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Global Markets for Orphan Drugs

  • September 2015
  • -
  • BCC Research
  • -
  • 162 pages

This BCC Research report analyzes the therapeutic applications of orphan drugs in rare and orphan diseases as well as regulatory framework, patents, and recent innovations. Includes forecasts from 2014 to 2019.

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.


Table Of Contents

Global Markets for Orphan Drugs
CHAPTER 1 INTRODUCTION 2
STUDY OBJECTIVES 2
REASONS FOR DOING THIS REPORT 2
CONTRIBUTIONS OF THE REPORT AND FOR WHOM 2
SCOPE OF THE REPORT 3
METHODOLOGY 3
INFORMATION SOURCES 3
ANALYSTS' CREDENTIALS 3
RELATED BCC RESEARCH REPORTS 4
BCC RESEARCH WEBSITE 4
DISCLAIMER 5
CHAPTER 2 EXECUTIVE SUMMARY 7
SUMMARY TABLE GLOBAL REVENUES OF ORPHAN DRUGS BY TYPE, THROUGH
2019 ($ MILLIONS) 8
SUMMARY FIGURE GLOBAL REVENUES OF ORPHAN DRUGS BY TYPE, 2012-2019 ($
MILLIONS) 8
CHAPTER 3 OVERVIEW 10
DIFFERENT KINDS OF ORPHAN DRUGS 10
BIOLOGICAL ORPHAN DRUGS 10
CHEMICAL OR NON-BIOLOGICAL ORPHAN DRUGS 10
GLOBAL DEFINITIONS OF RARE DISEASES 11
U.S. 11
EU 11
TAIWAN 11
JAPAN 11
AUSTRALIA 11
TABLE 1 RARE DISEASES AND THEIR PREVALENCE 11
PERSPECTIVE AND HISTORY OF ORPHAN DRUG ACT 12
TABLE 2 HISTORY OF RARE DISEASES AND ORPHAN DRUG LEGISLATION 13
LEGISLATION IN THE U.S. 14
NATIONAL ORGANIZATION FOR RARE DISORDERS (NORD) 14
ORPHAN DRUG ACT 15
TABLE 3 AMENDMENTS OF U.S. ORPHAN DRUG ACT 15
GLOBAL PERSPECTIVE OF ORPHAN DRUGS 16
EUROPE 16
AUSTRALIA 17
SINGAPORE 17
JAPAN 18
TAIWAN 19
CANADA 19
BRAZIL 19
SOUTH KOREA 20
ISRAEL 20
RUSSIA 20
KAZAKHSTAN 21
TABLE 4 COMPARISON OF ORPHAN DRUG LEGISLATION IN THE U.S., EU,
AUSTRALIA AND JAPAN 21
IMPACT OF ORPHAN DRUG ACT 22
TABLE 5 NUMBER OF FDA ORPHAN DRUG DESIGNATIONS AND APPROVALS PER
YEAR, 1983-2014 23
DIFFERENCE BETWEEN ORPHAN DRUGS VS NORMAL DRUGS 23
TABLE 6 DIFFERENCES BETWEEN ORPHAN DRUGS AND NORMAL DRUGS 23
APPLICATION OF APPROVED ORPHAN DRUGS 24
TABLE 7 APPROVED ORPHAN DRUGS AND THEIR THERAPEUTIC USE 24
CHAPTER 4 REGULATORY ASPECTS 28
TABLE 8 MARKET APPROVALS OF ORPHAN DRUGS, 2010-2014 28
RECALLS 36
TABLE 9 RECALLS OF ORPHAN DRUGS, 2010-2014 36
SAFETY ALERTS 37
TABLE 10 SAFETY ALERTS OF ORPHAN DRUGS, 2010-2014 38
CHAPTER 5 NEW DEVELOPMENTS 42
TABLE 11 ORPHAN DRUGS IN CLINICAL TRIALS 42
MERGERS AND ACQUISITIONS 47
TABLE 12 MERGERS AND ACQUISITIONS OF ORPHAN DRUG COMPANIES,
2010-2014 47
CHAPTER 6 MARKET ANALYSIS 52
MARKET BY TYPE 52
MARKET OVERVIEW 53
MARKET REVENUE 54
TABLE 13 GLOBAL REVENUE FOR ORPHAN DRUGS BY TYPE, THROUGH 2019 ($
MILLIONS) 55
FIGURE 1 GLOBAL REVENUE FOR ORPHAN DRUGS BY TYPE, 2012-2019 ($
MILLIONS) 55
