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市場調査レポート

稀少疾病用医薬品 (オーファンドラッグ) の世界市場

Global Markets for Orphan Drugs

発行 BCC Research 商品コード 121229
出版日 ページ情報 英文 162 Pages
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稀少疾病用医薬品 (オーファンドラッグ) の世界市場 Global Markets for Orphan Drugs
出版日: 2015年09月21日 ページ情報: 英文 162 Pages
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BCC Research社のレポートは、Reuter、Wall Street Journal、Fortuneなどで引用されることも多く、それぞれの業界の識者の意見として重きを置かれています。同社レポートを複数冊ご購入の場合年間パッケージのご契約がお得です。詳細は右の担当者のおすすめ商品よりご覧下さい。
概要

稀少疾病用医薬品 (オーファンドラッグ) の世界市場は2014年には総計で約1230億米ドルの規模を有し、今後も9.2%のCAGR (年平均成長率) で伸び続け、2019年には市場規模がほぼ1910億米ドルに達する見通しです。

当レポートは、医薬品市場の中で特に稀少疾病用医薬品 (オーファンドラッグ) の世界市場について精査しており、稀少疾病用医薬品の治療への応用状況、法規制の枠組み、特許、ならびに最近のイノベーションについて詳細な分析を行っています。また各医療分野の下位市場とそれらにおける稀少疾病用医薬品の適用状況、市場シェア、技術上の最新動向や開発状況についても分析を加え、さらに今後の市場予測を行っています。

第1章 序論

第2章 要点

  • まとめ図表:タイプ別に分類した稀少疾病用医薬品の世界市場収益額 (〜2019年)

第3章 概要

  • 各種の稀少疾病用医薬品
    • 稀少疾病用バイオ医薬品
    • 稀少疾病用化学医薬品/非バイオ医薬品
  • 稀少疾病の世界的定義
    • 米国
    • EU
    • 台湾
    • 日本
    • オーストラリア
  • 稀少疾病用医薬品法の歴史と展望
  • 米国の法規
  • 稀少疾病用医薬品の世界的展望
    • 欧州
    • オーストラリア
    • シンガポール
    • 日本
    • 台湾
    • カナダ
    • ブラジル
    • 韓国
    • イスラエル
    • ロシア
    • カザフスタン
  • 稀少疾病用医薬品法の影響
  • 稀少疾病用医薬品と通常の医薬品の差異
  • 承認済み稀少疾病用医薬品の投薬

第4章 法規制状況

  • 稀少疾病用医薬品の市場での承認 - 2010〜2014年
  • リコール
  • 安全警告

第5章 新開発

  • 臨床試験段階の稀少疾病用医薬品
  • 企業吸収合併

第6章 市場分析

  • タイプ別市場分類
    • 市場概要
    • 各市場の収益額
    • 市場シェア
  • 地域別市場分類
    • 市場概要
    • 各地域市場の収益額
    • 市場シェア
  • 稀少疾病用バイオ医薬品
    • 市場概要
    • 市場収益額
    • 市場シェア
    • 地域市場
  • 稀少疾病用非バイオ医薬品
    • 市場概要
    • 市場収益額
    • 市場シェア
    • 地域市場

第7章 業界構造

  • 稀少疾病用バイオ医薬品
    • トップ企業
    • 市場シェア
  • 稀少疾病用非バイオ医薬品
    • トップ企業
    • 市場シェア

第8章 適用分野別市場分析

  • 適用分野別に見た稀少疾病用医薬品の世界市場
    • 市場概要
    • 市場収益額
    • 市場シェア
    • 腫瘍疾患
    • 肺疾患
    • 心疾患および腎疾患
    • 自己免疫異常
    • 血液異常
    • 神経疾患
    • ホルモン異常および感染症

第9章 特許分析

年度別主要特許 タイプ別/カテゴリー別主要特許 企業別主要特許 国別主要特許 譲受人別主要特許

第10章 現在の動向

  • 稀少疾病用医薬品市場の成長促進要因
  • 課題

第11章 主要企業プロファイル

第12章 略語一覧

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目次
Product Code: PHM038E

REPORT HIGHLIGHTS

The global orphan drug market totaled nearly $123 billion in 2014 and will continue to grow to reach nearly $191 billion by 2019, demonstrating a compound annual growth rate (CAGR) of 9.2% during the forecast period (2014 to 2019).

