The Worldwide Market for In Vitro Diagnostic Tests, 14th Edition

Table of Contents

ONE: EXECUTIVE SUMMARY

• Figure 1-1: The Worldwide IVD Market, 2021-2026 ($millions)
• Scope and Methodology
  • Table 1-1: Exchange Rate Fluctuations, 2018-2020
• Finding What You Are Looking For in the 14th Edition
  • Table 1-2: Finding What You Are Looking For in the 14th Edition
• Size and Growth of the Market
  • Table 1-3: Global In Vitro Diagnostic Sales by Product Market, 2021-2026 ($ millions)
• IVD Market Highlights
  • At Home Testing
  • Competitive Picture in IVD
  • COVID-19 Recovery
  • • Variants
  • What to Watch
  • • Next-Generation Sequencing and IVD
  • • 2021 – Year for Liquid Biopsy?
  • • Urgent Care Proves Out

TWO: INTRODUCTION

IVD Landscape

• Market Analysis of IVD Market Segments
  • Table 2-1: Global In Vitro Diagnostic Sales by Product Market, 2021-2026 ($ million) (COVID-19 Molecular, COVID-19 Immunoassay, Clinical Chemistry; Immunoassays, Infectious Disease; Immunoassays, Other; Blood Bank Screening; Drugs of Abuse; HbA1c Immunoassays, Lab-Based; Hematology; Microbiology (ID/AST); Molecular Microbiology; Radioimmunoassays; Coagulation; Histology/Cytology; HPV, molecular; Nucleic Acid Assays; Blood Grouping/Typing; Blood Bank Molecular; Circulating Tumor Cells; POC, OTC diabetes; Continuous Glucose; POC, OTC Other; POC Professional; Mass Spectrometry)
• Top Suppliers and Niche Players
• Introduction
• Overview of the Top Tier Companies
  • Table 2-2: Revenues of Selected Top IVD Companies, 2015-2019 ($ million, estimated)
• Overview of Selected Second Tier Companies
  • Table 2-3: Revenues of Selected Niche Players, 2015-2019 ($ million, estimated)
• IVD Companies Mergers & Acquisitions
  • Table 2-4: Selected IVD Mergers and Acquisitions
  • Figure 2-1: Share of IVD Market by Segment, Percentage, 2000 and 2021 Compared (Clinical Chemistry, Hematology, Coagulation, Immunoassays, Microbiology (ID/AST), POC Diabetes, POC ‚Äì Other, Histology/Cytology, Molecular, Blood Banking [imm & typing], Others)
• Future
• Point of View

THREE: THE GLOBAL PICTURE FOR IVD MARKETS

• Background
• Simultaneous Threats: Chronic and Acute
• Expected World IVD Market Developments
• The Aging Planet
• Table 3-1: Elderly Support Ratio in Various Countries (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

• Table 3-2: Age Under 15 and Over 65, by Continent (Africa, L. America/Caribbean, Asia, Oceania, N. America, Europe, World))
  • Is the World Prepared for Aging?

Shifting Disease Burdens

• Table 3-3: Changing DALY ranking of Disease Threats (disability-adjusted life year) Worldwide (HIV/AIDS, Malaria, Lung Cancer, TB, Neonatal Preterm Birth, Asthma, Heart Disease, Depression, Stroke, Cerebral Hemorrhage, Low Back Pain, Alzheimer’s, COPD))

Increase in Chronic Diseases

• Emerging and Emerged Markets
• Table 3-4: Available Market Data, 2018 (China, India, United States, Brazil, Russia, Mexico, Nigeria, Turkey, S. Korea, S. Africa, Vietnam, Poland, Saudi Arabia, Canada, Columbia, Ukraine, Egypt, Malaysia))

Emerging Nations and Health Insurance

• Size and Forecast for the Global IVD Market
• Table 3-5: Global In Vitro Diagnostic Market (including non-traditional IVD revenues); Major Country/Region Markets, 2021 and 2025 ($ millions) (United States, EU 15/W. Europe, Japan, China, Canada, Eastern Europe, Brazil, India, Russia, Australia, Turkey, Mexico, Saudi Arabia, South Korea)

