Published : Sep-2017
No. of Pages : 330
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 10
2 Executive Summary 12
2.1 Alzheimer's Market Forecast to See Double-Digit Sales Growth out to 2026 13
2.2 Allergan, Biogen, and Roche Are Forecast to Lead the AD Market in 2026 14
2.3 Lack of Treatments and Biomarkers Remain As Key Unmet Needs in the AD Market 16
2.4 Opportunities Remain for Disease-Modifying and Symptomatic Drugs Entering the AD Market 16
2.5 Twenty Promising Drugs in Phase II/III or Phase III of Development 17
2.6 What Do Physicians Think? 18
3 Introduction 21
3.1 Catalyst 21
3.2 Related Reports 21
4 Disease Overview 22
4.1 Etiology and Pathophysiology 22
4.1.1 Etiology 23
4.1.2 Pathophysiology 25
4.2 Disease Staging Systems 33
4.3 Symptoms 36
4.4 Prognosis 37
4.5 Quality of Life 38
5 Epidemiology 39
5.1 Disease Background 39
5.2 Risk Factors and Comorbidities 41
5.3 Global and Historical Trends 42
5.4 Forecast Methodology 44
5.4.1 Sources 44
5.4.2 Forecast Assumptions and Methods 47
5.4.3 Total Prevalent Cases of AD 47
5.4.4 Total Prevalent Cases of AD by Severity 50
5.4.5 Total Prevalent Cases of MCI 53
5.5 Epidemiological Forecast for AD (2016-2026) 56
5.5.1 Total Prevalent Cases of AD 56
5.5.2 Age-Specific Total Prevalent Cases of AD 57
5.5.3 Sex-Specific Total Prevalent Cases of AD 58
5.5.4 Total Prevalent Cases of AD by Severity 59
5.6 Epidemiological Forecast for MCI (2016-2026) 60
5.6.1 Total Prevalent Cases of MCI 60
5.6.2 Age-Specific Total Prevalent Cases of MCI 61
5.6.3 Sex-Specific Total Prevalent Cases of MCI 62
5.7 Discussion 62
5.7.1 Epidemiological Forecast Insight 62
5.7.2 Limitations of Analysis 63
5.7.3 Strengths of Analysis 64
6 Disease Management 65
6.1 Diagnosis Overview 65
6.1.1 Probable AD Dementia 68
6.1.2 Preclinical AD 70
6.1.3 MCI 71
6.2 Treatment Overview 73
6.3 Clinical Practice 74
6.3.1 Leading Prescribed Therapies 76
6.4 US 77
6.5 5EU 79
6.6 Japan 82
7 Competitive Assessment 84
7.1 Overview 84
7.2 Product Profiles - Major Brands 85
7.2.1 Aricept (Donepezil Hydrochloride) 85
7.2.2 Exelon (Rivastigmine, Rivastigmine tartrate) 92
7.2.3 Razadyne (Galantamine Hydrobromide) 98
7.2.4 Namenda (Memantine Hydrochloride) 104
7.2.5 Namzaric (Memantine and Donepezil Hydrochlorides) 110
7.3 Other Therapeutic Classes 113
8 Unmet Needs and Opportunity Assessment 115
8.1 Overview 115
8.2 Drugs with Disease-Modifying Mechanisms of Action 116
8.2.1 Unmet Need 116
8.2.2 Gap Analysis 117
8.2.3 Opportunity 118
8.3 Diagnosis in the Prodromal or Presymptomatic Stages 120
8.3.1 Unmet Need 120
8.3.2 Gap Analysis 121
8.3.3 Opportunity 122
8.4 Improved Control of Symptoms 123
8.4.1 Unmet Need 123
8.4.2 Gap Analysis 124
8.4.3 Opportunity 125
8.5 Easier Access to Treatment 126
8.5.1 Unmet Need 126
8.5.2 Gap Analysis 127
8.5.3 Opportunity 128
9 Pipeline Assessment 129
9.1 Overview 129
9.2 Clinical Trial Mapping 130
9.2.1 Clinical Trials by Class 130
9.3 Promising Drugs in Clinical Development 131
9.3.1 Biopharmaceutical Products 134
9.3.2 Gantenerumab 134
9.3.3 Crenezumab 140
9.3.4 Aducanumab 146
9.3.5 Flebogamma + Albutein 151
9.3.6 CAD106 157
9.3.7 Small Molecule 161
9.3.8 Verubecestat 161
