체외 진단 검사 시장 : 제18판(2025-2030년)

Kalorama Information's "The Worldwide Market for In Vitro Diagnostic (IVD) Tests", now in its 18th edition, is the essential resource for anyone interested in or involved in the IVD industry. This comprehensive report provides reliable estimates, real-world forecasts from 2025 to 2030, and essential insights needed to understand the IVD market in its entirety. With every significant test category covered in detail, it's like having ten market research reports in one comprehensive volume.

Key Features:

• Extensive Coverage: Detailed estimates and forecasts for every significant IVD test category, with chapters on Clinical Chemistry, Hematology, Histology, Molecular, Immunoassay, Infectious Disease, Coagulation, Blood Bank IVD, Point of Care (POC), and more.
• In-Depth Analysis: Based on vendor reporting, interviews, and global activities, this 1,700-page report offers a full assessment of the IVD market.
• Trusted Source: Published since 1999, it's the most trusted report by top companies in the IVD industry.
• Growth Projections: Market size, future projections, and compound annual growth rates for all test segments through 2030.
• Company Profiles: In-depth profiles of hundreds of companies, including the top 40, covering financial results, product launches, and strategic plans.
• Global Scope: Analysis includes market size for every significant country and major market segments globally.

Essential Insights for Business Planning:

• Market Size and Trends: Understand the size and breakdown of IVD market segments.
• Future Projections: Forecasts for where these markets will be in five years.
• Industry Changes: Track the evolution of the IVD market over time.
• Competitive Landscape: Identify key players, mergers, and groundbreaking product launches.
• Strategic Opportunities: Discover growth markets for potential entry or investment.

Country-Level Coverage:

This report reflects the global scope of the IVD market, covering:

• Regions: US, Europe, Asia Pacific, Latin America, Eastern Europe, Emerging Markets, Rest of World.
• Countries: Germany, UK, France, Spain, Italy, Russia, Netherlands, Turkey, Poland, Canada, China, Japan, Malaysia, Singapore, South Korea, Australia, Saudi Arabia, Brazil, Argentina, Colombia, Chile, Peru, South Africa, and more.

Table of Contents

Chapter 1: Executive Summary

• Overview
  • Figure 1-1: Worldwide IVD Market, 2020, 2025, and 2030 ($ billion)
  • IVD's Value to Healthcare Is Undersold
• IVD Market Drivers and Limiters
• Size and Growth of the Market
  • Table 1-1: Global In Vitro Diagnostic (IVD) Sales, by Product Segment, 2025-2030 ($ million) [Blood Bank Molecular; Blood Bank Screening; Drugs of Abuse; Blood Grouping/Typing; Circulating Tumor Cells; Clinical Chemistry; Coagulation; Histology/Cytology; Continuous Glucose; Diabetes HbA1c Immunoassays, Lab-Based; Hematology; HPV, Molecular; Immunoassays - Infectious Disease; Immunoassays - Other Immunoassays; Mass Spectrometry; Microbiology (ID/AST); Molecular Microbiology; Nucleic Acid Assays - Genetic/Inherited Disease; Nucleic Acid Assays - Oncology; POC, OTC Diabetes; POC, OTC Other; POC, Professional; Other]
  • IVD Market Results Notes
• Changes in Market Segments, 2024-2025
  • Figure 1-2: YOY Changes in IVD Market, by Segment, 2024-2025 (%)
  • IVD Market Assumptions
    • Table 1-2: IVD Market Assumptions 2025 Outlook
• Competitive Landscape in The IVD Market
  • Figure 1-3: Competitors in the IVD Market, Ranked by 2024 IVD Revenues ($ million)
  • IVD Competition Notes
• Trends to Watch
• Scope and Methodology
• About Kalorama Information

Chapter 2: Overall IVD Market

• Market Analysis of the Overall IVD Market
  • Table 2-1: Global In Vitro Diagnostic (IVD) Sales, by Product Segment, 2025-2030 ($ million) (%) [Blood Bank Molecular, Blood Bank Screening, Drugs of Abuse, Blood Grouping/Typing, Circulating Tumor Cells, Clinical Chemistry, Coagulation, Histology/Cytology, Continuous Glucose, COVID-19 Dx, Diabetes HbA1c Immunoassays, Lab-Based, Hematology, HPV, Molecular, Immunoassays - Infectious Disease, Immunoassays - Other Immunoassays, Mass Spectrometry, Microbiology (ID/AST), Molecular Microbiology, Nucleic Acid Assays - Genetic/Inherited, Nucleic Acid Assays - Oncology, POC, OTC Diabetes, POC, OTC Other, POC, Professional, Other]
  • Table 2-2: Additional Global In Vitro Diagnostic (IVD) Markets of Interest (Not in Totals), Sales by Product Segment, 2025-2030 ($ million) (%) [Clinical Sequencing, Drugs of Abuse, Criminal, Drugs of Abuse, Employment (non IVD), DTC Genetic Testing, Flow Cytometry, Prenatal Test Services]
  • Changes Between 17th and 18th Editions
  • Scope Considerations
• Top IVD Market Companies
  • Introduction
    • Table 2-3: Clinical Diagnostic Revenues of Selected Top 20 IVD Companies*, 2024 and estimated 2025 ($ million)
• Second Tier/Niche Players
  • Table 2-4: Revenues of Selected Top 20 Niche IVD Players, 2024 and estimated 2025 ($ million)*
  • Figure 2-1: Top Tier Market Distribution, 2024 and estimated 2025 (%)
  • IVD Company Revenues: International Growth
• IVD Companies Mergers & Acquisitions
  • Table 2-5: Selected IVD Mergers and Acquisitions, July 2023- July 2025
• Collaboration, Partnership, Alliance Agreements
• Historical IVD Market vs Today
  • Figure 2-2: Share of IVD Market, by Segment, 2000 and 2025 Compared (%) [Blood Banking (imm & typing), Clinical Chemistry, Coagulation, Hematology, Immunoassays, Microbiology (ID/AST), Molecular, POC - Other, Histology/Cytology, POC Diabetes, Others]
• PAMA: Delayed But Not Removed from Discussion
• Laboratory Diagnostics Services Market
  • Figure 2-3: Clinical Laboratory Test Service Market Forecasted Growth, by Segment, 2024-2029 (%) [Clinical Chemistry - Routine & Essential Testing, COVID-19 Testing, Cytology & Histology Testing, Genetic Testing, Immunology & Microbiology Testing, Toxicology Testing]
  • Table 2-6: Global Lab Market Segmentation, 2024 ($ billion) [Hospital and Acute Care Labs. Independent Labs, Physician Office Labs]
  • Quest
  • Labcorp
    • Table 2-7: Total Revenues for Leading U.S.-based Reference Labs, 2022-2024 ($ million) [Bio-Reference Lab/OPKO, Labcorp, Quest Diagnostics]
  • COVID-19 Market: Where We Are Now?
    • Figure 2-4: Combined Performance in COVID-19 and non-COVID-19 IVD Market Segments, 2020-2030 ($ million)

