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Pulmonary Arterial Hypertension Market Forecast 2034: Clinical Trials, FDA Approvals, Medication, Statistics, Revenue, and Companies by DelveInsight | Merck, Bristol Myers Squibb, United Therapeutics, Liquidia Technologies, Tenax Therapeutics, Respira The
Pulmonary Arterial Hypertension Market Summary:The Pulmonary Arterial Hypertension market features both established and emerging therapies such as UPTRAVI, TYVASO, OPSUMIT, and the newly approved OPSYNVI. Drugs like REVATIO and TRACLEER now face generic competition. The 7MM market was valued at ~$7 billion in 2024 and is expected to grow through 2034, with the US leading in market share. Late-stage pipeline therapies like ralinepag and YUTREPIA show strong promise. Increased diagnosis rates, therapeutic advancements, and strong R&D pipelines will continue to shape the evolving PAH treatment landscape.
DelveInsight's comprehensive report, Pulmonary Arterial Hypertension - Market Insight, Epidemiology, and Market Forecast - 2034, provides a detailed analysis of the current and future market landscape. This report covers the epidemiological data, treatment trends, and key pipeline developments across major markets, including the US, EU, and Japan. With the continued progression of research and promising innovations, the PAH market is set for exceptional growth and transformation through 2034.
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Some of the key insights of the Pulmonary Arterial Hypertension Market Report:
• Pulmonary arterial hypertension is more common in women, with idiopathic and heritable forms occurring at least twice as frequently in women compared to men.
• The PAH market in the 7MM is expected to grow significantly, reaching over USD 7 billion in 2024, with further growth projected by 2034.
• While the exact cause of PAH is unknown, mutations in the BMPR2 gene are the most common cause of heritable pulmonary arterial hypertension (HPAH), an autosomal dominant genetic condition.
• Although no cure exists for PAH, management options include medications, oxygen therapy, and, in some cases, lung or heart-lung transplantation.
• According to DelveInsight's estimates, the number of prevalent PAH cases in the 7MM was approximately 113K in 2024, with numbers expected to rise by 2034.
• The US accounts for the largest share of diagnosed PAH cases in the 7MM, representing around 45% of the total patient population.
• PAH symptoms can go unnoticed for 2 to 3 years before diagnosis, leading to delays or misdiagnosis, particularly in early stages.
• For patients who respond to a vasoreactivity test during a right heart catheterization (RHC), calcium channel blockers (CCBs) such as nifedipine, diltiazem, and amlodipine are commonly used.
• Approved therapies for PAH treatment across various WHO Functional Classes (FC) include Johnson & Johnson/Nippon Shinyaku's UPTRAVI (selexipag) and OPSUMIT (macitentan), United Therapeutics and Mochida Pharmaceutical's TYVASO (treprostinil, Inhaled), United Therapeutics' ORENITRAM (treprostinil), Sotatercept (MK-7962) by Merck/Bristol Myers Squibb, and Bayer/Merck's ADEMPAS (riociguat).
• In March 2025, Liquidia Corporation (NASDAQ: LQDA) announced that the FDA has accepted its New Drug Application (NDA) resubmission for YUTREPIATM (treprostinil) inhalation powder, intended to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
• In January 2025, AliveGen USA Inc. (AliveGen), a clinical-stage biopharmaceutical company, announced that the FDA granted Orphan Drug Designation to ALG-801 for the treatment of pulmonary arterial hypertension (PAH). PAH is a rare, serious, and life-threatening condition marked by high blood pressure in the lung arteries, which can eventually lead to right-sided heart failure.
• In August 2024, Liquidia Corporation (NASDAQ: LQDA) announced that the FDA has granted tentative approval for YUTREPIA (treprostinil) inhalation powder. This treatment is designed for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). While YUTREPIA has met all FDA requirements for safety, quality, and efficacy, final approval is pending the expiration of regulatory exclusivity for a competing product.
