Science and Medicine Group

The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 17th Edition 29 Aug 2024

Report details
21 Figures
266 Tables

Chapter 1: Executive Summary
- Scope and Methodology
- Size and Growth of the Market
- Market Highlights
- Competitive Picture in IVD
- Finding What You Are Looking For in the 17th Edition
Chapter 2: Introduction
- IVD Landscape
- Report Design
  - Changes Between 16th and 17th Editions
- PAMA and CMS
- Market Analysis of IVD Market Segments
- Top Suppliers and Niche Players
  - Introduction
  - Overview of the Top Tier Companies
  - Overview of Selected Second 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 3: 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
- WHO Essential IVD List
  - Increase in Chronic Diseases
- COVID-19
- Emerging and Emerged Markets
- Size and Forecast for the Global IVD Market
- The IVD Market in the United States
  - PAMA and Reimbursement Changes
  - LDT Update
  - Bundled Insurance Payments for ESRD Patients
  - Advanced Laboratory Tests (ADLT)
  - Precision Medicine and NGS
- IVD Market in Europe: Growing Markets
  - EU Regulation
  - Precision Medicine in Europe
  - Brexit
- Japan
- Eastern Europe: Growth Region
- China: Current IVD Market
  - Clinical Laboratory Market in China
  - IVD Distribution in China
- India: Population and Opportunity
  - Clinical Laboratory Market in India
  - IVD Regulation
- Rest of Asia
- Brazil
  - Disease Trends
  - Clinical Laboratory Market in Brazil
  - IVD Regulation
- Mexico
- The Russian Federation
- Canada
- Emerging Markets
  - Saudi Arabia IVD Market
  - South Africa IVD Market
  - South Korea IVD Market
  - Turkey IVD Market
  - United Arab Emirates (UAE) IVD Market
  - Other Markets to Watch
- IVD Market Opportunity by Country
Chapter 4: Company and Industry Trends
- Introduction
  - Advanced Medicine Without Borders
  - China Market Information
  - Direct to Consumer Genetic Test Services
  - Future Trends
- Gene Editing
  - CRISPR as a Diagnostic Tool
  - CRISPR and the Food Industry
- Microbiome
- Next Generation Sequencing
  - Liquid Biopsy
  - Quality Assurance
  - Product News
  - Market Cleared Products
  - Liquid Biopsy in Microbiology
  - Liquid Biopsy Companies in 2021-2024
  - The Future for Liquid Biopsy
- Information Technology Advances and Artificial Intelligence
  - AI in Clinical Practice
  - The Regulatory Pathway
  - Product Initiatives
- AI in Liquid Biopsy
  - Future Trends
- Exosome Sequencing
- Biotin Interference in Immunoassay Detection Errors
- Traumatic Brain Injury and IVD
- Personalized Medicine
  - Companion Diagnostics
- Telehealth
  - Telehealth eMed to Implement Home Test to Treat Program
- Blockchain
- Substance Abuse
  - Opioid Epidemic
  - COVID-19 and Substance Abuse
  - Biomarkers and Substance Abuse
  - Clinical Laboratory Testing for Drugs of Abuse
  - Urine
  - Blood
  - Oral
  - Hair
- Saliva Testing
- Breath Test Advances
- Micro-Hospital Opportunities
- Climate Change and Infectious Disease
- Kickback Schemes
- Early Sepsis Detection
- Staffing Shortages
Chapter 5: Point-of-Care (POC) Tests
- Overview and Trends
- POC Industry Drivers
  - Patient focused drivers
  - Medical/Healthcare related drivers
  - Technology drivers
  - Economic drivers
  - Other drivers
- POC Industry Challenges
- Regulatory Challenges
- Professional POC
- OTC Self Testing
- Home Collection Trend
- 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 6: The Core Lab
- Core Lab Overview and Trends
- Connectivity
- Overview of Chemistry Tests
  - Lab Automation
- Market Analysis
  - Rapid Response Systems
  - Critical Care Analysis
  - Urinalysis
- The Commercial Outlook for Chemistry Tests
Chapter 7: 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
  - Vitamin D
  - Anemia
  - Toxicology/DAU
  - Allergy
- Maturing Immunoassays
  - Proteins
- Growth Immunoassays
  - Tumor Markers
  - Cardiac Markers
Chapter 8: Molecular Assays
- Overview
- Sample Preparation and Quality Control
- Molecular Evolution
  - 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
  - Depression and Psychiatric Disorders
  - Prenatal and Newborn Testing
  - Transplant Diagnostics
- The Commercial Outlook for Molecular Tests
Chapter 9: 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 10: 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 11: Microbiology and Virology
- The Real Impact of Infections
  - Herpes and Alzheimer’s Disease
  - Ebola and Cancer
  - HIV and Cancer
  - H pylori and Cancer
  - Bacteria and Parkinson's
  - HPV and Cancer
- Microbial Antibiotic Resistance – The Role of Clinical Tests
  - Fast Identification
- 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/Multiplex Testing
- New Infectious Disease Threats
  - Tickborne Diseases (TBDs)
  - Zika
  - Chagas
  - Dengue
  - Ebola
  - Chikungunya
  - Middle East Respiratory Syndrome-Coronavirus (MERS-CoV)
