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The World Market for Tissue Diagnostics and Cell-Based Diagnostics: Forecasts to 2018 (Histology and Cytology Tests, in situ hybridization (ISH), HPV Tests, Flow Cytometry, Digital Pathology/Image Cytometry, Hematology Cell Assays, Immunohistochemistry, C

Histology and cytology tests are essential for identifying cancer, inherited, infectious disease and other diseases.  This report focuses on tissue and cell diagnostic assays and technologies, providing the world markets for histology and cytology diagnostics for the current market and forecasted to 2018.  All of the technologies and applications discussed in this report share the characteristic that they start with tissue or cell specimens.  Global revenues are provided, broken out type of technology, including: 

  •  Digital Pathology 
  •  Pap Smear 
  •  HPV Tests
  •  Flow Cytometry
  •  Circulating tumor cells (CTCs)
  •  Hematology (cell assays)
  •  In situ hybridization (ISH)
  •  Immunohistochemistry (IHC)
  •  Stains [non-Pap]
  • Traditional Histology
 
Along with standard technologies are now being applied in this field, including MS mass spectrometry, next-generation sequencing, CTCs, and others.     Advanced products in tissue and cell testing are still under development.    

A global report, revenues for the overall  tissue diagnostics market are broken out by geographical region for 2013 and 2018, covering
  •  North America
  •  Europe
  •  Asia
  •  Rest of World

In the past, tissue and cell diagnostics work had been highly labor intensive and subjective in results.  This is no longer the case.  The procedures have been changed in some part by the introduction of automated processes and  digital analysis, and the development of cancer gene and HPV molecular tests.  

Tissue diagnostics is a rapidly growing market driven by growth in global HPV diagnostics,  new precision cancer treatment techniques, and novel companion diagnostic tests for drugs.   Flow cytometry platforms have been available for many years.  From flow cytometry and slide preparation through analysis, all the way to result reporting, combined and automated solutions enable faster turn-around time while providing standardized results. 

The report profiles key companies in the industry, including
  •  20/20 GeneSystems, Inc.
  •  3DHISTECH Ltd.
  •  Abbott Laboratories
  •  Abcam plc
  •  AB SCIEX (A Danaher Corporation company)
  •  Adaptive Biotechnologies Corporation
  •  AdnaGen GmbH (An Alere Company)
  •  Advanced Cell Diagnostics
  •  Affymetrix, Inc.
  •  Agena Bioscience Inc.
  •  Agendia BV
  •  Agilent Technologies Inc.
  •   Aurora Interactive
  •  AutoGenomics, Inc.
  •  Aviva BioSciences Corporation
  •  Beckman Coulter, Inc. (Subsidiary of Danaher Corporation)
  •  Becton Dickinson and Co. (BD)
  •  Biocare Medical, LLC
  •  Biocartis S.A.
  •   Bio-Rad Laboratories, Inc.
  •   Bruker Corporation
  •  Cancer Genetics, Inc.
  •  Canopus Bioscience Ltd.
  •  Caris Life Sciences
  •   CellaVision AB
  •   Dako A/S (An Agilent Technologies Company)
  •  Danaher Corporation
  •   DiaTech Oncology
  •   Elitech Group
  •  EMD Millipore (Merck Millipore)
  •  Enzo Biochem, Inc.
  •  Epic Sciences, Inc.
  •  Fluidigm Corporation
  •  GE Healthcare
  •   Hologic, Inc.
  •  HORIBA Medical
  •   Janssen Diagnostics
  •  Leica Biosystems Inc. (Part of Danaher Corporation)
  •  Leica Microsystems (A Danaher Company)
  •  LeucoDx Inc.
  •  Life Technologies Corporation (Acquired by Thermo Fisher Scientific Inc.)
  •  MDxHealth SA
  •   Olympus Group
  •  Omnyx
  •   Oxford Gene Technology
  •  Panagene Inc.
  •  PerkinElmer, Inc.
  •  Protea Biosciences Group, Inc.
  •  Qiagen N.V.
  •  QuanDx
  •  QuantuMDx Group
  •  Rarecells SAS
  •  Response Genetics, Inc.
  •  Rheonix, Inc.
  •  Roche Diagnostics
  •   Siemens Healthcare Diagnostics
  •  Ventana Medical Systems Inc. (Member of the Roche Group)
And many other companies...

