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

Trends, Opportunities, and Insights in a High-Value CNS Therapy Area

Publication Date   December 2005
Publisher   Spectra Intelligence
Product Type   Report
Pages   78
ISBN Number   not applicable
Product Code   SPE004
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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.

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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

  • Content


    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

    List of Tables

    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