Molecular Diagnostics Markets

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Publication Date: 2008-09-02

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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

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

By Purchasing This Report You Will Have:

This report will cover the following molecular diagnostics technologies:

Analysis includes the use of charts and graphs measuring product growth and trends within the marketplace. In addition, a discussion of research into the molecular diagnostics arena provides the reader with a deeper understanding of the possibilities for future treatment and avenues for possible research and development budgets. Company-specific information, including sales figures, product pipeline status and research and development trends is provided throughout the report.

The report will:

This report answers the following questions:

Table of Contents

 

  • Appendix 1: Biowarfare Agents269


  • LIST OF FIGURES

  • Figure 2.1: Segment of Double-Stranded DNA Showing the Base-Pair Relationship16
  • Figure 3.1: Applications of Molecular Diagnostics Technology Platforms30
  • Figure 3.2: Overall Structure of Nucleic Acid Testing Market32
  • Figure 3.3: Applications of Key Players and Market Share in Molecular Diagnostics Testing Markets35
  • Figure 3.4: Serologic and Clinical Course of Acute HBV Infection56
  • Figure 3.5: Primary Causes of Chronic Liver Disease58
  • Figure 3.6: Combination Therapy in Typical HCV Infection59
  • Figure 3.7: Time Course of Markers in Typical HCV Infection60
  • Figure 3.8: Bacillus anthracis109
  • Figure 8.1: Molecular Diagnostics Market Segmentation261
  • Figure 8.2: Molecular Diagnostics Market Segmentation by Technology262
  • Figure 8.3: Breakout of the Molecular Diagnostics Marketplace264
  • Figure 8.4: U.S. Molecular Diagnostics Market Segments 2007265


