Global IVD Market - Market Research, Industry Trends, Market Share


Published: 08/27/2018
Pages: 1812
Full Study Price: US$ 7,500

The world market for diagnostics is estimated to grow 4% annually through 2023, a slower than normal pace. This includes all commercial laboratory and hospital-based products, some research use products used in clinical laboratories, and OTC product sales (not test services). The anticipated slower market growth (versus the traditional 5%-6%) is related to:

  • recovery in some forms from the 2008 economic meltdown and accompanying decrease in demand and in pricing for diagnostic tests in the major markets - U.S., Japan and Europe;
  • Europe improving but still substandard growth rates;
  • Impact of PAMA price cutting in the U.S. and consolidation and cuts in Europe. Particularly in the glucose segments, where the price-cutting have lead to a continued erosion of the market share held by the top global glucose monitoring companies. Low priced products from small companies have stepped in to take their place. Also many local suppliers provide lower priced products in developing countries. The result has been that the dollar value of the market for blood glucose products no longer sees annual growth of 10-15%; at the same time more tests in use. Continuous blood glucose meters will augment, but not replace, this growth;
  • decrease in reimbursement for pathology tests in the U.S.;
  • migration of previously low volume tests such as D-Dimer, preeclampsia, procalcitonin, Vitamin D and HbA1c and others to integrated analyzers, that decreases the cost per test; and
  • lab consolidation in the U.S. that leads to price erosion.

As IVD markets in N. America and Europe offer little growth opportunities for the vast number of tests, even the top tier of suppliers and players are is feeling the effects of the slowdown in Europe and the U.S. Therefore many now count on emerging countries for growth. Primary of these is China that has recently published its 13th 5-Year Plan focused on innovation, healthcare and precision medicine, environment and food safety. With a growing clinical market, nascent consumer demand, and increased government investment, China is becoming an emerging market of choice.

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Table Of Contents

ONE: EXECUTIVE SUMMARY
Figure 1-1: The Worldwide IVD Market, 2018 -2023 ($millions)
SCOPE AND METHODOLOGY
Table 1-1: Exchange Rate Fluctuations, 2012–2016
SIZE AND GROWTH OF THE MARKET
Figure 1-2: Regional Distribution of IVD market, 2018
Table 1-2: Worldwide In Vitro Diagnostic Reagent Sales by Market Segment, 2016-2021 ($ million)
COMPETITIVE PICTURE IN IVD
IVD MARKET HIGHLIGHTS
WHAT TO WATCH
LAB MEDICINE DISCIPLINES AND APPLICATIONS
TWO: INTRODUCTION
A PARADOX OF SORTS
REPORT DESIGN
THE CHALLENGE OF PAMA
MARKET ANALYSIS OF IVD MARKET SEGMENTS
Table 2-1: Worldwide In Vitro Diagnostic Sales by Product Market, 2018-2023 ($ million)
TOP SUPPLIERS AND NICHE PLAYERS
Introduction
Overview of the Top Tier Companies
Table 2-2: Revenues of Selected Top IVD Companies, 2013-2017 ($ million, estimated)
Overview of Selected Second Tier Companies
Table 2-3: Revenues of Selected Niche Players, 2013-2017 ($ million)
IVD COMPANIES MIX AND MATCH
Table 2-4: Selected Diagnostics Industry Acquisitions, 2016, 2017, & 2018
MARKET EXPANSION INITIATIVES
Table 2-5: Selected Market Geographic or Product Expansion Initiatives
DISTRIBUTION AGREEMENTS
Table 2-6: Selected Diagnostics Industry Distribution Agreements, H2 2016, 2017, 2018
LICENSES AND COLLABORATION AGREEMENTS
Table 2-7: Selected IVD Partnerships/Collaborations/Licensing Agreements, H2 2016, 2017, 2018
TEST SERVICES
Table 2-8: Selected Test Services, Sales 2012-2016 ($ millions, estimated where applicable)
Table 2-9: Lab Market Segmentation, Worldwide, 2018 (estimated)
Table 2-10: Revenues for a Selection of U.S.-based Reference Labs, 2012-2016 ($ million, estimated)
Table 2-11: Selected Company-Sponsored Labs Established 2015-2017
IVDS THEN AND NOW – A 22 YEAR PERSPECTIVE
In the Beginning to Now
Figure 2-1: Share of IVD Market by Segment, Percentage, 2000 and 2018 Compared
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
Workforce Reduction
Table 3-2: Age Under 15 and Over 65, by Continent
Is the World Prepared for Aging?
