Table of Contents
CHAPTER ONE: EXECUTIVE SUMMARY
• Figure 1-1: The Worldwide IVD Market, 2018, 2023 and 2028 ($billions)
• Figure 1-2: COVID-19 IVD Market Share, by Segment (Immunoassay Lab-Based, Molecular Dx Lab-Based, Point-of-Care), 2022
SCOPE AND METHODOLOGY
SIZE AND GROWTH OF THE MARKET
• Table 1-1: Global In Vitro Diagnostic Sales by Product Market, 2023-2028 ($ million) (Clinical Chemistry; Immunoassays- Infectious disease, Other immunoassays, Blood bank screening, Drugs of Abuse, Diabetes HbA1c – lab; Hematology – Core Lab; Microbiology (ID/AST); Microbiology (molecular); Coagulation; Histology/cytology; HPV, molecular; Nucleic acid assays; Blood grouping/typing; Blood bank molecular -NAT Screens; Circulating tumor cells; POC, OTC diabetes; Continuous Glucose, POC, OTC other; POC, professional/hospital; Mass Spectrometry) and COVID-19 Dx
MARKET HIGHLIGHTS
COMPETITIVE PICTURE IN IVD
• Figure 1-3: IVD Leaders, by Company (Abbott, Danaher, Roche, Siemens Healthineers)
WHAT TO WATCH LONG-TERM
China
Emerging Market Growth
Globalization, Climate Change
FINDING WHAT YOU ARE LOOKING FOR IN THE 16TH EDITION
• Table 1-2: Finding What You Are Looking For in the 16th Edition
CHAPTER TWO: INTRODUCTION
IVD LANDSCAPE
REPORT DESIGN
Changes Between 15th and 16th Editions
PAMA AND CMS
MARKET ANALYSIS OF IVD MARKET SEGMENTS
• Table 2-1: Global In Vitro Diagnostic Sales by Product Market, 2023-2028 ($ million) (Clinical Chemistry; Immunoassays- Infectious disease, Other immunoassays, Blood bank screening, Drugs of Abuse, Diabetes HbA1c – lab; Hematology – Core Lab; Microbiology (ID/AST); Microbiology (molecular); Coagulation; Histology/cytology; HPV, molecular; Nucleic acid assays; Blood grouping/typing; Blood bank molecular -NAT Screens; Circulating tumor cells; POC, OTC diabetes; Continuous Glucose, POC, OTC other; POC, professional/hospital; Mass Spectrometry) and COVID-19 Dx
• Figure 2-1: Developed vs. Developing IVD Market Shares, 2023 and projected 2028 (%)
TOP SUPPLIERS AND NICHE PLAYERS
Introduction
Overview of the Top Tier Companies
• Table 2-2: Clinical Diagnostic Revenues of Selected Top 20 IVD Companies, 2022 and estimated 2023 ($ million)
• Abbott Diagnostics
• Roche Diagnostics
• Ventana Medical Systems/ Roche Tissue Diagnostics
• Danaher Corporation
• Cepheid
• Radiometer
• Beckman Coulter
• Siemens Healthineers
• Thermo Fisher Scientific
• Illumina
• Becton Dickinson & Co
• Dexcom
• bioMérieux
• Sysmex Corporation
• QuidelOrtho Corporation
• Exact Sciences
• Werfen
• Instrumentation Laboratory
• Inova Diagnostics
• Hologic
• Bio-Rad Laboratories
• Agilent
• DiaSorin Group
• QIAGEN N.V.
• Mindray
• Natera
Overview of Selected Second Tier Companies
• Table 2-3: Revenues of Selected Top 20 Niche Players, 2022 and estimated 2023 ($ million, estimated)
• Bruker/CALID Group
• PerkinElmer (Revvity)
• Myriad Genetics
• Grifols S.A.
• BGI Genomics
• Guardant Health
• Sekisui Diagnostics
• Invitae
• Diagnostica Stago
• Fujirebio
• OraSure Technologies
• Eiken Chemical Co
• Nihon Kohden
• Fulgent Genetics
• Meridian
• Horiba/ABX
• Menarini Diagnostics
• Masimo
• Veracyte
• BioCartis
THE IMPACT OF COVID FOR THE TOP TIER COMPANIES
• Figure 2-2: Top Tier Market Distribution, 2022 and 2023, estimated (%)
IVD COMPANIES MERGERS & ACQUISITIONS
• Table 2-4: Selected IVD Mergers and Acquisitions 2019-2023 (first half)
COLLABORATION, PARTNERSHIP, ALLIANCE AGREEMENTS
• Table 2-5: Selected IVD Partnerships/Collaborations/Alliance Agreements, 2016-2019
TEST SERVICES
• Table 2-6: Selected Test Services, Sales, by Company (Exact Sciences Corp. Myriad Genetics, NeoGenomics), 2017-2022 ($ millions, estimated where applicable)
• Table 2-7: Global Lab Market Segmentation, by Segment (Hospital and Acute Care Labs, Independent Labs, Physician Office Labs), 2022 ($ billions)
• Table 2-8: Clinical Laboratory Revenues for Selected of U.S.-based Reference Labs, by Company (Bio-Reference Lab/OPKO, Labcorp, Quest Diagnostics), 2017-2022 ($ million, estimated)
• Table 2-9: Estimated Clinical Test Volume, by Select Independent Laboratory (Bio-Reference Lab/Opko, Eurofins Scientific, Labcorp, Medicover, NeoGenomics, Quest Diagnostic, Sonic Healthcare, Unilabs), 2022 (millions of units)
• Table 2-10: Estimated COVID-19 Test Volume, by Select Independent Laboratory (Bio-Reference Lab/Opko, Eurofins Scientific, Labcorp, Medicover, Medicover, NeoGenomics, Quest Diagnostic, Sonic Healthcare, SynLab, Unilabs), 2022 (millions of units)
HISTORICAL IVD MARKET VS TODAY
In the Beginning to Now
• Figure 2-3: Share of IVD Market by Segment, Percentage, 2000 and 2023 Compared (Clinical Chemistry, Hematology, Coagulation, Immunoassays, Microbiology (ID/AST), POC Diabetes, POC – Other, Histology/Cytology, Molecular, Blood Banking [imm & typing], Others)
Future
• Next-Generation Sequencing
• Cancer Testing (Liquid Biopsy)
• Companion Diagnostics
POINT OF VIEW
• Figure 2-4: IVD Market, by Segment (Clinical Chemistry; Immunoassays- non isotopic: Infectious disease, immunoassays, Blood bank screening, Drugs of Abuse, Diabetes HbA1c – lab; Hematology – Core Lab; Microbiology (ID/AST); Microbiology [molecular]; Microbiology – Mass Spectrometry; Coagulation [PT/INR]; Coagulation, molecular; Histology/cytology; HPV, molecular; Nucleic acid assays; Blood grouping/typing; Blood bank molecular – NAT Screens; Circulating tumor cells; POC, OTC diabetes; POC, OTC other; POC, professional/hospital; Mass Spectrometry), 2019 Compared to 2023 (%)
COVID-19 IMPACT AND SUMMARY
• Figure: 2-5: Combined Performance in COVID-19 and non-COVID-19 IVD Market Segments, 2020-2028 ($ million)
COVID-19 Market Value
• Table 2-11: COVID-19 Market Share, by Segment (Immunoassay, Molecular, Rapid – POC), 2023 (%)
• Figure 2-6: IVD COVID-19 Market, Distribution by Region (North America, Europe, Asia Pacific, RoW), 2023 (%)
CHAPTER THREE: THE GLOBAL PICTURE FOR IN VITRO DIAGNOSTIC MARKETS
BACKGROUND
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 (billions)
• Figure 3-2: Global Population Distribution, 2022
• 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), 2010 vs. 2050
Workforce Reduction
• Table 3-2: Age Under 15 and Over 65, by Continent (Africa, L. America/Caribbean, Asia, Oceania, N. America, Europe, World) 2020
WHO ESSENTIAL IVD LIST
• Table 3-3: WHO Model List of Essential In Vitro Diagnostics (EDL)
Increase in Chronic Diseases
• Figure 3-3: Leading Causes of Death Globally, 2019
COVID-19
• Table 3-4: Selected Molecular EUA Tests for COVID-19
• Table 3-5: Selected Antigen Immunoassay Tests for SARS-CoV-2
• Table 3-6: Individual EUAs for Serology Tests for SARS-CoV-2
• Table 3-7: Individual EUAs For IVDs for Management of COVID-19 Patients
