The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 11th Edition

Best Price Guarantee	Length	Publisher	Published Date	SKU
from $7,500	1812 Pages	Kalorama Information	August, 2018	KLI15715010

Attention: There is an updated edition available for this report.

Best Price Guarantee
Price	from $7,500
Length	1812 Pages
Publisher	Kalorama Information
Published Date	August, 2018
SKU	KLI15715010

This Kalorama Information report, The Worldwide Market for In Vitro Diagnostic Tests, represents the 11th edition of this comprehensive look at the IVD industry. At 1,800 pages report provides market size estimates and projections for the entirety of the clinical diagnostics testing market. It also profiles hundreds of competitors, notes significant acquisitions and other deals, discusses trends and breaks out regional and country markets. The report provides market size and forecasts to 2023 for defined segments of the IVD market and various sub-segments. The 1,800-page report provides in vitro diagnostics market size estimates and projections for the entirety of the in vitro diagnostics testing market.

Current 2018 IVD Market Estimates For Essential Segments

The Worldwide Market for In Vitro Diagnostic (IVD) Tests estimates the current in vitro diagnostics market size and forecasted market size to 2023 for defined segments of the IVD market and various sub-segments, including:

• Molecular Assays (Infectious Disease, Blood Screening, Inherited Diseases, Oncology, Pharmacodiagnostics, Tissue Typing, Prenatal)

• Clinical Chemistry and "Core Lab" Markets (including sub segment revenues for General Chemistries, Workstations, Analyzers Blood Gases, Urinalysis, Critical Care)

• Point-of-Care Testing (POC), (Professional and Self-Testing, Glucose Testing, Pregnancy Tests, drugs of abuse, HIV, H. pylori, Other, OTC/Self Total, Professional POC, Cardiac Markers, Drugs of Abuse, HbA1c, Pregnancy, Other)

• 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 (Grouping, Immunoassay Screens, NAT Screens)

• Tissue-Based Testing - Histology and Cytology (Pap, ISH, IHC, HPV)

• Infectious Disease Immunoassay Testing (Hepatitis, HIV, STDs, TORCH, Respiratory, Sepsis, Parasitology, Mycology, Others)

• Hematology

• Flow Cytometry

• Molecular Tests in Infectious Diseases (HAI, HIV, Hepatitis, GC/Chlamydia, Respiratory, Organism ID, Mycobacteria, TB, Others)

• Non-Infectious Disease Immunoassay Sales by Analyte Type (Cardiac markers, Tumor markers, Diabetes/HbA1c, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic drugs, Tox/Drugs of abuse, Vitamin D)

• Coagulation Tests (Lab-Based, POC, Genetic Markers)

• Mass Spectrometry

• Molecular Point-Of-Care

• Next Generation Sequencing

• Direct-to-Consumer Testing

The report also tracks hundreds of competitors, notes significant partnerships, distribution deals and acquisitions and defines the market share situation for the in vitro diagnostic market and competitive analysis for many segments.

The Future of IVD: Market Segment Projections to 2023

For each of the listed in vitro diagnostics market segments, 2018 in vitro diagnostics market size, 2023 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, 11th 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 Global Market Regional and Country IVD Markets

The in vitro diagnostics market is a global one, and The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 11th 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

• Europe

• Germany

• UK

• France

• Spain

• Italy

• Russia

• Netherlands

• Turkey

• Poland

• Canada

• China

• Japan

• Saudi Arabia

• Brazil

• 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 2018.

Superior In Vitro Diagnostic Company Profiles

Kalorama Information's report, The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 11th Edition contains hundreds of profiles of companies operating within the in vitro diagnostics industry. Top-tier IVD companies such as Roche Diagnostics, Abbott, Siemens, Beckman Coulter, bioMerieux, Qiagen and Ortho Clinical Diagnostics are discussed at great length and hundreds of smaller companies are detailed. Modest in vitro diagnostics technology growth in developed countries, stronger growth in developing countries with a simultaneous shift from a preoccupation with infectious diseases to chronic conditions, is expected. Also discussed within the report is increased privatization of healthcare services throughout the world, developed and emerging economies included and thus increased pricing pressure on all devices including in vitro diagnostics technology.

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.

