Stakeholder Perspectives: Pulmonary Arterial Hypertension

Summary

This report expects the global pulmonary arterial hypertension (PAH) market to grow from $636m in 2004 to just over $2 billion by 2014, as new product and formulation launches in the US and a healthy late-stage pipeline drive sales growth. With this increased interest, combined with increased awareness and R&D activity, treatment for this orphan disease is set to enter a new era

Highlights

PAH is a rare condition with an estimated 146,000 sufferers across the US, EU and Japan. However, despite this low patient population, this market has attracted R&D investment due to the high unmet needs and high treatment values per patientDespite low patient numbers, it is estimated that up to 75% of these patients are not recognized and treated with therapy, creating significant room for growth in the number of patients treated with PAH therapies over the next decadeActelion's Tracleer, the first oral therapy approved by the FDA in 2001, will come under significant competitive pressure over the next three years. With approval for Encysive's Thelin expected in March 2006 and Myogen's ambrisentan expected to launch in 2007, an intense marketing battle is expected as each company fights for market share

Scope

• Comprehensive analysis of the attractiveness of the PAH market based on epidemiology, unmet needs, R&D activity and potential revenue
• Analysis of clinical trial data and market potential of the recently launched PAH specific therapies and compounds in late stage development
• Detailed comparative analysis of all PAH specific compounds in terms of efficacy, drug delivery, target audience and cost
• In-depth profiles of current treatments, including PAH specific and non-PAH specific compounds

Reasons to Purchase

• Assess the attractiveness of the PAH market for R&D investment and/or in-licensing activity
• Gain insight into the current challenges and commercial opportunities associated with this devastating disease
• Access key opinion leader views on the relative merits and weaknesses of current and future treatments for PAH, and the unmet needs therein

Contents

• Chapter 1 Executive Summary
• Chapter 2 Pulmonary Arterial Hypertension Overview
  • Pulmonary arterial hypertension background
  • Pulmonary arterial hypertension is a deadly disease
  • Epidemiology
  • Idiopathic pulmonary arterial hypertension rates support market estimates
  • An estimated 146,000 patients in US, Europe, and Japan
  • Pulmonary arterial hypertension severity is segmented into four classes
  • Presentation and diagnosis of pulmonary arterial hypertension
  • Breakdown by class
  • Current treatment of pulmonary arterial hypertension
  • Three approved drug classes have improved outlook for patients.
  • Unmet need in pulmonary arterial hypertension management
  • Efficacy, improved delivery, and reduced costs linked needs in treatment
  • Combination therapy unproven, but growing in popularity
  • Increased awareness needed, particularly for oral therapy success
  • Greater understanding of patient population required
• Chapter 3 Current Pulmonary Arterial Hypertension Therapies
  • Tracleer (bosentan)
  • BREATHE-1 trial data forms basis for approval
  • Bosentan has also been supported by several other BREATHE studies
  • Datamonitor comment
  • Flolan (epoprostenol sodium)
  • Pivotal study, follow-up studies, show survival benefit
  • Datamonitor comment
  • Remodulin (treprostinil)
  • Bioequivalence data used for intravenous extension
  • Phase IV clinical study data looks promising
  • Datamonitor comment
  • Ventavis (iloprost)
  • Clinical trial data
  • Datamonitor comment
  • Revatio (sildenafil)
  • Clinical trial data
  • Cost of Revatio
  • Datamonitor comment
  • Benchmarking therapies
• Chapter 4 Pulmonary Arterial Hypertension Therapies In Development
  • Thelin (sitaxsentan)
  • Clinical data supports benefit
  • Datamonitor comment
  • Ambrisentan
  • Clinical data points to potential class winner
  • Datamonitor comment
  • Tadalafil
  • Datamonitor comment
  • Inhaled treprostinil
  • Oral treprostinil also holds considerable promise
  • Datamonitor comment
  • Aviptadil
  • Datamonitor comment
  • Other early stage therapies
  • UK-369003
  • ABT-306552
  • PRX-08066
  • PulmoLAR
  • Gleevec (imatinib)
• Chapter 5 Pulmonary Arterial Hypertension Market Forecast
  • Oral therapies forecast assumptions
  • Prostacyclin forecast assumptions
  • Timings of pulmonary arterial hypertension launches
  • PAH market forecasts, 2005-2014
• Appendix
  • About Datamonitor
  • About Datamonitor Healthcare
  • Disclaimer
• List Of Tables
  • Table 1: Estimated PAH prevalence, US, Europe, and Japan, 2005
  • Table 2: Current breakdown of presenting PAH patients, by severity
  • Table 3: Currently available PAH therapies and 2004 sales
  • Table 4: Timeline of product launches and other key regulatory events
  • Table 5: US PAH market forecast, $m, 2005-2014
  • Table 6: Global PAH market forecast, $m, 2005-2014
• List Of Figures
  • Figure 1: ProDose (top) and I-neb AAD systems (bottom)
  • Figure 2: Position of currently available therapies, by disease severity
  • Figure 3: Comparative strengths and weaknesses of PAH therapies, including late-stage therapies