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Opportunity Analyzer: Pulmonary Arterial Hypertension - Opportunity Analysis and Forecast to 2024

Summary

GlobalData estimates the 2014 sales for pulmonary arterial hypertension (PAH) at approximately $3.45 billion across the 7MM covered in this report, which include the US, 5EU and Japan. The market will grow moderately at a CAGR of 3.20% during the 10-year forecast period, generating sales of approximately $4.75 billion at the end of 2024. The US market is expected to grow the fastest of the three regions, recording a CAGR of 3.70% and generating around 75% of global sales in 2024. The major drivers for this growth across the 7MM will be the launch of Actelion’s Uptravi and the increased use of double and triple combination therapy.

Highlights

Key Questions Answered

- The level of unmet needs in the PAH market is significantly high. Will the pipeline drugs fulfil these unmet needs of the market? Key Opinion Leaders (KOLs) interviewed by GlobalData provide insights and highlight opportunities for drug developers.
- The 10-year forecast period will mark the launch of two late-stage pipeline drugs and the patent expirations of seven marketed drugs. How will the market be impacted? Which of the marketed and pipeline drugs will have the highest peak sales at the highest CAGR, and why?
- Is combination therapy the new standard-of-care in the PAH market? How will reimbursement affect the adoption of combination therapy in the different markets?

Key Findings

- The major drivers for growth across the 7MM in the PAH market during the forecast period will be the launch of the first-in-class prostacyclin receptor agonist, Uptravi marketed by Actelion and the increased use of combination therapy.
- KOLs interviewed by GlobalData opined that Uptravi has a promising future as a second-line therapy in the PAH market, and has the potential to displace oral treprostinil’s market position.
- The highest revenue generators in the 7MM market at the end of 2024 will be Actelion’s Veletri, Opsumit and Uptravi and Bayer’s Adempas.
- In other interviews, KOLs highlighted that the greatest unmet need in the PAH disease space is the need to develop novel drugs with curative or disease-stabilizing properties.
- Low disease awareness, declining population in the 5EU and Japan, high cost of drugs and patent expirations of branded drugs are the major barriers for growth in the PAH market during the forecast period.

Scope

- Overview of PAH, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized PAH therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the PAH therapeutics market.
- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
- Analysis of the current and future market competition in the global PAH therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the PAH therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the PAH therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
- Track drug sales in the 7MM PAH therapeutics market from 2014-2024.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table Of Contents

Opportunity Analyzer: Pulmonary Arterial Hypertension - Opportunity Analysis and Forecast to 2024
1 Table of Contents
1 Table of Contents 9
1.1 List of Tables 13
1.2 List of Figures 16
2 Introduction 18
2.1 Catalyst 18
2.2 Related Reports 18
3 Disease Overview 19
3.1 Etiology and Pathophysiology 19
3.1.1 Etiology 19
3.1.2 Pathophysiology 20
3.2 Symptoms 22
3.3 Diagnosis 23
3.4 Prognosis 24
3.5 Quality of Life 25
4 Epidemiology 26
4.1 Disease Background 26
4.2 Risk Factors and Comorbidities 28
4.3 Global Trends 29
4.3.1 Incidence and Prevalence 29
4.4 Forecast Methodology 31
4.4.1 Sources Used 34
4.4.2 Sources Not Used 39
4.4.3 Forecast Assumptions and Methods 40
4.5 Epidemiological Forecast for PAH (2014-2024) 46
4.5.1 Epidemiological Forecast for PAH - Based on Registry Data 46
4.5.2 Epidemiological Forecast for PAH - Adjusted for Underestimation 61
4.6 Discussion 74
4.6.1 Epidemiological Forecast Insight 74
4.6.2 Limitations of the Analysis 75
4.6.3 Strengths of the Analysis 76
5 Competitive Assessment 78
5.1 Overview 78
5.2 Diagnosis and Treatment 78
5.3 Clinical Practice 81
5.4 Product Profiles - Endothelin Receptor Antagonists 83
5.4.1 Tracleer (bosentan) 83
5.4.2 Volibris/Letairis (Ambrisentan) 87
5.4.3 Opsumit (macitentan) 91
5.5 Product Profiles - Phosphodiesterase Type 5 Inhibitors 94
5.5.1 Revatio (sildenafil citrate) 94
5.5.2 Adcirca (tadalafil) 96
5.6 Product Profile - Soluble Guanylate Cyclase Stimulator 99
5.6.1 Adempas (riociguat) 99
5.7 Product Profiles - Prostacyclin Derivatives 103
5.7.1 Flolan and Generics (epoprostenol) 103
5.7.2 Veletri (epoprostenol) 106
5.7.3 Ventavis (iloprost) 108
5.7.4 Remodulin (treprostinil) 111
5.7.5 Tyvaso (Treprostinil) 114
5.7.6 Orenitram (treprostinil) 117
6 Unmet Needs Assessment and Opportunity Analysis 121
6.1 Overview 121
6.1.1 Novel Curative or Stabilizing Therapeutics 122
6.1.2 Improved Efficacy 124
6.1.3 Biomarkers and Assays to Tailor Treatment 126
6.1.4 Drugs to Prevent Right Heart Failure 127
7 RandD Strategies 129
7.1 Overview 129
7.1.1 Reformulation of Existing PAH Drugs 129
7.1.2 Repurposing of Known Drugs from Other Therapy Areas 130
7.1.3 Novel Anti-inflammatory and Anti-Proliferative Therapeutic Targets 130
7.1.4 Licensing Agreements and Acquisitions 131
7.2 Clinical Trial Design 132
7.2.1 Current Clinical Trial Design 132
7.2.2 Future Clinical Trial Design 133
8 Pipeline Assessment 135
8.1 Overview 135
8.2 Promising Drugs in Late-Stage Clinical Development 136
8.2.1 Uptravi (selexipag) 136
8.2.2 Beraprost Sodium 314d (Beraprost sodium) 140
8.3 Innovative Early-Stage Approaches 144
9 Pipeline Valuation Analysis 146
9.1 Clinical Benchmark of Key Pipeline Drugs 146
9.2 Commercial Benchmark of Key Pipeline Drugs 148
9.3 Competitive Assessment 149
9.4 Top Line 10-Year Forecast 150
9.4.1 US 153
9.4.2 5EU 154
9.4.3 Japan 155
10 Appendix 156
10.1 Bibliography 156
10.2 Abbreviations 164
10.3 Methodology 167
10.4 Forecasting Methodology 167
10.4.1 Diagnosed PAH patients 167
10.4.2 Percent Drug-Treated Patients 167
10.4.3 Drugs Included in Each Therapeutic Class 168
10.4.4 General Pricing Assumptions 169
10.4.5 Individual Drug Assumptions 170
10.4.6 Pricing of Pipeline agents 175
10.5 Physicians Included in This Study 176
10.6 Primary Research - Prescriber Survey 178
10.7 About the Authors 179
10.7.1 Analyst 179
10.7.2 Epidemiologist 179
10.7.3 Therapy Director - CVMD 180
10.7.4 Global Head of Healthcare 180
10.8 About GlobalData 181
10.9 Disclaimer 181

