Science and Medicine Group

The Worldwide Market for In Vitro Diagnostic Tests, 13th Edition 26 Aug 2020

Report details
19 Figures
328 Tables

One: Executive Summary
- Scope and Methodology
- Size and Growth of the Market
- IVD Market Highlights
- Competitive Picture in IVD
- What to Watch Long-Term
  - COVID-19
  - China and New Emerging Markets
  - Liquid Biopsy: A Testing Ground for AI in Diagnostics?
  - CRISPR-Based Diagnostics and First FDA Authorization
  - Today Urgent Care, Tomorrow Micro-hospitals
  - Globalization, Climate Change
- Finding What You Are Looking For in the 13th Edition
Two: Introduction
- Report Design and Changes in Segments
  - Reporting Changes for Segments from the 12th Edition
- IVD Landscape
- 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
- Distribution Agreements
- Licenses and Collaboration 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
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
- Shifting Disease Burdens
  - Increase in Chronic Diseases
- COVID-19
- Emerging and Emerged Markets
  - Emerging Nations and Health Insurance
- Size and Forecast for the Global IVD Market
  - COVID-19 Impact for 2020
  - Regional Reporting Differences with the 12th Edition
- The IVD Market in the United States
  - PAMA and Reimbursement Changes
  - LDT Oversight Update
  - Rare Disease Testing
  - 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: Return to Growth
- 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
Four: Company and Industry Trends
- Introduction
  - Advanced Medicine Without Borders
  - China IVD Market
  - IVD Company Initiatives in China
  - 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
- Liquid Biopsy
  - Quality Assurance for Liquid Biopsy
  - Product News in Liquid Biopsy
  - Market Cleared Products
  - RUO Liquid Biopsy
  - Liquid Biopsy Products in Development
  - Liquid Biopsy in Microbiology
  - Liquid Biopsy Companies in 2020
  - The Future for Liquid Biopsy
- IVD Information Technology and AI
  - AI in Clinical Practice
  - The Regulatory Pathway for AI
  - Product Initiatives
  - IBM Watson Health
  - Future Trends in AI
- Substance Abuse: IVD Implications
  - Opioid Epidemic
  - Biomarkers and Substance Abuse
  - Clinical Laboratory Testing for Drugs of Abuse
  - Urine
  - Blood
  - Oral
  - Hair
- Clinical Laboratory Kickback Schemes
- Sepsis: A 17 Billion-Dollar Problem
Five: Point-of-Care Tests
- Overview and Trends
- Professional POC
- OTC Self Testing
- Pregnancy/Fertility Tests
- Colon Cancer Screening
- Lipid Testing
- 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
  - COVD-19 POC Market
  - Other Developments
- Diabetes Testing – Blood Glucose Monitoring
  - Glucose Testing in Tight Economics
  - IT to Aid Diabetes Management
  - Diabetes Market Analysis
  - POC Glucose Competitors
  - Blood Glucose Self-Testing
  - Noninvasive Testing Devices
  - Continuous Self Testing en Route to the Artificial Pancreas
  - Blood Glucose Testing by Professionals
  - Diabetes Testing – Glycated Hemoglobin
  - Genes and Other Markers of Diabetes
  - Drugs of Abuse Testing
- The Major POC Test Players
Six: The Core Lab
- Core Lab Overview and Trends
- Connectivity
- Overview of Chemistry Tests
  - Lab Automation
  - Service Plans
- Market Analysis
  - Rapid Response Systems
  - Critical Care Analysis
  - User Apps
  - Urinalysis
- Sleep Apnea Testing: Core Lab Solution?
- The Commercial Outlook for Chemistry Tests
Seven: Immunoassays
- Overview and Trends
  - Immunoassay Technology Continues to Evolve
  - Mass Spectrometry
  - Immunoassays in the Core Lab
  - Radioimmunoassays
- Market Analysis
