Pulmonary Arterial Hypertension (PAH) Market By Drug Class (Prostacyclin And Prostacyclin Analogs, Soluble Guanylate Cyclase (SGC) Stimulators, Endothelin Receptor Antagonists (ERA), Phosphodiesterase 5 (PDE-5)) And Segment Forecasts To 2025

Market Size and Trends

The global pulmonary arterial hypertension (PAH) market size was valued at USD 5.0 billion in 2015 owing to the increasing prevalence and incidence rates of this disease and supportive government legislation. The global prevalence of PAH is around 15 to 50 cases per million, hence, it is classified as a rare disorder. Cumulatively, the cases of PAH are in the range of 100,000 to 200,000 per year. 

However, in the past few years, the prevalence of this disorder is rising due to risk factors like sedentary lifestyle, HIV, smoking, alcohol/tobacco consumption, and other idiopathic conditions.

Pulmonary Arterial Hypertension market, by drug class, 2014 - 2025 (USD Million)

PAH may occur in association with various diseases, such as lung and cardiac diseases. Frequently observed underlying causes include connective tissue disorders, congenital heart disorders, coronary artery disorder, blood clots, and high blood pressure. The symptoms for pulmonary arterial hypertension include breathlessness, fatigue, dizziness, and chest pain. 

The presence of a large population over 60 years, which has lower immunity levels and is prone to this disorder and associated diseases, is a high impact-rendering driver for the growth of this industry over the forecast period. Although the onset age for this disorder is 45 years, it is frequently observed to occur in population above 60 years of age. 

Supportive legislations such the Orphan Drug Act (ODA) 1983, and Rare Disease Act 2002 in the U.S. are the two most important acts that facilitate the ethical usage and distribution of orphan drugs. With the help of organizations such as the National Organization of Rare Disorders, the development of orphan drugs is promoted, which have a smaller market share. 

The incentives offered by aforementioned legislations are in the form of tax benefits, enhanced exclusivity or extended patent protection term, financial subsidization and funding for clinical research in rare diseases and creating government run facilities that have exclusive focus on rare diseases and orphan drugs. 

Loss of exclusivity of key drugs in this domain is anticipated to have significant impact on industry dynamics. This is discouraging pharmaceutical companies to invest in R&D. Furthermore, in case of rare diseases, including PAH, the target population and market size is relatively small and the drug developers are hesitant to invest time and money in the same. 

Drug Class Insights

ERA dominated PAH industry with a substantial share of around 40.0% in 2015. Tracleer and Opsumit target both the Endothelin A (ETA) and Endothelin B (ETB) receptors, whereas Letairis/Volibris targets only the ETA receptor. The cumulative sales from these drugs are expected to marginally decline over the next few years. Tracleer and Letairis/Volibris are expected to see heavy generic erosion during this time period resulting in a negative CAGRs, whereas Opsumit, launched in 2013 (and not anticipated to be subject to generic competition), is expected to grow strongly over the forecast period. 

U.S. PAH market by drug class, 2015

Prostacyclin and prostacyclin analogues are anticipated to exhibit lucrative growth over the forecast period. The sales of these drugs are expected to grow sharply over the forecast period, primarily due to the growth expected in oral prostacyclin agents (Uptravi and Orenitram). Adempas, a SGC stimulator launched in 2013, is expected to grow at a healthy rate during forecast period.

Regional Insights

North America with its supportive infrastructure for development and distribution of high quality therapies dominated global pulmonary arterial hypertension industry with more than 50.0% share in 2015. High awareness and well planned reimbursement structure resulted in superlative diagnosis rate. Moreover, supportive legislations such as the ODA 1983, and Rare Disease Act 2002 in the U.S. fostered development of novel medication for this disorder. 

On the other hand, Asia Pacific with its rapid economic developments, huge population base and improving healthcare systems is anticipated to grow at a lucrative growth rate. Economic developments in countries such as India and China are complimenting the growth of this region. Moreover, high burden of diseases such as HIV which are responsible for development of PAH are foster the growth of this region.

Market Share

Some of the major companies include Actelion Pharmaceuticals, Ltd., Gilead Sciences, Inc, United Therapeutics Corporation, GlaxoSmithKline Plc., Pfizer, Inc, Bayer HealthCare and Arena Pharmaceuticals. 

Pulmonary Arterial Hypertension market competitive strategic framework

Geographical expansion, collaboration, new product development and launches are key strategic undertakings. For instance, in October 2015, Gilead Sciences, Inc the U.S. FDA obtained approval for new combination treatment of Letairis with Tadalafil for PAH (WHO Group 1), this helped company to increase their product penetration in the U.S. market.

 Report Scope

* 15% free customization -The 15% report customization is equivalent to work done by one research analyst for 5 working days.

Market Segments Covered in the Report

This report forecasts revenue growth and provides an analysis on the market trends in each of the sub-markets from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the pulmonary arterial hypertension (PAH) market on the basis of drug class and region:

• Drug Class Outlook (Revenue, USD Million, 2014 - 2025)
  • Prostacyclin and Prostacyclin Analogs
  • SGC Stimulators
  • ERA
  • PDE-5
• Regional Outlook (Revenue, USD Million, 2014 - 2025)
  • North America
    • U.S.
    • Canada
  •  Europe
    • UK
    • Germany
  • Asia Pacific
    • Japan
    • China
  • Latin America
    • Brazil
    • Mexico
  • MEA
    • South Africa