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