SHIFTING DISEASE BURDENS
Table 3-3: Changing DALY ranking of Disease Threats (disability-adjusted life year) Worldwide
Increase in Chronic Diseases
EMERGING AND EMERGED MARKETS
Table 3-4: Available Market Data, 2017
Emerging Nations and Health Insurance
SIZE AND FORECAST FOR THE WORLD IVD MARKET
Table 3-5: Worldwide In Vitro Diagnostic Market by Country, 2018 and 2023
THE IVD MARKET IN THE UNITED STATES
PAMA and Reimbursement Changes
LDT Oversight Update
Rare Disease Testing
Personalized Medicine
Table 3-6: United States IVD Market by Segment
IVD MARKET IN EUROPE: SOME RECOVERY
Figure 3-1: Europe: Growth in Healthcare Expenditure by Country, 2012-2017 vs. 2017-2022
Industry Punches Back
Table 3-7: European IVD Market by Country, 2018 ($million)
European Directive 98/79/EC
Individual Country Markets
Table 3-8: IVD Market Per Capita, Europe
Personalized Medicine in Europe
Brexit
Austerity
OPPORTUNITY IN EASTERN EUROPE
Figure 3-2: Growth in Healthcare Expenditure in Eastern Europe, 2012-2017 vs. 2017-2022
Table 3-9: Eastern Europe In Vitro Diagnostic Sales by Country, 2018-2023 ($ millions) (Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Russia, Slovakia, Slovenia, Ukraine, Other Eastern Europe, Total)
JAPAN: SECOND-LARGEST COUNTRY MARKET
CHINA: LARGEST FAST-GROWER
Table3-10: Total Midyear Population by Broad Age Group: China (million persons), 2010-2050
Clinical Laboratory Tests in China
Figure 3-3: Number of Visits and Admissions to Hospital Institutions in China Annually, 2015
Private Laboratories
Distribution in China
INDIA: HOME TO EVERY SIXTH PERSON IN THE WORLD
Labs in India
REST OF ASIA
Figure 3-4: Growth in Health Expenditure in Asia, 2012-2017 vs. 2017-2022
BRAZIL: LATAM LEADER
Disease Trends
IVD Market
MEXICO
THE RUSSIAN FEDERATION
CANADA
EMERGING MARKETS
Saudi Arabia
South Africa
Turkey IVD Market
Figure 3-5: Selected Emerging Growth in Health Expenditure, 20012-2017 vs. 2017-2022
Columbia IVD Market
United Arab Emirates (UAE)
South Korea
Other Markets to Watch
FOUR: COMPANY AND INDUSTRY TRENDS
INTRODUCTION
GENE EDITING
Table 4-1: Selected Gene Editing / CRISPR Innovations
MICROBIOME
Table 4-2: Selected Microbiome Test Innovations
LIQUID BIOPSY
Table 4-3: Liquid Biopsy: Selected Liquid Biopsy Innovations
INFORMATION TECHNOLOGY TAKES CENTER STAGE
Table 4-4: Selected IT Innovations
EXOSOME SEQUENCING
Table 4-5: Selected Exosome Test Innovations
BIOTIN INTERFERENCE IN IMMUNOASSAY DETECTION ERRORS
Table 4-6: Biotin-free Offerings Currently on the Market
SINGLE DROP BLOOD TESTS
Theranos
Genalyte
NOWDiagnostics
ApolloDx
1Drop Diagnostics
Abbott i-STAT System
Siemens Healthineers epoc Blood Analysis System
Seventh Sense Biosystems
THREE SIGNS REGULATORS ARE CLEARING A PATH FOR NEXT GENERATION SEQUENCING
1. The FDA Released Regulatory Guidance
2. More NGS Tests Are Getting FDA Approval
3. Medicaid Is Willing to Pay for NGS Tests
HIGH-SENSITIVITY CARDIAC TROPONIN TESTS FINALLY REACH THE U.S.
Detecting Heart Attacks Faster
Beyond Heart Attacks
LAB TEST HARMONIZATION GETS A $2 MILLION BOOST
BLOCKCHAIN
SUBSTANCE ABUSE
Opiod Epidemic
Biomarkers and Substance Abuse
Clinical Laboratory Testing for Drugs of Abuse
Table 4-7: Global Drug Abuse Statistics
Urine
Blood
Oral
Hair
Table 4-8: Selected Opioid FDA Approvals, 2015-2018
FIVE: POINT-OF-CARE TESTS
OVERVIEW AND TRENDS
Professional POC
Table 5-1 Professional POC Test Sales by Category, Worldwide 2018 -2023 ($million)
Table 5-2: Hospital POC Test Usage, U.S. (% of hospital using; % of hospitals not using)
Table 5-3: POC Test Use among Survey Respondents, Current and Desired
Table 5-4: Selected Profession POC Test Innovations
OTC Self Testing
Table 5-5: POC Self-Test Sales by Category, Worldwide, 2018-2023 ($million)
Colon Cancer Screening
Lipid Testing
THE MAJOR POC TEST PLAYERS
Table 5-6: POC Test Revenues of Selected IVD Companies, 2013-2015 ($ million, estimated)
POC INFECTIOUS DISEASE TESTING
Table 5-7: Selected Molecular POC Platforms Currently on Market
Products
HIV and Hepatitis Testing and Monitoring
Tuberculosis
Tropical and Neglected Diseases
Respiratory Diseases
Sepsis and Nosocomial Disease
Sexual Health
Table 5-8: Innovations in Molecular POC Infectious Disease Diagnostics
Market Size and Growth
DIABETES TESTING – BLOOD GLUCOSE MONITORING
Glucose Testing in Tight Economics
IT to Aid Diabetes Management
Table 5-9: Selected Apps and Glucose Management IT
Diabetes Market Analysis
Table 5-10: Diabetes Sales by Test Category, Worldwide, 2018-2023 (Glucose, OTC; Glucose, professional; Glucose, continuous; HbA1c, POC; TOTAL; HbA1c, Lab) ($ millions)
Blood Glucose Self-Testing
Table 5-11: Selected Glucose Self-Test Meter Innovations
Noninvasive Testing Devices
Table 5-12: Selected Noninvasive Glucose Monitoring Devices
Continuous Self Testing en Route to the Artificial Pancreas
