Abstract
D&MD' s Molecular Diagnostics: Effective Tools for Disease Management, 3rd Edition market analysis report offers a comprehensive coverage of the scientific and technological developments which are creating new opportunities for the development of improved molecular diagnostics. This information will benefit developers of in vitro diagnostics as well as drug developers. The report analyses significant recent developments in molecular diagnostics which have implications for all developers of in vitro diagnostics and drugs. The first generation of molecular diagnostics on the market analyze protein and DNA biomarkers. New tests and services utilizing protein or DNA biomarkers continue to be launched and these are analyzed in the report.
Table of Contents
CHAPTER 1: EXECUTIVE SUMMARY
CHAPTER 2: INTRODUCTION
- Molecular Diagnostics
- The IVD Industry and Molecular Diagnostics
- Uses of Molecular Diagnostics in Clinical Settings
- Regulation of Molecular Diagnostics
- FDA' s New Pharmacogenomic Guidelines
- Scope of this Report
CHAPTER 3: TECHNOLOGY DEVELOPMENTS
- Overview of Technology Platforms
- Immunoassay Technology
- Introduction
- Immunoassay Formats
- Basic Assay Designs
- Automation and Miniaturization
- Rapid Immunochromatographic Assays
- Chromatographic Lateral Flow Devices
- Proteomics Technology
- Introduction
- Mass Spectrometry
- Protein Arrays
- SELDI ProteinChip Technology
- Nucleic Acid Testing Technology
- Introduction
- Isolation of Nucleic Acids
- DNA Sequencing
- Probe-based NAT
- PCR-based Amplification Technologies
- Alternative Amplification Technologies
- Automation
- DNA Microarrays
- Introduction
- Gene Activity Analysis
- Transcriptional Profiling
- Methylation Analysis
CHAPTER 4: MOLECULAR DIAGNOSTICS IN INFECTIOUS DISEASES
- Introduction
- Role of Molecular Diagnostics
- Viral Infections
- HIV
- Hepatitis Viruses
- Influenza and RSV
- Severe Acute Respiratory Syndrome (SARS)
- West Nile Virus (WNV)
- Human Papillomavirus (HPV)
- Bacterial Infections
- Chlamydia and Gonorrhea
- Mycobacteria
- Methicillin-resistent Staphylococcus Aureus (MRSA)
- Anthrax
- Sepsis Screening
- Fungal and Parasitic Infections
- Screening of Blood and Blood Products
CHAPTER 5: CARDIOVASCULAR DISEASES
- Overview of Cardiovascular Diseases
- Role of Molecular Diagnostics
- Biochemical Risk Factors for Coronary Disease
- Lipoprotein-related Markers
- CRP
- Lp-PLA2
- Homocysteine
- Myeloperoxidase (MPO)
- Other Markers
- Acute Chest Pain
- Markers of Necrosis
- Markers of Ischemia
- Heart Failure
- Multi Marker Strategies in Acute Coronary Syndromes (ACS)
- Stroke
- Susceptibility to Cardiovascular Disease
- Monogenic Cardiovascular Diseases
- Non-monogenic Diseases
- Prediction of Drug Efficacy
CHAPTER 6: CANCER
- Overview of Cancer
- Role of mMolecular Diagnostics
- Protein Analysis
- Gene Expression Analysis
- DNA Analysis
- Breast Cancer
- Diagnostic Markers
- Prognostic Markers
- Markers of Disease Susceptibility
- Markers of Drug Response
- Prostate Cancer
- Diagnostic Markers
- Prognostic Markers
- Markers of Disease Susceptibility
- Markers of Drug Response
- Colorectal Cancer
- Diagnostic Markers
- Prognostic Markers
- Markers of Disease Susceptibility
- Markers of Dug Response
- Lung Cancer
- Diagnostic Markers
- Markers of Drug Response
- Ovarian Cancer
- Diagnostic Markers
CHAPTER 7: MISCELLANEOUS DISEASES AND CONDITIONS
- Introduction
- Genetic Disorders
- Chromosomal Abnormalities
- Down Syndrome
- Monogenic Diseases
- Cystic Fibrosis
- Chromosomal Abnormalities
- Neurodegenerative/neuropsychiatric Diseases
- Alzheimer' s Disease
- Other Diseases
- Metabolic Diseases
- Diabetes and Its Complications
- Osteoporosis
- Preeclampsia
- Other Conditions
- Predictions of Drug Adverse Effects
