The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 18th Edition (2025-2030)

Table of Contents

Chapter 1: Executive Summary

Overview

• Figure 1-1: Worldwide IVD Market, 2020, 2025, and 2030 ($ billion)

IVD’s Value to Healthcare Is Undersold

IVD Market Drivers and Limiters

Size and Growth of the Market

• Table 1-1: Global In Vitro Diagnostic (IVD) Sales, by Product Segment, 2025-2030 ($ million) [Blood Bank Molecular; Blood Bank Screening; Drugs of Abuse; Blood Grouping/Typing; Circulating Tumor Cells; Clinical Chemistry; Coagulation; Histology/Cytology; Continuous Glucose; Diabetes HbA1c Immunoassays, Lab-Based;  Hematology;  HPV, Molecular; Immunoassays – Infectious Disease;  Immunoassays – Other Immunoassays; Mass Spectrometry; Microbiology (ID/AST); Molecular Microbiology; Nucleic Acid Assays – Genetic/Inherited Disease; Nucleic Acid Assays – Oncology; POC, OTC Diabetes; POC, OTC Other; POC, Professional; Other]

IVD Market Results Notes

Changes in Market Segments, 2024-2025

• Figure 1-2: YOY Changes in IVD Market, by Segment, 2024-2025 (%)

IVD Market Assumptions

• Table 1-2: IVD Market Assumptions 2025 Outlook

Competitive Landscape in The IVD Market

• Figure 1-3: Competitors in the IVD Market, Ranked by 2024 IVD Revenues ($ million)

IVD Competition Notes

Trends to Watch

Scope and Methodology

About Kalorama Information

 

Chapter 2: Overall IVD Market

Market Analysis of the Overall IVD Market

• Table 2-1: Global In Vitro Diagnostic (IVD) Sales, by Product Segment, 2025-2030 ($ million) (%) [Blood Bank Molecular, Blood Bank Screening, Drugs of Abuse, Blood Grouping/Typing, Circulating Tumor Cells, Clinical Chemistry, Coagulation, Histology/Cytology, Continuous Glucose, COVID-19 Dx, Diabetes HbA1c Immunoassays, Lab-Based, Hematology, HPV, Molecular, Immunoassays – Infectious Disease, Immunoassays – Other Immunoassays, Mass Spectrometry, Microbiology (ID/AST), Molecular Microbiology, Nucleic Acid Assays – Genetic/Inherited, Nucleic Acid Assays – Oncology, POC, OTC Diabetes, POC, OTC Other, POC, Professional, Other]
• Table 2-2: Additional Global In Vitro Diagnostic (IVD) Markets of Interest (Not in Totals), Sales by Product Segment, 2025-2030 ($ million) (%) [Clinical Sequencing, Drugs of Abuse, Criminal, Drugs of Abuse, Employment (non IVD), DTC Genetic Testing, Flow Cytometry, Prenatal Test Services]

Changes Between 17^th and 18th Editions

Scope Considerations

Top IVD Market Companies

Introduction

• Table 2-3: Clinical Diagnostic Revenues of Selected Top 20 IVD Companies*, 2024 and estimated 2025 ($ million)

Second Tier/Niche Players

• Table 2-4: Revenues of Selected Top 20 Niche IVD Players, 2024 and estimated 2025 ($ million)*
• Figure 2-1: Top Tier Market Distribution, 2024 and estimated 2025 (%)

IVD Company Revenues: International Growth

IVD Companies Mergers & Acquisitions

• Table 2-5: Selected IVD Mergers and Acquisitions, July 2023- July 2025

Collaboration, Partnership, Alliance Agreements

Historical IVD Market vs Today

• Figure 2-2: Share of IVD Market, by Segment, 2000 and 2025 Compared (%) [Blood Banking (imm & typing), Clinical Chemistry, Coagulation, Hematology, Immunoassays, Microbiology (ID/AST), Molecular, POC – Other, Histology/Cytology, POC Diabetes, Others]

PAMA: Delayed But Not Removed from Discussion

Laboratory Diagnostics Services Market

• Figure 2-3: Clinical Laboratory Test Service Market Forecasted Growth, by Segment, 2024-2029 (%) [Clinical Chemistry – Routine & Essential Testing, COVID-19 Testing, Cytology & Histology Testing, Genetic Testing, Immunology & Microbiology Testing, Toxicology Testing]
• Table 2-6: Global Lab Market Segmentation, 2024 ($ billion) [Hospital and Acute Care Labs. Independent Labs, Physician Office Labs]

Quest

Labcorp

• Table 2-7: Total Revenues for Leading U.S.-based Reference Labs, 2022-2024 ($ million) [Bio-Reference Lab/OPKO, Labcorp, Quest Diagnostics]

COVID-19 Market: Where We Are Now?

• Figure 2-4: Combined Performance in COVID-19 and non-COVID-19 IVD Market Segments, 2020-2030 ($ million)

 

Chapter 3: IVD Market by Country and Region

Chapter Scope

Overview

Expected World IVD Market Developments

Global Population and Aging

• Figure 3-1: Global Fertility Rate vs. Population Size, 1950-2050 (billion)
• Figure 3-2: Global Population Distribution, 2025
• Table 3-1: Elderly Support Ratio in Various Countries, 2010 and 2050 [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]

Workforce Reduction

WHO Essential IVD List

• Table 3-2: WHO Model List of Essential In Vitro Diagnostics (EDL)

Increase in Chronic Diseases

• Figure 3-3: Leading Causes of Death Globally, 2021* (number of deaths in millions)

Emerging and Emerged Markets

• Table 3-3: Developed/Developing Economies, UN Classification*, 2025
• Figure 3-4: Developed vs. Developing IVD Market Shares, 2025 and Projected 2030 (%)
• Table 3-4: Countries To Watch for IVD Opportunities, by Total Population and Percent Urban, 2025 [Australia, Brazil, China, France, Germany, Hungary, India, Mexico, Netherlands, Peru, Poland, Romania, Saudi Arabia, South Africa, South Korea, Sweden, Switzerland, Turkey, United Kingdom, United States]

