PharmaPoint: Alzheimer’s Disease – Global Drug Forecast and Market Analysis to 2023 – Event-Driven Update
Alzheimer’s Disease (AD) is a progressive neurodegenerative disease that is characterized by memory loss, cognitive impairment, and functional decline. During the early stages of disease, sleep disturbances and forgetfulness are generally the first presenting symptoms. In the severe stages, patients with AD require permanent observation either by a home care professional or family member. The rapidly declining status of patients with AD results in a drastic reduction in quality of life (QOL), both for the patients and their caretakers. With rapidly accelerating worldwide prevalence, AD has been identified as a major global health threat by the international medical community. Significant efforts have been made to develop a new treatment for AD, as current pharmacologic management is known to only provide temporary improvement of symptoms. Without therapies that effectively stop or reverse the course of the disease, a large area opportunity exists for the development of an effective pharmacologic approach.
Key Questions Answered
– What are the preferred therapies for each country?
– The developmental pipeline consists of disease-modifying therapies (DMTs) that aim to prevent the disease in early- and presymptomatic patients. Which of these DMTs will attain high sales revenues during 2013-2023, and in which markets?
– Will amyloid-based therapies face adoption challenges in the market? What is the projected uptake of new passive immunotherapies and BACE inhibitors over the forecast period?
– How large an impact will Lundbeck’s LuAE-58054 and Forum/Mitsubishi Tanabe’s EVP-6124 have on the schizophrenia market? What do key opinion leaders think of these treatment approaches?
– What are the unique challenges in AD, and how will they affect the growth of the market globally?
– Guidelines are not closely followed due to the heterogeneity of symptoms.
– There is a widespread reluctance to seek treatment in the absence of curative therapies.
– Diagnosis in early stages of the disease remains a challenge and will affect the growth of the market over the 2013-2023 forecast period.
– Poor consensus over clinical trial endpoints required for approval.
– Symptoms related to AD require better treatment options.
– Amyloid beta is the focus of the late-stage pipeline.
– Disease-modifying therapies such as passive immunotherapies and BACE inhibitors will revitalize the AD market.
– Overview of AD and mild cognitive impairment (MCI), including etiology, general symptoms, country-specific compliance/caregiving data and epidemiology.
– Annualized AD market revenue, annual cost of treatment and usage patterns from 2013 and forecast for ten years to 2023.
– Key topics covered include strategic competitor assessment, unmet needs, clinical trial mapping and implications for the AD market.
– Pipeline analysis: comprehensive data split across AD disease severities for disease-modifying and symptomatic therapies with novel mechanisms of action in AD, including Lilly’s solanezumab, Biogen’s aducanumab, Roche’s gantenerumab and crenezumab (Phase II). Merck & Co.’s M-8931, and Lilly/AstraZeneca’s AZD-3293.
– Analysis of the current and future market competition in the global AD drug market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Reasons to buy
– 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 competitive pipelines.
– Develop business strategies by understanding the trends shaping and driving the AD market.
– Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global AD market in the future.
– Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
– Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
– Track drug sales in the global AD market from 2013-2023.
– Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 15
1.2 List of Figures 21
2 Introduction 24
2.1 Catalyst 24
2.2 Related Reports 25
2.3 Upcoming Related Reports 25
3 Disease Overview 26
3.1 Etiology and Pathophysiology 26
3.1.1 Etiology 27
3.1.2 Pathophysiology 29
3.2 Disease Staging Systems 38
3.3 Symptoms 41