Chapter 3: IVD Market by Country and Region

• Chapter Scope
• Overview
• Expected World IVD Market Developments
  • Global Population and Aging
    • Figure 3-1: Global Fertility Rate vs. Population Size, 1950-2050 (billion)
    • Figure 3-2: Global Population Distribution, 2025
    • Table 3-1: Elderly Support Ratio in Various Countries, 2010 and 2050 [Australia, Brazil, Canada, China, China (Hong Kong SAR), France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, Singapore, South Africa, Spain, Turkey, United Kingdom, United States, World]
  • Workforce Reduction
  • WHO Essential IVD List
    • Table 3-2: WHO Model List of Essential In Vitro Diagnostics (EDL)
  • Increase in Chronic Diseases
    • Figure 3-3: Leading Causes of Death Globally, 2021* (number of deaths in millions)
• Emerging and Emerged Markets
  • Table 3-3: Developed/Developing Economies, UN Classification*, 2025
  • Figure 3-4: Developed vs. Developing IVD Market Shares, 2025 and Projected 2030 (%)
  • Table 3-4: Countries To Watch for IVD Opportunities, by Total Population and Percent Urban, 2025 [Australia, Brazil, China, France, Germany, Hungary, India, Mexico, Netherlands, Peru, Poland, Romania, Saudi Arabia, South Africa, South Korea, Sweden, Switzerland, Turkey, United Kingdom, United States]
• Size and Forecast for the Global IVD Market by Country/Region
  • Table 3-5: Global In Vitro Diagnostic Market, Major Country/Region Markets, 2025 and 2030 ($ million) [Australia, Brazil, Canada, China, Eastern Europe, Western Europe, India, Japan, Mexico, Peru, Russia, Saudi Arabia, South Africa, South Korea, Turkey, UAE, United States, Vietnam, RoW]
  • Table 3-6: Global In Vitro Diagnostic Market, Regional Markets, 2025 and 2030 ($ million) [Africa, Asia Pacific, Europe, Latin America, Middle East, North America]
  • Table 3-7: Global In Vitro Diagnostic Market, YOY Growth, by Segment, 2024-2025 (%) [(Blood Bank Molecular, Blood Bank Screening - Immunoassays, Blood Grouping/Typing, Clinical Chemistry, Coagulation (PT/INR, Molecular), D-dimer, Diabetes HbA1c, Lab, Drugs of Abuse, Hematology - Core Lab, Histology/Cytology, Immunoassays - Infectious Disease, Immunoassays - Other Immunos, Mass Spectrometry (Micro/Non-Micro)Microbiology (ID/AST), Microbiology (Molecular), Molecular Oncology, Molecular Genetic/Inherited, POC, OTC Glucose OTC, POC Continuous Glucose, POC, OTC Other, POC, Professional/Hospital)]
  • Table 3-8: Global In Vitro Diagnostic Market, Regional Markets, 2024-2025 YOY Change (%) (Africa, Asia Pacific, Europe, Latin America, Middle East, North America]
• The IVD Market in the United States
  • Table 3-9: United States IVD Market Share, by Segment, 2025 (%) [Blood Grouping, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay Infectious Disease, Immunoassay Other, Microbiology ID/AST, Molecular Infectious Disease, Nucleic Acid Assays, POC Diabetes, POC Other, Others]
  • PAMA and Reimbursement Changes
  • Impact of CARES Act on PAMA
    • Table 3-10: Proposed Clinical Diagnostic Laboratory Test (CDLT) Rates, 2020-2028
  • Saving Access to Laboratory Service Act (SALSA)
  • LDT Update
  • Bundled Insurance Payments for ESRD Patients
    • Table 3-11: Laboratory Tests Subject to ESRD Consolidated Billing
  • Advanced Laboratory Tests (ADLT)
    • Table 3-12: List of Approved ADLTs, March 2025
  • Precision Medicine and NGS
• IVD Market in Europe: Growing Markets
  • Figure 3-5: International Monetary Fund Inflation Map, Global 2024
  • Table 3-13: Western European IVD Market, by Country, 2025 ($ million, estimated) [Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK]
  • EU Regulation
    • Table 3-14: IVD Market Per Capita, Europe, 2025 Estimates (USD $) [Bulgaria, Croatia, Czech Republic, France, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Poland, Romania, Russia, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Ukraine, UK]
  • Precision Medicine in Europe
  • Brexit
• Japan
  • Table 3-15: Japan IVD Market, Share by Segment, 2025 (%) [Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay Infectious Disease, Immunoassay Other, Microbiology ID/AST, Molecular Infectious Disease, POC Diabetes, POC Other, Others]
• Eastern Europe: Growth Region
  • Table 3-16: Eastern European IVD Market, by Country, 2025 ($ million) [Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, Ukraine, Other]
  • Figure 3-6: Eastern Europe IVD Market, by Country, 2025 ($ million) [Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, Ukraine, Other]
• China: Current IVD Market
  • Table 3-17: China IVD Market, Share by Segment, 2025 (%) [Blood Bank Screening, Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay Infectious Disease, Immunoassay Other, Microbiology ID/AST, Molecular Infectious Disease, POC Diabetes, POC Other, Others]
  • Table 3-18: Total Midyear Population, by Broad Age Group: China, 2010-2050 (million persons)
  • Clinical Laboratory Market in China
  • IVD Distribution in China
  • China and Volume-Based Procurement (VBP)
• India: Population and Opportunity
  • Table 3-19: India IVD Market, Share by Segment, 2025 (%) [Clinical Chemistry, Hematology, Coagulation, Histology, Immunoassay, Microbiology, POC Glucose, POC Other, Others]
  • Clinical Laboratory Market in India
  • IVD Regulation
• Rest of Asia
  • Table 3-20: Asia Pacific Region IVD Market, by Country, 2025 ($ million) [Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Thailand, Vietnam]
• Brazil
  • Table 3-21: Brazil IVD Market, by Broad Segment, 2025 (%) [Clinical Chemistry, Hematology, Coagulation, Histology, Immunoassay, Microbiology, POC Glucose, POC Other, Others]
  • Disease Trends
  • Clinical Laboratory Market in Brazil
  • IVD Regulation
• Mexico
  • Table 3-22: Mexico IVD Market, by Broad Segment, 2025 (%) [Clinical Chemistry, Histology, Immunoassay, Microbiology, POC Diabetes, POC Other, Others]
• The Russian Federation
• Canada
• Emerging Markets
  • Saudi Arabia IVD Market
  • South Africa IVD Market
  • South Korea IVD Market
  • Turkey IVD Market
  • United Arab Emirates (UAE) IVD Market
  • Other Markets to Watch
• IVD Market Opportunity by Country
  • Table 3-23: IVD Market Opportunity, by Country (2025 Market Rank, Country CAGR 2025-2030) (%) [Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, U.S., Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam]

Chapter 4: IVD Industry Trends

• Possible Impact of Tariffs on the IVD Market
  • Table 4-1: Selected Company Reported 2025 Impact
• Next-Generation Sequencing and IVD
  • Table 4-2: Selected Clinical NGS Platforms on the Market
• Staffing Shortages
• China IVD Market, VBP and Other Trends
  • China Foreign-Owned Hospitals
  • China VBP
• Gene Editing Developments
  • Table 4-3: Selected Gene Editing / CRISPR Innovations
• Microbiome IVD-Related Developments
  • Table 4-4: Selected Microbiome Test Innovations
• AI and IVD
  • Table 4-5: Selected AI Market Cleared Tests
  • Table 4-6: Selected AI Product Initiatives in Development and Collaborations
  • 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 4-7: Selected AI/Liquid Biopsy Initiatives
• Future Trends
• Traumatic Brain Injury and IVD
• Personalized Medicine and Companion Diagnostics
  • Companion Diagnostics
    • Table 4-8: FDA Approved Companion Diagnostics, 2025
• Earlier Sepsis Detection
• Liquid Biopsy
  • Quality Assurance
  • Product News

