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In Vitro Diagnostics (IVD) in the United States: Comprehensive Market Overview 2024-2029

Best Price Guarantee Length Publisher Published Date SKU
from $5,000 210 Pages Kalorama Information November, 2024 KLI19343379
Best Price Guarantee
Price from $5,000
Length 210 Pages
Publisher Kalorama Information
Published Date November, 2024
SKU KLI19343379

In Vitro Diagnostics (IVD) in the United States: Comprehensive Market Overview 2024-2029


The U.S. IVD market is a cornerstone of global healthcare innovation—but it is also a market in transition In Vitro Diagnostics (IVD) in the United States: Comprehensive Market Overview 2024-2029, the fifth edition in Kalorama’s ongoing series, offers unparalleled access to insights on the trends and technologies that will define the industry's future.

This report is essential for:

Identifying market gaps and opportunities for product innovation.
  • Gaining a competitive edge with strategic insights into the U.S. diagnostic landscape.
  • Making informed decisions by understanding market dynamics and future potential.
  • Staying updated on how evolving regulations are shaping the IVD market.
The U.S. in vitro diagnostics (IVD) market remains the largest and most influential in the world This multi-billion-dollar industry serves as the incubator for cutting-edge medical technologies, driving innovation and setting the benchmark for diagnostic standards worldwide. Yet, this dynamic market faces a period of transformation, balancing challenges such as cost pressures, regulatory changes, and the lingering impacts of COVID-19—all while adapting to a rapidly aging population and increasing demand for precision diagnostics.

Kalorama Information's latest report, In Vitro Diagnostics (IVD) in the United States: Comprehensive Market Overview 2024-2029, delivers a comprehensive analysis of the trends, technologies, and players driving this critical sector. With data-backed insights, this report is your definitive guide to understanding the complexities of the U.S. IVD market.

What’s in the Report
  • Comprehensive Market Analysis: Gain detailed insights into key U.S. IVD segments, including:
  • 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
  • Stay Ahead of the Curve: Understand how demographic shifts, technological advancements, and public health challenges are reshaping the market.
  • Competitive Intelligence: Explore profiles of leading IVD companies, such as Roche Diagnostics, Abbott, Siemens Healthineers, and Thermo Fisher Scientific, and stay informed about their latest developments.
  • Data-Driven Insights: With market data spanning 2024–2029, this report equips readers with the knowledge to identify growth opportunities and make informed decisions.
    • Report Highlights
  • Extensive Market Coverage: Dive deep into U.S. IVD segments, from microbiology and hematology to histology and blood typing.
  • Top Company Profiles: Learn about the strategies and innovations of 20+ key players, including emerging trends and M&A activities.
  • Actionable Insights: Leverage the report's findings to assess the current standard of care, forecast future trends, and anticipate market penetration for new tests and technologies.