Market analyses in this report cover world markets for tissue and cell diagnostics. However, the reader will find a bias toward the developed areas of the globe -- North America, Japan and Western Europe, the areas in which most tissue and cell diagnostic testing is currently performed. The information presented is derived from publicly available information sources such as company reports and announcements, government reports and databases, medical organization reports, medical associations, and other publications. The analysis is based on the author's industry knowledge combined with literature searches and discussions with industry professionals and experts in the areas of point-of-care tests, decentralized healthcare and healthcare economics.


  • Executive Summary
    • OVERVIEW
    • SCOPE AND METHODOLOGY
    • MARKET OVERVIEW
      • Table Tissue and Cell Diagnostics Sales, Worldwide, 2013 and 2018 (in millions USD)
    • FUTURE PROSPECTS IN THE TISSUE AND CELL DIAGNOSTICS MARKET
  • Introduction
    • OVERVIEW OF TISSUE AND CELL DIAGNOSTICS
      • Histology and Cytology
      • Tissue and Cell Diagnostics
    • POINT-OF-VIEW
  • Tissue and Cell Analysis Technologies
    • TYPES OF SPECIMENS
    • MICROSCOPY
      • Table Selected Companies That Market Microscopes or Products Used with Microscopes for Analysis of Tissues and Cells
    • CELL-BASED ASSAYS; CELLULAR IMAGING SYSTEMS AND HIGH CONTENT SCREENING (HCS)
      • Table Selected Companies Marketing Cell-Based Assays
      • Table Selected Companies with Cellular Imaging Systems; High Content Screening (Does not include flow cytometry or standard microscopes)
    • HEMATOLOGY ANALYZERS
      • Table Selected Companies with Hematology Analyzers to Characterize Blood Cells
    • STAINS
      • Table Selected Companies Providing Stains and Other Histology Products (Reagents and Instrumentation)
    • ANTIBODY-BASED TECHNOLOGIES
      • Immunohistochemistry (IHC)
        • Table Selected Companies Marketing Antibodies for Research and/or Diagnostic Applications
        • Table Immunohistochemistry Tests Approved by the FDA as Companion Diagnostic Tests
      • Flow Cytometry
        • Table Selected Companies Marketing Flow Cytometry Platforms or Consumables
    • CHROMOSOME ANALYSIS (KARYOTYPING)
    • MOLECULAR DIAGNOSTIC ANALYSIS OF TISSUES AND NUCLEIC ACID FROM TISSUES
      • Fluorescence In Situ Hybridization (FISH) and Chromogenic In Situ Hybridization (CISH)
        • Table Selected Companies Marketing Probes for FISH or Other Applications
        • Table In Situ Hybridization Tests Approved by the FDA as Companion Diagnostic Tests
      • Polymerase Chain Reaction (PCR) to Detect Biomarkers in Tissue Specimens
        • Table Selected Companies Using PCR to Detect Biomarkers in Tissues
        • Table PCR-Based Tests Approved by the FDA as Companion Diagnostic Tests
      • Analysis of Gene Expression Patterns ("Gene Signatures")
        • Table Selected Companies Analyzing Gene Expression Patterns ("Gene Signatures") in Tissues
      • Next Generation Sequencing
        • Table Selected Companies Using Sequencing to Analyze Nucleic Acid Extracted from Tissue
    • TISSUEMICROARRAYS
      • Table Selected Companies Marketing Tissue Microarrays or Tissue Microarray Related Products
    • CIRCULATING TUMOR CELLS (CTCS)
      • Table Selected Companies Working with Circulating Tumor Cells (CTCs)
