The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 8th Edition

Jul 27, 2012
1400 Pages - Pub ID: KLI3811539
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In eight best-selling editions, Shara Rosen has detailed the market for in vitro diagnostic (IVD) testing, throughout the world,  in one complete volume. The report, The Worldwide Market for In Vitro Diagnostic Tests, is a testament to the Kalorama methodology. Real industry knowledge combined with an exhaustive review of the medical, business, and company literature. Market numbers for business planning matched with a discovery of the trends that are impacting the industry. A realistic forecast five years into the future for companies already participating in or considering entry into this growing industry.

Comprehensive Coverage of a High Interest Industry

This year, Kalorama has published its eighth edition of this informative volume based on the market events of 2011. The report is over 1400 pages, reflecting the dramatic change in IVD.  New entrants, net technologies have entered the stage and all important events are cataloged in this report.  The idea behind Kalorama's unique report is that the entire market can be captured in one volume and business planners avoid multiple purchases. Published every two years, this volume includes coverage of the most important aspects of all of the major segments of clinical lab testing, including:

  • Point of Care (POC), (Professional and Self-Testing)
  • Histology and Cytology (Pap, ISH, IHC, traditional non-pap, HPV)
  • Core Lab (General Chemistries, Workstations, Analyzers)
  • Immunoassays (Blood Gases, Urinalysis, Critical Care)
  • Molecular Assays (Infectious Disease, Blood Screening, Inherited Diseases, Oncology, Pharmacodiagnostics, Tissue Typing, Prenatal)
  • Hematology
  • Coagulation (Lab-Based, POC, Genetic Markers)
  • Microbiology and Virology
  • Blood Banking (Grouping, Immunoassay Screens, NAT Screens)
Market sizes, forecasts and shares are provided, as well as a geographic breakdown of the segments, where possible. Changes in technology development, regulatory and reimbursement issues, clinical care, and business environments are discussed. Current market numbers are presented for 2011, with projections given through 2016.

The "Bible of the IVD Industry"

Now in 8 editions, this report has become the go-to market research reference for the industry.  Many of the top IVD companies use this product for business planning, which means that this volume can provide a uniform standard for in vitro diagnostic market numbers. This edition greatly expands coverage of the field and tracks the most important developments.  See aspects of the industry that might not be available in your company's internal resources.  View the market from an independent point of view.  Learn about competitors in away that may be invisible to internal personnel.  Know the market players - your competitors and potential partners, in proper context and classification.  Save countless hours of staff time and other research expenses with the authoritative guide for IVD market estimates and forecasts.

A Global Report

From the first edition, this report was designed as a global resource in order to give market-watchers a true picture of the industry.  IVD is a worldwide business. While the US is a large healthcare market, much of the dynamism, the growth, and also competition is occurring in other areas. Many of the most interesting opportunities for companies are occurring in emerging markets. As part of its coverage, the report breaks down the entire IVD market for the following regions.

  • North America
  • Europe (EU countries, incl. IVD market sizes by country)
  • Eastern Europe
  • South America
  • Asia (Japan, China and India)
  • Rest of World
A Report Designed for a Changing Industry
A number of totally disparate phenomena have come together to change the IVD industry. Human genome research is finding links between a person’s genome and several lifestyle situations such as nutrition, dieting, skin conditions and other essentially non-medical conditions. This has attracted consumer product companies such as Proctor & Gamble and Nestlé to develop products and services based on IVD technologies. Decreases in life science grants has encouraged companies active in this space to migrate their technologies for clinical applications.

 The result is the entry of companies such as Caliper Life Sciences, Illumina, Affymetrix and Life Technologies to the diagnostics market with products and test services. Miniaturization of traditional immunoassay and molecular test technologies has finally matured to the point where they may be ready for scale-up and then commercialization into products. Here electronics companies such as Sony, Samsung, Dell Computers and Intel Corp. have invested in clinical diagnostics ventures. These exciting developments join expansion into new market segments by companies already involved in the IVD industry.

In 2010 and 2011, there were at least 74 acquisitions and some 36 distribution agreements. And this is only a small portion of what is really happening. There are many more deals that have not been announced. The goal is to build better tests and stronger companies. The future of the industry lies in the development of more sensitive, faster, user-friendly, IT capable devices for a host of new protein and molecular markers.

In this eighth edition of The Worldwide Market for In Vitro Diagnostic Tests Kalorama Information addresses all of the key issues affecting the diagnostic industry in 2012 and how competitors are faring. Among the topics tackled in this report:

Molecular diagnostics including infectious disease mdx, pharmacodiagnostics, molecular poc and test services are put in a context.

