The pulmonary arterial hypertension (PAH) market in the seven major markets (7MM*) is expected to increase from $4.6 billion in 2019 to $7.5 billion in 2029 at a compound annual growth rate (CAGR) of 5%, driven by the launch of pipeline therapies and an increased uptake in combination therapy, according to GlobalData, a leading data and analytics company.

GlobalData’s latest report, ‘Pulmonary Arterial Hypertension: Seven-Market Drug Forecast and Market Analysis’, reveals the greatest unmet need in the PAH space is the absence of disease-modifying therapies that target vascular remodeling. Consequently, the launch of Merck’s blockbuster drug sotatercept will likely be the most significant event in the PAH space over the forecast period.

Kaya Olczak, Healthcare Analyst at GlobalData, comments: “Sotatercept is a first-in-class fusion protein that prevents blood vessel remodeling via the inhibition of bone morphogenetic protein 10. Set to launch in the US in 2024 and in the five major European markets (5EU**) in 2025, sotatercept is forecast to generate $1.13 billion in sales for Merck in 2029. As the first disease-modifying therapy, sotatercept will be a game changer in the PAH space.”

A popular strategy adopted by drug companies to boost their PAH portfolios is reformulation of current therapies to improve safety and efficacy, as well as providing easier administration for patients.

Olczak notes: “Drug reformulation is a dominant trend in the PAH pipeline. One such example is United Therapeutics’ ralinepag, a ‘me-too’ drug to Johnson & Johnson’s currently marketed high-performing Uptravi with an improved pharmacokinetic profile. GlobalData forecasts that ralinepag will capture significant market share from other prostacyclin therapies, including Uptravi, upon its launch.

“Another example is AV-101, an inhalation formulation of imatinib developed by Aerovate Therapeutics in the US. Oral imatinib was previously investigated by Novartis and showed promising clinical improvements in Phase III trials. However, severe side effects led to trial discontinuation. Inhalation imatinib has the potential to avoid these systemic side-effects via direct administration to the lungs. If successful, AV-101 will be another first-in-class disease-modifying therapy for PAH, further addressing the unmet need of an absence of curative treatment.”

While the PAH market is projected to grow steadily during the forecast period, potential barriers to growth include patent expiry of multiple branded drugs over the forecast period, and low diagnosis rates across the 7MM.

Olczak concludes: “Throughout the forecast period, the patents for several marketed drugs will expire, leading to generic erosion. Notably, sales of the current market leader, Johnson & Johnson’s Opsumit, are predicted to drop by around 40% in 2026 after US and 5EU patent expiry.

“Furthermore, low disease diagnosis rates and delayed diagnosis are expected to continue throughout the forecast period, due to low disease awareness among patients and physicians—thus reducing the growth potential of the PAH market. Nonetheless, the launch of pipeline therapies, including sotatercept and ralinepag, coupled with increased uptake of combination therapy, will fuel market growth in the PAH space.”

* 7MM: The US, France, Germany, Italy, Spain, the UK, and Japan

** 5EU: France, Germany, Italy, Spain, and the UK