Table 5-13: Selected Continuous Blood Glucose System Developments
Blood Glucose Testing by Professionals
Table 5-14: Selected Innovations in Hospital-based Glucose Monitoring
Diabetes Testing – Glycated Hemoglobin
Table 5-15: Selected POC HbA1c Devices
Genes and Other Markers of Diabetes
Table 5-16: Selected POC Diabetes Monitoring Tests
DRUG OF ABUSE TESTING
Products
Table 5-17: Drugs of Abuse Tests on the Market
SIX: THE CORE LAB
CORE LAB OVERVIEW AND TRENDS
Table 6-1: Workstation Sales, 2018-2023 (General Chemistries, Immunos on workstations; $ millions)
Table 6-2: Core Lab Sales of the Top Five Manufacturers, 2014-2017 ($ millions, estimated)
Table 6-3: Selected New Analytes for the Core Lab, 2016-2018
CONNECTIVITY
OVERVIEW OF CHEMISTRY TESTS
Lab Automation
Table 6-4: Selected Lab Automation Innovations
Service Plans
MARKET ANALYSIS
Table 6-5: Worldwide Clinical Chemistry Sales by Test Category, 2018-2023 ($millions)
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
User Apps
Table 6-9: Selected Apps, Critical Care and Urinalysis IT Innovations, 2016
Urinalysis
Table 6-10: Selected Urinalysis Innovations, 2016
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 2017
Mass Spectrometry
Table 7-2: Selected Innovation in Mass Spectrometry for Routine Analyses
Immunoassays in the Core Lab
Table 7-3: Selected Immunoassay Innovations on Core Lab Instruments
Radioimmunoassays
MARKET ANALYSIS
Leading Suppliers and Growth Potential
Table 7-4 Worldwide Lab-based Immunoassay Sales by Analyte Type, 2018-2023
Table 7-5: Selected Immunoassay Quality Control Products
Table 7-6: 2017 Revenue of Leading Immunoassay Vendors (in millions $)
MATURE ASSAY SEGMENT
Thyroid Function
Therapeutic Drug Monitoring
Anemia
Toxicology/DAU
Allergy
MATURING IMMUNOASSAYS
Proteins
GROWTH IMMUNOASSAYS
Vitamin D
Table 7-7: Selected Vitamin D Immunoassays 2015-2017
Tumor Markers
Table 7-8: Selected Tumor Marker Innovations 2015-2017
Cardiac Markers
Table 7-9: Selected Cardiac Marker Innovations
Autoimmune
Table 7-10: Selected Autoimmune Test Innovations
Rheumatoid Arthritis
Table 7-11: Selected Arthritis Immunoassay Innovations
Gastrointestinal Disorders
Table 7-12: Selected Inflammatory Bowel Disease Test Innovations
Transplant Management
Table 7-13: Selected Immunoassays for Transplant Medicine
Women’s Health
Table 7-14: Selected Women’s Health Innovations
Alzheimer’s Disease
Table 7-15: Selected Innovations for Alzheimer’s Disease Immunoassays
Sleep Apnea
Miscellaneous
Table 7-16: Selected Immunoassay Innovations
Point-of-Care OTC and Professional Use
Table 7-17: POC Immunoassay Test Sales by Test Category, 2018-2023 (millions $)
Table 7-18: Selected Self-Test Immunoassay Innovations
Pregnancy Testing
Cardiovascular Diagnostics
Drugs of Abuse/Therapeutic Drug Monitoring
Table 7-19: Selected POC Test Innovations
Table 7-20: 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 Biospy 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, 2013-2017 (in millions $)
MARKET ANALYSIS
Table 8-10: Worldwide Molecular Test Sales by Type 2018-2023
Oncology
Pharmacodiagnostics
Table 8-11: Selected Molecular Tumor Marker Test Innovations
Inherited Diseases and Thrombophilia SNPs
Table 8-12: Most Frequently Requested Genetic Tests
Table 8-13: Selected Genomic Tests for Inherited Diseases
Prenatal and Newborn Testing
Table 8-15: Prenatal Services Provided
Table 8-16: Selected Molecular Tests for Prenatal Analysis
Tissue Typing
Table 8-17: Selected HLA Typing Test Innovations
THE COMMERCIAL OUTLOOK FOR MOLECULAR TESTS
NINE: HEMATOLOGY
OVERVIEW OF HEMATOLOGY AND TRENDS
Digital Image Analysis
Table 9-1: CellaVision Placement Data by Hematology Vendor (as of February 2017)
Table 9-2: Selected Hematology Image Analysis Innovations, 2014-2018
Digital Evolution
Quality Control Measurement Programs
LABORATORY-BASED HEMATOLOGY TESTING
Table 9-3: Selected Hematology Innovations, 2014-2018
Table 9-4: Laboratory-based Hematology Test and Instrument Market, 2018 and 2023 ($ millions)
Regional Laboratory-based Hematology Test and Instrument Market
Figure 9-1: Laboratory-based Hematology Test and Instrument Market, Regional Analysis, 2017
DECENTRALIZED HEMATOLOGY TESTING
Hemoglobin/Hematocrit at the POC
Table 9-5: Selected POC Hematology Innovations, 2016-2018
Table 9-6: Decentralized Hematology Test and Instrument Market, 2018 and 2023 ($ millions)
Regional Decentralized Hematology Test and Instrument Market
Figure 9-2: Decentralized Hematology Test and Instrument Market, Regional Analysis, 2017
MARKET ANALYSIS: LEADING SUPPLIERS
Table 9-7: Top Hematology, including d-dimer, Company Revenues, (laboratory and POC), 2017 ($ millions)
THE COMMERCIAL OUTLOOK FOR HEMATOLOGY TESTS
TEN: COAGULATION
OVERVIEW AND TRENDS OF COAGULATION AND IMMUNOHEMATOLOGY TESTS
SPECIAL TOPICS
Direct Oral Anticoagulants (DOACs)
