The Convergence of Biomarkers and Diagnostics: Therapy area analyses, key products and future trends

Table of Contents

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  • Draft guidance on multivariate analysis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