pulmonary arterial hypertension Market

The pulmonary arterial hypertension market is expected to grow from US$ 7,369.89 million in 2021 to US$ 10,889.08 million by 2028; it is estimated to grow at a CAGR of 5.8% from 2022 to 2028.

The market growth is attributed to the growing incidence of pulmonary arterial hypertension and the rising approvals of pulmonary arterial hypertension drugs. However, the side effects of drugs used to treat pulmonary arterial hypertension hamper the market growth.

Pulmonary arterial hypertension (PAH) is a rare, progressive disorder caused due to high blood pressure (hypertension) in the arteries of the lungs. The increased pressure in the vessels may be caused by an obstruction in the small arteries in the lung for various reasons. The exact cause of PAH is unknown and although treatable; there is no permanent cure for the disease. PAH usually affects women between the age of 30-60 years..

Patent expiry permits generic drugs to penetrate the pulmonary arterial hypertension market and diversify product offerings. Over the next seven-eight years till 2030, the patented products are expected to go off-patent. This would provide an enormous opportunity for generic formulation companies in the coming years. AMBRISENTAN + TADALAFIL drug by Gilead Sciences, Inc. is used to treat PAH, and its patent will be expired by December 11, 2027. Many pharma companies are already working to develop the generic version of patented products, finds Care Ratings. After patent expiration, generic versions of drugs can become available. While consumers benefit from low prices, losing patent protection can expose pharmaceutical companies to growing competition. Thus, patent expiration is expected to open an opportunity for generic drug manufacturers to enter a new market during the forecast period.

Moreover, over the past 20 years, the arrival of 14 FDA-approved therapies for treating PAH is seen as a major feat considering that this disease affects a small population. The key to success in developing PAH therapies has been the immense advances in understanding the genetic and molecular mechanisms that drive the pathogenesis of the disease. With the growing awareness, the treatment strategies will continue to evolve and diversify from the current paradigm focused on vasoconstriction. Clinical trials are exploring the clinical efficacy of novel delivery devices and their utility in other forms of pulmonary hypertension and combination therapies. This will be the standard for clinical trials in the future.

Route of Administration-Based Insights

Based on route of administration, the pulmonary arterial hypertension market is segmented into oral, intravenous/subcutaneous, and inhalational. The oral segment held the largest pulmonary arterial hypertension market share in 2021 and is anticipated to register the highest CAGR during the forecast period. Orally administered agents used for the treatment of symptomatic, moderate-to-severe PAH include sildenafil and the endothelin (ET) receptor antagonists (ERAs), bosentan and sitaxentan (sitaxsentan), and abrisentan oral ET(A) receptor-selective ERA, with higher ET receptor affinity than bosentan. Moreover, new oral drugs for treating PAH include macitentan, riociguat, and treprostinil. Ambrisentan is an endothelin receptor antagonist indicated for treating PAH; WHO Group 1 and delay clinical worsening. In combination with tadalafil, ambrisentan is indicated to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability..

The pulmonary arterial hypertension market in North America held the largest share in the forecast period. The market growth in the region is attributed to the high prevalence of pulmonary arterial hypertension and initiatives by the government and manufacturers. The US pulmonary arterial hypertension market holds a significant share of the regional market. The prevalence of PAH in the US is much higher, although it is a rare disease. According to the American Lung Association, PAH is a rare and progressive disorder that accounts for about 500-1,000 new cases being diagnosed each year in the US. Additionally, as per the same source, ~15-20% of PAH patients have heritable PAH caused by genetic mutations.

Further, manufacturers undergo various initiatives to provide information and resources to healthcare practitioners, fueling the market growth. The PAH Initiative supported by United Therapeutics provides resources and information to assist healthcare providers in treating patients affected by PAH. In addition, the United States Pulmonary Hypertension Scientific Registry was established as the first US PAH patient registry to investigate genetic information, reproductive histories, and environmental exposure data in a patient population. Thus, the rising cases of PAH diagnosed each year and initiatives undertaken by manufacturers fuel the demand for pulmonary arterial hypertension drugs and other treatment methods, further bolstering the pulmonary arterial hypertension market growth in the US.

Canada holds the second-largest share of the pulmonary arterial hypertension market in North America. Canada has a high prevalence of pulmonary arterial hypertension. According to the PHA Canada, it is estimated that ~10,000 population in the country are affected by pulmonary hypertension (PH), but ~5,000 have been diagnosed with it. A limited number of treatments are approved in Canada to slow the progression of PH and alleviate symptoms. Over the last two decades, only 10 PH-specific medical treatments have been approved in Canada for treating PAH. However, the centers specializing in treating PAH in adults and children are located across the country. Additionally, a study (2022) published in European Respiratory Journal reported that the 1-, 3- and 5-year survival rates in the Canadian PAH cohort were 89.2%, 75.6%, and 56.0%, respectively. Thus, PAH patients in Canada are reported to have a high death rate in the long term.

The World Health Organization (WHO), US Food and Drug Administration (FDA), and National Organization for Rare Disorders (NORD) are among the primary and secondary sources referred to while preparing the report on the pulmonary arterial hypertension market.