Table of Contents
OVERVIEW
EXECUTIVE SUMMARY
- Strategic scoping and focus
- Datamonitor insight into the Alzheimer' s disease market
- Related reports
1. PIPELINE OVERVIEW AND DYNAMICS
- Key findings
- Pipeline overview
- Interest remains strong in this high risk/high reward indication
- Trends in the current pipeline
- Comparative forecasts - Pfizer' s Dimebon best positioned for
commercial success
- Datamonitor Pipeline Assessment Summary - disease modification
enhances clinical attractiveness
- Key companies involved in the Alzheimer' s disease pipeline
- Big Pharma companies partner their way into Alzheimer' s pipeline
- Key R&D company strategies
- Diverse drug discovery approaches
- Beta-amyloid is the primary drug discovery target
- Secondary indications are possible but not yet under development
2. ALZHEIMER' S DISEASE: MARKET POTENTIAL
- Key findings
- Definition
- Overview
- World Health Organization classification and scope
- Syndrome description and patient segmentation
- Dementia
- Mild cognitive impairment
- Epidemiology
- Seven major markets
- Rest of the world
- Diagnosis rate of cognitive disorders
- Dementia (including Alzheimer' s disease)
- Mild cognitive impairment
- Current treatment options
- Brand dynamics and key past events
- Current gold standard and comparator therapies
- Gold standard or comparator therapy: Aricept
- Current market overview
- Global Alzheimer' s disease market
- Alzheimer' s disease-specific sales across the seven major markets
- Unmet need in Alzheimer' s disease
- Disease modifying/slowing treatments
- Improved symptomatic efficacy
- Better diagnostic tools
- Better understanding of the disease etiology
- Current level of attainment vs. target product profile
3. R&D APPROACH
- Key findings
- Clinical trial design in Alzheimer' s disease
- What constitutes disease modification?
- Determination of disease modification
- Clinical trial endpoints
4. PIPELINE ANALYSIS & FORECASTS: DRUGS TARGETING BETA-AMYLOID
- Key findings
- Overview for drugs targeting beta-amyloid
- Pipeline summary
- Comparative forecasts
- Bapineuzumab - passive immunotherapy
- Drug overview
- Drug profile
- SWOT analysis
- Clinical trial data
- Clinical attractiveness
- Commercial attractiveness
- Datamonitor drug assessment score card for bapineuzumab
- Satisfaction of unmet needs
- Forecasts to 2018
- Gammagard - passive immunotherapy
- Drug overview
- Drug profile
- SWOT analysis
- Clinical trial data
- Clinical attractiveness
- Commercial attractiveness
- Datamonitor drug assessment score card for Gammagard
- Satisfaction of unmet needs
- Forecasts to 2018
- Other drugs targeting beta-amyloid
- LY450139 - gamma secretase
- PBT2 - aggregation inhibition
- LY2062430 - passive immunotherapy
- PF-04494700 - other beta-amyloid
- Posiphen - other beta-amyloid
- Amyloid vaccines ACC-01 and CAD106
- Octagam - passive immunization
- ELND005 - beta-amyloid aggregation inhibitor
- ACI91 - beta-secretase inhibition
- EHT0202 - alpha-secretase activator
- NIC515 - gamma-secretase inhibitor
- ARC029 - other beta-amyloid
- PF4360365 - passive immunization
- Late-stage development compounds recently discontinued
5. PIPELINE ANALYSIS & FORECASTS: DRUGS TARGETING TAU HYPERPHOSPHORILATION
- Key findings
- Overview for drugs targeting tau tangles
- Rember - tau hyperphosphorylation inhibitor
- Drug overview
- Clinical trial data
- Datamonitor' s comments
- Other drugs targeting tau tangles
- AL108 - tau hyperphosphorylation inhibitor
- NP-12 - Glycogen synthase kinase-3 beta inhibitor
6. PIPELINE ANALYSIS & FORECASTS: GENERAL NEUROPROTECTIVE DRUGS
- Key findings
- Overview for general neuroprotective drugs
- Dimebon - MPTP, NMDA, cholinesterase inhibitor
- Drug overview
- Drug profile
- SWOT analysis
- Clinical trial data
- Clinical attractiveness
- Commercial attractiveness
- Datamonitor drug assessment score card for Dimebon
- Satisfaction of unmet needs
- Forecasts to 2018
