Alzheimer’s Disease Therapeutics in Major Developed Markets to 2021 - Aging Population and Improved Disease Understanding Increase Demand for Disease Modifying Agents

GBI Research
144 Pages - GBI10535
$4,995.00

Summary

Alzheimer's Disease (AD) is an irreversible, progressive neurodegenerative disease, characterized by cognitive impairment, memory loss and functional decline. Symptoms typically begin to first appear in patients in their mid-sixties, with symptoms appearing in varying stages. The pathological features of AD comprise histopathological changes within the brain. Mild Cognitive Impairment (MCI) is a heterogeneous condition between normal cognition and dementia, whereby cognitive changes in mental abilities, such as memory or thinking, are affected. Almost all cases of AD begin with MCI, but it should be noted that not all patients with MCI go on to develop AD.

Although there is a high degree of failure and uncertainty within the R&D of AD drugs, the number of drugs in the pipeline is considerably high at 559. The majority of the pipeline products are novel drugs, with a total of seven repositioned and five generic drugs. This shows advancement in the progression of the different molecules being developed as therapeutic agents within the AD pipeline.

Scope

The AD market has a lack of therapeutic options.
 - Which classes of drug dominate the market?
 - What newly approved therapies have entered the market?
 - How do the leading marketed therapies compare clinically?
 - How will the new therapies be positioned in the treatment of AD?
 - How have selected late-stage pipeline therapies performed in clinical trials?
The pipeline contains a range of molecule types and molecular targets, including those that are well established in AD, and novel, first-in-class therapies.
 - Which molecular targets appear most frequently in the pipeline?
AD clinical trials have an overall attrition rate of 94%.
 - What are the failure rates for individual Phases of clinical development?
 - How do AD clinical trial characteristics, including failure rate, duration, and size compare against respiratory and industry averages?
The AD market is forecast to rise from a value of $5.2 billion in 2014 to $11.3 billion in 2021, at a CAGR of 11.8% across the eight major markets assessed.
 - How much of a role will disease prevalence and new product approvals play in market growth?
 - Will generic competition have a significant impact on the market over the forecast period?
There have been 170 licensing deals and 104 co-development deals pertaining to AD products since 2006.
 - Which territories show the most deal activity?
 - What were the trends in deal completion by product stage of development?
 - What were the conditions of the key licensing or co-development deals to take place in AD?

Reasons to buy

This report will allow you to -
- Understand the current clinical and commercial landscape through a comprehensive study of disease pathogenesis, diagnosis, prognosis, and the current treatment algorithm used in AD.
- Assess the safety and efficacy of current treatment options, with extensive product profiles on prominent marketed therapies, and a heatmap directly comparing safety and efficacy data.
- Analyze the AD pipeline and stratify by stage of development, molecule type, and molecular target. The most promising late-stage therapies are profiled and assessed in terms of clinical performance and competitiveness, alongside a single-product forecast.
- Predict growth in market size in eight major markets, with in-depth market forecasting from 2014 to 2021. The forecasts will provide an understanding of how epidemiology trends, new drug entries, and patent expirations will influence market value.
- Identify commercial opportunities in the AD deals landscape by analyzing trends in licensing and co-development deals, and by profiling the most significant deals that have occurred in this indication in recent years.

