Science and Medicine Group

The Worldwide Market for In Vitro Diagnostic Tests, 14th Edition 25 Aug 2021

Report details
16 Figures
300 Tables

Chapter One: Executive Summary
- Significant Gains in IVD Segments, 2020-2021
- Scope and Methodology
- Size and Growth of the Market
- Differences Between the 13th and 14th Edition
- A Note on Growth Rates
- COVID-19 Market Value
- IVD Market Highlights
- What to Watch Long-Term
  - The Newer Emerging Markets
  - At Home Testing: COVID -19 Trend or Here to Stay?
  - Collaborations Between IVDs
  - Synthetic Biology and Diagnostics
Chapter Two: Introduction
- IVD Landscape
- Report Design
  - Reporting Changes for Segments from the 13th Edition
- The Challenge of PAMA
- Market Analysis of IVD Market Segments
- Top Suppliers and Niche Players
  - Introduction
  - Overview of the Top Tier Companies
  - Overview of Selected Second Tier Companies
- The Impact of COVID for the Top Tier Companies
- IVD Companies Mergers & Acquisitions
- Collaboration, Partnership, Alliance Agreements
- Test Services
- Historical IVD Market vs Today
  - In the Beginning to Now
  - Future
- Point of View
- COVID-19 Impact and Summary
  - COVID-19 Market Value
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
  - Workforce Reduction
  - Addressing the Aging Trend
- WHO Essential IVD List
  - Increase in Chronic Diseases
- COVID-19
- Emerging and Emerged Markets
- Size and Forecast for the Global IVD Market
  - COVID-19 Impact for 2021
- The IVD Market in the United States
  - PAMA and Reimbursement Changes
  - LDT Oversight Update
  - Personalized Medicine and NGS
- IVD Market in Europe: Growing Markets
  - Europe Industry Actions
  - EU Regulation
  - Personalized Medicine in Europe
  - Brexit
- Eastern Europe: Growth Region
- Japan
- China: Current IVD Market
  - Clinical Laboratory Tests in China
  - Private Laboratories
  - Distribution in China
- India: Population and Opportunity
  - Labs in India
- Rest of Asia
- Brazil
  - Disease Trends
- Mexico
- The Russian Federation
- Canada
- Emerging Markets
  - Saudi Arabia IVD Market
  - South Africa IVD Market
  - Turkey IVD Market
  - Colombia IVD Market
  - United Arab Emirates (UAE) IVD Market
  - South Korea IVD Market
  - Other Markets to Watch
- IVD Market Opportunity by Country
Chapter Four: Company and Industry Trends
- Introduction
  - Advanced Medicine Without Borders
  - China Market Information
  - Clinical Genetic Test Advances
  - Direct to Consumer Genetic Test Services
  - Programs and Initiatives
  - Future Trends
- Gene Editing
  - CRISPR as a Diagnostic Tool
  - Basic Research
  - Food Industry
  - Investor Interest
- Microbiome
- Next Generation Sequencing
- Liquid Biopsy
  - Quality Assurance
  - Product News
  - Market Cleared Products
  - For Research Use Only
  - Products in Development
  - Liquid Biopsy in Microbiology
  - Liquid Biopsy Companies in 2021
  - The Future for Liquid Biopsy
- Information Technology Advances and Artificial Intelligence
  - AI in Clinical Practice
  - The Regulatory Pathway
  - Product Initiatives
  - IBM Watson Health
  - AI in Liquid Biopsy
  - Future Trends
- Exosome Sequencing
- Biotin Interference in Immunoassay Detection Errors
- 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
  - Urine
  - Blood
  - Oral
  - Hair
- Micro-hospital Opportunities
- Climate Change and Infectious Disease
- Kickback Schemes
- Early Sepsis Detection
Chapter Five: Point-of-Care Tests
- Overview and Trends
- Professional POC
- OTC Self Testing
- Pregnancy/Fertility Tests
- Colon Cancer Screening
- Lipid Testing
- Drugs of Abuse Testing
  - Products
- Rapid and POC Infectious Disease Testing
  - Products
  - HIV and Hepatitis Testing and Monitoring
  - Tuberculosis
  - Tropical and Neglected Diseases
  - Respiratory Diseases
  - Sepsis and Nosocomial Disease
  - Sexual Health
  - Lyme Disease
  - COVID-19
  - Market Size and Growth
- Diabetes Testing – Blood Glucose Monitoring
  - IT to Aid Diabetes Management
  - Diabetes Market Analysis
  - POC Glucose Competitors
  - Blood Glucose Self-Testing
  - Noninvasive Testing Devices
  - Continuous Glucose Monitoring
  - Blood Glucose Testing by Professionals
  - Diabetes Testing – Glycated Hemoglobin
  - Genes and Other Markers of Diabetes
- The Major POC Test Players
Chapter Six: The Core Lab
- Core Lab Overview and Trends
- Connectivity
- Overview of Chemistry Tests
  - Lab Automation
- Market Analysis
  - Rapid Response Systems
  - Critical Care Analysis
  - User Apps
  - Urinalysis
- The Commercial Outlook for Chemistry Tests
Chapter Seven: Immunoassays
- Overview and Trends
  - Immunoassay Technology Continues to Evolve
  - Mass Spectrometry
  - Radioimmunoassays
- Market Analysis
  - Leading Suppliers and Growth Potential
- Mature Assay Segment
  - Thyroid Function
  - Therapeutic Drug Monitoring
  - Anemia
  - Toxicology/DAU
  - Allergy
- Maturing Immunoassays
  - Proteins
- Growth Immunoassays
  - Vitamin D
  - Tumor Markers
  - Cardiac Markers
  - Autoimmune
  - Rheumatoid Arthritis
  - Gastrointestinal Disorders
  - Transplant Management
  - Women’s Health
  - Alzheimer’s Disease
  - Sleep Apnea
  - Miscellaneous
  - Point-of-Care OTC and Professional Use
