Histology and Cytology IVD Market Update, 2024

Histology and Cytology IVD Market Update, 2024


This report, Histology and Cytology IVD Market Update, 2024, provides competitive analysis of the histology/cytology market from 2023 to 2028. Histology/cytology has been a mainstay of the pathological lab, providing information about cells, tissues and organs. A variety of diseases can be identified with a histopathological examination. Physicians rely on information from the pathologist as to whether there is cancer present or other disease. The physician bases their treatment and prognosis on the pathological information obtained. Technological advancements have increased the knowledge and understanding of the shape-function relationships within tissues and organs and their relationship to disease.

The industry has forged ahead with new technologies that offer increased accuracy and automated workflow. In the coming years, digital imaging, quantitative microscopy, precision microscopy, artificial intelligence and virtual histology will take the histology/cytology industry to the next level.

As discussed in the report, the histology market is a growing market with much potential. This report only looks at traditional histology. The histology report is segmented into five areas:
  • Traditional non-PAP Stains
  • PAP
  • In situ Hybridization
  • Immunohistochemistry
  • HPV
The histology report also examines and profiles five key market participants:
  • Agilent
  • Danaher Corporation
  • Hologic
  • Illumina
  • Roche Diagnostics
Scope and Methodology

The information for this report was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, databases, investment reports, and medical and business journals. Telephone interviews, in-person interviews and email correspondence were the primary methods of gathering information. For the purpose of this study, Kalorama Information conducted interviews with industry officials, consultants, health care providers, and government personnel. These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Additional interviews were completed with relevant company representatives including marketing directors, division managers, and product representatives.

All market data pertains to the world market at the manufacturers’ level. The market includes manufacturer tests. The base year for data was 2023. Data are provided for 2023 and 2028 with compound annual growth rates (CAGRs) for 2023 and 2028. Competitive analysis is provided for the top five participants in the market. Regional breakdowns are surveyed for United States, Europe, Asia-Pacific and Rest of World for 2023. The forecasted market analysis for 2023-2028 was largely based on demographic trends, new developments, innovative technology and global expansion.


