OpportunityAnalyzer: Pulmonary Arterial Hypertension – Opportunity Analysis and Forecast to 2024

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.2Symptoms

3.3Diagnosis

3.4Prognosis

3.5Quality of Life

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends

4.3.1Incidence and Prevalence

4.4Forecast Methodology

4.4.1Sources Used

4.4.2Sources Not Used

4.4.3Forecast Assumptions and Methods

4.5Epidemiological Forecast for PAH (2014–2024)

4.5.1Epidemiological Forecast for PAH — Based on Registry Data

4.5.2Epidemiological Forecast for PAH – Adjusted for Underestimation

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Competitive Assessment

5.1Overview

5.2Diagnosis and Treatment

5.3Clinical Practice

5.4Product Profiles – Endothelin Receptor Antagonists

5.4.1Tracleer (bosentan)

5.4.2Volibris/Letairis (Ambrisentan)

5.4.3Opsumit (macitentan)

5.5Product Profiles – Phosphodiesterase Type 5 Inhibitors

5.5.1Revatio (sildenafil citrate)

5.5.2Adcirca (tadalafil)

5.6Product Profile – Soluble Guanylate Cyclase Stimulator

5.6.1Adempas (riociguat)

5.7Product Profiles – Prostacyclin Derivatives

5.7.1Flolan and Generics (epoprostenol)

5.7.2Veletri (epoprostenol)

5.7.3Ventavis (iloprost)

5.7.4Remodulin (treprostinil)

5.7.5Tyvaso (Treprostinil)

5.7.6Orenitram (treprostinil)

6Unmet Needs Assessment and Opportunity Analysis

6.1Overview

6.1.1Novel Curative or Stabilizing Therapeutics

6.1.2Improved Efficacy

6.1.3Biomarkers and Assays to Tailor Treatment

6.1.4Drugs to Prevent Right Heart Failure

7R&D Strategies

7.1Overview

7.1.1Reformulation of Existing PAH Drugs

7.1.2Repurposing of Known Drugs from Other Therapy Areas

7.1.3Novel Anti-inflammatory and Anti-Proliferative Therapeutic Targets

7.1.4Licensing Agreements and Acquisitions

7.2Clinical Trial Design

7.2.1Current Clinical Trial Design

7.2.2Future Clinical Trial Design

8Pipeline Assessment

8.1Overview

8.2Promising Drugs in Late-Stage Clinical Development

8.2.1Uptravi (selexipag)

8.2.2Beraprost Sodium 314d (Beraprost sodium)

8.3Innovative Early-Stage Approaches

9Pipeline Valuation Analysis

9.1Clinical Benchmark of Key Pipeline Drugs

9.2Commercial Benchmark of Key Pipeline Drugs

9.3Competitive Assessment

9.4Top Line 10-Year Forecast

9.4.1US

9.4.25EU

9.4.3Japan

10Appendix

10.1Bibliography

10.2Abbreviations

10.3Methodology

10.4Forecasting Methodology

10.4.1Diagnosed PAH patients

10.4.2Percent Drug-Treated Patients

10.4.3Drugs Included in Each Therapeutic Class

10.4.4General Pricing Assumptions

10.4.5Individual Drug Assumptions

10.4.6Pricing of Pipeline agents

10.5Physicians Included in This Study

10.6Primary Research – Prescriber Survey

10.7About the Authors

10.7.1Analyst

10.7.2Epidemiologist

10.7.3Therapy Director – CVMD

10.7.4Global Head of Healthcare

10.8About GlobalData

10.9Contact Us

10.10Disclaimer

Table 1: NYHA/WHO Functional Classification of PAH

Table 2: WHO Guidelines, Modified New York Heart Association Functional Classes I–IV

Table 3: Risk Factors and Comorbidities for PAH

Table 4: 7MM, Global Trends for the Diagnosed Incidence of PAH

Table 5: 7MM, Global Trends for the Diagnosed Prevalence of PAH

Table 6: 7MM Sources of Epidemiological Data Used for the Forecast for PAH Diagnosed Incident Cases (Based on Registry Data)

Table 7: 7MM Sources of Epidemiological Data Used for the Forecast for PAH Diagnosed Prevalent Cases (Based on Registry Data)

Table 8: 7MM Sources of Epidemiological Data Used for the Classification of Diagnosed Prevalent Cases* According to the NYHA Functional Classes I–IV

Table 9: 7MM, Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, 2014–2024 (Based on Registry Data)

Table 10: 7MM, Age-Specific Diagnosed Incident Cases of PAH, Both Sexes, N (Row %), 2014 (Based on Registry Data)

Table 11: 7MM, Sex-Specific Diagnosed Incident Cases of PAH, All Ages, N (Row %), 2014 (Based on Registry Data)

Table 12: 7MM, Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, 2014–2024 (Based on Registry Data)

Table 13: 7MM Age-Specific Diagnosed Prevalent Cases of PAH, Both Sexes, N (Row %), 2014 (Based on Registry Data)

Table 14: 7MM, Sex-Specific Diagnosed Prevalent Cases of PAH, All Ages, N (Row %), 2014 (Based on Registry Data)

Table 15:7MM, Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, 2014–2024 (Adjusted for Underestimation)

Table 16: 7MM, Age-Specific Diagnosed Incident Cases of PAH, Both Sexes, N (Row %), 2014 (Adjusted for Underestimation)

Table 17: 7MM, Sex-Specific Diagnosed Incident Cases of PAH, All Ages, N (Row %), 2014 (Adjusted for Underestimation)

