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

$8,250.00 – $16,500.00

The most essential report on the IVD industry, this 1,500-plus page report has provided reliable estimates and real-world forecasts for the in vitro diagnostics industry for two decades.

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SKU: 20-050 Category: Diagnostics Market Research Tags: Clinical Chemistry, Immunoassays, in vitro diagnostics, In Vitro Diagnostics (IVD) Market, Infectious Disease, ivd, ivd market, Microbiology (ID/AST), Molecular Microbiology, OTC diabetes, Other, POC, POC Professional Pages: 1920
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Description

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What is the Size of the IVD Market in 2020?

In its latest report Kalorama Information estimates the market for in vitro diagnostic products, including instruments, reagents and associated supplies to be $83.3 billion dollars.   This is a substantial increase over our 2019 estimates, with 9 billion dollars of revenue originating from molecular and antibody COVD-19 testing responsible for most of the growth.  Other infectious diseases (particularly respiratory pathogens), advanced cancer IVDs and increasing used of critical care and hematology tests are among the factors for additional growth.

Kalorama Information’s estimates stand out from others because the firm is a focused publisher of in vitro diagnostics market research and not an entity publishing reports on all topics.    Months of analysis ad review of secondary sources by seasoned analysts, critical readings of current and historic company filings and releases, interviews with relevant experts and searching of government sources and journal lite rature result in reliable global market modeling, trusted by many of the top companies in the market.

Never before has in vitro diagnostics been so crucial. Tests for cancer and infectious disease detection, transplant success, pharmaceutical selection have added healthcare value and improved outcomes. Genetic tests for rare diseases and prenatal assessment are increasingly utilized. And now, the COVID-19 pandemic has highlighted how important testing is in a way that could not be imagined.

But in vitro diagnostics represents a large market, with scores of significant competitors. Sorting out the marketplace can be difficult without a definitive guide. What is the market size for clinical chemistry, immunoassays, molecular tests, hematology tests and other test categories?

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.

Country-Level Coverage

The in vitro diagnostics market is a global one, and The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 13th Edition reflects the international scope of the in vitro diagnostics market size. In the healthcare market, IVD companies sell globally and think globally. Trends in one part of the world affect IVD manufacturers’ product decisions and company financial performance in others. Thus, this is a global report, and the following regional and country overall IVD markets are included:

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

The Worldwide Market for In Vitro Diagnostic Tests is a testament to the Kalorama methodology. It is the result of months of painstaking work by an experienced IVD industry analyst, who has tracked hundreds of in vitro diagnostic companies for developments, trends and financial results. This research is compiled along with the opinion, observations and insights of industry experts to produce an unparalleled vision of the in vitro diagnostics industry as it is in 2020.

IVD Market Infographic

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Competitive Analysis and Corporate Profiling

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

  • A. Menarini Diagnostics
  • Abbott Diagnostics
  • Arkray
  • Becton, Dickinson (BD)
  • Beckman Coulter
  • bioMerieux
  • Bio-Rad
  • Bruker
  • Cepheid
  • Danaher
  • DiaSorin
  • Eiken Chemical
  • Fujirebio
  • Grifols
  • Hologic
  • Illumina
  • Instrumentation Laboratory
  • Lab Corp.
  • Leica Biosystems
  • Nova Biomedical
  • Meridian Bioscience, Inc.
  • Mindray
  • Perkin Elmer
  • Qiagen
  • Quest
  • Quidel
  • Radiometer
  • Randox
  • Roche Diagnostics
  • Siemens Healthineers
  • Sysmex
  • Thermo Fisher Scientific
  • Werfen

Table of Contents

One: Executive Summary

Figure 1-1: The Worldwide IVD Market, 2020-2025 ($millions)

  • Scope and Methodology
    • Table 1-1: Exchange Rate Fluctuations, 2016-2019

Finding What You Are Looking For in the 13th Edition

  • Table 1-2: Finding What You Are Looking For in the 13th Edition

Size and Growth of the Market

  • Table 1-3: Global In Vitro Diagnostic Sales by Product Market, 2020-2025 ($ millions)

IVD Market Highlights

  • Competitive Picture in IVD
  • What to Watch
  • Next-Generation Sequencing and IVD
  • Direct-to-Consumer
  • Gene Editing
  • Liquid Biopsy
  • Information Technology and AI
  • New Venues – Urgent & Retail Care

Two: Introduction

  • IVD Landscape

Market Analysis of IVD Market Segments

  • Table 2-1: Global In Vitro Diagnostic Sales by Product Market, 2020-2025 ($ million) (COVID-19 Molecular, COVID-19 Immunoassay, Clinical Chemistry; Immunoassays, Infectious Disease; Immunoassays, Other; Blood Bank Screening; Drugs of Abuse; HbA1c Immunoassays, Lab-Based; Hematology; Microbiology (ID/AST); Molecular Microbiology; Radioimmunoassays; Coagulation; Histology/Cytology; HPV, molecular; Nucleic Acid Assays; Blood Grouping/Typing; Blood Bank Molecular; Circulating Tumor Cells; POC, OTC diabetes; Continuous Glucose; POC, OTC Other; POC Professional; Mass Spectrometry)

Top Suppliers and Niche Players

  • Introduction
  • Overview of the Top Tier Companies
    • Table 2-2: Revenues of Selected Top IVD Companies, 2015-2019 ($ million, estimated)
  • Overview of Selected Second Tier Companies
    • Table 2-3: Revenues of Selected Niche Players, 2015-2019 ($ million, estimated)

IVD Companies Mergers & Acquisitions

  • Table 2-4: Selected IVD Mergers and Acquisitions
  • Figure 2-1: Share of IVD Market by Segment, Percentage, 2000 and 2020 Compared (Clinical Chemistry, Hematology, Coagulation, Immunoassays,

Microbiology (ID/AST), POC Diabetes, POC – Other, Histology/Cytology, Molecular, Blood Banking [imm & typing], Others)
Future
Point of View

Three: The Global Picture for In Vitro Diagnostic Markets

  • Background
  • Simultaneous Threats: Chronic and Acute
  • Expected World IVD Market Developments
  • The Aging Planet
    • Table 3-1: Elderly Support Ratio in Various Countries (Australia; Brazil; Canada; China; China, Hong Kong SAR; France; Germany; India; Italy; Japan; Mexico; Saudi Arabia; Singapore; South Africa; Spain; Turkey; United Kingdom; United States; World)

    Workforce Reduction

      • Table 3-2: Age Under 15 and Over 65, by Continent (Africa, L. America/Caribbean, Asia, Oceania, N. America, Europe, World))

    Is the World Prepared for Aging?
    Shifting Disease Burdens

      • Table 3-3: Changing DALY ranking of Disease Threats (disability-adjusted life year) Worldwide (HIV/AIDS, Malaria, Lung Cancer, TB, Neonatal Preterm Birth, Asthma, Heart Disease, Depression, Stroke, Cerebral Hemorrhage, Low Back Pain, Alzheimer’s, COPD))

