IVD 검사 시장(제19판)

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; H. 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]