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In Vitro Diagnostic (IVD) Test Procedure Volumes, 8th Edition
Publication Date: September 8, 2026
Tags: Blood, Cardiovascular Disease, Clinical Chemistry, Coagulation, COVID-19, Critical Care, Cytology, Diagnostics, Diagnostics Market Research, Drug Testing, Fertility, Glucose, Hematology, Hepatitis, Histology, Histology and Cytology, Immunoassay, In Vitro Diagnostics (IVD), Infectious Diseases, IVD, Mass Spectrometry, Microbiology, Molecular, Molecular Diagnostics, POC, Point of Care, Point-of-Care (POC) Diagnostics, Point-of-Care (POC) Testing, Pregnancy, Respiratory Diseases, Sepsis
Pages: 283
SKU: 26-025KA
The world runs on roughly 150 billion diagnostic tests a year—and that number is climbing faster than the revenue behind it. IVD Test Procedure Volumes, 8th Edition quantifies that divergence with precision, tracking global procedure volumes segment by segment and region by region as the diagnostics industry completes its transition out of the pandemic era. Test demand is rising meaningfully faster than test dollars, and that widening gap between how many procedures the world performs and what those procedures are worth is the central strategic story of this decade. It’s the story IVD Test Procedure Volumes, 8th Edition is built to explain. The report serves as the essential companion to Kalorama Information’s flagship The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 19th Edition (2025–2030).
Where the Volume Is—and Where the Growth Is
Routine testing still carries the load. Clinical chemistry, immunoassays, hematology, coagulation, and microbiology continue to generate the overwhelming majority of the world’s procedure volume, and any credible market model has to start there. But the momentum sits elsewhere: molecular oncology, companion diagnostics, and targeted point-of-care applications are expanding well ahead of the market average. This edition separates the two clearly—thirteen testing categories, procedure counts and product sales, blood glucose included and excluded—so decision-makers can see not just how big a segment is, but which direction it is moving and how much revenue each test actually captures.
From Pandemic Capacity to Precision Demand
The infrastructure built for COVID-19—PCR capacity, lab automation, respiratory panels, home testing, and a durable acceptance of decentralized diagnostics—has not disappeared; it has been redirected. It now drives testing for influenza, RSV, STIs, tuberculosis, healthcare-associated infections, and emerging pathogens. Meanwhile, next-generation sequencing (NGS) is moving into cancer profiling, inherited disease, reproductive health, and transplant testing, and liquid biopsy is extending genomic analysis into therapy selection and recurrence monitoring.
The Pressures That Will Decide Winners
Volume growth does not guarantee margin growth. Payers increasingly demand evidence that a test changes clinical management rather than simply adding data. Laboratories are absorbing staffing shortages, supply-chain risk, cybersecurity requirements, and the cost of maintaining multiple specialized platforms. Regulation is reshaping availability on both sides of the Atlantic. This report frames key forces not as background noise but as the specific variables that will separate the companies that scale from those that stall.
Built for the Decisions You Actually Make
Drawing on Kalorama’s proprietary, transparent methodology, IVD Test Procedure Volumes, 8th Edition delivers procedure volumes, product sales, and per-procedure cost dynamics across every major segment and across key markets from North America and Western Europe to the highest-opportunity developing regions. For executives sizing a portfolio, strategists choosing where to invest, and marketers positioning against real utilization data rather than headline hype, it answers the question that matters most: not just where the IVD market is going, but where the testing is and what it’s worth.
