Table of Contents
Addendum
Chapter 1: Worldwide IVD Market – March 2023 Update
IVD Market Demand and Growth
- Figure 1-1: Quarter-by-Quarter Segment Performance Commentary, 2022
- Table 1-1: Global In Vitro Diagnostic Sales by Product Market, 2022 ($ million) (Clinical Chemistry; Immunoassays: Infectious disease, Other immunos, 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; Other IVD)
- Figure 1-2: IVD Segment Performance (Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay, Microbiology, POC, Other), Q1 2022 – Q4 2022 ($MN)
- Figure 1-3: IVD Segment Performance (Clinical Chemistry, Coagulation, Hematology, Histology, Immunoassay, Microbiology, POC, Other), Total Market Value, 2022 ($MN)
COVID-19 Diagnostic Markets
- Table 1-2: COVID-19 Product Sales — Immunoassay (Antigen, Serology), Molecular, Rapid — 2022 ($ millions)
Effect of COVID-19 on Market Segments
- Table 1-3: IVD Market excluding and with COVID-19, 2022
- Figure 1-4: IVD Market Distribution by Segment (COVID-19 Assays and Instruments, IVD Market excluding COVID-19 Assays and Instruments), 2022
- Figure 1-5: IVD Market by COVID-19 and non-COVID markets, Quarterly Performance, 2022
- Table 1-4: Global In Vitro Diagnostic Market – YoY Growth 2021-2022
- Figure 1-6: Global In Vitro Diagnostic Market – YoY Growth, by Segment (Blood Bank Molecular – NAT Screens, Blood Grouping/Typing, Clinical Chemistry, Coagulation (PT/INR), D-Dimer, Diabetes HbA1c lab, Drugs of Abuse, Hematology – Core Lab, Histology/Cytology, Immuno – Blood Bank Screening, Immuno – Infectious Disease, Microbiology (ID/AST), Microbiology (Molecular), Nucleic Acid Assays/genetic Tests, Other Immunos, POC – OTC Diabetes, POC – OTC Other, POC – Professional/Hospital), 2021-2022
Chapter 2: Product Trends and New Developments
Selected New – Q4 2022 and Q1 2023 – Core IVD Product Launches, Developments and Trends
Immunoassay
Molecular
Personalized Medicine
POC
Sequencing
Selected COVID-19 Developments – Q4 2022 – Q1 2023
- Figure 2-1: COVID-19 Test Market by Type, Q1-Q4 2022 – COVID-19 Testing Wanes
Antigen/Antibody
Molecular
Chapter 3: Top IVD Market Participant Results
Selected Competitive Leader Updates
- Figure 3-1: IVD Segment Growth by Leading Competitors (Abbott Diagnostics, Becton Dickinson, bioMérieux, Danaher, Hologic, QuidelOrtho, Roche Diagnostics, Siemens Healthineers, Sysmex Corporation, Thermo Fisher Scientific), Change in Sales, 2021-2022
- Figure 3-2: Changes in Market Distribution for IVD Sales, 2019-2022 – Roche and Abbott Battle for #1 Spot
- Figure 3-3: Comparison of Total Diagnostic Sales for Abbott vs Roche 2020-2022 (in millions $)
2022 M&A Activity
- Table 3-1: IVD-Relevant M&A Activity, 2022
- Figure 3-4: Count of IVD Industry M&A Deals by Month, Full Year 2022 and Jan-Feb 2023
Abbott Laboratories
- Table 3-2: Abbott Corporate Summary
- Figure 3-5: Abbott Diagnostics Revenue by Segment (Core Laboratory, Molecular, Point-of-Care, Rapid Diagnostics, COVID-19), Full Year 2021 and 2022 $M
Becton Dickinson and Co
- Table 3-3: Becton Dickinson Corporate Summary
- Figure 3-6: BD Life Sciences, Revenues by Business FY End September 30, 2021, and 2022 $M
bioMérieux SA
- Table 3-4: bioMérieux Corporate Summary
- Figure 3-7: bioMérieux Clinical Applications Segment, Full Year Results, 2021, 2022 € MN
Danaher Corporation
- Table 3-5: Danaher Corporation Summary
- Figure 3-8: Danaher Diagnostic Segment Performance, Full Year Results, 2021 ,2022 $M
Hologic, Inc.
