Alzheimer’s Therapeutics in Asia-Pacific Markets to 2021 - Growth Driven by Rising Prevalence, Growing Awareness and Expected Launch of Disease Modifying Therapies

GBI Research
151 Pages - GBI10532
$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 occur in patients in their mid-sixties, 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 considerable, at 559. The majority of the pipeline products are novel, and there are only seven repositioned drugs and five generic drugs. This shows progression in terms 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 $3 billion in 2014 to $5.1 billion in 2021, at a CAGR of 7.9% across the four Asia-Pacific 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 four Asia-Pacific 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 5
1.1 List of Tables 8
1.2 List of Figures 8
2 Introduction 10
2.1 Disease Introduction 10
2.2 Epidemiology 11
2.3 Symptoms 12
2.4 Etiology and Pathophysiology 14
2.5 Diagnosis 16
2.6 Disease Stages 19
2.7 Prognosis 20
2.8 Treatment Options 21
2.8.1 Treatment Algorithm 21
2.8.2 Pharmacological Treatments 23
2.8.3 Non-pharmacological Treatments 25
3 Marketed Products 26
3.1 Overview 26
3.2 Acetylcholinesterase Inhibitors 26
3.2.1 Aricept (donepezil) - Eisai 26
3.2.2 Exelon (rivastigmine) - Novartis 27
3.2.3 Razadyne (galantamine) - Janssen 27
3.2.4 Cognex (tacrine) - Shionogi 28
3.3 NMDA Receptor Antagonists 28
3.3.1 Namenda/Ebixa/Axura/Abixa (Memantine), Merz/Lundbeck/Forest/Daiichi Sankyo 28
3.4 AChEI and NMDA Receptor Antagonists 29
3.4.1 Namzaric (memantine ER + donepezil), Actavis and Adamas 29
3.5 Heat Map - Marketed Products Overview 29
4 Pipeline Analysis 31
4.1 Pipeline by Stage of Development, Molecule Type, Route of Administration and Program Type 31
4.2 Pipeline Analysis by Mechanism of Action 33
4.3 Promising Pipeline Candidates 36
4.3.1 MK-8931- Merck 36
4.3.2 LMTX (methylthioninium chloride) - TauRX Therapeutics 37
4.3.3 Gantenerumab (RG-1540) - Roche 39
4.3.4 AZD3293 - AstraZeneca 40
4.3.5 AB1010 (masitinib) - AB Science 41
4.3.6 BIIB037 - Biogen 42
4.3.7 TTP488 - vTv Therapeutics 42
4.3.8 EVP-6124 - FORUM Pharmaceuticals 43
4.3.9 Lu AE58054 - Lundbeck 44
4.3.10 Sodium Oligomannurarate 45
4.4 Heat Map for Pipeline Products 45
5 Clinical Trial Analysis 47
5.1 Failure Rate 47
5.1.1 Overall Failure Rate 47
5.1.2 Failure Rate by Phase and Molecular Target 47
5.2 Clinical Trial Size 48
5.2.1 Patient Enrollment per Product by Stage of Development by Molecule Type and Molecular Target 48
5.2.2 Patient Enrollment per Trial by Stage of Development by Molecule Type and Molecular Target 50
5.3 Clinical Trial Duration 52
5.3.1 Trial Duration by Stage of Development and Molecule Type 52
5.3.2 Trial Duration by Stage of Development and Molecular Target 53
5.4 Summary of Clinical Trial Metrics 55
6 Multi-Scenario Forecast 56
6.1 Geographical Markets 56
6.2 Asia-Pacific Market 56
6.3 India 60
6.3.1 Treatment Usage Patterns 60
6.3.2 Annual Cost of Therapy 62
6.3.3 Market Size 63
6.4 China 65
6.4.1 Treatment Usage Patterns 65
6.4.2 Annual Cost of Therapy 67
6.4.3 Market Size 68
6.5 Australia 70
6.5.1 Treatment Usage Patterns 70
6.5.2 Annual Cost of Therapy 72
6.5.3 Market Size 74
6.6 Japan 75
6.6.1 Treatment Usage Patterns 75
6.6.2 Annual Cost of Therapy 77
6.6.3 Market Size 78
7 Drivers and Barriers 81
7.1 Drivers 81
7.1.1 Rising Prevalence 81
7.1.2 Increasing Healthcare Reforms for Elderly Population 81
7.1.3 Increasing Health Insurance Coverage for Aged Population 81
7.1.4 Increasing Public and Policy-Maker Awareness 82
7.1.5 Greater Focus on Prodromal and Presymptomatic AD 82
7.2 Barriers 82
7.2.1 High Rate of Clinical Trial Failure 82
7.2.2 Impending Patent Cliffs and Generic Erosion 82
7.2.3 Drug Testing in Patients with Established AD and Advanced Neurodegeneration 83