MARKET SHARES 56
TABLE 14 GLOBAL MARKET SHARE OF MAJOR ORPHAN DRUGS BY TYPE, 2013 (%) 56
FIGURE 2 GLOBAL MARKET SHARE OF MAJOR ORPHAN DRUGS BY TYPE, 2013 (%) 56
MARKET BY REGION 57
MARKET OVERVIEW 57
MARKET REVENUE 58
TABLE 15 GLOBAL REVENUE FOR ORPHAN DRUGS BY REGION, THROUGH 2019 ($
MILLIONS) 59
FIGURE 3 GLOBAL REVENUE FOR ORPHAN DRUGS BY REGION, 2012-2019 ($
MILLIONS) 59
MARKET SHARE 60
TABLE 16 GLOBAL MARKET SHARE OF ORPHAN DRUGS BY REGION, 2013 (%) 60
FIGURE 4 GLOBAL MARKET SHARE OF ORPHAN DRUGS BY REGION, 2013 (%) 60
BIOLOGICAL ORPHAN DRUGS 60
MARKET OVERVIEW 61
Ilaris (canakinumab) 62
Proleukin (aldesleukin) 62
Nplate (romiplostim) 62
Enbrel (etanercept) 62
Neupogen (filgrastim) 62
Sensipar/Mimpara (cinacalcet) 63
Neulasta (pegfilgrastim) 63
Xgeva (denosumab) 63
Epogen/Procrit (epoetin alfa) 64
Yervoy (ipilimumab) 64
Betaseron/Betaferon (interferon beta-1b) 64
Intron A (interferon Alfa-2b) 64
Kogenate (Recombinant Anti-hemophilic Factor) 65
Remicade (infliximab) 65
Rebetol (ribavirin) 65
Novoseven (Recombinant Coagulation Factor VIIa) 65
Norditropin, Saizen, Genotropin and Nutropin (Somatotropin
Recombinant Deoxyribo Nucleic Acid (rDNA)) 65
Benefix (Recombinant Coagulation Factor IX) 66
Avastin (bevacizumab) 66
Rituxan/Mab Thera (rituximab) 66
Herceptin (trastuzumab) 67
Aldurazyme (laronidase) 67
Fabrazyme (agalsidase beta) 67
Myozyme/Lumizyme (aglucosidase alpha) 67
Thymoglobulin/Thymoglobulime (Anti-thymocyte Globulin) 68
Mozobil (plerixafor injection) 68
Naglazyme (galsulfase) 68
Soliris (eculizumab) 68
Humira (adalimumab) 68
Elaprase (idursulfase) and VPRIV (velaglucerase alfa) 69
Replagal (agalsidase alfa) 69
Gammagard Liquid (Human Immune Globulin Intravenous) 69
Avonex and Rebif (interferon beta 1-alpha) 69
Other Biological Orphan Drugs 69
MARKET REVENUE 70
TABLE 17 GLOBAL REVENUE OF BIOLOGICAL ORPHAN DRUGS BY ACTIVE
INGREDIENT, THROUGH 2019 ($ MILLIONS) 71
MARKET SHARE 72
TABLE 18 GLOBAL MARKET SHARES OF BIOLOGICAL DRUGS, 2013 (%) 73
FIGURE 5 GLOBAL MARKET SHARES OF NON-BIOLOGICAL DRUGS, 2013 (%) 74
MARKET BY REGION 74
Market Overview 75
Market Revenue 76
TABLE 19 GLOBAL REVENUE FOR BIOLOGICAL ORPHAN DRUGS BY REGION,
THROUGH 2019 ($ MILLIONS) 77
FIGURE 6 GLOBAL REVENUE FOR BIOLOGICAL ORPHAN DRUGS BY REGION,
2012-2019 ($ MILLIONS) 77
Market Share 77
TABLE 20 GLOBAL MARKET SHARE OF BIOLOGICAL ORPHAN DRUG MARKET BY
REGION, 2013 (%) 78
FIGURE 7 GLOBAL MARKET SHARE OF BIOLOGICAL ORPHAN DRUG MARKET BY
REGION, 2013 (%) 78
NON-BIOLOGICAL ORPHAN DRUGS 78
MARKET OVERVIEW 79
Exjade (deferasirox) 79
Sandostatin LAR (octreotide acetate) 79
Afinitor/Votubia (everolimus) 80
TOBI (tobramycin) 80
