In Vitro Diagnostics (IVD) in the United States, 6th Edition

Chapter 1: Executive Summary

About Kalorama Information

U.S. IVD Market

• Table 1-1: U.S. IVD Market, by Segment, 2025-2030 ($ million) [Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Microbiology – ID/AST, Molecular (Molecular Infectious Disease (with NAT & mass spec), Molecular – non-Infectious Disease), POC Diabetes (all), Immunoassay (Immunoassay Infectious Disease, Immunoassay non-Infectious), POC – Other, Others]
• Figure 1-1: IVD Market Segments, by Share of Total U.S. Market, 2025 (%) [Blood Grouping, Clinical Chemistry, Coagulation, Hematology, Histology, Microbiology – ID/AST, Microbiology – Molecular, Molecular – non-Infectious Disease, POC Diabetes, Immunoassay – Infectious, Immunoassay – Other, POC – Other, Others]

Top 12 U.S. IVD Market Participants and Rankings

• Table 1-2: Top 12 Companies – S. IVD Market Rankings, by Estimated US Revenue, 2025

Scope and Methodology

Conclusions

Chapter 2: Introduction to U.S. Health Care

The United States and In Vitro Diagnostics

U.S. Patient Population

Healthcare System Utilization

Aging

• Figure 2-1: U.S. Projections of Older Adult Population, 2016-2060

Disease Prevalence and Incidence

• Table 2-1: U.S. Cancer Cases, 2025 Estimates
• Table 2-2: Reported Cases of Selected Notifiable Diseases in the U.S., 2022

U.S. Clinical Lab Expenditure

• Table 2-3: U.S. Clinical Lab Market, by Channel by Share of Market, 2024 (%)

Preventive Health Care

Product Innovation from Value-Based Pricing

Clinical Testing under Medicare – Reimbursement Cuts and Market-Based Pricing

PAMA

• Table 2-4: Implemented and Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2027

Impact of CARES Act on PAMA

Saving Access to Laboratory Service Act (SALSA)

RESULTS Act

Advanced Laboratory Tests (ADLT)

• Table 2-5: List of Approved ADLTs, March 2025

Personalized Medicine

Companion Diagnostics

• Table 2-6: FDA Approved Companion Cancer Diagnostics, 2025

AI in Clinical Practice

• Table 2-7: Selected AI Market Cleared Tests

Regulatory Pathway

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 2-8: Selected AI/Liquid Biopsy Initiatives

Effect of Tariffs on U.S. IVD Market

• Table 2-9: Selected Company Reported 2025 Impact

Telehealth

Telehealth eMed to Implement Home Test to Treat Program

Notable Acquisitions

• Table 2-10: Notable Selected Second Half 2025 US Company Acquisitions

Laboratory-Developed Tests (LDTs)

FDA

U.S. Healthcare Infrastructure and Testing Channels

Hospitals

Independent Labs

Physician Office Laboratories

At-Home Testing

Home Collection Trend

• Table 2-11: Worldwide Home Collection Test Kit Market*, by Category, 2025 (% Estimated Share) [Cholesterol, Drug of Abuse, Fertility Testing, Genetic, Infectious Disease (COVID-19, STDs, HIV, etc.), Tumor DNA Markers, Other (Hormone, Allergies, HbA1c, Heavy Metals, etc.)]
• Table 2-12: Selected Molecular Tests EUAs for Home Collection SARS-CoV-2 Tests

Retail Clinics

Conclusions

Chapter 3: U.S. IVD Market Analysis

Clinical Chemistry

• Table 3-1: U.S. Clinical Chemistry Market, 2025-2030 ($ million) [Blood Gases, General Chemistry, Urinalysis]
• Figure 3-1: U.S. Clinical Chemistry Market, 2025 and 2030 ($ million)

Microbiology and Virology – ID/AST and Molecular

• Table 3-2: U.S. ID/AST Microbiology Market, 2025-2030 ($ million) [Auto ID/AST Systems, Blood Culture, Chromogenic Media, Manual ID/AST Systems, Rapid Micro]
• Figure 3-2: U.S. ID/AST Microbiology Market, 2025 and 2030 ($ million)

Molecular Infectious Disease

• Table 3-3: U.S. Molecular Infectious Disease, Market Distribution Estimates, by Segment, 2025-2030 (%) [GC/Chlamydia, HAI (c. diff, sepsis, MRSA, VRE, others), Hepatitis, HIV, Mycobacteria/TB, Other Microbiology, Respiratory (including COVID-19)]
• Figure 3-3: U.S. Molecular Microbiology/Virology Market Distribution Estimates, by Segment, 2025 (%) [GC/Chlamydia, HAI (c. diff, sepsis, MRSA, VRE, others), Hepatitis, HIV, Mycobacteria/TB, Other Microbiology, Respiratory (including COVID-19)]