  - Marburg
  - SARS-CoV-2 (COVID-19)
  - Monkeypox
- 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 12: Blood Banking Services
- Overview
  - The Current Status of Global Blood Collection
- Global Blood Safety
  - Zika Virus
  - Blood and Component Collection
  - Reevaluating Blood Transfusions
- Blood Typing and Grouping Market
  - Manual Blood Typing Methods
  - Automated Blood Typing and Screening Methods
  - Molecular Methods
  - 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 13: Histology and Cytology
- Overview
- Special Topics
  - Histology Automation
  - Advanced Analysis Solutions
  - HPV meets Core Lab
- Market Analysis
  - Total Market
  - Regional Market Analysis
  - Pap Testing
  - 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 14: Company Profiles: The Top Tier
- Abbott Diagnostics
  - Core Lab
  - Hematology
  - Blood Banking
  - Infectious Diseases - Molecular
  - Diabetes
  - HIV Point of Care
  - i-STAT Business
  - Companion Diagnostic Testing
  - Liquid Biopsy
  - COVID-19
- Agilent Technologies
  - Genomics
  - Cytogenetic Analysis
  - Sequencing
  - CRISPR
  - Flow Cytometry
  - Companion Diagnostics - Dako
  - COVID-19
- Beckman Coulter / Danaher
  - Hematology
  - Hematology IT
  - Clinical Chemistry
  - Immunoassays
  - Microbiology
  - IT Clinical
  - Flow Cytometry
  - Blood Banking
  - Beckman Coulter Life Sciences
  - COVID-19
- Becton, Dickinson and Company (BD)
  - Cytology
  - Molecular Microbiology
  - Traditional Microbiology - ID/AST
  - Blood Culture
  - Hospital Acquired Infections
  - Blood Collection
  - Mass Spectrometry
  - Flow Cytometry
  - 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
  - Liquid Biopsy
  - Droplet Digital PCR
  - Sequencing
  - COVID-19
- Bruker Corporation
  - Acquisitions and Collaborations
  - Mass Spectrometry
  - Microbiology
  - Molecular PCR
  - COVID-19
- Cepheid / Danaher
  - GeneXpert/ Xpress Line
  - Tuberculosis
  - Microbiology
  - POC Testing
  - Cancer
  - COVID-19
- Danaher Corporation
  - Acquisitions
- Dexcom
- DiaSorin S.p.A
  - Development Plan
  - Expansion
  - Immunoassays
  - Molecular
  - Molecular Oncology
  - COVID-19
- Exact Sciences
  - COVID-19
- Hologic, Inc.
  - Acquisitions
  - PANTHER Molecular System
  - HIV Testing
  - Sexually Transmitted Infections
  - Infectious Diseases
  - Panther Fusion
  - Cytology
  - COVID-19
- Illumina
  - China
  - COVID-19
- Instrumentation Laboratory (IL) / Werfen
  - Expansion
  - Coagulation
  - Acute Care
  - Information Technology
- Leica Biosystems/Danaher
  - Digital Pathology
  - Companion Diagnostics
  - Stain Reagents
  - Lab Systems
  - Sample Handling
  - Circulating Tumor Cells (CTCs)
  - Artificial Intelligence
  - COVID-19
- Natera
- QuidelOrtho Corporation
  - Immunoassays
  - Rapid Immunoassays
  - The Solana Business
  - Molecular – Savanna
  - Blood Bank
  - COVID-19
- Radiometer A/S / Danaher
  - Critical Care
  - Immunoassays
  - HemoCue
  - Transcutaneous Monitoring
- Revvity
  - COVID-19
- Roche Diagnostics
  - Hematology
  - Immunoassays
  - HIV
  - Molecular Expansion
  - Core Molecular
  - Digital PCR
  - Diabetes Care
  - Coagulation
  - cobas Liat System – POC
  - HPV
  - Blood Bank
  - Transplant Medicine
  - Cancer Companion Testing
  - IT in Anatomical Pathology
  - Information Technology
  - Digital Pathology
  - COVID-19
- Roche Tissue Diagnostics
  - Immunohistochemistry - IHC
  - Cervical Cancer Screening
  - Companion Diagnostics
- Siemens Healthineers (Siemens)
  - Core Lab
  - Lab Automation
  - Immunoassays
  - Hematology
  - Urinalysis
  - Molecular
  - Expansion to Support Molecular Diagnostics – Fast Track Diagnostics
  - Sequencing with Artificial Intelligence
  - Acute Care – POC
  - POC Connectivity
  - Business Expansion
  - COVID-19
- Sysmex Corporation
  - Hematology
  - Coagulation
  - Urinalysis and Infectious Disease
  - Immunoassays
  - Lab Information System
  - Information Technology
  - Flow Cytometry
  - Precision Medicine / Companion Test Diagnostics
  - Liquid Biopsy
  - Oncology
  - Sysmex Inostics
  - Forging New Markets
  - COVID-19
- Thermo Fisher Scientific Inc.
  - Immunoassays
  - Microbiology
  - Molecular Test Business
  - Next Generation Sequencing
  - qPCR
  - Oncology Companion Diagnostics
  - Transplant Medicine
  - Microbiome
  - Mass Spectrometry
  - Collaborations
  - Gene Editing and Cell Therapy
  - China
  - COVID-19
- Werfen
Chapter 15: Company Profiles: The Second Tier
- BGI Genomics (formerly Beijing Genome Institute)
  - PCR and Fluorescence
  - MGI Tech Co., Limited, China
  - Prenatal Testing
  - Test Services
  - Whole Genome Sequencing (WGS)
  - NGS Sequencing
  - Collaborations
  - COVID-19
- Biocartis
  - COVID-19
- Diagnostica Stago S.A.S.
- Eiken Chemical Co., Ltd
  - Product News
  - COVID-19
- Fujirebio Diagnostics, Inc.
- Fulgent Genetics, Inc
  - COVID-19
