PharmaFocus: Biomarkers in Alzheimer’s Disease

Published: June 2013
No. of Pages: 179
   

Alzheimer’s disease (AD) is a progressive neurodegenerative disease that is characterized by memory loss, cognitive impairment, and functional decline. The disease has emerged as a major global health priority especially because of its rapidly accelerating prevalence worldwide. In order to tackle the AD scourge , there is an urgent need for tools that will allow for the early and accurate diagnosis of AD, as well as the identification of populations at risk. A biomarker is an indicator of biological processes that can be objectively measured and evaluated, and well-validated biomarkers are required to satisfy these needs in AD.

The search for biomarkers that are reflective of the disease process in AD has been and continues to be an active area of research, but has been hampered by a lack of clear understanding of the pathological mechanisms that underlie the disease. Nonetheless, several biomarkers have been developed to date that indicate the presence of AD pathology and AD-associated neuronal injury in vivo. Such biomarkers have the potential for clinical use in etiological determination, predictive prognosis, monitoring disease progression, and in clinical trials of potential disease-modifying therapies for AD.

Key Questions Answered

  • What are the main biomarkers in AD? What AD biomarkers are commercially available in the market and which are in pipeline development?
  • What are the roles of biomarkers in AD diagnosis and drug discovery?
  • What are the major unmet needs with regards to AD biomarkers?
  • What are the views of KOLs on the present and future landscape of the AD biomarkers market?
  • What is the impact of government regulation on AD biomarker development and market adoption? What governmental and industry changes are likely to influence the use of biomarkers in the near future?

Key Findings

  • Amyloid-based biomarkers, and in particular, amyloid PET ligands, are the furthest developed biomarkers for AD and although they have immense value in diagnosis and drug discovery, there is a remaining need for biomarkers of other pathological processes.
  • There is a great need for simple inexpensive biomarker assays that can be implement as diagnostic screens for AD and there are numerous blood-based biomarker assays in pipeline aiming to target this need.
  • Government regulation will play a major role in biomarker development, clinical market access and use in drug discovery both in the US and in the EU.

Scope

  • Overview of Alzheimer's disease, including disease etiology and pathophysiology and how these inform biomarker targets.
  • Overview of AD biomarkers, the major classes of biomarkers an the different potential roles of biomarkers in clinical use and drug development.
  • Key topics covered include amyloid biomarkers, tau biomarkers, and other molecular biomarkers for AD in development with product profiles for marketed as well as promising pipeline assays. Also discussed are functional and structural imaging biomarkers for AD.
  • Analysis of the unmet needs, and opportunities within the AD biomarker arena, as well as drivers and barriers impacting the AD biomarker market.
  • Insightful review of the regulatory considerations impacting biomarker development, market access and use in clinical drug development

Key Benefits

  • Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
  • Develop business strategies by understanding the factors shaping and driving AD biomarker development and market adoption.
  • Drive revenues by understanding the key trends, innovative products and technologies, and companies likely to impact the AD biomarker market in future.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

