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Diagnostics in Infectious Disease Testing
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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 14
1.1 Statement of Report 14
1.2 About This Report 15
1.3 Scope of the Report 15
1.4 Objectives 17

2. 1.5 Methodology 17
1.6 Executive Summary 19
2. Introduction to Molecular Diagnostics for Infectious Disease Testing 27
2.1 Molecular Diagnostics Testing and Opportunities in the Infectious Disease Sector 27
2.2 The Infectious Disease Problem 31
2.3 Impact of the Human Genome Project on Molecular Diagnostics 35
2.4 Opportunities for Molecular and Clinical Diagnostics 35
2.4.1 Companion Diagnostics 36
2.5 Development of Molecular Diagnostics Testing Markets 37
2.6 Target-based Gene Amplification 38
2.6.1 Polymerase Chain Reaction (PCR) 38
2.6.2 Real-time PCR (RT-PCR) 39
2.6.3 Nucleic Acid Sequence-based Amplification (NASBA) 39
2.6.4 Market Drivers and Restraints 46
2.6.4.1 Market Drivers 46
2.6.4.2 Market Restraints 46
2.6.5 Market and Technology Trends 46
2.6.5.1 Market Trends 46
2.6.5 2 Technology Trends 47
2.6.6 Strategic Recommendations 47
2.7 PCR Reagents for Clinical Diagnostics 48
3. Infectious Disease Diagnostics Molecular Testing Market 50
3.1 Market Overview 50
3.1.1 Overall Infectious Disease Market Analysis 53

3. 3.2 NAT Molecular Diagnostics Market 65
3.3 Infectious Disease Molecular Diagnostic Testing Markets 66
3.3.1 HIV 66
3.3.1.1 Disease Background and Statistics 66
3.3.1.2 Measuring Viral Loads 74
3.3.1.3 Instruments and MD Reagents 75
3.3.1.4 Method Comparisons 81
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