PharmaPoint: Alzheimer’s Disease – Global Drug Forecast and Market Analysis to 2026

Alzheimer’s disease (AD) is a progressive neurodegenerative disease that is characterized by impaired memory and thinking (known as dementia), and functional decline. With a rapidly accelerating worldwide prevalence, there is a growing societal pressure for curative treatment for AD patients. The burden of AD encompasses clinical burden to patients as well as economic burden to payers and patients and caregiver burden, adding to the urgent need for improved AD therapy. Significant efforts are being made to develop a new treatment for AD, as current pharmacologic management is known to only provide a temporary improvement in symptoms.

 

GlobalData estimates the 2016 sales for AD at approximately $3.0B across the 7MM covered in this report.

The AD pipeline activity is strong, with twenty active Phase III (or Phase II/III) pipeline agents, most notable drug classes of which being passive immunotherapies and BACE inhibitors. These late-phase drugs also include those targeted for AD-linked agitation and cognitive impairments. Despite the fierce competition, GlobalData expects AD drug development to continue to see considerable struggles until reliable biomarkers and diagnostics are developed. Nevertheless, the treatment landscape of AD is expected to see a substantial change during the forecast period of 2016-2026.

Scope

Overview of AD: including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.

Annualized AD market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (including mild cognitive impairment, mild AD, moderate AD, and severe AD), forecast from 2016 to 2026.

Key topics covered: strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the AD therapeutics market

Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for AD therapy. The most promising candidate in Phase III (and Phase II/III) development is profiled.

Analysis of the current and future market competition in the global AD therapeutics 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

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 AD therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global AD 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.

Companies mentioned

AB Science

Abbvie

AC Immune

Acadia

Actinogen Medical

Adamas Pharmaceuticals

Allergan

Amgen

Archer Pharmaceuticals

AstraZeneca

Ausio Pharmaceuticals

Axovant

AZ Therapies

BioArctic NeuroScience AB

Biogen

Biogen ...

AB Science

Abbvie

AC Immune

Acadia

Actinogen Medical

Adamas Pharmaceuticals

Allergan

Amgen

Archer Pharmaceuticals

AstraZeneca

Ausio Pharmaceuticals

Axovant

AZ Therapies

BioArctic NeuroScience AB

Biogen

Biogen

Bionomics

Boehringer Ingelheim

Boehringer Ingelheim

Bristol-Myers Squibb

Charsire Biotechnology Corp

Chugai

Cytos Biotechnology

Daiichi Sankyo

Eisai

Eli Lilly

Enzymotec

Glovia Co

Grifols

ImmunoBrain

Checkppoint

IntraCellular Therapies

Ionis

Janssen

Kyowa Hakko Kirin

Ligand

Lundbeck

Lupin

Mediti Pharma Inc

Merck & Co

Merz

Metabolic Therapy Inc

MorphoSys

Nature Cell

Nature Cell

Neurim Pharmaceuticals

Neurimmune

Neurotrope BioScience

Novartis

Ono Pharmaceutical

Orion Oyj

Otsuka

Pfizer

PharmatrophiX

Probiodrug AG

Proclara Biosciences

Purdue Pharma

QR Pharm

QR Pharma

Roche

Shionogi

Suven Life Sciences

T3D Therapeutics

Takeda

TauRx

Tetra Discovery Partners

Toyama Chemical

vTv Therapeutics

Zinfandel

Table of Contents

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 ...

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 2026

2.2 Allergan, Biogen, and Roche Are Forecast to Lead the AD Market in 2026

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 Twenty 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

