PharmaPoint: Alzheimer’s Disease - US Drug Forecast and Market Analysis to 2022

Summary

GlobalData has released its new Country report, “PharmaPoint: Alzheimer’s Disease - US Drug Forecast and Market Analysis to 2022”. There are no long-term effective therapies for Alzheimer’s Disease (AD), so this remains at the top of the list for unmet needs. While physicians agree that symptomatic therapies are relatively safe and effective, these therapies are still lacking because of they cannot maintain their effects and lack mechanisms that alter the course of the disease.


In recent years, the US has given AD the attention it deserves, and we expect that this will result in a push for increased rates of diagnosis. Because the “Baby-Boomer” generation is entering into its senior years, the AD market will see significant growth throughout the forecast period. New treatments anticipated for patients with presymptomatic AD or MCI will also increase the size of the market, since these populations were not targeted with the available symptomatic treatments. GlobalData will provide estimates for the approximate size of these populations, which are slated to integrate into the AD consumer market when disease-modifying drugs become available, in an upcoming report.

Scope

- Overview of Alzheimer’s Disease, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.

- Detailed information on the key drugs in the US including product description, safety and efficacy profiles as well as a SWOT analysis.

- Sales forecast for the top drugs in the US from 2012-2022.

- Analysis of the impact of key events as well the drivers and restraints affecting the US Alzheimer’s Disease market.

Reasons to buy

- Understand and capitalize by identifying products that are most likely to ensure a robust return

- Stay ahead of the competition by understanding the changing competitive landscape for Alzheimer’s Disease

- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential

- Make more informed business decisions from insightful and in-depth analysis of drug performance

- Obtain sales forecast for drugs from 2012-2022 in the US

Table Of Contents

Table of Contents

1 Table of Contents 5
1.1 List of Tables 9
1.2 List of Figures 11
2 Introduction 12
2.1 Catalyst 12
2.2 Related Reports 13
3 Disease Overview 15
3.1 Etiology and Pathophysiology 16
3.1.1 Etiology 16
3.1.2 Pathophysiology 19
3.2 Symptoms 31
4 Disease Management 33
4.1 Diagnosis 33
4.1.1 Probable Alzheimer’s Disease Dementia 34
4.1.2 Possible AD Dementia 35
4.1.3 Probable AD Dementia with Evidence of AD Pathophysiological Process 35
4.1.4 Possible Alzheimer’s Dementia with Evidence of the Alzheimer’s Disease Pathophysiological Process 36
4.1.5 Preclinical AD 36
4.1.6 Mild Cognitive Impairment 37
4.2 Treatment Overview 39
4.3 United States 42
4.3.1 Diagnosis 42
4.3.2 Clinical Practice 42
5 Competitive Assessment 44
5.1 Overview 44
5.2 Strategic Competitor Assessment 44
5.3 Product Profiles - Major Brands 46
5.3.1 Aricept (donepezil hydrochloride) 46
5.3.2 Exelon (rivastigmine, rivastigmine tartrate) 50
5.3.3 Razadyne (galantamine hydrobromide) 55
5.3.4 Namenda (memantine hydrochloride) 59
6 Opportunity and Unmet Need 63
6.1 Unmet Needs Overview 63
6.1.1 Public Awareness 65
6.1.2 Specialized Institutions at Local Levels 66
6.1.3 Screening and Diagnosis 66
6.1.4 Early Intervention 67
6.1.5 Improved Clinical Trial Design 68
6.1.6 Effective Therapy 69
6.1.7 Behavioral Treatments 70
6.2 Gap Analysis 70
6.2.1 Disease Prevention 71
6.2.2 Diagnosis from Biomarkers 72
6.2.3 Behavioral Therapies 73
7 Pipeline Assessment 74
7.1 Overview 74
7.2 Early-Stage Pipeline Assessment 74
7.3 AD Pipeline by Mechanism of Action 77
7.4 Enzymatic Processing 77
7.5 Immunization 78
7.6 Anti-Aggregation 79
7.7 “Me-Too” 79
7.8 Novel Therapeutic Approaches 80
7.9 Technology Trends Analytic Framework 81
7.10 Promising Drugs in Clinical Development 82
7.10.1 Namenda XR 83
7.10.2 Arimenda 86
7.10.3 Gammagard Liquid 10% 89
7.10.4 Solanezumab 91
7.10.5 Gantenerumab 95
7.10.6 Crenezumab 100
7.10.7 TRx0237 103
7.10.8 MK-8931 107
7.10.9 EVP-6124 110
7.10.10 Lu AE58054 113
8 Market Outlook 117
8.1 United States 117
8.1.1 Forecast 117
8.1.2 Key Events 121
8.1.3 Drivers and Barriers 121
9 Appendix 125
9.1 Bibliography 125
9.2 Abbreviations 140
9.3 Methodology 147
9.4 Forecasting Methodology 147
9.4.1 Diagnosed AD patients 148
9.4.2 Percent Drug-treated Patients 148
9.4.3 Drugs Included in Each Therapeutic Class 149
9.4.4 Launch and Patent Expiry Dates 149
9.4.5 General Pricing Assumptions 150
9.4.6 Individual Drug Assumptions 150
9.4.7 Generic Erosion 156
9.4.8 Pricing of Pipeline Agents 156
9.5 Physicians and Specialists Included in this Study 158
9.6 About the Authors 159
9.6.1 Author 159
9.6.2 Global Head of Healthcare 160
9.7 About GlobalData 161
9.8 Disclaimer 161