    • DIGITAL PATHOLOGY AND IMAGE CYTOMETRY
      • Table Selected Digital Pathology Companies
    • HISTOLOGY LABORATORY AUTOMATION
    • MASS SPECTROMETRY - IMAGING AND ANALYSIS OF DNA
      • Table Companies Marketing Mass Spectrometry Imaging Platforms or Services
  • Tissue and Cell Diagnostics Applications
    • RESEARCH, DRUG DISCOVERY AND DEVELOPMENT
      • Table Selected Pharmaceutical Companies That Made Deals to Access/Develop Tissue or Cell Diagnostics Tests
      • IN VITRO DIAGNOSTICS
  • Disease Applications - Tissue and Cell Diagnostics
    • CANCER
      • Cancer Screening - Pap Smear and Human Papillomavirus (HPV) Testing
        • Table Selected Companies Developing/Marketing Assays for Human Papillomavirus (HPV)
      • Diagnosis of Cancer
      • Pharmacodiagnostics
        • Table Selected Companies Developing/Marketing Tissue/Cell Based Tests for Cancer
    • PRENATAL TESTING
    • OTHER DISEASE APPLICATIONS OF TISSUE AND CELL DIAGNOSTICS
      • Table Selected Companies Developing/Marketing Tissue/Cell Based Tests for Other Indications (Includes Prenatal Testing)
  • Deals - Tissue and Cell Diagnostic Companies
    • INVESTMENTS AND FINANCING AGREEMENTS FOR TISSUE AND CELL DIAGNOSTIC COMPANIES
      • Table Selected Investments and Other Financing Agreements for Tissue and Cell Diagnostics Companies
    • AGREEMENTS WITH OTHER COMPANIES
      • Table Selected Agreements between Tissue/Cell Diagnostics Companies and Other Diagnostic Companies or Clinical Laboratories
      • Table Selected Agreements between Tissue/Cell Diagnostics Companies and Pharmaceutical or Biopharmaceutical Companies
      • Table Selected Agreements between Two Tissue/Cell Diagnostics Companies
      • Table Selected Other Tissue/Cell Diagnostics Company Agreements
    • ACQUISITIONS OF TISSUE AND CELL DIAGNOSTICS COMPANIES
      • Table Selected Acquisitions of Tissue/Cell Diagnostics Companies
    • SELECTED OTHER AGREEMENTS
      • Table Selected Tissue/Cell Diagnostics Company Agreements with Academic or Other Non-Profit Organizations
  • Tissue/Cell Diagnostics - Market Drivers and Challenges
    • TISSUE/CELL DIAGNOSTICS MARKET DRIVERS
    • ISSUES AND HURDLES FACED BY COMPANIES SELLING TO THE RESEARCH MARKET
    • ISSUES AND HURDLES FACED BY IN VITRODIAGNOSTIC COMPANIES
    • INCREASING NUMBERS OF TESTS ON SMALL BIOPSY SPECIMENS
    • FUTURE PROSPECTS
  • Market Analysis
    • TISSUE AND CELL DIAGNOSTICS MARKET BY TECHNOLOGY
      • Table Tissue and Cell Diagnostics Sales by Type of Technology, Worldwide, 2013 and 2018 (in millions USD)
      • Table Histology and Cytology Diagnostics Sales by Type of Technology, Worldwide, 2013 and 2018 (in millions USD)
    • TISSUE AND CELL DIAGNOSTICS MARKET BY GEOGRAPHICAL DISTRIBUTION
      • Table Tissue/Cell Diagnostics Sales by Geographical Region, 2013 and 2018 (North America, Europe, Asia, Rest of World, Total) (in millions USD)
    • TISSUE AND CELL DIAGNOSTICS MARKET BY DISEASE INDICATION
    • TISSUE AND CELL DIAGNOSTICS - PROPRIETARY TESTS FROM COMPANIES WITH CLIA-CERTIFIED LABORATORIES
    • ANALYSIS OF TISSUES AND CELLS IN THE LIFE SCIENCES
    • PROSPECTS FOR GROWTH OF THE TISSUE AND CELL DIAGNOSTICS MARKET
  • Company Profiles: Companies Marketing or Developing Tissue Diagnostic Products or Services
    • 20/20 GENESYSTEMS, INC.
    • 3DHISTECH LTD.
    • ABBOTT LABORATORIES
      • Recent Revenue History