5.4.3 Total Prevalent Cases of AD

5.4.4 Total Prevalent Cases of AD by Severity

5.4.5 Total Prevalent Cases of MCI

5.5 Epidemiological Forecast for AD (2016–2026)

5.5.1 Total Prevalent Cases of AD

5.5.2 Age-Specific Total Prevalent Cases of AD

5.5.3 Sex-Specific Total Prevalent Cases of AD

5.5.4 Total Prevalent Cases of AD by Severity

5.6 Epidemiological Forecast for MCI (2016–2026)

5.6.1 Total Prevalent Cases of MCI

5.6.2 Age-Specific Total Prevalent Cases of MCI

5.6.3 Sex-Specific Total Prevalent Cases of MCI

5.7 Discussion

5.7.1 Epidemiological Forecast Insight

5.7.2 Limitations of Analysis

5.7.3 Strengths of 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

7 Competitive Assessment

7.1 Overview

7.2 Product Profiles – Major Brands

7.2.1 Aricept (Donepezil Hydrochloride)

7.2.2 Exelon (Rivastigmine, Rivastigmine tartrate)

7.2.3 Razadyne (Galantamine Hydrobromide)

7.2.4 Namenda (Memantine Hydrochloride)

7.2.5 Namzaric (Memantine and Donepezil Hydrochlorides)

7.3 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 Clinical Trial Mapping

9.2.1 Clinical Trials by Class

9.3 Promising Drugs in Clinical Development

9.3.1 Biopharmaceutical Products

9.3.2 Gantenerumab

9.3.3 Crenezumab

9.3.4 Aducanumab

9.3.5 Flebogamma + Albutein

9.3.6 CAD106

9.3.7 Small Molecule

9.3.8 Verubecestat

9.3.9 Elenbecestat

9.3.10 Lanabecestat

9.3.11 JNJ-54861911

9.3.12 CNP520

9.3.13 Azeliragon

9.3.14 Pioglitazone

9.3.15 Nilvadipine

9.3.16 Intepirdine

9.3.17 ALZT-OP1

9.3.18 TRx-0237 (LMTX)

9.3.19 Brexipiprazole

9.3.20 Aripiprazole

9.3.21 AVP-786

9.3.22 ITI-007

9.3.23 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 Pfizer

10.3.5 Novartis

10.3.6 Roche

10.3.7 Biogen

10.3.8 Eli lilly

10.3.9 Merck & Co.

10.3.10 AstraZeneca

10.3.11 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

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 Disclaime

List of Tables

Table 1: MCI and AD: Key Metrics in the 7MM

Table 2: Three-Stage Classification of AD

Table 3: The Seven-Stage Reisberg Scale of AD

Table ...

Table 1: MCI and AD: Key Metrics in the 7MM

Table 2: Three-Stage Classification of AD

Table 3: The Seven-Stage Reisberg Scale of AD

Table 4: Common Symptoms of AD.

Table 5: DSM-IV Criteria for the Diagnosis of Dementia

Table 6: NINCDS-ADRDA Criteria for the Diagnosis of AD

Table 7: Risk Factors and Comorbidities for AD

Table 8: 7MM, Total Prevalent Cases of AD, Both Sexes, Ages ≥60 Years, Selected Years 2016–2026.

Table 9: 7MM, Total Prevalent Cases of MCI, Both Sexes, Ages ≥60 Years, Selected Years 2016–2026.

Table 10: Commonly Used Diagnostic Guidelines for Alzheimer’s Disease

Table 11: Summary of NINCDS-ARDA Diagnostic Criteria for Alzheimer’s Disease

Table 12: Proposed NIA-AA Staging Classification for Preclinical AD

Table 13: NIA-AA Biomarker Criteria for MCI

Table 14: Commonly Used Treatment Guidelines for Alzheimer’s Disease in the 7MM

Table 15: Most Prescribed Drugs for AD by Class in the 7MM, 2016

Table 16: Most Commonly Prescribed Off-Label Drug Classes for AD, by Treatment Line, in the 7MM

Table 17: Country Profile – US

Table 18: Region Profile – 5EU, 2017

Table 19: Country Profile – Japan

Table 20: Leading Therapies in AD

Table 21: Product Profile – Aricept

Table 22: Efficacy Results for Aricept in Mild to Moderate AD

Table 23: Efficacy Results for Aricept in Moderate to Severe AD

Table 24: Efficacy Results for Aricept in Severe AD

Table 25: Aricept SWOT Analysis, 2017

Table 26: Product Profile – Exelon

Table 27: Efficacy Results for Exelon Capsule and Oral Solution in AD

Table 28: Efficacy Results for Exelon Patch in AD

Table 29: Adverse Events Occurring in at Least 2% of Patients and at a Higher Frequency than Placebo-Treated Patients

Table 30: Exelon SWOT Analysis, 2017

Table 31: Product Profile – Razadyne

Table 32: Efficacy Results for Razadyne in Probable AD

Table 33: Razadyne SWOT Analysis, 2017

Table 34: Product Profile – Namenda

Table 35: Efficacy Results for Namenda and Namenda XR in Alzheimer’s Disease

Table 36: Safety Results for Namenda and Namenda XR in Alzheimer’s Disease

Table 37: Namenda SWOT Analysis, 2017

Table 38: Product Profile – Namzaric

Table 39: Namzaric SWOT Analysis, 2017

Table 40: Summary of Minor Therapeutic Classes, 2017

Table 41: Comparison of Therapeutic Classes in Development for AD

Table 42: Product Profile – Gantenerumab

Table 43: Key Efficacy Results For Gantenerumab

Table 44: Pipeline Gantenerumab SWOT Analysis, 2017

Table 45: Ongoing Phase III Trials For Crenezumab, 2017

Table 46: Product Profile – Crenezumab

Table 47: Key Efficacy Data for Crenezumab

Table 48: Pipeline Crenezumab SWOT Analysis, 2017

Table 49: Product Profile – Aducanumab

Table 50: Key Efficacy Data for Aducanumab

Table 51: Key Safety Results For Aducanumab From Phase Ib PRIME Study

Table 52: Pipeline Aducanumab SWOT Analysis, 2017

Table 53: Product Profile – Flebogamma + Albutein

Table 54: Key Efficacy Data for Flebogamma + Albutein

Table 55: Key Safety Results For Flebogamma + Albutein From AMBAR (Interim Analysis)