Chapter 5: Point-of-Care (POC) Tests

• Chapter Scope
  • Edition-Specific Notes
• POC Industry Drivers
  • Patient-focused drivers
  • Medical/Healthcare-related drivers
  • Technology drivers
  • Economic drivers
  • Other drivers
• POC Industry Challenges
• Regulatory Challenges
• Professional POC
  • Table 5-1: Worldwide Professional POC Test Sales, by Category, 2025 -2030 ($ million) [Cardiac Markers, Cholesterol, Coagulation, Critical Care POC, Drugs of Abuse, Fecal Occult Blood, Fertility, Glucose, HbA1c POC, Hematology, Infectious Diseases, Urinalysis, Others]
  • Table 5-2: Selected Professional POC Test Competitors & Innovations
• OTC Self Testing
  • Table 5-3: Worldwide POC Self-Test Sales, by Category, 2025-2030($ million) [Cholesterol, Coagulation, Drugs of Abuse, Fecal Occult Blood, Glucose, Continuous, Glucose, Self, pylori, HIV, Other (TSH, Allergy, Autoimmune, etc.), Infectious Disease (inc. COVID-19), Pregnancy, Urinalysis]
  • OTC Self Testing, Without Glucose
• Pregnancy/Fertility Tests
  • Table 5-4: POC Pregnancy and Fertility Test Market Distribution, by End User, 2025 (%) [OTC, PRO]
  • Table 5-5: Pregnancy/Fertility POC Test Sales Distribution, by Global Region, 2025 (%) [Europe, Japan, United States, RoW]
• Colon Cancer Screening
  • Table 5-6: Selected POC Colon Cancer Tests
  • Table 5-7: Colon Cancer POC Test Sales Distribution, by Global Region, 2025 (%) [Europe, Japan, United States, RoW]
• Lipid Testing
  • Table 5-8: Lipid POC Test Sales Distribution, by Global Region, 2025 (%) [Europe, Japan, United States, RoW]
• Drugs of Abuse (DOA) Testing
  • Table 5-9: POC Drugs of Abuse Test Sales Distribution, by Setting, 2025 (%) [Criminal Justice, Critical Care - Traditional POC, Employment Screening]
  • Products
    • Table 5-10: Drugs of Abuse Tests on the Market
    • Table 5-11: Drugs of Abuse POC Test Sales Distribution, by Global Region, 2025 (%) [Europe, Japan, United States, RoW]
• POC Infectious Disease Testing
  • Molecular Point of Care
    • Table 5-12: Innovations in Molecular POC Infectious Disease Diagnostics
  • Rapid Products: Diverse Tech For Diverse Pathogens
    • Table 5-13: POC Infectious Disease Test Summary by Disease and Technology
  • POC HIV and Hepatitis Testing and Monitoring
  • POC Tuberculosis Tests
  • POC Tropical and Neglected Diseases Tests
  • Respiratory Diseases POC - Growth Means Competition
  • Sepsis and Nosocomial Disease
  • Sexually-Transmitted Infections (STI)
  • Sexually-Transmitted Infections POC: Binx, Visby, Now Shake Up Market
  • Lyme Disease
    • Table 5-14: Innovations in Molecular POC Infectious Disease Diagnostics
  • COVID-19
    • Table 5-15: Selected Antigen POC Home Immunoassay Tests for SARS-CoV-2
• POC Infectious Disease Testing: Market Size and Growth
  • POC Infectious Disease Testing by Disease
    • Table 5-16: Infectious Disease POC Test Demand, by Type, 2025 ($ million) [C. difficile, COVID-19, E. coli, H. pylori, Hepatitis, HIV, Home Test/OTC, Influenza, Malaria, Other Respiratory, STI, Others]
  • POC Infectious Disease Testing: Respiratory vs. Non-Respiratory
    • Figure 5-1: Respiratory POC Infectious Disease Testing vs. Non-Respiratory POC Market Breakout, 2025 (%)
  • POC Infectious Disease Testing by Geography
    • Table 5-17: Infectious Disease POC Test Sales Distribution, by Global Region, 2025 (%) [Europe, Japan, United States, RoW]
• Diabetes Testing - Blood Glucose Monitoring
  • Table 5-18: Glucose POC Test Sales Distribution, by Global Region, 2025 (%) [Europe, Japan, United States, RoW]
  • Figure 5-2: POC Glucose Testing Market Growth, by Category, 2025-2030 (%) [Glucose OTC, Glucose Professional, Continuous Glucose, HbA1c POC-Professional]
  • IT to Aid Diabetes Management
    • Table 5-19: Selected Apps and Glucose Management IT
  • Diabetes Market Analysis
    • Table 5-20: Global Diabetes Sales, by Test Category, 2025-2030 ($ million) [Glucose OTC, Continuous Glucose, HbA1c Lab, HbA1c POC]
  • POC Glucose Competitors
    • Table 5-21: Top Three POC Test Vendors by Glucose Test Revenues, 2025 ($ million, estimated)
  • Blood Glucose Self-Testing
    • Table 5-22: Selected Glucose Self-Test Meter Innovations
  • Noninvasive Testing Devices
    • Table 5-23: Selected Noninvasive Glucose Monitoring Devices
  • Continuous Glucose Monitoring
    • Table 5-24: Selected Continuous Blood Glucose System Developments
  • Blood Glucose Testing by Professionals
    • Table 5-25: Selected Innovations in Hospital-based Glucose Monitoring
  • Diabetes Testing - Glycated Hemoglobin
    • Table 5-26: Global HbA1c Test Sales Market and Distribution, by Setting, 2025-2030 ($ million) [HbA1c Lab, HbA1c POC]
    • Table 5-27: Selected POC HbA1c Devices
  • Genes and Other Markers of Diabetes
    • Table 5-28: Selected POC Diabetes Monitoring Tests
• The Major POC Test Players
  • Table 5-29: POC Test Revenues of Selected IVD Companies, 2025 ($ million, estimated)

Chapter 6: Chemistry & Core Lab

• Chapter Scope
  • Edition-Specific Notes
• Core Lab Overview and Trends
  • Table 6-1: Selected Analytes for the Core Lab
• Connectivity
• Overview of Chemistry Tests
  • Lab Automation
• Market Analysis
  • Table 6-2: Global Clinical Chemistry Sales, by Test Category, 2025-2030 ($ million) [Blood Gases, General Chemistries, Urinalysis]
  • Table 6-3: Global Clinical Chemistry Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
  • Table 6-4: Selected Major Clinical Chemistry Companies, by Sales, 2025 ($ million, estimated) [Abbott Laboratories, Beckman Coulter/Danaher, QuidelOrtho, Radiometer/Danaher, Roche Diagnostics, Siemens Healthineers, Sysmex, Werfen]
  • Table 6-5: Selected Clinical Chemistry Innovations
  • Rapid Response Systems
    • Table 6-6: Selected Major Whole Blood Chemistry Analyzers
  • Critical Care Analysis
    • Table 6-7: Blood Gas, Electrolyte, and Critical Care Instrument Market, by End User, 2025 and 2030 ($ million) [Lab-based, POC-based]
    • Table 6-8: Blood Gas, Electrolyte, and Critical Care Market Leaders including POC, 2025 (% distribution of total sales)
  • Urinalysis
    • Table 6-9: Urinalysis Market, by End User, 2025 and 2030 ($ million) [Lab-based, POC-based]
    • Table 6-10: Urinalysis Systems (including POC) Market Leaders, 2025 (% distribution of total sales) estimated
    • Table 6-11: Selected Urinalysis Innovations
• The Commercial Outlook for Chemistry Tests

