不眠症治療薬市場

Introduction

The launch of serotonin antagonists which are largely aimed at treating sleep maintenance is set to make a substantial impact on the insomnia market, which will increase in value across the seven major markets from $6.1 billion in 2006 to $7.7 billion in 2016.

Scope

• Analysis of patient potential, unmet needs and clinical trial design in insomnia
• Overview of drugs in late- and early-stage clinical development; with analysis of key companies involved in the R&D pipeline
• Detailed profiles of key compounds in development for use in insomnia, with forecasts of drug revenues to 2016
• Discussion of Sanofi-Aventis' and Neurocrine' s strategies, and insight from key industry opinion leaders

Highlights

Serotonin receptor antagonists are the most prevalent drug class in the late-stage insomnia pipeline. This represents a move away from the GABA agonists which currently dominate the market. Datamonitor predicts that serotonin antagonist companies will be important players in the market in the future, led by Sanofi-Aventis' eplivanserin.

The majority of pipeline drugs are being investigated for sleep maintenance as opposed to sleep onset insomnia and there is a trend towards the development of drugs for the treatment of co-morbid disorders.

In March 2007, Merck & Co. and Lundbeck discontinued development of their Phase III drug, gaboxadol, due to disappointing trial results. Although this is a considerable blow to Lundbeck, the reduction in competition is positive news for current and future insomnia market players.

Reasons to Purchase

• Understand unmet needs in the insomnia market based on key opinion leader comments
• Benchmark key late-stage insomnia compounds against current market leaders
• Assess the global (US, Japan, five major EU) sales forecasts of key late-stage pipeline drugs; and examine their clinical and commercial potential

