Pulmonary Arterial Hypertension Market

Market Overview

The global pulmonary arterial hypertension market size was valued at USD 5.89 billion in 2022. It is estimated to reach USD 9.53 billion by 2031, growing at a CAGR of 5.50% during the forecast period (2023–2031). 

The rise in the incidents of Pulmonary Arterial Hypertension (PAH) and the growing geriatric population are the factors stimulating pulmonary arterial hypertension market growth. 

Pulmonary arterial hypertension is a rare and severe illness characterized by elevated blood pressure in the arteries supplying the lungs. It occurs when the pulmonary arteries, the small blood vessels in the lungs, become narrow, blocked, or damaged. This leads to increased pressure in these arteries, making the heart pump blood through the lungs harder. PAH can be categorized into different types, including idiopathic (no known cause), heritable (caused by genetic factors), and associated with other conditions like connective tissue diseases or congenital heart defects.

Symptoms of PAH can vary and may include shortness of breath, fatigue, chest pain, dizziness, fainting, and feet, legs, and stomach swelling. Over time, these symptoms may worsen and significantly impact a person's quality of life. PAH is a progressive disease that can result in complications such as right-sided heart failure, arrhythmias, blood clots in the lungs, and, in severe cases, death. Therefore, early diagnosis and treatment are vital for effectively managing the condition. Regular monitoring by a specialized healthcare team, including pulmonologists, cardiologists, and other specialists, is crucial for individuals with PAH. They can monitor the condition, adjust medications, and provide the necessary support. Lifestyle modifications, such as regular exercise, a balanced diet, and avoiding smoking and respiratory irritants, may also be recommended to manage the condition effectively.

Market Dynamics

Global Market Drivers

Incidents of Pulmonary Arterial Hypertension (PAH)

Pulmonary arterial hypertension (PAH) is indeed classified as a rare disorder, with a relatively low global prevalence of approximately 15 to 50 cases per million people. This means that in a given population, only a small number of individuals are diagnosed with PAH. Cumulatively, the number of new cases reported each year ranges from 100,000 to 200,000 worldwide. PAH can also occur in association with other underlying diseases. It is frequently viewed as a harmful lung and cardiac disorder. For instance, individuals with chronic obstructive pulmonary disease (COPD), interstitial lung disease, or pulmonary fibrosis have a higher risk of developing PAH.

Congenital heart disorders, such as atrial septal defect or ventricular septal defect, can also contribute to the development of PAH. Additionally, coronary artery disease, blood clots in the lungs, and high blood pressure can be underlying causes of PAH. It's important to note that while these conditions may increase the risk of PAH, not everyone with these factors will develop the disorder. The exact mechanisms by which these conditions lead to the development of PAH are still being studied.

Growing Geriatric Population

The presence of a large population over sixty years, which has lower immunity levels and is prone to PAH and associated diseases, is a high impact-rendering driver for the growth of the PAH market over the forecast period. Although the onset age for PAH is 45 years, it is frequently observed to occur in populations above 60 years of age. This population is expected to avail the best possible treatments, increasing the life span. The chart below forecasts the number of geriatric patients over the next six years who may form a routine target group contributing toward the increasing demand for PAH drugs. 

Healthcare professionals, policymakers, and the pharmaceutical industry need to recognize this trend and allocate resources accordingly to ensure the availability and accessibility of appropriate treatments for this population. By addressing the specific needs of the aging population and providing effective management of PAH, we can contribute to improved healthcare outcomes and enhanced quality of life for these individuals.

Global Market Restraint

Patent Expiration of Key Molecules

Loss of exclusivity has a direct impact on the market of branded pharmaceutical products. Also, with the Drug Price Competition and Patent Term Restoration Act of 1984, informally known as the Hatch-Waxman Act, the development of generic drugs is encouraged, which impacts the sale of branded molecules. The license expiry of some blockbuster drugs is making way for generic drug penetration. The increased sales of generic drugs adversely affect the overall revenue generation of the market since it is 70 to 80 percent cheaper as compared to branded drugs. Cutting-edge therapies are developed for treating PAH. Therefore, the future of the market is presumed to be brighter in the years to come.

Global Market Opportunity

Development of Drugs Stimulating Soluble Guanylate Cyclase (SGC)

The development of drugs stimulating soluble guanylate cyclase (SGC) represents a significant opportunity in the global pulmonary arterial hypertension market. Soluble guanylate cyclase is an enzyme involved in cyclic guanosine monophosphate (cGMP) production, which is crucial in regulating blood vessel dilation and maintaining vascular tone. In PAH, the production or response is deficient to cGMP, leading to vasoconstriction and increased blood pressure in the pulmonary arteries.

By targeting and stimulating soluble guanylate cyclase, drugs can enhance cGMP production, promoting vasodilation and reducing the elevated pulmonary artery pressure associated with PAH. The global market opportunity for SGC stimulators in PAH is significant, as there is a growing demand for more effective and targeted therapies for this rare disease. PAH is a chronic and progressive condition that requires lifelong management, and currently available treatments have limitations in terms of efficacy and tolerability.

Regional Analysis

Based on region, the global pulmonary arterial hypertension market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America is the most significant global pulmonary arterial hypertension market shareholder and is estimated to grow at a CAGR of 4.2% over the forecast period. The North American area, especially the United States, has greatly impacted, a big impact on the growth of the worldwide pulmonary arterial hypertension (PAH) market. The main thing that led to this growth is the well-developed healthcare infrastructure in the United States. This advanced infrastructure enables access to specialized healthcare services, advanced diagnostic tools, and innovative therapeutics for PAH patients. The availability of these resources has facilitated early diagnosis, effective management, and improved outcomes for individuals with PAH.