- Table 3-6: Hologic Corporate Summary
- Figure 3-9: Hologic Diagnostic Segment Performance, Full Year Results, FY 2021 and FY 2022, $M
QuidelOrtho Corporation
- Table 3-7: QuidelOrtho Corporate Summary
- Figure 3-10: QuidelOrtho, Full Year Results, by Segment (Immunoassay/Clinical Lab, Molecular Diagnostics, Point-of-Care, Transfusion Medicine) $M (2021, 2022)
Roche Diagnostic
- Table 3-8: Roche Diagnostic Corporate Summary
- Figure 3-11: Roche Diagnostics Revenue by Product Group (Core Lab, Diabetes Care, Molecular, Pathology Lab, Point-of-Care), Full Year Results 2021, 2022, CHF MN
Siemens Healthineers
- Table 3-9: Siemens Healthineers Corporate Summary
- Figure 3-12: Siemens Diagnostics Revenue, FY 2021 and FY 2022, € MN
Sysmex Corporation
- Table 3-10: Sysmex Corporate Summary
- Figure 3-13: Sysmex Revenue by Product Segment (Clinical Chemistry, FCM, Hematology, Hemostasis, Immunochemistry, Urinalysis, Others), FY 2021, 2022 and 2023, JPY MN
Thermo Fisher Scientific
- Table 3-11: Thermo Fisher Scientific Corporate Summary
- Figure 3-14: Thermo Fisher Scientific COVID-19 Response Revenue, 2021 and 2022, by Quarter $B
Chapter 4: New Opportunities
Artificial Intelligence Future Trends
At-Home Testing
Multiplex Testing
Telehealth
The Worldwide Market for In Vitro Diagnostic Tests, 15th Edition
Chapter One: Executive Summary
Figure 1-1: The Worldwide IVD Market, 2022 and 2027 ($billions)
Scope and Methodology
Table 1-1: Exchange Rate Fluctuations, 2018–2022
Size and Growth of the Market
Table 1-1a: Global In Vitro Diagnostic Sales by Product Market, 2022-2027 ($ million) (Clinical Chemistry; Immunoassays- non isotopic: Infectious disease, Other 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) and COVID-19 Dx 2022
Table 1-1b: Global In Vitro Diagnostic Products, Markets of Interest, 2022-2027 (Sequencing—clinical, Prenatal Test Services, DTC Genetic Testing, Flow Cytometry, Drugs of Abuse: Employment (non-IVD), and Drugs of Abuse: Criminal)
IVD Market Highlights
Figure 1-1: Top Tier IVD Company Sales, 2021 vs. 2022 (percent)
Point of View
Significant Gains in IVD Segments Over Three Years
Figure: 1-2: Combined Performance in COVID-19 and non-COVID-19 IVD Market Segments 2020-2027
Figure 1-3: IVD Market by Segment, 2019 Compared to 2022
COVID-19 Impact and Summary
What to Watch Long-Term
Regions of Market Influence: Korea and China
Collaborations Between IVDs
New Sample Methods
PAMA on the Horizon, Particularly for POC
African Nations IVD Market
Chapter Two: Introduction
IVD Landscape
Report Design
Changes Between 14th and 15th Editions
PAMA and CMS
Market Analysis of IVD Market Segments
Table 2-1a: Global In Vitro Diagnostic Sales by Product Market, 2022-2027 ($ million) (Clinical Chemistry; Immunoassays- non isotopic: Infectious disease, Other immunos, 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) and COVID-19 Dx 2022
Table 2-1b: Global In Vitro Diagnostic Products, Markets of Interest, 2022-2027 (Sequencing—clinical, Prenatal Test Services, DTC Genetic Testing, Flow Cytometry, Drugs of Abuse: Employment (non-IVD), and Drugs of Abuse: Criminal)
Figure 2-1: Developed vs. Developing IVD Market Shares, 2022 and projected 2027 (%)
Top Suppliers and Niche Players
Introduction
Overview of the Top Tier Companies
Table 2-2: Clinical Diagnostic Revenues of Selected Top 20 IVD Companies*, 2021 and estimated 2022 ($ 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
bioMérieux
Sysmex Corporation
Dexcom
Hologic
Quidel Corporation
Werfen
* Instrumentation Laboratory
*Inova Diagnostics
Exact Sciences
Ortho Clinical Diagnostics
PerkinElmer
DiaSorin Group
Bio-Rad Laboratories
Agilent
QIAGEN N.V.
Overview of Selected Second Tier Companies
Table 2-3: Revenues of Selected Top 20 Niche Players, 2021 and estimated 2022 ($ million, estimated) *
Mindray
BGI Genomics
Bruker/CALID Group
Natera
Fulgent Genetics
Myriad Genetics
Fujirebio
Grifols S.A.
