This TriMark Publications 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.

1. Molecular Diagnostics Markets
Published: July 2011
No. of Pages: 335
Price: $3400
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 TriMark Publications 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
1.1 Statement of Report
1.2 About This Report
1.3 Scope of the Report
1.4 Objectives
1.5 Methodology
1.6 Executive Summary
2. Introduction to Molecular Diagnostics and PCR Technology
2.1 Introduction to Genomics and Its Opportunity
2.2 Impact of the Human Genome Project on Molecular Diagnostics
2.3 Key Considerations for Molecular Diagnostics
2.4 Molecular Diagnostics in the Post-Genomic Era
2.5 Advances in Molecular Diagnostics Technologies
2.6 Genetic Variability and Disease

2. 2.7 Major Technology Platforms
2.7.1 Gene-based Amplification Technologies
2.7.2 Detection of Amplified Gene Products
2.7.3 Target-based Gene Amplification
2.7.3.1 Polymerase Chain Reaction (PCR)
2.7.3.2 Real-Time PCR
2.7.3.3 Nucleic Acid Sequence-based Amplification (NASBA)
2.7.4 Probe-based Amplification
2.7.4.1 Ligase Chain Reaction (LCR)
2.7.4.2 Strand Displacement Amplification (SDA)
2.7.4.3 QB-Replicase Amplified Probe Assay
2.7.5 Signal-based Amplification
2.7.5.1 Branched DNA (bDNA)
2.7.6 Other Gene Amplification Technologies
2.7.6.1 Immuno-PCR (IPCR)
2.7.6.2 Bio-Barcode Amplification Assay (BCA)
2.7.6.3 Hybrid Capture
2.7.7 Next Generation Sequencing
2.8 PCR Reagents for Clinical Diagnostics
3. Nucleic Acid Test Applications
3.1 Molecular Diagnostic Testing and Infectious Diseases
3.1.1 Genomics Molecular Diagnostics Market
3.1.1.1 Methods for DNA Detection and Gene Sequencing
3.1.1.2 Products and Applications
3.1.1.3 Oncology
3.1.2 SNPs and Genes: Medical Utility (Clinical Applications)
3.1.2.1 Clinical Application Initiatives
3.1.2.2 Sampling of Affymetrix's Clinical Application Collaborations
3.2 Infectious Disease Testing Using Molecular Diagnostics
3.2.1 HIV
3.2.2 Hepatitis Serologic Markers and Nucleic Acid Testing
3.2.2.1 Hepatitis A Virus (HAV)
3.2.2.2 Hepatitis B Virus (HBV)
3.2.2.2.1 Hepatitis B Market Size
3.2.2.3 Hepatitis C Virus (HCV)
3.2.2.4 Hepatitis D Virus (HDV)
3.2.2.5 Hepatitis E Virus (HEV)
3.2.3 Human Papillomavirus (HPV)
3.2.4 Influenza Viruses
3.2.4.1 H5N1 Influenza Virus
3.2.4.2 H1N1 Influenza Virus
3.2.5 Cancer Detection Using Molecular Diagnostics
3.2.5.1 Lung Cancer
3.2.5.2 Oral Cancer
3.2.5.3 Prostate Cancer
3.2.5.3.1 PCA3
3.2.5.3.2 Companies Active in Molecular Diagnostics and Prostate Cancer Analysis
3.2.5.4 Chronic Myelogenous Leukemia
3.2.5.5 Malignant Gliomas

3. 3.2.5.6 Colorectal Cancer
3.2.5.6.1 Background on KRAS Mutation
3.2.5.7 Breast Cancer
3.2.5.8 Bladder Cancer