• In August 2024, Merck announced that the European Commission approved WINREVAIR (sotatercept) for use in combination with other therapies to treat pulmonary arterial hypertension (PAH) in adult patients with WHO Functional Class II to III. WINREVAIR, the first activin signaling inhibitor therapy for PAH, was approved across all 27 EU member states, Iceland, Liechtenstein, and Norway. The approval is based on positive safety and efficacy results from the Phase 3 STELLAR trial.
• Emerging therapies for pulmonary arterial hypertension include Ralinepag, YUTREPIA (inhaled treprostinil), Seralutinib (GB002), Vardenafil (RT234), L606 (liposomal treprostinil), and others.
• Key companies involved in the treatment of pulmonary arterial hypertension include Merck, Bristol Myers Squibb, United Therapeutics, Liquidia Technologies, Tenax Therapeutics, Respira Therapeutics, Gossamer Bio, Pharmosa Biopharm, Aerovate Therapeutics, Insmed, Novartis, Cumberland Pharmaceuticals, Sumitomo Pharma (Enzyvant Therapeutics), Cereno Scientific, AstraZeneca, and others.
To know in detail about the pulmonary arterial hypertension market outlook, drug uptake, treatment scenario, and epidemiology trends, click here: https://www.delveinsight.com/report-store/pulmonary-arterial-hypertension-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Pulmonary Arterial Hypertension Overview
Pulmonary Arterial Hypertension (PAH) is a rare, progressive disease characterized by increased pulmonary vascular resistance and elevated arterial pressure within the lungs. Affecting an estimated 15-60 individuals per million globally, PAH is more commonly diagnosed in women and often presents with nonspecific symptoms such as breathlessness, fatigue, chest pain, and weakness. As the disease advances, it leads to severe complications, including right-sided heart failure, and significantly increases morbidity and mortality rates.
Symptoms of PAH are primarily caused by insufficient oxygen levels in the blood, with shortness of breath being the hallmark symptom. Other symptoms include fatigue, dizziness, swelling in the limbs, blue lips, irregular heartbeats, and chest pain. The severity and progression of these symptoms can vary significantly between individuals, making treatment and management highly individualized. The impact on physical mobility and emotional well-being profoundly affects health-related quality of life (HRQoL), with patients experiencing significant challenges in daily functioning and coping with the disease.
Despite the lack of a cure, ongoing advancements in PAH research are leading to more targeted therapies, offering hope for better management and improved outcomes for affected individuals.
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Pulmonary Arterial Hypertension Epidemiology
The epidemiology section offers an overview of historical, current, and projected trends in the seven major countries (7MM) from 2020 to 2034. It helps identify the factors influencing these trends by examining various studies and perspectives from key opinion leaders. Additionally, the section provides an in-depth analysis of the diagnosed patient population and future trends.
Pulmonary Arterial Hypertension Epidemiology Segmentation:
The pulmonary arterial hypertension market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM, segmented into:
• Total Prevalent cases of PAH
• Total Diagnosed Prevalent cases of PAH
• Age-specific cases of PAH
• Gender-specific cases of PAH
• Class-specific cases of PAH
• Subtype-specific cases of PAH
• Total treated cases of PAH
Pulmonary Arterial Hypertension Drugs Uptake and Pipeline Development Activities
The drug uptake section examines the adoption rates of newly launched and upcoming pulmonary arterial hypertension drugs over the study period. It analyzes the uptake of these treatments, evaluating how patients adopt these therapies and the sales performance of each drug. This section provides a comprehensive overview of the factors that influence the acceptance and success of pulmonary arterial hypertension treatments on the market.
In addition, the therapeutics assessment section highlights the pulmonary arterial hypertension drugs that have experienced the fastest uptake. It delves into the key drivers behind their widespread use and provides a comparison of market share among these drugs. This section helps identify which therapies are gaining traction and the reasons behind their rapid adoption.
