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

  • ID: 4450542
  • Drug Pipelines
  • 182 pages
  • GlobalData
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FEATURED COMPANIES

  • Eiger BioPharmaceuticals
  • Gilead
  • Merck
  • Nippon Shinyaku Co. Ltd.
  • Pluristem Therapeutics
  • Roche
  • MORE
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 Organization’s (WHO’s) classification of the different types of pulmonary hypertension (PH). PAH is characterized by an abnormal rise in the resting mean pulmonary artery pressure (PAP) (>25mmHg compared with normal levels of around 14mmHg), a pulmonary vascular resistance of more than 3 Wood units, and a pulmonary capillary wedge pressure less than 15mmHg (Foshat and Boroumand, 2017).

Pulmonary arterial hypertension (PAH) market has generated much interest and investment from drug developers over the past several years, despite PAH being a rare disease. Current treatments include 13 marketed drugs from five different therapeutics classes, while there are four drugs in late-stage development. The forecast period from 2016-2026 will be marked by the patent expirations of several of these marketed drugs, including Volibris/Letairis, Opsumit, Adcirca, Adempas, Remodulin, Tyvaso, and Uptravi.

It is estimated that the 2016 sales for the pulmonary arterial hypertension (PAH) market was approximately $3.8B across the 7MM, encompassing the US, the five major European countries (5EU: France, Germany, Italy, Spain, and UK), and Japan. By 2026, it is expected that the overall market will grow at a moderate compound annual growth rate (CAGR) of 2.2% over the 10-year period.

Major drivers to this growth in the PAH market during the forecast period will include:
  • Increased use of combination therapy following the positive outcomes from recent clinical trials will boost PAH sales due to higher treatment costs of drug combinations.
  • Launch of Reata Pharmaceuticals’ first-in-class antioxidant inflammation modulator, bardoxolone methyl, will provide an effective oral therapy for PAH patients with the potential of being used in combination with other therapies.
  • Patient assistance programs by manufacturers will provide reimbursement support to the patients.
  • Launch of Arena Pharmaceuticals’ pipeline drug, ralinepag, will provide an effective oral alternative to parenteral prostacyclin therapy.
The report "OpportunityAnalyzer: Pulmonary Arterial Hypertension - Opportunity Analysis and Forecasts to 2026", provideoverview of pulmonary arterial hypertension, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

In particular, this report provides the following:
  • 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.
Companies mentioned in this report: Actelion Pharmaceuticals (now key subsidiary of Johnson & Johnson), Arena Pharmaceuticals Bayer, EigerBioPharmaceuticals, Eli Lilly, Gilead, GlaxoSmithKline, Merck, Mochida Pharmaceutical.

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.
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Note: Product cover images may vary from those shown
2 of 4

FEATURED COMPANIES

  • Eiger BioPharmaceuticals
  • Gilead
  • Merck
  • Nippon Shinyaku Co. Ltd.
  • Pluristem Therapeutics
  • Roche
  • MORE
1 Table of Contents

2 Executive Summary
2.1 PAH Market Will Exhibit Moderate Growth Between 2016 and 2026
2.2 Upfront and Sequential Dual and Triple Combination Therapies and Launch of Bardoxolone Methyl Will Fuel Market Growth
2.3 Bardoxolone Methyl Has the Potential to Become a Blockbuster Therapy and Fulfill an Unmet Need
2.4 Reformulation of Existing Drugs Will Continue to Dominate the PAH Pipeline
2.5 What Do Physicians Think?

3 Introduction
3.1 Catalyst
3.2 Related Reports

4 Disease Overview
4.1 Etiology and Pathophysiology
4.1.1 Etiology
4.1.2 Pathophysiology
4.2 Symptoms
4.3 Diagnosis
4.4 Prognosis
4.5 Quality of Life

