United States Market for In Vitro Diagnostic (IVD) Tests, 4th Edition

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