3.4 Prognosis 43
3.5 Quality of Life 43
4 Epidemiology 45
4.1 Disease Background 45
4.2 Risk Factors and Comorbidities 46
4.2.1 A family history of Alzheimer’s increases the risk of developing the disease by 7.5 times 47
4.2.2 The APOE ε4 allele triples the risk for AD 48
4.2.3 Cardiovascular risk factors in midlife significantly increase the risk of developing AD in later life 48
4.2.4 The incidence and prevalence of AD double every five years after age 65 years 49
4.2.5 Diabetes doubles the risk of AD in men, but only marginally affects the risk in women 49
4.2.6 Women are 1.5 times more likely to develop AD than men 50
4.2.7 Depression triples the risk for AD, and is the most common comorbidity 50
4.2.8 Up to 70% of AD patients also suffer from anxiety 51
4.2.9 Psychosis and agitation are common comorbidities in Alzheimer’s patients 51
4.3 Global Trends 51
4.3.1 US 52
4.3.2 5EU 53
4.3.3 Japan 55
4.3.4 China 56
4.3.5 India 56
4.4 Forecast Methodology 57
4.4.1 Sources Used 62
4.4.2 Forecast Assumptions and Methods 69
4.4.3 Sources Not Used 79
4.5 Epidemiology Forecast (2013-2023) 81
4.5.1 Total Prevalent Cases of AD 81
4.5.2 Age-Specific Total Prevalent Cases of AD 83
4.5.3 Sex-Specific Total Prevalent Cases of AD 85
4.5.4 Age-Standardized Total Prevalence of AD 88
4.5.5 Total Prevalent Cases of AD, by Severity 89
4.5.6 Total Prevalent Cases of MCI 91
4.5.7 Age-Specific Total Prevalent Cases of MCI 93
4.5.8 Sex-Specific Total Prevalent Cases of MCI 95
4.5.9 Age-Standardized Total Prevalence of MCI 98
4.6 Discussion 99
4.6.1 Conclusions Regarding the Epidemiological Trends 99
4.6.2 Limitations of the Analysis 101
4.6.3 Strengths of the Analysis 102
5 Disease Management 103
5.1 Diagnosis Overview 103
5.1.1 Probable AD Dementia 106
5.1.2 Preclinical AD 107
5.1.3 MCI 108
5.2 Treatment Overview 110
5.3 Clinical Practice 112
5.3.1 Leading Prescribed Therapies 114
5.4 US 115
5.5 France 118
5.6 Germany 120
5.7 Italy 122
5.8 Spain 124
5.9 UK 126
5.10 Japan 129
5.11 China 131
5.12 India 133
6 Competitive Assessment 135
6.1 Overview 135
6.2 Product Profiles – Major Brands 136
6.2.1 Aricept (donepezil hydrochloride) 136
6.2.2 Exelon (rivastigmine, rivastigmine tartrate) 141
6.2.3 Razadyne (galantamine hydrobromide) 146
6.2.4 Namenda (memantine hydrochloride) 151
6.3 Other Drugs/Classes 157
7 Unmet Need and Opportunity 159
7.1 Overview 159
7.2 Drugs with Disease-Modifying Mechanisms of Action 160
7.2.1 Unmet Need 160
7.2.2 Gap Analysis 161
7.2.3 Opportunity 162
7.3 Diagnosis in the Prodromal or Presymptomatic Stages 163
7.3.1 Unmet Need 163
7.3.2 Gap Analysis 164
7.3.3 Opportunity 165
7.4 Improved Control of Symptoms 166
7.4.1 Unmet Need 166
7.4.2 Gap Analysis 167
7.4.3 Opportunity 168
7.5 Easier Access to Treatment 169
7.5.1 Unmet Need 169
7.5.2 Gap Analysis 169
7.5.3 Opportunity 170
8 Pipeline Assessment 172
8.1 Overview 172
8.2 Clinical Trial Mapping 173
8.2.1 Clinical Trials by Class 173
8.3 Promising Drugs in Clinical Development 174
8.3.1 Biopharmaceutical Products 176
8.3.2 Small Molecule 209
8.3.3 Other Drugs in Development 258
9 Current and Future Players 260
9.1 Overview 260
9.2 Trends in Corporate Strategy 261
9.3 Company Profiles 262
9.3.1 Actavis 262
9.3.2 Lundbeck 265
9.3.3 Eisai 268
9.3.4 Pfizer 270
9.3.5 Novartis 272
9.3.6 Roche 274
9.3.7 Eli Lilly 276
9.3.8 Merck & Co. 280
9.3.9 AstraZeneca 281
9.3.10 Takeda 283
10 Market Outlook 286
10.1 Global Markets 286
10.1.1 Forecast 286
10.1.2 Drivers and Barriers – Global Issues 294
10.2 United States 297
10.2.1 Forecast 297
10.2.2 Key Events 301
10.2.3 Drivers and Barriers 302
10.3 France 305
10.3.1 Forecast 305
10.3.2 Key Events 308
10.3.3 Drivers and Barriers 309
10.4 Germany 312
10.4.1 Forecast 312
10.4.2 Key Events 315
10.4.3 Drivers and Barriers 315
10.5 Italy 317
10.5.1 Forecast 317
10.5.2 Key Events 321
■ 英文：PharmaPoint: Alzheimer’s Disease - Global Drug Forecast and Market Analysis to 2023 - Event-Driven Update
|アルツハイマー病治療薬の世界市場予測および分析 (PharmaPoint: Alzheimer’s Disease - Global Drug Forecast and Market Analysis to 2023 - Event-Driven Update / GDHC010EPIDR)|
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