Global Market for Sleep-Wake Disorders, 2005-2012, The

Summary

The market for sleep-wake disorders is expanding based on new indications and novel drugs which offer efficacious sleep solutions and wake-promoting effects while limiting adverse side effects that are associated with conventional drugs. in a global market estimated at US$4.3 billion and forecast to increase 158% to US$11 billion by 2012, drugs for sleep-wake disorders such as insomnia, excessive daytime sleepiness, shift-work sleep disorder, sleep apnoea, and restless legs syndrome are predicted to transform the market to a high-value CNS therapy area within a decade. Furthermore, new therapies in the pipeline that provide complete sleep solutions to patients with impaired sleep-wake rhythms or drugs that improve wakefulness in occupational settings will offer new market opportunities and treatment options.

Trailblazer Cephalon has been integral in expanding the wake-promotion sector with Provigil and has stimulated the market to develop more drugs for conditions such as sleep apnoea, occupational shift-work disorders, and delayed-phase circadian rhythm disorders. despite an optimistic outlook, immediate challenges in the market include short-term saturation in the insomnia therapy area as three new products were recently approved, namely Ambien CR, Lunesta, and Rozerem, with up to four further drugs expected to be approved and launched over the next 18 months including Indiplon, Gaboxadol, Doxepin, and Posidorm. in view of expanded product choice companies will need to adopt aggressive marketing approaches and utilize key therapeutic differentiators to claim market share for their products. However, the majority of sleep-wake disorders are underdiagnosed or misdiagnosed which indicates a significant market opportunity for manufacturers to redefine marketing strategies to optimize revenues for their products. This report comments on strategic and commercial issues that may affect current product positioning and discusses key compounds that have the potential to become high-value products over the next decade. The report also provides insights into forthcoming market dynamics and product sales to 2012 to enable the reader to make assumptions about future markets and prospects, and utilize the data for proprietary predictive market modelling.

Report Highlights and Key Findings

• The current market for sleep-wake disorders is valued at US$4.3 billion, which is forecast to increase 158% CAGR to US$11 billion by 2012
• Critical analysis of insomnia, excessive daytime sleepiness, narcolepsy, sleep apnoea, shift-work sleep disorder, and restless legs syndrome
• Review of epidemiological, aetiological, and demographic data for sleep-wake disorders
• Analysis of over 10 key marketed products and inclusion of 30 R&D candidates identified in preclinical to clinical stages of development for sleep-wake disorders
• Sales estimates (US$) to 2012 for major therapy areas
• Strategic insights for life-cycle optimization and product development
• Critical evaluation of leading sleep-wake disorder pharmacotherapies
• Trend analysis of industry events and activities over past 2 years
• Detailed R&D themes and clusters by therapy area
• Data generation on sector and market values between 2004 and 2012 and therapy forecasts by 2020 (US$)
• High revenue-yielding prospects identified with projected sales estimations
• R&D pipeline positioning for novel candidates
• Market insights for product development and drug promotion

