Click here to close now.

Welcome!

News Feed Item

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

__________________________
Contact Clare:
[email protected]
US: (339)-368-6001
Intl: +1 339-368-6001

SOURCE Reportlinker

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
DevOps Summit, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development...
Live Webinar with 451 Research Analyst Peter Christy. Join us on Wednesday July 22, 2015, at 10 am PT / 1 pm ET In a world where users are on the Internet and the applications are in the cloud, how do you maintain your historic SLA with your users? Peter Christy, Research Director, Networks at 451 Research, will discuss this new network paradigm, one in which there is no LAN and no WAN, and discuss what users and network administrators gain and give up when migrating to the agile world of clo...
DevOps is about increasing efficiency, but nothing is more inefficient than building the same application twice. However, this is a routine occurrence with enterprise applications that need both a rich desktop web interface and strong mobile support. With recent technological advances from Isomorphic Software and others, it is now feasible to create a rich desktop and tuned mobile experience with a single codebase, without compromising performance or usability.
Containers are revolutionizing the way we deploy and maintain our infrastructures, but monitoring and troubleshooting in a containerized environment can still be painful and impractical. Understanding even basic resource usage is difficult – let alone tracking network connections or malicious activity. In his session at DevOps Summit, Gianluca Borello, Sr. Software Engineer at Sysdig, will cover the current state of the art for container monitoring and visibility, including pros / cons and liv...
SYS-CON Media announced today that CloudBees, the Jenkins Enterprise company, has launched ad campaigns on SYS-CON's DevOps Journal. CloudBees' campaigns focus on the business value of Continuous Delivery and how it has been recognized as a game changer for IT and is now a top priority for organizations, and the best ways to optimize Jenkins to ensure your continuous integration environment is optimally configured.
The 4th International Internet of @ThingsExpo, co-located with the 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - announces that its Call for Papers is open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than
SYS-CON Events announced today that ProfitBricks, the provider of painless cloud infrastructure, will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. ProfitBricks is the IaaS provider that offers a painless cloud experience for all IT users, with no learning curve. ProfitBricks boasts flexible cloud servers and networking, an integrated Data Center Designer tool for visual control over the...
"In the IoT space we are helping customers, mostly enterprises and industry verticals where time-to-value is critical, and we help them with the ability to do faster insights and actions using our platform so they can transform their business operations," explained Venkat Eswara, VP of Marketing at Vitria, in this SYS-CON.tv interview at @ThingsExpo, held June 9-11, 2015, at the Javits Center in New York City.
The most often asked question post-DevOps introduction is: “How do I get started?” There’s plenty of information on why DevOps is valid and important, but many managers still struggle with simple basics for how to initiate a DevOps program in their business. They struggle with issues related to current organizational inertia, the lack of experience on Continuous Integration/Delivery, understanding where DevOps will affect revenue and budget, etc. In their session at DevOps Summit, JP Morgenthal...
"We provide a web application framework for building really sophisticated web applications that run on a browser without any installation need so we get used for biotech, defense, and banking applications," noted Charles Kendrick, CTO and Chief Architect at Isomorphic Software, in this SYS-CON.tv interview at @DevOpsSummit (http://DevOpsSummit.SYS-CON.com), held June 9-11, 2015, at the Javits Center in New York
In his session at 16th Cloud Expo, Simone Brunozzi, VP and Chief Technologist of Cloud Services at VMware, reviewed the changes that the cloud computing industry has gone through over the last five years and shared insights into what the next five will bring. He also chronicled the challenges enterprise companies are facing as they move to the public cloud. He delved into the "Hybrid Cloud" space and explained why every CIO should consider ‘hybrid cloud' as part of their future strategy to achie...
"Plutora provides release and testing environment capabilities to the enterprise," explained Dalibor Siroky, Director and Co-founder of Plutora, in this SYS-CON.tv interview at @DevOpsSummit, held June 9-11, 2015, at the Javits Center in New York City.
DevOps tends to focus on the relationship between Dev and Ops, putting an emphasis on the ops and application infrastructure. But that’s changing with microservices architectures. In her session at DevOps Summit, Lori MacVittie, Evangelist for F5 Networks, will focus on how microservices are changing the underlying architectures needed to scale, secure and deliver applications based on highly distributed (micro) services and why that means an expansion into “the network” for DevOps.
"The idea of polyglot persistence is you have to apply the right database for the job - you always have to have many different databases in play. We offer that whole system as a service," explained Raj Singh, Developer Advocate for IBM Cloud Data Services, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
SYS-CON Events announced today that WHOA.com, an ISO 27001 Certified secure cloud computing company, participated as “Bronze Sponsor” of SYS-CON's 16th International Cloud Expo® New York, which took place June 9-11, 2015, at the Javits Center in New York City, NY. WHOA.com is a leader in next-generation, ISO 27001 Certified secure cloud solutions. WHOA.com offers a comprehensive portfolio of best-in-class cloud services for business including Infrastructure as a Service (IaaS), Secure Cloud Desk...