Pulmonary Arterial Hypertension Market Research Report and Outlook by 2028

The pulmonary arterial hypertension (PAH) market is projected to expand from approximately US$ 7,369.89 million in 2021 to around US$ 10,889.08 million by 2028, reflecting a compound annual growth rate (CAGR) of 5.8% from 2022 to 2028.

This growth is primarily driven by the increasing prevalence of pulmonary arterial hypertension and the rising number of drug approvals for its treatment. Nevertheless, the adverse effects associated with PAH medications pose challenges to market expansion.

Pulmonary arterial hypertension is a rare and progressive condition characterized by elevated blood pressure in the pulmonary arteries. This heightened pressure can result from blockages in the small arteries of the lungs due to various factors. Although the precise cause of PAH remains unclear, it is treatable, albeit without a definitive cure. The condition predominantly affects women aged between 30 and 60 years.

The expiration of patents allows generic medications to enter the pulmonary arterial hypertension market, thereby broadening the range of available products. Over the next several years, particularly until 2030, numerous patented drugs are expected to lose their patent protection. This situation presents a significant opportunity for companies specializing in generic formulations. For instance, the drug combination AMBRISENTAN + TADALAFIL, developed by Gilead Sciences, Inc., is set to have its patent expire on December 11, 2027. Many pharmaceutical firms are already in the process of creating generic alternatives for these patented medications, as noted by Care Ratings. Once patents expire, generic versions of these drugs will become accessible, benefiting consumers through reduced prices, while also intensifying competition among pharmaceutical companies. Consequently, the expiration of patents is anticipated to create avenues for generic drug manufacturers to penetrate the market during the forecast period.

Furthermore, the last two decades have witnessed the introduction of 14 FDA-approved therapies for PAH, marking a significant achievement given the limited patient population affected by this condition. The success in developing treatments for PAH can be attributed to substantial advancements in understanding the genetic and molecular mechanisms underlying the disease's pathogenesis. As awareness increases, treatment strategies are expected to evolve and diversify beyond the current focus on vasoconstriction. Ongoing clinical trials are investigating the effectiveness of innovative delivery systems and their potential applications in other types of pulmonary hypertension, as well as in combination therapies. This approach is likely to set the standard for future clinical trials.

Insights Based on Route of Administration

The pulmonary arterial hypertension market is categorized by the route of administration into oral, intravenous/subcutaneous, and inhalational methods. The oral segment dominated the market in 2021 and is projected to exhibit the highest CAGR throughout the forecast period. Medications administered orally for the treatment of symptomatic, moderate-to-severe PAH include sildenafil and endothelin (ET) receptor antagonists such as bosentan, sitaxentan, and ambrisentan, which has a higher affinity for ET receptors compared to bosentan. Additionally, new oral treatments for PAH include macitentan, riociguat, and treprostinil. Ambrisentan, an endothelin receptor antagonist, is indicated for PAH treatment, specifically for WHO Group 1, and aims to delay clinical deterioration. When used in conjunction with tadalafil, ambrisentan helps reduce the risks associated with disease progression and hospitalization due to worsening PAH, while also enhancing exercise capacity.

In North America, the pulmonary arterial hypertension market holds the largest share during the forecast period. The growth in this region is attributed to the high incidence of PAH and various initiatives undertaken by both the government and manufacturers. The US market for pulmonary arterial hypertension is particularly significant, with a notably higher prevalence of the condition, despite its classification as rare. According to the American Lung Association, PAH accounts for approximately 500 to 1,000 new diagnoses annually in the US. Furthermore, around 15-20% of PAH cases are hereditary, stemming from genetic mutations.

Moreover, manufacturers are actively engaging in initiatives to provide healthcare professionals with essential information and resources, which further stimulates market growth. The PAH Initiative, supported by United Therapeutics, offers valuable resources to assist healthcare providers in managing PAH patients. Additionally, the establishment of the United States Pulmonary Hypertension Scientific Registry marks the first patient registry in the US dedicated to PAH, focusing on genetic data, reproductive histories, and environmental exposures within the patient population. Consequently, the increasing number of PAH diagnoses each year, coupled with the initiatives by manufacturers, is driving the demand for PAH medications and treatment options, thereby enhancing the growth of the pulmonary arterial hypertension market in the US.

Canada ranks second in terms of market share for pulmonary arterial hypertension in North America, with a significant prevalence of the condition. According to PHA Canada, approximately 10,000 individuals in the country are affected by pulmonary hypertension, with around 5,000 diagnosed. The number of approved treatments in Canada to manage PH and alleviate symptoms is limited, with only 10 specific medical treatments authorized in the last two decades for PAH. However, specialized centers for treating PAH in both adults and children are available across the country. A study published in the European Respiratory Journal in 2022 indicated that the survival rates for PAH patients in Canada at 1, 3, and 5 years were 89.2%, 75.6%, and 56.0%, respectively, highlighting a concerning long-term mortality rate among PAH patients in Canada.

The report on the pulmonary arterial hypertension market references primary and secondary sources, including the World Health Organization (WHO), the US Food and Drug Administration (FDA), and the National Organization for Rare Disorders (NORD).