      • Company Overview (Focusing on Diagnostics, Especially Immunoassays)
    • ABCAM PLC
      • Recent Revenue History
      • Company Overview
    • AB SCIEX (A DANAHER CORPORATION COMPANY)
    • ADAPTIVE BIOTECHNOLOGIES CORPORATION
    • ADNAGEN GMBH (AN ALERE COMPANY)
    • ADVANCED CELL DIAGNOSTICS
    • AFFYMETRIX, INC.
      • Recent Revenue History
      • Company Overview (Focusing on Proteomics Activities)
    • AGENA BIOSCIENCE INC.
    • AGENDIA NV
    • AGILENT TECHNOLOGIES INC.
      • Recent Revenue History
      • Company Overview
    • AMOY DIAGNOSTICS CO., LTD.
    • ANGLE PLC
    • APOCELL, INC.
    • APOGEE FLOW SYSTEMS LTD.
    • APOLLO PACS, INC.
    • APPLIED CYTOMETRY
    • APPLIED SPECTRAL IMAGING, INC.
    • ARBOR VITA CORPORATION
    • ASURAGEN, INC.
      • Diagnostic Products
      • Clinical Lab
      • Genomic Services
      • Companion Diagnostics
    • AURORA INTERACTIVE
    • AUTOGENOMICS, INC.
    • AVIVA BIOSCIENCES CORPORATION
    • BECKMAN COULTER, INC. (SUBSIDIARY OF DANAHER CORPORATION)
      • Recent Revenue History
      • Company Overview
      • Hematology
      • Flow Cytometry
    • BECTON, DICKINSON AND COMPANY (BD)
      • Recent Revenue History
      • Company Overview
    • BIOCARE MEDICAL, LLC
    • BIOCARTIS SA
    • BIOCEP LTD
    • BIOCEPT, INC.
    • BIODOT INC.
    • BIOFLUIDICA, INC.
    • BIOGENEX
    • BIOMARKER STRATEGIES
    • BIOMÉRIEUX SA
      • Recent Revenue History
      • Company Overview
    • BIOMOSAICS INC.
    • BIO-RAD LABORATORIES, INC.
      • Recent Revenue History
      • Company Overview
    • BIO SB
    • BIOTEK INSTRUMENTS, INC.
    • BIOTHERANOSTICS (A BIOMÉRIEUX COMPANY)
    • BIOVIEW LTD.
    • BRUKER CORPORATION
      • Recent Revenue History
      • Company Overview
    • CANCER GENETICS, INC.
      • Recent Revenue History
      • Company Overview
    • CANOPUS BIOSCIENCE LTD.
    • CARIS LIFE SCIENCES
    • CARL ZEISS AG
    • CARL ZEISSMICROSCOPY GMBH
      • Recent Revenue History
      • Company Overview
    • CASTLE BIOSCIENCES INC.
    • CCC DIAGNOSTICS, LLC
    • CDX DIAGNOSTICS
    • CELERUS DIAGNOSTICS, INC.
    • CELLAVISION AB
    • CELLTRAFFIX, INC.
    • CELLULAR DYNAMICS INTERNATIONAL
    • CELULA, INC.
    • CERNOSTICS
    • CIRDAN IMAGING LTD
    • CISBIO BIOASSAYS
    • CLARIENT DIAGNOSTIC SERVICES, INC. (AGEHEALTHCARE COMPANY)
    • CLEARBRIDGE BIOMEDICS
    • CLONTECH LABORATORIES, INC (MEMBER OF THE TAKARA BIO GROUP)
    • COMBIMATRIX CORPORATION
      • Recent Revenue History
      • Company Overview
    • CREATV MICROTECH, INC.
    • CYMOGEN DX, LLC (BEING ACQUIRED BY BIOCARE MEDICAL, LLC)
    • CYNVENIO BIOSYSTEMS, INC.
    • CYTEK DEVELOPMENT INC.
    • CYTOTRACK APS
    • DAKO A/S (AN AGILENT COMPANY)
      • Recent Revenue History
      • Company Overview
    • DANAHER CORPORATION
      • Recent Revenue History
      • Company Overview
    • DEFINIENS AG
    • DIACARTA INC.
    • DIATECH ONCOLOGY
    • DISCOVERX CORPORATION
    • ELITECH GROUP
    • EMDMILLIPORE (MERCKMILLIPORE)
      • Recent Revenue History
      • Company Overview
    • ENZO BIOCHEM, INC
    • ENZO LIFE SCIENCES, INC.
    • ENZO CLINICAL LABS, INC.
      • Recent Revenue History
      • Company Overview
    • EPIC SCIENCES, INC.
    • FLUIDIGM CORPORATION
      • Recent Revenue History
      • Company Overview
    • FLUXION BIOSCIENCES, INC.
    • FOUNDATION MEDICINE, INC.
      • Recent Revenue History
      • Company Overview
