In Vitro Diagnostic (IVD) Trends and Market Update, 2025

Table of Contents (December 2025)

Chapter One: Worldwide IVD Market – December 2025 Update

About Kalorama Information

IVD Market Demand and Growth

• Figure 1-1: Q1-Q3 IVD Segment Performance Commentary, 2025 [Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay, Microbiology (Molecular), Point-of-Care (POC)]
• Table 1-1: Global In Vitro Diagnostic Sales by Product Market, 2025 ($ million) [Blood Bank Molecular – NAT Screens; Blood Grouping/Typing; Circulating Tumor Cells; Clinical Chemistry; Coagulation (PT/INR); Coagulation, Molecular; D-dimer; Diabetes HbA1c, lab; Drugs of Abuse; Hematology – Core Lab; Histology/Cytology; HPV, Molecular; Immuno – Blood Bank Screening; Immuno-Infectious Disease; Immunoassays – Non-isotopic; Mass Spectrometry; Microbiology (ID/AST); Microbiology (Molecular); Microbiology – Mass Spectrometry; NAAT – Oncology; Nucleic Acid Assays – Genetic/Inherited; Other Immunos; POC, OTC Diabetes; POC, OTC Other; POC, Professional/Hospital]
• Figure 1-2: IVD Segment Performance, Q1 2025–Q4 2025 estimated ($ million) [Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay, Microbiology, Point-of-Care (POC), Other]
• Figure 1-3: IVD Segment Performance, Total Market Value, 2025 estimated ($ million) [Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay, Microbiology, Point-of-Care (POC), Other]

COVID-19 Diagnostic Markets

• Table 1-2: COVID-19 Product Sales, 2025 ($ million) [Immunoassay (Antigen, Serology), Molecular, Rapid]

Effect of COVID-19 on Market Segments

• Table 1-3: IVD Market excluding and including COVID-19, 2025 ($ million)
• Figure 1-4: IVD Market Distribution, by Segment, 2025 (%) [COVID-19 Assays and Instruments, IVD Market excluding COVID-19 Assays and Instruments]
• Figure 1-5: IVD Market by COVID-19 and non-COVID markets, Quarterly Performance, 2025 estimated ($ million)
• Table 1-4: Global In Vitro Diagnostic Market – YoY Growth, 2024-2025 (%) [Blood Bank Molecular – NAT Screens, Blood Grouping/Typing, Circulating Tumor Cells, Clinical Chemistry, Coagulation (PT/INR), Coagulation, Molecular, D-dimer, Diabetes HbA1c, Lab, Drugs of Abuse, Hematology – Core Lab, Histology/Cytology, HPV, Molecular, Immuno – Blood Bank Screening, Immuno – Infectious Disease, Immunoassays- non-isotopic, Microbiology (ID/AST), Microbiology (Molecular), Microbiology – Mass Spectrometry, NAAT – Oncology, Nucleic Acid Assays – Genetic/Inherited, Other Immunos, POC, OTC Diabetes, POC, OTC Other, POC, Professional/Hospital]
• Figure 1-6: Global In Vitro Diagnostic Market – YoY Growth 2024-2025 (%) [Blood Bank Molecular – NAT Screens, Blood Grouping/Typing, Circulating Tumor Cells, Clinical Chemistry, Coagulation (PT/INR), Coagulation, Molecular, D-dimer, Diabetes HbA1c, Lab, Drugs of Abuse, Hematology – Core Lab, Histology/Cytology, HPV, Molecular, Immuno – Blood Bank Screening, Immuno – Infectious Disease, Immunoassays- non-isotopic, Microbiology (ID/AST), Microbiology (Molecular), Microbiology – Mass Spectrometry, NAAT – Oncology, Nucleic Acid Assays – Genetic/Inherited, Other Immunos, POC, OTC Diabetes, POC, OTC Other, POC, Professional/Hospital]