Chapter One: Executive Summary
About Kalorama Information
Overview
IVD Procedure Volume Estimate and Forecast
- Figure 1-1: Global IVD Procedure Volumes, 2025 and 2030 (in millions # volume)
Scope & Methodology
Chapter Two: Introduction
Scope
Overview
Industry Trends
- Table 2-1: Global IVD Procedural Volume & Product Sales (includes glucose tests), 2025-2030 (in millions # volume; US$ millions)
Demographic Trends
Global Population and Aging
- Figure 2-1: Global Fertility Rate vs. Population Size, 1950-2050 (billion)
- Figure 2-2: Global Population Distribution, 2022
- Table 2-2: Elderly Support Ratio in Various Countries, 2010 and 2050
Workforce Reduction
- Table 2-3: WHO Model List of Essential In Vitro Diagnostics (EDL)
Increase in Chronic Diseases
- Table 2-3: WHO Model List of Essential In Vitro Diagnostics (EDL)
Personalized Medicine
High-Consequence Disease Threats
- Figure 2-3: Leading Causes of Death Globally, 2021 (number of deaths in millions)
Tickborne Diseases (TBDs)
Zika
Chagas
Dengue
Ebola
Chikungunya
Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
Marburg
Mpox
Emerging and Emerged Markets
- Table 2-5: Developed/Developing Economies, UN Classification*, 2025
- Figure 2-4: Developed vs. Developing IVD Market Shares, 2025 and Projected 2030 (%)
- Table 2-6: Countries To Watch for IVD Opportunities, by Total Population and Percent Urban, 2025 (population in millions)
Chapter Three: IVD Testing Segments
Scope
IVD Testing Trends
- Table 3-1: IVD Procedural Volume including Blood Glucose Tests, by Item, 2025-2030 (millions) [Blood Grouping/Typing, Clinical Chemistry, Coagulation, Conventional Microbiology, Hematology, Histology/Cytology, Immunoassays, Mass Spectrometry (Immuno), Mass Spectrometry (Micro), Molecular, POC Professional Tests, POC Self Testing, Other]
- Table 3-2: IVD Procedural Volume including Blood Glucose Tests, Share by Item, 2025-2030 (%) [Blood Grouping/Typing, Clinical Chemistry, Coagulation, Conventional Microbiology, Hematology, Histology/Cytology, Immunoassays, Mass Spectrometry (Immuno), Mass Spectrometry (Micro), Molecular, POC Professional Tests, POC Self Testing, Other]
- Table 3-3: IVD Procedural Volume excluding Blood Glucose Tests, 2025-2030 (millions) [Blood Grouping/Typing, Clinical Chemistry, Coagulation, Conventional Microbiology, Hematology, Histology/Cytology, Immunoassays, Mass Spectrometry (Immuno), Mass Spectrometry (Micro), Molecular, POC Professional Tests, POC Self Testing, Other]
- Table 3-4: IVD Procedural Volume excluding Blood Glucose Tests, Share by Item, 2025-2030 (%) [Blood Grouping/Typing, Clinical Chemistry, Coagulation, Conventional Microbiology, Hematology, Histology/Cytology, Immunoassays, Mass Spectrometry (Immuno), Mass Spectrometry (Micro), Molecular, POC Professional Tests, POC Self Testing, Other]
Segment Growth Projections
POC Testing
Clinical Chemistry
Immunoassays
Mass Spectrometry (Immuno)
Molecular Assays
Hematology
Coagulation
Conventional Microbiology
Blood Grouping/Typing
Histology/Cytology
Segment Product Sales
- Table 3-5: IVD Product Sales including Blood Glucose Tests, 2025-2030 (US$ millions) [Blood Grouping/ Typing, Clinical Chemistry, Coagulation, Conventional Microbiology, Hematology, Histology/ Cytology, Immunoassays, Mass Spectrometry (Immuno), Mass Spectrometry (Micro), Molecular, POC Professional Tests, POC Self Testing, Other]
- Figure 3-1: IVD Product by Item including Blood Glucose Tests, Share of Test Volume vs. Share of Sales, 2025 (%) [Blood Grouping/ Typing, Clinical Chemistry, Coagulation, Conventional Microbiology, Hematology, Histology/ Cytology, Immunoassays, Mass Spectrometry (Immuno), Mass Spectrometry (Micro), Molecular, POC Professional Tests, POC Self Testing, Other]
- Figure 3-2: IVD Product by Item including Blood Glucose Tests, Share of Test Volume vs. Share of Sales, 2025-2030 (%) [Blood Grouping/ Typing, Clinical Chemistry, Coagulation, Conventional Microbiology, Hematology, Histology/ Cytology, Immunoassays, Mass Spectrometry (Immuno), Mass Spectrometry (Micro), Molecular, POC Professional Tests, POC Self Testing, Other]