- Grifols S.A.
  - Blood Transfusion Business
  - ABO Blood Typing
  - Molecular ABO Blood Typing
  - Immunoassays
  - Market Expansion
  - Self-Testing
- Guardant Health, Inc.
- Horiba Medical
- Invitae
- Menarini Diagnostics
  - COVID-19
- Meridian Bioscience, Inc.
  - Immunoassays
  - Molecular Tests
  - COVID-19
- Mindray - Shenzhen Mindray Bio-medical Electronics Co., Ltd.
- Myriad Genetics, Inc.
- Nihon Kohden
- OraSure Technologies, Inc.
  - COVID-19
- QIAGEN
  - Tuberculosis.
  - Molecular Expansion
  - Precision Medicine / Companion Diagnostics
  - Molecular Microbiology
  - Prenatal Testing
  - Next Generation Sequencing
  - Sample Prep, Informatics
  - Digital PCR
  - Liquid Biopsy
  - Cervical Cancer
  - Expansion
  - COVID-19
- Randox Laboratories Ltd.
  - Clinical Chemistries
  - POC
  - Controls
  - Evidence Series - Multistat Biochip Analyzers
  - Molecular
  - COVID-19
- Sekisui Diagnostics LLC
  - COVID-19
- Veracyte, Inc.
Chapter 16: Company Profiles: Blood Bank Specialists
- AliveDx
  - COVID-19
- Cerus Corporation
  - COVID-19
Chapter 17: Company Profiles: Core Lab and Other Companies
- AB SCIEX Pte Ltd.
- ARKRAY
  - Dry Chemistry / Immunoassays
  - Urinalysis
  - Diabetes
  - Molecular
- EKF Diagnostics Holdings Plc
  - COVID-19
- ELITech Group S.A.S.
  - COVID-19
- Shimadzu Scientific Instruments
- Snibe Co. Ltd., (Shenzhen New Industries Biomedical Engineering Co. Ltd.)
  - COVID-19
- Tosoh Bioscience
  - COVID-19
- Trinity Biotech Plc
  - COVID-19
Chapter 18: Company Profiles: CTC & Liquid Biopsy Test Providers
- Biocept, Inc.
  - COVID-19
- Biodesix
  - COVID-19
- Epic Sciences
- Epigenomics AG
- Foundation Medicine, Inc.
- Menarini-Silicon Biosystems
  - COVID-19
- NeoGenomics
Chapter 19: Company Profiles: Specialists
- Ascensia Diabetes Care Holdings AG
- Bigfoot Biomedical Inc. (Abbott)
- Debiotech SA
  - COVID-19
- Glooko Inc.
- Insulet Corporation
- Lifescan Inc.
- Medtronic plc
- Nemaura Medical Inc.
  - COVID-19
- Verily Life Sciences LLC
  - COVID-19
Chapter 20: Company Profiles: Hematology (Cell Analysis) and Coagulation Special…
- CellaVision AB
- Masimo Corporation
- Nova Biomedical Corporation (Nova)
Chapter 21: Company Profiles: Histopathology Specialists
- Amoy Diagnostics Co. Ltd.
- Applied Spectral Imaging Inc. (ASI)
- BioGenex Laboratories, Inc.
- BioView Ltd.
- Visiopharm
Chapter 22: Company Profiles: Immunoassay Specialists
- Biohit Healthcare
- Biomerica Inc.
  - COVID-19
- Bio-Techne Corporation
  - COVID-19
- Eurobio Scientific
  - COVID-19
- EUROIMMUN AG (Revvity)
  - COVID-19
- Immunodiagnostic Systems (IDS)
- INOVA Diagnostics, Inc.
- One Lambda, Inc
- Response Biomedical Corp.
  - COVID-19
- Theradiag
  - COVID-19
- VolitionRx Limited
  - COVID-19
Chapter 23: 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)
- COPAN ITALIA S.p.A. and COPAN Diagnostics, Inc.
  - COVID-19
- Curetis
  - COVID-19
- Genetic Analysis AS
  - COVID-19
- Greiner Bio-One International GmbH
- Mast Group
  - COVID-19
- Mobidiag
  - COVID-19
- Q-linea AB
- OpGen, Inc.
  - COVID-19
- Seegene, Inc.
  - COVID-19
- T2 Biosystems
  - COVID-19
Chapter 24: Company Profiles: Molecular Test Specialists
- Enzo Biochem Inc.
  - COVID-19
- NanoString Technologies, Inc. (Bruker)
  - COVID-19
- Pacific Biosciences of California, Inc. (PacBio)
  - COVID-19
- Standard BioTools
  - COVID-19
- Takara Bio Inc.
  - COVID-19
- Vela Diagnostics
  - COVID-19
Chapter 25: Company Profiles: Point of Care Test Specialists
- Abingdon Health Ltd.
  - COVID-19
- binx Health
  - COVID-19
- Biomeme, Inc.
  - COVID-19
- Chembio Diagnostic Systems, Inc.
  - COVID-19
- Co-Diagnostics, Inc.
- Cue Health
  - Test to Treat
- Diazyme
  - COVID-19
- DNA Electronics Ltd (DNAe)
- DxGen Corp
- Genedrive plc (formerly Epistem Holdings)
  - COVID-19
- Immunostics, Inc.
  - COVID-19
- MedMira, Inc.
  - COVID-19
- QuantuMDx Group, Ltd.
  - COVID-19
- Rheonix, Inc.
  - COVID-19
Chapter 26: Company Profiles: Prenatal Test Service Providers
- Berry Genomics Co. ltd.
- CooperGenomics (Division of CooperSurgical)
- INEX Innovate
  - COVID-19
- Oxford Gene Technology
- Yourgene Health
  - COVID-19
Chapter 27: 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.
  - COVID-19
- Quanterix Corporation
  - COVID-19
- Streck Inc.
Chapter 28: Test Service Providers
- 23andMe
- Agendia BV
- Ambry Genetics
  - COVID-19
- ARUP Laboratories
  - COVID-19
- Aspira Women’s Health
- BioReference Laboratories
  - COVID-19
- Biotheranostics
- BluePrint Genetics Oy
- Boston Heart Diagnostics
- CareDx, Inc.
- Predictive Oncology
- Labcorp, Laboratory Corporation of America
  - COVID-19
- Mayo Clinic Laboratories
- MDxHealth SA
- OPKO Diagnostics
  - COVID-19
- Quest Diagnostics
  - Diagnostic Services
  - Oncology
  - Infectious Diseases
  - Prenatal and Women’s Health
  - Retail / Consumer Health
  - Expansion
  - COVID-19
- Sonic Healthcare

