The Convergence Of Biomarkers And Diagnostics: Therapy Area Analyses, Key Products And Future Trends

Published by: Business Insights

Published: Apr. 1, 2008 - 265 Pages

Table of Contents

The Convergence of Biomarkers and Diagnostics

Executive Summary

Overview of biomarker-based diagnostics

Biomarker discovery and validation

Opportunities in cancer

Opportunities in cardiovascular disease

Opportunities in other diseases

Market considerations and forecasts

Trends and opportunities

Chapter 1 Overview of biomarker-based diagnostics

Summary

Introduction

Information provided by biomarkers

DNA biomarkers

RNA biomarkers

Protein biomarkers

Metabolite biomarkers

Technologies for in vitro biomarker detection

Nucleic acid testing

Probe-based NAT

DNA microarrays

DNA methylation analysis

Gene expression analysis

Protein analysis

Immunoassays

Mass spectrometry

Multimarker diagnostic panels

Regulation of in vitro diagnostic tests

Europe

US

Guidance on pharmacogenomic data submission

Drug-diagnostic co-development concept paper

Draft guidance on multivariate analysis

In vivo biomarker diagnostics

Chapter 2 Biomarker discovery and validation

Summary

Introduction

Omics approaches

Genomics

Transcriptomics

Proteomics

Metabolomics

Other omics and systems biology

Streamlining biomarker validation

Case studies

BG Medicine

Caprion Proteomics

Clinical Data

Compugen

Digilab Peptidomics

Metabolon

Monarch LifeSciences

Pronota

Source MDx

Vermillion

Chapter 3 Opportunities in cancer

Summary

Background on cancer

Biomarker-based diagnostics

Targeted therapies and companion diagnostics

Tests based on DNA biomarkers

Tests based on RNA biomarkers

Tests based on protein biomarkers

Biomarkers in breast cancer

Susceptibility

Detection

Prognosis and selection for therapy

Chemotherapy

Tamoxifen

HER2-targeting treatments

Biomarkers in prostate cancer

Susceptibility

Detection

Classification, prognosis, and treatment

Biomarkers in colorectal cancer

Susceptibility

Detection

Classification, prognosis, and treatment

Biomarkers in lung cancer

Susceptibility

Detection

Classification, prognosis, and treatment

Biomarkers in ovarian cancer

Detection

Classification and prognosis

Chapter 4 Opportunities in cardiovascular diseases

Summary

Background on cardiovascular disease

Biomarker-based diagnostics

Tests based on protein biomarkers

Tests based on other biomarkers

Biomarkers in coronary artery disease

Lipid/lipoprotein biomarkers

Biomarkers of inflammation, plaque instability

Genetic biomarkers

Biomarkers from omic studies

Biomarkers in acute coronary syndromes

Biomarkers of necrosis

Other biomarkers

Biomarkers for risk stratification

Multimarker strategies

Biomarkers in congestive heart failure

Biomarkers of hemodynamic strain

Pharmacogenomic biomarkers

Biomarkers in stroke

Prediction of drug efficacy

Chapter 5 Opportunities in other diseases

Summary

Biomarkers in infectious diseases

Viral infections

HIV

Hepatitis viruses

HPV

Influenza and SARS

Bacterial infections

Chlamydia and gonorrhea

Mycobacteria

MRSA

Sepsis screening

Biomarkers in CNS disorders

Alzheimer's disease

Other neurodegenerative disorders

Multiple sclerosis

Traumatic brain injury

Biomarkers of CNS drug efficacy

Biomarkers in diabetes and obesity

Type 1 diabetes

Obesity and type 2 diabetes

Chapter 6 Market considerations and forecasts

Summary

Introduction

Overview of the total pharmaceuticals market

Overview of the total in vitro diagnostics market

Outlook for the diagnostic biomarkers market

Cancer: immunoassays and microarrays

Cardiovascular disease: immunoassays

Infection biomarkers

Predisposition and pharmacogenomic tests

Chapter 7 Trends and opportunities

Summary

Prospects for omics-derived biomarkers

Genomic variants as biomarkers

Gene expression signatures as biomarkers

Proteomic patterns as biomarkers

Translating omic discoveries into immunoassays

Factors affecting acceptance of biomarkers

Prospects for companion diagnostics

Biomarkers patent survey

Chapter 8 Appendix

Research Methodology

Proteomic Cancer Biomarkers

Biomarkers of Cardiovascular Disease and Stroke

Index

List of Figures

Figure 4.1: Biomarkers of Acute Coronary Syndromes

List of Tables

Table 1.1: In Vitro Diagnostic Multivariate Index Assays - FDA Draft Guidance (July, 07)

Table 4.2: Further Biomarkers of Cardiovascular Disease and Stroke

Table 6.3: Worldwide In Vitro Diagnostic Sales by Country 2007-2012 ($m)

Table 6.4: Worldwide In Vitro Diagnostic Sales by Application 2007-12 ($m)

Table 6.5: Biomarker Markets by Application 2007-2012 ($m)

Table 6.6: Biomarker Markets by Geographical Region 2007-2012 ($m)

Table 7.7: Analysis of filling and publication dates for biomarker patents, 2000-2007

Table 7.8: Biomarker assignees with six or more patents

Table 7.9: Biomarker patents: technologies and applications

Table 7.10: Biomarker assignees with six or more patents

Table 7.11: Patent activity analysis for top four biomarker assignees, Part 1

Table 7.12: Patent activity analysis for top four biomarker assignees, Part 2

Table 8.13: High Priority Proteomic Cancer Biomarkers

Table 8.14: Other Proteomic Cancer Biomarkers

Table 8.15: Biomarkers of Cardiovascular Disease and Stroke

Abstract

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