9.3.9 Elenbecestat 166
9.3.10 Lanabecestat 171
9.3.11 JNJ-54861911 175
9.3.12 CNP520 179
9.3.13 Azeliragon 182
9.3.14 Pioglitazone 186
9.3.15 Nilvadipine 192
9.3.16 Intepirdine 196
9.3.17 ALZT-OP1 201
9.3.18 TRx-0237 (LMTX) 205
9.3.19 Brexipiprazole 212
9.3.20 Aripiprazole 216
9.3.21 AVP-786 220
9.3.22 ITI-007 224
9.3.23 Other Drugs in Development 228
10 Current and Future Players 231
10.1 Overview 231
10.2 Trends in Corporate Strategy 234
10.3 Company Profiles 235
10.3.1 Allergan 235
10.3.2 Lundbeck 238
10.3.3 Eisai 241
10.3.4 Pfizer 244
10.3.5 Novartis 246
10.3.6 Roche 249
10.3.7 Biogen 251
10.3.8 Eli lilly 253
10.3.9 Merck & Co. 257
10.3.10 AstraZeneca 259
10.3.11 Takeda 261
11 Market Outlook 264
11.1 Global Markets 264
11.1.1 Forecast 264
11.1.2 Drivers and Barriers - Global Issues 268
11.2 US 269
11.2.1 Forecast 269
11.2.2 Key Events 272
11.2.3 Drivers and Barriers 273
11.3 5EU 273
11.3.1 Forecast 273
11.3.2 Key Events 276
11.3.3 Drivers and Barriers 277
11.4 Japan 277
11.4.1 Forecast 277
11.4.2 Key Events 280
11.4.3 Drivers and Barriers 281
12 Appendix 282
12.1 Bibliography 282
12.2 Abbreviations 304
12.3 Methodology 309
12.3.1 Forecasting Methodology 309
12.3.2 Diagnosed Patients 310
12.3.3 Percent Drug-Treated Patients 310
12.3.4 Drugs Included in Each Therapeutic Class 310
12.3.5 Launch and Patent Expiry Dates 311
12.3.6 General Pricing Assumptions 312
12.3.7 Individual Drug Assumptions 313
12.3.8 Generic Erosion 321
12.3.9 Pricing of Pipeline Agents 321
12.4 Primary Research - KOLs Interviewed for This Report 323
12.4.1 KOLs 323
12.4.2 Payers 325
12.5 Primary Research - Prescriber Survey 325
12.6 About the Authors 326
12.6.1 Analyst 326
12.6.2 Therapy Area Director 326
12.6.3 Epidemiologist 326
12.6.4 Managing Epidemiologist 327
12.6.5 Global Director of Therapy Analysis and Epidemiology 327
12.6.6 Global Head and EVP of Healthcare Operations and Strategy 328
12.7 About GlobalData 329
12.8 Contact Us 329
12.9 Disclaimer 330
1.1 List of Tables
Table 1: MCI and AD: Key Metrics in the 7MM 12
Table 2: Three-Stage Classification of AD 34
Table 3: The Seven-Stage Reisberg Scale of AD 35
Table 4: Common Symptoms of AD. 37
Table 5: DSM-IV Criteria for the Diagnosis of Dementia 40
Table 6: NINCDS-ADRDA Criteria for the Diagnosis of AD 41
Table 7: Risk Factors and Comorbidities for AD 42
Table 8: 7MM, Total Prevalent Cases of AD, Both Sexes, Ages =60 Years, Selected Years 2016-2026. 56
Table 9: 7MM, Total Prevalent Cases of MCI, Both Sexes, Ages =60 Years, Selected Years 2016-2026. 60
Table 10: Commonly Used Diagnostic Guidelines for Alzheimer's Disease 66
Table 11: Summary of NINCDS-ARDA Diagnostic Criteria for Alzheimer's Disease 68
Table 12: Proposed NIA-AA Staging Classification for Preclinical AD 70
Table 13: NIA-AA Biomarker Criteria for MCI 72
Table 14: Commonly Used Treatment Guidelines for Alzheimer's Disease in the 7MM 74
Table 15: Most Prescribed Drugs for AD by Class in the 7MM, 2016 76
Table 16: Most Commonly Prescribed Off-Label Drug Classes for AD, by Treatment Line, in the 7MM 76
Table 17: Country Profile - US 78
Table 18: Region Profile - 5EU, 2017 80
Table 19: Country Profile - Japan 83
