Pulmonary Arterial Hypertension Market Size, Share & Trends Analysis Report By Drug Class, By Type (Branded, Generics), By Route Of Administration (Oral, Intravenous/ Subcutaneous, Inhalational), By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global pulmonary arterial hypertension market size was valued at USD 7.3 billion in 2022 and is estimated to grow at a compound annual growth rate (CAGR) of 5.32% from 2023 to 2030. Growing initiatives by key market players, high prevalence of pulmonary arterial hypertension, adoption rate, availability of reimbursement, and entry of generics are some of the key drivers of this market. As per the American Lung Association, about 500 to 1000 new PAH patients are being diagnosed every year in the U.S.

Market players reported a significant impact of the COVID-19 pandemic on operational activity, financial performance, and results of operations. These ranged from delay in clinical trials, supply chain challenges, dampened demand, reduced new patient visits, among others. Gilead for instance reported adverse impact on its clinical studies including the company’s ability to initiate and complete trials within the estimated timelines. The imposition of restrictions on patient visits lead to delays with new subject enrollment for most of Gilead’s clinical trials during 2020. The pandemic also disrupted regulatory reviews and inspections thus impacting the ability of market players to launch new commercial products. The market witnessed low demand due to the limited ability or willingness of patients to initiate new therapies and to access and seek care from healthcare providers. By 2021, the market recovered gradually. The pandemic had minimal to no negative impact on sales of pulmonary arterial hypertension drugs as major companies ensured a continuous supply of stock for existing customers.

COVID-19 Pulmonary Arterial Hypertension market impact: Dampened growth due to low patient access and disruption in clinical trials. However, minimal to no negative impact of the pandemic on sales of PAH drugs.

United Therapeutics estimates that about 45,000 patients suffer from pulmonary arterial hypertension in the U.S. According to the American Lung Association PAH more frequently occurs in women between the ages of 30 and 60. The cause may be idiopathic or genetic with about 15 to 20% of patients estimated to have heritable PAH. Other conditions associated with PAH include infections including HIV and schistosomiasis, cirrhosis of the liver; connective tissue disorders, and congenital heart abnormalities. The high incidence and prevalence of the condition as well as its severity and threat to lifespan are expected to contribute to the growing demand for pulmonary arterial hypertension drugs in the near future.

The increasing expiry of patents presents opportunities that can be leveraged to offer generics at affordable costs over the forecast period. The demand and consumption of generics are estimated to rise significantly driven by R&D initiatives and regulatory approvals in developed and developing markets. In March 2019, Sandoz (a division of Novartis) for instance, exclusively launched the first generic version of Remodulin treprostinil injection, in the U.S. Cipla launched ambrisentan generics across Europe and emerging markets during FY 2020-21. Teva Pharmaceutical Industries Ltd. on the other hand launched the generic version of Letairis (ambrisentan tablets) in the U.S. in May 2019.

Drug Class Insights

The prostacyclin and prostacyclin analogs segment dominated the market and accounted for the largest revenue share of around 45.0% in 2022. The key factors contributing to the large share include a high demand and growing indications. In July 2021, Uptravi belonging to Prostacyclin and Prostacyclin Analogs segment received FDA approval for intravenous use in pulmonary arterial hypertension patients. The SGC simulators segment is expected to grow at the fastest CAGR of over 5%. sGC stimulators can ensure maximum activation of sGC by potentiating NO-sGC signaling. Riociguat (Adempas from Bayer) is the only drug approved for PAH in this category. Adempas sales grew by over 50% in 2020 compared to 2019 indicating a high demand.

Type Insights

The branded segment dominated the market and accounted for the largest revenue share in 2022, while the generics segment is anticipated to witness the fastest CAGR of 6.0% in the coming years. The factors contributing to the growth include the expiry of key patents, the rising launch of generics, growing consumption in developing markets, and initiatives by major companies. In April 2021, Zydus Healthcare Limited, for instance, received FDA clearance to commercialize a generic version of Opsumit Macitentan Tablets. Bayer on the other hand reported a significant increase in revenue of its branded PAH product- Adempas, driven by higher volume sales in the U.S. both in 2020 and 2021. However, the active ingredient patent of Adempas is set to expire in several key markets during the forecast period which may dampen sales in the coming years.

Route Of Administration Insights

The oral segment dominated the market and held the largest revenue share of over 50.0% in 2022. This is attributable to the growing availability of oral formulations for pulmonary arterial hypertension and patient preference for the oral route of administration. Letairis, Opsumit, Adcirca, and Revatio are some examples of oral PAH drugs. Johnson & Johnson’s Opsumit tablets, for instance, recorded total sales of USD 1.6 billion in 2020. The sales represented a 23.5% Y-o-Y growth compared to 2019. In addition, patient safety, affordability, high efficacy, and rapid delivery of drugs are some other factors driving the adoption of oral drug administration.

