Pulmonary arterial hypertension (PAH) is a progressive disorder characterized by high blood pressure in pulmonary arteries that carry blood from the heart to the lungs. PAH is a very rare condition that occurs when pulmonary arteries become narrow in diameter or get blocked. Based on information gathered from various sources including WHO and CDC, the worldwide prevalence of PAH has been estimated to be between 100,000 – 200,000, approximately 15 – 50 cases per million people. Although, there is no cure for PAH, treatments are available to reduce symptoms, improve the quality of life, and slow down disease progression. Prostacyclin and prostacyclin analogs, endothelin receptor antagonists (ERAs), and phosphodiesterase-5 (PDE-5) inhibitors are the most-prescribed drug classes for the treatment of PAH. Recently, a new drug class, soluble guanylate cyclase (sGC) stimulators, has been identified to treat people suffering from PAH.
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The recent approval of drugs and the anticipated approval of new PAH drugs in the coming years have been identified as the major growth drivers of the PAH market during the forecast period between 2014 and 2020. Opsumit (macitentan), Orenitram (treprostinil extended release tablet), and Adempas (riociguat) are the PAH drugs that received approval from various regulatory agencies across the world in the recent years (2013 and 2014). A new therapeutic agent Uptravi (selexipag) is anticipated to be introduced in the first half of 2016. In addition, governments of various countries providing incentives to companies engaged in the development and manufacturing of PAH drugs are also expected to contribute to the market growth.
On the other hand, the patent expiry of major PAH drugs such as Tracleer, Letairis, Adcirca, and Tyvaso is expected to affect the market revenue during the forecast period, as their generic versions would be sold at prices 70% to 80% lower than that of the branded ones. Development of breakthrough therapy for the treatment of PAH is expected to be a growth opportunity for drug manufacturers, as the currently available drugs are not enough to meet the medical needs of people suffering from PAH.
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The global PAH market has been segmented into prostacyclin and prostacyclin analogs, ERAs, PDE-5 inhibitors, and sGC stimulators, based on the commercially-available drug classes, to treat PAH. Of these, ERAs represented the largest segment in 2013 with a revenue share of 55.8%. However, during the forecast period, the prostacyclin and prostacyclin analogs segment is expected to record the highest growth, mainly due to the approval of Orenitram (treprostinil extended release tablet) in December 2013 and the anticipated approval of Uptravi (selexipag) in the first quarter of 2016. Adempas (riociguat) is the only approved sGC stimulator for the treatment of PAH. Adempas was first approved by the U.S. FDA in October 2013.
In terms of geography, the global pulmonary arterial hypertension (PAH) market has been segmented into four major regions: North America, Europe, Asia-Pacific, and Rest of the World (RoW). North America, with a share of 44.6%, represented the largest regional market for PAH in terms of revenue in 2013, followed by Europe. These two developed regions are expected to witness substantial growth during the forecast period, primarily due to the recently approved PAH drugs in the market and products that are anticipated to receive approval during the next few years. In the Asia Pacific region, Japan, China, India, Australia, and New Zealand exhibit immense opportunities for the companies operating in the PAH market. In RoW, the low level of awareness regarding the diagnosis and treatment of PAH is one of the prime reasons restraining the market growth. However, during the forecast period, growing awareness regarding PAH would drive growth of the market.
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Actelion Pharmaceuticals, Ltd., Bayer HealthCare, Gilead Sciences, Inc., GlaxoSmithKline plc, Novartis International AG, Pfizer, Inc. and United Therapeutics Corporation are the key players operating in the global PAH market.
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