Zometa/Zomera/Aclasta/Reclast (zoledronic or zoledronate) 80
Gleevec/Glivec (imatinib mesylate) 80
Copaxone (glatiramer acetate) 81
Tasigna (nilotinib) 81
Sprycel (dasatanib) 81
Onfi (clobazam) 82
Revlimid (lenalidomide) 82
Thalomid (thalidomide) 82
Vidaza (azacitidine for injection) 82
Pomalyst/Imnovid (pomalidomide) 83
Flolan (epoprostenol sodium) 83
Volibris/Letairis/Pulmonext (ambrisentan) 83
Lamictal (lamatrigine) 84
Promacta/Revolade (eltrombopag) 84
Votrient (pazopanib) 84
Velcade (bortezomib) 84
Aromasin (exemestane) 85
Celebrex (Celecoxib) 85
Xalkori (crizotinib) 85
Cerezyme (imiglucerase for injection) 85
Kuvan (6R-BH4) 86
Tracleer (bosentan) 86
Opsumit (macitentan) 86
Zavesca (miglustat) 86
Ventavis (iloprost) 87
Kalydeco (ivacaftor) 87
Treanda (bendamustine), Copaxone (glatiramer) 87
Lialda (mesalamine) 87
Other Non-Biological Orphan Drugs 87
MARKET REVENUE 88
TABLE 21 GLOBAL REVENUE FOR NON-BIOLOGICAL ORPHAN DRUGS BY ACTIVE
INGREDIENT, THROUGH 2019 ($ MILLIONS) 90
MARKET SHARE 92
TABLE 22 GLOBAL MARKET SHARES OF NON-BIOLOGICAL DRUGS, 2013 (%) 92
FIGURE 8 GLOBAL MARKET SHARES OF NON-BIOLOGICAL DRUGS, 2013 (%) 94
MARKET BY REGION 94
Market Overview 95
Market Revenue 95
TABLE 23 GLOBAL REVENUE FOR NON-BIOLOGICAL ORPHAN DRUGS BY REGION,
THROUGH 2019 ($ MILLIONS) 96
FIGURE 9 GLOBAL REVENUE FOR NON-BIOLOGICAL ORPHAN DRUGS BY REGION,
2012-2019 ($ MILLIONS) 96
Market Share 97
TABLE 24 GLOBAL MARKET SHARE OF NON-BIOLOGICAL ORPHAN DRUG MARKET
BY REGION, 2013 (%) 97
FIGURE 10 GLOBAL MARKET SHARE OF NON-BIOLOGICAL ORPHAN DRUG MARKET
BY REGION, 2013 (%) 97
CHAPTER 7 INDUSTRY STRUCTURE 99
BIOLOGICAL ORPHAN DRUGS 99
MARKET LEADERS 99
TABLE 25 LEADING MANUFACTURERS/SUPPLIERS OF BIOLOGICAL ORPHAN DRUGS,
2013 99
MARKET SHARE 101
TABLE 26 GLOBAL MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS FOR
BIOLOGICAL ORPHAN DRUGS, 2013 (%) 101
FIGURE 11 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR
BIOLOGICAL ORPHAN DRUGS, 2013 (%) 101
NON-BIOLOGICAL ORPHAN DRUGS 102
MARKET LEADERS 102
TABLE 27 LEADING MANUFACTURERS/SUPPLIERS OF NON-BIOLOGICAL ORPHAN
DRUGS, 2013 102
MARKET SHARE 104
TABLE 28 GLOBAL MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS FOR
NON-BIOLOGICAL ORPHAN DRUGS, 2013 (%) 104
FIGURE 12 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR NON-BIOLOGICAL
ORPHAN DRUGS, 2013 (%) 104
CHAPTER 8 MARKET BY APPLICATION 107
GLOBAL ORPHAN DRUGS MARKET BY APPLICATION 107
MARKET OVERVIEW 108
MARKET REVENUE 108
TABLE 29 GLOBAL REVENUES FOR ORPHAN DRUGS BY MEDICAL APPLICATION,
THROUGH 2019 ($ MILLIONS) 109
FIGURE 13 GLOBAL REVENUES FOR ORPHAN DRUGS BY MEDICAL APPLICATION,
2012-2019 ($ MILLIONS) 109