Table of Contents

• About the Disease pharmaceutical analysis team
• CHAPTER 1 EXECUTIVE SUMMARY
  • Key metrics
• CHAPTER 2 PIPELINE OVERVIEW AND DYNAMICS
  • Drugs in late-stage development focus on treating sleep maintenance
  • Recently discontinued pipeline drugs
    • Gaboxadol
      • A big blow for Lundbeck but good news for competition
    • Sonata MR
      • Further disappointment from the underperforming Sonata brand
  • Key companies involved in the insomnia pipeline
    • Sanofi-Aventis: Endeavoring to maintain leadership of the insomnia market
      • CNS is Sanofi-Aventis' s second largest franchise
      • Ambien currently dominates the insomnia market
      • Ambien CR will fail to sustain the Ambien franchise growth
      • Breaking into the depression market will strengthen relationship with insomnia prescribers
    • Neurocrine: Focused on penetrating insomnia market
      • Neurocrine has six drug candidates in clinical development but has yet to market a product
      • Indiplon is Neurocrine' s most advanced product candidate
      • Neurocrine will face difficulty in securing a big-pharmaceutical partnering company for indiplon
  • Key R&D company strategies
    • Key drug delivery strategies in the insomnia pipeline
      • Controlled release formulations offer the greatest commercial potential
      • Oral and nasal delivery reformulations are expected to be of limited commercial value
    • Investigating insomnia drugs in co-morbid disorders
      • Co-morbid psychiatric disorders are prevalent in insomnia
      • Four pipeline hypnotics are under investigation for co-morbid disorders
    • Potential marketing partners for small pharmaceutical companies
      • GSK is in contact with key prescribers through Requip
      • Cephalon has experience in the sleep disorders market with Provigil for hypersomnia
      • Sepracor requires a follow-on compound to Lunesta
• CHAPTER 3 INSOMNIA - DISEASE OVERVIEW AND MARKET POTENTIAL
  • Definition of insomnia
  • Segmentation of insomnia
    • Insomnia is categorized according to etiology and duration
      • Transient insomnia
      • Intermittent or short-term insomnia
      • Chronic insomnia
      • Other forms of insomnia
    • Etiology of insomnia
  • Epidemiology of insomnia
    • Diagnosis of insomnia
      • Only a small percentage of individuals with symptoms of insomnia receive a diagnosis
    • Insomnia is more prevalent in women than in men
      • Symptoms of the menopause are associated with insomnia
    • Insomnia is most prevalent in young adults and the elderly
    • Insomnia impacts on quality of life and occupational functioning
    • Insomnia carries a high socioeconomic impact
  • Unmet need in insomnia
    • Unmet need 1: Reduction of residual daytime sedation
    • Unmet need 2: More effective treatments for insomnia in the elderly
    • Unmet need 3: Improvement in sleep maintenance
    • Unmet need 4: Lack of potential for tolerance and addiction
    • Unmet need 5: More effective treatments for pediatric insomnia
• CHAPTER 4 R&D Approach
  • Classification of insomnia pharmaceutical therapies
    • Drug classes of currently marketed insomnia products and non-pharmacological therapy
      • Benzodiazepines
      • Melatonin agonists
      • Herbal hypnotics and sedatives
      • Anti-histamines
      • Antidepressants
      • Other drugs
      • Non-pharmacological therapy
    • Drug classes of pipeline insomnia products
      • GABAa receptor agonists
      • Melatonin agonists
      • Serotonin receptor antagonists (5-HT)
      • Other drug classes
  • Clinical trial design in insomnia
    • Objective and subjective measures provide complementary information
    • Clinical trial endpoints in insomnia
      • Sleep questionnaires
      • Alertness tests
      • Quality of life measures
      • Psychological measures
      • Sleep monitoring
  • Recommended directions for insomnia research
    • National Institutes of Health recommendations
    • NICE: A broader range of outcome measures are required, including those that evaluate QOL
• CHAPTER 5 GABA A RECEPTOR AGONIST LATE-STAGE DRUG ANALYSIS & FORECASTS
  • Comparative forecasts
  • Comparative Datamonitor drug assessment summaries
  • Overview of GABAa receptor agonist drugs
    • Pipeline summary
  • Definition of current comparator therapy
    • Clinical trials
    • Adverse reactions and next-day residual effects reported with the use of Ambien
    • Ambien' s major competitors and key strengths and weaknesses
  • Indiplon
    • Profile
      • Drug overview
      • Clinical data - Indiplon IR
      • Clinical data - Indiplon MR
      • Patient potential
      • Marketing factors
      • Satisfaction of unmet need
    • Forecasts to 2016
    • Datamonitor drug assessment summary
  • Zolpidem (sublingual spray)
    • Profile
      • Drug overview
      • Clinical data
      • Patient potential
      • Marketing factors
      • Satisfaction of unmet needs
    • Forecasts to 2016
    • Datamonitor drug assessment summary
  • Sublinox
    • Profile
      • Drug overview
      • Clinical data
      • Patient potential
      • Marketing factors
      • Satisfaction of unmet needs
    • Forecasts to 2016
    • Datamonitor drug assessment summary
  • Other drugs
    • NG2-73
      • Drug overview
      • Clinical data
      • Patient potential
      • Marketing factors
