美國體外診斷 (IVD) 市場（第六版）

"美國體外診斷 (IVD) 市場（第六版）" 對全球規模最大、最具影響力的體外診斷市場進行了全面分析。本報告是企業、製造商、高階主管、行銷人員和其他關鍵利害關係人獲取美國體外診斷產業實用見解的重要資源。美國體外診斷市場是全球診斷創新孵化器，並制定了全球醫療技術標準。

我們提供以美元計價的可靠市場估算和預測，涵蓋 2025 年至 2030 年期間，並依主要檢測類別、技術和關鍵分析參數進行分類。所有數據均基於製造商收入，確保其準確性和對策略規劃的相關性。我們的分析反映了當前的技術、新興創新和護理標準的預期變化，同時也探討了基於價值的定價、報銷趨勢、監管發展和醫療保健利用模式等關鍵因素。

主要功能包括：

• 市場區隔與預測：臨床化學、微生物學和病毒學（包括分子診斷）、即時檢測、免疫分析、凝血、組織學、血液學、血液篩檢等領域的詳細收入預測。
• 競爭格局：美國體外診斷 (IVD) 市場主要參與者的排名和簡介，包括雅培、羅氏、西門子醫療、丹納赫和其他行業領導者。
• 監管和政策分析：探討 "保護美國醫療補助計劃法案" (PAMA)、 "美國實驗室診斷和補充法案" (SALSA) 和 "新冠病毒援助、救濟和經濟安全法案" (CARES Act) 對報銷的影響、FDA 關於實驗室自建檢測 (LDT) 的舉措，以及人工智能驅動的診斷和活檢的發展。
• 市場驅動因素與趨勢：個人化醫療、伴隨診斷、遠距醫療整合、資費以及居家和零售檢測管道的興起。
• 創新管道：人工智慧診斷、數位連結以及新一代分子和免疫分析平台將塑造未來的成長。

本報告的研究方法結合了公開資料、公司揭露資訊、專家訪談和專有分析，以確保透明度和嚴謹性。儘管市場預測本身存在不確定性，但Calahorra Information採用最合理、最有效的方法，為策略決策提供可靠的預測。

目錄

第一章：摘要整理

第二章：美國醫療保健系統概述

• 美國與體外診斷
• 美國患者群
• 醫療保險中的臨床試驗：報銷減少與市場定價
• 個人化醫療
• 人工智慧在臨床上的應用
• 人工智慧在液體切片中的應用
• 關稅對美國體外診斷市場的影響
• 遠距醫療
• 遠距醫療公司eMed推出居家檢測與治療項目
• 重要收購
• 實驗室檢測 (LDT)
• 美國醫療保健基礎設施和偵測管道
• 結論

第三章 美國體外診斷市場分析

• 臨床化學
• 微生物學和病毒學 - 鑑定/藥敏試驗和分子檢測
• 分子傳染病
  • 分子傳染病檢測的最新趨勢
  • 近期市場趨勢
• 即時偵測
  • 近期趨勢
• 免疫測定
  • 非傳染病免疫測定
  • 傳染病免疫測定
  • 性傳染病檢測的最新趨勢
• 分子非傳染病診斷
• 凝血
• 組織學
• 血液學
• 血液檢測、分類與分型
• 美國體外診斷 (IVD) 市場總額
• 雅培實驗室
• 貝克頓‧迪金森公司
• 生物梅里埃公司
• 丹納赫公司
• 德康公司
• Exact Sciences公司
• Hologic公司
• Natera公司
• Quidel Ortho公司
• 羅氏診斷
• 西門子醫療
• 賽默飛世爾科技

"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