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

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 fifth edition in the series, 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.
Table of Contents
  • Chapter 1: Executive Summary
    • U.S. IVD Market
    • Top 12 U.S. IVD Market Participants and Rankings
    • Scope and Methodology
    • 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
      • 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)
      • Impact of CARES Act on PAMA
      • Saving Access to Laboratory Service Act (SALSA)
      • Advanced Laboratory Tests (ADLT)
    • Personalized Medicine
      • Companion Diagnostics
    • AI Use in U.S. Liquid Biopsy Segment
    • 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
      • 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: Competitor U.S. IVD Market Players
    • Abbott Diagnostics
      • Abbott Diagnostic Recent Revenue History
      • Core Lab
      • Hematology
      • Blood Banking
      • Infectious Diseases - Molecular
      • Diabetes
      • HIV Point of Care
      • i-STAT Business
    • Becton, Dickinson and Company (BD)
      • Recent Revenue History
      • Cytology
      • Molecular Microbiology
      • Traditional Microbiology - ID/AST
      • Blood Culture
      • Hospital Acquired Infections
      • Blood Collection
      • Mass Spectrometry
      • Flow Cytometry
    • bioMérieux
      • Traditional Microbiology
      • Immunoassays
      • BIOFIRE Diagnostics Business
    • Danaher Corporation
      • Recent Revenue History
      • Beckman Coulter
      • Cepheid
    • Dexcom
    • Exact Sciences
      • Recent Revenue History
    • Hologic, Inc.
      • Recent Revenue History
      • Panther Molecular System
      • Panther Fusion
      • Infectious Diseases
      • Sexually Transmitted Infections
      • Cytology
    • Illumina
    • Natera
      • Recent Revenue History
    • QuidelOrtho Corporation
      • Immunoassays
      • Rapid Immunoassays
      • The Solana Business
      • Molecular – Savanna
      • Blood Bank
    • Roche Diagnostics
      • Recent Revenue History
      • Immunoassays
      • Core Molecular
      • Digital PCR
      • Diabetes Care
      • cobas Liat System – POC
      • HPV
      • Blood Bank
      • Cancer Companion Testing
    • Siemens Healthineers (Siemens)
      • Recent Revenue History
      • Core Lab
      • Immunoassays
      • Hematology
      • Molecular
    • Thermo Fisher Scientific Inc.
      • Recent Revenue History
      • Immunoassays
      • Microbiology
      • Molecular Test Business
      • Next Generation Sequencing
      • qPCR
      • Oncology Companion Diagnostics
      • Mass Spectrometry