- Table 3-6: IVD Product Sales excluding Blood Glucose Tests, 2025-2030 (US$ millions) [Blood Grouping/ Typing, Clinical Chemistry, Coagulation, Conventional Microbiology, Hematology, Histology/ Cytology, Immunoassays, Mass Spectrometry (Immuno), Mass Spectrometry (Micro), Molecular, POC Professional Tests, POC Self Testing, Other]
- Figure 3-3: IVD Product by Item excluding Blood Glucose Tests, Share of Test Volume vs. Share of Sales, 2025 (%) [Blood Grouping/ Typing, Clinical Chemistry, Coagulation, Conventional Microbiology, Hematology, Histology/ Cytology, Immunoassays, Mass Spectrometry (Immuno), Mass Spectrometry (Micro), Molecular, POC Professional Tests, POC Self Testing, Other]
- Figure 3-4: IVD Product by Item excluding Blood Glucose Tests, Share of Test Volume vs. Share of Sales, 2025-2030 (%) [Blood Grouping/ Typing, Clinical Chemistry, Coagulation, Conventional Microbiology, Hematology, Histology/ Cytology, Immunoassays, Mass Spectrometry (Immuno), Mass Spectrometry (Micro), Molecular, POC Professional Tests, POC Self Testing, Other]
Chapter Four: Global IVD Markets
General
- Table 4-1: IVD Procedural Volume including Blood Glucose Tests, by Region, 2025-2030 (millions) [Africa; Asia/Pacific (China, Japan, Other Countries & Territories); Eastern Europe; Middle East, Mexico, Central, & South America; North America (Canada, United States); Western Europe]
- Table 4-2: IVD Procedural Volume including Blood Glucose Tests, Share by Region, 2025-2030 (%) [Africa; Asia/Pacific (China, Japan, Other Countries & Territories); Eastern Europe; Middle East, Mexico, Central, & South America; North America (Canada, United States); Western Europe]
North America
United States
Canada
Mexico, Central, & South America
Brazil
Mexico
Other Central & South America
Argentina
Chile
Colombia
Peru
Venezuela
All Other Countries & Territories
Western Europe
France
Germany
Italy
Spain
United Kingdom
Other Western Europe
Austria
Belgium
Denmark
Finland
Greece
Ireland
Norway
Netherlands
Portugal
Sweden
Switzerland
All Other Countries & Territories
Eastern Europe
Russia
Other Eastern Europe
Czech Republic
Hungary
Poland
Romania
Ukraine
All Other Countries
Asia/Pacific
China
Japan
Other Asian Countries and Territories
Australia
Hong Kong
India
Indonesia
Malaysia
Pakistan
Philippines
Singapore
South Korea
Taiwan
Thailand
Vietnam
New Zealand
All Other Countries & Territories
Middle East
Turkey
Other Middle East
Iran
Iraq
Israel
Saudi Arabia
United Arab Emirates
All Other Countries
Africa
Nigeria
South Africa
All Other Countries & Territories
Chapter Five: Point-of-Care (POC) Procedures
Scope
Introduction
Global POC Procedure Volume by Test Type
- Table 5-1: Total POC Procedural Volume & Product Sales including blood glucose tests, 2025-2030
- Figure 5-1: POC Procedure Volume and Product Sales Share, by Test Type including blood glucose tests, 2025 and 2030 (%)
- Figure 5-2: POC Revenue per Test, by Test Type including blood glucose tests, 2025 and 2030 (US$)
- Figure 5-3: Regional POC Procedure Volumes including blood glucose tests, 2025
- Table 5-2: Total POC Procedural Volume & Product Sales excluding blood glucose tests, 2025-2030
- Figure 5-4: POC Procedure Volume and Product Sales Share, by Test Type excluding blood glucose tests, 2025 and 2030 (%)
- Figure 5-5: POC Revenue per Test, by Test Type excluding blood glucose tests, 2025 and 2030 (US$)
POC Self Tests
- Table 5-3: POC Self-Test Procedural Volume, by Type, 2025-2030 (millions) [Cholesterol, Coagulation, Drugs of Abuse, Fecal Occult Blood, Glucose (Continuous), Glucose (Self), pylori, HIV, Infectious disease (inc. COVID-19), Pregnancy, Urinalysis, Other (TSH, Allergy, Autoimmune, etc.)]
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, 2025-2030 (US$ millions) [Cholesterol, Coagulation, Drugs of Abuse, Fecal Occult Blood, Glucose (Continuous), Glucose (Self), pylori, HIV, Other Infectious Disease (inc. COVID-19), Pregnancy, Urinalysis, Other (TSH, Allergy, Autoimmune, etc.)]
Pricing Trends
- Table 5-5: POC Self-Test $ IVD Product Sales Per Procedure, 2025-2030 [Cholesterol, Coagulation, Drugs of Abuse, Fecal Occult Blood, Glucose (Continuous), Glucose (Self), pylori, HIV, Other Infectious Disease (inc. COVID-19), Pregnancy, Urinalysis, Other (TSH, Allergy, Autoimmune, etc.)]