Leading Trends in Molecular Infectious Disease Testing

Recent Market Developments

Point-of-Care Testing

Recent Developments

• Table 3-4: U.S. Point-of-Care (POC) Diagnostics Markets, 2025 and 2030 ($ million) [Blood & Electrolytes, Cancer Tumor Marker, Cardiac Markers, Coagulation, Drugs of Abuse, FOB, Glucose incl. HbA1c, CGM, Infectious Disease, Lipid, Pregnancy & Fertility, Urine, Miscellaneous]
• Figure 3-4: U.S. Point-of-Care (POC) Diabetes Market, 2025 and 2030 ($ million)
• Figure 3-5: U.S. Point-of-Care (POC) Market without Diabetes, 2025 and 2030 ($ million)

Immunoassays

Non-Infectious Disease Immunoassay

• Table 3-5: S. Immunoassays Market – non-Infectious Disease, 2025-2030 ($ million) [Allergy, Anemia, Autoimmune, Cardiac Markers, Fertility, HbA1c, Proteins, Therapeutic Drugs, Thyroid, Tumor Markers, Vitamin D, Others]]
• Figure 3-6: S. Immunoassays Market – non-Infectious Disease, 2025 and 2030 ($ million)

Infectious Disease Immunoassay

• Table 3-6: U.S. Immunoassays Market – Infectious Disease, 2025-2030 ($ million) [HAIs/Sepsis, Hepatitis, HIV, Respiratory (including COVID-19), STDs, ToRCH, Others]
• Figure 3-7: U.S. Immunoassays Market – Infectious Disease, 2025 and 2030 ($ million)

Recent Developments in STD Testing

Molecular Non-Infectious Disease Diagnostics

• Figure 3-8: U.S. Molecular – non-Infectious Disease Revenues, 2025 and 2030 ($ million)

Coagulation

• Table 3-7: U.S. Coagulation Diagnostics Market, by Segment, 2025-2030 ($ million) [Molecular-lab Thrombophilia SNPs, PT/INR, D-Dimer]
• Figure 3-9: U.S. Coagulation Diagnostics Market, 2025 and 2030 ($ million)

Histology

• Table 3-8: U.S. Histology/Cytology IVD Market, by Segment, 2025-2030 ($ million) [HPV Molecular, Immunohistochemistry, in situ Hybridization, Pap Tests, Traditional non-Pap Stains]
• Figure 3-10: U.S. Histology and Cytology Diagnostics Market, 2025 and 2030 ($ million)

Hematology

• Table 3-9: U.S. Lab-based Hematology Market, by Analyte, 2025-2030 ($ million) [CBC, Hemoglobin, Other]
• Figure 3-11: U.S. Hematology Diagnostics Market, 2025 and 2030 ($ million)

Blood Screening, Grouping and Typing

• Table 3-10: U.S. Blood Screening and Grouping/Typing, by Segment, 2025-2030 ($ million) [ABO Grouping/Typing, Screening]
• Figure 3-12: U.S. Blood Grouping and Typing Diagnostics Market, 2025 and 2030 ($ million)
• Figure 3-13: U.S. Blood Screening Diagnostics Market, 2025 and 2030 ($ million) [Immunoassay Blood Screening, Molecular (NAT) Blood Screening]

Total U.S. IVD Market

• Table 3-11: U.S. IVD Market including COVID-19, by Segment, 2025-2030 ($ million) [Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Microbiology – ID/AST, Molecular (Molecular Infectious Disease (with NAT & mass spec), Molecular – non-Infectious Disease), POC Diabetes (all), Immunoassay (Immunoassay Infectious Disease, Immunoassay non-Infectious), POC – Other, Others]
• Figure 3-14: IVD Market Segments, by Share of Total U.S. Market, 2025 (%) [Blood Grouping, Clinical Chemistry, Coagulation, Hematology, Histology, Microbiology – ID/AST, Microbiology – Molecular, Molecular – non-Infectious Disease, POC Diabetes, Immunoassay – Infectious, Immunoassay – Other, POC – Other, Others]
• Table 3-12: Top 12 U.S. IVD Competitor Revenues, 2025 ($ million) Estimated

Abbott Laboratories

Becton Dickinson and Co

bioMérieux

Danaher Corporation

Dexcom, Inc

Exact Sciences

Hologic

Natera

QuidelOrtho

Roche Diagnostics

Siemens Healthineers

Thermo Fisher Scientific