Additionally, the presence of reimbursement programs for PAH therapies in North America has been instrumental in supporting the market’s growth. These reimbursement programs help alleviate the financial burden associated with PAH treatments, making them more accessible to patients and healthcare providers. Another contributing factor is the growing awareness of PAH among healthcare professionals and the general population in North America. Increased awareness has improved diagnosis rates, with healthcare providers actively screening for PAH and individuals seeking medical attention for related symptoms. Early detection and intervention are crucial in managing PAH and preventing disease progression. Supportive government initiatives have also played a role in the growth of the North American PAH market. These initiatives aim to improve patient outcomes, enhance access to care, and promote research and development in the field of PAH. Such initiatives create a favorable environment for developing and adopting new therapies and technologies.

Europe is anticipated to exhibit a CAGR of 5% over the forecast period. Europe is another important part of the world’s pulmonary arterial hypertension (PAH) market. In 2020, Europe, followed by North America, held a substantial pulmonary arterial hypertension market share of around 21.1%. The European Medicines Agency and the European Society of Cardiology have played a vital role in shaping the guidelines for diagnosing and treating PAH in Europe. These guidelines provide healthcare professionals with standardized recommendations for managing PAH, ensuring consistent and effective care across the region.

Moreover, these agencies are actively involved in awareness initiatives to promote early and preventive diagnosis of PAH. These efforts aim to increase awareness among healthcare professionals and the general population about the signs, symptoms, and risk factors associated with PAH. By fostering early detection, these initiatives can lead to timely interventions and better patient outcomes. These initiatives and developments underscore the active engagement of pharmaceutical companies and regulatory authorities in addressing the unmet needs of PAH patients in Europe. Continued research, development, and awareness efforts are essential to effectively manage the growing burden of PAH in the region.

Asia Pacific will likely witness lucrative growth over the estimated period owing to increasing government initiatives and better healthcare infrastructure. Moreover, economic developments in countries like India and China are expected to help market growth. High population and low per capita income led to a rise in demand for affordable treatment options. MNCs are focused on investing in developing countries such as India and China. Thus, organizations in this region are undertaking many partnerships and strategic alliances. Rapid development in the Asia Pacific region, high population, and improving healthcare systems are anticipated to aid in the lucrative growth of the region.

The market in Latin America is forecasted to show gainful growth over the forecast period. Increasing government and per capita health spending and continual initiatives undertaken by the WHO are anticipated to boost the market growth in Latin America. The steadily increasing prevalence of obesity and Type-2 diabetes is expected to be a prominent market driver during the forecast period.

The Middle East and African countries are also expected to surge during the forecast period. Middle East and Africa together accounted for a market share of around 4.0% in 2015. The regional disease burden, increasing privatization, expanding health insurance penetration, and a desire to attract skilled healthcare providers have presented a good scenario for these devices in Middle Eastern countries. Countries like Saudi Arabia, Qatar, United Arab Emirates, Kuwait, and Oman are prospering economies, and advancements in the healthcare system are expected to increase the demand for PAH agents in this region. On the contrary, some countries in the African region lack adequate healthcare infrastructure, to address which the countries are taking initiatives to coordinate with the WHO or other independent organizations. This is expected to help this market to develop further.

Segmental Analysis

The global pulmonary arterial hypertension market is bifurcated into drug classes.

Based on drug class, the global pulmonary arterial hypertension market is bifurcated into prostacyclin and prostacyclin analogs, SGC stimulators, ERA, and PDE-5. 

The prostacyclin and prostacyclin analogs segment dominates the global market and is projected to exhibit a CAGR of 4.2% over the forecast period. Prostacyclin is a potent vasodilator and one of the most effective drugs for treating PAH. It is produced from arachidonic acid through the Cyclooxygenase (COX) pathway and is released by endothelial cells in the pulmonary artery. Prostacyclin binds to the prostaglandin receptors to promote the relaxation of smooth muscles and vasodilation by activating G protein and protein kinase. Prostacyclin levels are reduced in PAH patients, reducing dilatory and antiproliferative effects.

Prostacyclin analogs and IP receptor agonists have been approved to target the prostacyclin pathway in PAH patients. Iloprost (Ventavis), Epoprostenol (Flolan and Veletri), and Treprostinil (Remodulin, Tyvaso, and Orenitram) are some of the drugs from this category approved for use in PAH patients. Drugs from the prostacyclin and analogs segment are expected to rise significantly over the anticipated period, primarily due to the opportunities presented in the oral prostacyclin subsegment (e.g., Uptravi and Orenitram).

Recent Developments

• March 2023- United Therapeutics Corporation announced the approval of its new drug, Tyvaso DPI, for treating PAH. Tyvaso DPI is a dry powder inhaler that delivers Treprostinil, a prostacyclin analog drug. Prostacyclin analogs are a class of drugs that are effective in treating PAH.
• February 2023- Bayer AG announced the acquisition of MyoKardia, Inc., for $1.6 billion. MyoKardia is a clinical-stage biopharmaceutical company developing a new mavacamten drug to treat PAH. Mavacamten is a cardiac myosin inhibitor that has been shown to improve exercise capacity and quality of life in patients with PAH.