Size and Forecast for the Global IVD Market by Country/Region

• Table 3-5: Global In Vitro Diagnostic Market, Major Country/Region Markets, 2025 and 2030 ($ million) [Australia, Brazil, Canada, China, Eastern Europe, Western Europe, India, Japan, Mexico, Peru, Russia, Saudi Arabia, South Africa, South Korea, Turkey, UAE, United States, Vietnam, RoW]
• Table 3-6: Global In Vitro Diagnostic Market, Regional Markets, 2025 and 2030 ($ million) [Africa, Asia Pacific, Europe, Latin America, Middle East, North America]
• Table 3-7: Global In Vitro Diagnostic Market, YOY Growth, by Segment, 2024-2025 (%) [(Blood Bank Molecular, Blood Bank Screening – Immunoassays, Blood Grouping/Typing, Clinical Chemistry, Coagulation (PT/INR, Molecular), D-dimer, Diabetes HbA1c, Lab, Drugs of Abuse, Hematology – Core Lab, Histology/Cytology, Immunoassays – Infectious Disease, Immunoassays – Other Immunos, Mass Spectrometry (Micro/Non-Micro)Microbiology (ID/AST), Microbiology (Molecular), Molecular Oncology, Molecular Genetic/Inherited, POC, OTC Glucose OTC, POC Continuous Glucose, POC, OTC Other, POC, Professional/Hospital)]
• Table 3-8: Global In Vitro Diagnostic Market, Regional Markets, 2024-2025 YOY Change (%) (Africa, Asia Pacific, Europe, Latin America, Middle East, North America]

The IVD Market in the United States

• Table 3-9: United States IVD Market Share, by Segment, 2025 (%) [Blood Grouping, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay Infectious Disease, Immunoassay Other, Microbiology ID/AST, Molecular Infectious Disease, Nucleic Acid Assays, POC Diabetes, POC Other, Others]

PAMA and Reimbursement Changes

Impact of CARES Act on PAMA

• Table 3-10: Proposed Clinical Diagnostic Laboratory Test (CDLT) Rates, 2020-2028

Saving Access to Laboratory Service Act (SALSA)

LDT Update

Bundled Insurance Payments for ESRD Patients

• Table 3-11: Laboratory Tests Subject to ESRD Consolidated Billing

Advanced Laboratory Tests (ADLT)

• Table 3-12: List of Approved ADLTs, March 2025

Precision Medicine and NGS

IVD Market in Europe: Growing Markets

• Figure 3-5: International Monetary Fund Inflation Map, Global 2024
• Table 3-13: Western European IVD Market, by Country, 2025 ($ million, estimated) [Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK]

EU Regulation

• Table 3-14: IVD Market Per Capita, Europe, 2025 Estimates (USD $) [Bulgaria, Croatia, Czech Republic, France, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Poland, Romania, Russia, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Ukraine, UK]

Precision Medicine in Europe

Brexit

Japan

• Table 3-15: Japan IVD Market, Share by Segment, 2025 (%) [Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay Infectious Disease, Immunoassay Other, Microbiology ID/AST, Molecular Infectious Disease, POC Diabetes, POC Other, Others]

Eastern Europe: Growth Region

• Table 3-16: Eastern European IVD Market, by Country, 2025 ($ million) [Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, Ukraine, Other]
• Figure 3-6: Eastern Europe IVD Market, by Country, 2025 ($ million) [Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, Ukraine, Other]

China: Current IVD Market

• Table 3-17: China IVD Market, Share by Segment, 2025 (%) [Blood Bank Screening, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay Infectious Disease, Immunoassay Other, Microbiology ID/AST, Molecular Infectious Disease, POC Diabetes, POC Other, Others]
• Table 3-18: Total Midyear Population, by Broad Age Group: China, 2010-2050 (million persons)

Clinical Laboratory Market in China

IVD Distribution in China

China and Volume-Based Procurement (VBP)

India: Population and Opportunity

• Table 3-19: India IVD Market, Share by Segment, 2025 (%) [Clinical Chemistry, Hematology, Coagulation, Histology, Immunoassay, Microbiology, POC Glucose,  POC Other, Others]

Clinical Laboratory Market in India

IVD Regulation

Rest of Asia

• Table 3-20: Asia Pacific Region IVD Market, by Country, 2025 ($ million) [Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Thailand, Vietnam]

Brazil

• Table 3-21: Brazil IVD Market, by Broad Segment, 2025 (%) [Clinical Chemistry, Hematology, Coagulation, Histology, Immunoassay, Microbiology, POC Glucose,  POC Other, Others]

Disease Trends

Clinical Laboratory Market in Brazil

IVD Regulation

Mexico

• Table 3-22: Mexico IVD Market, by Broad Segment, 2025 (%) [Clinical Chemistry, Histology, Immunoassay, Microbiology, POC Diabetes, POC Other, Others]

The Russian Federation

Canada

Emerging Markets

Saudi Arabia IVD Market

South Africa IVD Market

South Korea IVD Market

Turkey IVD Market

United Arab Emirates (UAE) IVD Market

Other Markets to Watch

IVD Market Opportunity by Country

• Table 3-23: IVD Market Opportunity, by Country (2025 Market Rank, Country CAGR 2025-2030) (%) [Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, U.S., Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam]

 

Chapter 4: IVD Industry Trends

Possible Impact of Tariffs on the IVD Market

• Table 4-1: Selected Company Reported 2025 Impact

Next-Generation Sequencing and IVD

• Table 4-2: Selected Clinical NGS Platforms on the Market

Staffing Shortages

China IVD Market, VBP and Other Trends

China Foreign-Owned Hospitals

China VBP

Gene Editing Developments

• Table 4-3: Selected Gene Editing / CRISPR Innovations

Microbiome IVD-Related Developments

• Table 4-4: Selected Microbiome Test Innovations

AI and IVD

• Table 4-5: Selected AI Market Cleared Tests
• Table 4-6: Selected AI Product Initiatives in Development and Collaborations

AI in Liquid Biopsy

Role of AI in Liquid Biopsy Interpretation

Industry Leaders and Initiatives

New Liquid Biopsy / AI Products in Development or Recently Launched

• Table 4-7: Selected AI/Liquid Biopsy Initiatives

Future Trends

Traumatic Brain Injury and IVD

Personalized Medicine and Companion Diagnostics

Companion Diagnostics

• Table 4-8: FDA Approved Companion Diagnostics, 2025

Earlier Sepsis Detection

Liquid Biopsy

Quality Assurance

Product News

 

Chapter 5: Point-of-Care (POC) Tests

Chapter Scope

Edition-Specific Notes

POC Industry Drivers

Patient-focused drivers

Medical/Healthcare-related drivers

Technology drivers

Economic drivers

Other drivers

POC Industry Challenges

Regulatory Challenges

Professional POC

• Table 5-1: Worldwide Professional POC Test Sales, by Category, 2025 -2030 ($ million) [Cardiac Markers, Cholesterol, Coagulation, Critical Care POC, Drugs of Abuse, Fecal Occult Blood, Fertility, Glucose, HbA1c POC, Hematology, Infectious Diseases, Urinalysis, Others]
• Table 5-2: Selected Professional POC Test Competitors & Innovations

OTC Self Testing

• Table 5-3: Worldwide POC Self-Test Sales, by Category, 2025-2030($ million) [Cholesterol, Coagulation, Drugs of Abuse, Fecal Occult Blood, Glucose, Continuous, Glucose, Self,  pylori, HIV, Other (TSH, Allergy, Autoimmune, etc.), Infectious Disease (inc. COVID-19), Pregnancy, Urinalysis]

