미국의 체외진단약 시장 규모, 점유율, 동향 분석(2025-2032년)

U.S. In Vitro Diagnostics Market Report to 2032

The U.S. in vitro diagnostics market was valued at $23.9 billion in 2025. It is expected to grow at a compound annual growth rate (CAGR) of 4.2%, reaching $31.8 billion by 2032.

This comprehensive report covers the U.S. market for in vitro diagnostics, including immunochemistry, urinalysis, molecular diagnostics, molecular blood donor screening, hematology, hemostasis, POC blood gas diagnostics and POC blood glucose monitoring.

The analysis includes unit sales, average selling prices (ASPs), market size, growth trends, market drivers and limiters, market forecasts through 2032, and historical data back to 2022. It also includes recent mergers and acquisitions, company profiles, product portfolios and leading competitors.

Growth is supported by rising chronic and infectious disease testing needs, technological innovation, laboratory automation and decentralized testing. However, pricing pressure, cost constraints and federal insurance program changes are expected to limit some areas of utilization.

Market Overview

The U.S. in vitro diagnostics market includes diagnostic tests, analyzers, reagents and assay kits used to detect, monitor and support treatment decisions across a wide range of clinical conditions. These products are used in core laboratories, hospitals, blood donor screening settings, point-of-care environments and near-patient testing locations.

The market covers several major diagnostic categories, including immunochemistry, urinalysis, molecular diagnostics, molecular blood donor screening, hematology, hemostasis, POC blood gas diagnostics and POC blood glucose monitoring. Each category supports different testing needs, from routine screening to specialized disease detection.

Automation remains a central trend in the post-COVID diagnostic environment. In the years immediately after the pandemic, major hospitals expanded core laboratory capacity through purchases and rental agreements for high-throughput integrated systems that combined chemistry and immunochemistry on one platform.

Decentralized testing is also reshaping the market. Point-of-care and near-patient systems allow testing to move closer to the patient, supporting faster clinical decisions and broader access. This is especially important in areas such as molecular diagnostics, blood gas testing, glucose monitoring and urgent infectious disease testing.

Market Drivers

The rising prevalence of chronic and infectious diseases is a key driver of the U.S. in vitro diagnostics market. Conditions such as diabetes, cardiovascular disease, cancer and autoimmune disorders require ongoing testing for diagnosis, monitoring and treatment planning. Persistent and emerging infectious diseases also continue to support demand for molecular and immunochemistry-based testing.

IVDs play a central role in routine care and specialized medicine. Testing helps clinicians detect disease earlier, monitor treatment response and guide clinical decisions. As patient volumes increase and chronic disease management becomes more testing-dependent, diagnostic products remain essential across hospitals, laboratories and point-of-care settings.

Technological innovation is also supporting market growth. Advances in molecular diagnostics, next-generation sequencing, PCR technologies, automation and point-of-care testing improve speed, accuracy and access. These innovations expand diagnostic use from centralized laboratories into near-patient and home testing environments. Established diagnostics companies continue to invest in R&D and product launches, sustaining momentum across multiple IVD segments.

Market Limiters

Legislative changes to Medicare and Medicaid are expected to limit market growth over the forecast period. The One Big Beautiful Bill Act places new restrictions on federal health insurance programs. Sizeable groups of non-permanent residents and certain individuals who do not meet specific work requirements are expected to become ineligible for Medicare and Medicaid coverage.

With more frequent eligibility checks, an estimated 10 million people are expected to lose health insurance coverage. A projected reduction in Medicare funding of up to $375 billion between 2026 and 2032 is expected to force health systems to tighten budgets. Lower-priority IVD tests may be compressed in utilization as hospitals and patients prioritize essential testing pathways.

Pricing pressure and cost constraints are also limiting factors. Competitive pricing and healthcare cost containment efforts place downward pressure on diagnostic prices, which can squeeze margins and limit reinvestment in innovation. State-of-the-art instruments, reagents and specialized tests can be expensive, limiting adoption in smaller laboratories or underserved regions where budgets are tighter.

Market Coverage and Data Scope

• Quantitative coverage: Market size, market shares, market forecasts, market growth rates, units sold and average selling prices.
• Qualitative coverage: Market drivers and limiters, market size and growth trends, recent mergers and acquisitions, company profiles, product portfolios and leading competitors.
• Time frame: Base year 2025, forecasts to 2032, and historical data back to 2022.
• Data types included: Unit sales, average selling prices, market size and growth trends, market drivers and limiters, market forecasts through 2032, historical data, recent mergers and acquisitions, company profiles and product portfolios.
• Method note: Market revenue is modeled using unit sales and average selling prices, with segmentation used to assess demand across immunochemistry, urinalysis, molecular diagnostics, molecular blood donor screening, hematology, hemostasis, POC blood gas diagnostics and POC blood glucose monitoring.

