World In Vitro Diagnostics (IVD) Market Bundle: Molecular Diagnostics (Microbiology, Oncology, Blood, Prenatal, Inherited, Others), Cancer Diagnostics (HPV, ISH, Cytometry, PSA, FOB, Others), Infectious Diseases (ID/AST, POC, HAIs, STDs, Other)

  • ID: 3512738
  • Report
  • Region: Global
  • 2100 Pages
  • Kalorama Information
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This Kalorama Information In Vitro Diagnostics (IVD) Market Bundle represents three reports, as published in 2015. These reports, representing over 2,000 pages of market information,
delve into some of the fastest-growing and most critical areas of
clinical diagnostics: cancer diagnostics, molecular assays and systems,
and infectious disease tests.  Together, these three in vitro diagnostic
areas represent nearly one-half of the IVD market and the best growth
opportunities. The Bundle features the exact published content in each of the three major Kalorama studies, sold as intact PDFs with separate table of contents, including the following:

  • The World Market for Molecular Diagnostics, 6th Edition
    • In the World Market for Molecular Diagnostics, 6th Edition, Kalorama IVD market analyst Shara Rosen, R.T., MBA provides complete analysis of the IVD molecular testing kit and reagent industry by segment. In this report, exclusive  market sizing and forecasts are provided for the following diagnostic segments:
      • Cancer Markers & PGx
      • Histology (In situ hybridization, HPV)
      • Microbiology/Virology (HAI; HIV; Hepatitis; GC/Chlamydia; Respiratory;Organism ID; Mycobacteria, TB; Others)
      • Blood Screening
      • Coagulation & PGx
      • Prenatal Testing
      • Inherited Diseases Testing
      • Tissue Typing
      • Organ Transplant Testing (HLA Typing)
      • Circulating Tumor Cells (CTCs)
      • Clinical Sequencing
      • Flow Cytometry
      The amount of activity over the last few years is short of phenomenal with a continuous stream of new platforms, tests  and quality control materials for test standardization coming to market. There is intense competition but also opportunities for entrants in some areas.
  • The World Market for Cancer Diagnostics, 6th Edition
    • Kalorama has, in five previous editions of The World Market for Cancer Diagnostics, defined the oncology testing market. This 850-page report contains detailed market data on the following IVD segments for their use in cancer diagnostics:
      • Cancer IVD Market
      • Cancer Test Services Market
      • Sequencing in Cancer Testing
      • Tissue Function Tests
      • PSA, CEA and Other Immunoassays
      • Flow Cytometry
      • Pap and HPV Testing
      • FOB and Other Rapid Tests
      • Molecular Oncology Assays
      • Tissue Microarrays
      • Methylated DNA
      • In situ hybridization (ISH)
      • Immunohistochemistry (IHC)
      • Circulating Tumor Cells
      • Companion Testing and CDX Products
      The report also details investments and financing agreements for cancer diagnostics companies, selected agreements between cancer diagnostic companies, selected agreements between cancer diagnostic companies and other diagnostic companies, pharmaceutical companies and non-profit organizations, and selected acquisitions of cancer diagnostic companies. The report provides detailed company profiles in several sections.
  • The World Market for Infectious Disease Diagnostics
    • This report, The World Market for Infectious Disease Tests, contains detailed market estimates and forecasts for four major areas of infectious disease testing. Specific market details provided include:
      • ID/AST Test Market by Type (Auto ID/AST Systems, Manual ID/AST Systems, Blood Culture, Chromogenic Media, Rapid Micro)
      • ID/AST Leader Market Shares
      • Infectious Disease Immunoassays by Type (Lab-Based, POC, Home Testing)
      • Laboratory Infectious Disease
      • Immunoassays Sales by Disease(Hepatitis, HIV, Mycology, Parasitology, Respiratory, Sepsis, STDs, ToRCH, Others)
      • Infectious Disease Diagnostic Sales by Region – North America, Western Europe, Japan, China, India, Latin America, ROW (2015-2020)
      • Blood Screening Test Market Size and Company Market Share