MARKET SHARE 110
TABLE 30 GLOBAL MARKET SHARE OF ORPHAN DRUGS BY MEDICAL APPLICATION,
2013 (%) 110
FIGURE 14 GLOBAL MARKET SHARE OF ORPHAN DRUGS BY MEDICAL APPLICATION,
2013 (%) 110
ONCOLOGY 111
TABLE 31 ONCOLOGY DISEASES 111
Market Overview 112
Market Revenue 115
TABLE 32 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN ONCOLOGY, THROUGH
2019 ($ MILLIONS) 115
PULMONOLOGY 116
TABLE 33 PULMONOLOGY DISEASES 117
Market Overview 117
Market Revenue 118
TABLE 34 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN PULMONOLOGY,
THROUGH 2019 ($ MILLIONS) 119
FIGURE 15 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN PULMONOLOGY,
2012-2019 ($ MILLIONS) 119
CARDIOLOGY AND NEPHROLOGY 120
TABLE 35 CARDIOLOGY AND NEPHROLOGY DISEASES 120
Market Overview 121
Market Revenue 122
TABLE 36 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN CARDIOLOGY AND
NEPHROLOGY, THROUGH 2019 ($ MILLIONS) 123
FIGURE 16 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN CARDIOLOGY AND
NEPHROLOGY, 2012-2019 ($ MILLIONS) 123
AUTOIMMUNE DISORDERS 124
TABLE 37 AUTOIMMUNE DISORDERS 125
Market Overview 126
Market Revenue 127
TABLE 38 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN AUTOIMMUNE
DISORDERS, THROUGH 2019 ($ MILLIONS) 127
FIGURE 17 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN AUTOIMMUNE
DISORDERS, 2012-2019 ($ MILLIONS) 128
BLOOD DISORDERS 128
TABLE 39 BLOOD DISORDERS 129
Market Overview 129
Market Revenue 130
TABLE 40 GLOBAL REVENUE OF ORPHAN DRUGS USED IN BLOOD DISORDERS,
THROUGH 2019 ($ MILLIONS) 131
FIGURE 18 GLOBAL REVENUE OF ORPHAN DRUGS USED IN BLOOD DISORDERS,
2012-2019 ($ MILLIONS) 131
NEUROLOGY 132
TABLE 41 NEUROLOGICAL DISEASES 133
Market Overview 133
Market Revenue 134
TABLE 42 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN NEUROLOGICAL
DISORDERS, THROUGH 2019 ($ MILLIONS) 135
FIGURE 19 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN NEUROLOGICAL
DISORDERS, 2012-2019 ($ MILLIONS) 135
HORMONAL DISORDERS AND INFECTIONS 136
TABLE 43 HORMONAL DISORDERS AND INFECTIONS 137
Market Overview 138
Market Revenue 138
TABLE 44 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN HORMONAL
DISORDERS AND INFECTIONS, THROUGH 2019 ($ MILLIONS) 139
FIGURE 20 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN HORMONAL
DISORDERS AND INFECTIONS, 2012-2019 ($ MILLIONS) 139
CHAPTER 9 PATENT ANALYSIS 142
PATENTS BY YEAR 142
TABLE 45 NUMBER OF SIGNIFICANT U.S. PATENTS BY YEAR, 2010-2014 143
FIGURE 21 NUMBER OF SIGNIFICANT U.S. PATENTS BY YEAR, 2010-2014 143
PATENTS BY TYPE/CATEGORY 143
TABLE 46 NUMBER OF U.S. PATENTS BY CATEGORY, 2010-2014 143