    Increase in Chronic Diseases
    Emerging and Emerged Markets

    • Table 3-4: Available Market Data, 2018 (China, India, United States, Brazil, Russia, Mexico, Nigeria, Turkey, S. Korea, S. Africa, Vietnam, Poland, Saudi Arabia, Canada, Columbia, Ukraine, Egypt, Malaysia))

Emerging Nations and Health Insurance
Size and Forecast for the Global IVD Market

  • Table 3-5: Global In Vitro Diagnostic Market (including non-traditional IVD revenues); Major Country/Region Markets, 2019 and 2024 ($ millions) (United States, EU 15/W. Europe, Japan, China, Canada, Eastern Europe, Brazil, India, Russia, Australia, Turkey, Mexico, Saudi Arabia, South Korea)

The IVD Market in the United States

  • Table 3-6: United States IVD Market by Segment, 2019 (%) (Clinical Chemistry, Microbiology ID/AST, Microbiology Molecular, POC Diabetes, POC Other, Immunoassay Infectious Disease, Immunoassay Other, Clinical Sequencing, Nucleic Acid Assays, Coagulation, Histology, Hematology, Blood Grouping, Others)
  • PAMA and Reimbursement Changes
  • LDT Oversight Update
  • Rare Disease Testing
  • Personalized Medicine and NGS

IVD Market in Europe: Continued Recovery

  • Figure 3-1: Europe: Growth in Healthcare Expenditure by Country, Projections 2018-2025 (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom)

Industry Punches Back

  • Table 3-7: Western European IVD Market by Country, 2019 ($ millions) (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, UK)

European Directive 98/79/EC
Individual Country Markets

  • Figure 3-2: German IVD Market by Broad IVD Segment, 2020 ($ millions) (Chemistry / Hematology, Immunoassays, Microbiology/Virology, Point-of-Care, Histology/Cytology, Other segments)
  • Figure 3-3: French IVD Market by Broad IVD Segment, 2020 ($ millions) (Chemistry / Hematology, Immunoassays, Microbiology/Virology, Point-of-Care, Histology/Cytology, Other segments)
  • Figure 3-4: Italian IVD Market by Broad IVD Segment, 2020 ($ millions) (Chemistry / Hematology, Immunoassays, Microbiology/Virology, Point-of-Care, Histology/Cytology, Other segments)
  • Figure 3-5: Spanish IVD Market by Broad IVD Segment, 2020 ($ millions) (Chemistry / Hematology, Immunoassays, Microbiology/Virology, Point-of-Care, Histology/Cytology, Other segments)
  • Figure 3-6: UK IVD Market by Broad IVD Segment, 2020 ($ millions) (Chemistry / Hematology, Immunoassays, Microbiology/Virology, Point-of-Care, Histology/Cytology, Other segments)
  • Table 3-8: IVD Market Per Capita, Europe, 2018 Estimates (Switzerland, Germany, Netherlands, Sweden, France, Slovenia, United Kingdom, Italy, Spain, Slovakia, Greece, Croatia, Lithuania, Czech Republic, Hungary, Poland, Romania, Serbia, Bulgaria, Russia, Ukraine)

Personalized Medicine in Europe

  • Brexit
  • Austerity

Opportunity in Eastern Europe

  • Figure 3-7: Europe: Growth in Healthcare Expenditure by Country, Projections 2018-2025 (Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Slovak Republic, Slovenia)

Table 3-9: Eastern European IVD Market by Country, 2019 ($ millions) (Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, Ukraine)

  • Figure 3-8: Eastern Europe IVD Market by Country – Segment Distribution, 2019 ($ millions) (Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, Ukraine)

Japan: Second-Largest Country Market

  • Table 3-10: Japan IVD Market by Segment, 2019 (%) (Clinical Chemistry, Microbiology ID/AST, Microbiology Molecular, POC Diabetes, POC Other, Immunoassay Infectious Disease, Immunoassay Other, Coagulation, Histology, Hematology, Others)

China: Largest High-Growth Market

  • Table 3-11: China IVD Market by Segment, 2019 (%) (Clinical Chemistry, Microbiology ID/AST, Microbiology Molecular, POC Diabetes, POC Other, Immunoassay Infectious Disease, Immunoassay Other, Coagulation, Histology, Hematology, Others)
  • Table 3-12: Total Midyear Population by Broad Age Group: China (million persons), 2010-2050

Clinical Laboratory Tests in China

  • Figure 3-9: Number of Visits and Admissions to Hospital Institutions in China Annually, 2015 (General Hospitals, Specialized Hospitals, Chinese Medical Hospitals, Community Health Service Centers, Health Centers [Urban and Township], Village Clinics, Others)

Private Laboratories
Distribution in China
India: Home to Every Sixth Person in the World

  • Table 3-13: India IVD Market by Segment, 2019 (%) (Clinical Chemistry, Hematology, Coagulation; Microbiology; POC Diabetes; POC Other; Immunoassay; Histology; Others)

Labs in India
Rest of Asia

  • Table 3-14: Asia Pacific IVD Market by Country, 2019 ($ millions) (Australia, South Korea, Indonesia, Thailand, Philippines, Malaysia, Singapore, Vietnam)

Brazil: LATAM Leader
Disease Trends

  • Table 3-15: Brazil IVD Market by Segment, 2019 (%)

Mexico

  • Table 3-16: Mexico IVD Market by Segment, 2019 (%) (Clinical Chemistry, Microbiology ID/AST, Microbiology Molecular, POC Diabetes, POC Other, Immunoassay Infectious Disease, Immunoassay Other, Coagulation, Histology, Hematology, Others)

The Russian Federation
Canada
Emerging Markets
Saudi Arabia IVD Market
South Africa IVD Market
Turkey IVD Market
Columbia IVD Market
United Arab Emirates (UAE) IVD Market
South Korea IVD Market
Other Markets to Watch
IVD Market Opportunity

  • Table 3-17: IVD Market Opportunity by Country (2019 Market Rank, 2018 Market Rank, Country CAGR 2020-2025) (China, Philippines, Brazil, Israel, Malaysia, India, Mexico, Indonesia, Chile, Poland, Saudi Arabia, South Korea, Romania, Colombia, United Arab Emirates, Argentina, Hungary, Vietnam, Iraq, Peru, Japan, France, Turkey, Egypt, Singapore, Luxembourg, Croatia, Jordan, U.S., Germany, United Kingdom, Canada, Spain, Russia, Netherlands, Switzerland, Belgium, Sweden, Austria, Denmark, Ireland, Finland, Iran, Thailand, Venezuela, Italy, Australia, Portugal, Greece, Czech Republic, South Africa, Norway, Bulgaria, Slovakia, Slovenia)