  - Leading Suppliers and Growth Potential
  - Quality Control
  - Immunoassay Market Growth and Competitive Picture
- 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
Eight: Molecular Assays
- Overview
- Sample Preparation and Quality Control
- Advanced Molecular Tests and Technologies
  - Exosome Sequencing
  - Liquid Biopsy
  - Metabolomic Profiling
  - Information Technology for Test Value
  - Artificial Intelligence AI
  - Forensic Studies – An Emerging Opportunity
  - Test Platforms
- Major Players
- Market Analysis
  - Oncology
  - Pharmacodiagnostics
  - Inherited Diseases and Thrombophilia SNPs
  - Psychiatric Disorders
  - Prenatal and Newborn Testing
  - Tissue Typing
- The Commercial Outlook for Molecular Tests
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
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
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
  - 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
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
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
Fourteen: Company Profiles: The Top Tier
- Abbott Diagnostics
  - COVID-19
  - Point of Care
  - Core Lab
  - Hematology
  - Blood Banking
  - Coagulation
  - Infectious Diseases - Molecular
  - Diabetes
  - HIV Point of Care
  - i-STAT Business
  - Companion Testing
  - Liquid Biopsy
- Agilent Technologies
  - Dako / Pathology
  - Agilent in Genomics
  - Cytogenetic Analysis
  - Information Technology
  - Capillary Electrophoresis
  - Sequencing
  - CRISPR
  - Flow Cytometry
- Beckman Coulter, Inc. / Danaher
  - COVID-19
  - Hematology
  - Hematology IT
  - Clinical Chemistry
  - Immunoassays
  - Coagulation
  - Microbiology
  - Urinalysis
  - Clinical Information Technology
  - Molecular Tissue Analysis
  - Flow Cytometry
  - A Fight for Brain Natriuretic Peptide (BNP) Assay Rights
  - Beckman Coulter Life Sciences
  - Collaborations
- 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
  - Data Analysis
  - BioFire Diagnostics Business
  - Food Testing
  - 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
  - COVID-19
  - GeneXpert Xpress Line
  - High Burden Expansion
  - India
  - Tuberculosis
  - Microbiology
  - POC Testing
  - Cancer
- 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.
  - Hologic Global Access Initiative
  - PANTHER Molecular System
  - HIV Testing
  - Sexually Transmitted Infections
  - Infectious Diseases
  - Panther Fusion
  - Cytology
- Instrumentation Laboratory (IL) / Werfen
  - Expansion
  - Coagulation
  - Acute Care
  - Information Technology
- Leica Biosystems/Danaher
  - COVID-19
  - Digital Pathology
  - Stain Reagents
  - Lab Systems
  - Sample Handling
  - Circulating Tumor Cells (CTCs)
  - Artificial Intelligence
- Ortho Clinical Diagnostics (Ortho)
  - COVID-19
  - Blood Bank
  - Core Lab / Immunoassays
  - Lab Automation
  - Connectivity
  - Expansion
- PerkinElmer, Inc. (PE)
  - Diagnostics
  - Sequencing /Genomics
  - Liquid Biopsy
  - Histology
  - Prenatal Business
  - COVID-19
  - Lab Services
  - Mass Spectrometry
- QIAGEN
  - Tuberculosis
  - Molecular Expansion
  - Precision Medicine / Companion Diagnostics
  - Molecular Microbiology
  - Prenatal Testing
  - Next Generation Sequencing
  - Sample Prep, Informatics
  - Digital PCR
  - Bioinformatics
  - COVID-19
  - Liquid Biopsy
  - Microbiome
  - Cervical Cancer
  - Transplant Medicine
  - Forensic
  - Expansion
- Quidel Corporation
  - COVID-19
  - The Alere Triage Business
  - Immunoassays
  - Rapid Immunoassays
  - The Solana Business
  - Molecular – Savanna
- Radiometer A/S / Danaher
  - Critical Care
  - Immunoassays
  - HemoCue
