According to Coherent Market Insights, global pulmonary arterial hypertension (PAH) market was valued at US$ 5,821.90 million in 2018 and is expected to exhibit a CAGR of 5.9% over the forecast period (2019-2027).
Key Trends and Analysis of the Pulmonary Arterial Hypertension (PAH) Market:
Key trends in the market include rising cases of chronic lung diseases and increasing product approvals and launches coupled with novel development of treatment of pulmonary arterial hypertension (PAH) by players, which is expected to propel the market growth over the forecast period.
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Increasing cases of pulmonary arterial hypertension (PAH) is expected to boost growth of the market over the forecast period. For instance, according to the National Organization for Rare Disorder (NORD), 2018, around 500 to 1,000 new cases of pulmonary arterial hypertension are diagnosed each year in the U.S.
Moreover, various mergers, agreements, and acquisitions by key players are expected to propel the market growth. For instance, in January 2017, Acetlion announced that Johnson & Johnson acquired shares of Actelion for US$ 280 per share. This definitive transaction agreement expected to accelerate Johnson & Johnson’s revenue and earnings growth rates. This acquisition took place, as Actelion had established a franchise of differentiated & innovative products for treating pulmonary arterial hypertension (PAH), which was complementary to the existing portfolio of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Furthermore, increasing number of players are focusing on developing innovative drugs, in order to fulfill the unmet need in the market, which is expected to drive the market growth over the forecast period. For instance, in 2018, according to the National Institute of Health, around 15 clinical trials involving Iloprost were active globally. For instance, in November 2015, the National Cancer Institute initiated a phase I clinical trial for evaluating iloprost in preventing recurrence of lung cancer for patients who smoke and the study is expected to complete in 2020.
However, stringent regulations for drugs are expected to restrain the market growth over the forecast period. For instance, according to the Congressional Research Service, article published in May 2018, reports that the Food and Drug Administration (FDA), a regulatory agency within the Department of Health and Human Services, regulates the safety and effectiveness of any novel drugs that is approved or launched or sold in the U.S. FDA approves in the two phases, preapproval (premarket) phase, and postapproval (postmarket) phase. For processing a novel drug, the company or manufacturer must seek and receive FDA approval through investigational new drug (IND) application. If approved by FDA, it leads to Clinical Trials, which comprises of Phase I, II, III & IV. Then the manufacturer then compiles the resulting data and analysis in a new drug application (NDA). FDA reviews the NDA through the Federal Food, Drug, and Cosmetic Act (FFDCA) in detail for safety & efficacy with the drugs’ identity, strength, quality, and purity. Once FDA has approved an NDA, the drug may enter the U.S. market, but FDA continues to address drug production, distribution, and use. All these above steps take 10-12 years to launch a drug in the market.
Key Market Takeaways:
- The global pulmonary arterial hypertension (PAH) market is expected to exhibit a CAGR of 5.9% over the forecast period (2019-2027) due to rising prevalence of heart problems leading to pulmonary arterial hypertension. For instance, according to the American Heart Association, Inc., globally heart failures are the most common cause of the pulmonary arterial hypertension (PAH). Moreover, according to the Centers for Disease Control and Prevention (CDC), a report- Heart disease and stroke statistics-2019, from the American Heart Association states that around 6.5 million adults in the U.S. suffered from heart failure.
- Key players in the market are focused on developing new products with improved clinical outcomes to enhance their product portfolio, which is expected to propel the market growth over the forecast period. For instance, in October 2019, Actelion Pharmaceuticals Ltd, a Janssen Pharmaceutical Company of Johnson & Johnson Services Inc., released new data evaluating initial combination therapy with OPSUMIT (macitentan) and tadalafIl, a PDE5 inhibitor studied on patients with pulmonary arterial hypertension (PAH). This combination showed hemodynamic improvement, as well as improvements in functional parameters.
- Key players operating in the global pulmonary arterial hypertension (PAH) market include United Therapeutics Corporation, GlaxoSmithKline plc, Novartis AG, AstraZeneca, Bayer AG, Merck KGaA, Pfizer Inc., Gilead Sciences, Inc., Actelion Pharmaceuticals Ltd, Arena Pharmaceuticals, and Daiichi Sankyo Company, Limited.
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