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

  • Report

  • 394 Pages
  • September 2023
  • Region: Global
  • Kalorama Information
  • ID: 5880015

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 the report 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 the report'sf major IVD publication (i.e., The Worldwide Market for In Vitro Diagnostic Tests, 16th Edition).

The 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.

Table of Contents

Chapter One: Executive Summary
  • Introduction
  • IVD Procedure Volume Estimate and Forecast
  • Figure 1-1: Global IVD Procedure Volumes, 2023 and 2028
  • Scope & Methodology
Chapter Two: Introduction
  • Overview
  • Industry Trends
  • Table 2-1: Global IVD Procedural Volume & Product Sales (includes glucose tests), 2023-2028
  • COVID-19
  • Demographic Trends
  • Global Population and Aging
  • Figure 2-1: Global Fertility Rate vs. Population Size (BN). 1950-2050
  • Figure 2-2: Global Population Distribution, 2022
  • Table 2-2: 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 2-3: Age Under 15 and Over 65, by Continent (Africa, L. America/Caribbean, Asia, Oceania, N. America, Europe, World), 2020
  • Increase in Chronic Diseases
  • Figure 2-3: Leading Causes of Death Globally, 2019
  • Personalized Medicine
  • New Infectious Disease Threats
  • Table 2-4: 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)
  • Figure 2-4: Total COVID-19 Test Volume by Country, Average Estimates June-August 2023 (Thousands)
  • Figure 2-5: Estimated Market Distribution, COVID-19 Test Value, 2023
  • Monkeypox
  • Emerging and Emerged Markets
  • Table 2-5: 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)
Chapter Three: IVD Testing Segments
  • IVD Testing Trends
  • Table 3-1: IVD Procedural Volume including blood glucose tests (millions), 2023-2028
  • Table 3-2: 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 3-3: IVD Product Sales including blood glucose tests ($ millions), 2023-2028
  • Table 3-4: IVD Product Sales excluding blood glucose tests ($ millions), 2023-2028
Chapter Four: Global IVD Markets
  • General
  • Table 4-1: 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
  • Argentina
  • Colombia
  • Chile
  • Peru
  • Venezuela
  • All Other Countries & Territories
  • Western Europe
  • France
  • Germany
  • Italy
  • Spain
  • United Kingdom
  • Other Western Europe
  • Netherlands
  • Belgium
  • Austria
  • Sweden
  • Switzerland
  • Denmark
  • Portugal
  • Norway
  • Greece
  • Ireland
  • Finland
  • All Other Countries & Territories
  • Eastern Europe
  • Russia
  • Other Eastern Europe
  • Poland
  • Romania
  • Czech Republic
  • Ukraine
  • Hungary
  • All Other Countries
  • Asia/Pacific
  • China
  • Japan
  • Other Asian Countries and Territories
  • India
  • South Korea
  • Australia
  • Taiwan
  • Vietnam
  • Pakistan
  • Thailand
  • Malaysia
  • Indonesia
  • Hong Kong
  • Philippines
  • Singapore
  • New Zealand
  • All Other Countries & Territories
  • Middle East
  • Turkey
  • Other Middle East
  • Iran
  • Saudi Arabia
  • Iraq
  • Israel
  • United Arab Emirates
  • All Other Countries
  • Africa
  • South Africa
  • Nigeria
  • All Other Countries & Territories
Chapter Five: Point-of-Care (POC) Procedures
  • Global POC Procedure Volume by Test Type
  • Table 5-1: Total POC Procedural Volume & Product Sales including blood glucose tests, 2023-2028
  • Table 5-2: Total POC Procedural Volume & Product Sales excluding blood glucose tests, 2023-2028
  • Figure 5-1: Regional POC Procedure Volumes excluding blood glucose tests by Percent, 2023
  • POC Self Tests
  • Table 5-3: 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
  • Pylori Testing
  • HIV Testing
  • Infectious Disease
  • Cholesterol Testing
  • POC Urinalysis Testing
  • Other POC Self-Testing
  • POC Self-Testing Product Sales
  • Table 5-4: POC Self-Test Product Sales by Type ($ millions), 2023-2028
  • Pricing Trends
  • Table 5-5: POC Self-Test $ IVD Product Sales Per Procedure, 2023-2028
  • POC Professional Testing
  • Table 5-6: 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 5-7: POC Professional IVD Product Sales by Type ($ millions), 2023-2028
