In Vitro Diagnostic (IVD) Procedure Volumes (Chemistry, Immunoassays, Hematology, Microbiology, Histology, Point of Care), 2023-2028

In Vitro Diagnostic (IVD) Procedure Volumes (Chemistry, Immunoassays, Hematology, Microbiology, Histology, Point of Care), 2023-2028


In vitro diagnostic (IVD) test volumes are the gold standard for sizing the market opportunity for new entrants with diagnostic products, and they can be useful for existing product marketers. The market analysis in Kalorama Information’s In Vitro Diagnostic (IVD) Procedure Volumes (Chemistry, Immunoassays, Hematology, Microbiology, Histology, Point of Care), 2023-2028 saves time with calculations and estimates of both the existing number of procedures for scores of diagnostic tests and the future potential. In the process, pricing analysis is also performed.

This report is an essential resource for the IVD business planner. It is intended to serve as a companion piece to Kalorama’s major IVD publication (i.e., The Worldwide Market for In Vitro Diagnostic Tests, 16th Edition).

Kalorama’s IVD procedures report presents projections covering the 2023 to 2028 period for:
  • the global number of IVD procedures by type (self and professional point-of-care, clinical chemistry, immunoassay, molecular, hematology, coagulation, microbiology, blood banking, and histology/cytology)
  • the total number of IVD tests by region and selected countries
  • the average and total worldwide cost of various IVD tests
  • The report estimates IVD test procedure volume and IVD pricing for the following segments:
  • Worldwide IVD Market and Test Volume
  • Point-of-Care (POC) Market and Test Volume
  • Clinical Chemistry Market and Test Volume
  • Molecular Market and Test Volume
  • Laboratory-based Hematology Market and Test Volume
  • Coagulation Market and Test Volume
  • Microbiology Market and Test Volume
  • Blood Banking Market and Test Volume
  • COVID-19 Market and Test Volume
  • Histology/Cytology Market and Test Volume
  • Immunoassay Market and Test Volume
Global IVD markets covered in the report include:
  • North America:
  • United States
Canada
  • Mexico, Central & South America
  • Western Europe
  • Eastern Europe
  • Asia/Pacific:
  • China
  • Japan
  • Other Countries & Territories
  • Middle East
  • Africa
In Vitro Diagnostic (IVD) Procedure Volumes, 2023-2028 includes profiles of the top IVD market competitors, looking in detail where possible at procedural volume by type. The companies covered are the following:
  • Abbott Laboratories
  • Agilent Technologies
  • Beckman Coulter
  • Becton, Dickinson and Company (BD)
  • bioMérieux Inc.
  • Bio-Rad Laboratories, Inc.
  • Bruker Corporation
  • Cepheid
  • Danaher Corporation
  • Dexcom
  • DiaSorin
  • Exact Sciences
  • Hologic, Inc.
  • Illumina
  • Mindray
  • Natera
  • QIAGEN N.V.
  • Roche
  • Siemens Healthineers
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.
  • Ventana Medical Systems
  • Werfen
Scope

Data statistics appearing in this report correlate to IVD procedures based on commercially sold and distributed tests. Procedures that employ laboratory developed tests (LDTs) and tests implemented for research purposes only are excluded from the analysis.

Global volumes of various IVD procedures are presented in millions and reflect the evaluation of a single analyte, marker, or other variable of interest. It should be noted that some IVD tests involve more than one procedure as they provide for the analysis of multiple analytes.

Global sales of IVD products are expressed in current United States dollars and reflect sales for the year 2023 and forecasts for the 2028 period. A table that measures the total amount of IVD product sales against the total volume of IVD procedures is presented for each major testing category.


