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Pulmonary Arterial Hypertension (PAH) - Market Outlook and Competitive Landscape 2015 - 2030

05-28-2019 06:34 PM CET | Health & Medicine

Press release from: Thelansis Knowledge Partners

Market insight report on PAH

Market insight report on PAH

Report Overview
 The report provides a comprehensive view of disease events, types, severity, progression, symptoms, risk factors, pathogenesis and treatment guidelines at country level
 Comprehensive insight on patient segmentation has been provided into the epidemiology of the Pulmonary Arterial Hypertension (PAH) and its treatment in the 8 MM countries, covering the United States, EU5 (Germany, Spain, France, Italy, UK), Japan, and China
 Drug utilization and analysis on the current clinical practice, KOL perspective on upcoming therapies, estimated TPP for pipeline assets, clinical characteristics upcoming therapies and future treatment paradigm
 Market aggregation on a newly diagnosed patient pool, Thelansis estimation on persistence, compliance, adherence and a historic view of changing market dynamics and product-level patient flow of Pulmonary Arterial Hypertension (PAH) in the 8 MM Countries for the period 2015-2030
 A comprehensive record of both the present and rising treatments for PAH are provided, along with the impact of the new treatments and patent expiry on the current clinical practice and overall market level
 A detailed review of 8MM current and forecasted PAH market is included in the report, covering drug outreach in the 8 MM Countries based on their order of entry

Clinical Overview:
 Pulmonary hypertension (PH) is a hemodynamic and pathophysiological condition defined as an increase in mean pulmonary arterial pressure ≥ 25 mmHg at rest as assessed by right heart catheterization (RHC). While the progression of PH is highly variable, the disease is progressive and fatal in nature
 The clinical classification of PH categorizes multiple clinical conditions into five groups according to their similar clinical presentation, pathological findings, and hemodynamic characteristics. These are referred to different WHO functional classes
 Median word-wide survival for patients with primary PH is of 2.8 years and the survival rates at 1 and 3 years were observed to be 68% and 48%, respectively. However, the median survival is a little more for the US and EU-5 countries

Commercial Overview:
 PAH is an orphan indication with high competitive activity in the market and in pipeline alike. Janssen alone has two blockbuster products for PAH namely Opsumit and Uptravi
 The total market for PAH in 2019 stands >$5B WW among which 68% revenues are generated from the US alone
 From a regulatory perspective, data on mortality endpoints and reduced risk of hospitalization can provide an edge to the label. Historically products have got approval based on improvements in 6MWD and mPAP
 From a pricing and reimbursement perspective, the approved therapies in PH command a premium pricing. While coverage from payers is good in the US, EU follows a more policy stringent pathway for a few countries. Due to the genericization of the market, pharmacy benefit managers also play a key role in medication access

Epidemiology
 With reference to the study “Prevalence of Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension in the United States” by Noam Y et al. Prevalence of Pulmonary Arterial Hypertension was observed to be 109 per million individuals (PMI) among the population of fewer than 65 years old. Prevalence of Pulmonary Arterial Hypertension was found to be 451 per million individuals (PMI) among age-groups older than 65 years
According to Pulmonary Hypertension Association Registry (PHAR) in the United States, Pulmonary Arterial Hypertension associated with Connective Tissue Disease is the most common and which accounts for approximately 38% of patients with Pulmonary Arterial Hypertension. The most commonly reported subtype of PAH in adult patients is IPAH, followed by PAH associated with concomitant diseases such as CTD, CHD. Depending on the registry, the proportions range from 35% to 63% for IPAH, 10% to 30% for CTD-PAH, 10% to 20% for CHD-PAH and 5% to 10% for portopulmonary hypertension-PAH
 According to Thelansis, ~ XXX patients are being diagnosed and treated worldwide with Pulmonary Arterial Hypertension (PAH) among which 8MM countries are comprised of ~XX% of the total yearly reported cases
 Total prevalent population of Pulmonary Arterial Hypertension (PAH) in the USA ranges between 50,384 in 2015 to 66,150 in 2030
 Diagnosed prevalent population of PAH in 8MM is expected to increase at a CAGR of 1.73% for the study period i.e. 2015 - 2030
 In terms of epidemiology trend, the annual incidence was observed to be increasing from 24.1 to 28.7 cases/100 000 population in the US from 2005 to 2017. In the EU, the incidence was XX.X/100,000 population in 2005 which increased at the rate of X.X% to XX.X/100,000 population in 2017
 The estimates suggest a higher diagnosed prevalence of Pulmonary Arterial Hypertension (PAH) in China followed by the United States with 27,384 in 2015 to 38,480 in 2030
 Among the European countries, Germany had the highest prevalent population of PAH with XXXXX cases, followed by France which had a prevalent population of XXXX in 2015. On the other hand, Spain had the lowest diagnosed prevalent population of XXXXX in 2015. Japan XXXXX prevalent cases of Pulmonary Arterial Hypertension in 2018
 Considering the country level perspective the EU5 are contributing around ~33% of the total diagnosed patient pool, however, in terms of market USA is leading considering the current disease burden and treatment cost

