Molecular Diagnostics in Infectious Disease Testing

NEW YORK, July 18, 2011 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Molecular Diagnostics in Infectious Disease Testing

http://www.reportlinker.com/p0368860/Molecular-Diagnostics-in-Infectious-Disease-Testing.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=In_Vitro_Diagnostic

This TriMark Publications report describes the specific segment of the in vitro diagnostics market known as molecular diagnostics testing for infectious disease. In the current medical diagnostics market, molecular diagnostics in infectious disease testing offers one of the most promising areas for growth and innovation. The confluence of breakthroughs in genomics and proteomics--along with the development of microarray devices to measure analytes in the blood--has led to this revolutionary market development. Specifically, molecular diagnostics offers the power of advanced analytical techniques to diagnose infectious diseases. Whereas before, the detection of many infectious agents was slow and expensive due to reliance upon culturing methods, researchers are now at the cusp of overcoming such limitations via the use of nucleic acid-mediated molecular diagnostics testing. The purpose of this report is to describe the emerging field of molecular diagnostics in infectious disease testing. The infectious disease space is the most dominant and profitable sector of molecular diagnostics. Topics covered in this study include: 1) the existing and emerging technologies in the field, 2) the U.S. and global market size for molecular diagnostic products and 3) the profiles of companies that are focusing on the molecular diagnostic sector. The research examines drivers and restraints for sales growth, market share and technical trends. In addition, an in-depth analysis of the competitive situation of prominent market venders is provided with five-year sales 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 for Infectious Disease Testing

