SYS-CON MEDIA Authors: Adine Deford, Cynthia Dunlop, Harry Trott, Xenia von Wedel, Peter Silva

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Early-Stage Minimally-Invasive Biomarkers in Alzheimer's Disease: A Comprehensive Analysis and Market Study of New Developments and Opportunities, 2014

NEW YORK, Sept. 1, 2014 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:  Early-Stage Minimally-Invasive Biomarkers in Alzheimer%s Disease: A Comprehensive Analysis and Market Study of New Developments and Opportunities, 2014

http://www.reportlinker.com/p02348380-summary/Early-Stage-Minimally-Invasive-Biomarkers-in-Alzheimer-s-Disease-A-Comprehensive-Analysis-and-Market-Study-of-New-Developments-and-Opportunities.html

REPORT DESCRIPTION

Biopharm Reports has carried out a comprehensive analysis and market study of new developments relating to early-stage minimally-invasive biomarkers in Alzheimer's disease, which have been 'functionally reviewed' alongside existing AD drugs and candidates in the AD drug pipeline, and applicable commercial AD diagnostics.

This Report

New advances have been made in the discovery and validation of biomarkers in Alzheimer's disease (AD), offering much-needed opportunities to accelerate disease research, drug discovery and the development of low-cost minimally-invasive tests that will be available to much wider patient populations.

This report gives a comprehensive and up-to-date analysis of new findings relating to the discovery and clinical evaluation of AD-related biomarkers with potential to allow early detection or progression of this disease, based on minimally-invasive or non-invasive methods. With a focus on controlled human studies of AD, these biomarker findings are 'functionally reviewed' alongside drugs and drug candidates in the development pipeline, and a market analysis of applicable (minimally-invasive) AD-related diagnostics tests, platforms and developments. This report also includes an analysis of related opportunities in AD research, drug discovery, clinical trials and clinical diagnostics.

This work was carried out to provide a detailed and up-to-date analysis of minimally-invasive AD biomarkers and related opportunities to commercial developers in this field, including companies involved in AD drug R&D, diagnostics companies and others supplying applicable technologies into life science and clinical research laboratories. New and emerging developments relating to early-stage biomarkers of AD, presented in this report, are broadly classified into approximately 35 different 'groups', which indicate their biological associations or origins relating to this disease. Overall, more than 270 biomarkers have been identified (where multivariate panels of partially-defined species are identified as one biomarker) and these are further classified in terms of the molecular groups to which they below.

Recent years have seen major advances in the discovery of minimally-invasive biomarkers of AD and early stages of this disease, and related applicable diagnostics capabilities. These include three methods with AD diagnostic accuracies from 95% – 96% and another that predicted conversion from MCI to AD within the year, with an accuracy of 87%. Of seven others, three gave diagnostic sensitivities and specificities relating to early-stage AD ranging from 85% to 89% and 82% to 97%, respectively, and four provided sensitivities and specificities relating to the detection of AD, ranging from 82% to 95% and 79% to 97%, respectively.

While larger long-term studies are required, these and other findings show that diagnostic capabilities relating to AD have reached an important breakthrough point, offering opportunities to accelerate research, drug discovery and the development of low-cost minimally-invasive tests that will be available to much wider patient populations.- An in-depth review of candidate biomarkers in Alzheimer's disease - A focused analysis of early-stage biomarkers identified in AD patient studies - Covering more than thirty five areas of the AD biomarker landscape- Early-stage disease, predictive conversion to AD and disease progression - Validated patient studies citing diagnostic sensitivity, specificity and accuracy - Blood, saliva, urine and other minimally-invasive techniques- Most recent findings and reviewed developments - Functionally reviewed with drugs and drug candidates in the development pipeline - Potential opportunities for companion diagnostics- An in-depth review of the current AD drug development pipeline and companies - Commercial review of minimally-invasive AD diagnostic tests and companies

Background

Few major diseases have proved as unyielding to research as Alzheimer's disease (AD). Even in the 60's and 70's, drugs developed to meet the challenges of cancer were changing the time-course of this disease, and today some cancers can be treated very successfully. Unfortunately, similar progress has not been seen in the case of AD. In 2014, after decades that have seen some of the greatest achievements in medicine, there are still no disease-altering therapies for AD and those few treatments that do exist provide only small, and generally short-lived, benefits for some patients.

The fundamental challenges to the development of more effective treatments for AD reflect scientist's poor understanding of this disease. While hallmark neurological changes seen in AD have been mapped in some detail, efforts to translate this knowledge into an understanding of the underlying causative mechanisms, and the subsequent use of this understanding to produce disease-altering treatments, have not so far been successful. More fundamentally, scientist's poor understanding of AD is also seen in uncertainties relating to the diagnosis of this disease, particularly in its early stages, and the consequential absence of adequate diagnostic tests.