D-dimer
MARKET ANALYSIS
Table 10-1: Global Coagulation Sales by Segment, 2018-2023 ($millions)
Figure 10-1: Global Coagulation Test and Instrument Market, Regional Analysis, 2017
LAB-BASED TESTING
Table 10-2: Selected Lab-based Coagulation Innovations, 2015-2018
Genetic Markers of Hypercoagulopathies
Table 10-3: Selected Molecular Coagulation Test Innovations
LEADING SUPPLIERS: LABORATORY SYSTEMS
Table 10-4: Top Coagulation Company Revenues, Laboratory-based - 2017 ($ millions)
DECENTRALIZED COAGULATION TESTING – PROFESSIONAL USE
Decentralized Coagulation Testing – OTC
Table 10-5: Selected POC Coagulation Test Innovations
Platelet Testing
Table 10-6: Selected Platelet Activity Test Innovations
LEADING SUPPLIERS: POC SYSTEMS
Table 10-7: Top Coagulation Company Revenues, POC - 2017 ($ millions)
THE COMMERCIAL MARKET FOR COAGULATION TESTS
Table 10-8: 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
The Holy Grail – Faster Identification
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 MIX AND MATCH
MARKET ANALYSIS
MARKET ANALYSIS - TRADITIONAL MICROBIOLOGY ID/AST
Table 11-7: Microbiology ID/AST Market, 2018-2023 (in millions USD)
ID/AST
Blood Culture
Table 11-8: 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 11-9: Selected Infectious Disease Immunoassay Innovations
Table 11-10: World Clinical Laboratory Based Microbiology/Infectious Disease Immunoassay Market by Pathogen, 2018
Hepatitis Testing
Sepsis
HIV Immunoassay Testing
Table 11-11: Selected HIV Assays
Sexually Transmitted Diseases (STDs)
TORCH
Lyme Disease
Rapid Immunoassay Tests
MARKET ANALYSIS - MOLECULAR MICROBIOLOGY
Table 11-12: Worldwide Molecular Microbiology Market, by Pathogen/Disease Indication, 2018-20223
Molecular Respiratory Infection Testing
Table 11-14: Selected Molecular Point of Care Innovations in Microbiology
Molecular Testing for Sexually Transmitted Diseases
Molecular Hepatitis Testing
Molecular HIV Testing
Molecular Tests for Hospital-Acquired Infections (HAIs)
Table 11-15: Frequency of the Most Common Nosocomial Infections
Clostridium Difficile
MRSA
Molecular TB Testing
Limitations of Molecular Microbiology Testing
MASS SPECTROMETRY
Table 11-16: 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
INTRODUCTION
Table 12-1: History of Blood Testing
THE CURRENT STATUS OF GLOBAL BLOOD COLLECTION
Table 12-2: Distribution of Blood Units Collected
GLOBAL BLOOD SAFETY
Table 12-3: Laboratory Screening of Blood Donations for Transfusion-Transmissible Infections, Number of Countries
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
Table 12-8: Blood Typing Market, 2018-2023 (Typing)
Manual Blood Typing Methods
Automated Blood Typing and Screening Methods
Molecular Methods
Reducing Blood Typing Errors
Table 12-9: Selected Blood Typing and Grouping Innovations
Size and Growth of Typing Markets
BLOOD TESTING MARKET
Table 12-10: Selected Blood Testing Innovations
Preventing Bacterial Infections
Immunoassays
Nucleic Acid Testing (NAT)
Size and Growth of the Market
Table 12-11: Blood Banking Diagnostics Market, 2018-2023 (Typing, Immunoassay Screen, NAT Screens)
Blood Testing Market by Geography
Figure 12-1: Blood Testing Market by Geography
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: Selected HPV Test Innovations
MARKET ANALYSIS
Table 13-5: Worldwide Histology/Cytology Sales by Type, 2018-2023 ($ millions)
Histology/Cytology
Table 13-6: Revenues of the Major Histology Companies, 2012-2017 ($ millions, estimated)
Table 13-7: Selected Vendors of Traditional Histology Stains
Immunohistochemistry and In Situ Hybridization
Table 13-8: Selected In Situ Hybridization-based Tests
Table 13-9: Selected IHC Test Innovations
Pharmacodiagnostic Histology
Table 13-10: Major Pharmacodiagnostic Markers
Table 13-11: Selected Pharmacodiagnostic Histology Tests
Digital Imaging and Computational Pathology
Table 13-12: Selected Digital Imaging Innovations
Circulating Tumor Cells
Table 13-13: 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
2016-2017 Business Highlights
Alere Acquisition Update
Core Lab
Coagulation
Infectious Diseases - Molecular
Diabetes
iSTAT Business
Companion Testing
Liquid Biopsy
Zika
Alere Performance
Recent Revenue History
Innovation Milestones
Abbott Acquisition Update
Diabetes
HIV
Alere Reader
Coagulation
Molecular POC
Market Expansion
ARKRAY
Key Comment
Recent Revenue History
Molecular
Immunoassays
Urinalysis
Diabetes
BECKMAN COULTER, INC. / DANAHER
Key Comment
Hematology
Clinical Chemistry
Immunoassays
Coagulation
Microbiology
Lab Management
Molecular Tissue Analysis
Flow Cytometry
Urinalysis
A Fight for BNP Rights
BECTON, DICKINSON AND COMPANY (BD)
Key Comment
Recent Revenue History
Cytology
BD Max Molecular
ID/AST
Connectivity
POC Veritor
Mass Spectrometry
Blood Collection
Flow Cytometry
Licensing
BIOMÉRIEUX INC.