  • Executive Summary
    • Introduction
    • IVD Procedure Volume Estimate and Forecast
    • Scope & Methodology
    • About Kalorama Information
  • Introduction
    • Overview
    • Industry Trends
      • Table Global IVD Procedural Volume & Product Sales (includes glucose tests), 2023-2028
      • COVID 19
    • Demographic Trends
      • Global Population and Aging
        • Table Elderly Support Ratio in Various Countries (Australia; Brazil; Canada; China; China, Hong Kong SAR; France; Germany; India; Italy; Japan; Mexico; Saudi Arabia; Singapore; South Africa; Spain; Turkey; United Kingdom; United States; World), 2010 and 2050
      • Workforce Reduction
        • Table Age Under 15 and Over 65, by Continent (Africa, L. America/Caribbean, Asia, Oceania, N. America, Europe, World), 2020
    • Increase in Chronic Diseases
    • Personalized Medicine
    • New Infectious Disease Threats
      • Table Selected Companies Marketing Products Addressing Emerging Infectious Disease Threats
      • Tickborne Diseases (TBDs)
      • Zika
      • Chagas
      • Dengue
      • Ebola
      • Chikungunya
      • Middle East Respiratory Syndrome-Coronavirus (MERS-CoV)
      • Marburg
      • SARS-CoV-2 (COVID-19)
      • Monkeypox
    • Emerging and Emerged Markets
      • Table Market Potential by Total Population, and Percent Urban 2020 (China, India, United States, Brazil, Russia, Mexico, Nigeria, Turkey, S. Korea, S. Africa, Vietnam, Poland, Saudi Arabia, Canada, Colombia, Ukraine, Egypt, Malaysia)
  • IVD Testing Segments
    • IVD Testing Trends
      • Table IVD Procedural Volume including blood glucose tests (millions), 2023-2028
      • Table IVD Procedural Volume excluding blood glucose tests (millions), 2023-2028
    • Segment Growth Projections
      • POC Testing
      • Clinical Chemistry
      • Immunoassays
      • Mass Spectrometry (Immuno)
      • Molecular Assays
      • Hematology
      • Coagulation
      • Conventional Microbiology
      • Blood Grouping/Typing
      • Histology/Cytology
        • Table IVD Product Sales including blood glucose tests ($ millions), 2023-2028
        • Table IVD Product Sales excluding blood glucose tests ($ millions), 2023-2028
  • Global IVD Markets
    • General
      • Table IVD Procedural Volume including blood glucose tests by Region (millions), 2023-2028
    • North America
      • United States
      • Canada
    • Mexico, Central & South America
      • Brazil
      • Mexico
      • Other Central & South America
    • Western Europe
      • France
      • Germany
      • Italy
      • Spain
      • United Kingdom
      • Other Western Europe
    • Eastern Europe
      • Russia
      • Other Eastern Europe
    • Asia/Pacific
      • China
      • Japan
      • Other Asian Countries and Territories
    • Middle East
      • Turkey
      • Other Middle East
    • Africa
  • Point-of-Care (POC) Procedures
    • Global POC Procedure Volume by Test Type
      • Table Total POC Procedural Volume & Product Sales including blood glucose tests, 2023-2028
      • Table Total POC Procedural Volume & Product Sales excluding blood glucose tests, 2023-2028
    • POC Self Tests
      • Table POC Self-Test Procedural Volume by Type (millions), 2023-2028
      • Traditional Blood Glucose Monitoring Activities
      • Continuous Blood Glucose Monitoring
      • Pregnancy and Fertility Testing
      • Coagulation Testing
      • Fecal Occult Blood Testing
      • Drugs of Abuse Testing
      • H. Pylori Testing
      • HIV Testing
      • Infectious Disease
      • Cholesterol Testing
      • POC Urinalysis Testing
      • Other POC Self-Testing
    • POC Self-Testing Product Sales
      • Table POC Self-Test Product Sales by Type ($ millions), 2023-2028
    • Pricing Trends
      • Table POC Self-Test $ IVD Product Sales Per Procedure, 2023-2028
