Research and Markets: Opioid Antagonists Are the Most Prevalent Drug Class in Late-Stage Development for the Alcohol Dependence Pipeline Which Include Two Reformulations of Naltrexone
Research and Markets (http://www.researchandmarkets.com/reports/c81994) has announced the addition of Pipeline Insight: Substance Dependence – Part II: Alcohol to their offering.
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 of this title
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. The author 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.
Key reasons to purchase this title
– 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.
Content Outline:
ABOUT US HEALTHCARE 2
About the CNS pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Scope of the analysis 3
Our insight into the alcohol dependence market 4
Key metrics 5
Our pipeline assessment summary 6
Contributing experts 6
Related reports 7
CHAPTER 2 ALCOHOL DEPENDENCE – MARKET POTENTIAL 9
Definition of alcohol dependence 10
Both genetic and environmental factors play a role in the etiology of alcohol dependence 11
Screening and diagnosis of alcohol dependence 13
Verbal assessment 13
Self-report instruments 14
Alcohol dependence is often under-diagnosed and under-treated 16
Epidemiology of alcohol dependence 17
Alcohol dependence is estimated to affect 19.8 million people in the seven major markets 17
The prevalence of alcohol dependence is in decline in the US 19
However, key opinion leaders believe the prevalence of alcohol dependence is on the rise in developing nations 21
Alcohol dependence is more common in men than women 21
The prevalence of alcoholism declines with increasing age 22
Psychiatric co-morbidity is prevalent in alcohol-dependent patients 23
Alcohol dependence carries considerable adverse health and social consequences 25
Alcohol dependence is a major determinant of ill-health 25
Alcohol dependence carries a high socioeconomic impact 26
Current market overview 26
Although small, the alcohol dependence market demonstrates consistently strong growth 26
The EU dominates sales revenue of the alcohol dependence market 28
Only one alcohol dependence product is currently available in Japan 29
France is the largest alcohol dependence market in the 5EU 29
There are a limited number of drugs available to treat alcohol dependence 30
Merck KGaA and Forests Campral dominates the market with a 65% market share 32
Pharmacological treatment is commonly delivered in conjunction with non-pharmacologic treatment 33
Unmet need in alcohol dependence 33
Environmental unmet need: Greater resources and funding for treatments 34
Clinical unmet need: Greater efficacy 35
Clinical unmet need: Improved compliance 36
CHAPTER 3 PIPELINE OVERVIEW AND DYNAMICS 38
Pipeline overview 39
Opioid antagonists are the most prevalent drug class in the current pipeline 39
A paradigm shift is required to expand the alcohol dependence market 41
Definition of current comparator therapy 41
Vivitrol is Ours comparator therapy 41
Forecasts to 2016 43
Clinical trials 44
Phase III 6-month study 44
Vivitrols major competitor and key strengths and weaknesses 45
Classification of pipeline products 46
Recently discontinued or failed projects 46
Neramexane 47
Clinical trial design 47
There is a need for agreed research standards in alcohol dependence 47
Patient populations 47
Primary and secondary endpoints 48
CHAPTER 4 OPIOID ANTAGONIST LATE-STAGE DRUG ANALYSIS & FORECASTS 50
Overview for opioid antagonist class 51
Pipeline summary 51
Nalmefene (CPH-101) 51
Drug overview 51
Forecasts to 2016 52
Our drug assessment summary 53
Marketing factors 54
Nalmefene will benefit from the marketing resources of Lundbeck and Britannia 54
Gaining additional indications will serve to expand patient potential 55
Efficacy in the absence of formal psychosocial support provides a differentiating factor 56
Patient potential 56
Nalmefene set to be indicated for non-abstinent patients on an as-needed basis 56
Nalmefene will be aimed at reducing heavy drinking days rather than total abstinence 57
Satisfaction of unmet needs 57
Nalmefene does not match Vivitrols ability to improve compliance 57
Clinical trial data 58
Phase III data (Finland) 58
Phase III data (UK) 59
Naltrel (naltrexone depot) 59
Drug overview 59
Forecasts to 2016 60
Our drug assessment summary 61
Marketing factors 62
Naltrel will experience competition from Vivitrol 62
Elbion would benefit from seeking a marketing partner for Naltrel 63
Patient potential 63
Satisfaction of unmet needs 63
Clinical trial data 63
Phase III trial data 63
Depotrex (naltrexone) 65
Drug overview 65
CHAPTER 5 OTHER LATE-STAGE DRUG ANALYSIS 66
Overview for other drugs in late-stage development 67
Pipeline summary 67
ALKS-29 67
Drug overview 67
LY-686017 68
Drug overview 68
Ongoing clinical trials 69
BIBLIOGRAPHY 70
Journal papers 70
Books 74
Our reports 75
Websites 75
APPENDIX A 81
Methodology 81
Our forecast methodology 81
Epidemiology forecasts 81
Product forecasts 81
Definition of a standard unit 81
Contributing experts 83
APPENDIX B 84
Methodology 84
Definition of alcohol dependence market 84
About Our 85
About Our Healthcare 85
Our Healthcares therapy area capabilities 86
About the Disease analysis team 86
Disclaimer 88
List of Tables
List of Figures
Companies Mentioned:
– Alkermes Inc
– Barr Pharmaceuticals
– Britannia Building Society
– Cephalon
– DrugAbuse Sciences SAS
– Eli Lilly and Company
– Forest Laboratories, Inc
– Grant Supply Co.
– Grupo Radio Centro SA
– IMS Health
– Insight Communications Company, Inc.
– Merck & Co., Inc.
– Merck KGaA
– Miller Group Limited, The
– New York & Company, Inc.
– Odyssey Healthcare Inc
– RM plc
– Unit Corporation
– Wyeth
For more information visit http://www.researchandmarkets.com/reports/c81994
Source: Datamonitor