The Worldwide Market for In Vitro Diagnostic Tests, 15th Edition

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Best Price Guarantee
Price	from $8,500
Length	1583 Pages
Publisher	Kalorama Information
Published Date	August, 2022
SKU	KLI17399072

The Worldwide Market for In Vitro Diagnostic Tests, 15th Edition

The Most Comprehensive Market Research in IVD…Now in its 15th Edition

In Vitro Diagnostics (IVD) is an enormous market and having comprehensive information on the state of IVD and its future is a vital part of making well-informed decisions. The 15th edition of Kalorama’s Worldwide Market for In Vitro Diagnostic Tests provides readers with reliable estimates, real-world forecasts, and insights needed to understand the IVD market in its entirety. This 1,500+ page report is based on vendor reporting, interviews, vendor activities, and more on a global scale. Kalorama’s full assessment of the IVD diagnostic market makes The Worldwide Market for In Vitro Diagnostics Tests the most trusted report by top companies in the industry.

Why The Worldwide Market for In Vitro Diagnostic Tests?

Access the Most Comprehensive Report on the IVD Market
Gain Reliable Information from a Publication Focused Specifically on IVD Market Research
Better Navigate the IVD Market with this Report as Your Guide
Obtain Perspective and Data on Others in the IVD Industry
Learn Who is Tracking and Investing in the IVD Industry
Leverage Findings to Understand the Market on a Global Scale
Understand Market Data in the Context of Real-World Industry and Medical Practice Trends

Report Overview & Methodology

The Worldwide Market for In Vitro Diagnostic Tests is the result of months of analysis and review of secondary sources by seasoned analysts, critical readings of current and historic company filings and releases, interviews with relevant experts and searching of government sources and journal literature. All test segments contain valuable information on current market size and future projection. Compound annual growth rate is provided, as well as significant IVD companies in the market and IVD manufacturer’s product innovations. This detailed look at the IVD market yields unparalleled global market modeling.

This report gives you definitive answers to important questions like:

What is the Size of IVD Market Segments?
Who’s Winning?
Who’s Merged?
Who’s Launched Game-Changing Products?
What is the Competitive Landscape?
What are the Corporate Profiles of Companies in the Industry?
And more…

The most essential report on the IVD industry, The Worldwide Market for In Vitro Diagnostic Test, is a must-have tool for understanding the IVD market on a deeper level. Interested in learning more? Contact us today!

Country-Level Coverage

The in vitro diagnostics market is a global one, and The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 14th Edition reflects the international scope of the in vitro diagnostics market size. In the healthcare market, IVD companies sell globally and think globally. Trends in one part of the world affect IVD manufacturers’ product decisions and company financial performance in others. Thus, this is a global report, and the following regional and country overall IVD markets are included:

US
Germany
UK
France
Spain
Italy
Russia
Netherlands
Turkey
Poland
Canada
China
Japan
Malaysia
Singapore
South Korea
Australia
Saudi Arabia
Brazil
Argentina
Colombia
Chile
Peru
South Africa
Eastern Europe
Emerging Markets
Rest of World

The Worldwide Market for In Vitro Diagnostic Tests is a testament to the Kalorama methodology. It is the result of months of painstaking work by an experienced IVD industry analyst, who has tracked hundreds of in vitro diagnostic companies for developments, trends and financial results. This research is compiled along with the opinion, observations and insights of industry experts to produce an unparalleled vision of the in vitro diagnostics industry as it is in 2022.

Competitive Analysis and Corporate Profiling

The report concentrates over a thousand pages on detailed and tiered profiles of companies in the in vitro diagnostics market. The experience that Kalorama Information has in the in vitro diagnostic market is evident in its tiering and segmentation of companies. First tier, second-tier and specialist companies are profiled. Financial results, product launches, company history and strategic plans are analyzed in the profiles. Over 200 Profiles are included in the report.

Companies profiled include these, and many others:

Abbott Diagnostics
Accelerate Diagnostics, Inc.
Altona Diagnostics
Amoy Diagnostics Co. Ltd.
Angle
Arkray
ARUP Laboratories
Ascensia Diabetes Care Holdings AG
Beckman Coulter
Becton Dickinson (BD)
BGI Genomics (formerly Beijing Genome Institute)
Binding Site Group Ltd. (The)
Biocartis
Biocept, Inc.
Biohit
Biomerica Inc.
bioMerieux
Bio-Rad
BioReference Laboratories
Bio-Techne Corporation
Biotheranostics
Bruker
CareDx, Inc.
CellaVision AB
Cepheid
Cepheid / Danaher
Cerner Corp.
Copan
Corgenix Medical Corporation
Critical Diagnostics
Curetis
Cynvenio Biosystems (LungLife AI)
Dako A/S
Danaher
Dexcom Inc.
Diagnostica Stago, S.A.S.
DIAGON Kft. Hungary
DiaSorin
Edico Genome (Illumina)
Eiken Chemical Co., Ltd
EKF Diagnostics Holdings Plc
ELITech Group S.A.S.
Epic Sciences
Epigenomics AG
ERBA Diagnostics, Inc.
Fujirebio
Fujirebio Diagnostics, Inc.
Genomic Health (Exact Sciences)
Greiner Bio-One International GmbH
Grifols
Guardant Health, Inc.
Hain Lifescience GmbH
Hologic
Horiba Medical
HTG Molecular Diagnostics
Human Longevity Inc.
Illumina
Immucor
Immunodiagnostic Systems (IDS)
INOVA Diagnostics, Inc.
Instrumentation Laboratory
Lab Corp
Leica Biosystems
LifeScan Inc.
Luminex Corporation
Medica Corporation
MedTest DX
Menarini Diagnostics
Meridian Bioscience, Inc.
MilliporeSigma
Mindray
Nova Biomedical
Perkin Elmer
PerkinElmer, Inc. (PE)
Qiagen
Quest
Quest Diagnostics
Quidel Ortho
Radiometer
Randox
Randox Laboratories Ltd.
Rennova Health, Inc.
Response Biomedical Corp.
Roche Diagnostics
SD Biosensor
Seegene
Sekisui Diagnostics LLC
Shimadzu Scientific Instruments
Siemens Healthineers
Singulex, Inc.
Snibe Co. Ltd.
Sonic Healthcare
Sysmex
Tecan Group
Thermo Fisher Scientific
Tosoh Bioscience
Trinity Biotech Plc
Werfen