- Other drugs with general neuroprotective characteristics
- Memryte - Gonadotrophin releasing hormone
- HF0220 - endogenous human steroid
- Cogane - neurotrophic factor inducer
- T817MA - neurotrophic agent
7. PIPELINE ANALYSIS & FORECASTS: SYMPTOMATIC RELIEF
- Key findings
- Overview for drugs targeting symptomatic relief
- Pipeline summary
- Comparative forecasts
- Aricept SR - acetylcholinesterase inhibitor
- Drug overview
- Drug profile
- SWOT analysis
- Clinical trial data
- Clinical attractiveness
- Commercial attractiveness
- Datamonitor drug assessment score card for Aricept SR
- Satisfaction of unmet needs
- Forecasts to 2018
- Aricept patch - acetylcholinesterase inhibitor
- Drug overview
- Drug profile
- SWOT analysis
- Clinical trial data
- Clinical attractiveness
- Commercial attractiveness
- Datamonitor drug assessment score card Aricept patch
- Satisfaction of unmet needs
- Forecasts to 2018
- Memantine extended-release - NMDA receptor antagonist
- Drug overview
- Drug profile
- SWOT analysis
- Clinical trial data
- Clinical attractiveness
- Commercial attractiveness
- Datamonitor drug assessment score card for memantine extended-release
- Satisfaction of unmet needs
- Forecasts to 2018
- Other drugs targeting symptomatic relief
- Huperzine A - acetylcholinesterase inhibitor
- Mimopezil/Debio9902 SR - acetylcholinesterase inhibitor
- Ispronicline/AZD3480 - neuronal nicotinic receptor agonist
- Pozanicline/ABT-089 - neuronal nicotinic receptor agonist
- R3487 - neuronal nicotinic receptor agonist
- EVP6124 - neuronal nicotinic receptor agonist
- SAM-531 - 5-HT6 receptor antagonist
- SB-742457 - 5-HT6 receptor antagonist
- PRX03140 - 5-HT4 receptor agonist
- CX717 - AMPA receptor agonist
- MK-0249
8. INNOVATIVE EARLY-STAGE APPROACHES
- Key findings
- Delivery across the blood-brain barrier
- Carniotomy-based drug delivery
- Molecular Trojan horse
- Tau immunotherapy
- The future of treatment in Alzheimer' s disease
- Prophylactic treatment
- Biomarkers significantly expand the patient population
BIBLIOGRAPHY
APPENDIX
- Methodology
- Datamonitor forecast methodology
- Contributing experts
TABLES
- Table: Products in Phase II/III clinical development for Alzheimer' s
disease, 2009
- Table: Sales forecasts ($m) for each pipeline drug, 2010 - 18
- Table: Elan' s Alzheimer' s disease late-stage pipeline, 2009
- Table: Pfizer/Wyeth Alzheimer' s disease late-stage pipeline, 2009
- Table: DIAG4 (ICD-10 derived) codes constituting >1% of total brand sales
for drugs approved for Alzheimer' s disease, 2008
- Table: Dementia ICD-10 codes
- Table: Forms of dementia
- Table: Common clinical features in Alzheimer' s disease
- Table: Population size and p revalence rate of Alzheimer' s disease and
other cognitive disorders across the seven major pharmaceutical markets, 2009
- Table: Age-group trends in Alzheimer' s disease prevalence
- Table: Current and projected patient populations (millions) for cognitive
disorders, 2008 - 18
- Table: Alzheimer' s disease prevalence and patient population comparison
across the seven major pharmaceutical markets and BRIC countries, 2009
- Table: Projected Alzheimer' s disease population across the seven major
pharmaceutical markets, the 5EU and the BRIC nations, 2008 - 18
- Table: Leading treatments for Alzheimer' s disease, 2009
- Table: Total brand and indication-specific sales for drugs approved for
Alzheimer' s disease, ($m), 2008
- Table: Percentage of total brand sales attributed to each indication
group, 2004 - 08
- Table: Aricept (donepezil) - drug profile, 2009
- Table: Efficacy of acetylcholinesterase inhibitors as measured by change
in ADAS-Cog above placebo
- Table: Head-to-head clinical trials of Aricept and other
acetylcholinesterase inhibitors
- Table: Comparison of acetylcholinesterase inhibitor treatment response
outcomes, according to a meta-analysis of clinical trials
- Table: Minimum acceptable product profile and target product profile
