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Alzheimer’s Disease – Global Drug Forecast and Market Analysis to 2028

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 the 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 a family member. The rapidly declining status of patients with AD results in a drastic reduction in quality of life (QOL) for both patients and their caretakers. With rapidly increasing 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 a temporary improvement in symptoms. Without therapies that effectively stop or reverse the course of the disease, a large area of opportunity exists for the development of an effective pharmacologic approach.

The current competitive landscape in AD consists only of symptomatic treatments, of which there are currently six approved medications: three ChEIs (donepezil, rivastigmine, and galantamine), one NMDA-R antagonist (memantine), one combination therapy (memantine/donepezil), and one Aβ A4 protein inhibitor (sodium oligomannate). Improvements to the approved therapies, such as easier routes of administration and reduced dosing frequencies, along with the developments that are expected to occur within the next decade, could have a significant effect on the way the disease is managed. Earlier disease detection may render the currently available therapies more useful, but until disease-modifying agents are introduced, the landscape will not change significantly.

GlobalData estimates that drug sales for AD in 2018 were approximately $2.2B across the eight major markets covered in this report. Over the 10-year forecast period, the market is expected to grow to $12.9B at a CAGR of 19.3%. This growth will be driven by the increasing prevalence of AD and MCI worldwide, and the introduction of DMTs including Biogen’s aducanumab, Eisai’s BAN-2401, and Roche’s gantenerumab. This growth will be driven by the launch of eleven late-stage pipeline products.

Key Questions Answered

• What are the key AD treatments in 2018?

• When will the late stage pipeline products launch, and how will it affect drug sales and the overall AD market in the 8MM?

• Which unmet needs will remain unaddressed in the forecast period and what opportunities remain for pharmaceutical companies?

Scope

Overview of Alzheimer’s Disease, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.

Annualized Alzheimer’s Disease therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in four patient segments (MCI, Mild, Moderate and Severe) forecast from 2018 to 2028.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the Alzheimer’s Disease therapeutics market.

Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for Alzheimer’s Disease therapy. The most promising candidates in Phase III development are profiled.

Analysis of the current and future market competition in the global Alzheimer’s Disease therapeutics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

Significant growth is expected in the AD market from 2018 to 2028

GlobalData’s anticipate that eighteen late stage pipeline drugs will launch over the forecast period. These are expected to be the main driver of growth in the MS market across the 8MM.

GlobalData projects that Biogen’s aducanumab will be one of the highest-selling DMT for AD, generating $4.2B in the 8MM in 2028.

There are no curative therapies for AD, and most existing DMTs only have limited efficacy on treating symptoms.

Opportunities are expected for pharmaceutical companies to develop drugs which have novel MOAs; which have potential disease modifying properties.

Reasons to Buy

The report will enable you to:

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 trends shaping and driving the global Alzheimer’s Disease therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global Alzheimer’s Disease therapeutics market in the future.

