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Published by: Datamonitor
Published: Dec. 19, 2007 - 93 Pages
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
- Phase III 6-month study
- Vivitrol's major competitor and key strengths and weaknesses
- Classification of pipeline products
- Recently discontinued or failed projects
- Neramexane
- 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
- Pipeline summary
- 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
- Phase III trial data
- Depotrex (naltrexone)
- Drug overview
- CHAPTER 5 OTHER LATE-STAGE DRUG ANALYSIS
- Overview for other drugs in late-stage development
- Pipeline summary
- ALKS-29
- Drug overview
- 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
AbstractIntroduction
The continued uptake of existing brands and the launch of two opioid antagonists will cause the market to grow at a compound annual growth rate of 13.5% from 2006 to reach $304m across the seven major markets by 2016. The alcohol dependence market requires a paradigm shift away from the public perception that it is a behavioral disorder towards being regarded as a treatable medical condition.
Scope
Analysis of epidemiology, unmet needs and clinical trial design in alcohol dependence with insight from key opinion leaders Overview of the current alcohol dependence market. Analysis of patient potential, marketing factors, commercial attractiveness and clinical attractiveness of key late-stage pipeline drugs. Indication-specific forecasts of key drug key late-stage pipeline drugs revenues to 2016.
Highlights
The current alcohol dependence pipeline is small in comparison to other central nervous system markets. Opioid antagonists are the most prevalent drug class in late-stage development and include two reformulations of naltrexone. Datamonitor therefore believes the current alcohol dependence pipeline to be weak and lacking in innovation. The efficacy of currently marketed pharmaceutical products is limited, thereby leaving market opportunity for new therapies. Furthermore, in view of the poor medication compliance rate in alcohol dependent patients, pipeline drugs that possess the potential to improve patient compliance can expect to receive a strong uptake. Companies developing naltrexone depot drugs will experience difficulty distinguishing their products from Vivitrol (naltrexone once-monthly controlled-release, Alkermes/Cephalon) unless they price their drugs competitively and/or incorporate an injection device that produces less pain and fewer injection site reactions.
Reasons to Purchase
Understand unmet needs and opportunities in this market based on the comments of interviewed key opinion leaders. Benchmark key late-stage alcohol dependence compounds against the current market leader. Assess the seven major market total sales forecasts of key late-stage pipeline drugs; and examine their clinical and commercial potential.
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