Molecular Diagnostics: Major World Markets

Table of Contents

Chapter One: Executive Summary

• Background
• Scope and Methodology
• Size and Growth of Market
• Competitive Picture
• Market Trends and Factors

Chapter Two: Introduction

• Background
• Market Erosion
• Clinical Relevance
• Cost-Benefit Relationships
• Scientific Limitations
• Essential Scientific Foundations
• Genomics
• Genes, Functional Genomics and Disease
• Proteomics

Chapter Three: Molecular Diagnostics Technologies

• Background
• Amplification Technologies
• Gene Amplification
• Signal Amplification
• Probe Technologies
• Microchip Technologies
• Electrophoretic Technologies
• Blotting Technologies
• Single Nucleotide Polymorphism (SNP) Analysis
• Restriction Fragment Length Polymorphism (RFLP) Analysis
• RNA Inhibition (RNAi) Analysis
• Biophotonics

Chapter Four: Applications of Molecular Diagnostics

• The Testing Environment
• Regulatory Issues and Home-Brew Assays
• Molecular Diagnostics Test Distribution and Factors
• Privacy Issues and Legislation
• The Blood Banking Industry
• Commercial Clinical Laboratory Operations
• University/Hospital Laboratory Operations
• Projections
  • Blood Banking Analysis
  • Genetic Diseases
  • Oncology
  • Pharmacogenetics
  • Infectious Disease Testing
  • Chlamydia trachomatis
  • Neisseria gonorrhoeae
  • Pneumonia
  • Human Immunodeficiency Virus (HIV)
  • Tuberculosis
  • Hepatitis B (HBV)
  • Hepatitis C (HCV)
  • Human Papillomavirus (HPV)
  • Herpes Simplex (HSV)
  • West Nile Virus (WNV)

Chapter Five: The Market for Molecular Diagnostics

• Market Size and Trending
• Blood Bank Testing
• Gene and Chromosome Testing
• Oncology Testing
• Pharmacogenetic Testing
• Infectious Disease Testing
• Competitive Picture and Industry Structure
• Future Prospects

Chapter Six: Company Profiles

• Overview
• Abbott Diagnostics (Vysis Division)
• Bayer Diagnostics Division of Bayer Healthcare
• Biotest Diagnostics (Division of Biotest AG)
• Celera Diagnostics (Celera Genomics Group/Applera Corporation)
• Cepheid, Inc.
• Digene Corporation
• Gen-Probe Incorporated
• Innogenetics NV
• Roche Diagnostics Division/Roche Molecular Systems (F. Hoffmann-LaRoche Ltd.)
• Third Wave Technologies

Chapter Seven: Conclusions and Strategic Implications

• First Conclusion
• Implications:
• Second Conclusion
• Implications:
• Third Conclusion
• Implications:
• Fourth Conclusion
• Implications:
• Fifth Conclusion
• Implications:
• Sixth Conclusion
• Implications:
• Seventh Conclusion
• Implications:
• Eighth Conclusion
• Implications:
• Ninth Conclusion
• Implications:
• Tenth Conclusion
• Implications:
• Eleventh Conclusion
• Implications:
• Twelfth Conclusion
• Implications:
• Thirteenth Conclusion
• Implications:
• Fourteenth Conclusion
• Implications:

Appendix: Company Directory

List of Exhibits

Chapter One: Executive Summary

• Table 1-1: Molecular Diagnostics Technologies Description, Advantages, Disadvantages
• Table 1-2: Projected Molecular Diagnostics Market Potential in the Seven Major World Healthcare Markets by Country 2006 - 2016
• Figure 1-1: Trending in the Projected Molecular Diagnostics Market Potential in the Seven Major World Healthcare Markets by Applications Segment (Blood Banking, Cancer, Infectious Disease, Gene/Chromosome Testing, Pharmacogenetics) 2006 - 2016
• Figure 1-2: Trending in the Composition of the Projected Molecular Diagnostics Market Potential in the Seven Major World Healthcare Markets by Applications Segment (Blood Banking, Cancer, Infectious Disease, Gene/Chromosome Testing, Pharmacogenetics) 2006 - 2016
• Table 1-3: Key Active Competitors in the Molecular Diagnostics Products Market by Technologies 2007