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Key Players

Teva

AC Immune

Roche

Amneal

Lundbeck

Lupin

Eli Lilly

Mylan Pharmaceuticals

Otsuka

Sun Pharma

Merz

AbbVie

Biogen

Adamas

vTv Therapeutics

BioArctic Neuroscience

Takeda

Amgen

Pfizer

AZ Therapies

Biohaven Pharmaceuticals

AB Science

Green Valley Pharmaceuticals

Axsome Therapeutics

Janssen

Grifols

Genentech

Cortexyme

GE Healthcare

Avanir Pharmaceuticals

Changchun Huayang High-Tech

TauRx Pharmaceuticals

AgeneBio

Novartis

Cerecin

MorphoSys

Allergan

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

2.1 Alzheimer’s Market Forecast to See Double-Digit Sales Growth out to 2028

2.2 Allergan, Biogen, Eisai, and Roche Are Forecast to Lead the AD Market in 2028

2.3 Lack of Treatments and Biomarkers Remain As Key Unmet Needs in the AD Market

2.4 Opportunities Remain for Disease-Modifying and Symptomatic Drugs Entering the AD Market

2.5 Eighteen Promising Drugs in Phase II/III or Phase III of Development

2.6 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

4.2 Disease Staging Systems

4.3 Symptoms

4.4 Prognosis

4.5 Quality of Life

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.4 Forecast Methodology

5.4.1 Sources

5.4.2 Forecast Assumptions and Methods

5.5 Epidemiological Forecast for AD (2018–2028)

5.5.1 Total Prevalent Cases of AD

5.5.2 Sex-Specific Total Prevalent Cases of AD

5.5.3 Age-Specific Total Prevalent Cases of AD

5.5.4 Total Prevalent Cases of AD by Severity

5.5.5 Diagnosed Prevalent Cases of AD

5.5.6 Sex-Specific Diagnosed Prevalent Cases of AD

5.5.7 Age-Specific Diagnosed Prevalent Cases of AD

5.5.8 Diagnosed Prevalent Cases of AD by Severity

5.5.9 Total Prevalent Cases of Mild Cognitive Impairment

5.5.10 Sex-Specific Total Prevalent Cases of Mild Cognitive Impairment

5.5.11 Age-Specific Total Prevalent Cases of Mild Cognitive Impairment

5.5.12 Diagnosed Prevalent Cases of Mild Cognitive Impairment

5.5.13 Sex-Specific Diagnosed Prevalent Cases of Mild Cognitive Impairment

5.5.14 Age-Specific Diagnosed Prevalent Cases of Mild Cognitive Impairment

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of the Analysis

5.6.3 Strengths of the Analysis

6 Disease Management

6.1 Diagnosis Overview

6.1.1 Probable AD Dementia

6.1.2 Preclinical AD

6.1.3 MCI

6.2 Treatment Overview

6.3 Clinical Practice

6.3.1 Leading Prescribed Therapies

6.4 US

6.5 5EU

6.6 Japan

6.7 China

7 Current Treatment Options

7.1 Overview

7.2 Other Therapeutic Classes

8 Unmet Needs and Opportunity Assessment

8.1 Overview

8.2 Drugs with Disease-Modifying Mechanisms of Action

8.2.1 Unmet Need

8.2.2 Gap Analysis

8.2.3 Opportunity

8.3 Diagnosis in the Prodromal or Presymptomatic Stages

8.3.1 Unmet Need

8.3.2 Gap Analysis

8.3.3 Opportunity

8.4 Improved Control of Symptoms

8.4.1 Unmet Need

8.4.2 Gap Analysis

8.4.3 Opportunity

8.5 Easier Access to Treatment

8.5.1 Unmet Need

8.5.2 Gap Analysis

8.5.3 Opportunity

9 Pipeline Assessment

9.1 Overview

9.2 Late-Stage Pipeline Products

9.3 Other Drugs in Development

10 Current and Future Players

10.1 Overview

10.2 Trends in Corporate Strategy

10.3 Company Profiles

10.3.1 Allergan

10.3.2 Lundbeck

10.3.3 Eisai

10.3.4 Novartis

10.3.5 Roche

10.3.6 Biogen

10.3.7 Eli Lilly

10.3.8 Takeda

11 Market Outlook

11.1 Global Markets

11.1.1 Forecast

11.1.2 Drivers and Barriers – Global Issues

11.2 US

11.2.1 Forecast

11.2.2 Key Events

11.2.3 Drivers and Barriers

11.3 5EU

11.3.1 Forecast

11.3.2 Key Events

11.3.3 Drivers and Barriers

11.4 Japan

11.4.1 Forecast

11.4.2 Key Events

11.4.3 Drivers and Barriers

11.5 China

11.5.1 Forecast

11.5.2 Key Events

11.5.3 Drivers and Barriers

12 Appendix

12.1 Bibliography