7.2.4 Low Diagnosis and Treatment Rate 83
7.2.5 Additional Competition from Traditional Medicines 83
8 Deals and Strategic Consolidations 84
8.1 Licensing Deals 84
8.1.1 Deals by Region and Value 84
8.1.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 85
8.1.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 85
8.1.4 Key Licensing Deals 88
8.2 Co-development Deals 90
8.2.1 Deals by Region and Value 90
8.2.2 Number of Disclosed and Undisclosed Deals by Year, Aggregate Deal Value 90
8.2.3 Deal Value by Stage of Development, Molecule Type, and Molecular Target 91
8.2.4 Key Co-development Deals 94
9 Appendix 96
9.1 All Pipeline Drugs by Stage of Development 96
9.1.1 Discovery 96
9.1.2 Preclinical 104
9.1.3 Phase I 122
9.1.4 Phase II 125
9.1.5 Phase III 128
9.2 Market Forecasts to 2021 129
9.2.1 Asia-Pacific 129
9.2.2 India 130
9.2.3 China 131
9.2.4 Australia 133
9.2.5 Japan 134
9.3 Bibliography 137
9.4 Abbreviations 146
9.5 Research Methodology 147
9.5.1 Secondary Research 148
9.5.2 Marketed Product Profiles 148
9.5.3 Late-Stage Pipeline Candidates 148
9.5.4 Comparative Efficacy and Safety Heat Map for Marketed and Pipeline Products 149
9.5.5 Product Competitiveness Framework 149
9.5.6 Pipeline Analysis 149
9.5.7 Forecasting Model 150
9.5.8 Deals Data Analysis 151
9.6 Contact Us 151
9.7 Disclaimer 151

1.1 List of Tables
Table 1: AD Market, Symptoms of AD at Different Stages of Disease 13
Table 2: AD Market, Symptoms of Mid Cognitive Impairment 13
Table 3: AD Market, Mini Mental State Exam 17
Table 4: AD Market, Alzheimer’s Disease Assessment Scale Cognitive Subscale 18
Table 5: AD Market, Mild Cognitive Impairment Diagnosis Guidelines 19
Table 6: AD Market, Global Deterioration Scale for AD 20
Table 7: AD Market, Management of AD Symptoms 23
Table 8: AD Market, Global, Pipeline Products, Discovery, 2016 96
Table 9: AD Market, Global, Pipeline Products, Preclinical, 2016 104
Table 10: AD Market, Global, Pipeline Products, Phase I, 2016 122
Table 11: AD Market, Global, Pipeline Products, Phase II, 2016 125
Table 12: AD Market, Global, Pipeline Products, Phase III, 2016 128
Table 13: MCI Market, Asia-Pacific, Market Forecast, 2014-2021 129
Table 14: AD Market, Asia-Pacific, Market Forecast, 2014-2021 129
Table 15: AD and MCI Combined Market, Asia-Pacific, Market Forecast, 2014-2021 130
Table 16: MCI Market, India, Market Forecast, 2014-2021 130
Table 17: AD Market, India, Market Forecast, 2014-2021 130
Table 18: AD and MCI Combined Market, India, Market Forecast, 2014-2021 131
Table 19: MCI Market, China, Market Forecast, 2014-2021 131
Table 20: AD Market, China, Market Forecast, 2014-2021 132
Table 21: AD and MCI Combined Market, China, Market Forecast, 2014-2021 132
Table 22: MCI Market, Australia, Market Forecast, 2014-2021 133
Table 23: AD Market, Australia, Market Forecast, 2014-2021 133
Table 24: AD and MCI Combined Market, Australia, Market Forecast, 2014-2021 133
Table 25: MCI Market, Japan, Market Forecast, 2014-2021 134
Table 26: AD Market, Japan, Market Forecast, 2014-2021 135
Table 27: MCI and AD Combined Market, Japan, Market Forecast, 2014-2021 136

1.2 List of Figures
Figure 1: AD Market, Treatment Algorithm of AD 22
Figure 2: AD Market, Heat Map for Marketed Products 30
Figure 3: AD Market, Overall Pipeline 32
Figure 4: AD Market, Pipeline by Mechanism of Action (%) 35
Figure 5: AD Market, Asia-Pacific, Verubecestat Market Forecast ($m), 2020-2021 37
Figure 6: AD Market, Asia-Pacific, LMTX Market Forecast ($m), 2018-2021 38
Figure 7: AD Market, Asia-Pacific, Gantenerumab Market Forecast ($m), 2020-2021 40
Figure 8: AD Market, Heat Map for Pipeline Products 46
Figure 9: AD Market, Clinical Trial Failure Rates by Phase (%) 47
