The global pulmonary arterial hypertension (PAH) market is highly consolidated, with the top four players representing nearly 92% of the market in 2013, finds Transparency Market Research (TMR) in a new study. The top four players in the market are Actelion Pharmaceuticals Ltd., GlaxoSmithKline plc, Gilead Sciences Inc., and United Therapeutics Corporation. “With the expiration of branded drugs, the production of generic drugs is anticipated to heat up,” says the author of the report. While the well-established players are engaging in the development of new branded drugs, new companies are trying to enter the market with the generic versions of existing drugs. However, the massive capital requirements and stringent government regulations are alleviating the threat of new entrants significantly.
The global PAH market was valued at US$4.55 bn in 2015 and is anticipated to rise to US$5.18 bn by the end of 2020, expanding at a CAGR of 2.3% from 2014 to 2020. Based on drug class, endothelin receptor antagonists (ERAs) was the leading segment in 2015. However, the segment will lose its dominance to prostacyclin and prostacyclin analogs by 2017. The latter is expected to account for a dominant 41.5% of the overall market by 2020. The aGC stimulators segment is anticipated grow at a noteworthy CAGR of 39.2% from 2014 to 2020.
On the basis of geography, North America was the leading segment in 2015. Due to launch of highly effective pipeline drugs, the region is expected to retain its leadership until 2020, with a share of 41.5% of the overall market. Asia Pacific is estimated to expand at a CAGR of 4.7% owing to a large population of patients present in the region.
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Approval of Superior Quality Drugs to Fuel Growth of PAH Market
The approval of some highly effective pulmonary arterial hypertension drugs such as Uptravi (selexipag), Orenitram (treprostinil extended release tablet), and Opsumit (macitentan) has triggered the growth of the global PAH market. “These drugs have superiority over existing therapy options with respect to the therapeutic efficacy, route of administration, and side effects,” says a TMR analyst. The rising sales of these newly-approved therapeutic agents are likely to contribute to the overall revenue of the market.
Globally, regulatory bodies have granted an Orphan Drug Designation (ODD) status to all those drugs intended to diagnose and treat or cure a rare disease. For instance, in the U.S., the Orphan Drug Act (ODA) encourages pharmaceutical industries to develop orphan drugs by offering benefits such as tax credits, research grants, and orphan drug exclusivity of seven years. These benefits are escalating the development, manufacturing, and marketing of drugs intended to treat PAH, thereby driving market growth.
Patent Expiry of Blockbuster Drugs to Hamper Overall Revenue of PAH Market
The patent expiration of block buster drugs such as Tracleer and Letairis (ambrisentan) has negatively influenced the growth of the global PAH market. The generic versions of these drugs are sold at prices 70% to 80% lower than that of branded products. The patent expirations of major PAH drugs along with the availability of generic drugs are expected to adversely affect the overall revenue of the market. However, increasing emphasis from governments to focus on the development of breakthrough products for the effective treatment of PAH is expected to be beneficial for companies in this market in the long run.
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