Table 18: 7MM, Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, 2014–2024 (Adjusted for Underestimation)

Table 19: 7MM, Age-Specific Diagnosed Prevalent Cases of PAH, Both Sexes, N (Row %), 2014 (Adjusted for Underestimation)

Table 20: 7MM, Sex-Specific Diagnosed Prevalent Cases of PAH, All Ages, N (Row %), 2014 (Adjusted for Underestimation)

Table 21: PAH Diagnosis and Treatment Guidelines

Table 22: Leading Treatments for PAH

Table 23: Product Profile – Tracleer

Table 24: Tracleer SWOT Analysis, 2015

Table 25: Product Profile – Volibris/Letairis

Table 26: Volibris/Letairis SWOT Analysis, 2015

Table 27: Product Profile – Opsumit

Table 28: Opsumit SWOT Analysis, 2015

Table 29: Product Profile – Revatio

Table 30: Revatio SWOT Analysis, 2015

Table 31: Product Profile – Adcirca

Table 32: Adcirca SWOT Analysis, 2015

Table 33: Product Profile – Adempas

Table 34: Adempas SWOT Analysis, 2015

Table 35: Product Profile – Flolan

Table 36: Flolan SWOT Analysis, 2015

Table 37: Product Profile – Veletri

Table 38: Veletri SWOT Analysis, 2015

Table 39: Product Profile – Ventavis

Table 40: Ventavis SWOT Analysis, 2015

Table 41: Product Profile – Remodulin

Table 42: Remodulin SWOT Analysis, 2015

Table 43: Product Profile – Tyvaso

Table 44: Tyvaso SWOT Analysis, 2015

Table 45: Product Profile – Orenitram

Table 46: Orenitram SWOT Analysis, 2015

Table 47: Unmet Needs in PAH

Table 48: Examples of Endpoints Used in the Pivotal Trials for Approved Treatments for PAH

Table 49: PAH – Late-Stage Clinical Pipeline, 2015

Table 50: Product Profile — Uptravi

Table 51: Uptravi SWOT Analysis, 2015

Table 52: Product Profile — Beraprost Sodium 314d

Table 53: Beraprost Sodium 314d SWOT Analysis, 2015

Table 54: Innovative Early-Stage Pipeline Products in PAH

Table 55: Clinical Benchmark of Key Pipeline Drugs for PAH

Table 56: Commercial Benchmark of Key Pipeline Drugs for PAH

Table 57: Top-Line Sales Forecasts ($m) for PAH, 2014–2024

Table 58: Key Events Impacting Sales for PAH, 2014–2024

Table 59: Pulmonary Arterial Hypertension Market — Drivers and Barriers, 2014–2024

Table 60: Key Launch Dates

Table 61: Key Patent Expiration Dates

Table 62: High-Prescribing Physicians (Non-KOLs) Surveyed, By Country

Figure 1: Target Pathways of the Currently Marketed Drugs for PAH

Figure 2: Diagnostic Approach to PAH

Figure 3: 7MM, Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, 2014–2024 (Based on Registry Data)

Figure 4: 7MM, Age-Specific Diagnosed Incident Cases of PAH, Both Sexes, N, 2014 (Based on Registry Data)

Figure 5: 7MM, Sex-Specific Diagnosed Incident Cases of PAH, All Ages, N, 2014 (Based on Registry Data)

Figure 6: 7MM, Age-Standardized Diagnosed Incidence of PAH (Cases per 100,000 Population), All Ages, by Sex, 2014 (Based on Registry Data)

Figure 7: 7MM, Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, 2014–2024 (Based on Registry Data)

Figure 8: 7MM Age-Specific Diagnosed Prevalent Cases of PAH, Both Sexes, N, 2014 (Based on Registry Data)

Figure 9: 7MM, Sex-Specific Diagnosed Prevalent Cases of PAH, All Ages, N, 2014 (Based on Registry Data)

Figure 10: 7MM, Age-Standardized Diagnosed Prevalence of PAH (%), All Ages, by Sex, 2014 (Based on Registry Data)

Figure 11: 7MM, Diagnosed Prevalent Cases of PAH Categorized into NYHA Functional Classes (N), All Ages, 2014 (Based on Registry Data)

Figure 12: 7MM, Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, 2014–2024 (Adjusted for Underestimation)

Figure 13: 7MM, Age-Specific Diagnosed Incident Cases of PAH, Both Sexes, N, 2014 (Adjusted for Underestimation)

Figure 14: 7MM, Sex-Specific Diagnosed Incident Cases of PAH, All Ages, N, 2014 (Adjusted for Underestimation)

Figure 15: 7MM, Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, 2014–2024 (Adjusted for Underestimation)

Figure 16: 7MM, Age-Specific Diagnosed Prevalent Cases of PAH, Both Sexes, N, 2014 (Adjusted for Underestimation)

Figure 17: 7MM, Sex-Specific Diagnosed Prevalent Cases of PAH, All Ages, N, 2014 (Adjusted for Underestimation)

Figure 18: 7MM, Diagnosed Prevalent Cases of PAH Categorized into NYHA Functional Classes (N), All Ages, 2014 (Adjusted for Underestimation)

Figure 19: PAH Treatment Algorithm

Figure 20: Competitive Assessment of Key Pipeline Drugs for PAH, 2014–2024

Figure 21: Sales for PAH in the US, 5EU, and Japan, 2014–2024