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The Worldwide Market for IVD Tests, 19th Edition
Publication Date: May 21, 2026
Tags: Coagulation, COVID-19, Diagnostic Instruments, Genetic Diseases, Hematology, Histology and Cytology, Immunoassay, In Vitro Diagnostics (IVD), Infectious Diseases, Liquid Biopsy, Molecular Diagnostics, Next-Generation Sequencing (NGS), Oncology and Cancer, Point-of-Care (POC) Testing
Pages: 1138
SKU: 26-050KA
The global in vitro diagnostics (IVD) market is entering a period of measured but positive growth, shaped less by disruptive platform launches and more by strategic portfolio realignment, digital integration, and selective innovation. Kalorama Information’s 19th Edition of The Worldwide Market for In Vitro Diagnostic (IVD) Tests examines how industry participants are navigating competitive pressures, cost constraints, and evolving healthcare needs while positioning for sustainable growth through 2030.
Shifting Areas of Strategic Focus
Since publication of the 18th Edition, Kalorama Information has identified three dominant areas of concentration across the IVD industry:
- Portfolio expansion
- Customization
- Digital health
Research conducted for the 19th Edition indicates that companies are prioritizing portfolio and menu expansion over investment in entirely new platforms or disruptive instrumentation. This evolution reflects a strategic shift rather than a retreat from innovation.
Portfolio Expansion as a Core Growth Strategy
Portfolio expansion has emerged as the primary mechanism for growth, driven by several factors:
- Expansion of test menus on existing platforms
- Entry into adjacent disease areas
- Increased reliance on acquisitions and restructuring to strengthen portfolio breadth
Examples include acquisitions aimed at expanding cancer diagnostics portfolios and corporate restructuring efforts designed to refocus on high‑value strengths within existing portfolios.
New products continue to enter the market, particularly in select growth areas such as proteins. However, the overall pace of new platform introductions remains limited.
Innovation Pathways and Partnership Models
While disruptive platform innovation is currently constrained, meaningful innovation continues across several key technology areas:
- Molecular diagnostics
- Companion diagnostics
- Point‑of‑care (POC) molecular diagnostics
- Digital pathology
- AI‑driven diagnostics
Notably, companies are increasingly acquiring or partnering to access innovation rather than relying solely on internal development.
The Expanding Role of Digital Health
Digital health is becoming a central element of competitive differentiation, advancing through:
- Connectivity
- Data management
- Artificial intelligence
These capabilities are enabling companies to move toward integrated solution models that support recurring revenue streams, strengthen customer relationships, and enhance differentiation in a crowded marketplace.
Market Growth Outlook and Segment Performance
Kalorama Information’s analysis points to incremental annual growth across the forecast period, though performance will vary widely by segment.
Segment Dynamics
- Routine testing areas may see flat or modest growth
- Higher‑growth segments are expected to outperform the market average
Epidemiological Drivers of Demand
At the foundation of sustained IVD demand is the growing global burden of chronic disease, particularly the prevalence of multiple chronic conditions within individual patients.
Key indicators include:
- Approximately 40% of Americans and 33% of the global population live with at least one chronic condition
- Nearly 20% of U.S. adults live with two or more chronic conditions
The co‑occurrence of conditions such as hypertension, chronic lung disease, asthma, heart disease, and cancer drives:
- Increased healthcare utilization
- Longer care cycles or extended treatment plans
- Rising demand for home‑based diagnostics
These trends continue to fuel IVD test volume growth across care settings.
Over the next five to ten years, Kalorama Information anticipates moderate, gradual shifts in IVD product markets. Growth will be driven primarily by:
- An aging global population
- Rising disease burden
- Expansion of international healthcare infrastructure
These forces are expected to offset, though not eliminate, fiscal and policy‑related headwinds.
Report Scope and Methodology
- Global IVD market coverage with forecasts for 2025–2030, presented in U.S. dollars
- Market size based on manufacturer revenues, not retail or reimbursement pricing
- Segment analysis by test category and, where possible, analyte
- Emphasis on corporate developments, financial performance, and vendor activity
- Recognition that all market values and forecasts are estimates, subject to evolving market conditions, trade policies, and reported company revenues
Long‑term trends including artificial intelligence, next‑generation sequencing, gene editing, and microbiome research are examined in dedicated sections of the report.
Value to Industry Stakeholders
This 19th Edition provides senior executives, marketers, and strategic decision makers with:
- A clear view of how investment priorities are reshaping the IVD industry
- Insight into which segments and technologies are positioned to outperform
- Context for evaluating growth opportunities amid fiscal, regulatory, and policy uncertainty
By combining industry expertise, extensive secondary research, and interviews with market participants, the report delivers a grounded, transparent assessment of where the IVD market is headed and how companies can position themselves to compete effectively.