12.2 Abbreviations

12.3 Methodology

12.3.1 Forecasting Methodology

12.3.2 Diagnosed Patients

12.3.3 Percent Drug-Treated Patients

12.3.4 Drugs Included in Each Therapeutic Class

12.3.5 Launch and Patent Expiry Dates

12.3.6 General Pricing Assumptions

12.3.7 Individual Drug Assumptions

12.3.8 Generic Erosion

12.3.9 Pricing of Pipeline Agents

12.4 Primary Research – KOLs Interviewed for This Report

12.4.1 KOLs

12.4.2 Payers

12.5 Primary Research – Prescriber Survey

12.6 About the Authors

12.6.1 Analyst

12.6.2 Therapy Area Director

12.6.3 Epidemiologist

12.6.4 Managing Epidemiologist

12.6.5 Global Director of Therapy Analysis and Epidemiology

12.6.6 Global Head and EVP of Healthcare Operations and Strategy

12.7 About GlobalData

12.8 Contact Us

12.9 Disclaimer

List of Tables

Table 1: MCI and AD: Key Metrics in the 8MM

Table 2: Three-Stage Classification of AD

Table 3: The Seven-Stage Reisberg Scale of AD

Table 4: Common Symptoms of AD

Table 5: Risk Factors and Comorbidities for AD

Table 6: Commonly Used Diagnostic Guidelines for Alzheimer’s Disease

Table 7: Summary of NINCDS-ARDA Diagnostic Criteria for Alzheimer’s Disease

Table 8: Proposed NIA-AA Staging Classification for Preclinical AD

Table 9: NIA-AA Biomarker Criteria for MCI

Table 10: Commonly Used Treatment Guidelines for Alzheimer’s Disease in the 8MM

Table 11: Most Prescribed Drugs for AD by Class in the 8MM, 2018

Table 12: Most Commonly Prescribed Off-Label Drug Classes for AD, by Treatment Line, in the 8MM

Table 13: Country Profile – US

Table 14: Region Profile – 5EU

Table 15: Country Profile – Japan

Table 16: Country Profile – China

Table 17: Leading Therapies in AD

Table 18: Summary of Minor Therapeutic Classes, 2020

Table 19: Comparison of Therapeutic Classes in Development for AD

Table 20: Drugs in Development for AD and AD-Related Symptoms, 2020

Table 21: Key Companies in the AD Market in the 8MM, 2020

Table 22: Allergan’s AD Portfolio Assessment, 2020

Table 23: Lundbeck’s AD Portfolio Assessment, 2020

Table 24: Eisai’s AD Portfolio Assessment, 2020

Table 25: Novartis’ AD Portfolio Assessment, 2020

Table 26: Roche’s AD Portfolio Assessment, 2020

Table 27: Biogen’s AD Portfolio Assessment, 2020

Table 28: Eli Lilly’s AD Portfolio Assessment, 2020

Table 29: Takeda’s AD Portfolio Assessment, 2020

Table 30: AD Market – Global Drivers and Barriers, 2018–2028

Table 31: Key Events Impacting Sales for Alzheimer’s Disease in the US, 2018–2028

Table 32: AD Market – Drivers and Barriers in the US, 2018–2028

Table 33: Key Events Impacting Sales for AD in the 5EU, 2018–2028

Table 34: AD Market – Drivers and Barriers in the 5EU, 2018–2028

Table 35: Key Events Impacting Sales for AD in Japan, 2018–2028

Table 36: AD Market – Global Drivers and Barriers in Japan, 2018–2028

Table 37: Key Events Impacting Sales for AD in China, 2018–2028

Table 38: AD Market – Global Drivers and Barriers in China, 2018–2028

Table 39: Key Historical and Projected Launch Dates for AD

Table 40: Key Historical and Projected Patent Expiry Dates for AD

Table 41: High-Prescribing Physicians (non-KOLs) Surveyed, by Country

List of Figures

Figure 1: Global Sales Forecast by Country for AD, 2018–2028

Figure 2: Company Portfolio Gap Analysis in AD, 2018–2028

Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in AD, 2018–2028

Figure 4: AD Biomarker Tests by Pathophysiology

Figure 5: Dynamic Changes in AD Biomarker Over Time

Figure 6: 8MM, Total Prevalence of AD (%), Men and Women, Ages ≥60 Years, 2018

Figure 7: 8MM, Total Prevalence of AD (%), Men and Women, Ages ≥60 Years, 2018

Figure 8: 8MM, Sources Used and Not Used to Forecast the Total Prevalent Cases of AD Based on the DSM-IV and Clinical Criteria