  • Merging IT and IVD: Establishing the EMR Record from IVD Tests
  • Healthcare Reform and its Possible Impact on IVD.
  • The Status of Automation in the Lab; Core Lab Section Includes Both Workstation and Automated Panel Revenues.
  • Mass Spec, Next Gen Sequencing and Other Technology Entrants
  • Hospital Infection Testing - the latest
  • Several Hundred Company profiles. Top tier companies, Second and Third Tier companies but also Smaller Innovators. The report‘s profiles distinguish between companies that are leaders in all aspects of IVD, those that are Specialists in one particular area or a few.
  • Major Mergers as well as Partnerships, Distribution Agreements.
  • Brazil, India and China - Important Emerging Markets for IVD.  
  • Innovations in Blood Banking
  • Histology/Cytology innovations; the role of FISH testing and Digital Images
  • Healthcare statistics for various countries -healthcare spending as a percent of GDP, new hospitals, cost increases and other information.
  • Tables that document the most competitive products on the market and under development in each area of IVD.
  • Country-level Breakout of IVD market for major European and Asian countries.
  • The Current Economic Situation
  • Update on the Regulation of Novel Devices
CHAPTER ONE: EXECUTIVE SUMMARY
  • Introduction – Doing more with less
  • Scope and Methodology
  • Size and Growth of the Market
  • Market Trends
CHAPTER TWO: INTRODUCTION
  • Background
  • Report Design
  • Lab Medicine Disciplines And Applications
  • Market Analysis of IVD Market Segments
  • The lure of IVD – new majors and entrants
  • Licenses and distribution agreements
  • Test Services
  • Top Suppliers and Niche players
  • Point of View
CHAPTER THREE: OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC MARKETS
  • Background
  • Population and Disease Demographics, Worldwide
  • Chronic Diseases as a Market Driver
    • Cancer
    • Diabetes
    • Allergy
  • The BRIC Effect
  • World Segments of the IVD Market and IVD Market Evolution
  • Specific Country Information
  • The United States of America – a world in flux
    • RUO/IUO Issues
    • The Patient Protection and Affordable Care Act
    • Accountable Care Organizations
    • LDT Oversight
    • Accent on Preventative Care
    • In Patient Bundling
    • Molecular test reimbursement
  • Japan
  • Europe – effects of austerity
    • IVD Directive Update
  • China
  • India
  • Brazil
  • Russia
CHAPTER FOUR: TRENDS AND INNOVATION
  • Background
  • Looking to the East
  • Looking Past the Hospital ER
  • Telemedicine and Home Care Trends
  • Commercialization of Novel Tests
  • EMR Update
  • Wireless Connectivity and Healthcare Efficiencies
  • Apps everywhere
  • The search for non-invasive tools
CHAPTER FIVE: POINT-OF-CARE TEST PLATFORMS
  • Overview of POC Tests
  • The Major POC Test Players
  • Market Analysis
    • Blood Glucose Monitoring
    • Blood Glucose Self Testing
    • Continuous Self Testing
    • Blood Glucose Testing by Professionals
    • Diabetes Testing – Glycated Hemoglobin
    • The Genetics of Diabetes
  • The Commercial Outlook for POC Tests
CHAPTER SIX: THE CORE LAB
  • Core Lab Overview
  • Overview of Chemistry Tests
  • Market Analysis : Leading Suppliers and Growth Potential
    • Lab-based Chemistries
    • Critical Care Analysis
    • Urinalysis
  • The Commercial Outlook for the Core Lab
CHAPTER SEVEN: IMMUNOASSAYS
  • Overview of Immunoassays
  • Market Analysis
    • Immunoassay Test Segments - Mature and Emerging
    • Point-of-care OTC and Professional Use
  • The Commercial Outlook for Immunoassays
CHAPTER EIGHT: MOLECULAR ASSAY PLATFORMS
  • Overview of Molecular Assays
  • Worldwide Opportunities for Molecular Tests
  • Molecular Test User Markets
  • Next generation Sequencing
  • Mass Spectroscopy
  • Molecular Technologies And Players
  • Market Analysis
    • Oncology
    • Inherited Diseases
    • Pharmacodiagnostics
    • Prenatal Chromosome Analysis
    • Tissue Typing
  • The Commercial Outlook for Molecular Tests
CHAPTER NINE: HEMATOLOGY
  • Overview of Hematology
    • Automation and IT
    • Digital Evolution
  • Decentralized Hematology Testing
  • Market Analysis : Leading Suppliers
  • The Commercial Outlook for Hematology Tests
CHAPTER TEN: COAGULATION
  • Overview of Coagulation / Immunohematology Tests
  • Special Topic
    • Genetics and Personalized Medicine
    • Warfarin
    • Plavix
  • Market Analysis
    • Lab-based Testing
    • Genetic markers of hypercoagulopathies
    • Decentralized Coagulation testing – Professional Use
    • Decentralized Coagulation testing – OTC
    • Platelet Testing
    • Leading Suppliers
  • The Commercial Outlook for Coagulation Tests
CHAPTER ELEVEN: MICROBIOLOGY AND VIROLOGY
  • Overview of Microbiology / Virology Tests
  • Special Topics
    • Antimicrobial Drug Resistance
    • Genome Sequencing and Mass Spectrometry
    • Sepsis Serology
  • Market Analysis
    • Supplies
    • Chromogenic Media
    • Microbial Identification and Antimicrobial Sensitivity Tests
    • Liquid Microbiology
    • Blood Culture
    • Immunoassays – lab based
    • Immunoassays – rapid
    • Molecular Tests
  • The Commercial Outlook for Microbiology / Virology Tests
CHAPTER TWELVE: BLOOD BANKING SERVICES
  • Overview of Blood Banking
  • Blood Management – are all these transfusions good medicine
  • Blood Tracking
  • Chagas Disease
  • Platelet Safety
  • Market Analysis
    • Blood Grouping
    • Immunoassay Screens
    • Nucleic Acid Testing Continues to Grow
    • Leading Suppliers
  • The Commercial Outlook for Blood Banking
CHAPTER THIRTEEN: HISTOLOGY AND CYTOLOGY
  • Overview of Histology / Cytology
  • Special Topics
  • Companies expand with test services
  • Market Analysis
    • Histology/Cytology
      • Traditional Stains
      • Pap and HPV Tests
    • Immunochemistry and In Situ Hybridization
    • Pharmacodiagnostic Histology
    • Digital Imaging
    • Tissue Microarrays
    • Circulating Tumor Cells
    • Chromosome Analysis
    • Flow Cytometry
  • The Commercial Outlook for Histology and Cytology Tests