Table 56: Flebogamma + Albutein SWOT Analysis, 2017

Table 57: Product Profile – CAD106

Table 58: CAD106 SWOT Analysis, 2017

Table 59: Product Profile – Verubecestat

Table 60: Verubecestat SWOT Analysis, 2017

Table 61: Product Profile – Elenbecestat

Table 62: Key Efficacy Data for Elenbecestat

Table 63: Elenbecestat SWOT Analysis, 2017

Table 64: Product Profile – Lanabecestat

Table 65: Key Efficacy Data for Lanabecestat

Table 66: Lanabecestat SWOT Analysis, 2017

Table 67: Product Profile – JNJ-54861911

Table 68: Key Efficacy Data for JNJ-54861911

Table 69: JNJ-54861911 SWOT Analysis, 2017

Table 70: Product Profile – CNP520

Table 71: Key Efficacy Data for CNP520

Table 72: CNP520 SWOT Analysis, 2017

Table 73: Product Profile – Azeliragon

Table 74: Azeliragon SWOT Analysis, 2017

Table 75: Product Profile – Pioglitazone

Table 76: Key Safety Results For Pioglitazone

Table 77: Pioglitazone SWOT Analysis, 2017

Table 78: Product Profile – Nilvadipine

Table 79: Nilvadipine SWOT Analysis, 2017

Table 80: Product Profile – Intepirdine

Table 81: Key Efficacy Results For Intepirdine

Table 82: Intepirdine SWOT Analysis, 2017

Table 83: Product Profile – ALZT-OP1

Table 84: ALZT-OP1 SWOT Analysis, 2017

Table 86: Product Profile – TRx-0237

Table 87: Key Efficacy Results for TRx-0237

Table 88: Key Safety Results For TRx-0237 from the Phase III TRx-237-005 Study

Table 89: TRx-0237 SWOT Analysis, 2017

Table 90: Product Profile – Brexipiprazole

Table 91: Key Efficacy Results For Brexipiprazole

Table 92: Brexipiprazole SWOT Analysis, 2017

Table 93: Product Profile – Aripiprazole

Table 94: Key Efficacy Results For Aripiprazole

Table 95: Key Safety Results For Aripiprazole

Table 96: Aripiprazole SWOT Analysis, 2017

Table 97: Product Profile – AVP-786

Table 98: AVP-786 SWOT Analysis, 2017

Table 99: Product Profile – ITI-007

Table 100: ITI-007 SWOT Analysis, 2017

Table 101: Drugs in Development for AD and AD-Related Symptoms, 2017

Table 102: Key Companies in the AD Market in the 7MM, 2017

Table 103: Allergan’s AD Portfolio Assessment, 2017

Table 104: Lundbeck’s AD Portfolio Assessment, 2017

Table 105: Eisai’s AD Portfolio Assessment, 2017

Table 106: Pfizer’s AD Portfolio Assessment, 2017

Table 107: Novartis’s AD Portfolio Assessment, 2017

Table 108: Roche’s AD Portfolio Assessment, 2017

Table 109: Biogen’s AD Portfolio Assessment, 2017

Table 110: Eli Lilly’s AD Portfolio Assessment, 2017

Table 111: Merck’s AD Portfolio Assessment, 2017

Table 112: AstrasZeneca’s AD Portfolio Assessment, 2017

Table 113: Takeda’s AD Portfolio Assessment, 2017

Table 114: AD Market – Global Drivers and Barriers, 2016–2026

Table 115: Key Events Impacting Sales for Alzheimer’s Disease in the US, 2016–2026

Table 116: AD Market – Drivers and Barriers in the US, 2016–2026

Table 117: Key Events Impacting Sales for AD in the 5EU, 2016–2026

Table 118: AD Market – Drivers and Barriers in the 5EU, 2016–2026

Table 119: Key Events Impacting Sales for AD in Japan, 2016–2026

Table 120: AD Market – Global Drivers and Barriers in Japan, 2016–2026

Table 121: Key Historical and Projected Launch Dates for AD

Table 122 : Key Historical and Projected Patent Expiry Dates for AD

Table 123: High-Prescribing Physicians (non-KOLs) Surveyed, by Country

List of Figures

Figure 1: Global Sales Forecast by Country for AD, 2016–2026

Figure 2: Company Portfolio Gap Analysis in AD, 2016–2026

Figure 3: Competitive Assessment ...