      Trends in infectious diseases and in products are discussed. The information contained in this report has been assembled from primary and secondary data. Primary research was conducted via telephone conversations with selected diagnostic marketers of in vitro diagnostics to assess the current market and trends in laboratory medicine
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IVD Market Bundle
I.  The World Market for Cancer Diagnostics, 6th Edition (Histology [ISH, IHC, HPV, Pap], Flow Cytometry, PSA, CEA, Liquid Biopsy, FOB and Other Rapid, Image Cytometry, Sequencing, Digital Pathology, Molecular Assays) 
ONE: EXECUTIVE SUMMARY
OverviewScope and MethodologyMarket OverviewPrognosis for Growth
TWO: INTRODUCTION
Diagnosis and Treatment of CancerPoint of ViewTHREE: TECHNOLOGIES USED IN CANCER DIAGNOSTICS
Chromosome Analysis (Karyotyping)Cytology/Histology StainsTests for Fecal Occult BloodImmunoassaysOverview - ImmunoassaysImmunoassay Instrument PlatformsImmunohistochemistry (IHC)Flow CytometryFluorescence in situ Hybridization (FISH) and Chromogenic in situ Hybridization(CISH)Nucleic Acid Amplification TechnologiesAnalysis of Gene Expression Patterns (Gene Signatures)MicroarraysProtein MicroarraysDNA MicroarraysChromosomal MicroarraysTissue MicroarraysSequencing TechnologiesSanger SequencingEarly Next Generation Sequencing TechnologiesSequencing by Synthesis (SBS)Supported Oligonucleotide Ligation and Detection (SOLiD)Ion Torrent SequencingTrue Single Molecule Sequencing (tSMS)Single Molecule Real Time (SMRT) SequencingDNA Nanoball SequencingNanopore SequencingOther Sequencing TechnologiesMass SpectrometryMass Spectrometry TechnologyResearch and Clinical Applications of Mass SpectrometryCirculating Tumor DNA (Cell Free DNA)Circulating Tumor Cells (CTCs)Cell-Based Assays (Live Cell Cancer Tests)Digital Pathology and Image CytometryInformation Technology
FOUR: CANCER DIAGNOSTICS – APPLICATIONS
Assess Risk of Developing CancerCancer ScreeningCancer Screening – Pap Smear and Human Papillomavirus (HPV) TestingColorectal Cancer ScreeningProstate Cancer ScreeningScreening for Other CancersDiagnosis/Prognosis/Monitoring of CancerPersonalized Medicine/Companion Diagnostics/Precision TestingDrug MetabolismPredicting Response to TherapyFIVE: CANCER DIAGNOSTIC MARKETS
In Vitro Diagnostic Kits Marketed to Clinical LaboratoriesPoint-of-Care Tests for CancerClinical Laboratory Test Services
SIX: DEALS – CANCER DIAGNOSTICS
Investments and Financing Agreements for Cancer Diagnostic CompaniesAgreements with Other CompaniesAcquisitions of Cancer Diagnostic CompaniesSelected Other Agreements
SEVEN: CANCER DIAGNOSTICS – MARKET DRIVERS AND CHALLENGES
Cancer Diagnostic Market DriversAdvances in Technology Changing the Future of Cancer DiagnosticsImpact of Companion Diagnostic TestsLimited Tissue from Biopsies for Growing Number of Cancer TestsLaboratory Developed Tests and the FDACost and Reimbursement IssuesPhysician Education, Acceptance, and Use of New Cancer TestsCompetitionFuture Prospects
EIGHT: IN VITRO CANCER DIAGNOSTICS MARKET ANALYSIS
In Vitro Cancer Diagnostics Market by Geographical DistributionClinical Laboratory Testing Market – Cancer DiagnosticsIn Vitro Cancer Diagnostics Market SegmentsHistology/CytologyImmunoassaysRapid TestsMolecular (Nucleic Acid-Based) AssaysNINE: COMPANY PROFILES: CANCER DIAGNOSTIC COMPANIES
M Genomics Ltd.20/20 GeneSystems, Inc.AB SCIEXAbbott Laboratories Abcodia Ltd.Abingdon Health LtdAbnova CorporationACT Genomics Co., Ltd.Adaptive Biotechnologies CorporationAdmera Health (a GENEWIZ company)Advanced Cell DiagnosticsAffymetrix, Inc. Agena Bioscience Inc.Agendia NVAgilent Technologies Inc. Alere Inc. Ambry Genetics Corp.Amoy Diagnostics Co., Ltd.ANGLE plcApoCell, Inc.Applied Proteomics, Inc.Applied Spectral Imaging, Inc.Arbor Vita CorporationARKRAY, Inc.ARUP LaboratoriesAstra Biotech GmbHAsuragen, Inc.AsymmetRx Medical, Inc.Atossa Genetics Inc. AutoGenomics, IncAvant Diagnostics, Inc. (formerly Arrayit Diagnostics Inc.)Axela, IncAXO ScienceBeckman Coulter, Inc. (subsidiary of Danaher Corporation) Becton, Dickinson and Company (BD) BGI-ShenzhenThe Binding Site Group Ltd.Biocare Medical, LLCBiocartis