OTC Self Testing, Without Glucose

Pregnancy/Fertility Tests

• Table 5-4: POC Pregnancy and Fertility Test Market Distribution, by End User, 2025 (%) [OTC, PRO]
• Table 5-5: Pregnancy/Fertility POC Test Sales Distribution, by Global Region, 2025 (%) [Europe, Japan, United States, RoW]

Colon Cancer Screening

• Table 5-6: Selected POC Colon Cancer Tests
• Table 5-7: Colon Cancer POC Test Sales Distribution, by Global Region, 2025 (%) [Europe, Japan, United States, RoW]

Lipid Testing

• Table 5-8: Lipid POC Test Sales Distribution, by Global Region, 2025 (%) [Europe, Japan, United States, RoW]

Drugs of Abuse (DOA) Testing

• Table 5-9: POC Drugs of Abuse Test Sales Distribution, by Setting, 2025 (%) [Criminal Justice, Critical Care – Traditional POC, Employment Screening]

Products

• Table 5-10: Drugs of Abuse Tests on the Market
• Table 5-11: Drugs of Abuse POC Test Sales Distribution, by Global Region, 2025 (%) [Europe, Japan, United States, RoW]

POC Infectious Disease Testing

Molecular Point of Care

• Table 5-12: Innovations in Molecular POC Infectious Disease Diagnostics

Rapid Products: Diverse Tech For Diverse Pathogens

• Table 5-13: POC Infectious Disease Test Summary by Disease and Technology

POC HIV and Hepatitis Testing and Monitoring

POC Tuberculosis Tests

POC Tropical and Neglected Diseases Tests

Respiratory Diseases POC – Growth Means Competition

Sepsis and Nosocomial Disease

Sexually-Transmitted Infections (STI)

Sexually-Transmitted Infections POC: Binx, Visby, Now Shake Up Market

Lyme Disease

• Table 5-14: Innovations in Molecular POC Infectious Disease Diagnostics

COVID-19

• Table 5-15: Selected Antigen POC Home Immunoassay Tests for SARS-CoV-2

POC Infectious Disease Testing: Market Size and Growth

POC Infectious Disease Testing by Disease

• Table 5-16: Infectious Disease POC Test Demand, by Type, 2025 ($ million) [C. difficile, COVID-19, E. coli, H. pylori, Hepatitis, HIV, Home Test/OTC, Influenza, Malaria, Other Respiratory, STI, Others]

POC Infectious Disease Testing: Respiratory vs. Non-Respiratory

• Figure 5-1: Respiratory POC Infectious Disease Testing vs. Non-Respiratory POC Market Breakout, 2025 (%)

POC Infectious Disease Testing by Geography

• Table 5-17: Infectious Disease POC Test Sales Distribution, by Global Region, 2025 (%) [Europe, Japan, United States, RoW]

Diabetes Testing – Blood Glucose Monitoring

• Table 5-18: Glucose POC Test Sales Distribution, by Global Region, 2025 (%) [Europe, Japan, United States, RoW]
• Figure 5-2: POC Glucose Testing Market Growth, by Category, 2025-2030 (%) [Glucose OTC, Glucose Professional, Continuous Glucose, HbA1c POC-Professional]

IT to Aid Diabetes Management

• Table 5-19: Selected Apps and Glucose Management IT

Diabetes Market Analysis

• Table 5-20: Global Diabetes Sales, by Test Category, 2025-2030 ($ million) [Glucose OTC, Continuous Glucose, HbA1c Lab, HbA1c POC]

POC Glucose Competitors

• Table 5-21: Top Three POC Test Vendors by Glucose Test Revenues, 2025 ($ million, estimated)

Blood Glucose Self-Testing

• Table 5-22: Selected Glucose Self-Test Meter Innovations

Noninvasive Testing Devices

• Table 5-23: Selected Noninvasive Glucose Monitoring Devices

Continuous Glucose Monitoring

• Table 5-24: Selected Continuous Blood Glucose System Developments

Blood Glucose Testing by Professionals

• Table 5-25: Selected Innovations in Hospital-based Glucose Monitoring

Diabetes Testing – Glycated Hemoglobin

• Table 5-26: Global HbA1c Test Sales Market and Distribution, by Setting, 2025-2030 ($ million) [HbA1c Lab, HbA1c POC]
• Table 5-27: Selected POC HbA1c Devices

Genes and Other Markers of Diabetes

• Table 5-28: Selected POC Diabetes Monitoring Tests

The Major POC Test Players

• Table 5-29: POC Test Revenues of Selected IVD Companies, 2025 ($ million, estimated)

 

Chapter 6: Chemistry & Core Lab

Chapter Scope

Edition-Specific Notes

Core Lab Overview and Trends

• Table 6-1: Selected Analytes for the Core Lab

Connectivity

Overview of Chemistry Tests

Lab Automation

Market Analysis

• Table 6-2: Global Clinical Chemistry Sales, by Test Category, 2025-2030 ($ million) [Blood Gases, General Chemistries, Urinalysis]
• Table 6-3: Global Clinical Chemistry Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
• Table 6-4: Selected Major Clinical Chemistry Companies, by Sales, 2025 ($ million, estimated) [Abbott Laboratories, Beckman Coulter/Danaher, QuidelOrtho, Radiometer/Danaher, Roche Diagnostics, Siemens Healthineers, Sysmex, Werfen]
• Table 6-5: Selected Clinical Chemistry Innovations

Rapid Response Systems

• Table 6-6: Selected Major Whole Blood Chemistry Analyzers

Critical Care Analysis

• Table 6-7: Blood Gas, Electrolyte, and Critical Care Instrument Market, by End User, 2025 and 2030 ($ million) [Lab-based, POC-based]
• Table 6-8: Blood Gas, Electrolyte, and Critical Care Market Leaders including POC, 2025 (% distribution of total sales)

Urinalysis

• Table 6-9: Urinalysis Market, by End User, 2025 and 2030 ($ million) [Lab-based, POC-based]
• Table 6-10: Urinalysis Systems (including POC) Market Leaders, 2025 (% distribution of total sales) estimated
• Table 6-11: Selected Urinalysis Innovations

The Commercial Outlook for Chemistry Tests

 

