Pulmonary Hypertension | Landscape & Forecast | Disease Landscape & Forecast

Publish date: June 2019

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Pulmonary hypertension (PH) is a devastating disease, for which there is no cure. Despite the rarity of the disease, the potential commercial rewards from drugs approved for it are considerable, driven by the premium price that may be charged for PH agents. Commercial interest in PH is high as a result of recent and significant advances in the understanding of its etiology and pathophysiology and the emergence of new therapies to treat the disease.

Questions Answered:

  • Several novel agents—United Therapeutics’ ralinepag, novel Remodulin formulations, and esuberaprost; Reata Pharmaceuticals’ bardoxolone methyl; dry-powder inhaled treprostinil from Liquidia and United Therapeutics/MannKind—are in late-stage development, registered, or recently launched for the treatment of pulmonary hypertension. What do interviewed thought leaders say about the advantages and disadvantages of these therapy? How do they anticipate using them in the pulmonary hypertension treatment algorithm? Which agents in the current market are most vulnerable to being replaced by these novel therapies, and which ones will constrain uptake of the new drugs?
  • Actelion has submitted FDA and EMA label expansion for Opsumit (macitentan) for the treatment of inoperable CTEPH patients. How will Opsumit be prescribed in these patients? How will this impact the sales of Adempas?
  • Several key branded therapies will are set to loose patent protection/exclusivity during the forecast period. How will the launch of generic formulations affect their market share? What effect will the launch of novel agents have on their patient share?
  • A large unmet needs exists for therapies for the treatment of pulmonary hypertension WHO groups 2, 3, and 5. What is the other key unmet needs in pulmonary hypertension? How likely are these unmet needs to be fulfilled within the forecast period?
  • Pulmonary arterial hypertension 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 these 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

  • Disease Landscape & Forecast
    • Key Updates
      • June 2019
      • November 2018
      • September 2018
      • August 2018
    • Market Outlook
      • Key Findings
        • Key Findings
        • Market Overview
      • Market Drivers and Constraints
        • What Factors Are Driving the Market for Pulmonary Hypertension?
        • What Factors Are Constraining the Market for Pulmonary Hypertension?
      • Drug-Class-Specific Trends
        • Endothelin Receptor Antagonists
        • Phosphodiesterase-Type 5 Inhibitors
        • Prostacyclin Analogues
        • Soluble Guanylate Cyclase Stimulators
        • Antioxidant Inflammation Modulators
    • Forecast
      • Market Forecast Assumptions - PAH
      • Market Forecast Dashboard - PAH
      • Market Forecast Assumptions - CTEPH
      • Market Forecast Dashboard - CTEPH
    • Etiology and Pathophysiology
      • Etiology and Pathophysiology
        • Disease Overview
        • Pulmonary Arterial Hypertension (PAH)
        • Pulmonary Hypertension Due to Left Heart Disease (PH-LHD)
        • Pulmonary Hypertension Due to Lung Disease
        • Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
        • Pulmonary Hypertension with Unclear Multifactorial Mechanisms
        • Key Pathways and Drug Targets
    • Epidemiology Overview
      • Key Findings
        • Key Findings
      • Epidemiology Populations
        • Diagnosed Prevalent Cases of Pulmonary Hypertension (All Causes)
        • Diagnosed Prevalent Cases of Pulmonary Arterial Hypertension
        • Diagnosed Prevalent Cases of Pulmonary Hypertension Due to Left Heart Disease
        • Diagnosed Prevalent Cases of Pulmonary Hypertension Due to Lung Diseases and/or Hypoxia
        • Diagnosed Prevalent Cases of Chronic Thrombotic and/or Embolic Disease
        • Diagnosed Prevalent Cases of Pulmonary Hypertension Due to Inoperable Chronic Thrombotic and/or Embolic Pulmonary Hypertension
        • Diagnosed Pulmonary Hypertension Due to Miscellaneous Causes
        • Diagnosed Prevalent Cases of Pulmonary Arterial Hypertension by Functional Class
        • Drug-Treated Cases of Pulmonary Arterial Hypertension
    • Current Treatment Overview
      • Key Findings
      • Treatment Goals
      • Key Current Therapies
        • Overview
        • Endothelin Receptor Antagonists
        • PDE-5 Inhibitors
        • Prostacyclin Analogues
        • Soluble Guanylate Cyclase Stimulators
      • Medical Practice
        • Overview
        • Treatment Guidelines
        • Country/Region-Specific Treatment Practices
    • Unmet Need Overview
      • Current and Future Attainment of Unmet Needs in Pulmonary Hypertension
    • Emerging Therapies Overview
      • Key Findings
      • Key Emerging Therapies
        • Notable Developments Among Key Emerging Therapies for Pulmonary Arterial Hypertension
        • Prostacyclin Analogues
        • Nitric Oxide
        • Antioxidant Inflammation Modulators
      • Early-Phase Pipeline Analysis
        • Notable Developments in the Early-Phase Pipeline for Pulmonary Hypertension
      • Key Discontinuations
    • Access and Reimbursement Overview
      • Region-Specific Reimbursement Practices
        • United States
        • EU5
        • Japan
    • Methodology
      • Bottom-Up Forecasting Overview
        • Patient Populations
        • Drug-Specific Assumptions
      • Bottom-Up Forecast Assumptions
        • General Sources of Data
        • General Statements About Pricing
        • Dosing, Days of Therapy, and Compliance
        • Generic Erosion
        • Out-Year Forecasting
        • Emerging Therapy Prices
      • Primary Market Research
        • Experts Interviewed
    • Appendix
      • Pulmonary Hypertension Bibliography

Author(s): David Rees, Ph.D; Dr. Ravdeep Kaur, MPH

David Rees, , 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 from the University of Bath.

Ravdeep Kaur started working in Decision Resources Inc. as an associate epidemiologist since December 31 st , 2015. She performs fully documented systematic reviews of both published and grey literature on the epidemiology of assigned diseases and their risk factors to estimate incidence/prevalence over a 10-30 year period. She produces analyses for pharmaceutical drug developers on the descriptive epidemiology of major drug indications in mature and developing markets. She holds a Master’s in Public Health degree from School of Public Health, Post-Graduate Institute of Medical Education and Research and a Bachelor’s in dental surgery from Rajiv Gandhi University of Health Sciences, India. She also has a Fellowship in Heath care Technology Assessment from World health Organization (WHO), India office.  Prior to joining Decision Resources, Ravdeep worked as a Consultant in Reproductive, Maternal, Child and Adolescent Health Program in a United States Agency for International development (USAID) funded project.