SABiocept, Inc. Biodesix, Inc.BioFluidicaBioGenexBiological Dynamics Inc.BioMarker StrategiesbioMérieux SA BioMosaicsBio-Rad Laboratories, Inc. Bio-Reference Laboratories, Inc. (BRLI) BioSystemsbioTheranostics (a bioMérieux company)Biotype Diagnostic GmbHBioView LtdBoditech Med Inc. Cancer Genetics, Inc. Canopus Bioscience Ltd.Caprion, Inc.Caris Life SciencesCastle Biosciences, Inc.CDx DiagnosticsCelerus Diagnostics, Inc.Cellmid Ltd.Centogene AGCepheid CernosticsCirdan Imaging LtdClarient Diagnostic Services, Inc. (a GE Healthcare company)Clearbridge BioMedics Pte LtdColor Genomics, Inc.Counsyl, Inc.Cube Dx GmbHCynvenio Biosystems, Inc.CytoTest Inc.Dako A/S (an Agilent company)Danaher CorporationDermTech, Inc.DiaCarta, Inc.DiaSorin S.p.A.DiaTech OncologyEDP Biotech CorporationEiken Chemical Co., Ltd. EntroGen, Inc.Enzo Biochem, IncEnzo Life Sciences, Inc.Enzo Clinical Labs, Inc.Epic Sciences, Inc.Epigenomics AG Eutropics PharmaceuticalsExact Sciences Corporation Exosome Diagnostics, Inc.Fluxion Biosciences, Inc.Foundation Medicine, Inc. Fujirebio Inc.Fujirebio Diagnositics, Inc. GE Healthcare Genalyte, Inc.GeneCentric Diagnostics, Inc.Genection, Inc. (an Invivoscribe company)GeneDxGeneNews LimitedGenetic Technologies Limited / Phenogen Sciences, Inc. (U.S. division) GenomeDx BiosciencesGenomica S.A.U.Genomic Health, Inc. Genomic Vision Genoptix (a Novartis company)GenPath / GenPath Women’s Health and GenPath OncologyGuardant Health, Inc.HalioDxHealgen Scientific LLCHelomics CorporationHologic, Inc. HTG Molecular Diagnostics, Inc. Human Longevity, Inc.Icellate ABIkonisys, Inc.Illumina, Inc. ImCare BioTechImmunovia ABIncellDx, Inc.Inform Genomics, Inc.FinancingsOther AgreementsInivata Ltd.Innovations Exchange Pte Ltd (INEX)Insight Genetics, Inc.IntegraGen SA Integrated Diagnostics, Inc.Invitae Corporation Invivoscribe Technologies, Inc.Iris BioTechnologies Inc.Janssen Diagnostics / Janssen Diagnostics BVBAJanssen Diagnostics, LLCLaboratory Corporation of America (LabCorp) / Integrated Genetics Leica Biosystems Inc. (a Danaher company)Leica Microsystems (a Danaher company)Lifecode, Inc.MagArray, Inc.Martell Diagnostic Laboratories, Inc.Matrix-Bio, Inc.Mayo Medical Laboratories and Mayo ClinicMedical & Biological Laboratories Co., Ltd. (MBL)MBL International Corporation MDxHealth SA Metamark Genetics, Inc.MetaStat, Inc.MolecularMD CorporationMultiplicom NVMyriad Genetics, Inc.Myriad RBM, Inc. NanoIVD, Inc.NanoString Technologies, Inc. NeoGenomics, Inc. / NeoGenomics Laboratories NewGene Ltd.New Oncology AGNuclea Biotechnologies, Inc.Ohmx CorporationOmnyxOncimmune Ltd.Oncimmune (USA) LLC (acquired by HDL Inc.)Health Diagnostic Laboratory, Inc.OncoCyte CorporationOncoDNA SAOncoHealth Corp.Oncolab, Inc.Oncolys BioPharma Inc.Oncompass GmbHOnconome, Inc.OncoPlex Diagnostics (OncoPlexDx)Oncospire GenomicsOPKO Health, Inc. / OPKO Diagnostics Orion GenomicsOrtho-Clinical Diagnostics OvaGene Oncology Inc.Oxford Cancer Biomarkers Ltd.Oxford Gene TechnologyPacific Edge Limited Pathway Genomics CorporationPersonal Genome Diagnostics, Inc.PGXL LaboratoriesPhenomenome Discoveries Inc.Polymedco, Inc.PreTect ASPrognosDx Health, Inc.Provista Diagnostics, Inc.QIAGEN N.V.QuanDxQuanterix CorporationQuantuMDx GroupQuest Diagnostics RainDance Technologies, Inc.Randox Laboratories LtdRarecells SASResponse Genetics, Inc. Rheonix, Inc.RiboMed Biotechnologies, Inc.Roche Rosetta Genomics Ltd. ScheBo-Biotech AGScreenCellSequenom, Inc. Siemens Healthcare DiagnosticsSymbiodxSysmex Corporation TeloVISION, LLCTheranostics Health Inc.Thermo Fisher Scientific, Inc. Tosoh CorporationTosoh Bioscience, Inc. Transgenomic, Inc.TrimGen CorporationTrovaGene, Inc. Vela DiagnosticsVentana Medical Systems, Inc. (member of the Roche Group)Veracyte, Inc. Wako DiagnosticsWako Pure Chemical Industries, Ltd.,,LIST OF EXHIBITS

ONE: EXECUTIVE SUMMARY
Table 1-1: Worldwide Cancer Diagnostic Market, 2014 and 2019 (Global Cancer IVD Market, Clinical Laboratory Services) (in millions USD)
TWO: INTRODUCTION
Table 2-1: Estimated Global Incidence and Mortality due to Cancer, 2012
THREE: TECHNOLOGIES USED IN CANCER DIAGNOSTICS