3.2.5.9 Ovarian Cancer
3.2.5.10 Molecular Diagnostic Screening Test for Cancer
3.2.5.11 Cervical Cancer
3.2.6 Microbiology Testing Using Molecular Diagnostics
3.2.6.1 Chlamydia
3.2.6.1.1 Revenue Forecasts
3.2.6.2 Gonorrhea
3.2.6.3 Tuberculosis (TB)
3.2.6.4 Group B Streptococcus (GBS)
3.2.6.5 Bordetella pertussis
3.2.6.6 Legionella pneumophila
3.2.6.7 Periodontal Bacteria
3.2.6.8 Pneumocystis carinii
3.2.6.9 Methicillin-resistant Staphylococcus Aureus (MRSA)
3.2.6.10 Clostridium difficile
3.2.6.11 Vancomycin-resistant Enterococci (VRE)
3.2.6.12 Fungal Infections
3.2.6.13 Herpes
3.2.6.14 Other Infectious Diseases
3.2.7 Blood Screening Using Molecular Diagnostics
3.2.7.1 Blood Screening Competitive Positions
3.3 Genetics Testing in Molecular Diagnostics
3.3.1 Functional Genomics
3.3.2 Genetic and Paternity Testing
3.4 Molecular Diagnostics Uses in Industrial Testing and Food Diagnostics
3.4.1 The Market
3.4.2 Detection of Helicobacter pylori by PCR
3.4.3 Detection of Escherichia coli 0157
3.4.4 Detection of Enteric Viruses
3.4.5 Industrial Microorganisms
3.5 Molecular Diagnostics Forensics Testing Market
3.5.1 Analysis by PCR-based DNA Typing
3.5.2 Rapid Isolation of DNA for Restriction Fragment Length Polymorphism (RFLP)and PCR
3.5.3 DNA for PCR-STR Typing
3.6 Bioterrorism and Molecular Diagnostics
3.6.1 Introduction
3.6.1.1 Current Biological Threat Detection Systems
3.6.1.2 Use of DNA Microarrays and Biochips for Gene Expression Profiles in BWAs
3.6.1.3 Advantages and Disadvantages of Host Gene Expression Profiling as a Biothreat
Detection
3.6.2 Biological Warfare Agents (BWAs)
3.6.2.1 Anthrax
3.6.2.2 Botulinum Toxin
3.6.2.3 Ricin
3.6.2.4 IVD Industry and Bioterrorism Preparedness
3.6.2.4.1 Brucellosis

4. 3.6.2.4.2 Cholera
3.6.2.5 Rapid Lateral Flow Immunoassays
3.6.2.6 Biosensors
3.6.3 Anthrax in Clinical Samples
3.6.3.1 Overview of Anthrax and its Infectivity
3.6.3.2 Rapid Tests
3.7 Cystic Fibrosis Testing
3.8 Human Leukocyte Antigen (HLA) Sequencing-based Typing Kits
3.8.1 Transplantation of Tissues
3.9 Molecular Cytogenetic Testing
3.9.1 Hereditary Hemochromatosis
3.9.2 Apolipoprotein E (ApoE) Genotyping
3.9.3 Fragile X Syndrome (FXS)
3.9.4 Methylenetetrahydrofolate Reductase (MTHFR) Carrier Testing
3.9 5 Other Genetic Testing Procedures
3.10 Developments in DNA Biochips for Clinical Applications
3.10.1 Product Analysis
3.10.2 Breast Cancer DNA Arrays
3.10.3 eSensor DNA Detection System
3.11 Personalized Medicine, Pharmacogenomics and Molecular Diagnostics Testing
3.11.1 Coumadin (Warfarin)
3.12 Thrombic Disorders
3.13 Respiratory Virus Panel
3.14 HFE (Hemochromatosis)
3.15 Lupus
3.16 Down's Syndrome and Prenatal Screening
3.17 Molecular Diagnostics Technology Platforms and their Impact on Personalized Medicine