FIGURE 22 NUMBER OF U.S. PATENTS BY CATEGORY, 2010-2014 144
PATENTS BY COMPANY 144
TABLE 47 NUMBER OF U.S. PATENTS BY COMPANY, 2010-2014 145
PATENTS BY COUNTRY 146
TABLE 48 NUMBER OF U.S. PATENTS BY COUNTRY, 2010-2014 146
FIGURE 23 NUMBER OF U.S. PATENTS BY COUNTRY, 2010-2014 ($ MILLIONS) 147
TABLE 49 PATENT SHARES BY COUNTRY, 2010-2014 (NO/%) 147
FIGURE 24 PATENT SHARES BY COUNTRY, 2010-2014 (%) 148
PATENTS BY ASSIGNEE 148
TABLE 50 NUMBER OF PATENTS BY ASSIGNEE, 2010-2014 148
FIGURE 25 NUMBER OF PATENTS BY ASSIGNEE, 2010-2014 149
CHAPTER 10 CURRENT TRENDS 151
FACTORS THAT ARE BOOSTING THE ORPHAN DRUG MARKET 151
ORPHAN DRUG ACT AND SIMILAR LEGISLATIONS 151
TECHNOLOGICAL ADVANCES AND GENETIC CODE 151
GENERIC COMPETITION 152
PATENT EXPIRATIONS 152
PREMIUM PRICING 152
INNOVATIONS IN MANUFACTURING TECHNOLOGIES 152
COLLABORATIONS AND LICENSING AGREEMENTS 153
MERGERS AND ACQUISITIONS 154
CHALLENGES 154
LACK OF TRAINED PROFESSIONALS 154
VULNERABLE TARGET GROUPS 155
MULTIPLE USAGES 155
REGULATORY CHALLENGE 155
CHAPTER 11 COMPANY PROFILES 157
ACORDA THERAPEUTICS 157
ACTELION PHARMACEUTICALS LTD. 157
AEGERION PHARMACEUTICALS 158
ALEXION PHARMACEUTICALS 158
AMGEN 158
BAXTER INTERNATIONAL 159
BAYER HEALTHCARE PHARMACEUTICALS 159
BIOGEN IDEC 160
BIOMARIN PHARMACEUTICAL INC. 160
BRISTOL-MYERS SQUIBB 161
CANGENE CORP. 161
CELGENE 162
GENZYME 162
GILEAD SCIENCES INC. 163
GLAXOSMITHKLINE 163
JOHNSON and JOHNSON 164
LUNDBECK LLC 164
MERCK 165
NOVARTIS 165
NOVO NORDISK INC. 166
ONYX THERAPEUTICS 166
PFIZER INC. 167
ROCHE 167
SEATTLE GENETICS 168
SHIRE PLC 169
TAKEDA PHARMACEUTICAL U.S.A. INC. 170
VECTURA GROUP PLC 170
VERTEX PHARMACEUTICALS 170
CHAPTER 12 ABBREVIATIONS 173
PHM038E - Global Markets for Orphan Drugs

LIST OF TABLES
SUMMARY TABLE GLOBAL REVENUES OF ORPHAN DRUGS BY TYPE, THROUGH 2019
($ MILLIONS) 8
TABLE 1 RARE DISEASES AND THEIR PREVALENCE 11
TABLE 2 HISTORY OF RARE DISEASES AND ORPHAN DRUG LEGISLATION 13
TABLE 3 AMENDMENTS OF U.S. ORPHAN DRUG ACT 15
TABLE 4 COMPARISON OF ORPHAN DRUG LEGISLATION IN THE U.S., EU, AUSTRALIA
AND JAPAN 21
TABLE 5 NUMBER OF FDA ORPHAN DRUG DESIGNATIONS AND APPROVALS PER
YEAR, 1983-2014 23
TABLE 6 DIFFERENCES BETWEEN ORPHAN DRUGS AND NORMAL DRUGS 23
TABLE 7 APPROVED ORPHAN DRUGS AND THEIR THERAPEUTIC USE 24
TABLE 8 MARKET APPROVALS OF ORPHAN DRUGS, 2010-2014 28
TABLE 9 RECALLS OF ORPHAN DRUGS, 2010-2014 36
TABLE 10 SAFETY ALERTS OF ORPHAN DRUGS, 2010-2014 38
TABLE 11 ORPHAN DRUGS IN CLINICAL TRIALS 42
TABLE 12 MERGERS AND ACQUISITIONS OF ORPHAN DRUG COMPANIES, 2010-2014 47
TABLE 13 GLOBAL REVENUE FOR ORPHAN DRUGS BY TYPE, THROUGH 2019 ($
MILLIONS) 55
TABLE 14 GLOBAL MARKET SHARE OF MAJOR ORPHAN DRUGS BY TYPE, 2013 (%) 56