Executive Summary
- Table The Worldwide IVD Market, 2022 and 2027 ($billions)
- Scope and Methodology
  - Table Exchange Rate Fluctuations, 2018–2022
- Size and Growth of the Market
  - Table Global In Vitro Diagnostic Sales by Product Market, 2022-2027 ($ 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 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
  - Table Top Tier IVD Company Sales, 2021 vs. 2022 (percent)
- Point of View
- Significant Gains in IVD Segments Over Three Years
  - Table Combined Performance in COVID-19 and non-COVID-19 IVD Market Segments 2020-2027
  - Table 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
Introduction
- IVD Landscape
- Report Design
  - Changes Between 14th and 15th Editions
- Market Analysis of IVD Market Segments
  - Table 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 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)
  - Table Developed vs. Developing IVD Market Shares, 2022 and projected 2027 (%)
- Top Suppliers and Niche Players
  - Introduction
  - Overview of the Top Tier Companies
    - Table Clinical Diagnostic Revenues of Selected Top 20 IVD Companies*, 2021 and estimated 2022 ($ million)
  - Overview of Selected Second Tier Companies
    - Table Revenues of Selected Top 20 Niche Players, 2021 and estimated 2022 ($ million, estimated) *
- The Impact of COVID for the Top Tier Companies
  - Table Top Tier Market Distribution, 2021 and 2022, estimated (%)
- IVD Companies Mergers & Acquisitions
  - Table Selected IVD Mergers and Acquisitions 2019-2022 (first half)
- Collaboration, Partnership, Alliance Agreements
  - Table Selected IVD Partnerships/Collaborations/Alliance Agreements 2016-2019
- Test Services
  - Table Selected Test Services, Sales 2017-2021 ($ millions, estimated where applicable)
  - Table Global Lab Market Segmentation, 2021 ($ billions)
  - Table Revenues for a Selection of U.S.-based Reference Labs, 2017-2021 ($ million, estimated)
  - Table Estimated Clinical Test Volume by Select Independent Laboratory, 2021 (millions of units)
  - Table Estimated COVID-19 Test Volume by Select Independent Laboratory, 2021 (millions of units)
- Historical IVD Market vs Today
  - In the Beginning to Now
    - Table 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
- Point of View
  - Table IVD Market by Segment, 2019 Compared to 2022
- COVID-19 Impact and Summary
  - Table Combined Performance in COVID-19 and non-COVID-19 IVD Market Segments 2020-2027
  - COVID-19 Market Value
    - Table COVID-19 Market Estimates by Segment (Immunoassay, Molecular, Rapid – POC), 2022 ($ millions)
    - Table IVD COVID-19 Market, Distribution by Region (North America, Europe, Asia Pacific, RoW), 2022 (by %)
The Global Picture for In Vitro Diagnostic Markets
- Background
  - Simultaneous Threats: Chronic and Acute
  - Expected World IVD Market Developments
- Global Population and Aging
  - Table Global Fertility Rate vs. Population Size (BN). 1950-2050
  - Table Global Population Distribution, 2022
  - Table 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 Age Under 15 and Over 65, by Continent (Africa, L. America/Caribbean, Asia, Oceania, N. America, Europe, World) 2020
- WHO Essential IVD List
  - Table WHO Model List of Essential In Vitro Diagnostics (EDL)
  - Increase in Chronic Diseases
    - Table Leading Causes of Death Globally, 2019
- COVID-19
  - Table Individual EUAs for Molecular Tests for SARS-CoV-2
  - Table Authorized Molecular-Based Laboratory Developed Tests for Detection of Nucleic Acid from SARS-CoV-2
  - Table Individual EUAs for Antigen Diagnostic Tests for SARS-CoV-2
  - Table Individual EUAs for Serology Tests for SARS-CoV-2
  - Table Individual EUAs For IVDs for Management of COVID-19 Patients
- Emerging and Emerged Markets
  - Table 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 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 Global In Vitro Diagnostic Market; Regional Markets, 2022 and 2027 ($ millions) (North America, Europe, Asia Pacific, Latin America, ROW)
  - Table Global In Vitro Diagnostic Market – YOY Growth 2021-2022
  - Table 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 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
    - Table Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2025
  - LDT Oversight Update
  - Precision Medicine and NGS
- IVD Market in Europe: Growing Markets
  - Table Economic Indicators (GDP Growth, Inflation Growth) by Select European Country (Germany, France, Italy, Spain), 2020-2023 (%)
  - Table Economic Commission Inflation Map, 2022
  - Table 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 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 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 Eastern European IVD Market by Country, 2022 ($ millions) (Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, Ukraine, Other)
  - Table Eastern Europe IVD Market by Country, 2022 ($ millions) (Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, Ukraine)
