Molecular Diagnostics Markets

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Publication Date: 2010-10-02

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The technologies that constitute molecular diagnostics--like first-generation amplification, DNA probes, fluorescent in situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors, and molecular labels--are influencing the discovery of therapeutic molecules, the screening and diagnosis of patients, and the optimization of drug therapy. In the past few years, this rapidly evolving field has seen several fascinating developments. This report describes the specific market segment of the in vitro diagnostics market known as molecular diagnostics and includes all of the generally accepted clinical analytical activities in use today. It examines the prevalent clinical-measurement devices, as well as their reagents and supplies as utilized in hospitals, clinics, large reference laboratories and doctor's offices. Diagnostic tests marketed primarily as over-the-counter are generally not included in this report, although there is inevitably some overlap.

The main objectives of this analysis are:

1) identifying viable technology drivers through a comprehensive look at platform technologies for molecular diagnostics, including probe-based nucleic acid assays, microarrays and sequencing;

2) obtaining a complete understanding of the chief molecular diagnostics tests--i.e., predictive, screening, prognostic, monitoring, pharmacogenomic and theranostic--from their basic principles to their applications;

3) discovering feasible market opportunities by identifying high-growth applications in different clinical diagnostic areas and by focusing on expanding markets, such as communicable diseases, cardiology and oncology; and

4) focusing on global industry development through an in-depth analysis of the major world markets for molecular diagnostics, including growth forecasts.

Table of Contents

1. Overview 9


2. Introduction to Molecular Diagnostics and PCR Technology 16


3. Nucleic Acid Test Applications 30

  • 3.5.1 Analysis by PCR-based DNA Typing 118
  • 3.5.2 Rapid Isolation of DNA for Restriction Fragment Length Polymorphism (RFLP) and PCR 118
  • 3.5.3 DNA for PCR-STR Typing 118


4. Trends in Molecular Diagnostics 154


5. Molecular Diagnostics Automated Instrumentation Approved for Market by the FDA 180


6. Market Trends and Forecasts 186


7. Company Profiles 205


8. Market Overview 250



INDEX OF FIGURES

Figure 2.1: Segment of Double-stranded DNA Showing the Base-Pair Relationship 16
Figure 3.1: Overall Structure of Nucleic Acid Testing Market 33
Figure 3.2: Key Players Market Share in Global Molecular Diagnostics Testing Markets 37
Figure 3.3: Revenue Mix from BioChips 45
Figure 3.4: Markers of Acute HBV Infection as a Function of Time after Exposure to Infection 57
Figure 3.5: Primary Causes of Chronic Liver Disease 61
Figure 3.6: Markers of Acute HCV Infection as a Function of Time after Exposure to Infection 62
Figure 3.7: Market Share Estimates for Molecular Diagnostic HPV Testing, 2009 70
Figure 3.8: U.S. Total Infectious Disease Molecular Diagnostics Markets, 2009 82
Figure 3.9: Blood Screening Market Share, 2009 100
Figure 3.10: Bacillus anthracis 129
Figure 8.1: Molecular Diagnostics Market Segmentation 251
Figure 8.2: Molecular Diagnostics Market Segmentation by Technology 251
Figure 8.3: Global Distribution of Molecular Diagnostics Testing, 2009 254