Chapter Three: Molecular Diagnostics Technologies

• Table 3-1: Molecular Diagnostics Technologies Description, Advantages, Disadvantages
• Table 3-2: Gene Amplification Technologies
• Table 3-3: Commonly Used Signal Amplification Technologies for Genetic Analysis

Chapter Four: Applications of Molecular Diagnostics

• Table 4-1: Commercially Available Molecular Diagnostics Tests (Company, Analyte, Test Category, Test Name, Technology)
• Table 4-2: Key "Home-Brew" Molecular Diagnostics Assays (Disease/Condition, Specimen Type, Assay Method, Turn-Around Time, Comments)
• Figure 4-1: Distribution of Molecular Diagnostics Testing by Application (Blood Bank, Cancer, Pharmacogenetic, Tissue Typing, Gene/Chromosome, Infectious Disease) 2006
• Table 4-3: Populations of the Seven Major World Healthcare Markets 2006 - 2016
• Table 4-4: Distribution of Populations of the Seven Major World Healthcare Markets: 2006 - 2016
• Table 4-5: Potential Test Volumes for Molecular Diagnostics in the Seven Major World Healthcare Markets by Testing Area (Blood Banking, Gene/Chromosome Disease, Oncology, Pharmacogenetics, Infectious Disease) 2006 - 2016
• Table 4-6: Distribution of Potential Test Volumes for Molecular Diagnostics in the Seven Major World Healthcare Markets by Testing Area (Blood Banking, Gene/Chromosome Disease, Oncology, Pharmacogenetics, Infectious Disease) 2006 - 2016
• Table 4-7: Estimated Blood/Plasma Donation Levels in the Seven Major World Healthcare Markets 2006 - 2016
• Table 4-8: Potential Levels of Molecular Testing in Blood Banking in the Seven Major World Healthcare Markets 2006 - 2016
• Table 4-9: Commercially Available Molecular (Nucleic Acid) Tests for Blood, Plasma and Organ Donor Screening in the United States (Trade Name, Format, Sample, Use, Manufacturer, Approval Date) 2006
• Table 4-10: Potential Levels of Molecular Testing in Blood Banking in France by Category (HIV, HCV, HBV, HAV, HTLV, WNV, Others) 2006 - 2016
• Table 4-11: Potential Levels of Molecular Testing in Blood Banking in Germany by Category (HIV, HCV, HBV, HAV, HTLV, WNV, Others) 2006 - 2016
• Table 4-12: Potential Levels of Molecular Testing in Blood Banking in Italy by Category (HIV, HCV, HBV, HAV, HTLV, WNV, Others) 2006 - 2016
• Table 4-13: Potential Levels of Molecular Testing in Blood Banking in Japan by Category (HIV, HCV, HBV, HAV, HTLV, WNV, Others) 2006 - 2016
• Table 4-14: Potential Levels of Molecular Testing in Blood Banking in Spain by Category (HIV, HCV, HBV, HAV, HTLV, WNV, Others) 2006 - 2016
• Table 4-15: Potential Levels of Molecular Testing in Blood Banking in the United Kingdom by Category (HIV, HCV, HBV, HAV, HTLV, WNV, Others) 2006 - 2016
• Table 4-14: Potential Levels of Molecular Testing in Blood Banking in the United States by Category (HIV, HCV, HBV, HAV, HTLV, WNV, Others) 2006 - 2016
• Table 4-17: Key Hereditary Diseases (Condition, Incidence, and Inheritance/Cause)
• Table 4-18: Potential Levels of Molecular Testing in Genetic Analysis in the Seven Major World Healthcare Markets by Category (Heterozygote, Presymptomatic, Prenatal, Newborn Screening) 2006 - 2016
• Table 4-19: Potential Levels of Molecular Testing in Genetic Analysis in the Seven Major World Healthcare Markets by Country 2006 - 2016
• Table 4-20: Potential Levels of Molecular Testing in Oncology in the Seven Major World Healthcare Markets by Category (Management vs Susceptibility) 2006 - 2016
• Table 4-21: Potential Levels of Molecular Testing in Oncology in the Seven Major World Healthcare Markets by Country 2006 - 2016
• Table 4-22: Drugs Affected by the Cytochrome p450 System
• Table 4-23: Potential Levels of Molecular Testing in Pharmacogenetics in the Seven Major World Healthcare Markets by Category (HIV/AIDS, Neuropharmacology, Immune Disease, Cancer, Other) 2006 - 2016
• Table 4-24: Potential Levels of Molecular Testing in Pharmacogenetics in the Seven Major World Healthcare Markets by Country 2006 - 2016
• Table 4-25: Potential Levels of Molecular Testing in Infectious Disease in the Seven Major World Healthcare Markets by Category (CT, NG, Pneumonia, HIV, HBV, HCV, HPV, MT, HSV) 2006 - 2016
• Table 4-26: Potential Levels of Molecular Testing in Infectious Disease in the Seven Major World Healthcare Markets by Country 2006 - 2016