This report provides:

  • An overview of orphan drug criteria, the history of the Orphan Drug Act and its influence, advantages inherent in orphan drug designation, and future growth trends.
  • Analyses of global market trends, with data from 2013 and 2014, and projections of compound annual growth rates (CAGRs) through 2019.
  • Detailed discussion of successful orphan products.
  • Detailed analysis of blockbuster orphan drugs.
  • The rising influence of pharmacogenomics in the orphan drug market.
  • A discussion of specific rare diseases for which orphan drugs exist.
  • Analysis of the most promising therapeutic areas in the industry and leading orphan drugs in these areas.
  • An outline of legislation and regulation, including public and private agencies involved in support and development.
  • Technology trends analysis within the orphan drug market.
  • Comprehensive company profiles of major players in the industry.

SCOPE OF THE REPORT

The scope of this study includes orphan drugs used in pharmaceutical markets globally. This report analyzes the therapeutic applications of orphan drugs in rare and orphan diseases as well as regulatory framework, patents, and recent innovations. The report also analyzes each submarket and its applications, projections and market shares. Technological issues include the latest trends and developments.

This report covers U.S. and European markets as well as emerging global markets like India, Japan, China, Singapore, Taiwan, Korea, Canada, Brazil, Africa, Australia, New Zealand, etc.

ANALYSTS' CREDENTIALS

The study was carried out by a team of professionals in the biotechnology industry. The manager for this project was Shalini S. Dewan, who holds a master's degree in pharmaceutical chemistry, and has over 14 years of industry experience. Shalini was awarded a Gold Medal by the Prime Minister of India for her work and has collaborated with top companies in India and the U.S.

Table of Contents

CHAPTER 1 - INTRODUCTION

  • STUDY OBJECTIVES
  • REASONS FOR DOING THIS REPORT
  • CONTRIBUTIONS OF THE REPORT AND FOR WHOM
  • SCOPE OF THE REPORT
  • METHODOLOGY
  • INFORMATION SOURCES
  • ANALYSTS' CREDENTIALS
  • RELATED BCC RESEARCH REPORTS
  • BCC RESEARCH WEBSITE
  • DISCLAIMER

CHAPTER 2 - EXECUTIVE SUMMARY

  • SUMMARY TABLE: GLOBAL REVENUES OF ORPHAN DRUGS BY TYPE, THROUGH 2019 ($ MILLIONS)
  • SUMMARY FIGURE: GLOBAL REVENUES OF ORPHAN DRUGS BY TYPE, 2012-2019 ($ MILLIONS)

CHAPTER 3 - OVERVIEW

  • DIFFERENT KINDS OF ORPHAN DRUGS
    • BIOLOGICAL ORPHAN DRUGS
    • CHEMICAL OR NON-BIOLOGICAL ORPHAN DRUGS
  • GLOBAL DEFINITIONS OF RARE DISEASES
    • U.S.
    • EU
    • TAIWAN
    • JAPAN
    • AUSTRALIA
      • TABLE 1: RARE DISEASES AND THEIR PREVALENCE
    • PERSPECTIVE AND HISTORY OF ORPHAN DRUG ACT
      • TABLE 2: HISTORY OF RARE DISEASES AND ORPHAN DRUG LEGISLATION
  • LEGISLATION IN THE U.S.
    • NATIONAL ORGANIZATION FOR RARE DISORDERS (NORD)
    • ORPHAN DRUG ACT
      • TABLE 3: AMENDMENTS OF U.S. ORPHAN DRUG ACT
  • GLOBAL PERSPECTIVE OF ORPHAN DRUGS
    • EUROPE
    • AUSTRALIA
    • SINGAPORE
    • JAPAN
    • TAIWAN
    • CANADA
    • BRAZIL
    • SOUTH KOREA
    • ISRAEL
    • RUSSIA
    • KAZAKHSTAN
      • TABLE 4: COMPARISON OF ORPHAN DRUG LEGISLATION IN THE U.S., EU, AUSTRALIA AND JAPAN
    • IMPACT OF ORPHAN DRUG ACT
      • TABLE 5: NUMBER OF FDA ORPHAN DRUG DESIGNATIONS AND APPROVALS PER YEAR, 1983-2014
    • DIFFERENCE BETWEEN ORPHAN DRUGS VS NORMAL DRUGS
      • TABLE 6: DIFFERENCES BETWEEN ORPHAN DRUGS AND NORMAL DRUGS
    • APPLICATION OF APPROVED ORPHAN DRUGS
      • TABLE 7: APPROVED ORPHAN DRUGS AND THEIR THERAPEUTIC USE