- China: Current IVD Market
  - Table 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 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 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 Asia Pacific IVD Market by Country, 2022 ($ millions) (Australia, South Korea, Indonesia, Thailand, Philippines, Malaysia, Singapore, Vietnam)
- Brazil
  - Table 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 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
- IVD Market Opportunity by Country
  - Table 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)
  - Table IVD Market Opportunity by Country: Top 20 Markets (Country Market Value ($millions), Country CAGR 2022-2027(%) (United States, Germany, Japan, France, United Kingdom, Italy, Canada, Spain, Australia, Brazil, Russia, India, Switzerland, Netherlands, Poland, Turkey, Sweden, Belgium, Mexico)
Company and Industry Trends
- Introduction
  - Advanced Medicine Without Borders
    - Table Key Emerging IVD Markets (Brazil, Russia, India, China, South Korea, Mexico, Turkey, Vietnam) 2017-2022 ($millions)
  - China Market Information
  - Direct to Consumer Genetic Test Services
  - Future Trends
- Gene Editing
  - Table Selected Gene Editing / CRISPR Innovations
  - CRISPR as a Diagnostic Tool
  - CRISPR and the Food Industry
- Microbiome
  - Table Selected Microbiome Test Innovations
- Next Generation Sequencing
  - Table 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 Selected AI Market Cleared Tests
  - The Regulatory Pathway
  - Product Initiatives
    - Table Selected AI Product Initiatives in Development and Collaborations
  - IBM Watson Health
- AI in Liquid Biopsy
  - Table Selected AI/Liquid Biopsy Initiatives
  - Future Trends
- Exosome Sequencing
- Biotin Interference in Immunoassay Detection Errors
  - Table 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 Global Drug Abuse Statistics
  - Urine
  - Blood
  - Oral
  - Hair
    - Table Selected Opioid Test FDA Approvals
- Micro-hospital Opportunities
- Climate Change and Infectious Disease
- Kickback Schemes
- Early Sepsis Detection
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 Professional POC Test Sales by Category, Worldwide 2022 -2027 ($million) (Glucose, Critical Care POC, Fertility, Infectious Diseases, Cardiac Markers, Cholesterol, Coagulation, HbA1c POC, Hematology, Fecal Occult Blood, Drugs of Abuse, Others)
  - Table Selected Professional POC Test Innovations (excluding COVID-19 testing)
- OTC Self Testing
  - Table POC Self-Test Sales by Category, Worldwide, 2022-2027($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 Home Collection Test Market*, 2022 and 2027 ($million), CAGR 2022-2027
  - Table Home Collection Test Kit Market by Category, Worldwide, 2022(% Estimated Share)
  - Table Selected Molecular Tests EUAs for Home Collection SARS-CoV-2 Tests
- Pregnancy/Fertility Tests
  - Table POC Pregnancy and Fertility Test Market Distribution by End User, 2022 (%) (OTC, PRO)
  - Table Pregnancy/Fertility POC Test Sales Distribution by Global Region, 2022 (United States, Europe, Japan, RoW)
- Colon Cancer Screening
  - Table Selected POC Colon Cancer Tests
  - Table Colon Cancer POC Test Sales Distribution by Global Region, 2022 (United States, Europe, Japan, RoW)
- Lipid Testing
  - Table Lipid POC Test Sales Distribution by Global Region, 2022 (United States, Europe, Japan, RoW)
- Drugs of Abuse Testing
  - Table POC Drugs of Abuse Test Sales Distribution by Setting, 2022 (Employment Screening, Criminal Justice, Critical Care - Traditional POC)
  - Table Drugs of Abuse Tests on the Market
- Rapid and POC Infectious Disease Testing
  - Table 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 Innovations in Molecular POC Infectious Disease Diagnostics
  - COVID-19
  - Market Size and Growth
    - Table Infectious Disease POC Test Demand by Type, 2022 (Influenza, HIV, STD, Hepatitis, Malaria, C.Difficile, E.coli, H.pylori, Home Test/OTC, Others)
    - Table Infectious Disease POC Test Sales Distribution by Global Region, 2022 (United States, Europe, Japan, RoW)
- Diabetes Testing – Blood Glucose Monitoring
  - Table Glucose POC Test Sales Distribution by Global Region, 2022 (United States, Europe, Japan, RoW)
  - Table POC Glucose Testing Market Growth by Category, 2022-2027
  - IT to Aid Diabetes Management
    - Table Selected Apps and Glucose Management IT
  - Diabetes Market Analysis
    - Table Global Diabetes Sales by Test Category, 2022-2027 (Glucose, OTC; Glucose, professional; Glucose, continuous; HbA1c, POC; TOTAL; HbA1c, Lab) ($ millions)
  - POC Glucose Competitors
    - Table POC Test Revenues of Selected IVD Glucose Companies, 2022 ($ million, estimated)
  - Blood Glucose Self-Testing
    - Table Selected Glucose Self-Test Meter Innovations
  - Noninvasive Testing Devices
    - Table Selected Noninvasive Glucose Monitoring Devices
  - Continuous Glucose Monitoring
