GlobalData says pulmonary arterial hypertension therapy market will hit $4.75bn by 2024

The company’s latest report states that the increase in PAH treatment sales, which will occur across the seven major markets of the US, France, Germany, Italy, Spain, the UK, and Japan, will be driven by new drug launches, the increased use of double and triple combination therapies, and patient assistance programs by manufacturers.

GlobalData senior analyst covering cardiovascular and metabolic disorders Lakshmi Dharmarajan said that despite these developments and growth in the PAH arena, significant unmet needs will remain by 2024, the most crucial of which is to find a cure for the fatal disease.

Dharmarajan explains: "While there are currently 12 marketed PAH therapies available, they only serve to slow disease progression. There is no marketed drug that addresses the underlying disease mechanism and targets to cure patients.

"The main challenges in developing curative or stabilizing therapies come from a lack of understanding of the disease mechanism. This is not helped by the fact that most companies in the field are focusing their attention on reformulating existing PAH drugs and enhancing patient convenience, rather than improving efficacy."

The analyst adds that there is a great need to develop biomarkers and assays that could be used to predict patient response upfront and make treatment more personalized. However, there are no ongoing efforts to address this need in the PAH therapeutics market.

In terms of what the PAH treatment pipeline does have to offer, there are only two drugs in late-stage clinical development.

Dharmarajan continues: "The more promising of the two late-stage pipeline PAH drugs is Actelion’s Uptravi, a first-in-class prostacyclin IP receptor agonist with a favorable clinical efficacy and safety profile. Uptravi was recently launched in the US in January 2016 and is estimated to be the highest revenue generator of the PAH market at the end of the forecast period, recording near-blockbuster sales of $996 million in 2024.

"The other Phase III candidate, Beraprost sodium 314d, does not demonstrate as much potential due to its lack of clinical superiority over other existing prostacyclin-based therapies."

GlobalData believes that pharmaceutical companies should address unmet needs by focusing their attention on PAH-specific mechanisms which, although wrought with a high risk of failure, could potentially lead to innovative and effective disease-modifying treatments.