Pulmonary Hypertension – Landscape & Forecast – Disease Landscape & Forecast
Pulmonary hypertension (PH) is a devastating disease with high levels of morbidity and mortality and no cure. Despite the rarity of the disease, the potential commercial opportunities for drugs approved for PH are considerable, driven by premium pricing and the likelihood of polypharmacy. Although this market has become congested, commercial interest in PH remains high owing to the need for more-efficacious and disease-modifying agents, as well as the lack of approved treatment options for unserved populations.
Questions answered
- Novel agents such as Merck & Co.’s sotatercept, United Therapeutics’ ralinepag, and Gossamer Bio’s seralutinib are in late-phase development for 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?
- Generic formulations have launched for several key branded therapies in recent years. How have these launches influenced prescribing patterns? What effect have generic launches had on entrenched brands, and what will be their impact on the performance of emerging therapies?
- A large unmet need exists for the treatment of PH WHO 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?
- Patients with pulmonary arterial hypertension are typically prescribed PDE-5 inhibitors and/or ERAs as first-line therapy. What are the prescribing considerations dictating physician preferences for later-line treatments, and how do they vary between countries/geographical regions?
Content highlights
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, Yutrepia, Tyvaso DPI, sotatercept, seralutinib, macitentan / tadalafil FDC.
Key companies mentioned: Johnson & Johnson, United Therapeutics, Bayer HealthCare, GlaxoSmithKline, Gilead Sciences, Pfizer, MannKind Corporation, Merck & Co., Liquidia Technologies, Gossamer Bio.
Product description
Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.
Solution enhancement
Disease Landscape & Forecast will be updated throughout the year to provide timely insights and analyses as material indication-specific news and events unfold.
Disease Landscape & Forecast features a Drug Pipeline chapter with real-time, global pipeline intelligence content directly from Cortellis. This chapter is updated daily and features interactive figures that can be easily downloaded for detailed analysis or presentations.
Table of contents
- Pulmonary Hypertension - Landscape & Forecast - Disease Landscape & Forecast
- Key findings
- Pulmonary hypertension u2013 key findings u2013 May 2023
- Key updates
- May 2023
- March 2023
- Q4 2022
- December 2022
- November 2022
- October 2022
- Q3 2022
- August 2022
- July 2022
- Market outlook
- Key findings
- Market share of drug classes for pulmonary arterial hypertension: 2022
- Market share of drug classes for pulmonary arterial hypertension: 2032
- 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 pulmonary arterial hypertension sales and patient share by drug class: 2022-2032
- Overall pulmonary arterial hypertension market by functional class: 2022-2032
- Overall pulmonary arterial hypertension sales by region: 2022-2032
- Overall pulmonary arterial hypertension patient share by brand / generic: 2022-2032
- Overall inoperable chronic thromboembolic pulmonary hypertension sales and patient share: 2022-2032
- Overall inoperable chronic thromboembolic pulmonary hypertension sales by region: 2022-2032
- Overall inoperable chronic thromboembolic pulmonary hypertension patient share by brand / generic: 2022-2032
- Overall pulmonary hypertension due to interstitial lung disease sales and patient share: 2022-2032
- Overall pulmonary hypertension due to interstitial lung disease sales by region: 2022-2032
- Overall pulmonary hypertension due to interstitial lung disease patient share by brand / generic: 2022-2032
- Drug-class-specific trends
- Pulmonary arterial hypertension sales and patient share for phosphodiesterase-5 inhibitors: 2022-2032
- Oral prostacyclins
- Inhaled prostacyclins
- Parenteral prostacyclins
- Pulmonary arterial hypertension sales and patient share for oral prostacyclin analogues: 2022-2032
- Pulmonary arterial hypertension sales and patient share for inhaled prostacyclin analogues: 2022-2032
- Pulmonary hypertension due to interstitial lung disease sales and patient share for inhaled prostacyclin analogues: 2022-2032
- Pulmonary arterial hypertension sales and patient share for parenteral prostacyclin analogues: 2022-2032
- Pulmonary arterial hypertension sales and patient share for soluble guanylate cyclase stimulators: 2022-2032
- Inoperable chronic thromboembolic pulmonary hypertension sales and patient share for soluble guanylate cyclase stimulators: 2022-2032
- Pulmonary arterial hypertension sales and patient share for TGF-u03b2 ligand trap: 2022-2032
- Pulmonary arterial hypertension sales and patient share for endothelin receptor antagonist / phosphodiesterase-5 inhibitor fixed-dose combinations: 2022-2032
- Pulmonary arterial hypertension sales and patient share for tyrosine kinase inhibitors: 2022-2032
- Key findings
- Forecast
- Market forecast assumptions: pulmonary arterial hypertension
- Market forecast dashboard: pulmonary arterial hypertension
- Market forecast assumptions: inoperable chronic thromboembolic pulmonary hypertension
- Market forecast dashboard: inoperable chronic thromboembolic pulmonary hypertension
- Market forecast assumptions: pulmonary hypertension-interstitial lung disease
- Market forecast dashboard: pulmonary hypertension-interstitial lung disease
- Etiology and pathophysiology
- Epidemiology
- Key findings
- Epidemiology populations
- Disease definition, methods, and sources used
- Disease definition, methods, and sources used
- Diagnosed prevalent cases of pulmonary arterial hypertension: 2022-2032
- Disease definition, methods, and sources used
- Diagnosed prevalent cases of pulmonary hypertension due to left heart disease: 2022-2032