The report further explores the pipeline for pulmonary arterial hypertension, providing insights into therapeutic candidates at various stages of development. It identifies the key companies involved in developing targeted treatments for pulmonary arterial hypertension. The report also covers recent developments in the field, including collaborations, mergers, acquisitions, licensing agreements, and other significant updates on emerging therapies for pulmonary arterial hypertension.
Explore how emerging pulmonary arterial hypertension therapies are aligning with evolving patient populations @ https://www.delveinsight.com/report-store/pulmonary-arterial-hypertension-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Pulmonary Arterial Hypertension Market Outlook
The Pulmonary Arterial Hypertension market continues to evolve with significant advancements in targeted therapies that have improved survival rates, with median survival increasing from 2-3 years to over 6-10 years. Although still incurable, current treatments focus on dilating the pulmonary vasculature, reducing resistance, and supporting right ventricular function. Treatment decisions are made based on the patient's WHO functional class, exercise capacity, lab markers, and hemodynamic/echo data.
The market is dominated by four key drug classes: PDE5 inhibitors, sGC stimulators, ERAs, and prostacyclin analogs/agonists, which target the prostacyclin, endothelin, and nitric oxide pathways. Approved therapies like UPTRAVI, TYVASO, ADEMPAS, OPSUMIT, ORENITRAM, WINREVAIR, and OPSYNVI are currently in use, while older therapies such as REVATIO, ADCIRCA, and TRACLEER face revenue erosion due to generic competition.
The pulmonary arterial hypertension market remains strong, with promising developments in the pipeline. Next-generation therapies like ralinepag, which offers superior anti-proliferative and vasodilatory effects, along with Merck's inhaled MK-5475 and innovative treprostinil formulations such as TPIP, are expected to significantly reshape the treatment landscape in the near future.
Pulmonary Arterial Hypertension Market Drivers
• IThe development of next-generation treatments that target key pathways in PAH, such as prostacyclin, endothelin, and nitric oxide, is driving market growth. These therapies offer improved survival rates and better disease management.
• Growing awareness of PAH and advancements in diagnostic technologies are leading to earlier and more accurate diagnoses. This, in turn, is contributing to an increase in the number of diagnosed cases and a higher demand for effective treatments.
Pulmonary Arterial Hypertension Market Barriers
• The cost of advanced therapies for PAH, including targeted drugs and inhaled treatments, remains a significant barrier. These high treatment costs can limit access to therapy, especially in low- and middle-income regions.
• The individualized nature of PAH treatment, coupled with the need for ongoing monitoring and adjustments, makes disease management complex and burdensome for both healthcare providers and patients. This complexity may hinder optimal treatment and patient adherence.
Scope of the Pulmonary Arterial Hypertension Market Report
• Study Period: 2020-2034
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan].
• Key Pulmonary Arterial Hypertension Companies: Merck, Bristol Myers Squibb, United Therapeutics, Liquidia Technologies, Tenax Therapeutics, Respira Therapeutics, Gossamer Bio, Pharmosa Biopharm, Aerovate Therapeutics, Insmed, Novartis, Cumberland Pharmaceuticals, Sumitomo Pharma (Enzyvant Therapeutics), Cereno Scientific, AstraZeneca, and others.
• Key Pulmonary Arterial Hypertension Therapies: Ralinepag, YUTREPIA (inhaled treprostinil), Seralutinib (GB002), Vardenafil (RT234), L606 (liposomal treprostinil), and others.
• Pulmonary Arterial Hypertension Therapeutic Assessment: Pulmonary Arterial Hypertension currently marketed, and Pulmonary Arterial Hypertension emerging therapies.
• Pulmonary Arterial Hypertension Market Dynamics: Pulmonary Arterial Hypertension market drivers and Pulmonary Arterial Hypertension market barriers.
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies.
• Pulmonary Arterial Hypertension Unmet Needs, KOL's views, Analyst's views, Pulmonary Arterial Hypertension Market Access and Reimbursement.
To learn more about pulmonary arterial hypertension companies working in the treatment market, visit @ https://www.delveinsight.com/report-store/pulmonary-arterial-hypertension-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
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
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