TABLE 15 GLOBAL REVENUE FOR ORPHAN DRUGS BY REGION, THROUGH 2019 ($
MILLIONS) 59
TABLE 16 GLOBAL MARKET SHARE OF ORPHAN DRUGS BY REGION, 2013 (%) 60
TABLE 17 GLOBAL REVENUE OF BIOLOGICAL ORPHAN DRUGS BY ACTIVE
INGREDIENT, THROUGH 2019 ($ MILLIONS) 71
TABLE 18 GLOBAL MARKET SHARES OF BIOLOGICAL DRUGS, 2013 (%) 73
TABLE 19 GLOBAL REVENUE FOR BIOLOGICAL ORPHAN DRUGS BY REGION,
THROUGH 2019 ($ MILLIONS) 77
TABLE 20 GLOBAL MARKET SHARE OF BIOLOGICAL ORPHAN DRUG MARKET BY
REGION, 2013 (%) 78
TABLE 21 GLOBAL REVENUE FOR NON-BIOLOGICAL ORPHAN DRUGS BY ACTIVE
INGREDIENT, THROUGH 2019 ($ MILLIONS) 90
TABLE 22 GLOBAL MARKET SHARES OF NON-BIOLOGICAL DRUGS, 2013 (%) 92
TABLE 23 GLOBAL REVENUE FOR NON-BIOLOGICAL ORPHAN DRUGS BY REGION,
THROUGH 2019 ($ MILLIONS) 96
TABLE 24 GLOBAL MARKET SHARE OF NON-BIOLOGICAL ORPHAN DRUG MARKET BY
REGION, 2013 (%) 97
TABLE 25 LEADING MANUFACTURERS/SUPPLIERS OF BIOLOGICAL ORPHAN DRUGS,
2013 99
TABLE 26 GLOBAL MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS FOR
BIOLOGICAL ORPHAN DRUGS, 2013 (%) 101
TABLE 27 LEADING MANUFACTURERS/SUPPLIERS OF NON-BIOLOGICAL ORPHAN
DRUGS, 2013 102
TABLE 28 GLOBAL MARKET SHARE OF THE MANUFACTURERS/SUPPLIERS FOR
NON-BIOLOGICAL ORPHAN DRUGS, 2013 (%) 104
TABLE 29 GLOBAL REVENUES FOR ORPHAN DRUGS BY MEDICAL APPLICATION,
THROUGH 2019 ($ MILLIONS) 109
TABLE 30 GLOBAL MARKET SHARE OF ORPHAN DRUGS BY MEDICAL APPLICATION,
2013 (%) 110
TABLE 31 ONCOLOGY DISEASES 111
TABLE 32 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN ONCOLOGY, THROUGH
2019 ($ MILLIONS) 115
TABLE 33 PULMONOLOGY DISEASES 117
TABLE 34 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN PULMONOLOGY,
THROUGH 2019 ($ MILLIONS) 119
TABLE 35 CARDIOLOGY AND NEPHROLOGY DISEASES 120
TABLE 36 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN CARDIOLOGY AND
NEPHROLOGY, THROUGH 2019 ($ MILLIONS) 123
TABLE 37 AUTOIMMUNE DISORDERS 125
TABLE 38 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN AUTOIMMUNE
DISORDERS, THROUGH 2019 ($ MILLIONS) 127
TABLE 39 BLOOD DISORDERS 129
TABLE 40 GLOBAL REVENUE OF ORPHAN DRUGS USED IN BLOOD DISORDERS,
THROUGH 2019 ($ MILLIONS) 131
TABLE 41 NEUROLOGICAL DISEASES 133
TABLE 42 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN NEUROLOGICAL
DISORDERS, THROUGH 2019 ($ MILLIONS) 135
TABLE 43 HORMONAL DISORDERS AND INFECTIONS 137
TABLE 44 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN HORMONAL DISORDERS
AND INFECTIONS, THROUGH 2019 ($ MILLIONS) 139
TABLE 45 NUMBER OF SIGNIFICANT U.S. PATENTS BY YEAR, 2010-2014 143
TABLE 46 NUMBER OF U.S. PATENTS BY CATEGORY, 2010-2014 143
TABLE 47 NUMBER OF U.S. PATENTS BY COMPANY, 2010-2014 145