The report is designed to help readers evaluate how chronic disease testing, infectious disease demand, automation, point-of-care testing, reimbursement changes and pricing pressure are shaping the U.S. in vitro diagnostics market.

Markets Covered and Segmentation

Immunochemistry Market

• Setting: Core and POC.

Urinalysis Market

• Technology: Core lab and POC.

Molecular Diagnostics Market

• Market type: Molecular diagnostics instrument, molecular diagnostics assay kit and near-patient molecular diagnostic.

Molecular Blood Donor Screening Market

• Market type: Analyzer and assay kit.

Hematology Market

• Market type: Hematology analyzer and hematology reagent.

Hemostasis Market

• Market type: Hemostasis analyzer and hemostasis reagent.

POC Blood Gas Diagnostics Market

• Product type: Analyzer and reagent.

POC Blood Glucose Monitoring Market

• Product type: Analyzer and test strip.

Each segment is analyzed through relevant quantitative measures, including market size, market shares, market forecasts, market growth rates, units sold and average selling prices.

Competitive Analysis

Cepheid was the leading company in the U.S. IVD market in 2025. The company's GeneXpert(R) line of systems is widely used because it supports platform consolidation and enables a broad range of tests to be run on one machine. The platform provides high walk-away time, which is valuable for both laboratory efficiency and near-patient workflows.

The GeneXpert(R) portfolio includes models used in both point-of-care and near-patient settings. This flexibility supports Cepheid's leadership in a market where hospitals and healthcare providers are looking for faster results, simplified workflows and diagnostic platforms that can support multiple test categories.

bioMerieux was the second-largest company in the U.S. IVD market in 2025. The company has a significant molecular diagnostics portfolio, including the FilmArray near-patient analyzer and SpotFire POC analyzer. These systems support fast infectious disease testing and align with the broader shift toward decentralized molecular diagnostics.

• Abbott ranked third in 2025. Abbott has two different departments represented in this report: Abbott Diagnostics and Abbott Laboratories. In the core immunochemistry market, the company offers the Alinity ci-series and ARCHITECT platforms, supporting its position across high-volume laboratory testing.

Technology and Practice Trends

Laboratory automation continues to shape the U.S. IVD market. Hospitals and large laboratories are adopting integrated systems that combine chemistry and immunochemistry testing to improve throughput, reduce manual steps and support more consistent workflows.

Point-of-care testing is expanding as providers seek faster results and more convenient testing access. POC blood gas diagnostics, POC blood glucose monitoring, urinalysis and immunochemistry testing all benefit from care models that prioritize rapid decision-making closer to the patient.

Near-patient molecular diagnostics continues to gain importance. Platforms that deliver fast molecular results outside the traditional core lab support timely infectious disease detection and help reduce delays in treatment decisions.

Molecular diagnostics remains an innovation-heavy category. Advances in PCR, assay design and next-generation sequencing are expanding the clinical role of molecular testing across infectious disease, oncology and other specialized applications.

Blood donor screening remains an important safety-focused segment. Analyzer and assay kit demand is tied to the need for reliable screening of donated blood and the continued use of molecular methods to reduce transfusion-related risk.

Cost containment is influencing technology adoption. While advanced platforms offer clinical and workflow benefits, smaller laboratories and underserved regions may face barriers due to capital equipment costs, reagent pricing and budget pressure.

Geography

This edition covers the United States.

Why This Report

How large is the U.S. in vitro diagnostics market, and how is it expected to grow through 2032?

How are immunochemistry, urinalysis, molecular diagnostics, molecular blood donor screening, hematology, hemostasis, POC blood gas diagnostics and POC blood glucose monitoring performing in the U.S. market?

How are unit sales, average selling prices and market values changing over time?

How are chronic diseases and infectious diseases driving demand for diagnostic testing?

How are automation, integrated laboratory platforms and decentralized testing reshaping IVD workflows?

How are molecular diagnostics, PCR, NGS and point-of-care testing expanding clinical use cases?

How are Medicare and Medicaid changes, pricing pressure and cost constraints limiting market growth?

Which companies lead the U.S. IVD market, and how are Cepheid, bioMerieux and Abbott positioned?

The U.S. In Vitro Diagnostics Market Report from iData Research answers these questions with detailed market sizing, ASP trends, forecasts and competitive share insights. Use it to evaluate demand, benchmark leading competitors, assess technology adoption and plan for growth across the U.S. in vitro diagnostics market.

