Table of Contents
EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the nicotine dependence market
- Key metrics
- Related reports
PATIENT POTENTIAL
- Definition of nicotine dependence
- The DSM-IV provides the most widely used definition of nicotine
dependence
- Diagnostic assessment tool characterizes level of dependence
- Prevalence of tobacco smoking
- Global number of smokers is expected to rise to 1.7 billion by 2025
- Approximately 150 million people in the seven major markets are
estimated to be current tobacco smokers
- Smoking rates in developing nations are generally much higher than in
developed countries
- Global tobacco epidemic accounts for 5.4 million deaths annually
- Epidemiology of nicotine dependence
- Use of different criteria and methodologies limits study consistency
- Risk factors for nicotine dependence
- Patient dynamics
- Quit rate success is low with few individuals seeking help from their
primary care physician or local services
- Unmet needs in nicotine dependence
- Reduction in relapse rate remains the primary clinical unmet need
- Treatment duration is often too short for some patients
- Need to increase presentation rates
- Lack of reimbursement and/or high cost of products is often a deterrent
to quitting smoking
- Safety of smoking cessation therapies
- Nicotine replacement therapy options are still not broad enough
MARKET OVERVIEW
- Market definition for this report
- Treatment of nicotine dependence
- Behavioral therapy
- Nicotine replacement therapies
- Approved non-nicotine containing medications
- Clinical practice treatment guidelines
- US Department of Health and Human Services
- National Institute for Health and Clinical Excellence (NICE) published
guidance
- Current market assessment
- Prescription market sales dynamics
- Over-the-counter market sales dynamics
- Future market assessment
- The nicotine dependence market is forecast to grow strongly from 2009 to
total over $3.82 billion in 2018
- Chantix (varenicline, Pfizer) - key marketed brand overview
- Drug overview
- Brand dynamics
- Expert opinion
- Forecasts to 2018
- Drug assessment
- Clinical trial data - studies showed 44% of Chantix users remained
abstinent during weeks 9 - 12 of treatment
PIPELINE OVERVIEW AND R&D DYNAMICS
- Pipeline overview
- Few companies appear willing to seize the opportunity in the vast
nicotine dependence market
- Vaccine products remain a key focus in the nicotine dependence pipeline
- Relapse prevention as a conceivable target indication for pipeline agents
- Discontinued or on-hold projects
- Sanofi-Aventis - three late-stage development discontinuations scupper
plans to expand into nicotine dependence market
- Nalmefene (Somaxon) - development program ‘on hold' following
unsuccessful Phase II/III study in pathological gambling
- Clinical trial design in nicotine dependence
- Recommended measures to assess efficacy
- Patient populations
- Relapse prevention study designs
LATE-STAGE DRUG ANALYSIS AND FORECASTS
- Key late-stage pipeline summary
- Comparative forecasts
- Comparative drug assessment
- NicVAX (Nabi Biopharmaceuticals)
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- NIC-002 (Novartis and Cytos Biotechnology)
- Drug overview
- Forecasts to 2017
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Unforecasted pipeline drugs
- TA-NIC (Celtic Pharma)
- GW-468816 (GlaxoSmithKline)
- EVT-302 (Evotec)
- Niccine (Independent Pharmaceutica AB)
- ARD1600 (Aradigm)
- Nicotine MDTS (Acrux)
- QuitPak/INT003 (Cary Pharmaceuticals and IntelGenx)
BIBLIOGRAPHY
- Journal papers, books, and conference abstracts
- Websites
- Datamonitor reports
APPENDIX A
- Data definitions, limitations and assumptions
- Standard units
- Japanese market data
- Estimated 2008 sales revenue
- Derivation of sales forecasts and pricing trends
- Methodology
- Indication-specific sales calculations
- Forecast “sanity checking” - parallel patient population
dynamics assessment
APPENDIX B
TABLES
- Table: DSM-IV criteria for nicotine dependence
- Table: Fagerstrom Test for Nicotine Dependence
- Table: Adult prevalence of tobacco smoking (%) across the seven major
markets as reported by the World Health Organization, 2008
- Table: Current tobacco smoking prevalence in the seven major markets, 2008
- Table: Adult prevalence of tobacco smoking (%) in Brazil, Russia, India
and China, 2001 - 06
- Table: Results of epidemiology studies of nicotine dependence across the
seven major markets
- Table: Key nicotine replacement therapies, 2008
- Table: Prescription sales and growth dynamics of the key nicotine
dependence products in the seven major markets, 2004 - 07