1.1 List of Tables
Table 1: NYHA/WHO Functional Classification of PAH 23
Table 2: WHO Guidelines, Modified New York Heart Association Functional Classes I-IV 27
Table 3: Risk Factors and Comorbidities for PAH 28
Table 4: 7MM, Global Trends for the Diagnosed Incidence of PAH 30
Table 5: 7MM, Global Trends for the Diagnosed Prevalence of PAH 31
Table 6: 7MM Sources of Epidemiological Data Used for the Forecast for PAH Diagnosed Incident Cases (Based on Registry Data) 32
Table 7: 7MM Sources of Epidemiological Data Used for the Forecast for PAH Diagnosed Prevalent Cases (Based on Registry Data) 33
Table 8: 7MM Sources of Epidemiological Data Used for the Classification of Diagnosed Prevalent Cases* According to the NYHA Functional Classes I-IV 34
Table 9: 7MM, Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, 2014-2024 (Based on Registry Data) 47
Table 10: 7MM, Age-Specific Diagnosed Incident Cases of PAH, Both Sexes, N (Row %), 2014 (Based on Registry Data) 49
Table 11: 7MM, Sex-Specific Diagnosed Incident Cases of PAH, All Ages, N (Row %), 2014 (Based on Registry Data) 51
Table 12: 7MM, Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, 2014-2024 (Based on Registry Data) 54
Table 13: 7MM Age-Specific Diagnosed Prevalent Cases of PAH, Both Sexes, N (Row %), 2014 (Based on Registry Data) 56
Table 14: 7MM, Sex-Specific Diagnosed Prevalent Cases of PAH, All Ages, N (Row %), 2014 (Based on Registry Data) 58
Table 15: 7MM, Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, 2014-2024 (Adjusted for Underestimation) 62
Table 16: 7MM, Age-Specific Diagnosed Incident Cases of PAH, Both Sexes, N (Row %), 2014 (Adjusted for Underestimation) 64
Table 17: 7MM, Sex-Specific Diagnosed Incident Cases of PAH, All Ages, N (Row %), 2014 (Adjusted for Underestimation) 66
Table 18: 7MM, Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, 2014-2024 (Adjusted for Underestimation) 68
Table 19: 7MM, Age-Specific Diagnosed Prevalent Cases of PAH, Both Sexes, N (Row %), 2014 (Adjusted for Underestimation) 70
Table 20: 7MM, Sex-Specific Diagnosed Prevalent Cases of PAH, All Ages, N (Row %), 2014 (Adjusted for Underestimation) 72
Table 21: PAH Diagnosis and Treatment Guidelines 79
Table 22: Leading Treatments for PAH 81
Table 23: Product Profile - Tracleer 85
Table 24: Tracleer SWOT Analysis, 2015 87
Table 25: Product Profile - Volibris/Letairis 89
Table 26: Volibris/Letairis SWOT Analysis, 2015 90
Table 27: Product Profile - Opsumit 92
Table 28: Opsumit SWOT Analysis, 2015 93
Table 29: Product Profile - Revatio 95
Table 30: Revatio SWOT Analysis, 2015 96
Table 31: Product Profile - Adcirca 98
Table 32: Adcirca SWOT Analysis, 2015 99
Table 33: Product Profile - Adempas 101
Table 34: Adempas SWOT Analysis, 2015 103
Table 35: Product Profile - Flolan 104
Table 36: Flolan SWOT Analysis, 2015 106
Table 37: Product Profile - Veletri 107
Table 38: Veletri SWOT Analysis, 2015 108
Table 39: Product Profile - Ventavis 109
Table 40: Ventavis SWOT Analysis, 2015 111
Table 41: Product Profile - Remodulin 113
Table 42: Remodulin SWOT Analysis, 2015 114
Table 43: Product Profile - Tyvaso 116
Table 44: Tyvaso SWOT Analysis, 2015 117
Table 45: Product Profile - Orenitram 119
Table 46: Orenitram SWOT Analysis, 2015 120
Table 47: Unmet Needs in PAH 122
Table 48: Examples of Endpoints Used in the Pivotal Trials for Approved Treatments for PAH 133
Table 49: PAH - Late-Stage Clinical Pipeline, 2015 136
Table 50: Product Profile - Uptravi 139
Table 51: Uptravi SWOT Analysis, 2015 140
Table 52: Product Profile - Beraprost Sodium 314d 142
Table 53: Beraprost Sodium 314d SWOT Analysis, 2015 143
Table 54: Innovative Early-Stage Pipeline Products in PAH 144
Table 55: Clinical Benchmark of Key Pipeline Drugs for PAH 146
Table 56: Commercial Benchmark of Key Pipeline Drugs for PAH 148
Table 57: Top-Line Sales Forecasts ($m) for PAH, 2014-2024 151
Table 58: Key Events Impacting Sales for PAH, 2014-2024 152
Table 59: Pulmonary Arterial Hypertension Market - Drivers and Barriers, 2014-2024 153
Table 60: Key Launch Dates 168
Table 61: Key Patent Expiration Dates 169
Table 62: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country 178

