Pulmonary hypertension (PH) is a devastating disease with high levels of morbidity and mortality and no cure. Despite the disease’s rarity, the potential commercial opportunities for drugs approved for PH are considerable, driven by premium pricing and the propensity for polypharmacy. Although this market has become congested, commercial interest in PH remains high. The need for more-efficacious and disease-modifying agents fuels this attention, along with the PHpopulations lacking any approved treatments.

Questions answered:

  • Novel agents such as United Therapeutics’ ralinepag, Reata Pharmaceuticals’ bardoxolone methyl, and Liquidia/United Therapeutics/MannKind’s dry-powder inhaled treprostinil are in late-phase development for the treatment of PH. What do interviewed thought leaders say about the advantages and disadvantages of these therapies? How will the launch of these agents affect prescribing decisions?
  • Actelion is developing Opsumit (macitentan) and Uptravi (selexipag)for the treatment of inoperable CTEPH. How would these therapies be prescribed to these patients? How would their launches impact the sales of Adempas?
  • Several key branded therapies are set to lose patent protection/exclusivity during the forecast period. How will the launch of generic formulations affect their market share? What effect will generic launches have on entrenched and emerging branded therapies?
  • ·A large unmet need exists for treatments for PHWHO groups 2, 3, and 5. What are the other key unmet needs in PH? How likely are these unmet needs to be fulfilled during the forecast period?
  • Pulmonary arterial hypertension (PAH) patients are normally prescribed PDE-5 inhibitors and/or ERAs as first-line therapy. What are the treatment guidelines for later lines of therapy? How do the guidelines vary between geographical regions?

Geographies:

United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Key drugs covered:

Uptravi, Orenitram, Adempas, Opsumit, Adcirca, Tracleer, Revatio, Letairis / Volibris, Remodulin, Flolan, Veletri, Tyvaso, Ventavis, Beraprost, ralinepag, esuberaprost, bardoxolone methyl, inhaled dry powder treprostinil, INOpulse

Key companies mentioned:

Actelion, United Therapeutics, Bayer HealthCare, GlaxoSmithKline, Gilead Sciences, Pfizer, Arena Pharmaceuticals, Mannkind Corporation, Bellerophon Therapeutics, Liquidia Technologies, Reata Pharmaceuticals