  - Pregnancy Testing
  - Cardiovascular Diagnostics
  - Drugs of Abuse/Therapeutic Drug Monitoring
- Innovating POC
- The Commercial Outlook for Immunoassays
Chapter Eight: Molecular Assays
- Overview
- Sample Preparation and Quality Control
- Advanced Molecular Tests and Technologies
  - Exosome Sequencing
  - Liquid Biopsy
  - Metabolomic Profiling
  - Information Technology
  - Artificial Intelligence AI
  - Forensic Studies – An Emerging Opportunity
  - Test Platforms
- Major Players
- Market Analysis
  - Oncology
  - Inherited Diseases and Thrombophilia SNPs
  - Psychiatric Disorders
  - Prenatal and Newborn Testing
  - Transplant Diagnostics
- The Commercial Outlook for Molecular Tests
Chapter Nine: Hematology
- Overview of Hematology and Trends
  - Digital Image Analysis
  - Digital Evolution
  - Quality Control Measurement Programs
- Laboratory-based Hematology Testing
  - Regional Laboratory-based Hematology Test and Instrument Market
- Decentralized Hematology Testing
  - Hemoglobin/Hematocrit at the POC
- Market Analysis: Leading Suppliers
- 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)
  - D-dimer
- Market Analysis
- Lab-based Testing
  - Genetic Markers of Hypercoagulopathies
- Leading Suppliers: Laboratory Systems
- Decentralized Coagulation Testing – Professional Use
  - Decentralized Coagulation Testing – OTC
  - Platelet Testing
- Leading Suppliers: POC Systems
- The Commercial Market for Coagulation 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
- Microbial Antibiotic Resistance – The Role of Clinical Tests
  - “Faster Identification: Where Are We?”
- 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
  - Microbiome-Related Microbiology Tests
  - Next Generation Sequencing-Based Microbiology Approaches
  - Syndromic Testing
- New Infectious Disease Threats
  - Tickborne Diseases (TBDs)
  - Zika
  - Chagas
  - Dengue
  - Ebola
  - Chikungunya
  - Next Threats?
- Microbiology Firms Acquisitions and Collaborations
- Market Analysis
- Market Analysis - Traditional Microbiology ID/AST
  - Traditional ID/AST
  - Blood Culture
  - Chromogenic Media
  - Rapid Tests Performed on Colonies from Culture Media
  - Supplies
- Market Analysis - Microbiology Immunoassays
  - Improvements in Microbiology Immunoassays
  - Hepatitis Testing
  - Sepsis
  - HIV Immunoassay Testing
  - Sexually Transmitted Diseases (STDs)
  - ToRCH
  - Lyme Disease
  - Rapid Immunoassay Tests
- Market Analysis - Molecular Microbiology
  - Lab Automation and Molecular Diagnostics
  - Molecular Respiratory Infection Testing
  - The Respiratory Trio – Flu, Strep, RSV
  - Molecular Testing for Sexually Transmitted Diseases
  - Molecular Hepatitis Testing
  - Molecular HIV Testing
  - Molecular Tests for Hospital-Acquired Infections (HAIs)
  - Assessing the Problem: Nosocomial Infection Statistics
  - Clostridium Difficile
  - MRSA
  - Molecular TB Testing
  - Limitations of Molecular Microbiology Testing
- Mass Spectrometry
- The Future Outlook for Microbiology
Chapter Twelve: Blood Banking Services
- Overview
  - The Current Status of Global Blood Collection
- Global Blood Safety
  - Zika Virus
  - Blood and Component Collection
  - COVID-19 Impact on Plasma Collection
  - Reevaluating Blood Transfusions
- Blood Typing and Grouping Market
  - Manual Blood Typing Methods
  - Automated Blood Typing and Screening Methods
  - Molecular Methods
  - Reducing Blood Typing Errors
  - Size and Growth of Typing Markets
  - Blood Typing Market by Geography
- Blood Testing Market
  - Preventing Bacterial Infections
  - Immunoassays
  - Nucleic Acid Testing (NAT)
  - Size and Growth of the Market
  - Blood Testing Market by Geography
- The Commercial Outlook for Blood Banking Testing
Chapter Thirteen: Histology and Cytology
- Overview
- Special Topics
  - Histology Automation
  - Advanced Analysis Solutions
  - HPV Goes Core Lab
- Market Analysis
  - Histology/Cytology
  - Immunohistochemistry and In Situ Hybridization
  - Pharmacodiagnostic Histology
  - Digital Imaging and Computational Pathology
  - COVID-19 and Digital Pathology
  - Circulating Tumor Cells
  - Flow Cytometry
- The Commercial Outlook for Histology and Cytology Tests
Chapter Fourteen: Company Profiles: The Top Tier
- Abbott Diagnostics
  - Alere Acquisition Update and Point of Care
  - Core Lab
  - Hematology
  - Blood Banking
  - Coagulation
  - Infectious Diseases - Molecular
  - Diabetes
  - HIV Point of Care
  - i-STAT Business
  - Companion Testing
  - Liquid Biopsy
  - COVID-19
- Agilent Technologies
  - Agilent in Genomics
  - Cytogenetic Analysis
  - Sequencing
  - CRISPR
  - Flow Cytometry
  - Companion Diagnostics - Dako
  - COVID-19
- Beckman Coulter, Inc. / Danaher
  - Hematology
  - Hematology IT
  - Clinical Chemistry
  - Immunoassays
  - Coagulation
  - Microbiology
  - Clinical Information Technology
  - Flow Cytometry
  - Blood Banking
  - Beckman Coulter Life Sciences
  - Collaborations
  - COVID-19
- Becton, Dickinson and Company (BD)
  - Cytology
  - Molecular Microbiology
  - Traditional Microbiology - ID/AST
  - Blood Culture
  - Hospital Acquired Infections
  - Connectivity
  - Blood Collection
  - Mass Spectrometry
  - Flow Cytometry