Invitae
Diagnostica Stago
Cue Health
Guardant Health
Eiken Chemical Co
Nihon Kohden
Horiba/ABX
Luminex Corporation
OraSure Technologies
Menarini Diagnostics
Meridian
Masimo
The Impact of COVID for the Top Tier Companies
Figure 2-2: Top Tier Market Distribution, 2021 and 2022, estimated (%)
IVD Companies Mergers & Acquisitions
Table 2-4: Selected IVD Mergers and Acquisitions 2019-2022 (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 2017-2021 ($ millions, estimated where applicable)
Table 2-7: Global Lab Market Segmentation, 2021 ($ billions)
Table 2-8: Revenues for a Selection of U.S.-based Reference Labs, 2017-2021 ($ million, estimated)
Table 2-9: Estimated Clinical Test Volume by Select Independent Laboratory, 2021 (millions of units)
Table 2-10: Estimated COVID-19 Test Volume by Select Independent Laboratory, 2021 (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 2022 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, 2019 Compared to 2022
COVID-19 Impact and Summary
Figure: 2-5: Combined Performance in COVID-19 and non-COVID-19 IVD Market Segments 2020-2027
COVID-19 Market Value
Table 2-11: COVID-19 Market Estimates by Segment (Immunoassay, Molecular, Rapid – POC), 2022 ($ millions)
Figure 2-6: IVD COVID-19 Market, Distribution by Region (North America, Europe, Asia Pacific, RoW), 2022 (by %)
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 (BN). 1950-2050
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)
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: Individual EUAs for Molecular Tests for SARS-CoV-2
Table 3-5: Authorized Molecular-Based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2
Table 3-6: Individual EUAs for Antigen Diagnostic 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, Turkey, S. Korea, S. Africa, Vietnam, Poland, Saudi Arabia, Canada, Colombia, Ukraine, Egypt, Malaysia, Peru, and Chile)
Size and Forecast for the Global IVD Market
Table 3-9: Global In Vitro Diagnostic Market; Major Country/Region Markets, 2022 and 2027 ($ 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, 2022 and 2027 ($ millions) (North America, Europe, Asia Pacific, Latin America, ROW)
Table 3-11: Global In Vitro Diagnostic Market – YOY Growth 2021-2022
Table 3-12: Global In Vitro Diagnostic Market; Regional Markets, 2021-2022 YOY Growth (North America, Europe, Asia Pacific, Latin America, ROW)
The IVD Market in the United States
Table 3-13: United States IVD Market Share by Segment, 2022 (%) (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), Total Market Value $54,033 million; Clinical Sequencing $2,916 million ($ millions)
PAMA and Reimbursement Changes
Impact of CARES Act on PAMA
Table 3-14: Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2025
LDT Oversight 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: Economic Commission Inflation Map, 2022
Table 3-16: Western European IVD Market by Country, 2022 ($ 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, 2022 (%) (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, 2022 ($ millions) (Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, Ukraine, Other)
Figure 3-5: Eastern Europe IVD Market by Country, 2022 ($ millions) (Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, Ukraine)
China: Current IVD Market
Table 3-20: China IVD Market by Segment, 2022 (%) (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, 2022 (%) (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, 2022 ($ millions) (Australia, South Korea, Indonesia, Thailand, Philippines, Malaysia, Singapore, Vietnam)
Brazil
Table 3-24: Brazil IVD Market by Broad Segment, 2022 (%) (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, 2022 (%) (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
I
IVD Market Opportunity by Country
Table 3-26: IVD Market Opportunity by Country (2022 Market Rank, Country CAGR 2022-2027) (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 ($millions), Country CAGR 2022-2027(%) (United States, Germany, Japan, France, United Kingdom, Italy, Canada, Spain, Australia, Brazil, Russia, India, Switzerland, Netherlands, Poland, Turkey, Sweden, Belgium, Mexico)
Chapter Four: Company and Industry Trends
Introduction
Advanced Medicine Without Borders
Table 4-1: Key Emerging IVD Markets (Brazil, Russia, India, China, South Korea, Mexico, Turkey, Vietnam) 2017-2022 ($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 2021-2022
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
IBM Watson Health
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
Telehealth
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
Micro-hospital Opportunities
Climate Change and Infectious Disease
Kickback Schemes
Early Sepsis Detection
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
Professional POC
