Table of Contents
1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 4
2 Executive Summary 6
2.1 Limited Treatment Options despite Large Market Opportunity 6
2.2 Exceptionally High Level of First-in-Class Innovation within Alzheimer’s Disease Pipeline 6
2.3 Active Deals Landscape Dominated by GPCR-Targeting Products 6
3 The Case for Innovation 7
3.1 Growing Opportunities for Biologic Products 8
3.2 Diversification of Molecular Targets 8
3.3 Innovative First-in-Class Product Developments Remain Attractive 9
3.4 Regulatory and Reimbursement Policy Shifts Favor First-in-Class Product Innovation 9
3.5 Sustained Innovation in Alzheimer’s Disease 10
3.6 GBI Research Report Guidance 10
4 Clinical and Commercial Landscape 12
4.1 Disease Overview 12
4.2 Classification of Dementia and Mild Cognitive Impairment 12
4.3 Symptoms, Disease Staging and Prognosis 13
4.4 Diagnosis 14
4.4.1 Mini Mental State Exam 15
4.4.2 Alzheimer’s Disease Assessment Scale – Cognitive 15
4.4.3 Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory 16
4.4.4 Imaging Techniques 16
4.4.5 Lumbar Puncture 17
4.4.6 Blood Tests 17
4.5 Epidemiology 17
4.6 Etiology and Pathophysiology 17
4.6.1 Etiological Risk Factors 17
4.6.2 Pathophysiology 18
4.7 Management and Treatment of Alzheimer’s Disease 21
4.7.1 Pharmacological Intervention 21
4.7.2 Non-pharmacological Intervention 22
4.8 Overview of Marketed Products 23
4.9 Indications Associated with Alzheimer’s Disease 26
4.9.1 Anxiety 26
4.9.2 Depression 27
4.9.3 Psychosis 28
4.9.4 Insomnia 29
5 Assessment of Pipeline Product Innovation 30
5.1 Overview 30
5.2 Pipeline by Stage of Development and Molecule Type 30
5.2.1 Alzheimer’s Disease 30
5.2.2 Alzheimer’s-Disease-Associated Indications 31
5.3 Pipeline by Molecular Target 33
5.3.1 Alzheimer’s Disease 33
5.3.2 Alzheimer’s-Disease-Associated Indications 35
5.4 Comparative Distribution of Programs between the Market and Pipeline by Molecular Target Class 36
5.4.1 Alzheimer’s Disease 36
5.4.2 Alzheimer’s-Disease-Associated Indications 37
5.5 First-in-Class Programs Targeting Novel Molecular Targets 37
5.5.1 Alzheimer’s Disease 37
5.5.2 Alzheimer’s-Disease-Associated Indications 41
5.6 Ratio of First-in-Class Products to First-in-Class Targets 44
5.6.1 Alzheimer’s Disease 44
5.6.2 Alzheimer’s-Disease-Associated Indications 46
5.7 List of All First-in-Class Pipeline Programs 48
6 Signaling Network, Disease Causation and Innovation Alignment 58
6.1 Complexity of Signaling Networks 58
6.2 Signaling Pathways and First-in-Class Molecular Target Integration 58
6.3 First-in-Class Matrix Assessment 59
7 First-in-Class Target Profiles 64
7.1 Pipeline Programs Targeting XXX 64
7.2 Pipeline Programs Targeting XXX for Alzheimer’s Disease 65
7.3 Pipeline Programs Targeting XXX for Alzheimer’s Disease 66
7.4 Pipeline Programs Targeting XXX for Alzheimer’s Disease 69
7.5 Pipeline Programs Targeting XXX for Alzheimer’s Disease, Anxiety, Depression and Psychosis 70
7.6 Pipeline Programs Targeting XXX for Depression and Anxiety 76
7.7 Pipeline Programs Targeting XXX for Insomnia and Anxiety 78
8 Strategic Consolidations 80
8.1 Industry-Wide First-in-Class Deals 80
8.2 Licensing Deals 82
8.2.1 Deals by Region, Value and Year 82
8.2.2 Deals by Indication 83
8.2.3 Deals by Stage of Development and Value 83
8.2.4 Deals by Molecule Type, Molecular Target and Value 84
8.2.5 List of Deals with Deal Values Exceeding $100m 86
8.3 Co-development Deals 87
8.3.1 Deals by Region, Value and Year 87
8.3.2 Deals by Indication 88
8.3.3 Deals by Stage of Development and Value 88
8.3.4 Deals by Molecule Type, Molecular Target and Value 89
8.3.5 List of Deals with Deal Values Exceeding $100m 90
8.4 First-in-Class Programs with and without Prior Involvement in Licensing and Co-development Deals 90
9 Appendix 91
9.1 References 91
9.2 Abbreviations 98
9.3 Research Methodology 99
9.3.1 Data integrity 99
9.3.2 Innovative and meaningful analytical techniques and frameworks: 99
9.3.3 Evidence based analysis and insight: 99
9.4 Secondary Research 99
9.4.1 Market Analysis 99
9.4.2 Pipeline Analysis 99
9.4.3 First-in-Class Matrix Assessment 100
9.4.4 First-in-Class Target Profiles 100
9.4.5 Licensing and Co-Development Deals 101
9.5 Contact Us 101
9.6 Disclaimer 101