      • Satisfaction of unmet needs
    • EVT-201
      • Drug overview
      • Limited clinical data for EVT-201
      • Datamonitor comments
    • Hypnostat (triazolam)
      • Drug overview
      • Limited clinical trial data published for Hypnostat
      • Datamonitor comments
• CHAPTER 6 MELATONIN AGONIST LATE-STAGE DRUG ANALYSIS AND FORECASTS
  • Comparative forecasts
  • Comparative Datamonitor drug assessment summaries
  • Overview of melatonin agonist drugs
    • Pipeline summary
  • Definition of current comparator therapy
    • Clinical trial data
    • Side effect profile and key strengths and weaknesses
  • VEC-162
    • Profile
      • Drug overview
      • Clinical data
      • Patient potential
      • Marketing factors
      • Satisfaction of unmet need
    • Forecasts to 2016
    • Datamonitor drug assessment summary
  • PD-6735
    • Profile
      • Drug overview
      • Clinical data
      • Patient potential
      • Marketing factors
      • Satisfaction of unmet need
    • Forecasts to 2016
    • Datamonitor drug assessment summary
• CHAPTER 7 SEROTONIN RECEPTOR ANTAGONISTS AND AGONISTS LATE-STAGE DRUG ANALYSIS & FORECASTS
  • Comparative forecasts
  • Comparative Datamonitor drug assessment summaries
  • Overview of serotonin receptor antagonists and agonists
    • Pipeline summary
  • Definition of current comparator therapy
  • Eplivanserin
    • Profile
      • Drug overview
      • Clinical data
      • Patient potential
      • Marketing factors
      • Satisfaction of unmet need
    • Forecasts to 2016
    • Datamonitor drug assessment summary
  • Org-50081
    • Drug overview
      • Clinical data
      • Patient potential
      • Marketing factors
      • Satisfaction of unmet needs
    • Forecasts to 2016
    • Datamonitor drug assessment summary
  • Other drugs
    • HY-10275
      • Drug overview
      • Clinical data
      • Patient potential
      • Marketing factors
      • Satisfaction of unmet needs
    • ACP-103
      • Drug overview
      • Clinical trial data
      • Patient potential
      • Marketing factors
      • Satisfaction of unmet needs
    • Pruvanserin
      • Datamonitor comments
    • Volinanserin
      • Clinical trial data
      • Datamonitor comments
    • MN-305
      • Clinical trial data
      • Ongoing clinical trials
      • Datamonitor comments
    • APD-125
      • Datamonitor comments
• CHAPTER 8 OTHER LATE-STAGE DRUG ANALYSIS AND FORECASTS
  • Comparative forecasts
  • Comparative Datamonitor drug assessment summaries
  • Pipeline summary
  • Definition of current comparator therapy
  • Doxepin (Silenor)
    • Profile
      • Drug overview: NDA filing expected in Q3 2007
      • Clinical data
      • Patient potential
      • Marketing factors
      • Satisfaction of unmet needs
    • Forecasts to 2016
    • Datamonitor drug assessment summary
  • ACT-078573
    • Profile
      • Drug overview
      • Clinical data
      • Patient potential
      • Marketing factors
      • Satisfaction of unmet needs
    • Forecasts to 2016
  • PD-200390
• CHAPTER 9 INNOVATIVE EARLY-STAGE PROJECTS
  • Key Phase I and preclinical compounds in insomnia
    • The early stage insomnia pipeline is characterized by a dearth of innovation
  • G-protein-coupled receptor modulator
    • PGR-683
  • Melatonin agonist
    • BDD- 40001
• BIBLIOGRAPHY
  • Books and journals
  • Datamonitor Reports
  • Websites
• APPENDIX A
  • Methodology
    • Product forecasts
    • Definition of a standard unit
    • Patient expiry and generic assumptions
  • Contributing experts
  • Report methodology
• APPENDIX B
  • About the Disease analysis team
  • Disclaimer
  • List of Tables
    • Table 1: Forecast key pipeline products for insomnia in the seven major markets ($m), 2006-2016
    • Table 2: Pipeline drugs in pre-registration and Phase III development for insomnia, 2007
    • Table 3: Pipeline drugs in Phase II development for insomnia, 2007
    • Table 4: Pipeline drugs in Phase I development and discovery for insomnia, 2007
    • Table 5: Number of key insomnia drugs by class and phase of development, 2007
    • Table 6: Insomnia drugs recently discontinued from development
    • Table 7: Key events preceding the discontinuation of gaboxadol' s development
    • Table 8: Sanofi-Aventis' s marketed CNS products, 2007
    • Table 9: Sanofi-Aventis' s marketed and pipeline insomnia drugs, 2007
    • Table 10: ICSD-R Criteria for severity of insomnia
    • Table 11: Epidemiology of diagnosed insomnia in the seven major markets, 2007
    • Table 12: Prevalence of diagnosed insomnia in the seven major markets, 2007
    • Table 13: The average rating of the clinical unmet needs in insomnia
    • Table 14: Non-pharmacological insomnia therapy
    • Table 15: Advantages and disadvantages of pharmacological therapy, alone and combined with drug treatment
    • Table 16: Widely used primary and secondary clinical trial endpoints
    • Table 17: Important directions for insomnia related research
    • Table 18: Key products in late-stage R&D pipeline of the benzodiazepine class, 2007
    • Table 19: Sanofi Aventis' s Ambien: key facts
    • Table 20: Key events and launch dates impacting indiplon IR and MR revenue forecasts for insomnia in the seven major markets, 2007-2016
    • Table 21: Key events and launch dates impacting revenue forecasts of zolpidem sublingual spray in the seven major markets, 2007-2016