Table 5-1 Professional POC Test Sales by Category, Worldwide 2022 -2027 ($million) (Glucose, Critical Care POC, Fertility, Infectious Diseases, Cardiac Markers, Cholesterol, Coagulation, HbA1c POC, Hematology, Fecal Occult Blood, Drugs of Abuse, Others)
Table 5-2: Selected Professional POC Test Innovations (excluding COVID-19 testing)
OTC Self Testing
Table 5-3: POC Self-Test Sales by Category, Worldwide, 2022-2027($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, 2022 (%) (OTC, PRO)
Table 5-8: Pregnancy/Fertility POC Test Sales Distribution by Global Region, 2022 (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, 2022 (United States, Europe, Japan, RoW)
Lipid Testing
Table 5-11: Lipid POC Test Sales Distribution by Global Region, 2022 (United States, Europe, Japan, RoW)
Drugs of Abuse Testing
Table 5-12: POC Drugs of Abuse Test Sales Distribution by Setting, 2022 (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, 2022 (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, 2022 (United States, Europe, Japan, RoW)
Diabetes Testing – Blood Glucose Monitoring
Table 5-18: Glucose POC Test Sales Distribution by Global Region, 2022 (United States, Europe, Japan, RoW)
Figure 5-1: POC Glucose Testing Market Growth by Category, 2022-2027
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, 2022-2027 (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, 2022 ($ 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, 2022-2027 ($ 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, 2022 ($ 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, 2022-2027 ($millions) (General Chemistries, Blood Gases, Urinalysis)
Table 6-3: Global Clinical Chemistry Sales Distribution by Region, 2022 (North America, Europe, Asia Pacific, RoW)
Table 6-4: Major Clinical Chemistry Companies (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, 2022 and 2027 (Lab-based, POC-based) (in $ millions)
Table 6-8: Blood Gas, Electrolyte, and Critical Care Market Leaders including POC, 2022 (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, 2022 and 2027 (Lab-based, POC-based)
Table 6-11: Urinalysis Systems (including POC) Market Leaders, 2022 (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, 2022-2027 ($millions) (Cardiac Markers, Tumor Markers, Autoimmune, Diabetes/HbA1c, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Drugs of Abuse, Vitamin D, Total; w/o HbA1c)
Table 7-4: Global Immunoassay (excluding infectious disease and blood screening) Sales Distribution by Region, 2022 (%) (North America, Europe, Japan, Asia Pacific, RoW)
Table 7-5: IVD Quality Control Market (estimated), 2022 ($millions)
Table 7-6: Selected Immunoassay Quality Control Products
Table 7-7: 2021-2022 Revenues of Leading Lab-based Immunoassay Vendors (in millions $), Estimated
Mature Assay Segment
Thyroid Function
Therapeutic Drug Monitoring
Anemia
Toxicology/DAU
Allergy
Maturing Immunoassays
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
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, 2022 (United States, Europe, Japan, RoW)
Table 7-19: Global POC Immunoassay Test Sales by Test Category, 2022-2027 (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, 2016-2021, 2022 estimated (in millions $)
Market Analysis
Table 8-10: Global Genomic, HLA and Oncology Molecular Test Sales by Type with NIPT 2022-2027 (in millions $)
Oncology
Table 8-11: Global Molecular Cancer Test Sales Distribution by Region, 2022 (North America, Europe, Asia Pacific, RoW)
Table 8-12: Selected Molecular Tumor Marker Test Innovations
Inherited Diseases and Thrombophilia SNPs
Table 8-13: Most Frequently Requested Genetic Tests
Table 8-14: Global Molecular Thrombophilia Assay Sales Distribution by Region, 2022 (North America, Europe, Asia Pacific, RoW)
Table 8-15: Selected Genomic Tests for Inherited Diseases
Depression and Psychiatric Disorders
Prenatal and Newborn Testing
Table 8-16: Global Prenatal Test Sales Distribution by Region, 2022 (North America, Europe, Asia Pacific, RoW)
Table 8-17: Selected Prenatal Services Provided
Table 8-18: Selected Molecular Tests for Prenatal Analysis
Transplant Diagnostics
Table 8-19: Global Molecular HLA Testing Sales Distribution by Region, 2022 (North America, Europe, Asia Pacific, RoW)
Table 8-20: Selected Innovations of Molecular Transplant Diagnostics
The Commercial Outlook for Molecular Tests
Chapter Nine: Hematology
Overview of Hematology and Trends
Table 9-1: Hematology Analyzer Distribution of Sales by Menu Capability, 2022 estimated
Table 9-2: Lab-based Hematology Sales by Analyte Average Annual Distribution %
Digital Image Analysis
Table 9-3: Selected Hematology Image Analysis Innovations, 2014-2022
Digital Evolution
Quality Control Measurement Programs
Table 9-4: Selected Quality Control Hematology FDA Registrations, 2021
Laboratory-based Hematology Testing
Table 9-5: Selected Hematology Innovations, 2014-2022
Table 9-6: Global Laboratory-based Hematology Test and Instrument Market, 2022 and 2027 ($ millions)