TABLE OF CONTENT

U.S. In Vitro Diagnostics Market Overview

Competitive Analysis

Market Trends

Market Developments

Market Segmentation

Key Analysis Updates

Key Report Updates

Version History

Research Methodology

• Step 1: Project Initiation & Team Selection
• Step 2: Prepare Data Systems And Perform Secondary Research
• Step 3: Preparation For Interviews & Questionnaire Design
• Step 4: Performing Primary Research
• Step 5: Research Analysis: Establishing Baseline Estimates
• Step 6: Market Forecast And Analysis
• Step 7: Identify Strategic Opportunities
• Step 8: Final Review And Market Release
• Step 9: Customer Feedback And Market Monitoring

Impact Of Global Tariffs

U.S. In Vitro Diagnostics Market Overview

• 3.1 Introduction
• 3.2 Market Overview & Trend Analysis
• 3.3 Drivers And Limiters
  • 3.3.1 Market Drivers
  • 3.3.2 Market Limiters
• 3.4 Competitive Market Share Analysis
• 3.5 Mergers And Acquisitions

Immunochemistry Market

• 4.1 Introduction
  • 4.1.1 Immunoassay
  • 4.1.2 Clinical Chemistry
• 4.2 Market Overview
• 4.3 Market Analysis And Forecast
  • 4.3.1 Core Immunochemistry Market
    • 4.3.1.1 Core Immunoassay Market
    • 4.3.1.1.1 Immunoassay Analyzer Market
    • 4.3.1.1.2 Immunoassay Reagent Market
    • 4.3.1.2 Clinical Chemistry Market
    • 4.3.1.2.1 Clinical Chemistry Analyzer Market
    • 4.3.1.2.2 Clinical Chemistry Reagent Market
    • 4.3.1.3 Integrated Immunochemistry Analyzer Market
  • 4.3.2 Poc Immunochemistry Market
    • 4.3.2.1 Poc Immunoassay Market
    • 4.3.2.1.1 Poc Immunoassay Analyzer Market
    • 4.3.2.1.2 Poc Immunoassay Reagent Market
    • 4.3.2.2 Poc Clinical Chemistry Market
    • 4.3.2.2.1 Poc Clinical Chemistry Analyzer Market
    • 4.3.2.2.2 Poc Clinical Chemistry Reagent Market
• 4.4 Drivers And Limiters
  • 4.4.1 Market Drivers
  • 4.4.2 Market Limiters
• 4.5 Competitive Market Share Analysis

Urinalysis Market

• 5.1 Introduction
• 5.2 Market Overview
• 5.3 Market Analysis And Forecast
  • 5.3.1 Core Lab Urinalysis Market
    • 5.3.1.1 Core Lab Automated Urinalysis Analyzer Market
    • 5.3.1.2 Core Lab Automated Urinalysis Analyzer Reagent Market
  • 5.3.2 Poc Urinalysis Market
    • 5.3.2.1 Poc Urinalysis Analyzer Market
    • 5.3.2.2 Poc Urinalysis Test Strip Market
• 5.4 Drivers And Limiters
  • 5.4.1 Market Drivers
  • 5.4.2 Market Limiters
• 5.5 Competitive Market Share Analysis

Molecular Diagnostics Market

• 6.1 Introduction
  • 6.1.1 Pcr
  • 6.1.2 Gel Electrophoresis
• 6.2 Market Overview
• 6.3 Market Analysis And Forecast
  • 6.3.1 Molecular Diagnostics Instrument Market
    • 6.3.1.1 Core Lab Molecular Diagnostics Analyzer Market
    • 6.3.1.2 Poc Molecular Diagnostics Analyzer Market
  • 6.3.2 Molecular Diagnostics Assay Kit Market
    • 6.3.2.1 Infectious Disease Molecular Diagnostics Assay Kit Market
    • 6.3.2.1.1 Blood Borne Virus Infection Disease Molecular Diagnostics Assay Kit Market
    • 6.3.2.1.2 Respiratory Infectious Disease Assay Molecular Diagnostics Market
    • 6.3.2.1.3 Women's Health Molecular Diagnostics Assay Kit Market
    • 6.3.2.1.4 Other Infectious Disease Molecular Diagnostics Assay Kit Market
    • 6.3.2.2 Pcr Molecular Diagnostics Assay Kit Market
    • 6.3.2.2.1 Lung Cancer Pcr Molecular Diagnostics Assay Kit Market
    • 6.3.2.2.2 Prostate Cancer Pcr Molecular Diagnostics Assay Kit Market
    • 6.3.2.2.3 Colorectal Cancer Pcr Molecular Diagnostics Assay Kit Market
    • 6.3.2.2.4 Myeloma Leukemia Molecular Diagnostics Assay Kit Market
    • 6.3.2.2.5 Thrombophilia Assay Molecular Diagnostics Kit Market
    • 6.3.2.3 Panel & Ngs Tests Molecular Diagnostic Assay Kit Market
    • 6.3.2.3.1 Oncology Cancer Panel & Ngs Tests Market
    • 6.3.2.3.2 Prostate Cancer Assay Market
    • 6.3.2.4 Near Patient Molecular Diagnostic Market
    • 6.3.2.4.1 Near Patient Molecular Diagnostic Analyzer Market
    • 6.3.2.4.2 Near Patient Molecular Diagnostic Reagent Market
• 6.4 Drivers And Limiters
  • 6.4.1 Market Drivers
  • 6.4.2 Market Limiters
• 6.5 Competitive Market Share Analysis