The IVD Market in the United States

• Table 3-6: United States IVD Market by Segment, 2021 (%) (Clinical Chemistry, Microbiology ID/AST, Microbiology Molecular, POC Diabetes, POC Other, Immunoassay Infectious Disease, Immunoassay Other, Clinical Sequencing, Nucleic Acid Assays, Coagulation, Histology, Hematology, Blood Grouping, Others)
• PAMA and Reimbursement Changes
• LDT Oversight Update
• Rare Disease Testing
• Personalized Medicine and NGS
• IVD Market in Europe: Continued Recovery
  • Figure 3-1: Europe: Growth in Healthcare Expenditure by Country, Projections 2018-2025 (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom)
• Industry Punches Back
  • Table 3-7: Western European IVD Market by Country, 2021 ($ millions) (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK)
• European Directive 98/79/EC
• Individual Country Markets
  • Figure 3-2: German IVD Market by Broad IVD Segment, 2021 ($ millions) (Chemistry / Hematology, Immunoassays, Microbiology/Virology, Point-of-Care, Histology/Cytology, Other segments)
  • Figure 3-3: French IVD Market by Broad IVD Segment, 2021 ($ millions) (Chemistry / Hematology, Immunoassays, Microbiology/Virology, Point-of-Care, Histology/Cytology, Other segments)
  • Figure 3-4: Italian IVD Market by Broad IVD Segment, 2021 ($ millions) (Chemistry / Hematology, Immunoassays, Microbiology/Virology, Point-of-Care, Histology/Cytology, Other segments)
  • Figure 3-5: Spanish IVD Market by Broad IVD Segment, 2021 ($ millions) (Chemistry / Hematology, Immunoassays, Microbiology/Virology, Point-of-Care, Histology/Cytology, Other segments)
  • Figure 3-6: UK IVD Market by Broad IVD Segment, 2021 ($ millions) (Chemistry / Hematology, Immunoassays, Microbiology/Virology, Point-of-Care, Histology/Cytology, Other segments)
  • Table 3-8: IVD Market Per Capita, Europe, 2018 Estimates (Switzerland, Germany, Netherlands, Sweden, France, Slovenia, United Kingdom, Italy, Spain, Slovakia, Greece, Croatia, Lithuania, Czech Republic, Hungary, Poland, Romania, Serbia, Bulgaria, Russia, Ukraine)

Personalized Medicine in Europe

• Brexit
• Austerity
• Opportunity in Eastern Europe
  • Figure 3-7: Europe: Growth in Healthcare Expenditure by Country, Projections 2018-2025 (Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Slovak Republic, Slovenia)
  • Table 3-9: Eastern European IVD Market by Country, 2021 ($ millions) (Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, Ukraine)
  • Figure 3-8: Eastern Europe IVD Market by Country ‚Äì Segment Distribution, 2021 ($ millions) (Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, Ukraine)
• Japan: Second-Largest Country Market
  • Table 3-10: Japan IVD Market by Segment, 2021 (%) (Clinical Chemistry, Microbiology ID/AST, Microbiology Molecular, POC Diabetes, POC Other, Immunoassay Infectious Disease, Immunoassay Other, Coagulation, Histology, Hematology, Others)
• China: Largest High-Growth Market
  • Table 3-11: China IVD Market by Segment, 2021 (%) (Clinical Chemistry, Microbiology ID/AST, Microbiology Molecular, POC Diabetes, POC Other, Immunoassay Infectious Disease, Immunoassay Other, Coagulation, Histology, Hematology, Others)
  • Table 3-12: Total Midyear Population by Broad Age Group: China (million persons), 2010-2050
  • Clinical Laboratory Tests in China
  • • Figure 3-9: Number of Visits and Admissions to Hospital Institutions in China Annually, 2015 (General Hospitals, Specialized Hospitals, Chinese Medical Hospitals, Community Health Service Centers, Health Centers [Urban and Township], Village Clinics, Others)
  • Private Laboratories
  • Distribution in China
• India: Home to Every Sixth Person in the World
  • Table 3-13: India IVD Market by Segment, 2021 (%) (Clinical Chemistry, Hematology, Coagulation; Microbiology; POC Diabetes; POC Other; Immunoassay; Histology; Others)
• Labs in India
• Rest of Asia
• Table 3-14: Asia Pacific IVD Market by Country, 2021 ($ millions) (Australia, South Korea, Indonesia, Thailand, Philippines, Malaysia, Singapore, Vietnam)
• Brazil: LATAM Leader
• Disease Trends
  • Table 3-15: Brazil IVD Market by Segment, 2021 (%)
• Mexico
  • Table 3-16: Mexico IVD Market by Segment, 2021 (%) (Clinical Chemistry, Microbiology ID/AST, Microbiology Molecular, POC Diabetes, POC Other, Immunoassay Infectious Disease, Immunoassay Other, Coagulation, Histology, Hematology, Others)
• The Russian Federation
• Canada
• Emerging Markets
• Saudi Arabia IVD Market
• South Africa IVD Market
• Turkey IVD Market
• Columbia IVD Market
• United Arab Emirates (UAE) IVD Market
• South Korea IVD Market
• Other Markets to Watch
• IVD Market Opportunity
  • Table 3-17: IVD Market Opportunity by Country (2020 Market Rank, 2021 Market Rank, Country CAGR 2021-2026) (China, Philippines, Brazil, Israel, Malaysia, India, Mexico, Indonesia, Chile, Poland, Saudi Arabia, South Korea, Romania, Colombia, United Arab Emirates, Argentina, Hungary, Vietnam, Iraq, Peru, Japan, France, Turkey, Egypt, Singapore, Luxembourg, Croatia, Jordan, U.S., Germany, United Kingdom, Canada, Spain, Russia, Netherlands, Switzerland, Belgium, Sweden, Austria, Denmark, Ireland, Finland, Iran, Thailand, Venezuela, Italy, Australia, Portugal, Greece, Czech Republic, South Africa, Norway, Bulgaria, Slovakia, Slovenia)