  - Transcutaneous Monitoring
- Roche Diagnostics
  - COVID-19
  - 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
  - Consulting Program
  - 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
  - Gene Editing
  - Oncology Companion Diagnostics
  - Liquid Biopsy
  - Zika Virus
  - Transplant Medicine
  - Microbiome
  - Forensics
  - Mass Spectrometry
  - Collaborations
  - China
  - COVID-19
- Ventana Medical Systems Inc. / Roche Tissue Diagnostics
  - Immunohistochemistry - IHC
  - Cervical Cancer Screening
  - Companion Diagnostics
  - Quality Control
  - DISCOVERY Product Line
- Werfen
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
- Fujirebio Diagnostics, Inc.
  - Molecular
- GenMark Diagnostics
  - COVID-19
- Guardant Health
- Horiba
- 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
  - LabCorp Buys Sequenom
  - 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
  - Menarini-Silicon Biosystems Inc. (Bologna, Italy)
  - COVID-19
- Meridian Bioscience, Inc.
  - Immunoassays
  - Molecular Tests
  - Building U.S. and International Partnerships
  - China Businesses
  - COVID-19
- Mindray - Shenzhen Mindray Bio-medical Electronics Co., Ltd.
  - Core Lab
  - Hematology
- Myriad Genetics, Inc.
- Nihon Kohden Corporation
- 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
Sixteen: Company Profiles: Blood Bank Specialists
- Bloodsource (Vitalant)
- Cerus Corporation
  - COVID-19
- Haemokinesis Pty Ltd
- Immucor
- MicroTyping Concepts
- Quotient Limited
  - COVID-19
- Reliance Life Sciences
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
- ERBA Diagnostics, Inc.
- 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
- Tosoh Bioscience
- Trinity Biotech Plc
Eightteen: Company Profiles: CTC & Liquid Biopsy Test Providers
- Angle, plc
- Biocartis
- Biocept, Inc.
  - COVID-19
- Biodesix
- Epic Sciences
- Epigenomics AG
- Foundation Medicine, Inc.
- Genomic Health (Exact Sciences)
- Guardant Health, Inc.
- LungLife AI
- Menarini-Silicon Biosystems
  - COVID-19
- Myriad Genetics, Inc.
- Natera
- NeoGenomics
Nineteen: Company Profiles: Specialists
- Ascensia Diabetes Care Holdings AG
- Bigfoot Biomedical Inc.
- Debiotech SA
  - COVID-19
- Dexcom Inc.
- Gentag Inc.
- Glooko Inc.
- GlySure Limited
- Glytec LLC
- iHealth Labs Inc.
- Insulet Corporation
- Integrity Applications Inc.
- LifeScan Inc.
- Medtronic plc
- Nemaura Medical Inc.
  - COVID-19
- Nightscout Project
- Trividia Health Inc.
- Verily Life Sciences LLC
Twenty: Company Profiles: Hematology (Cell Analysis) and Coagulation Specialists
- CellaVision AB
- Diagnostica Stago, S.A.S.
- DIAGON Kft. Hungary
- Horiba Medical
- Medica Corporation
- Microvisk Technologies
- West Medica
Twenty-One: Company Profiles: Histopathology Specialists
- Advanced Cell Diagnostics (ACD)
- Amoy Diagnostics Co. Ltd.
- Applied Spectral Imaging Inc. (ASI)
- BioGenex Laboratories, Inc.
- BioView Ltd.
- Circulomics Inc.
- Dako A/S
- HTG Molecular Diagnostics
- Leica Biosystems
- MilliporeSigma (formerly EMD Millipore)
  - COVID-19
- Visiopharm
Twenty-Two: Company Profiles: Immunoassay Specialists
- BG Medicine, Inc
- Binding Site Group Ltd. (The)
  - COVID-19
- Biodesix
  - COVID-19
- Biohit Healthcare
- Biomerica Inc.
  - COVID-19
- Bio-Techne Corporation
  - COVID-19
- Corgenix Medical Corporation
- Critical Diagnostics
- Eurobio Scientific
  - COVID-19
- EUROIMMUN AG
- HOB Biotech
  - COVID-19
- Immunodiagnostic Systems (IDS)
- INOVA Diagnostics, Inc.
- One Lambda, Inc
- Orgentec Diagnostika
- Protagen Diagnostics
- Response Biomedical Corp.
  - COVID-19
- Theradig
  - COVID-19
- VolitionRx Limited
  - COVID-19