Four: Company and Industry Trends
Introduction
Advanced Medicine Without Borders
China Market Information
IVD Company Initiatives in China

  • Table 4-1: Selected IVD Initiatives in China

Clinical Genetic Test Advances
Direct to Consumer Genetic Test Services
Programs and Initiatives

  • Table 4-2: Selected Genomic Test Innovations

Future Trends
Gene Editing

  • Table 4-3: Selected Gene Editing / CRISPR Innovations

CRISPR as a Diagnostic Tool
Basic Research
Food Industry
Investor Interest
Microbiome

  • Table 4-4: Selected Microbiome Test Innovations

Liquid Biopsy

  • Table 4-5: Liquid Biopsy: Selected Liquid Biopsy Innovations

AI in Clinical Practice

  • Table 4-5: Selected AI Market Cleared Tests

The Regulatory Pathway
Product Initiatives

  • Table 4-6: Selected AI Product Initiatives in Development and Collaborations

IBM Watson Health
AI in Liquid Biopsy

  • Table 4-7: Selected AI/Liquid Biopsy Initiatives

Future Trends
Exosome Sequencing

  • Table 4-8: Selected Exosome Test Innovations

Biotin Interference in Immunoassay Detection Errors

  • Table 4-9: Biotin-free Offerings Currently on the Market

Traumatic Brain Injury and IVD
Blockchain
Substance Abuse
Early Sepsis Detection

Five: Point-of-Care Tests
Overview and Trends
Professional POC

  • Table 5-1 Professional POC Test Sales by Category, Worldwide 2019 -2024 ($million) (Glucose, Critical Care POC, Fertility, Infectious Diseases, Cardiac Markers, Cholesterol, Coagulation, HbA1c POC, Hematology, Fecal Occult Blood, Drugs of Abuse, Others)
  • Table 5-2: Selected Profession POC Test Innovations

OTC Self Testing

  • Table 5-3: POC Self-Test Sales by Category, Worldwide, 2020-2025 ($million) (Glucose, Self; Glucose, Continuous; Pregnancy; Coagulation; Fecal Occult Blood; Drugs of Abuse; H. pylori; HIV; Cholesterol; Urinalysis; Other [TSH, Allergy, Autoimmune, etc])

Pregnancy/Fertility Tests

  • Table 5-4: POC Pregnancy and Fertility Test Market Distribution by End User, 2019 (%) (OTC, PRO)
  • Table 5-5: Pregnancy/Fertility POC Test Sales Distribution by Global Region, 2019 (United States, Europe, Japan, RoW)

Colon Cancer Screening

  • Table 5-6: Colon Cancer POC Test Sales Distribution by Global Region, 2019 (United States, Europe, Japan, RoW)

Lipid Testing

  • Table 5-7: Lipid POC Test Sales Distribution by Global Region, 2019 (United States, Europe, Japan, RoW)

POC Infectious Disease Testing

  • Table 5-8: Innovations in Molecular POC Infectious Disease Diagnostics

Products
HIV and Hepatitis Testing and Monitoring
Tuberculosis
Tropical and Neglected Diseases
Respiratory Diseases
Sepsis and Nosocomial Disease
Sexual Health
Lyme Disease

  • Table 5-9: Innovations in Molecular POC Infectious Disease Diagnostics

Market Size and Growth

  • Table 5-10: Infectious Disease POC Test Demand by Type, 2019 (Influenza, HIV, STD, Hepatitis, Malaria, c.difficile, E.Coli, H.pylori, Home Test/OTC, Others)
  • Table 5-11: Infectious Disease POC Test Sales Distribution by Global Region, 2019 (United States, Europe, Japan, RoW)

Diabetes Testing – Blood Glucose Monitoring
Glucose Testing in Tight Economics

  • Table 5-12: Glucose POC Test Sales Distribution by Global Region, 2019 (United States, Europe, Japan, RoW)
  • Figure 5-1: POC Glucose Testing Market Growth by Category, 2020-2025 CAGR (%) (Glucose OTC; Glucose Professional; Glucose, continuous; HbA1c POC)

IT to Aid Diabetes Management

  • Table 5-13: Selected Apps and Glucose Management IT

Diabetes Market Analysis

  • Table 5-14: Global Diabetes Sales by Test Category, 2020-2025 (Glucose, OTC; Glucose, professional; Glucose, continuous; HbA1c, POC; TOTAL; HbA1c, Lab) ($ millions)
  • Table 5-15: POC Test Revenues of Selected IVD Glucose Companies, 2019 ($ million, estimated)

Blood Glucose Self-Testing

  • Table 5-16: Selected Glucose Self-Test Meter Innovations

Noninvasive Testing Devices

  • Table 5-17: Selected Noninvasive Glucose Monitoring Devices

Continuous Self Testing en Route to the Artificial Pancreas

  • Table 5-18: Selected Continuous Blood Glucose System Developments

Blood Glucose Testing by Professionals

  • Table 5-19: Selected Innovations in Hospital-based Glucose Monitoring

Diabetes Testing – Glycated Hemoglobin

  • Table 5-20: Global HbA1c Test Sales Market and Distribution by Setting, 2020-2025 ($ millions) (HbA1c POC, HbA1c Lab)
  • Table 5-21: Selected POC HbA1c Devices

Genes and Other Markers of Diabetes

  • Table 5-22: Selected POC Diabetes Monitoring Tests

Drugs of Abuse Testing

  • Table 5-23: POC Drugs of Abuse Test Sales Distribution by Setting, 2019 (Employment Screening, Criminal Justice, Critical Care – Traditional POC)

Products

  • Table 5-24: Drugs of Abuse Tests on the Market

The Major POC Test Players

  • Table 5-25: POC Test Revenues of Selected IVD Companies (excluding glucose), 2018-2019 ($ million, estimated)

Six: The Core Lab
Core Lab Overview and Trends

  • Table 6-1: Workstation Sales, 2020-2025 (General Chemistries, Immunoassays on workstations; $ millions)
  • Table 6-2: Workstation Sales (General Chemistries, Immunos on Workstations) of the Top Five Manufacturers, 2018-2019 ($ millions, estimated)
  • Table 6-3: Selected New Analytes for the Core Lab, 2016-2019

Connectivity
Overview of Chemistry Tests
Lab Automation
Service Plans
Market Analysis

  • Table 6-4: Global Clinical Chemistry Sales by Test Category, 2020-2025 ($millions) (General Chemistries, Blood Gases, Urinalysis)
  • Table 6-5: Global Clinical Chemistry Sales Distribution by Region, 2020 (North America, Europe, Asia Pacific, RoW)
  • Table 6-6: Major Clinical Chemistry Companies
  • Table 6-7: Selected Clinical Chemistry Innovations