Chapter 7: Immunoassays

• Chapter Scope
• Overview and Trends
  • Immunoassay Technology Continues to Evolve
    • Table 7-1: Selected Immunoassay Technologies
  • Mass Spectrometry
    • Table 7-2: Selected Innovation in Mass Spectrometry for Routine Analyses
  • Radioimmunoassays
• Market Analysis
  • Table 7-3: Global Lab-based Immunoassay (excluding infectious disease and blood screening) Sales, by Analyte Type, 2025-2030 ($ million) [Allergy, Anemia, Autoimmune, Cardiac Markers, Diabetes/HbA1c, Drug of Abuse, Fertility, Proteins, Therapeutic Drugs, Thyroid, Tumor Markers, Vitamin D, Others]
  • Table 7-4: Global Immunoassay (excluding infectious disease and blood screening) Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, Japan, North America, RoW]
  • Table 7-5: IVD Quality Control (immunoassay/molecular) Market, 2025 ($ million, estimated)
  • Table 7-6: Selected Immunoassay Quality Control Products
  • Table 7-7: Revenues of Leading Lab-based Immunoassay Vendors, 2024-2025 ($ million, estimated)
• Mature Assay Segment
  • Thyroid Function
  • Therapeutic Drug Monitoring
  • Vitamin D
    • Table 7-8: Selected Vitamin D Immunoassays
  • Anemia
  • Toxicology/DAU
  • Allergy
• Growth Immunoassays
  • Proteins
  • Tumor Markers
    • Table 7-9: Selected Tumor Marker Innovations
  • Cardiac Markers
    • Table 7-10: Regional Cardiac Marker Immunoassay Market Share, 2025 (%) [EU Countries, Japan, Latin America, Middle East, North America, Rest of Asia Pacific, Rest of Europe, RoW]
    • Table 7-11: Selected Cardiac Marker Innovations
  • Autoimmune
    • Table 7-12: Selected Autoimmune Test Innovations
  • Rheumatoid Arthritis
    • Table 7-13: Selected Arthritis Immunoassay Innovations
  • Gastrointestinal Disorders
    • Table 7-14: Selected Inflammatory Bowel Disease Test Innovations
  • Transplant Management
    • Table 7-15: Selected Immunoassays for Transplant Medicine
  • Women's Health
    • Table 7-16: Selected Women's Health Innovations
  • Alzheimer's Disease
    • Table 7-17: Selected Innovations for Alzheimer's Disease Immunoassays
  • Traumatic Brain Injury
  • Miscellaneous
    • Table 7-18: Selected Immunoassay Innovations
• Point-of-Care OTC and Professional Use Immunoassays
  • Table 7-19: Global POC Immunoassay Sales Distribution, by Region, 2025 (%) [Europe, Japan, United States, RoW]
  • Table 7-20: Global POC Immunoassay Test Sales, by Test Category, 2025-2030 ($ million) [OTC/Self Tests (Pregnancy/Ovulation, Drugs of Abuse, HIV, H. pylori, Infectious Disease/COVID-19, Other) and Professional POC (Cardiac Markers, Drugs of Abuse, HbA1c, Pregnancy, Infectious Disease/COVID-19, Other)]
  • Table 7-21: Selected Self-Test Immunoassay Innovations
  • Pregnancy Testing
  • Cardiovascular Diagnostics
  • Drugs of Abuse/Therapeutic Drug Monitoring
• Innovating POC
  • Table 7-22: Selected POC Test Innovations
  • Table 7-23: Selected POC Immunoassay Test Platforms
• The Commercial Outlook for Immunoassays

Chapter 8: Molecular Assays

• Chapter Scope
• Edition-Specific Notes
• Overview
  • Table 8-1: Common Next Generation Molecular Test Traits
• Sample Preparation and Quality Control
  • Table 8-2: Selected Molecular Test Sample Preparation and QC Innovations
• Molecular Evolution
  • Exosome Sequencing
    • Table 8-3: Selected Exosome Test Innovations
  • Liquid Biopsy
    • Table 8-4: Selected Liquid Biopsy Innovations
  • Metabolomic Profiling
  • Information Technology
    • Table 8-5: Selected IT Innovations in Molecular Diagnostics
  • Artificial Intelligence (AI)
  • Forensic Studies - An Emerging Opportunity
    • Table 8-6: Selected Innovations in Forensic DNA Testing
  • Test Platforms
    • Table 8-7: Key Molecular Technologies and Major Players
    • Table 8-8: Selected Molecular Test Platform Innovations
• Major Players
  • Table 8-9: Molecular Test Revenues of Selected IVD Vendors, 2022-2025 ($ million) estimated
• Market Analysis
  • Table 8-10: Global Genomic, HLA and Oncology Molecular Test Sales, by Type with NIPT, 2025-2030 ($ million) [Genetic/Inherited Disease Assays, Oncology Assays (incl. CDx), Prenatal Testing - NIPT, Transplant Testing (HLA)]
  • Oncology
    • Table 8-11: Global Molecular Cancer Test Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
    • Table 8-12: Selected Molecular Tumor Marker Test Innovations
  • Inherited/Genetic Diseases, Thrombophilia SNPs and Other Disorders
    • Table 8-13: Most Frequently Requested Genetic Tests
    • Table 8-14: Global Molecular Thrombophilia Assay Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
  • Alzheimer's Disease and Dementia
  • Cardiovascular Disease
    • Table 8-15: Selected Genomic Tests for Inherited Diseases
  • Depression and Psychiatric Disorders
  • Prenatal and Newborn Testing
    • Table 8-16: Global Prenatal Test Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
    • Table 8-17: Selected Prenatal Services Provided
    • Table 8-18: Selected Molecular Tests for Prenatal Analysis
  • Transplant Diagnostics
    • Table 8-19: Global Molecular HLA Testing Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
    • Figure 8-1: Global Transplant Rate, by Region, 2024
    • Table 8-20: Selected Innovations of Molecular Transplant Diagnostics
  • Women's Health
• The Commercial Outlook for Molecular Tests

Chapter 9: Hematology

• Chapter Scope
  • Edition-Specific Notes
• Overview of Hematology and Trends
  • Table 9-1: Hematology Analyzer Distribution of Unit Sales, by Menu Capability, 2025 estimated (%) [3-part diff analyzers, 5-part diff analyzers, Other analyzers]
  • Table 9-2: Lab-based Hematology Sales by Analyte Average Annual Distribution (%) [CBC, Hemoglobin, Other specialized]
  • Digital Image Analysis
    • Table 9-3: Selected Hematology Image Analysis Innovations
  • Digital Evolution
  • Quality Control Measurement Programs
    • Table 9-4: Selected Quality Control Hematology FDA Registrations, 2024
• Laboratory-based Hematology Testing
  • Table 9-5: Selected Hematology Innovations
  • Table 9-6: Global Laboratory-based Hematology Test and Instrument Market, 2025 and 2030 ($ million)
  • Regional Laboratory-based Hematology Test and Instrument Market
    • Table 9-7: Global Laboratory-based Hematology Test and Instrument Market, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
• Decentralized Hematology Testing
  • Hemoglobin/Hematocrit at the POC
    • Table 9-8: POC Hematology Distribution, by Specialty, 2025 (%) [Hematocrit/Hemoglobin vs. Other Routine Hematology (WBC, Erythrocyte, Platelet)]
    • Table 9-9: Selected POC Hemoglobin and Hematocrit Systems
    • Table 9-10: Selected POC Hematology Analyzer Systems
    • Table 9-11: Decentralized Hematology Test and Instrument Market, by Type, 2025 and 2030 ($ million) [Instruments, Lab-Style, Handheld Devices]
• Market Analysis: Leading Suppliers
  • Table 9-12: Top Hematology Company Revenues (Laboratory and POC), by Market Leaders, 2025 ($ million)
  • Figure 9-1: Hematology Revenue Estimates, 2025 ($ million)
  • Table 9-13: Global Hematology (Laboratory-based and POC) Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
• The Commercial Outlook for Hematology Tests

