CNS Drug Discoveries: Sleep Disorders Chapter

SUMMARY

This chapter of CNS Drug Discoveries focuses on the developments in the insomnia market and the substantial changes beginning to take place.

The insomnia market is a maturing market and we believe the landscape will change dramatically over the next five years as the market enters a transition phase and becomes more fragmented. We forecast it will grow to nearly US$6 billion by 2012 driven by a number of factors including the launch of new formulations, new drug classes, patient dynamics (ageing patient population) and changes in the way insomnia is treated.

Sleep disorders cover a range of problems, the best known types being insomnia, sleep apnoea and restless legs syndrome. Insomnia is the most prevalent sleep disorder and it is estimated to affect over 37 million US citizens and over 100 million people worldwide with approximately 25% of elderly people and 15% of the general population suffering from the condition. Studies suggest that less than 20% of insomniacs seek help and less than 20% of sufferers are prescribed a medication from their doctor.

Global insomnia market Approximately US$2.4 billion is currently spent on hypnotics and sedatives in the treatment of insomnia, the 10th largest segment of CNS drug sales. The global market for insomnia drugs is unevenly distributed. In 2005, the US insomnia market accounted for 66% of the global market compared to 24% in Europe and 10% in the rest of world (largely Japan). This is mainly due to the pricing differential between the European and the US market.

GABA-A receptor agonists (non-benzodiazepines) continue to remain the cornerstone for the treatment of both acute and chronic insomnia. However, the launch of several new products over the next 3 years will help to increase patient awareness, particularly in the elderly.

TABLE OF CONTENTS

INSOMNIA

• EXECUTIVE SUMMARY
• THE FACTS
  • What is insomnia and why are we interested in it?
• PATIENT STATISTICS
  • Summary of insomnia patient population in top 5 European countries
• PATIENT MODEL
  • The addressable insomnia market will have a CAGR 2005-2012 = 5.9%
    • Patient population and sub-types of insomnia
    • Summary of patient population (for top seven countries) forecasts
• DRUG GROWTH DRIVERS
• DRUG GROWTH RISKS/DAMPNERS

GLOBAL INSOMNIA MARKET

• Global CNS Market (US$68.7 billion)
• GLOBAL SALES SPLIT
  • US market
    • Insomnia US drugs sales split (2005A)
  • European market
    • Insomnia European drugs sales split (2005A)
  • Japanese market
    • Insomnia Japanese drugs sales split (2005A)
  • The major players
    • Market share of insomnia players by sales (Dec 2005A)
  • Players and Products in 2005
  • Players and Products in 2012
    • Market share of insomnia players by sales (Dec 2012E)
• CURRENT TREATMENTS
  • Leading Brands
    • Comparison of Leading Brands
  • Current Products Patent Exposure
    • Patent exposure of leading brands
• ANALYSIS OF LEADING BRANDS
  • GABA-A Receptor Agonists
  • Melatonin Receptor Agonist
• GABA-A Receptor Agonists
  • Ambien/Stilnox/Myslee and Ambien CR (sanofi-aventis)
  • Lunesta (Sepracor)
  • Sonata (King Pharmaceuticals)
• Melatonin Receptor Agonist
  • Rozerem (Takeda)
    • Distribution of ML-1 and ML-2 receptors
• GLOBAL SALES FORECASTS OF CURRENT TREATMENTS 2005 - 2012
  • Sales Forecasts of Current Leading Insomnia Drugs (US$ million)
  • Model assumptions
• NEW DRUGS IN R&D
  • Drugs in Development to Treat Insomnia
• ANALYSIS OF PHASE III DRUGS
  • Drugs in Phase III Development to Treat Insomnia
  • GABA-A Receptor Agonists
  • Histamine Receptor Antagonist
  • 5-HT2A Receptor Antagonist
  • Melatonin Receptor Agonist
  • indiplon (Neurocrine Biosciences)
  • gaboxadol (Lundbeck)
  • Silenor (Somaxon)
  • Eplivanserin (sanofi-aventis)
    • Effect of eplivanserin on sleep parameters in Phase IIb trial
  • VEC-162 (Vanda Pharmaceuticals)
    • Efficacy of VEC-162 in transient insomnia trials
• GLOBAL SALES FORECASTS OF PHASE III INSOMNIA DRUGS 2006 - 2012
  • Sales Forecasts of Phase III Developmental Insomnia Drugs
  • Model assumptions
• ANALYSIS OF PHASE II DRUGS
  • New Drugs in Early Clinical Development to Treat Insomnia
  • 5-HT2A Receptor Antagonists
  • GABA-A Receptor Modulator
  • Melatonin Analogue
• 5-HT2A RECEPTOR ANTAGONISTS
  • M100907 (sanofi-aventis)
  • Pruvanserin (Eli Lilly)
• GABA-A MODULATORS
  • NG2-73 (Neurogen)
• MELATONIN ANALOGUE
  • PD-6735 (Phase II Discovery)
• GLOBAL SALES FORECASTS OF PHASE II INSOMNIA DRUGS 2006 - 2012
  • Sales Forecasts of Insomnia Drugs in Phase III
  • Model assumptions
    • CR Analysis of Insomnia Agents Approved by 2012 - Based on Drug Class
• COMPETITOR RATIO ANALYSIS - COMPANIES
  • CR Analysis of Insomnia Agents Approved by 2012 - Based on Company
  • WINNERS & LOSERS
    • Summary of Key Companies and Drugs in the Insomnia Market by 2012
  • Winners
  • Losers
• DISCONTINUATION OF DRUGS
• INSOMNIA APPENDIX 1
  • Analysis of clinical trial data
• INSOMNIA APPENDIX 2
  • Phase transition probability
    • Probability of launch
• INSOMNIA APPENDIX 3
  • Patient Model
    • Summary of US Insomnia Patient Population Forecasts
    • Summary of Europe (Top 5) Insomnia Patient Population Forecasts
    • Summary of Japan Insomnia Patient Population Forecasts
• INSOMNIA APPENDIX 4
  • Global Drug Sales 2005-2012 (US$ million)
• INSOMNIA APPENDIX 5
  • Competitor Ratio Analysis Criteria
    • Key insomnia drugs due to be launched by 2012
• INSOMNIA GLOSSARY
• INSOMNIA REFERENCES
• Acronyms