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OpportunityAnalyzer: Pulmonary Arterial Hypertension - Opportunity Analysis and Forecasts to 2026

Published By :

GlobalData

Published Date : Oct 2017

Category :

Pharmaceutical

No. of Pages : 182 Pages

OpportunityAnalyzer: Pulmonary Arterial Hypertension - Opportunity Analysis and Forecasts to 2026

Summary

Pulmonary arterial hypertension (PAH) is a rare, fatal cardiopulmonary disease with an annual mortality rate of 15%. The disease is a subset (Group 1) within the World Health Organizations (WHOs) classification of the different types of pulmonary hypertension (PH). PAH is characterized by an abnormal rise in the resting mean pulmonary arterial pressure (>25mmHg compared with normal levels of around 14mmHg). This increased pressure is caused by pulmonary arterial obstruction due to endothelial dysfunction and vascular remodeling, and leads to increased resistance in the arterial blood vessels. Since PAH is a progressive disorder, the pulmonary pressure keeps building up as the patient advances through the later stages of the disease, leading to reduced cardiac output, right heart failure, and ultimately, death.

GlobalData estimates the 2016 sales for the PAH market at approximately $3.79 billion across the 7MM, encompassing the US, the five major European countries (5EU: France, Germany, Italy, Spain, and UK), and Japan. By 2026 GlobalData expects the overall market to grow at a moderate compound annual growth rate (CAGR) of 2.2% to reach sales of $4.72 billion over the 10-year period. The 5EU market is anticipated to grow the fastest of the three regions, recording a CAGR of 5.4%, while the US and Japan will each record CAGRs of 1.2% and 1.0%, respectively. At the end of 2026, the US will contribute around 67% of global sales, while the 5EU and Japan will account for 28% and 5% of global sales, respectively. The higher sales numbers for the US can be attributed to the higher price of pharmaceuticals and the greater diagnosed prevalence of PAH in the region.