Regional Laboratory-based Hematology Test and Instrument Market
Table 9-7: Global Laboratory-based Hematology Test and Instrument Market, by Region, 2022 (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, 2022 and 2027($ millions) (Instruments, lab-style; Handheld devices)
Market Analysis: Leading Suppliers
Table 9-12: Top Hematology Company Revenues (laboratory and POC), 2022 ($ millions)
Table 9-13: Global Hematology (Laboratory-based and POC) Sales Distribution by Region, 2022 (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: Major Anticoagulants
D-dimer
Table 10-2: Global D-dimer Sales Distribution by Region, 2022 (North America, Europe, Asia Pacific, RoW)
Market Analysis
Table 10-3: Global Coagulation Sales by Segment, 2022-2027 ($millions) (PT/INR Labs, Molecular, Professional POC, Professional Self; D-dimer)
Table 10-4: Global Coagulation Test and Instrument Market by Region, 2022 (North America, Europe, Asia Pacific, RoW)
Lab-based Testing
Table 10-5: Selected Lab-based Coagulation Innovations
Genetic Markers of Hypercoagulopathies
Table 10-6: Related CMS Codes for Reimbursement National Limits, Molecular, 2022
Table 10-7: Global Molecular – Thrombophilia SNP Sales Distribution by Region, 2022 (North America, Europe, Asia Pacific, RoW)
Table 10-8: Selected Molecular Coagulation Test Innovations
Leading Suppliers: Laboratory Systems
Table 10-9: Top Coagulation Company Revenues, Laboratory-based – 2022 ($ 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 – 2022 ($ 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
inBiome BV
Biohit Oyj
DNA Genotek
Biocartis
Abbott
Enterome / Nestlé Health Science
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
Keystone
SARS-CoV-2 (COVID-19)
Figure 11-1: Total COVID-19 Test Volume by Country, Average Estimates June-August 2022 (Thousands)
Figure 11-2: Estimated Market Distribution, COVID-19 Test Value, 2022
Monkeypox
Microbiology Firms Acquisitions and Collaborations
Market Analysis
Table 11-6: Global Microbiology Sales Distribution by Region, 2022 (North America, Europe, Asia Pacific, RoW)
Market Analysis – Traditional Microbiology ID/AST
Table 11-7: Global Microbiology ID/AST Market, 2022-2027 (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, 2022 (North America, Europe, Asia Pacific, RoW)
Traditional ID/AST
Table 11-9: Global ID/AST Testing, Distribution by Systems, 2022 (%) (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, 2022 (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, 2022 (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, 2022 (%) (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, 2022 (%) (North America, Europe, Asia Pacific, RoW)
Table 11-17: Global Molecular Microbiology Market, by Pathogen/Disease Indication, 2022-2027(in $ millions) (HAI, HIV, Hepatitis, GC/Chlamydia, Respiratory, Organism ID, Mycobacteria/TB, Others; 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 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
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, 2022-2027 (Typing) (in $ millions)
Blood Typing Market by Geography
Table 12-8: Global Blood Typing Sales Distribution by Region, 2022 (%) (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, 2022-2027 (Immunoassay Screen, NAT Screens) (in $ millions)
Blood Testing Market by Geography
Table 12-11: Global Blood Testing Market by Geography, 2022 (%) (North America, Europe, Asia Pacific, RoW)
Table 12-12: Global Blood Testing Market by Country, 2022 (%) (United States, Canada, Germany, United Kingdom, France, Japan, China, Latin America) est.
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, 2022 (%) (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, 2022-2027 ($ 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, 2022 (%) (North America, Europe, Asia Pacific, RoW)
Table 13-8: Revenues of the Major Histology Companies, 2017-2022 ($ 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, 2019
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, 2017-2021 ($ million)
Table 14-2: Abbott Diagnostic Revenues by Segment, 2017-2021 ($ 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, 2017-2021 ($ million)
Genomics
Cytogenetic Analysis
Sequencing
CRISPR
Flow Cytometry
Companion Diagnostics – Dako
COVID-19
Beckman Coulter, Inc. / Danaher
Table 14-4: Beckman Coulter Revenue History, 2017-2021 ($ million, estimated)
Table 14-5: Beckman Coulter Diagnostic Revenues by Segment, 2017-2021 ($ 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 14-5: BD Revenue History, 2017-2021 ($ million, estimated) FYE Sept 30
Table 14-6: BD Diagnostic Revenues by Segment, 2017-2021 ($ million)
Cytology
Molecular Microbiology
Traditional Microbiology – ID/AST
Blood Culture
Hospital Acquired Infections
Blood Collection
Mass Spectrometry
Flow Cytometry
COVID-19
bioMérieux Inc.
