In Vitro Diagnostics (IVD) in the United States: Comprehensive Market Overview 2024-2029

Table of Contents

Chapter 1: Executive Summary

U.S. IVD Market

• Table 1-1: U.S. IVD Market by Segment 2024-2029 ($ million) (Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay [Immunoassay Infectious Disease, Immunoassay non-Infectious], Microbiology – ID/AST, Molecular [Molecular Infectious Disease with NAT & mass spec, Molecular – non-Infectious Disease], POC – Other, POC Diabetes [all], Others)
• Figure 1-1: U.S. IVD Market Segments by % of the Total U.S. IVD Market, 2024 (Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay [Immunoassay Infectious Disease, Immunoassay non-Infectious], Microbiology – ID/AST, Molecular [Molecular Infectious Disease with NAT & Mass Spec, Molecular – non-Infectious Disease], POC – Other, POC Diabetes [all], Others)

Top 12 U.S. IVD Market Participants and Rankings

• Table 1-2: U.S. IVD Market Rankings by Estimated 2024 US Revenue – Top 12 Companies (Abbott Diagnostics, Becton, Dickinson & Co. [BD], bioMérieux, Danaher Corporation [Beckman Coulter, Leica Biosystems, Radiometer, Cepheid], Dexcom, Exact Sciences, Illumina, Natera, QuidelOrtho, Roche Diagnostics, Siemens Healthcare Diagnostics, Thermo Fisher Scientific)

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. Projects of Older Adult Population, 2016-2060 (million)

Disease Prevalence and Incidence

• Table 2-1: U.S. Cancer Cases, Estimates 2024
• Table 2-2: Reported Cases of Selected Notifiable Diseases, U.S., 2022

U.S. Clinical Lab Expenditure

• Table 2-3: U.S. Clinical Lab Market, by Channel, 2023 (% of Market)

Preventive Health Care

Product Innovation from Value-Based Pricing

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

Protecting Access to Medicare Act of 2014 (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)

Advanced Laboratory Tests (ADLT)

• Table 2-5: List of Approved ADLTs, March 2024

Personalized Medicine

Companion Diagnostics

• Table 2-6: FDA Approved Companion Cancer Diagnostics, 2024

AI Use in U.S. Liquid Biopsy Segment

• Table 2-7: Selected S. AI/Liquid Biopsy Initiatives

Telehealth

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 2-8: Home Collection Test Kit Market, by Category, Worldwide, 2022 (% 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 2-9: Selected Molecular Tests EUAs for Home Collection SARS-CoV-2 Tests, 2020-2024

Retail Clinics

Conclusions

Chapter 3: U.S. IVD Market Analysis

Clinical Chemistry

• Table 3-1: U.S. Clinical Chemistry Market, by Segment, 2024-2029 ($ million) (Blood Gases, General Chemistry, Urinalysis)
• Figure 3-1: U.S. Clinical Chemistry Market, 2024-2029 ($ million)

Microbiology and Virology – ID/AST and Molecular

• Table 3-2: US ID/AST Microbiology ID/AST Market, by Segment, 2024-2029 ($ million) (Auto ID/AST, Manual ID/AST, Blood Culture, Chromogenic Media, Rapid, Micro)
• Figure 3-2: U.S. ID/AST Microbiology Market, 2024-2029 ($ million)

Molecular Infectious Disease

• Table 3-3: U.S. Molecular Infectious Disease, Market Distribution Estimates by Segment, 2024 (%) (HAI/Sepsis, HIV, Hepatitis, GC/Chlamydia, Respiratory, Mycobacteria/TB, Other Microbiology)
• Figure 3-3: U.S. Molecular Microbiology/Virology Market Distribution Estimates, by Segment, 2024 (%) (HAI/Sepsis, HIV, Hepatitis, GC/Chlamydia, Respiratory, Mycobacteria/TB, Other Microbiology)