Chapter 1: Executive Summary
About Kalorama Information
Overview
- Figure 1-1: Worldwide IVD Market Sales, 2020, 2025, and 2030 ($ billion)
- Figure 1-2: COVID-19 IVD Market, Share by Segment, 2025 (%) [Immunoassay Lab-Based, Molecular Dx Lab-Based, Point-of-Care]
Scope and Methodology
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; Mass Spectrometry; Microbiology (ID/AST); Molecular Microbiology; Nucleic Acid Assays; POC, OTC Diabetes; POC, OTC Other; POC, Professional; Other]
Market Highlights
Market Assumptions
- Table 1-2: IVD Market Assumptions 2025 Outlook
Competitive Picture in IVD
Finding What You Are Looking For in the 19th Edition
- Table 1-3: Finding What You Are Looking For in the 19th Edition
Chapter 2: Introduction
IVD Landscape
Scope
Edition-Specific Notes
- Shifting Areas of Concentration
Report Design
PAMA and CMS
Market Analysis of IVD Market Segments
- 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; Mass Spectrometry; Microbiology (ID/AST); Molecular Microbiology; 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]
Top Suppliers and Niche Players
Introduction
Overview of the Top Tier Companies
- Table 2-3: Clinical Diagnostic Revenues of Selected Top 20 IVD Companies, 2024 and 2025 ($ million)
Abbott Diagnostics
Roche Diagnostics
Danaher Corporation
Cepheid
Radiometer
Beckman Coulter
Thermo Fisher Scientific
Dexcom
Siemens Healthineers
bioMérieux
Illumina
Exact Sciences
Sysmex Corporation
Becton Dickinson & Co
QuidelOrtho Corporation
Werfen
Natera
Mindray
Hologic
Agilent
Bio-Rad Laboratories
QIAGEN N.V.
Revvity
Overview of Selected Second-Tier Companies
- 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 (%)
Diasorin Group
Bruker/CALID Group
Guardant Health
Myriad Genetics
Grifols S.A.
Diagnostica Stago
BGI Genomics
Sekisui Diagnostics
ARKAY
GeneDx
Fujirebio
Fulgent Genetics
Seegene
Horiba
Randox
Eiken Chemical Co
Nihon Kohden
Meridian
Menarini Diagnostics
Haemonetics
IVD Companies Mergers & Acquisitions
- Table 2-5: Selected IVD Mergers and Acquisitions, 2023-2026 (first half)
Collaboration, Partnership, Alliance Agreements
Test Services
- Figure 2-2: Clinical Laboratory Test Service Market Forecasted Growth, by Segment, 2024-2029 (%)
- Table 2-6: Global Lab Market Segmentation, 2024 ($ billion) [Hospital and Acute Care Labs, Independent Labs, Physician Office Labs]
- Table 2-7: Total Revenues for Leading U.S.-based Reference Labs, 2023-2025 ($ million)
Historical IVD Market vs Today
In the Beginning to Now
- Figure 2-3: Share of Global 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]
Future
Next-Generation Sequencing
Cancer Testing (Liquid Biopsy)
Companion Diagnostics
Chapter 3: The Global Picture for In Vitro Diagnostic Markets
Scope
Overview
Simultaneous Threats: Chronic and Acute
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)
COVID-19
- Table 3-3: Selected Molecular EUA Tests for COVID-19, 2024-July 2025
- Table 3-4: Selected Antigen Immunoassay Tests for SARS-CoV-2, 2024-2025
Emerging and Emerged Markets
- Table 3-5: Developed/Developing Economies, UN Classification* Table, 2025
- Figure 3-4: Developed vs. Developing IVD Market Shares, 2025 and Projected 2030 (%)
- Table 3-6: Countries To Watch for IVD Opportunities, by Total Population and Percent Urban, 2025 [Australia; Brazil; China; France; Germany; Hungary; India; Mexico; Netherlands; Poland; Romania; Saudi Arabia; South Africa; South Korea; Sweden; Switzerland, Turkey; United Kingdom; United States]
Size and Forecast for the Global IVD Market
- Table 3-7: Global In Vitro Diagnostic Market, Major Country/Region Markets, 2025 and 2030 ($ million) [Australia; Brazil; Canada; China; Eastern Europe; EU 15/W. Europe; India; Japan; Mexico; Peru; Russia; Saudi Arabia; South Africa; South Korea; Turkey; UAE; United States; Vietnam; Rest of World]
- Table 3-8: Global In Vitro Diagnostic Market, Regional Markets, 2025 and 2030 ($ million) [Africa, Asia Pacific, Europe, Latin America, Middle East, North America]
- Table 3-9: 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); NAAT – Oncology; NAAT – Genetic/Inherited; POC, OTC Glucose OTC; POC Continuous Glucose; POC, OTC Other; POC, Professional/Hospital]
- Table 3-10: 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 3-11: United States IVD Market Share, by Segment, 2025 (%) [Blood Grouping; Clinical Chemistry; Coagulation; Hematology; Histology; Immunoassay Infectious Disease; Immunoassay Other; Microbiology ID/AST; Microbiology Molecular; Nucleic Acid Assays; POC Diabetes; POC Other; Others]
PAMA and Reimbursement Changes
Impact of CARES Act on PAMA
- Table 3-12: Proposed Clinical Diagnostic Laboratory Test (CDLT) Rates, 2020-2027