5 Epidemiology
5.1 Disease Background
5.2 Risk Factors and Comorbidities
5.3 Global and Historical Trends
5.4 Forecast Methodology
5.4.1 Sources
5.4.2 Forecast Assumptions and Methods
5.5 Epidemiological Forecast for PAH (2016-2026) - Based on Registry Data
5.5.1 Diagnosed Incident Cases of PAH (Forecast Based on Registry Data)
5.5.2 Diagnosed Prevalent Cases of PAH (Forecast Based on Registry Data)
5.5.3 Diagnosed Prevalent Cases of PAH by NYHA Functional Classes (Forecast Based on Registry Data)
5.5.4 Comorbidities Among the Diagnosed Prevalent Cases of PAH (Forecast Based on Registry Data)
5.6 Epidemiological Forecast for PAH (2016-2026) - Adjusted for Underestimation of Registry Data
5.6.1 Diagnosed Incident Cases of PAH (Forecast Adjusted for Underestimation of Registry Data)
5.6.2 Age-Specific Diagnosed Incident Cases of PAH (Forecast Adjusted for Underestimation of Registry Data)
5.6.3 Sex-Specific Diagnosed Incident Cases of PAH (Forecast Adjusted for Underestimation of Registry Data)
5.6.4 Diagnosed Prevalent Cases of PAH (Forecast Adjusted for Underestimation of Registry Data)
5.6.5 Age-Specific Diagnosed Prevalent Cases of PAH (Forecast Adjusted for Underestimation of Registry Data)
5.6.6 Sex-Specific Diagnosed Prevalent Cases of PAH (Forecast Adjusted for Underestimation of Registry Data)
5.6.7 Diagnosed Prevalent Cases of PAH by NYHA Functional Class I-IV (Forecast Adjusted for Underestimation of Registry Data)
5.6.8 Comorbidities Among the Diagnosed Prevalent Cases of PAH (Forecast Adjusted for Underestimation of Registry Data)
5.7 Discussion
5.7.1 Epidemiological Forecast Insight
5.7.2 Limitations of Analysis
5.7.3 Strengths of Analysis

6 Current Treatment Options
6.1 Overview
6.2 Diagnosis and Treatment
6.3 Clinical Practice
6.4 Product Profiles - Endothelin Receptor Antagonists
6.4.1 Tracleer and Generics (bosentan)
6.4.2 Volibris/Letairis (ambrisentan)
6.4.3 Opsumit (macitentan)
6.5 Product Profiles - Phosphodiesterase Type 5 Inhibitors
6.5.1 Revatio and Generics (sildenafil citrate)
6.5.2 Adcirca (tadalafil)
6.6 Product Profiles - Soluble Guanylate Cyclase Stimulators
6.6.1 Adempas (riociguat)
6.7 Product Profiles - Prostacyclin Derivatives
6.7.1 Flolan and Generics (epoprostenol)
6.7.2 Veletri (epoprostenol)
6.7.3 Ventavis (iloprost)
6.7.4 Remodulin (treprostinil)
6.7.5 Tyvaso (treprostinil)
6.7.6 Orenitram (treprostinil)
6.8 Product Profiles - Prostacyclin IP Receptor Agonists
6.8.1 Uptravi (selexipag)

7 Unmet Needs and Opportunity Assessment
7.1 Overview
7.2 Novel Curative or Stabilizing Therapeutics
7.2.1 Unmet Need
7.2.2 Gap Analysis
7.2.3 Opportunity
7.3 Improved Efficacy
7.3.1 Unmet Need
7.3.2 Gap Analysis
7.3.3 Opportunity
7.4 Biomarkers and Assays to Tailor Treatment
7.4.1 Unmet Need
7.4.2 Gap Analysis
7.4.3 Opportunity
7.5 Drugs to Prevent Right Heart Failure
7.5.1 Unmet Need
7.5.2 Gap Analysis
7.5.3 Opportunity
7.6 Anti-inflammatory Therapies
7.6.1 Unmet Need
7.6.2 Gap Analysis
7.6.3 Opportunity

8 R&D Strategies
8.1 Overview
8.1.1 Reformulation of Existing PAH Drugs
8.1.2 Repurposing of Known Drugs from Other Therapy Areas
8.1.3 Novel Anti-inflammatory and Anti-proliferative Therapeutic Targets
8.1.4 Licensing Agreements and Acquisitions
8.2 Clinical Trials Design
8.2.1 Current Clinical Trial Design
8.2.2 Future Clinical Trial Design