Contents

• Executive Summary
• Objectives of the Report
• Research Methodology
• Chapter 1 Introduction to Sleep-Wake Disorders
  • Sleep Disorders
  • Insomnia
  • Prevalence of Insomnia
  • Causes of Insomnia
  • Restless Legs Syndrome
  • Prevalence of Restless Legs Syndrome
  • Circadian Rhythm Sleep Disorders
  • Delayed Sleep Disorders
  • Shift-Work Sleep Disorder
  • Jet-Lag Sleep Disorders
  • Excessive Daytime Sleepiness and Narcolepsy
  • Narcolepsy
  • Prevalence of Narcolepsy
  • Neurobiological Basis to Narcolepsy
  • Treatments for Narcolepsy
  • Sleep Apnoea
  • Obstructive Sleep Apnoea
  • Prevalence of Obstructive Sleep Apnoea
  • Therapeutics for Sleep Apnoea
• Chapter 2 The Market for Sleep-Wake Disorders
  • Sleep-Wake Disorders
  • Market Overview for Sleep-Wake Disorders
  • Insomnia
  • Wake-Promotion
  • Restless Legs Syndrome
  • Market Analysis for Sleep-Wake Disorder Drugs
  • Insomnia
  • Market Analysis for the Insomnia Pharmacotherapies
  • Key Insomnia Drugs
  • Ambien/Stilnox/Stilnoct/Myslee (Zolpidem) - Sanofi-Aventis
  • Mechanism of Action
  • Efficacy
  • Reformulation
  • Sales Estimates
  • Commercial Outlook
  • Halcion (Triazolam) - Pfizer
  • Mechanism of Action
  • Reformulation
  • Sales Estimates
  • Commercial Outlook
  • Lunesta (Eszopiclone) - Sepracor
  • Mechanism of Action
  • Sales Estimates
  • Commercial Outlook
  • Rozerem (Ramelteon) - Takeda Pharmaceuticals
  • Mechanism of Action
  • Efficacy
  • Sales Estimates
  • Commercial Outlook
  • Sonata (Zaleplon) - Wyeth/King Pharmaceuticals
  • Mechanism of Action
  • Efficacy
  • Reformulation
  • Sales Estimates
  • Commercial Outlook
  • Premarket Focus - Late-Stage Development Drugs for Insomnia
  • Indiplon - Neurocrine Biosciences/Pfizer
  • Mechanisms of Action
  • Formulation Development
  • Efficacy
  • Commercial Prospects
  • Gaboxadol - Lundbeck/Merck & Co
  • Mechanisms of Action
  • Efficacy
  • Commercial Prospects
  • Other Pipeline Drug Candidates for Insomnia
  • Silenor (Doxepin) - Somaxon Pharmaceuticals
  • Posidorm - Alliance Pharma
  • Future Considerations and Market Outlook for the Insomnia Drug Market
  • Wake-Promotion
  • Narcolepsy/Excessive Daytime Sleepiness
  • Market Analysis for Key Drugs for Narcolepy/Excessive Daytime Sleepiness
  • Provigil (Modafanil) - Cephalon
  • Mechanism of Action
  • Efficacy
  • Supplementary Indications
  • Reformulation
  • Sales Estimates
  • Commercial Prospects
  • Xyrem (Sodium oxybate) - Orphan Medical/Jazz Pharmaceuticals
  • Efficacy
  • Side Effects
  • Sales Estimates
  • Commerical Prospects
  • Future Considerations and Market Outlook for Wake-Promoting Drugs
  • Restless Legs Syndrome
  • Requip/Adartrel/Repreve (Ropinirole) - GlaxoSmithKline
  • Mechanisms of Action
  • Efficacy
  • Sales Estimates
  • Commercial Outlook
  • Drugs in Development for Restless Legs Syndrome
  • Premarket Focus: Pramipexole - Boehringer Ingelheim
  • Efficacy
  • Commerical Prospects
  • Sleep Apnoea - An Emerging High-Growth Sector
  • Obstructive Sleep Apnoea-Hyponoea Syndrome - An Underdiagnosed
  • Problem
  • Commercial Insights
  • Pipeline Focus
  • BTG/University of Illinois at Chicago
  • Organon/Cypress Bioscience
  • Future Considerations and Market Insights for Drugs to Treat Sleep
  • Disorders
• Chapter 3 Drugs in Research and Development
  • Sleep-Wake Disorders
  • Research and Development Overview
• Chapter 4 Market Analysis, Therapy Forecasting, and Prospect Mining
  • Sleep-Wake Disorders
  • Therapy Area Forecasts
  • Comparative Analysis: Sleep-Wake Disorder Product Sales
  • Prospect Mining
  • Sleep-Wake Disorder Prospects
  • Therapy Area Forecasts 2012 and 2020
• Chapter 5 Report Synopsis
  • Sleep-Wake Disorders - Key Data Points
  • Bibliography and Reference Sources
  • Table 1.1 Insomnia Categorized by Duration of Symptoms
  • Table 1.2 Causes of Insomnia
  • Table 1.3 Symptoms of Narcolepsy
  • Table 1.4 Medical and Surgical Treatment Options for Sleep Apnoea
  • Table 2.1 Estimated Global Sales (US$) & Forecasts of Leading Drugs for Sleep-Wake Disorders, 2004-2012
  • Table 2.2 Marketed Drugs to Treat Insomnia, 2005
  • Table 2.3 Drugs in Development for Restless Legs Syndrome, 2005
  • Table 3.1 Drugs in Development for Sleep-Wake Disorders, 2005
  • Table 4.1 Global Market for Sleep-Wake Pharmacotherapies (US$m), 2004-2012
  • Table 4.2 Therapy Area Forecasts for Sleep-Wake Disorders, 2012 & 2020
• List of Figures
  • Figure 2.1 Estimated Sales (US$) and Forecasts of Sleep-Wake Disorder Drugs Segmented by Therapeutic Area, 2004-2012
  • Figure 2.2 Estimated Global Market Share of Sleep-Wake Disorder Drugs by Therapy Area, 2005 & 2012
  • Figure 4.1 Sleep-Wake Disorder Therapy Area Forecasts, 2005 & 2012 (US$m)
  • Figure 4.2 Comparative Analysis of Leading Sleep-Wake Disorder Products, 2004-2012 (US$m)
  • Figure 4.3 Key Sleep-Wake Disorder Drug Prospects, 2005