Abstract
In recent years, there have been concerted efforts to enhance the precision of disease diagnosis and monitoring as the hetrogeneity of conditions becomes increasingly understood. Targeting broad patient populations in a ' one-pill-fits-all' approach has begun to attract criticism, with the average efficacy of such drugs being estimated at 50% or less. In the current climate, biomarkers have emerged as key tools in the realisation of personalised medicine by characterizing specific diseases and treatment responses at the DNA, RNA, protein, or metabolite level. ' The Convergence of Biomarkers and Diagnostics' is a new report published by Business Insights that provides a detailed assessment of recent developments and future opportunities for biomarker companies in all major therapeutic areas. This report analyzes the markets for diagnostic biomarkers, including currently marketed products and products in development, and examines current trends in the discovery, validation and clinical application of biomarkers. Advances in biomarker detection technologies are profiled and the strategies of companies involved in biomarker discovery or diagnostic development are assessed. This report also forecasts growth in biomarker and diagnostic segments to 2012. Identify the latest developments in diagnostic biomarkers, examine biomarker-related patent trends and benchmark the strategies used to identify and validate novel biomarkers with this new report.
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- Draft guidance on multivariate analysis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