Table 3-1: Selected Examples of Companies Marketing Fecal Occult Blood TestsTable 3-2: Selected Companies with Immunoassays and/or Automated Immunoassay Platforms on the Market or In Development for Cancer DiagnosticsTable 3-3: Selected Examples of Companies Marketing Rapid Lateral Flow Tests for Tumor AntigensTable 3-4: Selected Companies with Immunohistochemistry Tests on the Market or In Development for Cancer DiagnosticsTable 3-5: Selected Companies Marketing Flow Cytometry Platforms or ConsumablesTable 3-6: Selected Companies with in situ hybridization tests on the Market or In Development for Cancer Diagnostics (Company, Comment, Market Status)Table 3-7: Selected Companies with PCR or Other Nucleic Acid Amplification Based Tests for Cancer DiagnosticsTable 3-8: Selected Examples of Companies Analyzing Gene Expression Patterns (“Gene Signatures”) in TissuesTable 3-9: Selected Companies Developing/Marketing Cancer Diagnostic Products Based on Microarray TechnologiesTable 3-10: Selected Sequencing Technologies and PlatformsTable 3-11: Selected Diagnostic Companies and Clinical Laboratories with Sequencing-Based Cancer TestsTable 3-12: Selected Companies Developing/Marketing Mass Spectrometry- Based Oncology Diagnostic TestsTable 3-13: Selected Examples of Companies Developing/Commercializing Cancer Diagnostic Assays Based on ctDNATable 3-14: Selected Companies Working with Circulating Tumor Cells (CTCs)Table 3-15: Selected Companies Developing or Commercializing Cell-Based Assays for Cancer DiagnosticsTable 3-16: Selected Digital Pathology Companies
FOUR: CANCER DIAGNOSTICS – APPLICATIONS
Table 4-1: Selected Companies Developing/Marketing Assays to Determine Risk of CancerTable 4-2: Selected Companies Developing/Marketing Diagnostic Tests for HPVTable 4-3: Selected Companies Developing/Marketing Cancer IVD Tests for Colorectal Cancer ScreeningTable 4-4: Selected Companies Developing/Marketing Screening Tests for Prostate Specific AntigenTable 4-5: Selected Companies Developing/Marketing Other Tests for Prostate CancerTable 4-6: Selected Companies Developing/Marketing Screening Tests for Other CancersTable 4-7: Selected Widely Used Tumor MarkersTable 4-8: Selected Companies Developing/Marketing Tests for Diagnosis/Prognosis/Monitoring of CancerTable 4-9: Selected Companies Developing/Marketing Tests for Drug Metabolism – To Personalize Treatment of CancerTable 4-10: Selected Companies Developing/Marketing Tests to Predict Response to Therapy; Precision MedicineTable 4-11: Selected FDA Cleared/Approved Companion Diagnostic Tests
FIVE: CANCER DIAGNOSTIC MARKETS
Table 5-1: Selected Examples - Companies Developing and Marketing Cancer Diagnostics Tests and Platforms to Clinical LaboratoriesTable 5-2: Selected Examples - Companies Developing and/or Marketing Pointof-Care and/or Rapid Platforms and Tests for Cancer – Moving Beyond Lateral FlowTable 5-3: Selected Examples - Companies Developing and/or Offering Cancer Diagnostic Tests as Laboratory Developed Tests
SIX: DEALS – CANCER DIAGNOSTICS
Table 6-1: Selected Investments and Other Financing Agreements for CancerDiagnostic CompaniesTable 6-2: Selected Agreements Between Cancer Diagnostic Companies and Other Diagnostic Companies or Clinical LaboratoriesTable 6-3: Selected Agreements Between Cancer Diagnostic Companies and Pharmaceutical or Biopharmaceutical CompaniesTable 6-4: Selected Agreements Between Two Cancer Diagnostic CompaniesTable 6-5: Selected Other Cancer Diagnostic Company AgreementsTable 6-6: Selected Acquisitions of Cancer Diagnostic CompaniesTable 6-7: Selected Cancer Diagnostic Company Agreements with Academic or Other Non-Profit Organizations
EIGHT: IN VITRO CANCER DIAGNOSTICS MARKET ANALYSIS
Table 8-1: World Cancer Test Market (In Vitro Diagnostic Kits) by Region (North America, EU, Japan, ROW), 2014 and 2019 ($ millions)Table 8-2: World Cancer Test Market (Clinical Laboratory Test Services), 2014 and 2019 ($ millions)Table 8-3: Worldwide Market for Selected Cancer IVD Tests (Sold to ClinicalLabs) (Histology/Cytology, Immunoassays, Flow Cytometry, Rapid Tests, Molecular Assays, CTCs), 2014 and 2019 ($ millions)Figure 8-1: Geographical Distribution of Pap Smear Testing, 2013Table 8-4: Worldwide Histology/Cytology Sales (Pap Smears, Other [non-Pap] Stains, HPV, Immunohistochemistry, and In Situ Hybridization), 2014 and 2019($ millions)Table 8-5: Cancer Immunoassay Sales, Lab-Based (PSA, CEA, CA 125, AFP,Others), 2014 and 2019 ($ millions)Table 8-6: Rapid Cancer Test Sales by Test Category (FOB, PSA, NMP22, Other)Worldwide, 2014 and 2019 ($ millions)