Key Comment
Recent Revenue History
Traditional Microbiology
Blood Culture
Immunoassays
Mass Spectrometry
Platelet Safety
Sequencing
Sample Preparation, Molecular
Data Analysis
BioFire Diagnostics Business
BIO-RAD LABORATORIES, INC.
Key Comment
Recent Revenue History
Company Highlights
Quality Control
Blood Bank
Infectious Diseases - Molecular
Immunoassays
Liquid Biopsy
Microbiome
Droplet Digital PCR
Sequencing
DANAHER CORPORATION
Key Comment
ecent Revenue History
DIASORIN S.P.A.
Key Comment
Recent Revenue History
Development Plan
Expansion
Immunoassays
Zika Testing
Molecular
GRIFOLS S.A.
Key Comment
Blood Transfusion Business
Blood Bank CLIA Lab
Coagulation
HOLOGIC, INC.
Key Comment
Recent Revenue History
Panther Molecular System
Panther Fusion
Blood Bank - Zika Virus
Collaboration
INSTRUMENTATION LABORATORY (IL) / WERFEN
Key Comment
Recent Revenue History
Expansion
Coagulation
Critical Care
Information Technology
ORTHO CLINICAL DIAGNOSTICS (ORTHO)
Key Comment
Recent Revenue History
Blood Bank
Core Lab / Immunoassays
Lab Automation
Connectivity
QIAGEN N.V.
Key Comment
Recent Revenue History
Molecular Test Business
Prenatal Teting
Tuberculosis
Cancer and Companion Diagnostics
Digital Sequencing
Bioinformatics
Liquid Biopsy
Microbiome
Cervical Cancer
Transplant Medicine
Forensic
Expansion
RADIOMETER A/S / DANAHER
Key Comment
Recent Revenue History
POC
Critical Care
Immunoassays
ROCHE DIAGNOSTICS
Key Comment
Recent Revenue History
Hematology
Immunoassays
Global Access Program for HIV
Molecular Expansion
Core Molecular
Diabetes
Coagulation
cobas Liat System - POC
HPV
Blood Bank
Transplant Medicine
Cancer Companion Testing
Prenatal
Liquid Biopsy
Information Technology
SIEMENS HEALTHINEERS
Key Comment
Recent Revenue History
Business Expansion
Expansion to Support Molecular Diagnostics – Fast Track Diagnostics
Core Lab
Lab Automation
Hematology
Coagulation
Immunoassays
Molecular
Zika Virus Testing
Acute Care – POC
POC Connectivity
SYSMEX CORPORATION
Key Comment
Recent Revenue History
Business Expansion
Hematology
Coagulation
Urinalysis
Forging New Markets
Companion Test Diagnostics
Exosomes
Sysmex Inostics
THERMO FISHER SCIENTIFIC INC.
Key Comment
Recent Revenue History
Immunoassays
Microbiology
Molecular Test Business
Next Generation Sequencing
Oncology Companion Diagnostics
Liquid Biopsy
Zika
Transplant Medicine
Quality Control IT
Point of Care
Mass Spectrometry
Forensic
Expansion
Research
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
Sequencing
CRISPR
Dako
BGI GENOMICS (FORMERLY BEIJING GENOME INSTITUTE)
Key Comment
Recent Revenue History
Prenatal Testing
Test Services
Liquid Biopsy
With Complete Genomics
Advancements
CEPHEID / DANAHER
Key Comment
Recent Revenue History
Tuberculosis
Microbiology
Respiratory Infections
GeneXpert Omni – POC molecular
POC TESTING
Cancer
EIKEN CHEMICAL CO., LTD
Key Comment
Recent Revenue History
FUJIFILM WAKO PURE CHEMICAL CORPORATION
Key Comment
Recent Revenue History
Products
FUJIREBIO DIAGNOSTICS, INC.
Key Comment
Recent Revenue History
Molecular
ILLUMINA
Key Comment
Recent Revenue History
Reported Highlights in 2016 and 2017
Sequencing
Advancing in the Clinical Market
Sequencing Data Analysis
Sample Preparation
Microarrays
Project Firefly
Liquid Biopsy
Forensic Medicine
Prenatal Testing Business
LABCORP, LABORATORY CORPORATION OF AMERICA
Key Comment
Recent Revenue History
LabCorp Buys Sequenom
Diagnostics Services
Prenatal
Retail Outlets
LUMINEX CORPORATION
Key Comment
Recent Revenue History
Assay Development
Verigene Business
Business Expansion
MERIDIAN BIOSCIENCE, INC.
