Market Overview, Key in-line Products, Market Share Distribution, Competitive Dynamics, Regulatory Outlook, Pipeline Development, Growth Catalysts & Challenges, Leading Market & R&D Trends, Partnership & Deals Analyses, Global Sales forecast of in-line and pipeline products, Fast Growing Private Companies, Management Perspectives, Commentaries, Market Outlook & Summary Conclusions
Global Pulmonary Arterial Hypertension (PAH) market was valued at $5.0bn in 2015 and is forecast to grow at a modest 6.0% CAGR between 2015 and 2024, to result in 2024 global sales of $9.0bn.
PAH is broadly split into two classes, primary or secondary. Primary pulmonary hypertension (PPH) refers to pulmonary hypertension occurring without an identifiable cause. Secondary pulmonary arterial hypertension (PAH) occurs in association with some other identifiable medical condition.
Primary pulmonary hypertension (PPH) is estimated has an estimated worldwide patient population of 8,000-10,000. Secondary pulmonary arterial hypertension (PAH) is more prevalent, with an estimated worldwide incidence of greater than 100,000.
The exact etiology of pulmonary hypertension is not well understood although a genetic linkage has been identified. PPH occurs most commonly in young adult females and has no obvious related disorder. Recently, the familial form of PPH has been linked to a mutated form of the bone morphogenic protein receptor-2 (BMPR2) gene.
U.S. Pulmonary Arterial Hypertension Market, By biochemical pathways, 2013 - 2024 (USD Million)
PAH patients’ population is slowly increasing, likely due to increased awareness of the disease. With a number of companies actively promoting therapies in the decade, physicians think that their colleagues, particularly at community centers, have become better at recognizing and diagnosing the condition. This has led to an increase in the rate of referrals to PAH expert centers.
There are three major biochemical pathways that have been shown to be associated with PAH: the endothelin pathway, nitric oxide pathway, and prostacyclin pathway. These pathways play a critical role in the regulation of vascular tone and their dysregulation results in vasoconstriction and pulmonary smooth muscle cell proliferation.
Despite the relatively small number of patients afflicted, the market for pulmonary hypertension treatment is actually quite large in value terms. Infused and inhaled prostanoids can demand $100,000+ in the annual cost of treatment. With approximately 110,000 patients worldwide, and perhaps 50,000+ patients in the U.S. alone, worldwide sales for PAH therapies approached ~$5.0bn in 2015. We project worldwide sales of PAH drugs to grow at a CAGR of 6.0% from 2015 to 2024.
“Cost of PAH Treatment”
The estimated annual cost of treatment for PAH remains at $120,000 globally. However, with growth in diagnosis, market access, and patient support program, OPP and Range of Acceptable Prices (RAP) are going to change. We at Optima Insights continuously track these prices with our proprietary pricing model.
“Treatment Algorithm for PAH Patients”
Right-sided heart catheterization (RHC) is generally used to establish the hemodynamic criteria to arrive at a diagnosis for PAH. If PAH is confirmed at an expert center, then an acute vasoreactivity test is conducted to identify a small number of PAH patients (< 15%) that are vasoreactive and can be successfully treated with high dose calcium channel blockers like nifedipine, diltiazem, and amlodipine. All of these drugs are available as generics. A majority of diagnosed PAH patients, however, are non-vasoreactive and thus their treatment sequence is determined by their WHO functional classification.
"Bayer, Pfizer, United Therapeutics are some of the key players for Pulmonary Arterial Hypertension Treatment market"
Key players include Actelion Pharmaceuticals, Arena Pharmaceuticals, Bayer, Gilead Sciences, GSK, Merck, Pfizer, Reata Pharmaceuticals., SteadyMed, United Therapeutics, & Teva among others. The companies are focused on deals & alliances with a goal to expand the product portfolio. For instance, Actelion gained U.S. rights to Ventavis through its 2007 acquisition of CoTherix. Ventavis sales have been modest due to competition from Tyvaso, the second inhaled therapy for PAH. There are currently thirteen drugs indicated for the treatment of PAH in the U.S.
United Therapeutics believes this patient volume can support at least $1.0bn in Orenitram sales. Our consultants agree with the FDA that Orenitram is safe and effective. They note that it is potent and sufficiently well tolerated in these patients.
Our analysts indicated that as of July 2015, ~1,000 patients were on drug or awaiting reimbursement approval. This was an increase from ~800 patients in April 2015. The majority of patients (~70%) are switching from other oral therapies or Tyvaso and are therefore systemic treprostinil naïve.
Among Medicare enrollees in the US, 117 in 495 (23.6%) patients with PAH with readmission were readmitted within 30 days of discharge from their initial hospitalization, the time period over which Medicare assesses readmissions to determine reimbursement reduction to penalize excessive readmission.
Data Collation (Primary & Secondary)
In-house Estimation (Based on proprietary databases and Models)
Market-related information is assembled from both primary and secondary sources.
Primary sources involved participants from all global stakeholders such as experts from several related industries and suppliers that have been interviewed to obtain and verify critical information as well as to assess prospects of the market. The participants included are CXOs, VPs, and managers. Plus, our in-house industry experts having decades of industry experience contribute their consulting and advisory services.
Secondary sources include public sources such as regulatory frameworks, government IT spending, government demographic indicators, industry association statistics, and company publications annual reports press releases along with paid sources such as Factiva, OneSource, Bloomberg among others.
Top-down and bottom-up approaches: The overall market size was used in the top-down approach to estimate the sizes of other individual submarkets (mentioned in the market segmentation by product, type of manufacturing, and disease) through percentage splits from secondary and primary research. The bottom-up approach was also implemented (wherever applicable) for data extracted from secondary research to validate the market segment revenues obtained.