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Cell-Based Diagnostics: Technology, Applications, and Markets, 2nd Edition

No longer is cell-based diagnostics simply a histological study of biopsied and surgical tissues. Combinations of tests and technologies are coming together to create a new map of cell diagnostics. Image cytometry, microfluidics, microarrays, and biosensors, special immunohistochemical and in situ hybridization probes are creating new approaches to cell and tissue observation, diagnostics and pharmacogenomics.

This report covers assay systems that use cells as the basic source material. Sources of the cells to be studied include peripheral blood, cord blood, bone marrow, urine, cerebrospinal and other body fluids and tissue samples. The market is highly diversified involving several lab disciplines, including

  • hematology,
  • histology,
  • cytology,
  • microbiology, and
  • tissue transplant medicine
It also involves several technologies, including
  • complete blood count,
  • flow cytometry,
  • microscopy, and
  • molecular diagnostics
Until recently, there was little interaction between these disciplines and technologies; hematology analyzers were used for a complete blood count, flow cytometry for leukocyte analysis, stains for tissue section slides, etc. Further, most companies involved in one market were rarely active in another. However, the evolution of molecular tests, cell research, and cell analysis technologies has turned cell diagnostics into a melting pot of companies, clinical applications, and technologies.

This completely new edition of Kalorama's best-selling 2005 report sets out the coordinates of this new geography and quantifies the market value of cell-based testing for various applications through 2011. This report considers the market for, and technology development and commercialization of, cell-based diagnostic tests for

  • Cell assays in cancer management—flow cytometry, circulating tumor cells, tissue microarrays
  • Cell assays in hematology—CBC and new immunocytometry assays
  • Cell assays in histopathology/cytology- IHC, ISH, traditional stains, processors and imaging systemsc
  • Cell assays in microbiology/virology—FISH, flow cytometry
  • Cell assays in blood product safety—flow cytometry
  • Cell assays in tissue transplant management—molecular assays
  • Cell assays in prenatal testing—PCR, FISH
Cell analysis techniques and trends are discussed from the point of view of their present and potential market impact. The report discusses cell-based diagnostic techniques that are currently available and those that are expected to take their place. The world market for cell and tissue diagnostics is provided in U.S. dollars for the base year of 2006 with forecasts to 2011. Market analysis in this report covers world markets; however the reader will find a bias toward the developed areas of the globe: North America, Japan, and Western Europe.

The report covers::

  • A survey of cell and tissue diagnostics past, present, and future
  • The impact of cell-based diagnostics on patient care in selected diseases
  • Technological aspects of cell-based diagnostics that impact their use in routine patient care
  • Market trends and issues that can make or break successful commercialization of cell-based diagnostics
  • An analysis of current and future market opportunities for cell-based analysis
  • Discussion of companies and technologies to watch as the cell diagnostics industry evolves
The following are examples of market data within this report:
  • Selected Acquisitions and Collaborations in Cell Diagnostics
  • Worldwide Cell Diagnostics Product Sales by Testing Area (Hematology, Histology/Cytology [without Pap], Flow Cytometry, DNA Microarrays, Pap, Protein Microarrays, Prenatal Testing, Tissue Typing, Tissue Microarrays, Microbiology/Virology, Rare Cell Event Detection, Blood Safety) 2006-2011
  • Selected IVD Cancer Markers
  • Worldwide Market for Cell Diagnostics for Cancer by Testing Area (Histology/Cytology [without Pap], Flow Cytometry, Pap, Tissue Microarrays, DNA Microarrays, Protein Microarrays, Rare Cell Event Detection, In Situ Hybridization, Immunohistochemical Staining) 2006
  • Selected New Hematology Analyzer Tests, 1990s-2007
  • Revenue History of the Top 5 Hematology Vendors 2001-2006
  • Selected POC CBC Systems
  • Worldwide Histology/Cytology Sales by Type (Traditional Non-Pap, Pap, IHC, ISH, Image Cytometry, Tissue Microarrays) 2006-2011
  • Selected Vendors of Traditional Histology Stains
  • Selected Automated Pap Systems
  • Selected HPV Test Innovators
  • Selected IHC and ISH Product Companies
  • Major Protein and Molecular Markers Used in Tissue Staining
  • Selected Digital Pathology Systems
  • Selected Cell Diagnostics for Microbiology/Virology
  • Selected Simplified, Inexpensive CD4 Test Systems

As with all Kalorama Information reports, this survey of the cell-based diagnostics is the result of primary research. The analyst based models and captured trends with thorough research of company, trade and government soruces, enhanced by interviews with executives in the diagnostic industry.