COMPANIES PROFILED

CHAPTER FOURTEEN: The Top Tier

    Abbott Diagnostics
  • Alere
  • Arkray
  • Beckman Coulter Inc.
  • Becton, Dickinson and Company (BD)
  • bioMérieux Inc.
  • Bio-Rad Laboratories Inc.
  • Danaher Corporation
  • Gen-Probe Inc.
  • Hologic, Inc.
  • Horiba Medical
  • Instrumentation Laboratory (IL)
  • Ortho Clinical Diagnostics
  • QIAGEN N.V.
  • Radiometer A/S
  • Roche Diagnostics
  • Siemens Healthcare Diagnostics
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.
CHAPTER FIFTEEN: The Second Tier
  • Affymetrix, Inc.
  • Agilent Technologies Inc.
  • Axis-Shield plc
  • Bruker BioSciences Corporation
  • Celera Diagnostics
  • Cepheid
  • China Medical Technologies
  • Dako A/S
  • DiaSorin S.p.A.
  • Eiken Chemical Co., Ltd
  • ELITech Group
  • Fujirebio Diagnostics, Inc.
  • General Electric - GE Healthcare
  • Grifols, S.A.
  • Illumina Inc.
  • IRIS International, Inc.
  • Life Technologies
  • Luminex Corporation
  • Magellan Biosciences
  • A. Menarini Diagnostics
  • Mindray Bio-Medical Electronics Co., Ltd
  • Nanosphere, Inc.
  • Nova Biomedical
  • Novartis Diagnostics
  • PerkinElmer, Inc.
  • Phadia AB
  • Quidel Corporation
  • Randox Laboratories Ltd.
  • Sequenom
  • Tosoh Corporation
  • Transasia Bio-Medicals Ltd.
  • Trinity Biotech plc
  • Ventana Medical Systems Inc.
  • Veridex, LLC
  • Wako Pure Chemical Industries, Ltd.
  • Werfen Group S.A
CHAPTER SIXTEEN: The Third Tier
    Arrayit Diagnostics Inc.
  • Astra Biotech GmbH
  • BG Medicine, Inc.
  • Caliper Life Sciences
  • Enzo Biochem Inc.
  • Epigenomics AG
  • Idaho Technology Inc.
  • Innogenetics NV
  • International Technidyne Corp (ITC)
  • Intrinsic Bioprobes Inc.
  • Ivax Diagnostics Inc.
  • Linkage Biosciences, Inc.
  • Millipore – EMD Millipore
  • Mitsubishi Chemical Medience Corporation
  • Nanosphere, Inc.
  • OPTI Medical Systems
  • OptiGene Ltd
  • Polymedco, Inc.
  • Radient Pharmaceuticals Corporation
  • Seegene, Inc.
  • SensiGen LLC
  • Spartan Bioscience Inc.
  • TessArae, LLC
  • Transgenomic, Inc.
  • TrimGen Genetic Technology
  • TrovaGene, Inc.
  • Vermillion Inc
CHAPTER SEVENTEEN: Blood Bank Specialists
  • AbSorber AB
  • Alien Technology
  • AXO Science
  • BIO-key International, Inc.,
  • BloodCenter of Wisconsin
  • Cerus Corporation
  • Core Dynamics
  • CytoSorbents Corporation
  • Fenwal Inc.
  • GMS Biotech
  • Haemonetics Corporation
  • Immucor, Inc.
  • Immunetics Inc.
  • Mediware Information Systems, Inc.
  • Monash University
  • Progenika Inc.
  • Quotient Biodiagnostics Inc.
  • Terumo Corporation
  • Transfusion Management Services, Inc. (TxMS)
  • Verax Biomedical Inc.
CHAPTER EIGHTEEN: Coagulation Specialists
  • Accumetrics
  • Diagnostica Stago
  • Gamma Therapeutics, Inc.
  • Microvisk Technologies
  • Novo Nordisk
  • TCoag
CHAPTER NINETEEN: Diabetes Specialists
  • AgaMatrix, Inc.
  • ALR Technologies Inc.
  • Animas Corporation
  • Bayer Diabetes Care
  • Breath Testing at Home
  • C8 MediSensors
  • Cellnovo, Inc.
  • DexCom, Inc.
  • Diagnostic Devices, Inc.
  • Echo Therapeutics, Inc.
  • Entra Health Systems
  • Epinex Diagnostics, Inc.
  • Glycomark
  • GlySens Incorporated
  • HealthPartners
  • Infopia Co Ltd
  • Insulet Corporation
  • Integrity Applications Ltd.
  • Lifescan Inc.
  • Luminous Medical, Inc.:
  • Mayo Clinic
  • Medtronic Inc.
  • MicroCHIPS, Inc.
  • Nipro Diagnostics/Home Diagnostics, Inc.
  • OptiScan Biomedical Corporation
  • OrSense Ltd.
  • Oxford Medical Diagnostics (OMD)
  • PositiveID Corporation
  • Solianis Monitoring AG
  • Tandem Diabetes Care, Inc.
  • TelCare Inc.
  • VeraLight, Inc.
CHAPTER TWENTY: Hematology Specialist
  • Accuri Cytometers
  • Burnet Institute