2.1 Molecular Diagnostics Testing and Opportunities in the Infectious Disease Sector

2.2 The Infectious Disease Problem

2.3 Impact of the Human Genome Project on Molecular Diagnostics

2.4 Opportunities for Molecular and Clinical Diagnostics

2.4.1 Companion Diagnostics

2.5 Development of Molecular Diagnostics Testing Markets

2.6 Target-based Gene Amplification

2.6.1 Polymerase Chain Reaction (PCR)

2.6.2 Real-time PCR (RT-PCR)

2.6.3 Nucleic Acid Sequence-based Amplification (NASBA)

2.6.4 Market Drivers and Restraints

2.6.4.1 Market Drivers

2.6.4.2 Market Restraints

2.6.5 Market and Technology Trends

2.6.5.1 Market Trends

2.6.5 2 Technology Trends

2.6.6 Strategic Recommendations

2.7 PCR Reagents for Clinical Diagnostics

3. Infectious Disease Diagnostics Molecular Testing Market

3.1 Market Overview

3.1.1 Overall Infectious Disease Market Analysis

3.2 NAT Molecular Diagnostics Market

3.3 Infectious Disease Molecular Diagnostic Testing Markets

3.3.1 HIV

3.3.1.1 Disease Background and Statistics

3.3.1.2 Measuring Viral Loads

3.3.1.3 Instruments and MD Reagents

3.3.1.4 Method Comparisons

3.3.1.5 Market Size

3.3.1.5.1 HIV Diagnostic Testing

3.3.1.6 HIV Market Challenges and Strategic Recommendations

3.3.1.6.1 HIV Molecular Diagnostic Market History

3.3.1.7 Market Drivers and Restraints

3.3.1.7.1 Market Drivers

3.3.1.7.2 Market Restraints

3.3.1.8 Market and Technology Trends

3.3.1.8.1 Market Trends

3.3.1.8.2 Technology Trends

3.3.1.9 Strategic Recommendations

3.3.2 Hepatitis

3.3.2.1 Hepatitis B Virus

3.3.2.1.1 Hepatitis B Disease Background and Statistics

3.3.2.1.2 Instruments and Reagents for Hepatitis B Detection

3.3.2.1.3 Method Comparisons

3.3.2.1.4 Hepatitis B Market Size

3.3.2.1.5 HBV Market Challenges and Strategic Recommendations

3.3.2.1.5.1 Market Drivers and Restraints

3.3.2.1.5.1.1 Market Drivers

3.3.2.1.5.1.2 Market Restraints

3.3.2.1.6 Market and Technology Trends

3.3.2.1.6.1 Market Trends

3.3.2.1.6.2 Technology Trends

3.3.2.1.7 Strategic Recommendations

3.3.2.2 Hepatitis C Virus (HCV) Testing

3.3.2.2.1 Disease Background and Statistics

3.3.2.2.2 Instruments and Reagents for Hepatitis C Detection

3.3.2.2.3 Method Comparisons for HCV Tests

3.3.2.2.4 Hepatitis C Market Size

3.3.2.2.4.1 HCV Market Share

3.3.2.2.5 HCV Market Challenges and Strategic Recommendations

3.3.2.2.5.1 Market Drivers and Restraints

3.3.2.2.5.1.1 Market Drivers

3.3.2.2.5.1.2 Market Restraints

3.3.2.2.5.2 Market and Technology Trends

3.3.2.2.5.2.1 Market Trends

3.3.2.2.5.2.2 Technology Trends

3.3.2.2.6 Strategic Recommendations

3.3.3 Human Papillomavirus (HPV)

3.3.3.1 Disease Background and Statistics

3.3.3.2 Instruments and Reagents for HPV Detection

3.3.3.3 Method Comparison

3.3.3.4 HPV Market Size

3.3.3.4.1 North American Market

3.3.3.4.2 European Market

3.3.3.5 Market Challenges and Strategic Recommendations

3.3.3.5.1 Market Drivers and Restraints

3.3.3.5.1.1 Market Drivers

3.3.3.5.1.2 Market Restraints

3.3.3.5.2 Market and Technology Trends

3.3.3.5.2.1 Market Trends

3.3.3.5.2.2 Technology Trends

3.3.3.5.3 Strategic Recommendations

3.3.4 Influenza Viruses

3.3.4.1 Disease Background and Statistics

3.3.4.2 Instruments and Reagents for Influenza Detection

3.3.4.3 Method Comparisons

3.3.4.4 Influenza Market Size

3.3.4.5 Influenza Market Challenges and Strategic Recommendations

3.3.4.5.1 Market Drivers and Restraints

3.3.4.5.1.1 Market Drivers

3.3.4.5.1.2 Market Restraints

3.3.4.5.2 Market and Technology Trends

3.3.4.5.2.1 Market Trends

3.3.4.5.2.2 Technology Trends

3.3.4.5.3 Strategic Recommendations

3.3.5 STD Testing

3.3.5.1 Chlamydia

3.3.5.1.1 Disease Background and Description

3.3.5.1.2 Product Analysis: Instruments and Reagents for Testing Chlamydia

3.3.5.1.3 Method Comparison

3.3.5.1.4 Chlamydia/Gonorrhea Molecular Diagnostic Testing Market Size

3.3.5.1.5 Competitive Structure and Market Share Analysis

3.3.5.1.6 Market Forecasts

3.3.5.1.6.1 Revenue Forecasts

3.3.5.1.7 Market Forecasts