FOUR: COMPANY TRENDS

• Introduction
• COVID-19
• At-Home Testing
  • Table 4-3: Selected Gene Editing / CRISPR Innovations
• CRISPR as a Diagnostic Tool
• Basic Research
• Food Industry
• Investor Interest
• Microbiome
  • Table 4-4: Selected Microbiome Test Innovations
• Liquid Biopsy
• AI in Clinical Practice
• Sepsis
• Other Trends

FIVE: POINT OF CARE TESTS

• Overview and Trends
• Professional POC
  • Table 5-1 Professional POC Test Sales by Category, Worldwide 2020 -2025 ($million) (Glucose, Critical Care POC, Fertility, Infectious Diseases, Cardiac Markers, Cholesterol, Coagulation, HbA1c POC, Hematology, Fecal Occult Blood, Drugs of Abuse, Others)
  • Table 5-2: Selected Profession POC Test Innovations
• OTC Self Testing
  • able 5-3: POC Self-Test Sales by Category, Worldwide, 2021-2026 ($million) (Glucose, Self; Glucose, Continuous; Pregnancy; Coagulation; Fecal Occult Blood; Drugs of Abuse; H. pylori; HIV; Cholesterol; Urinalysis; Other [TSH, Allergy, Autoimmune, etc])
• Pregnancy/Fertility Tests
  • Table 5-4: POC Pregnancy and Fertility Test Market Distribution by End User, 2021 (%) (OTC, PRO)
  • Table 5-5: Pregnancy/Fertility POC Test Sales Distribution by Global Region, 2021 (United States, Europe, Japan, RoW)
• Colon Cancer Screening
  • Table 5-6: Colon Cancer POC Test Sales Distribution by Global Region, 2021 (United States, Europe, Japan, RoW)
• Lipid Testing
  • Table 5-7: Lipid POC Test Sales Distribution by Global Region, 2021 (United States, Europe, Japan, RoW)
• POC Infectious Disease Testing
  • Table 5-8: Innovations in Molecular POC Infectious Disease Diagnostics
  • Products
  • • HIV and Hepatitis Testing and Monitoring
  • • Tuberculosis
  • • Tropical and Neglected Diseases
  • • Respiratory Diseases
  • • Sepsis and Nosocomial Disease
  • • Sexual Health
  • • Lyme Disease
  • Table 5-9: Innovations in Molecular POC Infectious Disease Diagnostics
  • Market Size and Growth
  • • Table 5-10: Infectious Disease POC Test Demand by Type, 2021 (Influenza, HIV, STD, Hepatitis, Malaria, c.difficile, E.Coli, H.pylori, Home Test/OTC, Others)
  • • Table 5-11: Infectious Disease POC Test Sales Distribution by Global Region, 2021 (United States, Europe, Japan, RoW)
• Diabetes Testing ‚Äì Blood Glucose Monitoring
• Glucose Testing in Tight Economics
  • • Table 5-12: Glucose POC Test Sales Distribution by Global Region, 2021 (United States, Europe, Japan, RoW)
  • • Figure 5-1: POC Glucose Testing Market Growth by Category, 2021-2026 CAGR (%) (Glucose OTC; Glucose Professional; Glucose, continuous; HbA1c POC)
  • IT to Aid Diabetes Management
  • • Table 5-13: Selected Apps and Glucose Management IT
  • Diabetes Market Analysis
  • • Table 5-14: Global Diabetes Sales by Test Category, 2021-2026 (Glucose, OTC; Glucose, professional; Glucose, continuous; HbA1c, POC; TOTAL; HbA1c, Lab) ($ millions)
  • • Table 5-15: POC Test Revenues of Selected IVD Glucose Companies, 2021 ($ million, estimated)

