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The Worldwide Market for In Vitro Diagnostic Tests: 12th Edition

The Worldwide Market for In Vitro Diagnostic Tests: 12th Edition

What is the Size of the 2019 IVD Market?

How fast will the market grow?

What companies stand to gain?

Kalorama has answered these questions for readers for two decades. Now in its 12th edition, this Kalorama Information report, The Worldwide Market for In Vitro Diagnostic (IVD) Tests, is the most essential report on the IVD industry.

The market for IVD currently stands at $69.2 billion dollars. It is poised for growth over the next five years, improved growth from the last edition of Kalorama’s report. There are hundreds of companies competing in the market in some form, and scores of large multi-test players.

Kalorama’s 2,000-page report provides in vitro diagnostics market size estimates and projections for the entirety of the in vitro diagnostics testing market. It is a global report, a comprehensive report and a reliable report that has been industry standard for two decades.

  • 2000-Page Report Based on Vendor Reporting, Interviews, Vendor Activities
  • Authored by Veteran IVD Analysts with Industry Knowledge
  • 12 Detailed Market Chapters with 2019 Market Estimate
  • Relevant Segmentation for Test Business Planners, Investors, New Entrants and Other Market Watchers
  • Where is IVD Heading? – Market Segment Projections to 2024
  • What’s Behind the Growth and Declines? – Market Numbers and Analysis
  • Regional Breakouts Including Country IVD Markets
  • Sections on China, Europe, Japan and The United States IVD Markets
  • Macro Analysis of Major Trends
  • Superior Company Profiles of Top Tier Companies and Hundreds of Smaller Concerns
  • Used by Major IVD Firms for Business Planning
  • Coverage of Trends and Market Estimates for Essential IVD Segments: Clinical Chemistry, Point-of-Care, Molecular, Infectious Disease, Histology and More.
In vitro diagnostic testing costs little to the healthcare system and contributes much to clinical practice. For some time this has been stated as educated conjecture; a recent study of U.S and German physicians offers proof. The study found that 66% of clinical decisions made were based on a diagnostic test, while the costs of those tests were just 2.3% of healthcare expenditure (Rohr U., Binder C, PLoS One. 2016). When the cost-effectiveness of in vitro diagnostic testing is then considered along with beneficial effects on treatment outcomes, therapy choices, and hospital management, there should be little surprise about the amount of interest in IVDs and the amount of activity in the market for them.

The Worldwide Market for In Vitro Diagnostic (IVD) Tests estimates the current in vitro diagnostics market size and forecasted market size to 2024 for defined segments of the IVD market and various sub-segments, including:
  • Molecular Assays: Infectious Disease [HIV, Hepatitis, Respiratory, Others] Blood Screening, Inherited Diseases, Oncology, PGx, Tissue Typing, Prenatal
  • Clinical Chemistry and “Core Lab” Markets: General Chemistries, Blood Gases, Urinalysis, Immunos run on Workstations
  • Point-of-Care Testing (POC): Professional and Self-Testing, Fertility, Colon Cancer, HbA1c POC, Influenza, HIV, STD, Hepatitis, Malaria, c.difficile, E.Coli, H.pylori, Home Test/OT
  • Glucose Testing: Meters, Professional Testing, Continuous Glucose
  • Substance Abuse Testing (Employment Screening, Criminal Justice, Critical Care – Traditional POC)
  • 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 (Typing, Immunoassay Screen, NAT Blood Testing)
  • Histology and Cytology: Pap Tests, in situ hybridization, immunohistochemistry, traditional non-Pap stains, HPV
  • Immunoassay Testing: Infectious Disease, Cardiac Markers, Tumor Markers, Autoimmune, Diabetes/HbA1c, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Drugs of Abuse, Vitamin D, Total; w/o HbA1c
  • Hematology
  • Cardiac Markers, Tumor Markers, Diabetes/hbA1c, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs
  • Coagulation Tests
  • Direct-to-Consumer Testing
For each of the listed in vitro diagnostics market segments, 2019 in vitro diagnostics market size, 2024 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, 12th 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.