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1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 6
1.2 List of Figures 7
2 Introduction 9
2.1 Disease Introduction 9
2.2 Epidemiology 9
2.3 Symptoms 10
2.4 Etiology 12
2.5 Pathophysiology 12
2.6 Disease Stages 13
2.7 Diagnosis 14
2.8 Prognosis 17
2.9 Treatment 18
2.9.1 Treatment Algorithm 18
2.9.2 Mild-to-Moderate AD 20
2.9.3 Moderate-to-Severe AD 21
3 Marketed Products 22
3.1 Aricept (donepezil) - Eisai 22
3.2 Exelon (rivastigimine) - Novartis 22
3.3 Razadyne (galanatamine) - Janssen 23
3.4 Namenda/Ebixa/Axura/Abixa (memantine), Merz Pharma/Lundbeck/Forest/Daiichi Sankyo 23
3.5 Cognex (tacrine) - Shiniogi 24
3.6 Namzaric (memantine ER + donepezil), Actavis-Adamas 24
4 Heat Map - Marketed Products Overview 25
5 Pipeline Product Developments 26
5.1 The Pipeline Development Landscape 26
5.2 Mechanisms of Action in the Pipeline 27
5.3 Clinical Trials 31
5.3.1 Failure Rate 31
5.3.2 Clinical Trial Duration 32
5.3.3 Clinical Trial Size 34
5.3.4 Competitive Clinical Trials Metric Analysis 38
5.4 Promising Pipeline Molecules 39
5.4.1 MK-8931 - Merck & Co. 39
5.4.2 LMTX (methylthioninium chloride) - TauRX Therapeutics 40
5.4.3 AZD3293 - AstraZeneca 41
5.4.4 AB1010 - AB Science 42
5.4.5 BIIB037 - Biogen 43
5.4.6 TP488 - vTv Therapeutics 44
5.4.7 EVP-6124 - FORUM Pharmaceuticals 45
5.4.8 LuAE58054 - Lundbeck 46
5.4.9 Gantenerumab (R-1540/RG-1450) - Roche 47
6 Heat Map - Pipeline Products Overview 50
7 Market Forecast to 2021 51
7.1 Geographical Markets 51
7.1.1 Global Market 51
7.1.2 North America 55
7.1.3 European Union Five 61
7.1.4 Japan 68
8 Drivers and Barriers 74
8.1 Drivers 74
8.1.1 Rising Prevalence 74
8.1.2 Increasing Public and Policy-Maker Awareness 74
8.1.3 Innovation in Pipeline 74
8.1.4 Growing Understanding of AD Pathophysiology 74
8.2 Barriers 74
8.2.1 Sales Erosion by Generics 74
8.2.2 High Clinical Failure RatesAD has a particularly high clinical trial failure rate. 75
8.2.3 Drug Testing in Patients with Established AD and Advanced Neurodegeneration 75
8.2.4 Low Diagnosis and Treatment Rate 75
9 Strategic Consolidations 76
9.1 Licensing Deals 76
9.1.1 Cephalon Enters into Licensing Agreement with Mesoblast 80
9.1.2 Lundbeck Enters into Licensing Agreement with Otsuka 80
9.1.3 Roche Enters into Licensing Agreement with Prothera 80
9.1.4 GlaxoSmithKline Enters into Licensing Agreement with AFFiRiS 81
9.2 Major Co-development Deals 81
9.2.1 Lundbeck Enters into Co-development Agreement with Otsuka 85
9.2.2 GlaxoSmithKline Enters into Agreement with EPIX Pharma 85
9.2.3 Evotec Enters into Co-development Agreement with Roche 86
9.2.4 Pfizer Enters into Co-development Agreement with Medivation 86
10 Appendix 87
10.1 All Pipeline Drugs by Phase 87
10.1.1 Discovery 87
10.1.2 Preclinical 96
10.1.3 Phase I 116
10.1.4 Phase II 119
10.1.5 Phase III 122
10.1.6 Market Forecasts to 2021 124
10.2 Bibliography 133
10.3 Abbreviations 139
10.4 Research Methodology 140
10.4.1 Secondary Research 141
10.4.2 Marketed Product Profiles 141
10.4.3 Late-Stage Pipeline Candidates 141
10.4.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 141
10.4.5 Product Competitiveness Framework 142
10.4.6 Pipeline Analysis 142
10.4.7 Forecasting Model 143
10.4.8 Deals Data Analysis 144
10.5 Contact Us 144
10.6 Disclaimer 144

1.1 List of Tables
Table 1: Alzheimer’s Disease Therapeutics Market, Symptoms of Alzheimer’s Disease at Different Stages of Disease 11
Table 2: Alzheimer’s Disease Therapeutics Market, Symptoms of Mild Cognitive Impairment 11
Table 3: Alzheimer’s Disease Therapeutics Market, Global Deterioration Scale for Alzheimer’s Disease 14
Table 4: Alzheimer’s Disease Therapeutics Market, Mini-Mental State Exam 15
Table 5: Alzheimer’s Disease Therapeutics Market, Alzheimer’s Disease Assessment Scale Cognitive Subscale 16
Table 6: Alzheimer’s Disease Therapeutics Market, Mild Cognitive Impairment Diagnosis Guidelines 17
Table 7: Management of AD Symptoms 20
Table 8: AD Market, Global, Pipeline Products, Discovery, 2016 87
Table 9: AD Market, Global, Pipeline Products, Preclinical, 2016 96
Table 10: AD Market, Global, Pipeline Products, Phase I, 2016 116
Table 11: AD Market, Global, Pipeline Products, Phase II, 2016 119
Table 12: AD Market, Global, Pipeline Products, Phase III, 2016 122
Table 13: MCI Market, Global, Market Forecast, 2014-2021 124
Table 14: AD Market, Global, Market Forecast, 2014-2021 124
Table 15: MCI & AD Combined Market, Global, Market Forecast, 2014-2021 124
Table 16: MCI Market, US, Market Forecast, 2014-2021 125
Table 17: AD Market, US, Market Forecast, 2014-2021 125
Table 18: MCI & AD Market, US, Market Forecast, 2014-2021 125
Table 19: MCI Market, Canada, Market Forecast, 2014-2021 126
Table 20: AD Market, Canada, Market Forecast, 2014-2021 126
Table 21: MCI & AD Combined Market, Canada, Market Forecast, 2014-2021 126
Table 22: MCI Market, UK, Market Forecast, 2014-2021 127
Table 23: AD Market, UK, Market Forecast, 2014-2021 127
Table 24: MCI & AD Combined Market, UK, Market Forecast, 2014-2021 127
Table 25: MCI Market, France, Market Forecast, 2014-2021 128
Table 26: AD Market, France, Market Forecast, 2014-2021 128
Table 27: MCI & AD Market Combined, France, Market Forecast, 2014-2021 128
Table 28: MCI Market, Germany, Market Forecast, 2014-2021 129
Table 29: AD Market, Germany, Market Forecast, 2014-2021 129
Table 30: MCI & AD Combined Market, Germany, Market Forecast, 2014-2021 129
Table 31: MCI Market, Italy, Market Forecast, 2014-2021 130
Table 32: AD Market, Italy, Market Forecast, 2014-2021 130
Table 33: MCI & AD Combined Market, Italy, Market Forecast, 2014-2021 130
Table 34: MCI Market, Spain, Market Forecast, 2014-2021 131
Table 35: AD Market, Spain, Market Forecast, 2014-2021 131
Table 36: MCI & AD Combined Market, Spain, Market Forecast, 2014-2021 131
Table 37: MCI Market, Japan, Market Forecast, 2014-2021 132
Table 38: AD Market, Japan, Market Forecast, 2014-2021 132
Table 39: MCI & AD Combined Market, Japan, Market Forecast, 2014-2021 132

