[Report] Alzheimer's Disease Pipeline & Commercial Insight Market Research, Trends, Analysis TOC

ABOUT DATAMONITOR HEALTHCARE
- About the Central Nervous System pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY
- Scope of the analysis
- Contributing experts
- Datamonitor insight into the Alzheimer' s disease market
  - Scenario forecasts - a pivotal point in the Alzheimer' s disease market
  - Base scenario
    - Total market forecast
    - Drug forecasts
    - Key pipeline drug assessment
- Related reports
CHAPTER 2 MARKET OVERVIEW AND POTENTIAL
- Market and disease definition
  - Definition of Alzheimer' s disease market
- Current market value
  - 5- year AD market size
    - Growth stimulated by Namenda uptake
    - The US has dominated sales over the last 5 years
  - Drug sales split by AD and non-AD indications
    - Percentage of AChEIs and Namenda sales attributed to AD
    - Total all-indication sales of AChEIs and Namenda
- Market forecasts
  - Four possible future market scenarios are presented
    - 1. Base scenario
    - 2. No bapineuzumab scenario
    - 3. No potentially disease slowing therapy (PDST) scenario
    - 4. High US prevalence scenario
- Epidemiology of Alzheimer' s disease
  - Prevalence
    - Datamonitor' s AD epidemiology methodology
  - Comparison with other reported AD prevalence rates in the US
  - Diagnosis and presentation rate
- Unmet need in AD
  - Disease modifying/slowing treatments
  - Improved symptomatic efficacy
  - Better diagnostic tools
  - Disease subtype targeted therapy
- Etiology of AD
  - Beta-amyloid hypothesis
  - Tau neurofibrillary tangles
  - Neuronal death caused by beta-amyloid deposition and neurofibrillary tangles formation
- Diagnosis and treatment options
  - Diagnosis techniques
    - Diagnosis still poses a large challenge but there is hope on the horizon
  - Diagnostic guidelines for AD are provided by multiple sources
    - Severity of AD is often assessed using symptomatic subscales
  - A holistic view of AD progression is lacking
- Drug classes used to treat AD
  - Acetylcholinesterase inhibitors
  - NMDA receptor antagonist: memantine (Namenda/Ebixa/Axura)
CHAPTER 3 BRAND DYNAMICS AND LEADING COMPARATOR THERAPIES
- Marketed brands overview
  - Historical and forecasted sales of current marketed brands and reformulations
- Aricept (donepezil) - Current gold standard AD treatment
  - Drug overview
  - Forecast
    - Drug assessment
  - SWOT analysis
  - Clinical trial data
    - 12-week study
    - 24-week study
  - Aricept SR
    - Drug overview
    - Datamonitor comments
- Razadyne (galantamine)
  - Drug overview
  - Forecast
  - SWOT analysis
- Oral Exelon and Exelon patch (rivastigmine)
  - Drug overview
  - Forecast
  - SWOT analysis
- Namenda (memantine)
  - Drug overview
  - Forecast
  - SWOT analysis
  - Once daily Namenda reformulation
CHAPTER 4 FORECAST ANALYSIS
- Key events
  - New product launches and reformulations
  - Patent expiries
    - Aricept (donepezil)
    - Razadyne (galantamine)
    - Exelon (rivastigmine)
    - Namenda (memantine)
- Data definitions, limitations and assumptions
  - Standard units
  - Japanese market data
  - Derivation of sales forecasts and pricing trends
- Forecast methodology
CHAPTER 5 GLOBAL OPPORTUNITIES AND THREATS
- Overview
- Key opportunities
  - Ageing population
    - Changing population demographic - ageing population
    - AD patient population grows dramatically as the general population ages
  - Poor current therapies leave room for new market entrants
  - Improved diagnostic tools facilitate indication expansions and improve treatment rates
- Key threats
  - Unproven neurodegenerative pathway introduces high risk
  - Generic incursion
CHAPTER 6 PIPELINE OVERVIEW - R&D DYNAMICS AND APPROACH
- Late-stage pipeline overview
  - Revenue potential of three key drugs
  - Clear movement towards disease modification in the late-stage pipeline
- Clinical trial endpoints
  - Alzheimer' s Disease Assessment Scale-cognitive portion (ADAS-Cog)
  - Neuropsychological Test Battery (NTB)
  - Mini-Mental Status Exam (MMSE)
  - Clinician' s Interview-Based Impression of Change
  - Severe Impairment Battery
  - Alzheimer' s Disease Cooperative Study: Activities of Daily Living (ADCS-ADL)
  - Neuropsychiatric Inventory
  - Clinical Dementia Rating
CHAPTER 7 POTENTIALLY DISEASE SLOWING THERAPIES - LATE-STAGE DRUG ANALYSIS & FORECASTS
- Beta-amyloid modulating drug class
  - Flurizan (tarenflurbil)
    - Drug overview
    - Forecasts to 2017
    - Marketing factors