The intravenous/ subcutaneous segment is anticipated to register the fastest growth of over 5.0% over the forecast period due to increasing indications and approvals by regulatory agencies and advances in drug delivery systems to increase patient compliance. In February 2021, United Therapeutics launched Remunity subcutaneous Pump for delivering Remodulin to PAH patients in prefilled cassettes. The product offers notable enhancements over current subcutaneous pumps owing to its compact size and features such as water resistance and wireless remote programming.

Regional Insights

North America dominated the pulmonary arterial hypertension market and held the largest revenue share of over 40.0% in 2022. The large share is due to the developed healthcare infrastructure in the U.S. and Canada that facilitates access to advanced therapeutics. Also, increased awareness, a high diagnosis rate, and supportive government initiatives support the growth of the market in this region. A well-planned reimbursement structure and the presence of key players also contribute to the regional market growth. The rising prevalence of chronic and infectious diseases and high diagnosis rate is driving the demand for developed healthcare facilities related to pulmonary arterial hypertension in the region.

In the Asia Pacific, the market is estimated to witness the fastest CAGR of more than 6.0% over the next few years. This is owing to the growing consumption of generics, the presence of key pharmaceutical companies, and developing healthcare infrastructure. For example, in April 2019 Cipla, headquartered in India, received U.S. FDA clearance for Ambrisentan Tablets (generic version of Gilead Sciences’ Letairis). This enhanced the company’s portfolio. In addition, the large population base and rising burden of diseases including HIV, which are responsible for PAH are driving the demand for improved healthcare systems in the region.

Key Companies & Market Share Insights

In terms of branded or patented drugs, a few companies hold a notable share of the market for pulmonary arterial hypertension. These include United Therapeutics, Johnson & Johnson, Gilead Sciences, Viatris, Bayer, and more. However, with the rising number of patent expiries, many pharmaceutical companies are entering the PAH market by launching generic versions of pulmonary arterial hypertension drugs. This is estimated to increase the competition in the coming years. Gilead Sciences, Inc. for instance, reported a decline in Letairis sales in 2020 and 2021, because of continued competition from generics, after the product lost exclusivity in 2019.

Market players are involved in deploying various strategic initiatives to increase their market share. This includes product R&D and launches, distribution network expansion, partnerships, and mergers and acquisitions. In November 2020, Mylan N.V. merged with Pfizer Inc.’s Upjohn Business to form Viatris Inc. Viatris offers a robust portfolio of biosimilars, branded and complex generics, over-the-counter products, including the PAH drug Revatio. Some of the prominent players in the pulmonary arterial hypertension market include:

• United Therapeutics Corporation

• Bayer

• Gilead Sciences, Inc.

• Johnson & Johnson

• Viatris Inc.

• GlaxoSmithKline

• Sandoz Inc. (Novartis)

• Lupin Pharmaceuticals, Inc.

• Sun Pharmaceutical Industries, Inc.

• Teva Pharmaceutical Industries Ltd.

Recent Developments

• In July 2023, Novartis and the Novartis US Foundation revealed the extension of their decade-long collaboration for Beacon of Hope, a co-create program aimed at tackling health and education disparities while fostering diversity, equity, inclusion, and trust within the research and development ecosystem. The program will encompass various clinical trials, including pulmonary arterial hypertension, hypertension, urticaria, giant cell arteritis, and breast cancer studies.

• In April 2021, United Therapeutics Corporation made a significant announcement regarding the FDA approval and market launch of Tyvaso® for treating Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD). This milestone marked a major treatment advancement, offering a promising solution to address the needs of patients suffering from PH-ILD and represents a strategic growth opportunity for the company in the pulmonary hypertension market.

Pulmonary Arterial Hypertension Market Report Scope

Global Pulmonary Arterial Hypertension Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2030. For the purpose of this report, Grand View Research has segmented the global pulmonary arterial hypertension market report on the basis of drug class, type, route of administration, and region:

• Drug Class Outlook (Revenue, USD Million, 2017 - 2030)

  • Endothelin Receptor Antagonists (ERAs)

  • PDE-5 Inhibitors

  • Prostacyclin and Prostacyclin Analogs

  • SGC Stimulators

• Type Outlook (Revenue, USD Million, 2017 - 2030)

  • Branded

  • Generics

• Route of Administration Outlook (Revenue, USD Million, 2017 - 2030)

  • Oral

  • Intravenous/ subcutaneous

  • Inhalational

• Regional Outlook (Revenue, USD Million, 2017 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

  • Asia Pacific

    • China

    • India

    • Japan

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • MEA

    • South Africa

    • Saudi Arabia

    • UAE