Rapid Response Systems

  • Table 6-8: Major Whole Blood Chemistry Analyzers

Critical Care Analysis

  • Table 6-9: Blood Gas, Electrolyte and Critical Care Instrument Market by End User, 2019 and 2024 (Lab-based, POC-based)
  • Table 6-10: Blood Gas, Electrolyte, and Critical Care Market Leaders, 2019 (percent distribution of total sales)

User Apps

  • Table 6-11: Selected Apps, Critical Care and Urinalysis IT Innovations

Urinalysis

  • Table 6-12: UA Market by End User, 2019 and 2024 (Lab-based, POC-based)
  • Table 6-13: Urinalysis Systems Market Leaders, 2019 (percent distribution of total sales)
  • Table 6-14: Selected Urinalysis Innovations

Sleep Apnea Testing: Core Lab Solution?
The Commercial Outlook for Chemistry Tests

Seven: Immunoassays
Overview and Trends
Immunoassay Technology Continues to Evolve

  • Table 7-1: Selected Immunoassay Technologies 2019

Mass Spectrometry

  • Table 7-2: Selected Innovation in Mass Spectrometry for Routine Analyses

Immunoassays in the Core Lab

  • Figure 7-1: Workstation (General Chemistries, Immunos on Workstations) Sales Growth, CAGR 2020-2025
  • Table 7-3: Selected Immunoassay Innovations on Core Lab Instruments

Radioimmunoassays
Market Analysis
Leading Suppliers and Growth Potential

  • Table 7-4 Global Lab-based Immunoassay (excluding infectious disease and blood screening) Sales, by Analyte Type, 2020-2025 ($millions) (Cardiac Markers, Tumor Markers, Autoimmune, Diabetes/HbA1c, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Drugs of Abuse, Vitamin D, Total; w/o HbA1c)
  • Table 7-5: Global Immunoassay (excluding infectious disease and blood screening) Sales Distribution by Region, 2020 (%) (North America, Europe, Asia Pacific, RoW)
  • Table 7-6: Selected Immunoassay Quality Control Products
  • Table 7-7: 2019 Revenue of Leading Immunoassay Vendors (in millions $), Estimated

Mature Assay Segment
Thyroid Function
Therapeutic Drug Monitoring
Anemia
Toxicology/DAU
Allergy
Maturing Immunoassays
Proteins
Growth Immunoassays
Vitamin D

  • Table 7-8: Selected Vitamin D Immunoassays

Tumor Markers

  • Table 7-9: Selected Tumor Marker Innovations

Cardiac Markers

  • Table 7-10: Selected Cardiac Marker Innovations

Autoimmune

  • Table 7-11: Selected Autoimmune Test Innovations

Rheumatoid Arthritis

  • Table 7-12: Selected Arthritis Immunoassay Innovations

Gastrointestinal Disorders

  • Table 7-13: Selected Inflammatory Bowel Disease Test Innovations

Transplant Management

  • Table 7-14: Selected Immunoassays for Transplant Medicine

Women’s Health

  • Table 7-15: Selected Women’s Health Innovations

Alzheimer’s Disease

  • Table 7-16: Selected Innovations for Alzheimer’s Disease Immunoassays

Sleep Apnea
Miscellaneous

  • Table 7-17: Selected Immunoassay Innovations

Point-of-Care OTC and Professional Use

  • Table 7-18: Global POC Immunoassay Sales Distribution by Region, 2020 (United States, Europe, Japan, RoW)
  • Table 7-19: Global POC Immunoassay Test Sales by Test Category, 2020-2025 (millions $) (OTC/Self Tests: Pregnancy/Ovulation, Drugs of Abuse, HIV, H. pylori, Other, OTC/Self Total; Professional POC: Cardiac Markers, Drugs of Abuse, HbA1c, Pregnancy, Other, Professional Total)
  • Table 7-20: Selected Self-Test Immunoassay Innovations

Pregnancy Testing
Cardiovascular Diagnostics
Drugs of Abuse/Therapeutic Drug Monitoring
Innovating POC

  • Table 7-21: Selected POC Test Innovations
  • Table 7-22: Selected POC Immunoassay Test Platforms

The Commercial Outlook for Immunoassays

Eight: Molecular Assays
Overview

  • Table 8-1: Common Next Generation Molecular Test Traits

Sample Preparation and Quality Control

  • Table 8-2: Selected Molecular Test Sample Preparation and QC Innovations

Advanced Molecular Tests and Technologies
Exosome Sequencing

  • Table 8-3: Selected Exosome Test Innovations

Liquid Biopsy

  • Table 8-4: Selected Liquid Biopsy Innovations

Metabolomic Profiling
Information Technology for Test Value

  • Table 8-5: Selected IT Innovations in Molecular Diagnostics

Forensic Studies – An Emerging Opportunity

  • Table 8-6: Selected Innovations in Forensic DNA Testing
  • Test Platforms
  • Table 8-7: Key Molecular Technologies and Major Players
  • Table 8-8: Selected Molecular Test Platform Innovations

Major Players

  • Table 8-9: Molecular Test Revenues of Selected IVD Vendors, 2016-2019 (in millions $)

Market Analysis

  • Table 8-10: Global Molecular Test Sales by Type 2020-2025 (in millions $) (Oncology, Transplant Testing, Thrombophilia SNPs, Pharmacodiagnostics, Inherited Diseases)

Oncology

  • Table 8-11: Global Molecular Cancer Test Sales Distribution by Region, 2020 (North America, Europe, Asia Pacific, RoW)

Pharmacodiagnostics

  • Table 8-12: Global Pharmacodiagnostic Sales Distribution by Region, 2020 (North America, Europe, Asia Pacific, RoW)
  • Table 8-13: Selected Molecular Tumor Marker Test Innovations

Inherited Diseases and Thrombophilia SNPs

Psychiatric Disorders
Prenatal and Newborn Testing

The Commercial Outlook for Molecular Tests

Nine: Hematology
Overview of Hematology and Trends
Digital Image Analysis

  • Table 9-1: CellaVision Market Share Data by Hematology Vendor 2019
  • Table 9-2: Selected Hematology Image Analysis Innovations, 2014-2019

Digital Evolution
Quality Control Measurement Programs
Laboratory-based Hematology Testing

  • Table 9-3: Selected Hematology Innovations, 2014-2019
  • Table 9-4: Global Laboratory-based Hematology Test and Instrument Market, 2019 and 2024 ($ millions)

Regional Laboratory-based Hematology Test and Instrument Market

  • Table 9-5: Global Laboratory-based Hematology Test and Instrument Market, by Region, 2020 (North America, Europe, Asia Pacific, RoW)

Decentralized Hematology Testing
Hemoglobin/Hematocrit at the POC

  • Table 9-6: Selected POC Hemoglobin and Hematocrit Systems
  • Table 9-7: Decentralized Hematology Test and Instrument Market, 2019 and 2024 ($ millions) (Instruments, lab-style; Handheld devices)

