Pipeline Insight: Substance Dependence - Alcohol
Scope
Report Highlights
Reasons to Purchase
Table of Contents
- ABOUT DATAMONITOR HEALTHCARE - page 2
- About the CNS pharmaceutical analysis team - page 2
- CHAPTER 1 EXECUTIVE SUMMARY - page 3
- Scope of the analysis - page 3
- Datamonitor insight into the alcohol dependence market - page 4
- Key metrics - page 5
- Datamonitor pipeline assessment summary - page 6
- Contributing experts - page 6
- Related reports - page 7
- CHAPTER 2 ALCOHOL DEPENDENCE - MARKET POTENTIAL - page 9
- Definition of alcohol dependence - page 10
- Both genetic and environmental factors play a role in the etiology of alcohol dependence - page 11
- Screening and diagnosis of alcohol dependence - page 13
- Verbal assessment - page 13
- Self-report instruments - page 14
- Alcohol dependence is often under-diagnosed and under-treated - page 16
- Epidemiology of alcohol dependence - page 17
- Alcohol dependence is estimated to affect 19.8 million people in the seven major markets - page 17
- The prevalence of alcohol dependence is in decline in the US - page 19
- However, key opinion leaders believe the prevalence of alcohol dependence is on the rise in developing nations - page 21
- Alcohol dependence is more common in men than women - page 21
- The prevalence of alcoholism declines with increasing age - page 22
- Psychiatric co-morbidity is prevalent in alcohol-dependent patients - page 23
- Alcohol dependence carries considerable adverse health and social consequences - page 25
- Alcohol dependence is a major determinant of ill-health - page 25
- Alcohol dependence carries a high socioeconomic impact - page 26
- Alcohol dependence is estimated to affect 19.8 million people in the seven major markets - page 17
- Current market overview - page 26
- Although small, the alcohol dependence market demonstrates consistently strong growth - page 26
- The EU dominates sales revenue of the alcohol dependence market - page 28
- Only one alcohol dependence product is currently available in Japan - page 29
- France is the largest alcohol dependence market in the 5EU - page 29
- There are a limited number of drugs available to treat alcohol dependence - page 30
- Merck KGaA and Forest's Campral dominates the market with a 65% market share - page 32
- Pharmacological treatment is commonly delivered in conjunction with non-pharmacologic treatment - page 33
- Although small, the alcohol dependence market demonstrates consistently strong growth - page 26
- Unmet need in alcohol dependence - page 33
- Environmental unmet need: Greater resources and funding for treatments - page 34
- Clinical unmet need: Greater efficacy - page 35
- Clinical unmet need: Improved compliance - page 36
- Definition of alcohol dependence - page 10
- CHAPTER 3 PIPELINE OVERVIEW AND DYNAMICS - page 38
- Pipeline overview - page 39
- Opioid antagonists are the most prevalent drug class in the current pipeline - page 39
- A paradigm shift is required to expand the alcohol dependence market - page 41
- Opioid antagonists are the most prevalent drug class in the current pipeline - page 39
- Definition of current comparator therapy - page 41
- Vivitrol is Datamonitor's comparator therapy - page 41
- Forecasts to 2016 - page 43
- Clinical trials - page 44
- Phase III 6-month study - page 44
- Vivitrol's major competitor and key strengths and weaknesses - page 45
- Classification of pipeline products - page 46
- Recently discontinued or failed projects - page 46
- Neramexane - page 47
- Clinical trial design - page 47
- There is a need for agreed research standards in alcohol dependence - page 47
- Patient populations - page 47
- Primary and secondary endpoints - page 48
- There is a need for agreed research standards in alcohol dependence - page 47
- Pipeline overview - page 39
- CHAPTER 4 OPIOID ANTAGONIST LATE-STAGE DRUG ANALYSIS & FORECASTS - page 50
- Overview for opioid antagonist class - page 51
- Pipeline summary - page 51
- Nalmefene (CPH-101) - page 51
- Drug overview - page 51
- Forecasts to 2016 - page 52
- Datamonitor drug assessment summary - page 53
- Marketing factors - page 54
- Nalmefene will benefit from the marketing resources of Lundbeck and Britannia - page 54
- Gaining additional indications will serve to expand patient potential - page 55