Table 14-7: bioMerieux Revenue History, 2017-2021 ($ million)
Table 14-8: bioMerieux Diagnostic Revenues by Segment, 2017-2021 ($ million)
Traditional Microbiology
Blood Culture
Immunoassays
Mass Spectrometry
BioFire Diagnostics Business
Expansion
COVID-19
Bio-Rad Laboratories, Inc.
Table 14-9: Bio-Rad Revenue History, 2017-2021 ($ million, estimated)
Table 14-10: Bio-Rad Diagnostic Revenues by Segment, 2017-2021 ($ million) est
Quality Control
Blood Bank
Diabetes
Immunoassays
Liquid Biopsy
Droplet Digital PCR
Sequencing
COVID-19
Bruker Corporation
Table 14-11: Bruker Revenue History Product revenue, 2017-2021 (all; $ million)
Acquisitions and Collaborations
Mass Spectrometry
Microbiology
Molecular PCR
COVID-19
Cepheid / Danaher
Table 14-12: Cepheid Revenue History, 2017-2021 ($ million, clinical product sales)
GeneXpert Xpress Line
Tuberculosis
Microbiology
POC Testing
Cancer
COVID-19
Danaher Corporation
Table 14-13: Danaher Revenue History, 2017-2021 ($ million, Diagnostics, estimated)
Acquisitions
DiaSorin S.p.A
Table 14-14: DiaSorin Revenue History, 2017-2021 ($ million)
Development Plan
Expansion
Immunoassays
Molecular
Molecular Oncology
COVID-19
Grifols S.A.
Table 14-15: Grifols Revenue History, 2017-2021 ($ million)
Table 14-16: Grifols Diagnostic Revenues by Segment, 2017-2021 ($ million)
Blood Transfusion Business
ABO Blood Typing
Molecular ABO Blood Typing
Immunoassays
Coagulation
Market Expansion
COVID-19
Hologic, Inc.
Table 14-17: Hologic Revenue History estimated diagnostic product revenue, 2017-2021 ($ million, estimated)
Table 14-18: Hologic Diagnostic Revenues by Segment, 2017-2021 ($ million)
Acquisitions
PANTHER Molecular System
HIV Testing
Sexually Transmitted Infections
Infectious Diseases
Panther Fusion
Cytology
COVID-19
Instrumentation Laboratory (IL) / Werfen
Table 14-19: Recent Revenue History, 2017-2021 ($ million, estimated)
Table 14-20: IL Diagnostic Revenues by Segment, 2017-2021 ($ million)
Expansion
Coagulation
Acute Care
Information Technology
Leica Biosystems/Danaher
Table 14-21: Leica Revenue History, 2017-2021 ($ millions) estimated
Digital Pathology
Companion Diagnostics
Stain Reagents
Lab Systems
Sample Handling
Circulating Tumor Cells (CTCs)
Artificial Intelligence
COVID-19
Ortho Clinical Diagnostics (QuidelOrtho)
Table 14-22: OrthoClinical Revenue History, 2017-2021 ( in $ millions, estimated)
Table 14-23: Ortho Clinical Diagnostic Revenues by Segment ($ million) est. 2021
Blood Bank
Core Lab / Immunoassays
Expansion
COVID-19
PerkinElmer, Inc. (PE)
Table 14-24: PerkinElmer Revenue History, 2017-2021 ($ million, estimated)
Table 14-25: PerkinElmer Diagnostic Revenues by Segment, 2017-2021 ($ million) est
Diagnostics
Sequencing /Genomics
Liquid Biopsy
Histology
Prenatal Business
Lab Services
Mass Spectrometry
COVID-19
QIAGEN
Table 14-26: QIAGEN Revenue History, 2017-2021 ($ million)
Table 14-27: QIAGEN Diagnostic Revenues by Segment, 2017-2021 ($ 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
Quidel Corporation (QuidelOrtho)
Table 14-28: Quidel Revenue History, 2017-2021 ($ million)
Table 14-29: Quidel Diagnostic Revenues by Segment, 2017-2021 ($ million) est
Immunoassays
Rapid Immunoassays
The Solana Business
Molecular – Savanna
COVID-19
Radiometer A/S / Danaher
Table 14-30: Radiometer A/S Revenue History, 2017-2021 (estimated, $ million)
Critical Care
Immunoassays
HemoCue
Transcutaneous Monitoring
Roche Diagnostics
Table 14-31: Roche Revenue History, 2017-2021 (in millions $)