Saving Access to Laboratory Service Act (SALSA)
LDT Update
Bundled Insurance Payments for ESRD Patients
- Table 3-13: Laboratory Tests Subject to ESRD Consolidated Billing
Advanced Laboratory Tests (ADLT)
- Table 3-14: List of Approved ADLTs, March 2026
Precision Medicine and NGS
IVD Market in Europe
- Figure 3-5: International Monetary Fund Inflation Map, Global 2024
- Table 3-15: 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 3-16: IVD Market Per Capita, Europe, 2025 Estimates [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 3-17: Japan IVD Market, Share by Segment, 2025 (%) [Clinical Chemistry; Coagulation; Hematology; Histology; Immunoassay Infectious Disease; Immunoassay Other; Microbiology ID/AST; Microbiology Molecular; POC Diabetes; POC Other; Others]
Eastern Europe: Growth Region
- Table 3-18: 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 3-19: China IVD Market, Share by Segment, 2025 (%) [Blood Bank Screening; Clinical Chemistry; Coagulation; Hematology; Histology; Immunoassay Infectious Disease; Immunoassay Other; Microbiology ID/AST; Microbiology Molecular; POC Diabetes; POC Other; Others]
- Table 3-20: Total Midyear Population, by Broad Age Group: China, 2010-2050 (million persons)
Clinical Laboratory Market in China
Volume-Based Procurement in China
India: Population and Opportunity
- Table 3-21: India IVD Market, Share by Segment, 2025 (%) [Clinical Chemistry, Hematology, Coagulation; Histology/Cytology; Immunoassays; Microbiology/Virology; POC Glucose; POC Other; Others]
Clinical Laboratory Market in India
IVD Regulation
India’s Mukt Bharat Campaign
Rest of Asia
- Table 3-22: Asia Pacific Region IVD Market, by Country, 2025 ($ million) [Australia; China; India; Indonesia; Japan; Malaysia; Philippines; Singapore; South Korea; Thailand; Vietnam]
Brazil
- Table 3-23: Brazil IVD Market, by Broad Segment, 2025 (%) [Core Lab; Histology; Immunoassays; Microbiology/Virology; Point-of-Care – glucose; Point-of-Care – other]
Disease Trends
Clinical Laboratory Market in Brazil
IVD Regulation
Mexico
- Table 3-24: Mexico IVD Market, by Broad Segment, 2025 (%) [Clinical Chemistry, Hematology, Coagulation; Histology; Immunoassays; Microbiology; Point-of-Care; 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
Chile
Colombia
Indonesia
Malaysia
Peru
Philippines
Poland
Romania
Thailand
Vietnam
IVD Market Opportunity by Country
- Table 3-25: IVD Market Opportunity, by Country (2025 Market Rank, Country CAGR 2025-2030) (%)
Chapter 4: Company and Industry Trends
Scope
Edition-Specific Notes
Advanced Medicine Without Borders
- Table 4-1: Key Emerging IVD Markets, 2020-2025 ($ million)
China Market Update
Direct to Consumer Genetic Test Services
Genetic Testing in Disease
Genomic Testing
Gene Editing
- Table 4-2: Selected Gene Editing / CRISPR Innovations
CRISPR as a Diagnostic Tool
CRISPR and the Food Industry
Microbiome
- Table 4-3: Selected Microbiome Test Innovations
Next-Generation Sequencing
- Table 4-4: Selected Clinical NGS Platforms on the Market
Liquid Biopsy
Quality Assurance
Product News
Market Cleared Products
Liquid Biopsy in Microbiology
Liquid Biopsy Companies in 2022-2025
The Future for Liquid Biopsy
Information Technology Advances and Artificial Intelligence
AI in Clinical Practice
- Table 4-5: Selected AI Market Cleared Tests
AI Physician Usage
The Regulatory Pathway
Product Initiatives
- 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
Exosome Sequencing
Biotin Interference in Immunoassay Detection Errors
- Table 4-8: Biotin-free Offerings Currently on the Market
- Table 4-9: Biotin Interference with Troponin Lab Tests – Assays Subject to Biotin Interference
Clinical Applications and Liquid Biopsy
Traumatic Brain Injury and IVD
Personalized Medicine
Companion Diagnostics
- Table 4-10: Selected FDA Approved Companion Diagnostics 2025
Telehealth
Blockchain
Substance Abuse
Biomarkers and Substance Abuse
Clinical Laboratory Testing for Drugs of Abuse
- Table 4-11: Global Drug Abuse Statistics
Urine
Blood
Oral
Hair
Saliva Testing
Breath Test Advances
- Table 4-12: Selected Disease Markers in Exhaled Breath
Micro-Hospital Opportunities
Climate Change and Infectious Disease
Kickback Schemes
Early Sepsis Detection
Medical Diagnostics and 3D Printing
Staffing Shortages
Targeted Testing
Chapter 5: Point-of-Care (POC) Tests
Scope
Overview and Trends
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 Innovations (excluding COVID-19 testing)
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 Infectious Disease (inc. COVID-19); Pregnancy; Urinalysis; Other (TSH, Allergy, Autoimmune, etc.)]