EMERGING AND EMERGED MARKETS
• Table 3-8: Market Potential by Total Population, and Percent Urban 2020 (China, India, United States, Brazil, Russia, Mexico, Nigeria, Turkey, S. Korea, S. Africa, Vietnam, Poland, Saudi Arabia, Canada, Colombia, Ukraine, Egypt, Malaysia)
SIZE AND FORECAST FOR THE GLOBAL IVD MARKET
• Table 3-9: Global In Vitro Diagnostic Market; Major Country/Region Markets, 2023 and 2028 ($ millions) (United States, EU 15, W. Europe, Japan, China, Canada, India, Eastern Europe, Brazil, Peru, Mexico, Saudi Arabia, Turkey, UAE, Vietnam, Russia, South Africa, South Korea, Australia, ROW)
• Table 3-10: Global In Vitro Diagnostic Market; Regional Markets, 2023 and 2028 ($ millions) (Africa, North America, Europe, Asia Pacific, Latin America, Middle East)
• Table 3-11: Global In Vitro Diagnostic Market – YOY Growth, 2022-2023
• Table 3-12: Global In Vitro Diagnostic Market; Regional Markets, 2022-2023 YOY Change (North America, Europe, Asia Pacific, Latin America, Middle East, Africa)
THE IVD MARKET IN THE UNITED STATES
• Table 3-13: United States IVD Market Share by Segment, 2023 (%) (Clinical Chemistry, Microbiology ID/AST, Microbiology Molecular, POC Diabetes, POC Other, Immunoassay Infectious Disease, Immunoassay Other, Nucleic Acid Assays, Coagulation, Histology, Hematology, Blood Grouping, Others), ($ millions)
PAMA and Reimbursement Changes
• Impact of CARES Act on PAMA
• Table 3-14: Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2026
LDT Update
• Changes Resulting from COVID-19 Pandemic
Precision Medicine and NGS
IVD MARKET IN EUROPE: GROWING MARKETS
• Table 3-15: Economic Indicators (GDP Growth, Inflation Growth), by Select European Country (Germany, France, Italy, Spain), 2020-2023 (%)
• Figure 3-4: International Monetary Fund Inflation Map, Global 2023
• Table 3-16: Western European IVD Market by Country, 2023 ($ millions, estimated) (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK)
EU Regulation
• Table 3-17: IVD Market Per Capita, Europe, 2021/2022 Estimates (Switzerland, Germany, Netherlands, Sweden, France, Slovenia, United Kingdom, Italy, Spain, Slovakia, Greece, Croatia, Czech Republic, Hungary, Poland, Romania, Bulgaria, Russia, Ukraine)
Precision Medicine in Europe
Brexit
JAPAN
• Table 3-18: Japan IVD Market by Segment, 2023 (%) (Clinical Chemistry, Microbiology ID/AST, Microbiology Molecular, POC Diabetes, POC Other, Immunoassay Infectious Disease, Immunoassay Other, Coagulation, Histology, Hematology, Others)
EASTERN EUROPE: GROWTH REGION
• Table 3-19: Eastern European IVD Market, by Country, 2023 ($ millions) (Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, Ukraine, Other)
• Figure 3-5: Eastern Europe IVD Market, by Country, 2023 ($ millions) (Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, Ukraine)
CHINA: CURRENT IVD MARKET
• Table 3-20: China IVD Market by Segment, 2023 (%) (Clinical Chemistry, Microbiology ID/AST, Microbiology Molecular, POC Diabetes, POC Other, Immunoassay Infectious Disease, Immunoassay Other, Coagulation, Histology, Hematology, Others)
• Table 3-21: Total Midyear Population, by Broad Age Group: China (million persons), 2010-2050
Clinical Laboratory Market in China
IVD Distribution in China
INDIA: POPULATION AND OPPORTUNITY
• Table 3-22: India IVD Market by Segment, 2023 (%) (Clinical Chemistry, Hematology, Coagulation; Microbiology; POC Diabetes; POC Other; Immunoassay; Histology; Others)
Clinical Laboratory Market in India
IVD Regulation
REST OF ASIA
• Table 3-23: Asia Pacific IVD Market by Country, 2023 ($ millions) (Australia, South Korea, Indonesia, Thailand, Philippines, Malaysia, Singapore, Vietnam)
BRAZIL
• Table 3-24: Brazil IVD Market by Broad Segment, 2023 (%) (Clinical Chemistry, Microbiology, POC Diabetes, POC Other, Immunoassay, Histology, Others)
Disease Trends
Clinical Laboratory Market in Brazil
IVD Regulation
MEXICO
• Table 3-25: Mexico IVD Market by Broad Segment, 2023 (%) (Clinical Chemistry, Microbiology, POC, Immunoassay, Histology, Others)
THE RUSSIAN FEDERATION
CANADA
EMERGING MARKETS
Saudi Arabia IVD Market
South Africa IVD Market
South Korea IVD Market
Turkey IVD Market
United Arab Emirates (UAE) IVD Market
Other Markets to Watch
IVD MARKET OPPORTUNITY BY COUNTRY
• Table 3-26: IVD Market Opportunity by Country, 2023 Market Rank, Country CAGR 2023-2028 (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)
• Figure 3-6: IVD Market Opportunity by Country: Top 20 Markets (Country Market Value in $millions), Country CAGR 2023-2028 (%) (United States, Germany, Japan, France, United Kingdom, Italy, Canada, Spain, Australia, Brazil, Russia, India, Switzerland, Netherlands, Poland, Turkey, Sweden, Belgium, Mexico)
CHAPTER FOUR: COMPANY AND INDUSTRY TRENDS
INTRODUCTION
Advanced Medicine Without Borders
• Table 4-1: Key Emerging IVD Markets, by Country (Brazil, Russia, India, China, South Korea, Mexico, Turkey, Vietnam) 2018-2023 ($millions)
China Market Information
Direct to Consumer Genetic Test Services
Future Trends
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 2021-2023
The Future for Liquid Biopsy
INFORMATION TECHNOLOGY ADVANCES AND ARTIFICIAL INTELLIGENCE
AI in Clinical Practice
• Table 4-5: Selected AI Market Cleared Tests
The Regulatory Pathway
Product Initiatives
• Table 4-6: Selected AI Product Initiatives in Development and Collaborations
AI IN LIQUID BIOPSY
• 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
TRAUMATIC BRAIN INJURY AND IVD
PERSONALIZED MEDICINE
TELEHEALTH
Telehealth eMed to Implement Home Test to Treat Program
BLOCKCHAIN
SUBSTANCE ABUSE
Opioid Epidemic
COVID-19 and Substance Abuse
Biomarkers and Substance Abuse
Clinical Laboratory Testing for Drugs of Abuse
• Table 4-9: Global Drug Abuse Statistics
Urine
Blood
Oral
Hair
• Table 4-10: Selected Opioid Test FDA Approvals
SALIVA TESTING
BREATH TEST ADVANCES
• Table 4-11: Selected Disease Markers in Exhaled Breath
MICRO-HOSPITAL OPPORTUNITIES
CLIMATE CHANGE AND INFECTIOUS DISEASE
KICKBACK SCHEMES
EARLY SEPSIS DETECTION
STAFFING SHORTAGES
CHAPTER FIVE: POINT-OF-CARE TESTS
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: Professional POC Test Sales by Category, Worldwide 2023 -2028 ($million) (Glucose, Critical Care POC, Fertility, Infectious Diseases, Cardiac Markers, Cholesterol, Coagulation, HbA1c POC, Hematology, Fecal Occult Blood, Drugs of Abuse, Others)
• Table 5-2: Selected Professional POC Test Innovations (excluding COVID-19 testing)
OTC SELF TESTING
• Table 5-3: POC Self-Test Sales by Category, Worldwide, 2023-2028 ($million) (Glucose, Self; Glucose, Continuous; Pregnancy; Coagulation; Fecal Occult Blood; Drugs of Abuse; H. pylori; HIV; Cholesterol; Urinalysis; Other [TSH, Allergy, Autoimmune, etc.])
