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 classification of the different types of pulmonary hypertension. PAH is characterized by an abnormal rise in the resting mean pulmonary arterial pressure caused by pulmonary arterial obstruction due to endothelial dysfunction and vascular remodeling, and leads to increased resistance in the arterial blood vessels. Since PAH is a progressive disorder, the pulmonary pressure keeps building up as the patient advances through the later stages of the disease, leading to reduced cardiac output, right heart failure, and ultimately, death.
The PAH market has generated much interest and investment from drug developers over the past several years, despite PAH being a rare disease. Current treatment strategies are symptomatic, and there is an unmet need of an absence of disease-modifying therapies. Development of disease-modifying therapies is a key opportunity for drug developers, and will be a major driver the PAH market over the forecast period.
The PAH market has generated much interest and investment from drug developers over the past several years, despite PAH being a rare disease. Current treatment strategies are symptomatic, and there is an unmet need of an absence of disease-modifying therapies. Development of disease-modifying therapies is a key opportunity for drug developers, and will be a major driver the PAH market over the forecast period.
Key Highlights
- Strong growth is expected in the PAH market from 2019 to 2029.
- The publisher anticipates that nine late stage pipeline drugs will launch over the forecast period. These are expected to be the main driver of growth in the PAH market across the 7MM, alongside uptake of combination therapies.
- A major unmet need is the absence of disease-modifying therapies in the PAH space. Companies are aiming to address this with first-in-line pipeline therapies, notably sotatercept.
- The publisher expects Merck's sotatercept to become the top-selling drug in the PAH market with sales of $1.13 Billion in 2029.
- In 2019, Johnson & Johnson dominated the PAH space. Throughout the forecast period, this is shifting to United Therapeutics, primarily due to development and launch of drug reformulations. The publisher predicts by 2029 Merck will become a leading competitor primarily due to its breakthrough therapy, sotatercept.
Key Questions Answered
- What are the current key PAH treatments?
- When will the late stage pipeline products launch, and how will it affect drug sales and the overall PAH market in the 7MM?
- Which unmet needs will remain unaddressed in the forecast period and what opportunities remain for pharmaceutical companies?
Scope
- Overview of PAH, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized PAH therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (NYHA functional classes I and II, NYHA functional class III, and NYHA functional class IV) forecast from 2019 to 2029.
- 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 assessing emerging trends and mechanisms of action under development for PAH therapy. The most promising candidates in Phase III and IIb development are profiled.
- 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.
- 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 the 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.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
Table of Contents
1 Pulmonary Arterial Hypertension: Executive Summary - Updated December 2022, Based on Events Up to November 22, 20221.1 PAH market will exhibit moderate growth between 2019 and 2029
1.2 Sotatercept has the potential to become a blockbuster therapy and address an unmet need in PAH
1.3 Reformulation of existing drugs will continue to dominate the PAH pipeline
1.4 What do physicians think?
2 Introduction - Updated December 2022, Based on Events Up to November 22, 2022
2.1 Catalyst
2.2 Related reports
3 Disease Overview - Updated December 2022, Based on Events Up to November 22, 2022
3.1 Etiology and pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.2 Classification or staging systems
4 Epidemiology
4.1 Disease background
4.2 Risk factors and comorbidities
4.3 Global and historical trends
4.4 Forecast methodology
4.4.1 Sources used
4.4.2 Forecast assumptions and methods
4.5 Epidemiological forecast for PAH (2019-2029)
4.5.1 Diagnosed incident cases of PAH
4.5.2 Sex-specific diagnosed incident cases of PAH
4.5.3 Age-specific diagnosed incident cases of PAH
4.5.4 Diagnosed prevalent cases of PAH
4.5.5 Sex-specific diagnosed prevalent cases of PAH
4.5.6 Age-specific diagnosed prevalent cases of PAH
4.5.7 Diagnosed prevalent cases of PAH by NYHA functional classes
4.5.8 Diagnosed prevalent cases of PAH by comorbidities
4.6 Discussion
4.6.1 Epidemiological forecast insight
4.6.2 COVID-19 impact
4.6.3 Limitations of the analysis
4.6.4 Strengths of the analysis
5 Disease Management - Updated December 2022, Based on Events Up to November 22, 2022
5.1 Diagnosis and treatment overview
5.2 Clinical practice
5.3 Overview of treatment guidelines
5.4 US
5.5 5EU
5.6 Japan
6 Competitive Assessment - Updated December 2022, Based on Events Up to November 22, 2022
6.1 Overview
7 Unmet Needs and Opportunity Assessment - Updated December 2022, Based on Events Up to November 22, 2022
7.1 Overview
7.2 Curative or stabilizing therapeutics targeting a novel, fourth pathway
7.3 Improved drug administration and side effects
7.4 Improved clinical trial design and slowing disease progression
7.5 Drugs to prevent right heart failure
8 Pipeline Assessment - Updated December 2022, Based on Events Up to November 22, 2022