Blood Glucose Self-Testing

• • • Table 5-16: Selected Glucose Self-Test Meter Innovations

Noninvasive Testing Devices

• • • Table 5-17: Selected Noninvasive Glucose Monitoring Devices
• • Continuous Self Testing en Route to the Artificial Pancreas
• • • Table 5-18: Selected Continuous Blood Glucose System Developments
• • Blood Glucose Testing by Professionals
• • • Table 5-19: Selected Innovations in Hospital-based Glucose Monitoring
• • Diabetes Testing ‚Äì Glycated Hemoglobin
• • • Table 5-20: Global HbA1c Test Sales Market and Distribution by Setting, 2021-2026 ($ millions) (HbA1c POC, HbA1c Lab)
• • • Table 5-21: Selected POC HbA1c Devices
• • Genes and Other Markers of Diabetes
• • • Table 5-22: Selected POC Diabetes Monitoring Tests
• • Drugs of Abuse Testing
• • • Table 5-23: POC Drugs of Abuse Test Sales Distribution by Setting, 2021 (Employment Screening, Criminal Justice, Critical Care ‚Äì Traditional POC)
• • Products
• • • Table 5-24: Drugs of Abuse Tests on the Market
• • The Major POC Test Players
• • • Table 5-25: POC Test Revenues of Selected IVD Companies (excluding glucose), 2018-2019 ($ million, estimated)

SIX: THE CORE LAB

• • Core Lab Overview and Trends
• • • Table 6-1: Workstation Sales, 2021-2026 (General Chemistries, Immunoassays on workstations; $ millions)
• • • Table 6-2: Workstation Sales (General Chemistries, Immunos on Workstations) of the Top Five Manufacturers, 2018-2019 ($ millions, estimated)
• • • Table 6-3: Selected New Analytes for the Core Lab, 2018-2020
• • Connectivity
• • Overview of Chemistry Tests
• • Lab Automation
• • Service Plans
• • Market Analysis
• • • Table 6-4: Global Clinical Chemistry Sales by Test Category, 2021-2026 ($millions) (General Chemistries, Blood Gases, Urinalysis)
• • • Table 6-5: Global Clinical Chemistry Sales Distribution by Region, 2021 (North America, Europe, Asia Pacific, RoW)
• • • Table 6-6: Major Clinical Chemistry Companies
• • • Table 6-7: Selected Clinical Chemistry Innovations
• • Rapid Response Systems
• • • Table 6-8: Major Whole Blood Chemistry Analyzers
• • Critical Care Analysis
• • • Table 6-9: Blood Gas, Electrolyte and Critical Care Instrument Market by End User, 2021 and 2025 (Lab-based, POC-based)
• • • Table 6-10: Blood Gas, Electrolyte, and Critical Care Market Leaders, 2021 (percent distribution of total sales)
• • User Apps
• • • Table 6-11: Selected Apps, Critical Care and Urinalysis IT Innovations
• • Urinalysis
• • • Table 6-12: UA Market by End User, 2021 and 2025 (Lab-based, POC-based)
• • • Table 6-13: Urinalysis Systems Market Leaders, 2021 (percent distribution of total sales)
• • • Table 6-14: Selected Urinalysis Innovations
• • Sleep Apnea Testing: Core Lab Solution?
• • The Commercial Outlook for Chemistry Tests

SEVEN: IMMUNOASSAYS

• • Overview and Trends
• • Immunoassay Technology Continues to Evolve
• • • Table 7-1: Selected Immunoassay Technologies 2020
• • Mass Spectrometry
• • • Table 7-2: Selected Innovation in Mass Spectrometry for Routine Analyses
• • Immunoassays in the Core Lab
• • • Figure 7-1: Workstation (General Chemistries, Immunos on Workstations) Sales Growth, CAGR 2021-2026
• • • Table 7-3: Selected Immunoassay Innovations on Core Lab Instruments
• • Radioimmunoassays
• • Market Analysis
• • Leading Suppliers and Growth Potential
• • • Table 7-4 Global Lab-based Immunoassay (excluding infectious disease and blood screening) Sales, by Analyte Type, 2021-2026 ($millions) (Cardiac Markers, Tumor Markers, Autoimmune, Diabetes/HbA1c, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Drugs of Abuse, Vitamin D, Total; w/o HbA1c)
• • • Table 7-5: Global Immunoassay (excluding infectious disease and blood screening) Sales Distribution by Region, 2021 (%) (North America, Europe, Asia Pacific, RoW)
• • • Table 7-6: Selected Immunoassay Quality Control Products
• • • Table 7-7: 2019 Revenue of Leading Immunoassay Vendors (in millions $), Estimated
• • Thyroid Function
• • Therapeutic Drug Monitoring
• • Anemia
• • Toxicology/DAU
• • Allergy
• • Proteins
• • Growth Immunoassays
• • Vitamin D
• • • Table 7-8: Selected Vitamin D Immunoassays
• Tumor Markers
  • • Table 7-9: Selected Tumor Marker Innovations
• Cardiac Markers
  • • Table 7-10: Selected Cardiac Marker Innovations
• Autoimmune
  • • Table 7-11: Selected Autoimmune Test Innovations
• Rheumatoid Arthritis
  • • Table 7-12: Selected Arthritis Immunoassay Innovations
• Gastrointestinal Disorders
  • • Table 7-13: Selected Inflammatory Bowel Disease Test Innovations
• Transplant Management
  • • Table 7-14: Selected Immunoassays for Transplant Medicine
• Women’s Health
  • • Table 7-15: Selected Women’s Health Innovations
• Alzheimer’s Disease
  • • Table 7-16: Selected Innovations for Alzheimer’s Disease Immunoassays
• Sleep Apnea
• Miscellaneous
  • Table 7-17: Selected Immunoassay Innovations
  • • Point-of-Care OTC and Professional Use
  • Table 7-18: Global POC Immunoassay Sales Distribution by Region, 2021 (United States, Europe, Japan, RoW)
  • Table 7-19: Global POC Immunoassay Test Sales by Test Category, 2021-2026 (millions $) (OTC/Self Tests: Pregnancy/Ovulation, Drugs of Abuse, HIV, H. pylori, Other, OTC/Self Total; Professional POC: Cardiac Markers, Drugs of Abuse, HbA1c, Pregnancy, Other, Professional Total)
  • Innovations
  • • Table 7-20: Selected Self-Test Immunoassay Innovations
  • Pregnancy Testing
  • Cardiovascular Diagnostics
  • Drugs of Abuse/Therapeutic Drug Monitoring
  • Innovating POC
  • • Table 7-21: Selected POC Test Innovations
  • • Table 7-22: Selected POC Immunoassay Test Platforms
• The Commercial Outlook for Immunoassays