Key Comment
Diagnostics Business Unit
Recent Revenue History
Immunoassays
Molecular Tests
Sample Collection
MINDRAY MEDICAL INTERNATIONAL LIMITED
Key Comment
Recent Revenue History
Core Lab
Hematology
Coagulation
PERKINELMER, INC. (PE)
Key Comment
Recent Revenue History
Diagnostics
Sequencing
Histology
Prenatal Business
Lab Services
Mass Spectrometry
PHILIPS (ROYAL PHILIPS)
Key Comment
Histology
Cancer Genomics
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
Neurology
Retail / Direct to Consumer
QUIDEL CORPORATION
Key Comment
Recent Revenue History
The Alere Triage Business
Immunoassays
Rapid Immunoassays
The Solana Business
Molecular – Savanna
RANDOX LABORATORIES LTD.
Key Comment
Recent Revenue History
Clinical Chemistries
Controls
Evidence Series - Multistat Biochip Analyzers
Molecular
VENTANA MEDICAL SYSTEMS INC. / ROCHE TISSUE DIAGNOSTICS
Key Comment
Recent Revenue History
Immunohistochemistry - IHC
Histology
Companion Diagnostics
Quality Control
DISCOVERY Product Line
SIXTEEN: COMPANY PROFILES: BLOOD BANK SPECIALISTS
BLOODSOURCE
CERUS CORPORATION
Recent Revenue History
HAEMOKINESIS PT
IMMUCOR
Recent Revenue History
Transfusion Medicine
Transplant Diagnostics
IMMUCOR DX Laboratory Service
MICROTYPING CONCEPTS
MICRONICS
QUOTIENT LIMITED
Recent Revenue History
Traditional Blood Grouping
MosaiQ Platform
RELIANCE LIFE SCIENCES
SEVENTEEN: COMPANY PROFILES: COAGULATION SPECIALISTS
DIAGNOSTICA STAGO, S.A.S.
Instrumentation
Test Kits
MICROVISK TECHNOLOGIES
DIAGON KFT. HUNGARY
EIGHTEEN: COMPANY PROFILES: CORE LAB AND OTHER COMPANIES
AB SCIEX PTE LTD.
EKF DIAGNOSTICS HOLDINGS PLC
EKF Diagnostics Holdings Recent Revenue History ($ millions, converted from GBP)
Lab-based Assays
Molecular
ELITECH GROUP S.A.S.
ERBA DIAGNOSTICS, INC.
MEDTEST DX
MICROSAIC SYSTEMS PLC
Microsaic Systems Recent Revenue History ($ millions, converted from GBP)
NOVA BIOMEDICAL
Diabetes
SCIENION AG
SEKISUI DIAGNOSTICS
SHIMADZU SCIENTIFIC INSTRUMENTS
SNIBE CO. LTD., (SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO. LTD.)
TECAN GROUP
Tecan Group Recent Revenue History ($ millions, converted from CHF)
TOSOH BIOSCIENCE
TRINITY BIOTECH PLC
Trinity Biotech Recent Revenue ($ millions)
NINETEEN: COMPANY PROFILES: CTC & LIQUID BIOPSY TEST PROVIDERS
ANGLE, PLC
BIOCARTIS
Recent Revenue History
Connectivity
DMAT Instrumentation - MyCartis
Idylla News
Infectious Diseases
Collaborations
BIOCEPT, INC.
BIODESIX
CYNVENIO BIOSYSTEMS
EPIC SCIENCES
EPIGENOMICS AG
FOUNDATION MEDICINE, INC.
Recent Revenue History
Collaborations
GENOMIC HEALTH
Recent Revenue History
Market Uptake
Liquid Biopsy
Service Spin-off
GUARDANT HEALTH, INC.
MENARINI-SILICON BIOSYSTEMS
MYRIAD GENETICS, INC.
NATERA
Recent Revenue History
Products
NEOGENOMICS
TWENTY: DIABETES SPECIALISTS
ANIMAS CORPORATION
ASCENSIA DIABETES CARE HOLDINGS AG
BIGFOOT BIOMEDICAL INC.
CELLNOVO GROUP SA
Recent Revenue History
DEBIOTECH SA
DEXCOM INC.
Recent Revenue History
GENTAG INC.
GLOOKO INC.
GLYSURE LIMITED
GLYTEC LLC
IHEALTH LABS INC.
INSULET CORPORATION
Recent Revenue History
INTEGRITY APPLICATIONS INC.
LIFESCAN INC.
MEDTRONIC PLC
Recent Revenue History
NEMAURA MEDICAL INC.
NIGHTSCOUT PROJECT
SANOFI
TRIVIDIA HEALTH INC.
VERILY LIFE SCIENCES LLC
TWENTY-ONE: COMPANY PROFILES: HEMATOLOGY (CELL ANALYSIS) SPECIALISTS
CELLAVISION AB
Recent Revenue History
HORIBA MEDICAL
Recent Revenue History
Chemistry
MEDICA CORPORATION
ONCA XT LTD
WEST MEDICA
TWENTY-TWO: COMPANY PROFILES: HISTOPATHOLOGY SPECIALISTS
ADVANCED CELL DIAGNOSTICS (ACD)
AMOY DIAGNOSTICS CO. LTD.
Amoy Diagnostics Recent Revenue History ($ millions, converted from CNY)
APPLIED SPECTRAL IMAGING INC. (ASI)
BIOGENEX LABORATORIES, INC.
