Pipeline and Commercial Insight: Alzheimer's Disease - Market cautiously awaits the first generation of disease-modifying therapies

Introduction

Current management of Alzheimer’s disease is wholly inadequate, providing only symptomatic benefit to patients in whom the underlying neurodegeneration continues unabated. However, with the launch of the first disease-modifying drugs, combined with the availability of predictive biomarker tests that enable earlier diagnosis, the Alzheimer’s disease treatment paradigm is set to change radically.

Features and benefits

Forecasts of Alzheimer's disease patient population numbers based on a comprehensive epidemiology review.
Breakdown of historic (2005-09) and future (2010-19) prescription sales across the seven major markets consisting of the US, Japan, and 5EU.
Review of the Alzheimer's disease drug pipeline dynamics, including detailed profiles of key late-stage products.
Commercial and clinical assessment of key late-stage pipeline drugs, with key opinion leader comment and region-specific sales forecasts to 2019.
Analysis of current treatment approaches, patient acquisition and clinical unmet needs.

Highlights

The value of the Alzheimer’s disease market across the seven major markets was $4.7bn in 2009 and is forecast to reach $11.9bn by 2019. Future market growth is set to be driven by the first disease-modifying drugs, given their significant price premium, likely therapeutic role as an adjunctive and potential utility in prodromal Alzheimer's disease.

Datamonitor forecasts that the current late-stage pipeline will yield three blockbusters, but this is by no means guaranteed considering the high risk of failure in Phase III Alzheimer’s disease trials. Of the pipeline drugs, Datamonitor believes that bapineuzumab and solanezumab have the most commercial and clinical potential.

Datamonitor expects the symptomatic market will remain active in this disease. New symptomatic entrants to the market will include Aricept patch and the first-in-class 5-HT6 receptor antagonist SB-742457.

Your key questions answered

Who will be the winners and losers in the future Alzheimer's disease market?
What are the commercial prospects of potentially disease-modifying therapies in Alzheimer's disease patients over the next 10 years?
Is the market still receptive to drugs with a purely symptomatic mode of action, in light of the impending availability of generic donepezil?
How will biomarker tests and novel therapeutics affect the way Alzheimer's disease is treated? How can this be exploited by drug developers?

TABLE OF CONTENTS

Overview 1
Catalyst 1
Summary 1
About Datamonitor Healthcare 2
About the central nervous system pharmaceutical analysis team 2
Executive Summary 3
Strategic scoping and focus 3
Datamonitor insight into the Alzheimer’s disease market 3
Related reports 5
Upcoming related reports 5

1. Patient Potential 10
Key findings 10
Current treatment options 11
Unmet need in Alzheimer’s disease 12
Diagnosis rate of Alzheimer’s disease 22

2. Epidemiology 25
Introduction 25
Key findings 25
Disease definition, classification and diagnosis criteria 26
Risk factors 28
Co-morbidities 31
Global variation and temporal trends 31
Epidemiological forecasting of Alzheimer’s disease 31
Results 34
Discussion 36

3. Market Overview 38
Key findings 38
Market definition for this report 39
Seven major markets 39
Rest of the world snapshot 47
Patient acquisition process 50
Key developers 53

4. Brand Dynamics 58
Key findings 58
Overview of competitive landscape 59
Reimbursement: tiering of key brands 60
Aricept (donepezil; Eisai/Pfizer) 62
Exelon (rivastigmine; Novartis) 66
Razadyne (galantamine; Johnson & Johnson/Shire) 71
Namenda (memantine; Forest/Merz/Lundbeck) 75

5. Pipeline Overview and R&D Dynamics 81
Key findings 81
Pipeline overview 82
Clinical trial design in Alzheimer’s disease 86

6. Pipeline Drug Analysis & Forecasts: Drugs Targeting Beta-Amyloid 93
Key findings 93
Overview of drugs targeting beta-amyloid 94
Definition of current comparator therapy 102
Bapineuzumab (AAB-001; Elan/Johnson & Johnson/Pfizer) 103
Gammagard (immune globulin intravenous [human]; Baxter) 116
LY2062430 (solanezumab; Eli Lilly) 126
ELND005 (scyllo-inositol; Elan/Transition Therapeutics) 136
Other drugs targeting beta-amyloid 143
Late-stage development compounds recently discontinued 156

7. Pipeline Drug Analysis & Forecasts: Drugs Targeting Tau 158
Key findings 158
Overview for drugs targeting tau 159
Definition of current comparator therapy 162
Rember (methylthioninium chloride; TauRx Pharmaceuticals) 162
Other drugs targeting tau hyperphosphorylation 171

8. Pipeline Drug Analysis & Forecasts: General Neuroprotection 174
Key findings 174
Overview for general neuroprotective drugs 175
Definition of current comparator therapy 175
Dimebon (latrepirdine; Pfizer/Medivation) 176
Other general neuroprotective drugs 184

9. Pipeline Drug Analysis & Forecasts: Symptomatic Relief 191
Key findings 191
Overview for drugs targeting symptomatic relief 192
Definition of current comparator therapy 197
Aricept patch (transdermal donepezil patch; Eisai/Teikoku USA) 198
SB-742457 (GlaxoSmithKline) 205
Other symptomatic drugs 214

10. Innovative Early-Stage Approaches 224
Key findings 224
Drug delivery across the blood-brain barrier 225
Tau immunotherapy 226
Neuroregeneration 227
The future of treatment in Alzheimer’s disease 228
Bibliography 236
Patient potential 236
Epidemiology 237
Market overview 240
Brand dynamics 241
Pipeline overview and R&D dynamics 242
Pipeline drug analysis & forecasts: drugs targeting beta-amyloid 243
Pipeline drug analysis & forecasts: drugs targeting tau 248
Pipeline drug analysis & forecasts: general neuroprotection 250
Pipeline drug analysis & forecasts: symptomatic relief 252
Innovative early-stage approaches 255

Appendix 256
Appendix 258
Forecasting assumptions 258
Methodology 259
Contributing experts 272
About Datamonitor 273
Datamonitor consulting 274
Disclaimer 276