EIGHT: MOLECULAR ASSAYS

• 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
• Advanced Molecular Tests and Technologies
• Exosome Sequencing
  • Table 8-3: Selected Exosome Test Innovations
• Liquid Biopsy
  • Table 8-4: Selected Liquid Biopsy Innovations
• Metabolomic Profiling
• Information Technology for Test Value
  • Table 8-5: Selected IT Innovations in Molecular Diagnostics
• Forensic Studies ‚Äì 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, 2018-2020 (in millions $)
• Market Analysis
  • Table 8-10: Global Molecular Test Sales by Type 2021-2026 (in millions $) (Oncology, Transplant Testing, Thrombophilia SNPs, Pharmacodiagnostics, Inherited Diseases)
• Oncology
  • Table 8-11: Global Molecular Cancer Test Sales Distribution by Region, 2021 (North America, Europe, Asia Pacific, RoW)

Pharmacodiagnostics

• • Table 8-12: Global Pharmacodiagnostic Sales Distribution by Region, 2021 (North America, Europe, Asia Pacific, RoW)
• • Table 8-13: Selected Molecular Tumor Marker Test Innovations
• Inherited Diseases and Thrombophilia SNPs
• Psychiatric Disorders
• Prenatal and Newborn Testing
• The Commercial Outlook for Molecular Tests

NINE: HEMATOLOGY

• Overview of Hematology and Trends
• Digital Image Analysis
  • Table 9-1: CellaVision Market Share Data by Hematology Vendor
  • Table 9-2: Selected Hematology Image Analysis Innovations
• Digital Evolution
• Quality Control Measurement Programs
• Laboratory-based Hematology Testing
  • Table 9-3: Selected Hematology Innovations
  • Table 9-4: Global Laboratory-based Hematology Test and Instrument Market, 2021 and 2025 ($ millions)
• Regional Laboratory-based Hematology Test and Instrument Market
  • Table 9-5: Global Laboratory-based Hematology Test and Instrument Market, by Region, 2021 (North America, Europe, Asia Pacific, RoW)
• Decentralized Hematology Testing
• Hemoglobin/Hematocrit at the POC
  • Table 9-6: Selected POC Hemoglobin and Hematocrit Systems
  • Table 9-7: Decentralized Hematology Test and Instrument Market, 2021 and 2025 ($ millions) (Instruments, lab-style; Handheld devices)
• Market Analysis: Leading Suppliers
  • Table 9-8: Top Hematology, including d-dimer, Company Revenues (laboratory and POC), 2021 ($ millions)
  • Table 9-9: Global Hematology (Laboratory-based and POC) Sales Distribution by Region, 2021 (North America, Europe, Asia Pacific, RoW)
• The Commercial Outlook for Hematology Tests