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Worldwide IVD, 17th Edition - 24-050 - updated.pdf

The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 17th Edition

29 Aug 2024

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Kalorama Information's The Worldwide Market for In Vitro Diagnostic (IVD) Tests, now in its 17th edition, is the essential resource for anyone interested in or involved in the IVD industry. This comprehensive report provides reliable estimates, real-world forecasts from 2024 to 2029, and essential insights needed to understand the IVD market in its entirety. With every significant test category covered in detail, it's like having ten market research reports in one comprehensive volume.

Key Features:

Extensive Coverage: Detailed estimates and forecasts for every significant IVD test category, with chapters on Clinical Chemistry, Hematology, Histology, Molecular, Immunoassay, Infectious Disease, Coagulation, Blood Bank IVD, Point of Care (POC), and more.
In-Depth Analysis: Based on vendor reporting, interviews, and global activities, this 1,700 page report offers a full assessment of the IVD market.
Trusted Source: Published since 1999, it’s the most trusted report by top companies in the IVD industry.
Growth Projections: Market size, future projections, and compound annual growth rates for all test segments through 2029.
Company Profiles: In-depth profiles of hundreds of companies, including the top 40, covering financial results, product launches, and strategic plans.
Global Scope: Analysis includes market size for every significant country and major market segments globally.

