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Introduction
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?Executive SummaryMolecular diagnostic technologiesHealthcare-associated infectionsSexually transmitted HPVsHIV and hepatitis virusesViral respiratory pathogensMarket outlook and forecastsAbout the authorDisclaimerMolecular diagnostic technologiesSummaryRole of molecular diagnostics in infectious diseasesOverview of nucleic acid testing (NAT)Sample processingProbe-based testingInnovations in nucleic acid amplification technologiesPCR-based amplification technologiesAlternative amplification technologiesAutomated platforms for NATPoint-of-care real-time PCR testing systemsMicrofluidicsDigital PCRInnovations in nucleic acid microarraysDevelopment of microarray formatsSuspension bead and other 3D arraysInnovations in next-generation sequencingInnovations in mass spectrometry methodsInnovations in protein arraysHealthcare-associated infectionsSummaryThe challenge of drug-resistant pathogensMRSACulture vs. nucleic acid testsFDA-approved nucleic acid testsExamples of technologies and products in developmentClostridium difficileTraditional testsFDA approved nucleic acid testsVancomycin-resistant enterococci (VRE)Culture and nucleic acid testsBloodstream pathogensBlood cultureMicroorganisms found in blood culturesFDA-approved nucleic acid testsAmplification-based products in developmentMass spectrometry-based products in developmentSexually transmitted HPVsSummaryHPV infectionsThe HPV genomeScreening for cervical cancerAnalytical versus clinical sensitivity of HPV testsGenotyping HPV in clinical specimensVaccination and implications for testingProducts on the market and in developmentTarget amplification techniquesReverse line blot and linear array testsAmplicorPapilloCheckBead-based assaysAssays using real-time PCR amplificationSignal amplification techniquesHybrid Capture 2 assay (FDA-approved)Cervista (FDA-approved)Detection of HPV mRNANuclisensAptima HPV (FDA-approved)HIV and hepatitis virusesSummaryIntroductionHIV infectionsCharacteristics of HIVHIV testing strategiesHIV load testingFDA-approved assaysTests in developmentDigital PCR approachDrug resistance testingHBV infectionsCharacteristics of HBVHBV load testingDrug resistance testingDetection of co-infecting HDVHCV infectionsCharacteristics of HCVHCV load testingDrug resistance and drug efficacy testingFDA-approved blood screening testsOccult HBV and HCV infectionsHCV-RNA assaysHBV-DNA assaysViral respiratory pathogensSummaryIntroductionImportant respiratory virusesInfluenza A/B virusesRespiratory syncytial virusHuman parainfluenza virusAdenovirus 1RhinovirusEmerging respiratory virusesAvian influenza and influenza A swine fluSARS-covirus and other human coronavirusesHuman metapneumovirusHuman bocavirusMultiplex respiratory virus panelsInfluenza virus panelsRespiratory virus panelsLuminex's xTAG RVPQiagen's RespPlex IIEraGen Biosciences' MultiCode-PLx RVPComparison of xTAG, ResPlex II, and MultiCode-PlxAutoGenomics' Infiniti SystemSeegene's Seeplex RP AssayIdaho's real-time PCR FilmArrayBD's real-time PCR Jaguar SystemPrimeraDx's quantitative PCR STAR technologyAbbott's PLEX-ID for pathogen discoveryMarket outlook and forecastsSummaryIntroductionMDx opportunities in viral hemorrhagic feversMDx opportunities in other emerging pathogensMultiplexed MDx technology trendsMicroarrays and microfluidic devicesMass spectrometry
To order this report:In Vitro Diagnostic Industry: Innovations in Molecular Diagnostics for Infectious Diseases
