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Biomarkers - Promising Research, Potential Applications and New Developments


Description: Mapping of the Human Genome Leads to Discovery of New Biomarkers

Remarkable progress has been made by the Human Genome Project (HGP) in mapping the human genome and identifying key genes that play a major role in regulating the normal functioning of the human body. About 30,000 genes have been identified so far. After the successful mapping of the genome, the research focus is now shifting to understand the products of gene expression i.e. proteins. This shift in focus can be attributed to the realization of the fact that proteins and not genes are responsible for performing most life functions. Currently, scientists are striving to find proteins (biomarkers) that are specific to various disorders. More and more biomarkers are being identified with the help of sophisticated enabling instruments and technologies such as mass spectrometers and protein microarrays. These novel biomarkers are likely to aid researchers in developing precise clinical diagnostics and drugs that are capable of detecting and curing fatal diseases.

Frost & Sullivan’s recent study focuses on the key research advancements and product development in enabling technologies that assist in discovery of biomarkers. The research discusses the application of biomarkers in drug discovery, clinical diagnostics, and personalized medicine. It also provides detailed information on end users and key participants that are in the forefront of technology development and commercialization.

Biomarker-based Screening Tests Gain Acceptance Despite Shortcomings

The early detection and diagnosis of fatal diseases - particularly cancer, Alzheimer’s, and Parkinson’s - enhances the prospects of curing the affected patients. This would encourage physicians to recommend patients to undertake biomarker-based screening tests that can predict these deadly diseases in the early stages. These tests are also likely to help physicians in prescribing personalized medication to patients after pinpointing the particular pathway that is playing an active role in the disease progression. This would not only lead to reduction in side-effects but also ensure that patients are adminstered the right medication.

Impressed by such overwhelming benefits, health insurance companies may insist that their customers undertake biomarkers-based screening tests, as these tests are expected to help them avoid spending on ineffective therapies and reduce expenditure. However, sensitivity and specificity of these tests is a major challenge that has to be overcome if they are to gain prominence. Developing diagnostic and screening tests that employ multiple biomarkers rather than relying on tests with a solo biomarker is one possible solution to this problem, says the analyst.

Biomarkers Enhance Success Rate in Drug Discovery

Biomarkers are extremely useful in screening, identifying, and developing drugs or other suitable interventions for several kinds of diseases. A high failure rate of potential drugs is currently driving research on the identification of biomarkers that are likely to act as surrogate primary end points in clinical trials for predicting drug efficacy in animals and humans. Biomarkers not only help in selecting suitable patients to participate in the clinical trials but also enable toxicity profiling, says the analyst. By reviewing the drugs’ toxicity profile by employing biomarkers, pharmaceuticals companies can retain or drop the drug at the initial stage of development itself, and thereby, avoid spending precious resources on drug candidates that may prove to be unviable at a later stage of drug development.

The shift in focus from discovering genomic biomarkers to protein biomarkers is driving demand for robust research instruments that enable multiplexing and reduce manual steps such as sample preparation. Technological developments in terms of automation and increase in throughput are enabling researchers to solve the riddle of the human proteome - which is much more complex than the human genome. Companies that manufacture protein chips containing high-density arrays of functional proteins and microfluidics-based platforms are likely to cash in on these novel research efforts aimed at discovering new biomarkers.


