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M&A in pharma

Explores the merits of mega-deal in contrast to a more measured portfolio growth strategy

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

 

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 

Benedek Tanya