Scope

- Overview of pulmonary arterial hypertension, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized PAH therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2016 and forecast for ten years to 2026.
- 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 global PAH therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global 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 global PAH therapeutics market from 2016-2026.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 8
2 Executive Summary 10
2.1 PAH Market Will Exhibit Moderate Growth Between 2016 and 2026 10
2.2 Upfront and Sequential Dual and Triple Combination Therapies and Launch of Bardoxolone Methyl Will Fuel Market Growth 12
2.3 Bardoxolone Methyl Has the Potential to Become a Blockbuster Therapy and Fulfill an Unmet Need 13
2.4 Reformulation of Existing Drugs Will Continue to Dominate the PAH Pipeline 14
2.5 What Do Physicians Think? 14
3 Introduction 18
3.1 Catalyst 18
3.2 Related Reports 18
4 Disease Overview 19
4.1 Etiology and Pathophysiology 19
4.1.1 Etiology 19
4.1.2 Pathophysiology 19
4.2 Symptoms 22
4.3 Diagnosis 23
4.4 Prognosis 25
4.5 Quality of Life 25
5 Epidemiology 27
5.1 Disease Background 27
5.2 Risk Factors and Comorbidities 28
5.3 Global and Historical Trends 29
5.4 Forecast Methodology 31
5.4.1 Sources 31
5.4.2 Forecast Assumptions and Methods 39
5.5 Epidemiological Forecast for PAH (2016-2026) - Based on Registry Data 51
5.5.1 Diagnosed Incident Cases of PAH (Forecast Based on Registry Data) 51
5.5.2 Diagnosed Prevalent Cases of PAH (Forecast Based on Registry Data) 52
5.5.3 Diagnosed Prevalent Cases of PAH by NYHA Functional Classes (Forecast Based on Registry Data) 53
5.5.4 Comorbidities Among the Diagnosed Prevalent Cases of PAH (Forecast Based on Registry Data) 53
5.6 Epidemiological Forecast for PAH (2016-2026) - Adjusted for Underestimation of Registry Data 54
5.6.1 Diagnosed Incident Cases of PAH (Forecast Adjusted for Underestimation of Registry Data) 54
5.6.2 Age-Specific Diagnosed Incident Cases of PAH (Forecast Adjusted for Underestimation of Registry Data) 56
5.6.3 Sex-Specific Diagnosed Incident Cases of PAH (Forecast Adjusted for Underestimation of Registry Data) 57
5.6.4 Diagnosed Prevalent Cases of PAH (Forecast Adjusted for Underestimation of Registry Data) 58
5.6.5 Age-Specific Diagnosed Prevalent Cases of PAH (Forecast Adjusted for Underestimation of Registry Data) 59
5.6.6 Sex-Specific Diagnosed Prevalent Cases of PAH (Forecast Adjusted for Underestimation of Registry Data) 60
5.6.7 Diagnosed Prevalent Cases of PAH by NYHA Functional Class I-IV (Forecast Adjusted for Underestimation of Registry Data) 61
5.6.8 Comorbidities Among the Diagnosed Prevalent Cases of PAH (Forecast Adjusted for Underestimation of Registry Data) 62
5.7 Discussion 63
5.7.1 Epidemiological Forecast Insight 63
5.7.2 Limitations of Analysis 64
5.7.3 Strengths of Analysis 64
6 Current Treatment Options 66
6.1 Overview 66
6.2 Diagnosis and Treatment 66
6.3 Clinical Practice 68
6.4 Product Profiles - Endothelin Receptor Antagonists 71
6.4.1 Tracleer and Generics (bosentan) 71
6.4.2 Volibris/Letairis (ambrisentan) 74
6.4.3 Opsumit (macitentan) 77
6.5 Product Profiles - Phosphodiesterase Type 5 Inhibitors 80
6.5.1 Revatio and Generics (sildenafil citrate) 80
6.5.2 Adcirca (tadalafil) 83
6.6 Product Profiles - Soluble Guanylate Cyclase Stimulators 85
6.6.1 Adempas (riociguat) 85
6.7 Product Profiles - Prostacyclin Derivatives 89
6.7.1 Flolan and Generics (epoprostenol) 89
6.7.2 Veletri (epoprostenol) 92
6.7.3 Ventavis (iloprost) 94
6.7.4 Remodulin (treprostinil) 96
6.7.5 Tyvaso (treprostinil) 99
6.7.6 Orenitram (treprostinil) 101
6.8 Product Profiles - Prostacyclin IP Receptor Agonists 104
6.8.1 Uptravi (selexipag) 104
7 Unmet Needs and Opportunity Assessment 109
7.1 Overview 109
7.2 Novel Curative or Stabilizing Therapeutics 110
7.2.1 Unmet Need 110
7.2.2 Gap Analysis 112
7.2.3 Opportunity 112
7.3 Improved Efficacy 113
7.3.1 Unmet Need 113
7.3.2 Gap Analysis 113
7.3.3 Opportunity 114
7.4 Biomarkers and Assays to Tailor Treatment 114
7.4.1 Unmet Need 114
7.4.2 Gap Analysis 115
7.4.3 Opportunity 115
7.5 Drugs to Prevent Right Heart Failure 115
7.5.1 Unmet Need 115
7.5.2 Gap Analysis 116
7.5.3 Opportunity 116
7.6 Anti-inflammatory Therapies 117
7.6.1 Unmet Need 117
7.6.2 Gap Analysis 117
7.6.3 Opportunity 117
8 R&D Strategies 118
8.1 Overview 118
8.1.1 Reformulation of Existing PAH Drugs 118
8.1.2 Repurposing of Known Drugs from Other Therapy Areas 119
8.1.3 Novel Anti-inflammatory and Anti-proliferative Therapeutic Targets 119
8.1.4 Licensing Agreements and Acquisitions 120
8.2 Clinical Trials Design 121
8.2.1 Current Clinical Trial Design 121
8.2.2 Future Clinical Trial Design 122
9 Pipeline Assessment 124
9.1 Overview 124
9.2 Promising Drugs in Clinical Development 126
9.3 Promising Drugs in Clinical Development, Prostacyclin Derivatives 126
9.3.1 Trevyent (treprostinil diolamine) 126
9.3.2 Tysuberprost (esuberaprost sodium + treprostinil) 128
9.4 Promising Drugs in Clinical Development, Prostacyclin IP Receptor Agonists 131
9.4.1 Ralinepag 131
9.5 Promising Drugs in Clinical Development, Antioxidant Inflammation Modulators 133
9.5.1 Bardoxolone Methyl 133
9.6 Innovative Early-Stage Approaches 136
10 Pipeline Valuation Analysis 139
10.1 Clinical Benchmark of Key Pipeline Drugs 139
10.2 Commercial Benchmark of Key Pipeline Drugs 141
10.3 Competitive Assessment 143
10.4 Top-Line 10-Year Forecast 145
10.4.1 US 149
10.4.2 5EU 151
10.4.3 Japan 151
11 Appendix 153
11.1 Bibliography 153
11.2 Abbreviations 161
11.3 Methodology 164
11.3.1 Forecasting Methodology 164
11.3.2 Diagnosed Patients 164
11.3.3 Percent Drug-Treated Patients 164
11.3.4 Drugs Included in Each Therapeutic Class 165
11.3.5 Launch and Patent Expiry Dates 165
11.3.6 General Pricing Assumptions 166
11.3.7 Individual Drug Assumptions 167
11.3.8 Generic Erosion 171
11.3.9 Pricing of Pipeline Agents 171
11.4 Primary Research - KOLs Interviewed for This Report 173
11.5 Primary Research - Prescriber Survey 176
11.6 About the Authors 177
11.6.1 Analyst 177
11.6.2 Therapy Area Director 177
11.6.3 Epidemiologist 178
11.6.4 Director of Epidemiology 178
11.6.5 Global Director of Therapy Analysis and Epidemiology 179
11.6.6 Global Head of Healthcare 180
11.7 About GlobalData 181
11.8 Contact Us 181
11.9 Disclaimer 182