Twenty-Three: Information Technology Specialists in In Vitro Diagnostics
- Advaita Corp.
  - COVID-19
- Cerner Corp.
- Dell Technologies Inc.
- Desktop Genetics Ltd.
- DNAnexus Inc.
- Edico Genome (Illumina)
- Euformatics Oy
- GenomOncology LLC
- Google LLC
- Human Longevity Inc.
- Intel Corporation
- International Business Machines Corp. (IBM)
- N-of-One
- PierianDx
- Rennova Health, Inc.
- SOPHiA GENETICS SA
  - COVID-19
- Sunquest Information Systems Inc.
  - COVID-19
- WuXi NextCODE
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
- Bruker BioSciences Corporation
  - COVID-19
- COPAN ITALIA S.p.A. and COPAN Diagnostics, Inc.
  - COVID-19
- Curetis
  - COVID-19
- Fast Track Diagnostics (Acquired by Siemens Healthineers)
- Focus Diagnostics, Inc.
- Genetic Analysis AS
  - COVID-19
- GeneWEAVE Biosciences, Inc.
- Greiner Bio-One International GmbH
- Hain Lifescience GmbH
  - COVID-19
- Mast Group
- Mobidiag
  - COVID-19
- Q-linea AB
- OpGen, Inc.
- Seegene, Inc.
  - COVID-19
- Specific Technologies
- Synbiosis Ltd.
- T2 Biosystems
  - COVID-19
Twenty-Five: Company Profiles: Molecular Test Specialists
- Asuragen Inc.
  - COVID-19
- AutoGenomics Inc.
- Enzo Biochem Inc.
  - COVID-19
- Exosome Diagnostics, Inc.
- Fluidigm Corporation
  - COVID-19
- GenMark Diagnostics, Inc
  - 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
- QuanDx Inc
- Takara Bio Inc.
  - COVID-19
- Vela Diagnostics
  - COVID-19
Twenty-Six: Company Profiles: Point of Care Test Specialists
- Abaxis, Inc.
- Abingdon Health Ltd.
- Binx Health
- Biomeme, Inc.
- Chembio Diagnostic Systems, Inc.
- DNA Electronics Ltd (DNAe)
- Entopsis
- Fio Corporation
- Genedrive plc (formerly Epistem Holdings)
- NuGenerex Diagnostics (HDS)
- Immunostics, Inc.
- InSilixa Inc.
- Loop Medical
- MedMira, Inc.
- OraSure Technologies, Inc.
- PTS Diagnostics
- QuantuMDx Group, Ltd.
  - COVID-19
- Rheonix, Inc.
- Samsung Healthcare
- Veredus Laboratories Pte Ltd
  - COVID-19
Twenty-Seven: Company Profiles: Prenatal Test Service Providers
- Affymetrix, Inc.
- Berry Genomics Co. ltd.
- CooperGenomics (Division of CooperSurgical)
- Eurofins LifeCodexx AG
- Myriad Women’s Health
- Genoma Group
- Innovations Exchange Pte Ltd (INEX) and iGene Diagnostics Pte Ltd
- Invitae
- Oxford Gene Technology
- Ravgen
- Reproductive Genetics Innovations
- Sequenom, Inc.
- Yourgene Health
  - COVID-19
Twenty-Eight: Company Profiles: Quality Control & Sample Pretreatment Specialist…
- 10x Genomics
- Agena Bioscience, Inc.
- Biotype Diagnostic GmbH
  - COVID-19
- DxTerity Diagnostics Inc.
  - COVID-19
- Horizon Discovery Group plc
- IncellDx
- LGC SeraCare Life Sciences, Inc.
  - COVID-19
- Oasis Diagnostics Corporation
- PreAnalytiX GmbH
- Precipio, Inc. (formerly Transgenomic)
- Quanterix Corporation
  - COVID-19
- Streck Inc.
Twenty-Nine: Test Service Providers
- 23andMe
- Agendia BV
- Ambry Genetics
- ARUP Laboratories
  - COVID-19
- The BioCollective
- BioReference Laboratories
  - COVID-19
- Biotheranostics
- BluePrint Genetics Oy
- Boston Heart Diagnostics
- CareDx, Inc.
- Cleveland HeartLab Inc.
- Eurofins Genomics
  - COVID-19
- Exact Sciences Corp.
- Genomic Vision
- Helomics Corporation
- Mayo Medical Laboratories
- MDxHealth SA
- OPKO Diagnostics
  - COVID-19
- Pathway Genomics Corporation
- Sonic Healthcare
- Veracyte, Inc.
- Vermillion Inc.
Special Section Table : Antigen Testing and Other COVID-19 Developments
- COVID-19 Testing Developments
  - Clinical Lab Situation: Volume Returns
  - No Slowing in PCR Demand
  - Large Number of Authorizations
  - Entry of Antigen Tests
- COVID-19 Testing Market Estimates
- Antigen Testing for COVID-19
  - Introduction

