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Innovations in Molecular Diagnostics for Infectious Diseases
Description:
This report examines the opportunities presented to the developers of molecular diagnostics by the emergence of novel/variant pathogens and ways in which new molecular testing technologies are being translated into superior diagnostic products in areas such as healthcare-associated infections; HPV infections, blood-borne viral infections and respiratory viral infections.
Features and benefits:
- Understand the nature and limitations of traditional molecular diagnostics and the improved features of molecular testing technologies in development.
- Evaluate the competitive landscape in infectious disease molecular diagnostics and identify potential licensing/collaborative partners.
- Analyze the factors stimulating increased demand for molecular testing in specific infectious disease areas to inform investment decisions.
- Gain an insight into new and untapped opportunities revealed by recent research findings in the more mature sectors of the MDx market.
- Identify key trends in the MDx market and plan future developments with the aid of market forecasts for the individual segments of the market.
Highlights:
- The latest molecular diagnostics to enter development are multiplex tests which can identify several pathogens or variants of these pathogens present in small-volume samples. Low- and medium-density bead-based microarrays are being developed and are expected to play an increasingly important role in multiplex pathogen detection and genotyping.
- It is likely that future diagnostic tests will target many more pathogens than is currently the case. Promising approaches include miniaturized microfluidic systems, in particular continuous-flow droplet-based PCR systems, and mass spectrometry-based detection methods which use direct specimen testing and virtually no reagents.
- Growth forecasts are derived for key MDx market segments for the period 2010-2015: the HPV testing market is forecast to grow with a 5-year CAGR of 20%, the hospital-associated infection (HAI) testing market is forecast to grow with a 5-year CAGR of 19%. and the virology (HIV/HCV/HBV) testing market is forecast to grow with a 5-year CAGR of 8%.
Your key questions answered:
- Which are the areas of unmet need in infectious disease testing and potential new areas of opportunity for MDx in infectious disease?
- What forces are shaping molecular diagnostic testing trends and what drivers and restraints operate in the infectious disease testing market?
- Who is developing new innovative products for the infectious disease MDx market and what paths to commercialization are they following?
- How are the different sectors of the infectious disease MDx market forecast to develop and what are the prospects for new market entrants?
- What are the estimated current market sizes and 5-year growth forecasts for the expanding sectors of the infectious disease MDx market?
Features and benefits:
- Understand the nature and limitations of traditional molecular diagnostics and the improved features of molecular testing technologies in development.
- Evaluate the competitive landscape in infectious disease molecular diagnostics and identify potential licensing/collaborative partners.
- Analyze the factors stimulating increased demand for molecular testing in specific infectious disease areas to inform investment decisions.
- Gain an insight into new and untapped opportunities revealed by recent research findings in the more mature sectors of the MDx market.
- Identify key trends in the MDx market and plan future developments with the aid of market forecasts for the individual segments of the market.
Highlights:
- The latest molecular diagnostics to enter development are multiplex tests which can identify several pathogens or variants of these pathogens present in small-volume samples. Low- and medium-density bead-based microarrays are being developed and are expected to play an increasingly important role in multiplex pathogen detection and genotyping.
- It is likely that future diagnostic tests will target many more pathogens than is currently the case. Promising approaches include miniaturized microfluidic systems, in particular continuous-flow droplet-based PCR systems, and mass spectrometry-based detection methods which use direct specimen testing and virtually no reagents.
- Growth forecasts are derived for key MDx market segments for the period 2010-2015: the HPV testing market is forecast to grow with a 5-year CAGR of 20%, the hospital-associated infection (HAI) testing market is forecast to grow with a 5-year CAGR of 19%. and the virology (HIV/HCV/HBV) testing market is forecast to grow with a 5-year CAGR of 8%.
Your key questions answered:
- Which are the areas of unmet need in infectious disease testing and potential new areas of opportunity for MDx in infectious disease?
- What forces are shaping molecular diagnostic testing trends and what drivers and restraints operate in the infectious disease testing market?