CHAPTER 4 - REGULATORY ASPECTS

  • TABLE 8: MARKET APPROVALS OF ORPHAN DRUGS, 2010-2014
  • RECALLS
    • TABLE 9: RECALLS OF ORPHAN DRUGS, 2010-2014
  • SAFETY ALERTS
    • TABLE 10: SAFETY ALERTS OF ORPHAN DRUGS, 2010-2014

CHAPTER 5 - NEW DEVELOPMENTS

  • TABLE 11: ORPHAN DRUGS IN CLINICAL TRIALS
  • MERGERS AND ACQUISITIONS
    • TABLE 12: MERGERS AND ACQUISITIONS OF ORPHAN DRUG COMPANIES, 2010-2014

CHAPTER 6 - MARKET ANALYSIS

  • MARKET BY TYPE
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 13: GLOBAL REVENUE FOR ORPHAN DRUGS BY TYPE, THROUGH 2019 ($ MILLIONS)
      • FIGURE 1: GLOBAL REVENUE FOR ORPHAN DRUGS BY TYPE, 2012-2019 ($ MILLIONS)
    • MARKET SHARES
      • TABLE 14: GLOBAL MARKET SHARE OF MAJOR ORPHAN DRUGS BY TYPE, 2013 (%)
      • FIGURE 2: GLOBAL MARKET SHARE OF MAJOR ORPHAN DRUGS BY TYPE, 2013 (%)
  • MARKET BY REGION
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 15: GLOBAL REVENUE FOR ORPHAN DRUGS BY REGION, THROUGH 2019 ($ MILLIONS)
      • FIGURE 3: GLOBAL REVENUE FOR ORPHAN DRUGS BY REGION, 2012-2019 ($ MILLIONS)
    • MARKET SHARE
      • TABLE 16: GLOBAL MARKET SHARE OF ORPHAN DRUGS BY REGION, 2013 (%)
      • FIGURE 4: GLOBAL MARKET SHARE OF ORPHAN DRUGS BY REGION, 2013 (%)
  • BIOLOGICAL ORPHAN DRUGS
    • MARKET OVERVIEW
      • Ilaris (canakinumab)
      • Proleukin (aldesleukin)
      • Nplate (romiplostim)
      • Enbrel (etanercept)
      • Neupogen (filgrastim)
      • Sensipar/Mimpara (cinacalcet)
      • Neulasta (pegfilgrastim)
      • Xgeva (denosumab)
      • Epogen/Procrit (epoetin alfa)
      • Yervoy (ipilimumab)
      • Betaseron/Betaferon (interferon beta-1b)
      • Intron A (interferon Alfa-2b)
      • Kogenate (Recombinant Anti-hemophilic Factor)
      • Remicade (infliximab)
      • Rebetol (ribavirin)
      • Novoseven (Recombinant Coagulation Factor VIIa)
      • Norditropin, Saizen, Genotropin and Nutropin (Somatotropin Recombinant Deoxyribo Nucleic Acid (rDNA))
      • Benefix (Recombinant Coagulation Factor IX)
      • Avastin (bevacizumab)
      • Rituxan/Mab Thera (rituximab)
      • Herceptin (trastuzumab)
      • Aldurazyme (laronidase)
      • Fabrazyme (agalsidase beta)
      • Myozyme/Lumizyme (aglucosidase alpha)
      • Thymoglobulin/Thymoglobulime (Anti-thymocyte Globulin)
      • Mozobil (plerixafor injection)
      • Naglazyme (galsulfase)
      • Soliris (eculizumab)
      • Humira (adalimumab)
      • Elaprase (idursulfase) and VPRIV (velaglucerase alfa)
      • Replagal (agalsidase alfa)
      • Gammagard Liquid (Human Immune Globulin Intravenous)
      • Avonex and Rebif (interferon beta 1-alpha)
      • Other Biological Orphan Drugs
    • MARKET REVENUE