The IVD Market Opportunity by Country

The in vitro diagnostics market is a global one, and The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 12th 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.

IVD Market Opportunity by Country is provided for the following countries: 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.

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 2019.

Who’s In The Market? Who’s Winning?

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.
  • Abbott Diagnostics
  • Arkray
  • Becton, Dickinson and Company (BD)
  • Beckman Coulter, Inc. / Danaher
  • bioMérieux Inc.
  • Bio-Rad Laboratories, Inc.
  • Danaher Corporation
  • DiaSorin S.p.A
  • Grifols S.A.
  • Hologic, Inc.
  • Instrumentation Laboratory (IL) / Werfen
  • Ortho Clinical Diagnostics (Ortho)
  • QIAGEN N.V.
  • Radiometer A/S / Danaher
  • Roche Diagnostics
  • Siemens Healthineers (Siemens)
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.
  • Werfen
  • Agilent Technologies
  • BGI Genomics (formerly Beijing Genome Institute)
  • Bruker Corporation
  • Cepheid
  • Eiken Chemical Co., Ltd
  • Fujirebio Diagnostics, Inc.
  • Illumina
  • LabCorp, Laboratory Corporation of America
  • Leica Biosystems
  • Luminex Corporation
  • A. Menarini Diagnostics
  • Meridian Bioscience, Inc.
  • Mindray – Shenzhen Mindray Bio-medical Electronics Co., Ltd.
  • Nova Biomedical Corporation (Nova)
  • PerkinElmer, Inc. (PE)
  • Philips (Royal Philips)
  • Quest Diagnostics
  • Quidel Corporation
  • Randox Laboratories Ltd.
  • Ventana Medical Systems Inc. / Roche Tissue Diagnostics
  • Diagnostica Stago, S.A.S.
  • 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
  • Biocartis
  • Biocept, Inc.
  • Biodesix
  • Cynvenio Biosystems (LungLife AI)
  • Epigenomics AG
  • Foundation Medicine, Inc.
  • Genomic Health (Exact Sciences)
  • Guardant Health, Inc.
  • Menarini-Silicon Biosystems
  • Myriad Genetics, Inc.
  • Natera
  • NeoGenomics
  • Dexcom Inc.
  • Gentag Inc.
  • LifeScan Inc.
  • Medtronic plc
  • Nemaura Medical Inc.
  • 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)
  • 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.
  • Cerner Corp.
  • Dell Technologies Inc.
  • Desktop Genetics Ltd.
  • 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
  • Greiner Bio-One International GmbH
  • Hain Lifescience GmbH
  • Mast Group
  • Mobidiag Ltd.
  • Nanosphere, Inc. (Luminex)
  • OpGen, Inc.
  • PositiveID Corporation
  • Q-linea AB
  • Seegene, Inc.
  • 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.
  • Trovagene, Inc.
  • Vela Diagnostics
  • WaferGen Bio-systems, Inc.
  • 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)
  • PTS Diagnostics
  • QuantuMDx Group, Ltd.
  • Rheonix, Inc.
  • Samsung Healthcare
  • Veredus Laboratories Pte Ltd
  • and others …


