Description
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:
- 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
About Kalorama Information
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
