Market Report Source

Overview

Introduction
Datamonitor 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

Table of Contents

TABLE OF 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