1.2 List of Figures
Figure 1: Alzheimer’s Disease Therapeutics Market, Treatment Algorithm of Alzheimer’s Disease 19
Figure 2: Alzheimer’s Disease Therapeutics Market, Heat Map for Marketed Products 25
Figure 3: Alzheimer’s Disease Therapeutics Market, Overall Pipeline 27
Figure 4: Alzheimer’s Disease Therapeutics Market, Pipeline by Mechanism of Action (%) 30
Figure 5: Alzheimer’s Disease Therapeutics Market, Clinical Trial Failure Rates by Phase (%) 31
Figure 6: Alzheimer’s Disease Therapeutics Market, Clinical Trial Failure Rates by Mechanism of Action, (%) 32
Figure 7: Alzheimer’s Disease Therapeutics Market, Clinical Trial Duration by Molecule Type (months) 33
Figure 8: Alzheimer’s Disease Therapeutics Market, Clinical Trial Duration by Mechanism of Action (months) 34
Figure 9: Alzheimer’s Disease Therapeutics Market, Clinical Trial Size per Product by Molecule Type (participants) 35
Figure 10: Alzheimer’s Disease Therapeutics Market, Clinical Trial Size per Product by Mechanism of Action (participants) 36
Figure 11: Alzheimer’s Disease Therapeutics Market, Clinical Trial Size per Trial by Molecule Type (participants) 37
Figure 12: Alzheimer’s Disease Therapeutics Market, Clinical Trial Size per Trial by Mechanism of Action (participants) 38
Figure 13: Alzheimer’s Disease Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 38
Figure 14: Alzheimer’s Disease Therapeutics Market, Global, Comparison of Average Trial Metrics by Phase and Mechanism of Action 39
Figure 15: Alzheimer’s Disease Therapeutics Market, Global, Verubecestat Market Forecast ($m), 2018-2021 40
Figure 16: Alzheimer’s Disease Therapeutics Market, Global, LMTX Market Forecast ($m), 2017-2021 41
Figure 17: Alzheimer’s Disease Market, Global, AZD3293 Market Forecast ($m), 2019-2021 42
Figure 18: Alzheimer’s Disease Therapeutics Market, Global, Masitinib Market Forecast ($m), 2017-2021 43
Figure 19: Alzheimer’s Disease Therapeutics Market, Global, Aducanumab Market Forecast ($m), 2019-2021 44
Figure 20: Alzheimer’s Disease Therapeutics Market, Global, Azeliragon Market Forecast ($m), 2017-2021 45
Figure 21: Alzheimer’s Disease Therapeutics Market, Global, Encenicline Hydrochloride Market Forecast ($m), 2017-2021 46
Figure 22: Alzheimer’s Disease Therapeutics Market, Global, Idalopirdine Market Forecast ($m), 2017-2021 47
Figure 23: Alzheimer’s Disease Therapeutics Market, Global, Gantenerumab Market Forecast ($m), 2020-2021 49
Figure 24: Alzheimer’s Disease Therapeutics Market, Heat Map for Marketed Products 50
Figure 25: Alzheimer’s Disease and Mild Cognitive Impairment Therapeutics Markets, Global, Treatment Patterns (‘000), 2014-2021 52
Figure 26: Alzheimer’s Disease and Mild Cognitive Impairment Aggregate Therapeutics Market, Global, Treatment Patterns (‘000), 2014-2021 53
Figure 27: Alzheimer’s Disease and Mild Cognitive Impairment Therapeutics Markets, Global, Market Size ($bn), 2014-2021 54
Figure 28: Alzheimer’s Disease and Mild Cognitive Impairment Aggregate Therapeutics Market, Global, Market Size ($bn), 2014-2021 55
Figure 29: Alzheimer’s Disease and Mild Cognitive Impairment Therapeutics Markets, North America, Treatment Patterns (‘000), 2014-2021 56
Figure 30: Alzheimer’s Disease and Mild Cognitive Impairment Aggregate Therapeutics Market, North America, Treatment Patterns (‘000), 2014-2021 57