      • TABLE 17: GLOBAL REVENUE OF BIOLOGICAL ORPHAN DRUGS BY ACTIVE INGREDIENT, THROUGH 2019 ($ MILLIONS)
    • MARKET SHARE
      • TABLE 18: GLOBAL MARKET SHARES OF BIOLOGICAL DRUGS, 2013 (%)
      • FIGURE 5: GLOBAL MARKET SHARES OF NON-BIOLOGICAL DRUGS, 2013 (%)
    • MARKET BY REGION
      • Market Overview
      • Market Revenue
        • TABLE 19: GLOBAL REVENUE FOR BIOLOGICAL ORPHAN DRUGS BY REGION, THROUGH 2019 ($ MILLIONS)
        • FIGURE 6: GLOBAL REVENUE FOR BIOLOGICAL ORPHAN DRUGS BY REGION, 2012-2019 ($ MILLIONS)
      • Market Share
        • TABLE 20: GLOBAL MARKET SHARE OF BIOLOGICAL ORPHAN DRUG MARKET BY REGION, 2013 (%)
        • FIGURE 7: GLOBAL MARKET SHARE OF BIOLOGICAL ORPHAN DRUG MARKET BY REGION, 2013 (%)
  • NON-BIOLOGICAL ORPHAN DRUGS
    • MARKET OVERVIEW
      • Exjade (deferasirox)
      • Sandostatin LAR (octreotide acetate)
      • Afinitor/Votubia (everolimus)
      • TOBI (tobramycin)
      • Zometa/Zomera/Aclasta/Reclast (zoledronic or zoledronate)
      • Gleevec/Glivec (imatinib mesylate)
      • Copaxone (glatiramer acetate)
      • Tasigna (nilotinib)
      • Sprycel (dasatanib)
      • Onfi (clobazam)
      • Revlimid (lenalidomide)
      • Thalomid (thalidomide)
      • Vidaza (azacitidine for injection)
      • Pomalyst/Imnovid (pomalidomide)
      • Flolan (epoprostenol sodium)
      • Volibris/Letairis/Pulmonext (ambrisentan)
      • Lamictal (lamatrigine)
      • Promacta/Revolade (eltrombopag)
      • Votrient (pazopanib)
      • Velcade (bortezomib)
      • Aromasin (exemestane)
      • Celebrex (Celecoxib)
      • Xalkori (crizotinib)
      • Cerezyme (imiglucerase for injection)
      • Kuvan (6R-BH4)
      • Tracleer (bosentan)
      • Opsumit (macitentan)
      • Zavesca (miglustat)
      • Ventavis (iloprost)
      • Kalydeco (ivacaftor)
      • Treanda (bendamustine), Copaxone (glatiramer)
      • Lialda (mesalamine)
      • Other Non-Biological Orphan Drugs
    • MARKET REVENUE
      • TABLE 21: GLOBAL REVENUE FOR NON-BIOLOGICAL ORPHAN DRUGS BY ACTIVE INGREDIENT, THROUGH 2019 ($ MILLIONS)
    • MARKET SHARE
      • TABLE 22: GLOBAL MARKET SHARES OF NON-BIOLOGICAL DRUGS, 2013 (%)
      • FIGURE 8: GLOBAL MARKET SHARES OF NON-BIOLOGICAL DRUGS, 2013 (%)
    • MARKET BY REGION
      • Market Overview
      • Market Revenue
        • TABLE 23: GLOBAL REVENUE FOR NON-BIOLOGICAL ORPHAN DRUGS BY REGION, THROUGH 2019 ($ MILLIONS)
        • FIGURE 9: GLOBAL REVENUE FOR NON-BIOLOGICAL ORPHAN DRUGS BY REGION, 2012-2019 ($ MILLIONS)
      • Market Share
        • TABLE 24: GLOBAL MARKET SHARE OF NON-BIOLOGICAL ORPHAN DRUG MARKET BY REGION, 2013 (%)
        • FIGURE 10: GLOBAL MARKET SHARE OF NON-BIOLOGICAL ORPHAN DRUG MARKET BY REGION, 2013 (%)