Table 20: Leading Therapies in AD 85
Table 21: Product Profile - Aricept 87
Table 22: Efficacy Results for Aricept in Mild to Moderate AD 88
Table 23: Efficacy Results for Aricept in Moderate to Severe AD 89
Table 24: Efficacy Results for Aricept in Severe AD 89
Table 25: Aricept SWOT Analysis, 2017 91
Table 26: Product Profile - Exelon 93
Table 27: Efficacy Results for Exelon Capsule and Oral Solution in AD 94
Table 28: Efficacy Results for Exelon Patch in AD 95
Table 29: Adverse Events Occurring in at Least 2% of Patients and at a Higher Frequency than Placebo-Treated Patients 96
Table 30: Exelon SWOT Analysis, 2017 97
Table 31: Product Profile - Razadyne 99
Table 32: Efficacy Results for Razadyne in Probable AD 101
Table 33: Razadyne SWOT Analysis, 2017 103
Table 34: Product Profile - Namenda 105
Table 35: Efficacy Results for Namenda and Namenda XR in Alzheimer's Disease 107
Table 36: Safety Results for Namenda and Namenda XR in Alzheimer's Disease 108
Table 37: Namenda SWOT Analysis, 2017 109
Table 38: Product Profile - Namzaric 111
Table 39: Namzaric SWOT Analysis, 2017 112
Table 40: Summary of Minor Therapeutic Classes, 2017 114
Table 41: Comparison of Therapeutic Classes in Development for AD 134
Table 42: Product Profile - Gantenerumab 136
Table 43: Key Efficacy Results For Gantenerumab 137
Table 44: Pipeline Gantenerumab SWOT Analysis, 2017 139
Table 45: Ongoing Phase III Trials For Crenezumab, 2017 140
Table 46: Product Profile - Crenezumab 142
Table 47: Key Efficacy Data for Crenezumab 143
Table 48: Pipeline Crenezumab SWOT Analysis, 2017 145
Table 49: Product Profile - Aducanumab 148
Table 50: Key Efficacy Data for Aducanumab 149
Table 51: Key Safety Results For Aducanumab From Phase Ib PRIME Study 149
Table 52: Pipeline Aducanumab SWOT Analysis, 2017 151
Table 53: Product Profile - Flebogamma + Albutein 154
Table 54: Key Efficacy Data for Flebogamma + Albutein 155
Table 55: Key Safety Results For Flebogamma + Albutein From AMBAR (Interim Analysis) 155
Table 56: Flebogamma + Albutein SWOT Analysis, 2017 157
Table 57: Product Profile - CAD106 158
Table 58: CAD106 SWOT Analysis, 2017 160
Table 59: Product Profile - Verubecestat 163
Table 60: Verubecestat SWOT Analysis, 2017 165
Table 61: Product Profile - Elenbecestat 167
Table 62: Key Efficacy Data for Elenbecestat 169
Table 63: Elenbecestat SWOT Analysis, 2017 170
Table 64: Product Profile - Lanabecestat 172
Table 65: Key Efficacy Data for Lanabecestat 173
Table 66: Lanabecestat SWOT Analysis, 2017 174
Table 67: Product Profile - JNJ-54861911 176
Table 68: Key Efficacy Data for JNJ-54861911 177
Table 69: JNJ-54861911 SWOT Analysis, 2017 178
Table 70: Product Profile - CNP520 180
Table 71: Key Efficacy Data for CNP520 180
Table 72: CNP520 SWOT Analysis, 2017 182
Table 73: Product Profile - Azeliragon 184
Table 74: Azeliragon SWOT Analysis, 2017 186
Table 75: Product Profile - Pioglitazone 188
Table 76: Key Safety Results For Pioglitazone 190
Table 77: Pioglitazone SWOT Analysis, 2017 192
Table 78: Product Profile - Nilvadipine 194
Table 79: Nilvadipine SWOT Analysis, 2017 196
Table 80: Product Profile - Intepirdine 198