8.1 Overview
8.2 Promising drugs in clinical development
9 Current and Future Players - Updated December 2022, Based on Events Up to November 22, 2022
9.1 Overview
9.2 Trends in corporate strategy
9.3 United Therapeutics portfolio assessment
9.4 GlaxoSmithKline portfolio assessment
9.5 Johnson & Johnson portfolio assessment
9.6 Merck portfolio assessment
9.7 CMP Pharma portfolio assessment
9.8 Aerovate Therapeutics portfolio assessment
9.9 Tenax Therapeutics portfolio assessment
9.10 Liquidia Technologies portfolio assessment
9.11 Pharmosa Biopharm portfolio assessment
10 Market Outlook - Updated December 2022, based on events up to November 22, 2022
10.1 Global markets
10.1.1 Forecast
10.1.2 Drivers and barriers - global issues
10.2 US
10.2.1 Forecast
10.2.2 Key events
10.2.3 Drivers and barriers
10.3 5EU
10.3.1 Forecast
10.3.2 Key events
10.3.3 Drivers and barriers
10.4 Japan
10.4.1 Forecast
10.4.2 Key events
10.4.3 Drivers and barriers
11 Appendix
11.1 Bibliography
11.2 Abbreviations
11.3 Methodology
11.3.1 Forecasting methodology
11.4 Primary research - KOLs interviewed for this report
11.4.1 KOLs
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 Managing Epidemiologist
11.6.5 Vice President of Disease Analysis and Intelligence
11.6.6 Global Head and EVP of Healthcare Operations and Strategy
- Contact the Publisher
Table 1: PAH: key metrics in the 7MM
Table 2: NYHA/WHO functional class (FC)
Table 3: Risk factors and comorbidities for PAH
Table 4: Diagnosed prevalent cases of PAH by comorbidities, N, both sexes, all ages, 2019
Table 5: Treatment guidelines for PAH
Table 6: Country profile - US
Table 7: Country profile - 5EU
Table 8: Country profile - Japan
Table 9: Leading treatments for PAH, 2022
Table 10: United Therapeutics's disease portfolio assessment, 2022
Table 11: GlaxoSmithKline's disease portfolio assessment, 2022
Table 12: J&J's disease portfolio assessment, 2022
Table 13: Merck's disease portfolio assessment, 2022
Table 14: CMP Pharma's disease portfolio assessment, 2022
Table 15: Aerovate Therapeutics's disease portfolio assessment, 2022
Table 16: Tenax Therapeutics's disease portfolio assessment, 2022
Table 17: Liquidia Technologies's disease portfolio assessment, 2022
Table 18: Pharmosa Biopharm's disease portfolio assessment, 2022
Table 19: PAH market - global drivers and barriers, 2019-2029
Table 20: Key events impacting sales for PAH in the US, 2019-2029
Table 21: PAH market - drivers and barriers in the US, 2019-2029
Table 22: Key events impacting sales for PAH in the 5EU, 2019-2029
Table 23: PAH market - drivers and barriers in the 5EU, 2019-2029
Table 24: Key events impacting sales for PAH in Japan, 2019-2029
Table 25: PAH market - global drivers and barriers in Japan, 2019-2029
Table 26: High-prescribing physicians (non-KOLs) surveyed, by country
List of Figures
Figure 1: Global sales forecast by country for PAH in 2019 and 2029
Figure 2: Analysis of the company portfolio gap in PAH during the forecast period
Figure 3: Competitive assessment of the late-stage pipeline agents that the publisher expects to be licensed for the treatment of PAH during the forecast period
Figure 4: Target pathways of the currently marketed drugs for PAH
Figure 5: 7MM, diagnosed incidence of PAH (cases per 100,000 population), both sexes, all ages, 2019
Figure 6: 7MM, diagnosed prevalence of PAH (%), both sexes, all ages, 2019
Figure 7: 7MM, sources used and not used to forecast the diagnosed incident and diagnosed prevalent cases of PAH
Figure 8: 7MM, sources used to forecast the diagnosed prevalent cases of PAH by NYHA functional classes
Figure 9: 7MM, sources used to forecast the diagnosed prevalent cases of PAH by comorbidities: CTD, PH, CHD, and COPD
Figure 10: 7MM, sources used to forecast the diagnosed prevalent cases of PAH by comorbidities: scleroderma, diabetes
Figure 11: 7MM, diagnosed incident cases of PAH, N, both sexes, all ages, 2019
Figure 12: 7MM, diagnosed incident cases of PAH, N, by sex, all ages, 2019
Figure 13: 7MM, diagnosed incident cases of PAH by age, N, both sexes, 2019
Figure 14: 7MM, diagnosed prevalent cases of PAH, N, both sexes, all ages, 2019
Figure 15: 7MM, diagnosed prevalent cases of PAH, N, by sex, all ages, 2019
Figure 16: 7MM, diagnosed prevalent cases of PAH by age, N, both sexes, 2019
Figure 17: 7MM, diagnosed prevalent cases of PAH by NYHA functional classes, N, both sexes, all ages, 2019
Figure 18: Diagnostic approach to PAH
Figure 19: Unmet needs and opportunities in PAH
Figure 20: Overview of the development pipeline in PAH
Figure 21: Key Phase II/III trials for the promising pipeline agents that the publisher expects to be licensed for PAH in the 7MM during the forecast period
Figure 22: Competitive assessment of the late-stage pipeline agents that the publisher expects to be licensed for the treatment of PAH during the forecast period
Figure 23: Analysis of the company portfolio gap in PAH during the forecast period
Figure 24: Global (7MM) sales forecast by country for PAH in 2019 and 2029
Figure 25: Sales forecast by class for PAH in the US in 2019 and 2029
Figure 26: Sales forecast by class for PAH in the 5EU in 2019 and 2029
Figure 27: Sales forecast by class for PAH in the 5EU in 2019 and 2029
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Acceleron (now a key subsidiary of Merck)
- Actelion (now a key subsidiary of Johnson & Johnson)
- Aerovate Therapeutics
- Bayer
- CMP Pharma
- Eli Lilly
- Gilead
- GlaxoSmithKline
- Johnson & Johnson
- Liquidia Technologies
- Merck
- Mochida Pharmaceuticals
- Northern Therapeutics
- Pfizer
- Pharmosa Biopharm
- United Therapeutics