- Table: Typical Phase III clinical trial design in Alzheimer' s disease, 2009
- Table: Key products in late-stage R&D pipeline targeting beta-amyloid, 2009
- Table: Sales forecasts ($m) for beta-amyloid focused pipeline drugs across
the seven major pharmaceutical markets, 2012 - 18
- Table: Bapineuzumab - drug profile, 2009
- Table: Bapineuzumab vs. the minimum acceptable product profile and target
product profile
- Table: Impacting factors on the revenues of bapineuzumab, 2009 - 18
- Table: Bapineuzumab forecast methodology, US, 2012 - 18
- Table: Bapineuzumab forecast methodology, 5EU, 2012 - 18
- Table: Bapineuzumab forecast methodology, Japan, 2012 - 18
- Table: Bapineuzumab forecast across the seven major markets ($m), 2012 - 18
- Table: Gammagard - drug profile, 2009
- Table: Gammagard vs. minimum acceptable product profile and target product
profile
- Table: Gammagard forecast methodology, US, 2012 - 18
- Table: Gammagard forecast methodology, 5EU, 2012 - 18
- Table: Gammagard forecast methodology, Japan, 2012 - 18
- Table: Gammagard forecast across the seven major markets ($m), 2012 - 18
- Table: Ongoing LY450139 clinical trials
- Table: Key products in late-stage R&D pipeline targeting tau tangles, 2009
- Table: Clinical trial results for high dose of AL-108 (15mg twice a day)
in mild cognitive impairment subjects
- Table: Key products in late-stage R&D pipeline with a general
neuroprotective mechanism, 2009
- Table: Dimebon - drug profile, 2009
- Table: Mean change from baseline on the ADAS-Cog at weeks 12 and 26 in the
intention-to-treat population
- Table: Estimates from Dimebon Staggered Start and NHSS
- Table: Ongoing Dimebon clinical trials, 2009
- Table: Dimebon vs. the minimum acceptable product profile and target
product profile
- Table: Dimebon forecast methodology, US, 2012 - 18
- Table: Dimebon forecast methodology, 5EU, 2012 - 18
- Table: Dimebon forecast methodology, Japan, 2012 - 18
- Table: Dimebon forecast across the seven major markets ($m), 2012 - 18
- Table: Key products in late-stage R&D pipeline providing symptomatic
relief, 2009
- Table: Sales forecasts for pipeline symptomatic treatments across the
seven major pharmaceutical markets, ($m), 2010 - 18
- Table: Aricept SR (donepezil sustained release) - drug profile, 2009
- Table: Aricept SR vs. the minimum acceptable product profile and target
product profile
- Table: Aricept SR forecast methodology, US, 2010 - 18
- Table: Aricept SR forecast methodology, 5EU, 2011 - 18
- Table: Aricept SR forecast methodology, Japan, 2012 - 18
- Table: Aricept SR forecast across the seven major markets, 2010 - 18
- Table: Aricept patch - drug profile, 2009
- Table: Aricept patch vs. the minimum acceptable product profile and target
product profile
- Table: Aricept patch forecast methodology, US, 2010 - 18
- Table: Aricept patch forecast methodology, 5EU, 2010 - 18
- Table: Aricept patch forecast methodology, Japan, 2012 - 18
- Table: Aricept patch forecast across the seven major markets, 2010 - 18
- Table: Memantine extended release - drug profile, 2009
- Table: Memantine extended-release vs. the minimum acceptable product
profile and target product profile
- Table: Memantine extended-release forecast methodology, US, 2010 - 18
- Table: Memantine extended-release forecast methodology, 5EU, 2010 - 18
- Table: Memantine extended-release forecast across the seven major markets,
2010 - 18
- Table: Tracers for beta-amyloid plaques and other hallmarks of Alzheimer' s
disease
- Table: Example of alternative tests to cerebrospinal fluid biomarkers in
neurological conditions
FIGURES
- Figure: Late-stage pipeline Alzheimer' s disease drugs by class, 2009
- Figure: Datamonitor Pipeline Assessment Summary for Alzheimer' s disease,
2009
- Figure: Companies with more than one late-stage product in development of
Alzheimer' s disease, 2009
- Figure: Potential relation between symptom classification and outcomes in
mild cognitive impairment patients