Table 81: Key Efficacy Results For Intepirdine 199
Table 82: Intepirdine SWOT Analysis, 2017 200
Table 83: Product Profile - ALZT-OP1 202
Table 84: ALZT-OP1 SWOT Analysis, 2017 204
Table 86: Product Profile - TRx-0237 207
Table 87: Key Efficacy Results for TRx-0237 208
Table 88: Key Safety Results For TRx-0237 from the Phase III TRx-237-005 Study 210
Table 89: TRx-0237 SWOT Analysis, 2017 211
Table 90: Product Profile - Brexipiprazole 213
Table 91: Key Efficacy Results For Brexipiprazole 214
Table 92: Brexipiprazole SWOT Analysis, 2017 215
Table 93: Product Profile - Aripiprazole 217
Table 94: Key Efficacy Results For Aripiprazole 218
Table 95: Key Safety Results For Aripiprazole 218
Table 96: Aripiprazole SWOT Analysis, 2017 220
Table 97: Product Profile - AVP-786 221
Table 98: AVP-786 SWOT Analysis, 2017 224
Table 99: Product Profile - ITI-007 225
Table 100: ITI-007 SWOT Analysis, 2017 227
Table 101: Drugs in Development for AD and AD-Related Symptoms, 2017 229
Table 102: Key Companies in the AD Market in the 7MM, 2017 232
Table 103: Allergan's AD Portfolio Assessment, 2017 237
Table 104: Lundbeck's AD Portfolio Assessment, 2017 240
Table 105: Eisai's AD Portfolio Assessment, 2017 243
Table 106: Pfizer's AD Portfolio Assessment, 2017 245
Table 107: Novartis's AD Portfolio Assessment, 2017 248
Table 108: Roche's AD Portfolio Assessment, 2017 250
Table 109: Biogen's AD Portfolio Assessment, 2017 252
Table 110: Eli Lilly's AD Portfolio Assessment, 2017 256
Table 111: Merck's AD Portfolio Assessment, 2017 258
Table 112: AstrasZeneca's AD Portfolio Assessment, 2017 260
Table 113: Takeda's AD Portfolio Assessment, 2017 263
Table 114: AD Market - Global Drivers and Barriers, 2016-2026 268
Table 115: Key Events Impacting Sales for Alzheimer's Disease in the US, 2016-2026 272
Table 116: AD Market - Drivers and Barriers in the US, 2016-2026 273
Table 117: Key Events Impacting Sales for AD in the 5EU, 2016-2026 276
Table 118: AD Market - Drivers and Barriers in the 5EU, 2016-2026 277
Table 119: Key Events Impacting Sales for AD in Japan, 2016-2026 280
Table 120: AD Market - Global Drivers and Barriers in Japan, 2016-2026 281
Table 121: Key Historical and Projected Launch Dates for AD 311
Table 122 : Key Historical and Projected Patent Expiry Dates for AD 312
Table 123: High-Prescribing Physicians (non-KOLs) Surveyed, by Country 325
1.2 List of Figures
Figure 1: Global Sales Forecast by Country for AD, 2016-2026 14
Figure 2: Company Portfolio Gap Analysis in AD, 2016-2026 15
Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in AD, 2016-2026 18
Figure 4: AD Biomarker Tests by Pathophysiology 31
Figure 5: Dynamic Changes in AD Biomarker Over Time 32
Figure 6: 7MM, Age-Standardized Total Prevalence of AD (%), Ages =60 Years 43
Figure 7: 7MM, Age-Standardized Total Prevalence of MCI (%), Ages =60 Years 44
Figure 8: 7MM, Sources Used and Not Used, Total Prevalent Cases of AD 45
Figure 9: 7MM, Sources Used, Total Prevalent Cases of AD by Severity 46
Figure 10: 7MM, Sources Used, Total Prevalent Cases of MCI 46
Figure 11: 7MM, Age-Specific Total Prevalent Cases of AD, Both Sexes, 2016 57