1.1 List of Tables
Table 1: Pulmonary Arterial Hypertension Key Metrics in the 7MM 10
Table 2: NYHA/WHO Functional Classification of PAH 23
Table 3: WHO Guidelines, Modified NYHA Functional Classes I-IV 28
Table 4: Risk Factors and Comorbidities for PAH 29
Table 5: 7MM, Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, Selected Years 2016-2026 (Based on Registry Data) 51
Table 6: 7MM, Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, Selected Years 2016-2026 (Forecast Based on Registry Data). 52
Table 7: 7MM, Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, Selected Years 2016-2026 (Forecast Adjusted for Underestimation of Registry Data) 55
Table 8: 7MM, Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, Selected Years 2016-2026 (Forecast Adjusted for Underestimation of Registry Data) 58
Table 9: Treatment Guidelines for PAH 67
Table 10: Most Prescribed Drugs for PAH by Class in the Global Markets, 2017 68
Table 11: Product Profile - Tracleer 72
Table 12: Tracleer SWOT Analysis, 2017 74
Table 13: Product Profile - Volibris/Letairis 75
Table 14: Volibris/Letairis SWOT Analysis, 2017 77
Table 15: Product Profile - Opsumit 78
Table 16: Opsumit SWOT Analysis, 2017 80
Table 17: Product Profile - Revatio 81
Table 18: Revatio SWOT Analysis, 2017 82
Table 19: Product Profile - Adcirca 84
Table 20: Adcirca SWOT Analysis, 2017 85
Table 21: Product Profile - Adempas 87
Table 22: Adempas SWOT Analysis, 2017 88
Table 23: Product Profile - Flolan 90
Table 24: Flolan SWOT Analysis, 2017 91
Table 25: Product Profile - Veletri 93
Table 26: Veletri SWOT Analysis, 2017 94
Table 27: Product Profile - Ventavis 95
Table 28: Ventavis SWOT Analysis, 2017 96
Table 29: Product Profile - Remodulin 98
Table 30: Remodulin SWOT Analysis, 2017 99
Table 31: Product Profile - Tyvaso 100
Table 32: Tyvaso SWOT Analysis, 2017 101
Table 33: Product Profile - Orenitram 103
Table 34: Orenitram SWOT Analysis, 2017 104
Table 35: Product Profile - Uptravi 107
Table 36: Uptravi SWOT Analysis, 2017 108
Table 37: Examples of Endpoints Used in the Pivotal Trials for Approved Treatments for PAH 122
Table 38: PAH - Late-Stage Clinical Pipeline, 2017 126
Table 39: Product Profile - Trevyent 127
Table 40: Trevyent SWOT Analysis, 2017 128
Table 41: Product Profile - Tysuberprost 130
Table 42: Tysuberprost SWOT Analysis, 2017 131
Table 43: Product Profile - Ralinepag 132
Table 44: Ralinepag SWOT Analysis, 2017 133
Table 45: Product Profile - Bardoxolone Methyl 134
Table 46: Bardoxolone Methyl SWOT Analysis, 2017 136
Table 47: Drugs in Development for PAH, 2016 138
Table 48: Clinical Benchmark of Key Pipeline Drugs - Prostacyclin Derivatives 139
Table 49: Clinical Benchmark of Key Pipeline Drugs - Prostacyclin IP Receptor Agonists 140
Table 50: Commercial Benchmark of Key Pipeline Drugs - Prostacyclin Derivatives 141
Table 51: Commercial Benchmark of Key Pipeline Drugs - Prostacyclin IP Receptor Agonists 142
Table 52: Key Events Impacting Sales for PAH, 2016-2026 148
Table 53: PAH Market - Global Drivers and Barriers, 2016-2026 149
Table 54: Key Historical and Projected Launch Dates for PAH 165
Table 55: Key Historical and Projected Patent Expiry Dates for PAH 166
Table 56: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 176