Chapter Five: The Market for Molecular Diagnostics

• Table 5-1: Projected Molecular Diagnostics Market Potential in the Seven Major World Healthcare Markets by Country 2006 - 2016
• Table 5-2: Potential Market for Molecular Diagnostics Testing in France by Testing Area (Blood Banking, Gene/Chromosome Disease, Oncology, Pharmacogenetics, Infectious Disease) 2006 - 2016
• Table 5-3: Potential Market for Molecular Diagnostics Testing in Germany by Testing Area (Blood Banking, Gene/Chromosome Disease, Oncology, Pharmacogenetics, Infectious Disease) 2006 - 2016
• Table 5-4: Potential Market for Molecular Diagnostics Testing in Italy by Testing Area (Blood Banking, Gene/Chromosome Disease, Oncology, Pharmacogenetics, Infectious Disease) 2006 - 2016
• Table 5-5: Potential Market for Molecular Diagnostics Testing in Japan by Testing Area (Blood Banking, Gene/Chromosome Disease, Oncology, Pharmacogenetics, Infectious Disease) 2006 - 2016
• Table 5-6: Potential Market for Molecular Diagnostics Testing in Spain by Testing Area (Blood Banking, Gene/Chromosome Disease, Oncology, Pharmacogenetics, Infectious Disease) 2006 - 2016
• Table 5-7: Potential Market for Molecular Diagnostics Testing in the United Kingdom by Testing Area (Blood Banking, Gene/Chromosome Disease, Oncology, Pharmacogenetics, Infectious Disease) 2006 - 2016
• Table 5-8: Potential Market for Molecular Diagnostics Testing in the United States by Testing Area (Blood Banking, Gene/Chromosome Disease, Oncology, Pharmacogenetics, Infectious Disease) 2006 - 2016
• Figure 5-1: Trending in the Potential Markets for Molecular Diagnostics in the Seven Major World Healthcare Markets 2006 - 2016
• Figure 5-2: Trending in the Composition of Potential Markets for Molecular Diagnostics in the Seven Major World Healthcare Markets 2006 - 2016
• Table 5-9: Table 5-8 Potential Market for Molecular Diagnostics Testing in the Seven Major World Healthcare Markets by Testing Area (Blood Banking, Gene/ Chromosome Disease, Oncology, Pharmacogenetics, Infectious Disease) 2006 - 2016
• Figure 5-3: Trending in the Potential Test Volume for Molecular Diagnostics in the Seven Major World Healthcare Markets by Testing Area (Blood Banking, Gene/Chromosome Disease, Oncology, Pharmacogenetics, Infectious Disease) 2006 - 2016
• Figure 5-4: Trending in the Composition of Potential Test Volume for Molecular Diagnostics in the Seven Major World Healthcare Markets by Testing Area (Blood Banking, Gene/Chromosome Disease, Oncology, Pharmacogenetics, Infectious Disease) 2006 - 2016
• Table 5-10: Projected Blood Banking and Plasmapheresis Molecular Diagnostics Testing Market Potential in the Seven Major World Healthcare Markets by Country 2006 - 2016
• Figure 5-5: Trending in the Projected Blood Banking and Plasmapheresis Molecular Diagnostics Testing Market Potential in the Seven Major World Healthcare Markets 2006 - 2016
• Figure 5-6: Trending in the Projected Blood Banking and Plasmapheresis Molecular Diagnostics Potential Testing Volume in the Seven Major World Healthcare Markets 2006 - 2016
• Table 5-11: Projected Blood Banking and Plasmapheresis Molecular Diagnostics Testing Volume Potential in the Seven Major World Healthcare Markets by Test Type (HIV, HCV, HBV, HAV, HTLV, WNV, Others) 2006 - 2016
• Figure 5-7: Trending in the Composition of the Projected Blood Banking and Plasmapheresis Molecular Diagnostics Testing Volume Potential in the Seven Major World Healthcare Markets 2006 - 2016
