Alzheimer’s Disease Market and Forecast Analysis 2034

CONTENTS

11 FORECAST: ALZHEIMER’S DISEASE (Published on 21 June 2017)
11 OVERVIEW
12 EXECUTIVE SUMMARY
13 MARKET OVERVIEW AND TRENDS
25 MARKET DEFINITION AND METHODOLOGY
32 ADUCANUMAB
37 ARICEPT (DONEPEZIL)
40 CRENEZUMAB
45 EXELON/EXELON PATCH (RIVASTIGMINE)
48 NAMENDA/XR (MEMANTINE)
52 RAZADYNE (GALANTAMINE)
55 RVT-101
58 PRIMARY RESEARCH METHODOLOGY

61 TREATMENT: ALZHEIMER’S DISEASE (Published on 21 June 2017)
61 OVERVIEW
62 EXECUTIVE SUMMARY
63 PRIMARY RESEARCH METHODOLOGY
65 DISEASE DEFINITION AND DIAGNOSIS
78 PATIENT SEGMENTATION
85 COUNTRY TREATMENT TREES
86 CURRENT TREATMENT OPTIONS
91 PRESCRIBING TRENDS
114 UNMET NEEDS IN ALZHEIMER’S DISEASE

130 EPIDEMIOLOGY: ALZHEIMER’S DISEASE (Published on 25 February 2019)
130 OVERVIEW
131 DISEASE BACKGROUND
133 METHODOLOGY
136 FORECAST
141 BIBLIOGRAPHY
143 APPENDIX: MILD COGNITIVE IMPAIRMENT

148 MARKETED DRUGS: ALZHEIMER’S DISEASE (Published on 21 June 2017)
148 OVERVIEW
149 EXECUTIVE SUMMARY
150 PRODUCT OVERVIEW
152 PRODUCT PROFILE: ARICEPT
162 PRODUCT PROFILE: EXELON/EXELON PATCH
174 PRODUCT PROFILE: NAMENDA
183 PRODUCT PROFILE: RAZADYNE

191 PIPELINE: ALZHEIMER’S DISEASE (Published on 21 June 2017)
191 OVERVIEW
192 EXECUTIVE SUMMARY
194 CLINICAL PIPELINE OVERVIEW
197 CLINICAL TRIAL DESIGN
210 RECENTLY DISCONTINUED DRUGS
217 ADDITIONAL PHARMA INTELLIGENCE PIPELINE RESOURCES
218 PRODUCT PROFILE (LATE STAGE): LMTX
231 PRODUCT PROFILE (LATE STAGE): RVT-101
244 PRODUCT PROFILE (LATE STAGE): ADUCANUMAB
256 PRODUCT PROFILE (LATE STAGE): AZELIRAGON
268 PRODUCT PROFILE (LATE STAGE): CRENEZUMAB
279 PRODUCT PROFILE (LATE STAGE): GANTENERUMAB
288 PRODUCT PROFILE (LATE STAGE): VERUBECESTAT

