Table of Contents
EXECUTIVE SUMMARY
- Scope of the analysis
- Datamonitor insight into the mild cognitive impairment market
- Key metrics
- Datamonitor Pipeline Assessment Summary
- Contributing experts
- Related reports
- Upcoming reports
PIPELINE OVERVIEW AND DYNAMICS
- Pipeline overview
- Lack of pipeline drugs targeting mild cognitive impairment
- Key companies involved in the mild cognitive impairment pipeline
- Allon Therapeutics
- Pfizer/Medivation/Wyeth
- Key R&D company strategies
- Mild cognitive impairment - a future indication expansion opportunity
- Working on the development of better diagnostic tools
PATIENT POTENTIAL
- Definition of mild cognitive impairment
- Mild cognitive impairment - a borderline condition between normal aging
and dementia
- Working areas and their significance for pharmaceutical companies
- Cognitive disorders - mild cognitive impairment and beyond
- Epidemiology of mild cognitive impairment
- Prevalence of mild cognitive impairment
- Prevalence and progression of mild cognitive impairment subtypes
- Treatable population
- Etiology of mild cognitive impairment
- Etiology of mild cognitive impairment can be linked to underlying
neurodegenerative disorder
- Diagnosis of mild cognitive impairment
- Lack of consensus in diagnostic tools
- Accurate diagnosis may demand a combination of exams
- Diagnostic tools
- Unmet needs in mild cognitive impairment
- Unmet need overview
- Consensus on the definition and categorization of mild cognitive
impairment
- Development of diagnostic tools
- Development of therapeutic solution
MARKET OVERVIEW AND POTENTIAL
- Current market size
- Market value methodology
- MCI market value estimates
- Forecast methodology
- Overview of Datamonitor' s forecast methodology
- Evolution in patient numbers over the forecast period
- Market forecast overview
- Total market forecasts
- Key late-stage pipeline drug forecasts
R&D APPROACH
- Classification of pipeline products
- Lack of pipeline drugs targeting MCI as a primary indication
- Patient potential
- Symptomatic treatments
- Disease-modifying treatments
- Clinical trial design in mild cognitive impairment
POTENTIAL DISEASE SLOWING THERAPIES
- Overview for potentially disease-slowing therapies
- Definition of current comparator therapy - Aricept
- Aricept - a symptomatic drug prescribed off-label for the treatment of
mild cognitive impairment
- Aricept' s strengths and weaknesses
- Historical sales for Aricept and other anti-Alzheimer' s diseases drugs
in mild cognitive impairment
- Factors required to compete with Aricept
- Bapineuzumab
- Drug overview
- Forecasts to 2018
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- LY450139 - semagacestat
- Drug overview
- Forecasts to 2018
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Gammagard
- Drug overview
- Forecasts to 2018
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Rember
- Drug overview
- Forecasts to 2018
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- PBT2
- Drug overview
- Forecasts to 2018
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- AL-108
- Drug overview
- Clinical trial data
- LY2062430
- Drug overview
- Clinical trial data
- PF-04494700 (TTP488)
- Drug overview
- Clinical trial data
SYMPTOMATIC TREATMENTS
- Overview for symptomatic drugs
- Definition of current comparator therapy - Aricept
- Dimebon
- Drug overview
- Forecasts to 2018
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- Clinical trial data
- Aricept (donepezil) SR
- Drug overview
- Forecasts to 2018
- Datamonitor drug assessment summary
- Marketing factors
- Patient potential
- Satisfaction of unmet needs
- SB-742457
- Drug overview
- Datamonitor comments
BIBLIOGRAPHY
- Journals
- Websites
- Annual reports
- Datamonitor reports
APPENDIX
- Methodology
- Datamonitor forecast methodology
TABLES
- Table: Key parameters of mild cognitive impairment (MCI) across the seven
major markets, 2007- 2017