  • CellaVision AB
  • Constitution Medical, Inc.
  • Guava Technologies, Inc.
  • Partec GmbH
  • PointCare Technologies
  • QBC Diagnostics, Inc.
  • Zyomyx Inc.
  • Chapter 20A
CHAPTER TWENTY A: Companies Specializing in Circulating Tumor Cells
  • ApoCell, Inc.
  • Clearbridge BioMedics
  • NaturalNano, Inc.
  • On-Q-ity
  • RareCyte, Inc.
  • ScreenCell
CHAPTER TWENTY-ONE: Histology Specialists
  • Advanced Cell Diagnostics
  • Almac Diagnostics
  • Aperio Technologies, Inc.
  • Biocare Medical, LLC
  • BioGenex Laboratories, Inc.
  • BioImagene
  • BioMarker Strategies
  • Biomoda Inc.
  • Cambridge Research & Instrumentation, Inc.
  • Cancer Genetics, Inc.
  • Celerus Diagnostics
  • Cernostics, Inc.
  • ChipDX, LLC
  • CytoCore, Inc.
  • Definiens
  • Foundation Medicine Inc.
  • Genetix Applied Imaging
  • HistoRx, Inc.
  • Holomic LLC
  • Horizon Discovery Ltd
  • HTG Molecular Diagnostics
  • Ikonisys, Inc.
  • Leica Microsystems
  • Massachusetts General Hospital
  • Maven Biotechnologies histo
  • OvaGene Oncology Inc.
CHAPTER TWENTY-TWO: Immunoassay Specialists
  • Abkine Pharmaceuticals
  • Acumen Pharmaceuticals, Inc.
  • Akers Biosciences, Inc.
  • Arbor Vita Corporation
  • ARK Diagnostics Inc.
  • AspenBio Pharma, Inc.
  • Associates of Cape Cod, Inc. (ACC)
  • Augurex Life Sciences Corp.
  • Avantra Biosciences Corporation
  • Autobio Group
  • AXA Diagnostics Srl
  • Axela Biosensors, Inc.
  • Binding Site (The)
  • BioCurex, Inc.
  • Biomedical Diagnostics
  • Biomerica Inc.
  • Biophor Diagnostics
  • BioPorto A/S
  • BioSystems International (BSI)
  • B•R•A•H•M•S Aktiengesellschaft
  • Cellmid Ltd.
  • Corgenix Medical Corporation
  • Correlogic Systems, Inc.
  • Critical Diagnostics
  • Cylex, Inc.
  • diaDexus, Inc.
  • Diagnosticum Inc.
  • Diazyme Laboratories
  • Euroimmun AG
  • GenBio
  • GlysBy
  • Gold Standard Diagnostics, Corporation
  • HealthLinx Limited
  • Hycor Biomedical, Inc.
  • IMMCO Diagnostics, Inc.
  • Immunodiagn
  • ostic Systems Ltd. (IDS)
  • Inova Diagnostics Inc.
  • Innovative Health Diagnostics
  • Jeev Diagnostics
  • LifeAssays AB
  • MabCure Inc.
  • Mediomics, LLC
  • Miraculins Inc.
  • Neogenix Oncology, Inc.
  • Oasis Diagnostics Corporation
  • OJ-Bio Ltd.
  • OncoCyte Corp.
  • OncoHealth Corp.
  • Orgentec Diagnostika
  • PrognostiX Inc.
  • Protagen AG
  • Proteomics International Pty Ltd.
  • Saladax Biomedical, Inc.
  • Sera Prognostics, Inc.
  • Shanghai Kehua Bio-engineering
  • Shionogi Diagnostic
  • Sialix Inc.
  • SQI Diagnostics Inc.
  • Sword Diagnostics
  • Wistar Institute, The
CHAPTER TWENTY-THREE: Microbiology Specialists
  • Accelr8 Technology Corporation
  • Advanced Biological Laboratories (ABL)
  • ABS Advanced Biomedical Systems (ABS
  • AdvanDx, Inc.
  • Akonni Biosystems Inc.
  • Avioq, Inc.
  • bioLytical Laboratories
  • Biomagnetics Diagnostics Corporation
  • BioVei Incorporated
  • BlackBio S.L.
  • Calypte Biomedical Corporation
  • Canon US Life Sciences
  • CapitalBio Corporation
  • Catalysis Foundation for Health
  • Cellestis Ltd
  • Chembio Diagnostic Systems, Inc.
  • Ceeram S.A.S.
  • CHROMagar
  • Cooperative Diagnostics, LLC
  • Copan Diagnostics Inc.
  • Diagnostic HYBRIDS, Inc. (DHI)
  • Don Whitley Scientific
  • Dynacon Inc.
  • Enigma Diagnostics Limited
  • Focus Diagnostics, Inc.
  • Great Basin Scientific, Inc.
  • Hain Lifescience GmbH
  • Hardy Diagnostics
  • Ibis Biosciences
  • Immunexpress Inc.
  • Immuno-Mycologics (IMMY)
  • InBios International, Inc.
  • Ingen Biosciences
  • Innovotech Inc.
  • Intelligent Medical Devices, Inc. (IMDx)
  • IQuum Inc.
  • Lab M
  • MBio Diagnostics, Inc.
  • Miacom Diagnostics GmbH