  • Pricing Trends
  • Table 5-8: POC Professional $ IVD Products Per Procedure by Type (millions), 2023-2028
Chapter Six: Clinical Chemistry Procedures
  • Table 6-1: Clinical Chemistry Procedural Volume by Type (millions), 2023-2028
  • Figure 6-1: Regional Clinical Chemistry Procedure Volumes by Percent, 2023
  • Types of Tests
  • General Chemistry
  • Enzymes
  • Glucose
  • Lipids
  • Proteins
  • Other Compounds
  • Blood Gases & Electrolytes
  • Urinalysis
  • Global Sales of Clinical Chemistry Products
  • Table 6-2: Clinical Chemistry Product Sales by Type ($ millions), 2023-2028
  • Pricing Trends
  • Table 6-3: Clinical Chemistry $ IVD Product Sales Per Procedure ($), 2023-2028
Chapter Seven: Immunoassay Procedures
  • Technologies
  • Labeling Techniques
  • Enzyme Immunoassays
  • Fluorescence Polarization Immunoassays (FPIAs)
  • Radioimmunoassays (RIAs)
  • Table 7-1: Immunoassay Procedural Volume by Type (millions), 2023-2028
  • Figure 7-1: Regional Immunoassay Procedure Volumes by Percent, 2023
  • Testing Procedures & Product Sales
  • Table 7-2: Immunoassay Product Sales by Type (millions), 2023-2028
  • Cardiac Markers
  • Tumor Markers
  • Autoimmune Conditions
  • Allergy Conditions
  • Thyroid Conditions
  • Proteins
  • Alzheimer’s Disease
  • Anemia
  • Fertility Testing
  • Therapeutic Drug Monitoring
  • Vitamin D
  • Diabetes/HbA1c
  • Drugs of Abuse
  • Infectious Diseases
  • Table 7-3: Immunoassay Infectious Disease Procedural Volume by Type (millions), 2023-2028
  • Table 7-4: Immunoassay Infectious Disease Product Sales by Type ($ millions), 2023-2028
  • Instruments
  • Pricing Trends
  • Table 7-5: Immunoassay $ Product Sales Per Procedure by Type, 2023-2028
Chapter Eight: Molecular Testing Procedures
  • Table 8-1: Molecular Assay Procedural Volume by Type (millions), 2023-2028
  • Figure 8-1: Regional Molecular Assay Procedure Volumes by Percent, 2023
  • Types of Test
  • Testing Technologies
  • Infectious Diseases
  • Table 8-2: 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 8-3: Molecular Assay Product Sales by Type ($ millions), 2023-2028
  • Table 8-4: Molecular Assay Infectious Disease Product Sales by Type ($ millions), 2023-2028
  • Pricing Trends
  • Table 8-5: Molecular Assays $ Products per Procedure by Type, 2023-2028
Chapter Nine: Laboratory-Based Hematology Procedures
  • Table 9-1: Laboratory-Based Hematology Procedural Volume by Type (millions), 2023-2028
  • Figure 9-1: Regional Laboratory-Based Hematology Procedure Volumes by Percent, 2023
  • Types of Tests
  • Global Sales of Hematology Products
  • Table 9-2: Laboratory-Based Hematology Product Sales by Type ($ millions), 2023-2028
  • Pricing Trends
  • Table 9-3: Hematology $ Product Sales Per Procedure by Type, 2023-2028
Chapter Ten: Coagulation Testing Procedures
  • Table 10-1: Coagulation Procedural Volume (millions), 2023-2028
  • Figure 10-1: US/ROW Coagulation Procedure Volumes by Percent, 2023
  • Types of Tests
  • Global Sales of Coagulation Products
  • Table 10-2: Coagulation Product Sales ($ millions), 2023-2028
  • Pricing Trends
  • Table 10-3: Coagulation $ Products per Procedure, 2023-2028
Chapter Eleven: Microbiology Procedures
  • Table 11-1: Conventional Microbiology Procedural Volume by Type (millions), 2023-2028
  • Figure 11-1: Regional Microbiology Procedure Volumes by Percent, 2023
  • 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 11-2: Conventional Microbiology Product Sales by Type ($ millions), 2023-2028
  • Pricing Trends
  • Table 11-3: Conventional Microbiology $ Product Sales Per Procedures by Type, 2023-2028
Chapter Twelve: Blood Grouping/Typing Procedures
  • Table 12-1: Blood Grouping/Typing Procedure Volumes ($ millions), 2023-2028
  • Figure 12-1: Regional Blood Grouping/Typing Procedure Volumes by Percent, 2023
  • Types of Tests
  • Blood Grouping/Typing Product Sales
  • Table 12-2: Blood Grouping/Typing Product Sales ($ millions), 2023-2028
  • Pricing Trends
  • Table 12-3: Blood Grouping/Matching $ Product Sales/Procedure, 2023-2028