- Cytochrome P450 Gene Family
CHAPTER 8: PATENTS FOR DIAGNOSTIC USE OF BIOMARKERS
- Introduction
- Overview of Patents
- Role of Patents in the Biomedical Industry
- Patenting of Genes and Antibodies
- The Biomarkers Patent Data Set
- Biomarker Patent Activities
- Forward Citations
- Patent Assignees
CHAPTER 9: MARKET CONSIDERATIONS AND FORECASTS
- Introduction
- Overview of the Total Pharmaceuticals Market
- Overview of the Total In Vitro Diagnostics Market
- Outlook for the Total Immunoassay Market
- General Immunoassays
- Infectious Disease Immunoassays
- Cancer Immunoassays
- Specialty (e.g. Cardiovascular) Immunoassays
- Outlook for the Total NAT Market
- Infectious Diseases
- Bacterial tests
- Viral Detection and Load
- Viral and Bacterial Genotyping
- Blood Screening
- Infectious Diseases
- Cancer
- Cervical Cancer (HPV) Screening
- Chromosomal Aberrations and Shed Nucleic Acids
- Gene Expression Profiling
- Genetic Testing and Hereditary Cancers
- Predisposition and Pharmacogenomic Tests
- Human Identity Testing
- Outlook for the Proteomic Assay Market
- Forecasts by Geographical Region
- Leading Companies and Analytes
CHAPTER 10: COMPANY PROFILES
- Abbott
- Bayer
- Becton Dickinson
- Chiron
- Genaissance Pharmaceuticals
- Innogenetics
- Johnson & Johnson
- Myriad Genetics
- Nuvelo
- Nymox
- OXIS
- Proteome Sciences
- Sequenom
CHAPTER 11: TRENDS AND OPPORTUNITIES
- Next Generation of Molecular Diagnostics
- Exploiting Protein Biomarkers
- Exploiting Gene Expression Profiling
- Exploiting DNA Biomarkers
- The Rise of Companion Diagnostics
TABLE OF EXHIBITS
- Exhibit 4.1 Immunoassays and Nucleic Acid Tests for Viruses
- Exhibit 4.2 Immunoassays and Nucleic Acid Tests for Bacteria
- Exhibit 4.3 Immunoassays and Nucleic Acid Tests for Fungi, Parasites, and Protozoa
- Exhibit 5.1 Marker Tests for Cardiovascular Disease Management
- Exhibit 5.2 Human Genes Associated with Cardiovascular Disorders
- Exhibit 5.3 Human Genes Associated with Diabetes and Obesity
- Exhibit 6.1 Marker Tests for Cancer Management
- Exhibit 6.2 Human Genes Associated with Cancer
- Exhibit 7.1 Human Genes Associated with Mental Disorders
- Exhibit 8.1 Biomarker Patents: Filing and Publication Dates
- Exhibit 8.2 Activity Analysis for US Biomarker Patents, 2000-2006
- Exhibit 8.3 Top Cited Biomarker Patents (US Filings 2000 - 2006)
- Exhibit 8.4 Top 20 Biomarker Patent Assignees
- Exhibit 8.5 Biomarker Methodology Patents (US Filings 2000 - 2006)
- Exhibit 8.6 Cancer Related Biomarker Patents (US Filings 2000 - 2006)
- Exhibit 8.7 Cardiovascular-related Biomarker Patents (US Filings 2000 - 2006)
- Exhibit 8.8 Pharmacogenomic Biomarker Patents (US Filings 2000 - 2006)
- Exhibit 8.9 Infection-related Biomarker Patents (US Filings 2000 - 2006)
- Exhibit 8.10 Other Clinical Biomarker Patents (US Filings 2000 - 2006)
- Exhibit 9.1 World Pharma Market by Region in 2005 and 2010 (in $US millions)
- Exhibit 9.2 World Pharma Market by Indication in 2005 and 2010 (in $US millions)
- Exhibit 9.3 Worldwide In Vitro Diagnostic Sales by Country, 2005 - 2010 ($US M)
- Exhibit 9.4 Worldwide In Vitro Diagnostic Sales by Application, 2005-2010 ($M)
- Exhibit 9.5 Immunoassay and NAT Markets by Application, 2005-2010
- Exhibit 9.6 Immunoassay and NAT Markets by Geographical Region, 2005-2010
- Exhibit 9.7 Immunoassay Markets by Geographical Region, 2005-2010
- Exhibit 9.8 NAT Markets by Geographical Region, 2005-2010
- Exhibit 9.9 CLIA Kits by Application, 2000 - 2006
- Exhibit 9.10 Leading CLIA Analytes by Application Group
- Exhibit 9.11 FDA IVD Approvals 2000-2006 by Test Complexity
- Exhibit 9.12 CLIA Applications by Test Complexity
- Exhibit 9.13 Leading CLIA Analytes, 2000-2006
- Exhibit 9.14 Leading CLIA Kit Manufacturers, 2000-2006
