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オーファンドラッグ (希少疾病用医薬品) の世界市場

Orphan Drugs

発行 Global Industry Analysts, Inc. 商品コード 285000
出版日 ページ情報 英文 369 Pages
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オーファンドラッグ (希少疾病用医薬品) の世界市場 Orphan Drugs
出版日: 2015年04月01日 ページ情報: 英文 369 Pages
概要

当レポートでは、世界のオーファンドラッグ市場について調査し、2014〜2020年までの市場動向予測、製品概要、地域別動向、および市場に参入する企業のプロファイルなどをまとめています。

第1章 イントロダクション、調査方法、製品定義

第2章 エグゼクティブサマリー

  • 業界概要
    • 序論
    • 様々な国のオーファンドラッグ指定基準リスト
    • 1983年のOrphan Drug Act (ODA)が業界のキックスタート
    • 世界のオーファンドラッグ法規制
    • 市場の潜在性
    • 市場の課題
    • 競合
    • 医薬品パイプラインにおいてオーファンドラッグは強いまま
  • オーファンドラッグに対するFDAの人か
  • 成長牽引因子および阻害因子
    • 法規制インセンティブ:正しい方向への後押し
    • 拡大する医療のアンメットニーズ:ギャップを埋める
    • アジアの認識向上と人口拡大が売上を促進
    • 珍しい種類の癌の発症率上昇
    • 癌のためのオーファンドラッグ
    • 腎細胞癌の発症率上昇
    • AMLにおけるアンメットニーズ
    • 高齢化が成長可能性に
    • 市場ベースを拡大する症状前スクリーニング
  • 現在の市場動向
  • 奇病治療における画期的事項
  • 法規制シナリオ
  • 製品概要
  • 製品認可
  • 近年の業界活動
  • 主要企業
    • AbbVie, Inc.
    • Actelion Pharmaceuticals Ltd.
    • Amgen, Inc
    • AstraZeneca Plc.
    • Bayer HealthCare AG
    • Biogen Idec, Inc.
    • Boehringer Ingelheim GmbH
    • Bristol-Myers Squibb Company
    • Celgene Corp.
    • CEL-SCI Corporation
    • Concordia Healthcare Corp.
    • Eli Lilly and Company
    • F. Hoffmann-La Roche Ltd.
    • GlaxoSmithKline Plc.
    • Johnson & Johnson
    • Merck & Co., Inc.
    • Merck Serono International S.A.
    • Novartis AG
    • Pfizer, Inc.
    • Recordati S.p.A.
    • Orphan Europe
    • Sanofi SA
    • Genzyme Corp.
  • 世界市場見通し

第3章 国別市場

  • 米国
  • 日本
  • 欧州
  • その他の諸国

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目次
Product Code: MCP-7443

This report analyzes the worldwide markets for Orphan Drugs in US$ Million. The report provides separate comprehensive analytics for the US, Japan, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2014 through 2020. Also, a seven-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 142 companies including many key and niche players such as -

AbbVie, Inc.
Actelion Pharmaceuticals Ltd.
Amgen, Inc.
AstraZeneca Plc
Bayer HealthCare AG

Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

  • Study Reliability and Reporting Limitations
  • Disclaimers
  • Data Interpretation & Reporting Level
    • Quantitative Techniques & Analytics
  • Product Definitions and Scope of Study

II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW

  • A Prelude
  • List of Orphan Drug Designation Criteria in Various Countries
    • Table 1: Select Orphan Diseases and their Prevalence (includes corresponding Graph/Chart)
  • The 1983 Orphan Drugs Act (ODA) Kickstarts the Industry
  • Orphan Drugs Legislations Worldwide
  • Market Potential
  • Market Challenges
  • Competition
    • Table 2: Global Orphan Drugs Market by Leading Player (2013): Percentage Market Share Breakdown of Value Sales for Actelion, Alexion, Amgen, Baxter, Bayer, Biogen Idec, BMS, Celgene, Lilly, GSK, J&J, Merck, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi, Shire, vertex, and Others (includes corresponding Graph/Chart)
    • Table 3: Top 10 Blockbuster Orphan Drugs Ranked by Revenue: 2013 (includes corresponding Graph/Chart)
  • Orphan Drugs Remain Strong in the Pharmaceutical Pipeline
    • Table 4: Global Orphan Drugs Market (2012-2018E): Percentage Share of Orphan Drug Sales in Prescription Drugs Market (includes corresponding Graph/Chart)