  • Executive Summary
    • INTRODUCTION
    • SCOPE AND METHODOLOGY
    • SIZE AND GROWTH OF THE MARKET
      • Table Worldwide Cell Diagnostics Product Sales by Type 2006-2011
    • MARKET TRENDS
  • Introduction
    • BACKGROUND: CELL-BASED TESTING IN THE 21ST CENTURY
    • THE CELL, INSIDE AND OUT
    • THE STATUS QUO AND HUGE POTENTIAL OF CELL-BASED DIAGNOSTICS
    • POINT OF VIEW
  • Medical Trends and Market Issues in the Commercialization of Cell-Based Diagnostics
    • BACKGROUND
    • THE MOLECULAR REVOLUTION, NEW TESTING OPPORTUNITIES
      • Table Selected Cell-Based Molecular Tests
      • Table Selected Commercial Cell-Based Molecular Tests
    • REIMBURSEMENT AND COMMERCIALIZATION OF NOVEL TESTS
    • REGULATORY AFFAIRS
    • WORLDWIDE OPPORTUNITIES FOR CELL-BASED TESTS
    • DRUG DISCOVERY
      • Table Selected Cell-Based Tests Used in Drug Discovery
  • Technological Trends That Enable the Future of Cell-Based Diagnostics
    • BACKGROUND
    • NEW ASSAY DESIGNS
      • Table Selected Tests and Cell Diagnostics Technology Crossovers
      • Table Selected Cell-Based Lateral Flow Tests
    • THE IN VITRO/IN VIVO MIX
    • PERSONALIZED MEDICINE, DRUG SELECTION, AND CELL-BASED ASSAYS
      • Table Selected Cell-Based Pharmacodiagnostic Tests
    • RARE CELL EVENT TESTING
      • Table Selected Rare Cell Event Tests
    • CANCER CELLS: STEM CELL COUSINS
    • MINIATURIZATION AND MULTIPLEXED BIOLOGICAL ASSAYS
    • CELL MARKER DEVELOPMENT
    • HISTOLOGY AUTOMATION
    • CELL CULTURE
      • Table Selected Cell Culture Tests
  • Technology Platforms at the Forefront of Cell-Based Assays
    • BACKGROUND
    • HEMATOLOGY ANALYZERS
      • Table Selected New Hematology Analyzer Tests, 1990s-2007
      • Table Selected New Immunohematology Research Projects
    • FLOW CYTOMETRY
      • Table Revenue History of Leading Companies in Flow Cytometry 2001-2006
      • Table Selected Flow Cytometry Applications
      • Table Selected Flow Cytometry Product Companies
    • MICROSCOPY AND IMAGE-BASED PLATFORMS
      • Table Selected Microscopy and Image Analysis Product Companies
      • Table Cytometry Imaging Market Revenues by Competitor 2006
    • LASER CAPTURE MICRODISSECTION AND TISSUE MICROARRAYS
      • Table Selected LCM Systems on the Market, 2007
    • IN SITU HYBRIDIZATION
      • Table Major Molecular Markers for Tissue Staining
      • Table Selected In Situ Hybridization Histopathology Tests
    • MOLECULAR TECHNIQUES
      • Table Selected Cell-Based Molecular Tests
      • Table Selected DNA Sample Preparation Companies
  • Market Analysis
    • BACKGROUND
      • Table Selected Acquisitions and Collaborations in Cell Diagnostics
    • CELL-BASED DIAGNOSTICS AND IVD MARKETS
      • Table Worldwide Cell Diagnostics Product Sales by Testing Area (Hematology, Histology/Cytology [without Pap], Flow Cytometry, DNA Microarrays, Pap, Protein Microarrays, Prenatal Testing, Tissue Typing, Tissue Microarrays, Microbiology/Virology, Rare Cell Event Detection, Blood Safety) 2006-2011
    • THE MARKET FOR CELL ASSAYS IN CANCER MANAGEMENT
      • Table Selected IVD Cancer Markers
      • Table Worldwide Market for Cell Diagnostics for Cancer by Testing Area (Histology/Cytology [without Pap], Flow Cytometry, Pap, Tissue Microarrays, DNA Microarrays, Protein Microarrays, Rare Cell Event Detection, In Situ Hybridization, Immunohistochemical Staining) 2006
    • THE MARKET FOR CELL ASSAYS IN HEMATOLOGY
      • Table Selected New Hematology Analyzer Tests, 1990s-2007
      • Table Revenue History of the Top 5 Hematology Vendors 2001-2006