Market Analysis: Leading Suppliers

  • Table 9-8: Top Hematology, including d-dimer, Company Revenues (laboratory and POC), 2019 ($ millions)
  • Table 9-9: Global Hematology (Laboratory-based and POC) Sales Distribution by Region, 2020 (North America, Europe, Asia Pacific, RoW)

The Commercial Outlook for Hematology Tests

Ten: Coagulation
Overview and Trends of Coagulation and Immunohematology Tests
Special Topics
Direct Oral Anticoagulants (DOACs)
D-dimer

  • Table 10-1: Global D-dimer Sales Distribution by Region, 2020 (North America, Europe, Asia Pacific, RoW)

Market Analysis

  • Table 10-2: Global Coagulation Sales by Segment, 2020-2025 ($millions) (PT/INR Labs, Molecular, Professional POC, Professional Self; D-dimer)
  • Table 10-3: Global Coagulation Test and Instrument Market by Region, 2020 (North America, Europe, Asia Pacific, RoW)

Lab-based Testing

  • Table 10-4: Selected Lab-based Coagulation Innovations

Genetic Markers of Hypercoagulopathies

  • Table 10-5: Global Molecular – Thrombophilia SNP Sales Distribution by Region, 2020 (North America, Europe, Asia Pacific, RoW)
  • Table 10-6: Selected Molecular Coagulation Test Innovations

Leading Suppliers: Laboratory Systems

  • Table 10-7: Top Coagulation Company Revenues, Laboratory-based – 2019 ($ millions)

Decentralized Coagulation Testing – Professional Use
Decentralized Coagulation Testing – OTC

  • Table 10-8: Selected POC Coagulation Test Innovations

Platelet Testing

  • Table 10-9: Selected Platelet Activity Test Innovations

Leading Suppliers: POC Systems

  • Table 10-10: Top Coagulation Company Revenues, POC – 2019 ($ millions)

The Commercial Market for Coagulation Tests

  • Table 10-11: Major Anticoagulants Uses and Tests

Eleven: Microbiology and Virology
The Burden of Infectious Disease

  • Table 11-1: The Top Ten Leading Causes of Death

Hidden Costs of Non-Detection: Secondary Effects
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
Table 11-2: Selected Companies Developing Faster Identification, Some Also with Antimicrobial Susceptibility/Resistance Tests
Traditional Microbiology and Its Limits
The New Microbiology – Innovations
Liquid Based Microbiology and Automation Innovations
Post-Blood Culture Microbial ID
PCR and Other NAAT-Based Tests for Infectious Diseases

  • Table 11-3: Selected Nucleic Acid Amplification Test and Other Molecular Companies in Microbiology

Microbiome-Related Microbiology Tests

  • Table 11-4: Selected Microbiome-Based Tests

Next Generation Sequencing-Based Microbiology Approaches

  • Table 11-5: Selected Companies Applying DNA/RNA Sequencing to Microbiology

Syndromic Testing
Emerging Infectious Disease Threats

  • Table 11-6: Selected Companies Marketing Products Addressing Emerging Infectious Disease Threats

Tickborne Diseases: Beyond Lyme
Zika
Chagas
Dengue
Ebola
Chikungunya
Next Threats?
Microbiology Firms Acquisitions and Collaborations
Market Analysis

  • Table 11-7: Global Microbiology Sales Distribution by Region, 2020 (North America, Europe, Asia Pacific, RoW)

Market Analysis – Traditional Microbiology ID/AST

  • Table 11-8: Global Microbiology ID/AST Market, 2020-2025 (in millions USD) (ID/AST Auto, ID/AST Panels, Blood Culture, Chromogenic Media, Rapid Microbiology; ID/AST Supplies)
  • Table 11-9: Global ID/AST Testing Sales Distribution by Region, 2020 (North America, Europe, Asia Pacific, RoW)

Traditional ID/AST

  • Table 11-10: Global ID/AST Testing, Distribution by Systems, 2019 (%) (Panel, Auto)

Blood Culture

  • Table 11-11: Selected Advanced Techniques in Positive Blood Culture

Chromogenic Media
Rapid Tests Performed on Colonies from Culture Media
Supplies
Market Analysis – Microbiology Immunoassays
Improvements in Microbiology Immunoassays

  • Table 11-12: Selected Infectious Disease Immunoassay Innovations
  • Table 11-13: Global Clinical Laboratory-Based Microbiology/Infectious Disease Immunoassay Market by Pathogen, 2019 (in $ millions) (Hepatitis, HIV, STDs, TORCH, Respiratory, HAIs/Sepsis, Parasitology, Mycology, Lyme disease, Other)
  • Table 11-14: Global Clinical Chemistry Laboratory-Based Microbiology/Infectious Disease Immunoassay Market Distribution (by %) by Region, 2020 (North America, Europe, Asia Pacific, RoW)

Hepatitis Testing
Sepsis
HIV Immunoassay Testing

  • Table 11-15: Selected HIV Assays

Sexually Transmitted Diseases (STDs)
TORCH
Lyme Disease
Rapid Immunoassay Tests

  • Table 11-16: Global Rapid Immunoassay Testing Market, Sales Distribution by Pathogen, 2019 (%) (Influenza, HIV, STD, Hepatitis, Malaria, c.difficile, E.Coli, H.pylori, Home Test/OTC, Others)

Market Analysis – Molecular Microbiology

  • Table 11-17: Global Molecular Microbiology Sales Distribution by Region, 2020 (%) (North America, Europe, Asia Pacific, RoW)
  • Table 11-18: Global Molecular Microbiology Market, by Pathogen/Disease Indication, 2020-2025 (in $ millions) (HAI, HIV, Hepatitis, GC/Chlamydia, Respiratory, Organism ID, Mycobacteria/TB, Others; Blood Bank Screening)

Molecular Respiratory Infection Testing

  • Table 11-19: Selected Molecular Point of Care Innovations in Microbiology

Molecular Testing for Sexually Transmitted Diseases
Molecular Hepatitis Testing
Molecular HIV Testing

  • Table 11-20: Innovations in Molecular POC Diagnostics for HIV

Molecular Tests for Hospital-Acquired Infections (HAIs)

  • Table 11-21: Frequency of the Most Common Nosocomial Infections

Clostridium Difficile
MRSA
Molecular TB Testing
Limitations of Molecular Microbiology Testing
Mass Spectrometry

  • Table 11-22: Selected Companies Marketing Mass Spectrometers and/or Assays for the Clinical Laboratory [CE-Marked and/or 510(k) cleared]

The Future Outlook for Microbiology

Twelve: Blood Banking Services
Overview

  • Table 12-1: History of Blood Testing

The Current Status of Global Blood Collection

  • Table 12-2: Distribution of Blood Units Collected, 2011-2013 (United States, United Kingdom, India, Japan, China, Canada, ROW, World Total)

