Pulmonary Arterial Hypertension Drug Market is Estimated to Witness High Growth Owing To Increasing Disease Prevalence and Product Approvals
The Global Pulmonary Arterial Hypertension Drug Market is estimated to be valued at USD 8.10 Bn in 2024, exhibiting a CAGR of 5.7% over the forecast period (2024-2031). The market is expected to gain significant growth owing to the increasing prevalence of pulmonary arterial hypertension and rising product approvals. Furthermore, introduction of novel therapeutics and expansion of treatment options are projected to propel the market growth during the forecast period.
Market Dynamics:
The global pulmonary arterial hypertension drug market is primarily driven by the increasing prevalence of pulmonary arterial hypertension across the globe. Furthermore, various product approvals by regulatory bodies are also fueling the market growth. For instance, in 2023, the U.S. FDA approved Alyq (crisdantinib) oral suspension, the first and only once-daily medication for treatment of adults with symptomatic pulmonary arterial hypertension. The drug offers a new mechanism of action and is well-tolerated with potential to improve exercise capacity for patients.
Growing Prevalence of Pulmonary Arterial Hypertension is Driving the Market Growth
Pulmonary arterial hypertension is a chronic, life-threatening disorder characterized by high blood pressure in the arteries connecting the heart and lungs. The growing prevalence of PAH across the globe is a major driver of growth in the pulmonary arterial hypertension drug market. In February 2020, according to the World Health Organization (WHO), PAH affects approximately 15 to 50 individuals per million population. North America and Europe have the highest prevalence rates, while Asia Pacific is seeing rapid rise in cases due to lifestyle changes and increasing life expectancy. The increasing awareness about early diagnosis and treatment of PAH among patients and doctors is also helping identify more cases, further boosting the demand for PAH drugs.
Rising Research and Development Spending by Pharmaceutical Companies
Pharmaceutical companies have been ramping up investments in R&D activities focused on developing novel drug formulations and treatment approaches for PAH. This is another key growth driver for the market. Companies are conducting clinical trials to evaluate new drug candidates that could offer improved efficacy, reduced side effects and new mechanisms of action compared to existing therapies. For instance, United Therapeutics, a biotechnology company, has several new drug candidates in late-stage clinical trials that could generate billions in annual sales once approved. Increased R&D activity is expected to result in the launch of new innovative drugs in the coming years, thereby fueling the market growth.
High Cost of PAH Therapy Acts as a Major Restraint
While the availability of several effective treatments over the past decades has improved patient outcomes, the high cost of PAH drugs remains a significant restraint to the market's growth potential. Targeted PAH therapies such as prostacyclin analogs, ERAs and PDE-5 inhibitors are very expensive, with average annual drug costs ranging from US$ 30,000 to over US$ 100,000 per patient in the United States. The financial burden and lack of universal healthcare coverage push these life-saving medications out of reach for many patients, especially in developing nations. Generic competition is also limited, preventing a natural decrease in prices. This cost barrier negatively impacts treatment adherence and disease management.
Reimbursement Issues Limit Uptake of New PAH Drugs
Obtaining insurance reimbursement for expensive specialty PAH drugs poses major challenges across global markets. Private insurers and government programs often limit or delay reimbursement for novel drugs entering the market due to uncertainties regarding long term safety, efficacy and health economic outcomes. Even approved products may receive restricted or undesirable coverage policies that leave patients bearing high out-of-pocket costs. Reimbursement issues discourage physicians from prescribing newly launched premium-priced drugs and patients from taking them, which hampers uptake of modern therapies. This reimbursement constraint on the PAH drug landscape needs to be addressed to realize full market potential.
Rise in Healthcare Expenditure in Emerging Economies
With rapidly growing economies, countries such as China, India, Brazil, and others in Asia Pacific and Latin America are dedicating higher budgets to healthcare and implementing universal coverage programs. This increases affordability and access to modern PAH therapies in emerging patient pools. On one hand, an enlarged base of patients with paying capabilities expands the addressable market size for drug developers. On the other hand, government spending on healthcare augments clinical research activities and drug imports in these regions. The market sees this as a noteworthy opportunity to penetrate developing markets and realize greater sales in the future.
Increasing Population of Elderly Provides New Opportunities
PAH predominantly affects adults and is more common among the elderly. With a rising proportion of geriatric population worldwide due to higher life expectancy and declining fertility rates, there will be a surging prevalence of age-related medical conditions including PAH in the coming decades. This demographic shift presents significant opportunities for PAH drug suppliers to serve a fast-growing pool of at-risk patients. Advanced therapies are also enabling elderly patients to live longer with better quality of life. Therefore, the market will likely witness heightened demand for improved treatment solutions tailored for older PAH patients worldwide in the foreseen future.
Link - https://www.coherentmarketinsights.com/market-insight/pulmonary-arterial-hypertension-pah-market-203
Key Developments:
- In March 2024, the USFDA approved OPSYNVI (macitentan and tadalafil), the first once-daily combination therapy for pulmonary arterial hypertension (PAH). Based on positive Phase 3 A DUE study results, it enhances Johnson & Johnson’s PAH portfolio by addressing all guideline-recommended pathways.
- In March 2024, Merck, a pharmaceutical company received USFDA approval for WINREVAIR (sotatercept-csrk), the first activin signaling inhibitor for PAH. This novel therapy improves exercise capacity, WHO functional class, and reduces risks of clinical worsening, introducing a new class of treatment for PAH. WINREVAIR had previously been granted Breakthrough Therapy Designation.
- In August 2023, Keros Therapeutics, a clinical-stage biopharmaceutical company, reported positive Phase 2 trial results for KER-012, highlighting its potential efficacy in treating PAH.
- In May 2023, Janssen, a subsidiary of Johnson & Johnson, submitted a new drug application to the FDA for its combination therapy of tadalafil 40mg and macitentan 10mg for the treatment of PAH.
- In April 2023, Mochida Pharmaceutical, a Japan-based leader in healthcare innovations, launched its Treprost inhalation solution for PAH, introducing the therapy to the Japanese market.
Key Players:
United Therapeutics Corporation, Actelion Pharmaceuticals, Bayer AG, Gilead Sciences, Inc., Merck & Co., Inc., GlaxoSmithKline plc, Pfizer Inc., Novartis International AG, Teva Pharmaceutical Industries Ltd., Amgen Inc., Bristol-Myers Squibb Company, Arena Pharmaceuticals, Sun Pharmaceutical Industries Ltd., Sandoz Inc., and Lupin Pharmaceuticals, Inc.