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; Rest of World]
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; Rest of World]
Lipid Testing
- Table 5-8: Lipid POC Test Sales Distribution, by Global Region, 2025 (%) [Europe; Japan; United States; Rest of World]
Drugs of Abuse 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; Rest of World]
Rapid and POC Infectious Disease Testing
- Table 5-12: Innovations in Molecular POC Infectious Disease Diagnostics
Products
- Table 5-13: POC Infectious Disease Test Summary by Disease and Technology
HIV and Hepatitis Testing and Monitoring
Tuberculosis
Tropical and Neglected Diseases
Respiratory Diseases
Sepsis and Nosocomial Disease
Sexual Health
Lyme Disease
COVID-19
Market Size and Growth
Point-of-Care OTC and Professional Use Immunoassays
- Table 5-14: Global POC Immunoassay Sales Distribution, by Region, 2025 (%) [Europe; Japan; United States; Rest of World]
- Table 5-15: Global POC Immunoassay Test Sales, by Test Category, 2025-2030 ($ million) [OTC/Self Tests (Drugs of Abuse; H. pylori; HIV; Infectious Disease/COVID-19; Pregnancy/Ovulation; Other) and Professional POC (Cardiac Markers; Drugs of Abuse; HbA1c; Infectious Disease/COVID-19; Pregnancy; Other)]
- Table 5-16: Selected Self-Test Immunoassay Innovations
Pregnancy Testing
Cardiovascular Diagnostics
Drugs of Abuse/Therapeutic Drug Monitoring
- Table 5-17: Infectious Disease POC Test Demand, by Type, 2025 (%) [C. difficile; COVID-19; E. coli; H. pylori; Hepatitis; HIV; Home Test/OTC; Influenza; Malaria; Other respiratory; STD; Others]
- Table 5-18: Infectious Disease POC Test Sales Distribution, by Global Region, 2025 (%) [Europe; Japan; United States; Rest of World]
Diabetes Testing – Blood Glucose Monitoring
- Table 5-19: Glucose POC Test Sales Distribution, by Global Region, 2025 (%) [Europe; Japan; United States; Rest of World]
- Figure 5-1: POC Glucose Testing Market Growth, by Category, 2025-2030 (%) [Continuous; HbA1c POC, Professional; OTC; Professional]
IT to Aid Diabetes Management
- Table 5-20: Selected Apps and Glucose Management IT
Diabetes Market Analysis
- Table 5-21: Global Diabetes Sales, by Test Category, 2025-2030 ($ million) [Glucose OTC; Glucose, continuous; HbA1c Lab; HbA1c POC]
POC Glucose Competitors
- Table 5-22: Top Three POC Test Vendors, by Glucose Test Revenues, 2025 ($ million)
Blood Glucose Self-Testing
- Table 5-23: Selected Glucose Self-Test Meter Innovations
Non-invasive Testing Devices
- Table 5-24: Selected Noninvasive Glucose Monitoring Devices
Continuous Glucose Monitoring
- Table 5-25: Selected Continuous Blood Glucose System Developments
Blood Glucose Testing by Professionals
- Table 5-26: Selected Innovations in Hospital-based Glucose Monitoring
Diabetes Testing – Glycated Hemoglobin
- Table 5-27: Global HbA1c Test Sales Market and Distribution, by Setting, 2025-2030 ($ million) [HbA1c Lab; HbA1c POC]
- Table 5-28: Selected POC HbA1c Devices
Genes and Other Markers of Diabetes
- Table 5-29: Selected POC Diabetes Monitoring Tests
The Major POC Test Players
- Table 5-30: POC Test Revenues of Selected IVD Companies, 2025 ($ million)
Chapter 6: The Core Lab
Scope
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 Lab-based 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; Rest of World]
- Table 6-4: Selected Major Clinical Chemistry Companies, by Sales, 2025 ($ million, estimated)
- 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, 2025 (% distribution of total sales, including POC)
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
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 Sales (excluding infectious disease and blood screening), 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, Rest of World]
- 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)
Mature Assay Segment
Thyroid Function
Therapeutic Drug Monitoring
Vitamin D
- Table 7-8: Selected Vitamin D Immunoassays
Anemia
Toxicology/DAU
Allergy
Growth Immunoassays
Proteins
- Figure 7-1: Other Proteins, by Percent of Total, 2025 (%)
Tumor Markers
- Table 7-9: Selected Tumor Marker Innovations
Cardiac Markers
- Table 7-10: Regional Cardiac Marker Immunoassay Market Share, by Country, 2025 (%) [EU Countries; Japan; Latin America; Middle East; North America; Rest of Asia Pacific; Rest of Europe; Rest of World]