POC Professional Testing
- Table 5-6: POC Professional Procedural Volume, by Type, 2025-2030 [Cardiac Markers, Cholesterol, Coagulation, Critical Care POC, Drugs of Abuse, Fecal Occult Blood, Fertility, Glucose, HbA1c POC, Hematology, Infectious Diseases, Urine, Others]
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, 2025-2030 (US$ millions) [Cardiac Markers, Cholesterol, Coagulation, Critical Care POC, Drugs of Abuse, Fertility, Fecal Occult Blood, Glucose, HbA1c POC, Hematology, Infectious Diseases, Urine, Others]
Pricing Trends
- Table 5-8: POC Professional $ IVD Product Sales Per Procedure, by Type, 2025-2030 [Cardiac Markers, Cholesterol, Coagulation, Critical Care POC, Drugs of Abuse, Fertility, Fecal Occult Blood, Glucose, HbA1c POC, Hematology, Infectious Diseases, Urine, Others]
Chapter Six: Clinical Chemistry Procedures
Scope
Introduction
- Table 6-1: Clinical Chemistry Procedural Volume, by Type, 2025-2030 [Blood Gas Analysis, General Chemistry, Urinalysis]
- Figure 6-1: Regional Clinical Chemistry Procedure Volumes, 2025
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, 2025-2030 (US$ millions) [Blood Gas Analysis, General Chemistry, Urinalysis]
Pricing Trends
- Table 6-3: Clinical Chemistry $ IVD Product Sales Per Procedure, 2025-2030 [Blood Gas Analysis, General Chemistry, Urinalysis]
Chapter Seven: Immunoassay Procedures
Scope
Introduction
Technologies
Labeling Techniques
Enzyme and Chemiluminescent Immunoassays
Radioimmunoassays
- Table 7-1: Immunoassay Procedural Volume, by Type, 2025-2030 [Allergy, Anemia, Autoimmune, Cardiac Markers, Diabetes/HbA1c, Fertility, Infectious Disease, Mass Spec, Proteins, Therapeutic Drugs, Thyroid, Tox/Drug of Abuse, Tumor Markers, Vitamin D, Others]
- Figure 7-1: Regional Immunoassay Procedure Volumes, 2025
Testing Procedures & Product Sales
- Table 7-2: Immunoassay Product Sales, by Type, 2025-2030 (US$ millions) [Allergy, Anemia, Autoimmune, Cardiac Markers, Diabetes/HbA1c, Fertility, Infectious Disease, Mass Spec, Proteins, Therapeutic Drugs, Thyroid, Tox/Drug of Abuse, Tumor Markers, Vitamin D, Others]
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, 2025-2030 [HAI, Hepatitis, HIV, Resp, STD, ToRCH, Other]
- Table 7-4: Immunoassay Infectious Disease Product Sales, by Type, 2025-2030 (US$ millions) [HAI, Hepatitis, HIV, Resp, STD, ToRCH, Other]
Instruments
Pricing Trends
- Table 7-5: Immunoassay $ Product Sales Per Procedure, by Type, 2025-2030 [Allergy, Anemia, Autoimmune, Cardiac Markers, Diabetes/HbA1c, Fertility, Infectious Disease, Mass Spec, Proteins, Therapeutic Drugs, Thyroid, Tox/Drug of Abuse, Tumor Markers, Vitamin D, Others]
Chapter Eight: Molecular Testing Procedures
Introduction
- Table 8-1: Molecular Assay Procedural Volume, by Type, 2025-2030 [Molecular Assays – Oncology, Molecular Blood Bank, Molecular Histology – Non Cancer, Molecular Histology – Cancer, Molecular HPV, Molecular Infectious Disease, Molecular Inherited Diseases, Molecular Other, Molecular PT/INR (Thrombophilia SNP Tests), Molecular Transplant Testing (HLA) Tissue Typing, Prenatal]
- Figure 8-1: Regional Molecular Assay Procedure Volumes, 2025
Types of Tests
Testing Technologies
Infectious Diseases
- Table 8-2: Molecular Assay Infectious Disease Procedural Volume, by Type, 2025-2030 [COVID, GC, HAI, Hepatitis, HIV, Respiratory, TB, Other]
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, 2025-2030 (US$ millions) [Molecular Assays – Oncology, Molecular Blood Bank, Molecular Histology – Non Cancer, Molecular Histology – Cancer, Molecular HPV, Molecular Infectious Disease, Molecular Inherited Diseases, Molecular Other, Molecular PT/INR (Thrombophilia SNP Tests), Molecular Transplant Testing (HLA) Tissue Typing, Prenatal]