3.3.5.1.7.1 Revenue Forecasts

3.3.5.1.8 Market Challenges

3.3.5.1.8.1 Market Drivers

3.3.5.1.8.2 Market Restraints

3.3.5.1.9 Market and Technology Trends

3.3.5.1.9.1 Market Trends

3.3.5.1.9.2 Technology Trends

3.3.5.1.10 Strategic Recommendations

3.3.6 Gonorrhea

3.3.6.1 Disease Background and Description

3.3.6.2 Product Analysis: Instruments and Reagents

3.3.6.3 Method Comparison

3.3.6.4 Competitive Structure and Market Share Analysis

3.3.6.5 Market Forecasts

3.3.6.5.1 Revenue Forecasts

3.3.6.6 Market Challenges

3.3.6.6.1 Market Drivers

3.3.6.6.2 Market Restraints

3.3.6.7 Market and Technology Trends

3.3.6.7.1 Market Trends

3.3.6.7.2 Technology Trends

3.3.6.8 Strategic Recommendations

3.3.7 Tuberculosis (TB)

3.3.7.1 Disease Background and Description

3.3.7.2 Product Analysis: Instruments and Reagents

3.3.7.3 Method Comparison

3.3.7.4 Tuberculosis Market Size

3.3.7.5 Competitive Structure and Market Share Analysis

3.3.7.6 Market Forecasts

3.3.7.6.1 Revenue Forecasts

3.3.7.7 Market Challenges

3.3.7.7.1 Market Drivers

3.3.7.7.2 Market Restraints

3.3.7.8 Market and Technology Trends

3.3.7.8.1 Market Trends

3.3.7.8.2 Technology Trends

3.3.7.9 Strategic Recommendations

3.3.8 Methicillin-resistant Staphylococcus Aureus (MRSA)

3.3.8.1 Disease Background and Description

3.3.8.2 Product Analysis: Instruments and Reagents

3.3.8.3 Method Comparison

3.3.8.4 MRSA Market Size

3.3.8.5 Competitive Structure and Market Share Analysis

3.3.8.6 Market Forecasts

3.3.8.6.1 Revenue Forecasts

3.3.8.7 Market Challenges

3.3.8.7.1 Market Drivers

3.3.8.7.2 Market Restraints

3.3.8.8 Market and Technology Trends

3.3.8.8.1 Market Trends

3.3.8.8.2 Technology Trends

3.3.8.9 Strategic Recommendations

3.3.9 Vancomycin-resistant Enterococci (VRE)

3.3.9.1 Disease Background and Description

3.3.9.2 Product Analysis: Instruments and Reagents

3.3.9.3 Method Comparison

3.3.9.4 Competitive Structure and Market Share Analysis

3.3.9.5 Market Forecasts

3.3.9.5.1 Revenue Forecasts

3.3.9.6 Market Challenges

3.3.9.6.1 Market Drivers

3.3.9.6.2 Market Restraints

3.3.9.7 Market and Technology Trends

3.3.9.7.1 Market Trends

3.3.9.7.2 Technology Trends

3.3.9.8 Strategic Recommendations

3.3.10 Herpes Simplex Virus (HSV)

3.3.11 C. difficile

3.3.12 Cytomegalovirus

3.4 Blood Screening

3.4.1 Product Analysis: Instruments and Reagents

3.4.2 Method Comparison

3.4.3 Blood Screening Market Size

3.4.4 Competitive Positions

3.4.5 Market Challenges and Strategic Recommendations

3.4.5.1 Market Drivers and Restraints

3.4.5.1.1 Market Drivers

3.4.5.1.2 Market Restraints

3.4.5.2 Market and Technology Trends

3.4.5.2.1 Market Trends

3.4.5.2.2 Technology Trends

3.4.5.3 Strategic Recommendations

4. Molecular Diagnostic Testing Technology for Infectious Disease Testing

4.1 Infectious Disease Diagnostic Tests

4.1.2 Molecular Diagnostic Tools Solutions

4.1.3 Technology of Gene Expression Analysis

4.1.3.1 Amplification and Detection of RNA

4.1.3.2 Analysis of Multiple Genes

4.1.3.3 Advanced Information Technology

4.2 Use of Molecular Tests in Infectious Disease

4.2.1 Molecular Screening

4.2.2 Early Detection

4.2.3 Detection of Specific Resistance Genes and Viral Loading Tests

4.2.4 Pharmacogemomics and Personalized Medicine in MD Infectious Disease Testing

4.2.5 Molecular Strain Typing

4.3 Cost of Molecular Diagnostic Testing

4.4 Use of Multiplex PCR Tests

4.5 Next Generation Sequencing

4.6 Patient Flow Software

4.7 Digital PCR

5. Business

5.1 Technology and Market Trends

5.1.1 Technology Trends

5.2 M&A Activity

5.3 Partnerships

5.4 Competitive Analysis

5.4.1 Primary Competitors

5.4.2 Industry Challenges and Strategic Recommendations

5.4.3 Commercialization of Molecular Diagnostic Products

5.5 Intellectual Property Rights

5.5.1 New Patents

5.5.2 Current Patent Disputes

5.6 Opportunities and Strategic Recommendations

5.6.1 The Key Technical Opportunities with Significant Market Appeal in the Molecular Diagnostic Space in the Next Five Years