  - Licensing
  - COVID-19
- bioMérieux Inc.
  - Traditional Microbiology
  - Blood Culture
  - Immunoassays
  - Mass Spectrometry
  - BioFire Diagnostics Business
  - Expansion
  - COVID-19
- Bio-Rad Laboratories, Inc.
  - Quality Control
  - Blood Bank
  - Diabetes
  - Immunoassays
  - Autoimmune Testing
  - Liquid Biopsy
  - Microbiome
  - Droplet Digital PCR
  - Sequencing
  - COVID-19
- Bruker Corporation
  - Acquisitions and Collaborations
  - Microbiology
  - Molecular PCR
  - COVID-19
- Cepheid / Danaher
  - GeneXpert Xpress Line
  - High Burden Expansion
  - India
  - Tuberculosis
  - Microbiology
  - POC Testing
  - Cancer
  - COVID-19
- Danaher Corporation
  - Acquisitions
- DiaSorin S.p.A
  - Development Plan
  - Expansion
  - Immunoassays
  - Zika Testing
  - Molecular
  - Molecular Oncology
  - COVID-19
- Grifols S.A.
  - Blood Transfusion Business
  - ABO Blood Typing
  - Molecular ABO Blood Typing
  - Immunoassays
  - Coagulation
  - Market Expansion
  - COVID-19
- Hologic, Inc.
  - Acquisitions
  - PANTHER Molecular System
  - HIV Testing
  - Sexually Transmitted Infections
  - Infectious Diseases
  - Panther Fusion
  - Cytology
  - COVID-19
- Instrumentation Laboratory (IL) / Werfen
  - Expansion
  - Coagulation
  - Acute Care
  - Information Technology
- Leica Biosystems/Danaher
  - Digital Pathology
  - Stain Reagents
  - Lab Systems
  - Sample Handling
  - Circulating Tumor Cells (CTCs)
  - Artificial Intelligence
  - COVID-19
- Ortho Clinical Diagnostics (Ortho)
  - Blood Bank
  - Core Lab / Immunoassays
  - Lab Automation
  - Connectivity
  - Expansion
  - COVID-19
- PerkinElmer, Inc. (PE)
  - Diagnostics
  - Sequencing /Genomics
  - Liquid Biopsy
  - Histology
  - Prenatal Business
  - Lab Services
  - Mass Spectrometry
  - COVID-19
- QIAGEN
  - Tuberculosis
  - Molecular Expansion
  - Precision Medicine / Companion Diagnostics
  - Molecular Microbiology
  - Prenatal Testing
  - Next Generation Sequencing
  - Sample Prep, Informatics
  - Digital PCR
  - Bioinformatics
  - Liquid Biopsy
  - Cervical Cancer
  - Transplant Medicine
  - Expansion
  - COVID-19
- Quidel Corporation
  - The Alere Triage Business
  - Immunoassays
  - Rapid Immunoassays
  - The Solana Business
  - Molecular – Savanna
  - COVID-19
- Radiometer A/S / Danaher
  - Critical Care
  - Immunoassays
  - HemoCue
  - Transcutaneous Monitoring
- Roche Diagnostics
  - Hematology
  - Core Lab
  - Immunoassays
  - HIV
  - Molecular Expansion
  - Core Molecular
  - Digital PCR
  - Diabetes Care
  - Coagulation
  - cobas Liat System – POC
  - HPV
  - Blood Bank
  - Transplant Medicine
  - Cancer Companion Testing
  - Prenatal
  - Liquid Biopsy
  - IT in Anatomical Pathology
  - Information Technology
  - COVID-19
- Siemens Healthineers (Siemens)
  - Core Lab
  - Lab Automation
  - Immunoassays
  - Hematology
  - Urinalysis
  - Molecular
  - Expansion to Support Molecular Diagnostics – Fast Track Diagnostics
  - Sequencing with Artificial Intelligence
  - Zika Virus Testing
  - Acute Care – POC
  - POC Connectivity
  - Business Expansion
  - COVID-19
- Sysmex Corporation
  - Hematology
  - Coagulation
  - Urinalysis
  - Immunoassays
  - Lab Information System
  - Information Technology
  - Flow Cytometry
  - Precision Medicine / Companion Test Diagnostics
  - Liquid Biopsy
  - Exosomes
  - Oncology
  - Sysmex Inostics
  - Forging New Markets
  - COVID-19
- Thermo Fisher Scientific Inc.
  - Immunoassays
  - Microbiology
  - Molecular Test Business
  - Next Generation Sequencing
  - qPCR
  - Oncology Companion Diagnostics
  - Liquid Biopsy
  - Zika Virus
  - Transplant Medicine
  - Microbiome
  - Forensics
  - Mass Spectrometry
  - Collaborations
  - Gene Editing and Cell Therapy
  - China
  - COVID-19
- Ventana Medical Systems Inc. / Roche Tissue Diagnostics
  - Immunohistochemistry - IHC
  - Cervical Cancer Screening
  - Companion Diagnostics
- Werfen
Chapter Fifteen: Company Profiles: The Second Tier
- ARKRAY
  - Dry Chemistry / Immunoassays
  - Urinalysis
  - Diabetes
  - Molecular
- BGI Genomics (formerly Beijing Genome Institute)
  - MGI Tech Co., Limited, China
  - Complete Genomics
  - Prenatal Testing
  - Test Services
  - Liquid Biopsy
  - Whole Genome Sequencing (WGS)
  - Collaborations
  - COVID-19
- Dexcom
- Diagnostica Stago S.A.S.
- Eiken Chemical Co., Ltd
  - Product News
  - COVID-19
- Exact Sciences
  - COVID-19
- Fujirebio Diagnostics, Inc.
- GenMark Diagnostics, Inc
  - COVID-19
- Guardant Health, Inc.
- Horiba Medical
- Illumina
  - Sequencing
  - Advancing in the Clinical Market
  - Sequencing Data Analysis
  - Project Firefly
  - Transplant Medicine
  - Liquid Biopsy
  - Forensic Medicine
  - Prenatal Testing Business
  - Collaborations
  - China
  - COVID-19
- LabCorp, Laboratory Corporation of America
  - Precision Medicine
  - Diagnostics Services
  - DTC Home Testing
  - Prenatal
  - Retail Services
  - Collaborations and Expansion
  - COVID-19
- Luminex Corporation
  - Assay Development
  - VERIGENE Business
  - PCR
  - Flow Cytometry
  - Business Expansion
  - COVID-19
- Masimo Corporation
- A. Menarini Diagnostics
  - COVID-19
- Meridian Bioscience, Inc.
  - Immunoassays
  - Molecular Tests
  - COVID-19
