Pulmonary arterial hypertension market to reach $9.3 bn in 7MM by 2034

The pulmonary arterial hypertension (PAH) market across the seven major markets (7MM*) is poised to grow at a compound annual growth rate (CAGR) of 2.0 per cent from $7.6 billion in 2024 to $9.3 billion in 2034, driven by the adoption of triple combination therapy, novel prostacyclin formulations, and the entry of disease-modifying therapies, according to GlobalData.

GlobalData’s latest report, “Pulmonary Arterial Hypertension: Seven-Market Drug Forecast and Market Analysis,” reveals that the US market is the largest PAH market in the 7MM, accounting for 76.3 per cent of global sales in 2024 ($5.8 billion), and is expected to gain further market value during the forecast period, reaching $7.0 billion in 7MM PAH sales by 2034. While the growth is modest, the therapeutic and commercial landscape is undergoing a fundamental shift as developers move beyond symptomatic control toward structural disease modification.

PAH is a rare, progressive condition marked by elevated pulmonary arterial pressure and vascular remodelling, which eventually leads to right heart failure. It primarily affects middle-aged women and is often misdiagnosed due to nonspecific symptoms like fatigue and breathlessness. Despite advances, long-term prognosis remains poor, and treatment access is often delayed.

Sulayman Patel, Senior Analyst in Cardiovascular & Metabolic Disorders, GlobalData, comments: “The approval of Winrevair (sotatercept), the first drug to target the BMPR2 signalling pathway, is a watershed moment in PAH. By addressing the underlying vascular remodelling, it reframes treatment expectations and redefines the clinical ambition for this disease.”

The current treatment standards involve dual oral therapy, typically an endothelin receptor antagonist (ERA) and a phosphodiesterase type 5 (PDE5) inhibitor, as supported by the AMBITION trial. Prostacyclin therapies—including Uptravi (selexipag) and Tyvaso (inhaled treprostinil)—offer options for patients needing escalation, but parenteral drugs like Flolan (epoprostenol) and Remodulin (treprostinil) remain crucial for high-risk patients despite the complexity in administration.

The arrival of Winrevair introduces a new therapeutic class focused on anti-proliferative and disease-modifying mechanisms, catalysing a shift in pipeline development.

According to the key opinion leaders (KOLs) interviewed by GlobalData, this marks a deliberate pivot away from symptom relief and toward true modification of disease progression.

Patel notesl, “Patients and clinicians alike are seeking therapies that combine clinical impact with convenience. Winrevair has opened the door, but future leaders will be those that deliver meaningful outcomes via oral, inhaled, or infrequent injectable routes—especially for advanced and comorbid patients.”

GlobalData highlights a pipeline aligned with these goals. Late-stage assets such as ralinepag (oral IP receptor agonist) and Yutrepia (dry powder treprostinil) aim to expand prostacyclin utility while improving usability. Seralutinib, an inhaled kinase inhibitor, and a reformulated imatinib represent next-generation, targeted approaches with disease-modifying intent. Sustained-release oral treprostinil is also in development to mitigate gastrointestinal tolerability issues.

The commercial success will hinge on differentiated efficacy, ease of use, and real-world outcomes. As key patents expire, companies must prioritise lifecycle strategies—from fixed-dose combinations and digital adherence tools to data generation that reinforces long-term value.

Patel concludes, “The PAH treatment paradigm is shifting from reactive symptom management to proactive vascular intervention. As disease-modifying therapies gain ground, success will require not just breakthrough science but seamless integration into real-world care.”

*7MM = US, France, Germany, Italy, Spain, the UK, and Japan.