Table 14-32: Roche Diagnostic Revenues by Segment, 2017-2021 ($ 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 14-33: Siemens Healthineers Revenue History, 2017-2021 ($ million, estimated)
Table 14-34: Siemens Healthineers Diagnostic Revenues by Segment, 2021 ($ 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 14-35: Sysmex Revenue History, , 2018-2021 ($ million) FYE March 31
Table 14-36: Sysmex Diagnostic Revenues by Segment, 2018-2021 ($ million) est
Hematology
Coagulation
Urinalysis
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 14-37: Thermo Fisher Revenue History, 2017-2021 (clinical diagnostics, $ million)
Table 14-38: Thermo Fisher Scientific Diagnostic Revenues by Segment, 2017-2021 ($ 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 14-39: Ventana Medical Systems Revenue History, 2017-2021 ($ millions)
Immunohistochemistry – IHC
Cervical Cancer Screening
Companion Diagnostics
Werfen
Table 14-40: Werfen Recent Revenue History, 2017-2021 ($ million estimated)
Chapter Fifteen: Company Profiles: The Second Tier
ARKRAY
Dry Chemistry / Immunoassays
Urinalysis
Diabetes
Molecular
B
GI Genomics (formerly Beijing Genome Institute)
Table 15-1: BGI Genomics Revenue History ($ millions)
PCR – Fluorescence
MGI Tech Co., Limited, China
Prenatal Testing
Test Services
Whole Genome Sequencing (WGS)
Collaborations
COVID-19
Cue Health
Table 15-2: Cue Health Revenue History, 2020-2021 ($ million)
COVID-19
Dexcom
Table 15-3: Dexcom Revenue History, 2017-2021 ($ million)
Diagnostica Stago S.A.S.
Eiken Chemical Co., Ltd
Table 15-4: Eiken Chemical Revenue History FYE March 31, 2017-2021 ( $millions)
Product News
COVID-19
Exact Sciences
Table 15-5: Exact Sciences Revenue History, 2017-2021 (in $ millions)
COVID-19
Fulgent Genetics, Inc
Table 15-6: Fulgent Revenue History, 2017-2021 ($ million)
COVID-19
Fujirebio Diagnostics, Inc.
Table 15-7: Fujirebio Diagnostics Revenue History, 2017-2021 ($ millions) FYE March 31
GenMark Diagnostics, Inc
Table 15-8: GenMark Revenue History, 2017-2021 ($ million)
COVID-19
Guardant Health, Inc.
Table 15-9: Guardant Health Revenue History, 2019-2021 ($ million)
Horiba Medical
Table 15-10: Horiba Medical Revenue History, 2017-2021 (in millions USD) (medical diagnostic sales)
Illumina
Table 15-11: Illumina Revenue History, 2017-2021 ($ million – not all revenues are for clinical products and services; estimated)
Table 15-12: Illumina Diagnostic Revenues by Segment, 2017-2021 ($ million) est
China
COVID-19
Invitae
Labcorp, Laboratory Corporation of America
Table 15-13: Labcorp Revenue History, 2017-2021 ($ millions)
Precision Medicine
Diagnostics Services
DTC Home Testing
Collaborations and Expansion
COVID-19
Luminex Corporation (DiaSorin)
Table 15-14: Luminex Revenue History, 2017-2021 ($ million; company developed tests, estimated)
COVID-19
Masimo Corporation
Table 15-15: Masimo Revenues History, 2017-2021 ($ millions)
Menarini Diagnostics
COVID-19
Meridian Bioscience, Inc.
Table 15-16: Meridian Bioscience Revenue History, 2017-2021 ($ million, estimated) FYE Sept 30
Immunoassays
Molecular Tests
COVID-19
Mindray – Shenzhen Mindray Bio-medical Electronics Co., Ltd.
Natera
Table 15-17: Natera Revenue History, 2017-2021 ($ millions)
Myriad Genetics, Inc.
Table 15-18: Myriad Genetics Revenue History, 2017-2021 ($ millions) FYE June 30
Nihon Kohden
Table 15-19: Nihon Kohden Revenues History, 2017-2021 ($ millions)
Nova Biomedical Corporation (Nova)
OraSure Technologies, Inc.