ONE: EXECUTIVE SUMMARY
Figure 1-1: The Worldwide IVD Market, 2019-2024 ($millions)
SCOPE AND METHODOLOGY
Table 1-1: Exchange Rate Fluctuations, 2014–2018
FINDING WHAT YOU ARE LOOKING FOR IN THE 12TH EDITION
Table 1-2: Finding What You Are Looking For in the 12th Edition
SIZE AND GROWTH OF THE MARKET
Table 1-3: Global In Vitro Diagnostic Sales by Product Market, 2019-2024 ($ million)
Figure 1-2: Regional Distribution of IVD Market, 2019
IVD MARKET HIGHLIGHTS
COMPETITIVE PICTURE IN IVD
WHAT TO WATCH
China and Top Emerging Nations Markets
Next-Generation Sequencing and IVD
Direct-to-Consumer
Gene Editing
Liquid Biopsy
Information Technology and AI
New Venues – Urgent & Retail Care, “Microhospitals”
TWO: INTRODUCTION
IVD LANDSCAPE
REPORT DESIGN
THE CHALLENGE OF PAMA
MARKET ANALYSIS OF IVD MARKET SEGMENTS
Table 2-1: Global In Vitro Diagnostic Sales by Product Market, 2019-2024 ($ million) (Clinical Chemistry;
Immunoassays- non isotopic: Infectious disease, Other immunos, Blood bank screening, Drugs of Abuse,
Diabetes HbA1c - lab; Hematology - Core Lab; Microbiology (ID/AST); Microbiology (molecular);
Microbiology - Mass Spectrometry; Radioimmunoassays; Coagulation (PT/INR); Coagulation, molecular;
Histology/cytology; HPV, molecular; Nucleic acid assays; Blood grouping/typing; Blood bank molecular -
NAT Screens; Circulating tumor cells; POC, OTC diabetes; POC, OTC other; POC, professional/hospital; Mass
Spectrometry)
TOP SUPPLIERS AND NICHE PLAYERS
Introduction
Overview of the Top Tier Companies
Table 2-2: Revenues of Selected Top IVD Companies, 2014-2018 ($ million, estimated)
Overview of Selected Second Tier Companies
Table 2-3: Revenues of Selected Niche Players, 2014-2018 ($ million, estimated)
IVD COMPANIES MERGERS & ACQUISITIONS
Table 2-4: Selected IVD Mergers and Acquisitions late 2018 to mid-2019
MARKET EXPANSION INITIATIVES
Table 2-5: Selected Market Expansion Initiatives, 2018 & H1 2019
DISTRIBUTION AGREEMENTS
Table 2-6: Selected Diagnostics Industry Distribution Agreements, 2016, 2017, 2018, 2019
LICENSES AND COLLABORATION AGREEMENTS
Table 2-7: Selected IVD Partnerships/Collaborations/Licensing Agreements, 2016, 2017, 2018, 2019
TEST SERVICES
Table 2-8: Selected Test Services, Sales 2013-2018 ($ millions, estimated where applicable)
Table 2-9: Global Lab Market Segmentation, 2018 ($ billions) (Hospital Labs, Independent Labs, Physician
Office Labs)
Table 2-10: Revenues for a Selection of U.S.-based Reference Labs, 2013-2018 ($ million, estimated)
HISTORICAL IVD MARKET VS TODAY
In the Beginning to Now
Figure 2-1: Share of IVD Market by Segment, Percentage, 2000 and 2019 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
GLOBAL POPULATION AND AGING
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)
Addressing the Aging Trend
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, Colombia, Ukraine, Egypt, Malaysia)
Emerging Nations and Health Insurance
SIZE AND FORECAST FOR THE GLOBAL IVD MARKET
Table 3-5: Global In Vitro Diagnostic Market; Major Country/Region Markets, 2019 and 2024 ($ millions)
(United States, EU 15/W. Europe, Japan, China, Canada, India, Eastern Europe, Brazil, Colombia, Mexico,
Saudi Arabia, Turkey, UAE, Malaysia, Russia, South Africa, South Korea, Australia, ROW)
Regional Reporting Differences with the 11th Edition
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) . 124
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)
Europe Industry Actions
Table 3-7: Western European IVD Market by Country, 2019 ($ millions, estimated) (Austria, Belgium,
Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Portugal, Spain, Sweden,
Switzerland/Norway, UK)
EU Regulation
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
EASTERN EUROPE: GROWTH REGION
Figure 3-2: 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 3-3: Eastern Europe IVD Market by Country - Segment Distribution, 2019 ($ millions) (Bulgaria,
Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, Ukraine)
JAPAN: RETURN TO GROWTH
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: CURRENT IVD 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 3-4: 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: POPULATION AND OPPORTUNITY
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
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
Colombia IVD Market
United Arab Emirates (UAE) IVD Market
South Korea IVD Market
Other Markets to Watch
IVD MARKET OPPORTUNITY BY COUNTRY
Table 3-17: IVD Market Opportunity by Country (2019 Market Rank, 2018 Market Rank, Country CAGR
2019-2024) (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
Quality Assurance
Product News
Market Cleared Products
For Research Use Only
Products in Development
Liquid Biopsy in Microbiology
The Future for Liquid Biopsy
INFORMATION TECHNOLOGY ADVANCES AND ARTIFICIAL INTELLIGENCE
AI in Clinical Practice
Table 4-6: Selected AI Market Cleared Tests
The Regulatory Pathway
Product Initiatives
Table 4-7: Selected AI Product Initiatives in Development and Collaborations
IBM Watson Health
AI in Liquid Biopsy
Table 4-8: Selected AI/Liquid Biopsy Initiatives
Future Trends
EXOSOME SEQUENCING
Table 4-9: Selected Exosome Test Innovations
BIOTIN INTERFERENCE IN IMMUNOASSAY DETECTION ERRORS
Table 4-10: Biotin-free Offerings Currently on the Market
TRAUMATIC BRAIN INJURY AND IVD
BLOCKCHAIN
SUBSTANCE ABUSE
Opioid Epidemic
Biomarkers and Substance Abuse
Clinical Laboratory Testing for Drugs of Abuse
Table 4-11: Global Drug Abuse Statistics
Urine
Blood
Oral
Hair
Table 4-12: Selected Opioid FDA Approvals, 2015-2019
MICRO-HOSPITAL OPPORTUNITIES
CLIMATE CHANGE AND INFECTIOUS DISEASE
KICKBACK SCHEMES
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 ($million) (Glucose, Critical Care
POC, Fertility, Infectious Diseases, Cardiac Markers, Cholesterol, Coagulation, HbA1c POC, Hematology,
Fecal Occult Blood, Drugs of Abuse, Others)
Table 5-2: Selected Profession POC Test Innovations
OTC SELF TESTING
Table 5-3: POC Self-Test Sales by Category, Worldwide, 2019-2024 ($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) 289
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, 2019-2024 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, 2019-2024 (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, 2019-2024 ($ 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, 2019-2024 (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, 2019-2024 ($millions) (General Chemistries,
Blood Gases, Urinalysis)
Table 6-5: Global Clinical Chemistry Sales Distribution by Region, 2019 (North America, Europe, Asia Pacific,RoW)
Table 6-6: Major Clinical Chemistry Companies
Table 6-7: Selected Clinical Chemistry Innovations
Rapid Response Systems
Table 6-8: Major Whole Blood Chemistry Analyzers
Critical Care Analysis
Table 6-9: Blood Gas, Electrolyte and Critical Care Instrument Market by End User, 2019 and 2024 (Labbased,
POC-based)
Table 6-10: Blood Gas, Electrolyte, and Critical Care Market Leaders, 2019 (percent distribution of totalsales)
User Apps
Table 6-11: Selected Apps, Critical Care and Urinalysis IT Innovations
Urinalysis
Table 6-12: UA Market by End User, 2019 and 2024 (Lab-based, POC-based)