- Who is developing new innovative products for the infectious disease MDx market and what paths to commercialization are they following?
- How are the different sectors of the infectious disease MDx market forecast to develop and what are the prospects for new market entrants?
- What are the estimated current market sizes and 5-year growth forecasts for the expanding sectors of the infectious disease MDx market?
Contents:
EXECUTIVE SUMMARY
Molecular diagnostic technologies
Healthcare-associated infections
Sexually transmitted HPVs
HIV and hepatitis viruses
Viral respiratory pathogens
Market outlook and forecasts
Molecular diagnostic technologies
Summary
Role of molecular diagnostics in infectious diseases
Overview of nucleic acid testing (NAT)
Sample processing
Probe-based testing
Innovations in nucleic acid amplification technologies
PCR-based amplification technologies
Alternative amplification technologies
Automated platforms for NAT
Point-of-care real-time PCR testing systems
Microfluidics
Digital PCR
Innovations in nucleic acid microarrays
Development of microarray formats
Suspension bead and other 3D arrays
Innovations in next-generation sequencing
Innovations in mass spectrometry methods
Innovations in protein arrays
Healthcare-associated infections
Summary
The challenge of drug-resistant pathogens
MRSA
Culture vs. nucleic acid tests
FDA-approved nucleic acid tests
Examples of technologies and products in development
Clostridium difficile
Traditional tests
FDA approved nucleic acid tests
Vancomycin-resistant enterococci (VRE)
Culture and nucleic acid tests
Bloodstream pathogens
Blood culture
Microorganisms found in blood cultures
FDA-approved nucleic acid tests
Amplification-based products in development
Mass spectrometry-based products in development
Sexually transmitted HPVs
Summary
HPV infections
The HPV genome
Screening for cervical cancer
Analytical versus clinical sensitivity of HPV tests
Genotyping HPV in clinical specimens
Vaccination and implications for testing
Products on the market and in development
Target amplification techniques
Reverse line blot and linear array tests
Amplicor
PapilloCheck
Bead-based assays
Assays using real-time PCR amplification
Signal amplification techniques
Hybrid Capture 2 assay (FDA-approved)
Cervista (FDA-approved)
Detection of HPV mRNA
Nuclisens
Aptima HPV (FDA-approved)
HIV and hepatitis viruses
Summary
Introduction
HIV infections
Characteristics of HIV
HIV testing strategies
HIV load testing
FDA-approved assays
Tests in development
Digital PCR approach
Drug resistance testing
HBV infections
Characteristics of HBV
HBV load testing
Drug resistance testing
Detection of co-infecting HDV
HCV infections
Characteristics of HCV
HCV load testing
Drug resistance and drug efficacy testing
FDA-approved blood screening tests
Occult HBV and HCV infections
HCV-RNA assays
HBV-DNA assays
Viral respiratory pathogens
Summary
Introduction
Important respiratory viruses
Influenza A/B viruses
Respiratory syncytial virus
Human parainfluenza virus
Adenovirus 1
Rhinovirus
Emerging respiratory viruses
Avian influenza and influenza A swine flu
SARS-covirus and other human coronaviruses
Human metapneumovirus
Human bocavirus
Multiplex respiratory virus panels
Influenza virus panels
Respiratory virus panels
Luminex’s xTAG RVP
Qiagen’s RespPlex II
EraGen Biosciences’ MultiCode-PLx RVP
Comparison of xTAG, ResPlex II, and MultiCode-Plx
AutoGenomics’ Infiniti System
Seegene’s Seeplex RP Assay
Idaho’s real-time PCR FilmArray
BD’s real-time PCR Jaguar System
PrimeraDx’s quantitative PCR STAR technology
Abbott’s PLEX-ID for pathogen discovery
Market outlook and forecasts
Summary
Introduction
MDx opportunities in viral hemorrhagic fevers
MDx opportunities in other emerging pathogens
Multiplexed MDx technology trends
Microarrays and microfluidic devices
Mass spectrometry
Widening adoption of MDx tests