Many believe that current AD treatments are not effective since by the time the disease is symptomatic, the point at which current treatments are given, the underlying neurological damage has already reached a point of no return. Current treatments may therefore be 'too little, too late'. It is also believed that the changes leading to AD may begin many years or even decades before the first symptoms are seen. Unfortunately, causative basic of these early changes are not understood either. This has focused much attention on fundamental disease research and the discovery of disease markers, in the hope that new findings will provide insights into the changes that take place as this disease develops, while also identifying new treatment strategies.

Some of the most important advances in AD biomarker discovery have been provided by imaging methods such as MRI and PET, which have helped to map the time-course of this disease, as well as changes relating to molecules such as Abeta and Tau. Studies have also profiled biomarkers in cerebrospinal fluid (CSF), particularly relating to Abeta. However, while these methods are important in AD research, both are complex and expensive and are therefore not readily available to the wider population.

The lack of accessibility of these techniques in routine research and diagnostic testing has limited their use, with inevitable consequences on the progress of AD research and clinical investigation. Moreover, there is significant interest, and a rational basis for, investigating AD from changes that take place outside of the central nervous system, notably those that might be identified and monitored in the blood and other biofluids. Such approaches, if successfully translated into accurate and reliable diagnostic methods, offer minimally-invasive or non-invasive approaches and the hope of simpler and cheaper tests that will be available to much wider populations. With a focus on the most recent advances, this report provides an in-depth analysis of AD biomarkers identified using minimally invasive approaches, mostly in blood, but also including urine, saliva and other areas.

Methods

The goal for this study was to identify and profile as many advances relevant to early-stage minimally invasive candidate AD biomarkers as possible, by combining a 'wide-net' approach on the one hand, and focused analyses around the most promising findings on the other. With a focus on human studies involving AD patients (and those with (presumed) early-stage disease) and studies published over the last five year, 40,000+ AD were identified, which were narrowed down to 800 by in-depth analysis. During this process, study findings were analysed by structured systematic manual approaches and the use of in-house developed tools designed to assist the identification of biomarker relationships, correlations or associations in this field. Subsequently, these findings were functionally reviewed* alongside current drugs and drug candidates in the development pipeline (marketed, Phases 3 to 1 and preclinical) and applicable commercially available or developmental minimally-invasive diagnostics. Biomarkers

New and emerging developments relating to early-stage biomarkers of AD, presented in this report, are broadly classified into approximately 35 different 'groups', which indicate their biological associations or origins relating to this disease. Together, these areas embrace the current AD-biomarker landscape. Overall, more than 270 biomarkers have been identified (where multivariate panels of partially-defined species are identified as one biomarker) and these are further classified in terms of the molecular groups to which they below.

AD Drug Pipeline

This report covers today's AD drug development pipeline, up until August 2014. These are 'functionally reviewed'* where currently known minimally invasive AD biomarkers allow. Today, there are four FDA approved drugs for AD and 103 in the development pipeline. Of these, 11, 41, 30 and 21 candidates are at phase 3, phase 2, phase 1 and preclinical stages, respectively. An analysis of these drugs and candidates in terms of molecule types shows that small molecules represent the major group (70% overall), followed by antibodies (8%), vaccines (7%) and others (15%). In terms of the general pharmacological targeting strategies, 34 (32%) of candidates are targeted around Abeta. *'Functional integration' in this context relates to links, associations or direct connections between specific biomarkers and the underlying drug pharmacological mechanisms of specific drugs.

AD Minimally-Invasive Diagnostics

This report identifies 20 companies with AD-related diagnostics tests, platforms and developments relating to minimally-invasive techniques and capabilities. These diagnostic capabilities are presented on a company-by-company basis, however this group does not include laboratory suppliers of technologies such as PCR, microarray, mass spectrometry, flow cytometry, immunoassay, which are used or are generally applicable to AD research and clinical testing. Companies with imaging technologies or other related specifically to tests on CSF (which requires invasive techniques) are not included.

Functional Review

This report provides a systematic 'functional analysis' of minimally-invasive AD biomarkers presented in this report. This is based on the analysis of links, associations or direct relationships between specific biomarkers and the underlying pharmacological mechanisms of specific drugs. For example, there are a number of candidate biomarkers relating to Abeta, which are discussed in the context of Abeta targeting drugs. This has been carried out to assist in the identification of biomarkers that may provide important insights in research, drugs discovery, clinical trial end-points and potential companion diagnostics.

Opportunities

This report includes an in-depth analysis of biomarkers-related opportunities in AD research, drug discovery, clinical trials and clinical diagnostics.