- Figure: Prevalence of mild cognitive impairment (MCI) symptom and outcome
subtypes
- Figure: Patient population estimates derived from different US Alzheimer' s
disease estimates, 2009
- Figure: Projected patient population for all cognitive disorders across
the seven major markets, 2005 - 18
- Figure: Demographic changes in the general US population, 2005 - 18
- Figure: Alzheimer' s disease patient population across the seven major
pharmaceutical markets and BRIC nations, 2005 - 18
- Figure: Percentage change in elderly population (65 years and older), 2009
- 18
- Figure: Percentage of total brand sales Aricept, Namenda, Exelon and
Razadyne (inc ER version sales) for Alzheimer' s disease, other dementia, and
mild cognitive impairment across the seven major markets, 2008
- Figure: Alzheimer' s disease-specific sales revenue generated by Aricept
across the seven major pharmaceutical markets, ($m), 2009
- Figure: Percentage of total Aricept brand sales for each indication group,
2004 - 08
- Figure: Regional distribution of global Alzheimer' s disease-specific sales
for the four drugs approved for Alzheimer' s disease, 2008
- Figure: Alzheimer' s disease-specific sales revenue across the seven major
markets, ($m), 2004 - 08
- Figure: Percentage of total brand sales for each indication group, 2004 -
08
- Figure: Unmet need in Alzheimer' s disease treatment, 2009
- Figure: Cognitive decline of untreated Alzheimer' s disease patients and
patients treated with a symptomatic drug
- Figure: Alzheimer' s disease symptom progression in the presence of a
disease slowing therapy
- Figure: Alzheimer' s disease symptom progression in the presence of a
disease modifying treatment administered at an early stage of the disease due
to better diagnostic tools
- Figure: Alzheimer' s disease symptom progression in the presence of a
disease modifying treatment administered at an early stage of the disease due
to better diagnostic tools
- Figure: Clinical trial designs proposed to determine disease modification
- Figure: Amyloidogenic pathway: formation of toxic beta-amyloid
- Figure: Proposed passive immunization mechanism of action in Alzheimer' s
disease
- Figure: SWOT analysis for bapineuzumab, 2009
- Figure: Bapineuzumab Phase II clinical trial design and results
- Figure: Datamonitor' s competitive positioning analysis of bapineuzumab in
Alzheimer' s disease, 2009
- Figure: Sales forecasts for bapineuzumab in the seven major markets ($m),
2010 - 18
- Figure: SWOT analysis for Gammagard, 2009
- Figure: Datamonitor' s competitive positioning analysis of Gammagard in
Alzheimer' s disease, 2009
- Figure: Sales forecasts for Gammagard (immunoglobulin) in the seven major
markets ($m, 2012 - 18
- Figure: LY450139 Phase II clinical trial design and results
- Figure: SWOT analysis forDimebon, 2009
- Figure: Datamonitor' s competitive positioning analysis of Dimebon in
Alzheimer' s disease, 2009
- Figure: Sales forecasts for Dimebon in the seven major markets ($m), 2012
- 18
- Figure: SWOT analysis for Aricept SR, 2009
- Figure: Datamonitor' s competitive positioning analysis of Aricept SR in
Alzheimer' s disease, 2009
- Figure: Sales forecasts for Aricept SR in the seven major markets, ($m),
2010 - 18
- Figure: SWOT analysis for Aricept patch, 2009
- Figure: Percentage of total sales for Exelon oral and Exelon patch in the
US, 2008
- Figure: Datamonitor' s competitive positioning analysis of Aricept patch in
Alzheimer' s disease, 2009
- Figure: Sales forecasts for Aricept patch in the seven major markets. 2010
- 18 ($m)
- Figure: SWOT analysis for memantine extended-release, 2009
- Figure: Efficacy of memantine extended-release in moderate-to-severe
Alzheimer' s disease
- Figure: Datamonitor' s competitive positioning analysis of memantine
extended-release in Alzheimer' s disease, 2009
- Figure: Sales forecasts for memantine extended-release in the seven major
markets. 2010 - 18 ($m)
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