9 Pipeline Assessment
9.1 Overview
9.2 Promising Drugs in Clinical Development
9.3 Promising Drugs in Clinical Development, Prostacyclin Derivatives
9.3.1 Trevyent (treprostinil diolamine)
9.3.2 Tysuberprost (esuberaprost sodium + treprostinil)
9.4 Promising Drugs in Clinical Development, Prostacyclin IP Receptor Agonists
9.4.1 Ralinepag
9.5 Promising Drugs in Clinical Development, Antioxidant Inflammation Modulators
9.5.1 Bardoxolone Methyl
9.6 Innovative Early-Stage Approaches

10 Pipeline Valuation Analysis
10.1 Clinical Benchmark of Key Pipeline Drugs
10.2 Commercial Benchmark of Key Pipeline Drugs
10.3 Competitive Assessment
10.4 Top-Line 10-Year Forecast
10.4.1 US
10.4.2 5EU
10.4.3 Japan

11 Appendix
11.1 Bibliography
11.2 Abbreviations
11.3 Methodology
11.3.1 Forecasting Methodology
11.3.2 Diagnosed Patients
11.3.3 Percent Drug-Treated Patients
11.3.4 Drugs Included in Each Therapeutic Class
11.3.5 Launch and Patent Expiry Dates
11.3.6 General Pricing Assumptions
11.3.7 Individual Drug Assumptions
11.3.8 Generic Erosion
11.3.9 Pricing of Pipeline Agents
11.4 Primary Research - KOLs Interviewed for This Report
11.5 Primary Research - Prescriber Survey
11.6 About the Authors
11.6.1 Analyst
11.6.2 Therapy Area Director
11.6.3 Epidemiologist
11.6.4 Director of Epidemiology
11.6.5 Global Director of Therapy Analysis and Epidemiology
11.6.6 Global Head of Healthcare
11.7 About
11.8 Contact
11.9 Disclaimer