Chapter 7: Immunoassays

Chapter Scope

Overview and Trends

Immunoassay Technology Continues to Evolve

• Table 7-1: Selected Immunoassay Technologies

Mass Spectrometry

• Table 7-2: Selected Innovation in Mass Spectrometry for Routine Analyses

Radioimmunoassays

Market Analysis

• Table 7-3: Global Lab-based Immunoassay (excluding infectious disease and blood screening) Sales, by Analyte Type, 2025-2030 ($ million)  [Allergy, Anemia, Autoimmune, Cardiac Markers, Diabetes/HbA1c, Drug of Abuse, Fertility, Proteins, Therapeutic Drugs, Thyroid, Tumor Markers, Vitamin D, Others]
• Table 7-4: Global Immunoassay (excluding infectious disease and blood screening) Sales Distribution, by Region, 2025 (%)  [Asia Pacific, Europe, Japan, North America, RoW]
• Table 7-5: IVD Quality Control (immunoassay/molecular) Market, 2025 ($ million, estimated)
• Table 7-6: Selected Immunoassay Quality Control Products
• Table 7-7: Revenues of Leading Lab-based Immunoassay Vendors, 2024-2025 ($ million, estimated)

Mature Assay Segment

Thyroid Function

Therapeutic Drug Monitoring

Vitamin D

• Table 7-8: Selected Vitamin D Immunoassays

Anemia

Toxicology/DAU

Allergy

Growth Immunoassays

Proteins

Tumor Markers

• Table 7-9: Selected Tumor Marker Innovations

Cardiac Markers

• Table 7-10: Regional Cardiac Marker Immunoassay Market Share, 2025 (%) [EU Countries, Japan, Latin America, Middle East, North America, Rest of Asia Pacific, Rest of Europe, RoW]
• Table 7-11: Selected Cardiac Marker Innovations

Autoimmune

• Table 7-12: Selected Autoimmune Test Innovations

Rheumatoid Arthritis

• Table 7-13: Selected Arthritis Immunoassay Innovations

Gastrointestinal Disorders

• Table 7-14: Selected Inflammatory Bowel Disease Test Innovations

Transplant Management

• Table 7-15: Selected Immunoassays for Transplant Medicine

Women’s Health

• Table 7-16: Selected Women’s Health Innovations

Alzheimer’s Disease

• Table 7-17: Selected Innovations for Alzheimer’s Disease Immunoassays

Traumatic Brain Injury

Miscellaneous

• Table 7-18: Selected Immunoassay Innovations

Point-of-Care OTC and Professional Use Immunoassays

• Table 7-19: Global POC Immunoassay Sales Distribution, by Region, 2025 (%) [Europe, Japan, United States, RoW]
• Table 7-20: Global POC Immunoassay Test Sales, by Test Category, 2025-2030 ($ million) [OTC/Self Tests (Pregnancy/Ovulation, Drugs of Abuse, HIV, H. pylori, Infectious Disease/COVID-19, Other) and Professional POC (Cardiac Markers, Drugs of Abuse, HbA1c, Pregnancy, Infectious Disease/COVID-19, Other)]
• Table 7-21: Selected Self-Test Immunoassay Innovations

Pregnancy Testing

Cardiovascular Diagnostics

Drugs of Abuse/Therapeutic Drug Monitoring

Innovating POC

• Table 7-22: Selected POC Test Innovations
• Table 7-23: Selected POC Immunoassay Test Platforms

The Commercial Outlook for Immunoassays

 

Chapter 8: Molecular Assays

Chapter Scope

Edition-Specific Notes

Overview

• Table 8-1: Common Next Generation Molecular Test Traits

Sample Preparation and Quality Control

• Table 8-2: Selected Molecular Test Sample Preparation and QC Innovations

Molecular Evolution

Exosome Sequencing

• Table 8-3: Selected Exosome Test Innovations

Liquid Biopsy

• Table 8-4: Selected Liquid Biopsy Innovations

Metabolomic Profiling

Information Technology

• Table 8-5: Selected IT Innovations in Molecular Diagnostics

Artificial Intelligence (AI)

Forensic Studies – An Emerging Opportunity

• Table 8-6: Selected Innovations in Forensic DNA Testing

Test Platforms

• Table 8-7: Key Molecular Technologies and Major Players
• Table 8-8: Selected Molecular Test Platform Innovations

Major Players

• Table 8-9: Molecular Test Revenues of Selected IVD Vendors, 2022-2025 ($ million) estimated

Market Analysis

• Table 8-10: Global Genomic, HLA and Oncology Molecular Test Sales, by Type with NIPT, 2025-2030 ($ million) [Genetic/Inherited Disease Assays, Oncology Assays (incl. CDx), Prenatal Testing – NIPT, Transplant Testing (HLA)]

Oncology

• Table 8-11: Global Molecular Cancer Test Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
• Table 8-12: Selected Molecular Tumor Marker Test Innovations

Inherited/Genetic Diseases, Thrombophilia SNPs and Other Disorders

• Table 8-13: Most Frequently Requested Genetic Tests
• Table 8-14: Global Molecular Thrombophilia Assay Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]

Alzheimer’s Disease and Dementia

Cardiovascular Disease

• Table 8-15: Selected Genomic Tests for Inherited Diseases

Depression and Psychiatric Disorders

Prenatal and Newborn Testing

• Table 8-16: Global Prenatal Test Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
• Table 8-17: Selected Prenatal Services Provided
• Table 8-18: Selected Molecular Tests for Prenatal Analysis

Transplant Diagnostics

• Table 8-19: Global Molecular HLA Testing Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
• Figure 8-1: Global Transplant Rate, by Region, 2024
• Table 8-20: Selected Innovations of Molecular Transplant Diagnostics

Women’s Health

The Commercial Outlook for Molecular Tests

 

Chapter 9: Hematology

Chapter Scope

Edition-Specific Notes

Overview of Hematology and Trends

• Table 9-1: Hematology Analyzer Distribution of Unit Sales, by Menu Capability, 2025 estimated (%) [3-part diff analyzers, 5-part diff analyzers, Other analyzers]
• Table 9-2: Lab-based Hematology Sales by Analyte Average Annual Distribution (%) [CBC, Hemoglobin, Other specialized]

Digital Image Analysis

• Table 9-3: Selected Hematology Image Analysis Innovations

Digital Evolution

Quality Control Measurement Programs

• Table 9-4: Selected Quality Control Hematology FDA Registrations, 2024

Laboratory-based Hematology Testing

• Table 9-5: Selected Hematology Innovations
• Table 9-6: Global Laboratory-based Hematology Test and Instrument Market, 2025 and 2030 ($ million)

Regional Laboratory-based Hematology Test and Instrument Market

• Table 9-7: Global Laboratory-based Hematology Test and Instrument Market, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]

Decentralized Hematology Testing

Hemoglobin/Hematocrit at the POC

• Table 9-8: POC Hematology Distribution, by Specialty, 2025 (%) [Hematocrit/Hemoglobin vs. Other Routine Hematology (WBC, Erythrocyte, Platelet)]
• Table 9-9: Selected POC Hemoglobin and Hematocrit Systems
• Table 9-10: Selected POC Hematology Analyzer Systems
• Table 9-11: Decentralized Hematology Test and Instrument Market, by Type, 2025 and 2030 ($ million) [Instruments, Lab-Style, Handheld Devices]