1.2 List of Figures
Figure 1: Global Sales Forecast by Country for PAH in 2016 and 2026 12
Figure 2: Target Pathways of the Currently Marketed Drugs for PAH 22
Figure 3: Diagnostic Approach to PAH 24
Figure 4: 7MM, Age-Standardized Diagnosed Incidence of PAH (Cases per 100,000 Population), All Ages, by Sex, 2016 (Forecast Based on Registry Data) 30
Figure 5: 7MM, Age-Standardized Diagnosed Prevalence of PAH (%), All Ages, by Sex, 2016 (Forecast Based on Registry Data) 31
Figure 6: 7MM, Sources Used and Not Used for the Diagnosed Incident Cases of PAH and Diagnosed Prevalent Cases of PAH (for Forecast Based on Registry Data and Forecast Adjusted for Underestimation of Registry Data) 33
Figure 7: 7MM, Sources Used for the Diagnosed Prevalent Cases of PAH* by NYHA Functional Classes I-IV (for Forecast Based on Registry Data and Forecast Adjusted for Underestimation of Registry Data) 34
Figure 8: 7MM, Sources Used for the Diagnosed Prevalent Cases of PAH with CTD (for Forecast Based on Registry Data and Forecast Adjusted for Underestimation of Registry Data) 35
Figure 9: 7MM, Sources Used for the Diagnosed Prevalent Cases of PAH with SS (for Forecast Based on Registry Data and Forecast Adjusted for Underestimation of Registry Data) 36
Figure 10: 7MM, Sources Used for the Diagnosed Prevalent Cases of PAH with Diabetes (for Forecast Based on Registry Data and Forecast Adjusted for Underestimation of Registry Data) 36
Figure 11: 7MM, Sources Used for the Diagnosed Prevalent Cases of PAH with COPD (for Forecast Based on Registry Data and Forecast Adjusted for Underestimation of Registry Data) 37
Figure 12: 7MM, Sources Used for the Diagnosed Prevalent Cases of PAH with PT (for Forecast Based on Registry Data and Forecast Adjusted for Underestimation of Registry Data) 38
Figure 13: 7MM, Sources Used for the Diagnosed Prevalent Cases of PAH with CHD (for Forecast Based on Registry Data and Forecast Adjusted for Underestimation of Registry Data) 39
Figure 14: 7MM, Diagnosed Prevalent Cases of PAH, by NYHA Functional Class I-IV, Both Sexes, All Ages, N, 2016 (Forecast Based on Registry Data) 53
Figure 15: 7MM, Comorbidities Among the Diagnosed Prevalent Cases of PAH (N), All Ages, 2016 (Forecast Based on Registry Data) 54
Figure 16: 7MM, Age-Specific Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, 2016 (Forecast Adjusted for Underestimation of Registry Data) 56
Figure 17: 7MM, Sex-Specific Diagnosed Incident Cases of PAH, All Ages, N, 2016 (Forecast Adjusted for Underestimation of Registry Data) 57
Figure 18: 7MM, Age-Specific Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, 2016 (Forecast Adjusted for Underestimation of Registry Data) 59
Figure 19: 7MM, Sex-Specific Diagnosed Prevalent Cases of PAH, All Ages, 2016 (Forecast Adjusted for Underestimation of Registry Data) 60
Figure 20: 7MM, Diagnosed Prevalent Cases of PAH Categorized into NYHA Functional Class I-IV (N), Both Sexes, All Ages, 2016 (Forecast Adjusted for Underestimation of Registry Data) 61
Figure 21: 7MM, Comorbidities Among the Diagnosed Prevalent Cases of PAH (N), Both Sexes, All Ages, 2016 (Forecast Adjusted for Underestimation of Registry Data) 62
Figure 22: Unmet Need and Opportunity in PAH, 2017 110
Figure 23: Overview of the Development Pipeline in PAH 125
Figure 24: Competitive Assessment of the Marketed and Pipeline Prostacyclin Derivative Drugs Benchmarked Against the SOC, Remodulin 143
Figure 25: Competitive Assessment of the Marketed and Pipeline Prostacyclin IP Receptor Agonist Drugs Benchmarked Against the SOC, Uptravi 144
Figure 26: Global (7MM) Sales Forecast by Country for PAH in 2016 and 2026 146
Figure 27: Global Sales Forecast by Class for PAH in 2016 and 2026 147
Figure 28: Sales Forecast by Class for PAH in the US in 2016 and 2026 150

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