- Mindray - Shenzhen Mindray Bio-medical Electronics Co., Ltd.
  - Core Lab
  - Hematology
- Myriad Genetics, Inc.
- Nova Biomedical Corporation (Nova)
- Philips (Royal Philips)
  - Histology
  - Cancer Genomics
  - Precision Medicine
  - Precision Medicine IT
  - Patient Monitoring
  - Point of Care
  - Wearable Self Monitor
- Quest Diagnostics
  - 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
  - COVID-19
- Quotient Limited
  - COVID-19
Chapter Seventeen: Company Profiles: Core Lab and Other Companies
- AB SCIEX Pte Ltd.
- EKF Diagnostics Holdings Plc
  - COVID-19
- ELITech Group S.A.S.
  - COVID-19
- MedTest DX
  - COVID-19
- Microsaic Systems plc
- Nova Biomedical
- Scienion AG
- Sekisui Diagnostics LLC
  - COVID-19
- Shimadzu Scientific Instruments
- Snibe Co. Ltd., (Shenzhen New Industries Biomedical Engineering Co. Ltd.)
  - COVID-19
- Tecan Group
  - COVID-19
- Tosoh Bioscience
  - COVID-19
- Trinity Biotech Plc
  - COVID-19
Chapter Eighteen: Company Profiles: CTC & Liquid Biopsy Test Providers
- Biocartis
  - COVID-19
- Biocept, Inc.
  - COVID-19
- Biodesix
  - COVID-19
- Epic Sciences
- Epigenomics AG
- Foundation Medicine, Inc.
- LungLife AI
- Menarini-Silicon Biosystems
  - COVID-19
- Natera
- NeoGenomics
Chapter Nineteen: Company Profiles: Specialists
- Ascensia Diabetes Care Holdings AG
- Bigfoot Biomedical Inc.
- Debiotech SA
  - COVID-19
- Glooko Inc.
- Insulet Corporation
- Integrity Applications Inc.
- LifeScan Inc.
- Medtronic plc
- Nemaura Medical Inc.
  - COVID-19
- Verily Life Sciences LLC
  - COVID-19
Chapter Twenty: Company Profiles: Hematology (Cell Analysis) and Coagulation…
- CellaVision AB
Chapter Twenty-One: Company Profiles: Histopathology Specialists
- Amoy Diagnostics Co. Ltd.
- Applied Spectral Imaging Inc. (ASI)
- BioGenex Laboratories, Inc.
- BioView Ltd.
- HTG Molecular Diagnostics
- Leica Biosystems
  - COVID-19
- MilliporeSigma (formerly EMD Millipore)
  - COVID-19
- Visiopharm
Chapter Twenty-Two: Company Profiles: Immunoassay Specialists
- Binding Site Group Ltd. (The)
  - COVID-19
- Biohit Healthcare
- Biomerica Inc.
  - COVID-19
- Bio-Techne Corporation
  - COVID-19
- Eurobio Scientific
  - COVID-19
- EUROIMMUN AG
  - COVID-19
- HOB Biotech
  - 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
- Advaita Corp.
  - COVID-19
- Cerner Corp.
- Dell Technologies Inc.
- Euformatics Oy
- GenomOncology LLC
- Google LLC
- Intel Corporation
- International Business Machines Corp. (IBM)
- PierianDx
- Rennova Health, Inc.
- SOPHiA GENETICS SA
  - COVID-19
- Sunquest Information Systems Inc.
  - COVID-19
- WuXi NextCODE (now Genuity Science)
Chapter Twenty-Four: Company Profiles: Microbiology Specialists
- Accelerate Diagnostics, Inc.
  - 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
- Hain Lifescience GmbH
  - COVID-19
- Mast Group
  - COVID-19
- Mobidiag
  - COVID-19
- Q-linea AB
- OpGen, Inc.
  - COVID-19
- Seegene, Inc.
  - COVID-19
- Specific Technologies
- T2 Biosystems
  - COVID-19
Chapter Twenty-Five: Company Profiles: Molecular Test Specialists
- Asuragen Inc.
  - COVID-19
- Enzo Biochem Inc.
  - COVID-19
- Exosome Diagnostics, Inc. (Bio-Techne)
  - COVID-19
- Fluidigm Corporation
  - COVID-19
- Genome Diagnostics BV (GenDx)
- NanoString Technologies, Inc.
  - COVID-19
- Oxford Nanopore Technologies Ltd
  - COVID-19
- Pacific Biosciences of California, Inc. (PacBio)
  - COVID-19
- Takara Bio Inc.
  - COVID-19
- Vela Diagnostics
  - COVID-19
Chapter Twenty-Six: Company Profiles: Point of Care Test Specialists
- Abaxis, Inc.
- Abingdon Health Ltd.
  - COVID-19
- binx Health
  - COVID-19
- Biomeme, Inc.
  - COVID-19
- Chembio Diagnostic Systems, Inc.
  - COVID-19
- Diazyme
  - COVID-19
- DNA Electronics Ltd (DNAe)
- Fio Corporation
  - COVID-19
- Genedrive plc (formerly Epistem Holdings)
  - COVID-19
- NuGenerex Diagnostics (HDS)
- Immunostics, Inc.
  - COVID-19
- Loop Medical
- MedMira, Inc.
  - COVID-19
- OraSure Technologies, Inc.
  - COVID-19
- PTS Diagnostics
  - In March 2020, the company launched its A1CNow + Controls DiaSorin Group
  - 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)
- Eurofins LifeCodexx AG
- Myriad Women’s Health
- INEX Innovate
  - COVID-19
- Invitae
- Oxford Gene Technology
- Sequenom, Inc. (Integrated Genetics)
- Yourgene Health
  - COVID-19
Chapter Twenty-Eight: Company Profiles: Quality Control & Sample Pretreatment…
- 10x Genomics
- Agena Bioscience, Inc.
  - COVID-19
- Biotype Diagnostic GmbH
  - COVID-19
- DxTerity Diagnostics Inc.
  - COVID-19
- Horizon Discovery Group plc
- IncellDx
- LGC SeraCare Life Sciences, Inc.
  - COVID-19
- PreAnalytiX GmbH
- Precipio, Inc. (formerly Transgenomic)
  - COVID-19
- Quanterix Corporation
  - COVID-19
- Streck Inc.
Chapter Twenty-Nine: Test Service Providers
- 23andMe
- Agendia BV
- Ambry Genetics
  - COVID-19
- ARUP Laboratories
  - COVID-19
- Aspira Women’s Health (formerly Vermillion Inc.)
- BioReference Laboratories
  - COVID-19
- Biotheranostics
- BluePrint Genetics Oy
- Boston Heart Diagnostics
- CareDx, Inc.
- Eurofins Genomics
  - COVID-19
- Helomics Corporation
- Mayo Clinic Laboratories
- MDxHealth SA
- OPKO Diagnostics
  - COVID-19
- Sonic Healthcare
- Veracyte, Inc.