Figure 1: Global Sales Forecast by Country for AD, 2016–2026

Figure 2: Company Portfolio Gap Analysis in AD, 2016–2026

Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in AD, 2016–2026

Figure 4: AD Biomarker Tests by Pathophysiology

Figure 5: Dynamic Changes in AD Biomarker Over Time

Figure 6: 7MM, Age-Standardized Total Prevalence of AD (%), Ages ≥60 Years

Figure 7: 7MM, Age-Standardized Total Prevalence of MCI (%), Ages ≥60 Years

Figure 8: 7MM, Sources Used and Not Used, Total Prevalent Cases of AD

Figure 9: 7MM, Sources Used, Total Prevalent Cases of AD by Severity

Figure 10: 7MM, Sources Used, Total Prevalent Cases of MCI

Figure 11: 7MM, Age-Specific Total Prevalent Cases of AD, Both Sexes, 2016

Figure 12: 7MM, Sex-Specific Total Prevalent Cases of AD, Both Sexes, Ages >60 Years, 2016

Figure 13: 7MM, Total Prevalent Cases of AD by Severity, Both Sexes, Ages ≥60 Years, 2016

Figure 14: 7MM, Age-Specific Total Prevalent Cases of MCI, Both Sexes, 2016

Figure 15: 7MM, Sex-Specific Total Prevalent Cases of MCI, Both Sexes, Ages >60 Years, 2016

Figure 16: Disease Management Timeline For Alzheimer’s Disease

Figure 17: Unmet Need and Opportunity in AD, 2017

Figure 18: Overview of the Development Pipeline in MCI and AD

Figure 19 : Active Phase II and Phase III Clinical Trials in MCI and AD by Drug Class, 2017

Figure 20: Key Phase II/III and III Trials, Promising Pipeline Agents for MCI and AD, 7MM, 2016-2026

Figure 21: Key Phase III Trials of Promising Pipeline Agents for AD-Associated Agitation, 7MM, 2016–2026

Figure 22: Competitive Assessment of the Late-Stage Pipeline Agents for MCI and AD, 2017–2027

Figure 23: Clinical and Commercial Positioning of Gantenerumab

Figure 24: Clinical and Commercial Positioning of Crenezumab

Figure 25: Clinical and Commercial Positioning of Pipeline aducanumab

Figure 26: Clinical and Commercial Positioning of Pipeline Flebogamma + Albutein

Figure 27: Clinical and Commercial Positioning of Pipeline CAD106

Figure 28: Clinical and Commercial Positioning of Verubecestat

Figure 29: Clinical and Commercial Positioning of Elenbecestat

Figure 30: Clinical and Commercial Positioning of Lanabecestat

Figure 31: Clinical and Commercial Positioning of JNJ-54861911

Figure 32: Clinical and Commercial Positioning of CNP520

Figure 33: Clinical and Commercial Positioning of Azeliragon

Figure 34: Clinical and Commercial Positioning of Pioglitazone

Figure 35: Clinical and Commercial Positioning of Nilvadipine

Figure 36: Clinical and Commercial Positioning of Intepirdine

Figure 37: Clinical and Commercial Positioning of ALZT-OP1

Figure 38: Clinical and Commercial Positioning of TRx-0237

Figure 39: Clinical and Commercial Positioning of Brexipiprazole

Figure 40: Clinical and Commercial Positioning of Aripiprazole

Figure 41: Clinical and Commercial Positioning of AVP-786

Figure 42: Clinical and Commercial Positioning of ITI-007

Figure 43: Global Sales of AD Products, by Company, 2016 and 2026

Figure 44: Company Portfolio Gap Analysis in AD, 2016–2026

Figure 45: Allergan SWOT Analysis, 2017

Figure 46: Lundbeck SWOT Analysis, 2017

Figure 47: Eisai SWOT Analysis, 2017

Figure 48: Pfizer SWOT Analysis, 2017

Figure 49: Novartis SWOT Analysis, 2017

Figure 50: Roche SWOT Analysis, 2017

Figure 51: Biogen SWOT Analysis, 2017

Figure 52: Eli Lilly SWOT Analysis, 2017

Figure 53: Merck SWOT Analysis, 2017

Figure 54: AstraZeneca SWOT Analysis

Figure 55: Takeda SWOT Analysis, 2017

Figure 56: 7MM Sales Forecast by Country for AD, 2016 and 2026

Figure 57: Sales Forecast by Class for AD in the US in 2016 and 2026

Figure 58: Sales Forecast by Class for AD in the 5EU, 2016 and 2026

Figure 59: Sales Forecast by Class for AD in Japan in 2016 and 2026

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