Essential Insights for Business Planning:

Market Size and Trends: Understand the size and breakdown of IVD market segments.
Future Projections: Forecasts for where these markets will be in five years.
Industry Changes: Track the evolution of the IVD market over time.
Competitive Landscape: Identify key players, mergers, and groundbreaking product launches.
Strategic Opportunities: Discover growth markets for potential entry or investment.

Country-Level Coverage:

This report reflects the global scope of the IVD market, covering:

Regions: US, Europe, Asia Pacific, Latin America, Eastern Europe, Emerging Markets, Rest of World.
Countries: Germany, UK, France, Spain, Italy, Russia, Netherlands, Turkey, Poland, Canada, China, Japan, Malaysia, Singapore, South Korea, Australia, Saudi Arabia, Brazil, Argentina, Colombia, Chile, Peru, South Africa, and more.

For further details and to purchase directly, please contact us.

Sample Report: A sample is available as a PDF upon request.

Related Report: This report is the companion to Kalorama Information’s annual market research study, In Vitro Diagnostic (IVD) Procedure Volumes (Chemistry, Immunoassays, Hematology, Microbiology, Histology, Point of Care). The 2024 edition of In Vitro Diagnostic (IVD) Procedure Volumes will be released in September.

Page Count: 1700

Table of Contents

Chapter 1: Executive Summary
- Scope and Methodology
- Size and Growth of the Market
- Market Highlights
- Competitive Picture in IVD
- Finding What You Are Looking For in the 17th Edition
Chapter 2: Introduction
- IVD Landscape
- Report Design
  - Changes Between 16th and 17th Editions
- PAMA and CMS
- Market Analysis of IVD Market Segments
- Top Suppliers and Niche Players
  - Introduction
  - Overview of the Top Tier Companies
  - Overview of Selected Second 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 3: 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
- WHO Essential IVD List
  - Increase in Chronic Diseases
- COVID-19
- Emerging and Emerged Markets
- Size and Forecast for the Global IVD Market
- The IVD Market in the United States
  - PAMA and Reimbursement Changes
  - LDT Update
  - Bundled Insurance Payments for ESRD Patients
  - Advanced Laboratory Tests (ADLT)
  - Precision Medicine and NGS
- IVD Market in Europe: Growing Markets
  - EU Regulation
  - Precision Medicine in Europe
  - Brexit
- Japan
- Eastern Europe: Growth Region
- China: Current IVD Market
  - Clinical Laboratory Market in China
  - IVD Distribution in China
- India: Population and Opportunity
  - Clinical Laboratory Market in India
  - IVD Regulation
- Rest of Asia
- Brazil
  - Disease Trends
  - Clinical Laboratory Market in Brazil
  - IVD Regulation
- Mexico
- The Russian Federation
- Canada
- Emerging Markets
  - Saudi Arabia IVD Market
  - South Africa IVD Market
  - South Korea IVD Market
  - Turkey IVD Market
  - United Arab Emirates (UAE) IVD Market
  - Other Markets to Watch
- IVD Market Opportunity by Country
Chapter 4: Company and Industry Trends
- Introduction
  - Advanced Medicine Without Borders
  - China Market Information
  - Direct to Consumer Genetic Test Services
  - Future Trends
- Gene Editing
  - CRISPR as a Diagnostic Tool
  - CRISPR and the Food Industry
- Microbiome
- Next Generation Sequencing
  - Liquid Biopsy
  - Quality Assurance
  - Product News
  - Market Cleared Products
  - Liquid Biopsy in Microbiology
  - Liquid Biopsy Companies in 2021-2024
  - The Future for Liquid Biopsy
- Information Technology Advances and Artificial Intelligence
  - AI in Clinical Practice
  - The Regulatory Pathway
  - Product Initiatives
- AI in Liquid Biopsy
  - Future Trends
- Exosome Sequencing
- Biotin Interference in Immunoassay Detection Errors
- Traumatic Brain Injury and IVD
- Personalized Medicine
  - Companion Diagnostics
- Telehealth
  - Telehealth eMed to Implement Home Test to Treat Program
- Blockchain
- Substance Abuse
  - Opioid Epidemic
  - COVID-19 and Substance Abuse
