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Diseases

Pipeline and Commercial Insight: Alzheimer's Disease

Scenario Forecasts Reveal Vast Market Potential

Publication Date March 2008
Publisher Datamonitor
Product Type Report
Pages 222
ISBN Number not applicable
Product Code DAT01401

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Summary

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.

Contents

  • 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