5.6.2 Developments for Molecular Diagnostic Instrumentation Products

5.6.3 Market Penetration Strategies for Infectious Disease Testing

5.7 Business Models and Requirements for a Successful Molecular Diagnostics Infectious Disease Products Industry

5.7.1 Scope of This Section

5.7.2 The Success Achieved by the Molecular Diagnostics Infectious Disease Products

5.7.3 Business Models in Molecular Diagnostics Infectious Disease Products

5.7.4 SWOT Comparison of Business Models for MD Infectious Disease Diagnostic Testing

5.7.5 Commercial Manufacturing of Molecular Diagnostics Infectious Disease Products: Requirements

5.7.5.1 Elements of Commercial Manufacturing

5.7.5.1.1 Regulatory Requirements

5.7.5.1.2 Manufacturing Process Scale

5.7.5.1.3 In-House Manufacturing

5.7.5.2 Contract Manufacturing: Commercial and Academic

5.7.6 Sales and Marketing Strategies for Infectious Disease Tests

5.8 Companion Diagnostics Development in Partnership with a Pharmaceutical Company

5.8.1 Description of Business Model

5.8.2 Anti-infective Pharmaceutical Market

6. Reimbursement and Billing Landscape for Molecular Diagnostics Testing for Infectious Disease

6.1 Overview

6.2 Trends in Reimbursement Practice

6.2.1 Medicare Reimbursement Threats

6.2.2 Analysis of ROI for Molecular Diagnostic Tests for Infectious Disease Using Current Medicare Reimbursement Rules

6.3 Trends in Patient Care and Reimbursement

6.4 Revenue threats

6.4.1 Medicare Payment Exceptions

6.4.2 Three Areas for Denial of Claims

6.5 Billing Rules

6.5.1 Medicare Billing Procedures

6.5.2 Medicare CPT Coding Rules for MD Infectious Disease Testing

6.5.3 Infectious Disease Billing Strategies

7. Regulatory Requirements

7.1 U.S. Food and Drug Administration

7.2 CLIA Regulations

7.3 Clinical Laboratory Improvement Act (CLIA)

7.4 State Licensing for Service Laboratories

7.5 IVDMIAs

7.6 510(k) Clearance

7.7 Pre-Market Approval (PMA)

7.7.1 Pre-Market Approval Application

7.8 Analyte Specific Reagents (ASRs)

7.8.1 Laboratory Developed Tests

7.9 What Regulatory Guidance is Needed for Companion Biomarkers?

7.10 U.S. Patent and Trademark Office (USPTO)

7.11 IRB Approval in Clinical Trials

7.12 CE Marking and the IVDD (European In Vitro Diagnostic Device Directive)

7.13 De Novo Classification

7.14 Research Use Only Reagents

7.15 FDA Recommendations on MRSA Testing

8. Business Decisions using Molecular Diagnostic Tests in Infectious Disease Testing

8.1 What are Key Opportunities in Infectious Disease Testing Development and Commercialization?

8.2 What are the Current Obstacles for MD Infectious Disease Testing

Implementation?

8.3 How do Business Strategies, such as those relating to Acquisition, Drive MD Strategies?

8.4 How Might Novel Infectious Disease MD Test Development Lead to Acquisition

Strategies and their Implications for Deal Making?

8.5 How can Molecular Diagnostic Tests Increase Value in an Associated Drug Marketing Plan?

8.6 Which Types of Infectious Disease MD Testing should be Developed by Diagnostic Companies at Various Stages in the Development Pipeline?

8.7 How can Regulatory Oversight Drive Approval and Adoption of New Technologies?

8.8 What are the Noteworthy Deals?

8.9 Who are the Acquirers?

8.10 Who are the Target Companies?

8.11 How will Platform Technology Companies Enter the Space?

8.12 Will Pharma Integrate with Diagnostics?

8.13 How do Platform Technology Companies Position themselves for Diagnostics Development?

8.14 Evaluate how Partnering and M&As will Alter the Competitive Landscape

8.15 Predict how FDA Regs will Impact New Diagnostic Tests

8.16 How can Big Pharma and Diagnostic Companies Co-develop Biomarkers in a

Model for Regulatory Acceptance?

8.17 How to Maximize Business Development through Biomarker Strategies?

8.18 What is the Best Type of Business Model for Developing Genetic Biomarkers

for Infectious Disease?

8.19 How Best have Genetic Biomarkers Provided the Most Benefit in Infectious Disease Testing?

8.20 What are the Most Innovative Methods in Development of Molecular Diagnostic Biomarkers?

8.21 What are the Best Values for Genetic Biomarkers in Drug Development and in Diagnostics?

9. Economics of Anti-microbial Drug Resistance: The Persistent need for Anti-bacterials

9.1 Resistance and Antibiotic Usage

9.2 Infection Control Programs

10. Company Profiles

10.1 Abbott Laboratories

10.2 AdvanDx

10.3 Arcxis Biotechnologies

10.4 Atlas Genetics

10.5 AutoGenomics, Inc.

10.6 Becton, Dickinson and Company

10.7 BioGenex Laboratories, Inc.

10.8 BioHelix Corporation

10.9 bioMérieux

10.10 Biocartis

10.11 bioTheranostics

10.12 Celera

10.13 Cepheid

10.14 EraGen Biosciences

10.15 Exiqon A/S

10.16 Genera Biosystems

10.17 GenMark Diagnostics, Inc.

10.18 Genomix Biotech

10.19 Gen-Probe

10.20 Gene Express

10.21 Genomica

10.22 Great Basin Scientific

10.23 Hologic

10.24 Illumina, Inc.

10.25 Innogenetics NV

10.26 Life Technologies

10.27 Mobidiag

10.28 Myconostica

10.29 Nanosphere

10.30 NorDiag ASA

10.31 Qiagen NV

10.32 Roche Ltd.

10.33 Seegene

10.34 SIRS-Lab

10.35 Source MDx

10.36 TrimGen

10.37 TrovaGene

10.38 Veredus Laboratories

10.39 Veridex

Appendix 1: Draft Guidance for Industry and Food and Drug Administration Staff—Establishing the Performance Characteristics of Nucleic Acid-based In vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA)

INDEX OF FIGURES

Figure 2.1: Relationship of DNA Testing to Key Areas of Clinical Diagnosis

Figure 2.2: Finding Genes with Microassays

Figure 2.3: The Use of Microassays for Studying Gene Expression

Figure 2.4: Overall Structure of Nucleic Acid Testing Market

Figure 2.5: Global Market for Molecular Diagnostics, 2002-2016

Figure 3.1: Global Market for Molecular Diagnostics Testing, 2010

Figure 3.2: Share of Molecular Diagnostics Testing by Testing Type, 2009

Figure 3.3: Key Players Market Share in Global Molecular Diagnostics Testing Markets