  • LIST OF TABLES

  • Table 3.1: Global Market for Molecular Diagnostics Testing, 2000 to 201233
  • Table 3.2: U.S. Market for Molecular Diagnostics Testing, 2004 to 201233
  • Table 3.3: Global Market for Nucleic Acid Testing, 2000 to 201234
  • Table 3.4: Summary of Molecular Diagnostics Testing34
  • Table 3.5: Share of Molecular Diagnostics Testing by Testing Type35
  • Table 3.6: Key Players and Market Share in Molecular Diagnostics Testing Market35
  • Table 3.7: Annual U.S. Market for DNA Probe Diagnostics, 1998 to 201236
  • Table 3.8: Annual Global Market for DNA Probe Diagnostics, 1998 to 200936
  • Table 3.9: Estimated Market Share of Major Competitors in U.S. DNA/PCR Kit Research Market38
  • Table 3.10: Estimated Market Share of Major Competitors in U.S. DNA/PCR Kit Diagnostics Market38
  • Table 3.11: Roche PCR Licenses38
  • Table 3.12: DNA Probe Market Segments in the U.S.39
  • Table 3.13: Companies Marketing Products Using DNA Probes41
  • Table 3.14: Companies Marketing Multiple Products in Molecular Diagnostics Sector41
  • Table 3.15: Global Sales of DNA Probe Kits, 1998 to 200542
  • Table 3.16: Companies Marketing DNA Detection Platforms42
  • Table 3.17: Companies Marketing Genotyping Technologies45
  • Table 3.18: Companies Marketing Clinical Genotyping Technologies46
  • Table 3.19: Summary of Assays for HIV Viral Load Testing52
  • Table 3.20: Global Market for HIV Diagnostic Testing, 2000 to 201254
  • Table 3.21: U.S. Market for HIV Diagnostic Testing, 2000 to 201254
  • Table 3.22: Serologic Diagnosis of HBV Infections*56
  • Table 3.23: Unusual HBV Serologic Profiles Requiring Further Evaluation57
  • Table 3.24: Recommendations for HBV Diagnostic Testing57
  • Table 3.25: Lower Detection Limits of HBV DNA Assays57
  • Table 3.26: Recommendations for HCV Diagnostic Testing61
  • Table 3.27: Important HCV Statistics61
  • Table 3.28: Global Market for HAV Diagnostic Testing, 2000 to 200863
  • Table 3.29: U.S. Market for HAV Diagnostic Testing, 2000 to 200864
  • Table 3.30: Global Market for HBV Diagnostic Testing, 2000 to 200864
  • Table 3.31: U.S. Market for HBV Diagnostic Testing, 2000 to 200864
  • Table 3.32: Global Market for HCV Diagnostic Testing, 2000 to 200864
  • Table 3.33: U.S. Market for HCV Diagnostic Testing, 2000 to 200865
  • Table 3.34: Global Market for SARS Diagnostics Testing, 2002 to 200866
  • Table 3.35: U.S. Market for SARS Diagnostics Testing, 2002 to 200866
  • Table 3.36: Global Market for Molecular Diagnostics Cancer Testing, 2000 to 200869
  • Table 3.37: Annual Volume of NAT Infectious Disease Testing, 2000 to 200873
  • Table 3.39: Global Market Dollar Volume of NAT STD Testing, 2000 to 200873
  • Table 3.39: U.S. Market Dollar Volume of NAT STD Testing, 2000 to 200973
  • Table 3.40: U.S. Market Share of NAT STD Testing74
  • Table 3.41: Global Market for Chlamydia Diagnostic Testing, 2000 to 200974
  • Table 3.42: U.S. Market for Chlamydia Diagnostic Testing, 2000 to 200974
  • Table 3.43: Global Market for Gonorrhea Diagnostic Testing, 2000 to 200874
  • Table 3.44: Global Market for TB Diagnostic Testing, 2000 to 200875
  • Table 3.45: Global Market for DNA Group B Streptococcus Diagnostic Testing, 2000 to 200975
  • Table 3.46: U.S. Market for Group B Streptococcus Diagnostic Testing, 2000 to 200975
  • Table 3.47: Gen-Probe Clinical Diagnostic Products for the Detection of Non-Viral Micro-organisms77
  • Table 3.48: Global Market for Blood-Screening Diagnostic Testing, 2000 to 200881
  • Table 3.49: U.S. Market for Blood-Screening Diagnostic Testing, 2000 to 200881
  • Table 3.50: Leading Players in SNP Genotyping85
  • Table 3.51: Global Market for SNP Genotyping, 2000 to 201185
  • Table 3.52: DNA-Analysis Market Competitors88
  • Table 3.53: Leading Companies in Medical Utility of SNPs88
  • Table 3.54: Competitors in the Field of Identity Genomics Testing89
  • Table 3.55: U.S. Market for Food-Screening Diagnostic Testing Using Molecular Diagnostics Techniques, 2000 to 200891
  • Table 3.56: Methods for Detection of Salmonella in Food Using Molecular Diagnostics Methods92
  • Table 3.57: U.S. Market for Forensic Diagnostics Testing, 2000 to 201094
  • Table 3.58: U.S. Market for Biological Threat Detection Testing, 2000 to 201098
  • Table 3.59: Biotest Reagents101
  • Table 3.60: Variation of CF Carrier Risks by Ethnic Group112
  • Table 3.61: Reasons for CF Testing112
  • Table 3.62: Variation of CF Detection Rates by Ethnic Background112
  • Table 3.63: Global Market for CF Diagnostic Testing, 2000 to 2008112
  • Table 3.64: U.S. Market for CF Diagnostic Testing, 2000 to 2008112
  • Table 3.65: Commercial CF-Screening Products113
  • Table 3.66: Emerging CF-Screening Products113
  • Table 3.67: CF Screening Technology Summary113
  • Table 3.68: U.S. Market for HLA Type Testing, 2000 to 2008114
  • Table 3.69: Competitors in HLA Testing115
  • Table 3.70: U.S. Market for NAT Genetic-Disease Testing, 2000 to 2008116
  • Table 3.71: Non-U.S. Market for NAT Genetic-Disease Testing, 2000 to 2008116
  • Table 3.72: U.S. Market for NAT Cytogenetic-Disease Testing, 2000 to 2008116
  • Table 3.73: Non-U.S. Market for NAT Cytogenetic-Disease Testing, 2000 to 2008116
  • Table 3.74: Carrier Rates of Common HFE Mutations in Caucasians117
  • Table 3.75: Results and Diagnosis for Fragile X Syndrome118
  • Table 3.76: Principal Competitors in Pharmacogenetics R&D for Personalized Medicine122
  • Table 3.77: Principal Competitors in Pharmacogenetics Patient Testing122
  • Table 4.1: DNA-Sequencing Market Players129
  • Table 4.2: Global Market for DNA Chips, 2000 to 2007129
  • Table 4.3: Top Ten Companies for Molecular Diagnostics Patents147
  • Table 6.1: Companies Licensed to Sell Custom Molecular Beacon Probes167
  • Table 6.2: U.S. Sample Preparation Market, 2005 to 2012170
  • Table 7.1: Products Marketed by Abbott in the Diagnostics Market174
  • Table 7.2: Summary of Selected Affymetrix Expression-Profiling Customers178
  • Table 7.3: PACE Product Sales as a Percentage of Total Company Revenue, 2000 to 2005213
  • Table 7.4: Innogenetics HLA Products for Genetic Testing and Transplantation222
  • Table 7.5: Nanogen Product Sales, 2000 to 2006234
  • Table 7.6: Rarely-Expressed Genes as Therapeutic Product Candidates238
  • Table 7.7: Roche Diagnostics Key Products251
  • Table 7.8: Sales by Region251
  • Table 7.9: Sales by Business Area252
  • Table 7.10: Product Line Sales 2005252
  • Table 7.11: Growth Drivers252
  • Table 8.1: Number of Molecular Diagnostics Tests in the U.S., 2000 to 2008261
  • Table 8.2: Global Molecular Diagnostics Testing Revenues, 2000 to 2012264
  • Table 8.3: Global Distribution of Molecular Diagnostics Testing264
  • Table 8.4: U.S. Molecular Diagnostics Testing Market, 2004 to 2012266
  • Table 8.5: European Molecular Diagnostics Testing Market, 2005 to 2012266
  • Table 8.6: Japanese Molecular Diagnostics Testing Market, 2005 to 2012267

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