- 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 and Multiple Sclerosis
- Table 7-17: Selected Innovations for Alzheimer’s Disease Immunoassays
Traumatic Brain Injury
Other Immunoassays
- Figure 7-2: Other Select Immunoassays, by Percent of Total Immunoassays, 2025 (%) [Bone Marker; Endocrine/Adrenal; Radioimmunoassays; Others]
- Table 7-18: Selected Immunoassay Innovations
Innovating POC
- Table 7-19: Selected POC Test Innovations
- Table 7-20: Selected POC Immunoassay Test Platforms
The Commercial Outlook for Immunoassays
Chapter 8: Molecular Assays
Scope
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, 2023, 2024, and estimated 2025 ($ million)
Market Analysis
- Table 8-10: Global Genomic, HLA, NIPT, and Oncology Molecular Test Sales, by Type with NIPT, 2025-2030 ($ million)
Oncology
- Table 8-11: Global Molecular Cancer Test Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
- 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; Rest of World]
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; Rest of World]
- 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; Rest of World]
- 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
Scope
Overview of Hematology and Trends
- Table 9-1: Hematology Analyzer Distribution of Sales, by Menu Capability, 2025 estimated (%)
- Table 9-2: Lab-based Hematology Sales, by Analyte Average Annual Distribution, 2025 (%)
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; Rest of World]
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), 2025 ($ million)
- Figure 9-1: Market Share for Top Hematology Companies (Laboratory and POC), 2025 (%)
- Table 9-13: Global Hematology (Laboratory-based and POC) Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
The Commercial Outlook for Hematology Tests
Chapter 10: Coagulation
Scope
Overview and Trends of Coagulation and Immunohematology Tests
COVID-19
Direct Oral Anticoagulants (DOACs)
D-dimer
- Table 10-1: Global D-dimer Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
Market Analysis
- Table 10-2: Global Coagulation Sales, by Segment, 2025-2030 ($ million) [D-dimer; Molecular; Professional POC; Professional Self; PT/INR Labs]
- Table 10-3: Global Coagulation Test and Instrument Market, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
Lab-based Testing
- Table 10-4: Selected Lab-based Coagulation Innovations
Genetic Markers of Hypercoagulopathies
- Table 10-5: Related CMS Codes for Reimbursement National Limits, Molecular, 2025
- Table 10-6: Global Molecular – Thrombophilia SNP Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
- Table 10-7: Selected Molecular Coagulation Test Innovations
Leading Suppliers: Laboratory Systems
- Table 10-8: Top Coagulation Company Market Share Laboratory-based, 2025 (%)
Decentralized Coagulation Testing – Professional Use
Decentralized Coagulation Testing – OTC
- Table 10-9: Selected POC Coagulation Test Innovations
Platelet Testing
- Table 10-10: Selected Platelet Activity Test Innovations
Leading Suppliers: POC Systems
- Table 10-11: Top Coagulation Company Revenues, POC, 2025 ($ million, estimated)
The Commercial Market for Coagulation Tests
- Table 10-12: Major Anticoagulants Uses and Tests
Chapter 11: Microbiology and Virology
Scope
The Real Impact of Infections
Herpes and Alzheimer’s Disease
Ebola and Cancer
HIV and Cancer
H pylori and Cancer
Bacteria and Parkinson’s
HPV and Cancer
Microbial Antibiotic Resistance – The Role of Clinical Tests
Fast Identification
- Table 11-1: Selected Companies Developing Faster Identification, Some Also with Antimicrobial Susceptibility/Resistance Tests
Traditional Microbiology and Its Limits
The New Microbiology – Innovations
Liquid Based Microbiology 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
Thermo Fisher Scientific
Others
Next-Generation Sequencing-Based Microbiology Approaches
- Table 11-3: Selected Companies Applying DNA/RNA Sequencing to Microbiology
Syndromic/Multiplex Testing
High-Consequence Infectious Disease Threats
- Table 11-4: Selected Companies Marketing Products Addressing High-Consequence Infectious Disease Threats
Tickborne Diseases (TBDs)
