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

Published by: Datamonitor

Published: Mar. 26, 2008 - 222 Pages


Table of Contents


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


Abstract

Introduction

With the AD market entering a pivotal phase, Datamonitor has conducted several scenario forecasts in order to explore the possible market outlook over the next 10 years. Several pioneering Phase III disease slowing therapies offer blockbuster potential. However, should these drugs fail Phase III trials, generic competition of current therapies will see the market value decline.

Scope

Overview of key marketed brands and late-stage pipeline drugs. Indication-specific sales volume and value forecasts to 2017 under four different scenarios. Identification of future market events that are expected to affect AD drug revenues. Analysis of patient potential, unmet needs and clinical trial design in AD.

Highlights

Datamonitor's base scenario reveals three blockbuster potentially disease slowing drugs in the current late-stage pipeline. Wyeth/Elan's bapineuzumab has potential to generate multi-billion dollar revenues, and become one of the most lucrative drugs in medicine. The entry of potentially disease slowing therapies will not have a significant negative impact on the sales of branded current treatments. Along with the likely use of combined disease slowing and symptomatic treatments, slowing disease progression might actually increase the therapeutic window for symptomatic drugs. Scenario forecasts reveal a future upper limit market value of $12.7 billion to a lower limit value of $1.9 billion across the seven major markets in 2017. The affect on forecast sales revenues of different US AD prevalence rates and the success or failure of clinical programs on each key pipeline drug is explored.

Reasons to Purchase

Appreciate the lucrative potential of disease slowing AD therapies, and the impact of this class on the currently marketed symptomatic drugs. Assess region- (US, Japan and 5EU) and scenario-specific sales forecasts of key late-stage pipeline drugs and marketed brands. Understand unmet needs and opportunities in the AD market based on key opinion leader comments.


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