Table 15-20: OraSure Technologies Revenue History, 2017-2021 ($ million)
COVID-19
Philips (Royal Philips)
Table 15-21: Philips Revenue History, 2017-2021 ($ millions)
Histology
Precision Medicine
Precision Medicine IT
Patient Monitoring
Point of Care
Wearable Self Monitor
Quest Diagnostics
Table 15-22: Quest Diagnostics Revenue History, 2017-2021 ($ million)
Diagnostic Services
Oncology
Infectious Diseases
Prenatal and Women’s Health
Retail / Consumer Health
Expansion
COVID-19
Randox Laboratories Ltd.
Clinical Chemistries
Controls
Evidence Series – Multistat Biochip Analyzers
Molecular
COVID-19
Chapter Sixteen: Company Profiles: Blood Bank Specialists
Cerus Corporation
Table 16-1: Cerus Revenue History ($ million)
COVID-19
Quotient Limited
Table 16-2: Quotient Limited Revenue History, 2017-2021 ($ million)
COVID-19
Chapter Seventeen: Company Profiles: Core Lab and Other Companies
AB SCIEX Pte Ltd.
EKF Diagnostics Holdings Plc
Table 17-1: EKF Diagnostics Revenue History, 2016-2021 ($ millions)
COVID-19
ELITech Group S.A.S.
COVID-19
Nova Biomedical
Sekisui Diagnostics LLC
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, 2017-2021 ($ millions)
COVID-19
Chapter Eighteen: Company Profiles: CTC & Liquid Biopsy Test Providers
Biocartis
Table 18-1: Biocartis Revenue History, 2017-2021 ($ million)
COVID-19
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, 2017-2021 ($ million)
Integrity Applications Inc. (GlucoTrack)
LifeScan Inc.
Medtronic plc
Table 19-2: Medtronic Revenue History, 2017-2021 ($ million)
Nemaura Medical Inc.
COVID-19
Verily Life Sciences LLC
COVID-19
Chapter Twenty: Company Profiles: Hematology (Cell Analysis) and Coagulation Specialists
CellaVision AB
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, 2017-2021 ($ million)
COVID-19
Bio-Techne Corporation
Table 22-2: Bio-Techne Revenue History, 2017-2021 ($ million)
COVID-19
Eurobio Scientific
COVID-19
EUROIMMUN AG
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
Intel Corporation
International Business Machines Corp. (IBM)
PierianDx
SOPHiA GENETICS SA
COVID-19
Chapter Twenty-Four: Company Profiles: Microbiology Specialists
Accelerate Diagnostics, Inc.
Table 24-1: Accelerate Diagnostics Revenue History, 2017-2021 ($ 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
Asuragen Inc.
COVID-19
Enzo Biochem Inc.
Table 25-1: Enzo Biochem Revenue History, 2017-2021 ($ million)
COVID-19
Fluidigm Corporation (Standard BioTools)
Table 25-2: Fluidigm Revenue History, 2017-2021 ($ million)
COVID-19
Genome Diagnostics BV (GenDx)
NanoString Technologies, Inc.
Table 25-3: NanoString Revenue History, 2017-2021 ($ million)
COVID-19
Pacific Biosciences of California, Inc. (PacBio)
Table 25-4: PacBio Revenue History, 2017-2021 ($ million)
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, 2017-2021 ($ million)
COVID-19
Diazyme
COVID-19
DNA Electronics Ltd (DNAe)
Genedrive plc (formerly Epistem Holdings)
Table 26-2: genedrive Revenue History, 2017-2021 (in $ millions)
COVID-19
NuGenerex Diagnostics (HDS)
Immunostics, Inc.
COVID-19
Loop Medical
MedMira, Inc.
Table 26-3: MedMira Revenue History, 2017-2021 ($ 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
Randox Laboratories Ltd.
Clinical Chemistries
Controls
Evidence Series – Multistat Biochip Analyzers
Molecular
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, 2017-2021 (in $ millions)
BioReference Laboratories
COVID-19
Biotheranostics
BluePrint Genetics Oy
Boston Heart Diagnostics
CareDx, Inc.
Table 29-2: CareDx Revenue History, 2017-2021 ($ in thousands)
Helomics Corporation
Mayo Clinic Laboratories
MDxHealth SA
Table 29-3: MDxHealth Revenue History, 2017-2021 (in $ millions)
OPKO Diagnostics
Table 29-4: OPKO Diagnostics Revenue History, 2017-2021 (in $ millions)
COVID-19
Sonic Healthcare
Veracyte, Inc.
Table 29-5: Veracyte Revenue History, 2017-2021 (in $ millions)