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

25 Aug 2021

GSL

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21-050

Kalorama Information’s latest edition of our in vitro diagnostic market report represents the fourteenth time in two decades our analysts have fully assessed the in vitro diagnostic market from scratch and re-report numbers. Last year, the COVID-19 pandemic highlighted how important testing is in a way that could not be imagined This year, COVID-19 is to some degree a routine test category in respiratory and infectious disease testing, themselves high-growth segments. Now the question will be how increased back to work/back to school/back to physician office plans will affect IVD markets? This as well as the segment-specific testing market trends will be addressed in this volume.

What is the Size of the IVD Market in 2021?

This report answers this question and more. Beyond COVID-19, Tests for cancer and infectious disease detection, transplant success, pharmaceutical selection have added healthcare value and improved outcomes. Genetic tests for rare diseases and prenatal assessment are increasingly utilized. Tests for emerging diseases have also become increasingly important.

What is the Size of IVD Market Segments? Who’s Winning? Who’s Merged? Who’s Launched Game-Changing Products?

One book definitively answers these questions, from a publisher that is focused on in vitro diagnostics. Now in its 14th edition, this Kalorama Information report, The Worldwide Market for In Vitro Diagnostic (IVD) Tests, is the most essential report on the IVD industry. For two decades, the 1,500-plus page report has provided reliable estimates and real-world forecasts for the in vitro diagnostics industry.