Figure 3.4: Global Market for Infectious Disease Treatments, 2008-2014

Figure 3.5: Global Revenue Forecast for Molecular Diagnostics Testing for Infectious Disease, 2009-2016

Figure 3.6: Global Market Revenue Share Forecasts for Molecular Diagnostics Infectious Disease Testing Markets by Region, 2009 and 2015

Figure 3.7: Infectious Disease Testing Revenue Market Share of Total U.S. MD Market, 2009 and 2015

Figure 3.8: European Market Revenue Forecast for Molecular Diagnostics Testing for Infectious Disease, 2009-2015

Figure 3.9: Infectious Disease Testing Revenue Market Share of Total European MD Market, 2009 and 2015

Figure 3.10: Japanese Market Revenue Forecast for Molecular Diagnostics Testing for Infectious Disease, 2009-2016

Figure 3.11: Infectious Disease Testing Revenue Market Share of Total Japanese MD Market, 2009 and 2015

Figure 3.12: Total Global Infectious Disease Molecular Diagnostics Markets, 2010

Figure 3.13: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2010

Figure 3.14: Total Global Infectious Disease Molecular Diagnostics Markets, 2016

Figure 3.15: Total U.S. Infectious Disease Molecular Diagnostics Markets, 2016

Figure 3.16: Global Trend of HIV Infection, 1991-2007

Figure 3.17: Number of People Living with HIV, Newly Infected with HIV and Number of AIDS Deaths in the World, 1990-2008

Figure 3.18: Worldwide Rate of New HIV Cases, 1990-2007

Figure 3.19: Percentage of Adult Population in African Countries with HIV, 2007

Figure 3.20: Global View of HIV Infection, 2008

Figure 3.21: Ethnic Distribution of AIDS Patients in the U.S., 2007

Figure 3.22: Ten Best Selling AIDS Drugs in the U.S., 2008

Figure 3.23: U.S. Rates for New HIV Cases, 2008

Figure 3.24: U.S. Rates for New HIV Cases in Men, 2008

Figure 3.25: U.S. Rates for New HIV Cases in Women, 2008

Figure 3.26: Global Trend of HIV Infections, 1991-2007

Figure 3.27: Proposed HIV Testing Algorithm

Figure 3.28: Distribution of HIV Molecular Diagnostic Testing by Purpose

Figure 3.29: Estimated Market Forecast for Global HIV Molecular Diagnostic Testing, 2011-2016

Figure 3.30: Estimated Market Forecast for U.S. HIV Molecular Diagnostic Testing, 2011-2016

Figure 3.31: Market Share Viral Load HIV MD Diagnostic Testing

Figure 3.32: Geographic Distribution of Chronic HBV Infection

Figure 3.33: Rate of New Hepatitis A, B and C Infections in the U.S., 1982-2006

Figure 3.34: Global Prevalence of Hepatitis C

Figure 3.35: Primary Causes of Chronic Liver Disease

Figure 3.36: HCV Infection Prevalence

Figure 3.37: Hepatitis C Infection by Source

Figure 3.38: Growth and Projections of HCV Therapies by Drug Class, 2008 and 2013

Figure 3.39: U.S. Market Share of HCV Molecular Diagnostic Market, 2010

Figure 3.40: Global Market Share (Excluding U.S.) of HCV Molecular Diagnostic Market, 2010

Figure 3.41: Rate of New Cases and Deaths of Cervical Cancer by Age Group Worldwide, 2008

Figure 3.42: U.S. Market Share of HPV Molecular Diagnostic Market, 2010

Figure 3.43: Global Market Share (Excluding U.S.) of HPV Molecular Diagnostic Market, 2010

Figure 3.44: Market Share Estimates for Molecular Diagnostic HPV Testing, 2009

Figure 3.45: Number of Reported and Confirmed Cases of Influenza H1N1 Strain Worldwide, 2009

Figure 3.46: Distribution of H1N1 Flu in the U.S., 2009

Figure 3.47: H1N1 Confirmed and Probable Case Rate in the U.S., By Age Group

Figure 3:48: U.S. Rates of Sexually-transmitted Diseases, 1940-2007

Figure 3.49: Chlamydia Infection Rates: Total and by Gender: U.S., 1989-2009

Figure 3.50: Chlamydia U.S. Prevalence by Age Group and Race/Ethnicity

Figure 3.51: U.S. Market Share of CT/NG Molecular Diagnostic Market, 2010

Figure 3.52: Global Market Share (Excluding U.S.) of CT/NG Molecular Diagnostic Market, 2010

