Pulmonary Arterial Hypertension Market Poised for Robust Growth Through 2034, Says DelveInsight

Pulmonary Arterial Hypertension Market Poised for Robust Growth Through 2034, Says DelveInsight

Key Players: Merck, Janssen Pharma, Aerovate Therapeutics, Novartis, Insmed, Chugai Pharma, Keros Therapeutics, and Others

According to DelveInsight’s latest analysis, the Pulmonary Arterial Hypertension (PAH) market is projected to witness substantial growth through 2034, driven by rising disease prevalence, improved awareness, and continued innovation across therapeutic classes. Major companies shaping the competitive landscape include Aerovate Therapeutics, Novartis, Keros Therapeutics, Insmed Incorporated, Chugai Pharmaceutical, Merck Sharp & Dohme, Janssen Pharmaceutical, Actelion, Gossamer Bio, United Therapeutics, Gilead Sciences, AstraZeneca, and others.

DelveInsight’s report, “Pulmonary Arterial Hypertension Market Insights, Epidemiology, and Market Forecast 2034,” provides a comprehensive assessment of disease understanding, historical and forecasted epidemiology, and market trends across the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan.

Pulmonary Arterial Hypertension Market Outlook

The PAH market is expected to expand steadily during the forecast period, supported by higher diagnosis rates, advancements in disease management, and the anticipated launch of multiple late-stage pipeline therapies. These innovations are expected to redefine treatment paradigms and significantly influence competitive dynamics.

Understand how sotatercept is reshaping PAH treatment across the 7MM: https://www.delveinsight.com/sample-request/pulmonary-arterial-hypertension-market?utm_source=apac&utm_medium=pressrelease&utm_campaign=mpr

In 2022, the global PAH market was valued at approximately USD 4.9 billion, with the United States accounting for the largest share at nearly USD 3.9 billion. The EU4 and the UK together contributed around USD 816 million, representing close to 16% of total 7MM revenue.

Recent Developments Driving Market Evolution

• January & March 2025: Merck reported positive Phase III ZENITH trial outcomes for WINREVAIR™ (sotatercept-csrk), demonstrating a 76% reduction in major morbidity and mortality events in high-risk PAH patients despite optimized background therapy.
• October 2024: Inhibikase Therapeutics raised USD 110 million to support its Phase IIb ‘702’ trial in PAH.
• July 2024: Aerovate Therapeutics announced a workforce reduction following the Phase IIb failure of AV-101, highlighting ongoing development risks in the PAH space.

Companies and Clinical Trial Activities in Pulmonary Arterial Hypertension

Japan represents a strategically important market within the 7MM, with localized clinical development efforts focused on generating population-specific safety and efficacy data to support regulatory approval.

Request a free sample to uncover epidemiology insights and regional growth opportunities in the Pulmonary Arterial Hypertension market.

MSD K.K. (Merck Sharp & Dohme, Japan)

Drug Candidate: Sotatercept (MK-7962 / WINREVAIR™) Mechanism of Action: Sotatercept is a first-in-class activin signaling inhibitor, functioning as a recombinant fusion protein that traps activins and growth differentiation factors. By restoring balance in the BMP signaling pathway, it aims to reduce pulmonary vascular remodeling. The therapy is being evaluated as an add-on to standard PAH treatments.

Key Clinical Trials in Japan:

• Phase III Local Study:

  • Identifiers: jRCT2031230046 / NCT05818137
  • Design: Randomized Phase III study assessing the efficacy and safety of sotatercept in Japanese patients with WHO Functional Class II/III PAH
  • Status: Active, not recruiting
  • Significance: Highlights Merck’s Japan-specific Phase III strategy to generate localized regulatory and safety data

• Open-Label Extension Study:

  • Identifier: jRCT2061250021
  • Design: Open-label extension evaluating long-term safety and tolerability using weight-banded dosing
  • Status: Recruiting as of mid-2025

Latest Development: Sotatercept has received orphan drug designation in Japan, reinforcing its regulatory momentum. The ongoing Phase III and extension studies reflect MSD K.K.’s efforts to establish robust local evidence supporting future marketing authorization.

Explore Japan-specific PAH clinical development and global market trends download the full Pulmonary Arterial Hypertension Market Forecast Report.

Epidemiology Insights

In 2022, approximately 88,100 prevalent PAH cases were reported across the 7MM, with cases expected to increase modestly through 2032. Females were disproportionately affected compared to males. In Japan, PAH prevalence by WHO functional class showed a declining trend over the study period, despite continued clinical development activity.

Pipeline and Drug Uptake Trends

The PAH pipeline remains highly competitive, featuring innovative mechanisms such as activin signaling modulation, prostacyclin pathway enhancement, and inhaled formulations. Key pipeline candidates include sotatercept (Merck/Acceleron), ralinepag (United Therapeutics), seralutinib (Gossamer Bio), and treprostinil palmitil (Insmed), among others.

Table of Contents

1. Pulmonary Arterial Hypertension Market Report Introduction

2. Executive Summary for Pulmonary Arterial Hypertension

3. SWOT analysis of Pulmonary Arterial Hypertension

4. Pulmonary Arterial Hypertension Patient Share (%) Overview at a Glance

5. Pulmonary Arterial Hypertension Market Overview at a Glance

6. Pulmonary Arterial Hypertension Disease Background and Overview

7. Pulmonary Arterial Hypertension Epidemiology and Patient Population

8. Country-Specific Patient Population of Pulmonary Arterial Hypertension

9. Pulmonary Arterial Hypertension Current Treatment and Medical Practices

10. Pulmonary Arterial Hypertension Unmet Needs

11. Pulmonary Arterial Hypertension Emerging Therapies

12. Pulmonary Arterial Hypertension Market Outlook

13. Country-Wise Pulmonary Arterial Hypertension Market Analysis (2020–2034)

14. Pulmonary Arterial Hypertension Market Access and Reimbursement of Therapies

15. Pulmonary Arterial Hypertension Market Drivers

16. Pulmonary Arterial Hypertension Market Barriers

17. Pulmonary Arterial Hypertension Appendix

18. Pulmonary Arterial Hypertension Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

Media Contact Company Name: DelveInsight Contact Person: Mehul Malhotra Email: info@delveinsight.com Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Las Vegas State: NV Country: United States Website: https://www.delveinsight.com/