  - Biomarkers and Substance Abuse
  - Clinical Laboratory Testing for Drugs of Abuse
  - Urine
  - Blood
  - Oral
  - Hair
- Saliva Testing
- Breath Test Advances
- Micro-Hospital Opportunities
- Climate Change and Infectious Disease
- Kickback Schemes
- Early Sepsis Detection
- Staffing Shortages
Chapter 5: Point-of-Care (POC) Tests
- Overview and Trends
- POC Industry Drivers
  - Patient focused drivers
  - Medical/Healthcare related drivers
  - Technology drivers
  - Economic drivers
  - Other drivers
- POC Industry Challenges
- Regulatory Challenges
- Professional POC
- OTC Self Testing
- Home Collection Trend
- 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 6: The Core Lab
- Core Lab Overview and Trends
- Connectivity
- Overview of Chemistry Tests
  - Lab Automation
- Market Analysis
  - Rapid Response Systems
  - Critical Care Analysis
  - Urinalysis
- The Commercial Outlook for Chemistry Tests
Chapter 7: 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
  - Vitamin D
  - Anemia
  - Toxicology/DAU
  - Allergy
- Maturing Immunoassays
  - Proteins
- Growth Immunoassays
  - Tumor Markers
  - Cardiac Markers
Chapter 8: Molecular Assays
- Overview
- Sample Preparation and Quality Control
- Molecular Evolution
  - 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
  - Depression and Psychiatric Disorders
  - Prenatal and Newborn Testing
  - Transplant Diagnostics
- The Commercial Outlook for Molecular Tests
Chapter 9: 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 10: 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 11: Microbiology and Virology
- The Real Impact of Infections
  - Herpes and Alzheimer’s Disease
  - Ebola and Cancer
  - HIV and Cancer
  - H pylori and Cancer
  - Bacteria and Parkinson's
  - HPV and Cancer
- Microbial Antibiotic Resistance – The Role of Clinical Tests
  - Fast Identification
- 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/Multiplex Testing
- New Infectious Disease Threats
  - Tickborne Diseases (TBDs)
  - Zika
  - Chagas
  - Dengue
  - Ebola
  - Chikungunya
  - Middle East Respiratory Syndrome-Coronavirus (MERS-CoV)
  - Marburg
  - SARS-CoV-2 (COVID-19)
  - Monkeypox
- 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 12: Blood Banking Services
- Overview
  - The Current Status of Global Blood Collection
- Global Blood Safety
  - Zika Virus
  - Blood and Component Collection
  - Reevaluating Blood Transfusions
- Blood Typing and Grouping Market
  - Manual Blood Typing Methods
  - Automated Blood Typing and Screening Methods
  - Molecular Methods
  - 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 13: Histology and Cytology
- Overview
- Special Topics
  - Histology Automation
  - Advanced Analysis Solutions
  - HPV meets Core Lab
- Market Analysis
  - Total Market
  - Regional Market Analysis
  - Pap Testing
  - 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 14: Company Profiles: The Top Tier
- Abbott Diagnostics
  - Core Lab
  - Hematology
  - Blood Banking
  - Infectious Diseases - Molecular
  - Diabetes
  - HIV Point of Care
  - i-STAT Business
  - Companion Diagnostic Testing
  - Liquid Biopsy
  - COVID-19
- Agilent Technologies
  - Genomics
  - Cytogenetic Analysis
  - Sequencing
  - CRISPR
  - Flow Cytometry
  - Companion Diagnostics - Dako
  - COVID-19
- Beckman Coulter / Danaher
  - Hematology
  - Hematology IT
  - Clinical Chemistry
  - Immunoassays
  - Microbiology
  - IT Clinical
  - Flow Cytometry
  - Blood Banking
  - Beckman Coulter Life Sciences
  - COVID-19
- Becton, Dickinson and Company (BD)
  - Cytology
  - Molecular Microbiology
  - Traditional Microbiology - ID/AST
  - Blood Culture
  - Hospital Acquired Infections
  - Blood Collection
  - Mass Spectrometry
  - Flow Cytometry
  - 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
  - Liquid Biopsy
  - Droplet Digital PCR
  - Sequencing
  - COVID-19
- Bruker Corporation
  - Acquisitions and Collaborations
  - Mass Spectrometry