Contents: 1. Executive Summary
        1. Introduction
                1. Introduction to Biomarkers
                2. Biomarker Applications in Healthcare
An Overview
        2. Scope & Methodology
                1. Scope and Segmentation of the Research Service
                2. Methodology
2. Enabling Technologies for Biomarker Discovery
        1. Current Research and Development
                1. Biochip for Detection and Validation of Novel Biomarkers
                2. Automated 2D Gel Electrophoresis Promises to Improve Results and Save Time
                3. 3-In-1 Bioinformatics Software for Protein Identification
                4. De Novo Sequencing Software to Discover New Biomarkers
                5. Automated Gel Processor and Microscale On-Membrane Digestion for Protein Identification
                6. Mass Defect Labeling for Precise Screening of Biomarkers
                7. Tandem Mass Spectrometry to Identify Biomarkers
                8. Sensitive Bioanalytical System for Protein Profiling and Biomarker Discovery
                9. Lab-On-CD to Revolutionize Biomarker Discovery
                10. Microfluidic Chip to Automate and Streamline Manual Steps of Slab Gel Electrophoresis
                11. Liquid-Phase Protein Separation Technology to Detect Biomarkers
                12. Lab-On-Chip Concept Eliminates Microchannels
        2. Analysis
                1. Technology Drivers
                a. Increasing need to detect cancer at an early stage
                b. Pressure on pharma majors to accelerate their drug discovery programs
                c. Improving success rate in drug discovery
                d. Concept of personalized medicine gaining popularity within the medical community
                e. Information gap to be bridged
                2. Technology Challenges
                a. Complexity of the human proteome
                b. Dearth of samples and sample preparation bottle necks
                c. Lack of standardization in experiments leading to reproducibility issues
                d. Lack of bioinformatics tools
                e. Collaboration between varied fields for biomarker discovery
                f. Lack of a stand-alone test
                g. Stringent FDA regulations on validity of biomarkers
                h. Reluctance to adopt new technology
                3. Research Trends
3. Biomarkers in Drug Discovery and Development
        1. Current Research and Development
                1. Genomic Scanner Aids in Multiplexing Microarrays
                2. Biomarkers to Help Develop Interventions to Stall Senescence
                3. Lipomic Profiling to Help Prioritize Lead Compounds
                4. Multiplexed Molecular Profiling Technique for Drug Discovery and Diagnostics
                5. Software for Enhanced Data Security and Integrity in Drug Discovery and Biomarker Detection
                6. In Vitro Method for Generating High Affinity Antibodies
                7. Software to Simplify Microarray Data Analysis
                8. Technology to Address Content Problem in Designing Protein Chips
                9. Biomarkers in Clinical Trials and Animal Modeling
                10. Preparation of Custom Arrays by Ion Soft Landing
                11. Novel Biological CDs Rapidly Analyze Thousand Analytes
        2. Analysis
                1. Technology Drivers
                a. Increasing integration of biomarkers into clinical drug development
                b. Ability to shorten drug development times
                c. Gaining popularity of systems biology approach
                d. Technology developments
                e. Necessity of understanding the biological mechanisms of disease
                2. Technology Challenges
                a. Difficulty in identifying critical components
                b. Lack of cost-effective instruments
                c. Apprehensions relating to coupling of diagnostic tests with medication
                3. Technology Trends
4. Biomarkers in Clinical Diagnostics and Personalized Medicine
        1. Current Research and Development
                1. Study of Cellular Pathways and Clinical Biomarkers Made Easy
                2. Genomic Biomarker-Based Colorectal Diagnostic Kit
                3. DNA-Methylation Technology to Accurately Predict Cancer
                4. Multiplexed DNA Biochip
                5. Antibody Microarrays to Measure Differences in Protein Abundance
                6. Cardiac Biomarker to Detect Coronary Heart Disease
                7. Biomarker-Based Test for Early Prediction of Cystic Fibrosis
                8. Photoaptamer-Based Microarrays for Diagnostics and Drug Discovery Applications
                9. Supersensitive Method for PSA Diagnosis
                10. Biomarkers to Customize Cancer Therapy
                11. Glycoproteins for Cancer Detection
                12. Novel Chip Detects Influenza
                13. Microchip Detects Proteins
                14. Using Fluorescent Nanodots to Tag Faulty Genes
                15. Protein Chips to Profile Proteins for Diagnostic Applications
                16. Sensitive Chip to Detect Prostate Cancer
                17. EZH2 Gene for Prostate and Breast Cancer Prognosis
        2. Analysis
                1. Technology Drivers
                a. Mapping of the human genome
                b. Extended life spans
                c. Non-invasive nature of tests
                d. Early detection leading to better cure rates
                e. Personalized medicine
                f. Technology advances in automation
                g. Increasing demand for POC testing
                2. Technology Challenges
                a. Affordability of the tests
                b. Including the test in screening guidelines
                c. Lack of awareness
                d. Availability of sensitive and specific antibodies
                e. Costs associated with biomarker validation
                f. Cost-effectiveness of traditional tests
                3. Research Trends
5. Patents
Contacts
        1. Patents
                1. Patents Related to Biomarkers I
                2. Patents Related to Biomarkers II
        2. Contacts
                1. Companies
                2. Universities
6. Frost & Sullivan Technology Awards
        1. Technology Innovation Award
                1. Award Description
                2. Award Recipient
        2. Excellence in Technology Award
                1. Award Description
                2. Award Recipient
        3. Product Leadership Award
                1. Award Description
                2. Award Recipient
        4. Excellence in Research Award
                1. Award Description
                2. Award Recipient
        5. Technology Leadership Award
                1. Award Description
                2. Award Recipient
7. Decision Support Database
        1. Decision Support Database
                1. Total Health Care Expenditure
                2. Pharmaceutical R&D Expenditure
                3. Breast Cancer Mortality
                4. Prostate Cancer Mortality
                5. Lung Cancer Mortality




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