United States Market for In Vitro Diagnostic (IVD) Tests

$4,000 – $8,000

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SKU: 21-026 Category: Tags: , , , , , , , , , , , , , , , , Pages: 180

Published on: June 7, 2021

Description

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 Kalorama 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 from Kalorama Information, 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.

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
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