4. Trends in Molecular Diagnostics
4.1 Pharmacogenomics
4.1.1 The Market
4.1.1.1 Oncology
4.1.1.2 Toxicogenomics
4.1.2 Market Influences and Forecast
4.2 DNA Microarrays
4.2.1 Techniques
4.2.2 The Market
4.2.3 Identification of Sequence SNPs
4.2.4 Determining Gene Expression Levels
4.2.4.1 Hybridization Tests
4.2.4.2 Oligonucleotide Probes
4.2.5 Molecular Diagnostics Entry into Point-of-Care (POC) Testing
4.3 Emerging Markets of DNA Arrays
4.3.1 Pharmacogenomics
4.3.2 Adoption of Amplified Screening Technology
4.3.3 Advances in Automated Testing
4.3.4 Increased Focus on Safety of Blood Supply
4.3.5 Development of Emerging Markets for NAT Technology
4.3.6 Cancer
4.3.7 Human Leukocyte Antigen (HLA) Typing

5. 4.3.8 Neonatal Screening
4.4 Drivers and Restraints
4.5 Market Forecast
4.6 Business Trends in the Industry
4.6.1 Molecular Diagnostics Industry Trends
4.6.1.1 Adoption of Amplified Screening Technology
4.6.1.2 Advances in Automated Testing
4.6.1.3 Responsiveness to Newly Emerging Threats
4.6.1.4 Increased Focus on Safety of Blood Supply
4.6.1.5 Growth in Viral Load Testing
4.6.1.6 Development of Emerging Markets for NAT Technology
4.6.1.7 Improvements in Detection Technologies
4.6.1.8 Use of Multiplex PCR Tests
4.6.2 Pharmaceutical Industry Trends
4.6.3 Acquisitions, License Agreements and Partnerships
4.6.4 Ethical, Legal and Social Issues Related to the Use of Genetic Information
4.6.5 Regulatory Issues
4.6.5.1 U.S. Food and Drug Administration
4.6.5.2 CLIA Regulations
4.6.5.3 Clinical Laboratory Improvement Act (CLIA)
4.6.5.4 State Licensing for Service Laboratories
4.6.5.5 Multivariate Index Assays (IVDMIAs)
4.6.5.6 510(k) Clearance
4.6.5.6.1 Pre-Market Approval (PMA)
4.6.5.7 PMAs
4.6.5.8 ASRs
4.6.5.9 Laboratory Developed Tests
4.6.5.10 What Regulatory Guidance is needed for Companion Biomarkers?
4.6.5.11 U.S. Patent and Trademark Office (USPTO)
4.6.5.12 IRB Approval in Clinical Trials
4.6.5.13 CE marking and the IVDD (European In Vitro Diagnostic Device Directive)
4.6.5.14 De Novo Classification
4.6.5.15 Research Use Only Reagents
4.6.6 Reimbursement Issues and Billing Landscape for Molecular Diagnostics Testing
4.6.6.1 Cystic Fibrosis
4.6.6.2 Viral Load Testing
4.6.6.3 NMP22
4.6.6.4 Trends in Reimbursement Practice
4.6.6.5 Medicare Reimbursement Threats
4.7 Patent Protection and Intellectual Property Rights
4.7.1 New Patents
4.7.2 BRCA1 and BRCA2 Gene Patents
4.7.3 Current Patent Disputes
4.8 Micoarray Quality Control (MAQC)
5. Molecular Diagnostics Automated Instrumentation Approved for Market by the
FDA
5.1 Gene Expression Profiling
5.2 Proteomic Multiplex Assays
5.3 Solution-Phase Multiplexing

6. 5.4 RNA Interference (RNAi)