  • Micro Identification Technologies, Inc. (MIT)
  • MicroBionetics, Inc.
  • Microgen Bioproducts Ltd.
  • MicroPhage, Inc.
  • Mo Bio Laboratories
  • Molecular Detection Inc. (MDI)
  • Molzym GmbH & Co. KG
  • MP Biomedicals LLC
  • Myconostica
  • NanoLogix, Inc.
  • nanoMR Inc.
  • NetBio
  • Next Dimension Technologies, Inc.
  • OraSure Technologies, Inc.
  • Oxford Immunotec Ltd.
  • Oxoid
  • PathoGene
  • Pathogenica
  • Preventx Limited
  • Phthisis Diagnostics Inc.
  • Quantalife, Inc.
  • QuantuMDx Group Limited
  • QuickCheck Health Inc.
  • R-Biopharm AG
  • Renishaw Diagnostics Ltd
  • Serosep Limited
  • Signature Mapping Medical Sciences, Inc.
  • SIRS-Lab
  • T2 Biosystems, Inc.
CHAPTER TWENTY-FOUR:   Molecular Test Specialists
  • 20/20 GeneSystems, Inc.
  • Ahram Biosystems, Inc.
  • Alacris Theranostics GmbH
  • Allegro Diagnostics Corp.
  • Amoy Diagnostics Co. Ltd.
  • Anagnostics Bioanalysis GmbH
  • Applied BioCode, Inc.
  • ArcticDx Inc.
  • Ariosa Diagnostics
  • Asuragen, Inc.
  • Autogenomics Inc.
  • Beijing Genome Institute (BGI)
  • biOasis Technologies Inc.
  • Biocartis SA
  • Biodesix, Inc.
  • Biofortuna Ltd.
  • BioHelix Corporation
  • Biomatrica, Inc.
  • BioNanomatrix
  • BJS Biotechnologies
  • BlueGnome
  • CardioDx, Inc.
  • Curetis AG
  • DiaGenic ASA
  • DiagnoCure
  • Diagenode
  • Dimerix Bioscience Pty Ltd
  • DNA Genotek Inc.
  • DxTerity Diagnostics Inc.
  • EraGen Biosciences Inc.
  • Eutropics Pharmaceuticals
  • Everist Genomics
  • Evotec AG
  • EXACT Sciences Corporation
  • Exosome Diagnostics Inc.
  • Falcon Genomics Inc.
  • Fluidigm Corporation
  • Fluoresentric, Inc.
  • Foundation Medicine. Inc.
  • GeneNews Limited
  • Genetic Technologies Limited
  • GenMark Diagnostics Inc.
  • GenoID Ltd.
  • Genomic Expression, Inc.
  • Genomed AG
  • Genomica S.A.U.
  • Genomind, LLC
  • Genorama Ltd.
  • GenturaDx
  • GnuBIO, Inc.
  • Great Basin Corporation
  • Helicos BioSciences
  • IncellDx, Inc.
  • Inostics GmbH
  • Insight Genetics
  • IntegenX Inc.
  • Ipsogen SA
  • LifeCodexx AG
  • LifeGen Technologies, LLC
  • Linkage Biosciences, Inc.
  • Lumora Ltd.
  • Med BioGene, Inc. (MBI)
  • Microsaic Systems plc
  • Multiplicom N.V.
  • NABsys, Inc.
  • Nanostring Technologies, Inc.
  • NewGene
  • NIPD Genetics LTD
  • NobleGen Biosciences
  • Norgen Biotek Corp.
  • Nuvera Biosciences, Inc.
  • OptiGene Ltd
  • Orion Genomics
  • Oxford Gene Technology
  • Pharmigene
  • Population Diagnostics, Inc.
  • PrimeraDx
  • RainDance Technologies, Inc.
  • Rheonix Inc.
  • Sequenta, Inc.
  • Sirius Genomics
  • Skyline Diagnostics B.V.
  • Sony DADC Biosciences
  • SpotOn Clinical Diagnostics Ltd
  • Stratos Genomics Inc.
  • SureGene, LLC
  • TcLand Expression SA
  • VolitionRx Limited
  • WaferGen Biosystems, Inc.
  • Waters Corporation
  • Xagenic
  • ZyGEM Corp. Ltd.
CHAPTER TWENTY-FIVE: Point-of-Care Specialists
  • 3M Health Care
  • Abaxis, Inc.
  • Acon Laboratories, Inc.
  • Alfa Scientific Designs, Inc.
  • Augurix Diagnostics
  • BBInternational
  • CardioGenics Holdings Inc.
  • CIC microGUNE
  • Claros Diagnostics, Inc.
  • Clearbridge BioLoc Pte Ltd
  • EKF Diagnostics Holdings plc
  • Gentag Inc.
  • Hai Kang Life Corporation
  • Hema Diagnostic Systems (HDS)
  • Helena Laboratories USA
  • InstantLabs
  • Labonfoil Consortium
  • Metabolomx
  • Micronics
  • MycroLab Pty Ltd.
  • Ohmx Corporation
  • OPKO Health, Inc.
  • QuantRx Biomedical Corporation
  • Response Biomedical Corp.
  • Rheonix, Inc.
  • Samsung Electronics Co., Ltd.
  • SensiVida Medical Technologies, Inc.
  • Sphere Medical Ltd.
  • SuperNova Diagnostics, Inc.
  • Systagenix
  • T2 Biosystems, Inc.
  • True Diagnostics, Inc.
CHAPTER TWENTY-SIX: Test Service Providers