  - Microbiology
  - Molecular PCR
  - COVID-19
- Cepheid / Danaher
  - GeneXpert/ Xpress Line
  - Tuberculosis
  - Microbiology
  - POC Testing
  - Cancer
  - COVID-19
- Danaher Corporation
  - Acquisitions
- Dexcom
- DiaSorin S.p.A
  - Development Plan
  - Expansion
  - Immunoassays
  - Molecular
  - Molecular Oncology
  - COVID-19
- Exact Sciences
  - COVID-19
- Hologic, Inc.
  - Acquisitions
  - PANTHER Molecular System
  - HIV Testing
  - Sexually Transmitted Infections
  - Infectious Diseases
  - Panther Fusion
  - Cytology
  - COVID-19
- Illumina
  - China
  - COVID-19
- Instrumentation Laboratory (IL) / Werfen
  - Expansion
  - Coagulation
  - Acute Care
  - Information Technology
- Leica Biosystems/Danaher
  - Digital Pathology
  - Companion Diagnostics
  - Stain Reagents
  - Lab Systems
  - Sample Handling
  - Circulating Tumor Cells (CTCs)
  - Artificial Intelligence
  - COVID-19
- Natera
- QuidelOrtho Corporation
  - Immunoassays
  - Rapid Immunoassays
  - The Solana Business
  - Molecular – Savanna
  - Blood Bank
  - COVID-19
- Radiometer A/S / Danaher
  - Critical Care
  - Immunoassays
  - HemoCue
  - Transcutaneous Monitoring
- Revvity
  - COVID-19
- Roche Diagnostics
  - Hematology
  - Immunoassays
  - HIV
  - Molecular Expansion
  - Core Molecular
  - Digital PCR
  - Diabetes Care
  - Coagulation
  - cobas Liat System – POC
  - HPV
  - Blood Bank
  - Transplant Medicine
  - Cancer Companion Testing
  - IT in Anatomical Pathology
  - Information Technology
  - Digital Pathology
  - COVID-19
- Roche Tissue Diagnostics
  - Immunohistochemistry - IHC
  - Cervical Cancer Screening
  - Companion Diagnostics
- Siemens Healthineers (Siemens)
  - Core Lab
  - Lab Automation
  - Immunoassays
  - Hematology
  - Urinalysis
  - Molecular
  - Expansion to Support Molecular Diagnostics – Fast Track Diagnostics
  - Sequencing with Artificial Intelligence
  - Acute Care – POC
  - POC Connectivity
  - Business Expansion
  - COVID-19
- Sysmex Corporation
  - Hematology
  - Coagulation
  - Urinalysis and Infectious Disease
  - Immunoassays
  - Lab Information System
  - Information Technology
  - Flow Cytometry
  - Precision Medicine / Companion Test Diagnostics
  - Liquid Biopsy
  - Oncology
  - Sysmex Inostics
  - Forging New Markets
  - COVID-19
- Thermo Fisher Scientific Inc.
  - Immunoassays
  - Microbiology
  - Molecular Test Business
  - Next Generation Sequencing
  - qPCR
  - Oncology Companion Diagnostics
  - Transplant Medicine
  - Microbiome
  - Mass Spectrometry
  - Collaborations
  - Gene Editing and Cell Therapy
  - China
  - COVID-19
- Werfen
Chapter 15: Company Profiles: The Second Tier
- BGI Genomics (formerly Beijing Genome Institute)
  - PCR and Fluorescence
  - MGI Tech Co., Limited, China
  - Prenatal Testing
  - Test Services
  - Whole Genome Sequencing (WGS)
  - NGS Sequencing
  - Collaborations
  - COVID-19
- Biocartis
  - COVID-19
- Diagnostica Stago S.A.S.
- Eiken Chemical Co., Ltd
  - Product News
  - COVID-19
- Fujirebio Diagnostics, Inc.
- Fulgent Genetics, Inc
  - COVID-19
- Grifols S.A.
  - Blood Transfusion Business
  - ABO Blood Typing
  - Molecular ABO Blood Typing
  - Immunoassays
  - Market Expansion
  - Self-Testing
- Guardant Health, Inc.
- Horiba Medical
- Invitae
- Menarini Diagnostics
  - COVID-19
- Meridian Bioscience, Inc.
  - Immunoassays
  - Molecular Tests
  - COVID-19
- Mindray - Shenzhen Mindray Bio-medical Electronics Co., Ltd.
- Myriad Genetics, Inc.
- Nihon Kohden
- OraSure Technologies, Inc.
  - COVID-19
- QIAGEN
  - Tuberculosis.
  - Molecular Expansion
  - Precision Medicine / Companion Diagnostics
  - Molecular Microbiology
  - Prenatal Testing
  - Next Generation Sequencing
  - Sample Prep, Informatics
  - Digital PCR
  - Liquid Biopsy
  - Cervical Cancer
  - Expansion
  - COVID-19
- Randox Laboratories Ltd.
  - Clinical Chemistries
  - POC
  - Controls
  - Evidence Series - Multistat Biochip Analyzers
  - Molecular
  - COVID-19
- Sekisui Diagnostics LLC