5.4.1 Role of RNAi in Drug Target Validation
5.4.2 Other Companies involved in the RNAi Market
5.5 DNA Tags
5.6 Follow-on Optical Technologies
6. Market Trends and Forecasts
6.1 Market Dynamics
6.1.1 Molecular Diagnostics Market Opportunities
6.1.2 Market Forces
6.2 Future Considerations for Molecular Diagnosis
6.3 Role of Genomics in Transforming Pharmaceutical R&D
6.4 Cancer Markers
6.5 Cytology Markers
6.6 RNA Detection
6.7 Diagnosis of Inherited Disease
6.8 Ethical Considerations
6.9 NAT and Personalized Medicine
6.10 Five Molecular Diagnostics Growth Areas
6.11 Specific Commercial Nucleic Acid Probes
6.12 Novel Amplification Techniques in the Market
6.13 Ramification Amplification Method (RAM)
6.14 Invader Assays/Third Wave Technologies (Hologic)
6.15 Molecular Beacons
6.16 Human Leukocyte Antigen (HLA) Sequencing-based Typing Kits
6.17 Prenatal Diagnosis
6.18 Newborn Screening
6.19 NAT and Preventive Medicine: NAT-based Assays
6.20 Prenatal and Pre-Implantation Diagnosis
6.21 FISH-based Tests on Fetal Cells
6.22 Companion Therapeutic/Diagnostic Approach
6.23 Sample Preparation Market
6.24 Emerging Amplification Techniques
6.24.1 Gold Nanoparticle Molecular Probes
6.24.2 Real-Time Microfluidic PCR Using Magnetic Affinity Beads
6.25 ASRs (Analyte-Specific Reagents)
7. Company Profiles
7.1 Abbott Laboratories
7.2 Adnavance Technologies, Inc.
7.3 AdvanDx
7.4 Agendia
7.5 Agilent Technologies
7.6 Asuragen
7.7 Ambry Genetics
7.8 American Diagnostica
7.9 Applied Biosystems, Inc. (now Life Technologies)
7.10 ARCA biopharma
7.11 ArcticDx, Inc.
7.12 Arcxis Biotechnologies

7. 7.13 Atlas Genetics
7.14 Aureon Laboratories
7.15 AutoGenomics, Inc.
7.16 Beckman Coulter, Inc.
7.17 Becton, Dickinson and Company
7.18 BG Medicine
7.19 Biocartis
7.20 BioGenex Laboratories, Inc.
7.21 Biohelix Corporation
7.22 bioMerieux
7.23 Bio-Rad Laboratories
7.24 Biotage AB
7.25 Biotest AG
7.26 Caliper Life Sciences, Inc.
7.27 Celera
7.28 Cepheid
7.29 CombiMatrix Corporation
7.30 Cytocell Technologies Ltd.
7.31 CytoCore, Inc.
7.32 DiagnoCure, Inc.
7.33 DxS (Acquired by QIAGEN)
7.34 Enzo Biochem
7.35 Epigenomics
7.36 EraGen Biosciences
7.37 Eurogentec
7.38 EXACT Sciences Corporation
7.39 Exiqon A/S
7.40 GeneOhm Sciences
7.41 Genera Biosystems
7.42 Genzyme Corporation
7.43 GenMark Diagnostics, Inc.
7.44 Genomix Biotech
7.45 Gen-Probe
7.46 Gene Express
7.47 Genomica
7.48 Hologic
7.49 Illumina, Inc.
7.50 Innogenetics NV
7.51 Invitrogen (Life Technologies)
7.52 Life Technologies
7.53 Luminex
7.54 Inverness Medical Innovations
7.55 Monogram Biosciences, Inc.
7.56 Myconostica
7.57 Nanogen
7.58 Nanosphere
7.59 NorDiag ASA
7.60 PharMingen
7.61 QIAGEN N.V.
7.62 Roche Diagnostics