  • Executive Summary
    • U.S. IVD Market
      • Table U.S. IVD Market by Segment 2024-2029 ($ million) (Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay [Immunoassay Infectious Disease, Immunoassay non-Infectious], Microbiology - ID/AST, Molecular [Molecular Infectious Disease with NAT & mass spec, Molecular - non-Infectious Disease], POC - Other, POC Diabetes [all], Others)
      • Table U.S. IVD Market Segments by % of the Total U.S. IVD Market, 2024 (Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay [Immunoassay Infectious Disease, Immunoassay non-Infectious], Microbiology - ID/AST, Molecular [Molecular Infectious Disease with NAT & Mass Spec, Molecular - non-Infectious Disease], POC - Other, POC Diabetes [all], Others)
    • Top 12 U.S. IVD Market Participants and Rankings
      • Table U.S. IVD Market Rankings by Estimated 2024 US Revenue – Top 12 Companies (Abbott Diagnostics, Becton, Dickinson & Co. [BD], bioMérieux, Danaher Corporation [Beckman Coulter, Leica Biosystems, Radiometer, Cepheid], Dexcom, Exact Sciences, Illumina, Natera, QuidelOrtho, Roche Diagnostics, Siemens Healthcare Diagnostics, Thermo Fisher Scientific)
    • Scope and Methodology
    • Conclusions
  • Introduction to U.S. Health Care
    • The United States and In Vitro Diagnostics
    • U.S. Patient Population
      • Healthcare System Utilization
      • Aging
        • Table U.S. Projects of Older Adult Population, 2016-2060 (million)
      • Disease Prevalence and Incidence
        • Table U.S. Cancer Cases, Estimates 2024
        • Table Reported Cases of Selected Notifiable Diseases, U.S., 2022
      • U.S. Clinical Lab Expenditure
        • Table U.S. Clinical Lab Market, by Channel, 2023 (% 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 Implemented and Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2027
      • Impact of CARES Act on PAMA
      • Saving Access to Laboratory Service Act (SALSA)
      • Advanced Laboratory Tests (ADLT)
        • Table List of Approved ADLTs, March 2024
    • Personalized Medicine
      • Companion Diagnostics
        • Table FDA Approved Companion Cancer Diagnostics, 2024
    • AI Use in U.S. Liquid Biopsy Segment
      • Table Selected U.S. AI/Liquid Biopsy Initiatives
    • Telehealth
    • Laboratory-Developed Tests (LDTs)
      • FDA
    • U.S. Healthcare Infrastructure and Testing Channels
      • Hospitals
      • Independent Labs
      • Physician Office Laboratories
      • At-Home Testing
      • Home Collection Trend
        • Table Home Collection Test Kit Market, by Category, Worldwide, 2022 (% Estimated Share) (Cholesterol, Drug of Abuse, Fertility Testing, Genetic, Infectious Disease [COVID-19, STDs, HIV, etc.], Tumor DNA Markers, Other [Hormone, Allergies, HbA1c, Heavy Metals, etc.])
        • Table Selected Molecular Tests EUAs for Home Collection SARS-CoV-2 Tests, 2020-2024
      • Retail Clinics
    • Conclusions
  • U.S. IVD Market Analysis
    • Clinical Chemistry
      • Table U.S. Clinical Chemistry Market, by Segment, 2024-2029 ($ million) (Blood Gases, General Chemistry, Urinalysis)
      • Table U.S. Clinical Chemistry Market, 2024-2029 ($ million)
    • Microbiology and Virology – ID/AST and Molecular
      • Table US ID/AST Microbiology ID/AST Market, by Segment, 2024-2029 ($ million) (Auto ID/AST, Manual ID/AST, Blood Culture, Chromogenic Media, Rapid, Micro)
      • Table U.S. ID/AST Microbiology Market, 2024-2029 ($ million)
      • Molecular Infectious Disease
        • Table U.S. Molecular Infectious Disease, Market Distribution Estimates by Segment, 2024 (%) (HAI/Sepsis, HIV, Hepatitis, GC/Chlamydia, Respiratory, Mycobacteria/TB, Other Microbiology)
        • Table U.S. Molecular Microbiology/Virology Market Distribution Estimates, by Segment, 2024 (%) (HAI/Sepsis, HIV, Hepatitis, GC/Chlamydia, Respiratory, Mycobacteria/TB, Other Microbiology)
    • Point-of-Care Testing
      • Table U.S. Point-of-Care (POC) Diagnostics Markets by Segment, 2024-2029 ($ million) (Glucose, Blood & Electrolytes, Coagulation, Cardiac Markers, Drugs of Abuse, Pregnancy & Fertility, Fecal Occult Blood, Infectious Disease, Lipid, Cancer Tumor Markers, Urine, Miscellaneous)
      • Table U.S. POC Diabetes Market, 2024-2029 ($ million)
      • Table U.S. POC Market without Diabetes, 2024-2029 ($ million)
    • Immunoassays
      • Non-Infectious Disease Immunoassay
        • Table U.S. Immunoassays Market – Non Infectious, by Segment, 2024-2029 ($ million) (Cardiac Markers, Tumor Markers, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Vitamin D, HbA1c, Others)
        • Table U.S. Immunoassays Market – Non Infectious, 2024-2029 ($ million)
      • Infectious Disease Immunoassay
        • Table U.S. Immunoassays Market – Infectious, 2024-2029 ($ million) (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAIs/Sepsis, Others)
        • Table U.S. Immunoassay Infectious Disease, 2024-2029 ($ million)
    • Molecular Non-Infectious Disease Diagnostics
      • Table U.S. Molecular – Non-Infectious Disease Diagnostics Market, 2024-2029 ($ million)
    • Coagulation
      • Table U.S. Coagulation Diagnostics Market, by Segment, 2024-2029 ($ million) (PT/INR, Molecular-lab Thrombophilia SNPs, D-Dimer)
      • Table U.S. Coagulation Diagnostics Market, 2024-2029 ($ million)
    • Histology
      • Table U.S. Histology/Cytology IVD Market, by Segment, 2024-2029 ($ million) Pap Tests, in situ Hybridization, Immunohistochemistry, Traditional non-Pap Stains, HPV Molecular)
      • Table U.S. Histology and Cytology Diagnostics Market, 2024-2029 ($ million)
    • Hematology
      • Table U.S. Lab-based Hematology Market, by Analyte 2024-2029 ($ million)
      • Table U.S. Hematology Diagnostics Market, 2024-2029 ($ million)
    • Blood Testing and Typing
      • Table U.S. Blood Testing and Typing, by Segment, 2024-2029 ($ million) (ABO Grouping/Typing, Screening)
      • Table U.S. Blood Grouping and Typing Diagnostics Market, 2024-2029 ($ million)
