Table of Contents
- ABOUT DATAMONITOR HEALTHCARE
- About the CNS pharmaceutical analysis team
- CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the alcohol dependence market
- Key metrics
- Datamonitor pipeline assessment summary
- Contributing experts
- Related reports
- CHAPTER 2 ALCOHOL DEPENDENCE - MARKET POTENTIAL
- Definition of alcohol dependence
- Both genetic and environmental factors play a role in the etiology of
alcohol dependence
- Screening and diagnosis of alcohol dependence
- Verbal assessment
- Self-report instruments
- Alcohol dependence is often under-diagnosed and under-treated
- Epidemiology of alcohol dependence
- Alcohol dependence is estimated to affect 19.8 million people in the
seven major markets
- The prevalence of alcohol dependence is in decline in the US
- However, key opinion leaders believe the prevalence of alcohol
dependence is on the rise in developing nations
- Alcohol dependence is more common in men than women
- The prevalence of alcoholism declines with increasing age
- Psychiatric co-morbidity is prevalent in alcohol-dependent patients
- Alcohol dependence carries considerable adverse health and social
consequences
- Alcohol dependence is a major determinant of ill-health
- Alcohol dependence carries a high socioeconomic impact
- Current market overview
- Although small, the alcohol dependence market demonstrates
consistently strong growth
- The EU dominates sales revenue of the alcohol dependence market
- Only one alcohol dependence product is currently available in Japan
- France is the largest alcohol dependence market in the 5EU
- There are a limited number of drugs available to treat alcohol
dependence
- Merck KGaA and Forest' s Campral dominates the market with a 65%
market share
- Pharmacological treatment is commonly delivered in conjunction with
non-pharmacologic treatment
- Unmet need in alcohol dependence
- Environmental unmet need: Greater resources and funding for treatments
- Clinical unmet need: Greater efficacy
- Clinical unmet need: Improved compliance
- CHAPTER 3 PIPELINE OVERVIEW AND DYNAMICS
- Pipeline overview
- Opioid antagonists are the most prevalent drug class in the current
pipeline
- A paradigm shift is required to expand the alcohol dependence market
- Definition of current comparator therapy
- Vivitrol is Datamonitor' s comparator therapy
- Forecasts to 2016
- Clinical trials
- Vivitrol' s major competitor and key strengths and weaknesses
- Classification of pipeline products
- Recently discontinued or failed projects
- Clinical trial design
- There is a need for agreed research standards in alcohol dependence
- Patient populations
- Primary and secondary endpoints
- CHAPTER 4 OPIOID ANTAGONIST LATE-STAGE DRUG ANALYSIS & FORECASTS
- Overview for opioid antagonist class
- Nalmefene (CPH-101)
- Drug overview
- Forecasts to 2016
- Datamonitor drug assessment summary
- Marketing factors
- Nalmefene will benefit from the marketing resources of Lundbeck and
Britannia
- Gaining additional indications will serve to expand patient potential
- Efficacy in the absence of formal psychosocial support provides a
differentiating factor
- Patient potential
- Nalmefene set to be indicated for non-abstinent patients on an
' as-needed' basis
- Nalmefene will be aimed at reducing heavy drinking days rather than
total abstinence
- Satisfaction of unmet needs
- Nalmefene does not match Vivitrol' s ability to improve compliance
- Clinical trial data
- Phase III data (Finland)
- Phase III data (UK)
- Naltrel (naltrexone depot)
- Drug overview
- Forecasts to 2016
- Datamonitor drug assessment summary
- Marketing factors
- Naltrel will experience competition from Vivitrol
- Elbion would benefit from seeking a marketing partner for Naltrel
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Depotrex (naltrexone)
- CHAPTER 5 OTHER LATE-STAGE DRUG ANALYSIS
- Overview for other drugs in late-stage development
- ALKS-29
- LY-686017
- Drug overview
- Ongoing clinical trials
- BIBLIOGRAPHY
- Journal papers
- Books
- Datamonitor reports
- Websites
- APPENDIX A
- Methodology
- Datamonitor forecast methodology
- Epidemiology forecasts
- Product forecasts
- Definition of a standard unit
- Contributing experts
- APPENDIX B
- Methodology
- Definition of alcohol dependence market
- About Datamonitor
- About Datamonitor Healthcare
- Datamonitor Healthcare' s therapy area capabilities
- About the Disease analysis team
- Disclaimer
- List of Tables
- Table 1: DSM-IV criteria for alcohol dependence
- Table 2: Results of epidemiology studies of alcohol dependence across
the seven major markets
- Table 3: Prevalence of alcohol dependence in the seven major markets,
2007
- Table 4: Key players in the alcohol dependence market in 2007
- Table 5: Sales, growth and market share of marketed alcohol dependence
products, 2005-06
- Table 6: R&D pipeline for alcohol dependence, 2007
- Table 7: Vivitrol: key facts
- Table 8: Key opioid receptor antagonists in the late-stage R&D
pipeline for alcohol dependence, 2007
- Table 9: Factors impacting on the revenues of nalmefene, 2007-2016
- Table 10: Factors impacting on the revenues of Naltrel, 2007-2016
- Table 11: Other drugs in the late-stage R&D pipeline for alcohol
dependence, 2007
- Table 12: Datamonitor drug assessment parameters
- Table 13: ICD-10 codes used to size the alcohol dependence market
- List of Figures
- Figure 1: Datamonitor' s alcohol dependence market summary, 7MM,
2007-2016
- Figure 2: Drug assessment summary for alcohol dependence treatments,
7MM, 2007-2016
- Figure 3: Past-year prevalence of alcohol dependence in the US,
2000-2001
- Figure 4: 12-month prevalence of DSM-IV independent mood and anxiety
disorders among respondents to the NESARC study with a 12-month DSM-IV
alcohol dependence disorder
- Figure 5: Total sales of the alcohol dependence prescription drugs by
region of the 7MM ($m), 2003-06
- Figure 6: Performance of the 5EU alcohol dependence markets ($m),
2005-06
- Figure 7: Common reasons for patient non-adherence
- Figure 8: Datamonitor' s forecast sales of Vivitrol across the 7MM for
alcohol dependence ($m), 2007-2016
- Figure 9: Datamonitor' s forecast sales of nalmefene across the 7MM for
alcohol dependence ($m), 2007-2016
- Figure 10: Drug assessment summary for nalmefene, 2007-2016
- Figure 11: Datamonitor' s forecast sales of Naltrel across the 7MM for
alcohol dependence ($m), 2007-2016
- Figure 12: Drug assessment summary for Naltrel
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