LIST OF FIGURES
13 Figure 1: Alzheimer’s disease market sales value in the US, Japan, and five major EU markets, by country, 2015−24
16 Figure 2: Alzheimer’s disease drug class sales in the US, Japan, and five major EU markets, 2015−24
18 Figure 3: Sales of cholinesterase inhibitors in the US, Japan, and five major EU markets, by country, 2015−24
20 Figure 4: Sales of NMDA receptor antagonists in the US, Japan, and five major EU markets, by country, 2015−24
23 Figure 5: Alzheimer’s disease market sales value by disease severity in the US, Japan, and five major EU markets, 2015−24
26 Figure 6: Patient-based forecast methodology for Alzheimer’s disease
28 Figure 7: Price sources and calculations, by country
34 Figure 8: Aducanumab sales for Alzheimer’s disease across the US, Japan, and five major EU markets, by country, 2015−24
38 Figure 9: Aricept sales for Alzheimer’s disease across the US, Japan, and five major EU markets, by country, 2015−24
42 Figure 10: Crenezumab sales for Alzheimer’s disease across the US, Japan, and five major EU markets, by country, 2015−24
46 Figure 11: Exelon/Exelon Patch sales for Alzheimer’s disease across the US, Japan, and five major EU markets, by country, 2015−24
49 Figure 12: Namenda/XR sales for Alzheimer’s disease across the US, Japan, and five major EU markets, by country, 2015−24
53 Figure 13: Razadyne sales for Alzheimer’s disease across the US, Japan, and five major EU markets, by country, 2015−24
56 Figure 14: RVT-101 sales for Alzheimer’s disease across the US, Japan, and five major EU markets, by country, 2015−24
67 Figure 15: Hypothetical model of dynamic biomarkers taking place with disease severity
68 Figure 16: Neurologist-reported Alzheimer’s disease diagnosis rates, by country, 2015
70 Figure 17: Hypothesized beta-amyloid pathway in Alzheimer’s disease and therapeutic strategies
71 Figure 18: Hypothesized tau pathway in Alzheimer’s disease and therapeutic strategies
75 Figure 19: The dynamics in biomarkers of the Alzheimer’s disease pathological cascade
79 Figure 20: Estimated prevalent and diagnosed prodromal and Alzheimer’s disease patient populations in the US, Japan, and five major EU markets, by country, 2015
80 Figure 21: Diagnosed Alzheimer’s disease patients in the US, Japan, and five major EU markets, by disease severity and country, 2015
82 Figure 22: Estimated prevalent, diagnosed, and drug-treated prodromal and Alzheimer’s disease patients in the US, Japan, and five major EU markets, by country, 2015
83 Figure 23: Proportion of drug-treated patients in the US, Japan, and five major EU markets, by disease severity and country (%), 2015
91 Figure 24: Pharmacological treatment rates for diagnosed Alzheimer’s patients in the US, Japan, and five major EU markets, by disease severity and country (%), 2015
94 Figure 25: Treatment choices for patients diagnosed with prodromal Alzheimer’s disease in the US, Japan, and five major EU markets, by country (%), 2015
95 Figure 26: Treatment choices for patients diagnosed with mild Alzheimer’s disease in the US, Japan, and five major EU markets, by country (%), 2015
96 Figure 27: Treatment choices for patients diagnosed with moderate Alzheimer’s disease in the US, Japan, and five major EU markets, by country (%), 2015
97 Figure 28: Treatment choices for patients diagnosed with severe Alzheimer’s disease in the US, Japan, and five major EU markets, by country (%), 2015
98 Figure 29: Prescription trends in patients diagnosed with prodromal Alzheimer’s disease in the US, Japan, and five major EU markets, by country (%), 2015
101 Figure 30: Prescription trends in patients diagnosed with mild Alzheimer’s disease in the US, Japan, and five major EU markets, by country (%), 2015
104 Figure 31: Prescription trends in patients diagnosed with moderate Alzheimer’s disease in the US, Japan, and five major EU markets, by country (%), 2015
106 Figure 32: Prescription trends in patients diagnosed with severe Alzheimer’s disease in the US, Japan, and five major EU markets, by country (%), 2015
