United States Market for In Vitro Diagnostics Tests

The U.S. market dominates the IVD industry AND remains the core geographical IVD market in the world. Yet this major multi-billion-dollar IVD market is in a state of flux, trying to manage a myriad of issues, all of which collide with a huge system that costs more than any other in the world.

COVID-19 had a profound effect on the IVD diagnostic industry - some segments exploded and others languished. At this point in time, it is hard to predict how the coronavirus will impact the forecast years to 2025, but the analyst has attempted to provide insight into the industry by conversing with market participants and government entities. It is realistic to assume the market for COVID-19 will remain a component of the IVD market as the continued prevalence of the virus and the evolving variants are expected to remain. It should be noted that the market can be uncertain and ongoing research will help determine the long-term path of the segment in the coming months to years.

Demographic aging is also one of the primary market influencing trends for IVD in the United States. Aging is associated with rising incidences and rates of prevalence for several non-infectious diseases including diabetes and cancer. Individuals over the age of 60 are estimated to average at least four times the number of clinical tests of younger individuals.

This latest report, United States Market for In Vitro Diagnostic Tests, discusses these and other trends shaping the present and future of the IVD market in America.

The report discusses the following IVD market segments in the United States:

Clinical Chemistry
Microbiology (Traditional) - Identification and Antibiotic Susceptibility Testing (ID/AST)
Microbiology - Molecular - Infectious Disease
Point-of-Care (POC) Tests - Diabetes
Point-of-Care (POC) Tests - All Other
Immunoassays - Infectious Disease (non-POC)
Immunoassays - Other
Molecular - Non-infectious Disease
Hematology
Coagulation (non-POC)
Histology
Blood Testing and Typing
Others

In addition, the report profiles the top players in the U.S. IVD market. The profiles cover notable corporate events and developments from 2018, 2019 and 2020.

Featured companies include:

Abbott Diagnostics
Beckman Coulter, Inc./Danaher
Becton, Dickinson and Company (Bd)
Biomérieux
Bio-Rad Laboratories, Inc.
Cepheid/Danaher
Danaher Corporation
Hologic, Inc.
Ortho Clinical Diagnostics (Ortho)
Qiagen N.V.
Roche Diagnostics
Siemens Healthineers (Siemens)
Sysmex Corporation
Thermo Fisher Scientific Inc.

Chapter 1: Executive Summary

U.S. IVD Market
- Table 1-1: U.S. IVD Market by Segment 2020-2025 (in millions $)
- Figure 1-1: U.S. IVD Market Segments by % of the total U.S. IVD Market 2020
Top Tier U.S. IVD Market Participants and Rankings
- Table 1-2: U.S. IVD Market Rankings by Estimated 2020 Revenue - Top 12 Companies
Conclusions

Chapter 2: Introduction to U.S. Health Care

The United States and In Vitro Diagnostics
U.S. Patient Population
Healthcare System Utilization
Aging
- Table 2-1: Historical and Projected U.S. Aged Populations (60+) (% Share of Total Population,
Population in Millions) (1950-2050)
Disease Prevalence and Incidence
- Figure 2-1 : Rate of New Cancers by Age Group, All Types US 2013-2017
- Table 2-2 U.S. Cancer Deaths 2013-2017 per 100,000 by Type
- Table 2-3: Reported Cases of Selected Notifiable Diseases , U.S. 2016-2018 by Case Count
U.S. Clinical Lab Expenditure
- Table 2-4: U.S. Clinical Lab Market by Channel 2020-2025 by % of Market
Hospital-Acquired Infections (HAIs)
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 2-5: Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2023
Impact of CARES Act on PAMA
Personalized Medicine and NGS
Laboratory-Developed Tests (LDTs)
Changes Resulting from COVID-19 Pandemic
U.S. Healthcare Infrastructure and Testing Channels
Hospitals
Independent Labs
Physician Office Laboratories
Self-Testing
Retail Clinics
Conclusions