2. ORPHAN DRUG FDA APPROVALS

  • FDA-Approved Orphan Drugs (2015)
  • FDA-Approved Orphan Drugs (2014)
  • FDA-Approved Orphan Drugs (2013)
  • New FDA-Approved Orphan Drugs (2012)

3. GROWTH DRIVERS AND INHIBITORS

  • Regulatory Incentives - A Push in the Right Direction
  • Growing Unmet Medical Needs - Fulfilling the Gap
  • Asia's Rising Awareness and Growing Population to Drive Sales
  • Rise in Incidences of Rare forms of Cancer - Opportunities Galore
  • Select Orphan Drugs for Cancer
  • Rise in Incidence of Renal Cell Carcinoma
  • Unmet Needs in AML
  • Aging Population Offers Growth Potential
    • Table 5: Global Population Statistics for the 65+ Age Group: 2013 (includes corresponding Graph/Chart)
  • Pre-Symptomatic Screening to Expand Market Base

4. CURRENT MARKET TRENDS

  • Interest of Major Pharmaceutical Firms Signal a Shift in Commercial Dynamics
  • Select Mergers and Acquisitions in 2014
  • Full Reimbursements Critical for Spurring Uptake of High-Priced Orphan Drugs
    • Table 6: Select Orphan Drug Prices (Per Patient per Year) - 2014 (includes corresponding Graph/Chart)
  • Regulators to Scrutinize Exorbitant Pricing of Ultra-Orphan Drugs
    • Table 7: Select Ultra-Orphan Drug Prices (Per Patient per Year) - 2013 (includes corresponding Graph/Chart)
  • Increasing Patient Engagement - The PAG Trend
  • Early Access Programs Gain Ground
  • Gene Therapy and Bioprocessing Preferred Over Chronic Therapies
  • Increasing M&A Activity Consolidates the Market
  • International Collaboration - The Way Forward
  • CNS Therapeutics to Gain Focus in the Orphan Drugs Market
  • Treating Autism - The Next Big Thing?
  • Strong Market Potential for Ultra-Orphan Drugs for Amyloid Light-chain Amyloidosis
  • Sequencing Technology - The New Research Tool for Orphan Drugs
  • Innovations in Biotechnology - A Boon for Orphan Drug Research
  • Aging Gene Linked to Myeloma
  • Antibody with Potential to Treat Multiple Myeloma
  • Potential Treatment for Cystic Fibrosis Patients Infected with Mycobacterium abscessus
  • Genetic Variants to Improve Treatment of Non-small Cell Lung Cancer

5. BREAKTHROUGHS IN ORPHAN DISEASE TREATMENT - A RAY OF HOPE

  • Pirfenidone for Idiopathic Pulmonary Fibrosis (IPF)
  • Telaprevir and Boceprevir for Hepatitis C
  • Fingolimod for Multiple Sclerosis
  • Dabigatran and Rivaroxaban to Prevent Strokes in Atrial Fibrillation Patients
  • Ipilimumab and Vemurafenib for Melanoma
  • Sipuleucel-T for Prostate Cancer
  • Crizotinib for Non-Small Cell Lung Cancer

6. REGULATORY SCENARIO

  • The Need for Regulation
  • US - The Orphan Drug Act of 1983
  • The Amended Pharmaceutical Law 1993 (Japan)
  • The Australian Orphan Drugs Program - 1997
  • The European Regulation on Orphan Medicinal Products -1999

7. PRODUCT OVERVIEW

  • Orphan Drugs - A Prologue
    • Table 8: Number of Incidences Determining the Orphan Status of a Disease by Region (includes corresponding Graph/Chart)
  • Select Orphan Disease Definitions
  • Glioblastoma Multiforme
  • Cystic Fibrosis
  • Lyosomal Storage Disorders
    • Fabry Disease
    • Gaucher's Disease
    • Pompe Disease
  • Huntington's Disease
  • Lymphoma
  • Multiple Myeloma
  • Atypical Hemolytic Uremic Syndrome (aHUS)
  • Chronic Myelogenous Leukemia (CML)
  • Cushing's syndrome
  • Short Bowel Syndrome (SBS)
  • Duchenne's Muscular Dystrophy (DMD)
  • Hemophilia
  • Homozygous Familial Hypercholesterolemia (hoFH)
  • Idiopathic Pulmonary Fibrosis (IPF)
  • Metastatic Melanoma
  • Paroxysmal Nocturnal Hemoglobinuria (PNH)
  • Ph+ALL
  • Ultra-Orphan Drugs
    • Table 9: Select Ultra-Orphan Diseases with Global Registered Cases but No Available Prevalence Data (includes corresponding Graph/Chart)
  • Orphan Drug Categorization
  • Designation of Orphan Status
  • Personalized Medicine and Orphan Drugs