• Table 5-12: Projected Blood Banking and Plasmapheresis Molecular Diagnostics Testing Volume Potential in France by Test Type (HIV, HCV, HBV, HAV, HTLV, WNV, Others) 2006 - 2016
• Table 5-13: Projected Blood Banking and Plasmapheresis Molecular Diagnostics Testing Volume Potential in Germany by Test Type (HIV, HCV, HBV, HAV, HTLV, WNV, Others) 2006 - 2016
• Table 5-14: Projected Blood Banking and Plasmapheresis Molecular Diagnostics Testing Volume Potential in Italy by Test Type (HIV, HCV, HBV, HAV, HTLV, WNV, Others) 2006 - 2016
• Table 5-15: Projected Blood Banking and Plasmapheresis Molecular Diagnostics Testing Volume Potential in Japan by Test Type (HIV, HCV, HBV, HAV, HTLV, WNV, Others) 2006 - 2016
• Table 5-16: Projected Blood Banking and Plasmapheresis Molecular Diagnostics Testing Volume Potential in Spain by Test Type (HIV, HCV, HBV, HAV, HTLV, WNV, Others) 2006 - 2016
• Table 5-17: Projected Blood Banking and Plasmapheresis Molecular Diagnostics Testing Volume Potential in the United Kingdom by Test Type (HIV, HCV, HBV, HAV, HTLV, WNV, Others) 2006 - 2016
• Table 5-18: Projected Blood Banking and Plasmapheresis Molecular Diagnostics Testing Volume Potential in the United States by Test Type (HIV, HCV, HBV, HAV, HTLV, WNV, Others) 2006 - 2016
• Table 5-19: Projected Genetic and Chromosome Molecular Diagnostics Testing Market Potential in the Seven Major World Healthcare Markets by Country 2006- 2016
• Figure 5-8: Trending in the Projected Genetic and Chromosome Molecular Diagnostics Testing Market Potential in the Seven Major World Healthcare Markets 2006 - 2016
• Figure 5-9: Trending in the Projected Genetic and Chromosome Molecular Diagnostics Testing Market Assay Volume Potential in the Seven Major World Healthcare Markets 2006 - 2016
• Table 5-20: Projected Genetic and Chromosome Molecular Diagnostics Testing Volume Potential in the Seven Major World Healthcare Markets by Application (Heterozygote Testing, Presymptomatic Disease Testing, Prenatal Testing, Newborn Testing) 2006 - 2016
• Figure 5-10: Trending in the Composition of the Projected Genetic and Chromosome Molecular Diagnostics Testing Volume Potential in the Seven Major World Healthcare Markets 2006 - 2016
• Table 5-21: Projected Genetic and Chromosome Molecular Diagnostics Testing Volume Potential in France by Application (Heterozygote Testing, Presymptomatic Disease Testing, Prenatal Testing, Newborn Testing) 2006 - 2016
• Table 5-22: Projected Genetic and Chromosome Molecular Diagnostics Testing Volume Potential in Germany by Application (Heterozygote Testing, Presymptomatic Disease Testing, Prenatal Testing, Newborn Testing) 2006 - 2016
• Table 5-23: Projected Genetic and Chromosome Molecular Diagnostics Testing Volume Potential in Italy by Application (Heterozygote Testing, Presymptomatic Disease Testing, Prenatal Testing, Newborn Testing) 2006 - 2016
• Table 5-24: Projected Genetic and Chromosome Molecular Diagnostics Testing Volume Potential in Japan by Application (Heterozygote Testing, Presymptomatic Disease Testing, Prenatal Testing, Newborn Testing) 2006 - 2016
• Table 5-25: Projected Genetic and Chromosome Molecular Diagnostics Testing Volume Potential in Spain by Application (Heterozygote Testing, Presymptomatic Disease Testing, Prenatal Testing, Newborn Testing) 2006 - 2016
• Table 5-26: Projected Genetic and Chromosome Molecular Diagnostics Testing Volume Potential in the United Kingdom by Application (Heterozygote Testing, Presymptomatic Disease Testing, Prenatal Testing, Newborn Testing) 2006 - 2016