Chapter 10: Coagulation

• Chapter Scope
  • Edition-Specific Notes
• Overview and Trends of Coagulation and Immunohematology Tests
• Special Topics
  • COVID-19
  • Direct Oral Anticoagulants (DOACs)
    • Table 10-1: Select Major Anticoagulant Sales ($ billion)
  • D-dimer
    • Table 10-2: Global D-dimer Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
• Market Analysis
  • Table 10-3: Global Coagulation Sales, by Segment, 2025-2030 ($ million) [D-dimer, Molecular, Professional POC, Professional Self, PT/INR Labs]
  • Table 10-4: Global Coagulation Test and Instrument Market, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
• Lab-based Testing
  • Table 10-5: Selected Lab-based Coagulation Innovations
  • Genetic Markers of Hypercoagulopathies
    • Table 10-6: Related CMS Codes for Reimbursement National Limits, Molecular, 2025
    • Table 10-7: Global Molecular - Thrombophilia SNP Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
    • Table 10-8: Selected Molecular Coagulation Test Innovations
• Leading Suppliers: Laboratory Systems
  • Table 10-9: Top Coagulation Laboratory-based Company Market Share, 2025 (%)
• Decentralized Coagulation Testing - Professional Use
  • Decentralized Coagulation Testing - OTC
    • Table 10-10: Selected POC Coagulation Test Innovations
  • Platelet Testing
    • Table 10-11: Selected Platelet Activity Test Innovations
• Leading Suppliers: POC Systems
  • Table 10-12: Top Coagulation Company Revenues, POC, 2025 ($ million, estimated)
• The Commercial Market for Coagulation Tests
  • Table 10-13: Major Anticoagulants Uses and Tests

Chapter 11: Microbiology and Virology

• Chapter Scope
  • Edition-Specific Notes
• Microbial Antibiotic Resistance - Driving Clinical Tests
  • Fast Identification
    • Table 11-1: Selected Companies Developing Faster Identification, Some Also with Antimicrobial Susceptibility/Resistance Tests
• Traditional Microbiology
  • Microbiology Innovations
  • Liquid-Based ID/AST and Automation Innovations
  • Post-Blood Culture Microbial ID
  • PCR and Other NAAT-Based Tests for Infectious Diseases
    • Table 11-2: Selected Nucleic Acid Amplification Test and Other Molecular Companies in Microbiology
  • Microbiome-Related Microbiology Tests
  • Illumina
  • Bio-Rad
  • QIAGEN
  • Luminex (Diasorin)
  • inBiome BV
  • DNA Genotek
  • Abbott
  • Thermo Fisher Scientific
    • Table 11-3: Selected Microbiome-Based Tests
  • Next Generation Sequencing-Based Microbiology Approaches
    • Table 11-4: Selected Companies Applying DNA/RNA Sequencing to Microbiology
  • Syndromic/Multiplex Testing
  • Emerging, High-Consequence Infectious Disease Threats
    • Table 11-5: Selected Companies Marketing Products Addressing High-Consequence Infectious Disease Threats
  • Chagas
  • Dengue
  • Tickborne Diseases (TBDs)
  • Zika
  • Ebola
  • Chikungunya
  • Middle East Respiratory Syndrome-Coronavirus (MERS-CoV)
  • Marburg
  • Mpox
• Infectious Disease IVD Market Analysis Discussion
  • Table 11-6: Global Infectious Disease IVD Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
• Market Analysis - Traditional Microbiology ID/AST
  • Table 11-7: Global Microbiology ID/AST Market, by Segment, 2025-2030 ($ million) [Blood Culture, Chromogenic Media, ID/AST Auto, ID/AST Panels, Rapid Microbiology]
  • Table 11-8: Global ID/AST Testing Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
  • Traditional ID/AST
    • Table 11-9: Global ID/AST Testing, Distribution, by Systems, (%) [Panel, Auto]
  • Blood Culture
    • Table 11-10: Selected Advanced Techniques in Positive Blood Culture
  • Chromogenic Media
  • Rapid Tests Performed on Colonies from Culture Media
  • Supplies
• Market Analysis - Infectious Disease Immunoassays
  • Improvements in Infectious Disease Immunoassays
    • Table 11-11: Selected Infectious Disease Immunoassay Innovations
    • Table 11-12: Global Clinical Laboratory-Based Infectious Disease Immunoassay Market, by Pathogen, 2025 ($ million, estimated) [COVID-19, HAIs/Sepsis, Hepatitis, HIV, Lyme Disease, Mycology, Parasitology, Respiratory, STDs, ToRCH, Other]
    • Table 11-13: Global Laboratory-Based Infectious Disease Immunoassay Market Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
  • Hepatitis Testing
  • Sepsis
    • Figure 11-1: Lab-based Immunoassay Sepsis Market Distribution, by Type, 2025 (%) [PCT, Traditional Global]
  • HIV Immunoassay Testing
    • Table 11-14: Selected HIV Assays
  • Sexually Transmitted Diseases (STDs)
  • ToRCH
  • Lyme Disease
  • TBD-Serochip (Roche-associated)
  • Rapid Infectious Disease Immunoassay Tests
    • Table 11-15: Global Point-of-Care (Rapid) Immunoassay Testing Market, Sales Distribution, by Pathogen, 2025 ($ million) [C. difficile COVID-19, E. coli, H. pylori, Hepatitis, HIV, Influenza, Malaria, Other respiratory, STD, Other]
• Market Analysis - Molecular Microbiology
  • Table 11-16: Global Molecular Microbiology Sales Distribution, by Region, 2025 (%) [North America, Europe, Asia Pacific, RoW]
  • Table 11-17: Global Molecular Infectious Disease Market, by Pathogen/Disease Indication, 2025-2030 ($ million) [COVID-19, GC/Chlamydia, HAI, Hepatitis, HIV, Mycobacteria/TB, Organism ID, Respiratory, Others]
  • Lab Automation and Molecular Diagnostics
    • Table 11-18: Selected Automated Molecular Test Instrument Platforms
  • Molecular Respiratory Infection Testing
  • The Respiratory Trio - Flu, Strep, RSV
    • Table 11-19: Selected COVID-19, Flu, RSV Tests
  • Other Developments - Beyond the Respiratory Trio, Sequencing
  • Molecular Testing for Sexually Transmitted Infections (STIs)
  • Molecular Hepatitis Testing
  • Molecular HIV Testing
    • Table 11-20: Innovations in Molecular POC Diagnostics for HIV
  • Molecular Tests for Hospital-Acquired Infections (HAIs)
    • Table 11-21: Frequency of the Most Common Nosocomial Infections
  • Assessing the Problem: Nosocomial Infection Statistics
  • Clostridium Difficile
  • MRSA
  • Molecular TB Testing
  • Limitations of Molecular Microbiology Testing
• Mass Spectrometry Infectious Disease Testing
  • Table 11-22: Selected Companies Marketing Mass Spectrometers and/or Assays for the Clinical Laboratory [CE-Marked and/or 510(k) cleared]
• The Future Outlook for Infectious Disease IVD