8. PRODUCT APPROVALS

  • EC Approves Signifor® for Acromegaly
  • FDA Approves Isavucanazole for Invasive Candidiasis
  • FDA Grants Orphan Drug Designation to MabVax's Neuroblastoma Vaccine
  • SYN-005 mAb by Synthetic Biologics Granted Orphan Drug Designation by FDA
  • Soligenix Expands Pipeline with Orphan Drug SGX301
  • ABT-414 by AbbVie Granted Orphan Drug Designation
  • FDA Grants Orphan Drug Designation to AbbVie's HUMIRA
  • Ciprofloxacin DPI by Bayer HealthCare Granted Orphan Drug Status
  • Volasertib Granted Orphan Drug Designation for Treatment of AML
  • Actelion Launches VALCHLOR™ For Treatment of Rare CTCL
  • EC and EMA Grant Orphan Drug Status to hGH-CTP by PROLOR
  • FDA Grants Approval for Kynamro of Genzyme
  • FDA Accepts Biogen's BLA for rFIXFc
  • Boehringer Ingelheim Pharmaceuticals Obtains Priority Review for afatinib
  • Metreleptin Obtains FDA Priority Review
  • Celgene's POMALYST® Receives FDA Approval
  • Diffusion Pharmaceuticals Secures Orphan Drug Designation from FDA for TSC
  • Aerial Biopharma Obtains Orphan Designation from FDA for ARL-N05 for Narcolepsy
  • NPS Pharmaceuticals Secures NDA Acceptance for GATTEX®
  • Morphotek Obtains Orphan Drug Designation for Amatuximab for Mesothelioma
  • DARA BioSciences Submits Orphan Drug Application for KRN5500
  • UCB's Keppra® Obtains Approval from US FDA
  • Pfizer Obtains US FDA Approval for Bosulif
  • Novartis' Signifor® Wins FDA Approval
  • Janssen Research & Development Files NDA for bedaquiline
  • Chugai Pharmaceutical Obtains Approval for Pulmozyme Inhalation Solution
  • CSL Behring Obtains Orphan Drug Designation from FDA for rIX-FP
  • Stratatech Receives FDA Orphan Drug Designation for StrataGraft®
  • Andromeda Biotech Obtains Orphan Drug Designation for DiaPep277®
  • REGENX BioSciences Secures Orphan Drug Designation for REGENX Program
  • Lexicon Pharmaceuticals Obtains Orphan Drug Designation for LX1032
  • QLT Receives Orphan Drug Designation from FDA for iVisudyne
  • Promedior Obtains Orphan Drug Designation from FDA for PRM-151
  • SK Biopharmaceuticals Secures FDA Orphan Drug Designation for Carisbamate
  • Ultragenyx Pharmaceutical Receives Orphan Drug Designation for UX003
  • Cytokinetics Obtains Orphan Medicinal Product Designation for CK-2017357
  • Can-Fite BioPharma Obtains Orphan Drug Status for CF102
  • Glenveigh Medical Receives Orphan Drug Designation
  • Catalyst Pharmaceutical Partners Obtains Orphan Medicinal Product Designation for CPP-115
  • DelMar Pharmaceuticals Obtains Orphan Drug Designation for VAL-083
  • EC Approves CAPRELSA For Treatment of Medullary Thyroid Cancer