8. 7.63 SABiosciences Corporation
7.64 Seegene
7.65 Siemens Healthcare Diagnostics (Siemens)
7.66 SIRS-Lab
7.67 Source MDx
7.68 Targeted Molecular Diagnostics
7.69 Thermo Fisher Scientific
7.70 Thorne Diagnostics
7.71 TrimGen
7.72 TrovaGene
7.73 U.S. Genomics, Inc.
7.74 Veredus Laboratories
7.75 Veridex
8. Market Overview
8.1 Snapshot of Molecular Diagnostics Industry Structure
8.2 Global Molecular Diagnostics Testing Market
8.3 U.S. Molecular Diagnostics Testing Market
8.4 European Molecular Diagnostics Market
8.5 Japanese Molecular Diagnostics Testing Market
8.6 Overview of the European Molecular Diagnostics Country Markets
8.6.1 France
8.6.2 Germany
8.6.3 U.K.
8.6.4 Italy
8.6.5 Spain
8.7 Strategic Assessment and Business Development in the Molecular Diagnostics Sector
8.7.1 Industry Background
8.7.2 Competition
8.7.3 Business Strategy
8.7.4 Corporate Examples
8.7.4.1 Gen-Probe
8.7.4.2 Osmetech
8.7.4.3 Combimatrix
8.7.4.4 Sekisui Chemical Co. Ltd.
8.7.4.5 Myriad Genetics
8.7.4.6 Luminex
8.7.5 IVD Manufacturers' Goals in Detection Technology Development
8.7.5.1 New Developments in Molecular Diagnostic Markers are driven by Corporate Joint
Ventures
8.7.5.2 Factors for Growth in Molecular Diagnostics
8.7.5.3 How has the IVD Industry Changed?
8.7.5.4 What are the Challenges for the Future?
8.7.5.5 What New Trends are in the Future?
8.7.5.5.1 Market and Technology Trends
8.7.5.5.1.1 Market Trends
8.7.5.5.1.2 Technology Trends
8.7.5.5.1.3 Strategic Recommendations
LIST OF FIGURES

9. Figure 2.1: Segment of Double-stranded DNA Showing the Base-Pair Relationship
Figure 3.1: Overall Structure of Nucleic Acid Testing Market
Figure 3.2: Global Market for Molecular Diagnostics Testing, 2010
Figure 3.3: Share of Molecular Diagnostics Testing by Testing Type, 2009
Figure 3.4: Key Players Market Share in Global Molecular Diagnostics Testing Markets
Figure 3.5: Revenue Mix from BioChips
Figure 3.6: Global Revenue Forecast for Molecular Diagnostics Testing for Infectious
Disease, 2009-2016
Figure 3.7: Global Market Revenue Share Forecasts for Molecular Diagnostics Infectious
Disease Testing Markets by Region, 2009 and 2016
Figure 3.8: Forecast for Total Global Infectious Disease Molecular Diagnostics Markets, 2016
Figure 3.9: Forecast for Total U.S. Infectious Disease Molecular Diagnostics Markets, 2016
Figure 3.10: Key Players Market Share in Global Molecular Diagnostics Infectious Disease
Testing Markets
Figure 3.11: Estimated Market Forecast for Global HIV Molecular Diagnostic Testing, 2011-
2016
Figure 3.12: Markers of Acute HBV Infection as a Function of Time after Exposure to
Infection
Figure 3.13: Primary Causes of Chronic Liver Disease
Figure 3.14: Markers of Acute HCV Infection as a Function of Time after Exposure to
Infection
Figure 3.15: U.S. Market Share for Molecular Diagnostic HPV Testing, 2010
Figure 3.16: Analysis of Cancer Tissue by Microarray
Figure 3.17: Number of Genomic Health Oncotype DX Tests Performed, 1991-2006
Figure 3.18: U.S. Total Infectious Disease Molecular Diagnostics Markets, 2009
Figure 3.19: Estimated Market for Global Blood Screening Product Sales, 2007-2016
Figure 3.20: Blood Screening Market Share, 2010
Figure 3.21: Bacillus anthracis
Figure 4.1: Reimbursement for Diagnostics in Healthcare Decision Making
Figure 7.1: Gen-Probe Projected R&D Expenditures
Figure 8.1: Molecular Diagnostics Market Segmentation by Testing Type
Figure 8.2: Molecular Diagnostics Market Segmentation by Technology
Figure 8.3: Global Market for Molecular Diagnostics, 2002-2016
Figure 8.4: Global Distribution of Molecular Diagnostics Testing by Geographic Region, 2010
LIST OF TABLES
Table 2.1: Key Assay Technologies for Molecular Diagnostics
Table 2.2: Emerging Molecular Diagnostic Technologies
Table 2.3: Companies involved in Next Generation Sequencing Technology
Table 3.1: Applications of Molecular Diagnostics Technology Platforms