II.  The World Market for Molecular Diagnostics, 6th Edition (Microbiology, Oncology, Blood Screening and Typing, Prenatal, Inherited Diseases, Coagulation, Organ Transplant, PCR, Sequencing, cfDNA, CTC, in situ hybridization, Others) 

ONE: EXECUTIVE SUMMARYIntroductionScope and MethodologyReport DesignSize and Growth of the MarketMarket TrendsTWO: INTRODUCTIONBackgroundThe Buzz Is OnDTC in 2015 – Building EvidenceSequencing Enters the ClinicExome SequencingMetabolomic ProfilingLiquid BiopsyInformation Technology Brings ClarityForensic Studies – An Emerging OpportunityMulti-omic ITMolecular Test Expansion Supported by Quality MeasuresTest PlatformsTests and Technologies in 2014Molecular Diagnostics and Target MarketsTHREE: DELIVERING MOLECULAR TESTS TO THE CLINICBackgroundThe Reimbursement EnvironmentPhysician UptakeThe U.S. ExperiencePersonalized Precision Medicine Advances and BarriersThe Service Industry Is Here to StayFOUR: SEQUENCING – HOW FAR CAN WE GO?BackgroundCompanies and TechnologiesMarket AnalysisSequencing Research ProjectsCancer More PersonalizedPathogen SequencingFIVE: MARKET ANALYSIS: WORLD MARKETSBackgroundWorldwide Opportunities for Molecular TestsThe United States of AmericaCanadaEuropeChinaSIX: THE MARKET FOR BLOOD MARKERS IN CANCERIntroductionPrecision Medicine and a New Molecular PerceptionBack to the Status QuoSEVEN: THE MARKET FOR MOLECULAR ASSAYS IN HEMATOLOGY: CELL-BASED MOLECULAR TESTSFlow CytometryMarket AnalysisEIGHT: THE MARKET FOR MOLECULAR ASSAYS IN COAGULATIONThrombophilia SNPsPharmacodiagnosticsNINE: HISTOLOGY AND CYTOLOGYBackgroundAdvanced Analysis ToolsSample PreparationIn Situ HybridizationHPV TestingCirculating Tumor CellsPharmacodiagnostic HistologyTEN: MICROBIOLOGY AND VIROLOGYIntroductionMarket OverviewPOC and Decentralized TestingSample PreparationTest ServicesAntimicrobial Drug ResistanceNext Generation Sequencing in MicrobiologyThe Human MicrobiomeEmerging Disease ThreatsBlood Culture & Hospital Acquired InfectionsHIVHepatitisSexually Transmitted Diseases (STDs)Respiratory Tract InfectionsTuberculosisFungal InfectionsMiscellaneous TestsELEVEN: THE MARKET FOR MOLECULAR ASSAYS IN BLOOD TRANSFUSION MEDICINEBlood Pathogen ScreeningBlood TypingTWELVE: THE MARKET FOR MOLECULAR ASSAYS IN ORGAN TRANSPLANT MANAGEMENTTechnological AdvancementsMarket AnalysisTHIRTEEN: THE MARKET FOR MOLECULAR ASSAYS IN PRENATAL AND NEWBORN SCREENINGIntroduction and Market DatacfNIPT – Perception, Perception, PerceptionParental Carrier ScreeningIn Vitro FertilizationcfDNA Market ExpansionNewborn ScreeningFOURTEEN: THE MARKET FOR MOLECULAR ASSAYS FOR INHERITED DISEASESAutismAlzheimer’s DiseaseCardiovascular DiseaseDiabetesPsychiatric DisordersGastrointestinal ConditionsRare DiseasesFIFTEEN: CONCLUSIONS AND STRATEGIC IMPLICATIONSLDTs to Market Cleared TestsEsoteric Testing Scenario in EuropeFuture OutlookStrategic ImplicationsSIXTEEN: MAJOR VENDORS AND COMPANIES TO WATCHMarket Drivers and LeadersReview of Top CompaniesAcquisitions, Alliances and CollaborationsLooking Beyond BordersSEVENTEEN: COMPANY PROFILES: THE TOP TIERAbbott DiagnosticsIntelligentMDx AlliancePLEX-IDIridicaHistologyAlere Inc.Beckman Coulter, Inc. / DanaherLab ServicesSequencingGenomicsInformation TechnologyBecton, Dickinson and Company (BD)The BD MAX EnterpriseOncologyHPVSequencingInitiativesMass SpectrometryFlow SpectrometryBio-Rad Laboratories, Inc.ControlsDigital PCRbioMérieux IncExpansionOncologyMolecular StrategySequencing ServiceDanaher CorporationGeneral Electric - GE HealthcareClarient Diagnostic Services, Inc.Hologic, Inc.Product NewsThe Gen-Probe BusinessPanther SystemBlood BankQuest ContractQIAGEN N.V.Personalized HealthcareInfectious Disease TestingTransplant Medicine and HAIsHPVCompanion DiagnosticsLiquid Biopsy/CTCInstrumentation BaseRotor-Gene Q – Clinical DiagnosticsSequencingExosomesInformation TechnologyCollaborationsForensicsRoche DiagnosticsNew EnterprisesGlobal Access Program for