Table of contents

  • Pulmonary Hypertension - Landscape & Forecast - Disease Landscape & Forecast
    • COVID-19
      • Key Findings
        • Pulmonary Hypertension – Key Findings – September 2019
      • Key Updates
        • September 2020
        • December 2019
        • September 2019
        • June 2019
      • Market Outlook
        • Key Findings
          • Market Share of Drug Classes for Pulmonary Arterial Hypertension: 2018
          • Market Share of Drug Classes for Pulmonary Arterial Hypertension: 2028
          • Pulmonary Hypertension SWOT Analysis
        • Market Drivers and Constraints
          • What Factors Are Driving the Market for Pulmonary Hypertension?
          • What Factors Are Constraining the Market for Pulmonary Hypertension?
          • Overall PAH Sales and Patient Share by Drug Class: 2018-2028
          • Overall PAH Market by Functional Class: 2018-2028
          • Overall PAH Sales by Region: 2018-2028
          • Overall PAH Patient Share by Brand / Generic: 2018-2028
          • Overall CTEPH Sales and Patient Share: 2018-2028
          • Overall PH-ILD Sales and Patient Share: 2018-2028
          • Overall PH-COPD Sales and Patient Share: 2018-2028
        • Drug-Class-Specific Trends
          • PAH Sales and Patient Share for Endothelin Receptor Antagonists: 2018-2028
          • PAH Sales and Patient Share for Phosphodiesterase-5 Inhibitors: 2018-2028
          • Oral Prostacyclins
          • Inhaled Prostacyclins
          • Parenteral Prostacyclins
          • PAH Sales and Patient Share for Oral Prostacyclin Analogues: 2018-2028
          • PAH Sales and Patient Share for Inhaled Prostacyclin Analogues: 2018-2028
          • PAH Sales and Patient Share for Parenteral Prostacyclin Analogues: 2018-2028
          • PAH Sales and Patient Share for Soluble Guanylate Cyclase Stimulators: 2018-2028
          • PAH Sales and Patient Share for Antioxidant Inflammation Modulators: 2018-2028
          • PH-ILD Sales and Patient Share for Inhaled Nitric Oxides: 2018-2028
        • COVID-19: Areas of Potential Forecast Impact
        • Forecast
          • Market Forecast Assumptions - PAH
          • Market Forecast Dashboard - PAH
          • Market Forecast Assumptions - CTEPH
          • Market Forecast Dashboard - CTEPH
          • Market Forecast Assumptions - PH-ILD
          • Market Forecast Dashboard - PH-ILD
          • Market Forecast Assumptions - PH-COPD
          • Market Forecast Dashboard - PH-COPD
        • Etiology and Pathophysiology
          • Epidemiology Overview
            • Key Findings
              • Key Updates
            • Epidemiology Populations
              • Disease Definition
              • Methods
              • Sources Used for Prevalent Cases of Pulmonary Hypertension (All Causes)
              • Disease Definition
              • Methods
              • Sources Used for Diagnosed Prevalent Cases of Pulmonary Arterial Hypertension
              • Diagnosed Prevalent Cases of Pulmonary Arterial Hypertension in the Major Pharmaceutical Markets, 2018-2028
              • Disease Definition
              • Methods
              • Sources Used for Diagnosed Prevalent Cases of Pulmonary Hypertension due to Left Heart Disease
              • Diagnosed Prevalent Cases of Pulmonary Hypertension due to Left Heart Disease in the Major Pharmaceutical Markets, 2018-2028
              • Disease Definition
              • Methods
              • Sources Used for Diagnosed Prevalent Cases of Pulmonary Hypertension due to Lung Disease and/or Hypoxemia
              • Diagnosed Prevalent Cases of Pulmonary Hypertension due to Lung Disease and/or Hypoxemia in the Major Pharmaceutical Markets, 2018-2028
              • Disease Definition
              • Methods
              • Sources Used for Diagnosed Prevalent Cases of CTEPH
              • Diagnosed Prevalent Cases of Chronic Thromboembolic Pulmonary Hypertension in the Major Pharmaceutical Markets, 2018-2028
              • Methods
              • Sources Used for Diagnosed Prevalent Cases of Inoperable Chronic Thrombotic and/or Embolic Pulmonary Hypertension
              • Diagnosed Prevalent Cases of Inoperable Chronic Thrombotic and/or Embolic Pulmonary Hypertension in the Major Pharmaceutical Markets, 2018-2028
              • Disease Definition
              • Methods
              • Sources Used for Diagnosed Prevalent Cases of PH due to Miscellaneous Causes
              • Diagnosed Prevalent Cases of Pulmonary Hypertension due to Miscellaneous Causes in the Major Pharmaceutical Markets, 2018-2028
              • Disease Definition
              • Methods
              • Sources Used for Diagnosed Prevalent Cases of Pulmonary Arterial Hypertension by NYHA Functional Class
              • Diagnosed Prevalent Cases of Pulmonary Arterial Hypertension by NYHA Functional Class in the Major Pharmaceutical Markets, 2018-2028
              • Disease Definition
              • Methods
              • Sources Used for Diagnosed Prevalence of Pulmonary Hypertension due to Left Heart Disease by Subgroup
              • Disease Definition
              • Methods
              • Sources Used for Diagnosed Prevalence of Pulmonary Hypertension due to Lung Disease by Subgroup
              • Diagnosed Prevalence of Pulmonary Hypertension due to Lung Disease by Subgroup in the Major Pharmaceutical Markets, 2018-2028
              • Sources Used for Drug-Treated Cases of PAH and Inoperable CTEPH
              • Drug-Treated Cases of PAH
              • Drug-Treated Cases of Inoperable CTEPH
              • Drug-Treated Cases of PH-ILD
              • Drug-Treated Cases of PH-COPD
          • Current Treatment Overview
            • Key Findings
              • Treatment Goals
                • Key Endpoints Used in Clinical Trials for Pulmonary Hypertension
              • Key Current Therapies
                • Overview
                • Mechanism of Action of Key Current Drug Classes Used for Pulmonary Hypertension
                • Current Treatments Used for Pulmonary Hypertension
                • Market Events Impacting the Use of Key Current Therapies for Pulmonary Hypertension Market
                • Advantages and Disadvantages of Bosentan
                • Advantages and Disadvantages of Ambrisentan
                • Ongoing Clinical Development of Ambrisentan
                • Advantages and Disadvantages of Opsumit
                • Key Results from Select Clinical Trials Investigating Opsumit for the Treatment of PH
                • Key Ongoing Clinical Trials of Opsumit in the Treatment of PH
                • Expert Insight: Endothelin Receptor Antagonists
                • Advantages and Disadvantages of Sildenafil
                • Advantages and Disadvantages of Tadalafil
                • Expert Insight: PDE-5 Inhibitors
                • Advantages and Disadvantages of Parenteral Epoprostenol
                • Advantages and Disadvantages of Parenteral Treprostinil
                • Ongoing Clinical Development of Parenteral Treprostinil
                • Expert Insight: Parenteral Prostacyclins
                • Advantages and Disadvantages of Tyvaso
                • Key Ongoing Clinical Trials of Tyvaso in the Treatment of Pulmonary Hypertension
                • Advantages and Disadvantages of Ventavis
                • Key Ongoing Clinical Trials of Ventavis in the Treatment of Pulmonary Hypertension
                • Expert Insight: Inhaled Prostacyclin Therapy
                • Advantages and Disadvantages of Orenitram
                • Advantages and Disadvantages of Uptravi
                • Key Ongoing Clinical Trials of Uptravi in the Treatment of Pulmonary Hypertension
                • Advantages and Disadvantages of Beraprost and Beraprost MR
                • Expert Insight: Oral Prostacyclins
                • Advantages and Disadvantages of Adempas
                • Ongoing Clinical Development of Adempas
                • Key Ongoing Clinical Trials of Adempas in the Treatment of Pulmonary Hypertension
                • Expert Insight: Adempas
              • Medical Practice
                • Overview
                • Pulmonary Hypertension Treatment Guidelines by Market
                • Factors Influencing Drug Selection in Pulmonary Hypertension
                • Treatment Decision Tree for Pulmonary Arterial Hypertension: United States
                • Treatment Decision Tree for Pulmonary Arterial Hypertension: Europe
                • Treatment Decision Tree for Pulmonary Arterial Hypertension: Japan
            • Unmet Need Overview
              • Current and Future Attainment of Unmet Needs in Pulmonary Hypertension
              • Top Unmet Needs in Pulmonary Hypertension: Current and Future Attainment
              • Expert Insight: Unmet Need in Pulmonary Hypertension
            • Emerging Therapies Overview
              • Key Findings
                • Pipeline Trends for Pulmonary Arterial Hypertension
              • Key Emerging Therapies
                • Key Therapies in Development for Pulmonary Arterial Hypertension
                • Estimated Launch Dates of Key Emerging Therapies for the Treatment of Pulmonary Hypertension
                • Key Results from Select Clinical Trials Investigating Ralinepag for the Treatment of Pulmonary Arterial Hypertension
                • Key Ongoing Clinical Trials of Ralinepag in the Treatment of Pulmonary Arterial Hypertension
                • Ralinepag Clinical Development
                • Expert Insight: Ralinepag
                • Expectations for Launch and Sales Opportunity for Ralinepag in PAH
                • Key Results from Select Clinical Trials Investigating LIQ861 for the Treatment of Pulmonary Hypertension
                • Key Ongoing Clinical Trials of Dry Powder Treprostinil in the Treatment of Pulmonary Hypertension
                • Dry Powder Inhaled Treprostinil Clinical Development
                • Expert Insight: Dry Powder Inhaled Treprostinil
                • Expectations for Launch and Sales Opportunity for Dry Powder Inhaled Treprostinil in PAH
                • INOpulse Profile
                • Key Results from Select Clinical Trials Investigating INOpulse for the Treatment of Pulmonary Hypertension
                • INOpulse Clinical Development
                • Expert Insight: INOpulse
                • Expectations for Launch and Sales Opportunity of INOpulse in Pulmonary Hypertension
                • Bardoxolone Methyl Profile
                • Bardoxolone Methyl Clinical Development
                • Expert Insight: Bardoxolone Methyl
                • Expectations for Launch and Sales Opportunity of Bardoxolone Methyl in Pulmonary Hypertension
              • Early-Phase Pipeline Analysis
                • Select Compounds in Early-Phase / Phase II Development for Pulmonary Hypertension
              • Key Discontinuations
              • Access and Reimbursement Overview
                • Region-Specific Reimbursement Practices
                  • Key Market Access Considerations for Pulmonary Hypertension Therapies: United States
                  • Key Market Access Considerations for Pulmonary Hypertension Therapies: EU5
                  • Key Market Access Considerations for Pulmonary Hypertension Therapies: Japan
                  • Looking for More?
              • Appendix
                • Key Abbreviations Related to Pulmonary Hypertension
                • Brands, Marketers, and Generic Availability of Key Therapies for Pulmonary Hypertension by Market
                • Pulmonary Hypertension Bibliography