Table 3.2: Global Market for Molecular Diagnostics Testing, 2000-2016
Table 3.3: U.S. Market for Molecular Diagnostics Testing, 2004-2016
Table 3.4: Summary of Molecular Diagnostics Testing Clinical Focus and Detection
Table 3.5: Share of Molecular Diagnostics Testing by Testing Type, 2009
Table 3.6: Key Players and Market Share in Global Molecular Diagnostics Testing Market
Table 3.7: Revenue Model for Molecular Diagnostics Testing
Table 3.8: Annual U.S. Market for DNA Probe Diagnostics, 1998-2012
Table 3.9: Annual Global Market for DNA Probe Diagnostics, 1998-2010

10. Table 3.10: Roche PCR Licenses
Table 3.11: Companies Marketing Products Using DNA Probes
Table 3.12: Companies Marketing Multiple Products in Molecular Diagnostics Sector
Table 3.13: Global Sales of DNA Probe Kits, 1998-2009
Table 3.14: Companies Marketing DNA Detection Platforms
Table 3.15: Companies Marketing Genotyping Technologies
Table 3.16: Companies Marketing Clinical Genotyping Technologies
Table 3.17: Global Revenues and Forecast for Molecular Diagnostics Testing for Infectious
Disease, 2009-2016
Table 3.18: Molecular Diagnostic Markets for Infectious Disease Testing, 2010
Table 3.19: Molecular Diagnostic Markets for Infectious Disease Testing, 2016
Table 3.20: Key Players and Market Share in Global Molecular Diagnostics Infectious
Disease Testing Market
Table 3.21: Commercially Available Molecular Diagnostic Products for HIV Assay
Table 3.22: Summary of Assays for HIV Viral Load Testing
Table 3.23: Global Market for Molecular Diagnostic HIV Testing, 2007-2010
Table 3.24: U.S. Market for HIV Molecular Diagnostic Testing, 2007-2010
Table 3.25: Global Market Forecast for Molecular Diagnostic HIV Diagnostic Testing, 2011-
2016
Table 3.26: U.S. Market Forecast for Molecular Diagnostic HIV Diagnostic Testing, 2011-
2016
Table 3.27: Markers for Diagnosis of HBV Infections
Table 3.28: Recommendations for HBV Diagnostic Testing
Table 3.29: Lower Detection Limits of HBV DNA Assays
Table 3.30: Summary of Molecular Diagnostic Assays for Testing HBV
Table 3.31: Global Market for HBV Diagnostic Testing, 2000-2010
Table 3.32: U.S. Market for HBV Diagnostic Testing, 2000-2010
Table 3.33: Global Market Forecast for HBV Diagnostic Testing, 2011-2016
Table 3.34: U.S. Market Forecast for HBV Diagnostic Testing, 2011-2016
Table 3.35: Recommendations for HCV Diagnostic Testing
Table 3.36: Important HCV Statistics
Table 3.37: Commercially Available Molecular Diagnostic Products for HCV Assay
Table 3.38: Global Market for DNA HCV Diagnostic Testing, 2005-2010
Table 3.39: U.S. Market for DNA HCV Diagnostic Testing, 2005-2010
Table 3.40: Global Market Forecast for NAT HCV Diagnostic Testing, 2011-2016
Table 3.41: U.S. Market Forecast for NAT HCV Diagnostic Testing, 2011-2016
Table 3.42: Global Market for DNA HAV Diagnostic Testing, 2000-2008
Table 3.43: U.S. Market for DNA HAV Diagnostic Testing, 2000-2008
Table 3.44: Global Market for DNA HBV Diagnostic Testing, 2000-2008
Table 3.45: U.S. Market for DNA HBV Diagnostic Testing, 2000-2008
Table 3.46: Global Market for DNA HCV Diagnostic Testing, 2000-2008
Table 3.47: U.S. Market for DNA HCV Diagnostic Testing, 2000-2008
Table 3.48: Commercially Available Molecular Diagnostic Products for HPV Assay
Table 3.49: Major Companies Marketing HPV Molecular Diagnostic Tests: Market Size and
Share, 2010
Table 3.50: Global Market for HPV Molecular Diagnostic Testing, 2007-2010
Table 3.51: U.S. Market for HPV Diagnostic Testing, 2007-2010
Table 3.52: Global Market Forecast for HPV Molecular Diagnostic Testing, 2011-2016
Table 3.53: U.S. Market Forecast for HPV Diagnostic Testing, 2011-2016
Table 3.54: Commercially Available Molecular Diagnostic Products for Influenza Assay

11. Table 3.55: Global Market for Molecular Influenza Diagnostic Testing, 2007-2010