Figure 12: 7MM, Sex-Specific Total Prevalent Cases of AD, Both Sexes, Ages >60 Years, 2016 58
Figure 13: 7MM, Total Prevalent Cases of AD by Severity, Both Sexes, Ages =60 Years, 2016 59
Figure 14: 7MM, Age-Specific Total Prevalent Cases of MCI, Both Sexes, 2016 61
Figure 15: 7MM, Sex-Specific Total Prevalent Cases of MCI, Both Sexes, Ages >60 Years, 2016 62
Figure 16: Disease Management Timeline For Alzheimer's Disease 75
Figure 17: Unmet Need and Opportunity in AD, 2017 116
Figure 18: Overview of the Development Pipeline in MCI and AD 129
Figure 19 : Active Phase II and Phase III Clinical Trials in MCI and AD by Drug Class, 2017 130
Figure 20: Key Phase II/III and III Trials, Promising Pipeline Agents for MCI and AD, 7MM, 2016-2026 131
Figure 21: Key Phase III Trials of Promising Pipeline Agents for AD-Associated Agitation, 7MM, 2016-2026 132
Figure 22: Competitive Assessment of the Late-Stage Pipeline Agents for MCI and AD, 2017-2027 133
Figure 23: Clinical and Commercial Positioning of Gantenerumab 138
Figure 24: Clinical and Commercial Positioning of Crenezumab 144
Figure 25: Clinical and Commercial Positioning of Pipeline aducanumab 150
Figure 26: Clinical and Commercial Positioning of Pipeline Flebogamma + Albutein 156
Figure 27: Clinical and Commercial Positioning of Pipeline CAD106 160
Figure 28: Clinical and Commercial Positioning of Verubecestat 165
Figure 29: Clinical and Commercial Positioning of Elenbecestat 170
Figure 30: Clinical and Commercial Positioning of Lanabecestat 174
Figure 31: Clinical and Commercial Positioning of JNJ-54861911 178
Figure 32: Clinical and Commercial Positioning of CNP520 181
Figure 33: Clinical and Commercial Positioning of Azeliragon 185
Figure 34: Clinical and Commercial Positioning of Pioglitazone 191
Figure 35: Clinical and Commercial Positioning of Nilvadipine 195
Figure 36: Clinical and Commercial Positioning of Intepirdine 200
Figure 37: Clinical and Commercial Positioning of ALZT-OP1 204
Figure 38: Clinical and Commercial Positioning of TRx-0237 211
Figure 39: Clinical and Commercial Positioning of Brexipiprazole 215
Figure 40: Clinical and Commercial Positioning of Aripiprazole 219
Figure 41: Clinical and Commercial Positioning of AVP-786 223
Figure 42: Clinical and Commercial Positioning of ITI-007 227
Figure 43: Global Sales of AD Products, by Company, 2016 and 2026 233
Figure 44: Company Portfolio Gap Analysis in AD, 2016-2026 234
Figure 45: Allergan SWOT Analysis, 2017 238
Figure 46: Lundbeck SWOT Analysis, 2017 241
Figure 47: Eisai SWOT Analysis, 2017 243
Figure 48: Pfizer SWOT Analysis, 2017 246
Figure 49: Novartis SWOT Analysis, 2017 248
Figure 50: Roche SWOT Analysis, 2017 250
Figure 51: Biogen SWOT Analysis, 2017 253
Figure 52: Eli Lilly SWOT Analysis, 2017 257
Figure 53: Merck SWOT Analysis, 2017 259
Figure 54: AstraZeneca SWOT Analysis 261
Figure 55: Takeda SWOT Analysis, 2017 263
Figure 56: 7MM Sales Forecast by Country for AD, 2016 and 2026 267
Figure 57: Sales Forecast by Class for AD in the US in 2016 and 2026 271
Figure 58: Sales Forecast by Class for AD in the 5EU, 2016 and 2026 275
Figure 59: Sales Forecast by Class for AD in Japan in 2016 and 2026 279