HOME COLLECTION TREND
• Table 5-4: Home Collection Test Market, 2022 and 2027 ($million), CAGR 2022-2027
• Table 5-5: Home Collection Test Kit Market by Category, Worldwide, 2022 (% Estimated Share)
• Table 5-6: Selected Molecular Tests EUAs for Home Collection SARS-CoV-2 Tests
PREGNANCY/FERTILITY TESTS
• Table 5-7: POC Pregnancy and Fertility Test Market Distribution by End User, 2023 (%) (OTC, PRO)
• Table 5-8: Pregnancy/Fertility POC Test Sales Distribution by Global Region, 2023 (United States, Europe, Japan, RoW)
COLON CANCER SCREENING
• Table 5-9: Selected POC Colon Cancer Tests
• Table 5-10: Colon Cancer POC Test Sales Distribution by Global Region, 2023 (%) (United States, Europe, Japan, RoW)
LIPID TESTING
• Table 5-11: Lipid POC Test Sales Distribution by Global Region, 2023 (%) (United States, Europe, Japan, RoW)
DRUGS OF ABUSE TESTING
• Table 5-12: POC Drugs of Abuse Test Sales Distribution by Setting, 2023 (%) (Employment Screening, Criminal Justice, Critical Care – Traditional POC)
• Products
• Table 5-13: Drugs of Abuse Tests on the Market
RAPID AND POC INFECTIOUS DISEASE TESTING
• Table 5-14: 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 5-15: Innovations in Molecular POC Infectious Disease Diagnostics
COVID-19
Market Size and Growth
• Table 5-16: Infectious Disease POC Test Demand by Type, 2023 (%) (Influenza, HIV, STD, Hepatitis, Malaria, C.Difficile, E.coli, H.pylori, Home Test/OTC, Others)
• Table 5-17: Infectious Disease POC Test Sales Distribution by Global Region, 2023 (%) (United States, Europe, Japan, RoW)
DIABETES TESTING – BLOOD GLUCOSE MONITORING
• Table 5-18: Glucose POC Test Sales Distribution by Global Region, 2023 (%) (United States, Europe, Japan, RoW)
• Figure 5-1: POC Glucose Testing Market Growth by Category, 2023-2028
IT to Aid Diabetes Management
• Table 5-19: Selected Apps and Glucose Management IT
Diabetes Market Analysis
• Table 5-20: Global Diabetes Sales by Test Category, 2023-2028 (Glucose, OTC; Glucose, professional; Glucose, continuous; HbA1c, POC; TOTAL; HbA1c, Lab) ($ millions)
POC Glucose Competitors
• Table 5-21: POC Test Revenues of Selected IVD Glucose Companies, 2023 ($ million, estimated)
Blood Glucose Self-Testing
• Table 5-22: Selected Glucose Self-Test Meter Innovations
Noninvasive Testing Devices
• Table 5-23: Selected Noninvasive Glucose Monitoring Devices
Continuous Glucose Monitoring
• Table 5-24: Selected Continuous Blood Glucose System Developments
Blood Glucose Testing by Professionals
• Table 5-25: Selected Innovations in Hospital-based Glucose Monitoring
Diabetes Testing – Glycated Hemoglobin
• Table 5-26: Global HbA1c Test Sales Market and Distribution by Setting, 2023-2028 ($ millions) (HbA1c POC, HbA1c Lab)
• Table 5-27: Selected POC HbA1c Devices
Genes and Other Markers of Diabetes
• Table 5-28: Selected POC Diabetes Monitoring Tests
THE MAJOR POC TEST PLAYERS
• Table 5-29: POC Test Revenues of Selected IVD Companies, 2023 ($ million, estimated)
CHAPTER SIX: THE CORE LAB
CORE LAB OVERVIEW AND TRENDS
• Table 6-1: Selected Analytes for the Core Lab
CONNECTIVITY
OVERVIEW OF CHEMISTRY TESTS
Lab Automation
MARKET ANALYSIS
• Table 6-2: Global Clinical Chemistry Sales by Test Category, 2023-2028 ($millions) (General Chemistries, Blood Gases, Urinalysis)
• Table 6-3: Global Clinical Chemistry Sales Distribution by Region, 2023 (North America, Europe, Asia Pacific, RoW)
• Table 6-4: Major Clinical Chemistry Companies, 2023 ($millions) (Blood gas/electrolyte, general chemistries, UA)
• 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, 2023 and 2028 (Lab-based, POC-based) (in $ millions)
• Table 6-8: Blood Gas, Electrolyte, and Critical Care Market Leaders including POC, 2023 (percent distribution of total sales)
User Apps
• Table 6-9: Selected Apps, Critical Care and Urinalysis IT Innovations
Urinalysis
• Table 6-10: UA Market by End User, 2023 and 2028 (Lab-based, POC-based)
• Table 6-11: Urinalysis Systems (including POC) Market Leaders, 2023 (percent distribution of total sales) estimated
• Table 6-12: Selected Urinalysis Innovations
THE COMMERCIAL OUTLOOK FOR CHEMISTRY TESTS
CHAPTER SEVEN: IMMUNOASSAYS
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
Leading Suppliers and Growth Potential
• Table 7-3: Global Lab-based Immunoassay (excluding infectious disease and blood screening) Sales, by Analyte Type, 2023-2028 ($millions) (Cardiac Markers, Tumor Markers, Autoimmune, Diabetes/HbA1c, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Drugs of Abuse, Vitamin D, Total; w/o HbA1c)
• Table 7-4: Global Immunoassay (excluding infectious disease and blood screening) Sales Distribution by Region, 2023 (%) (North America, Europe, Japan, Asia Pacific, RoW)
• Table 7-5: IVD Quality Control Market (estimated), 2023 ($millions)
• Table 7-6: Selected Immunoassay Quality Control Products
• Table 7-7: 2022-2023 Revenues of Leading Lab-based Immunoassay Vendors (in millions $), Estimated
MATURE ASSAY SEGMENT
Thyroid Function
Therapeutic Drug Monitoring
Vitamin D
• Table 7-8: Selected Vitamin D Immunoassays
Anemia
Toxicology/DAU
Allergy
MATURING IMMUNOASSAYS
Proteins