Figure 3.53: U.S. Gonorrhea Infection Rates, 1941-2006

Figure 3.54: U.S. Gonorrhea Infection Rates by Race/Ethnicity, 1999-2008

Figure 3.55: Pipeline for TB Diagnostics

Figure 3.56: Number of Tuberculosis (TB) Cases Among U.S.- and Foreign-born Persons in the U.S., 1993-2008

Figure 3.57: Rate of Tuberculosis (TB) Cases Among U.S.- and Foreign-born Persons in the U.S., 1993-2008

Figure 3.58: Rate of Tuberculosis (TB) Cases by State/Area in the U.S., 2008

Figure 3.59: U.S.-born Tuberculosis (TB) Cases by Ethnicity, 2008

Figure 3.60: Reported Tuberculosis (TB) Cases in the U.S., 1983-2007

Figure 3.61: Global Market Share of MD TB Testing

Figure 3.62: Global Market Share of MD TB Testing by Region, 2010

Figure 3.63: Incidence Rates of Invasive MRSA Infections by Age

Figure 3.64: MRSA Trends According to Patient Location, 1998-2005

Figure 3.65: Incidence of Healthcare-associated MRSA Infections, 2005-2008

Figure 3.66: U.S. Market Share of MRSA Molecular Diagnostic Market, 2010

Figure 3.67: Global Market Share (Excluding U.S.) of MRSA Molecular Diagnostic Market, 2010

Figure 3.68: Global Frequency of Vancomycin-resistant Enterococci, 2006

Figure 3.69: U.S. Market Share of VRE Molecular Diagnostic Market, 2010

Figure 3.70: Estimated Market for Global Blood Screening Product Sales, 2007-2016

Figure 3.71: Gen-Probe Blood Screening Product Market Share, 2005-2009

Figure 3.72: Blood Screening Product Market Share by Company, 2010

Figure 4.1: Using DNA Microassays to Measure Gene Expression

Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients

Figure 5.1: FDA Co-developed Products as a Model for Collaboration

Figure 5.2: Market Growth of MD Infectious Disease Tests

Figure 5.3: Segmentation of the Biomarker Development Market

Figure 5.4: Global Distribution of Anti-infective Agent Sales by Geography

Figure 5.5: Leading Companies in Anti-infectives Market Share, 2008

Figure 6.1: Reimbursement for Diagnostics in Healthcare Decision Making

Figure 9.1: Global Multidrug Susceptibility in Pseudomonas aeruginosa

Figure 9.2: Global Frequency of Vancomycin-resistant Enterococci, 2006

Figure 10.1: Gen-Probe Key Acquisitions

Figure 10.2: Gen-Probe Projected R&D Expenditures

INDEX OF TABLES

Table 1.1: Market Trends in Infectious Disease DNA Testing

Table 1.2: Molecular Diagnostics Infectious Disease Market: Market Drivers Ranked in Order of Impact

Table 1.3: Molecular Diagnostics Infectious Disease Market: Market Restraints Ranked in Order of Impact

Table 1.4: Strategic Recommendations on Molecular Diagnostic Sector Business Functions

Table 2.1: Nucleic Acid-based Tests for Clinically Important Viral and Bacterial Pathogens

Table 2.2: Top Ten Causes of Death Worldwide

Table 2.3: The Most Prevalent Infectious Diseases Worldwide

Table 2.4: Annual Rates of Global Infectious Diseases

Table 2.5: Emerging Molecular Diagnostic Technologies

Table 2.6: Global Market for Molecular Diagnostics Testing, 2000-2016

Table 2.7: U.S. Market for Molecular Diagnostics Testing, 2004-2016

Table 2.8: Automated Molecular Diagnostics Platforms for Infectious Disease Testing

Table 2.9: Companies Marketing Products using DNA Probes

Table 2.10: Companies Marketing Multiple Products in Molecular Diagnostics Sector

Table 2.11: FDA-approved Molecular Diagnostic Commercial Kits for the Detection of Infectious Agents

Table 2.12: Global and U.S. Major Infectious Disease Market Size (Estimated Infected Persons)

Table 2.13: Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact

Table 2.14: Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact

Table 2.15: Attractive Growth Areas for Molecular Diagnostic Testing

Table 2.16: NAT Labs in U.S. and Five European Markets

Table 3.1: European Market for Molecular Diagnostics Testing, 2005-2015

Table 3.2: Japanese Market for Molecular Diagnostics Testing, 2009-2016

Table 3.3: Summary of Molecular Diagnostics Testing Sectors

Table 3.4: Share of Molecular Diagnostics Testing by Testing Type, 2009

Table 3.5: Key Players and Market Share in Global Molecular Diagnostics Testing Market

Table 3.6: Revenue Model for Molecular Diagnostics Testing

Table 3.7: Molecular Infectious Disease Diagnostics Market: Market Drivers Ranked in Order of Impact