TEN: COAGULATION

• Overview and Trends of Coagulation and Immunohematology Tests
• Special Topics
  • Direct Oral Anticoagulants (DOACs)
  • D-dimer
  • Table 10-1: Global D-dimer Sales Distribution by Region, 2021 (North America, Europe, Asia Pacific, RoW)
• Market Analysis
  • Table 10-2: Global Coagulation Sales by Segment, 2021-2026 ($millions) (PT/INR Labs, Molecular, Professional POC, Professional Self; D-dimer)
  • Table 10-3: Global Coagulation Test and Instrument Market by Region, 2021 (North America, Europe, Asia Pacific, RoW)
• Lab-based Testing
  • Table 10-4: Selected Lab-based Coagulation Innovations
• Genetic Markers of Hypercoagulopathies
  • Table 10-5: Global Molecular ‚Äì Thrombophilia SNP Sales Distribution by Region, 2021 (North America, Europe, Asia Pacific, RoW)
  • Table 10-6: Selected Molecular Coagulation Test Innovations
• Leading Suppliers: Laboratory Systems
  • Table 10-7: Top Coagulation Company Revenues, Laboratory-based ‚Äì 2021 ($ millions)
• Decentralized Coagulation Testing ‚Äì Professional Use
• Decentralized Coagulation Testing ‚Äì OTC
  • Table 10-8: Selected POC Coagulation Test Innovations
• Platelet Testing
  • Table 10-9: Selected Platelet Activity Test Innovations
• Leading Suppliers: POC Systems
  • Table 10-10: Top Coagulation Company Revenues, POC ‚Äì 2021 ($ millions)
• The Commercial Market for Coagulation Tests
  • Table 10-11: Major Anticoagulants Uses and Tests

ELEVEN: MICROBIOLOGY

The Burden of Infectious Disease

• • Table 11-1: The Top Ten Leading Causes of Death
• Hidden Costs of Non-Detection: Secondary Effects
• Herpes and Alzheimer’s Disease
• Ebola and Cancer
• HIV and Cancer
• H pylori and Cancer
• Bacteria and Parkinson’s
• Microbial Antibiotic Resistance ‚Äì The Role of Clinical Tests
  • Table 11-2: Selected Companies Developing Faster Identification, Some Also with Antimicrobial Susceptibility/Resistance Tests
• Traditional Microbiology and Its Limits
• The New Microbiology ‚Äì Innovations
• Liquid Based Microbiology and Automation Innovations
• Post-Blood Culture Microbial ID
• PCR and Other NAAT-Based Tests for Infectious Diseases
  • Table 11-3: Selected Nucleic Acid Amplification Test and Other Molecular Companies in Microbiology
• Microbiome-Related Microbiology Tests
  • Table 11-4: Selected Microbiome-Based Tests
• Next Generation Sequencing-Based Microbiology Approaches
  • Table 11-5: Selected Companies Applying DNA/RNA Sequencing to Microbiology
• Syndromic Testing
• Emerging Infectious Disease Threats
  • Table 11-6: Selected Companies Marketing Products Addressing Emerging Infectious Disease Threats
  • Tickborne Diseases: Beyond Lyme
  • Zika
  • Chagas
  • Dengue
  • Ebola
  • Chikungunya
  • Next Threats?
• Microbiology Firms Acquisitions and Collaborations
• Market Analysis
  • Table 11-7: Global Microbiology Sales Distribution by Region, 2021 (North America, Europe, Asia Pacific, RoW)
• Market Analysis ‚Äì Traditional Microbiology ID/AST
  • Table 11-8: Global Microbiology ID/AST Market, 2021-2026 (in millions USD) (ID/AST Auto, ID/AST Panels, Blood Culture, Chromogenic Media, Rapid Microbiology; ID/AST Supplies)
  • Table 11-9: Global ID/AST Testing Sales Distribution by Region, 2021 (North America, Europe, Asia Pacific, RoW)
• Traditional ID/AST
  • Table 11-10: Global ID/AST Testing, Distribution by Systems, 2021 (%) (Panel, Auto)
• Blood Culture
  • Table 11-11: Selected Advanced Techniques in Positive Blood Culture
• Chromogenic Media
• Rapid Tests Performed on Colonies from Culture Media
• Supplies
• Market Analysis ‚Äì Microbiology Immunoassays
• Improvements in Microbiology Immunoassays
  • Table 11-12: Selected Infectious Disease Immunoassay Innovations
  • Table 11-13: Global Clinical Laboratory-Based Microbiology/Infectious Disease Immunoassay Market by Pathogen, 2021 (in $ millions) (Hepatitis, HIV, STDs, TORCH, Respiratory, HAIs/Sepsis, Parasitology, Mycology, Lyme disease, Other)
  • Table 11-14: Global Clinical Chemistry Laboratory-Based Microbiology/Infectious Disease Immunoassay Market Distribution (by %) by Region, 2021 (North America, Europe, Asia Pacific, RoW)
• Hepatitis Testing
• Sepsis
• HIV Immunoassay Testing
  • Table 11-15: Selected HIV Assays
• Sexually Transmitted Diseases (STDs)
• TORCH
• Lyme Disease
• Rapid Immunoassay Tests
  • Table 11-16: Global Rapid Immunoassay Testing Market, Sales Distribution by Pathogen, 2021 (%) (Influenza, HIV, STD, Hepatitis, Malaria, c.difficile, E.Coli, H.pylori, Home Test/OTC, Others)
• Market Analysis ‚Äì Molecular Microbiology
  • Table 11-17: Global Molecular Microbiology Sales Distribution by Region, 2021 (%) (North America, Europe, Asia Pacific, RoW)
  • Table 11-18: Global Molecular Microbiology Market, by Pathogen/Disease Indication, 2021-2026 (in $ millions) (HAI, HIV, Hepatitis, GC/Chlamydia, Respiratory, Organism ID, Mycobacteria/TB, Others; Blood Bank Screening)
• Molecular Respiratory Infection Testing
  • Table 11-19: Selected Molecular Point of Care Innovations in Microbiology
• Molecular Testing for Sexually Transmitted Diseases
• 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
• Clostridium Difficile
• MRSA
• Molecular TB Testing
• Limitations of Molecular Microbiology Testing
• Mass Spectrometry
  • 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 Microbiology

