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.
The latest report United States Market for In Vitro Diagnostic (IVD) Tests, 4th Edition, discusses the trends shaping the present and future of the IVD market in America, including an aging population and the lingering impact of COVID-19 for the foreseeable future. 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 recent years. Featured companies include:
- Abbott Diagnostics
- Beckman Coulter, Inc. / Danaher
- Becton, Dickinson and Company (BD)
- bioMérieux
- Bio-Rad Laboratories, Inc.
- Cepheid / Danaher
- Danaher Corporation
- Dexcom
- Exact Sciences
- Hologic, Inc.
- Illumina
- Ortho Clinical Diagnostics (QuidelOrtho)
- QIAGEN N.V.
- Quidel Corporation (QuidelOrtho)
- PerkinElmer
- Roche Diagnostics
- Siemens Healthineers (Siemens)
- Sysmex Corporation
- Thermo Fisher Scientific Inc.
Table of Contents
Chapter 1: Executive Summary
- U.S. IVD Market
- Table 1-1: U.S. IVD Market by Segment (Clinical Chemistry, Microbiology - ID/AST, Molecular, Molecular Infectious Disease Molecular - non, Infectious Disease, POC Diabetes, POC - Other, Immunoassay, Immunoassay Infectious Disease, Immunoassay non-Infectious, Coagulation, Histology, Hematology, Blood Typing, and Others), 2022-2027 (in millions $)
- Figure 1-1: U.S. IVD Market Segments (Clinical Chemistry, Microbiology - ID/AST, Molecular, Molecular Infectious Disease Molecular - non, Infectious Disease, POC Diabetes, POC - Other, Immunoassay, Immunoassay Infectious Disease, Immunoassay non-Infectious, Coagulation, Histology, Hematology, Blood Grouping, and Others), by % of the total U.S. IVD Market, 2022
- Top 12 U.S. IVD Market Participants and Rankings
- Table 1-2: U.S. IVD Market Rankings, by Estimated 2022 US Revenue - Top 12 Companies (Abbott Diagnostics, Roche Diagnostics, Danaher Corporation, Siemens Healthcare Diagnostics, Thermo Fisher Scientific, Becton, Dickinson & Co. (BD), Hologic, Illumina, Dexcom, bioMérieux, Exact Sciences, and Ortho Clinical)
- 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
- Disease Prevalence and Incidence
- Table 2-1: U.S. New Cancer Cases 2022 Estimates, by Type (Female Breast, Prostate, Lung and Bronchus, Colon and Rectum, Corpus and Uterus, Melanomas of the Skin, Urinary Bladder, Non-Hodgkin Lymphoma, Kidney and Renal Pelvis, Thyroid, and Pancreas)
- Table 2-2 U.S. Estimated Cancer Deaths, by Cancer Type (Lung and Bronchus, Female Breast, Prostate, Colon and Rectum, Pancreas, Ovary, Liver and Intrahepatic Bile Duct, Leukemias, Non-Hodgkin Lymphoma, and Corpus and Uterus), 2022
- Table 2-3: Reported Cases of Selected Notifiable Diseases (Arboviral Diseases [incl. West Nile], Babesiosis, Brucellosis, Chlamydia, Cholera, Coccidiodomycosis, Cryptosporidiosis, Dengue, Ehrlichiosis/Anaplasmosis, Giardiasis, Gonorrhea, Hepatitis A, Hepatitis B, Hepatitis C, HIV/AIDS, Legionellosis, Listeriosis, Lyme Disease, Malaria, Meningococcal Disease, Pertussis, Q Fever, Salmonellosis, Shiga toxin-producing E Coli, Shigellosis, Spotted Fever Rickettsiosis, Syphilis, Tuberculosis, Vancomycin-intermediate Staphylococcus aureus, Vibriosis), U.S., 2016-2019, by Case Count
- U.S. Clinical Lab Expenditure
- Table 2-4: U.S. Clinical Lab Market by Channel (Hospital Labs/Acute Care Labs, Independent Labs, and Physician Office Labs/Outpatient Labs), 2021-2026 (% 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 2-5: Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2025
- Impact of CARES Act on PAMA
- Precision Medicine and NGS
- Laboratory-Developed Tests (LDTs)
- Changes Resulting from COVID-19 Pandemic
- COVID-19 Impact
- U.S. Healthcare Infrastructure and Testing Channels
- Hospitals
- Independent Labs