    - Patient potential
    - Satisfaction of unmet needs
    - Clinical trial data
    - Ongoing clinical trial program
  - Bapineuzumab (AAB-001)
    - Drug overview
    - Forecasts to 2017
    - Marketing factors
    - Patient potential
    - Satisfaction of unmet needs
    - Clinical trial data and mode of action
    - Ongoing clinical trial program
  - PBT-2
    - Drug overview
    - Clinical trial data
    - Ongoing clinical trial program
  - Other beta-amyloid modulating drugs
    - ACC-001 - immunization
    - PF-4360365- immunization
    - LY2062430- immunization
    - NIC5-15 - beta-amyloid modulation
    - ELND005 (AZD-103) - beta-amyloid modulation
    - LY450139 - beta-amyloid modulation
- Drugs targeting alternative potentially disease modifying modes of action
  - Dimebon
    - Drug overview
    - Forecasts to 2017
    - Marketing factors
    - Patient potential
    - Satisfaction of unmet needs
    - Clinical trial data
    - Ongoing clinical trials program
  - Rosiglitazone XR
    - Clinical trial data
    - Ongoing clinical trial program
  - Memryte
    - Drug overview
    - Clinical trial data
  - PRX-03140
    - Drug overview
    - Clinical trial data - Phase IIa clinical trial
  - Cogane
    - Drug overview
    - Clinical trial data
  - Other drugs targeting disease modifying modes of action
    - Ketasyn
    - AL-108
    - HF0220
    - Azilect (rasagiline)
    - Ampakine (CX717)
    - MND-21
    - Cereact (ONO-2506PO)
    - PF-4494700 (TTP488)
- Recently discontinued products
  - Alzhemed
    - Drug overview
    - Phase III trial results
    - The future for Alzhemed, a nutraceutical
CHAPTER 8 SYMPTOMATIC TREATMENTS - LATE-STAGE DRUG ANALYSIS & FORECASTS
- Acetylcholinesterase Inhibitors (AChEIs)
  - Huperzine A
    - Drug overview
    - Clinical trial data
    - Ongoing clinical trial program
  - Debio 9902
    - Drug overview
    - Ongoing clinical trial program
- NMDA receptor antagonists
  - Neramexane
- Drugs targeting alternative symptomatic modes of action
  - MEM 3454
    - Drug overview
    - Clinical trial data
  - Other drugs targeting alternative symptomatic modes of action
    - AZD3480 (ispronicline, TC-1734)
    - MK-0249
    - AC-3933
    - Lecozotan
BIBLIOGRAPHY
- Journals
- Websites
- Datamonitor Reports
APPENDIX
- Report methodology
  - Contributing experts
- About Datamonitor
  - About Datamonitor Healthcare
  - About the CNS analysis team
  - Disclaimer
- List of Tables
  - Table 1: Percentage of total drugs sales for AD, 2003-07
  - Table 2: Population size and prevalence rate of AD across the 7MM, 2008
  - Table 3: Prevalence of Alzheimer' s disease by gender and age, 2008
  - Table 4: DSM-IV criteria for Alzheimer' s disease type dementia
  - Table 5: Forecast launch dates in the US, 5EU and Japan
  - Table 6: Patent expiry dates for Aricept, 2010-12
  - Table 7: Patent expiry dates for Razadyne, 2008-2012
  - Table 8: Patent expiry dates for Exelon, 2011-12
  - Table 9: Patent expiry dates for Namenda, 2010-14
  - Table 10: Summary of key opportunities and threats to the future AD market
  - Table 11: Comparison of AChEI treatment response outcomes, according to a meta-analysis of clinical trials, 2008
  - Table 12: Key potentially disease slowing/modifying pipeline drugs in late-stage development for AD, 2008
  - Table 13: Key symptomatic pipeline drugs in late-stage development for AD, 2008
  - Table 14: Measures used for clinical efficacy endpoints in AD
  - Table 15: Flurizan base scenario forecast ($m), US, 2017
  - Table 16: Flurizan base scenario forecast ($m), 5EU, 2017
  - Table 17: Flurizan base scenario forecast ($m), Japan, 2017
  - Table 18: Key events for Flurizan, 2008-2017
  - Table 19: US sales revenue ($m) scenario matrix for Flurizan
  - Table 20: 5EU sales revenue ($m) scenario matrix for Flurizan
  - Table 21: Japan sales revenue ($m) scenario matrix for Flurizan
  - Table 22: Bapineuzumab base scenario forecast ($m), US, 2017
  - Table 23: Bapineuzumab base scenario forecast ($m), 5EU, 2017
  - Table 24: Bapineuzumab base scenario forecast ($m), Japan, 2017
  - Table 25: Key events for bapineuzumab, 2008-2017
  - Table 26: US sales revenue ($m) scenario matrix for bapineuzumab
  - Table 27: 5EU sales revenue ($m) scenario matrix for bapineuzumab
  - Table 28: Japan sales revenue ($m) scenario matrix for bapineuzumab
  - Table 29: Cost of other mAbs (or mAb-related fusion proteins) in the US
  - Table 30: Cost-benefit analysis of bapineuzumab, 7MM
  - Table 31: Savings following patent expiry of symptomatic treatments for AD, US