Table 3.8: Molecular Infectious Disease Diagnostics Market: Market Restraints Ranked in Order of Impact

Table 3.9: Global Revenue Forecast for Molecular Diagnostics Testing for Infectious Disease, 2009-2016

Table 3.10: U.S. Market Revenue Forecast for Molecular Diagnostics Testing for Infectious Disease, 2009-2016

Table 3.11: European Market Revenue Forecast for Molecular Diagnostics Testing for Infectious Disease, 2009-2015

Table 3.12: Japanese Market Revenue Forecast for Molecular Diagnostics Testing for Infectious Disease, 2009-2016

Table 3.13: Molecular Diagnostic Markets for Infectious Disease Testing, 2010

Table 3.14: Molecular Diagnostic Markets for Infectious Disease Testing, 2016

Table 3.15: Business Factors Influencing Advanced Infectious Disease MD Testing Services

Table 3.16: Global Summary of the HIV/AIDS Epidemic, 2008

Table 3.17: Global HIV Statistics, 2008

Table 3.18: HIV Resistance Testing Recommendations

Table 3.19: Summary of Assays for HIV Viral Load Testing

Table 3.20: Commercially Available Molecular Diagnostic Products for HIV Assay

Table 3.21: Global Market for Molecular Diagnostic HIV Testing, 2007-2010

Table 3.22: U.S. Market for HIV Molecular Diagnostic Testing, 2007-2010

Table 3.23: Global Market Forecast for Molecular Diagnostic HIV Diagnostic Testing, 2011-2016

Table 3.24: U.S. Market Forecast for Molecular Diagnostic HIV Diagnostic Testing, 2011-2016

Table 3.25: Global Market for HIV Viral Load Diagnostic Testing, 2007-2010

Table 3.26: U.S. Market for HIV Viral Load Diagnostic Testing, 2007-2010

Table 3.27: Global Market Forecast for HIV Viral Load Diagnostic Testing, 2011-2016

Table 3.28: U.S. Market Forecast for HIV Viral Load Diagnostic Testing, 2011-2016

Table 3.29: Global Market for HIV Genotyping Testing, 2007-2010

Table 3.30: U.S. Market for HIV Genotype Testing, 2007-2010

Table 3.31: Global Market Forecast for HIV Genotyping Testing 2011-2015

Table 3.32: U.S. Market Forecast for HIV Genotyping Testing, 2011-2016

Table 3.33: HIV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact

Table 3.34: HIV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact

Table 3.35: Clinical Application of Quantitative HBV DNA Testing

Table 3.36: Lower Detection Limits of HBV DNA Assays

Table 3.37: Summary of Molecular Diagnostic Assays for Testing HBV

Table 3.38: Global Market for HBV Diagnostic Testing, 2000-2010

Table 3.39: U.S. Market for HBV Diagnostic Testing, 2000-2010

Table 3.40: Global Market Forecast for HBV Diagnostic Testing, 2011-2016

Table 3.41: U.S. Market Forecast for HBV Diagnostic Testing, 2011-2016

Table 3.42: HBV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact

Table 3.43: HBV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact

Table 3.44: Hepatitis B Facts

Table 3.45: U.S. HCV Statistics

Table 3.46: Worldwide Rate of HCV Cases

Table 3.47: Efficiency of Available HCV Screening Tests

Table 3.48: Commercially Available Molecular Diagnostic Products for HCV Assay

Table 3.49: Global Market for DNA HCV Diagnostic Testing, 2005-2010

Table 3.50: U.S. Market for DNA HCV Diagnostic Testing, 2005-2010

Table 3.51: Global Market Forecast for NAT HCV Diagnostic Testing, 2011-2016

Table 3.52: U.S. Market Forecast for NAT HCV Diagnostic Testing, 2011-2016

Table 3.53: Major Companies Marketing HCV Molecular Diagnostic Tests: Market Size and Share, 2010

Table 3.54: HCV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact

Table 3.55: HCV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact

Table 3.56: Recommendations for HCV Diagnostic Testing

Table 3.57: Number of Pap Smears Performed by Country, 2009

Table 3.58: Qiagen's Digene HC2 High-risk HPV DNA Test

Table 3.59: Commercially Available Molecular Diagnostic Products for HPV Assay

Table 3.60: Major Companies Marketing HPV Molecular Diagnostic Tests: Market Size and Share, 2010

Table 3.61: Global Market for HPV Molecular Diagnostic Testing, 2007-2010

Table 3.62: U.S. Market for HPV Molecular Diagnostic Testing, 2007-2010

Table 3.63: Global Market Forecast for HPV Molecular Diagnostic Testing, 2011-2016

Table 3.64: U.S. Market Forecast for HPV Molecular Diagnostic Testing, 2011-2016

Table 3.65: HPV Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact

Table 3.66: HPV Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact

Table 3.67: Commercially Available Molecular Diagnostic Products for Influenza Assay