  • 23andMe
  • Agendia BV
  • AltheaDx Diagnostics, Inc.
  • Ambry Genetics
  • ARUP Laboratories
  • AssureRx Health
  • Atherotech Diagnostic Lab
  • Atossa Genetics, Inc.
  • Avesthagen Limited
  • Biocept, Inc.
  • Biophysical Corporation
  • BioReference Laboratories, Inc. (BRLI)
  • BioServe
  • bioTheranostics
  • Bostwick Laboratories
  • Cancer Treatment Centers of America
  • CardioDx
  • Caris Life Sciences
  • Castle Biosciences Inc.
  • Circadian Technologies
  • CDx Diagnostics
  • Chronix Biomedical Inc.
  • Clarient Inc.
  • Clinical Reference Laboratory, Inc. (CRL)
  • CombiMatrix Molecular Diagnostics, Inc.
  • Complete Genomics
  • Crescendo Bioscience, Inc.
  • DeCode Genetics
  • DermaGenoma, Inc.
  • DiaTech Oncology
  • Diatherix Laboratories Inc.
  • Exagen Diagnostics, Inc.
  • Existence Genetics
  • ExonHit Therapeutics
  • Gene Security Network Inc. (GSN)
  • Genelex Corporation
  • Genetadi Biotech SL
  • Genetic Disease Foundation
  • Genomas
  • Genomic Health, Inc.
  • Genoptix Medical Laboratory
  • GenoVive LLC
  • Genzyme Genetics
  • Good Start Genetics, Inc.
  • iGenix Inc.
  • IntegraGen SA
  • Interleukin Genetics, Inc.
  • Iverson Genetic Diagnostics, Inc.
  • Knome, Inc.
  • Lab21 Limited
  • Laboratory Corporation of America Holdings (LabCorp)
  • Lineagen Inc.
  • LipoScience, Inc.
  • Lumigenix
  • Mayo Medical Laboratories
  • MDxHealth SA (formerly Oncomethylome Sciences)
  • Medco Health Solutions Inc.
  • Medical Diagnostic Laboratories, L.L.C. (MDL)
  • Metabolon
  • MinuteClinic
  • Mira Dx
  • Mitomics, Inc.
  • MolecularMD Corp.
  • Molecular Response
  • Myriad Genetics, Inc.
  • Navigenics
  • Oncimmune LLC
  • OncoPlexDx
  • OralDNA Labs
  • OvaGene Oncology, Inc.
  • Pacific Edge Biotechnology Limited (PEB)
  • Partners HealthCare Center for Personalized Genetic Medicine (PCPGM)
  • Pathway Genomics
  • Pathwork Diagnostics
  • PersonaLabs
  • PGXL Laboratories
  • Pinpoint Genomics, Inc.
  • Power3 Medical Products, Inc.
  • Precision Therapeutics
  • Predictive Biosciences
  • Prometheus Laboratories Inc.
  • Provista Diagnostics
  • Psynomics Incorporated
  • Quest Diagnostics
  • RedPath Integrated Pathology Inc.
  • Response Genetics, Inc.
  • Ridge Diagnostics, Inc. svc
  • Rosetta Genomics Ltd.
  • Rules-Based Medicine, Inc. (RBM)
  • Signal Genetics
  • Signature Diagnostics AG
  • Sonic Healthcare
  • SpectraCell Laboratories, Inc.
  • SureGene, LLC
  • SynapDx
  • Tethys Bioscience
  • Veracyte. Inc.
  • Verinata Health, Inc
CHAPTER TWENTY-SEVEN: Information Technology Specialists
  • Caradigm
  • Cerner Corporation
  • CLC bio
  • CollabRx
  • ConnectedHealth Pte. Ltd.
  • Definiens
  • Dell Healthcare and Life Sciences
  • DNA Direct
  • EHealth2Share
  • Freescale Semiconductor
  • GenomeQuest Inc.
  • HolGenTech Inc.
  • Health Discovery Corporation (HDC)
  • IDBS
  • MediSapiens Ltd.
  • Personalis IT
  • Sciclips
  • Selventa
  • Sophic Systems Alliance
  • Stanford University
  • University of Houston
  • Wellpoint Inc.
  • Inc. – Expression Diagnostics
CHAPTER TWENTY-EIGHT: Core Lab and Other Companies
    77 Elektronika Kft.
  • Aetna
  • AGD Biomedicals Pvt. Ltd
  • Awareness Technology, Inc.
  • Dana Farber Cancer Institute
  • Daxor Corporation
  • Diatron Group
  • Intel Corporation
  • Mauna Kea Technologies
  • Medco Health
  • MedTest DX, Inc.
  • Minias Globe Diagnostics S.r.l.
  • Proctor & Gamble
  • QuantaLife, Inc.
  • Quanterix Corporation
  • Quantimetrix Corp.
  • Scripps Health
  • Sekisui Diagnostics
  • SeraCare Life Sciences, Inc.
  • Seventh Sense Biosystems, Inc.
  • University of Michigan
  • Veterans Administration Health
  • Walgreens
  • Walmart