      • Table Selected POC CBC Systems
    • THE MARKET FOR CELL ASSAYS IN HISTOPATHOLOGY/CYTOLOGY
      • Table Worldwide Histology/Cytology Sales by Type (Traditional Non-Pap, Pap, IHC, ISH, Image Cytometry, Tissue Microarrays) 2006-2011
      • Table Selected Vendors of Traditional Histology Stains
      • The Future of the Pap Smear & HPV Testing
        • Table Selected Automated Pap Systems
        • Table Selected HPV Test Innovators
      • IHC/ISH and Digital Cytometry
        • Table Selected IHC and ISH Product Companies
        • Table Major Protein and Molecular Markers Used in Tissue Staining
        • Table Selected Digital Pathology Systems
    • THE MARKET FOR CELL ASSAYS IN MICROBIOLOGY/VIROLOGY
      • Table Selected Cell Diagnostics for Microbiology/Virology
      • Table Selected Simplified, Inexpensive CD4 Test Systems
    • THE MARKET FOR CELL ASSAYS IN BLOOD PRODUCT SAFETY
    • THE MARKET FOR CELL ASSAYS IN TISSUE TRANSPLANT MANAGEMENT
    • THE MARKET FOR CELL ASSAYS IN PRENATAL TESTING
  • Conclusions and Strategic Implications
    • CONCLUSION
      • Implication
  • Company Profiles
    • ABBOTT DIAGNOSTICS
      • Table Recent Revenue History - ABBOTT DIAGNOSTICS
      • Key Comment
      • Hematology
      • Molecular Histology
    • ACCELR8 TECHNOLOGY CORPORATION
      • Recent Revenue History
      • Key Comment
      • Details
    • ACCURI CYTOMETERS
      • Recent Revenue History
      • Key Comment
      • Details
    • ACOLYTE BIOMEDICA [ACQUIRED BY 3M]
      • Recent Revenue History
      • Key Comment
      • Details
    • ADVANCED ANALYTICAL TECHNOLOGIES INC. (AATI)
      • Recent Revenue History
      • Key Comment
      • Details
    • ADVANDX, INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • ADVALYTIX AG
      • Recent Revenue History
      • Key Comment
      • Details
    • AGENDIA B.V.
      • Recent Revenue History
      • Key Comment
      • Details
    • ALMAC DIAGNOSTICS (FORMERLY ARRADX)
      • Recent Revenue History
      • Key Comment
      • Details
    • AMNIS CORPORATION
      • Recent Revenue History
      • Key Comment
      • Details
    • APERIO TECHNOLOGIES, INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • APPLIED IMAGING CORP./GENETIX
      • Recent Revenue History
      • Key Comment
      • Details
    • ASURAGEN, INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • AVIARADX (FORMERLY ARCTURUS BIOSCIENCES)
      • Recent Revenue History
      • Key Comment
      • Details
    • AVIVA BIOSCIENCES CORPORATION
      • Recent Revenue History
      • Key Comment
      • Details
    • BECTON DICKINSON & COMPANY
      • Recent Revenue History
        • Table Recent Revenue History - BECTON DICKINSON & COMPANY
      • Key Comment
      • Details
    • BECKMAN COULTER, INC.
      • Recent Revenue History
        • Table Recent Revenue History - BECKMAN COULTER, INC.
      • Key Comment
      • Details
    • BIOCEPT, INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • BIOGENEX LABORATORIES, INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • BIOMODA, INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • BIOMOSAICS
      • Recent Revenue History
      • Key Comment
      • Details
    • BIOVIEW, INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • BRUKER DALTONICS
      • Recent Revenue History
      • Key Comment
      • Details
    • CANCER GENETICS, INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • CELERA
      • Recent Revenue History
      • Key Comment
      • Details
    • CELERUS DIAGNOSTICS
      • Recent Revenue History
      • Key Comment
