United States Market for In Vitro Diagnostic (IVD) Tests, 3rd Edition

Table of Contents

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 2-2 : Rate of New Cancers by Age Group , All Types US 2013-2017
  • • Table 2-3 U.S. Cancer Deaths 2013-2017 per 100,000 by Type
  • • Table 2-4: Reported Cases of Selected Notifiable Diseases , U.S. 2016-2018 by Case Count
• U.S. Clinical Lab Expenditure
  • • Table 2-5: 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 2-6: 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 (in 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 In 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 in Millions of $
  • • 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 (in millions $)
• • • Figure 3-5: U.S. POC Market without Diabetes 2020-2025 (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) 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) in 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 (in millions $)
  • • Figure 3-8: U.S. Immunoassay Infectious Disease (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAI/Sepsis, COVID-19, Others) 2020-2025 in millions $

MOLECULAR NON-INFECTIOUS DISEASE DIAGNOSTICS

• • • Figure 3-9: 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 (in millions $)
• • • Figure 3-10: U.S. Coagulation Diagnostics Market (2020-2025) ($ 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 in millions $
• • • Figure 3-11: U.S. Histology and Cytology Diagnostics Market (2020-2025) ($ millions)

HEMATOLOGY

• • • Table 3-9: U.S. Lab-based Hematology Market by Analyte 2020-2025 (in millions $)
• • • Figure 3-12: U.S. Hematology Diagnostics Market (2020-2025) ($ millions)

BLOOD TESTING AND TYPING

• • • Table 3-10: U.S. Blood Testing and Typing by Segment 2020-2025 ( in millions $)
• • • Figure 3-13: U.S. Blood Testing and Typing Diagnostics Market (2020-2025) ($ millions)

TOTAL U.S. IVD MARKET

• • • Table 3-11: U.S. IVD Market including COVID-19 by Segment 2020-2025 (in millions $)
• • • Figure 3-14: 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 $)
  • • Figure 4-1: 2020 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in 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 $)
  • • Figure 4-2: 2020 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in 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 $)
  • • Figure 4-3: 2020 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in 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: bioMerieux IVD Revenues 2016-2020 (millions $)
  • • Figure 4-4: 2020 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in millions) estimated
  • • Table 4-9: bioMerieux 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 $)
  • • Figure 4-5: 2020 IVD U.S. Revenues vs Non U.S. IVD Revenues ($in 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 $)
• • • Figure 4-6: 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in 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 $)
  • • Figure 4-7: 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in 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 $)
  • • Figure 4-8: 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in 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 $)
  • • Figure 4-9: 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in 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 $)
  • • Figure 4-10: 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in 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 $)
  • • Figure 4-11: 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in 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 $)
  • • Figure 4-12: 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in 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 $)
  • • Figure 4-13: 2020 IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues ($in 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