Period CAGR 2007-2012 14.6% 2012-2017 11.5% 2007-2017 13.0% Source: Kalorama Information Chapter One: Executive Summary 6 Copyright 2013 Kalorama Information Reproduction without prior written permis
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