PharmaFocus: Biomarkers in Alzheimer’s Disease

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

List of Tables

Table 1: Biomarker Unmet Needs – Current Level of Attainment 48
Table 2: AD Biomarkers – Market Drivers and Barriers, 2013 59
Table 3: AD – Amyloid-Targeting Phase III Pipeline, 2013 67
Table 4: AD – Amyloid-Targeting Phase II Pipeline, 2013 68
Table 5: Aβ Biomarkers by Stage of Development, 2013 69
Table 6: SWOT Analysis of Amyloid PET Imaging in AD, 2013 75
Table 7: Product Profile of Amyvid, 2013 76
Table 8: SWOT Analysis of Amyvid, 2013 76
Table 9: Product Profile of [18F] Flutemetamol, 2013 77
Table 10: SWOT Analysis of [18F] Flutemetamol, 2013 77
Table 11: Product Profile of [18F] Florbetaben, 2013 78
Table 12: SWOT Analysis of [18F] Florbetaben, 2013 78
Table 13: Product Profile of NAV4694, 2013 79
Table 14: SWOT Analysis of NAV4694, 2013 79
Table 15: Characteristics of ELISA and xMAP Immunoassay Platforms for the Measurement of CSF Biomarkers in AD 81
Table 16: SWOT Analysis of CSF-Based Amyloid Tests, 2013 83
Table 17: Product Profile of INNOTEST β-Amyloid1-42, 2013 84
Table 18: SWOT Analysis of INNOTEST β-Amyloid1-42, 2013 84
Table 19: Product Profile of INNO-BIA AlzBio3, 2013 85
Table 20: SWOT Analysis of INNO-BIA AlzBio3, 2013 85
Table 21: Product Profile of EP-AD Diagnostic CSF Test, 2013 86
Table 22: SWOT Analysis of EP-AD Diagnostic CSF Test, 2013 87
Table 23: Product Profile of ABtest, 2013 87
Table 24: SWOT Analysis of ABtest, 2013 88
Table 25: Product Profile of SAPPHIRE II Eye Test, 2013 88
Table 26: SWOT Analysis of SAPPHIRE II Eye Test, 2013 89
Table 27: AD, Tau-Targeting Therapies, Phase III Pipeline, 2013 91
Table 28: AD, Tau-Targeting Therapies, Phase II Pipeline, 2013 91
Table 29: AD, Tau-Targeting Therapies, Phase I Pipeline, 2013 91
Table 30: Tau Biomarkers by Stage of Development, 2013 92
Table 31: SWOT Analysis of CSF-based Tau Assays, 2013 95
Table 32: Product Profile of INNOTEST hTau Ag, 2013 96
Table 33: SWOT Analysis of INNOTEST hTau Ag, 2013 96
Table 34: Product Profile of INNOTEST PHOSPHO-TAU(181P), 2013 97
Table 35: SWOT Analysis of INNOTEST PHOSPHO-TAU(181P), 2013 97
Table 36: SWOT Analysis of Tau PET Imaging in AD, 2013 99
Table 37: Potential Biomarkers of AD, 2013 103
Table 38: Product Profile of Alzheimer’s CSF 16-Plex Assay, 2013 104
Table 39: SWOT Analysis of Alzheimer’s CSF 16-Plex Assay, 2013 105
Table 40: Product Profile of AclarusDx, 2013 107
Table 41: SWOT Analysis of AclarusDx, 2013 108
Table 42: Product Profile of ADpredict Screening Test, 2013 108
Table 43: SWOT Analysis of ADpredict Screening Test, 2013 109
Table 44: Product Profile of Alzheimer’s Plasma 9-Plex Assay, 2013 110
Table 45: SWOT Analysis of Alzheimer’s Plasma 9-Plex Assay, 2013 110
Table 46: Product Profile of ADtect, 2013 111
Table 47: SWOT Analysis of ADtect, 2013 111
Table 48: Product Profile of MCItect, 2013 112
Table 49: SWOT Analysis of MCItect, 2013 112
Table 50: Product Profile of LymPro Test, 2013 113
Table 51: SWOT Analysis of LymPro Test, 2013 113
Table 52: Functional Brain Imaging Biomarkers by Stage of Development, 2013 114
Table 53: SWOT Analysis of FDG- PET Imaging in AD, 2013 118
Table 54: SWOT Analysis of FMRI Biomarkers in AD, 2013 122
Table 55: Structural Brain Imaging Biomarkers by Stage of Development, 2013 124
Table 56: SWOT Analysis of MRI Hippocampal Volumetry, 2013 128
Table 57: Features of an Early-AD Therapy Clinical Trial, 2013 132
Table 58: Summary of the FDA Guidance for Drug Development in Early AD, 2013 133
Table 59: Biomarker Use in Ongoing AD Drug Clinical Trials, 2013 139

List of Figures

Figure 1: The Continuum of Alzheimer’s Disease 17
Figure 2: Atrophy of the Brain in Alzheimer’s Disease 24
Figure 3: Key Pathological Features in Alzheimer’s Disease 26
Figure 4: Non-Amyloidogenic Metabolism of APP 28
Figure 5: Amyloidogenic Metabolism of APP 29
Figure 6: Neurofibrillary Tangles 31
Figure 7: Oxidative Damage due to Free Radicals 33
Figure 8: Biomarkers in Drug Discovery 40
Figure 9: AD Biomarker Tests by Pathophysiology 43
Figure 10: Dynamic Changes in Alzheimer’s Disease Biomarkers 44

Published By: GlobalData
Product Code: GlobalData27786


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