Global Blood Safety

  • Table 12-3: Laboratory Screening of Blood Donations for Transfusion-Transmissible Infections, Number of Countries (Syphilis, HCV, HBV, HIV, Chagas, Malaria, HTLV I/II)
  • Table 12-4: Prevalence of TTIs in Blood Donations [Median (Interquartile range)], by Income Group

Zika Virus
Blood and Component Collection

  • Table 12-5: Blood Component Usage for Selected Conditions
  • Table 12-6: Red Blood Cell and Platelet Use by Hospital Services (%)

Reevaluating Blood Transfusions

  • Table 12-7: Impact of Alloimmunization (% of Patients Screening Positive for One or More Antibodies)

Blood Typing and Grouping Market
Manual Blood Typing Methods
Automated Blood Typing and Screening Methods
Molecular Methods
Reducing Blood Typing Errors

  • Table 12-8: Selected Blood Typing and Grouping Innovations

Size and Growth of Typing Markets

  • Table 12-9: Global Blood Typing Market, 2020-2025 (Typing) (in $ millions)

Blood Typing Market by Geography

  • Table 12-10: Global Blood Typing Sales Distribution by Region, 2020 (%) (North America, Europe, Asia Pacific, RoW)

Blood Testing Market

  • Table 12-11: Selected Blood Testing Innovations

Preventing Bacterial Infections
Immunoassays
Nucleic Acid Testing (NAT)
Size and Growth of the Market

  • Table 12-12: Global Blood Banking Diagnostics Market, 2020-2025 (Immunoassay Screen, NAT Screens) (in $ millions)

Blood Testing Market by Geography

  • Table 12-13: Global Blood Testing Market by Geography, 2019 (%) (North America, Europe, Asia Pacific, RoW)
  • Table 12-14: Global Blood Testing Market by Country, 2019 (%) (United States, Canada, Germany, United Kingdom, France, Japan, China, Latin America)

The Commercial Outlook for Blood Banking Testing

Thirteen: Histology and Cytology
Overview
Special Topics
Histology Automation

  • Table 13-1: Selected Histology Lab Automation
  • Table 13-2: Histology Information Technology Tools

Advanced Analysis Solutions

  • Table 13-3: Selected Advanced Histology Techniques

HPV Goes Core Lab

  • Table 13-4: Global HPV Test Sales Distribution by Region, 2020 (%) (North America, Europe, Asia Pacific, RoW)
  • Table 13-5: Selected HPV Test Innovations

Market Analysis

  • Table 13-6: Global Histology/Cytology Sales by Type, 2020-2025 ($ millions) (Pap Tests, in situ hybridization, immunohistochemistry, traditional non-Pap stains, HPV, TOTAL; Digital Imaging, CTCs, Flow Cytometry)

Histology/Cytology

  • Table 13-7: Global Histology/Cytology Sales Distribution by Region, 2020 (%) (North America, Europe, Asia Pacific, RoW)
  • Table 13-8: Revenues of the Major Histology Companies, 2016-2019 ($ millions, estimated)
  • Table 13-9: Selected Vendors of Traditional Histology Stains

Immunohistochemistry and In Situ Hybridization

  • Table 13-10: Selected In Situ Hybridization-based Tests
  • Table 13-11: Selected IHC Test Innovations

Pharmacodiagnostic Histology

  • Table 13-12: Major Pharmacodiagnostic Markers
  • Table 13-13: Selected Pharmacodiagnostic Histology Tests

Digital Imaging and Computational Pathology

  • Table 13-14: Selected Digital Imaging Innovations

Circulating Tumor Cells

  • Table 13-15: Selected Innovations in CTC Technology

Flow Cytometry
The Commercial Outlook for Histology and Cytology Tests

Fourteen: Company Profiles: The Top Tier
Abbott Diagnostics

  • Key Comment
  • Recent Revenue History

Alere Acquisition Update and Point of Care

  • Core Lab
  • Hematology
  • Blood Banking
  • Coagulation
  • Infectious Diseases – Molecular
  • Diabetes
  • HIV Point of Care
  • i-STAT Business
  • Companion Testing
  • Liquid Biopsy

Arkray

  • Key Comment
  • Dry Chemistry / Immunoassays
  • Urinalysis
  • Diabetes
  • Molecular

Becton, Dickinson and Company (BD)

  • Key Comment
  • Recent Revenue History
  • Cytology
  • Molecular Microbiology
  • Traditional Microbiology – ID/AST
  • Blood Culture
  • Hospital Acquired Infections
  • Connectivity
  • Blood Collection
  • Mass Spectrometry
  • Flow Cytometry
  • Licensing

Beckman Coulter, Inc. / Danaher

  • Key Comment
  • Recent Revenue History
  • Hematology
  • Hematology IT
  • Clinical Chemistry
  • Immunoassays
  • Coagulation
  • Microbiology
  • Urinalysis
  • Clinical Information Technology
  • Molecular Tissue Analysis
  • Flow Cytometry
  • Beckman Coulter Life Sciences
  • Collaborations

bioMérieux Inc.

  • Key Comment
  • Recent Revenue History
  • Traditional Microbiology
  • Blood Culture
  • Immunoassays
  • Mass Spectrometry
  • Data Analysis
  • BioFire Diagnostics Business
  • Food Testing
  • Expansion

Bio-Rad Laboratories, Inc.

  • Key Comment
  • Recent Revenue History
  • Company Highlights in 2017 and 2018
  • Quality Control
  • Blood Bank
  • Diabetes
  • Immunoassays
  • Autoimmune Testing
  • Liquid Biopsy
  • Microbiome
  • Droplet Digital PCR
  • Sequencing

Danaher Corporation

  • Key Comment
  • Recent Revenue History
  • Acquisitions

DiaSorin S.p.A

  • Key Comment
  • Recent Revenue History
  • Development Plan
  • Expansion
  • Immunoassays

Grifols S.A.

  • Key Comment
  • Recent Revenue History
  • Blood Transfusion Business
  • ABO Blood Typing
  • Molecular ABO Blood Typing
  • Immunoassays

Hologic, Inc.

  • Key Comment
  • Recent Revenue History
  • Hologic Global Access Initiative
  • PANTHER Molecular System
  • HIV Testing
  • Sexually Transmitted Infections
  • Infectious Diseases
  • Panther Fusion
  • Cytology

Instrumentation Laboratory (IL) / Werfen

  • Key Comment
  • Recent Revenue History

Ortho Clinical Diagnostics (Ortho)

  • Key Comment
  • Recent Revenue History
  • Blood Bank
  • Core Lab / Immunoassays
  • Lab Automation

QIAGEN N.V.