    • POC Professional Testing
      • Table POC Professional Procedural Volume by Type (millions), 2023-2028
      • POC Professional Blood Glucose Testing Procedures
      • POC Professional Critical Care Testing
      • POC Fertility Testing
      • POC Professional Infectious Disease Testing
      • POC Professional Cardiac Marker Testing
      • POC Professional Cholesterol/Lipid Testing
      • POC Professional Coagulation Testing
      • POC Professional HbA1C Testing
      • POC Professional Hematology Testing
      • POC Professional Fecal Occult Blood Screening
      • POC Professional Drugs of Abuse Testing
      • POC Professional Urinalysis Testing
      • Other POC Professional Testing
    • POC IVD Product Sales
      • Table POC Professional IVD Product Sales by Type ($ millions), 2023-2028
    • Pricing Trends
      • Table POC Professional $ IVD Products Per Procedure by Type (millions), 2023-2028
  • Clinical Chemistry Procedures
    • Table Clinical Chemistry Procedural Volume by Type (millions), 2023-2028
    • Types of Tests
      • General Chemistry
      • Blood Gases & Electrolytes
      • Urinalysis
    • Global Sales of Clinical Chemistry Products
      • Table Clinical Chemistry Product Sales by Type ($ millions), 2023-2028
    • Pricing Trends
      • Table Clinical Chemistry $ IVD Product Sales Per Procedure ($), 2023-2028
  • Immunoassay Procedures
    • Technologies
    • Labeling Techniques
      • Enzyme Immunoassays
      • Fluorescence Polarization Immunoassays (FPIAs)
      • Radioimmunoassays (RIAs)
        • Table Immunoassay Procedural Volume by Type (millions), 2023-2028
    • Testing Procedures & Product Sales
      • Table Immunoassay Product Sales by Type (millions), 2023-2028
      • Cardiac Markers
      • Tumor Markers
      • Autoimmune Conditions
      • Allergy Conditions
      • Thyroid Conditions
      • Proteins
      • Anemia
      • Fertility Testing
      • Therapeutic Drug Monitoring
      • Vitamin D
      • Diabetes/HbA1c
      • Drugs of Abuse
      • Infectious Diseases
        • Table Immunoassay Infectious Disease Procedural Volume by Type (millions), 2023-2028
        • Table Immunoassay Infectious Disease Product Sales by Type ($ millions), 2023-2028
    • Instruments
    • Pricing Trends
      • Table Immunoassay $ Product Sales Per Procedure by Type, 2023-2028
  • Molecular Testing Procedures
    • Table Molecular Assay Procedural Volume by Type (millions), 2023-2028
    • Types of Test
      • Testing Technologies
      • Infectious Diseases
        • Table Molecular Assay Infectious Disease Procedural Volume by Type (millions), 2023-2028
      • Blood Screening
      • Cancer
      • Transplant Matching
      • Thrombophilia SNPs
      • Inherited Diseases
      • Other Molecular Tests
      • Prenatal
    • Global Sales of Molecular IVD Products
      • Table Molecular Assay Product Sales by Type ($ millions), 2023-2028
      • Table Molecular Assay Infectious Disease Product Sales by Type ($ millions), 2023-2028
    • Pricing Trends
      • Table Molecular Assays $ Products per Procedure by Type, 2023-2028
  • Laboratory-Based Hematology Procedures
    • Table Laboratory-Based Hematology Procedural Volume by Type (millions), 2023-2028
    • Types of Tests
    • Global Sales of Hematology Products
      • Table Laboratory-Based Hematology Product Sales by Type ($ millions), 2023-2028
    • Pricing Trends
      • Table Hematology $ Product Sales Per Procedure by Type, 2023-2028
  • Coagulation Testing Procedures
    • Table Coagulation Procedural Volume (millions), 2023-2028
    • Types of Tests
    • Global Sales of Coagulation Products
      • Table Coagulation Product Sales ($ millions), 2023-2028
    • Pricing Trends
      • Table Coagulation $ Products per Procedure, 2023-2028