1.2 List of Figures
Figure 1: Target Pathways of the Currently Marketed Drugs for PAH 22
Figure 2: Diagnostic Approach to PAH 24
Figure 3: 7MM, Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, 2014-2024 (Based on Registry Data) 47
Figure 4: 7MM, Age-Specific Diagnosed Incident Cases of PAH, Both Sexes, N, 2014 (Based on Registry Data) 50
Figure 5: 7MM, Sex-Specific Diagnosed Incident Cases of PAH, All Ages, N, 2014 (Based on Registry Data) 52
Figure 6: 7MM, Age-Standardized Diagnosed Incidence of PAH (Cases per 100,000 Population), All Ages, by Sex, 2014 (Based on Registry Data) 53
Figure 7: 7MM, Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, 2014-2024 (Based on Registry Data) 54
Figure 8: 7MM Age-Specific Diagnosed Prevalent Cases of PAH, Both Sexes, N, 2014 (Based on Registry Data) 57
Figure 9: 7MM, Sex-Specific Diagnosed Prevalent Cases of PAH, All Ages, N, 2014 (Based on Registry Data) 59
Figure 10: 7MM, Age-Standardized Diagnosed Prevalence of PAH (%), All Ages, by Sex, 2014 (Based on Registry Data) 60
Figure 11: 7MM, Diagnosed Prevalent Cases of PAH Categorized into NYHA Functional Classes (N), All Ages, 2014 (Based on Registry Data) 61
Figure 12: 7MM, Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, 2014-2024 (Adjusted for Underestimation) 62
Figure 13: 7MM, Age-Specific Diagnosed Incident Cases of PAH, Both Sexes, N, 2014 (Adjusted for Underestimation) 65
Figure 14: 7MM, Sex-Specific Diagnosed Incident Cases of PAH, All Ages, N, 2014 (Adjusted for Underestimation) 67
Figure 15: 7MM, Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, 2014-2024 (Adjusted for Underestimation) 68
Figure 16: 7MM, Age-Specific Diagnosed Prevalent Cases of PAH, Both Sexes, N, 2014 (Adjusted for Underestimation) 71
Figure 17: 7MM, Sex-Specific Diagnosed Prevalent Cases of PAH, All Ages, N, 2014 (Adjusted for Underestimation) 73
Figure 18: 7MM, Diagnosed Prevalent Cases of PAH Categorized into NYHA Functional Classes (N), All Ages, 2014 (Adjusted for Underestimation) 74
Figure 19: PAH Treatment Algorithm 80
Figure 20: Competitive Assessment of Key Pipeline Drugs for PAH, 2014-2024 149
Figure 21: Sales for PAH in the US, 5EU, and Japan, 2014-2024 151

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