INDEX OF TABLES

Table 2.1: Key Assay Technologies for Molecular Diagnostics 22
Table 3.1: Applications of Molecular Diagnostics Technology Platforms 31
Table 3.2: Global Market for Molecular Diagnostics Testing, 2000-2015 35
Table 3.3: U.S. Market for Molecular Diagnostics Testing, 2004-2015 35
Table 3.4: Summary of Molecular Diagnostics Testing Clinical Focus and Detection 36
Table 3.5: Share of Molecular Diagnostics Testing by Testing Type, 2009 36
Table 3.6: Key Players and Market Share in Global Molecular Diagnostics Testing Market 37
Table 3.7: Revenue Model for Molecular Diagnostics Testing 37
Table 3.8: Annual U.S. Market for DNA Probe Diagnostics, 1998-2012 38
Table 3.9: Annual Global Market for DNA Probe Diagnostics, 1998-2009 38
Table 3.10: Roche PCR Licenses 39
Table 3.11: Companies Marketing Products Using DNA Probes 41
Table 3.12: Companies Marketing Multiple Products in Molecular Diagnostics Sector 42
Table 3.13: Global Sales of DNA Probe Kits, 1998-2009 42
Table 3.14: Companies Marketing DNA Detection Platforms 43
Table 3.15: Companies Marketing Genotyping Technologies 46
Table 3.16: Companies Marketing Clinical Genotyping Technologies 47
Table 3.17: Summary of Assays for HIV Viral Load Testing 52
Table 3.18: Global Market for HIV Diagnostic Testing, 2000-2012 55
Table 3.19: U.S. Market for HIV Diagnostic Testing, 2000-2012 55
Table 3.20: Markers for Diagnosis of HBV Infections 58
Table 3.21: Recommendations for HBV Diagnostic Testing 58
Table 3.22: Lower Detection Limits of HBV DNA Assays 59
Table 3.23: Recommendations for HCV Diagnostic Testing 63
Table 3.24: Important HCV Statistics 64
Table 3.25: Global Market for DNA HAV Diagnostic Testing, 2000-2008 65
Table 3.26: U.S. Market for DNA HAV Diagnostic Testing, 2000-2008 66
Table 3.27: Global Market for DNA HBV Diagnostic Testing, 2000-2008 66
Table 3.28: U.S. Market for DNA HBV Diagnostic Testing, 2000-2008 66
Table 3.29: Global Market for DNA HCV Diagnostic Testing, 2000-2008 67
Table 3.30: U.S. Market for DNA HCV Diagnostic Testing, 2000-2008 67
Table 3.31: Global Market for HPV Diagnostic Testing, 2003-2011 71
Table 3.32: Global Market for Molecular Diagnostics Cancer Testing, 2004-2008 73
Table 3.33: U.S. Molecular Diagnostic Markets for Infectious Disease Testing, 2009 82
Table 3.34: CPT Code1 Description National Limitation Amount 86
Table 3.35: Annual Volume of NAT Infectious Disease Testing, 2000-2008 87
Table 3.36: Global Market Dollar Volume of NAT STD Testing, 2000-2008 87
Table 3.37: U.S. Market Dollar Volume of NAT STD Testing, 2000-2009 88
Table 3.38: Global Market for Chlamydia Diagnostic Testing, 2000-2009 88
Table 3.39: U.S. Market for Chlamydia Diagnostic Testing, 2000-2009 88
Table 3.40: Global Market for Gonorrhea Diagnostic Testing, 2000-2008 89
Table 3.41: Global Market for TB Diagnostic Testing, 2000-2008 89
Table 3.42: Global Market for DNA Group B Streptococcus Diagnostic Testing, 2000-2009 89
Table 3.43: U.S. Market for DNA Group B Streptococcus Diagnostic Testing, 2000-2009 90
Table 3.44: Gen-Probe Clinical Diagnostic Products for the Detection of Non-Viral Micro-Organisms 91
Table 3.45: Global Revenue and Forecast for Blood-Screening Market, 2000-2015 99
Table 3.46: U.S. Market and Forecast for Blood-Screening Market, 2000-2015 99
Table 3.47: Drivers of the Genetic Analysis Market 103
Table 3.48: Leading Players in the SNP Genotyping Space 104
Table 3.49: Global Market for SNP and Genotyping, 2009-2015 104