9. RECENT INDUSTRY ACTIVITY

  • Concordia to Acquire Covis Pharma
  • AbbVie to Acquire Pharmacyclics
  • Genzyme Announces Publication of Cerdelga® Trial Results
  • BioMarin to Acquire Prosensa Holding
  • AstraZeneca to Divest Myalept™ to Aegerion
  • Roche to Acquire InterMune
  • Baxter Acquires AesRx LLC
  • MabVax Therapeutics and Telik Enter Merger Agreement
  • Hyperion Acquires Andromeda Biotech
  • BioAlliance Pharma Enters Merger Agreement with Topotarget
  • TetraLogic to Acquire Shape Pharmaceuticals
  • Shire Completes Acquisition of ViroPharma
  • Jazz Pharmaceuticals to Acquire Gentium
  • MedImmune Acquires Spirogen
  • Opko Health Takes Over Prolor Biotech
  • Tranzyme Pharma Inks Agreement with Ocera Therapeutics
  • KLS Partners Enters Collaboration Agreement with Cydan
  • PPMD Partners with Siren Interactive
  • Nimbus Discovery Enters Agreement with Shire
  • Pfizer Signs Licensing Agreement with Repligen
  • Shire Inks Takeover Deal with Lotus Tissue Repair
  • Shire Concludes Collaboration with Acceleron Pharma for ACE-031
  • Boehringer Ingelheim and PatientsLikeMe Enter into Collaboration
  • AbbVie Inks Development License and Option Agreement with Receptos
  • Abbott Concludes Separation of Pharmaceuticals Business
  • Agility Clinical Enters into Partnership with PSR Orphan Experts
  • Imaxio Takes Over Trolovol® Drug from D&A Pharma
  • Merck Expands Line of Cancer Drugs
  • Orphan Europe Inks Agreement with ErytechPharma
  • Recordati Signs Agreement with Lundbeck
  • Catalyst Pharmaceutical Partners Enters into Collaboration with BioMarin Pharmaceutical
  • Alnylam Pharmaceuticals and Genzyme Sign Deal
  • Medunik Canada Inks Distribution Agreement with Orphan Europe
  • Shire Signs Research Collaboration Agreement with Fondazione Telethon
  • Biogen Idec Acquires Stromedix

10. FOCUS ON SELECT PLAYERS

  • AbbVie, Inc. (US)
  • Actelion Pharmaceuticals Ltd. (Switzerland)
  • Amgen, Inc. (US)
  • AstraZeneca Plc. (UK)
  • Bayer HealthCare AG (Germany)
  • Biogen Idec, Inc. (US)
  • Boehringer Ingelheim GmbH (Germany)
  • Bristol-Myers Squibb Company (US)
  • Celgene Corp. (US)
  • CEL-SCI Corporation (US)
  • Concordia Healthcare Corp. (Canada)
  • Eli Lilly and Company (US)
  • F. Hoffmann-La Roche Ltd. (Switzerland)
  • GlaxoSmithKline Plc. (UK)
  • Johnson & Johnson (US)
  • Merck & Co., Inc. (US)
  • Merck Serono International S.A. (Germany)
  • Novartis AG (Switzerland)
  • Pfizer, Inc. (US)
  • Recordati S.p.A. (Italy)
  • Orphan Europe (France)
  • Sanofi SA (France)
  • Genzyme Corp. (US)

11. GLOBAL MARKET PERSPECTIVE

    • Table 10: World Recent Past, Current & Future Analysis for Orphan Drugs by Geographic Region - US, Japan, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart)
    • Table 11: World Historic Review for Orphan Drugs by Geographic Region - US, Japan, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart)
    • Table 12: World 14-Year Perspective for Orphan Drugs by Geographic Region - Percentage Breakdown of Value Sales for US, Japan, Europe and Rest of World Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart)
  • Analysis by Product Segment
    • Table 13: World Recent Past, Current & Future Analysis for Orphan Biologic Drugs by Geographic Region - US, Japan, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart)
    • Table 14: World Historic Review for Orphan Biologic Drugs by Geographic Region - US, Japan, Europe and Rest of World Markets Independently Analyzed With Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart)
    • Table 15: World 14-Year Perspective for Orphan Biologic Drugs by Geographic Region - Percentage Breakdown of Value Sales for US, Japan, Europe and Rest of World Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart)
    • Table 16: World Recent Past, Current & Future Analysis for Orphan Non-Biologic Drugs by Geographic Region - US, Japan, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart)
    • Table 17: World Historic Review for Orphan Non-Biologic Drugs by Geographic Region - US, Japan, Europe and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart)
    • Table 18: World 14-Year Perspective for Orphan Non-Biologic Drugs by Geographic Region - Percentage Breakdown of Value Sales for US, Japan, Europe and Rest of World Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart)