  - Table 32: Key events for Dimebon, 2008-2017
  - Table 33: Dimebon base scenario forecast ($m), US, 2017
  - Table 34: Dimebon base scenario forecast ($m), 5EU, 2017
  - Table 35: Bapineuzumab base scenario forecast ($m), Japan, 2017
  - Table 36: US sales revenue ($m) scenario matrix for Dimebon
  - Table 37: 5EU sales revenue ($m) scenario matrix for Dimebon
  - Table 38: Japan sales revenue ($m) scenario matrix for Dimebon
  - Table 39: Datamonitor drug assessment parameters for AD market
- List of Figures
  - Figure 1: Base scenario - historical and forecast total AD market, 2004-2017
  - Figure 2: Historical (2006-07) and forecast (2008-17) AD sales revenue for key marketed and pipeline drugs across the 7MM
  - Figure 3: Drug assessment summary overview of key marketed and pipeline Alzheimer' s disease drugs, 2008
  - Figure 4: AD-specific sales revenue, 7MM, 2003-07
  - Figure 5: AD-specific sales revenue ($ billion) by region, 2004-07
  - Figure 6: Proportion of drug sales revenue for AD across the 7MM, E2007
  - Figure 7: Percentage of drug sales for AD across the 7MM, 2003-07
  - Figure 8: 7MM all indication sales revenue, 2006 and E2007
  - Figure 9: Base scenario - historical and forecast total AD market, 2004-2017
  - Figure 10: No bapineuzumab - AD total market forecast, 2004-2017
  - Figure 11: No PDST - AD total market forecast, 2004-2017
  - Figure 12: High US prevalence - AD total market forecast, 2004-2017
  - Figure 13: Overview of Datamonitor' s AD population size methodology, 2008
  - Figure 14: Comparison of data from individual AD incidence studies
  - Figure 15: Key unmet needs in AD, 2008
  - Figure 16: Cognitive decline of untreated AD patients, and patients treated with a symptomatic drug
  - Figure 17: AD symptom progression in the presence of a disease slowing therapy
  - Figure 18: AD symptom progression in the presence of a superior symptomatic drug
  - Figure 19: AD symptom progression in the presence of a disease modifying treatment administered at an early stage of the disease due to better diagnostic tools
  - Figure 20: Amyloidogenic pathway: Formation of toxic beta-amyloid
  - Figure 21: Base scenario: marketed AD drug and reformulation revenue forecasts, 2004-2017
  - Figure 22: Aricept sales revenue ($m) across the 7MM, 2004-07, 2008-2017 forecasts
  - Figure 23: Drug assessment of the commercial and clinical attractiveness of Aricept, 2008
  - Figure 24: Aricept SWOT analysis, 2008
  - Figure 25: Razadyne sales revenue in the US and 5EU ($m), 2004-07
  - Figure 26: Razadyne/Razadyne SR sales revenue ($m) across the 7MM, 2004-07, 2008-2017 forecasts
  - Figure 27: Razadyne SWOT analysis, 2008
  - Figure 28: The Exelon Patch
  - Figure 29: Exelon and Exelon patch sales revenue ($m) across the 7MM, 2004-07, 2008-2017 forecasts
  - Figure 30: SWOT analysis of Exelon franchise (i.e. oral and patch), 2008
  - Figure 31: Namenda and Namenda ER sales revenue ($m) across the 7MM, 2004-07, 2008-2017 forecasts
  - Figure 32: Namenda SWOT analysis, 2008
  - Figure 33: Impact of each key event on the AD market across the seven major markets, 2008-2017
  - Figure 34: Population distribution by age across the 7MM, 2005-2045
  - Figure 35: Ageing population across 7MM, 2005-2050
  - Figure 36: Forecast AD population, 2005-2050
  - Figure 37: Impact of generic incursion on 7MM branded drug sales, 2004-2017
  - Figure 38: Key late-stage pipeline overview in Datamonitor' s base scenario, 2008-2017
  - Figure 39: Number of symptomatic and potential disease slowing late-stage pipeline drugs in development for AD, 2008
  - Figure 40: Forecast Flurizan sales revenue ($m) across the 7MM, 2008-2017
  - Figure 41: Drug assessment of the commercial and clinical attractiveness of Flurizan, 2008
  - Figure 42: Cognitive status of an AD patient
  - Figure 43: Randomized withdrawal trial design
  - Figure 44: Staggered start trial design
  - Figure 45: Bapineuzumab sales revenue ($m), 2008-2017
  - Figure 46: Drug assessment of the commercial and clinical attractiveness of bapineuzumab, 2008
  - Figure 47: Equilibrium of beta-amyloid in the brain and the rest of the body
  - Figure 48: The effect of bapineuzumab on distribution of beta-amyloid
  - Figure 49: Dimebon sales revenue ($m), 2008-2017
  - Figure 50: Drug assessment of the commercial and clinical attractiveness of Dimebon, 2008

Pipeline and Commercial Insight: Alzheimer's Disease - Scenario forecasts reveal vast market potential

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