Chapter Thirteen: Histology/Cytology Procedures
  • Table 13-1: Histology/Cytology Procedural Volume by Type (millions), 2023-2028
  • Figure 13-1: Regional Histology/Cytology Procedure Volumes by Percent, 2023
  • 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 13-2: Histology/Cytology Product Sales by Type ($ millions), 2023-2028
  • Pricing Trends
  • Table 13-3: Histology/Cytology $ Product Sales Per Procedure by Type, 2023-2028
Chapter Fourteen: Company Profiles
  • Table 14-1: Revenues of Selected Top 20 IVD Companies, 2022 ($ million) est 2023
  • Abbott Diagnostics
  • Recent Revenue History
  • Table 14-2: 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 14-3: Agilent Revenues, 2017-2022 ($ million)
  • Agilent in Genomics
  • Cytogenetic Analysis
  • Sequencing
  • Flow Cytometry
  • Companion Diagnostics - Dako
  • COVID-19
  • Beckman Coulter
  • Recent Revenue History
  • Table 14-4: 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 14-5: 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 14-6: 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 14-7: Bio-Rad Diagnostics Revenues, 2017-2022 ($ million)
  • Blood Bank
  • Immunoassays
  • COVID-19
  • Bruker Corporation
  • Recent Revenue History
  • Table 14-8: 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 14-9: 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 14-10: Danaher Global IVD Diagnostic Sales, 2017-2022 ($ million)
  • Dexcom
  • Recent Revenue History
  • Table 14-11: Dexcom IVD Diagnostic Sales, 2017-2022 ($ million)
  • DiaSorin
  • Recent Revenue History
  • Table 14-12: DiaSorin Revenues, 2017-2022 ($ million)
  • Immunoassays
  • Molecular
  • COVID-19
  • Exact Sciences
  • Recent Revenue History
  • Table 14-13: Exact Sciences Revenues, 2017-2022 ($ million)
  • COVID-19
  • Hologic, Inc.
  • Recent Revenue History
  • Table 14-14: Hologic Revenues, 2017-2022 ($ million)
  • PANTHER Molecular System
  • HIV Testing
  • Sexually Transmitted Infections
  • Infectious Diseases
  • Cytology
  • COVID-19
  • Illumina
  • Recent Revenue History
  • Table 14-15: Illumina Diagnostics Revenues, 2017-2022 ($ million)
  • COVID-19
  • Mindray - Shenzhen Mindray Bio-medical Electronics Co., Ltd.
  • Recent Revenue History
  • Table 14-16: Mindray Revenue History, 2017-2022 ($ millions)
  • Natera
  • Recent Revenue History
  • Table 14-17: Natera Revenue History, 2017-2022 ($ millions)
  • Prenatal Paternity Testing
  • QIAGEN
  • Recent Revenue History
  • Table 14-18: 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 14-19: 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 14-20: Radiometer A/S Revenue History, 2017-2022 (estimated, $ million)
  • Critical Care
  • Immunoassays
  • HemoCue
  • Roche Diagnostics
  • Recent Revenue History
  • Table 14-21: 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 14-22: Siemens Healthineers IVD Revenues, 2017-2022 ($ million)
  • Core Lab
  • Immunoassays
  • Hematology
  • Molecular
  • Acute Care - POC
  • COVID-19
  • Sysmex Corporation
  • Recent Revenue History
  • Table 14-23: 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 14-24: 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 14-25: Ventana Medical Systems Revenue History, 2017-2022 ($ millions)
  • Immunohistochemistry - IHC
  • Cervical Cancer Screening
  • Companion Diagnostics
  • Werfen
  • Recent Revenue History
  • Table 14-26: Werfen IVD Revenues, 2017-2022 ($ million)
  • Hematology and Coagulation
  • Autoimmunity

Companies Mentioned

  • Abbott Diagnostics
  • Agilent Technologies
  • Beckman Coulter
  • Becton, Dickinson and Company (BD)
  • bioMérieux Inc.
  • Bio-Rad Laboratories, Inc.
  • Bruker Corporation
  • Cepheid/Danaher
  • Danaher Corporation
  • Dexcom
  • DiaSorin
  • Exact Sciences
  • Hologic, Inc.
  • Illumina
  • Mindray - Shenzhen Mindray Bio-medical Electronics Co., Ltd.
  • Natera
  • QIAGEN
  • QuidelOrtho Corporation
  • Radiometer A/S/Danaher
  • Roche Diagnostics
  • Siemens Healthineers (Siemens)
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.
  • Ventana Medical Systems Inc./Roche Tissue Diagnostics
  • Werfen