- Table: Key pipeline product sales in mild cognitive impairment (MCI)
across the seven major markets to 2018
- Table: Key potential disease-slowing treatments in development for
Alzheimer' s disease and potentially appropriate for mild cognitive impairment,
2009
- Table: Key symptomatic treatments in development for Alzheimer' s disease
and potentially appropriate for mild cognitive impairment, 2009
- Table: Number of key late-stage pipeline drugs potentially suitable for
mild cognitive impairment per class and phase of development, 2009
- Table: Allon Therapeutics' s drug pipeline, 2009
- Table: Prevalence of mild cognitive impairment (MCI) in the seven major
markets, 2007
- Table: Epidemiological studies on mild cognitive impairment, 2001- 08
- Table: Description of different types of dementias mild cognitive
impairment patients can go on to develop
- Table: Mild cognitive impairment-specific sales value ($) and volume (IMS
standard units, SU) and number of patients treated across the seven major
markets, 2007
- Table: Examples of cerebrospinal fluid tracers for beta-amyloid plaques
and acetylcholinesterase
- Table: Example of alternative tests to cerebrospinal fluid biomarkers in
neurological conditions
- Table: ICD-10 codes excluded from mild cognitive impairment (MCI) sales
estimate
- Table: Evolution of MCI patients flow across the seven major markets,
2007- 2018
- Table: Sales forecasts for the key late-stage pipeline drugs across the
seven major markets ($m), 2011- 18
- Table: Key potential disease-slowing treatments in development for
Alzheimer' s disease and potentially appropriate for mild cognitive impairment
(MCI), 2009
- Table: Pfizer/Eisai' s Aricept: key facts, 2009
- Table: Bapineuzumab - forecast methodology in mild cognitive impairment
in the US, 2012- 18
- Table: Bapineuzumab - forecast methodology in mild cognitive impairment
in the 5EU, 2012- 18
- Table: Bapineuzumab - forecast assumptions in mild cognitive impairment
in Japan, 2013- 18
- Table: LY450139 - forecast methodology in mild cognitive impairment in
the US, 2013- 18
- Table: LY450139 - forecast methodology in mild cognitive impairment in
the 5EU, 2013- 18
- Table: LY450139 - forecast methodology in mild cognitive impairment in
Japan, 2014- 18
- Table: Clinical trial summary for LY450139 in Alzheimer' s disease, 2009
- Table: Gammagard - forecast methodology in mild cognitive impairment in
the US, 2013- 18
- Table: Rember - forecast methodology in mild cognitive impairment in the
US, 2014- 18
- Table: Rember - forecast methodology in mild cognitive impairment in the
5EU, 2014- 18
- Table: PBT2 - forecast methodology in mild cognitive impairment in the
US, 2014- 18
- Table: PBT2 - forecast methodology in mild cognitive impairment in the
5EU, 2014- 18
- Table: Clinical trial results for high dose of AL-108 (15mg twice a day)
in mild cognitive impairment (MCI) subjects
- Table: Key symptomatic treatments in development for Alzheimer' s disease
and potentially appropriate for mild cognitive impairment (MCI), 2009
- Table: Dimebon - forecast methodology in mild cognitive impairment in the
US, 2012- 18
- Table: Dimebon - forecast methodology in mild cognitive impairment in the
5EU, 2012- 18
- Table: Dimebon - forecast methodology in mild cognitive impairment in
Japan, 2015- 18
- Table: Clinical trial summary for Dimebon in Alzheimer' s disease, 2009
- Table: Aricept (donepezil) SR - forecast methodology in mild cognitive
impairment in the US, 2011- 18
- Table: Aricept (donepezil) SR - forecast methodology in mild cognitive
impairment in the 5EU, 2011- 18
- Table: Patent' s expiry dates of key branded anti-Alzheimer' s disease drugs
across the US, the 5EU and Japan
- Table: Datamonitor drug assessment parameters
FIGURES
- Figure: Datamonitor' s drug assessment summary of key late-stage therapies
in development for Alzheimer' s disease and potentially effective in mild
cognitive impairment, 2007- 2018.