TWELVE: BLOOD BANKING SERVICES

• Overview
  • Table 12-1: History of Blood Testing
• The Current Status of Global Blood Collection
  • Table 12-2: Distribution of Blood Units Collected, 2011-2013 (United States, United Kingdom, India, Japan, China, Canada, ROW, World Total)
• Global Blood Safety
  • Table 12-3: Laboratory Screening of Blood Donations for Transfusion-Transmissible Infections, Number of Countries (Syphilis, HCV, HBV, HIV, Chagas, Malaria, HTLV I/II)
  • Table 12-4: Prevalence of TTIs in Blood Donations [Median (Interquartile range)], by Income Group
• Zika Virus
• Blood and Component Collection
  • Table 12-5: Blood Component Usage for Selected Conditions
  • Table 12-6: Red Blood Cell and Platelet Use by Hospital Services (%)
• Reevaluating Blood Transfusions
  • Table 12-7: 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
• Reducing Blood Typing Errors
  • Table 12-8: Selected Blood Typing and Grouping Innovations
• Size and Growth of Typing Markets
  • Table 12-9: Global Blood Typing Market, 2021-2026 (Typing) (in $ millions)
• Blood Typing Market by Geography
  • Table 12-10: Global Blood Typing Sales Distribution by Region, 2021 (%) (North America, Europe, Asia Pacific, RoW)
• Blood Testing Market
  • Table 12-11: Selected Blood Testing Innovations
• Preventing Bacterial Infections
• Immunoassays
• Nucleic Acid Testing (NAT)
• Size and Growth of the Market
  • Table 12-12: Global Blood Banking Diagnostics Market, 2021-2026 (Immunoassay Screen, NAT Screens) (in $ millions)
• Blood Testing Market by Geography
  • Table 12-13: Global Blood Testing Market by Geography, 2021 (%) (North America, Europe, Asia Pacific, RoW)
  • Table 12-14: Global Blood Testing Market by Country, 2021 (%) (United States, Canada, Germany, United Kingdom, France, Japan, China, Latin America)
• The Commercial Outlook for Blood Banking Testing

THIRTEEN: HISTOLOGY AND CYTOLOGY

• 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 Goes Core Lab
• Table 13-4: Global HPV Test Sales Distribution by Region, 2021 (%) (North America, Europe, Asia Pacific, RoW)
• Table 13-5: Selected HPV Test Innovations
• Market Analysis
• Table 13-6: Global Histology/Cytology Sales by Type, 2021-2026 ($ millions) (Pap Tests, in situ hybridization, immunohistochemistry, traditional non-Pap stains, HPV, TOTAL; Digital Imaging, CTCs, Flow Cytometry)

Histology/Cytology

• Table 13-7: Global Histology/Cytology Sales Distribution by Region, 2021 (%) (North America, Europe, Asia Pacific, RoW)
• Table 13-8: Revenues of the Major Histology Companies, 2018-2020 ($ millions, estimated)
• Table 13-9: Selected Vendors of Traditional Histology Stains
• Immunohistochemistry and In Situ Hybridization
• Table 13-10: Selected In Situ Hybridization-based Tests
• Table 13-11: Selected IHC Test Innovations
• Pharmacodiagnostic Histology
• Table 13-12: Major Pharmacodiagnostic Markers
• Table 13-13: Selected Pharmacodiagnostic Histology Tests
• Digital Imaging and Computational Pathology
• Table 13-14: Selected Digital Imaging Innovations
• Circulating Tumor Cells
  • Table 13-15: Selected Innovations in CTC Technology
• Flow Cytometry
• The Commercial Outlook for Histology and Cytology Tests

