美国体外诊断 (IVD) 市场（第六版）

"美国体外诊断 (IVD) 市场（第六版）" 对全球规模最大、最具影响力的体外诊断市场进行了全面分析。本报告是企业、製造商、高阶主管、行销人员和其他关键利害关係人获取美国体外诊断产业实用见解的重要资源。美国体外诊断市场是全球诊断创新孵化器，并制定了全球医疗技术标准。

我们提供以美元计价的可靠市场估算和预测，涵盖 2025 年至 2030 年期间，并依主要检测类别、技术和关键分析参数进行分类。所有数据均基于製造商收入，确保其准确性和对策略规划的相关性。我们的分析反映了当前的技术、新兴创新和护理标准的预期变化，同时也探讨了基于价值的定价、报销趋势、监管发展和医疗保健利用模式等关键因素。

主要功能包括：

• 市场区隔与预测：临床化学、微生物学和病毒学（包括分子诊断）、即时检测、免疫分析、凝血、组织学、血液学、血液筛检等领域的详细收入预测。
• 竞争格局：美国体外诊断 (IVD) 市场主要参与者的排名和简介，包括雅培、罗氏、西门子医疗、丹纳赫和其他行业领导者。
• 监管和政策分析：探讨 "保护美国医疗补助计划法案" (PAMA)、 "美国实验室诊断和补充法案" (SALSA) 和 "新冠病毒援助、救济和经济安全法案" (CARES Act) 对报销的影响、FDA 关于实验室自建检测 (LDT) 的举措，以及人工智能驱动的诊断和活检的发展。
• 市场驱动因素与趋势：个人化医疗、伴随诊断、远距医疗整合、资费以及居家和零售检测管道的兴起。
• 创新管道：人工智慧诊断、数位连结以及新一代分子和免疫分析平台将塑造未来的成长。

本报告的研究方法结合了公开资料、公司揭露资讯、专家访谈和专有分析，以确保透明度和严谨性。儘管市场预测本身存在不确定性，但Calahorra Information采用最合理、最有效的方法，为策略决策提供可靠的预测。

目录

第一章：摘要整理

第二章：美国医疗保健系统概述

• 美国与体外诊断
• 美国患者群
• 医疗保险中的临床试验：报销减少与市场定价
• 个人化医疗
• 人工智慧在临床上的应用
• 人工智慧在液体切片中的应用
• 关税对美国体外诊断市场的影响
• 远距医疗
• 远距医疗公司eMed推出居家检测与治疗项目
• 重要收购
• 实验室检测 (LDT)
• 美国医疗保健基础设施和侦测管道
• 结论

第三章 美国体外诊断市场分析

• 临床化学
• 微生物学和病毒学 - 鑑定/药敏试验和分子检测
• 分子传染病
  • 分子传染病检测的最新趋势
  • 近期市场趋势
• 即时侦测
  • 近期趋势
• 免疫测定
  • 非传染病免疫测定
  • 传染病免疫测定
  • 性传染病检测的最新趋势
• 分子非传染病诊断
• 凝血
• 组织学
• 血液学
• 血液检测、分类与分型
• 美国体外诊断 (IVD) 市场总额
• 雅培实验室
• 贝克顿‧迪金森公司
• 生物梅里埃公司
• 丹纳赫公司
• 德康公司
• Exact Sciences公司
• Hologic公司
• Natera公司
• Quidel Ortho公司
• 罗氏诊断
• 西门子医疗
• 赛默飞世尔科技

"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