- Table 8-4: Molecular Assay Infectious Disease Product Sales, by Type, 2025-2030 (US$ millions) [COVID-19, GC/Chlamydia, HAI, Hepatitis, HIV, Mycobacteria/TB, Respiratory – Non-COVID, Other]
Pricing Trends
- Table 8-5: Molecular Assays $ Product Sales Per Procedure, by Type, 2025-2030 [Molecular Assays – Oncology, Molecular Blood Bank, Molecular Histology – Cancer, Molecular Histology – Non Cancer, Molecular HPV, Molecular Inherited Diseases, Molecular Infectious Disease, Molecular Other, Molecular PT/INR (Thrombophilia SNP Tests), Molecular Transplant Testing (HLA) Tissue Typing, Prenatal]
Chapter Nine: Laboratory-Based Hematology Procedures
Scope
Introduction
- Table 9-1: Laboratory-Based Hematology Procedural Volume, by Type, 2025-2030 [Complete Blood Count, Other Hematology Tests]
- Figure 9-1: Regional Laboratory-Based Hematology Procedure Volumes, 2025
Types of Tests
Global Sales of Hematology Products
- Table 9-2: Laboratory-Based Hematology Product Sales, by Type, 2025-2030 (US$ millions) [Complete Blood Count, Other Hematology Tests]
Pricing Trends
- Table 9-3: Hematology $ Product Sales Per Procedure, by Type, 2025-2030 [Complete Blood Count, Other Hematology Tests]
Chapter Ten: Coagulation Testing Procedures
Introduction
- Table 10-1: Coagulation Procedural Volume, 2025-2030 [D-dimer, PT/INR]
- Figure 10-1: US/ROW Coagulation Procedure Volumes, 2025
Types of Tests
Global Sales of Coagulation Products
- Table 10-2: Coagulation Product Sales, 2025-2030 (US$ millions) [D-dimer, PT/INR]
Pricing Trends
- Table 10-3: Coagulation $ Product Sales Per Procedure, 2025-2030 [D-dimer, PT/INR]
Chapter Eleven: Microbiology Procedures
Scope
Introduction
- Table 11-1: Conventional Microbiology Procedural Volume, by Type, 2025-2030 [Blood Culture, Chromogenic Media, ID/AST Automated, ID/AST Panels, Mass Spectrometry, Rapid Microbiology]
- Figure 11-1: US/ROW Microbiology Procedure Volumes, 2025
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, 2025-2030 (US$ millions) [Blood Culture, Chromogenic Media, ID/AST Automated, ID/AST Panels, Mass Spectrometry, Rapid Microbiology]
Pricing Trends
- Table 11-3: Conventional Microbiology $ Product Sales Per Procedure, by Type, 2025-2030 [Blood Culture, Chromogenic Media, ID/AST Automated, ID/AST Panels, Mass Spectrometry (micro), Rapid Microbiology]
Chapter Twelve: Blood Grouping/Typing Procedures
Introduction
- Table 12-1: Blood Grouping/Typing Procedure Volumes, 2025-2030
- Figure 12-1: Regional Blood Grouping/Typing Procedure Volumes, 2025
Types of Tests
Blood Grouping/Typing Product Sales
- Table 12-2: Blood Grouping/Typing Product Sales, 2025-2030 (US$ millions)
Pricing Trends
- Table 12-3: Blood Grouping/Matching $ Product Sales Per Procedure, 2025-2030
Chapter Thirteen: Histology/Cytology Procedures
Scope
Introduction
- Table 13-1: Histology/Cytology Procedural Volume, by Type, 2025-2030 [Circulating Tumor Cells (CTCs), Flow Cytometry, Immunohistochemistry, In Situ Hybridization (ISH), Pap Tests, Traditional non-Pap Stains]
- Figure 13-1: Regional Histology/Cytology Procedure Volumes, 2025
Types of Tests
Immunohistochemistry Tests
In Situ Hybridization (ISH) Tests
Pap Tests
Traditional Non-Pap Stains
Circulating Tumor Cells
Flow Cytometry
Histology/Cytology IVD Product Sales
- Table 13-2: Histology/Cytology Product Sales, by Type, 2025-2030 (US$ millions) [Circulating Tumor Cells (CTCs), Flow Cytometry, Immunohistochemistry, In Situ Hybridization (ISH), Pap Tests, Traditional non-Pap Stains]
Pricing Trends
- Table 13-3: Histology/Cytology $ Product Sales Per Procedure, by Type, 2025-2030 [Circulating Tumor Cells (CTCs), Flow Cytometry, Immunohistochemistry, In Situ Hybridization (ISH), Pap Tests, Traditional non-Pap Stains]
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