109 Figure 33: Preference for rivastigmine patch over oral formulation for all severities of Alzheimer’s disease, by country (%), 2015
110 Figure 34: Proportion of Alzheimer’s disease patients receiving either memantine monotherapy or in combination, by country (%), 2015
111 Figure 35: Compliance rates to oral versus transdermal patch formulations in patients with Alzheimer’s disease, by country (%), 2015
114 Figure 36: Key unmet needs for Alzheimer’s disease, 2015
116 Figure 37: Impact of symptomatic versus disease-modifying drugs on quality of life/life expectancy over the course of the disease
126 Figure 38: NHS’s recommended referral pathway for patients presenting to primary care with dementia
140 Figure 39: Trends in total prevalent cases of Alzheimer’s disease in the US, Japan, and five major EU markets, by country, 2018–38
156 Figure 40: Aricept for Alzheimer’s disease – SWOT analysis
157 Figure 41: Datamonitor Healthcare’s drug assessment summary of Aricept in Alzheimer’s disease
158 Figure 42: Datamonitor Healthcare’s drug assessment summary of Aricept in Alzheimer’s disease
168 Figure 43: Exelon/Exelon Patch for Alzheimer’s disease – SWOT analysis
169 Figure 44: Datamonitor Healthcare’s drug assessment summary of Exelon in Alzheimer’s disease
170 Figure 45: Datamonitor Healthcare’s drug assessment summary of Exelon in Alzheimer’s disease
177 Figure 46: Namenda for Alzheimer’s disease – SWOT analysis
178 Figure 47: Datamonitor Healthcare’s drug assessment summary of Namenda in Alzheimer’s disease
179 Figure 48: Datamonitor Healthcare’s drug assessment summary of Namenda in Alzheimer’s disease
187 Figure 49: Razadyne for Alzheimer’s disease – SWOT analysis
188 Figure 50: Datamonitor Healthcare’s drug assessment summary of Razadyne in Alzheimer’s disease
189 Figure 51: Datamonitor Healthcare’s drug assessment summary of Razadyne in Alzheimer’s disease
206 Figure 52: Clinical trial designs proposed to determine disease modification
224 Figure 53: LMTX for Alzheimer’s disease – SWOT analysis
225 Figure 54: Datamonitor Healthcare’s drug assessment summary of LMTX in Alzheimer’s disease
226 Figure 55: Datamonitor Healthcare’s drug assessment summary of LMTX in Alzheimer’s disease
238 Figure 56: RVT-101 for Alzheimer’s disease – SWOT analysis
239 Figure 57: Datamonitor Healthcare’s drug assessment summary of RVT-101 in Alzheimer’s disease
240 Figure 58: Datamonitor Healthcare’s drug assessment summary of RVT-101 in Alzheimer’s disease
250 Figure 59: Aducanumab for Alzheimer’s disease – SWOT analysis
251 Figure 60: Datamonitor Healthcare’s drug assessment summary of aducanumab in Alzheimer’s disease
252 Figure 61: Datamonitor Healthcare’s drug assessment summary of aducanumab in Alzheimer’s disease
262 Figure 62: Azeliragon for Alzheimer’s disease – SWOT analysis
263 Figure 63: Datamonitor Healthcare’s drug assessment summary of azeliragon in Alzheimer’s disease
264 Figure 64: Datamonitor Healthcare’s drug assessment summary of azeliragon in Alzheimer’s disease
274 Figure 65: Crenezumab for Alzheimer’s disease – SWOT analysis
275 Figure 66: Datamonitor Healthcare’s drug assessment summary of crenezumab in Alzheimer’s disease
276 Figure 67: Datamonitor Healthcare’s drug assessment summary of crenezumab in Alzheimer’s disease
284 Figure 68: Gantenerumab for Alzheimer’s disease – SWOT analysis
285 Figure 69: Datamonitor Healthcare’s drug assessment summary of gantenerumab in Alzheimer’s disease
286 Figure 70: Datamonitor Healthcare’s drug assessment summary of gantenerumab in Alzheimer’s disease
293 Figure 71: Verubecestat for Alzheimer’s disease – SWOT analysis
294 Figure 72: Datamonitor Healthcare’s drug assessment summary of verubecestat in Alzheimer’s disease
295 Figure 73: Datamonitor Healthcare’s drug assessment summary of verubecestat in Alzheimer’s disease
296 Figure 74: Hypothetical model of dynamic biomarkers taking place with disease severity