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The Worldwide Market for In Vitro Diagnostic Tests, 13th Edition

26 Aug 2020

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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 13th 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.

Comprehensive Market Coverage

As part of its offering, this report includes:

COVID-19 Impact on Markets, and COVID-19 Test Markets
1500 + Page Report Based on Vendor Reporting, Interviews, Vendor Activities
Authored by Veteran IVD Analysts with Industry Knowledge
12 Detailed Market Chapters with 2020 Market Estimates
Where is IVD Heading? – Market Segment Projections to 2025
Regional Breakouts Including Country IVD Markets
Sections on China and The United States IVD Markets
Coverage of Growth Markets: Eastern Europe and the Middle East, and Southeast Asia
Superior Company Profiles of Top Tier Companies and Hundreds of Smaller Concerns
Industry-Standard Business Planning Tools
Coverage of Trends and Market Estimates for Essential IVD Segments

The Worldwide Market for In Vitro Diagnostic (IVD) Tests estimates the current in vitro diagnostics market size and forecasted market size to 2025 for defined segments of the IVD market and various sub-segments, including:

COVID Testing – Immunoassays and Molecular
Molecular Assays (Infectious Disease, Blood Screening, Inherited Diseases, Oncology, PGx, Tissue Typing, Prenatal)
Clinical Chemistry and “Core Lab” Markets
Point-of-Care Testing (POC) (Professional and Self-Testing)
Glucose Testing
Substance Abuse Testing
Microbiology and Virology by Test Type (Immunoassays, ID/AST, Infectious Diseases – DNA; ID/AST: Panels and Reagents, automated; Panels and Reagents, manual; Blood Culture; Chromogenic Media; Rapid Micro; Supplies)
Blood Banking
Pap, ISH, IHC, HPV and Other Tissue-Based Tests
Infectious Disease Immunoassay Testing
Hematology
Cardiac Markers, Tumor Markers, Diabetes/hbA1c, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs
Coagulation Tests
Quality Control

For each of the listed in vitro diagnostics market segments, 2019 in vitro diagnostics market size, 2025 projection and compound annual growth rate is provided, as well as significant in vitro diagnostic companies in the market and IVD manufacturers’ product innovations. The market data is put into a context with real-world industry and medical practice trends.

The Worldwide Market for In Vitro Diagnostic Tests has been called “The Bible of the IVD Industry” by customers, which include top IVD firms. Using Kalorama Information’s The Worldwide Market for In vitro Diagnostic (IVD) Tests, 13th Edition, ensures that your firm will have the perspective and data of others in the in vitro diagnostics industry, as well as of those who track and invest in the IVD industry.