Table 6-13: Urinalysis Systems Market Leaders, 2019 (percent distribution of total sales)
Table 6-14: Selected Urinalysis Innovations
SLEEP APNEA TESTING: CORE LAB SOLUTION?
THE COMMERCIAL OUTLOOK FOR CHEMISTRY TESTS
SEVEN: IMMUNOASSAYS
OVERVIEW AND TRENDS
Immunoassay Technology Continues to Evolve
Table 7-1: Selected Immunoassay Technologies 2019
Mass Spectrometry
Table 7-2: Selected Innovation in Mass Spectrometry for Routine Analyses
Immunoassays in the Core Lab
Figure 7-1: Workstation (General Chemistries, Immunos on Workstations) Sales Growth, CAGR 2019-2024
Table 7-3: Selected Immunoassay Innovations on Core Lab Instruments
Radioimmunoassays
MARKET ANALYSIS
Leading Suppliers and Growth Potential
Table 7-4 Global Lab-based Immunoassay (excluding infectious disease and blood screening) Sales, by
Analyte Type, 2019-2024 ($millions) (Cardiac Markers, Tumor Markers, Autoimmune, Diabetes/HbA1c,
Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Drugs of Abuse, Vitamin D, Total; w/oHbA1c)
Table 7-5: Global Immunoassay (excluding infectious disease and blood screening) Sales Distribution by
Region, 2019 (%) (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, 2019 (United States, Europe, Japan,RoW)
Table 7-19: Global POC Immunoassay Test Sales by Test Category, 2019-2024 (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 2019-2024 (in millions $) (Oncology, Transplant Testing,
Thrombophilia SNPs, Pharmacodiagnostics, Inherited Diseases)
Oncology
Table 8-11: Global Molecular Cancer Test Sales Distribution by Region, 2019 (North America, Europe, Asia
Pacific, RoW)
Pharmacodiagnostics
Table 8-12: Global Pharmacodiagnostic Sales Distribution by Region, 2019 (North America, Europe, Asia
Pacific, RoW)
Table 8-13: Selected Molecular Tumor Marker Test Innovations
Inherited Diseases and Thrombophilia SNPs
Table 8-14: Most Frequently Requested Genetic Tests
Table 8-15: Global Molecular Thrombophilia Assay Sales Distribution by Region, 2019 (North America,
Europe, Asia Pacific, RoW)
Table 8-16: Selected Genomic Tests for Inherited Diseases
Psychiatric Disorders
Prenatal and Newborn Testing
Table 8-17: Global Prenatal Test Sales Distribution by Region, 2019 (North America, Europe, Asia Pacific,
RoW)
Table 8-18: Prenatal Services Provided
Table 8-19: Selected Molecular Tests for Prenatal Analysis
Tissue Typing
Table 8-20: Global Molecular HLA Testing Sales Distribution by Region, 2019 (North America, Europe, Asia
Pacific, RoW)
Table 8-21: Selected HLA Typing Test Innovations
THE COMMERCIAL OUTLOOK FOR MOLECULAR TESTS
NINE: HEMATOLOGY
OVERVIEW OF HEMATOLOGY AND TRENDS
Digital Image Analysis
Table 9-1: CellaVision Market Share Data by Hematology Vendor 2019
Table 9-2: Selected Hematology Image Analysis Innovations, 2014-2019
Digital Evolution
Quality Control Measurement Programs
LABORATORY-BASED HEMATOLOGY TESTING
Table 9-3: Selected Hematology Innovations, 2014-2019
Table 9-4: Global Laboratory-based Hematology Test and Instrument Market, 2019 and 2024 ($ millions)
Regional Laboratory-based Hematology Test and Instrument Market
Table 9-5: Global Laboratory-based Hematology Test and Instrument Market, by Region, 2019 (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, 2019 (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, 2019 (North America, Europe, Asia Pacific, RoW)
MARKET ANALYSIS
Table 10-2: Global Coagulation Sales by Segment, 2019-2024 ($millions) (PT/INR Labs, Molecular,
Professional POC, Professional Self; D-dimer)
Table 10-3: Global Coagulation Test and Instrument Market by Region, 2019 (North America, Europe, Asia
