United States Market for In Vitro Diagnostic (IVD) Tests

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.

Table of Contents
  • Chapter 1: Executive Summary
    • U.S. IVD Market
    • Top Tier U.S. IVD Market Participants and Rankings
    • Conclusions
  • Chapter 2: Introduction to U.S. Health Care
    • The United States and In Vitro Diagnostics
    • U.S. Patient Population
      • Healthcare System Utilization
      • Aging
      • Disease Prevalence and Incidence
      • U.S. Clinical Lab Expenditure
    • Clinical Testing under Medicare – Reimbursement Cuts and Market-Based Pricing
      • Protecting Access to Medicare Act of 2014 (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
    • Microbiology and Virology – ID/AST and Molecular
      • Molecular Infectious Disease
    • Point-of-Care Testing
    • Immunoassays
      • Non-Infectious Disease Immunoassay
      • Infectious Disease Immunoassay
    • Molecular Non-Infectious Disease Diagnostics
    • Coagulation
    • Histology
    • Hematology
    • Blood Testing and Typing
    • Total U.S. IVD Market
  • Chapter 4: Top Tier U.S. IVD Market Players
    • Abbott Diagnostics
      • Recent Revenue History
      • 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
      • 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
      • 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
      • Traditional Microbiology
      • Blood Culture
      • Immunoassays
      • BIOFIRE Diagnostics Business
      • COVID-19
    • Bio-Rad Laboratories, Inc.
      • Recent Revenue History
      • Blood Bank
      • Diabetes
      • Immunoassays
      • COVID-19
    • Cepheid / Danaher
      • Recent Revenue History
      • GeneXpert Xpress Line
      • High Burden Expansion
      • India
      • Tuberculosis
      • Microbiology
      • POC Testing
      • Cancer
      • COVID-19
    • Danaher Corporation
      • Recent Revenue History
    • Hologic, Inc.
      • Recent Revenue History
      • PANTHER Molecular System
      • HIV Testing
      • Sexually Transmitted Infections
      • Cytology
      • COVID-19
    • Ortho Clinical Diagnostics (Ortho)
      • Recent Revenue History
      • Blood Bank
      • Core Lab / Immunoassays
      • COVID-19
    • QIAGEN N.V.
      • Recent Revenue History
      • 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
      • 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
      • Core Lab
      • Immunoassays
      • Hematology
      • Molecular
      • Coagulation
      • Acute Care – POC
      • COVID-19
    • Sysmex Corporation
      • Recent Revenue History
      • Hematology
      • Coagulation
      • Urinalysis
      • Immunoassays
      • Flow Cytometry
      • Precision Medicine / Companion Test Diagnostics
      • Oncology
      • COVID-19
    • Thermo Fisher Scientific Inc.
      • Recent Revenue History
      • Immunoassays
      • Microbiology
      • Next Generation Sequencing
      • qPCR
      • Mass Spectrometry
      • COVID-19
Attachments
  • 21-026 - United States IVD Market - June 2021.pdf