- Figure: Number of symptomatic and potential disease-slowing late-stage
pipeline drugs potentially appropriate for mild cognitive impairment, 2009
- Figure: Diagnosis algorithm and mild cognitive impairment (MCI)
segmentation according to clinical characterization of the symptoms
- Figure: Mild cognitive impairment prevalence by age in Unverzagt et al. ' s
study, 2001
- Figure: Prevalence of each subtype within the mild cognitive impairment
(MCI) population
- Figure: Potential relation between symptom classification and outcomes in
mild cognitive impairment patients
- Figure: Prevalent, diagnosed and treated population with mild cognitive
impairment aged 65 and over across the seven major markets, 2007
- Figure: Segmentation of the mild cognitive impairment population and the
treatable population across the seven major markets
- Figure: Unmet needs in mild cognitive impairment (MCI), 2009
- Figure: Datamonitor' s mild cognitive impairment (MCI) sales methodology,
2009
- Figure: US IMS diagnostic value sales ($m) for ATC classes N6D and N7D
limited to non-dementia indications per age group, 2007
- Figure: US IMS diagnostic value sales ($) for ATC classes N6D and N7D
limited to non-dementia indications per 1,000 persons, 2007
- Figure: Mild cognitive impairment (MCI)-specific sales value ($m) by class
across the seven major markets, 2005- 08
- Figure: Mild cognitive impairment (MCI)-specific sales volume (IMS
standard units) by class across the seven major markets, 2005- 08
- Figure: Mild cognitive impairment (MCI)-specific sales revenue ($m) in the
US, 5EU and Japan, 2007
- Figure: Datamonitor' s methodology for estimating the treatable MCI
population across the seven major markets.
- Figure: Evolution of the mild cognitive impairment presentation and
diagnosis combined rate across the seven major markets, 2005- 2018
- Figure: Number of mild cognitive impairment (MCI) patients treated by drug
type across the seven major markets ($m), 2005- 2018
- Figure: Mild cognitive impairment (MCI)-specific sales revenue
distribution by drug type across the seven major markets ($m), 2005- 2018
- Figure: Sales forecasts for key mild cognitive impairment-specific
late-stage pipeline drugs across the major markets, 2010- 2018
- Figure: Datamonitor' s drug assessment summary of key late-stage therapies
in development for Alzheimer' s disease and potentially effective in mild
cognitive impairment, 2007- 2018
- Figure: Mild cognitive impairment patient potential according to the type
of treatment
- Figure: Aricept (donepezil) - strengths and weaknesses, 2009
- Figure: Historical sales for the current anti-Alzheimer' s disease products
in the mild cognitive impairment market across the seven major markets, 2005-
08
- Figure: Off-label sales forecast for bapineuzumab in mild cognitive
impairment (MCI) to 2018 across the seven major markets
- Figure: Datamonitor' s competitive positioning analysis of bapineuzumab in
mild cognitive impairment across the seven major markets, 2007- 2018
- Figure: Off-label sales forecast for LY450139 in mild cognitive impairment
to 2018 across the seven major markets
- Figure: Datamonitor' s competitive positioning analysis of LY450139 in mild
cognitive impairment (MCI) across the seven major markets, 2007- 2018
- Figure: Off-label sales forecast for Gammagard in mild cognitive
impairment (MCI) to 2018 in the US
- Figure: Datamonitor' s competitive positioning analysis of Gammagard in
mild cognitive impairment (MCI) across the seven major markets, 2007- 2018
- Figure: Off-label sales forecast for Rember in mild cognitive impairment
(MCI) to 2018 in the US and 5EU
- Figure: Datamonitor' s competitive positioning analysis of Rember in mild
cognitive impairment (MCI) across the seven major markets, 2007- 2018
- Figure: Off-label s ales forecast for PBT2 in mild cognitive impairment
(MCI) to 2018 in the US and 5EU
- Figure: Datamonitor' s competitive positioning analysis of PBT2 in mild
cognitive impairment (MCI) across the seven major markets, 2007- 2018
- Figure: Off-label sales forecast for Dimebon in mild cognitive impairment
to across the seven major markets, 2012- 2018
- Figure: Datamonitor' s competitive positioning analysis of Dimebon in mild
cognitive impairment across the seven major markets, 2007- 2018
- Figure: Off-label sales forecast for Aricept (donepezil) SR in mild
cognitive impairment (MCI) to 2018 in the US and 5EU
- Figure: Datamonitor' s competitive positioning analysis of Aricept
(donepezil) SR in mild cognitive impairment (MCI) across the seven major
markets, 2007- 2018
- Figure: Datamonitor' s drug assessment summary of key late-stage therapies
in development for Alzheimer' s disease and potentially effective in mild
cognitive impairment, 2007- 2018
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