List of Tables

Table 1:Symptoms of AD 32
Table 2:Guidelines for the Treatment of AD 39
Table 3:Most Prescribed Drugs for AD by Class in the Global Markets, 2012 40
Table 4:Leading Branded Treatments for AD, 2013 45
Table 5:Product Profile - Aricept 48
Table 6:Aricept SWOT Analysis, 2013 50
Table 7:Product Profile- Exelon 52
Table 8:Exelon SWOT Analysis, 2012 55
Table 9:Product Profile - Razadyne 56
Table 10:Razadyne SWOT Analysis, 2013 59
Table 11:Product Profile- Namenda 60
Table 12:Namenda SWOT Analysis, 2013 62
Table 13:Overall Unmet Needs - Current Level of Attainment 64
Table 14:Clinical Unmet Needs - Gap Analysis, 2013 71
Table 15:Technology Trends Analytic Framework for the AD Pipeline, 2012 81
Table 16:Comparison of Therapeutic Classes in Development for AD, 2013 82
Table 17:Comparison of Therapeutic Classes in Development for AD, 2013 83
Table 18:Product Profile - Namenda XR 84
Table 19:Namenda XR SWOT Analysis, 2013 86
Table 20:Product Profile - Arimenda 87
Table 21:Arimenda SWOT Analysis, 2013 89
Table 22:Product Profile - Gammagard Liquid 10% 90
Table 23:Product Profile - Solanezumab 92
Table 24:Solanezumab SWOT Analysis, 2013 95
Table 25:Product Profile - Gantenerumab 96
Table 26:Gantenerumab SWOT Analysis, 2013 99
Table 27:Product Profile - Crenezumab 100
Table 28:Crenezumab SWOT Analysis, 2013 103
Table 29:Product Profile - TRx0237 104
Table 30:TRx0237 SWOT Analysis, 2013 106
Table 31:Product Profile - MK-8931 107
Table 32:MK-8931 SWOT Analysis, 2013 110
Table 33:Product Profile - EVP-6124 111
Table 34:EVP-6124 SWOT Analysis, 2013 113
Table 35:Product Profile - Lu AE58054 114
Table 36:Lu AE58054 SWOT Analysis, 2013 116
Table 37:Sales Forecasts ($m) for AD in the United States, 2012-2022 119
Table 38:Key Events Impacting Sales for AD in the United States, 2012-2022 121
Table 39:AD Market in the United States - Drivers and Barriers, 2012-2022 121
Table 40:Key Launch Dates 149
Table 41:Key Patent Expirations 150



List of Figures

Figure 1:Atrophy of the Brain in AD 21
Figure 2:Key Pathological Features in AD Versus a Healthy Neuron 23
Figure 3:Non-Amyloidogenic Metabolism of APP 25
Figure 4:Amyloidogenic Metabolism of APP 26
Figure 5:Neurofibrillary Tangles 28
Figure 6:Oxidative Damage Due to Free Radicals 30
Figure 7:Strategic Competitor Assessment of the Marketed Products in AD, 2013 46
Figure 8:AD - Pipeline Drugs by Target, 2012 76
Figure 9:Competitive Assessment of Late-Stage Pipeline Agents in AD, 2012-2022 82
Figure 10:Sales for AD in the United States by Drug Class, 2012-2022 120

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