Chapter Two: Product Trends and New Developments

Selected New – Q3 2025 – Core IVD Product Launches, Developments and Trends

Immunoassay

Mass Spectrometry

Molecular

Personalized Medicine

POC

Coagulation

Flow Cytometry

Sequencing

Selected COVID-19 Developments – Q3 2025

Antigen/Antibody

Molecular

Chapter Three: Top IVD Market Participant Results

Selected Competitive Leader Updates

• Figure 3-1: IVD Segment Growth by Leading Competitors, Change in Sales 2024-2025 (%)
• Figure 3-2: Changes in Market Distribution for IVD Sales, 2022-2025 estimated (%)
• Figure 3-3: Comparison of Total Diagnostic Sales for Abbott vs Roche, 2023-2025 estimated ($ million)

Q3 2025 M&A Activity

• Table 3-1: Q3 2025 Merger and Acquisition Activity

Abbott Laboratories

• Table 3-2: Abbott Corporate Summary

Becton Dickinson and Co

• Table 3-3: Becton Dickinson Corporate Summary

bioMérieux SA

• Table 3-4: bioMérieux Corporate Summary

Danaher Corporation

• Table 3-5: Danaher Corporation Summary

Dexcom, Inc

• Table 3-6: Dexcom Corporate Summary

Exact Sciences

• Table 3-7: Exact Sciences Corporate Summary

Roche Diagnostic

• Table 3-8: Roche Diagnostic Corporate Summary

Siemens Healthineers

• Table 3-9: Siemens Healthineers Corporate Summary

Sysmex Corporation

• Table 3-10: Sysmex Corporate Summary

Thermo Fisher Scientific

• Table 3-11: Thermo Fisher Scientific Corporate Summary

Chapter Four: New Opportunities

Personalized Medicine

Genetic Testing in Disease

Microbiome

IVD Digital Diagnostics

Tariffs

 

Table of Contents (April 2025)

Chapter 1: Worldwide IVD Market Update – April 2025

IVD Market Demand and Growth

• Figure 1-1: Segment Performance Commentary, Q1-Q4 2024
• Table 1-1: Global In Vitro Diagnostic Sales, by Product Market, 2024 ($ million) [Blood bank molecular – NAT Screens, Blood grouping/typing, Circulating tumor cells, Clinical Chemistry, Coagulation (PT/INR), Coagulation, molecular, D-dimer, Hematology – Core Lab, Histology/cytology, HPV, molecular, Immunoassays – non-isotopic (Immuno – Infectious disease, Other immune, Immuno – Blood bank screening, Drugs of Abuse, Diabetes HbA1c, lab), Mass Spectrometry, Microbiology (ID/AST), Microbiology (molecular), Microbiology – Mass Spectrometry, Nucleic acid assays/genetic tests, Other (transplant testing, other, etc.), POC, OTC diabetes, POC, OTC other, POC, professional/hospital]
• Figure 1-2: Quarterly IVD Segment Performance, by Segment, Q1 2024 – Q4 2024 ($ million) [Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay, Microbiology, POC, Other]
• Figure 1-3: IVD Segment Performance, Total Market Value, 2024 ($ million) [Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay, Microbiology, POC, Other]

COVID-19 Diagnostic Markets

• Table 1-2: COVID-19 Product Sales, 2024 ($ million) [Immunoassay (Antigen, Serology), Molecular, Rapid]