    - Table Selected Continuous Blood Glucose System Developments
  - Blood Glucose Testing by Professionals
    - Table Selected Innovations in Hospital-based Glucose Monitoring
  - Diabetes Testing – Glycated Hemoglobin
    - Table Global HbA1c Test Sales Market and Distribution by Setting, 2022-2027 ($ millions) (HbA1c POC, HbA1c Lab)
    - Table Selected POC HbA1c Devices
  - Genes and Other Markers of Diabetes
    - Table Selected POC Diabetes Monitoring Tests
- The Major POC Test Players
  - Table POC Test Revenues of Selected IVD Companies, 2022 ($ million, estimated)
The Core Lab
- Core Lab Overview and Trends
  - Table Selected Analytes for the Core Lab
- Connectivity
- Overview of Chemistry Tests
  - Lab Automation
- Market Analysis
  - Table Global Clinical Chemistry Sales by Test Category, 2022-2027 ($millions) (General Chemistries, Blood Gases, Urinalysis)
  - Table Global Clinical Chemistry Sales Distribution by Region, 2022 (North America, Europe, Asia Pacific, RoW)
  - Table Major Clinical Chemistry Companies (Blood gas/electrolyte, general chemistries, UA)
  - Table Selected Clinical Chemistry Innovations
  - Rapid Response Systems
    - Table Selected Major Whole Blood Chemistry Analyzers
  - Critical Care Analysis
    - Table Blood Gas, Electrolyte and Critical Care Instrument Market by End User, 2022 and 2027 (Labbased, POC-based) (in $ millions)
    - Table Blood Gas, Electrolyte, and Critical Care Market Leaders including POC, 2022 (percent distribution of total sales)
  - User Apps
    - Table Selected Apps, Critical Care and Urinalysis IT Innovations
  - Urinalysis
    - Table UA Market by End User, 2022 and 2027 (Lab-based, POC-based)
    - Table Urinalysis Systems (including POC) Market Leaders, 2022 (percent distribution of total sales) estimated
    - Table Selected Urinalysis Innovations
- The Commercial Outlook for Chemistry Tests
Immunoassays
- Overview and Trends
  - Immunoassay Technology Continues to Evolve
    - Table Selected Immunoassay Technologies
  - Mass Spectrometry
    - Table Selected Innovation in Mass Spectrometry for Routine Analyses
  - Radioimmunoassays
- Market Analysis
  - Leading Suppliers and Growth Potential
    - Table Global Lab-based Immunoassay (excluding infectious disease and blood screening) Sales, by Analyte Type, 2022-2027 ($millions) (Cardiac Markers, Tumor Markers, Autoimmune, Diabetes/HbA1c, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Drugs of Abuse, Vitamin D, Total; w/o HbA1c)
    - Table Global Immunoassay (excluding infectious disease and blood screening) Sales Distribution by Region, 2022 (%) (North America, Europe, Japan, Asia Pacific, RoW)
    - Table IVD Quality Control Market (estimated), 2022 ($millions)
    - Table Selected Immunoassay Quality Control Products
    - Table 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 Selected Vitamin D Immunoassays
  - Tumor Markers
    - Table Selected Tumor Marker Innovations
  - Cardiac Markers
    - Table Selected Cardiac Marker Innovations
  - Autoimmune
    - Table Selected Autoimmune Test Innovations
  - Rheumatoid Arthritis
    - Table Selected Arthritis Immunoassay Innovations
  - Gastrointestinal Disorders
    - Table Selected Inflammatory Bowel Disease Test Innovations
  - Transplant Management
    - Table Selected Immunoassays for Transplant Medicine
  - Women’s Health
    - Table Selected Women’s Health Innovations
  - Alzheimer’s Disease
    - Table Selected Innovations for Alzheimer’s Disease Immunoassays
  - Traumatic Brain Injury
  - Sleep Apnea
  - Miscellaneous
    - Table Selected Immunoassay Innovations
  - Point-of-Care OTC and Professional Use Immunoassays
    - Table Global POC Immunoassay Sales Distribution by Region, 2022 (United States, Europe, Japan, RoW)
    - Table 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 Selected Self-Test Immunoassay Innovations
  - Pregnancy Testing
  - Cardiovascular Diagnostics
  - Drugs of Abuse/Therapeutic Drug Monitoring
- Innovating POC
  - Table Selected POC Test Innovations
  - Table Selected POC Immunoassay Test Platforms
- The Commercial Outlook for Immunoassays
Molecular Assays
- Overview
  - Table Common Next Generation Molecular Test Traits
- Sample Preparation and Quality Control
  - Table Selected Molecular Test Sample Preparation and QC Innovations
- Molecular Evolution
  - Exosome Sequencing
    - Table Selected Exosome Test Innovations
  - Liquid Biopsy
    - Table Selected Liquid Biopsy Innovations
  - Metabolomic Profiling
  - Information Technology
    - Table Selected IT Innovations in Molecular Diagnostics
  - Artificial Intelligence AI
  - Forensic Studies – An Emerging Opportunity
    - Table Selected Innovations in Forensic DNA Testing
  - Test Platforms
    - Table Key Molecular Technologies and Major Players
    - Table Selected Molecular Test Platform Innovations
- Major Players
  - Table Molecular Test Revenues of Selected IVD Vendors, 2016-2021, 2022 estimated (in millions $)
