US In Vitro Diagnostics Market by Product & Service (Kits, Instruments), Technology (Immunoassay, Hematology, Glucose Monitoring), Specimen (Blood), Site of Testing, Application (Endocrinology, Cardiology, Infectious Diseases) - Forecast to 2031

The US In Vitro Diagnostics (IVD) market continues to demonstrate strong and sustained growth as healthcare providers, laboratories, and policymakers prioritize early and accurate disease detection across a broad spectrum of clinical conditions. According to a new industry report, the market is valued at an estimated USD 40.15 billion in 2026 and is projected to reach USD 57.18 billion by 2031, growing at a compound annual growth rate (CAGR) of 7.3% during the forecast period.

This expansion underscores the critical role of IVD technologies in supporting clinical decision-making, population health management, and cost-effective healthcare delivery across the United States.

Market Overview and Scope

The report titled “US In Vitro Diagnostics Market by Product & Service (Kits, Instruments), Technology (Immunoassay, Hematology, Glucose Monitoring), Specimen (Blood), Site of Testing, Application (Endocrinology, Cardiology, Infectious Diseases) – Forecast to 2031” offers a comprehensive assessment of the market landscape.

It includes 91 market data tables and 44 figures across 200 pages, delivering detailed insights into technology adoption, testing settings, and clinical applications shaping the US IVD ecosystem.

The market’s upward trajectory is driven by rising testing volumes linked to chronic diseases, infectious conditions, and routine preventive screening programs. As healthcare systems face increasing patient loads and an aging population, diagnostic testing has become a foundational element of timely intervention and improved outcomes.

What Is Driving Growth in the US IVD Market?

Why is the US IVD market expanding now? The answer lies in a convergence of clinical demand and technological innovation. Rapid advancements in molecular diagnostics, next-generation sequencing, automated laboratory systems, and point-of-care platforms are transforming diagnostic workflows, improving turnaround times, and enhancing operational efficiency.

At the same time, strong R&D investments, regulatory clearances for novel diagnostic platforms, and increased collaboration between industry and healthcare providers are accelerating product innovation. These developments are enabling laboratories and health systems to deliver higher-quality diagnostics while managing cost and efficiency pressures.

Blood-Based Specimens Dominate Diagnostic Testing

By specimen type, blood, serum, and plasma specimens accounted for the largest share of the US in vitro diagnostics market in 2025. Their dominance reflects the widespread use of blood-based testing across infectious disease diagnostics, chronic disease monitoring, oncology, and cardiovascular care.

What makes blood-based specimens so central? High clinical reliability, standardized collection procedures, and compatibility with a wide range of diagnostic technologies—including immunoassays and molecular platforms—continue to make them the preferred specimen choice across US healthcare settings.

Laboratory Testing Remains the Primary Site of Care

By site of testing, laboratory-based tests held the largest share of the US IVD market in 2025, outperforming point-of-care testing. Centralized and hospital-based laboratories benefit from high testing volumes, advanced automation, and the ability to run complex, high-throughput assays with consistent accuracy.

Continued investments in laboratory automation, digital workflow optimization, and quality standardization are reinforcing the importance of lab-based diagnostics, particularly for oncology, cardiology, infectious diseases, and chronic condition management.

Competitive Landscape and Industry Leadership

The US IVD market is characterized by strong competition among established global leaders and innovative technology providers. Key players operating in this market include Danaher Corporation (US), F. Hoffmann-La Roche Ltd. (Switzerland), Abbott (US), Siemens Healthineers AG (Germany), Thermo Fisher Scientific Inc. (US), Becton, Dickinson and Company (US), bioMérieux (France), Illumina, Inc. (US), QuidelOrtho Corporation (US), and Hologic, Inc. (US).

These companies continue to invest in platform expansion, automation, and next-generation diagnostic solutions to address evolving clinical needs and regulatory expectations.

Strategic Implications for Decision-Makers

For healthcare executives, laboratory leaders, and diagnostic manufacturers, the US IVD market represents a strategic growth opportunity anchored in clinical necessity and technological progress. As demand for early detection, precision diagnostics, and scalable testing infrastructure rises, organizations that invest in innovation, automation, and regulatory readiness will be best positioned to lead.

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