HIVCore Molecular TestsSTDsA POC Enterprise – LiatPrenatal and cfDNAHPVBlood BankLiquid BiopsySequencing – Putting the Pieces TogetherSiemens Healthcare DiagnosticsHistologyMolecularCompanion DiagnosticsSequencingChinaSysmex CorporationInostics GmbHIntraoperative TestFlow CytometryThermo Fisher Scientific Inc.Molecular MicrobiologyMicrobiology ITTransplantQuality ControlMass SpectrometryEIGHTEEN: COMPANY PROFILES: MAJOR MOLECULAR COMPANIESAffymetrix Inc.Agilent TechnologiesAgilent in GenomicsPCRSequencingArraysSample ManagementMass SpectrometryExpansionAsuragen Inc.ControlsSample CollectionSequencingBGIWith Complete GenomicsBGI ProjectsCepheidHospital Acquired Infections (HAI)TBInfectious DiseasesVirologyOncologyEiken Chemical Co., LtdEnzo Biochem Inc.IP SituationIlluminaSequencingSequencing KitsSample PrepIVD BusinessOncologyHLA TypingITForensicsCLIA Lab ServiceNanopore SequencingSample to InsightMaking a MarketIP SituationLife Technologies CorporationInstrumentation and ApplicationsLiquid BiopsySequencingLife Technologies an IVD CompanyPartnerships WorldwideLife and Quidel Develop Diagnostics on the 7500 Fast DxSepsisHIVEmerging PathogensBacterial TypingPersonalized MedicineForensicPerkinElmer, Inc. (PE)Newborn TestingPrenatal TestingSequencingMass SpectrometryInformation TechnologyChinaRainDance Technologies, Inc.Market ExpansionNINETEEN: COMPANY PROFILES: PARTICIPANTSAutoGenomics Inc.Biocartis SAConnectivityInstrumentationCollaborationsIdylla NewsDiaSorin S.p.AEKF Diagnostics Holdings PlcELITech GroupEpigenomicsExosome Diagnostics, Inc.Fluidigm CorporationFujirebio Diagnostics, Inc.GenMark DiagnosticsGenome Diagnostics BV (GenDx)Luminex CorporationBusiness ExpansionMAGPIX MultiplexingNext Generation NxTagProduct NewsMenarini DiagnosticsNanostring Technologies, Inc.AlliancesLDTsPacific Biosciences of California, Inc. (PacBio)Quidel CorporationLyra Product LineSolana Molecular SystemAmpliVue Product LineSavanna (formerly Wildcat)AcquisitionsRubicon Genomics, Inc.Transgenomic, Inc.AlliancesLab ServicesDiagnostic Tools DivisionTrovaGene, Inc.WaferGen Bio-systems, Inc.TWENTY: COMPANY PROFILES: GREAT EXPECTATIONSGenomic VisionGENOMICA S.A.U.IncellDx, Inc.InivataIntegenX IncLinkage Biosciences, Inc.Savyon DiagnosticsSelventaVolitionRx LimitedTWENTY-ONE: COMPANY PROFILES: NEWCOMERSB Braun CeGaT, LLCCanon BioMedical, Inc.DestiNA Genomics LtdDiamiR, LLCRandox Laboratories Ltd.TWENTY-TWO: COMPANY PROFILES: TEST SERVICE PROVIDERS23andMeWhat a Difference a Few Years MakesThe Move to Building a Research CompanyTherapeutics GroupAncestryOutside the U.S.Adaptive Biotechnologies CorporationAgendia BVAltheaDx Diagnostics, Inc.Ambry GeneticsOncologyCardiacPrenatalInformation TechnologyARUP LaboratoriesAssurex HealthAthena DiagnosticsBio-Reference Laboratories, Inc. (BRLI)bioTheranosticsCancer Genetics, Inc. (CGI)The Response Genetics AcquisitionCareDx, Inc.Caris Life SciencesCentogene AGComplete GenomicsCounsylExact Sciences Corp.Foundation Medicine Inc.Genomic Health, Inc.Market UptakeSequencingLiquid BiopsyService Spin OffHelomics CorporationIntegraGenInvitae CorporationLabCorp, Laboratory Corporation of AmericaInfectious DiseasesPrenatalSequencingOncologyBRCA SagaInformation TechnologyForensicCollaborationsMayo Medical LaboratoriesInformation TechnologyMDxHealth SAMyriad GeneticsProduct NewsCompanion TestsBeyond CancerThe U.S. MarketIP UpdatePathway Genomics CorporationQuest DiagnosticsOncologyToxicologyPrenatal and Women’s HealthMarket ExpansionQuest Partners for Market AccessibilityRosetta Genomics Ltd.ExpansionVeracyte, Inc.TWENTY-THREE: COMPANY PROFILES: POINT OF CARE TEST SPECIALISTSAtlas Genetics Ltd.Biomeme, Inc.DiAssess IncDNA Electronics Ltd (DNAe)Enigma Diagnostics LimitedEntopsisEpistem Holdings plcInSilixa Inc.LucigenPositiveID CorporationQuantuMDx Group LimitedRheonix, Inc.Scanogen Inc.UbiquitomeVeredus Laboratories Pte LtdXagenicTWENTY-FOUR: COMPANY PROFILES: SAMPLE PREPARATIONHorizon Discovery Group plcMO BIO Laboratories, Inc.PreAnalytiX GmbHQIAGEN N.V.SeraCare Life Sciences, Inc.TWENTY-FIVE: COMPANY PROFILES: INFORMATION TECHNOLOGY SPECIALISTSAdvaita BioinformaticsApple Inc.CartageniaCerner Corp.CLC bioCollabRx Inc.DNAnexusGENALICEGenomOncologyGoogle