Point-of-Care Testing

• Table 3-4: U.S. Point-of-Care (POC) Diagnostics Markets by Segment, 2024-2029 ($ million) (Glucose, Blood & Electrolytes, Coagulation, Cardiac Markers, Drugs of Abuse, Pregnancy & Fertility, Fecal Occult Blood, Infectious Disease, Lipid, Cancer Tumor Markers, Urine, Miscellaneous)
• Figure 3-4: U.S. POC Diabetes Market, 2024-2029 ($ million)
• Figure 3-5: U.S. POC Market without Diabetes, 2024-2029 ($ million)

Immunoassays

Non-Infectious Disease Immunoassay

• Table 3-5: U.S. Immunoassays Market – Non Infectious, by Segment, 2024-2029 ($ million) (Cardiac Markers, Tumor Markers, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Vitamin D, HbA1c, Others)
• Figure 3-6: U.S. Immunoassays Market – Non Infectious, 2024-2029 ($ million)

Infectious Disease Immunoassay

• Table 3-6: U.S. Immunoassays Market – Infectious, 2024-2029 ($ million) (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAIs/Sepsis, Others)
• Figure 3-7: U.S. Immunoassay Infectious Disease, 2024-2029 ($ million)

Molecular Non-Infectious Disease Diagnostics

• Figure 3-8: U.S. Molecular – Non-Infectious Disease Diagnostics Market, 2024-2029 ($ million)

Coagulation

• Table 3-7: U.S. Coagulation Diagnostics Market, by Segment, 2024-2029 ($ million) (PT/INR, Molecular-lab Thrombophilia SNPs, D-Dimer)
• Figure 3-9: U.S. Coagulation Diagnostics Market, 2024-2029 ($ million)

Histology

• Table 3-8: U.S. Histology/Cytology IVD Market, by Segment, 2024-2029 ($ million) Pap Tests, in situ Hybridization, Immunohistochemistry, Traditional non-Pap Stains, HPV Molecular)
• Figure 3-10: U.S. Histology and Cytology Diagnostics Market, 2024-2029 ($ million)

Hematology

• Table 3-9: U.S. Lab-based Hematology Market, by Analyte 2024-2029 ($ million)
• Figure 3-11: U.S. Hematology Diagnostics Market, 2024-2029 ($ million)

Blood Testing and Typing

• Table 3-10: U.S. Blood Testing and Typing, by Segment, 2024-2029 ($ million) (ABO Grouping/Typing, Screening)
• Figure 3-12: U.S. Blood Grouping and Typing Diagnostics Market, 2024-2029 ($ million)
• Figure 3-13: U.S. Blood Screening Diagnostics Market, 2024-2029 ($ million)

Total U.S. IVD Market

• Table 3-11: U.S. IVD Market by Segment 2024-2029 ($ million) (Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay [Immunoassay Infectious Disease, Immunoassay non-Infectious], Microbiology – ID/AST, Molecular [Molecular Infectious Disease with NAT & mass spec, Molecular – non-Infectious Disease], POC – Other, POC Diabetes [all], Others)
• Figure 3-14: U.S. IVD Market Segments by % of the Total U.S. IVD Market, 2024 (Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay [Immunoassay Infectious Disease, Immunoassay non-Infectious], Microbiology – ID/AST, Molecular [Molecular Infectious Disease with NAT & Mass Spec, Molecular – non-Infectious Disease], POC – Other, POC Diabetes [all], Others)

Chapter 4: Competitor U.S. IVD Market Players

• Table 4-1: Top 12 U.S. IVD Competitor Revenues, 2024 ($ million) (Abbott Diagnostics, Becton, Dickinson & Co. [BD], bioMérieux, Danaher Corporation [Beckman Coulter, Leica Biosystems, Radiometer, Cepheid], Dexcom, Exact Sciences, Illumina, Natera, QuidelOrtho, Roche Diagnostics, Siemens Healthcare Diagnostics, Thermo Fisher Scientific)

Abbott Diagnostics

Abbott Diagnostic Recent Revenue History

• Table 4-2: Global Abbott Diagnostics (and Diabetes Management) Revenues, 2019-2023 ($ million)
• Figure 4-1: Abbott Diagnostics – IVD U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
• Table 4-3: Global Abbott Diagnostics Revenues, 2019-2023 ($ million)