BIOVIEW LTD.
Recent Revenue History ($ millions, converted from NIS)
CIRCULOMICS INC.
DAKO A/S
Special Stains
Immunohistochemistry (ICH)
Companion Diagnostics
Flow Cytometry
Automation
Alliances
DEFINIENS
HTG MOLECULAR DIAGNOSTICS
HTG Molecular Diagnostics Recent Revenue History ($ millions)
Strategic Partnerships
KAPA BIOSYSTEMS INC.
LEICA BIOSYSTEMS
Collaborations
MILLIPORESIGMA (FORMERLY EMD MILLIPORE)
OMNYX LLC
VISIOPHARM
TWENTY-THREE: COMPANY PROFILES: IMMUNOASSAY SPECIALISTS
BG MEDICINE, INC
Recent Revenue History
BINDING SITE GROUP LTD. (THE)
BIOHIT OYJ (BIOHIT HEALTHCARE)
Recent Revenue History
Market Expansion
BIOMERICA INC.
Recent Revenue History
BIO-TECHNE CORPORATION
Recent Revenue History
CORGENIX MEDICAL CORPORATION
CRITICAL DIAGNOSTIC
DIAXONHIT (EUROBIO SCIENTIFIC)
Recent Revenue History
EUROIMMUN AG
Recent Revenue History
HOB BIOTECH
IMMUNODIAGNOSTIC SYSTEMS (IDS)
Recent Revenue History
INOVA DIAGNOSTICS, INC.
INTEGRATED DIAGNOSTICS (NOW BIODESIX)
ONE LAMBDA
ORGENTEC DIAGNOSTIKA
PROTAGEN DIAGNOSTICS
RESPONSE BIOMEDICAL CORP.
Recent Revenue History
SINGULEX, INC.
THERADIG
Recent Revenue History
VOLITIONRX LIMITED
TWENTY-FOUR: INFORMATION TECHNOLOGY SPECIALISTS IN IN VITRO DIAGNOSTICS
ADVAITA CORP.
CERNER CORP.
DELL TECHNOLOGIES INC.
DESKTOP GENETICS LTD.
DNANEXUS INC.
EDICO GENOME
EUFORMATICS OY
GENALICE
GENOMONCOLOGY LLC
GOOGLE LLC
HUMAN LONGEVITY INC.
INTERNATION BUSINESS MACHINES CORP. (IBM)
INTEL CORPORATION
N-OF-ONE
PIERIANDX
RENNOVA HEALTH, INC.
SOPHIA GENETICS SA
SUNQUEST INFORMATION SYSTEMS INC.
WUXI NEXTCODE
TWENTY-FIVE: COMPANY PROFILES: MICROBIOLOGY SPECIALISTS
ACCELERATE DIAGNOSTICS, INC.
Recent Revenue History
Company Overview
ADVANCED BIOLOGICAL LABORATORIES, S.A. (ABL)
ADVANDX, INC.
ALTONA DIAGNOSTICS
Selected altona Diagnostics POCTs for the Diagnosis of Illnesses Covered by Emergency Use Authorizations (EUAs) Currently in Effect
ARCDIA INTERNATIONAL OY LTD.
BIOFIRE DIAGNOSTICS, LLC. (ACQUIRED BY BIOMÉRIEUX)
Recent Revenue History and Other Financial Information
Company Overview
BRUKER BIOSCIENCES CORPORATION
Recent Revenue History
Company Overview
Microbiology
Tissue Analysis
COPAN ITALIA S.P.A. AND COPAN DIAGNOSTICS, INC.
Lab Automation
Partnerships
Swabs
CURETIS
Recent Revenue History
Company Overview
FAST TRACK DIAGNOSTICS (ACQUIRED BY SIEMENS HEALTHINEERS)
FOCUS DIAGNOSTICS, INC.
GENETIC ANALYSIS AS
GENEWEAVE BIOSCIENCES, INC.
About Smarticle Technology
GREINER BIO-ONE INTERNATIONAL GMBH
Preanalytical Products
HAIN LIFESCIENCE GMBH
MAST GROUP
MOBIDIAG LTD.
NANOSPHERE, INC. (LUMINEX)
Recent Revenue History
Company Overview
POSITIVEID CORPORATION
Recent Revenue History
Company Overview
Q-LINEA AB
SEEGENE, INC.
Recent Revenue History
Company Overview
Collaborations
Molecular Diagnostic Systems
Assay Panels
Instrumentation
SPECIFIC TECHNOLOGIES
Company Overview
Developments
SYNBIOSIS LTD.
T2 BIOSYSTEMS
Recent Revenue History
Company Overview
Financing
Collaborations
Assays
VIROCYT, LLC
TWENTY-SIX: COMPANY PROFILES: MOLECULAR TEST SPECIALISTS
ASURAGEN INC.
Controls
Sample Collection
Sequencing
AUTOGENOMICS INC.
ENZO BIOCHEM INC.
Recent Revenue History
IP Situation
EXOSOME DIAGNOSTICS, INC.
FLUIDIGM CORPORATION
Recent Revenue History
GENMARK DIAGNOSTICS, INC
Recent Revenue History
GENOME DIAGNOSTICS BV (GENDX)
NANOSTRING TECHNOLOGIES, INC.