Current therapies:
 The current therapeutic landscape for approved therapies is dominated by Janssen (acquired portfolio from Actelion). Their PAH portfolio includes ERAs (macitentan, bosentan), PCs (selexipag, Iloprost, epoprostenol), While bosentan is now generic, Actelion has been largely successful in transitioning the patients from bosentan to macitentan (Opsumit). Macitentan is now eyeing a line extension in CTEPH. It is expected that Actelion will get approval for macitentan in CTEPH in Europe by H2’2019
 Other players are Bayer and United Therapeutics which have brands like Adempas (riociguat) and treprostinil portfolio respectively, Generic PDE5i including sildenafil and tadalafil also prescribed to PAH patients predominantly in the eastern hemisphere of the word vs the west

Emerging therapies:
 The PAH market landscape is pretty crowded with multiple therapies approved and many more in the pipeline, The therapies majorly fall under three categories of mechanisms which are Endothelin Receptor Antagonists (ERAs), Prostacyclin Analogs (PCs) and Nitrous Oxide Stimulants (NO). The NO pathway further includes medications working on the inhibition of PDE5 or soluble guanylate cyclase (sGC) stimulators
 One of the major unmet need in PAH is the lack of curative therapy. Several companies are coming up with innovative molecules like Acceleron Pharma’s sotatercept which acts on growth differentiation factor
 Several big pharma is also aiming at the market such as Novartis which is developing an inhaled prostacyclin QCC374
 PAH market is also populated by several treprostinil formulations which are largely provided by United Therapeutics. Some new entrants are also coming up with their treprostinil formulations such as Liquidia’s LIQ-861 which is an inhaled dry powder formulation of treprostinil
 United Therapeutics is also investigating gene therapy for PAH, however, as per Thelansis’ research, the likelihood of approval for that gene therapy is not very high
 PAH market is now moving more and more towards upfront dual and triple combinations which combine several mechanisms like ambrisentan + tadalafil from GSK which combines ERA and PDE5i mechanisms

KOL perspective:
“…...…..Emerging therapy needs to address the symptoms or associated conditions that have the greatest impact on the daily life of Patients such as shortness of breath and fatigue, followed by dizziness and swelling of the legs and ankles………….” (Pulmonary Medicine, Jefferson University Hospitals)

“…...…..Orthostatic intolerance, heart palpitation, chest pain, and PAH-triggered tiredness are the common challenges and concern to manage for on clinical practitioners in case of elderly patients; combination therapy needs to be introduced to address such conditions…………...” (Academic & Researcher, Division of Pulmonary & Critical Care Medicine, Stanford University School of Medicine )

“…………...A standardized treatment guideline to be enforced which will state the drug regimen to be prescribed as a combination therapy in ICU patients…………...” (Cardiologist,  Frankel Cardiovascular Center, University of Michigan)

“………..The current clinical classification and treatment guidelines have helped improve the standardization of PAH care in the clinical setting, however, there is huge knowledge gap among clinical practitioners needs to be addressed going forward……………..” (Cardiologist & Pulmonary Medicine, Frankel Cardiovascular Center, University of Michigan)

Payer’s perspective:
 From the payer’s perspective majorly focused on cost savings as both at public and private payer entities are seeking methods to reduce PAH related expenditures. The treatment of Pulmonary Arterial Hypertension (PAH) has changed dramatically since a few years. The payer’s and reimbursement agencies more concern about strong clinical outcomes data which have great evidence on managing the symptomatic conditions including quality of life
 The European nations regulatory bodies and payers are having a very conservative mindset with respect to the approval and access of non-potential assets, which will raise the country level disease burden as well as the treatment cost in coming years. Apart from cost, payers have also concerned the continuous recommendation of services (e.g., therapies or diagnostic tests) that have not demonstrated improvements in the outcomes that matter to patients

Thelansis, as the name depicts Thelansis is specialized in “Therapy Area Landscape Analysis” along with market intelligence and consultancy that supports pharmaceutical, biotechnology, and diagnostics companies to successfully prepare, launch, and commercialize their products. Our Syndicated research reports include Market Insight, Pipeline Insight, Product Insight, Specialized Reports, Indication Outlook, and Market Access Reports. Our focused therapeutic approach provides our clients with clinical and disease area expertise from an integrated team of academic, medical, and industry specialists of our panel, Ask for our report offerings, and Indication specific sample pages by sharing your email ID with us at,
clientsupport@thelansis.com

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