GenomicsIBM HealthcareIntel CorporationKnome Inc.CollaborationsN-of-OnePierianDxSophia GeneticsTWENTY-SIX: COMPANY PROFILES: HISTOPATHOLOGY SPECIALISTSAdvanced Cell Diagnostics (ACD)Amoy Diagnostics Co. Ltd.Applied Spectral Imaging Inc. (ASI)BioView Ltd.Circulomics Inc.Covaris Inc.Cymogen Dx, LLCDako A/SCompanion DiagnosticsDigital ImagingFlow CytometryAutomationAlliancesDefiniensDxTerity Diagnostics Inc.HTG Molecular DiagnosticsLeica BiosystemsCompanion DiagnosticsPreTect AS (formerly Norchip)Kapa Biosystems Inc.Ventana Medical Systems Inc.Digital PathologyVirtuoso Software UpdateProduct NewsAutomationChinaPartnershipsTWENTY-SEVEN: COMPANY PROFILES: MICROBIOLOGY SPECIALISTSAccelerate Diagnostics, Inc.Advanced Biological Laboratories, S.A. (ABL)AdvanDx, Inc.altona DiagnosticsAperiomicsCo-Diagnostics HBDCCuretis AGDxNA, LLCFast-Track DiagnosticsFocus Diagnostics, Inc.Genetic Analysis ASGreat Basin Scientific, Inc.Greiner Bio-One International GmbHHain Lifescience GmbHHutman Diagnostics AGIntelligent Medical Devices, Inc. (IMDx)Abbott Diagnostics PartnershipQiagen PartnershipMeridian Bioscience, Inc.illumigeneMeridian Life ScienceMobidiag LtdMolbio Diagnostics Pvt Ltd.Nanosphere, Inc.Market ExpansionPathoGenetix, Inc.PathogenicaReference Genomics Inc.Seegene, Inc.InstrumentationCollaborationsSpecific TechnologiesT2 BiosystemsTWENTY-EIGHT: COMPANY PROFILES: BLOOD BANK SPECIALISTSAXO ScienceGrifolsBlood Transfusion Novartis BusinessInternational ProgramsImmucor, Inc.TWENTY-NINE: COMPANY PROFILES: PRENATAL TEST SERVICE PROVIDERSAriosa Diagnostics, Inc.IP StatusBerry Genomics Co. LtdCombimatrix Corp.OncologyGood Start Genetics, Inc.IlluminaIP IssuesCytogeneticsLifeCodexx AGMultiplicom N.V.NateraPremaitha Health plcSequenom IncMarket ExpansionProduct ExpansionIP IssuesCoagulationTHIRTY: COMPANY PROFILES: CTC & LIQUID BIOPSY TEST PROVIDERSAngle plcApoCell, Inc.Biocept, Inc.Menu ExpansionReimbursementClearbridge BioMedicsCynvenio Biosystems, Inc.EpicFluxion Biosciences, Inc.Genyo – Centre for GenomicsQiagen Hanover (formerly AdnaGen GmbH)ScreenCellVeridex, LLCWaveSense LLCLIST OF EXHIBITSONE: EXECUTIVE SUMMARYTable 1-1: Common Next Generation Molecular Test TraitsTable 1-2: Selected Salient Developments for Now and the FutureTable 1-3: Exchange Rate Fluctuations, 2009-2014 (Europe, Switzerland, UK, Denmark, Sweden, Norway, Japan, Hungary, Singapore, India)Table 1-4: Worldwide Molecular Test Sales, 2014 and 2019 (Microbiology/Virology Histology, Blood Screening, Coagulation & PGx, Inherited Diseases & PGx, Tissue Typing, Cancer Markers & PGx, CTCs, Total)Figure 1-1: Worldwide Molecular Test Sales, 2014-2019 (CTCs, Cancer Markers & PGx,Tissue Typing, Inherited Diseases & PGx, Coagulation & PGx, Blood Screening, Histology, Microbiology/Virology)Table 1-5: Market Penetration of Clinical Molecular Diagnostics by Geographic Area,2014 and 2019 (N. America, W. Europe [EU5], Japan, China, India, ROW, Total)TWO: INTRODUCTIONTable 2-1: Common Next Generation Molecular Test TraitsTable 2-2: Selected Salient Developments for Now and the FutureTable 2-3: Selected Exosome Sequencing Tests and ServicesTable 2-4: Selected Liquid Biopsy InnovationsTable 2-5: Selected IT Innovations in Molecular DiagnosticsTable 2-6: Selected Innovations in Forensic DNA TestingTable 2-7: Selected Multi-omic Test InnovationsTable 2-8: Selected Sample Preparation Tools, 2015Table 2-9: Selected Molecular Test Quality Control StandardsTable 2-10: Key Molecular TechnologiesTable 2-11: Selected Molecular Test Platform InnovationsTable 2-12: Worldwide Molecular Test Sales, 2014 and 2019 (Microbiology/Virology, Histology, Blood Screening, Coagulation & PGx, Inherited Diseases & PGx, Tissue Typing, Cancer Markers & PGx, CTCs, Total)Table 2-13: Key Molecular Test Applications and TechnologiesTable 2-14: Selected Rapid Molecular Test Innovations, 2013-2015THREE: DELIVERING MOLECULAR TESTS TO THE CLINICTable 3-1: Diseases with Drug LabelsTable 3-2: Selected Drug/Biomarker Targets in the U.S.Table 3-3: Selected Drugs That Recommend PGx Testing in EuropeTable 3-4: Selected Personalized Medicine Tests, 2013-2015Table 3-5: Revenues for a Selection of Molecular Test Service Labs Worldwide, 2010-2014Table 