Core Lab

Hematology

Blood Banking

Infectious Diseases – Molecular

Diabetes

HIV Point of Care

i-STAT Business

Becton, Dickinson and Company (BD)

Recent Revenue History

• Table 4-4: Global BD Life Sciences Revenues, 2019-2023 ($ million)
• Figure 4-2: BD – IVD U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)

Cytology

Molecular Microbiology

Traditional Microbiology – ID/AST

Blood Culture

Hospital Acquired Infections

Blood Collection

Mass Spectrometry

Flow Cytometry

bioMérieux

• Table 4-5: Global bioMérieux IVD Revenues, 2019-2023 ($ million)
• Figure 4-3: bioMérieux – IVD U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
• Table 4-6: Global bioMérieux Revenues in Selected Test Segments, 2019-2023 ($ million)

Traditional Microbiology

Immunoassays

BIOFIRE Diagnostics Business

Danaher Corporation

Recent Revenue History

• Table 4-7: Global Danaher Diagnostics Revenues, 2019-2023 ($ million)
• Figure 4-4: Danaher – IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)

Beckman Coulter

Cepheid

Dexcom

• Table 4-8: Global Dexcom Revenue History 2019-2023 ($ million)
• Figure 4-5: Dexcom – IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)

Exact Sciences

Recent Revenue History

• Table 4-9: Global Exact Sciences Revenue History, 2019-2023 ($ million)
• Figure 4-6: Exact Sciences – IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)

Hologic, Inc.

Recent Revenue History

• Table 4-10: Hologic Revenues, 2019-2023 ($ million)
• Figure 4-7: Hologic – IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
• Table 4-11: Global Hologic Revenues in Selected Test Segments, 2019-2023 ($ million) estimated

Panther Molecular System

Panther Fusion

Infectious Diseases

Sexually Transmitted Infections

Cytology

Illumina

• Table 4-12: Global Illumina Revenue History, 2019-2023  ($ million – not all revenues are for clinical products and services; estimated)
• Figure 4-8: IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million) estimated
• Table 4-13: Global Illumina Diagnostic Revenues, by Segment, 2019-2023 ($ million) estimated

Natera

Recent Revenue History

• Table 4-14: Natera Revenue History, 2019-2023 ($ million)
• Figure 4-9: Natera – IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million) estimated

QuidelOrtho Corporation

• Table 4-15: Global QuidelOrtho Revenue History, 2019-2023 ($ million)
• Figure 4-10: QuidelOrtho – IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million) estimated
• Table 4-16: Global QuidelOrtho Diagnostic Revenues, by Segment, 2020-2023 ($ million) estimated

Immunoassays

Rapid Immunoassays

The Solana Business

Molecular – Savanna

Blood Bank

Roche Diagnostics

Recent Revenue History

• Table 4-17: Global Roche IVD Diagnostics Revenues, 2019-2023 ($ million)
• Figure 4-11: Roche – IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million) estimated
• Table 4-18: Global Roche IVD Diagnostics Revenues, by Type, 2019-2023 (million) estimated

Immunoassays

Core Molecular

Digital PCR

Diabetes Care

cobas Liat System – POC

HPV

Blood Bank

Cancer Companion Testing

Siemens Healthineers (Siemens)

Recent Revenue History

• Table 4-19: Global Siemens Healthineers IVD Revenues, 2019-2023 ($ million)
• Figure 4-12: Siemens Healthineers – IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023  ($ million)
• Table 4-20: Global Siemens Healthineers Diagnostic Revenues, by Segment, 2021-2023 ($ million) estimated

Core Lab

Immunoassays

Hematology

Molecular

Thermo Fisher Scientific Inc.

Recent Revenue History

• Table 4-21: Global Thermo Fisher IVD Revenues, 2019-2023 ($ million)
• Figure 4-13: Thermo Fisher – IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
• Table 4-22: Global Thermo Fisher IVD Revenues, by Type, 2019-2023 (million) estimated

Immunoassays

Microbiology

Molecular Test Business

Next Generation Sequencing

qPCR

Oncology Companion Diagnostics

Mass Spectrometry