    • Table 22: Key events and launch dates impacting revenue forecasts of Sublinox in the seven major markets, 2007-2016
    • Table 23: Key products in late-stage R&D pipeline of the melatonin agonist class, 2007
    • Table 24: Rozerem: Key facts
    • Table 25: Key events and launch dates impacting revenue forecasts of VEC-162 in the seven major markets, 2007-2016
    • Table 26: Key events and launch dates impacting revenue forecasts of PD6735 in the seven major markets, 2007-2016
    • Table 27: Key products in late-stage R&D pipeline of the 5-HT class, 2007
    • Table 28: Ambien CR: Key facts
    • Table 29: Key events and launch dates impacting revenue forecasts of eplivanserin in the seven major markets, 2007-2016
    • Table 30: Key events and launch dates impacting revenue forecasts of Org-50081 in the seven major markets, 2007-2016
    • Table 31: Other key products in late-stage R&D pipeline, 2007
    • Table 32: Key events and launch dates impacting revenue forecasts of Silenor in the seven major markets, 2007-2016
    • Table 33: Key events and launch dates impacting revenue forecasts of ACT-078573 in the seven major markets, 2007-2016
    • Table 34: Drugs in Phase 1 and discovery for insomnia, 2007
    • Table 35: Estimated generic discounts by country, 2006*
    • Table 36: Estimates of brand erosion by following patent expiry by country
    • Table 37: pipeline drug assessment weighting scale
  • List of Figures
    • Figure 1: insomnia drug assessment summary for the seven major markets ($m), 2007-2016)
    • Figure 2: Symptoms of insomnia affecting the US population at least a few times a week
    • Figure 3: Breakdown of the prevalence of insomnia
    • Figure 4: Symptoms of insomnia experienced by the US population at least a few times a week (male vs female)
    • Figure 5: Prevalence of sleep disorders in peri-menopausal and post-menopausal women
    • Figure 6: Symptoms of insomnia in the US population at least a few times a week (age)
    • Figure 7: Impairment of quality of life associated with insomnia
    • Figure 8: Clinical unmet needs in insomnia, 2007
    • Figure 9: Characteristics of the ideal hypnotic drug
    • Figure 10: Drug classes in development for the treatment of insomnia, 2007
    • Figure 11: comparative forecast of sales for late-stage GABAa products across the seven major markets ($m), 2007-2016
    • Figure 12: competitive positioning analysis for indiplon IR, indiplon MR, zolpidem sublingual spray and Sublinox in the seven major markets, 2007-2016
    • Figure 13: forecast sales on indiplon IR across the seven major markets for insomnia ($m), 2007-2016
    • Figure 14: forecast sales of indiplon MR across the seven major markets for insomnia ($m) 2007-2016
    • Figure 15: competitive positioning analysis for indiplon IR in the seven major markets, 2007-2016
    • Figure 16: competitive positioning analysis for indiplon MR in the seven major markets, 2007-2016
    • Figure 17: forecast sales of zolpidem sublingual spray across the seven major markets for insomnia ($m), 2007-2016
    • Figure 18: competitive positioning analysis for zolpidem sublingual spray in the seven major markets, 2007-2016
    • Figure 19: forecast sales of Sublinox across the seven major markets for insomnia ($m), 2007-2016
    • Figure 20: competitive positioning analysis for Sublinox in the seven major markets, 2007-2016
    • Figure 21: comparative forecast of sales for late-stage melatonin agonists across the seven major markets ($m), 2007-2016
    • Figure 22: competitive positioning analysis for VEC-162 and PD-6735 in the seven major markets, 2007-2016
    • Figure 23: forecast sales of VEC-162 across the seven major markets for insomnia ($m), 2007-2016
    • Figure 24: competitive positioning analysis for VEC-162 in the seven major markets, 2007-2016
    • Figure 25: forecast sales of PD-6735 across the seven major markets for insomnia ($m), 2007-2016
    • Figure 26: competitive positioning analysis for PD-6735 in the seven major markets, 2007-2016
    • Figure 27: comparative forecast of sales for eplivanserin and VEC-162 across the seven major markets ($m), 2007-2016
    • Figure 28: competitive positioning analysis for eplivanserin and Org-50081 in the seven major markets, 2007-2016
    • Figure 29: forecast sales of eplivanserin across the seven major markets for insomnia ($m), 2007-2016
    • Figure 30: competitive positioning analysis for eplivanserin the seven major markets, 2007-2016
    • Figure 31: forecast sales of Org-50081 across the seven major markets for insomnia ($m), 2007-2016
    • Figure 32: competitive positioning analysis for Org-50081 in the seven major markets, 2007-2016
    • Figure 33: comparative forecast of sales for Silenor and ACT-078573 across the seven major markets ($m), 2007-2016
    • Figure 34: competitive positioning analysis for Silenor and ACT-078573 in the seven major markets, 2007-2016
    • Figure 35: forecast sales of Silenor across the seven major markets for insomnia ($m), 2007-2016
    • Figure 36: competitive positioning analysis for Silenor in the seven major markets, 2007-2016
    • Figure 37: forecast sales of ACT-078573 across the seven major markets for insomnia ($m), 2007-2016
    • Figure 38: competitive positioning analysis for ACT-078573 in the seven major markets, 2007-2016