GROWTH 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
Traumatic Brain Injury
Sleep Apnea
Miscellaneous
• Table 7-17: Selected Immunoassay Innovations
Point-of-Care OTC and Professional Use Immunoassays
• Table 7-18: Global POC Immunoassay Sales Distribution by Region, 2023 (United States, Europe, Japan, RoW)
• Table 7-19: Global POC Immunoassay Test Sales by Test Category, 2023-2028 (millions $) (OTC/Self Tests: Pregnancy/Ovulation, Drugs of Abuse, HIV, H. pylori, Infectious Disease/COVID-19, Other, OTC/Self Total; professional POC: Cardiac Markers, Drugs of Abuse, HbA1c, Pregnancy, Infectious Disease/COVID-19, Other, Professional Total)
• 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
CHAPTER 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
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, by Company (Agilent, bioMérieux, Cepheid, Exact Sciences, Hologic, Illumina, Myriad Genetics, QIAGEN, Roche, Thermo Fisher) 2018-2022, 2023 estimated (in millions $)
MARKET ANALYSIS
• Table 8-10: Global Genomic, HLA and Oncology Molecular Test Sales by Type with NIPT, 2023-2028 (in millions $)
Oncology
• Table 8-11: Global Molecular Cancer Test Sales Distribution by Region, 2023 (North America, Europe, Asia Pacific, RoW)
• Table 8-12: Selected Molecular Tumor Marker Test Innovations
Inherited Diseases and Thrombophilia SNPs
• Table 8-13: Most Frequently Requested Genetic Tests
• Table 8-14: Global Molecular Thrombophilia Assay Sales Distribution by Region, 2023 (North America, Europe, Asia Pacific, RoW)
• Table 8-15: Selected Genomic Tests for Inherited Diseases
Depression and Psychiatric Disorders
Prenatal and Newborn Testing
• Table 8-16: Global Prenatal Test Sales Distribution by Region, 2023 (North America, Europe, Asia Pacific, RoW)
• Table 8-17: Selected Prenatal Services Provided
• Table 8-18: Selected Molecular Tests for Prenatal Analysis
Transplant Diagnostics
• Table 8-19: Global Molecular HLA Testing Sales Distribution, by Region, 2023 (North America, Europe, Asia Pacific, RoW)
• Table 8-20: Selected Innovations of Molecular Transplant Diagnostics
THE COMMERCIAL OUTLOOK FOR MOLECULAR TESTS
CHAPTER NINE: HEMATOLOGY
OVERVIEW OF HEMATOLOGY AND TRENDS
• Table 9-1: Hematology Analyzer Distribution of Sales by Menu Capability, 2023 estimated
• Table 9-2: Lab-based Hematology Sales, by Analyte Average Annual Distribution (%)
Digital Image Analysis
• Table 9-3: Selected Hematology Image Analysis Innovations
Digital Evolution
Quality Control Measurement Programs
• Table 9-4: Selected Quality Control Hematology FDA Registrations, 2023
LABORATORY-BASED HEMATOLOGY TESTING
• Table 9-5: Selected Hematology Innovations, 2014-2023
• Table 9-6: Global Laboratory-based Hematology Test and Instrument Market, 2023 and 2028 ($ millions)
Regional Laboratory-based Hematology Test and Instrument Market
• Table 9-7: Global Laboratory-based Hematology Test and Instrument Market, by Region, 2023 (North America, Europe, Asia Pacific, RoW)
DECENTRALIZED HEMATOLOGY TESTING
Hemoglobin/Hematocrit at the POC
• Table 9-8: POC Hematology Distribution by Specialty (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, 2023 and 2028 ($ millions) (Instruments, lab-style; Handheld devices)
MARKET ANALYSIS: LEADING SUPPLIERS
• Table 9-12: Top Hematology Company Revenues (laboratory and POC), by Company (Abbott, Beckman Coultar/Danaher, Roche, Siemens, Sysmex), 2023 ($ millions)
• Table 9-13: Global Hematology (Laboratory-based and POC) Sales Distribution by Region, 2023 (North America, Europe, Asia Pacific, RoW)
THE COMMERCIAL OUTLOOK FOR HEMATOLOGY TESTS
CHAPTER TEN: COAGULATION
OVERVIEW AND TRENDS OF COAGULATION AND IMMUNOHEMATOLOGY TESTS
SPECIAL TOPICS
COVID-19
Direct Oral Anticoagulants (DOACs)
• Table 10-1: Select Major Anticoagulant Sales, by Drug (Apixaban, Rivaroxaban), 2022
D-dimer
• Table 10-2: Global D-dimer Sales Distribution by Region, 2023 (North America, Europe, Asia Pacific, RoW) (%)
MARKET ANALYSIS
• Table 10-3: Global Coagulation Sales by Segment, 2023-2028 ($millions) (PT/INR Labs, Molecular, Professional POC, Professional Self; D-dimer)
• Table 10-4: Global Coagulation Test and Instrument Market by Region, 2023 (North America, Europe, Asia Pacific, RoW)
LAB-BASED TESTING
• Table 10-5: Selected Lab-based Coagulation Innovations
Genetic Markers of Hypercoagulopathies
• Table 10-6: Related CMS Codes for Reimbursement National Limits, Molecular, 2022
• Table 10-7: Global Molecular – Thrombophilia SNP Sales Distribution by Region, 2023 (North America, Europe, Asia Pacific, RoW)
• Table 10-8: Selected Molecular Coagulation Test Innovations
LEADING SUPPLIERS: LABORATORY SYSTEMS
• Table 10-9: Top Coagulation Company Revenues, Laboratory-based, by Company (Diagnostica Stago, Instrumentation Laboratory [Werfen], Siemens Healthineers, Sysmex), 2023 ($ millions) est.
DECENTRALIZED COAGULATION TESTING – PROFESSIONAL USE
Decentralized Coagulation Testing – OTC
• Table 10-10: Selected POC Coagulation Test Innovations
Platelet Testing
• Table 10-11: Selected Platelet Activity Test Innovations
LEADING SUPPLIERS: POC SYSTEMS
• Table 10-12: Top Coagulation Company Revenues, POC, 2023 ($ millions) est.