- Market Analysis
  - Table Global Genomic, HLA and Oncology Molecular Test Sales by Type with NIPT 2022-2027 (in millions $)
  - Oncology
    - Table Global Molecular Cancer Test Sales Distribution by Region, 2022 (North America, Europe, Asia Pacific, RoW)
    - Table Selected Molecular Tumor Marker Test Innovations
  - Inherited Diseases and Thrombophilia SNPs
    - Table Most Frequently Requested Genetic Tests
    - Table Global Molecular Thrombophilia Assay Sales Distribution by Region, 2022 (North America, Europe, Asia Pacific, RoW)
    - Table Selected Genomic Tests for Inherited Diseases
  - Depression and Psychiatric Disorders
  - Prenatal and Newborn Testing
    - Table Global Prenatal Test Sales Distribution by Region, 2022 (North America, Europe, Asia Pacific, RoW)
    - Table Selected Prenatal Services Provided
    - Table Selected Molecular Tests for Prenatal Analysis
  - Transplant Diagnostics
    - Table Global Molecular HLA Testing Sales Distribution by Region, 2022 (North America, Europe, Asia Pacific, RoW)
    - Table Selected Innovations of Molecular Transplant Diagnostics
- The Commercial Outlook for Molecular Tests
Hematology
- Overview of Hematology and Trends
  - Table Hematology Analyzer Distribution of Sales by Menu Capability, 2022 estimated
  - Table Lab-based Hematology Sales by Analyte Average Annual Distribution %
  - Digital Image Analysis
    - Table Selected Hematology Image Analysis Innovations, 2014-2022
  - Digital Evolution
  - Quality Control Measurement Programs
    - Table Selected Quality Control Hematology FDA Registrations, 2021
- Laboratory-based Hematology Testing
  - Table Selected Hematology Innovations, 2014-2022
  - Table Global Laboratory-based Hematology Test and Instrument Market, 2022 and 2027 ($ millions)
  - Regional Laboratory-based Hematology Test and Instrument Market
    - Table 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 POC Hematology Distribution by Specialty (hematocrit/hemoglobin vs. other routine hematology (WBC, erythrocyte, platelet)
    - Table Selected POC Hemoglobin and Hematocrit Systems
    - Table Selected POC Hematology Analyzer Systems
    - Table Decentralized Hematology Test and Instrument Market, 2022 and 2027($ millions) (Instruments, lab-style; Handheld devices)
- Market Analysis: Leading Suppliers
  - Table Top Hematology Company Revenues (laboratory and POC), 2022 ($ millions)
  - Table Global Hematology (Laboratory-based and POC) Sales Distribution by Region, 2022 (North America, Europe, Asia Pacific, RoW)
- The Commercial Outlook for Hematology Tests
Coagulation
- Overview and Trends of Coagulation and Immunohematology Tests
- Special Topics
  - COVID-19
  - Direct Oral Anticoagulants (DOACs)
    - Table Major Anticoagulants
  - D-dimer
    - Table Global D-dimer Sales Distribution by Region, 2022 (North America, Europe, Asia Pacific, RoW)
- Market Analysis
  - Table Global Coagulation Sales by Segment, 2022-2027 ($millions) (PT/INR Labs, Molecular, Professional POC, Professional Self; D-dimer)
  - Table Global Coagulation Test and Instrument Market by Region, 2022 (North America, Europe, Asia Pacific, RoW)
- Lab-based Testing
  - Table Selected Lab-based Coagulation Innovations
  - Genetic Markers of Hypercoagulopathies
    - Table Related CMS Codes for Reimbursement National Limits, Molecular, 2022
    - Table Global Molecular - Thrombophilia SNP Sales Distribution by Region, 2022 (North America, Europe, Asia Pacific, RoW)
    - Table Selected Molecular Coagulation Test Innovations
- Leading Suppliers: Laboratory Systems
  - Table Top Coagulation Company Revenues, Laboratory-based – 2022 ($ millions) est.
- Decentralized Coagulation Testing – Professional Use
  - Decentralized Coagulation Testing – OTC
    - Table Selected POC Coagulation Test Innovations
  - Platelet Testing
    - Table Selected Platelet Activity Test Innovations
- Leading Suppliers: POC Systems
  - Table Top Coagulation Company Revenues, POC - 2022 ($ millions) est.
- The Commercial Market for Coagulation Tests
  - Table Major Anticoagulants Uses and Tests
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 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 Selected Nucleic Acid Amplification Test and Other Molecular Companies in Microbiology
  - Microbiome-Related Microbiology Tests
    - Table Selected Microbiome-Based Tests
  - Next Generation Sequencing-Based Microbiology Approaches
    - Table Selected Companies Applying DNA/RNA Sequencing to Microbiology
  - Syndromic/Multiplex Testing
- New Infectious Disease Threats
  - Table 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)
    - Table Total COVID-19 Test Volume by Country, Average Estimates June-August 2022 (Thousands)
    - Table Estimated Market Distribution, COVID-19 Test Value, 2022
  - Monkeypox
- Microbiology Firms Acquisitions and Collaborations
- Market Analysis