Page Count: 1792

Table of Contents

Chapter One: Executive Summary
- Significant Gains in IVD Segments, 2020-2021
- Scope and Methodology
- Size and Growth of the Market
- Differences Between the 13th and 14th Edition
- A Note on Growth Rates
- COVID-19 Market Value
- IVD Market Highlights
- What to Watch Long-Term
  - The Newer Emerging Markets
  - At Home Testing: COVID -19 Trend or Here to Stay?
  - Collaborations Between IVDs
  - Synthetic Biology and Diagnostics
Chapter Two: Introduction
- IVD Landscape
- Report Design
  - Reporting Changes for Segments from the 13th Edition
- The Challenge of PAMA
- Market Analysis of IVD Market Segments
- Top Suppliers and Niche Players
  - Introduction
  - Overview of the Top Tier Companies
  - Overview of Selected Second Tier Companies
- The Impact of COVID for the Top Tier Companies
- IVD Companies Mergers & Acquisitions
- Collaboration, Partnership, Alliance Agreements
- Test Services
- Historical IVD Market vs Today
  - In the Beginning to Now
  - Future
- Point of View
- COVID-19 Impact and Summary
  - COVID-19 Market Value
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
  - Workforce Reduction
  - Addressing the Aging Trend
- WHO Essential IVD List
  - Increase in Chronic Diseases
- COVID-19
- Emerging and Emerged Markets
- Size and Forecast for the Global IVD Market
  - COVID-19 Impact for 2021
- The IVD Market in the United States
  - PAMA and Reimbursement Changes
  - LDT Oversight Update
  - Personalized Medicine and NGS
- IVD Market in Europe: Growing Markets
  - Europe Industry Actions
  - EU Regulation
  - Personalized Medicine in Europe
  - Brexit
- Eastern Europe: Growth Region
- Japan
- China: Current IVD Market
  - Clinical Laboratory Tests in China
  - Private Laboratories
  - Distribution in China
- India: Population and Opportunity
  - Labs in India
- Rest of Asia
- Brazil
  - Disease Trends
- Mexico
- The Russian Federation
- Canada
- Emerging Markets
  - Saudi Arabia IVD Market
  - South Africa IVD Market
  - Turkey IVD Market
  - Colombia IVD Market
  - United Arab Emirates (UAE) IVD Market
  - South Korea IVD Market
  - Other Markets to Watch
- IVD Market Opportunity by Country
Chapter Four: Company and Industry Trends
- Introduction
  - Advanced Medicine Without Borders
  - China Market Information
  - Clinical Genetic Test Advances
  - Direct to Consumer Genetic Test Services
  - Programs and Initiatives
  - Future Trends
- Gene Editing
  - CRISPR as a Diagnostic Tool
  - Basic Research
  - Food Industry
  - Investor Interest
- Microbiome
- Next Generation Sequencing
- Liquid Biopsy
  - Quality Assurance
  - Product News
  - Market Cleared Products
  - For Research Use Only
  - Products in Development
  - Liquid Biopsy in Microbiology
  - Liquid Biopsy Companies in 2021
  - The Future for Liquid Biopsy
- Information Technology Advances and Artificial Intelligence
  - AI in Clinical Practice
  - The Regulatory Pathway
  - Product Initiatives
  - IBM Watson Health
  - AI in Liquid Biopsy
  - Future Trends
- Exosome Sequencing
- Biotin Interference in Immunoassay Detection Errors
- 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
  - Urine
  - Blood
  - Oral
  - Hair
- Micro-hospital Opportunities
- Climate Change and Infectious Disease
- Kickback Schemes
- Early Sepsis Detection
Chapter Five: Point-of-Care Tests
- Overview and Trends
- Professional POC
- OTC Self Testing
- Pregnancy/Fertility Tests
- Colon Cancer Screening
- Lipid Testing
- Drugs of Abuse Testing
  - Products
- Rapid and POC Infectious Disease Testing
  - Products
  - HIV and Hepatitis Testing and Monitoring
  - Tuberculosis
  - Tropical and Neglected Diseases
  - Respiratory Diseases
  - Sepsis and Nosocomial Disease
  - Sexual Health
  - Lyme Disease
  - COVID-19
  - Market Size and Growth
- Diabetes Testing – Blood Glucose Monitoring
  - IT to Aid Diabetes Management
  - Diabetes Market Analysis
  - POC Glucose Competitors
  - Blood Glucose Self-Testing
  - Noninvasive Testing Devices
  - Continuous Glucose Monitoring
  - Blood Glucose Testing by Professionals
  - Diabetes Testing – Glycated Hemoglobin
  - Genes and Other Markers of Diabetes
- The Major POC Test Players
Chapter Six: The Core Lab
- Core Lab Overview and Trends
- Connectivity
- Overview of Chemistry Tests
  - Lab Automation
- Market Analysis
  - Rapid Response Systems
  - Critical Care Analysis
  - User Apps
  - Urinalysis
- The Commercial Outlook for Chemistry Tests
Chapter Seven: Immunoassays
- Overview and Trends
  - Immunoassay Technology Continues to Evolve
  - Mass Spectrometry
  - Radioimmunoassays
- Market Analysis
  - Leading Suppliers and Growth Potential
- Mature Assay Segment
  - Thyroid Function
  - Therapeutic Drug Monitoring
  - Anemia
  - Toxicology/DAU
  - Allergy
- Maturing Immunoassays
  - Proteins
- Growth Immunoassays
  - Vitamin D
  - Tumor Markers
  - Cardiac Markers
  - Autoimmune
  - Rheumatoid Arthritis
  - Gastrointestinal Disorders
  - Transplant Management
  - Women’s Health
  - Alzheimer’s Disease
  - Sleep Apnea
  - Miscellaneous
  - Point-of-Care OTC and Professional Use
  - Pregnancy Testing
  - Cardiovascular Diagnostics
  - Drugs of Abuse/Therapeutic Drug Monitoring
- Innovating POC
- The Commercial Outlook for Immunoassays
Chapter Eight: Molecular Assays
- Overview
- Sample Preparation and Quality Control
- Advanced Molecular Tests and Technologies
  - Exosome Sequencing
  - Liquid Biopsy
  - Metabolomic Profiling
  - Information Technology
  - Artificial Intelligence AI
  - Forensic Studies – An Emerging Opportunity
  - Test Platforms
- Major Players
- Market Analysis
  - Oncology
  - Inherited Diseases and Thrombophilia SNPs
  - Psychiatric Disorders
  - Prenatal and Newborn Testing
  - Transplant Diagnostics
- The Commercial Outlook for Molecular Tests
Chapter Nine: Hematology
- Overview of Hematology and Trends
  - Digital Image Analysis
  - Digital Evolution
  - Quality Control Measurement Programs
- Laboratory-based Hematology Testing
  - Regional Laboratory-based Hematology Test and Instrument Market
- Decentralized Hematology Testing
  - Hemoglobin/Hematocrit at the POC
- Market Analysis: Leading Suppliers
- 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)
  - D-dimer
- Market Analysis
- Lab-based Testing
  - Genetic Markers of Hypercoagulopathies
- Leading Suppliers: Laboratory Systems
- Decentralized Coagulation Testing – Professional Use
  - Decentralized Coagulation Testing – OTC
  - Platelet Testing
- Leading Suppliers: POC Systems
- The Commercial Market for Coagulation 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
- Microbial Antibiotic Resistance – The Role of Clinical Tests
  - “Faster Identification: Where Are We?”
- 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
  - Microbiome-Related Microbiology Tests