Market Analysis: Leading Suppliers

• Table 9-12: Top Hematology Company Revenues (Laboratory and POC), by Market Leaders, 2025 ($ million)
• Figure 9-1: Hematology Revenue Estimates, 2025 ($ million)
• Table 9-13: Global Hematology (Laboratory-based and POC) Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]

The Commercial Outlook for Hematology Tests

 

Chapter 10: Coagulation

Chapter Scope

Edition-Specific Notes

Overview and Trends of Coagulation and Immunohematology Tests

Special Topics

COVID-19

Direct Oral Anticoagulants (DOACs)

• Table 10-1: Select Major Anticoagulant Sales ($ billion)

D-dimer

• Table 10-2: Global D-dimer Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]

Market Analysis

• Table 10-3: Global Coagulation Sales, by Segment, 2025-2030 ($ million) [D-dimer, Molecular, Professional POC, Professional Self, PT/INR Labs]
• Table 10-4: Global Coagulation Test and Instrument Market, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]

Lab-based Testing

• Table 10-5: Selected Lab-based Coagulation Innovations

Genetic Markers of Hypercoagulopathies

• Table 10-6: Related CMS Codes for Reimbursement National Limits, Molecular, 2025
• Table 10-7: Global Molecular – Thrombophilia SNP Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
• Table 10-8: Selected Molecular Coagulation Test Innovations

Leading Suppliers: Laboratory Systems

• Table 10-9: Top Coagulation Laboratory-based Company Market Share, 2025 (%)

Decentralized Coagulation Testing – Professional Use

Decentralized Coagulation Testing – OTC

• Table 10-10: Selected POC Coagulation Test Innovations

Platelet Testing

• Table 10-11: Selected Platelet Activity Test Innovations

Leading Suppliers: POC Systems

• Table 10-12: Top Coagulation Company Revenues, POC, 2025 ($ million, estimated)

The Commercial Market for Coagulation Tests

• Table 10-13: Major Anticoagulants Uses and Tests

 

Chapter 11: Microbiology and Virology

Chapter Scope

Edition-Specific Notes

Microbial Antibiotic Resistance – Driving Clinical Tests

Fast Identification

• Table 11-1: Selected Companies Developing Faster Identification, Some Also with Antimicrobial Susceptibility/Resistance Tests

Traditional Microbiology

Microbiology Innovations

Liquid-Based ID/AST and Automation Innovations

Post-Blood Culture Microbial ID

PCR and Other NAAT-Based Tests for Infectious Diseases

• Table 11-2: Selected Nucleic Acid Amplification Test and Other Molecular Companies in Microbiology

Microbiome-Related Microbiology Tests

Illumina

Bio-Rad

QIAGEN

Luminex (Diasorin)

inBiome BV

DNA Genotek

Abbott

Thermo Fisher Scientific

• Table 11-3: Selected Microbiome-Based Tests

Next Generation Sequencing-Based Microbiology Approaches

• Table 11-4: Selected Companies Applying DNA/RNA Sequencing to Microbiology

Syndromic/Multiplex Testing

Emerging, High-Consequence Infectious Disease Threats

• Table 11-5: Selected Companies Marketing Products Addressing High-Consequence Infectious Disease Threats

Chagas

Dengue

Tickborne Diseases (TBDs)

Zika

Ebola

Chikungunya

Middle East Respiratory Syndrome-Coronavirus (MERS-CoV)

Marburg

Mpox

Infectious Disease IVD Market Analysis Discussion

• Table 11-6: Global Infectious Disease IVD Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]

Market Analysis – Traditional Microbiology ID/AST

• Table 11-7: Global Microbiology ID/AST Market, by Segment, 2025-2030 ($ million) [Blood Culture, Chromogenic Media, ID/AST Auto, ID/AST Panels, Rapid Microbiology]
• Table 11-8: Global ID/AST Testing Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]

Traditional ID/AST

• Table 11-9: Global ID/AST Testing, Distribution, by Systems, (%) [Panel, Auto]

Blood Culture

• Table 11-10: Selected Advanced Techniques in Positive Blood Culture

Chromogenic Media

Rapid Tests Performed on Colonies from Culture Media

Supplies

Market Analysis — Infectious Disease Immunoassays

Improvements in Infectious Disease Immunoassays

• Table 11-11: Selected Infectious Disease Immunoassay Innovations
• Table 11-12: Global Clinical Laboratory-Based Infectious Disease Immunoassay Market, by Pathogen, 2025 ($ million, estimated)  [COVID-19, HAIs/Sepsis, Hepatitis, HIV, Lyme Disease, Mycology, Parasitology, Respiratory, STDs, ToRCH, Other]
• Table 11-13: Global Laboratory-Based Infectious Disease Immunoassay Market Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]

Hepatitis Testing

Sepsis

• Figure 11-1: Lab-based Immunoassay Sepsis Market Distribution, by Type, 2025 (%) [PCT, Traditional Global]

HIV Immunoassay Testing

• Table 11-14: Selected HIV Assays

Sexually Transmitted Diseases (STDs)

ToRCH

Lyme Disease

TBD-Serochip (Roche-associated)

Rapid Infectious Disease Immunoassay Tests

• Table 11-15: Global Point-of-Care (Rapid) Immunoassay Testing Market, Sales Distribution, by Pathogen, 2025 ($ million) [C. difficile COVID-19, E. coli, H. pylori, Hepatitis, HIV, Influenza, Malaria, Other respiratory, STD, Other]

Market Analysis – Molecular Microbiology

• Table 11-16: Global Molecular Microbiology Sales Distribution, by Region, 2025 (%) [North America, Europe, Asia Pacific, RoW]
• Table 11-17: Global Molecular Infectious Disease Market, by Pathogen/Disease Indication, 2025-2030 ($ million) [COVID-19, GC/Chlamydia, HAI, Hepatitis, HIV, Mycobacteria/TB, Organism ID, Respiratory, Others]

Lab Automation and Molecular Diagnostics

• Table 11-18: Selected Automated Molecular Test Instrument Platforms

Molecular Respiratory Infection Testing

The Respiratory Trio – Flu, Strep, RSV

• Table 11-19: Selected COVID-19, Flu, RSV Tests

Other Developments – Beyond the Respiratory Trio, Sequencing

Molecular Testing for Sexually Transmitted Infections (STIs)

Molecular Hepatitis Testing

Molecular HIV Testing

• Table 11-20: Innovations in Molecular POC Diagnostics for HIV

Molecular Tests for Hospital-Acquired Infections (HAIs)

• Table 11-21: Frequency of the Most Common Nosocomial Infections

Assessing the Problem: Nosocomial Infection Statistics

Clostridium Difficile

MRSA

Molecular TB Testing

Limitations of Molecular Microbiology Testing

Mass Spectrometry Infectious Disease Testing

• Table 11-22: Selected Companies Marketing Mass Spectrometers and/or Assays for the Clinical Laboratory [CE-Marked and/or 510(k) cleared]