  - Table Global Microbiology Sales Distribution by Region, 2022 (North America, Europe, Asia Pacific, RoW)
- Market Analysis - Traditional Microbiology ID/AST
  - Table 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 Global ID/AST Testing Sales Distribution by Region, 2022 (North America, Europe, Asia Pacific, RoW)
  - Traditional ID/AST
    - Table Global ID/AST Testing, Distribution by Systems, 2022 (%) (Panel, Auto)
  - Blood Culture
    - Table 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 Selected Infectious Disease Immunoassay Innovations
    - Table 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 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 Selected HIV Assays
  - Sexually Transmitted Diseases (STDs)
  - ToRCH
  - Lyme Disease
  - Rapid Immunoassay Tests
    - Table 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 Global Molecular Microbiology Sales Distribution by Region, 2022 (%) (North America, Europe, Asia Pacific, RoW)
  - Table 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 Selected Automated Molecular Test Instrument Platforms
  - Molecular Respiratory Infection Testing
  - The Respiratory Trio – Flu, Strep, RSV
    - Table Selected Molecular Point of Care Innovations in Microbiology
  - Molecular Testing for Sexually Transmitted Diseases
  - Molecular Hepatitis Testing
  - Molecular HIV Testing
    - Table Innovations in Molecular POC Diagnostics for HIV
  - Molecular Tests for Hospital-Acquired Infections (HAIs)
    - Table 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 Selected Companies Marketing Mass Spectrometers and/or Assays for the Clinical Laboratory [CE-Marked and/or 510(k) cleared]
- The Future Outlook for Microbiology
Blood Banking Services
- Overview
  - The Current Status of Global Blood Collection
- Global Blood Safety
  - Table Laboratory Screening of Blood Donations for Transfusion-Transmissible Infections, Number of Countries (Syphilis, HCV, HBV, HIV, Chagas, Malaria, HTLV I/II)
  - Table Prevalence of TTIs in Blood Donations [Median (Interquartile range)], by Income Group
  - Zika Virus
  - Blood and Component Collection
    - Table Blood Component Usage for Selected Conditions
    - Table Red Blood Cell and Platelet Use by Hospital Services (%)
  - COVID-19 Impact on Plasma Collection
  - Reevaluating Blood Transfusions
    - Table 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 Selected Blood Typing and Grouping Innovations
  - Size and Growth of Typing Markets
    - Table Global Blood Typing Market, 2022-2027 (Typing) (in $ millions)
  - Blood Typing Market by Geography
    - Table Global Blood Typing Sales Distribution by Region, 2022 (%) (North America, Europe, Asia Pacific, RoW)
- Blood Testing Market
  - Table Selected Blood Testing Innovations
  - Preventing Bacterial Infections
  - Immunoassays
  - Nucleic Acid Testing (NAT)
  - Size and Growth of the Market
    - Table Global Blood Banking Diagnostics Market, 2022-2027 (Immunoassay Screen, NAT Screens) (in $ millions)
  - Blood Testing Market by Geography
    - Table Global Blood Testing Market by Geography, 2022 (%) (North America, Europe, Asia Pacific, RoW)
    - Table 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
Histology and Cytology
- Overview
- Special Topics
  - Histology Automation
    - Table Selected Histology Lab Automation
    - Table Histology Information Technology Tools
  - Advanced Analysis Solutions
    - Table Selected Advanced Histology Techniques
  - HPV meets Core Lab
    - Table Global HPV Test Sales Distribution by Region, 2022 (%) (North America, Europe, Asia Pacific, RoW)
    - Table Selected HPV Test Innovations
- Market Analysis
  - Total Market
    - Table 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 Global Histology/Cytology Sales Distribution by Region, 2022 (%) (North America, Europe, Asia Pacific, RoW)
    - Table Revenues of the Major Histology Companies, 2017-2022 ($ millions, estimated)
    - Table Selected Vendors of Traditional Histology Stains
    - Table Primary and Secondary Prevention of Cervical Cancer, Screening Responses by Country, 2019
  - Immunohistochemistry and In Situ Hybridization
    - Table Selected In Situ Hybridization-based Tests
    - Table Selected IHC Test Innovations
  - Pharmacodiagnostic Histology
    - Table Major Pharmacodiagnostic Markers
    - Table Selected Pharmacodiagnostic Histology Tests
  - Digital Imaging and Computational Pathology
    - Table Selected Digital Pathology Image Capture and Viewing Solutions
  - COVID-19 and Digital Pathology
    - Table FDA Digital Pathology Device Review Classification During COVID-19
    - Table Selected Digital Imaging Innovations
  - Circulating Tumor Cells
    - Table Selected Innovations in CTC Technology
  - Flow Cytometry
- The Commercial Outlook for Histology and Cytology Tests
Company Profiles: The Top Tier
- Abbott Diagnostics
  - Table Abbott Diagnostics Revenue History, 2017-2021 ($ million)