Chapter 3: U.S. IVD Market Analysis

Clinical Chemistry
- Table 3-1: U.S. Clinical Chemistry Market (General Chemistry, Blood Gases, Urinalysis) 2020-2025 ($ millions)
- Figure 3-1: U.S. Clinical Chemistry Market (2020-2025) ($ millions)
Microbiology and Virology - ID/AST and Molecular
- Table 3-2: US ID/AST Microbiology ID/AST Market (ID/AST Auto, ID/AST Panels, Blood Culture,
Chromogenic Media, Rapid Micro 2020-2025 ($ millions)
- Figure 3-2: U.S. ID/AST Microbiology Market (Auto ID/AST, Manual ID/AST, Blood Culture,
Chromogenic Media, Rapid, Micro, COVID-19(2020-2025) ($ millions)
Molecular Infectious Disease
- Table 3-3: U.S. Molecular Infectious Disease by Segment ( HAI/Sepsis, HIV, Hepatitis, GC/Chlamydia,
Respiratory, Mycobacteria/TB, COVID-19, Other Molecular including Parasitology, Mycology,
Malaria, Chagas, Dengue etc.) 2020-2025 ($ millions)
- Figure 3-3: U.S. Molecular Microbiology/Virology Market (2020-2025) ($ millions)
Point-of-Care Testing
- Table 3-4: U.S. Point-of-Care (POC) Diagnostics Markets - Glucose, Blood & Electrolytes, Coagulation,
Cardiac Markers, Drugs of Abuse, Pregnancy & Fertility, Fecal Occult Blood, Infectious Disease, Lipid, Cancer Tumor Markers, Urine, Miscellaneous ($ millions)
- Figure 3-4: U.S. POC Diabetes Market 2020-2025 ($ millions)
- Figure 3-5: U.S. POC Market without Diabetes 2020-2025 ($ millions)
Immunoassays
Non-Infectious Disease Immunoassay
- Table 3-5: U.S. Immunoassays Market - Non Infectious (Cardiac Markers, Tumor Markers,
Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Vitamin D) and Others including HbA1c Lab, Drugs of Abuse (2020-2025) ($ millions)
- Figure 3-6: U.S. Immunoassay-Non-infectious including Cardiac Markers, Tumor Markers,
Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Vitamin D and others (inc. HbA1c lab and Drugs of Abuse) ($ millions)
Infectious Disease Immunoassay
- Table 3-6: U.S. Immunoassays Market - Infectious (Hepatitis, HIV, STDs, ToRCH, Respiratory,
HAIs/Sepsis, Others including Parasitology, Mycology, Others) 2020-2025 ($ millions)
- Figure 3-7: U.S. Immunoassay Infectious Disease (Hepatitis, HIV, STDs, ToRCH, Respiratory,
HAI/Sepsis, COVID-19, Others) 2020-2025 ($ millions)
Molecular Non-Infectious Disease Diagnostics
- Figure 3-8: U.S. Molecular Non-Infectious Disease Diagnostics Market (2020-2025) ($ millions)
Coagulation
- Table 3-7: U.S. Coagulation Diagnostics Market by Segment , PT/INR, Molecular-lab Thrombophilia
SNPs, D-Dimer, 2020-2025 ($ millions)
- Figure 3-9: U.S. Coagulation Diagnostics Market (2020-2025) ($ millions)
Histology
- Table 3-8: U.S. Histology/Cytology IVD Market by Segment including Pap Tests, in situ Hybridization,
Immunohistochemistry, Traditional non-Pap Stains, HPV Molecular) 2020-2025 ($ millions)
- Figure 3-10: U.S. Histology and Cytology Diagnostics Market (2020-2025) ($ millions)
Hematology
- Table 3-9: U.S. Lab-based Hematology Market by Analyte 2020-2025 ($ millions)
- Figure 3-11: U.S. Hematology Diagnostics Market (2020-2025) ($ millions)
Blood Testing and Typing
- Table 3-10: U.S. Blood Testing and Typing by Segment 2020-2025 ( ($ millions))
- Figure 3-12: U.S. Blood Testing and Typing Diagnostics Market (2020-2025) ($ millions)
Total U.S. IVD Market
- Table 3-11: U.S. IVD Market including COVID-19 by Segment 2020-2025 (in millions $)
- Figure 3-13: U.S. IVD Market Segments by % 2020