Executive Summary

Chapter 1. Background 26

1. Alzheimer's Disease

1.1 Statistics and Costs1.2 Histopathology1.3 Amyloid Beta (Abeta)1.4 Tau Proteins and Neurofibrillary Tangles1.5 Cholinergic Hypothesis1.6 Diagnosis1.7 Cognitive Tests1.8 Stages of AD1.9 Treatment of AD1.10 Biomarkers1.11 Genetics1.13 Blood Brain Barrier1.14 Pathogenesis of Alzheimer's disease

Chapter 2. Blood Biomarkers 40

Chapter 3. Autoantibodies 83

Chapter 4. Urinary Biomarkers 105

Chapter 5. Salivary Biomarkers 108

Chapter 6. Other Biomarkers 111

Chapter 7. AD Drug Pipeline 114

7.1 Background

7.2 Approved Drugs

7.3 Phase 3 Drugs

7.4 Phase 2 Drugs

7.5 Phase 1 Drugs

7.6 Preclinical Drugs

Chapter 8. Diagnostics Companies of Minimally-Invasive AD Diagnostics 147

Chapter 9. An Integrated Analysis of AD Biomarkers 156

9.1 Introduction9.2 Minimally-Invasive Biomarkers9.3 Diagnostic Sensitivity, Specificity and Accuracy9.4 The Drug Development Pipeline9.5 Drug Target Areas9.6 Integrated Analysis

Chapter 10. Conclusions and Opportunities 178

Figures

Figure 7.1 AD drugs and candidate AD drugs/treatments, from current marketed products, through to preclinical studies.

Figure 7.2 AD drugs and candidate AD drug/treatment by molecule types, from current marketed drugs, through to Preclinical studies.

Figure 7.3 AD drugs and AD candidate drug/treatment by general targeting strategies, from current marketed drugs, through to preclinical studies.

Figure 7.4 Phase 3 AD drug candidates by molecule types

Figure 7.5 Phase 3 AD drug candidates, by pharmacological targeting areas

Figure 7.6 Phase 2 AD drug candidates by molecule types

Figure 7.7 Phase 2 AD drug candidates, by pharmacological targeting areas

Figure 7.8 Phase 1 AD drug candidates by molecule types

Figure 7.9 Phase 1 AD drug candidates, by pharmacological targeting areas

Figure 7.10 Preclinical AD drug candidates by molecule types

Figure 7.11 Preclinical AD drug candidates, by pharmacological targeting areas

Figure 9.1 AD drugs and candidate AD drugs/treatments, from current marketed products, through to preclinical studies.

Figure 9.2 AD drugs and AD candidate drug/treatment by general targeting strategies, from current marketed drugs, through to preclinical studies.

Figure 9.3 AD drugs and AD candidate drug/treatment by general targeting strategies by phase, from current marketed drugs, through to preclinical studies.

Tables

Table 1. Statistics and Costs relation to Alzheimer's disease, based on WHO statistics on Global Dementia.

Table 7.1 Approved drugs for the treatment of AD.

Table 7.2 Phase 3 candidate drugs for the treatment of AD.

Table 7.3 Phase 2 candidate drugs for the treatment of AD.

Table 7.4 Phase 1 candidate drugs for the treatment of AD.

Table 7.5 Preclinical candidate drugs for the treatment of AD.

Table 8.1 Companies with marketed or developmental products relating to minimally-invasive AD diagnostics.

Table 9.1 Candidate biomarkers of with AD

Table 9.2 Sensitivity, specificity and accuracy levels reported from nineteen AD diagnostics studies

Table 9.3 Numbers of AD drugs and pipeline candidate AD drugs, classified according to their general pharmacological targeting mechanisms and pipeline phase

Table 9.4 AD drugs and pipeline candidate AD drugs, classified according to their general pharmacological targeting mechanisms.

Table 9.5 Abeta targeting drugs and pipeline candidate drugs/treatments from marketed products through to preclinical studies.

Table 9.6 Cholinergic targeting drugs and pipeline candidate drugs/treatments from marketed products through to preclinical studies.

Table 9.7 Serotonin targeting drugs and pipeline candidate drugs/treatments from marketed products through to preclinical studies.

Table 9.8 Energy metabolism targeting drugs and pipeline candidate drugs/treatments from marketed products through to preclinical studies.

Table 9.9 Tau targeting drugs and pipeline candidate drugs/treatments from marketed products through to preclinical studies.

Table 9.10 Other targeting drugs and pipeline candidate drugs/treatments from marketed products through to preclinical studies.

Table 9.11 Other AD drugs and AD drug candidates showing integrated biomarkers

To order this report: Early-Stage Minimally-Invasive Biomarkers in Alzheimer%s Disease: A Comprehensive Analysis and Market Study of New Developments and Opportunities, 2014 

http://www.reportlinker.com/p02348380-summary/Early-Stage-Minimally-Invasive-Biomarkers-in-Alzheimer-s-Disease-A-Comprehensive-Analysis-and-Market-Study-of-New-Developments-and-Opportunities.html

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