      • Details
    • CELLAVISION AB
      • Table Recent Revenue History - CELLAVISION AB
      • Key Comment
      • Details
    • CELLESTIS LTD
      • Table Recent Revenue History - CELLESTIS LTD
      • Key Comment
      • Details
    • CLARIENT INC. (FORMERLY CHROMAVISION)
      • Recent Revenue History
      • Key Comment
    • COMPUCYTE CORPORATION
      • Recent Revenue History
      • Key Comment
      • Details
    • CYLEX INCORPORATED
      • Recent Revenue History
      • Key Comment
      • Details
    • CYTOCORE, INC. (FORMERLY MOLECULAR DIAGNOSTICS, INC.)
      • Recent Revenue History
      • Key Comment
      • Details
    • CYTYC CORPORATION
      • Table Recent Revenue History - CYTYC CORPORATION
      • Key Comment
      • Details
    • DAKO A/S
      • Recent Revenue History
      • Key Comment
      • Details
    • DIAGENIC ASA
      • Recent Revenue History
      • Key Comment
      • Details
    • DIAGNOSTIC HYBRIDS, INC. (DHI)
      • Recent Revenue History
      • Key Comment
      • Details
    • DIAMICS, INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • DIGENE CORPORATION
      • Table Recent Revenue History - DIGENE CORPORATION
      • Key Comment
      • Details
    • EGENE INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • EXAGEN DIAGNOSTICS, INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • GENOMIC HEALTH
      • Table Recent Revenue History - GENOMIC HEALTH
      • Key Comment
      • Details
    • GREINER BIO-ONE INTERNATIONAL AG
      • Table Recent Revenue History - GREINER BIO-ONE INTERNATIONAL AG
      • Key Comment
      • Details
    • GUAVA TECHNOLOGIES, INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • GW MEDICAL TECHNOLOGIES, LLC
      • Recent Revenue History
      • Key Comment
      • Details
    • GYNECOR
      • Recent Revenue History
      • Key Comment
      • Details
    • HEMOSYSTEM SA
      • Recent Revenue History
      • Key Comment
      • Details
    • HISTORX, INC,
      • Recent Revenue History
      • Key Comment
      • Details
    • ICYT VISIONARY BIOSCIENCE
      • Recent Revenue History
      • Key Comment
      • Details
    • IKONISYS INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • IMMUNICON CORPORATION
      • Recent Revenue History
        • Table Recent Revenue History - IMMUNICON CORPORATION
      • Key Comment
      • Details
    • INTERGENETICS
      • Recent Revenue History
      • Key Comment
      • Details
    • INTRACELLULAR DIAGNOSTICS, INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • INVIRION DIAGNOSTICS, LLC
      • Recent Revenue History
      • Key Comment
      • Details
    • INVITROGEN CORPORATION
      • Recent Revenue History
      • Key Comment
      • Details
    • IPSOGEN
      • Recent Revenue History
      • Key Comment
      • Details
    • IRIS INTERNATIONAL, INC.
      • Table Recent Revenue History - IRIS INTERNATIONAL, INC.
      • Key Comment
      • Details
    • MDS/MOLECULAR DEVICES CORPORATION
      • Recent Revenue History
      • Key Comment
      • Details
    • MEDION DIAGNOSTICS AG
      • Recent Revenue History
      • Key Comment
      • Details
    • MICRO IMAGING TECHNOLOGY (MIT)
      • Recent Revenue History
      • Key Comment
      • Details
    • MICROGEN BIOPRODUCTS
      • Recent Revenue History
      • Key Comment
      • Details
    • MICRONICS, INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • MILESTONE MEDICAL
      • Recent Revenue History
      • Key Comment
      • Details
    • MODERN TECHNOLOGY CORP.
      • Recent Revenue History
      • Key Comment
      • Details
    • MONOGEN
