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
The IoTs will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, will demonstrate how to move beyond today's coding paradigm and share the must-have mindsets for removing complexity from the development proc...
Customer experience has become a competitive differentiator for companies, and it’s imperative that brands seamlessly connect the customer journey across all platforms. With the continued explosion of IoT, join us for a look at how to build a winning digital foundation in the connected era – today and in the future. In his session at @ThingsExpo, Chris Nguyen, Group Product Marketing Manager at Adobe, will discuss how to successfully leverage mobile, rapidly deploy content, capture real-time d...
In his session at 18th Cloud Expo, Andrew Cole, Director of Solutions Engineering at Peak 10, will discuss how the newest technology advances are reducing the cost and complexity of traditional business continuity and disaster recovery solutions. Attendees will: Learn why having a full disaster recovery strategy is more important now than ever before Explore the key drivers of a successful disaster recovery solution Achieve measurable operational and business value from a disaster recovery ...
The cloud era has reached the stage where it is no longer a question of whether a company should migrate, but when. Enterprises have embraced the outsourcing of where their various applications are stored and who manages them, saving significant investment along the way. Plus, the cloud has become a defining competitive edge. Companies that fail to successfully adapt risk failure. The media, of course, continues to extol the virtues of the cloud, including how easy it is to get there. Migrating...
SYS-CON Events announced today that Hanu Software will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Leveraging best-in-class people, processes, and technologies, Hanu provides high-quality, high-value software development and business process outsourcing services to independent software vendors (ISVs) and enterprises.
As organizations shift towards IT-as-a-service models, the need for managing and protecting data residing across physical, virtual, and now cloud environments grows with it. Commvault can ensure protection, access and E-Discovery of your data – whether in a private cloud, a Service Provider delivered public cloud, or a hybrid cloud environment – across the heterogeneous enterprise. In his general session at 18th Cloud Expo, Randy De Meno, Chief Technologist - Windows Products and Microsoft Part...
SYS-CON Events announced today that ContentMX, the marketing technology and services company with a singular mission to increase engagement and drive more conversations for enterprise, channel and SMB technology marketers, has been named “Sponsor & Exhibitor Lounge Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, New York. “CloudExpo is a great opportunity to start a conversation with new prospects, but what happens after the...
What a difference a year makes. Organizations aren’t just talking about IoT possibilities, it is now baked into their core business strategy. With IoT, billions of devices generating data from different companies on different networks around the globe need to interact. From efficiency to better customer insights to completely new business models, IoT will turn traditional business models upside down. In the new customer-centric age, the key to success is delivering critical services and apps wit...
Join us at Cloud Expo | @ThingsExpo 2016 – June 7-9 at the Javits Center in New York City and November 1-3 at the Santa Clara Convention Center in Santa Clara, CA – and deliver your unique message in a way that is striking and unforgettable by taking advantage of SYS-CON's unmatched high-impact, result-driven event / media packages.
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, will provide an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life ...
SYS-CON Events announced today that BMC Software has been named "Siver Sponsor" of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. BMC is a global leader in innovative software solutions that help businesses transform into digital enterprises for the ultimate competitive advantage. BMC Digital Enterprise Management is a set of innovative IT solutions designed to make digital business fast, seamless, and optimized from mainframe to mo...
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in Embedded and IoT solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/Big Data, HPC and ...
In the rush to compete in the digital age, a successful digital transformation is essential, but many organizations are setting themselves up for failure. There’s a common misconception that the process is just about technology, but it’s not. It’s about your business. It shouldn’t be treated as an isolated IT project; it should be driven by business needs with the committed involvement of a range of stakeholders.
SYS-CON Events announced today that MobiDev will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. MobiDev is a software company that develops and delivers turn-key mobile apps, websites, web services, and complex software systems for startups and enterprises. Since 2009 it has grown from a small group of passionate engineers and business managers to a full-scale mobile software company with over 200 develope...
SoftLayer operates a global cloud infrastructure platform built for Internet scale. With a global footprint of data centers and network points of presence, SoftLayer provides infrastructure as a service to leading-edge customers ranging from Web startups to global enterprises. SoftLayer's modular architecture, full-featured API, and sophisticated automation provide unparalleled performance and control. Its flexible unified platform seamlessly spans physical and virtual devices linked via a world...