• Table 5-27: Projected Genetic and Chromosome Molecular Diagnostics Testing Volume Potential in the United States by Application (Heterozygote Testing, Presymptomatic Disease Testing, Prenatal Testing, Newborn Testing) 2006 - 2016
• Table 5-28: Projected Oncology Molecular Diagnostics Testing Market Potential in the Seven Major World Healthcare Markets by Country 2006- 2016
• Figure 5-11: Trending in the Projected Oncology Molecular Diagnostics Testing Market Potential in the Seven Major World Healthcare Markets 2006 - 2016
• Figure 5-12: Trending in the Projected Oncology Molecular Diagnostics Testing Market Assay Volume Potential in the Seven Major World Healthcare Markets 2006 - 2016
• Table 5-29: Projected Molecular Oncology Diagnostics Testing Volume Potential in the Seven Major World Healthcare Markets by Application (Cancer Management vs Cancer Susceptibility) 2006 - 2016
• Figure 5-13: Trending in the Composition of the Projected Oncology Molecular Diagnostics Testing Market Assay Volume Potential in the Seven Major World Healthcare Markets: 2006 - 2016
• Table 5-30: Projected Molecular Oncology Diagnostics Testing Volume Potential in France by Application (Cancer Management vs Cancer Susceptibility) 2006 - 2016
• Table 5-31: Projected Molecular Oncology Diagnostics Testing Volume Potential in Germany by Application (Cancer Management vs Cancer Susceptibility) 2006 - 2016
• Table 5-32: Projected Molecular Oncology Diagnostics Testing Volume Potential in Italy by Application (Cancer Management vs Cancer Susceptibility) 2006 - 2016
• Table 5-33: Projected Molecular Oncology Diagnostics Testing Volume Potential in Japan by Application (Cancer Management vs Cancer Susceptibility) 2006 - 2016
• Table 5-34: Projected Molecular Oncology Diagnostics Testing Volume Potential in Spain by Application (Cancer Management vs Cancer Susceptibility) 2006 - 2016
• Table 5-35: Projected Molecular Oncology Diagnostics Testing Volume Potential in the United Kingdom by Application (Cancer Management vs Cancer Susceptibility) 2006 - 2016
• Table 5-36: Projected Molecular Oncology Diagnostics Testing Volume Potential in the United States by Application (Cancer Management vs Cancer Susceptibility) 2006 - 2016
• Table 5-37: Projected Pharmacogenetic Molecular Diagnostics Testing Market Potential in the Seven Major World Healthcare Markets by Country 2006 - 2016
• Figure 5-14: Trending in the Projected Pharmacogenetic Molecular Diagnostics Testing Market Potential in the Seven Major World Healthcare Markets 2006 - 2016
• Table 5-38: Projected Molecular Pharmacogenetics Testing Volume Potential in the Seven Major World Healthcare Markets by Application (HIV/AIDS Testing, Neuropharmaceutical Testing, Immune Therapeutics Testing, Cancer Testing, Other) 2006 - 2016
• Figure 5-15: Trending in the Projected Pharmacogenetics Molecular Diagnostics Testing Market Assay Volume Potential in the Seven Major World Healthcare Markets: 2006 - 2016
• Figure 5-16: Trending in the Composition of the Projected Pharmacogenetics Molecular Diagnostics Testing Market Assay Volume Potential in the Seven Major World Healthcare Markets: 2006 - 2016
• Table 5-39: Potential Pharmacogenetic Molecular Diagnostics Testing Volume in France by Application (HIV/AIDS Testing, Neuropharmaceutical Testing, Immune Therapeutics Testing, Cancer Testing, Other) 2006 - 2016
• Table 5-40: Potential Pharmacogenetic Molecular Diagnostics Testing Volume in Germany by Application (HIV/AIDS Testing, Neuropharmaceutical Testing, Immune Therapeutics Testing, Cancer Testing, Other) 2006 - 2016