Table 3.50: Instrumentation 105
Table 3.51 Consumables 106
Table 3.52: DNA Analysis Market Competitors 110
Table 3.53: Leading Companies in Medical Utility of SNPs 111
Table 3.54: Competitors in the Field of Identity, Family and Paternity Testing 112
Table 3.55: Competitors in the Field of Forensic Testing 112
Table 3.56: U.S. Market for Food-Screening Diagnostic Testing Using MD Techniques, 2000-2015 114
Table 3.57: Molecular Diagnostics Methods for Detection of Salmonella in Food 115
Table 3.58: U.S. Market for Forensic Diagnostics Testing, 2000-2015 116
Table 3.59: Barriers for Biologics Warfare Monitoring Systems 119
Table 3.60: U.S. Market for Biological Threat Detection Testing, 2000-2010 121
Table 3.61: Technical Problems for PCR Assays for Pathogen Genotyping and Detection 121
Table 3.62: Variation of CF Carrier Risks by Ethnic Group 133
Table 3.63: Reasons for CF Testing 133
Table 3.64: Variation of CF Detection Rates by Ethnic Background 133
Table 3.65: Global Market for CF Diagnostic Testing, 2000-2008 133
Table 3.66: U.S. Market for CF Diagnostic Testing, 2000-2008 134
Table 3.67: Projected Global Market for CF Diagnostic Testing, 2009-2013 134
Table 3.68: Projected U.S. Market for CF Diagnostic Testing, 2009-2013 134
Table 3.69: Commercial CF-Screening Products 134
Table 3.70: CF Screening Technology Summary 135
Table 3.71: U.S. Market for HLA Type Testing, 2000-2009 137
Table 3.72: Competitors in HLA Testing 138
Table 3.73: Carrier Rates of Common HFE Mutations in Caucasians 139
Table 3.74: Results and Diagnosis for Fragile X Syndrome 141
Table 3.75: Other Genetic Testing Procedures by Molecular Diagnostics 143
Table 3.76: DNA Chip Market Drivers and Restraints 144
Table 3.77: DNA Chip Major Players 144
Table 3.78: Applications of DNA Biochips 145
Table 3.79: Technology Trends in the DNA Microarray Market 147
Table 3.80: Global Revenue Forecasts for Prenatal and Newborn Testing Segment, 2007-2015 153
Table 4.1: DNA-Sequencing Molecular Diagnostics Market Players 157
Table 4.2: U.S. Market for DNA Chips, 2000-2015 158
Table 6.1: Limitations of Nucleic Acid Chip Probes 193
Table 6.2: Companies Licensed to Sell Custom Molecular Beacon Probes 198
Table 6.3: U.S. Sample Preparation Market, 2005-2012 201
Table 7.1: Products Marketed by Abbott in the Diagnostics Market 207
Table 7.2: Roche Diagnostics Key Products 246
Table 7.3: Sales by Region 246
Table 7.4: Sales by Business Area 246
Table 7.5: Product Line Sales 247
Table 7.6: Growth Drivers 247
Table 8.1: Number of Molecular Diagnostics Tests in the U.S., 2008-2015 250
Table 8.2: Global Molecular Diagnostics Testing Revenues, 2000-2015 254
Table 8.3: Global Distribution of Molecular Diagnostics Testing, 2009 254
Table 8.4: U.S. Molecular Diagnostics Testing Market, 2004-2015 256
Table 8.5: European Molecular Diagnostics Testing Market, 2005-2015 256
Table 8.6: Japanese Molecular Diagnostics Testing Market, 2005-2015 257
Table 8.7: Molecular Diagnostics Market: Strategic Recommendations on MD Sector Business Functions 267
Table 8.8: Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact 267
Table 8.9: Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact 267
Table 8.10: Large General Diagnostic Lab Services 267
Table 8.11: Small Specialized Diagnostic Lab Services 268
Table 8.12: MDx Sector Leaders 268
Table 8.13: Point-of-Care MDx Leaders 268
Table 8.14: Pure Play MDx Companies 268
Table 8.15: Array Platforms 269

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