  • Key Comment
  • Recent Revenue History
  • Tuberculosis
  • Molecular Expansion
  • Precision Medicine / Companion Diagnostics
  • Molecular Microbiology
  • Prenatal Testing
  • Next Generation Sequencing

Radiometer A/S / Danaher

  • Key Comment
  • Recent Revenue History
  • Critical Care
  • Immunoassays
  • HemoCue
  • Transcutaneous Monitoring

Roche Diagnostics

  • Key Comment
  • Recent Revenue History
    Table 14-1: Selected Roche Diagnostics Product Advances in 2018
  • Hematology
  • Core Lab
  • Immunoassays
  • Global Access Program for HIV
  • Molecular Expansion
  • Core Molecular
  • Digital PCR
  • Diabetes Care
  • Coagulation
  • cobas Liat System – POC
  • HPV
  • Blood Bank
  • Transplant Medicine
  • IT in Anatomical Pathology
  • Information Technology

Siemens Healthineers (Siemens)

  • Key Comment
  • Recent Revenue History
  • Core Lab
  • Lab Automation
  • Immunoassays
  • Hematology
  • Urinalysis
  • Molecular

Sysmex Corporation

  • Key Comment
  • Recent Revenue History
  • 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

Thermo Fisher Scientific Inc.

  • Key Comment
  • Recent Revenue History
  • Immunoassays
  • Microbiology
  • Molecular Test Business
  • Next Generation Sequencing
  • qPCR
  • Gene Editing
  • Oncology Companion Diagnostics
  • Liquid Biopsy
  • Zika Virus
  • Transplant Medicine
  • Microbiome
  • Forensics
  • Mass Spectrometry

Werfen

  • Key Comment
  • Recent Revenue History
  • Instrumentation Laboratory
  • Inova Diagnostics
  • Biokit

Fifteen: Company Profiles: The Second Tier

Agilent Technologies

  • Key Comment
  • Recent Revenue History
  • Agilent in Genomics
  • Cytogenetic Analysis
  • Information Technology
  • Capillary Electrophoresis
  • Sequencing
  • CRISPR
  • Flow Cytometry
  • Dako / Pathology

BGI Genomics (formerly Beijing Genome Institute)

  • Key Comment
  • Recent Revenue History
  • MGI Tech Co., Limited, China
  • With Complete Genomics
  • Prenatal Testing
  • Test Services
  • Liquid Biopsy
  • Whole Genome Sequencing (WGS)
  • Collaborations

Bruker Corporation

  • Key Comment
  • Recent Revenue History
  • Acquisitions and Collaborations
  • Microbiology
  • Molecular PCR

Cepheid / Danaher

  • Key Comment
  • Recent Revenue History
  • GeneXpert Xpress Line
  • High Burden Expansion

Eiken Chemical Co., Ltd

  • Key Comment
  • Recent Revenue History

Fujirebio Diagnostics, Inc.

  • Key Comment
  • Recent Revenue History

Illumina

  • Key Comment
  • Recent Revenue History
  • Company Reported Highlights in 2019
  • Liquid Biopsy
  • Sequencing
  • Advancing in the Clinical Market
  • Sequencing Data Analysis
  • Sample Preparation
  • Microarrays
  • Project Firefly
  • Transplant Medicine
  • Liquid Biopsy
  • Forensic Medicine
  • Prenatal Testing Business
  • Collaborations
  • China
  • Investment

LabCorp, Laboratory Corporation of America

  • Key Comment
  • Recent Revenue History

LabCorp Buys Sequenom

  • Precision Medicine
  • Diagnostics Services
  • DTC Home Testing
  • Prenatal
  • Retail Services
  • Expansion

Leica Biosystems

  • Key Comment
  • Recent Revenue History
  • Digital Pathology
  • Stain Reagents
  • Lab Systems
  • Sample Handling
  • Circulating Tumor Cells (CTCs)
  • Artificial Intelligence

Luminex Corporation

  • Key Comment
  • Recent Revenue History
  • Assay Development
  • Verigene Business
  • PCR
  • Flow Cytometry
  • Business Expansion

A. Menarini Diagnostics

  • Key Comment
  • Menarini-Silicon Biosystems Inc. (Bologna, Italy)
  • Meridian Bioscience, Inc.
  • Key Comment
  • Recent Revenue History
  • Immunoassays
  • Molecular Tests
  • Building U.S. and International Partnerships
  • China Businesses

Mindray – Shenzhen Mindray Bio-medical Electronics Co., Ltd.

  • Key Comment
  • Recent Revenue History
  • Core Lab
  • Hematology

Nova Biomedical Corporation (Nova)

  • Key Comment
  • Recent Revenue History

PerkinElmer, Inc. (PE)

  • Key Comment
  • Recent Revenue History
  • Diagnostics
  • Sequencing /Genomics
  • Liquid Biopsy
  • Histology
  • Prenatal Business
  • Lab Services
  • Mass Spectrometry

Philips

  • Key Comment
  • Histology
  • Cancer Genomics
  • Precision Medicine
  • Precision Medicine IT
  • Patient Monitoring
  • Point of Care
  • Wearable Self Monitor

Quest Diagnostics

  • Key Comment
  • Recent Revenue History
  • Reported Highlights
  • Diagnostic Services
  • Oncology
  • Infectious Diseases
  • Prenatal and Women’s Health
  • Retail / Consumer Health
  • Expansion

Quidel Corporation

  • Key Comment
  • Recent Revenue History
  • Immunoassays
  • Rapid Immunoassays
  • The Solana Business
  • Molecular – Savanna

Randox Laboratories Ltd.

  • Key Comment
  • Clinical Chemistries
  • Evidence Series – Multistat Biochip Analyzers
  • Molecular

Ventana Medical Systems Inc. / Roche Tissue Diagnostics

  • Key Comment
  • Recent Revenue History
  • Immunohistochemistry – IHC
  • Cervical Cancer Screening
  • Companion Diagnostics
  • Quality Control
  • DISCOVERY Product Line