- Physician Office Laboratories
- At-Home Testing
- Home Collection Trend
- Retail Clinics
- Conclusions
Chapter 3: U.S. IVD Market Analysis
- Clinical Chemistry
- Table 3-1: U.S. Clinical Chemistry Market (General Chemistry, Blood Gases, and Urinalysis) 2022-2027 (in millions $) est
- Figure 3-1: U.S. Clinical Chemistry Market, 2022-2027 ($ 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, and Rapid Micro) 2022-2027 ($ millions)
- Figure 3-2: U.S. ID/AST Microbiology Market (Auto ID/AST, Manual ID/AST, Blood Culture, Chromogenic Media, Rapid, Micro) 2022-2027 ($ millions)
- Molecular Infectious Disease
- Table 3-3: U.S. Molecular Infectious Disease, Market Distribution Estimates by Segment (HAI/Sepsis, HIV, Hepatitis, GC/Chlamydia, Respiratory, Mycobacteria/TB, Other Molecular including Parasitology, Mycology, Malaria, Chagas, Dengue, etc.), 2022-2027 (%)
- Figure 3-3: U.S. Molecular Microbiology/Virology Market Distribution Estimates by Segment, (HAI, HIV, Hepatitis, GC/Chlamydia, Respiratory, Mycobacteria/TB, Other Microbiology), 2022 (%)
- 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), 2022 and 2027 ($ millions)
- Figure 3-4: U.S. POC Diabetes Market, 2022-2027 (in millions $)
- Figure 3-5: U.S. POC Market without Diabetes, 2022-2027 (in millions $)
- Immunoassays
- Non-Infectious Disease Immunoassay
- Table 3-5: U.S. Immunoassays Market - Non Infectious (Cardiac Markers, Tumor Markers, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Vitamin D, HbA1c, others) 2022-2027 ($ millions)
- Figure 3-6: U.S. Immunoassay-Non-infectious (Cardiac Markers, Tumor Markers, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Vitamin D, HbA1c, others), 2022-2027 (in millions) $)
- Infectious Disease Immunoassay
- Table 3-6: U.S. Immunoassays Market - Infectious (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAIs/Sepsis, Others), 2022-2027 (in millions $)
- Figure 3-7: U.S. Immunoassay Infectious Disease (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAI/Sepsis, Others), 2022-2027 (in millions $)
- Molecular Non-Infectious Disease Diagnostics
- Figure 3-8: U.S. Molecular Non-Infectious Disease Diagnostics Market, 2022-2027 ($ millions)
- Coagulation
- Table 3-7: U.S. Coagulation Diagnostics Market by Segment , PT/INR, Molecular-lab Thrombophilia SNPs, D-Dimer, 2022-2027 (in millions $)
- Figure 3-9: U.S. Coagulation Diagnostics Market, 2022-2027 ($ millions)
- Histology
- Table 3-8: U.S. Histology/Cytology IVD Market by Segment (Pap Tests, in situ Hybridization, Immunohistochemistry, Traditional non-Pap Stains, HPV Molecular) 2022-2027 ($ millions)
- Figure 3-10: U.S. Histology and Cytology Diagnostics Market, 2022-2027 ($ millions)
- Hematology
- Table 3-9: U.S. Lab-based Hematology Market by Analyte Segment (CBC, Hemoglobin, and Other), 2022-2027 (in millions $)
- Figure 3-11: U.S. Hematology Diagnostics Market, 2022-2027 ($ millions)
- Blood Testing and Typing
- Table 3-10: U.S. Blood Testing and Typing by Segment (ABO Grouping/Typing and Screening), 2022-2027 (in millions $)
- Figure 3-12: U.S. Blood Grouping and Typing Diagnostics Market, 2022-2027 ($ millions)
- Figure 3-13: U.S. Blood Screening Diagnostics Market (Immunoassay Blood Screening and NAT Blood Screening), 2022-2027 ($ millions)
- Total U.S. IVD Market
- Table 3-11: U.S. IVD Market including COVID-19, by Segment (Clinical Chemistry, Microbiology - ID/AST, Molecular, Molecular Infectious Disease Molecular - non, Infectious Disease, POC Diabetes, POC - Other, Immunoassay, Immunoassay Infectious Disease, Immunoassay non-Infectious, Coagulation, Histology, Hematology, Blood Typing, and Others), 2022-2027 (in millions $)