- Disease definition, methods, and sources used
- Diagnosed prevalent cases of pulmonary hypertension due to lung disease and/or hypoxemia: 2022-2032
- Disease definition, methods, and sources used
- Diagnosed prevalent cases of chronic thromboembolic pulmonary hypertension: 2022-2032
- Diagnosed prevalent cases of inoperable chronic thromboembolic pulmonary hypertension: 2022-2032
- Disease definition, methods, and sources used
- Diagnosed prevalent cases of pulmonary hypertension due to miscellaneous causes: 2022-2032
- Disease definition, methods, and sources used
- Diagnosed prevalent cases of pulmonary arterial hypertension by NYHA functional class: 2022-2032
- Disease definition, methods, and sources used
- Disease definition, methods, and sources used
- Diagnosed prevalence of pulmonary hypertension due to lung disease by subgroup: 2022-2032
- Sources used for drug-treated cases of pulmonary hypertension
- Drug-treated cases of pulmonary arterial hypertension: 2022-2032
- Drug-treated cases of inoperable chronic thromboembolic pulmonary hypertension: 2022-2032
- Drug-treated cases of pulmonary hypertension-interstitial lung disease: 2022-2032
- Key findings
- Current treatment
- 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
- Advantages and disadvantages of bosentan
- Advantages and disadvantages of ambrisentan
- Advantages and disadvantages of Opsumit
- Key results from select clinical trials investigating Opsumit for the treatment of pulmonary hypertension
- Key ongoing clinical trials of Opsumit in the treatment of pulmonary hypertension
- 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
- 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
- Dry powder-inhaled treprostinil
- Advantages and disadvantages of dry powder treprostinil
- Expert insight: inhaled prostacyclin therapy
- Advantages and disadvantages of Orenitram
- Advantages and disadvantages of Uptravi
- Key results from select clinical trials investigating Uptravi for the treatment of pulmonary hypertension
- 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
- Key ongoing clinical trials of Adempas in the treatment of pulmonary hypertension
- Key results from clinical trials of Adempas in the treatment of pulmonary hypertension
- Expert insight: Adempas
- Medical practice
- Overview
- Factors influencing drug selection in pulmonary hypertension
- Generalized treatment decision tree for pulmonary arterial hypertension
- Key findings
- 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
- Drug pipeline
- Pipeline
- Regulatory Milestones
- Indication Comparison
- Emerging therapies
- Key findings
- Key emerging therapies
- Key therapies in development for pulmonary hypertension
- Estimated launch dates of key emerging therapies for the treatment of pulmonary hypertension
- Key results from select clinical trials investigating sotatercept for the treatment of pulmonary hypertension
- Key ongoing clinical trials of sotatercept in the treatment of pulmonary hypertension
- Analysis of the clinical development program for sotatercept
- Expert insight: sotatercept
- Expectations for launch and sales opportunity of sotatercept in pulmonary hypertension
- Key results from select clinical trials investigating ralinepag for the treatment of pulmonary hypertension
- Key ongoing clinical trials of ralinepag in the treatment of pulmonary hypertension
- Analysis of the clinical development program for ralinepag
- Expert insight: ralinepag
- Expectations for launch and sales opportunity for ralinepag in pulmonary hypertension
- Key results from select clinical trials investigating macitentan / tadalafil fixed-dose combination in the treatment of pulmonary hypertension
- Analysis of the clinical development program for macitentan / tadalafil fixed-dose combination
- Expert insight: macitentan / tadalafil fixed-dose combination
- Expectations for launch and sales opportunity of macitentan / tadalafil fixed-dose combination in pulmonary hypertension
- Key results from select clinical trials investigating seralutinib (GB002) for the treatment of pulmonary hypertension
- Analysis of the clinical development program for seralutinib (GB002)
- Expert insight: seralutinib (GB002)
- Expectations for launch and sales opportunity of seralutinib (GB002) in pulmonary hypertension
- Early-phase pipeline analysis
- Select compounds in early-phase / Phase II development for pulmonary hypertension
- Key discontinuations
- Key findings
- Access and reimbursement
- 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
- Region-specific reimbursement practices
- Appendix
- Abbreviations
- Pulmonary hypertension bibliography
- Key findings
Sayani Datta, M.Sc., Lead Healthcare Research & Data Analyst – Cardiovascular, Metabolic, Renal, and Hematologic (CMRH) Disorders. Sayani’s primary areas of focus are nonalcoholic steatohepatitis (NASH) and pulmonary hypertension (PH). Previously, she was an associate consultant with IQVIA. She has worked on various types of custom and syndicated research projects in several therapeutic areas and has experience in sales- and epidemiology-based forecasting, commercial opportunity assessments, and market tracking and intelligence. She is an M.Sc. in biotechnology from the University of Leeds, where she gained exposure to life sciences research and development working as a postgraduate research intern.
Ullas Ulahannan, MPH., Epidemiologist, Epidemiology. Before joining Clarivate, he worked at Jhpiego (a John Hopkins University affiliate) as a senior program officer evaluating, implementing, and monitoring various health programs in collaboration with the state and central governments of India. His qualifications include a master’s degree in public health from Manipal University, Manipal, and a bachelor’s degree in nursing from Rajiv Gandhi University of Health Sciences, Bangalore