  - COVID-19
- Veracyte, Inc.
Chapter 16: Company Profiles: Blood Bank Specialists
- AliveDx
  - COVID-19
- Cerus Corporation
  - COVID-19
Chapter 17: Company Profiles: Core Lab and Other Companies
- AB SCIEX Pte Ltd.
- ARKRAY
  - Dry Chemistry / Immunoassays
  - Urinalysis
  - Diabetes
  - Molecular
- EKF Diagnostics Holdings Plc
  - COVID-19
- ELITech Group S.A.S.
  - COVID-19
- Shimadzu Scientific Instruments
- Snibe Co. Ltd., (Shenzhen New Industries Biomedical Engineering Co. Ltd.)
  - COVID-19
- Tosoh Bioscience
  - COVID-19
- Trinity Biotech Plc
  - COVID-19
Chapter 18: Company Profiles: CTC & Liquid Biopsy Test Providers
- Biocept, Inc.
  - COVID-19
- Biodesix
  - COVID-19
- Epic Sciences
- Epigenomics AG
- Foundation Medicine, Inc.
- Menarini-Silicon Biosystems
  - COVID-19
- NeoGenomics
Chapter 19: Company Profiles: Specialists
- Ascensia Diabetes Care Holdings AG
- Bigfoot Biomedical Inc. (Abbott)
- Debiotech SA
  - COVID-19
- Glooko Inc.
- Insulet Corporation
- Lifescan Inc.
- Medtronic plc
- Nemaura Medical Inc.
  - COVID-19
- Verily Life Sciences LLC
  - COVID-19
Chapter 20: Company Profiles: Hematology (Cell Analysis) and Coagulation Specialists
- CellaVision AB
- Masimo Corporation
- Nova Biomedical Corporation (Nova)
Chapter 21: Company Profiles: Histopathology Specialists
- Amoy Diagnostics Co. Ltd.
- Applied Spectral Imaging Inc. (ASI)
- BioGenex Laboratories, Inc.
- BioView Ltd.
- Visiopharm
Chapter 22: Company Profiles: Immunoassay Specialists
- Biohit Healthcare
- Biomerica Inc.
  - COVID-19
- Bio-Techne Corporation
  - COVID-19
- Eurobio Scientific
  - COVID-19
- EUROIMMUN AG (Revvity)
  - COVID-19
- Immunodiagnostic Systems (IDS)
- INOVA Diagnostics, Inc.
- One Lambda, Inc
- Response Biomedical Corp.
  - COVID-19
- Theradiag
  - COVID-19
- VolitionRx Limited
  - COVID-19
Chapter 23: 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)
- COPAN ITALIA S.p.A. and COPAN Diagnostics, Inc.
  - COVID-19
- Curetis
  - COVID-19
- Genetic Analysis AS
  - COVID-19
- Greiner Bio-One International GmbH
- Mast Group
  - COVID-19
- Mobidiag
  - COVID-19
- Q-linea AB
- OpGen, Inc.
  - COVID-19
- Seegene, Inc.
  - COVID-19
- T2 Biosystems
  - COVID-19
Chapter 24: Company Profiles: Molecular Test Specialists
- Enzo Biochem Inc.
  - COVID-19
- NanoString Technologies, Inc. (Bruker)
  - COVID-19
- Pacific Biosciences of California, Inc. (PacBio)
  - COVID-19
- Standard BioTools
  - COVID-19
- Takara Bio Inc.
  - COVID-19
- Vela Diagnostics
  - COVID-19
Chapter 25: Company Profiles: Point of Care Test Specialists
- Abingdon Health Ltd.
  - COVID-19
- binx Health
  - COVID-19
- Biomeme, Inc.
  - COVID-19
- Chembio Diagnostic Systems, Inc.
  - COVID-19
- Co-Diagnostics, Inc.
- Cue Health
  - Test to Treat
- Diazyme
  - COVID-19
- DNA Electronics Ltd (DNAe)
- DxGen Corp
- Genedrive plc (formerly Epistem Holdings)
  - COVID-19
- Immunostics, Inc.
  - COVID-19
- MedMira, Inc.
  - COVID-19
- QuantuMDx Group, Ltd.
  - COVID-19
- Rheonix, Inc.
  - COVID-19
Chapter 26: Company Profiles: Prenatal Test Service Providers
- Berry Genomics Co. ltd.
- CooperGenomics (Division of CooperSurgical)
- INEX Innovate
  - COVID-19
- Oxford Gene Technology
- Yourgene Health
  - COVID-19
Chapter 27: 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.
  - COVID-19
- Quanterix Corporation
  - COVID-19
- Streck Inc.
Chapter 28: Test Service Providers
- 23andMe
- Agendia BV
- Ambry Genetics
  - COVID-19
- ARUP Laboratories
  - COVID-19
- Aspira Women’s Health
- BioReference Laboratories
  - COVID-19
- Biotheranostics
- BluePrint Genetics Oy
- Boston Heart Diagnostics
- CareDx, Inc.
- Predictive Oncology
- Labcorp, Laboratory Corporation of America
  - COVID-19
- Mayo Clinic Laboratories
- MDxHealth SA
- OPKO Diagnostics
  - COVID-19
- Quest Diagnostics
  - Diagnostic Services
  - Oncology
  - Infectious Diseases
  - Prenatal and Women’s Health
  - Retail / Consumer Health
  - Expansion
  - COVID-19
- Sonic Healthcare