• Table 5-41: Potential Pharmacogenetic Molecular Diagnostics Testing Volume in Italy by Application (HIV/AIDS Testing, Neuropharmaceutical Testing, Immune Therapeutics Testing, Cancer Testing, Other) 2006 - 2016
• Table 5-42: Potential Pharmacogenetic Molecular Diagnostics Testing Volume in Japan by Application (HIV/AIDS Testing, Neuropharmaceutical Testing, Immune Therapeutics Testing, Cancer Testing, Other) 2006 - 2016
• Table 5-43: Potential Pharmacogenetic Molecular Diagnostics Testing Volume in Spain by Application (HIV/AIDS Testing, Neuropharmaceutical Testing, Immune Therapeutics Testing, Cancer Testing, Other) 2006 - 2016
• Table 5-44: Potential Pharmacogenetic Molecular Diagnostics Testing Volume in the United Kingdom by Application (HIV/AIDS Testing, Neuropharmaceutical Testing, Immune Therapeutics Testing, Cancer Testing, Other) 2006 - 2016
• Table 5-45: Potential Pharmacogenetic Molecular Diagnostics Testing Volume in the United States by Application (HIV/AIDS Testing, Neuropharmaceutical Testing, Immune Therapeutics Testing, Cancer Testing, Other) 2006 - 2016
• Table 5-46: Projected Molecular Diagnostics Infectious Disease Testing Market Potential in the Seven Major World Healthcare Markets by Country 2006 - 2016
• Figure 5-17: Trending in the Projected Infectious Disease Molecular Diagnostics Testing Market Potential in the Seven Major World Healthcare Markets: 2006 - 2016
• Figure 5-18: Trending in the Projected Infectious Disease Molecular Diagnostics Testing Market Assay Volume Potential in the Seven Major World Healthcare Markets: 2006 - 2016
• Figure 5-19: Trending in the Composition of the Projected Infectious Disease Molecular Diagnostics Testing Market Assay Volume Potential in the Seven Major World Healthcare Markets: 2006 - 2016
• Figure 5-20: Trending in the Projected Test Volume for Molecular Diagnostics in Infectious Disease Testing in the Seven Major World Healthcare Markets by Application: 2006 - 2016
• Table 5-47: Projected Molecular Diagnostics Infectious Disease Testing Volume Potential in the Seven Major World Healthcare Markets by Application (CT, NG, Pneumonia, HIV, HBV, HCV, HPV, MT, HSV) 2006 - 2016
• Table 5-48: Projected Infectious Disease Molecular Diagnostics Potential Testing Volume in France by Application (CT, NG, Pneumonia, HIV, HBV, HCV, HPV, MT, HSV) 2006 - 2016
• Table 5-49: Projected Infectious Disease Molecular Diagnostics Potential Testing Volume in Germany by Application (CT, NG, Pneumonia, HIV, HBV, HCV, HPV, MT, HSV) 2006 - 2016
• Table 5-50: Projected Infectious Disease Molecular Diagnostics Potential Testing Volume in Italy by Application (CT, NG, Pneumonia, HIV, HBV, HCV, HPV, MT, HSV) 2006 - 2016
• Table 5-51: Projected Infectious Disease Molecular Diagnostics Potential Testing Volume in Japan by Application (CT, NG, Pneumonia, HIV, HBV, HCV, HPV, MT, HSV) 2006 - 2016
• Table 5-52: Projected Infectious Disease Molecular Diagnostics Potential Testing Volume in Spain by Application (CT, NG, Pneumonia, HIV, HBV, HCV, HPV, MT, HSV) 2006 - 2016
• Table 5-53: Projected Infectious Disease Molecular Diagnostics Potential Testing Volume in the United Kingdom by Application (CT, NG, Pneumonia, HIV, HBV, HCV, HPV, MT, HSV) 2006 - 2016
• Table 5-54: Projected Infectious Disease Molecular Diagnostics Potential Testing Volume in the United States by Application (CT, NG, Pneumonia, HIV, HBV, HCV, HPV, MT, HSV) 2006 - 2016
• Table 5-55: Key Active Competitors in the Molecular Diagnostics Products Market by Technologies 2007