LIST OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

  • Table 1-1: Exchange Rate Fluctuations, 2006–2011

  • Figure 1-1: World IVD Market, 2011 And 2016

  • Table 1-1: Worldwide In Vitro Diagnostic Sales By Market Segment 2011-2016

CHAPTER TWO: INTRODUCTION

  • Table 2-1: Worldwide In Vitro Diagnostic Sales By Product Market 2011-2016

  • Figure 2-1: Worldwide In Vitro Diagnostic Sales By Segment, 2011

  • Table 2-2: Selected New Entrants And Market Expansion Actions, 2011

  • Table 2-3: Selected Diagnostics Industry New Entrants 2010-2011

  • Table 2-4: Selected Diagnostics Industry Acquisitions 2010-2011

  • Table 2-5: Selected Diagnostics Industry Collaboration And Distribution Agreements 2010-2011

  • Table 2-6: Selected Test Services, Sales 2009-2011

  • Table 2-7: Lab Market Statistics, Worldwide, 2011

  • Table 2-8: Revenues For A Selection Of Reference Labs, Worldwide, 2011

  • Table 2-9: Selected CLIA-Certified Labs Established In 2011

  • Table 2-10: Revenues Of Selected IVD Companies, 2007-2009

  • Table 2-11: Revenues Of Selected Niche Players, 2009-2011

CHAPTER THREE: OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC MARKETS

  • Table 3-1: Selected Disease Statistics, Worldwide, As At July 2012

  • Table 3-2: Elderly Support Ratio In Selected Countries (2050)

  • Table 3-3: Available Market Data, 2010

  • Table 3-4: BRIC Healthcare Infrastructure Capacity

  • Table 3-5: Worldwide In Vitro Diagnostic Reagent Sales By Country/Region 2011-2016

  • Table 3-6: European Union IVD Sales By Country 2010

  • Table 3-7: Key Drivers For Healthcare In India

CHAPTER FOUR: TRENDS AND INNOVATION

  • Table 4-1: World Market For Telehealth, Number Of Subscribers

  • Table 4-2: Smartphone Use Among Physician Specialties, Percent

  • Table 4-3: Selected Phone-Based IVD Systems

  • Table 4-4: Selected Professional Use Apps

CHAPTER FIVE: POINT-OF-CARE TESTS

  • Table 5-1: POC Sales By Test Category, Worldwide 2011-2016 (Sales $ Millions)

  • Figure 5-1: Professional POC Market

  • Figure 5-2: OTC Point Of Care Market

  • Table 5-2: POC Test Revenues Of Selected IVD Companies, ($ Million), Estimated

  • Table 5-3: World Glucose Monitoring Sales, By Company, 2009-2011

  • Table 5-4: Selected Data Management Enabled Glucose Monitors, 2011

  • Table 5-5: Selected Noninvasive Glucose Monitoring Devices

  • Table 5-6: Selected Continuous BGM Sales, 2011

  • Table 5-7: Selected Continuous Blood Glucose System Developments, 2011

  • Table 5-8: Selected POC Hba1c Devices

CHAPTER SIX: THE CORE LAB

  • Table 6-1: Clinical Chemistry/Immunoassay Sales, 2011-2016 ($ Million)

  • Figure 6-1: Core Lab Market, 2011 And 2016

  • Table 6-2: Core Lab Sales Of The Top Five Manufacturers, 2009-2011, ($ Million)