Chapter 12: Blood Banking Services

• Chapter Scope
  • Edition-Specific Notes
• Overview
  • The Current Status of Global Blood Collection
• Global Blood Safety
  • Table 12-1: Laboratory Screening of Blood Donations for Transfusion-Transmissible Infections, Number of Countries [Chagas, HBV, HCV, HIV, HTLV I/II1, Malaria, Syphilis]
  • Table 12-2: Prevalence of TTIs in Blood Donations [Median (Interquartile range)], by Income Group
  • Zika Virus
  • Blood and Component Collection
    • Table 12-3: Blood Component Usage for Selected Conditions
  • Reevaluating Blood Transfusions
    • Table 12-4: Impact of Alloimmunization (% of Patients Screening Positive for One or More Antibodies)
• Blood Typing and Grouping Market
  • Manual Blood Typing Methods
  • Automated Blood Typing and Screening Methods
  • Molecular Methods
    • Table 12-5: Selected Blood Typing and Grouping Innovations
  • Size and Growth of Typing Markets
    • Table 12-6: Global Blood Typing Market, 2025-2030 ($ million)
  • Blood Typing Market by Geography
    • Table 12-7: Global Blood Typing Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
• Blood Testing Market
  • Table 12-8: Selected Blood Testing Innovations
  • Preventing Bacterial Infections
  • Immunoassays
  • Nucleic Acid Testing (NAT)
  • Size and Growth of the Market
    • Table 12-9: Global Blood Banking Diagnostics Market, 2025-2030 ($ million) [Immunoassay Screen, NAT Screens]
  • Blood Testing Market by Geography
    • Table 12-10: Global Blood Testing Market, by Geography, 2025 (%) [Asia Pacific, Europe, North America, RoW]
• The Commercial Outlook for Blood Banking Testing

Chapter 13: Histology and Cytology

• Chapter Scope
• Overview
• Special Topics
  • Histology Automation
    • Table 13-1: Selected Histology Lab Automation
    • Table 13-2: Histology Information Technology Tools
  • Advanced Analysis Solutions
    • Table 13-3: Selected Advanced Histology Techniques
  • HPV Testing: Clinical Significance, Technological Advances, and Global Market Trends
    • Table 13-4: Global HPV Test Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
    • Table 13-5: Selected HPV Test Innovations
• Market Analysis
  • Total Market for Histology and Cytology
    • Table 13-6: Global Histology/Cytology Sales by Type, 2025-2030 ($ million) [HPV, Immunohistochemistry, in situ hybridization, Pap Tests, traditional non-Pap stains]
  • Regional Market Analysis
    • Table 13-7: Global Histology/Cytology Sales Distribution, by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
    • Table 13-8: Revenues of the Major Histology Companies, 2019-2025 ($ million, estimated)
  • Traditional Stains
    • Table 13-9: Selected Vendors of Traditional Histology Stains
  • Pap Testing
    • Table 13-10: Primary and Secondary Prevention of Cervical Cancer, Screening Responses, by Country, 2021
    • Figure 13-1: Three approaches to cervical cancer screening and future tests
  • Immunohistochemistry and In Situ Hybridization (IHC and ISH)
    • Table 13-11: Selected In Situ Hybridization-based Tests
    • Table 13-12: Selected IHC Test Innovations
  • Pharmacodiagnostic Histology
    • Table 13-13: Major Pharmacodiagnostic Markers
    • Table 13-14: Selected Pharmacodiagnostic Histology Tests
  • Digital Imaging and Computational Pathology
    • Table 13-15: Selected Digital Pathology Image Capture and Viewing Solutions
    • Table 13-16: Selected Digital Imaging Innovations
  • Circulating Tumor Cells
    • Table 13-17: Innovations in CTC Technology
  • Flow Cytometry
• The Commercial Outlook for Histology and Cytology Tests