III. MARKET

1. THE UNITED STATES

  • A. Market Analysis
    • Current and Future Analysis
    • Table 19: Top 10 Orphan Drugs in the US by Sales: 2014 (includes corresponding Graph/Chart)
    • Orphan Drug Act - A Milestone Legislation
    • Table 20: US Annual Orphan Drug Approvals: 1983- Q1 2015 (includes corresponding Graph/Chart)
    • Table 21: US Orphan Drug Approvals (2002-2013): Percentage Share Breakdown by Indication Area (includes corresponding Graph/Chart)
      • Select Orphan Drugs Launched in 2013 & 2014
    • Regulatory Overview
      • US Orphan Drugs Policy - A Snapshot
      • Orphan Products Grants Program
      • Humanitarian Use Device (HUD) Program
      • Select CDRH Approved Devices for Rare Diseases (US)
    • Medicare Reimbursement for Orphan Drugs
      • Reimbursement for Orphan Drugs Not on Single-Indication List
    • Product Approvals
    • Strategic Corporate Developments
    • Select Key Players
  • B. Market Analytics
    • Table 22: The US Recent Past, Current & Future Analysis for Orphan Drugs by Product Segment - Biologic Drugs and Non-Biologic Drugs Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart)
    • Table 23: The US Historic Review for Orphan Drugs by Product Segment - Biologic Drugs and Non-Biologic Drugs Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart)
    • Table 24: The US 14-Year Perspective for Orphan Drugs by Product Segment - Percentage Breakdown of Value Sales for Biologic Drugs and Non-Biologic Drugs Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart)

2. JAPAN

  • A. Market Analysis
    • Current and Future Analysis
    • Regulatory Overview
      • Designated Orphan Agents in Japan (2012-2014)
    • Recent Orphan Drug Approval
  • B. Market Analytics
    • Table 25: Japanese Recent Past, Current & Future Analysis for Orphan Drugs by Product Segment - Biologic Drugs and Non-Biologic Drugs Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart)
    • Table 26: Japanese Historic Review for Orphan Drugs by Product Segment - Biologic Drugs and Non-Biologic Drugs Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart)
    • Table 27: Japanese 14-Year Perspective for Orphan Drugs by Product Segment - Percentage Breakdown of Value Sales for Biologic Drugs and Non-Biologic Drugs Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart)

3. EUROPE

  • A. Market Analysis
    • Current and Future Analysis
    • Table 28: Number of Medicinal Products with European Marketing Authorization (Intended for Rare Diseases) without Orphan Designation: 2002-2014 (includes corresponding Graph/Chart)
    • Table 29: Percentage Breakdown of Rare Disease Medicinal Products (without Orphan Designation) with European Market Authorization by Anatomical Therapeutic Chemical Category: 2014 (includes corresponding Graph/Chart)
    • Table 30: Percentage Breakdown of Orphan Disease Medicinal Products with European Marketing Authorization and Orphan Designation by Anatomical Therapeutic Chemical Category: 2014 (includes corresponding Graph/Chart)
      • Select EMA Approved Orphan Drugs - 2013- Q3 2014
    • The European Regulation on Orphan Medicinal Products - 1999
      • EU Orphan Drug Regulation Overview
      • Orphan Drug Legislation in Select EU Countries
      • Orphan Drugs Legislation in Select Non-EU Countries: 2014
    • EU Initiatives for Rare Disease Drug Development
      • Select EU Funded Rare Disease Projects - Category Wise Listings
    • Euro-Zone Crisis and Orphan Drug Prices
    • Product Approvals
    • Strategic Corporate Developments
    • Select Key Players
  • B. Market Analytics
    • Table 31: European Recent Past, Current & Future Analysis for Orphan Drugs by Product Segment - Biologic Drugs and Non-Biologic Drugs Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart)
    • Table 32: European Historic Review for Orphan Drugs by Product Segment - Biologic Drugs and Non-Biologic Drugs Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart)
    • Table 33: European 14-Year Perspective for Orphan Drugs by Product Segment - Percentage Breakdown of Value Sales for Biologic Drugs and Non-Biologic Drugs Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart)

4. REST OF WORLD

  • A. Market Analysis
    • Current and Future Analysis
    • Asia's Rising Awareness and Growing Population to Drive Sales
      • Orphan Drugs Legislation in Select Asia-Pacific Countries: 2014
    • Regulatory Scenario in Select Countries
      • Australia
      • China
      • Hong Kong
      • Singapore
      • South Africa
      • South Korea
      • Taiwan
    • Strategic Corporate Developments
  • B. Market Analytics
    • Table 34: Rest of World Recent Past, Current & Future Analysis for Orphan Drugs by Product Segment - Biologic Drugs and Non-Biologic Drugs Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2014 through 2020 (includes corresponding Graph/Chart)
    • Table 35: Rest of World Historic Review for Orphan Drugs by Product Segment - Biologic Drugs and Non-Biologic Drugs Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart)
    • Table 36: Rest of World 14-Year Perspective for Orphan Drugs by Product Segment - Percentage Breakdown of Value Sales for Biologic Drugs and Non-Biologic Drugs Markets for Years 2007, 2015 & 2020 (includes corresponding Graph/Chart)

IV. COMPETITIVE LANDSCAPE

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