Recent Revenue History
Immunohistochemistry
Alliances
LDTs
OXFORD NANOPORE TECHNOLOGIES LTD
PACIFIC BIOSCIENCES OF CALIFORNIA, INC. (PACBIO)
Recent Revenue History
QUANDX INC
RAINDANCE TECHNOLOGIES, INC.
Recent Revenue History
RUBICON GENOMICS, INC.
TAKARA BIO INC.
TROVAGENE, INC.
Recent Revenue History
VELA DIAGNOSTICS
WAFERGEN BIO-SYSTEMS, INC.
TWENTY-SEVEN: COMPANY PROFILES: POINT OF CARE TEST SPECIALISTS
ABAXIS, INC.
Recent Revenue History
ABINGDON HEALTH LTD.
ATLAS GENETICS LTD.
BIOMEME, INC.
CHEMBIO DIAGNOSTIC SYSTEMS, INC.
Recent Revenue History
DNA ELECTRONICS LTD (DNAE)
ENTOPSIS
FABPULOUS B.V.
FIO CORPORATION
GENEDRIVE PLC (FORMERLY EPISTEM HOLDINGS)
Recent Revenue History
HEMA DIAGNOSTIC SYSTEMS (HDS; DBA NUGENEREX DIAGNOSTICS)
IMEC
INSILIXA INC.
LOOP MEDICAL (FORMERLY QLOUDLAB SA)
MEDMIRA, INC.
Recent Revenue History
ORASURE TECHNOLOGIES, INC.
Recent Revenue History
The Genotek Business
PTS DIAGNOSTICS
QUANTUMDX GROUP, LTD.
RHEONIX, INC.
SAMSUNG HEALTHCARE
VEREDUS LABORATORIES PTE LTD
TWENTY-EIGHT: COMPANY PROFILES: PRENATAL TEST SERVICE PROVIDERS
AFFYMETRIX, INC.
Company Overview
Products
BERRY GENOMICS CO. LTD.
Company Overview
Products
COMBIMATRIX (INVITAE)
Company Overview
Products
COOPERGENOMICS (DIVISION OF COOPERSURGICAL)
Company Overview
Products
COUNSYL
Company Overview
Products
GENEPEEKS, INC.
Company Overview
Products
GENETADI BIOTECH S.L.
Company Overview
Products
GENOMA GROUP
Company Overview
Products
INNOVATIONS EXCHANGE PTE LTD (INEX) AND IGENE DIAGNOSTICS PTE LTD
Company Overview
Products
LIFECODEXX AG
Company Overview
Products
OXFORD GENE TECHNOLOGY
Company Overview
Products
PREMAITHA HEALTH
Company Overview
Products
Company Financials
RAVGEN
Company Overview
Products
REPRODUCTIVE GENETICS INNOVATIONS
Company Overview
Products
SEQUENOM, INC.
Company Overview
Products
TWENTY-NINE: COMPANY PROFILES: QUALITY CONTROL & SAMPLE PRETREATMENT SPECIALISTS
10X GENOMICS
AGENA BIOSCIENCE, INC.
Market Expansion
BIOTYPE DIAGNOSTIC GMBH
Sampletype i-sep System
Partnership with Qiagen
DXTERITY DIAGNOSTICS INC.
HORIZON DISCOVERY GROUP PLC
Recent Revenue History
Company Overview
Acquisition of Dharmacon
Collaborations
Gene Editing
INCELLDX
OASIS DIAGNOSTICS CORPORATION
PRECIPIO, INC. (FORMERLY TRANSGENOMIC)
PREANALYTIX GMBH
QUANTERIX CORPORATION
Recent Revenue History
Company Overview
SERACARE LIFE SCIENCES, INC.
Selected Products
Collaborations, etc.
STRECK INC.
Selected Products
Distribution Deals
THIRTY: TEST SERVICE PROVIDERS
23ANDME
The Move to Building a Research Company
Therapeutics Group
Ancestry
Outside the U.S.
AGENDIA BV
Agendia Recent Revenue History (estimated, $ millions)
AMBRY GENETICS
Ambry Genetics Recent Revenue History ($ millions)
Epilepsy
Oncology
Cardiac
Prenatal
Information Technology
ARUP LABORATORIES
ASSUREX HEALTH
THE BIOCOLLECTIVE
BIOREFERENCE LABORATORIES
BIOTHERANOSTICS
BLUEPRINT GENETICS OY
BOSTON HEART DIAGNOSTICS
CAREDX, INC.
CareDx Recent Revenue History ($ millions)
Sequencing
CLEVELAND HEARTLAB INC.
EUROFINS GENOMICS
EXACT SCIENCES CORP.
Exact Sciences Recent Revenue History ($ millions)
GENOMIC VISION
Genomic Vision Recent Revenue History ($ millions, converted from euros)
HELOMICS CORPORATION
MAYO MEDICAL LABORATORIES
Information Technology
Reference Laboratory Services
MDXHEALTH SA
MDxHealth Recent Revenue History ($ millions)
OPKO DIAGNOSTICS
OPKO Diagnostics Recent Revenue History ($ millions)
PATHWAY GENOMICS CORPORATION
SONIC HEALTHCARE
Sonic Healthcare Recent Revenue History (estimated clinical lab revenue, by region, $ millions)
VERACYTE, INC.
Veracyte Recent Revenue History ($ millions)
VERMILLION INC.
Vermillion Recent Revenue History ($ millions)