THE COMMERCIAL MARKET FOR COAGULATION TESTS
• Table 10-13: Major Anticoagulants Uses and Tests
CHAPTER ELEVEN: MICROBIOLOGY AND VIROLOGY
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
• Abbott
• Thermo Fisher Scientific
• Table 11-3: Selected Microbiome-Based Tests
Next Generation Sequencing-Based Microbiology Approaches
• Table 11-4: Selected Companies Applying DNA/RNA Sequencing to Microbiology
Syndromic/Multiplex Testing
NEW INFECTIOUS DISEASE THREATS
• Table 11-5: Selected Companies Marketing Products Addressing Emerging Infectious Disease Threats
Tickborne Diseases (TBDs)
Zika
Chagas
Dengue
Ebola
Chikungunya
Middle East Respiratory Syndrome-Coronavirus (MERS-CoV)
Marburg
SARS-CoV-2 (COVID-19)
• Figure 11-1: Total COVID-19 Test Volume by Country, Average Estimates June-August 2023 (Thousands)
• Figure 11-2: Estimated Market Distribution, COVID-19 Test Value, 2023
Monkeypox
MARKET ANALYSIS
• Table 11-6: Global Microbiology Sales Distribution by Region, 2023 (North America, Europe, Asia Pacific, RoW)
MARKET ANALYSIS – TRADITIONAL MICROBIOLOGY ID/AST
• Table 11-7: Global Microbiology ID/AST Market, 2023-2028 (in millions USD) (ID/AST Auto, ID/AST Panels, Blood Culture, Chromogenic Media, Rapid Microbiology; ID/AST Supplies)
• Table 11-8: Global ID/AST Testing Sales Distribution by Region, 2023 (North America, Europe, Asia Pacific, RoW)
Traditional ID/AST
• Table 11-9: Global ID/AST Testing, Distribution by Systems, (%) (Panel, Auto)
Blood Culture
• Table 11-10: Selected Advanced Techniques in Positive Blood Culture
Chromogenic Media
Rapid Tests Performed on Colonies from Culture Media
Supplies
MARKET ANALYSIS – MICROBIOLOGY IMMUNOASSAYS
Improvements in Microbiology Immunoassays
• Table 11-11: Selected Infectious Disease Immunoassay Innovations
• Table 11-12: Global Clinical Laboratory-Based Microbiology/Infectious Disease Immunoassay Market by Pathogen, 2023 (in $ millions) (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAIs/Sepsis, Parasitology, Mycology, Lyme disease, Other, COVID-19) est.
• Table 11-13: Global Laboratory-Based Microbiology/Infectious Disease Immunoassay Market Distribution (by %) by Region, 2023 (North America, Europe, Asia Pacific, RoW)
Hepatitis Testing
Sepsis
HIV Immunoassay Testing
• Table 11-14: Selected HIV Assays
Sexually Transmitted Diseases (STDs)
ToRCH
Lyme Disease
• TBD-Serochip (Roche associated)
Rapid Immunoassay Tests
• Table 11-15: Global Rapid Immunoassay Testing Market, Sales Distribution by Pathogen, 2023 (%) (Influenza, HIV, STD, Hepatitis, Malaria, C.Difficile, E.coli, H.pylori, Home Test/OTC, Others)
MARKET ANALYSIS – MOLECULAR MICROBIOLOGY
• Table 11-16: Global Molecular Microbiology Sales Distribution by Region, 2023 (%) (North America, Europe, Asia Pacific, RoW)
• Table 11-17: Global Molecular Microbiology Market, by Pathogen/Disease Indication, 2023-2028 (in $ millions) (HAI, HIV, Hepatitis, GC/Chlamydia, Respiratory, Organism ID, Mycobacteria/TB, Others, COVID-19; Blood Bank Screening)
Lab Automation and Molecular Diagnostics
• Table 11-18: Selected Automated Molecular Test Instrument Platforms
Molecular Respiratory Infection Testing
The Respiratory Trio – Flu, Strep, RSV
• Table 11-19: Selected COVID-19, Flu, RSV Tests
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
Assessing the Problem: Nosocomial Infection Statistics
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
CHAPTER TWELVE: BLOOD BANKING SERVICES
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 (Syphilis, HCV, HBV, HIV, Chagas, Malaria, HTLV I/II)
• 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
• Table 12-4: Red Blood Cell and Platelet Use by Hospital Services (%)
COVID-19 Impact on Plasma Collection
Reevaluating Blood Transfusions
• Table 12-5: 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 12-6: Selected Blood Typing and Grouping Innovations
Size and Growth of Typing Markets
• Table 12-7: Global Blood Typing Market, 2023-2028 (Typing) (in $ millions)
Blood Typing Market by Geography
• Table 12-8: Global Blood Typing Sales Distribution by Region, 2023 (%) (North America, Europe, Asia Pacific, RoW)
BLOOD TESTING MARKET
• Table 12-9: Selected Blood Testing Innovations
Preventing Bacterial Infections
Immunoassays
Nucleic Acid Testing (NAT)
Size and Growth of the Market
• Table 12-10: Global Blood Banking Diagnostics Market, 2023-2028 (Immunoassay Screen, NAT Screens) (in $ millions)
Blood Testing Market by Geography
• Table 12-11: Global Blood Testing Market by Geography, 2023 (%) (North America, Europe, Asia Pacific, RoW)
THE COMMERCIAL OUTLOOK FOR BLOOD BANKING TESTING
CHAPTER 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 meets Core Lab
• Table 13-4: Global HPV Test Sales Distribution by Region, 2023 (%) (North America, Europe, Asia Pacific, RoW)
• Table 13-5: Selected HPV Test Innovations
MARKET ANALYSIS
Total Market
• Table 13-6: Global Histology/Cytology Sales by Type, 2023-2028 ($ millions) (Pap Tests, in situ hybridization, immunohistochemistry, traditional non-Pap stains, HPV, TOTAL; Digital Imaging, CTCs, Flow Cytometry)
Regional Market Analysis
• Table 13-7: Global Histology/Cytology Sales Distribution by Region, 2023 (%) (North America, Europe, Asia Pacific, RoW)
• Table 13-8: Revenues of the Major Histology Companies, 2018-2023 ($ millions, 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
Immunohistochemistry and In Situ Hybridization
• Table 13-11: Selected In Situ Hybridization-based Tests
• Table 13-12: Selected IHC Test Innovations
Pharmacodiagnostic Histology
• Table 13-13: Major Pharmacodiagnostic Markers
• Table 13-14: Selected Pharmacodiagnostic Histology Tests
Digital Imaging and Computational Pathology
• Table 13-15: Selected Digital Pathology Image Capture and Viewing Solutions
COVID-19 and Digital Pathology
• Table 11-16: FDA Digital Pathology Device Review Classification During COVID-19
• Table 13-17: Selected Digital Imaging Innovations
Circulating Tumor Cells
• Table 13-18: Selected Innovations in CTC Technology
Flow Cytometry
THE COMMERCIAL OUTLOOK FOR HISTOLOGY AND CYTOLOGY TESTS
CHAPTER FOURTEEN: COMPANY PROFILES: THE TOP TIER
ABBOTT DIAGNOSTICS
• Table 14-1: Abbott Diagnostics Revenue History ($ million)
• Table 14-2: Abbott Diagnostic Revenues by Segment, 2017-2022 ($ million) est.