CHAPTER 7 - INDUSTRY STRUCTURE

  • BIOLOGICAL ORPHAN DRUGS
    • MARKET LEADERS
      • TABLE 25: LEADING MANUFACTURERS/SUPPLIERS OF BIOLOGICAL ORPHAN DRUGS, 2013
    • MARKET SHARE
      • TABLE 26: GLOBAL MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS FOR BIOLOGICAL ORPHAN DRUGS, 2013 (%)
      • FIGURE 11: GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR BIOLOGICAL ORPHAN DRUGS, 2013 (%)
  • NON-BIOLOGICAL ORPHAN DRUGS
    • MARKET LEADERS
      • TABLE 27: LEADING MANUFACTURERS/SUPPLIERS OF NON-BIOLOGICAL ORPHAN DRUGS, 2013
    • MARKET SHARE
      • TABLE 28: GLOBAL MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS FOR NON-BIOLOGICAL ORPHAN DRUGS, 2013 (%)
      • FIGURE 12: MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR NON-BIOLOGICAL ORPHAN DRUGS, 2013 (%)

CHAPTER 8 - MARKET BY APPLICATION

  • GLOBAL ORPHAN DRUGS MARKET BY APPLICATION
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 29: GLOBAL REVENUES FOR ORPHAN DRUGS BY MEDICAL APPLICATION, THROUGH 2019 ($ MILLIONS)
      • FIGURE 13: GLOBAL REVENUES FOR ORPHAN DRUGS BY MEDICAL APPLICATION, 2012-2019 ($ MILLIONS)
    • MARKET SHARE
      • TABLE 30: GLOBAL MARKET SHARE OF ORPHAN DRUGS BY MEDICAL APPLICATION, 2013 (%)
      • FIGURE 14: GLOBAL MARKET SHARE OF ORPHAN DRUGS BY MEDICAL APPLICATION, 2013 (%)
    • ONCOLOGY
      • TABLE 31: ONCOLOGY DISEASES
      • Market Overview
      • Market Revenue
        • TABLE 32: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN ONCOLOGY, THROUGH 2019 ($ MILLIONS)
    • PULMONOLOGY
      • TABLE 33: PULMONOLOGY DISEASES
      • Market Overview
      • Market Revenue
        • TABLE 34: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN PULMONOLOGY, THROUGH 2019 ($ MILLIONS)
        • FIGURE 15: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN PULMONOLOGY, 2012-2019 ($ MILLIONS)
    • CARDIOLOGY AND NEPHROLOGY
      • TABLE 35: CARDIOLOGY AND NEPHROLOGY DISEASES
      • Market Overview
      • Market Revenue
        • TABLE 36: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN CARDIOLOGY AND NEPHROLOGY, THROUGH 2019 ($ MILLIONS)
        • FIGURE 16: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN CARDIOLOGY AND NEPHROLOGY, 2012-2019 ($ MILLIONS)
    • AUTOIMMUNE DISORDERS
      • TABLE 37: AUTOIMMUNE DISORDERS
      • Market Overview
      • Market Revenue
        • TABLE 38: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN AUTOIMMUNE DISORDERS, THROUGH 2019 ($ MILLIONS)
        • FIGURE 17: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN AUTOIMMUNE DISORDERS, 2012-2019 ($ MILLIONS)
    • BLOOD DISORDERS
      • TABLE 39: BLOOD DISORDERS
      • Market Overview
      • Market Revenue
        • TABLE 40: GLOBAL REVENUE OF ORPHAN DRUGS USED IN BLOOD DISORDERS, THROUGH 2019 ($ MILLIONS)
        • FIGURE 18: GLOBAL REVENUE OF ORPHAN DRUGS USED IN BLOOD DISORDERS, 2012-2019 ($ MILLIONS)
    • NEUROLOGY
      • TABLE 41: NEUROLOGICAL DISEASES
      • Market Overview
      • Market Revenue
        • TABLE 42: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN NEUROLOGICAL DISORDERS, THROUGH 2019 ($ MILLIONS)
        • FIGURE 19: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN NEUROLOGICAL DISORDERS, 2012-2019 ($ MILLIONS)
    • HORMONAL DISORDERS AND INFECTIONS
      • TABLE 43: HORMONAL DISORDERS AND INFECTIONS
      • Market Overview
      • Market Revenue
        • TABLE 44: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN HORMONAL DISORDERS AND INFECTIONS, THROUGH 2019 ($ MILLIONS)
        • FIGURE 20: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN HORMONAL DISORDERS AND INFECTIONS, 2012-2019 ($ MILLIONS)