Migration of MDx out of core labs
Emergence of POC MDx platforms
MDx market characteristics
The global MDx market
Changing competitive landscape
Changing MDx regulation
Changing reimbursement
Forecasts for key MDx market sectors
HAIs
HPV
HIV, HCV, and HBV
Viral respiratory pathogens
Appendix
Scope
Methodology
Glossary/Abbreviations
Bibliography/References
Journal references
Website references
Additional information
TABLES
Table: FDA–approved real–time PCR amplification systems
Table: FDA–approved automated platforms for nucleic acid testing
Table: FDA-approved microarray systems
Table: FDA approved MRSA screening tests
Table: FDA approved C. difficile and VRE tests
Table: FDA approved tests for bloodstream pathogens
Table: Nucleic acid tests for HPV detection and genotyping
Table: Nucleic acid tests for HPV detection and genotyping (continued)
Table: Nucleic acid tests for HPV detection and genotyping (continued)
Table: FDA approved HIV quantification and drug resistance assays
Table: FDA approved HBV and HCV quantitative assays
Table: FDA approved blood screening assays for HBV, HCV, and HIV
Table: FDA approved tests for viral respiratory pathogens
Table: FDA approved tests for viral respiratory pathogens (continued)
Table: Global MDx market forecasts by reviewed segment, 2010–15
Table: Viral hemorrhagic fevers and other emerging viruses
Table: Viral hemorrhagic fevers and other emerging viruses
Table: Viral hemorrhagic fevers and other emerging viruses
Table: Viral hemorrhagic fevers and other emerging viruses
FIGURES
Figure: GeneXpert System for nucleic acid testing
Figure: The principle of digital PCR
Figure: Nucleic acid detection by suspension bead array
Figure: Real-time PCR digital microfluidics platform
Figure: Genotyping of microorganisms by PCR/ESI-mass spectrometry
Figure: PapilloCheck HPV microarray test
Figure: HPV assay with Invader technology
Figure: Digital PCR for viral load determination
Figure: FilmArray for diagnosis of respiratory infection
Figure: STAR technology for diagnosis of respiratory infection
Figure: Forecast growth in MDx market segments, 2010–15
Molecular diagnostic technologies
Healthcare-associated infections
Sexually transmitted HPVs
HIV and hepatitis viruses
Viral respiratory pathogens
Market outlook and forecasts
Molecular diagnostic technologies
Summary
Role of molecular diagnostics in infectious diseases
Overview of nucleic acid testing (NAT)
Sample processing
Probe-based testing
Innovations in nucleic acid amplification technologies
PCR-based amplification technologies
Alternative amplification technologies
Automated platforms for NAT
Point-of-care real-time PCR testing systems
Microfluidics
Digital PCR
Innovations in nucleic acid microarrays
Development of microarray formats
Suspension bead and other 3D arrays
Innovations in next-generation sequencing
Innovations in mass spectrometry methods
Innovations in protein arrays
Healthcare-associated infections
Summary
The challenge of drug-resistant pathogens
MRSA
Culture vs. nucleic acid tests
FDA-approved nucleic acid tests
Examples of technologies and products in development
Clostridium difficile
Traditional tests
FDA approved nucleic acid tests
Vancomycin-resistant enterococci (VRE)
Culture and nucleic acid tests
Bloodstream pathogens
Blood culture
Microorganisms found in blood cultures
FDA-approved nucleic acid tests
Amplification-based products in development
Mass spectrometry-based products in development
Sexually transmitted HPVs
Summary
HPV infections
The HPV genome
Screening for cervical cancer
Analytical versus clinical sensitivity of HPV tests
Genotyping HPV in clinical specimens
Vaccination and implications for testing
Products on the market and in development
Target amplification techniques
Reverse line blot and linear array tests
Amplicor
PapilloCheck
Bead-based assays