- Figure 3-14: U.S. IVD Market Segments (Clinical Chemistry, Microbiology - ID/AST, Molecular, Molecular Infectious Disease Molecular - non, Infectious Disease, POC Diabetes, POC - Other, Immunoassay, Immunoassay Infectious Disease, Immunoassay non-Infectious, Coagulation, Histology, Hematology, Blood Typing, and Others), 2022 (%)
Chapter 4: Top Tier U.S. IVD Market Players
- Table 4-1: 2021 U.S. IVD Competitor Revenues ($ millions)
- Abbott Diagnostics
- Recent Revenue History
- Table 4-2: Abbott Diagnostic Revenues 2017-2021 (millions $)
- Figure 4-1: 2021 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-3: Global Abbott Diagnostic Revenues, 2017-2021 (millions $)
- 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 4-4: Beckman Coulter Diagnostic Revenues 2017-2021 (millions $)
- Figure 4-2: 2021 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-5: Global Beckman Coulter Revenues in Selected Test Segments 2019-2021 (millions $) estimated
- Hematology
- Hematology IT
- Clinical Chemistry
- Immunoassays
- Microbiology
- Molecular Tissue Analysis
- Flow Cytometry
- Beckman Coulter Life Sciences
- COVID-19
- Becton, Dickinson and Company (BD)
- Recent Revenue History
- Table 4-6: BD Diagnostic Revenues 2017-2021 (millions $)
- Figure 4-3: 2021 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-7: Global BD Revenues in Flow Cytometry 2017- 2021 (millions $)
- Cytology
- Molecular Microbiology
- Traditional Microbiology - ID/AST
- Blood Culture
- Hospital Acquired Infections
- Blood Collection
- Mass Spectrometry
- Flow Cytometry
- COVID-19
- bioMérieux
- Recent Revenue History
- Table 4-8: bioMérieux IVD Revenues, 2017-2021 (millions $)
- Figure 4-4: 2021 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-9: bioMérieux Revenues in Selected Test Segments, 2017-2021 (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 2017-2021 (millions $)
- Figure 4-5: 2021 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-11: Global Bio-Rad Revenues in Selected Test Segments 2017-2021 (millions $)
- Blood Bank
- Diabetes
- Immunoassays
- COVID-19
- Cepheid/Danaher
- Recent Revenue History
- Table 4-12: Cepheid Revenues 2017-2021 (millions $)
- GeneXpert Xpress Line
- Tuberculosis
- Microbiology
- POC Testing
- Cancer
- COVID-19
- Danaher Corporation
- Recent Revenue History
- Table 4-13: Danaher Diagnostics Revenues 2017-2021 (millions $)
- Figure 4-6: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Dexcom
- Table 4-14: 2017-2021 Dexcom Revenue History ($ million)
- Figure 4-7: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Exact Sciences
- Table 4-15: Exact Sciences Revenue History, 2017-2021 (in $ millions)
- Figure 4-8: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions)estimated
- COVID-19
- Hologic, Inc.
- Recent Revenue History
- Table 4-16: Hologic Revenues 2017-2021 (millions $)
- Figure 4-9: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-17: Global Hologic Revenues in Selected Test Segments 2017-2021 (millions $)
- PANTHER Molecular System
- Panther Fusion
- Infectious Diseases
- Sexually Transmitted Infections
- Cytology
- COVID-19
- Illumina
- Table 4-18: Illumina Revenue History ($ million - not all revenues are for clinical products and services; estimated)
- Figure 4-10: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-19: Illumina Diagnostic Revenues by Segment ($ million) est
- COVID-19
- Ortho Clinical Diagnostics (QuidelOrtho)
- Recent Revenue History
- Table 4-20: Ortho Clinical Diagnostics Revenues 2017-2021 (millions $)
- Figure 4-11: 2021 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-21: Global Ortho Clinical Diagnostics Revenues in Selected Test Segments 2021 (millions $)
- Blood Bank
- Core Lab/Immunoassays
- COVID-19
- QIAGEN N.V.