CHAPTER 9 - PATENT ANALYSIS

  • PATENTS BY YEAR
    • TABLE 45: NUMBER OF SIGNIFICANT U.S. PATENTS BY YEAR, 2010-2014
    • FIGURE 21: NUMBER OF SIGNIFICANT U.S. PATENTS BY YEAR, 2010-2014
  • PATENTS BY TYPE/CATEGORY
    • TABLE 46: NUMBER OF U.S. PATENTS BY CATEGORY, 2010-2014
    • FIGURE 22: NUMBER OF U.S. PATENTS BY CATEGORY, 2010-2014
  • PATENTS BY COMPANY
    • TABLE 47: NUMBER OF U.S. PATENTS BY COMPANY, 2010-2014
  • PATENTS BY COUNTRY
    • TABLE 48: NUMBER OF U.S. PATENTS BY COUNTRY, 2010-2014
    • FIGURE 23: NUMBER OF U.S. PATENTS BY COUNTRY, 2010-2014 ($ MILLIONS)
    • TABLE 49: PATENT SHARES BY COUNTRY, 2010-2014 (NO/%)
    • FIGURE 24: PATENT SHARES BY COUNTRY, 2010-2014 (%)
  • PATENTS BY ASSIGNEE
    • TABLE 50: NUMBER OF PATENTS BY ASSIGNEE, 2010-2014
    • FIGURE 25: NUMBER OF PATENTS BY ASSIGNEE, 2010-2014

CHAPTER 10 - CURRENT TRENDS

  • FACTORS THAT ARE BOOSTING THE ORPHAN DRUG MARKET
    • ORPHAN DRUG ACT AND SIMILAR LEGISLATIONS
    • TECHNOLOGICAL ADVANCES AND GENETIC CODE
    • GENERIC COMPETITION
    • PATENT EXPIRATIONS
    • PREMIUM PRICING
    • INNOVATIONS IN MANUFACTURING TECHNOLOGIES
    • COLLABORATIONS AND LICENSING AGREEMENTS
    • MERGERS AND ACQUISITIONS
  • CHALLENGES
    • LACK OF TRAINED PROFESSIONALS
    • VULNERABLE TARGET GROUPS
    • MULTIPLE USAGES
    • REGULATORY CHALLENGE

CHAPTER 11 - COMPANY PROFILES

  • ACORDA THERAPEUTICS
  • ACTELION PHARMACEUTICALS LTD.
  • AEGERION PHARMACEUTICALS
  • ALEXION PHARMACEUTICALS
  • AMGEN
  • BAXTER INTERNATIONAL
  • BAYER HEALTHCARE PHARMACEUTICALS
  • BIOGEN IDEC
  • BIOMARIN PHARMACEUTICAL INC.
  • BRISTOL-MYERS SQUIBB
  • CANGENE CORP.
  • CELGENE
  • GENZYME
  • GILEAD SCIENCES INC.
  • GLAXOSMITHKLINE
  • JOHNSON & JOHNSON
  • LUNDBECK LLC
  • MERCK
  • NOVARTIS
  • NOVO NORDISK INC.
  • ONYX THERAPEUTICS
  • PFIZER INC.
  • ROCHE
  • SEATTLE GENETICS
  • SHIRE PLC
  • TAKEDA PHARMACEUTICAL U.S.A. INC.
  • VECTURA GROUP PLC
  • VERTEX PHARMACEUTICALS

