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Stakeholder Perspectives: Pulmonary Arterial Hypertension - A small market gets big attentionPublished by: Datamonitor Published: Feb. 1, 2006 - 59 Pages Table of ContentsTABLE OF CONTENTS CHAPTER 1 EXECUTIVE SUMMARY 3 CHAPTER 2 PULMONARY ARTERIAL HYPERTENSION OVERVIEW 11 Pulmonary arterial hypertension background 11 Pulmonary arterial hypertension is a deadly disease 12 Epidemiology 12 Idiopathic pulmonary arterial hypertension rates support market estimates 12 An estimated 146,000 patients in US, Europe, and Japan 13 Pulmonary arterial hypertension severity is segmented into four classes 14 Presentation and diagnosis of pulmonary arterial hypertension 15 Breakdown by class 16 Current treatment of pulmonary arterial hypertension 17 Three approved drug classes have improved outlook for patients. 17 Unmet need in pulmonary arterial hypertension management 18 Efficacy, improved delivery, and reduced costs linked needs in treatment 18 Combination therapy unproven, but growing in popularity 19 Increased awareness needed, particularly for oral therapy success 19 Greater understanding of patient population required 20 CHAPTER 3 CURRENT PULMONARY ARTERIAL HYPERTENSION THERAPIES 21 Tracleer (bosentan) 21 BREATHE-1 trial data forms basis for approval 22 Bosentan has also been supported by several other BREATHE studies 23 Datamonitor comment 23 Flolan (epoprostenol sodium) 24 Pivotal study, follow-up studies, show survival benefit 24 Datamonitor comment 25 Remodulin (treprostinil) 27 Bioequivalence data used for intravenous extension 28 Phase IV clinical study data looks promising 28 Datamonitor comment 29 Ventavis (iloprost) 31 Clinical trial data 32 Datamonitor comment 33 Revatio (sildenafil) 33 Clinical trial data 34 Cost of Revatio 34 Datamonitor comment 35 Benchmarking therapies 36 CHAPTER 4 PULMONARY ARTERIAL HYPERTENSION THERAPIES IN DEVELOPMENT 38 Thelin (sitaxsentan) 38 Clinical data supports benefit 39 Datamonitor comment 40 Ambrisentan 41 Clinical data points to potential class winner 42 Datamonitor comment 43 Tadalafil 44 Datamonitor comment 44 Inhaled treprostinil 45 Oral treprostinil also holds considerable promise 46 Datamonitor comment 47 Aviptadil 48 Datamonitor comment 48 Other early stage therapies 49 UK-369003 49 ABT-306552 49 PRX-08066 49 PulmoLAR 50 Gleevec (imatinib) 50 CHAPTER 5 PULMONARY ARTERIAL HYPERTENSION MARKET FORECAST 51 Oral therapies forecast assumptions 51 Prostacyclin forecast assumptions 53 Timings of pulmonary arterial hypertension launches 54 PAH market forecasts, 2005-2014 55 APPENDIX 57 About Datamonitor 57 About Datamonitor Healthcare 57 Disclaimer 59 LIST OF TABLES Table 1: Estimated PAH prevalence, US, Europe, and Japan, 2005 14 Table 2: Current breakdown of presenting PAH patients, by severity 16 Table 3: Currently available PAH therapies and 2004 sales 21 Table 4: Timeline of product launches and other key regulatory events 54 Table 5: US PAH market forecast, $m, 2005-2014 55 Table 6: Global PAH market forecast, $m, 2005-2014 56 LIST OF FIGURES Figure 1: ProDose (top) and I-neb AAD systems (bottom) 31 Figure 2: Position of currently available therapies, by disease severity 36 Figure 3: Comparative strengths and weaknesses of PAH therapies, including late-stage therapies 37 AbstractIntroductionDatamonitor 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 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 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 patient Despite 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 decade Actelion'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 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 Get Full Details About This Report >> |
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