Assays using real-time PCR amplification
Signal amplification techniques
Hybrid Capture 2 assay (FDA-approved)
Cervista (FDA-approved)
Detection of HPV mRNA
Nuclisens
Aptima HPV (FDA-approved)
HIV and hepatitis viruses
Summary
Introduction
HIV infections
Characteristics of HIV
HIV testing strategies
HIV load testing
FDA-approved assays
Tests in development
Digital PCR approach
Drug resistance testing
HBV infections
Characteristics of HBV
HBV load testing
Drug resistance testing
Detection of co-infecting HDV
HCV infections
Characteristics of HCV
HCV load testing
Drug resistance and drug efficacy testing
FDA-approved blood screening tests
Occult HBV and HCV infections
HCV-RNA assays
HBV-DNA assays
Viral respiratory pathogens
Summary
Introduction
Important respiratory viruses
Influenza A/B viruses
Respiratory syncytial virus
Human parainfluenza virus
Adenovirus 1
Rhinovirus
Emerging respiratory viruses
Avian influenza and influenza A swine flu
SARS-covirus and other human coronaviruses
Human metapneumovirus
Human bocavirus
Multiplex respiratory virus panels
Influenza virus panels
Respiratory virus panels
Luminex’s xTAG RVP
Qiagen’s RespPlex II
EraGen Biosciences’ MultiCode-PLx RVP
Comparison of xTAG, ResPlex II, and MultiCode-Plx
AutoGenomics’ Infiniti System
Seegene’s Seeplex RP Assay
Idaho’s real-time PCR FilmArray
BD’s real-time PCR Jaguar System
PrimeraDx’s quantitative PCR STAR technology
Abbott’s PLEX-ID for pathogen discovery
Market outlook and forecasts
Summary
Introduction
MDx opportunities in viral hemorrhagic fevers
MDx opportunities in other emerging pathogens
Multiplexed MDx technology trends
Microarrays and microfluidic devices
Mass spectrometry
Widening adoption of MDx tests
Migration of MDx out of core labs
Emergence of POC MDx platforms
MDx market characteristics
The global MDx market
Changing competitive landscape
Changing MDx regulation
Changing reimbursement
Forecasts for key MDx market sectors
HAIs
HPV
HIV, HCV, and HBV
Viral respiratory pathogens
Appendix
Scope
Methodology
Glossary/Abbreviations
Bibliography/References
Journal references
Website references
Additional information
TABLES
Table: FDA–approved real–time PCR amplification systems
Table: FDA–approved automated platforms for nucleic acid testing
Table: FDA-approved microarray systems
Table: FDA approved MRSA screening tests
Table: FDA approved C. difficile and VRE tests
Table: FDA approved tests for bloodstream pathogens
Table: Nucleic acid tests for HPV detection and genotyping
Table: Nucleic acid tests for HPV detection and genotyping (continued)
Table: Nucleic acid tests for HPV detection and genotyping (continued)
Table: FDA approved HIV quantification and drug resistance assays
Table: FDA approved HBV and HCV quantitative assays
Table: FDA approved blood screening assays for HBV, HCV, and HIV
Table: FDA approved tests for viral respiratory pathogens
Table: FDA approved tests for viral respiratory pathogens (continued)
Table: Global MDx market forecasts by reviewed segment, 2010–15
Table: Viral hemorrhagic fevers and other emerging viruses
Table: Viral hemorrhagic fevers and other emerging viruses
Table: Viral hemorrhagic fevers and other emerging viruses
Table: Viral hemorrhagic fevers and other emerging viruses
FIGURES
Figure: GeneXpert System for nucleic acid testing
Figure: The principle of digital PCR
Figure: Nucleic acid detection by suspension bead array
Figure: Real-time PCR digital microfluidics platform
Figure: Genotyping of microorganisms by PCR/ESI-mass spectrometry
Figure: PapilloCheck HPV microarray test
Figure: HPV assay with Invader technology
Figure: Digital PCR for viral load determination
Figure: FilmArray for diagnosis of respiratory infection
Figure: STAR technology for diagnosis of respiratory infection
Figure: Forecast growth in MDx market segments, 2010–15
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