PharmaFocus: Biomarkers in Alzheimer’s Disease...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 7
1.1 List of Tables 11
1.2 List of Figures 14
2 Introduction 15
2.1 Catalyst 15
3 Alzheimer’s Disease Overview 16
3.1 Continuum of AD – Preclinical, MCI and AD Dementia 16
3.1.1 Preclinical AD 17
3.1.2 MCI 18
3.1.3 AD Dementia 19
3.2 Etiology and Pathophysiology 19
3.2.1 Etiology 19
3.2.2 Pathophysiology 22
4 AD Biomarkers – Overview 34
4.1 What are Biomarkers? 34
4.2 Criteria for Good Biomarkers 35
4.2.1 Sensitivity and Specificity of Biomarkers 36
4.3 Role of Biomarkers in AD Diagnosis 37
4.3.1 Challenges in Establishing AD Biomarkers as Diagnostic Tools 38
4.4 Role of Biomarkers in Drug Development 38
4.5 Biomarker Development and Validation 41
4.6 Classes of AD Biomarkers by Pathophysiological Mechanism 42
4.6.1 Temporal Evolution of Biomarkers 44
5 Unmet Needs Assessment 47
5.1 Overview 47
5.2 Unmet Needs Analysis 48
5.2.1 Patient and Physician Knowledge/Awareness of AD Diagnosis 48
5.2.2 Generalized Biomarker Unmet Needs 51
5.2.3 Unmet Need for Diverse Types of Biomarkers 54
6 AD Biomarkers Market Drivers and Barriers 59
6.1 Driver: Increasing prevalence of AD corresponding to a growth in the aging population will rapidly expand the biomarker market size 59
6.2 Driver: Anticipated future cost of biologic AD treatments will drive the use of biomarker diagnostics 60
6.3 Driver: Favorable regulatory standards for the application of biomarkers in drug discovery 61
6.4 Barrier: Present lack of disease-modifying treatments hinders the use of diagnostic tests 61
6.5 Barrier: Rigorous, expensive, and time-consuming nature of biomarker development and validation 62
6.6 Barrier: Reimbursement restrictions for diagnostic testing 63
6.7 Barrier: Healthcare system and physician practice barriers limit patient referral to specialists and the use of biomarker tests 63
7 Amyloid Beta Biomarkers 66
7.1 Overview of Biomarker Class 66
7.2 Drug Therapies Targeting Amyloid Beta 67
7.2.1 Overview 67
7.2.2 Representative Pipeline Drugs 67
7.3 Amyloid Biomarker Assays 69
7.3.1 Amyloid PET-Imaging 69
7.3.2 CSF-Based Amyloid Assays 80
7.3.3 Other Amyloid Assays in Development 87
8 Tau-Related Biomarkers 90
8.1 Overview of Biomarker Class 90
8.2 Drug Therapies Targeting Tau 90
8.2.1 Overview 90
8.2.2 Representative Products 90
8.3 Tau Biomarker Assays 92
8.3.1 CSF-Based Tau Assays 93
8.3.2 Promising Pipeline Products – Tau PET Imaging Ligands 98
9 Beyond Amyloid and Tau: Other Molecular AD Biomarkers in Development 100
9.1 Overview 100
9.1.1 Neuronal and Synaptic Degeneration 100
9.1.2 Inflammation and Oxidative Stress 101
9.2 Promising Pipeline Products 104
9.2.1 Alzheimer’s CSF 16-Plex Assay (Proteome Sciences) 104
9.3 Blood-Based Biomarkers 105
9.3.1 Overview 105
9.3.2 Promising Pipeline Products 107
10 Functional Brain Imaging Biomarkers 114
10.1 Overview of Biomarker Class 114
10.2 Functional Brain Imaging Assays 114
10.2.1 FDG-PET 115
10.2.2 FMRI Biomarkers of AD 118
11 Structural Brain Imaging Biomarkers 123
11.1 Overview of Biomarker Class 123
11.2 Structural Brain Imaging Assays 124
11.2.1 MRI Hippocampal Volumetry 125
11.2.2 Other Structural Imaging Biomarkers in Pipeline Development 128
12 Regulatory Considerations Impacting AD Biomarkers 130
12.1 Clinical Trial Design in AD Drug Development 130
12.1.1 Regulatory Agency Recommendations 133
12.1.2 Key Opinion Leaders on the Use of Biomarkers in Drug Clinical Trials 134
12.1.3 Mapping the Use of Biomarkers in Key AD Drug Clinical Trials 139
12.1.4 AD Drug Approval, Population or Stage-Specific Indications, and Off-Label Use 140
12.2 Reimbursement of Biomarker-Based Testing 141
12.2.1 Concerns Limiting Reimbursement of Biomarker Testing for AD 141
12.2.2 Region-Specific Differences in Biomarker Test Reimbursement Policies and Pathways in the US and EU 145
13 Outlook and Opportunities for AD Biomarkers 148
13.1 Overview 148
13.2 Key Players, Partnerships, and Associations 150
13.2.1 National and International AD Biomarkers Consortia 151
13.2.2 Private Industry Biomarker Partnerships 152
13.3 Opportunity Analysis 153
13.3.1 Opportunity: Biomarkers to Determine Appropriate Use of Treatment 154
13.3.2 Opportunity: Biomarkers as Populations Screens for Alzheimer’s Disease 155
13.3.3 Opportunity: Continued Development of Varied Biomarkers of Pathophysiology 155
14 Appendix 156
14.1 Bibliography 156
14.2 Abbreviations 170
14.3 Research Methodology 174
14.4 Physicians and Specialists Included in this Study 175
14.5 About the Authors 176
14.5.1 Authors 176
14.5.2 Global Head of Healthcare 177
14.6 About GlobalData 178
14.7 Disclaimer 178