TB and Other Infectious Diseases
Chagas
Dengue
Ebola
Chikungunya
Middle East Respiratory Syndrome-Coronavirus (MERS-CoV)
Marburg
SARS-CoV-2 (COVID-19)
Monkeypox
Market Analysis
- Table 11-5: Global Microbiology Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
Market Analysis – Traditional Microbiology ID/AST
- Table 11-6: Global Microbiology ID/AST Market, by Segment, 2025-2030 ($ million) [Blood Culture; Chromogenic Media; ID/AST Auto; ID/AST Panels; Rapid Microbiology]
- Table 11-7: Global ID/AST Testing Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
Traditional ID/AST
- Table 11-8: Global ID/AST Testing, Distribution by Systems, (%) [Auto, Panel]
Blood Culture
- Table 11-9: Selected Advanced Techniques in Positive Blood Culture
Chromogenic Media
Rapid Tests Performed on Colonies from Culture Media
Supplies
Market Analysis – Microbiology Immunoassays
Improvements in Microbiology Immunoassays
- Figure 11-1: Immunoassay Respiratory Testing, by Target Pathogens, 2025 (%) [Multi-Target, Single-Target]
- Table 11-10: Selected Infectious Disease Immunoassay Innovations
- Table 11-11: Global Clinical Laboratory-Based Microbiology/Infectious Disease Immunoassay Market, by Pathogen, 2025($ million) [HAIs/Sepsis; Hepatitis; HIV; Lyme Disease; Mycology; Parasitology; Respiratory; STDs; ToRCH; Other]
- Table 11-12: Global Laboratory-Based Microbiology/Infectious Disease Immunoassay Market Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
Hepatitis Testing
Sepsis
- Figure 11-2: Global Lab-based Microbiology Immunoassay Sepsis Market Distribution, by Type, 2025 (%) [PCT, Traditional]
HIV Immunoassay Testing
- Table 11-13: Selected HIV Assays
Sexually Transmitted Diseases (STDs)
ToRCH
Lyme Disease
Market Analysis – Molecular Microbiology
- Table 11-14: Global Molecular Microbiology Sales Distribution by Region, 2025 (%) [Asia Pacific, Europe, North America, RoW]
- Table 11-15: Global Molecular Microbiology Market, by Pathogen/Disease Indication, 2025-2030 ($ million) [Blood Bank Screening; GC/Chlamydia; HAI; Hepatitis; HIV; Mycobacteria/TB; Organism ID; Respiratory; Others]
Lab Automation and Molecular Diagnostics
- Table 11-16: Selected Automated Molecular Test Instrument Platforms
Molecular Respiratory Infection Testing
The Respiratory Trio – Flu, Strep, RSV
- Figure 11-3: Molecular Respiratory Testing, by Target Pathogens, 2025 (%) [Multi-Target, Single-Target]
Molecular Testing for Sexually Transmitted Diseases
Molecular Hepatitis Testing
Molecular HIV Testing
- Table 11-17: Innovations in Molecular POC Diagnostics for HIV
Molecular Tests for Hospital-Acquired Infections (HAIs)
- Table 11-18: Frequency of the Most Common Nosocomial Infections
Assessing the Problem: Nosocomial Infection Statistics
Clostridium Difficile
MRSA
Molecular TB Testing
Limitations of Molecular Microbiology Testing
Rapid Microbiology Tests
- Table 11-19: Global Rapid Microbiology Testing Market, Sales Distribution, by Pathogen, 2025 (%) [C. Difficile; COVID-19; E. coli; H. pylori; Hepatitis; HIV; Influenza; Malaria; Other respiratory; STD; Other]
- Figure 11-4: Rapid Infectious Disease Test Sales, by Respiratory/Non-respiratory Segments, 2025 (%)
- Figure 11-5: Rapid Respiratory Testing, by Target Pathogens, 2025 (%) [Multi-Target, Single-Test]
Mass Spectrometry
- Table 11-20: Selected Companies Marketing Mass Spectrometers and/or Assays for the Clinical Laboratory [CE-Marked and/or 510(k) cleared]
The Future Outlook for Microbiology
Chapter 12: Blood Banking Services
Scope
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; Rest of World]
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; Rest of World]
The Commercial Outlook for Blood Banking Testing
Chapter 13: Histology and Cytology
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 IVD Testing Becomes Main Stream
- Table 13-4: Global HPV Test Sales Distribution, by Region, 2025 (%) [Asia Pacific; Europe; North America; Rest of World]
- Table 13-5: Selected HPV Test Innovations
Market Analysis
Total Market
- 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; Rest of World]
- Table 13-8: Revenues of the Major Histology Companies, 2018-2025 ($ 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