- Table: Datamonitor' s estimated launch dates for prescription nicotine
dependence products across the US, 5EU and Japan, 2009 - 2018
- Table: Chantix: key facts, 2009
- Table: Percentage of continuous abstinence from cigarette smoking at weeks
9 - 12 across three key clinical trials
- Table: Percentage of continuous abstinence from cigarette smoking at weeks
9 - 52 across three key clinical trials
- Table: R&D pipeline in nicotine dependence, February 2009
- Table: Discontinued or on-hold nicotine dependence projects, February 2009
- Table: Forecasted late-stage pipeline nicotine dependence developments,
2008
- Table: Key factors impacting on the revenues of NicVAX, 2009 - 2018
- Table: 12-month continuous abstinence results from NicVAX Phase IIb study
- Table: Key factors impacting on the revenues of NIC-002, 2009 - 2018
- Table: Continuous abstinence levels with NIC-002 at 6 and 12 months after
start of treatment
- Table: Datamonitor drug assessment parameters for nicotine dependence
products, 2009
- Table: Parallel forecast patient population dynamics assessment for the US
prescription nicotine dependence market, 2007 - 2018
FIGURES
- Figure: Historical (2007 - 08) and forecast (2009 - 2018)
prescription-based nicotine dependence sales revenue ($) for key marketed and
pipeline products across the seven major markets
- Figure: Prevalence of current tobacco use in adults in top-27 countries
- Figure: Adult prevalence of current tobacco smoking (%) across the seven
major markets as reported by the World Health Organization, 2008
- Figure: Prevalence of current smoking among adults aged 18 years and over
in the US, 1997 - June 2008
- Figure: Prevalence of current smoking among adults aged 16 years and over
in the UK by gender, 1998 - 2006
- Figure: People setting a quit date through the National Health Service by
pharmacotherapy received in England, 2007 - 08
- Figure: Percentage of successful quitters by type of pharmacotherapy
received in England through the National Health Service, 2007 - 08
- Figure: Unmet needs in the treatment of nicotine dependence, 2009
- Figure: Maintenance of abstinence with Chantix (varenicline, Pfizer) in a
52 - week clinical trial
- Figure: Plasma nicotine levels (nicotine replacement therapies and
cigarette) over 30 minutes
- Figure: Seven major market prescription nicotine dependence market value
($m) by molecule, 2004 - 08
- Figure: Prescription nicotine dependence market value ($m) by country in
the seven major markets, 2004 - 08
- Figure: Sales revenue of over-the-counter nicotine replacement therapies
across the seven major markets ($m), 2004 - 08
- Figure: Regional sales of the nicotine dependence market split by
prescription and over-the-counter revenues across the seven major markets
($m), 2007
- Figure: Prescription nicotine dependence market sales forecast ($ billion)
by seven major market region, 2007 - 2018
- Figure: Mechanism of action of varenicline (Chantix, Pfizer)
- Figure: Major events in the marketed lifecycle of Chantix (varenicline,
Pfizer), 2006 - 09
- Figure: Chantix (varenicline) quarterly US and international sales ($m)
dynamics, Q3 2006-Q4 2008
- Figure: Datamonitor' s sales forecast ($m) of Chantix (varenicline, Pfizer)
across the seven major markets, 2007 - 2018
- Figure: Sales ($m) forecast dynamics of the two scenarios regarding
Chantix' s (varenicline, Pfizer) future in the US, 2007 - 2018
- Figure: Sales ($m) forecast dynamics of the US prescription nicotine
dependence market according to two scenarios for Chantix' s (varenicline,
Pfizer) future, 2007 - 2018
- Figure: Datamonitor' s drug assessment summary for Chantix in the nicotine
dependence market in the seven major markets, 2009
- Figure: Smoking relapse prevention study designs
- Figure: Datamonitor' s competitive positioning analysis of pipeline
products in development for nicotine dependence in the seven major markets
over the forecast period, 2009 - 2018
- Figure: Datamonitor' s sales forecast ($m) for NicVAX (Nabi) for nicotine
dependence across the seven major markets, 2009 - 2018
- Figure: Datamonitor' s drug assessment summary for NicVAX in the nicotine
dependence market, 2009
- Figure: NicVAX Phase IIb proof-of-concept trial design
- Figure: Datamonitor' s sales forecast ($m) for NIC-002 (Novartis and Cytos)
for nicotine dependence across the seven major markets, 2009 - 2018
- Figure: Datamonitor' s drug assessment summary for NIC-002 in the nicotine
dependence market, 2009
- Figure: Datamonitor' s nicotine dependence market forecast sanity check
methodology
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