Figure 31: Alzheimer’s Disease Therapeutics Market, North America, Annual Cost of Therapy ($), 2014-2021 58
Figure 32: Alzheimer’s Disease Therapeutics Market, North America, Market Size ($m), 2014-2021 59
Figure 33: Alzheimer’s Disease and Mild Cognitive Impairment Aggregate Therapeutics Market, North America, Market Size, 2014-2021 60
Figure 34: Mild Cognitive Impairment Therapeutics Market, EU5, Treatment Patterns (‘000), 2014-2021 61
Figure 35: Alzheimer’s Disease Therapeutics Market, EU5, Treatment Patterns (‘000), 2014-2021 62
Figure 36: Alzheimer’s Disease and Mild Cognitive Impairment Aggregate Therapeutics Market, EU5, Treatment Patterns (‘000), 2014-2021 63
Figure 37: Mild Cognitive Impairment Therapeutics Market, EU5, Annual Cost of Therapy ($), 2014-2021 64
Figure 38: Alzheimer’s Disease Therapeutics Market, EU5, Annual Cost of Therapy ($), 2014-2021 65
Figure 39: Mild Cognitive Impairment Therapeutics Market, EU5, Market Size ($m), 2014-2021 66
Figure 40: Alzheimer’s Disease Therapeutics Market, EU5, Market Size ($m), 2014-2021 67
Figure 41: Alzheimer’s Disease and Mild Cognitive Impairment Aggregate Therapeutics Market, EU5, Market Size ($m), 2014-2021 68
Figure 42: Alzheimer’s Disease and Mild Cognitive Impairment Therapeutics Markets, Japan, Treatment Patterns (‘000), 2014-2021 69
Figure 43: Alzheimer’s Disease and Mild Cognitive Impairment Aggregate Therapeutics Market, Japan, Treatment Patterns (‘000), 2014-2021 70
Figure 44: Mild Cognitive Impairment Therapeutics Market, Japan, Annual Cost of Therapy ($), 2014-2021 70
Figure 45: Alzheimer’s Disease Therapeutics Market, Japan, Annual Cost of Therapy ($), 2014-2021 71
Figure 46: Mild Cognitive Impairment Therapeutics Market, Japan, Market Size ($bn), 2014-2021 72
Figure 47: Alzheimer’s Disease Therapeutics Market, Japan, Market Size ($m), 2014-2021 72
Figure 48: Alzheimer’s Disease and Mild Cognitive Impairment Aggregate Therapeutics Market, Japan, Market Size ($bn), 2014-2021 73
Figure 49: Alzheimer’s Disease Therapeutics Market, Licensing Deals by Value, 2006-2015 76
Figure 50: Alzheimer’s Disease Therapeutics Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value ($bn) and Aggregate Upfront Payment Value ($bn), 2006-2015 77
Figure 51: Alzheimer’s Disease Therapeutics Market, Global, Licensing Deals by Stage of Development, Deal Value ($m) and Upfront Payment Value ($m), 2006-2015 78
Figure 52: Alzheimer’s Disease Therapeutics Market, Global, Licensing Deals by Molecule Type and Value ($), 2006-2015 79
Figure 53: Alzheimer’s Disease Therapeutics Market, Global, Licensing Deals by Molecular Target and Aggregate Value ($bn), 2006-2015 80
Figure 54: Alzheimer’s Disease Therapeutics Market, Global, Co-development Deals by Value, 2006-2015 81
Figure 55: Alzheimer’s Disease Therapeutics Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value ($m) and Aggregate Upfront Payment Value ($m), 2006-2015 82
Figure 56: Alzheimer’s Disease Therapeutics Market, Global, Co-development Deals by Stage of Development, Deal Value ($) and Upfront Payment Value ($m), 2006-2015 83
Figure 57: Alzheimer’s Disease Therapeutics Market, Global, Co-development Deals by Molecule Type and Value ($), 2006-2015 84
Figure 58: Alzheimer’s Disease Therapeutics Market, Global, Licensing Deals by Molecular Target and Aggregate Value ($bn), 2006-2015 85

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