Bloodsource (Vitalant)
Cerus Corporation
Haemokinesis Pty Ltd
Immucor
MicroTyping Concepts
Quotient Limited
Reliance Life Sciences
Diagnostica Stago, S.A.S.
Microvisk Technologies
DIAGON Kft. Hungary
AB SCIEX Pte Ltd.
EKF Diagnostics Holdings Plc
ELITech Group S.A.S.
ERBA Diagnostics, Inc.
MedTest DX
Microsaic Systems plc
Nova Biomedical
Scienion AG
Sekisui Diagnostics LLC
Shimadzu Scientific Instruments
Snibe Co. Ltd., (Shenzhen New Industries Biomedical Engineering Co. Ltd.)
Tecan Group
Tosoh Bioscience
Trinity Biotech Plc
Angle, plc
Biocartis
Biocept, Inc.
Biodesix
Cynvenio Biosystems (LungLife AI)
Epic Sciences
Epigenomics AG
Foundation Medicine, Inc.
Genomic Health (Exact Sciences)
Guardant Health, Inc.
Menarini-Silicon Biosystems
Myriad Genetics, Inc.
Natera
NeoGenomics
Animas Corporation
Ascensia Diabetes Care Holdings AG
Bigfoot Biomedical Inc.
Cellnovo Group SA
Debiotech SA
Dexcom Inc.
Gentag Inc.
Glooko Inc.
GlySure Limited
Glytec LLC
Insulet Corporation
LifeScan Inc.
Medtronic plc
Nemaura Medical Inc.
Nightscout Project
Sanofi
Trividia Health Inc.
Verily Life Sciences LLC
CellaVision AB
Horiba Medical
Medica Corporation
Onca Xt Ltd
West Medica
Advanced Cell Diagnostics (ACD)
Amoy Diagnostics Co. Ltd.
Applied Spectral Imaging Inc. (ASI)
BioGenex Laboratories, Inc.
BioView Ltd.
Circulomics Inc.
Dako A/S
Definiens
HTG Molecular Diagnostics
Kapa Biosystems Inc.
Leica Biosystems
MilliporeSigma (formerly EMD Millipore)
Omnyx LLC
Visiopharm
BG Medicine, Inc
Binding Site Group Ltd. (The)
Biohit Oyj (Biohit Healthcare)
Biomerica Inc.
Bio-Techne Corporation
Corgenix Medical Corporation
Critical Diagnostics
Eurobio Scientific
EUROIMMUN AG
HOB Biotech
Immunodiagnostic Systems (IDS)
INOVA Diagnostics, Inc.
Integrated Diagnostics (now Biodesix)
One Lambda, Inc
Orgentec Diagnostika
Protagen Diagnostics
Response Biomedical Corp.
Singulex, Inc.
Theradig
VolitionRx Limited
Advaita Corp.
Cerner Corp.
Dell Technologies Inc.
Desktop Genetics Ltd.
DNAnexus Inc.
Edico Genome (Illumina)
Euformatics Oy
Genalice
GenomOncology LLC
Google LLC
Human Longevity Inc.
Intel Corporation
International Business Machines Corp. (IBM)
N-of-One
PierianDx
Rennova Health, Inc.
SOPHiA GENETICS SA
Sunquest Information Systems Inc.
WuXi NextCODE
Accelerate Diagnostics, Inc.
Advanced Biological Laboratories, S.A. (ABL)
altona Diagnostics
ArcDia International Oy Ltd.
BioFire Diagnostics, LLC. (acquired by bioMérieux)
Bruker BioSciences Corporation
COPAN ITALIA S.p.A. and COPAN Diagnostics, Inc.
Curetis
Fast Track Diagnostics (acquired by Siemens Healthineers)
Focus Diagnostics, Inc.
Genetic Analysis AS
GeneWEAVE Biosciences, Inc.
Greiner Bio-One International GmbH
Hain Lifescience GmbH
Mast Group
Mobidiag Ltd.
Nanosphere, Inc. (Luminex)
OpGen, Inc.
PositiveID Corporation
Q-linea AB
Seegene, Inc.
Synbiosis Ltd.
T2 Biosystems
Asuragen Inc.
AutoGenomics Inc.
Enzo Biochem Inc.
Exosome Diagnostics, Inc.
Fluidigm Corporation
GenMark Diagnostics, Inc
Genome Diagnostics BV (GenDx)

  • NanoString Technologies, Inc.
  • Oxford Nanopore Technologies Ltd
  • Pacific Biosciences of California, Inc. (PacBio)
  • QuanDx Inc
  • RainDance Technologies, Inc.
  • Rubicon Genomics, Inc.
  • Takara Bio Inc.
  • Vela Diagnostics
  • WaferGen Bio-systems, Inc.

Sixteen: Company Profiles: Point of Care Test Specialists

  • Abaxis, Inc.
  • Abingdon Health Ltd.
  • Atlas Genetics Ltd. (Binx Health)
  • Biomeme, Inc.
  • Chembio Diagnostic Systems, Inc.
  • DNA Electronics Ltd (DNAe)
  • Entopsis
  • FABPulous B.V.
  • Fio Corporation
  • Genedrive plc (formerly Epistem Holdings)
  • Hema Diagnostic Systems (HDS; dba NuGenerex Diagnostics)
  • Immunostics, Inc.
  • InSilixa Inc.
  • Loop Medical (formerly QloudLab SA)
  • MedMira, Inc.
  • OraSure Technologies, Inc.
  • PTS Diagnostics
  • QuantuMDx Group, Ltd.
  • Rheonix, Inc.
  • Samsung Healthcare
  • Veredus Laboratories Pte Ltd

Twenty-Eight: Company Profiles: Prenatal Test Service Providers

  • Affymetrix, Inc.
  • Berry Genomics Co. ltd.
  • CombiMatrix (Invitae)
  • CooperGenomics (Division of CooperSurgical)
  • Counsyl (Myriad Women’s Health)
  • GenePeeks, Inc.
  • Genetadi Biotech S.L.
  • Genoma Group
  • Innovations Exchange Pte Ltd (INEX) and iGene Diagnostics Pte Ltd
  • LifeCodexx AG
  • Oxford Gene Technology
  • Premaitha Health (Yourgene Health)
  • Ravgen
  • Reproductive Genetics Innovations
  • Sequenom, Inc.

Twenty-Nine: Company Profiles: Quality Control & Sample Pretreatment Specialists

  • 10x Genomics
  • Agena Bioscience, Inc.
  • Biotype Diagnostic GmbH
  • DxTerity Diagnostics Inc.
  • Horizon Discovery Group plc
  • IncellDx
  • Oasis Diagnostics Corporation
  • PreAnalytiX GmbH
  • Precipio, Inc. (formerly Transgenomic)
  • Quanterix Corporation
  • SeraCare Life Sciences, Inc.
  • Streck Inc.

Thirty: Test Service Providers

    • 23andMe
    • Agendia BV
    • Ambry Genetics
    • ARUP Laboratories
    • Assurex Health
    • The BioCollective
    • BioReference Laboratories
    • Biotheranostics
    • BluePrint Genetics Oy
    • Boston Heart Diagnostics
    • CareDx, Inc.
    • Cleveland HeartLab Inc.
    • Eurofins Genomics
    • Exact Sciences Corp.
    • Genomic Vision
    • Helomics Corporation
    • Mayo Medical Laboratories
    • MDxHealth SA
    • OPKO Diagnostics
    • Pathway Genomics Corporation
    • Sonic Healthcare
    • Veracyte, Inc.
    • Vermillion Inc.
    Worldwide Market for Point-of-Care (POC) Diagnostic Tests, 12th Edition
    May 13, 2025
    In Vitro Diagnostic (IVD) Trends and Market Update, 2025
    April 7, 2025
    In Vitro Diagnostics Business Outlook, 2025 (6 Issues)
    April 3, 2025
    Molecular Diagnostics Quarterly Datastream, 2025
    April 2, 2025

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