Figure 10: AD Market, Clinical Trial Failure Rates by Molecular Target (%) 48
Figure 11: AD Market, Clinical Trial Size per Product by Molecule Type (participants) 49
Figure 12: AD Market, Clinical Trial Size per Product by Molecular Target (participants) 50
Figure 13: AD Market, Clinical Trial Size per Trial by Molecule Type (participants) 51
Figure 14: AD Market, Clinical Trial Size per Trial by Molecular Target (participants) 52
Figure 15: AD Market, Clinical Trial Duration by Molecule Type (months) 53
Figure 16: AD Market, Clinical Trial Duration by Molecular Target (months) 54
Figure 17: AD Market, Global, Comparison of Average Trial Metrics by Phase and Molecule Type 55
Figure 18: AD Market, Global, Comparison of Average Trial Metrics by Phase and Molecular Target 55
Figure 19: AD and MCI Market, Asia-Pacific, Treatment Patterns (million), 2014-2021 57
Figure 20: AD and MCI Combined Market, Asia-Pacific, Treatment Patterns (million), 2014-2021 58
Figure 21: AD and MCI Market, Asia-Pacific, Market Size ($bn), 2014-2021 59
Figure 22: AD and MCI Combined Market, Asia-Pacific, Market Size ($bn), 2014-2021 60
Figure 23: AD and MCI Market, India, Treatment Patterns (million), 2014-2021 61
Figure 24: AD and MCI Combined Market, India, Treatment Patterns (million), 2014-2021 62
Figure 25: AD and MCI Market, India, Annual Cost of Therapy ($), 2014-2021 63
Figure 26: AD and MCI Market, India, Market Size ($m), 2014-2021 64
Figure 27: AD and MCI Combined Market, India, Market Size ($m), 2014-2021 65
Figure 28: AD and MCI Market, China, Treatment Patterns (million), 2014-2021 66
Figure 29: AD and MCI Combined Market, China, Treatment Patterns (million), 2014-2021 67
Figure 30: AD and MCI Market, China, Annual Cost of Therapy ($), 2014-2021 68
Figure 31: AD and MCI Market, China, Market Size ($m), 2014-2021 69
Figure 32: AD and MCI Combined Market, China, Market Size ($m), 2014-2021 70
Figure 33: AD and MCI Market, Australia, Treatment Patterns (‘000), 2014-2021 71
Figure 34: AD and MCI Combined Market, Australia, Treatment Patterns (‘000), 2014-2021 72
Figure 35: AD and MCI Market, Australia, Annual Cost of Therapy ($), 2014-2021 73
Figure 36: AD and MCI Market, Australia, Market Size ($m), 2014-2021 74
Figure 37: AD and MCI Combined Market, Australia, Market Size ($m), 2014-2021 75
Figure 38: AD and MCI Market, Japan, Treatment Patterns (million), 2014-2021 76
Figure 39: AD and MCI Combined Market, Japan, Treatment Patterns (million), 2014-2021 77
Figure 40: AD and MCI Market, Japan, Annual Cost of Therapy ($), 2014-2021 78
Figure 41: AD and MCI Market, Japan, Market Size ($m), 2014-2021 79
Figure 42: AD and MCI Combined Market, Japan, Market Size ($bn), 2014-2021 80
Figure 43: AD Market, Licensing Deals by Value, 2006-2015 84
Figure 44: AD Market, Global, Number of Disclosed and Undisclosed Licensing Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2015 85
Figure 45: AD Market, Global, Licensing Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2015 86
Figure 46: AD Market, Global, Licensing Deals by Molecule Type and Value, 2006-2015 87
Figure 47: AD Market, Global, Licensing Deals by Molecular Target and Aggregate Value, 2006-2015 88
Figure 48: AD Market, Global, Co-development Deals by Value, 2006-2015 90
Figure 49: AD Market, Global, Number of Disclosed and Undisclosed Co-development Deals by Year, Aggregate Deal Value and Aggregate Upfront Payment Value, 2006-2015 91
Figure 50: AD Market, Global, Co-development Deals by Stage of Development, Deal Value and Upfront Payment Value, 2006-2015 92
Figure 51: AD Market, Global, Co-development Deals by Molecule Type and Value, 2006-2015 93
Figure 52: AD Market, Global, Licensing Deals by Molecular Target and Aggregate Value, 2006-2015 94

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