  - Next Generation Sequencing-Based Microbiology Approaches
  - Syndromic Testing
- New Infectious Disease Threats
  - Tickborne Diseases (TBDs)
  - Zika
  - Chagas
  - Dengue
  - Ebola
  - Chikungunya
  - Next Threats?
- Microbiology Firms Acquisitions and Collaborations
- Market Analysis
- Market Analysis - Traditional Microbiology ID/AST
  - Traditional ID/AST
  - Blood Culture
  - Chromogenic Media
  - Rapid Tests Performed on Colonies from Culture Media
  - Supplies
- Market Analysis - Microbiology Immunoassays
  - Improvements in Microbiology Immunoassays
  - Hepatitis Testing
  - Sepsis
  - HIV Immunoassay Testing
  - Sexually Transmitted Diseases (STDs)
  - ToRCH
  - Lyme Disease
  - Rapid Immunoassay Tests
- Market Analysis - Molecular Microbiology
  - Lab Automation and Molecular Diagnostics
  - Molecular Respiratory Infection Testing
  - The Respiratory Trio – Flu, Strep, RSV
  - Molecular Testing for Sexually Transmitted Diseases
  - Molecular Hepatitis Testing
  - Molecular HIV Testing
  - Molecular Tests for Hospital-Acquired Infections (HAIs)
  - Assessing the Problem: Nosocomial Infection Statistics
  - Clostridium Difficile
  - MRSA
  - Molecular TB Testing
  - Limitations of Molecular Microbiology Testing
- Mass Spectrometry
- The Future Outlook for Microbiology
Chapter Twelve: Blood Banking Services
- Overview
  - The Current Status of Global Blood Collection
- Global Blood Safety
  - Zika Virus
  - Blood and Component Collection
  - COVID-19 Impact on Plasma Collection
  - Reevaluating Blood Transfusions
- Blood Typing and Grouping Market
  - Manual Blood Typing Methods
  - Automated Blood Typing and Screening Methods
  - Molecular Methods
  - Reducing Blood Typing Errors
  - Size and Growth of Typing Markets
  - Blood Typing Market by Geography
- Blood Testing Market
  - Preventing Bacterial Infections
  - Immunoassays
  - Nucleic Acid Testing (NAT)
  - Size and Growth of the Market
  - Blood Testing Market by Geography
- The Commercial Outlook for Blood Banking Testing
Chapter Thirteen: Histology and Cytology
- Overview
- Special Topics
  - Histology Automation
  - Advanced Analysis Solutions
  - HPV Goes Core Lab
- Market Analysis
  - Histology/Cytology
  - Immunohistochemistry and In Situ Hybridization
  - Pharmacodiagnostic Histology
  - Digital Imaging and Computational Pathology
  - COVID-19 and Digital Pathology
  - Circulating Tumor Cells
  - Flow Cytometry
- The Commercial Outlook for Histology and Cytology Tests
Chapter Fourteen: Company Profiles: The Top Tier
- Abbott Diagnostics
  - Alere Acquisition Update and Point of Care
  - Core Lab
  - Hematology
  - Blood Banking
  - Coagulation
  - Infectious Diseases - Molecular
  - Diabetes
  - HIV Point of Care
  - i-STAT Business
  - Companion Testing
  - Liquid Biopsy
  - COVID-19
- Agilent Technologies
  - Agilent in Genomics
  - Cytogenetic Analysis
  - Sequencing
  - CRISPR
  - Flow Cytometry
  - Companion Diagnostics - Dako
  - COVID-19
- Beckman Coulter, Inc. / Danaher
  - Hematology
  - Hematology IT
  - Clinical Chemistry
  - Immunoassays
  - Coagulation
  - Microbiology
  - Clinical Information Technology
  - Flow Cytometry
  - Blood Banking
  - Beckman Coulter Life Sciences
  - Collaborations
  - COVID-19
- Becton, Dickinson and Company (BD)
  - Cytology
  - Molecular Microbiology
  - Traditional Microbiology - ID/AST
  - Blood Culture
  - Hospital Acquired Infections
  - Connectivity
  - Blood Collection
  - Mass Spectrometry
  - Flow Cytometry
  - Licensing
  - COVID-19
- bioMérieux Inc.
  - Traditional Microbiology
  - Blood Culture
  - Immunoassays
  - Mass Spectrometry
  - BioFire Diagnostics Business
  - Expansion
  - COVID-19
- Bio-Rad Laboratories, Inc.
  - Quality Control
  - Blood Bank
  - Diabetes
  - Immunoassays
  - Autoimmune Testing
  - Liquid Biopsy
  - Microbiome
  - Droplet Digital PCR
  - Sequencing
  - COVID-19
- Bruker Corporation
  - Acquisitions and Collaborations
  - Microbiology
  - Molecular PCR
  - COVID-19
- Cepheid / Danaher
  - GeneXpert Xpress Line
  - High Burden Expansion
  - India
  - Tuberculosis
  - Microbiology
  - POC Testing
  - Cancer
  - COVID-19
- Danaher Corporation
  - Acquisitions
- DiaSorin S.p.A
  - Development Plan
  - Expansion
  - Immunoassays
  - Zika Testing
  - Molecular
  - Molecular Oncology
  - COVID-19
- Grifols S.A.
  - Blood Transfusion Business
  - ABO Blood Typing
  - Molecular ABO Blood Typing
  - Immunoassays
  - Coagulation
  - Market Expansion
  - COVID-19
- Hologic, Inc.
  - Acquisitions
  - PANTHER Molecular System
  - HIV Testing
  - Sexually Transmitted Infections
  - Infectious Diseases
  - Panther Fusion
  - Cytology
  - COVID-19
- Instrumentation Laboratory (IL) / Werfen
  - Expansion
  - Coagulation
  - Acute Care
  - Information Technology
- Leica Biosystems/Danaher
  - Digital Pathology
  - Stain Reagents
  - Lab Systems
  - Sample Handling
  - Circulating Tumor Cells (CTCs)
  - Artificial Intelligence
  - COVID-19
- Ortho Clinical Diagnostics (Ortho)
  - Blood Bank
  - Core Lab / Immunoassays
  - Lab Automation
  - Connectivity
  - Expansion
  - COVID-19
- PerkinElmer, Inc. (PE)
  - Diagnostics
  - Sequencing /Genomics
  - Liquid Biopsy
  - Histology
  - Prenatal Business
  - Lab Services
  - Mass Spectrometry
  - COVID-19
- QIAGEN
  - Tuberculosis
  - Molecular Expansion
  - Precision Medicine / Companion Diagnostics
  - Molecular Microbiology
  - Prenatal Testing
  - Next Generation Sequencing
  - Sample Prep, Informatics
  - Digital PCR
  - Bioinformatics
  - Liquid Biopsy
  - Cervical Cancer
  - Transplant Medicine
  - Expansion
  - COVID-19
- Quidel Corporation
  - The Alere Triage Business
  - Immunoassays
  - Rapid Immunoassays
  - The Solana Business
  - Molecular – Savanna
  - COVID-19
- Radiometer A/S / Danaher
  - Critical Care
  - Immunoassays
  - HemoCue
  - Transcutaneous Monitoring
- Roche Diagnostics
  - Hematology
  - Core Lab
  - Immunoassays
  - HIV
  - Molecular Expansion
  - Core Molecular
  - Digital PCR
  - Diabetes Care
  - Coagulation
  - cobas Liat System – POC
  - HPV
  - Blood Bank
  - Transplant Medicine
  - Cancer Companion Testing
  - Prenatal
  - Liquid Biopsy
  - IT in Anatomical Pathology
  - Information Technology
  - COVID-19
- Siemens Healthineers (Siemens)
  - Core Lab
  - Lab Automation
  - Immunoassays
  - Hematology
  - Urinalysis
  - Molecular
  - Expansion to Support Molecular Diagnostics – Fast Track Diagnostics
  - Sequencing with Artificial Intelligence
  - Zika Virus Testing
  - Acute Care – POC
  - POC Connectivity
  - Business Expansion
  - COVID-19
- Sysmex Corporation
  - Hematology
  - Coagulation
  - Urinalysis
  - Immunoassays
  - Lab Information System
  - Information Technology
  - Flow Cytometry
  - Precision Medicine / Companion Test Diagnostics
  - Liquid Biopsy