Table 3.56: U.S. Market for DNA Influenza Diagnostic Testing, 2007-2010
Table 3.57: Global Market Forecast for Influenza Molecular Diagnostic Testing, 2010-2016
Table 3.58: U.S. Market Forecast for Influenza Molecular Diagnostic Testing, 2010-2016
Table 3.59: Global Market for Molecular Diagnostics Cancer Testing, 2008-2016
Table 3.60: Leading Segments of the Molecular Diagnostic Testing Market
Table 3.61: KRAS Assays by Analytical Type
Table 3.62: KRAS Mutation Assay from Exiqon Diagnostics
Table 3.63: Players in the Breast Cancer Molecular Diagnostic Space
Table 3.64: U.S. Molecular Diagnostic Markets for Infectious Disease Testing, 2009
Table 3.65: Commercially Available Molecular Diagnostic Products for Chlamydia Assay
Table 3.66: Global Market for Molecular Diagnostic Chlamydia/Gonorrhea Diagnostic
Testing, 2000-2010
Table 3.67: U.S. Market for Chlamydia/Gonorrhea Diagnostic Testing, 2000-2010
Table 3.68: Global Market Forecast for Chlamydia/Gonorrhea Diagnostic Testing, 2011-2016
Table 3.69: U.S. Market Forecast for Chlamydia/Gonorrhea Diagnostic Testing, 2010-2016
Table 3.70: CPT Code1 Description National Limitation Amount
Table 3.71: Global Market for MD TB Diagnostic Testing, 2005-2010
Table 3.72: U.S. Market for MD TB Diagnostic Testing, 2005-2010
Table 3.73: Global Market for DNA Group B Streptococcus Diagnostic Testing, 2000-2009
Table 3.74: U.S. Market for DNA Group B Streptococcus Diagnostic Testing, 2000-2009
Table 3.75: Gen-Probe Clinical Diagnostic Products for the Detection of Non-Viral Micro-
Organisms
Table 3.76: Commercially Available Molecular Diagnostic Products for MRSA Assay
Table 3.77: Global Market for MRSA Diagnostic Testing, 2005-2010
Table 3.78: U.S. Market for MRSA Diagnostic Testing, 2005-2010
Table 3.79: Global Market Forecast for MD MRSA Diagnostic Testing, 2011-2016
Table 3.80: U.S. Market Forecast for MD MRSA Diagnostic Testing, 2011-2016
Table 3.81: Commercially Available Molecular Diagnostic Products for VRE Assay
Table 3.82: Global Market for VRE Diagnostic Testing, 2005-2010
Table 3.83: U.S. Market for VRE Diagnostic Testing, 2005-2010
Table 3.84: Global Market Forecast for MD VRE Diagnostic Testing, 2011-2016
Table 3.85: U.S. Market for MD VRE Diagnostic Testing, 2011-2016
Table 3.86: Global Market for Blood Screening Product Sales, 2007-2016
Table 3.87: Blood Screening Molecular Diagnostics Market: Market Drivers Ranked in Order
of Impact
Table 3.88: Blood Screening Molecular Diagnostics Market: Market Restraints Ranked in
Order of Impact
Table 3.89: Drivers of the Genetic Analysis Market
Table 3.90: Leading Players in the SNP Genotyping Space
Table 3.91: Global Market for SNP and Genotyping, 2009-2015
Table 3.92: Instrumentation
Table 3.93: Consumables
Table 3.94: DNA Analysis Market Competitors
Table 3.95: Leading Companies in Medical Utility of SNPs
Table 3.96: Competitors in the Field of Identity, Family and Paternity Testing
Table 3.97: Competitors in the Field of Forensic Testing
Table 3.98: U.S. Market for Food-Screening Diagnostic Testing Using MD Techniques, 2000-
2016
Table 3.99: Molecular Diagnostics Methods for Detection of Salmonella in Food

12. Table 3.100: U.S. Market for Forensic Diagnostics Testing, 2000-2016
Table 3.101: Barriers for Biologics Warfare Monitoring Systems
Table 3.102: U.S. Market for Biological Threat Detection Testing, 2000-2010
Table 3.103: Technical Problems for PCR Assays for Pathogen Genotyping and Detection
Table 3.104: Biological Warfare Agents Identified by PCR Methods
Table 3.105: Companies Developing Detection Devices for Biological Warfare Agents
Table 3.106: Variation of CF Carrier Risks by Ethnic Group
Table 3.107: Reasons for CF Testing
Table 3.108: Variation of CF Detection Rates by Ethnic Background
Table 3.109: Global Market for CF Diagnostic Testing, 2000-2008
Table 3.110: U.S. Market for CF Diagnostic Testing, 2000-2008