Chapter 4: Top Tier U.S. IVD Market Players

Abbott Diagnostics
Recent Revenue History
- Table 4-1: Abbott Diagnostic Revenues 2016-2020 (millions $)
- Figure 4-1: 2020 IVD U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
- Table 4-2: Global Abbott Diagnostic Revenues 2016-2020 (millions $)
Alere Acquisition Update and Point of Care
Core Lab
Hematology
Blood Banking
Infectious Diseases - Molecular
Diabetes
HIV Point of Care
i-STAT Business
COVID-19
Beckman Coulter, Inc./Danaher
Recent Revenue History
- Table 4-3: Beckman Coulter Diagnostic Revenues 2016-2020 (millions $)
- Figure 4-2: 2020 IVD U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
- Table 4-4: Global Beckman Coulter Revenues in Selected Test Segments 2017-2020 (millions $)
estimated
Hematology
Hematology IT
Clinical Chemistry
Immunoassays
Coagulation
Microbiology
Urinalysis
Clinical Information Technology
Molecular Tissue Analysis
Flow Cytometry
A Fight for Brain Natriuretic Peptide (BNP) Assay Rights
Beckman Coulter Life Sciences
Collaborations
COVID-19
Becton, Dickinson and Company (BD)
Recent Revenue History
- Table 4-5: BD Diagnostic Revenues 2016-2020 (millions $)
- Figure 4-3: 2020 IVD U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
- Table 4-6: Global BD Revenues in Selected Test Segments 2019-2020 (millions $) estimated
- Table 4-7: Global BD Revenues in Flow Cytometry 2016-2020 (millions $)
Cytology
Molecular Microbiology
Traditional Microbiology - ID/AST
Blood Culture
Blood culture collection products for the preanalytical phase
Hospital Acquired Infections
Blood Collection
Mass Spectrometry
Flow Cytometry
COVID-19
bioMérieux
Recent Revenue History
- Table 4-8: bioMérieux IVD Revenues 2016-2020 (millions $)
- Figure 4-4: 2020 IVD U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
- Table 4-9: bioMérieux Revenues in Selected Test Segments 2016-2020 (millions $)
Traditional Microbiology
Blood Culture
Immunoassays
BIOFIRE Diagnostics Business
COVID-19
Bio-Rad Laboratories, Inc.
Recent Revenue History
- Table 4-10: Bio-Rad Diagnostics Revenues 2016-2020 (millions $)
- Figure 4-5: 2020 IVD U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
- Table 4-11 Global Bio-Rad Revenues in Selected Test Segments 2016-2020 (millions $)
Blood Bank
Diabetes
Immunoassays
COVID-19
Cepheid/Danaher
Recent Revenue History
- Table 4-12: Cepheid Revenues 2016-2020 (millions $)
GeneXpert Xpress Line
High Burden Expansion
India
Tuberculosis
Microbiology
POC Testing
Cancer
COVID-19
Danaher Corporation
Recent Revenue History
- Table 4-13: Danaher Diagnostics Revenues 2015-2019 (millions $)
- Figure 4-6: 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
- Table 4-14: Global Danaher Revenues in Business Segments 2016-2020 (millions $)
Hologic, Inc.
Recent Revenue History
- Table 4-15: Hologic Revenues 2016-2020 (millions $)
- Figure 4-7: 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
- Table 4-16: Global Hologic Revenues in Selected Test Segments 2016-2020 (millions $)
PANTHER Molecular System
HIV Testing
Sexually Transmitted Infections
Cytology
COVID-19
Ortho Clinical Diagnostics (Ortho)
Recent Revenue History
- Table 4-17: Ortho Clinical Diagnostics Revenues 2016-2020 (millions $)
- Figure 4-8: 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
- Table 4-18: Global Ortho Clinical Diagnostics Revenues in Selected Test Segments 2019-2020 (millions $)
Blood Bank
Core Lab/Immunoassays
COVID-19
QIAGEN N.V.
Recent Revenue History
- Table 4-19: QIAGEN N.V. IVD Revenues 2016-2020 (millions $)
- Figure 4-9: 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
- Table 4-20: Global QIAGEN IVD Revenues by Type, 2016-2020 (million)
Tuberculosis
Lyme Disease
Molecular Expansion
Precision Medicine/Companion Diagnostics
Molecular Microbiology
Prenatal Testing
Next Generation Sequencing
Digital PCR
Liquid Biopsy
COVID-19
Roche Diagnostics
Recent Revenue History
- Table 4-21: Roche IVD Diagnostics Revenues 2016-2020 (millions $)
- Figure 4-10: 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
- Table 4-22: Global Roche IVD Diagnostics Revenues by Type, 2016-2020 (million)
Hematology
Core Lab
Immunoassays
Core Molecular
Digital PCR
Diabetes Care
Coagulation
cobas Liat System - POC
HPV
Blood Bank
Cancer Companion Testing
COVID-19
Siemens Healthineers (Siemens)
Recent Revenue History
- Table 4-23: Siemens Healthineers IVD Revenues 2016-2020 (millions $)
- Figure 4-11: 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
- Table 4-24: Global Siemens Healthineers IVD Revenues by Type, 2020 (million)
Core Lab
Immunoassays
Hematology
Molecular
Coagulation
Acute Care - POC
COVID-19
Sysmex Corporation
Recent Revenue History
- Table 4-25: Sysmex IVD Revenues 2016-2020 (millions $)
- Figure 4-12: 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
- Table 4-26: Global Sysmex IVD Revenues by Type, 2016-2020 (million)
Hematology
Coagulation
Urinalysis
Immunoassays
Flow Cytometry
Precision Medicine/Companion Test Diagnostics
Oncology
COVID-19
Thermo Fisher Scientific Inc.
Recent Revenue History
- Table 4-27: Thermo Fischer IVD Revenues 2016-2020 (millions $)
- Figure 4-13: 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues (millions $) estimated
- Table 4-28: Global Thermo Fisher IVD Revenues by Type, 2016-2020 (million)
Immunoassays
Microbiology
Next Generation Sequencing
qPCR
Mass Spectrometry
COVID-19