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CNS Drug Discoveries: Sleep Disorders Chapter - Insomnia

Published by: Espicom Healthcare Intelligence

Published: Nov. 27, 2006 - 90 Pages


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 = 59%


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$687 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

Abstract

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.

Tables Charts & Figures
  • Patient population forecast to 2012 by type showing % diagnosed and treated (acute & chronic)
  • US market share for 4 insomnia drugs 2005
  • European market share for insomnia drugs (Ambien & Imovane) 2005
  • Japanese market share for insomnia drugs (Ambien & Amobane) 2005
  • Major players in the market 2005 and 2012
  • Comparison of leading brands
  • Patent exposure of leading brands
  • Competitor analysis of currently available therapies
  • Forecast of global drug sales by year to 2012
  • Drugs in development to treat insomnia
  • Competitor analysis of upcoming products of note: indiplon (Neurocrine), eplivanserin (sanofi-aventis), gaboxadol (Merck & Co/Lundbeck), Silenor (Somaxon
  • Pharmaceuticals) and VEC-162 (Vanda Pharmaceuticals)
  • Forecast global sales by year to 2012 of new drugs
  • Competitor ratio analysis of drugs and companies
  • Winners & losers in the insomnia market
  • Discontinued insomnia drugs
Key questions answered in this chapter include:
  • What are the opportunities in treating chronic insomnia over the next 5 years?
  • What impact has Takeda’s Rozerem had on the market?
  • How will sanofi-aventis protect its insomnia franchise in the future?
  • What will be the leading treatments by 2012?
  • Why are the prospects for Neurocrine’s indiplon IR/CR?
  • How does gaboxadol (Merck & Co/Lundbeck) compare to market leaders and new products?


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