Table 3.111: Projected Global Market for CF Diagnostic Testing, 2009-2013
Table 3.112: Projected U.S. Market for CF Diagnostic Testing, 2009-2013
Table 3.113: Commercial CF-Screening Products
Table 3.114: CF Screening Technology Summary
Table 3.115: U.S. Market for HLA Type Testing, 2000-2009
Table 3.116: Competitors in HLA Testing
Table 3.117: Carrier Rates of Common HFE Mutations in Caucasians
Table 3.118: Results and Diagnosis for Fragile X Syndrome
Table 3.119: Other Genetic Testing Procedures by Molecular Diagnostics
Table 3.120: DNA Chip Market Drivers and Restraints
Table 3.121: DNA Chip Major Players
Table 3.122: Applications of DNA Biochips
Table 3.123: Technology Trends in the DNA Microarray Market
Table 3.124: Molecular Diagnostic Personalized Medicine Tests
Table 3.125: Global Revenue Forecasts for Prenatal and Newborn Testing Segment, 2007-
2015
Table 3.126: Various Molecular Diagnostics Technologies: Timeline for Impact
Table 3.127: Various Molecular Diagnostics Technologies: Impact on Different Therapeutic
Areas in Personalized Medicine
Table 3.128: Various Molecular Diagnostics Technologies: Technical Challenges in the
Deployment for Personalized Medicine
Table 4.1: DNA-Sequencing Molecular Diagnostics Market Players
Table 4.2: U.S. Market for DNA Chips, 2000-2015
Table 4.3: Affymetrix DNA Analysis Products
Table 4.4: PCR Segmentation by Sector
Table 4.5: Impediments to Incorporating Promising Molecular Tests into Clinical Practice
Table 4.6: Largest Market Opportunities in PCR Testing
Table 4.7: PCR Real-Time Applications
Table 4.8: Advantages of Using Real-Time PCR
Table 4.9: Pharmaceutical Company Challenges
Table 4.10: Molecular Diagnostic Sector Acquisitions, Agreements and Partnerships
Table 4.11: Regulatory Rules that Affect the Ability of a Diagnostic Testing Reagent
Company to Conduct Business
Table 4.12: Strengths of the 510k Process
Table 4.13.: Focus Areas for the FDA Critical Path Initiative
Table 4.14: Medicare Pricing Methods
Table 4.15: Factors Affecting Third-Party Reimbursement for Molecular Diagnostic Tests
Table 4.16: Documents for Protecting Intellectual Property Rights
Table 4.17: Recent Patents Related to PCR, Nucleic Acid Amplification, and Sample Prep

13. Table 5.1: Molecular Diagnostic High-throughput Automated Testing Systems
Table 6.1: Five Molecular Diagnostics Growth Areas
Table 6.2: Limitations of Nucleic Acid Chip Probes
Table 6.3: Companies Licensed to Sell Custom Molecular Beacon Probes
Table 6.4: U.S. Sample Preparation Market, 2005-2012
Table 7.1: Products Marketed by Abbott in the Diagnostics Market
Table 7.2: Gen-Probe Key Acquisitions
Table 7.3: Roche Diagnostics Key Products
Table 7.4: Sales by Region
Table 7.5: Sales by Business Area
Table 7.6: Product Line Sales
Table 7.7: Growth Drivers
Table 8.1: Number of Molecular Diagnostics Tests in the U.S., 2008-2015
Table 8.2: Global Molecular Diagnostics Testing Revenues, 2000-2016
Table 8.3: Global Distribution of Molecular Diagnostics Testing by Geographic Region, 2010
Table 8.4: U.S. Molecular Diagnostics Testing Market, 2004-2016
Table 8.5: European Molecular Diagnostics Testing Market, 2005-2016
Table 8.6: Japanese Molecular Diagnostics Testing Market, 2005-2016
Table 8.7: Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact
Table 8.8: Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact
Table 8.9: Large General Diagnostic Lab Services
Table 8.10: Small Specialized Diagnostic Lab Services
Table 8.11: MDx Sector Leaders
Table 8.12: Point-of-Care MDx Leaders
Table 8.13: Pure Play MDx Companies
Table 8.14: Array Platforms
Table 8.15: Molecular Diagnostic Testing Market Trends
Table 8.16: Molecular Diagnostic Testing Technology Trends
Table 8.17: Molecular Diagnostics Market: Strategic Recommendations on MD Sector
Business Functions
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