미국의 체외진단(IVD) 시장(제6판)

"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.

Table of Contents

Chapter 1: Executive Summary

• About Kalorama Information
• U.S. IVD Market
  • Table 1-1: U.S. IVD Market, by Segment, 2025-2030 ($ million) [Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Microbiology - ID/AST, Molecular (Molecular Infectious Disease (with NAT & mass spec), Molecular - non-Infectious Disease), POC Diabetes (all), Immunoassay (Immunoassay Infectious Disease, Immunoassay non-Infectious), POC - Other, Others]
  • Figure 1-1: IVD Market Segments, by Share of Total U.S. Market, 2025 (%) [Blood Grouping, Clinical Chemistry, Coagulation, Hematology, Histology, Microbiology - ID/AST, Microbiology - Molecular, Molecular - non-Infectious Disease, POC Diabetes, Immunoassay - Infectious, Immunoassay - Other, POC - Other, Others]
• Top 12 U.S. IVD Market Participants and Rankings
  • Table 1-2: Top 12 Companies - S. IVD Market Rankings, by Estimated US Revenue, 2025
• 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
    • Figure 2-1: U.S. Projections of Older Adult Population, 2016-2060
  • Disease Prevalence and Incidence
    • Table 2-1: U.S. Cancer Cases, 2025 Estimates
    • Table 2-2: Reported Cases of Selected Notifiable Diseases in the U.S., 2022
  • U.S. Clinical Lab Expenditure
    • Table 2-3: U.S. Clinical Lab Market, by Channel by Share of Market, 2024 (%)
  • Preventive Health Care
  • Product Innovation from Value-Based Pricing
• Clinical Testing under Medicare - Reimbursement Cuts and Market-Based Pricing
  • PAMA
    • Table 2-4: Implemented and Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2027
  • Impact of CARES Act on PAMA
  • Saving Access to Laboratory Service Act (SALSA)
  • RESULTS Act
  • Advanced Laboratory Tests (ADLT)
    • Table 2-5: List of Approved ADLTs, March 2025
• Personalized Medicine
  • Companion Diagnostics
    • Table 2-6: FDA Approved Companion Cancer Diagnostics, 2025
• AI in Clinical Practice
  • Table 2-7: Selected AI Market Cleared Tests
  • Regulatory Pathway
• AI in Liquid Biopsy
  • Role of AI in Liquid Biopsy Interpretation
  • Industry Leaders and Initiatives
  • New Liquid Biopsy / AI Products in Development or Recently Launched
    • Table 2-8: Selected AI/Liquid Biopsy Initiatives
• Effect of Tariffs on U.S. IVD Market
  • Table 2-9: Selected Company Reported 2025 Impact
• Telehealth
• Telehealth eMed to Implement Home Test to Treat Program
• Notable Acquisitions
  • Table 2-10: Notable Selected Second Half 2025 US Company Acquisitions
• 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 2-11: Worldwide Home Collection Test Kit Market*, by Category, 2025 (% 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 2-12: Selected Molecular Tests EUAs for Home Collection SARS-CoV-2 Tests
  • Retail Clinics
• Conclusions