      • Table U.S. Blood Screening Diagnostics Market, 2024-2029 ($ million)
    • Total U.S. IVD Market
      • Table U.S. IVD Market by Segment 2024-2029 ($ million) (Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay [Immunoassay Infectious Disease, Immunoassay non-Infectious], Microbiology - ID/AST, Molecular [Molecular Infectious Disease with NAT & mass spec, Molecular - non-Infectious Disease], POC - Other, POC Diabetes [all], Others)
      • Table U.S. IVD Market Segments by % of the Total U.S. IVD Market, 2024 (Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay [Immunoassay Infectious Disease, Immunoassay non-Infectious], Microbiology - ID/AST, Molecular [Molecular Infectious Disease with NAT & Mass Spec, Molecular - non-Infectious Disease], POC - Other, POC Diabetes [all], Others)
  • Competitor U.S. IVD Market Players
    • Table Top 12 U.S. IVD Competitor Revenues, 2024 ($ million) (Abbott Diagnostics, Becton, Dickinson & Co. [BD], bioMérieux, Danaher Corporation [Beckman Coulter, Leica Biosystems, Radiometer, Cepheid], Dexcom, Exact Sciences, Illumina, Natera, QuidelOrtho, Roche Diagnostics, Siemens Healthcare Diagnostics, Thermo Fisher Scientific)
    • Abbott Diagnostics
      • Abbott Diagnostic Recent Revenue History
        • Table Global Abbott Diagnostics (and Diabetes Management) Revenues, 2019-2023 ($ million)
        • Table Abbott Diagnostics - IVD U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
        • Table Global Abbott Diagnostics Revenues, 2019-2023 ($ million)
      • Core Lab
      • Hematology
      • Blood Banking
      • Infectious Diseases - Molecular
      • Diabetes
      • HIV Point of Care
      • i-STAT Business
    • Becton, Dickinson and Company (BD)
      • Recent Revenue History
        • Table Global BD Life Sciences Revenues, 2019-2023 ($ million)
        • Table BD - IVD U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
      • Cytology
      • Molecular Microbiology
      • Traditional Microbiology - ID/AST
      • Blood Culture
      • Hospital Acquired Infections
      • Blood Collection
      • Mass Spectrometry
      • Flow Cytometry
    • bioMérieux
      • Table Global bioMérieux IVD Revenues, 2019-2023 ($ million)
      • Table bioMérieux - IVD U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
      • Table Global bioMérieux Revenues in Selected Test Segments, 2019-2023 ($ million)
      • Traditional Microbiology
      • Blood Culture
      • Immunoassays
      • BIOFIRE Diagnostics Business
    • Danaher Corporation
      • Recent Revenue History
        • Table Global Danaher Diagnostics Revenues, 2019-2023 ($ million)
        • Table Danaher - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
      • Beckman Coulter
      • Cepheid
    • Dexcom
      • Table Global Dexcom Revenue History 2019-2023 ($ million)
      • Table Dexcom - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
    • Exact Sciences
      • Recent Revenue History
        • Table Global Exact Sciences Revenue History, 2019-2023 ($ million)
        • Table Exact Sciences - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
    • Hologic, Inc.
      • Recent Revenue History
        • Table Hologic Revenues, 2019-2023 ($ million)
        • Table Hologic - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
        • Table Global Hologic Revenues in Selected Test Segments, 2019-2023 ($ million) estimated
      • Panther Molecular System
      • Panther Fusion
      • Infectious Diseases
      • Sexually Transmitted Infections
      • Cytology
    • Illumina
      • Table Global Illumina Revenue History, 2019-2023 ($ million – not all revenues are for clinical products and services; estimated)
      • Table IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million) estimated
      • Table Global Illumina Diagnostic Revenues, by Segment, 2019-2023 ($ million) estimated
    • Natera
      • Recent Revenue History
        • Table Natera Revenue History, 2019-2023 ($ million)
        • Table Natera - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million) estimated
    • QuidelOrtho Corporation
      • Table Global QuidelOrtho Revenue History, 2019-2023 ($ million)
      • Table QuidelOrtho - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million) estimated
      • Table Global QuidelOrtho Diagnostic Revenues, by Segment, 2020-2023 ($ million) estimated
      • Immunoassays
      • Rapid Immunoassays
      • The Solana Business
      • Molecular – Savanna
      • Blood Bank
    • Roche Diagnostics
      • Recent Revenue History
        • Table Global Roche IVD Diagnostics Revenues, 2019-2023 ($ million)
        • Table Roche - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million) estimated
        • Table Global Roche IVD Diagnostics Revenues, by Type, 2019-2023 (million) estimated
      • Hematology
      • Immunoassays
      • Core Molecular
      • Digital PCR
      • Diabetes Care
      • cobas Liat System – POC
      • HPV
      • Blood Bank
      • Cancer Companion Testing
    • Siemens Healthineers (Siemens)
      • Recent Revenue History
        • Table Global Siemens Healthineers IVD Revenues, 2019-2023 ($ million)
        • Table Siemens Healthineers - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
        • Table Global Siemens Healthineers Diagnostic Revenues, by Segment, 2021-2023 ($ million) estimated
      • Core Lab
      • Immunoassays
      • Hematology
      • Molecular
    • Thermo Fisher Scientific Inc.
      • Recent Revenue History
        • Table Global Thermo Fisher IVD Revenues, 2019-2023 ($ million)
        • Table Thermo Fisher - IVD Diagnostic U.S. Revenues vs Non U.S. IVD Revenues, 2023 ($ million)
        • Table Global Thermo Fisher IVD Revenues, by Type, 2019-2023 (million) estimated
      • Immunoassays
      • Microbiology
      • Molecular Test Business
      • Next Generation Sequencing
      • qPCR
      • Oncology Companion Diagnostics
      • Mass Spectrometry

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