The Future Outlook for Infectious Disease IVD

 

Chapter 12: Blood Banking Services

Chapter Scope

Edition-Specific Notes

Overview

The Current Status of Global Blood Collection

Global Blood Safety

• Table 12-1: Laboratory Screening of Blood Donations for Transfusion-Transmissible Infections, Number of Countries [Chagas, HBV, HCV, HIV, HTLV I/II1, Malaria, Syphilis]
• Table 12-2: Prevalence of TTIs in Blood Donations [Median (Interquartile range)], by Income Group

Zika Virus

Blood and Component Collection

• Table 12-3: Blood Component Usage for Selected Conditions

Reevaluating Blood Transfusions

• Table 12-4: Impact of Alloimmunization (% of Patients Screening Positive for One or More Antibodies)

Blood Typing and Grouping Market

Manual Blood Typing Methods

Automated Blood Typing and Screening Methods

Molecular Methods

• Table 12-5: Selected Blood Typing and Grouping Innovations

Size and Growth of Typing Markets

• Table 12-6: Global Blood Typing Market, 2025-2030 ($ million)

Blood Typing Market by Geography

• Table 12-7: Global Blood Typing Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]

Blood Testing Market

• Table 12-8: Selected Blood Testing Innovations

Preventing Bacterial Infections

Immunoassays

Nucleic Acid Testing (NAT)

Size and Growth of the Market

• Table 12-9: Global Blood Banking Diagnostics Market, 2025-2030 ($ million) [Immunoassay Screen, NAT Screens]

Blood Testing Market by Geography

• Table 12-10: Global Blood Testing Market, by Geography, 2025 (%) [Asia Pacific, Europe, North America, RoW]

The Commercial Outlook for Blood Banking Testing

 

Chapter 13: Histology and Cytology

Chapter Scope

Overview

Special Topics

Histology Automation

• Table 13-1: Selected Histology Lab Automation
• Table 13-2: Histology Information Technology Tools

Advanced Analysis Solutions

• Table 13-3: Selected Advanced Histology Techniques

HPV Testing: Clinical Significance, Technological Advances, and Global Market Trends

• Table 13-4: Global HPV Test Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
• Table 13-5: Selected HPV Test Innovations

Market Analysis

Total Market for Histology and Cytology

• Table 13-6: Global Histology/Cytology Sales by Type, 2025-2030 ($ million) [HPV, Immunohistochemistry, in situ hybridization, Pap Tests, traditional non-Pap stains]

Regional Market Analysis

• Table 13-7: Global Histology/Cytology Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
• Table 13-8: Revenues of the Major Histology Companies, 2019-2025 ($ million, estimated)

Traditional Stains

• Table 13-9: Selected Vendors of Traditional Histology Stains

Pap Testing

• Table 13-10: Primary and Secondary Prevention of Cervical Cancer, Screening Responses, by Country, 2021
• Figure 13-1: Three approaches to cervical cancer screening and future tests

Immunohistochemistry and In Situ Hybridization (IHC and ISH)

• Table 13-11: Selected In Situ Hybridization-based Tests
• Table 13-12: Selected IHC Test Innovations

Pharmacodiagnostic Histology

• Table 13-13: Major Pharmacodiagnostic Markers
• Table 13-14: Selected Pharmacodiagnostic Histology Tests

Digital Imaging and Computational Pathology

• Table 13-15: Selected Digital Pathology Image Capture and Viewing Solutions
• Table 13-16: Selected Digital Imaging Innovations

Circulating Tumor Cells

• Table 13-17: Innovations in CTC Technology

Flow Cytometry

The Commercial Outlook for Histology and Cytology Tests

 

Chapter 14: Company Profiles: The Top Tier

Abbott Diagnostics

Abbott Park, IL

• Table 14-1: Abbott Diagnostics Revenue History, 2022-2024 ($ million)
• Table 14-2: Abbott Diagnostic Revenues, by Segment, 2022-2024 ($ million, estimated)

Abbott Result Notes

Core Lab

Hematology

Blood Banking

Infectious Diseases – Molecular

Diabetes

HIV Point of Care

i-STAT Business

Agilent Technologies

• Table 14-3: Agilent Revenue History, 2022-2024 ($ million)

Genomics

Cytogenetic Analysis

Sequencing

CRISPR

Flow Cytometry

Companion Diagnostics – Dako

Beckman Coulter / Danaher

Hematology

Hematology IT

Clinical Chemistry

Immunoassays

Microbiology

IT Clinical

Flow Cytometry

Blood Banking

Beckman Coulter Life Sciences

Becton, Dickinson and Company (BD)

• Table 14-4: BD Clinical Diagnostic Systems Revenue History, 2022-2024 ($ million, estimated) FYE Sept 30

Cytology

Molecular Microbiology

Traditional Microbiology – ID/AST

Blood Culture

Hospital Acquired Infections

Blood Collection

Mass Spectrometry

Flow Cytometry

Immunoassay

bioMérieux Inc.

• Table 14-5: bioMérieux Revenue History, 2022-2024 (€ million)

Traditional Microbiology

Blood Culture

Immunoassays

Mass Spectrometry

BIOFIRE Diagnostics Business

Expansion

Bio-Rad Laboratories, Inc.

• Table 14-6: Bio-Rad Revenue History, 2022-2024 ($ million, estimated)

Quality Control

Blood Bank

Diabetes

Immunoassays

Liquid Biopsy

Droplet Digital PCR

Sequencing

Bruker Corporation

• Table 14-7: Bruker Revenue History Product Revenue, 2022-2024 ($ million)

Acquisitions and Collaborations

Mass Spectrometry

Microbiology

Molecular PCR

Cepheid / Danaher

GeneXpert/ Xpress Line

Tuberculosis

Microbiology

POC Testing

Cancer

Danaher Corporation

• Table 14-8: Danaher Revenue History, Diagnostics Segment, 2022-2024 ($ million, estimated)

Acquisitions

Dexcom

• Table 14-9: Dexcom Revenue History, 2022-2024 ($ million)

Diasorin S.p.A

• Table 14-10: Diasorin Revenue History, 2022-2024 (€ million)

Development Plan

Expansion

Immunoassays

Molecular

Molecular Oncology

Exact Sciences

• Table 14-11: Exact Sciences Revenue History, 2022-2024 ($ million)

Hologic, Inc.

• Table 14-12: Hologic Revenue History, Diagnostic Product Revenue, 2022-2024 ($ million)

PANTHER Molecular System

HIV Testing

Sexually Transmitted Infections

Infectious Diseases

Panther Fusion

Cytology

Illumina

• Table 14-13: Illumina Revenue History, 2022-2024 ($ million, not all revenues are for clinical products and services; estimated)

China

Leica Biosystems/Danaher

Digital Pathology

Companion Diagnostics

Stain Reagents

Lab Systems

Sample Handling

Circulating Tumor Cells (CTCs)

Artificial Intelligence

Mindray – Shenzhen Mindray Bio-medical Electronics Co., Ltd.