Core Lab
Hematology
Blood Banking
Infectious Diseases – Molecular
Diabetes
HIV Point of Care
i-STAT Business
Companion Diagnostic Testing
Liquid Biopsy
COVID-19
AGILENT TECHNOLOGIES
• Table 14-3: Agilent Revenue History Diagnostics and Genomics, 2017-2022 ($ million)
Genomics
Cytogenetic Analysis
Sequencing
CRISPR
Flow Cytometry
Companion Diagnostics – Dako
COVID-19
BECKMAN COULTER BECKMAN COULTER, INC. / DANAHER
• Table 14-4: Beckman Coulter Revenue History, 2017-2022 ($ million, estimated)
• Table 14-5: Beckman Coulter Diagnostic Revenues by Segment, 2019-2022 ($ million) est
Hematology
Hematology IT
Clinical Chemistry
Immunoassays
Microbiology
IT Clinical
Flow Cytometry
Blood Banking
Beckman Coulter Life Sciences
COVID-19
BECTON, DICKINSON AND COMPANY (BD)
• Table 14-6: BD Revenue History, 2017-2022 ($ million, estimated) FYE Sept 30
• Table 14-7: BD Diagnostic Revenues by Segment, 2017-2022 ($ million)
Cytology
Molecular Microbiology
Traditional Microbiology – ID/AST
Blood Culture
Hospital Acquired Infections
Blood Collection
Mass Spectrometry
Flow Cytometry
COVID-19
BIOMÉRIEUX INC.
• Table 14-8: bioMérieux Revenue History, 2017-2022 ($ million)
• Table 14-9: bioMérieux Diagnostic Revenues by Segment, 2017-2022 ($ million)
Traditional Microbiology
Blood Culture
Immunoassays
Mass Spectrometry
BIOFIRE Diagnostics Business
Expansion
COVID-19
BIO-RAD LABORATORIES, INC.
• Table 14-10: BioRad Revenue History, 2017-2022 ($ million, estimated)
• Table 14-11: Bio-Rad Diagnostic Revenues by Segment ($ million) est
Quality Control
Blood Bank
Diabetes
Immunoassays
Liquid Biopsy
Droplet Digital PCR
Sequencing
COVID-19
CEPHEID / DANAHER
• Table 14-12: Cepheid Revenue History, 2017-2022 ($ million, clinical product sales)
GeneXpert/ Xpress Line
Tuberculosis
Microbiology
POC Testing
Cancer
COVID-19
DANAHER CORPORATION
• Table 14-13: Danaher Revenue History, 2017-2022 ($ million, Diagnostics, estimated)
Acquisitions
DEXCOM
• Table 14-14: Dexcom Revenue History, 2017-2022 ($ million)
DIASORIN S.P.A
• Table 14-15: DiaSorin Revenue History, 2017-2022 ($ million)
Development Plan
Expansion
Immunoassays
Molecular
Molecular Oncology
COVID-19
EXACT SCIENCES
• Table 14-16: Exact Sciences Revenue History, 2017-2022 (in $ millions)
COVID-19
HOLOGIC, INC.
• Table 14-17: Hologic Revenue History estimated diagnostic product revenue, 2017-2022 ($ million, estimated)
• Table 14-18: Hologic Diagnostic Revenues by Segment, 2017-2022 ($ million)
Acquisitions
PANTHER Molecular System
HIV Testing
Sexually Transmitted Infections
Infectious Diseases
Panther Fusion
Cytology
COVID-19
ILLUMINA
• Table 14-19: Illumina Revenue History, 2017-2022 ($ million – not all revenues are for clinical products and services; estimated)
• Table 14-20: Illumina Diagnostic Revenues by Segment, 2017-2022 ($ million) est
China
COVID-19
INSTRUMENTATION LABORATORY (IL) / WERFEN
• Table 14-21: Recent Revenue History, 2017-2022 ($ million, estimated)
• Table 14-22: IL Diagnostic Revenues by Segment, 2017-2022 ($ million)
Expansion
Coagulation
Acute Care
Information Technology
LEICA BIOSYSTEMS/DANAHER
• Table 14-23: Leica Revenue History, 2017-2022 ($ millions) estimated
Digital Pathology
Companion Diagnostics
Stain Reagents
Lab Systems
Sample Handling
Circulating Tumor Cells (CTCs)
Artificial Intelligence
COVID-19
MINDRAY – SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.
NATERA
• Table 14-24: Natera Revenue History, 2017-2022 ($ millions)
QIAGEN
• Table 14-25: QIAGEN Revenue History, 2017-2022 ($ million)
• Table 14-26: QIAGEN Diagnostic Revenues by Segment, 2017-2022 ($ million) est
Tuberculosis
Molecular Expansion
Precision Medicine / Companion Diagnostics
Molecular Microbiology
Prenatal Testing
Next Generation Sequencing
Sample Prep, Informatics
Digital PCR
Liquid Biopsy
Cervical Cancer
Expansion
COVID-19
QUIDELORTHO CORPORATION
• Table 14-27: QuidelOrtho Revenue History, 2018-2022 ($ million)
• Table 14-28: QuidelOrtho Diagnostic Revenues by Segment, 2020-2022 ($ million) est
Immunoassays
Rapid Immunoassays
The Solana Business
Molecular – Savanna
Blood Bank
COVID-19
RADIOMETER A/S / DANAHER
• Table 14-29: Radiometer A/S Revenue History, 2017-2022 (estimated, $ million)
Critical Care
Immunoassays
HemoCue
Transcutaneous Monitoring
ROCHE DIAGNOSTICS
• Table 14-30: Roche Revenue History, 2017-2022 (in millions $)
• Table 14-31: Roche Diagnostic Revenues by Segment, 2017-2022 ($ million) est
Hematology
Immunoassays
HIV
Molecular Expansion
Core Molecular
Digital PCR
Diabetes Care
Coagulation
cobas Liat System – POC
HPV
Blood Bank
Transplant Medicine
Cancer Companion Testing
IT in Anatomical Pathology
Information Technology
COVID-19
SIEMENS HEALTHINEERS (SIEMENS)
• Table 14-32: Siemens Healthineers Revenue History, 2017-2022 ($ million, estimated)
• Table 14-33: Siemens Healthineers Diagnostic Revenues by Segment, 2021-2022 ($ million)
Core Lab
Lab Automation
Immunoassays
Hematology
Urinalysis
Molecular
Expansion to Support Molecular Diagnostics – Fast Track Diagnostics
Sequencing with Artificial Intelligence
Acute Care – POC
POC Connectivity
Business Expansion
COVID-19
SYSMEX CORPORATION
• Table 14-34: Sysmex Revenue History, 2018-2022 ($ million) FYE March 31
• Table 14-35: Sysmex Diagnostic Revenues by Segment, 2018-2022 ($ million) est
Hematology
Coagulation
Urinalysis and Infectious Disease
Immunoassays
Lab Information System
Information Technology
Flow Cytometry
Precision Medicine / Companion Test Diagnostics
Liquid Biopsy
Oncology
Sysmex Inostics
Forging New Markets
COVID-19
THERMO FISHER SCIENTIFIC INC.