Page Count: 1920

Table of Contents

One: Executive Summary
- Scope and Methodology
- Size and Growth of the Market
- IVD Market Highlights
- Competitive Picture in IVD
- What to Watch Long-Term
  - COVID-19
  - China and New Emerging Markets
  - Liquid Biopsy: A Testing Ground for AI in Diagnostics?
  - CRISPR-Based Diagnostics and First FDA Authorization
  - Today Urgent Care, Tomorrow Micro-hospitals
  - Globalization, Climate Change
- Finding What You Are Looking For in the 13th Edition
Two: Introduction
- Report Design and Changes in Segments
  - Reporting Changes for Segments from the 12th Edition
- IVD Landscape
- 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
- Distribution Agreements
- Licenses and Collaboration 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
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
- Shifting Disease Burdens
  - Increase in Chronic Diseases
- COVID-19
- Emerging and Emerged Markets
  - Emerging Nations and Health Insurance
- Size and Forecast for the Global IVD Market
  - COVID-19 Impact for 2020
  - Regional Reporting Differences with the 12th Edition
- The IVD Market in the United States
  - PAMA and Reimbursement Changes
  - LDT Oversight Update
  - Rare Disease Testing
  - 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: Return to Growth
- 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
Four: Company and Industry Trends
- Introduction
  - Advanced Medicine Without Borders
  - China IVD Market
  - IVD Company Initiatives in China
  - 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
- Liquid Biopsy
  - Quality Assurance for Liquid Biopsy
  - Product News in Liquid Biopsy
  - Market Cleared Products
  - RUO Liquid Biopsy
  - Liquid Biopsy Products in Development
  - Liquid Biopsy in Microbiology
  - Liquid Biopsy Companies in 2020
  - The Future for Liquid Biopsy
- IVD Information Technology and AI
  - AI in Clinical Practice
  - The Regulatory Pathway for AI
  - Product Initiatives
  - IBM Watson Health
  - Future Trends in AI
- Substance Abuse: IVD Implications
  - Opioid Epidemic
  - Biomarkers and Substance Abuse
  - Clinical Laboratory Testing for Drugs of Abuse
  - Urine
  - Blood
  - Oral
  - Hair
- Clinical Laboratory Kickback Schemes
- Sepsis: A 17 Billion-Dollar Problem
Five: Point-of-Care Tests
- Overview and Trends
- Professional POC
- OTC Self Testing
- Pregnancy/Fertility Tests
- Colon Cancer Screening
- Lipid Testing
- 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
  - COVD-19 POC Market
  - Other Developments
- Diabetes Testing – Blood Glucose Monitoring
  - Glucose Testing in Tight Economics
  - IT to Aid Diabetes Management
  - Diabetes Market Analysis
  - POC Glucose Competitors
  - Blood Glucose Self-Testing
  - Noninvasive Testing Devices
  - Continuous Self Testing en Route to the Artificial Pancreas
  - Blood Glucose Testing by Professionals
  - Diabetes Testing – Glycated Hemoglobin
  - Genes and Other Markers of Diabetes
  - Drugs of Abuse Testing
- The Major POC Test Players
Six: The Core Lab
- Core Lab Overview and Trends
- Connectivity
- Overview of Chemistry Tests
  - Lab Automation
  - Service Plans
- Market Analysis
  - Rapid Response Systems
  - Critical Care Analysis
  - User Apps
  - Urinalysis
- Sleep Apnea Testing: Core Lab Solution?
- The Commercial Outlook for Chemistry Tests
Seven: Immunoassays
- Overview and Trends
  - Immunoassay Technology Continues to Evolve
  - Mass Spectrometry
  - Immunoassays in the Core Lab
  - Radioimmunoassays
- Market Analysis
  - Leading Suppliers and Growth Potential
  - Quality Control
  - Immunoassay Market Growth and Competitive Picture
- 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
Eight: Molecular Assays
- Overview
- Sample Preparation and Quality Control
- Advanced Molecular Tests and Technologies
  - Exosome Sequencing
  - Liquid Biopsy
  - Metabolomic Profiling
  - Information Technology for Test Value
  - Artificial Intelligence AI
  - Forensic Studies – An Emerging Opportunity
  - Test Platforms
- Major Players
- Market Analysis
  - Oncology
  - Pharmacodiagnostics
  - Inherited Diseases and Thrombophilia SNPs
  - Psychiatric Disorders
  - Prenatal and Newborn Testing
  - Tissue Typing
- The Commercial Outlook for Molecular Tests
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
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
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
  - 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
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
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
Fourteen: Company Profiles: The Top Tier
- Abbott Diagnostics
  - COVID-19
  - Point of Care
  - Core Lab
  - Hematology
  - Blood Banking
  - Coagulation
  - Infectious Diseases - Molecular
  - Diabetes
  - HIV Point of Care