- Efficacy in the absence of formal psychosocial support provides a differentiating factor - page 56
- Patient potential - page 56
- Nalmefene set to be indicated for non-abstinent patients on an 'as-needed' basis - page 56
- Nalmefene will be aimed at reducing heavy drinking days rather than total abstinence - page 57
- Satisfaction of unmet needs - page 57
- Nalmefene does not match Vivitrol's ability to improve compliance - page 57
- Clinical trial data - page 58
- Phase III data (Finland) - page 58
- Phase III data (UK) - page 59
- Naltrel (naltrexone depot) - page 59
- Drug overview - page 59
- Forecasts to 2016 - page 60
- Datamonitor drug assessment summary - page 61
- Marketing factors - page 62
- Naltrel will experience competition from Vivitrol - page 62
- Elbion would benefit from seeking a marketing partner for Naltrel - page 63
- Patient potential - page 63
- Satisfaction of unmet needs - page 63
- Clinical trial data - page 63
- Phase III trial data - page 63
- Depotrex (naltrexone) - page 65
- Drug overview - page 65
- Overview for opioid antagonist class - page 51
- CHAPTER 5 OTHER LATE-STAGE DRUG ANALYSIS - page 66
- Overview for other drugs in late-stage development - page 67
- Pipeline summary - page 67
- ALKS-29 - page 67
- Drug overview - page 67
- LY-686017 - page 68
- Drug overview - page 68
- Ongoing clinical trials - page 69
- Overview for other drugs in late-stage development - page 67
- BIBLIOGRAPHY - page 70
- Journal papers - page 70
- Books - page 74
- Datamonitor reports - page 75
- Websites - page 75
- APPENDIX A - page 81
- Methodology - page 81
- Datamonitor forecast methodology - page 81
- Epidemiology forecasts - page 81
- Product forecasts - page 81
- Definition of a standard unit - page 81
- Datamonitor forecast methodology - page 81
- Contributing experts - page 83
- Methodology - page 81
- APPENDIX B - page 84
- Methodology - page 84
- Definition of alcohol dependence market - page 84
- About Datamonitor - page 85
- About Datamonitor Healthcare - page 85
- Datamonitor Healthcare's therapy area capabilities - page 86
- About the Disease analysis team - page 86
- Disclaimer - page 88
- Methodology - page 84
- List of Tables
- Table 1: DSM-IV criteria for alcohol dependence - page 11
- Table 2: Results of epidemiology studies of alcohol dependence across the seven major markets - page 18
- Table 3: Prevalence of alcohol dependence in the seven major markets, 2007 - page 19
- Table 4: Key players in the alcohol dependence market in 2007 - page 31
- Table 5: Sales, growth and market share of marketed alcohol dependence products, 2005-06 - page 32
- Table 6: R&D pipeline for alcohol dependence, 2007 - page 40
- Table 7: Vivitrol: key facts - page 42
- Table 8: Key opioid receptor antagonists in the late-stage R&D pipeline for alcohol dependence, 2007 - page 51
- Table 9: Factors impacting on the revenues of nalmefene, 2007-2016 - page 53
- Table 10: Factors impacting on the revenues of Naltrel, 2007-2016 - page 61
- Table 11: Other drugs in the late-stage R&D pipeline for alcohol dependence, 2007 - page 67
- Table 12: Datamonitor drug assessment parameters - page 82
- Table 13: ICD-10 codes used to size the alcohol dependence market - page 84
- List of Figures
- Figure 1: Datamonitor's alcohol dependence market summary, 7MM, 2007-2016 - page 5
- Figure 2: Drug assessment summary for alcohol dependence treatments, 7MM, 2007-2016 - page 6
- Figure 3: Past-year prevalence of alcohol dependence in the US, 2000-2001 - page 22
- 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 - page 24
- Figure 5: Total sales of the alcohol dependence prescription drugs by region of the 7MM ($m), 2003-06 - page 27
- Figure 6: Performance of the 5EU alcohol dependence markets ($m), 2005-06 - page 30
- Figure 7: Common reasons for patient non-adherence - page 37
- Figure 8: Datamonitor's forecast sales of Vivitrol across the 7MM for alcohol dependence ($m), 2007-2016 - page 43
- Figure 9: Datamonitor's forecast sales of nalmefene across the 7MM for alcohol dependence ($m), 2007-2016 - page 53
- Figure 10: Drug assessment summary for nalmefene, 2007-2016 - page 54
- Figure 11: Datamonitor's forecast sales of Naltrel across the 7MM for alcohol dependence ($m), 2007-2016 - page 60
- Figure 12: Drug assessment summary for Naltrel - page 61
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