Pulmonary arterial hypertension (PAH) is a medical condition, characterized by restricted blood flow through the pulmonary arteries, which leads to a progressive increase in pulmonary vascular resistance and subsequently right heart failure. PAH is one of the five groups of pulmonary hypertension, classified by the World Health Organization (WHO). PAH occurs, when the pulmonary arteries become narrowed, thickened, or blocked. The advanced therapy to treat PAH includes prostacyclin and prostacyclin analogs, endothelin receptor antagonists (ERAs), phosphodiesterase-5 (PDE-5) inhibitors, and soluble guanylate cyclase (sGC) stimulators. This advanced therapy is directed towards PAH itself, and not at the underlying cause of PAH. In addition to the aforementioned classes of drugs, physicians also prescribe drugs such as calcium channel blockers, diuretics, digoxin and anticoagulants to patients with PAH.
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Endothelin receptor antagonists (ERAs) that inhibit the interaction between endothelin and endothelin receptors have emerged as one of the mainstays in the treatment of PAH. Tracleer (bosentan) is the first U.S. FDA approved ERA that is being used to treat PAH. Letairis/Volibris (ambrisentan) and Opsumit (macitentan) are the other approved ERAs for treating PAH. Of these, Opsumit was approved by the U.S. FDA and the European Commission in December 2013. Opsumit is expected to emerge as the most selling PAH drug by the end of 2020. Tracleer is set to go off-patent in the U.S. and Europe in 2015 and 2017, respectively. Patent expiry of Tracleer is likely to cause a huge set back in growth of the ERAs market during the forecast period from 2014 to 2020.
Revatio (sildenafil) from Pfizer, Inc. and Adcirca (tadalafil) from Eli Lilly/United Therapeutics Corporation are the two U.S. FDA approved PDE-5 inhibitors that are used to treat PAH. Adempas (riociguat) is the only approved sGC stimulator for the treatment of PAH. Adempas is designed to treat PAH by stimulating the nitric oxide receptor sGC, which induces vasodilation. Adempas was first approved by the U.S. FDA in October 2013. During the forecast period between 2014 and 2020, riociguat would face stiff competition from drugs such as macitentan and treprostinil (extended release tablet), as they all are meant for oral administration. The novel mode of action of riociguat would also play a key role in driving growth of this segment during the forecast period.
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The global pulmonary arterial hypertension (PAH) market was dominated by players such as Actelion Pharmaceuticals, Ltd., Gilead Sciences, Inc., GlaxoSmithKline plc, Pfizer, Inc., and United Therapeutics Corporation in 2013. Actelion Pharmaceuticals, Ltd. accounted for the largest share of the overall PAH market in 2013, as one of its products, Tracleer (bosentan), was the bestselling PAH drug in 2013. During the forecast period from 2014 to 2020, Bayer HealthCare, which recently launched a new drug Adempas (riociguat), is likely to witness substantial growth in the PAH space. Arena Pharmaceuticals, Inc., Dong-A ST Co., Ltd., Reata Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novartis International AG, and Aires Pharmaceuticals, Inc. are some major companies with PAH drugs in their clinical pipeline.
The global PAH market is segmented as follows:
Global Pulmonary Arterial Hypertension Market, by Drug Class
- Prostacyclin and Prostacyclin Analogs
- Endothelin Receptor Antagonists (ERAs)
- Phosphodiesterase-5 (PDE-5) Inhibitors
- Soluble Guanylate Cyclase (sGC) Stimulators
- Early-stage Drug Candidates (Phase I & Phase II)
- Late-stage Drug Candidates (Phase III & Registration Phase)
- North America
- Rest of the World (RoW)
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