  - Table 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 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 Beckman Coulter Revenue History, 2017-2021 ($ million, estimated)
  - Table 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 BD Revenue History, 2017-2021 ($ million, estimated) FYE Sept 30
  - Table 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 bioMerieux Revenue History, 2017-2021 ($ million)
  - Table 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 Bio-Rad Revenue History, 2017-2021 ($ million, estimated)
  - Table 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 Bruker Revenue History Product revenue, 2017-2021 (all; $ million)
  - Acquisitions and Collaborations
  - Mass Spectrometry
  - Microbiology
  - Molecular PCR
  - COVID-19
- Cepheid / Danaher
  - Table Cepheid Revenue History, 2017-2021 ($ million, clinical product sales)
  - GeneXpert Xpress Line
  - Tuberculosis
  - Microbiology
  - POC Testing
  - Cancer
  - COVID-19
- Danaher Corporation
  - Table Danaher Revenue History, 2017-2021 ($ million, Diagnostics, estimated)
  - Acquisitions
- DiaSorin S.p.A
  - Table DiaSorin Revenue History, 2017-2021 ($ million)
  - Development Plan
  - Expansion
  - Immunoassays
  - Molecular
  - Molecular Oncology
  - COVID-19
- Grifols S.A.
  - Table Grifols Revenue History, 2017-2021 ($ million)
  - Table 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 Hologic Revenue History estimated diagnostic product revenue, 2017-2021 ($ million, estimated)
  - Table 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 Recent Revenue History, 2017-2021 ($ million, estimated)
  - Table IL Diagnostic Revenues by Segment, 2017-2021 ($ million)
  - Expansion
  - Coagulation
  - Acute Care
  - Information Technology
- Leica Biosystems/Danaher
  - Table 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 OrthoClinical Revenue History, 2017-2021 ( in $ millions, estimated)
  - Table Ortho Clinical Diagnostic Revenues by Segment ($ million) est. 2021
  - Blood Bank
  - Core Lab / Immunoassays
  - Expansion
  - COVID-19
- PerkinElmer, Inc. (PE)
  - Table PerkinElmer Revenue History, 2017-2021 ($ million, estimated)
  - Table 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 QIAGEN Revenue History, 2017-2021 ($ million)
  - Table 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 Quidel Revenue History, 2017-2021 ($ million)
  - Table Quidel Diagnostic Revenues by Segment, 2017-2021 ($ million) est
  - Immunoassays
  - Rapid Immunoassays
  - The Solana Business
  - Molecular – Savanna
  - COVID-19
- Radiometer A/S / Danaher
  - Table Radiometer A/S Revenue History, 2017-2021 (estimated, $ million)
  - Critical Care
  - Immunoassays
  - HemoCue
  - Transcutaneous Monitoring
- Roche Diagnostics
  - Table Roche Revenue History, 2017-2021 (in millions $)
  - Table Roche Diagnostic Revenues by Segment, 2017-2021 ($ 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 Siemens Healthineers Revenue History, 2017-2021 ($ million, estimated)
  - Table 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 Sysmex Revenue History, , 2018-2021 ($ million) FYE March 31
  - Table 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 Thermo Fisher Revenue History, 2017-2021 (clinical diagnostics, $ million)
  - Table 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 Ventana Medical Systems Revenue History, 2017-2021 ($ millions)
  - Immunohistochemistry - IHC
  - Cervical Cancer Screening
  - Companion Diagnostics
- Werfen
  - Table Werfen Recent Revenue History, 2017-2021 ($ million estimated)
Company Profiles: The Second Tier
- ARKRAY
  - Dry Chemistry / Immunoassays
  - Urinalysis
  - Diabetes
  - Molecular
- GI Genomics (formerly Beijing Genome Institute)
  - Table 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 Cue Health Revenue History, 2020-2021 ($ million)
  - COVID-19
- Dexcom
  - Table Dexcom Revenue History, 2017-2021 ($ million)
- Diagnostica Stago S.A.S.
- Eiken Chemical Co., Ltd
  - Table Eiken Chemical Revenue History FYE March 31, 2017-2021 ( $millions)
  - Product News
  - COVID-19
- Exact Sciences
  - Table Exact Sciences Revenue History, 2017-2021 (in $ millions)
  - COVID-19
- Fulgent Genetics, Inc
  - Table Fulgent Revenue History, 2017-2021 ($ million)
  - COVID-19
- Fujirebio Diagnostics, Inc.
  - Table Fujirebio Diagnostics Revenue History, 2017-2021 ($ millions) FYE March 31
- GenMark Diagnostics, Inc
  - Table GenMark Revenue History, 2017-2021 ($ million)
  - COVID-19
- Guardant Health, Inc.
  - Table Guardant Health Revenue History, 2019-2021 ($ million)
- Horiba Medical
  - Table Horiba Medical Revenue History, 2017-2021 (in millions USD) (medical diagnostic sales)
- Illumina
  - Table Illumina Revenue History, 2017-2021 ($ million – not all revenues are for clinical products and services; estimated)
  - Table Illumina Diagnostic Revenues by Segment, 2017-2021 ($ million) est
  - China
  - COVID-19
- Invitae
- Labcorp, Laboratory Corporation of America