- Table 13-11: Three approaches to cervical cancer screening and future tests
Immunohistochemistry and In Situ Hybridization
- Table 13-12: Selected In Situ Hybridization-based Tests
- Table 13-13: Selected IHC Test Innovations
Pharmacodiagnostic Histology
- Table 13-14: Major Pharmacodiagnostic Markers
- Table 13-15: Selected Pharmacodiagnostic Histology Tests
Digital Imaging and Computational Pathology
- Table 13-16: Selected Digital Pathology Image Capture and Viewing Solutions
- Table 13-17: Selected Digital Imaging Innovations
Circulating Tumor Cells
- Table 13-18: Innovations in CTC Technology
Flow Cytometry
The Commercial Outlook for Histology and Cytology Tests
Chapter 14: Company Profiles: The Top Tier
Scope
Abbott Diagnostics
- Table 14-1: Abbott Diagnostics Revenue History, 2023-2025 ($ million)
- Table 14-2: Abbott Diagnostic Revenues, by Segment, 2023-2025 ($ million, estimated)
Core Lab
Hematology
Blood Banking
Infectious Diseases – Molecular
Diabetes
HIV Point of Care
i-STAT Business
Agilent Technologies
- Table 14-3: Agilent Revenue History, 2023-2025 ($ million)
Genomics
Cytogenetic Analysis
Sequencing
CRISPR
Flow Cytometry
Companion Diagnostics – Dako
Digital Pathology
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 Revenue History, 2023-2025 ($ million, estimated) FYE Sept 30
Cytology
Molecular Microbiology
Traditional Microbiology – ID/AST
Blood Culture
Hospital Acquired Infections
Blood Collection
Mass Spectrometry
Flow Cytometry
Immunoassay
bioMérieux Inc.
- Table 14-5: bioMérieux Revenue History, 2023-2025 (€ million)
Traditional Microbiology
Blood Culture
Immunoassays
Mass Spectrometry
BIOFIRE Diagnostics Business
Expansion
Bio-Rad Laboratories, Inc.
- Table 14-6: Bio-Rad Revenue History, 2023-2025 ($ million, estimated)
Quality Control
Blood Bank
Diabetes
Immunoassays
Liquid Biopsy
Droplet Digital PCR
Sequencing
Bruker Corporation
- Table 14-7: Bruker Revenue History Product Revenue, 2023-2025 ($ 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, 2023-2025 ($ million, estimated)
Dexcom
- Table 14-9: Dexcom Revenue History, 2023-2025 ($ million)
Exact Sciences
- Table 14-10: Exact Sciences Revenue History, 2023-2025 ($ million)
Hologic, Inc.
- Table 14-11: Hologic Revenue History, Diagnostic Product Revenue, 2023-2025 ($ million)
PANTHER Molecular System
Sexually Transmitted Infections
Infectious Diseases
PANTHER Fusion
Cytology
Illumina
- Table 14-12: Illumina Revenue History, 2023-2025 ($ million, not all revenues are for clinical products and services; estimated)
China
Leica Biosystems/Danaher
Digital Pathology
Tissue Staining
Lab Systems
Natera
- Table 14-13: Natera Revenue History, 2023-2025 ($ million)
QIAGEN
- Table 14-14: QIAGEN Revenue History, 2023-2025 ($ million)
Tuberculosis.
Molecular Expansion
Precision Medicine / Companion Diagnostics
Molecular Microbiology
Prenatal Testing
Next-Generation Sequencing
Liquid Biopsy
Cervical Cancer
Expansion
QuidelOrtho Corporation
- Table 14-15: QuidelOrtho Revenue History, 2023-2025 ($ million)
- Table 14-16: QuidelOrtho Diagnostic Revenues, by Segment, 2023-2025 ($ million, estimated)
Immunoassays
Rapid Immunoassays
The Solana Business
Blood Bank
Radiometer A/S / Danaher
Critical Care
Immunoassays
HemoCue
Transcutaneous Monitoring
Revvity
- Table 14-17: Revvity Revenue History, 2023-2025 ($ million, estimated)
Roche Diagnostics
- Table 14-18: Roche Revenue History, 2023-2025 (CHF million)
- Table 14-19: Roche Diagnostic Revenues, by Segment, 2023-2025 (CHF million)
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
Roche Tissue Diagnostics
Immunohistochemistry – IHC
Cervical Cancer Screening
Companion Diagnostics
Siemens Healthineers (Siemens)
- Table 14-20: Siemens Healthineers Revenue History, 2023-2025 (€ million)
Core Lab
Lab Automation
Immunoassays
Hematology
Urinalysis
Molecular
Sequencing with Artificial Intelligence
Acute Care – POC
POC Connectivity
Business Expansion
Sysmex Corporation
- Table 14-21: Sysmex Revenue History, 2023-2025 (billions of Yen) FYE March 31
Hematology
Coagulation
Urinalysis
Immunoassays
Lab Information System
Flow Cytometry
Precision Medicine / Companion Test Diagnostics
Liquid Biopsy
Sysmex Inostics
Forging New Markets
Thermo Fisher Scientific Inc.