Natera

• Table 14-14: Natera Revenue History, 2022-2024 ($ million)

QuidelOrtho Corporation

• Table 14-15: QuidelOrtho Revenue History, 2022-2024 ($ million)
• Table 14-16: QuidelOrtho Diagnostic Revenues, by Segment, 2020-2024 ($ million, estimated)

Immunoassays

Rapid Immunoassays

The Solana Business

Molecular – Savanna Phase Out

Blood Bank

Radiometer A/S / Danaher

Critical Care

Immunoassays

HemoCue

Transcutaneous Monitoring

Revvity

• Table 14-17: Revvity Revenue History, 2022-2024 ($ million, estimated)

Roche Diagnostics

• Table 14-18: Roche Revenue History, 2022-2024 (CHF million)
• Table 14-19: Roche Diagnostics Revenues, by Segment 2022-2024 (CHF million) [Core Lab, Molecular Lab, Near Patient Care, Pathology Lab]

Roche Results Notes

Hematology

Immunoassays

HIV

Molecular Expansion

Core Molecular

Digital PCR

Diabetes Care

Coagulation

cobas Liat System – POC

HPV

Blood Bank

Transplant Medicine

Sequencing and Mass Spectrometry

Cancer Companion Testing

Information Technology

Digital Pathology

Roche Tissue Diagnostics

Immunohistochemistry – IHC

Cervical Cancer Screening

Companion Diagnostics

Siemens Healthineers (Siemens)

• Table 14-20: Siemens Healthineers Revenue History, 2022-2024 (€ million)

Core Lab

Lab Automation

Immunoassays

Hematology

Urinalysis

Molecular

Expansion to Support Molecular Diagnostics – Fast Track Diagnostics

Sequencing with Artificial Intelligence

Acute Care – POC

POC Connectivity

Business Expansion

Sysmex Corporation

• Table 14-21: Sysmex Revenue History, 2022-2024 (billions of Yen) FYE March 31
• Table 14-22: Sysmex Diagnostic Revenues, by Segment, 2022-2024 (billions of Yen) FYE March 31 [Clinical Chem, Coagulation, Flow Cytometry, Hematology, Immunoassay, Urinalysis, Others]

Hematology

Coagulation

Urinalysis and Infectious Disease

Immunoassays

Lab Information System

Flow Cytometry

Precision Medicine / Companion Test Diagnostics

Liquid Biopsy

Sysmex Inostics

Forging New Markets

Thermo Fisher Scientific Inc.

• Table 14-23: Thermo Fisher Revenue History, Clinical Diagnostics, 2022-2024 ($ million)

Immunoassays

Microbiology

Molecular Test Business

Next Generation Sequencing

qPCR

Oncology Companion Diagnostics

Transplant Medicine

Mass Spectrometry

Werfen

• Table 14-24: Werfen Recent Revenue History, 2022-2024 (€ billion)

Alphabetized Company List

• 10X Genomics

• Abbott Diagnostics

• Abingdon Health Ltd.

• Accelerate Diagnostics, Inc.

• Advanced Biological Laboratories, S.A. (ABL)

• Agendia BV

• Agilent Technologies

• Alivedx

• Altona Diagnostics

• Amoy Diagnostics Co. Ltd.

• Ambry Genetics

• Applied Spectral Imaging Inc. (ASI)

• ArcDia International Oy Ltd.

• ARKRAY

• Aspira Women’s Health

• Beckman Coulter / Danaher

• Becton, Dickinson and Company (BD)

• Berry Genomics Co. Ltd.

• Biocartis

• BioFire Diagnostics (bioMérieux)

• Biohit Healthcare

• Biomerica Inc.

• Biomérieux Inc.

• Bio-Rad Laboratories, Inc.

• BioReference Laboratories

• Bio-Techne Corporation

• Binx Health

• Blueprint Genetics Oy

• Boston Heart Diagnostics

• Bruker Corporation

• CareDx, Inc.

• CellaVision AB

• Cerus Corporation

• Chembio Diagnostic Systems, Inc.

• Copan Italia S.p.A. and Copan Diagnostics, Inc.

• Danaher Corporation

• Dexcom

• Diasorin

• Diagnostica Stago

• Eiken Chemical Co., Ltd.

• EKF Diagnostics

• Elitech Group S.A.S. (part of Bruker)

• Epic Sciences

• Eurobio Scientific

• Euroimmun AG (Revvity)

• Exact Sciences

• Foundation Medicine, Inc.

• Fujirebio Diagnostics, Inc.

• Fulgent Genetics, Inc.

• Genedrive PLC

• Genetic Analysis AS

• Grifols S.A.

• Guardant Health, Inc.

• Hologic, Inc.

• Horiba

• Illumina

• Inex Innovate

• Inova Diagnostics, Inc.

• Invitae (now Labcorp)

• Leica Biosystems / Danaher

• LGC SeraCare Life Sciences, Inc.

• Masimo Corporation

• Mayo Clinic Laboratories

• MedMira, Inc.

• Medtronic PLC

• Menarini Diagnostics

• Meridian Bioscience, Inc.

• Mindray

• MGI Tech Co., Limited

• Myriad Genetics, Inc.

• Natera

• NeoGenomics

• Nova Biomedical Corporation

• OraSure Technologies, Inc.

• OPKO Diagnostics

• Oxford Gene Technology

• Pacific Biosciences of California, Inc. (PacBio)

• PreAnalytiX GmbH

• Precipio, Inc.

• Predictive Oncology

• Quanterix Corporation

• Qiagen

• Q-linea AB

• Quest Diagnostics

• QuidelOrtho Corporation

• Randox Laboratories Ltd.

• Radiometer A/S / Danaher

• Revvity

• Roche Diagnostics

• Sciex Pte Ltd.

• Seegene, Inc.

• Sekisui Diagnostics LLC

• Shimadzu Scientific Instruments

• Siemens Healthineers (Siemens)

• Snibe Co. Ltd. (Shenzhen New Industries Biomedical Engineering Co. Ltd.)

• Sonic Healthcare

• Standard BioTools

• Streck Inc.

• Sysmex Corporation

• Thermo Fisher Scientific Inc.

• Tosoh Bioscience

• Trinity Biotech PLC

• Veracyte, Inc.

• Verily Life Sciences LLC

• Visiopharm

• VolitionRx Limited

• Werfen

• Yourgene Health

 

Chapter 15: Company Profiles: The Second Tier

Chapter Scope

BGI Genomics

PCR and Fluorescence

MGI Tech Co., Limited, China

Prenatal Testing

Test Services

Whole Genome Sequencing (WGS)

NGS Sequencing

Collaborations

Biocartis

Diagnostica Stago S.A.S.