CHAPTER 12 - ABBREVIATIONS

LIST OF TABLES

  • SUMMARY TABLE: GLOBAL REVENUES OF ORPHAN DRUGS BY TYPE, THROUGH 2019 ($ MILLIONS)
    • TABLE 1: RARE DISEASES AND THEIR PREVALENCE
    • TABLE 2: HISTORY OF RARE DISEASES AND ORPHAN DRUG LEGISLATION
    • TABLE 3: AMENDMENTS OF U.S. ORPHAN DRUG ACT
    • TABLE 4: COMPARISON OF ORPHAN DRUG LEGISLATION IN THE U.S., EU, AUSTRALIA AND JAPAN
    • TABLE 5: NUMBER OF FDA ORPHAN DRUG DESIGNATIONS AND APPROVALS PER YEAR, 1983-2014
    • TABLE 6: DIFFERENCES BETWEEN ORPHAN DRUGS AND NORMAL DRUGS
    • TABLE 7: APPROVED ORPHAN DRUGS AND THEIR THERAPEUTIC USE
    • TABLE 8: MARKET APPROVALS OF ORPHAN DRUGS, 2010-2014
    • TABLE 9: RECALLS OF ORPHAN DRUGS, 2010-2014
    • TABLE 10: SAFETY ALERTS OF ORPHAN DRUGS, 2010-2014
    • TABLE 11: ORPHAN DRUGS IN CLINICAL TRIALS
    • TABLE 12: MERGERS AND ACQUISITIONS OF ORPHAN DRUG COMPANIES, 2010-2014
    • TABLE 13: GLOBAL REVENUE FOR ORPHAN DRUGS BY TYPE, THROUGH 2019 ($ MILLIONS)
    • TABLE 14: GLOBAL MARKET SHARE OF MAJOR ORPHAN DRUGS BY TYPE, 2013 (%)
    • TABLE 15: GLOBAL REVENUE FOR ORPHAN DRUGS BY REGION, THROUGH 2019 ($ MILLIONS)
    • TABLE 16: GLOBAL MARKET SHARE OF ORPHAN DRUGS BY REGION, 2013 (%)
    • TABLE 17: GLOBAL REVENUE OF BIOLOGICAL ORPHAN DRUGS BY ACTIVE INGREDIENT, THROUGH 2019 ($ MILLIONS)
    • TABLE 18: GLOBAL MARKET SHARES OF BIOLOGICAL DRUGS, 2013 (%)
    • TABLE 19: GLOBAL REVENUE FOR BIOLOGICAL ORPHAN DRUGS BY REGION, THROUGH 2019 ($ MILLIONS)
    • TABLE 20: GLOBAL MARKET SHARE OF BIOLOGICAL ORPHAN DRUG MARKET BY REGION, 2013 (%)
    • TABLE 21: GLOBAL REVENUE FOR NON-BIOLOGICAL ORPHAN DRUGS BY ACTIVE INGREDIENT, THROUGH 2019 ($ MILLIONS)
    • TABLE 22: GLOBAL MARKET SHARES OF NON-BIOLOGICAL DRUGS, 2013 (%)
    • TABLE 23: GLOBAL REVENUE FOR NON-BIOLOGICAL ORPHAN DRUGS BY REGION, THROUGH 2019 ($ MILLIONS)
    • TABLE 24: GLOBAL MARKET SHARE OF NON-BIOLOGICAL ORPHAN DRUG MARKET BY REGION, 2013 (%)
    • TABLE 25: LEADING MANUFACTURERS/SUPPLIERS OF BIOLOGICAL ORPHAN DRUGS, 2013
    • TABLE 26: GLOBAL MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS FOR BIOLOGICAL ORPHAN DRUGS, 2013 (%)
    • TABLE 27: LEADING MANUFACTURERS/SUPPLIERS OF NON-BIOLOGICAL ORPHAN DRUGS, 2013
    • TABLE 28: GLOBAL MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS FOR NON-BIOLOGICAL ORPHAN DRUGS, 2013 (%)
    • TABLE 29: GLOBAL REVENUES FOR ORPHAN DRUGS BY MEDICAL APPLICATION, THROUGH 2019 ($ MILLIONS)
    • TABLE 30: GLOBAL MARKET SHARE OF ORPHAN DRUGS BY MEDICAL APPLICATION, 2013 (%)
    • TABLE 31: ONCOLOGY DISEASES
    • TABLE 32: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN ONCOLOGY, THROUGH 2019 ($ MILLIONS)
    • TABLE 33: PULMONOLOGY DISEASES
    • TABLE 34: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN PULMONOLOGY, THROUGH 2019 ($ MILLIONS)
    • TABLE 35: CARDIOLOGY AND NEPHROLOGY DISEASES
    • TABLE 36: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN CARDIOLOGY AND NEPHROLOGY, THROUGH 2019 ($ MILLIONS)
    • TABLE 37: AUTOIMMUNE DISORDERS
    • TABLE 38: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN AUTOIMMUNE DISORDERS, THROUGH 2019 ($ MILLIONS)
    • TABLE 39: BLOOD DISORDERS
    • TABLE 40: GLOBAL REVENUE OF ORPHAN DRUGS USED IN BLOOD DISORDERS, THROUGH 2019 ($ MILLIONS)
    • TABLE 41: NEUROLOGICAL DISEASES
    • TABLE 42: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN NEUROLOGICAL DISORDERS, THROUGH 2019 ($ MILLIONS)
    • TABLE 43: HORMONAL DISORDERS AND INFECTIONS
    • TABLE 44: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN HORMONAL DISORDERS AND INFECTIONS, THROUGH 2019 ($ MILLIONS)
    • TABLE 45: NUMBER OF SIGNIFICANT U.S. PATENTS BY YEAR, 2010-2014
    • TABLE 46: NUMBER OF U.S. PATENTS BY CATEGORY, 2010-2014
    • TABLE 47: NUMBER OF U.S. PATENTS BY COMPANY, 2010-2014
    • TABLE 48: NUMBER OF U.S. PATENTS BY COUNTRY, 2010-2014
    • TABLE 49: PATENT SHARES BY COUNTRY, 2010-2014 (NO/%)
    • TABLE 50: NUMBER OF PATENTS BY ASSIGNEE, 2010-2014