Chapter 14: Company Profiles: The Top Tier

• Abbott Diagnostics
• Abbott Park, IL
  • Table 14-1: Abbott Diagnostics Revenue History, 2022-2024 ($ million)
  • Table 14-2: Abbott Diagnostic Revenues, by Segment, 2022-2024 ($ million, estimated)
  • Abbott Result Notes
  • Core Lab
  • Hematology
  • Blood Banking
  • Infectious Diseases - Molecular
  • Diabetes
  • HIV Point of Care
  • i-STAT Business
• Agilent Technologies
  • Table 14-3: Agilent Revenue History, 2022-2024 ($ million)
  • Genomics
  • Cytogenetic Analysis
  • Sequencing
  • CRISPR
  • Flow Cytometry
  • Companion Diagnostics - Dako
• Beckman Coulter / Danaher
  • Hematology
  • Hematology IT
  • Clinical Chemistry
  • Immunoassays
  • Microbiology
  • IT Clinical
  • Flow Cytometry
  • Blood Banking
  • Beckman Coulter Life Sciences
• Becton, Dickinson and Company (BD)
  • Table 14-4: BD Clinical Diagnostic Systems Revenue History, 2022-2024 ($ million, estimated) FYE Sept 30
  • Cytology
  • Molecular Microbiology
  • Traditional Microbiology - ID/AST
  • Blood Culture
  • Hospital Acquired Infections
  • Blood Collection
  • Mass Spectrometry
  • Flow Cytometry
  • Immunoassay
  • bioMerieux Inc.
    • Table 14-5: bioMerieux Revenue History, 2022-2024 (Euro- million)
  • Traditional Microbiology
  • Blood Culture
  • Immunoassays
  • Mass Spectrometry
  • BIOFIRE Diagnostics Business
  • Expansion
• Bio-Rad Laboratories, Inc.
  • Table 14-6: Bio-Rad Revenue History, 2022-2024 ($ million, estimated)
  • Quality Control
  • Blood Bank
  • Diabetes
  • Immunoassays
  • Liquid Biopsy
  • Droplet Digital PCR
  • Sequencing
• Bruker Corporation
  • Table 14-7: Bruker Revenue History Product Revenue, 2022-2024 ($ million)
  • Acquisitions and Collaborations
  • Mass Spectrometry
  • Microbiology
  • Molecular PCR
• Cepheid / Danaher
  • GeneXpert/ Xpress Line
  • Tuberculosis
  • Microbiology
  • POC Testing
  • Cancer
• Danaher Corporation
  • Table 14-8: Danaher Revenue History, Diagnostics Segment, 2022-2024 ($ million, estimated)
  • Acquisitions
• Dexcom
  • Table 14-9: Dexcom Revenue History, 2022-2024 ($ million)
• Diasorin S.p.A
  • Table 14-10: Diasorin Revenue History, 2022-2024 (Euro- million)
  • Development Plan
  • Expansion
  • Immunoassays
  • Molecular
  • Molecular Oncology
• Exact Sciences
  • Table 14-11: Exact Sciences Revenue History, 2022-2024 ($ million)
• Hologic, Inc.
  • Table 14-12: Hologic Revenue History, Diagnostic Product Revenue, 2022-2024 ($ million)
  • PANTHER Molecular System
  • HIV Testing
  • Sexually Transmitted Infections
  • Infectious Diseases
  • Panther Fusion
  • Cytology
• Illumina
  • Table 14-13: Illumina Revenue History, 2022-2024 ($ million, not all revenues are for clinical products and services; estimated)
  • China
• Leica Biosystems/Danaher
  • Digital Pathology
  • Companion Diagnostics
  • Stain Reagents
  • Lab Systems
  • Sample Handling
  • Circulating Tumor Cells (CTCs)
  • Artificial Intelligence
• Mindray - Shenzhen Mindray Bio-medical Electronics Co., Ltd.
• Natera
  • Table 14-14: Natera Revenue History, 2022-2024 ($ million)
• QuidelOrtho Corporation
  • Table 14-15: QuidelOrtho Revenue History, 2022-2024 ($ million)
  • Table 14-16: QuidelOrtho Diagnostic Revenues, by Segment, 2020-2024 ($ million, estimated)
  • Immunoassays
  • Rapid Immunoassays
  • The Solana Business
  • Molecular - Savanna Phase Out
  • Blood Bank
• Radiometer A/S / Danaher
  • Critical Care
  • Immunoassays
  • HemoCue
  • Transcutaneous Monitoring
• Revvity
  • Table 14-17: Revvity Revenue History, 2022-2024 ($ million, estimated)
• Roche Diagnostics
  • Table 14-18: Roche Revenue History, 2022-2024 (CHF million)
  • Table 14-19: Roche Diagnostics Revenues, by Segment 2022-2024 (CHF million) [Core Lab, Molecular Lab, Near Patient Care, Pathology Lab]
  • Roche Results Notes
  • Hematology
  • Immunoassays
  • HIV
  • Molecular Expansion
  • Core Molecular
  • Digital PCR
  • Diabetes Care
  • Coagulation
  • cobas Liat System - POC
  • HPV
  • Blood Bank
  • Transplant Medicine
  • Sequencing and Mass Spectrometry
  • Cancer Companion Testing
  • Information Technology
  • Digital Pathology
  • Roche Tissue Diagnostics
  • Immunohistochemistry - IHC
  • Cervical Cancer Screening
  • Companion Diagnostics
• Siemens Healthineers (Siemens)
  • Table 14-20: Siemens Healthineers Revenue History, 2022-2024 (Euro- million)
  • Core Lab
  • Lab Automation
  • Immunoassays
  • Hematology
  • Urinalysis
  • Molecular
  • Expansion to Support Molecular Diagnostics - Fast Track Diagnostics
  • Sequencing with Artificial Intelligence
  • Acute Care - POC
  • POC Connectivity
  • Business Expansion
• Sysmex Corporation
  • Table 14-21: Sysmex Revenue History, 2022-2024 (billions of Yen) FYE March 31
  • Table 14-22: Sysmex Diagnostic Revenues, by Segment, 2022-2024 (billions of Yen) FYE March 31 [Clinical Chem, Coagulation, Flow Cytometry, Hematology, Immunoassay, Urinalysis, Others]
  • Hematology
  • Coagulation
  • Urinalysis and Infectious Disease
  • Immunoassays
  • Lab Information System
  • Flow Cytometry
  • Precision Medicine / Companion Test Diagnostics
  • Liquid Biopsy
  • Sysmex Inostics
  • Forging New Markets
• Thermo Fisher Scientific Inc.
  • Table 14-23: Thermo Fisher Revenue History, Clinical Diagnostics, 2022-2024 ($ million)
  • Immunoassays
  • Microbiology
  • Molecular Test Business
  • Next Generation Sequencing
  • qPCR
  • Oncology Companion Diagnostics
  • Transplant Medicine
  • Mass Spectrometry
• Werfen
  • Table 14-24: Werfen Recent Revenue History, 2022-2024 (Euro- billion)
• Alphabetized Company List
  • 10X Genomics
  • Abbott Diagnostics
  • Abingdon Health Ltd.
  • Accelerate Diagnostics, Inc.
  • Advanced Biological Laboratories, S.A. (ABL)
  • Agendia BV
  • Agilent Technologies
  • Alivedx
  • Altona Diagnostics
  • Amoy Diagnostics Co. Ltd.
  • Ambry Genetics
  • Applied Spectral Imaging Inc. (ASI)
  • ArcDia International Oy Ltd.
  • ARKRAY
  • Aspira Women's Health
  • Beckman Coulter / Danaher
  • Becton, Dickinson and Company (BD)
  • Berry Genomics Co. Ltd.
  • Biocartis
  • BioFire Diagnostics (bioMerieux)
  • Biohit Healthcare
  • Biomerica Inc.
  • Biomerieux Inc.
  • Bio-Rad Laboratories, Inc.
  • BioReference Laboratories
  • Bio-Techne Corporation
  • Binx Health
  • Blueprint Genetics Oy
  • Boston Heart Diagnostics
  • Bruker Corporation
  • CareDx, Inc.
  • CellaVision AB
  • Cerus Corporation
  • Chembio Diagnostic Systems, Inc.
  • Copan Italia S.p.A. and Copan Diagnostics, Inc.
  • Danaher Corporation
  • Dexcom
  • Diasorin
  • Diagnostica Stago
  • Eiken Chemical Co., Ltd.
  • EKF Diagnostics
  • Elitech Group S.A.S. (part of Bruker)
  • Epic Sciences
  • Eurobio Scientific
  • Euroimmun AG (Revvity)
  • Exact Sciences
  • Foundation Medicine, Inc.
  • Fujirebio Diagnostics, Inc.
  • Fulgent Genetics, Inc.
  • Genedrive PLC
  • Genetic Analysis AS
  • Grifols S.A.
  • Guardant Health, Inc.
  • Hologic, Inc.
  • Horiba
  • Illumina
  • Inex Innovate
  • Inova Diagnostics, Inc.
  • Invitae (now Labcorp)
  • Leica Biosystems / Danaher
  • LGC SeraCare Life Sciences, Inc.
  • Masimo Corporation
  • Mayo Clinic Laboratories
  • MedMira, Inc.
  • Medtronic PLC
  • Menarini Diagnostics
  • Meridian Bioscience, Inc.
  • Mindray
  • MGI Tech Co., Limited
  • Myriad Genetics, Inc.
  • Natera
  • NeoGenomics
  • Nova Biomedical Corporation
  • OraSure Technologies, Inc.
  • OPKO Diagnostics
  • Oxford Gene Technology
  • Pacific Biosciences of California, Inc. (PacBio)
  • PreAnalytiX GmbH
  • Precipio, Inc.
  • Predictive Oncology
  • Quanterix Corporation
  • Qiagen
  • Q-linea AB
  • Quest Diagnostics
  • QuidelOrtho Corporation
  • Randox Laboratories Ltd.
  • Radiometer A/S / Danaher
  • Revvity
  • Roche Diagnostics
  • Sciex Pte Ltd.
  • Seegene, Inc.
  • Sekisui Diagnostics LLC
  • Shimadzu Scientific Instruments
  • Siemens Healthineers (Siemens)
  • Snibe Co. Ltd. (Shenzhen New Industries Biomedical Engineering Co. Ltd.)
  • Sonic Healthcare
  • Standard BioTools
  • Streck Inc.
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.
  • Tosoh Bioscience
  • Trinity Biotech PLC
  • Veracyte, Inc.
  • Verily Life Sciences LLC
  • Visiopharm
  • VolitionRx Limited
  • Werfen
  • Yourgene Health