Eiken Chemical Co., Ltd

• Table 15-1: Eiken Chemical Revenue History, 2022-2024, FYE March 31 (millions of yen)

Product News

Fujirebio Diagnostics, Inc.

• Table 15-2: Fujirebio Diagnostics Revenue History, 2022-2024, FYE March 31 (millions of yen)

Fulgent Genetics, Inc

• Table 15-3: Fulgent Revenue History, 2022-2024 ($ million)

Grifols S.A.

• Table 15-4: Grifols Revenue History, 2022-2024 (€ million)

Blood Transfusion Business

ABO Blood Typing

Molecular ABO Blood Typing

Immunoassays

Market Expansion

Self-Testing

Guardant Health, Inc.

• Table 15-5: Guardant Health Revenue History, 2022-2024 ($ million)

Horiba

• Table 15-6: Horiba Revenue History, Medical Diagnostic Sales, 2022-2024 (millions of yen)

Invitae (now Labcorp)

Menarini Diagnostics

Meridian Bioscience, Inc.

Immunoassays

Molecular Tests

Myriad Genetics, Inc.

• Table 15-7: Myriad Genetics Revenue History, 2022-2024 ($ million)

OraSure Technologies, Inc.

• Table 15-8: OraSure Technologies Revenue History, 2022-2024 ($ million)
• Table 15-9: OraSure Technologies Product Revenue History, by Segment, 2022-2024 ($ thousands)

QIAGEN

• Table 15-10: QIAGEN Revenue History, 2022-2024 ($ million)

Tuberculosis.

Molecular Expansion

Precision Medicine / Companion Diagnostics

Molecular Microbiology

Prenatal Testing

Next Generation Sequencing

Digital PCR

Liquid Biopsy

Cervical Cancer

Expansion

Randox Laboratories Ltd.

Clinical Chemistries

POC and Rapid

Companion Diagnostics

Controls

Evidence Series – Multistat Biochip Analyzers

Molecular

Sekisui Diagnostics LLC

Veracyte, Inc.

• Table 15-11: Veracyte Revenue History, 2022-2024 ($ million)

 

Chapter 16: Company Profiles: Blood Bank Specialists

Chapter Scope

AliveDx

Cerus Corporation

• Table 16-1: Cerus Revenue History, 2022-2024 ($ million)

 

Chapter 17: Company Profiles: Core Lab and Other Companies

Chapter Scope

ARKRAY

Dry Chemistry / Immunoassays

Urinalysis

Diabetes

Molecular

EKF Diagnostics Holdings Plc

ELITech Group S.A.S. (part of Bruker)

SCIEX Pte Ltd.

Shimadzu Scientific Instruments

Snibe Co. Ltd., (Shenzhen New Industries Biomedical Engineering Co. Ltd.)

Tosoh Bioscience

Trinity Biotech Plc

• Table 17-1: Trinity Biotech Revenue History, 2022-2024 ($ million)

 

Chapter 18: Company Profiles: CTC & Liquid Biopsy Test Providers

Chapter Scope

Epic Sciences

Foundation Medicine, Inc.

NeoGenomics

 

Chapter 19: Company Profiles: Specialists

Chapter Scope

Ascensia Diabetes Care Holdings AG

Insulet Corporation

• Table 19-1: Insulet Corp Revenue History, 2022-2024 ($ million)

Medtronic plc

Verily Life Sciences LLC

 

Chapter 20: Company Profiles: Hematology (Cell Analysis) and Coagulation Specialists

Chapter Scope

CellaVision AB

Masimo Corporation

• Table 20-1: Masimo Revenues History, 2022-2024 ($ million)

Nova Biomedical Corporation (Nova)

 

Chapter 21: Company Profiles: Histopathology Specialists

Chapter Scope

Amoy Diagnostics Co. Ltd.

Applied Spectral Imaging Inc. (ASI)

Visiopharm

 

Chapter 22: Company Profiles: Immunoassay Specialists

Chapter Scope

Biohit Healthcare

Biomerica Inc.

• Table 22-1: Biomerica Revenue History, 2022-2024 ($ million)

Bio-Techne Corporation

• Table 22-2: Bio-Techne Revenue History, 2022-2024($ million)

Eurobio Scientific

EUROIMMUN AG (Revvity)

Immunodiagnostic Systems (IDS)

INOVA Diagnostics, Inc.

VolitionRx Limited

 

Chapter 23: Company Profiles: Microbiology Specialists

Chapter Scope

Accelerate Diagnostics, Inc.

• Table 23-1: Accelerate Diagnostics Revenue History, 2022-2024 ($ thousands)

Advanced Biological Laboratories, S.A. (ABL)

altona Diagnostics

ArcDia International Oy Ltd.

COPAN ITALIA S.p.A. and COPAN Diagnostics, Inc.

Genetic Analysis AS

Q-linea AB

Seegene, Inc.

 

Chapter 24: Company Profiles: Molecular Test Specialists

Chapter Scope

Pacific Biosciences of California, Inc. (PacBio)

Standard BioTools

 

Chapter 25: Company Profiles: Point of Care Test Specialists

Chapter Scope

Abingdon Health Ltd.

binx Health

Chembio Diagnostic Systems, Inc.

Genedrive plc

MedMira, Inc.

 

Chapter 26: Company Profiles: Prenatal Test Service Providers

Chapter Scope

Berry Genomics Co. ltd.

INEX Innovate

Oxford Gene Technology

Yourgene Health

 

Chapter 27: Company Profiles: Quality Control & Sample Pretreatment Specialists

Chapter Scope

10x Genomics

Agena Bioscience, Inc.

Biotype Diagnostic GmbH

IncellDx

LGC SeraCare Life Sciences, Inc.

PreAnalytiX GmbH

Precipio, Inc.

Quanterix Corporation

Streck Inc.

 

Chapter 28: Test Service Providers

• Table 28-1: FDA Approved Companion Diagnostics, 2025

Chapter Scope

Agendia BV

Ambry Genetics

ARUP Laboratories

Aspira Women’s Health

BioReference Laboratories

Blueprint Genetics Oy

Boston Heart Diagnostics

CareDx, Inc.

Predictive Oncology

Labcorp, Laboratory Corporation of America

• Table 28-2: Labcorp Revenue History, 2022-2024 ($ million)

Mayo Clinic Laboratories

MDxHealth SA

OPKO Diagnostics/Opko Health

• Table 28-3: OPKO Diagnostics Revenue History, 2022-2024 ($ million)

Quest Diagnostics

• Table 28-4: Quest Diagnostics Revenue History, 2022-2024 ($ million)

Sonic Healthcare