• Table 14-36: Thermo Fisher Revenue History, 2017-2022 (clinical diagnostics, $ million)
• Table 14-37: Thermo Fisher Scientific Diagnostic Revenues by Segment, 2017-2022 ($ million)
Immunoassays
Microbiology
Molecular Test Business
Next Generation Sequencing
qPCR
Oncology Companion Diagnostics
Transplant Medicine
Microbiome
Mass Spectrometry
Collaborations
Gene Editing and Cell Therapy
China
COVID-19
VENTANA MEDICAL SYSTEMS INC. / ROCHE TISSUE DIAGNOSTICS
• Table 14-38: Ventana Medical Systems Revenue History, 2017-2022 ($ millions)
Immunohistochemistry – IHC
Cervical Cancer Screening
Companion Diagnostics
WERFEN
• Table 14-39: Werfen Recent Revenue History, 2017-2022 ($ million estimated)
CHAPTER FIFTEEN: COMPANY PROFILES: THE SECOND TIER
BGI GENOMICS (FORMERLY BEIJING GENOME INSTITUTE)
• Table 15-1: BGI Genomics Revenue History, 2017-2022 ($ millions)
PCR and Fluorescence
MGI Tech Co., Limited, China
Prenatal Testing
Test Services
Whole Genome Sequencing (WGS)
NGS Sequencing
Collaborations
COVID-19
BIOCARTIS
• Table 15-2: Biocartis Revenue History, 2017-2022 ($ million)
COVID-19
BRUKER CORPORATION
• Table 15-3: Bruker Revenue History Product revenue, 2017-2022 ($ million)
Acquisitions and Collaborations
Mass Spectrometry
Microbiology
Molecular PCR
COVID-19
DIAGNOSTICA STAGO S.A.S.
EIKEN CHEMICAL CO., LTD
• Table 15-4: Eiken Chemical Revenue History, 2017-2022 ($millions) FYE March 31
Product News
COVID-19
FULGENT GENETICS, INC
• Table 15-5: Fulgent Revenue History, 2017-2022 ($ million)
COVID-19
FUJIREBIO DIAGNOSTICS, INC.
• Table 15-6: Fujirebio Diagnostics Revenue History, 2017-2022 ($ millions) FYE March 31
GRIFOLS S.A.
• Table 15-7: Grifols Revenue History ($ million)
• Table 15-8: Grifols Diagnostic Revenues by Segment ($ million)
Blood Transfusion Business
ABO Blood Typing
Molecular ABO Blood Typing
Immunoassays
Market Expansion
Self-Testing
COVID-19
GUARDANT HEALTH, INC.
• Table 15-9: Guardant Health Revenue History, 2019-2022 ($ million)
HORIBA MEDICAL
• Table 15-10: Horiba Medical Revenue History, 2017-2022 (in millions USD) (medical diagnostic sales)
INVITAE
MASIMO CORPORATION
• Table 15-11: Masimo Revenues History, 2017-2022 ($ millions)
MENARINI DIAGNOSTICS
COVID-19
MERIDIAN BIOSCIENCE, INC.
• Table 15-12: Meridian Bioscience Revenue History, 2017-2022 ($ million, estimated) FYE Sept 30
Immunoassays
Molecular Tests
COVID-19
MYRIAD GENETICS, INC.
• Table 15-13: Myriad Genetics Revenue History, 2017-2022 ($ millions) FYE June 30
NIHON KOHDEN
• Table 15-14: Nihon Kohden Revenues History, 2017-2022 ($ millions)
ORASURE TECHNOLOGIES, INC.
• Table 15-15: OraSure Technologies Revenue History, 2017-2022 ($ million)
• Table 15-16: OraSure Technologies Product Revenue History, 2020-2022 ($ million)
COVID-19
PERKINELMER, INC. ( REVVITY)
• Table 15-17: PerkinElmer Revenue History, 2017-2022 ($ million, estimated)
• Table 15-18: PerkinElmer Diagnostic Revenues by Segment, 2017-2022 ($ million) est
Diagnostics
Sequencing /Genomics
Liquid Biopsy
Histology
Prenatal Business
Lab Services
Mass Spectrometry
COVID-19
SEKISUI DIAGNOSTICS LLC
COVID-19
VERACYTE, INC.
• Table 15-19: Veracyte Revenue History (in $ millions)
CHAPTER SIXTEEN: COMPANY PROFILES: BLOOD BANK SPECIALISTS
CERUS CORPORATION
• Table 16-1: Cerus Revenue History ($ million)
COVID-19
QUOTIENT LIMITED (ALIVEDX)
COVID-19
CHAPTER SEVENTEEN: COMPANY PROFILES: CORE LAB AND OTHER COMPANIES
AB SCIEX PTE LTD.
ARKRAY
Dry Chemistry / Immunoassays
Urinalysis
Diabetes
Molecular
EKF DIAGNOSTICS HOLDINGS PLC
• Table 17-1: EKF Diagnostics Revenue History ($ millions)
COVID-19
ELITECH GROUP S.A.S.
COVID-19
SHIMADZU SCIENTIFIC INSTRUMENTS
SNIBE CO. LTD., (SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO. LTD.)
COVID-19
TOSOH BIOSCIENCE
COVID-19
TRINITY BIOTECH PLC
• Table 17-2: Trinity Biotech Revenue History, 2017-2022 ($ millions)
COVID-19
CHAPTER EIGHTEEN: COMPANY PROFILES: CTC & LIQUID BIOPSY TEST PROVIDERS
BIOCEPT, INC.
COVID-19
BIODESIX
COVID-19
EPIC SCIENCES
EPIGENOMICS AG
FOUNDATION MEDICINE, INC.
MENARINI-SILICON BIOSYSTEMS
COVID-19
NEOGENOMICS
CHAPTER NINETEEN: COMPANY PROFILES: SPECIALISTS
ASCENSIA DIABETES CARE HOLDINGS AG
BIGFOOT BIOMEDICAL INC.
DEBIOTECH SA
COVID-19
GLOOKO INC.
INSULET CORPORATION
• Table 19-1: Insulet Corp Revenue History ($ million)
INTEGRITY APPLICATIONS INC. (GLUCOTRACK)
LIFESCAN INC.
MEDTRONIC PLC
• Table 19-2: Medtronic Revenue History, 2017-2022 ($ million)
NEMAURA MEDICAL INC.
COVID-19
VERILY LIFE SCIENCES LLC
COVID-19
CHAPTER TWENTY: COMPANY PROFILES: HEMATOLOGY (CELL ANALYSIS) AND COAGULATION SPECIALISTS
CELLAVISION AB
NOVA BIOMEDICAL CORPORATION (NOVA)
CHAPTER TWENTY-ONE: COMPANY PROFILES: HISTOPATHOLOGY SPECIALISTS
AMOY DIAGNOSTICS CO. LTD.
APPLIED SPECTRAL IMAGING INC. (ASI)
BIOGENEX LABORATORIES, INC.
BIOVIEW LTD.
LEICA BIOSYSTEMS
COVID-19
MILLIPORESIGMA
VISIOPHARM
CHAPTER TWENTY-TWO: COMPANY PROFILES: IMMUNOASSAY SPECIALISTS
BIOHIT HEALTHCARE
BIOMERICA INC.
• Table 22-1: Biomerica Revenue History, 2017-2022 ($ million)
COVID-19
BIO-TECHNE CORPORATION
• Table 22-2: Bio-Techne Revenue History, 2017-2022 ($ million)
COVID-19
EUROBIO SCIENTIFIC
COVID-19
EUROIMMUN AG (REVVITY)
COVID-19
IMMUNODIAGNOSTIC SYSTEMS (IDS)
COVID-19
INOVA DIAGNOSTICS, INC.