  • Microbiology Procedures
    • Table Conventional Microbiology Procedural Volume by Type (millions), 2023-2028
    • Types of Tests
      • ID/AST Automated Panels & Reagents
      • Manual Panels & Reagents
      • Blood Culture
      • Chromogenic Media
      • Rapid Microbiological Tests
      • Mass Spectrometry
    • Global Sales of Conventional IVD Microbiology Products
      • ID/AST Panels & Reagents
      • Blood Culture
      • Chromogenic Media
      • Rapid Microbiological Tests
      • Mass Spectrometry
        • Table Conventional Microbiology Product Sales by Type ($ millions), 2023-2028
    • Pricing Trends
      • Table Conventional Microbiology $ Product Sales Per Procedures by Type, 2023-2028
  • Blood Grouping/Typing Procedures
    • Table Blood Grouping/Typing Procedure Volumes ($ millions), 2023-2028
    • Types of Tests
    • Blood Grouping/Typing Product Sales
      • Table Blood Grouping/Typing Product Sales ($ millions), 2023-2028
    • Pricing Trends
      • Table Blood Grouping/Matching $ Product Sales/Procedure, 2023-2028
  • Histology/Cytology Procedures
    • Table Histology/Cytology Procedural Volume by Type (millions), 2023-2028
    • Types of Tests
      • Pap Tests
      • In Situ Hybridization Tests
      • Immunohistochemistry Tests
      • Traditional Non-Pap Stains
      • Circulating Tumor Cells
      • Flow Cytometry
    • Histology/Cytology IVD Product Sales
      • Table Histology/Cytology Product Sales by Type ($ millions), 2023-2028
    • Pricing Trends
      • Table Histology/Cytology $ Product Sales Per Procedure by Type, 2023-2028
  • Company Profiles
    • Table Revenues of Selected Top 20 IVD Companies, 2022 ($ million) est 2023
    • Abbott Diagnostics
      • Recent Revenue History
        • Table Abbott Diagnostic Revenues, 2017-2022 ($ million)
      • Core Lab
      • Hematology
      • Blood Banking
      • Infectious Diseases - Molecular
      • Diabetes
      • HIV Point of Care
      • i-STAT Business
      • COVID-19
    • Agilent Technologies
      • Recent Revenue History
        • Table Agilent Revenues, 2017-2022 ($ million)
      • Agilent in Genomics
      • Cytogenetic Analysis
      • Sequencing
      • Flow Cytometry
      • Companion Diagnostics - Dako
      • COVID-19
    • Beckman Coulter
      • Recent Revenue History
        • Table Beckman Coulter Revenue History, 2017-2022 ($ million, estimated)
      • Hematology
      • Clinical Chemistry
      • Immunoassays
      • Microbiology
      • Blood Banking
      • COVID-19
    • Becton, Dickinson and Company (BD)
      • Recent Revenue History
        • Table BD Diagnostic Revenues, 2017-2022 ($ million) FYE Sept 30
      • Cytology
      • Molecular Microbiology
      • Traditional Microbiology - ID/AST
      • Blood Culture
      • Hospital Acquired Infections
      • Blood Collection
      • Mass Spectrometry
      • COVID-19
    • bioMérieux Inc.
      • Recent Revenue History
        • Table bioMerieux IVD Revenues, 2017-2022 ($ million)
      • Traditional Microbiology
      • Blood Culture
      • Immunoassays
      • Mass Spectrometry
      • BioFire Diagnostics Business
      • COVID-19
    • Bio-Rad Laboratories, Inc.
      • Recent Revenue History
        • Table Bio-Rad Diagnostics Revenues, 2017-2022 ($ million)
      • Blood Bank
      • Immunoassays
      • COVID-19
    • Bruker Corporation
      • Recent Revenue History
        • Table Bruker Revenue History Product Revenue, 2017-2022 (all; $ million)
      • Acquisitions and Collaborations
      • Mass Spectrometry
      • Microbiology
      • Molecular PCR
      • COVID-19
    • Cepheid / Danaher
      • Recent Revenue History
        • Table Cepheid Revenue History, 2017-2022 ($ million, clinical product sales)
      • GeneXpert/ Xpress Line
