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In Vitro Diagnostics (IVD) in the United States, 6th Edition

Publisher Kalorama Information
Published Dec 01, 2025
Length 127 Pages
SKU # KLI20637886

Description

In Vitro Diagnostics (IVD) in the United States, 6th Edition provides a comprehensive analysis of the largest and most influential IVD market in the world. This report is an essential resource for companies, manufacturers, executives, marketers, and other key stakeholders seeking actionable insights into the U.S. IVD industry—a market that serves as a global incubator for diagnostic innovation and sets the standard for healthcare technologies worldwide.

Covering the period 2025–2030, the report delivers authoritative market size estimates and forecasts in U.S. dollars, segmented by major test categories, technologies, and leading analytes. All data are based on manufacturer revenues, ensuring accuracy and relevance for strategic planning. The analysis reflects current technologies, emerging innovations, and anticipated shifts in the standard of care, while addressing critical factors such as value-based pricing, reimbursement trends, regulatory developments, and healthcare utilization patterns.

Key features include:
  • Market Segmentation and Forecasts: Detailed revenue projections for clinical chemistry, microbiology and virology (including molecular diagnostics), point-of-care testing, immunoassays, coagulation, histology, hematology, blood screening, and more.
  • Competitive Landscape: Rankings and profiles of the top U.S. IVD market participants, including Abbott, Roche, Siemens Healthineers, Danaher, and other industry leaders.
  • Regulatory and Policy Analysis: Impact of PAMA, SALSA, and the CARES Act on reimbursement; FDA initiatives for laboratory-developed tests (LDTs); and evolving frameworks for AI-driven diagnostics and liquid biopsy.
  • Market Drivers and Trends: Personalized medicine, companion diagnostics, telehealth integration, tariffs, and the rise of at-home and retail testing channels.
  • Innovation Pipeline: AI-enabled diagnostics, digital connectivity, and next-generation molecular and immunoassay platforms shaping future growth.
The report’s methodology combines publicly available data, company disclosures, expert interviews, and proprietary analysis, ensuring transparency and rigor. While market estimates involve inherent uncertainty, Kalorama Information applies the most rational and validated approach to deliver reliable projections for strategic decision-making.

Please Note: Single user allows for up to 3 users for this report.

Table of Contents

127 Pages
    • About Kalorama Information
    • U.S. IVD Market
    • Top 12 U.S. IVD Market Participants and Rankings
    • Scope and Methodology
    • Conclusions
    • The United States and In Vitro Diagnostics
    • U.S. Patient Population
    • Clinical Testing under Medicare – Reimbursement Cuts and Market- Based Pricing
    • Personalized Medicine
    • AI in Clinical Practice
    • AI in Liquid Biopsy
    • Effect of Tariffs on U.S. IVD Market
    • Telehealth
    • Notable Acquisitions
    • Laboratory-Developed Tests (LDTs)
    • U.S. Healthcare Infrastructure and Testing Channels
    • Conclusions
    • Clinical Chemistry
    • Microbiology and Virology – ID/AST and Molecular
    • Point-of-Care Testing
    • Immunoassays
    • Molecular Non-Infectious Disease Diagnostics
    • Coagulation
    • Histology
    • Hematology
    • Blood Screening, Grouping and Typing
    • Total U.S. IVD Market

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