TABLE 48 NUMBER OF U.S. PATENTS BY COUNTRY, 2010-2014 146
TABLE 49 PATENT SHARES BY COUNTRY, 2010-2014 (NO/%) 147
TABLE 50 NUMBER OF PATENTS BY ASSIGNEE, 2010-2014 148

LIST OF FIGURES

SUMMARY FIGURE GLOBAL REVENUES OF ORPHAN DRUGS BY TYPE, 2012-2019 ($
MILLIONS) 8
FIGURE 1 GLOBAL REVENUE FOR ORPHAN DRUGS BY TYPE, 2012-2019 ($ MILLIONS) 55
FIGURE 2 GLOBAL MARKET SHARE OF MAJOR ORPHAN DRUGS BY TYPE, 2013 (%) 56
FIGURE 3 GLOBAL REVENUE FOR ORPHAN DRUGS BY REGION, 2012-2019 ($
MILLIONS) 59
FIGURE 4 GLOBAL MARKET SHARE OF ORPHAN DRUGS BY REGION, 2013 (%) 60
FIGURE 5 GLOBAL MARKET SHARES OF NON-BIOLOGICAL DRUGS, 2013 (%) 74
FIGURE 6 GLOBAL REVENUE FOR BIOLOGICAL ORPHAN DRUGS BY REGION,
2012-2019 ($ MILLIONS) 77
FIGURE 7 GLOBAL MARKET SHARE OF BIOLOGICAL ORPHAN DRUG MARKET BY
REGION, 2013 (%) 78
FIGURE 8 GLOBAL MARKET SHARES OF NON-BIOLOGICAL DRUGS, 2013 (%) 94
FIGURE 9 GLOBAL REVENUE FOR NON-BIOLOGICAL ORPHAN DRUGS BY REGION,
2012-2019 ($ MILLIONS) 96
FIGURE 10 GLOBAL MARKET SHARE OF NON-BIOLOGICAL ORPHAN DRUG MARKET
BY REGION, 2013 (%) 97
FIGURE 11 GLOBAL MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR
BIOLOGICAL ORPHAN DRUGS, 2013 (%) 101
FIGURE 12 MARKET SHARE OF MANUFACTURERS/SUPPLIERS FOR NON-BIOLOGICAL
ORPHAN DRUGS, 2013 (%) 104
FIGURE 13 GLOBAL REVENUES FOR ORPHAN DRUGS BY MEDICAL APPLICATION,
2012-2019 ($ MILLIONS) 109
FIGURE 14 GLOBAL MARKET SHARE OF ORPHAN DRUGS BY MEDICAL APPLICATION,
2013 (%) 110
FIGURE 15 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN PULMONOLOGY,
2012-2019 ($ MILLIONS) 119
FIGURE 16 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN CARDIOLOGY AND
NEPHROLOGY, 2012-2019 ($ MILLIONS) 123
FIGURE 17 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN AUTOIMMUNE
DISORDERS, 2012-2019 ($ MILLIONS) 128
FIGURE 18 GLOBAL REVENUE OF ORPHAN DRUGS USED IN BLOOD DISORDERS,
2012-2019 ($ MILLIONS) 131
FIGURE 19 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN NEUROLOGICAL
DISORDERS, 2012-2019 ($ MILLIONS) 135
FIGURE 20 GLOBAL REVENUE FOR ORPHAN DRUGS USED IN HORMONAL
DISORDERS AND INFECTIONS, 2012-2019 ($ MILLIONS) 139
FIGURE 21 NUMBER OF SIGNIFICANT U.S. PATENTS BY YEAR, 2010-2014 143
FIGURE 22 NUMBER OF U.S. PATENTS BY CATEGORY, 2010-2014 144
FIGURE 23 NUMBER OF U.S. PATENTS BY COUNTRY, 2010-2014 ($ MILLIONS) 147
FIGURE 24 PATENT SHARES BY COUNTRY, 2010-2014 (%) 148
FIGURE 25 NUMBER OF PATENTS BY ASSIGNEE, 2010-2014 149

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  • United Kingdom  

    United States  

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ref:plp2015

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