Pacific, RoW)
LAB-BASED TESTING
Table 10-4: Selected Lab-based Coagulation Innovations
Genetic Markers of Hypercoagulopathies
Table 10-5: Global Molecular - Thrombophilia SNP Sales Distribution by Region, 2019 (North America,
Europe, Asia Pacific, RoW)
Table 10-6: Selected Molecular Coagulation Test Innovations
LEADING SUPPLIERS: LABORATORY SYSTEMS
Table 10-7: Top Coagulation Company Revenues, Laboratory-based - 2019 ($ 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
IMPORTANT STATISTICS
Table 11-1: The Top Ten Leading Causes of Death
THE REAL IMPACT OF INFECTIONS
Herpes and Alzheimer’s Disease
Ebola and Cancer
HIV and Cancer
H pylori and Cancer
Bacteria and Parkinson's
MICROBIAL ANTIBIOTIC RESISTANCE – THE ROLE OF CLINICAL TESTS
“Faster Identification: Where Are We?”
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
NEW INFECTIOUS DISEASE THREATS
Table 11-6: Selected Companies Marketing Products Addressing Emerging Infectious Disease Threats
Tickborne Diseases (TBDs)
Zika
Chagas
Dengue
Ebola
Chikungunya
Next Threats?
MICROBIOLOGY FIRMS ACQUISITIONS AND COLLABORATIONS
MARKET ANALYSIS
Table 11-7: Global Microbiology Sales Distribution by Region, 2019 (North America, Europe, Asia Pacific,
RoW)
MARKET ANALYSIS - TRADITIONAL MICROBIOLOGY ID/AST
Table 11-8: Global Microbiology ID/AST Market, 2019-2024 (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, 2019 (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, 2019 (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, 2019 (%) (North America, Europe,Asia Pacific, RoW)
Table 11-18: Global Molecular Microbiology Market, by Pathogen/Disease Indication, 2019-2024 (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) .. 790
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, 2019-2024 (Typing) (in $ millions)
Blood Typing Market by Geography
Table 12-10: Global Blood Typing Sales Distribution by Region, 2019 (%) (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, 2019-2024 (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, 2019 (%) (North America, Europe, Asia Pacific,RoW)
Table 13-5: Selected HPV Test Innovations
MARKET ANALYSIS
Table 13-6: Global Histology/Cytology Sales by Type, 2019-2024 ($ millions) (Pap Tests, in situhybridization, immunohistochemistry, traditional non-Pap stains, HPV, TOTAL; Digital Imaging, CTCs, FlowCytometry)
Histology/Cytology
Table 13-7: Global Histology/Cytology Sales Distribution by Region, 2019 (%) (North America, Europe, AsiaPacific, 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
A Fight for Brain Natriuretic Peptide (BNP) Assay Rights
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
For 2018 vs 2017, Danaher Reported
Acquisitions
DIASORIN S.P.A
Key Comment
Recent Revenue History
Development Plan
Expansion
Immunoassays
Zika Testing
Molecular
Molecular Oncology
GRIFOLS S.A.
Key Comment
Recent Revenue History
Blood Transfusion Business
ABO Blood Typing
Molecular ABO Blood Typing
Immunoassays
Coagulation
Market Expansion
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
2018 Product Highlights
Expansion
Coagulation
Acute Care
Information Technology
ORTHO CLINICAL DIAGNOSTICS (ORTHO)
Key Comment
Recent Revenue History
Blood Bank
Core Lab / Immunoassays
Lab Automation
Connectivity
Expansion
QIAGEN N.V.
Key Comment
Recent Revenue History
Tuberculosis
Molecular Expansion
Precision Medicine / Companion Diagnostics
Molecular Microbiology
Prenatal Testing
Next Generation Sequencing
Sample Prep, Informatics
Digital PCR
Bioinformatics
Liquid Biopsy
Microbiome
Cervical Cancer