LIST OF TABLES
14 Table 1: Alzheimer’s disease market sales value in the US, Japan, and five major EU markets, by country ($m), 2015−24
17 Table 2: Alzheimer’s disease drug class sales in the US, Japan, and five major EU markets ($m), 2015−24
19 Table 3: Sales of cholinesterase inhibitors in the US, Japan, and five major EU markets, by country ($m), 2015−24
21 Table 4: Sales of NMDA receptor antagonists in the US, Japan, and five major EU markets, by country ($m), 2015−24
24 Table 5: Alzheimer’s disease market sales value by disease severity in the US, Japan, and five major EU markets ($m), 2015–24
25 Table 6: Summary of drug classes and molecules in Datamonitor Healthcare’s Alzheimer’s disease patient-based forecast
29 Table 7: Exchange rates used for calculating prices
29 Table 8: Estimated patent expiry/loss of exclusivity dates for key marketed brands in Alzheimer’s disease in the US, Japan, and five major EU markets, by country
30 Table 9: Estimated launch dates of key late-stage pipeline products in Alzheimer’s disease, by country, 2015−24
33 Table 10: Aducanumab’s dose and price assumptions, by country, 2016
35 Table 11: Aducanumab sales for Alzheimer’s disease across the US, Japan, and five major EU markets, by country ($m), 2015−24
39 Table 12: Aricept sales for Alzheimer’s disease across the US, Japan, and five major EU markets, by country ($m), 2015−24
41 Table 13: Crenezumab’s dose and price assumptions, by country, 2016
43 Table 14: Crenezumab sales for Alzheimer’s disease across the US, Japan, and five major EU markets, by country ($m), 2015−24
47 Table 15: Exelon/Exelon Patch sales for Alzheimer’s disease across the US, Japan, and five major EU markets, by country ($m), 2015−24
50 Table 16: Namenda/XR sales for Alzheimer’s disease across the US, Japan, and five major EU markets, by country ($m), 2015−24
54 Table 17: Razadyne sales for Alzheimer’s disease across the US, Japan, and five major EU markets, by country ($m), 2015−24
57 Table 18: RVT-101 sales for Alzheimer’s disease across the US, Japan, and five major EU markets, by country ($m), 2015−24
58 Table 19: Neurologists surveyed for the Alzheimer’s disease primary research study, 2015
60 Table 20: Pipeline products discussed in the key opinion leader research interviews
63 Table 21: Neurologists surveyed for the Alzheimer’s disease primary research study, 2015
72 Table 22: Common clinical features of Alzheimer’s disease
74 Table 23: Dementia caregiver tasks
80 Table 24: Estimated number of diagnosed Alzheimer’s disease patients in the US, Japan, and five major EU markets, by disease severity and country, 2015
83 Table 25: Estimated number of drug-treated Alzheimer’s disease patients in the US, Japan, and five major EU markets, by disease severity and country, 2015
87 Table 26: Leading therapies for Alzheimer’s disease
88 Table 27: Commonly used guidelines for the treatment of Alzheimer’s disease
92 Table 28: Pharmacological treatment rates for diagnosed Alzheimer’s patients in the US, Japan, and five major EU markets, by disease severity and country (%), 2015
99 Table 29: Prescription trends in patients diagnosed with prodromal Alzheimer’s disease in the US, Japan, and five major EU markets, by country (%), 2015
102 Table 30: Prescription trends in patients diagnosed with mild Alzheimer’s disease in the US, Japan, and five major EU markets, by country (%), 2015
105 Table 31: Prescription trends in patients diagnosed with moderate Alzheimer’s disease in the US, Japan, and five major EU markets, by country (%), 2015
107 Table 32: Prescription trends in patients diagnosed with severe Alzheimer’s disease in the US, Japan, and five major EU markets, by country (%), 2015
118 Table 33: Summary of the global and cognitive response of Alzheimer’s disease patients to acetylcholinesterase inhibitor treatment
122 Table 34: Aricept’s side-effect profile
133 Table 35: Sources used for the epidemiological analysis of Alzheimer’s disease in the US, Japan, and EU markets, by country
137 Table 36: Total prevalent cases of Alzheimer’s disease in the US, Japan, and five major EU markets, by country, 2018–38
145 Table 37: Total prevalent cases of mild cognitive impairment due to Alzheimer’s disease in the US, Japan, and five major EU markets, by country, 2018–38
151 Table 38: Key marketed drugs for Alzheimer’s disease
153 Table 39: Aricept drug profile
154 Table 40: Aricept pivotal trial data in Alzheimer’s disease
163 Table 41: Exelon/Exelon Patch drug profile
165 Table 42: Exelon pivotal trial data in Alzheimer’s disease
166 Table 43: Exelon Patch pivotal trial data in Alzheimer’s disease
175 Table 44: Namenda drug profile
176 Table 45: Namenda pivotal trial data in Alzheimer’s disease
184 Table 46: Razadyne drug profile
185 Table 47: Razadyne pivotal trial data in Alzheimer’s disease
195 Table 48: Phase III pipeline products in development for Alzheimer’s disease
201 Table 49: FDA and EMA recommendations for clinical trial endpoints in Alzheimer’s disease
207 Table 50: FDA and EMA recommendations on clinical trial design to demonstrate disease-modifying effects
210 Table 51: Encenicline drug profile
211 Table 52: Encenicline late-phase trials in Alzheimer’s disease
212 Table 53: Idalopirdine drug profile
213 Table 54: Idalopirdine late-phase trials in Alzheimer’s disease
214 Table 55: Solanezumab drug profile
215 Table 56: Solanezumab late-phase trials in Alzheimer’s disease
219 Table 57: LMTX drug profile
221 Table 58: LMTX Phase III data in Alzheimer’s disease
222 Table 59: LMTX Phase III trials in Alzheimer’s disease
232 Table 60: RVT-101 drug profile
233 Table 61: RVT-101 Phase II data in Alzheimer’s disease
236 Table 62: RVT-101 Phase III trials in Alzheimer’s disease
245 Table 63: Aducanumab drug profile
246 Table 64: Aducanumab Phase Ib data in Alzheimer’s disease
248 Table 65: Aducanumab Phase III trials in Alzheimer’s disease
257 Table 66: Azeliragon drug profile
258 Table 67: Azeliragon Phase IIb data in Alzheimer’s disease
260 Table 68: Azeliragon Phase III trials in Alzheimer’s disease
269 Table 69: Crenezumab drug profile
270 Table 70: Crenezumab Phase II data in Alzheimer’s disease
272 Table 71: Crenezumab Phase III trials in Alzheimer’s disease
280 Table 72: Gantenerumab drug profile
281 Table 73: Gantenerumab Phase III data in Alzheimer’s disease
282 Table 74: Gantenerumab Phase III trials in Alzheimer’s disease
289 Table 75: Verubecestat drug profile
290 Table 76: Verubecestat Phase Ib data in Alzheimer’s disease
291 Table 77: Verubecestat Phase II/III trials in Alzheimer’s disease