Table 3.68: Global Market for Molecular Influenza Diagnostic Testing, 2007-2010

Table 3.69: U.S. Market for DNA Influenza Diagnostic Testing, 2007-2010

Table 3.70: Global Market Forecast for Influenza Molecular Diagnostic Testing, 2010-2016

Table 3.71: U.S. Market Forecast for Influenza Molecular Diagnostic Testing, 2010-2016

Table 3.72: Influenza Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact

Table 3.73: Influenza Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact

Table 3.74: U.S. Chlamydia Infection Rates, 1985-2008

Table 3.75: U.S. Chlamydia Statistics

Table 3.76: Commercially Available Molecular Diagnostic Products for Chlamydia Assay

Table 3.77: Global Market for Molecular Diagnostic Chlamydia/NG Diagnostic Testing, 2000-2010

Table 3.78: U.S. Market for Molecular Diagnostic Chlamydia/NG Diagnostic Testing, 2000-2010

Table 3.79: Major Companies Marketing Chlamydia/Gonorrhea Molecular Diagnostic Tests: Market Size and Share, 2010

Table 3.80: Global Market Forecast for Chlamydia/Gonorrhea Diagnostic Testing, 2011-2016

Table 3.81: U.S. Market Forecast for Chlamydia/Gonorrhea Diagnostic Testing, 2010-2016

Table 3.82: Global Market Forecast for Chlamydia Molecular Diagnostic Testing, 2011-2016

Table 3.83: U.S. Market Forecast for Chlamydia Molecular Diagnostic Testing, 2011-2016

Table 3.84: Chlamydia Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact

Table 3.85: Chlamydia Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact

Table 3.86: U.S. Gonorrhea Statistics

Table 3.87: Commercially Available Molecular Diagnostic Products for Gonorrhea Assay

Table 3.88: Major Companies Marketing Chlamydia/Gonorrhea Molecular Diagnostic Tests: Market Size and Share, 2010

Table 3.89: Gonorrhea Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact

Table 3.90: Gonorrhea Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact

Table 3.91: Commercially Available Molecular Diagnostic Assays for Testing TB

Table 3.92: Global Market for MD TB Diagnostic Testing, 2005-2010

Table 3.93: U.S. Market for MD TB Diagnostic Testing, 2005-2010

Table 3.94: Global Market Share of MD TB Testing by Region, 2010

Table 3.95: Global Unit Sales of MD TB Testing by Region, 2010

Table 3.96: Comparative U.S. Claim Charges for TB Testing by Type, 2010

Table 3.97: Global Testing for TB by Testing Type, 2010

Table 3.98: Global Testing for TB by Testing Reason, 2010

Table 3.99: Global Market Forecast for MD TB Diagnostic Testing, 2011-2016

Table 3.100: U.S. Market Forecast for MD TB Diagnostic Testing, 2011-2016

Table 3.101: Tuberculosis Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact

Table 3.102: Tuberculosis Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact

Table 3.103: Leading Tuberculosis Therapeutic R&D Candidates

Table 3.104: Commercially Available Molecular Diagnostic Products for MRSA Assay

Table 3.105: Global Market for MRSA Diagnostic Testing, 2005-2010

Table 3.106: U.S. Market for MRSA Diagnostic Testing, 2005-2010

Table 3.107: Major Companies Marketing HCV Molecular Diagnostic Tests: Market Size and Share, 2010

Table 3.108: Global Market Forecast for MD MRSA Diagnostic Testing, 2011-2016

Table 3.109: U.S. Market Forecast for MD MRSA Diagnostic Testing, 2011-2016

Table 3.110: MRSA Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact

Table 3.111: MRSA Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact

Table 3.112: In vitro Susceptibility of Staphylococci to New Agents in Development

Table 3.113: Commercially Available Molecular Diagnostic Products for VRE Assay

Table 3.114: Global Market for VRE Diagnostic Testing, 2005-2010

Table 3.115: U.S. Market for VRE Diagnostic Testing, 2005-2010

Table 3.116: Major Companies Marketing VRE Molecular Diagnostic Tests: Market Size and Share, 2010

Table 3.117: Global Market Forecast for MD VRE Diagnostic Testing, 2011-2016

Table 3.118: U.S. Market Forecast for MD VRE Diagnostic Testing, 2011-2016

Table 3.119: VRE Molecular Diagnostics Market: Market Drivers Ranked in Order of Impact

Table 3.120: VRE Molecular Diagnostics Market: Market Restraints Ranked in Order of Impact

Table 3.121: Transmission-related Disease Screening from Blood Donor Pools

Table 3.122: Principal Blood Screening Products of Gen-Probe for HIV Assay

Table 3.1

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Nicolas Bombourg
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