    • GE HEALTHCARE
      • Recent Revenue History
      • Company Overview
    • GENECENTRIC DIAGNOSTICS, INC.
    • GENOMIC HEALTH, INC.
      • Recent Revenue History
      • Company Overview
    • HEMOGENIX
    • HISTOGENEX
    • HOLOGIC, INC.
      • Recent Revenue History
      • Company Overview
    • HORIBAMEDICAL
      • Recent Revenue History
      • Company Overview
    • HTGMOLECULAR DIAGNOSTICS
    • HURON TECHNOLOGIES INTERNATIONAL INC.
    • ICELLATE AB
    • IKONISYS, INC.
    • IMABIOTECH SAS
    • IMABIOTECH CORP
    • IMMCO DIAGNOSTICS, INC. (ATRINITY BIOTECH COMPANY)
    • INCELLDX, INC.
    • INDICA LABS, INC.
    • INSIGHT GENETICS, INC.
    • INTELLICYT CORPORATION
    • IRIS BIOTECHNOLOGIES INC.
      • Recent Revenue History
      • Company Overview
    • JANSSEN DIAGNOSTICS
      • JANSSEN DIAGNOSTICS BVBA
    • JANSSEN DIAGNOSTICS, LLC (ONCOLOGY DIAGNOSTICS)
    • LEICA BIOSYSTEMS INC. (PART OF DANAHER CORPORATION)
    • LEICA MICROSYSTEMS (A DANAHER COMPANY)
    • LEUCODX INC.
    • LIFE TECHNOLOGIES CORPORATION (ACQUIRED BY THERMO FISCHER SCIENTIFIC INC.)
      • Recent Revenue History
      • Company Overview
    • MDXHEALTH SA
      • Recent Revenue History
      • Company Overview
    • METAMARK GENETICS, INC.
    • METASYSTEMS GMBH
    • METASYSTEMS GROUP, INC.
    • MILTENYI BIOTEC GMBH
    • MOLECULAR DEVICES, LLC (A DANAHER COMPANY)
    • MOLECULARMDCORPORATION
    • MONOGRAM BIOSCIENCES (LABCORP SPECIALTY TESTING GROUP)
    • MULTIPLICOM NV
    • MYRIAD GENETICS, INC.
      • Recent Revenue History
      • Company Overview
    • NANOSTRING TECHNOLOGIES, INC.
      • Recent Revenue History
      • Company Overview
    • NIKON CORPORATION
    • NIKON INSTRUMENTS INC.
      • Recent Revenue History
      • Company Overview
    • NODALITY, INC.
    • NORCHIP AS
    • OLYMPUS GROUP
      • Recent Revenue History
      • Company Overview
    • OMNYX
    • ONCOHEALTH CORP.
    • ONCOPLEX DIAGNOSTICS (ONCOPLEXDX)
    • OXFORD CANCER BIOMARKERS LTD.
    • OXFORD GENE TECHNOLOGY
    • PANAGENE INC.
    • PERKINELMER, INC.
      • Recent Revenue History
      • Company Overview
      • Quantitative Pathology Imaging and Analysis Systems
      • Cellular Imaging and Analysis Systems
      • Histological Analysis
    • PROTEA BIOSCIENCES GROUP, INC.
      • Recent Revenue History
      • Company Overview
    • QIAGEN N.V.
      • Recent Revenue History
      • Company Overview
    • QUANDX
    • QUANTUMDX GROUP
    • RARECELLS SAS
    • RESPONSE GENETICS, INC.
      • Recent Revenue History
      • Company Overview
    • RHEONIX, INC.
    • ROCHE DIAGNOSTICS
      • Recent Revenue History
      • Company Overview
    • SCREENCELL
    • SIEMENS HEALTHCARE DIAGNOSTICS
      • Recent Revenue History
      • Company Overview
    • SIGMA-ALDRICH CORPORATION
      • Recent Revenue History
      • Company Overview
    • SILICON BIOSYSTEMS
    • SONY BIOTECHNOLOGY INC.
    • SPAN DIAGNOSTICS LTD.
    • SYSMEX CORPORATION
      • Recent Revenue History
      • Company Overview
    • TELOVISION, LLC
    • THERANOSTICS HEALTH INC.
    • THERMO FISHER SCIENTIFIC, INC.
      • Recent Revenue History
      • Company Overview
    • VENTANA MEDICAL SYSTEMS, INC. (MEMBER OF THE ROCHE GROUP)
    • VERACYTE, INC.
      • Recent Revenue History
      • Company Overview
    • VITATEX INC.
    • WAVESENSE, INC.

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