List of Tables
Table 1: Pulmonary Arterial Hypertension Key Metrics in the 7MM
Table 2: NYHA/WHO Functional Classification of PAH
Table 3: WHO Guidelines, Modified NYHA Functional Classes I-IV
Table 4: Risk Factors and Comorbidities for PAH
Table 5: 7MM, Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, Selected Years 2016-2026 (Based on Registry Data)
Table 6: 7MM, Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, Selected Years 2016-2026 (Forecast Based on Registry Data).
Table 7: 7MM, Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, Selected Years 2016-2026 (Forecast Adjusted for Underestimation of Registry Data)
Table 8: 7MM, Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, Selected Years 2016-2026 (Forecast Adjusted for Underestimation of Registry Data)
Table 9: Treatment Guidelines for PAH
Table 10: Most Prescribed Drugs for PAH by Class in the Global Markets, 2017
Table 11: Product Profile - Tracleer
Table 12: Tracleer SWOT Analysis, 2017
Table 13: Product Profile - Volibris/Letairis
Table 14: Volibris/Letairis SWOT Analysis, 2017
Table 15: Product Profile - Opsumit
Table 16: Opsumit SWOT Analysis, 2017
Table 17: Product Profile - Revatio
Table 18: Revatio SWOT Analysis, 2017
Table 19: Product Profile - Adcirca
Table 20: Adcirca SWOT Analysis, 2017
Table 21: Product Profile - Adempas
Table 22: Adempas SWOT Analysis, 2017
Table 23: Product Profile - Flolan
Table 24: Flolan SWOT Analysis, 2017
Table 25: Product Profile - Veletri
Table 26: Veletri SWOT Analysis, 2017
Table 27: Product Profile - Ventavis
Table 28: Ventavis SWOT Analysis, 2017
Table 29: Product Profile - Remodulin
Table 30: Remodulin SWOT Analysis, 2017
Table 31: Product Profile - Tyvaso
Table 32: Tyvaso SWOT Analysis, 2017
Table 33: Product Profile - Orenitram
Table 34: Orenitram SWOT Analysis, 2017
Table 35: Product Profile - Uptravi
Table 36: Uptravi SWOT Analysis, 2017
Table 37: Examples of Endpoints Used in the Pivotal Trials for Approved Treatments for PAH
Table 38: PAH - Late-Stage Clinical Pipeline, 2017
Table 39: Product Profile - Trevyent
Table 40: Trevyent SWOT Analysis, 2017
Table 41: Product Profile - Tysuberprost
Table 42: Tysuberprost SWOT Analysis, 2017
Table 43: Product Profile - Ralinepag
Table 44: Ralinepag SWOT Analysis, 2017
Table 45: Product Profile - Bardoxolone Methyl
Table 46: Bardoxolone Methyl SWOT Analysis, 2017
Table 47: Drugs in Development for PAH, 2016
Table 48: Clinical Benchmark of Key Pipeline Drugs - Prostacyclin Derivatives
Table 49: Clinical Benchmark of Key Pipeline Drugs - Prostacyclin IP Receptor Agonists
Table 50: Commercial Benchmark of Key Pipeline Drugs - Prostacyclin Derivatives
Table 51: Commercial Benchmark of Key Pipeline Drugs - Prostacyclin IP Receptor Agonists
Table 52: Key Events Impacting Sales for PAH, 2016-2026
Table 53: PAH Market - Global Drivers and Barriers, 2016-2026
Table 54: Key Historical and Projected Launch Dates for PAH
Table 55: Key Historical and Projected Patent Expiry Dates for PAH
Table 56: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures
Figure 1: Global Sales Forecast by Country for PAH in 2016 and 2026
Figure 2: Target Pathways of the Currently Marketed Drugs for PAH
Figure 3: Diagnostic Approach to PAH
Figure 4: 7MM, Age-Standardized Diagnosed Incidence of PAH (Cases per 100,000 Population), All Ages, by Sex, 2016 (Forecast Based on Registry Data)
Figure 5: 7MM, Age-Standardized Diagnosed Prevalence of PAH (%), All Ages, by Sex, 2016 (Forecast Based on Registry Data)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Figure 15: 7MM, Comorbidities Among the Diagnosed Prevalent Cases of PAH (N), All Ages, 2016 (Forecast Based on Registry Data)
Figure 16: 7MM, Age-Specific Diagnosed Incident Cases of PAH, Both Sexes, All Ages, N, 2016 (Forecast Adjusted for Underestimation of Registry Data)
Figure 17: 7MM, Sex-Specific Diagnosed Incident Cases of PAH, All Ages, N, 2016 (Forecast Adjusted for Underestimation of Registry Data)
Figure 18: 7MM, Age-Specific Diagnosed Prevalent Cases of PAH, Both Sexes, All Ages, N, 2016 (Forecast Adjusted for Underestimation of Registry Data)
Figure 19: 7MM, Sex-Specific Diagnosed Prevalent Cases of PAH, All Ages, 2016 (Forecast Adjusted for Underestimation of Registry Data)
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)
Figure 21: 7MM, Comorbidities Among the Diagnosed Prevalent Cases of PAH (N), Both Sexes, All Ages, 2016 (Forecast Adjusted for Underestimation of Registry Data)
Figure 22: Unmet Need and Opportunity in PAH, 2017
Figure 23: Overview of the Development Pipeline in PAH
Figure 24: Competitive Assessment of the Marketed and Pipeline Prostacyclin Derivative Drugs Benchmarked Against the SOC, Remodulin
Figure 25: Competitive Assessment of the Marketed and Pipeline Prostacyclin IP Receptor Agonist Drugs Benchmarked Against the SOC, Uptravi
Figure 26: Global (7MM) Sales Forecast by Country for PAH in 2016 and 2026
Figure 27: Global Sales Forecast by Class for PAH in 2016 and 2026
Figure 28: Sales Forecast by Class for PAH in the US in 2016 and 2026
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  • Actelion Pharmaceuticals (now key subsidiary of Johnson & Johnson)
  • Arena Pharmaceuticals Bayer
  • Eiger BioPharmaceuticals
  • Eli Lilly
  • Gilead
  • GlaxoSmithKline
  • Merck
  • Mochida Pharmaceutical
  • Nippon Shinyaku Co. Ltd.
  • Pfizer
  • Pluristem Therapeutics
  • Reata Pharmaceuticals
  • Roche
  • SteadyMed Therapeutics
  • Suda Ltd.
  • United Therapeutics
  • Vivus Inc
Note: Product cover images may vary from those shown
5 of 4
Note: Product cover images may vary from those shown
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