Chapter 15: Company Profiles: The Second Tier

• Chapter Scope
• BGI Genomics
  • PCR and Fluorescence
  • MGI Tech Co., Limited, China
  • Prenatal Testing
  • Test Services
  • Whole Genome Sequencing (WGS)
  • NGS Sequencing
  • Collaborations
• Biocartis
• Diagnostica Stago S.A.S.
• Eiken Chemical Co., Ltd
  • Table 15-1: Eiken Chemical Revenue History, 2022-2024, FYE March 31 (millions of yen)
  • Product News
• Fujirebio Diagnostics, Inc.
  • Table 15-2: Fujirebio Diagnostics Revenue History, 2022-2024, FYE March 31 (millions of yen)
• Fulgent Genetics, Inc
  • Table 15-3: Fulgent Revenue History, 2022-2024 ($ million)
• Grifols S.A.
  • Table 15-4: Grifols Revenue History, 2022-2024 (Euro- million)
  • Blood Transfusion Business
  • ABO Blood Typing
  • Molecular ABO Blood Typing
  • Immunoassays
  • Market Expansion
  • Self-Testing
• Guardant Health, Inc.
  • Table 15-5: Guardant Health Revenue History, 2022-2024 ($ million)
• Horiba
  • Table 15-6: Horiba Revenue History, Medical Diagnostic Sales, 2022-2024 (millions of yen)
• Invitae (now Labcorp)
• Menarini Diagnostics
• Meridian Bioscience, Inc.
  • Immunoassays
  • Molecular Tests
• Myriad Genetics, Inc.
  • Table 15-7: Myriad Genetics Revenue History, 2022-2024 ($ million)
• OraSure Technologies, Inc.
  • Table 15-8: OraSure Technologies Revenue History, 2022-2024 ($ million)
  • Table 15-9: OraSure Technologies Product Revenue History, by Segment, 2022-2024 ($ thousands)
• QIAGEN
  • Table 15-10: QIAGEN Revenue History, 2022-2024 ($ million)
• Tuberculosis.
  • Molecular Expansion
  • Precision Medicine / Companion Diagnostics
  • Molecular Microbiology
  • Prenatal Testing
  • Next Generation Sequencing
  • Digital PCR
  • Liquid Biopsy
  • Cervical Cancer
  • Expansion
• Randox Laboratories Ltd.
  • Clinical Chemistries
  • POC and Rapid
  • Companion Diagnostics
  • Controls
  • Evidence Series - Multistat Biochip Analyzers
  • Molecular
• Sekisui Diagnostics LLC
• Veracyte, Inc.
  • Table 15-11: Veracyte Revenue History, 2022-2024 ($ million)

Chapter 16: Company Profiles: Blood Bank Specialists

• Chapter Scope
• AliveDx
• Cerus Corporation
  • Table 16-1: Cerus Revenue History, 2022-2024 ($ million)

Chapter 17: Company Profiles: Core Lab and Other Companies

• Chapter Scope
• ARKRAY
  • Dry Chemistry / Immunoassays
  • Urinalysis
  • Diabetes
  • Molecular
• EKF Diagnostics Holdings Plc
• ELITech Group S.A.S. (part of Bruker)
• SCIEX Pte Ltd.
• Shimadzu Scientific Instruments
• Snibe Co. Ltd., (Shenzhen New Industries Biomedical Engineering Co. Ltd.)
• Tosoh Bioscience
• Trinity Biotech Plc
  • Table 17-1: Trinity Biotech Revenue History, 2022-2024 ($ million)

Chapter 18: Company Profiles: CTC & Liquid Biopsy Test Providers

• Chapter Scope
• Epic Sciences
• Foundation Medicine, Inc.
• NeoGenomics

Chapter 19: Company Profiles: Specialists

• Chapter Scope
• Ascensia Diabetes Care Holdings AG
• Insulet Corporation
  • Table 19-1: Insulet Corp Revenue History, 2022-2024 ($ million)
• Medtronic plc
• Verily Life Sciences LLC

Chapter 20: Company Profiles: Hematology (Cell Analysis) and Coagulation Specialists

• Chapter Scope
• CellaVision AB
• Masimo Corporation
  • Table 20-1: Masimo Revenues History, 2022-2024 ($ million)
• Nova Biomedical Corporation (Nova)

Chapter 21: Company Profiles: Histopathology Specialists

• Chapter Scope
• Amoy Diagnostics Co. Ltd.
• Applied Spectral Imaging Inc. (ASI)
• Visiopharm

Chapter 22: Company Profiles: Immunoassay Specialists

• Chapter Scope
• Biohit Healthcare
• Biomerica Inc.
  • Table 22-1: Biomerica Revenue History, 2022-2024 ($ million)
• Bio-Techne Corporation
  • Table 22-2: Bio-Techne Revenue History, 2022-2024($ million)
• Eurobio Scientific
• EUROIMMUN AG (Revvity)
• Immunodiagnostic Systems (IDS)
• INOVA Diagnostics, Inc.
• VolitionRx Limited

Chapter 23: Company Profiles: Microbiology Specialists

• Chapter Scope
• Accelerate Diagnostics, Inc.
  • Table 23-1: Accelerate Diagnostics Revenue History, 2022-2024 ($ thousands)
• Advanced Biological Laboratories, S.A. (ABL)
• altona Diagnostics
• ArcDia International Oy Ltd.
• COPAN ITALIA S.p.A. and COPAN Diagnostics, Inc.
• Genetic Analysis AS
• Q-linea AB
• Seegene, Inc.

Chapter 24: Company Profiles: Molecular Test Specialists

• Chapter Scope
• Pacific Biosciences of California, Inc. (PacBio)
• Standard BioTools

Chapter 25: Company Profiles: Point of Care Test Specialists

• Chapter Scope
• Abingdon Health Ltd.
• binx Health
• Chembio Diagnostic Systems, Inc.
• Genedrive plc
• MedMira, Inc.

Chapter 26: Company Profiles: Prenatal Test Service Providers

• Chapter Scope
• Berry Genomics Co. ltd.
• INEX Innovate
• Oxford Gene Technology
• Yourgene Health

Chapter 27: Company Profiles: Quality Control & Sample Pretreatment Specialists

• Chapter Scope
• 10x Genomics
• Agena Bioscience, Inc.
• Biotype Diagnostic GmbH
• IncellDx
• LGC SeraCare Life Sciences, Inc.
• PreAnalytiX GmbH
• Precipio, Inc.
• Quanterix Corporation
• Streck Inc.

Chapter 28: Test Service Providers

• Table 28-1: FDA Approved Companion Diagnostics, 2025
• Chapter Scope
• Agendia BV
• Ambry Genetics
• ARUP Laboratories
• Aspira Women's Health
• BioReference Laboratories
• Blueprint Genetics Oy
• Boston Heart Diagnostics
• CareDx, Inc.
• Predictive Oncology
• Labcorp, Laboratory Corporation of America
  • Table 28-2: Labcorp Revenue History, 2022-2024 ($ million)
• Mayo Clinic Laboratories
• MDxHealth SA
• OPKO Diagnostics/Opko Health
  • Table 28-3: OPKO Diagnostics Revenue History, 2022-2024 ($ million)
• Quest Diagnostics
  • Table 28-4: Quest Diagnostics Revenue History, 2022-2024 ($ million)
• Sonic Healthcare