  - i-STAT Business
  - Companion Testing
  - Liquid Biopsy
- Agilent Technologies
  - Dako / Pathology
  - Agilent in Genomics
  - Cytogenetic Analysis
  - Information Technology
  - Capillary Electrophoresis
  - Sequencing
  - CRISPR
  - Flow Cytometry
- Beckman Coulter, Inc. / Danaher
  - COVID-19
  - Hematology
  - Hematology IT
  - Clinical Chemistry
  - Immunoassays
  - Coagulation
  - Microbiology
  - Urinalysis
  - Clinical Information Technology
  - Molecular Tissue Analysis
  - Flow Cytometry
  - A Fight for Brain Natriuretic Peptide (BNP) Assay Rights
  - Beckman Coulter Life Sciences
  - Collaborations
- 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
  - Data Analysis
  - BioFire Diagnostics Business
  - Food Testing
  - 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
  - COVID-19
  - GeneXpert Xpress Line
  - High Burden Expansion
  - India
  - Tuberculosis
  - Microbiology
  - POC Testing
  - Cancer
- 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.
  - Hologic Global Access Initiative
  - PANTHER Molecular System
  - HIV Testing
  - Sexually Transmitted Infections
  - Infectious Diseases
  - Panther Fusion
  - Cytology
- Instrumentation Laboratory (IL) / Werfen
  - Expansion
  - Coagulation
  - Acute Care
  - Information Technology
- Leica Biosystems/Danaher
  - COVID-19
  - Digital Pathology
  - Stain Reagents
  - Lab Systems
  - Sample Handling
  - Circulating Tumor Cells (CTCs)
  - Artificial Intelligence
- Ortho Clinical Diagnostics (Ortho)
  - COVID-19
  - Blood Bank
  - Core Lab / Immunoassays
  - Lab Automation
  - Connectivity
  - Expansion
- PerkinElmer, Inc. (PE)
  - Diagnostics
  - Sequencing /Genomics
  - Liquid Biopsy
  - Histology
  - Prenatal Business
  - COVID-19
  - Lab Services
  - Mass Spectrometry
- QIAGEN
  - Tuberculosis
  - Molecular Expansion
  - Precision Medicine / Companion Diagnostics
  - Molecular Microbiology
  - Prenatal Testing
  - Next Generation Sequencing
  - Sample Prep, Informatics
  - Digital PCR
  - Bioinformatics
  - COVID-19
  - Liquid Biopsy
  - Microbiome
  - Cervical Cancer
  - Transplant Medicine
  - Forensic
  - Expansion
- Quidel Corporation
  - COVID-19
  - The Alere Triage Business
  - Immunoassays
  - Rapid Immunoassays
  - The Solana Business
  - Molecular – Savanna
- Radiometer A/S / Danaher
  - Critical Care
  - Immunoassays
  - HemoCue
  - Transcutaneous Monitoring
- Roche Diagnostics
  - COVID-19
  - 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
  - Consulting Program
  - 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
  - Gene Editing
  - Oncology Companion Diagnostics
  - Liquid Biopsy
  - Zika Virus
  - Transplant Medicine
  - Microbiome
  - Forensics
  - Mass Spectrometry
  - Collaborations
  - China
  - COVID-19
- Ventana Medical Systems Inc. / Roche Tissue Diagnostics
  - Immunohistochemistry - IHC
  - Cervical Cancer Screening
  - Companion Diagnostics
  - Quality Control
  - DISCOVERY Product Line
- Werfen
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
- Fujirebio Diagnostics, Inc.
  - Molecular
- GenMark Diagnostics
  - COVID-19
- Guardant Health
- Horiba
- 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
  - LabCorp Buys Sequenom
  - 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
  - Menarini-Silicon Biosystems Inc. (Bologna, Italy)
  - COVID-19
- Meridian Bioscience, Inc.
  - Immunoassays
  - Molecular Tests
  - Building U.S. and International Partnerships
  - China Businesses
  - COVID-19
- Mindray - Shenzhen Mindray Bio-medical Electronics Co., Ltd.
  - Core Lab
  - Hematology
- Myriad Genetics, Inc.
- Nihon Kohden Corporation
- 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
Sixteen: Company Profiles: Blood Bank Specialists
- Bloodsource (Vitalant)
- Cerus Corporation
  - COVID-19
- Haemokinesis Pty Ltd
- Immucor
- MicroTyping Concepts
- Quotient Limited
  - COVID-19
- Reliance Life Sciences
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
- ERBA Diagnostics, Inc.
- 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
- Tosoh Bioscience
- Trinity Biotech Plc
Eightteen: Company Profiles: CTC & Liquid Biopsy Test Providers
- Angle, plc
- Biocartis
- Biocept, Inc.
  - COVID-19
- Biodesix
- Epic Sciences
- Epigenomics AG
- Foundation Medicine, Inc.
- Genomic Health (Exact Sciences)
- Guardant Health, Inc.
- LungLife AI
- Menarini-Silicon Biosystems
  - COVID-19
- Myriad Genetics, Inc.
- Natera
- NeoGenomics
Nineteen: Company Profiles: Specialists
- Ascensia Diabetes Care Holdings AG
- Bigfoot Biomedical Inc.
- Debiotech SA
  - COVID-19
- Dexcom Inc.
- Gentag Inc.
- Glooko Inc.
- GlySure Limited
- Glytec LLC
- iHealth Labs Inc.
- Insulet Corporation
- Integrity Applications Inc.
- LifeScan Inc.
- Medtronic plc
- Nemaura Medical Inc.
  - COVID-19
- Nightscout Project
- Trividia Health Inc.
- Verily Life Sciences LLC