  - Table Labcorp Revenue History, 2017-2021 ($ millions)
  - Precision Medicine
  - Diagnostics Services
  - DTC Home Testing
  - Collaborations and Expansion
  - COVID-19
- Luminex Corporation (DiaSorin)
  - Table Luminex Revenue History, 2017-2021 ($ million; company developed tests, estimated)
  - COVID-19
- Masimo Corporation
  - Table Masimo Revenues History, 2017-2021 ($ millions)
- Menarini Diagnostics
  - COVID-19
- Meridian Bioscience, Inc.
  - Table 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 Natera Revenue History, 2017-2021 ($ millions)
- Myriad Genetics, Inc.
  - Table Myriad Genetics Revenue History, 2017-2021 ($ millions) FYE June 30
- Nihon Kohden
  - Table Nihon Kohden Revenues History, 2017-2021 ($ millions)
- Nova Biomedical Corporation (Nova)
- OraSure Technologies, Inc.
  - Table OraSure Technologies Revenue History, 2017-2021 ($ million)
  - COVID-19
- Philips (Royal Philips)
  - Table Philips Revenue History, 2017-2021 ($ millions)
  - Histology
  - Precision Medicine
  - Precision Medicine IT
  - Patient Monitoring
  - Point of Care
  - Wearable Self Monitor
- Quest Diagnostics
  - Table 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
Company Profiles: Blood Bank Specialists
- Cerus Corporation
  - Table Cerus Revenue History ($ million)
  - COVID-19
- Quotient Limited
  - Table Quotient Limited Revenue History, 2017-2021 ($ million)
  - COVID-19
Company Profiles: Core Lab and Other Companies
- AB SCIEX Pte Ltd.
- EKF Diagnostics Holdings Plc
  - Table 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 Trinity Biotech Revenue History, 2017-2021 ($ millions)
  - COVID-19
Company Profiles: CTC & Liquid Biopsy Test Providers
- Biocartis
  - Table 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
Company Profiles: Specialists
- Ascensia Diabetes Care Holdings AG
- Bigfoot Biomedical Inc.
- Debiotech SA
  - COVID-19
- Glooko Inc.
- Insulet Corporation
  - Table Insulet Corp Revenue History, 2017-2021 ($ million)
- Integrity Applications Inc. (GlucoTrack)
- LifeScan Inc.
- Medtronic plc
  - Table Medtronic Revenue History, 2017-2021 ($ million)
- Nemaura Medical Inc.
  - COVID-19
- Verily Life Sciences LLC
  - COVID-19
Company Profiles: Hematology (Cell Analysis) and Coagulation Specialists
- CellaVision AB
Company Profiles: Histopathology Specialists
- Amoy Diagnostics Co. Ltd.
- Applied Spectral Imaging Inc. (ASI)
- BioGenex Laboratories, Inc.
- BioView Ltd.
- Leica Biosystems
  - COVID-19
- MilliporeSigma
- Visiopharm
Company Profiles: Immunoassay Specialists
- Biohit Healthcare
- Biomerica Inc.
  - Table Biomerica Revenue History, 2017-2021 ($ million)
  - COVID-19
- Bio-Techne Corporation
  - Table 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
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
Company Profiles: Microbiology Specialists
- Accelerate Diagnostics, Inc.
  - Table 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
Company Profiles: Molecular Test Specialists
- Asuragen Inc.
  - COVID-19
- Enzo Biochem Inc.
  - Table Enzo Biochem Revenue History, 2017-2021 ($ million)
  - COVID-19
- Fluidigm Corporation (Standard BioTools)
  - Table Fluidigm Revenue History, 2017-2021 ($ million)
  - COVID-19
- Genome Diagnostics BV (GenDx)
- NanoString Technologies, Inc.
  - Table NanoString Revenue History, 2017-2021 ($ million)
  - COVID-19
- Pacific Biosciences of California, Inc. (PacBio)
  - Table PacBio Revenue History, 2017-2021 ($ million)
  - COVID-19
- Takara Bio Inc.
  - COVID-19
- Vela Diagnostics
  - COVID-19
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 Chembio Diagnostics Revenue History, 2017-2021 ($ million)
  - COVID-19
- Diazyme
  - COVID-19
- DNA Electronics Ltd (DNAe)
- Genedrive plc (formerly Epistem Holdings)
  - Table genedrive Revenue History, 2017-2021 (in $ millions)
  - COVID-19
- NuGenerex Diagnostics (HDS)
- Immunostics, Inc.
  - COVID-19
- Loop Medical
- MedMira, Inc.
  - Table MedMira Revenue History, 2017-2021 ($ thousands)
  - COVID-19
- QuantuMDx Group, Ltd.
  - COVID-19
- Rheonix, Inc.
  - COVID-19
- Veredus Laboratories Pte Ltd
  - COVID-19
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
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.
Test Service Providers
- 23andMe
- Agendia BV
- Ambry Genetics
  - COVID-19
- ARUP Laboratories
  - COVID-19
- Aspira Women’s Health ( formerly Vermillion Inc.)
  - Table Aspira Women’s Health Revenue History, 2017-2021 (in $ millions)
- BioReference Laboratories
  - COVID-19
- Biotheranostics
- BluePrint Genetics Oy
- Boston Heart Diagnostics
- CareDx, Inc.
  - Table CareDx Revenue History, 2017-2021 ($ in thousands)
- Helomics Corporation
- Mayo Clinic Laboratories
- MDxHealth SA
  - Table MDxHealth Revenue History, 2017-2021 (in $ millions)
- OPKO Diagnostics
  - Table OPKO Diagnostics Revenue History, 2017-2021 (in $ millions)
  - COVID-19
- Sonic Healthcare
- Veracyte, Inc.
  - Table Veracyte Revenue History, 2017-2021 (in $ millions)