- Table 14-22: Thermo Fisher Revenue History, Clinical Diagnostics, 2023-2025 ($ million)
Immunoassays
Microbiology
Molecular Test Business
Next-Generation Sequencing
qPCR
Oncology Companion Diagnostics
Transplant Medicine
Mass Spectrometry
Werfen
- Table 14-23: Werfen Recent Revenue History, 2023-2025 (€ billion)
Chapter 15: Company Profiles: The Second Tier
Scope
ARKRAY
Dry Chemistry / Immunoassays
Urinalysis
BGI Genomics (formerly Beijing Genome Institute)
MGI Tech Co., Limited, China
Prenatal Testing
Test Services
Whole Genome Sequencing (WGS)
NGS Sequencing
Biocartis
Diagnostica Stago S.A.S.
Diasorin S.p.A
POC
Immunoassays
Molecular
Molecular Oncology
Eiken Chemical Co., Ltd
Fujirebio Diagnostics, Inc.
Fulgent Genetics, Inc
GeneDx
Grifols S.A.
Blood Transfusion Business
ABO Blood Typing
Molecular ABO Blood Typing
Immunoassays
Guardant Health, Inc.
Haemonetics
Horiba
Menarini Diagnostics
Meridian Bioscience, Inc.
Mindray – Shenzhen Mindray Bio-medical Electronics Co., Ltd.
Myriad Genetics, Inc.
OraSure Technologies, Inc.
Randox Laboratories Ltd.
Clinical Chemistries
POC and Rapid
Companion Diagnostics
Controls
Evidence Series – Multistat Biochip Analyzers
Molecular
Seegene, Inc.
Sekisui Diagnostics LLC
Veracyte, Inc.
Chapter 16: Company Profiles: Blood Bank Specialists
Scope
AliveDx
Cerus Corporation
Chapter 17: Company Profiles: Core Lab and Other Companies
Scope
SCIEX Pte Ltd.
Diabetes
Molecular
EKF Diagnostics Holdings Plc
Shimadzu Scientific Instruments
Snibe Co. Ltd. (Shenzhen New Industries Biomedical Engineering Co. Ltd.)
Tosoh Bioscience
Trinity Biotech Plc
Chapter 18: Company Profiles: CTC & Liquid Biopsy Test Providers
Scope
Epic Sciences
Foundation Medicine, Inc.
NeoGenomics
Chapter 19: Company Profiles: Specialists
Scope
Ascensia Diabetes Care Holdings AG
Insulet Corporation
Medtronic plc
Verily Life Sciences LLC
Chapter 20: Company Profiles: Hematology (Cell Analysis) and Coagulation Specialists
Scope
CellaVision AB
Masimo Corporation
Nova Biomedical Corporation (Nova)
Chapter 21: Company Profiles: Histopathology Specialists
Scope
Amoy Diagnostics Co. Ltd.
Applied Spectral Imaging Inc. (ASI)
Visiopharm
Chapter 22: Company Profiles: Immunoassay Specialists
Scope
Biohit Healthcare
Biomerica Inc.
Bio-Techne Corporation
Eurobio Scientific
EUROIMMUN AG (Revvity)
INOVA Diagnostics, Inc.
VolitionRx Limited
Chapter 23: Company Profiles: Microbiology Specialists
Scope
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
Chapter 24: Company Profiles: Molecular Test Specialists
Scope
Pacific Biosciences of California, Inc. (PacBio)
Standard BioTools
Chapter 25: Company Profiles: Point of Care Test Specialists
Scope
Abingdon Health Ltd.
binx Health
Chembio Diagnostic Systems, Inc.
Genedrive plc (formerly Epistem Holdings)
MedMira, Inc.
Chapter 26: Company Profiles: Prenatal Test Service Providers
Scope
Berry Genomics Co. ltd.
INEX Innovate
Oxford Gene Technology
Yourgene Health
Chapter 27: Company Profiles: Quality Control & Sample Pretreatment Specialists
Scope
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
Scope
Agendia BV
Ambry Genetics
ARUP Laboratories
Aspira Women’s Health
Blueprint Genetics Oy
Boston Heart Diagnostics
CareDx, Inc.
Predictive Oncology
Labcorp, Laboratory Corporation of America
Mayo Clinic Laboratories
MDxHealth SA
OPKO Diagnostics/Opko Health
Quest Diagnostics
Sonic Healthcare