      • Tuberculosis
      • Microbiology
      • POC Testing
      • Cancer
      • COVID-19
    • Danaher Corporation
      • Recent Revenue History
        • Table Danaher Global IVD Diagnostic Sales, 2017-2022 ($ million)
    • Dexcom
      • Recent Revenue History
        • Table Dexcom IVD Diagnostic Sales, 2017-2022 ($ million)
    • DiaSorin
      • Recent Revenue History
        • Table DiaSorin Revenues, 2017-2022 ($ million)
      • Immunoassays
      • Molecular
      • COVID-19
    • Exact Sciences
      • Recent Revenue History
        • Table Exact Sciences Revenues, 2017-2022 ($ million)
      • COVID-19
    • Hologic, Inc.
      • Recent Revenue History
        • Table Hologic Revenues, 2017-2022 ($ million)
      • PANTHER Molecular System
      • HIV Testing
      • Sexually Transmitted Infections
      • Infectious Diseases
      • Cytology
      • COVID-19
    • Illumina
      • Recent Revenue History
        • Table Illumina Diagnostics Revenues, 2017-2022 ($ million)
      • COVID-19
    • Mindray - Shenzhen Mindray Bio-medical Electronics Co., Ltd.
      • Recent Revenue History
        • Table Mindray Revenue History, 2017-2022 ($ millions)
    • Natera
      • Recent Revenue History
        • Table Natera Revenue History, 2017-2022 ($ millions)
      • Prenatal Paternity Testing
    • QIAGEN
      • Recent Revenue History
        • Table QIAGEN IVD Revenues, 2017-2022 ($ million)
      • Tuberculosis
      • Precision Medicine / Companion Diagnostics
      • Molecular Microbiology
      • Prenatal Testing
      • Next Generation Sequencing
      • Liquid Biopsy
      • COVID-19
    • QuidelOrtho Corporation
      • Recent Revenue History
        • Table QuidelOrtho Revenue History, 2018-2022 ($ million)
      • Immunoassays
      • Rapid Immunoassays
      • The Solana Business
      • Molecular - Savanna
      • Blood Bank
      • COVID-19
    • Radiometer A/S / Danaher
      • Recent Revenue History
        • Table Radiometer A/S Revenue History, 2017-2022 (estimated, $ million)
      • Critical Care
      • Immunoassays
      • HemoCue
    • Roche Diagnostics
      • Recent Revenue History
        • Table Roche Diagnostics IVD Revenues, 2017-2022 ($ million)
      • Hematology
      • Core Lab
      • Immunoassays
      • HIV
      • Core Molecular
      • Digital PCR
      • Diabetes Care
      • Coagulation
      • cobas Liat System - POC
      • HPV
      • Blood Bank
      • Transplant Medicine
      • Cancer Companion Testing
      • COVID-19
    • Siemens Healthineers (Siemens)
      • Recent Revenue History
        • Table Siemens Healthineers IVD Revenues, 2017-2022 ($ million)
      • Core Lab
      • Immunoassays
      • Hematology
      • Molecular
      • Acute Care - POC
      • COVID-19
    • Sysmex Corporation
      • Recent Revenue History
        • Table Sysmex IVD Revenues 2018-2022 ($ million) FY March 31
      • Hematology
      • Coagulation
      • Urinalysis
      • Immunoassays
      • Precision Medicine / Companion Test Diagnostics
      • Oncology
      • COVID-19
    • Thermo Fisher Scientific Inc.
      • Recent Revenue History
        • Table Thermo Fischer IVD Revenues, 2017-2022 ($ million)
      • Immunoassays
      • Microbiology
      • Next Generation Sequencing
      • Molecular and qPCR
      • Mass Spectrometry
      • COVID-19
    • Ventana Medical Systems Inc. / Roche Tissue Diagnostics
      • Recent Revenue History
        • Table Ventana Medical Systems Revenue History, 2017-2022 ($ millions)
      • Immunohistochemistry - IHC
      • Cervical Cancer Screening
      • Companion Diagnostics
    • Werfen
      • Recent Revenue History
        • Table Werfen IVD Revenues, 2017-2022 ($ million)
      • Hematology and Coagulation
      • Autoimmunity

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