- Recent Revenue History
- Table 4-22: QIAGEN N.V. IVD Revenues 2017-2021 (millions $)
- Figure 4-12: 2021 QIAGEN IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-23: Global QIAGEN IVD Revenues by Type, 2017-2021 (million)
- Tuberculosis
- Lyme Disease
- Molecular Expansion
- Precision Medicine/Companion Diagnostics
- Molecular Microbiology
- Prenatal Testing
- Next Generation Sequencing
- Digital PCR
- Liquid Biopsy
- COVID-19
- Quidel Corporation (QuidelOrtho)
- Table 4-24: Quidel Revenue History ($ million)
- Figure 4-13: 2021 QIAGEN IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-25: Quidel Diagnostic Revenues by Segment ($ million) est
- Immunoassays
- Rapid Immunoassays
- The Solana Business
- Molecular - Savanna
- COVID-19
- PerkinElmer
- Table 4-26: PerkinElmer Revenue History, 2017-2021 ($ million, estimated)
- Figure 4-14: 2021 PerkinElmer IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-27: PerkinElmer Diagnostic Revenues by Segment, 2017-2021 ($ million) est
- Diagnostics
- Sequencing /Genomics
- Liquid Biopsy
- Histology
- Prenatal Business
- Lab Services
- Mass Spectrometry
- COVID-19
- Roche Diagnostics
- Recent Revenue History
- Table 4-28: Roche IVD Diagnostics Revenues 2017-2021 (millions $)
- Figure 4-15: 2021 Roche IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-29: Global Roche IVD Diagnostics Revenues by Type, 2017-2021 (million)
- Hematology
- Immunoassays
- Core Molecular
- Digital PCR
- Diabetes Care
- cobas Liat System - POC
- HPV
- Blood Bank
- Cancer Companion Testing
- COVID-19
- Siemens Healthineers (Siemens)
- Recent Revenue History
- Table 4-30: Siemens Healthineers IVD Revenues 2017-2021 (millions $)
- Figure 4-16: 2021 Siemens Healthineers IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-31: Global Siemens Healthineers IVD Revenues by Type, 2021 (million)
- Core Lab
- Immunoassays
- Hematology
- Molecular
- Acute Care - POC
- COVID-19
- Sysmex Corporation
- Recent Revenue History
- Table 4-32: Sysmex IVD Revenues 2017-2021 (millions $)
- Figure 4-17: 2021 Sysmex IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-33: Global Sysmex IVD Revenues by Type, 2017-2021 (million)
- Hematology
- Coagulation
- Urinalysis
- Flow Cytometry
- Precision Medicine/Companion Test Diagnostics
- Thermo Fisher Scientific Inc.
- Recent Revenue History
- Table 4-34: Thermo Fischer IVD Revenues 2017-2021 (millions $)
- Figure 4-18: 2021 Thermo Fisher IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
- Table 4-35: Global Thermo Fisher IVD Revenues by Type, 2017-2021 (million)
- Immunoassays
- Microbiology
- Molecular Test Business
- Next Generation Sequencing
- qPCR
- Oncology Companion Diagnostics
- Mass Spectrometry
- COVID-19
Companies Mentioned
- Abbott Diagnostics
- Beckman Coulter, Inc./Danaher
- Becton, Dickinson and Company (BD)
- bioMérieux
- Bio-Rad Laboratories, Inc.
- Cepheid/Danaher
- Danaher Corporation
- Dexcom
- Exact Sciences
- Hologic, Inc.
- Illumina
- Ortho Clinical Diagnostics (QuidelOrtho)
- QIAGEN N.V.
- Quidel Corporation (QuidelOrtho)
- PerkinElmer
- Roche Diagnostics
- Siemens Healthineers (Siemens)
- Sysmex Corporation
- Thermo Fisher Scientific Inc.