Molecular Blood Donor Screening Market

• 7.1 Introduction
  • 7.1.1 Human Immunodeficiency Virus (Hiv)
  • 7.1.2 West Nile Virus (Wnv)
  • 7.1.3 Hepatitis B (Hbv)
  • 7.1.4 Hepatitis C (Hcv)
• 7.2 Market Overview
• 7.3 Market Analysis And Forecast
  • 7.3.1 Molecular Blood Donor Screening Analyzer Market
  • 7.3.2 Molecular Blood Donor Screening Assay Kit Market
    • 7.3.2.1 Wnv Molecular Blood Donor Screening Reagent Market
    • 7.3.2.2 Hiv Molecular Blood Donor Screening Reagent Market
    • 7.3.2.3 Hbv Molecular Blood Donor Screening Reagent Market
    • 7.3.2.4 Hcv Molecular Blood Donor Screening Reagent Market
    • 7.3.2.5 Multiplex (Hiv, Hbv, Hcv) Molecular Blood Donor Screening Reagent Market
• 7.4 Drivers And Limiters
  • 7.4.1 Market Drivers
  • 7.4.2 Market Limiters
• 7.5 Competitive Market Share Analysis

Hematology Market

• 8.1 Introduction
• 8.2 Market Overview
• 8.3 Market Analysis And Forecast
  • 8.3.1 Hematology Analyzer Market
    • 8.3.1.1 High-End Hematology Analyzer Market
    • 8.3.1.2 Low-End Hematology Analyzer Market
  • 8.3.2 Hematology Reagent Market
• 8.4 Drivers And Limiters
  • 8.4.1 Market Drivers
  • 8.4.2 Market Limiters
• 8.5 Competitive Market Share Analysis

Hemostasis Market

• 9.1 Introduction
  • 9.1.1 Thrombosis
  • 9.1.2 Hemorrhage
  • 9.1.3 Hemophilia A And B
  • 9.1.4 Antiphospholipid Syndrome (Aps)
  • 9.1.5 Von Willebrand Disease (Vwd)
  • 9.1.6 Diagnosis And Monitoring
• 9.2 Market Overview
• 9.3 Market Analysis And Forecast
  • 9.3.1 Hemostasis Analyzer Market
  • 9.3.2 Hemostasis Reagent Market
• 9.4 Drivers And Limiters
  • 9.4.1 Market Drivers
  • 9.4.2 Market Limiters
• 9.5 Competitive Market Share Analysis

Poc Blood Gas Diagnostics Market

• 10.1 Introduction
• 10.2 Market Overview
• 10.3 Market Analysis And Forecast
  • 10.3.1 Poc Blood Gas Diagnostic Analyzer Market
    • 10.3.1.1 Handheld Poc Blood Gas Diagnostic Analyzer Market
    • 10.3.1.2 Decentralized Poc Blood Gas Diagnostic Analyzer Market
  • 10.3.2 Poc Blood Gas Diagnostic Reagent Market
    • 10.3.2.1 Single-Use Cartridge Poc Blood Gas Diagnostic Reagent Market
    • 10.3.2.2 Multi-Use Cartridge Poc Blood Gas Diagnostic Reagent Market
    • 10.3.2.3 Other Packaged Reagents And Electrode Poc Blood Gas Diagnostic Reagent Market
• 10.4 Drivers And Limiters
  • 10.4.1 Market Drivers
  • 10.4.2 Market Limiters
• 10.5 Competitive Market Share Analysis

Poc Blood Glucose Monitoring Market

• 11.1 Introduction
• 11.2 Market Overview
• 11.3 Market Analysis And Forecast
  • 11.3.1 Poc Blood Glucose Monitoring Analyzer Market
  • 11.3.2 Poc Blood Glucose Monitoring Test Strip Market
• 11.4 Drivers And Limiters
  • 11.4.1 Market Drivers
  • 11.4.2 Market Limiters
• 11.5 Competitive Market Share Analysis

Abbreviations