Effect of COVID-19 on Market Segments

• Table 1-3: IVD Market Excluding and with COVID-19, 2024 ($ million)
• Figure 1-4: IVD Market Distribution, by Segment, 2024 (%) [IVD Market Excluding COVID-19 Assays and Instruments, COVID-19 Assays and Instruments]
• Figure 1-5: IVD Market by COVID-19 and non-COVID Markets, Quarterly Performance, 2024 ($ million) [IVD Market Excluding COVID-19 Assays and Instruments, COVID-19 Assays and Instruments]
• Table 1-4: Global In Vitro Diagnostic Market, YoY Growth 2023-2024 (%) [Blood bank molecular – NAT Screens, Blood grouping/typing, Circulating tumor cells, Clinical Chemistry, Coagulation (PT/INR), Coagulation, molecular, D-dimer, Hematology – Core Lab, Histology/cytology, HPV, molecular, Immunoassays – non-isotopic (Immuno – Infectious disease, Other immune, Immuno – Blood bank screening, Drugs of Abuse, Diabetes HbA1c, lab), Mass Spectrometry, Microbiology (ID/AST), Microbiology (molecular), Microbiology – Mass Spectrometry, Nucleic acid assays/genetic tests, Other (transplant testing, other, etc.), POC, OTC diabetes, POC, OTC other, POC, professional/hospital]
• Figure 1-6: Global In Vitro Diagnostic Market – YoY Growth 2023-2024 (%) [Blood bank molecular – NAT Screens, Blood grouping/typing, Circulating tumor cells, Clinical Chemistry, Coagulation (PT/INR), Coagulation, molecular, D-dimer, Hematology – Core Lab, Histology/cytology, HPV, molecular, Immunoassays – non-isotopic (Immuno – Infectious disease, Other immune, Immuno – Blood bank screening, Drugs of Abuse, Diabetes HbA1c, lab), Mass Spectrometry, Microbiology (ID/AST), Microbiology (molecular), Microbiology – Mass Spectrometry, Nucleic acid assays/genetic tests, Other (transplant testing, other, etc.), POC, OTC diabetes, POC, OTC other, POC, professional/hospital]

Chapter 2: Product Trends and New Developments

Liquid Biopsy

Mass Spectrometry

Immunoassay

Molecular

Personalized Medicine

POC

Sequencing

Antigen/Antibody

Molecular

Chapter 3: Top IVD Market Participant Results

Selected Competitive Leader Updates

• Figure 3-1: IVD Segment Growth by Leading Competitors, Change in Sales 2023-2024 (%) [Abbott Diagnostics, Becton Dickinson, bioMérieux, Danaher, Dexcom, QuidelOrtho, Roche Diagnostics, Siemens Healthineers, Sysmex Corporation, Thermo Fisher Scientific]
• Figure 3-2: IVD Sales Changes in Market Distribution, 2021-2024 – Roche and Abbott Battle for #1 Spot (%) [Abbott Diagnostics, Becton Dickinson, bioMérieux, Danaher, Dexcom, Exact Sciences, Hologic, QuidelOrtho, Roche Diagnostics, Siemens Healthineers, Sysmex Corporation, Thermo Fisher Scientific, Werfen, Others]
• Figure 3-3: Comparison of Total Diagnostic Sales for Abbott vs Roche, 2022-2024 ($ million)

Q4 2024, Q1 2025 M&A Activity

• Table 3-1: Q4 2024, Q1 2025 Merger and Acquisition Activity

Abbott Laboratories

• Table 3-2: Abbott Corporate Summary

Becton Dickinson and Co

• Table 3-3: Becton Dickinson Corporate Summary

bioMérieux SA

• Table 3-4: bioMérieux Corporate Summary

Danaher Corporation

• Table 3-5: Danaher Corporation Summary

Dexcom, Inc

• Table 3-6: Dexcom Corporate Summary

Exact Sciences

• Table 3-7: Exact Sciences Corporate Summary

QuidelOrtho Corporation

• Table 3-8: QuidelOrtho Corporate Summary

Roche Diagnostic

• Table 3-9: Roche Diagnostic Corporate Summary

Siemens Healthineers

• Table 3-10: Siemens Healthineers Corporate Summary

Sysmex Corporation

• Table 3-11: Sysmex Corporate Summary

Thermo Fisher Scientific

• Table 3-12: Thermo Fisher Scientific Corporate Summary

Chapter 4: New Opportunities

Staffing Shortages

LDT Update

IVDR Compliance Deadline Approaches

• Table 4-1: IVDR New Risk-based Classification System

Telemedicine