FOURTEEN: COMPANY PROFILES: THE TOP TIER

• Abbott Diagnostics
• Arkray
• Beckman Coulter
• Becton, Dickinson and Company (BD)
• bioM√©rieux Inc.
• Bio-Rad Laboratories, Inc.
• Cepheid
• Danaher Corporation
• DiaSorin S.p.A
• Grifols S.A.
• Hologic, Inc.
• Instrumentation Laboratory (IL) / Werfen
• Illumina
• Ortho Clinical Diagnostics (Ortho)
• QIAGEN N.V.
• Quidel Corporation
• Radiometer A/S / Danaher
• Roche Diagnostics
• Siemens Healthineers (Siemens)
• Sysmex Corporation
• Thermo Fisher Scientific Inc.
• Werfen

Other Companies:

• AB SCIEX Pte Ltd.
• Accelerate Diagnostics, Inc.
• Advaita Corp.
• Advanced Biological Laboratories, S.A. (ABL)
• Advanced Cell Diagnostics (ACD)
• altona Diagnostics
• Amoy Diagnostics Co. Ltd.
• Angle, plc
• Animas Corporation
• Applied Spectral Imaging Inc. (ASI)
• ArcDia International Oy Ltd.
• ARUP Laboratories
• Ascensia Diabetes Care Holdings AG
• BGI Genomics (formerly Beijing Genome Institute)
• Bigfoot Biomedical Inc.
• Binding Site Group Ltd. (The)
• Biocartis
• Biocept, Inc.
• Biodesix
• BioFire Diagnostics, LLC. (acquired by bioM√©rieux)
• BioGenex Laboratories, Inc.
• Biohit Oyj (Biohit Healthcare)
• Biomerica Inc.
• BioReference Laboratories
• Bio-Techne Corporation
• Biotheranostics
• BioView Ltd.
• Bloodsource (Vitalant)
• BluePrint Genetics Oy
• Boston Heart Diagnostics
• Bruker Corporation
• CareDx, Inc.
• CellaVision AB
• Cepheid / Danaher
• Cerner Corp.
• Cerus Corporation
• Cervical Cancer Screening
• Cleveland HeartLab Inc.
• Companion Diagnostics
• COPAN ITALIA S.p.A. and COPAN Diagnostics, Inc.
• Corgenix Medical Corporation
• Critical Diagnostics
• Curetis
• Cynvenio Biosystems (LungLife AI)
• Dako A/S
• Dexcom Inc.
• Diagnostica Stago, S.A.S.
• DIAGON Kft. Hungary
• DISCOVERY Product Line
• DNAnexus Inc.
• Edico Genome (Illumina)
• Eiken Chemical Co., Ltd
• EKF Diagnostics Holdings Plc
• ELITech Group S.A.S.
• Epic Sciences
• Epigenomics AG
• ERBA Diagnostics, Inc.
• Foundation Medicine, Inc.
• Fujirebio Diagnostics, Inc.
• GeneWEAVE Biosciences, Inc.
• Genomic Health (Exact Sciences)
• Greiner Bio-One International GmbH
• Guardant Health, Inc.
• Haemokinesis Pty Ltd
• Hain Lifescience GmbH
• Helomics Corporation
• HOB Biotech
• Horiba Medical
• HTG Molecular Diagnostics
• Human Longevity Inc.
• Illumina
• Immucor
• Immunodiagnostic Systems (IDS)
• Immunohistochemistry ‚Äì IHC
• INOVA Diagnostics, Inc.
• Kapa Biosystems Inc.
• Key Comment
• LabCorp, Laboratory Corporation of America
• Leica Biosystems
• LifeScan Inc.
• Luminex Corporation
• Medica Corporation
• MedTest DX
• Medtronic plc
• Menarini Diagnostics
• Menarini-Silicon Biosystems
• Meridian Bioscience, Inc.
• MilliporeSigma
• Mindray
• Mobidiag Ltd.
• Myriad Genetics, Inc.
• Natera
• Nemaura Medical Inc.
• NeoGenomics
• One Lambda, Inc
• OpGen, Inc.
• OPKO Diagnostics
• Orgentec Diagnostika
• Pathway Genomics Corporation
• PerkinElmer, Inc. (PE)
• Quest Diagnostics
• Randox Laboratories Ltd.
• Reliance Life Sciences
• Rennova Health, Inc.
• Response Biomedical Corp.
• Sanofi
• Scienion AG
• Sekisui Diagnostics LLC
• Shimadzu Scientific Instruments
• Singulex, Inc.
• Snibe Co. Ltd.
• Sonic Healthcare
• Tecan Group
• Tosoh Bioscience
• Trinity Biotech Plc
• Trividia Health Inc.
• Veracyte, Inc.
• Verily Life Sciences LLC
• Vermillion Inc.
• Visiopharm
• VolitionRx Limited
• West Medica
• WuXi NextCODE