COVID-19
ONE LAMBDA, INC
RESPONSE BIOMEDICAL CORP.
COVID-19
THERADIG
COVID-19
VOLITIONRX LIMITED
COVID-19
CHAPTER TWENTY-THREE: INFORMATION TECHNOLOGY SPECIALISTS IN IN VITRO DIAGNOSTICS
CERNER CORP. (ORACLE)
DELL TECHNOLOGIES INC.
EUFORMATICS OY
GENOMONCOLOGY LLC
GOOGLE LLC (VERILY LIFE SCIENCES)
INTEL CORPORATION
INTERNATIONAL BUSINESS MACHINES CORP. (IBM)
PHILIPS (ROYAL PHILIPS)
• Table 23.1: Philips Revenue History ($ millions)
Histology
Precision Medicine
Precision Medicine IT
Patient Monitoring
Point of Care
Wearable Self Monitor
PIERIANDX (VELSERA)
SOPHIA GENETICS SA
COVID-19
CHAPTER TWENTY-FOUR: COMPANY PROFILES: MICROBIOLOGY SPECIALISTS
ACCELERATE DIAGNOSTICS, INC.
• Table 24-1: Accelerate Diagnostics Revenue History, 2017-2022 ($ thousands)
COVID-19
ADVANCED BIOLOGICAL LABORATORIES, S.A. (ABL)
COVID-19
ALTONA DIAGNOSTICS
COVID-19
ARCDIA INTERNATIONAL OY LTD.
COVID-19
BIOFIRE DIAGNOSTICS, LLC. (ACQUIRED BY BIOMÉRIEUX)
COVID-19
COPAN ITALIA S.P.A. AND COPAN DIAGNOSTICS, INC.
COVID-19
CURETIS
COVID-19
GENETIC ANALYSIS AS
COVID-19
GREINER BIO-ONE INTERNATIONAL GMBH
MAST GROUP
COVID-19
MOBIDIAG
COVID-19
Q-LINEA AB
OPGEN, INC.
COVID-19
SEEGENE, INC.
COVID-19
T2 BIOSYSTEMS
COVID-19
CHAPTER TWENTY-FIVE: COMPANY PROFILES: MOLECULAR TEST SPECIALISTS
ENZO BIOCHEM INC.
• Table 25-1: Enzo Biochem Revenue History, 2017-2022 ($ million)
COVID-19
FLUIDIGM CORPORATION (STANDARD BIOTOOLS)
• Table 25-2: Standard BioTools Revenue History, 2017-2022 ($ million)
COVID-19
GENOME DIAGNOSTICS BV (GENDX)
NANOSTRING TECHNOLOGIES, INC.
• Table 25-3: NanoString Revenue History ($ million)
COVID-19
PACIFIC BIOSCIENCES OF CALIFORNIA, INC. (PACBIO)
• Table 25-4: PacBio Revenue History ($ million)
COVID-19
RANDOX LABORATORIES LTD.
Clinical Chemistries
POC
Controls
Evidence Series – Multistat Biochip Analyzers
Molecular
COVID-19
TAKARA BIO INC.
COVID-19
VELA DIAGNOSTICS
COVID-19
CHAPTER TWENTY-SIX: COMPANY PROFILES: POINT OF CARE TEST SPECIALISTS
ABINGDON HEALTH LTD.
COVID-19
BINX HEALTH
COVID-19
BIOMEME, INC.
COVID-19
CHEMBIO DIAGNOSTIC SYSTEMS, INC.
• Table 26-1: Chembio Diagnostics Revenue History, 2017-2022 ($ million)
COVID-19
CUE HEALTH
• Table 26-2: Cue Health Revenue History, 2017-2022 ($ million)
Test to Treat
COVID-19
DIAZYME
COVID-19
DNA ELECTRONICS LTD (DNAE)
GENEDRIVE PLC (FORMERLY EPISTEM HOLDINGS)
• Table 26-3: genedrive Revenue History, 2020-2022 (in $ millions)
COVID-19
NUGENEREX DIAGNOSTICS (HDS)
IMMUNOSTICS, INC.
COVID-19
LOOP MEDICAL
MEDMIRA, INC.
• Table 26-4: MedMira Revenue History, 2017-2022 ($ thousands)
COVID-19
QUANTUMDX GROUP, LTD.
COVID-19
RHEONIX, INC.
COVID-19
VEREDUS LABORATORIES PTE LTD
COVID-19
CHAPTER TWENTY-SEVEN: COMPANY PROFILES: PRENATAL TEST SERVICE PROVIDERS
BERRY GENOMICS CO. LTD.
COOPERGENOMICS (DIVISION OF COOPERSURGICAL)
INEX INNOVATE
COVID-19
OXFORD GENE TECHNOLOGY
SEQUENOM, INC. (INTEGRATED GENETICS)
YOURGENE HEALTH
COVID-19
CHAPTER TWENTY-EIGHT: COMPANY PROFILES: QUALITY CONTROL & SAMPLE PRETREATMENT SPECIALISTS
10X GENOMICS
AGENA BIOSCIENCE, INC.
COVID-19
BIOTYPE DIAGNOSTIC GMBH
COVID-19
DXTERITY DIAGNOSTICS INC.
COVID-19
HORIZON DISCOVERY GROUP PLC
INCELLDX
LGC SERACARE LIFE SCIENCES, INC.
COVID-19
PREANALYTIX GMBH
PRECIPIO, INC. (FORMERLY TRANSGENOMIC)
COVID-19
QUANTERIX CORPORATION
COVID-19
STRECK INC.
CHAPTER TWENTY-NINE: TEST SERVICE PROVIDERS
23ANDME
AGENDIA BV
AMBRY GENETICS
COVID-19
ARUP LABORATORIES
COVID-19
ASPIRA WOMEN’S HEALTH ( FORMERLY VERMILLION INC.)
• Table 29-1: Aspira Women’s Health Revenue History, 2017-2022 (in $ millions)
BIOREFERENCE LABORATORIES
COVID-19
BIOTHERANOSTICS
BLUEPRINT GENETICS OY
BOSTON HEART DIAGNOSTICS
CAREDX, INC.
• Table 29-2: CareDx Revenue History, 2017-2022 ($ in thousands)
HELOMICS CORPORATION
LABCORP, LABORATORY CORPORATION OF AMERICA
• Table 29-3: Labcorp Revenue History, 2017-2022 ($ millions)
Precision Medicine
Diagnostics Services
DTC Home Testing
Collaborations and Expansion
COVID-19
MAYO CLINIC LABORATORIES
MDXHEALTH SA
• Table 29-4: MDxHealth Revenue History, 2017-2022 (in $ millions)
OPKO DIAGNOSTICS
• Table 29-5: OPKO Diagnostics Revenue History, 2017-2022 (in $ millions)
COVID-19
QUEST DIAGNOSTICS
• Table 29-6: Quest Diagnostics Revenue History, 2017-2022 ($ million)
Diagnostic Services
Oncology
Infectious Diseases
Prenatal and Women’s Health
Retail / Consumer Health
Expansion
COVID-19
SONIC HEALTHCARE