Twenty: Company Profiles: Hematology (Cell Analysis) and Coagulation Specialists
- CellaVision AB
- Diagnostica Stago, S.A.S.
- DIAGON Kft. Hungary
- Horiba Medical
- Medica Corporation
- Microvisk Technologies
- West Medica
Twenty-One: Company Profiles: Histopathology Specialists
- Advanced Cell Diagnostics (ACD)
- Amoy Diagnostics Co. Ltd.
- Applied Spectral Imaging Inc. (ASI)
- BioGenex Laboratories, Inc.
- BioView Ltd.
- Circulomics Inc.
- Dako A/S
- HTG Molecular Diagnostics
- Leica Biosystems
- MilliporeSigma (formerly EMD Millipore)
  - COVID-19
- Visiopharm
Twenty-Two: Company Profiles: Immunoassay Specialists
- BG Medicine, Inc
- Binding Site Group Ltd. (The)
  - COVID-19
- Biodesix
  - COVID-19
- Biohit Healthcare
- Biomerica Inc.
  - COVID-19
- Bio-Techne Corporation
  - COVID-19
- Corgenix Medical Corporation
- Critical Diagnostics
- Eurobio Scientific
  - COVID-19
- EUROIMMUN AG
- HOB Biotech
  - COVID-19
- Immunodiagnostic Systems (IDS)
- INOVA Diagnostics, Inc.
- One Lambda, Inc
- Orgentec Diagnostika
- Protagen Diagnostics
- Response Biomedical Corp.
  - COVID-19
- Theradig
  - COVID-19
- VolitionRx Limited
  - COVID-19
Twenty-Three: Information Technology Specialists in In Vitro Diagnostics
- Advaita Corp.
  - COVID-19
- Cerner Corp.
- Dell Technologies Inc.
- Desktop Genetics Ltd.
- DNAnexus Inc.
- Edico Genome (Illumina)
- Euformatics Oy
- GenomOncology LLC
- Google LLC
- Human Longevity Inc.
- Intel Corporation
- International Business Machines Corp. (IBM)
- N-of-One
- PierianDx
- Rennova Health, Inc.
- SOPHiA GENETICS SA
  - COVID-19
- Sunquest Information Systems Inc.
  - COVID-19
- WuXi NextCODE
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
- Bruker BioSciences Corporation
  - COVID-19
- COPAN ITALIA S.p.A. and COPAN Diagnostics, Inc.
  - COVID-19
- Curetis
  - COVID-19
- Fast Track Diagnostics (Acquired by Siemens Healthineers)
- Focus Diagnostics, Inc.
- Genetic Analysis AS
  - COVID-19
- GeneWEAVE Biosciences, Inc.
- Greiner Bio-One International GmbH
- Hain Lifescience GmbH
  - COVID-19
- Mast Group
- Mobidiag
  - COVID-19
- Q-linea AB
- OpGen, Inc.
- Seegene, Inc.
  - COVID-19
- Specific Technologies
- Synbiosis Ltd.
- T2 Biosystems
  - COVID-19
Twenty-Five: Company Profiles: Molecular Test Specialists
- Asuragen Inc.
  - COVID-19
- AutoGenomics Inc.
- Enzo Biochem Inc.
  - COVID-19
- Exosome Diagnostics, Inc.
- Fluidigm Corporation
  - COVID-19
- GenMark Diagnostics, Inc
  - 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
- QuanDx Inc
- Takara Bio Inc.
  - COVID-19
- Vela Diagnostics
  - COVID-19
Twenty-Six: Company Profiles: Point of Care Test Specialists
- Abaxis, Inc.
- Abingdon Health Ltd.
- Binx Health
- Biomeme, Inc.
- Chembio Diagnostic Systems, Inc.
- DNA Electronics Ltd (DNAe)
- Entopsis
- Fio Corporation
- Genedrive plc (formerly Epistem Holdings)
- NuGenerex Diagnostics (HDS)
- Immunostics, Inc.
- InSilixa Inc.
- Loop Medical
- MedMira, Inc.
- OraSure Technologies, Inc.
- PTS Diagnostics
- QuantuMDx Group, Ltd.
  - COVID-19
- Rheonix, Inc.
- Samsung Healthcare
- Veredus Laboratories Pte Ltd
  - COVID-19
Twenty-Seven: Company Profiles: Prenatal Test Service Providers
- Affymetrix, Inc.
- Berry Genomics Co. ltd.
- CooperGenomics (Division of CooperSurgical)
- Eurofins LifeCodexx AG
- Myriad Women’s Health
- Genoma Group
- Innovations Exchange Pte Ltd (INEX) and iGene Diagnostics Pte Ltd
- Invitae
- Oxford Gene Technology
- Ravgen
- Reproductive Genetics Innovations
- Sequenom, Inc.
- Yourgene Health
  - COVID-19
Twenty-Eight: Company Profiles: Quality Control & Sample Pretreatment Specialists
- 10x Genomics
- Agena Bioscience, Inc.
- Biotype Diagnostic GmbH
  - COVID-19
- DxTerity Diagnostics Inc.
  - COVID-19
- Horizon Discovery Group plc
- IncellDx
- LGC SeraCare Life Sciences, Inc.
  - COVID-19
- Oasis Diagnostics Corporation
- PreAnalytiX GmbH
- Precipio, Inc. (formerly Transgenomic)
- Quanterix Corporation
  - COVID-19
- Streck Inc.
Twenty-Nine: Test Service Providers
- 23andMe
- Agendia BV
- Ambry Genetics
- ARUP Laboratories
  - COVID-19
- The BioCollective
- BioReference Laboratories
  - COVID-19
- Biotheranostics
- BluePrint Genetics Oy
- Boston Heart Diagnostics
- CareDx, Inc.
- Cleveland HeartLab Inc.
- Eurofins Genomics
  - COVID-19
- Exact Sciences Corp.
- Genomic Vision
- Helomics Corporation
- Mayo Medical Laboratories
- MDxHealth SA
- OPKO Diagnostics
  - COVID-19
- Pathway Genomics Corporation
- Sonic Healthcare
- Veracyte, Inc.
- Vermillion Inc.
Special Section Table : Antigen Testing and Other COVID-19 Developments
- COVID-19 Testing Developments
  - Clinical Lab Situation: Volume Returns
  - No Slowing in PCR Demand
  - Large Number of Authorizations
  - Entry of Antigen Tests
- COVID-19 Testing Market Estimates
- Antigen Testing for COVID-19
  - Introduction