Transplant Medicine
Forensic
Expansion
RADIOMETER A/S / DANAHER
Key Comment
Recent Revenue History
Critical Care
Immunoassays
HemoCue
Transcutaneous Monitoring
ROCHE DIAGNOSTICS
Key Comment
Recent Revenue History
For 2018 Compared to 2017
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
Cancer Companion Testing
Prenatal
Liquid Biopsy
IT in Anatomical Pathology
Information Technology
NimbleGen Business
Consulting Program
SIEMENS HEALTHINEERS (SIEMENS)
Key Comment
Recent Revenue History
Core Lab
Lab Automation
Immunoassays
Hematology
Urinalysis
Molecular
Expansion to Support Molecular Diagnostics – Fast Track Diagnostics
Sequencing with Artificial Intelligence
Zika Virus Testing
Acute Care – POC
POC Connectivity
Business Expansion
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
Collaborations
China
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
India
Tuberculosis
Microbiology
POC Testing
Cancer
EIKEN CHEMICAL CO., LTD
Key Comment
Recent Revenue History
Road Map Initiatives
Product News
FUJIREBIO DIAGNOSTICS, INC.
Key Comment
Recent Revenue History
Molecular
ILLUMINA
Key Comment
Recent Revenue History
Company Reported Highlights in 2018
Reported Highlights in 2016, 2017
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 (ROYAL 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
Quidel Reported for 2018 . . .
The Alere Triage Business
Immunoassays
Rapid Immunoassays
The Solana Business
Molecular – Savanna
RANDOX LABORATORIES LTD.
Key Comment
Clinical Chemistries
Controls
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
SIXTEEN: COMPANY PROFILES: BLOOD BANK SPECIALISTS
BLOODSOURCE (VITALANT)
CERUS CORPORATION
HAEMOKINESIS PTY LTD
IMMUCOR
MICROTYPING CONCEPTS
QUOTIENT LIMITED
RELIANCE LIFE SCIENCES
SEVENTEEN: COMPANY PROFILES: COAGULATION SPECIALISTS
DIAGNOSTICA STAGO, S.A.S.
MICROVISK TECHNOLOGIES
DIAGON KFT. HUNGARY
EIGHTEEN: COMPANY PROFILES: CORE LAB AND OTHER COMPANIES
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
NINETEEN: COMPANY PROFILES: CTC & LIQUID BIOPSY TEST PROVIDERS
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
TWENTY: DIABETES SPECIALISTS
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
IHEALTH LABS INC.
INSULET CORPORATION
INTEGRITY APPLICATIONS INC.
LIFESCAN INC.
MEDTRONIC PLC
NEMAURA MEDICAL INC.
NIGHTSCOUT PROJECT
SANOFI
TRIVIDIA HEALTH INC.
VERILY LIFE SCIENCES LLC
TWENTY-ONE: COMPANY PROFILES: HEMATOLOGY (CELL ANALYSIS) SPECIALISTS
CELLAVISION AB
HORIBA MEDICAL
MEDICA CORPORATION
ONCA XT LTD
WEST MEDICA
TWENTY-TWO: COMPANY PROFILES: HISTOPATHOLOGY SPECIALISTS
ADVANCED CELL DIAGNOSTICS (ACD)
AMOY DIAGNOSTICS CO. LTD.
APPLIED SPECTRAL IMAGING INC. (ASI)
BIOGENEX LABORATORIES, INC.
BIOVIEW LTD.
CIRCULOMICS INC.
DAKO A/S
DEFINIENS
HTG MOLECULAR DIAGNOSTICS
KAPA BIOSYSTEMS INC.
LEICA BIOSYSTEMS
MILLIPORESIGMA (FORMERLY EMD MILLIPORE)
OMNYX LLC
VISIOPHARM
TWENTY-THREE: COMPANY PROFILES: IMMUNOASSAY SPECIALISTS
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
TWENTY-FOUR: INFORMATION TECHNOLOGY SPECIALISTS IN IN VITRO DIAGNOSTICS
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
TWENTY-FIVE: COMPANY PROFILES: MICROBIOLOGY SPECIALISTS
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.
Recent Revenue History
SPECIFIC TECHNOLOGIES
SYNBIOSIS LTD.
T2 BIOSYSTEMS
TWENTY-SIX: COMPANY PROFILES: MOLECULAR TEST SPECIALISTS
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.
TROVAGENE, INC.
VELA DIAGNOSTICS
WAFERGEN BIO-SYSTEMS, INC.
TWENTY-SEVEN: 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.

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