LIST OF FIGURES

  • SUMMARY FIGURE: GLOBAL REVENUES OF ORPHAN DRUGS BY TYPE, 2012-2019 ($ MILLIONS)
    • FIGURE 1: GLOBAL REVENUE FOR ORPHAN DRUGS BY TYPE, 2012-2019 ($ MILLIONS)
    • FIGURE 2: GLOBAL MARKET SHARE OF MAJOR ORPHAN DRUGS BY TYPE, 2013 (%)
    • FIGURE 3: GLOBAL REVENUE FOR ORPHAN DRUGS BY REGION, 2012-2019 ($ MILLIONS)
    • FIGURE 4: GLOBAL MARKET SHARE OF ORPHAN DRUGS BY REGION, 2013 (%)
    • FIGURE 5: GLOBAL MARKET SHARES OF NON-BIOLOGICAL DRUGS, 2013 (%)
    • FIGURE 6: GLOBAL REVENUE FOR BIOLOGICAL ORPHAN DRUGS BY REGION, 2012-2019 ($ MILLIONS)
    • FIGURE 7: GLOBAL MARKET SHARE OF BIOLOGICAL ORPHAN DRUG MARKET BY REGION, 2013 (%)
    • FIGURE 8: GLOBAL MARKET SHARES OF NON-BIOLOGICAL DRUGS, 2013 (%)
    • FIGURE 9: GLOBAL REVENUE FOR NON-BIOLOGICAL ORPHAN DRUGS BY REGION, 2012-2019 ($ MILLIONS)
    • FIGURE 10: GLOBAL MARKET SHARE OF NON-BIOLOGICAL ORPHAN DRUG MARKET BY REGION, 2013 (%)
    • FIGURE 11: GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR BIOLOGICAL ORPHAN DRUGS, 2013 (%)
    • FIGURE 12: MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR NON-BIOLOGICAL ORPHAN DRUGS, 2013 (%)
    • FIGURE 13: GLOBAL REVENUES FOR ORPHAN DRUGS BY MEDICAL APPLICATION, 2012-2019 ($ MILLIONS)
    • FIGURE 14: GLOBAL MARKET SHARE OF ORPHAN DRUGS BY MEDICAL APPLICATION, 2013 (%)
    • FIGURE 15: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN PULMONOLOGY, 2012-2019 ($ MILLIONS)
    • FIGURE 16: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN CARDIOLOGY AND NEPHROLOGY, 2012-2019 ($ MILLIONS)
    • FIGURE 17: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN AUTOIMMUNE DISORDERS, 2012-2019 ($ MILLIONS)
    • FIGURE 18: GLOBAL REVENUE OF ORPHAN DRUGS USED IN BLOOD DISORDERS, 2012-2019 ($ MILLIONS)
    • FIGURE 19: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN NEUROLOGICAL DISORDERS, 2012-2019 ($ MILLIONS)
    • FIGURE 20: GLOBAL REVENUE FOR ORPHAN DRUGS USED IN HORMONAL DISORDERS AND INFECTIONS, 2012-2019 ($ MILLIONS)
    • FIGURE 21: NUMBER OF SIGNIFICANT U.S. PATENTS BY YEAR, 2010-2014
    • FIGURE 22: NUMBER OF U.S. PATENTS BY CATEGORY, 2010-2014
    • FIGURE 23: NUMBER OF U.S. PATENTS BY COUNTRY, 2010-2014 ($ MILLIONS)
    • FIGURE 24: PATENT SHARES BY COUNTRY, 2010-2014 (%)
    • FIGURE 25: NUMBER OF PATENTS BY ASSIGNEE, 2010-2014
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