      • Recent Revenue History
      • Key Comment
      • Details
    • MONOGRAM BIOSCIENCES INC. (FORMERLY VIROLOGIC, INC.)
      • Table Recent Revenue History - MONOGRAM BIOSCIENCES INC. (FORMERLY VIROLOGIC, INC.)
      • Key Comment
      • Details
    • MTM LABORATORIES AG
      • Recent Revenue History
      • Key Comment
      • Details
    • NALGE NUNC INTERNATIONAL CORPORATION
      • Recent Revenue History
      • Key Comment
      • Details
    • NORCHIP
      • Recent Revenue History
      • Key Comment
      • Details
    • NUVERA BIOSCIENCES
      • Recent Revenue History
      • Key Comment
    • ONE CELL SYSTEMS, INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • ORPEGEN PHARMA
      • Recent Revenue History
      • Key Comment
      • Details
    • PARTEC GMBH
      • Recent Revenue History
      • Key Comment
      • Details
    • PATHWORK DIAGNOSTICS (FORMERLY PREDICANT BIOSCIENCES)
      • Recent Revenue History
      • Key Comment
      • Details
    • PERCEPTRONIX MEDICAL INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • PERKINELMER, INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • POINTCARE TECHNOLOGIES, INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • PROGENIKA BIOPHARMA S.A.
      • Recent Revenue History
      • Key Comment
      • Details
    • QBC DIAGNOSTICS INC.
      • Recent Revenue History
      • Key Comment
    • QUANTOMIX LTD.
      • Recent Revenue History
      • Key Comment
      • Details
    • RATIONAL THERAPEUTICS
      • Recent Revenue History
      • Key Comment
      • Details
    • RAVGEN
      • Recent Revenue History
      • Key Comment
      • Details
    • SAKURA FINETEK USA INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • SEQUENOM INC.
      • Table Recent Revenue History - SEQUENOM INC.
      • Key Comment
      • Details
    • SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
      • Table Recent Revenue History
      • Key Comment
      • Details
    • SIGNATURE GENOMIC LABORATORIES LLC
      • Recent Revenue History
      • Key Comment
      • Details
    • SOURCE MDX
      • Recent Revenue History
      • Key Comment
      • Details
    • SYSMEX CORPORATION
      • Table Recent Revenue History - SYSMEX CORPORATION
      • Key Comment
      • Details
    • TARGETED DIAGNOSTICS & THERAPEUTICS, INC. (TDT)
      • Recent Revenue History
      • Key Comment
      • Details
    • TRIPATH IMAGING, INC.
      • Table Recent Revenue History - TRIPATH IMAGING, INC.
      • Key Comment
      • Details
    • VENTANA MEDICAL SYSTEMS. INC.
      • Recent Revenue History
        • Table Recent Revenue History - VENTANA MEDICAL SYSTEMS. INC.
      • Key Comment
      • Details
    • VERAX BIOMEDICAL INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • VERIDEX, LLC
      • Recent Revenue History
      • Key Comment
      • Details
    • VISION BIOSYSTEMS LTD/DANAHER CORP.
      • Recent Revenue History
        • Table Recent Revenue History - VISION BIOSYSTEMS LTD/DANAHER CORP.
      • Key Comment
      • Details
    • VITATEX INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • WAVESENSE LLC
      • Recent Revenue History
      • Key Comment
      • Details
    • XDX, INC
      • Recent Revenue History
      • Key Comment
      • Details
    • XYTOS INC.
      • Recent Revenue History
      • Key Comment
      • Details
    • ZILA INC.
      • Recent Revenue History
      • Key Comment
      • Details
  • Selected Cell-Based Tests and Technologies
    • Table Selected Cell-Based Tests and Technologies

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