  • Table 6-3: Worldwide Clinical Chemistry Sales By Test Category 2011-2016

  • Figure 6-1: Clinical Chemistry Market

  • Table 6-4: Selected New Core Lab Analyzers

  • Table 6-5: Selected Critical Care Analysis Innovations, 2010-2011

  • Figure 6-3: Urinalysis Market, 2011 And 2016

  • Table 6-8: Selected Urinalysis Innovations, 2010-2011

CHAPTER SEVEN: IMMUNOASSAYS

  • Table 7-1: Selected Immunoassays On Core Lab Instruments

  • Table 7-2: Selected New Immunoassay Platforms, 2011

  • Table 7-3: Worldwide Lab-Based Immunoassay Sales By Analyte Type 2011-2016

  • Table 7-4: Revenue History Of Leading Immunoassay Vendors, 2007-2011

  • Table 7-5: Selected Tumor Marker Innovations, 2008-2011

  • Table 7-6: Selected Cardiac Marker Innovations, 2011

  • Table 7-7: Selected Autoimmune Immunoassay Innovations, 2011

  • Table 7-8: Selected Immunoassay Innovations, 2011

  • Table 7-9: POC Immunoassay Test Sales By Test Category 2010-2011

  • Table 7-11: Selected Professional POC Test Innovations, 2011

CHAPTER EIGHT: MOLECULAR ASSAYS
  • Table 8-1: Market Penetration Of Clinical Molecular Diagnostics, By Geographic Area, 2011-2016
  • Table 8-2: Selected Mass Specrometry Clinical Lab Applications
  • Table 8-3: Molecular Test Revenues Of Selected IVD Vendors, 2009-2011
  • Table 8-4: Selected Nucleic Acid Testing Platforms
  • Table 8-5: Worldwide Molecular Test Sales By Type, $Million 2011-2016
  • Table 8-6: Selected Molecular Tumor Marker Test Innovations
  • Table 8-7: Most Frequently Requested Genetic Tests
  • Table 8-8: Selected Molecular Tests For Prenatal Analysis
  • Table 8-9: Selected HLA Typing Tests
CHAPTER NINE: HEMATOLOGY
  • Table 9-1: Selected Hematology Innovations, 2011

  • Table 9-2: Selected POC Hematology Systems

  • Figure 9-1: Hematology Market, 2011 And 2016

  • Table 9-3: Revenue History Of The Major Hematology Vendors 2009-2011

CHAPTER TEN: COAGULATION
  • Table 10-1: Selected Commercial Plavix And Warfarin Dosing Tests, 2011

  • Table 10-2: Worldwide Coagulation Sales By Segment 2011-2016

  • Table 10-3: Selected Coagulation Innovations

  • Table 10-4: World POC Coagulation Sales, 2011

  • Table 10-5: Selected CLIA Waived PT Devices

  • Table 10-6: Top Coagulation Company Revenues 2009 – 2011

CHAPTER ELEVEN: MICROBIOLOGY AND VIROLOGY
  • Table 11-1: Selected Next Generation Sequencing Platforms

  • Table 11-2: Selected Advanced Microbiology Platforms

  • Table 11-3: Worldwide Microbiology/Virology Sales By Type 2011-2016

  • Table 11-4: Revenue Of Selected Microbiologyproduct Companies, 2011

  • Table 11-5: Selected Advanced Techniques For Positive Blood Cultures

  • Table 11-6: Lab-Based Infectious Disease Immunoassays, By Test, 2011

  • Table 11-7: Selected Infectious Disease Immunoassay Innovations

  • Table 11-8: Selected Professional-Use POC Tests For Infectious Diseases

  • Table 11-9: Selected New Instruments For Molecular Infectious Disease Testing

  • Table 11-10: Molecular Test Sales, Infectious Diseases, 2011-2016

  • Table 11-11: Selected Molecular Tests For Fungal Infections

  • Table 11-12: Selected Molecular POC Devices

  • Table 11-13: Selected Infectious Disease Molecular Test Innovations

CHAPTER TWELVE: BLOOD BANKING SERVICES
  • Table 12-1: Laboratory Screening Of Blood Donations For Transfusion-Transmissible Infections, Number Of Countries

  • Table 12-2: Blood Component Usage

  • Table 12-3: Worldwide Blood Bank Sales, 2011-2016

  • Table 12-4: Selected Blood Bank Innovations

CHAPTER THIRTEEN: HISTOLOGY AND CYTOLOGY

  • Table 13-1: Selected Lab Expansions

  • Table 13-2: Selected Histology Test Services

  • Table 13-3: Worldwide Histology/Cytology Sales By Type 2011-2016, ($ Million)

  • Table 13-4: Selected Histology Automation

  • Table 13-5: Selected Histology IT Solutions

  • Table 13-6: Revenues Of The Major Histology Companies $ Million, 2009-2011

  • Table 13-7: Selected Vendors Of Traditional Histology Stains

  • Table 13-8: Selected HPV Test Innovations

  • Table 13-9: Major Pharmacodiagnostic Markers

  • Table 13-10: Selected Pharmacodiagnostic Histology Tests

  • Table 13-11: Selected Digital Imaging Innovations

  • Table 13-12: Selected Tissue Microarray Products

  • Table 13-13: Selected Innovations In CTC Technology

  • Table 13-14: Selected Companies Involved In Chromosomal Analysis Of Cancer Cells

  • Table 13-15: Selected Innovations In Flow Cytometry

  • Table 13-16: Selected CD4 Test Innovations, 2008-2009

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