Chapter 3: U.S. IVD Market Analysis

• Clinical Chemistry
  • Table 3-1: U.S. Clinical Chemistry Market, 2025-2030 ($ million) [Blood Gases, General Chemistry, Urinalysis]
  • Figure 3-1: U.S. Clinical Chemistry Market, 2025 and 2030 ($ million)
• Microbiology and Virology - ID/AST and Molecular
  • Table 3-2: U.S. ID/AST Microbiology Market, 2025-2030 ($ million) [Auto ID/AST Systems, Blood Culture, Chromogenic Media, Manual ID/AST Systems, Rapid Micro]
  • Figure 3-2: U.S. ID/AST Microbiology Market, 2025 and 2030 ($ million)
• Molecular Infectious Disease
  • Table 3-3: U.S. Molecular Infectious Disease, Market Distribution Estimates, by Segment, 2025-2030 (%) [GC/Chlamydia, HAI (c. diff, sepsis, MRSA, VRE, others), Hepatitis, HIV, Mycobacteria/TB, Other Microbiology, Respiratory (including COVID-19)]
  • Figure 3-3: U.S. Molecular Microbiology/Virology Market Distribution Estimates, by Segment, 2025 (%) [GC/Chlamydia, HAI (c. diff, sepsis, MRSA, VRE, others), Hepatitis, HIV, Mycobacteria/TB, Other Microbiology, Respiratory (including COVID-19)]
  • Leading Trends in Molecular Infectious Disease Testing
  • Recent Market Developments
• Point-of-Care Testing
  • Recent Developments
    • Table 3-4: U.S. Point-of-Care (POC) Diagnostics Markets, 2025 and 2030 ($ million) [Blood & Electrolytes, Cancer Tumor Marker, Cardiac Markers, Coagulation, Drugs of Abuse, FOB, Glucose incl. HbA1c, CGM, Infectious Disease, Lipid, Pregnancy & Fertility, Urine, Miscellaneous]
    • Figure 3-4: U.S. Point-of-Care (POC) Diabetes Market, 2025 and 2030 ($ million)
    • Figure 3-5: U.S. Point-of-Care (POC) Market without Diabetes, 2025 and 2030 ($ million)
• Immunoassays
  • Non-Infectious Disease Immunoassay
    • Table 3-5: S. Immunoassays Market - non-Infectious Disease, 2025-2030 ($ million) [Allergy, Anemia, Autoimmune, Cardiac Markers, Fertility, HbA1c, Proteins, Therapeutic Drugs, Thyroid, Tumor Markers, Vitamin D, Others]]
    • Figure 3-6: S. Immunoassays Market - non-Infectious Disease, 2025 and 2030 ($ million)
  • Infectious Disease Immunoassay
    • Table 3-6: U.S. Immunoassays Market - Infectious Disease, 2025-2030 ($ million) [HAIs/Sepsis, Hepatitis, HIV, Respiratory (including COVID-19), STDs, ToRCH, Others]
    • Figure 3-7: U.S. Immunoassays Market - Infectious Disease, 2025 and 2030 ($ million)
  • Recent Developments in STD Testing
• Molecular Non-Infectious Disease Diagnostics
  • Figure 3-8: U.S. Molecular - non-Infectious Disease Revenues, 2025 and 2030 ($ million)
• Coagulation
  • Table 3-7: U.S. Coagulation Diagnostics Market, by Segment, 2025-2030 ($ million) [Molecular-lab Thrombophilia SNPs, PT/INR, D-Dimer]
  • Figure 3-9: U.S. Coagulation Diagnostics Market, 2025 and 2030 ($ million)
• Histology
  • Table 3-8: U.S. Histology/Cytology IVD Market, by Segment, 2025-2030 ($ million) [HPV Molecular, Immunohistochemistry, in situ Hybridization, Pap Tests, Traditional non-Pap Stains]
  • Figure 3-10: U.S. Histology and Cytology Diagnostics Market, 2025 and 2030 ($ million)
• Hematology
  • Table 3-9: U.S. Lab-based Hematology Market, by Analyte, 2025-2030 ($ million) [CBC, Hemoglobin, Other]
  • Figure 3-11: U.S. Hematology Diagnostics Market, 2025 and 2030 ($ million)
• Blood Screening, Grouping and Typing
  • Table 3-10: U.S. Blood Screening and Grouping/Typing, by Segment, 2025-2030 ($ million) [ABO Grouping/Typing, Screening]
  • Figure 3-12: U.S. Blood Grouping and Typing Diagnostics Market, 2025 and 2030 ($ million)
  • Figure 3-13: U.S. Blood Screening Diagnostics Market, 2025 and 2030 ($ million) [Immunoassay Blood Screening, Molecular (NAT) Blood Screening]
• Total U.S. IVD Market
  • Table 3-11: U.S. IVD Market including COVID-19, by Segment, 2025-2030 ($ million) [Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Microbiology - ID/AST, Molecular (Molecular Infectious Disease (with NAT & mass spec), Molecular - non-Infectious Disease), POC Diabetes (all), Immunoassay (Immunoassay Infectious Disease, Immunoassay non-Infectious), POC - Other, Others]
  • Figure 3-14: IVD Market Segments, by Share of Total U.S. Market, 2025 (%) [Blood Grouping, Clinical Chemistry, Coagulation, Hematology, Histology, Microbiology - ID/AST, Microbiology - Molecular, Molecular - non-Infectious Disease, POC Diabetes, Immunoassay - Infectious, Immunoassay - Other, POC - Other, Others]
  • Table 3-12: Top 12 U.S. IVD Competitor Revenues, 2025 ($ million) Estimated
• Abbott Laboratories
• Becton Dickinson and Co
• bioMerieux
• Danaher Corporation
• Dexcom, Inc
• Exact Sciences
• Hologic
• Natera
• QuidelOrtho
• Roche Diagnostics
• Siemens Healthineers
• Thermo Fisher Scientific