            Author(s): David Rees, Ph.D; Alison Isherwood, MSc, MRes, PhD

            David Rees, M.Biochem., Ph.D, is a Business Insights Analyst with the Cardiovascular, Metabolic, and Renal Disorders team at Decision Resources Group. Prior to joining Decision Resources Group, Dr. Rees was a Postdoctoral Research Associate at Imperial College London, and the Institute of Cancer Research. For his doctoral research, he studied the structures of molecular machines in the Nobel Prize winning laboratory of Prof. Sir John Walker at the University of Cambridge. Dr. Rees earned his undergraduate M.Biochem. from the University of Bath.

            Alison Isherwood, B.Sc., M.Res., M.Sc., Ph.D. joined Decision Resources Group in 2008, as an Epidemiologist. Alison holds a B.Sc. in Medical Microbiology, Masters by Research in the Life Sciences and a M.Sc. in Epidemiology all from the University of Edinburgh. Prior to joining Decision Resources Inc., she was working on her Ph.D. in Molecular Virology, specializing on the severe acute respiratory syndrome (SARS) coronavirus, at the University of Reading. In her role at Decision Resources Group, Alison is currently an Epidemiology team lead as well as project managing custom epidemiology work in multiple therapy areas. Alison’s area of specialization at DRG is cancer, particularly breast cancer.


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