3-6: Selected New Lab Services, 2015FOUR: SEQUENCING – HOW FAR CAN WE GO?Figure 4-1: Flatley’s LawTable 4-1: Major Sequencing PlatformsTable 4-2: Selected Sequencing-Based Test ServicesFIVE: MARKET ANALYSIS: WORLD MARKETSTable 5-1: Selected International AgreementsTable 5-2: Market Penetration of Clinical Molecular Diagnostics, by Geographic Area, 2014 and 2019 (N. America, W. Europe [EU5], Japan, China, India, ROW, Total)SIX: THE MARKET FOR BLOOD MARKERS IN CANCERTable 6-1: Selected Sample Preparation ReagentsTable 6-2: Selected Cancer Test Innovations, 2015SEVEN: THE MARKET FOR MOLECULAR ASSAYS IN HEMATOLOGY:CELL-BASED MOLECULAR TESTSTable 7-1: Selected Innovations in Molecular Cell-Based TestsEIGHT: THE MARKET FOR MOLECULAR ASSAYS IN COAGULATIONTable 8-1: Selected Molecular Pharmacodiagnostics for Anticoagulant Drug Testing, 2014NINE: HISTOLOGY AND CYTOLOGYTable 9-1: Worldwide Molecular Histology Sales, by Type, 2014 and 2019 (In situ hybridization, HPV, Histology Total)Table 9-2: Selected Molecular Histology Innovations, 2015Table 9-3: Selected FFPE DNA/RNA Sample Preparation InnovationsTable 9-4: Selected HPV Test InnovationsTable 9-5: Selected Innovations in CTC TechnologyTable 9-6: Major Pharmacodiagnostic MarkersTable 9-7: Selected Pharmacodiagnostic Histology TestsTEN: MICROBIOLOGY AND VIROLOGYTable 10-1: Molecular Test Sales, Microbiology/Virology, 2014 and 2019 (HAI; HIV; Hepatitis; GC/Chlamydia; Respiratory; Organism ID; Mycobacteria, TB; Others; Total)Table 10-2: Molecular Infectious Disease Company Sales, 2014Table 10-3: Selected New Instruments for Molecular Infectious Disease Testing,2015Table 10-4: Selected Molecular Test Innovations for Decentralized UseTable 10-5: Selected Molecular Infectious Diseases Sample Treatment ProductsTable 10-6: Selected Molecular Infectious Disease Test ServicesTable 10-7: Selected Tests for Antibiotic ResistanceTable 10-8: Selected Microbiology Sequencing InnovationsTable 10-9: Selected Microbiome-Based DiagnosticsTable 10-10: Tests with Emergency Use DesignationTable 10-11: Selected Innovations in Emerging Pathogen TestingTable 10-12: Selected Advanced Techniques for Hospital Acquired InfectionsTable 10-13: Selected Recent Molecular HIV Test InnovationsTable 10-14: Selected Molecular Hepatitis Test InnovationsTable 10-15: Selected Molecular STD Test InnovationsTable 10-16: Selected Molecular Tests for Respiratory Tract InfectionsTable 10-17: Selected Molecular Tests for TBTable 10-18: Selected Molecular Tests for Fungal InfectionsTable 10-19: Miscellaneous Molecular Infectious Disease Tests, 2013-2015ELEVEN: THE MARKET FOR MOLECULAR ASSAYS IN BLOOD TRANSFUSION MEDICINETable 11-1: Pathogen Commonly Tested in Donated Blood UnitsTable 11-2: Selected Pathogen Screening InnovationsTable 11-3: Selected Blood Typing InnovationsTWELVE: THE MARKET FOR MOLECULAR ASSAYS IN ORGAN TRANSPLANT MANAGEMENTTable 12-1: Selected HLA Typing Test Innovations, 2015Table 12-2: Selected cfDNA Innovations in Transplant MedicineTHIRTEEN: THE MARKET FOR MOLECULAR ASSAYS IN PRENATAL AND NEWBORN SCREENINGTable 13-1: Revenue Stream of Selected NIPT Service Companies, 2010-2015Table 13-2: Selected New IVF ServicesTable 13-3: Selected Genomic Newborn Screening ServicesFOURTEEN: THE MARKET FOR MOLECULAR ASSAYS FOR INHERITED DISEASESTable 14-1: Most Frequently Requested Genetic TestsTable 14-2: Selected Autism Test InnovationsTable 14-3: Selected Innovations in Genetic Tests for CVD, 2015Table 14-4: Selected Molecular Diabetes Tests, 2015Table 14-5: Selected Innovations in Personalized Tests for Psychiatric DisordersTable 14-6: Selected Tests for Irritable Bowel DiseasesTable 14-7: Selected Molecular Tests for Inherited Diseases, 2015SIXTEEN: MAJOR VENDORS AND COMPANIES TO WATCHTable 16-1: Estimated Revenues of the Top Ten Molecular Test Vendors, 2010-2014Table 16-2: Estimated Revenues of Selected Molecular Test Vendors, 2010-2014Table 16-3: Selected Acquisitions in Molecular Diagnostics, 2013-2015Table 16-4: Selected Collaborations and Licensing Agreements, 2013-2015Table 16-5: Selected Distribution Agreements, 2013-2015

III.  The World Market for Infectious Disease Diagnostic Tests 
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