  • Executive Summary
    • Industry at a Glance
    • Scope and Methodology
    • Size and Growth of the Market
      • Table Global Histology IVD Market, 2023-2028 ($ millions)
    • Competitive Outlook
  • Market Overview
    • Overview Of Histology/Cytology
    • Histology and Cancer
    • Advanced Analysis Solutions
      • Table Selected Advanced Histology Techniques
    • Laboratory Developed Tests
    • AI and Histology
  • Market Size and Growth
    • Market Segments
      • Table Global Histology/Cytology Sales, by Type (Pap Tests, In situ hybridization, Immunohistochemistry, Traditional non-Pap stains, HPV), 2023-2028 ($ millions)
      • Table Global Histology/Cytology IVD Market, 2023-2028 ($ millions)
      • Table Histology/Cytology Diagnostic Market Distribution, by Broad Test Category (Pap Tests, In situ hybridization, Immunohistochemistry, Traditional non-Pap stains, HPV), 2023 (%)
      • Traditional Tissue Stains
        • Table Selected Vendors of Traditional Histology Stains
      • PAP Tests
        • Table Primary and Secondary Prevention of Cervical Cancer, Screening Responses by Country, 2022 (last updated 2022-5-6)
      • Immunohistochemistry and In Situ Hybridization
        • Table Selected in Situ Hybridization-based Tests
        • Table Selected IHC Test Innovations
      • HPV
        • Table HPV Screening Market: HPV DNA and Pap Test Distribution of Sales, 2023
        • Table Global HPV Molecular (DNA/RNA) Test Sales Distribution, by Region (North America, Europe, Asia Pacific, RoW), 2023 (%)
        • Table Selected HPV Test Innovations
    • Market by Region
      • Table Global Histology/Cytology Market, by Region (North America, Europe, Asia, RoW), 2023-2028 ($ millions)
      • Table Global Histology/Cytology Market, by Region (North America, Europe, Asia, RoW), 2023-2028 (%)
      • Table Global Histology/Cytology Sales Distribution, by Region (North America, Europe, Asia Pacific, RoW), 2023 (%)
      • North America
        • Table North America Histology/Cytology Market, by Segment (Pap Test, In situ hybridization, Immunohistochemistry, Traditional non-Pap test, HPV-DNA), 2023-2028 ($ millions)
        • Table North America Histology/Cytology Market, by Segment (Pap Test, In situ hybridization, Immunohistochemistry, Traditional non-Pap test, HPV-DNA), 2023-2028 (%)
      • Europe
        • Table Europe Histology/Cytology Market, by Segment (Pap Test, In situ hybridization, Immunohistochemistry, Traditional non-Pap test, HPV-DNA), 2023-2028 ($ millions)
        • Table Europe Histology/Cytology Market, by Segment (Pap Test, In situ hybridization, Immunohistochemistry, Traditional non-Pap test, HPV-DNA), 2023-2028 (%)
      • Asia Pacific
        • Table Asia Pacific Histology/Cytology Market, by Segment (Pap Test, In situ hybridization, Immunohistochemistry, Traditional non-Pap test, HPV-DNA), 2023-2028 ($ millions)
        • Table Asia Pacific Histology/Cytology Market, by Segment (Pap Test, In situ hybridization, Immunohistochemistry, Traditional non-Pap test, HPV-DNA), 2023-2028 (%)
      • Rest of World (RoW)
        • Table Rest of World (RoW) Histology/Cytology Market, by Segment (Pap Test, In situ hybridization, Immunohistochemistry, Traditional non-Pap test, HPV-DNA), 2023-2028 ($ millions)
        • Table Rest of World (RoW) Histology/Cytology Market, by Segment (Pap Test, In situ hybridization, Immunohistochemistry, Traditional non-Pap test, HPV-DNA), 2023-2028 (%)
    • Competitive Analysis
      • Table Revenues of the Major Histology Companies, 2017-2023 ($ millions, estimated)
      • Table Pathology Launches by Roche
    • The Commercial Outlook for Histology
  • Major Market Participants
    • Abbott Diagnostics
      • Table Abbott Corporate Summary
      • Table Abbott Revenue History, 2017-2023 ($ million)
    • Agilent
      • Table Agilent Corporate Summary
      • Table Agilent Diagnostic Revenues, 2017-2023 ($ millions)
      • Table Agilent Revenues, by Group, 2022-2023 ($ millions)
    • Becton, Dickinson and Company
      • Table Becton Dickinson Corporate Summary
      • Table BD Revenue History, 2017-2023 ($ million, FYE Sept 30)
    • Biocare Medical
      • Table Biocare Medical Corporate Summary
    • BioGenex
      • Table BioGenex Corporate Summary
    • Danaher Corporation
      • Table Danaher Corporation Summary
      • Table Danaher Revenue History, 2017-2023 ($ million, estimated)
      • Table Danaher Diagnostics (Recurring/Nonrecurring), Full Year 2022 and 2023 ($ millions)
    • Hologic
      • Table Hologic Corporate Summary
      • Table Hologic Revenue History, 2017-2023 ($ million, estimated)
      • Table Hologic Diagnostic Product Revenues, FY 2022 and FY 2023 ($ million)
    • Illumina, Inc
      • Table Illumina Corporate Summary
      • Table Illumina Diagnostics Revenues, 2017-2023 ($ millions)
      • Table Illumina Diagnostic Revenues, 2022-2023 ($ millions)
    • Medimeas
      • Table Medimeas Corporate Summary
    • QIAGEN N.V.
      • Table QIAGEN Corporate Summary
      • Table QIAGEN Revenue History, 2017-2023 ($ million, estimated)
    • Roche Diagnostic (Roche Tissue Diagnostics)
      • Table Roche Diagnostic Corporate Summary
      • Table Roche Revenue History ($ million, estimated)
      • Table Roche Diagnostic Performance, Full Year 2022 and 2023 (CHF Mn)
    • Sysmex
      • Table Sysmex Corporate Summary
      • Table Sysmex Revenue History, 2017-2023 ($ million, estimated)
    • Thermo Fisher Scientific
      • Table Thermo Fisher Corporate Summary
      • Table Thermo Fisher Revenue History, 2017-2023 ($ million, estimated)

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