Figure 9: 8MM, Sources Used and Not Used to Forecast the Total Prevalent Cases of MCI

Figure 10: 8MM, Sources Used to Forecast the Total Prevalent Cases of AD by Severity

Figure 11: 8MM, Total Prevalent Cases of AD, Both Sexes, Ages ≥60 Years

Figure 12: 8MM, Total Prevalent Cases of AD, by Sex, Ages ≥60 Years, N, 2018

Figure 13: 8MM, Total Prevalent Cases of AD by Age, Both Sexes, N, 2018

Figure 14: 8MM, Total Prevalent Cases of AD by Severity, Both Sexes, Ages ≥60 Years, N, 2018

Figure 15: 8MM, Diagnosed Prevalent Cases of AD, Both Sexes, Ages ≥60 Years, N, 2018

Figure 16: 8MM, Diagnosed Prevalent Cases of AD, by Sex, Ages ≥60 Years, N, 2018

Figure 17: 8MM, Diagnosed Prevalent Cases of AD by Age, Both Sexes, N, 2018

Figure 18: 8MM, Diagnosed Prevalent Cases of AD by Severity, Both Sexes, Ages ≥60 Years, N, 2018

Figure 19: 8MM, Total Prevalent Cases of MCI, Both Sexes, Ages ≥60 Years

Figure 20: 8MM, Total Prevalent Cases of MCI, by Sex, Ages ≥60 Years, N, 2018

Figure 21: 8MM, Total Prevalent Cases of MCI by Age, Both Sexes, N, 2018

Figure 22: 8MM, Diagnosed Prevalent Cases of MCI, Both Sexes, Ages ≥60 Years

Figure 23: 8MM, Diagnosed Prevalent Cases of MCI, by Sex, Ages ≥60 Years, N, 2018

Figure 24: 8MM, Diagnosed Prevalent Cases of MCI by Age, Both Sexes, N, 2018

Figure 25: Disease Management Timeline For Alzheimer’s Disease

Figure 26: Unmet Need and Opportunity in AD, 2020

Figure 27: Overview of the Development Pipeline in MCI and AD

Figure 28: Active Phase II and Phase III Clinical Trials in MCI and AD by Drug Class, 2020

Figure 29: Key Phase II/III and III Trials, Promising Pipeline Agents for MCI and AD, 8MM, 2018–2028

Figure 30: Key Phase III Trials of Promising Pipeline Agents for AD-Associated Agitation, 8MM, 2018–2028

Figure 31: Competitive Assessment of the Late-Stage Pipeline Agents for MCI and AD, 2018–2028

Figure 32: Company Portfolio Gap Analysis in AD, 2018–2028

Figure 33: Allergan SWOT Analysis, 2020

Figure 34: Lundbeck SWOT Analysis, 2020

Figure 35: Eisai SWOT Analysis, 2020

Figure 36: Novartis SWOT Analysis, 2020

Figure 37: Roche SWOT Analysis, 2020

Figure 38: Biogen SWOT Analysis, 2020

Figure 39: Eli Lilly SWOT Analysis, 2020

Figure 40: Takeda SWOT Analysis, 2020

Figure 41: 8MM Sales Forecast by Country for AD, 2018 and 2028

Figure 42: Sales Forecast by Class for AD in the US in 2018 and 2028

Figure 43: Sales Forecast by Class for AD in the 5EU, 2018 and 2028

Figure 44: Sales Forecast by Class for AD in Japan in 2018 and 2028

Figure 45: Sales Forecast by Class for AD in China in 2018 and 2028

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