  - Exosomes
  - Oncology
  - Sysmex Inostics
  - Forging New Markets
  - COVID-19
- Thermo Fisher Scientific Inc.
  - Immunoassays
  - Microbiology
  - Molecular Test Business
  - Next Generation Sequencing
  - qPCR
  - Oncology Companion Diagnostics
  - Liquid Biopsy
  - Zika Virus
  - Transplant Medicine
  - Microbiome
  - Forensics
  - Mass Spectrometry
  - Collaborations
  - Gene Editing and Cell Therapy
  - China
  - COVID-19
- Ventana Medical Systems Inc. / Roche Tissue Diagnostics
  - Immunohistochemistry - IHC
  - Cervical Cancer Screening
  - Companion Diagnostics
- Werfen
Chapter Fifteen: Company Profiles: The Second Tier
- ARKRAY
  - Dry Chemistry / Immunoassays
  - Urinalysis
  - Diabetes
  - Molecular
- BGI Genomics (formerly Beijing Genome Institute)
  - MGI Tech Co., Limited, China
  - Complete Genomics
  - Prenatal Testing
  - Test Services
  - Liquid Biopsy
  - Whole Genome Sequencing (WGS)
  - Collaborations
  - COVID-19
- Dexcom
- Diagnostica Stago S.A.S.
- Eiken Chemical Co., Ltd
  - Product News
  - COVID-19
- Exact Sciences
  - COVID-19
- Fujirebio Diagnostics, Inc.
- GenMark Diagnostics, Inc
  - COVID-19
- Guardant Health, Inc.
- Horiba Medical
- Illumina
  - Sequencing
  - Advancing in the Clinical Market
  - Sequencing Data Analysis
  - Project Firefly
  - Transplant Medicine
  - Liquid Biopsy
  - Forensic Medicine
  - Prenatal Testing Business
  - Collaborations
  - China
  - COVID-19
- LabCorp, Laboratory Corporation of America
  - Precision Medicine
  - Diagnostics Services
  - DTC Home Testing
  - Prenatal
  - Retail Services
  - Collaborations and Expansion
  - COVID-19
- Luminex Corporation
  - Assay Development
  - VERIGENE Business
  - PCR
  - Flow Cytometry
  - Business Expansion
  - COVID-19
- Masimo Corporation
- A. Menarini Diagnostics
  - COVID-19
- Meridian Bioscience, Inc.
  - Immunoassays
  - Molecular Tests
  - COVID-19
- Mindray - Shenzhen Mindray Bio-medical Electronics Co., Ltd.
  - Core Lab
  - Hematology
- Myriad Genetics, Inc.
- Nova Biomedical Corporation (Nova)
- Philips (Royal Philips)
  - Histology
  - Cancer Genomics
  - Precision Medicine
  - Precision Medicine IT
  - Patient Monitoring
  - Point of Care
  - Wearable Self Monitor
- Quest Diagnostics
  - 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
  - COVID-19
- Quotient Limited
  - COVID-19
Chapter Seventeen: Company Profiles: Core Lab and Other Companies
- AB SCIEX Pte Ltd.
- EKF Diagnostics Holdings Plc
  - COVID-19
- ELITech Group S.A.S.
  - COVID-19
- MedTest DX
  - COVID-19
- Microsaic Systems plc
- Nova Biomedical
- Scienion AG
- Sekisui Diagnostics LLC
  - COVID-19
- Shimadzu Scientific Instruments
- Snibe Co. Ltd., (Shenzhen New Industries Biomedical Engineering Co. Ltd.)
  - COVID-19
- Tecan Group
  - COVID-19
- Tosoh Bioscience
  - COVID-19
- Trinity Biotech Plc
  - COVID-19
Chapter Eighteen: Company Profiles: CTC & Liquid Biopsy Test Providers
- Biocartis
  - COVID-19
- Biocept, Inc.
  - COVID-19
- Biodesix
  - COVID-19
- Epic Sciences
- Epigenomics AG
- Foundation Medicine, Inc.
- LungLife AI
- Menarini-Silicon Biosystems
  - COVID-19
- Natera
- NeoGenomics
Chapter Nineteen: Company Profiles: Specialists
- Ascensia Diabetes Care Holdings AG
- Bigfoot Biomedical Inc.
- Debiotech SA
  - COVID-19
- Glooko Inc.
- Insulet Corporation
- Integrity Applications Inc.
- LifeScan Inc.
- Medtronic plc
- 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.
- HTG Molecular Diagnostics
- Leica Biosystems
  - COVID-19
- MilliporeSigma (formerly EMD Millipore)
  - COVID-19
- Visiopharm
Chapter Twenty-Two: Company Profiles: Immunoassay Specialists
- Binding Site Group Ltd. (The)
  - COVID-19
- Biohit Healthcare
- Biomerica Inc.
  - COVID-19
- Bio-Techne Corporation
  - COVID-19
- Eurobio Scientific
  - COVID-19
- EUROIMMUN AG
  - COVID-19
- HOB Biotech
  - 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
- Advaita Corp.
  - COVID-19
- Cerner Corp.
- Dell Technologies Inc.
- Euformatics Oy
- GenomOncology LLC
- Google LLC
- Intel Corporation
- International Business Machines Corp. (IBM)
- PierianDx
- Rennova Health, Inc.
- SOPHiA GENETICS SA
  - COVID-19
- Sunquest Information Systems Inc.
  - COVID-19
- WuXi NextCODE (now Genuity Science)
Chapter Twenty-Four: Company Profiles: Microbiology Specialists
- Accelerate Diagnostics, Inc.
  - 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
- Hain Lifescience GmbH
  - COVID-19
- Mast Group
  - COVID-19
- Mobidiag
  - COVID-19
- Q-linea AB
- OpGen, Inc.
  - COVID-19
- Seegene, Inc.
  - COVID-19
- Specific Technologies
- T2 Biosystems
  - COVID-19
Chapter Twenty-Five: Company Profiles: Molecular Test Specialists
- Asuragen Inc.
  - COVID-19
- Enzo Biochem Inc.
  - COVID-19
- Exosome Diagnostics, Inc. (Bio-Techne)
  - COVID-19
- Fluidigm Corporation
  - COVID-19
- Genome Diagnostics BV (GenDx)
- NanoString Technologies, Inc.
  - COVID-19
- Oxford Nanopore Technologies Ltd
  - COVID-19
- Pacific Biosciences of California, Inc. (PacBio)
  - COVID-19
- Takara Bio Inc.
  - COVID-19
- Vela Diagnostics
  - COVID-19
Chapter Twenty-Six: Company Profiles: Point of Care Test Specialists
- Abaxis, Inc.
- Abingdon Health Ltd.
  - COVID-19
- binx Health
  - COVID-19
- Biomeme, Inc.
  - COVID-19
- Chembio Diagnostic Systems, Inc.
  - COVID-19
- Diazyme
  - COVID-19
- DNA Electronics Ltd (DNAe)
- Fio Corporation
  - COVID-19
- Genedrive plc (formerly Epistem Holdings)
  - COVID-19
- NuGenerex Diagnostics (HDS)
- Immunostics, Inc.
  - COVID-19
- Loop Medical
- MedMira, Inc.
  - COVID-19
- OraSure Technologies, Inc.
  - COVID-19
- PTS Diagnostics
  - In March 2020, the company launched its A1CNow + Controls DiaSorin Group
  - 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)
- Eurofins LifeCodexx AG
- Myriad Women’s Health
- INEX Innovate
  - COVID-19
- Invitae
- Oxford Gene Technology
- Sequenom, Inc. (Integrated Genetics)
- Yourgene Health
  - COVID-19
Chapter Twenty-Eight: Company Profiles: Quality Control & Sample Pretreatment Specialists
- 10x Genomics
- Agena Bioscience, Inc.
  - COVID-19
- Biotype Diagnostic GmbH
  - COVID-19
- DxTerity Diagnostics Inc.
  - COVID-19
- Horizon Discovery Group plc
- IncellDx
- LGC SeraCare Life Sciences, Inc.
  - COVID-19
- PreAnalytiX GmbH
- Precipio, Inc. (formerly Transgenomic)
  - COVID-19
- Quanterix Corporation
  - COVID-19
- Streck Inc.
Chapter Twenty-Nine: Test Service Providers
- 23andMe
- Agendia BV
- Ambry Genetics
  - COVID-19
- ARUP Laboratories
  - COVID-19
- Aspira Women’s Health (formerly Vermillion Inc.)
- BioReference Laboratories
  - COVID-19
- Biotheranostics
- BluePrint Genetics Oy
- Boston Heart Diagnostics
- CareDx, Inc.
- Eurofins Genomics
  - COVID-19
- Helomics Corporation
- Mayo Clinic Laboratories
- MDxHealth SA
- OPKO Diagnostics
  - COVID-19
- Sonic Healthcare
- Veracyte, Inc.