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The report covers both the dominant companies in the in vitro diagnostics industry and the fast up-and-comers for a complete picture of the market. For each company, extensive, discussion of recent financial performance is provided. These IVD manufacturers' main products are detailed and any significant company strategies, partnerships and acquisitions are considered:

• Abbott Diagnostics

• Beckman Coulter, Inc. / Danaher

• Becton, Dickinson and Company (BD)

• bioMérieux Inc.

• Bio-Rad Laboratories

• Hologic

• Instrumentation Laboratory (IL)

• Ortho Clinical Diagnostics (OCD)

• QIAGEN N.V

• Roche Diagnostics

• Siemens Healthineers

• Sysmex Corporation

• Thermo FisherScientific

• Werfen Group S.A.

• ERBA Diagnostics, Inc

• DiaSorin S.p.A

• Illumina

• Luminex Corporation

• Menarini Diagnostics.

• Mindray Medical International Limited

• Myriad Genetics

• Perkin Elmer, Inc. (PE)

• Quidel Corporation

• Randox Laboratories Ltd

• Royal Philips

• TOSOH Corporation

• Trinity Biotech

• Wako Pure Chemical Industries

Executive Summary
- Table The Worldwide IVD Market, 2018 -2023 ($millions)
- Scope and Methodology
  - Table Exchange Rate Fluctuations, 2012–2016
- Size and Growth of the Market
  - Table Regional Distribution of IVD market, 2018
  - Table Worldwide In Vitro Diagnostic Reagent Sales by Market Segment, 2016-2021 ($ million)
- Competitive Picture in IVD
- IVD Market Highlights
- What to Watch in the Future
- Lab Medicine Disciplines and Applications
Introduction
- A Paradox of Sorts
- Report Design
- The Challenge of PAMA
- Market Analysis of IVD Market Segments
  - Table Worldwide In Vitro Diagnostic Sales by Product Market, 2018-2023 ($ million)
- Top Suppliers and Niche Players
  - Introduction
  - Overview of the Top Tier Companies
    - Table Revenues of Selected Top IVD Companies, 2013-2017 ($ million, estimated)
  - Overview of Selected Second Tier Companies
    - Table Revenues of Selected Niche Players, 2013-2017 ($ million)
- IVD Companies Mix and Match
  - Table Selected Diagnostics Industry Acquisitions, 2016, 2017, & 2018
- Market Expansion Initiatives
  - Table Selected Market Geographic or Product Expansion Initiatives
- Distribution Agreements
  - Table Selected Diagnostics Industry Distribution Agreements, H2 2016, 2017, 2018
- Licenses and Collaboration Agreements
  - Table Selected IVD Partnerships/Collaborations/Licensing Agreements, H2 2016, 2017, 2018
- Test Services
  - Table Selected Test Services, Sales 2012-2016 ($ millions, estimated where applicable)
  - Table Lab Market Segmentation, Worldwide, 2018 (estimated)
  - Table Revenues for a Selection of U.S.-based Reference Labs, 2012-2016 ($ million, estimated)
  - Table Selected Company-Sponsored Labs Established 2015-2017
- IVDs Then and Now – A 22 Year Perspective
  - In the Beginning to Now
    - Table Share of IVD Market by Segment, Percentage, 2000 and 2018 Compared
  - Future
- Point of View
The Global Picture for In Vitro Diagnostic Markets
- Background
  - Simultaneous Threats: Chronic and Acute
  - Expected World IVD Market Developments
- The Aging Planet
  - Table Elderly Support Ratio in Various Countries
  - Workforce Reduction
    - Table Age Under 15 and Over 65, by Continent
  - Is the World Prepared for Aging?
- Shifting Disease Burdens
  - Table Changing DALY ranking of Disease Threats (disability-adjusted life year) Worldwide
  - Increase in Chronic Diseases
- Emerging and Emerged Markets
  - Table Available Market Data, 2017
  - Emerging Nations and Health Insurance
- Size and Forecast for the World IVD Market
  - Table 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 United States IVD Market by Segment
- IVD Market in Europe: Limited Recovery
  - Table Europe: Growth in Healthcare Expenditure by Country, 2012-2017 vs. 2017-2022
  - Industry Punches Back
    - Table European IVD Market by Country, 2018 ($million)
  - European Directive 98/79/EC
  - Individual Country Markets
    - Table IVD Market Per Capita, Europe
  - Personalized Medicine in Europe
  - Brexit
  - Austerity
- Opportunity in Eastern Europe
  - Table Growth in Healthcare Expenditure in Eastern Europe, 2012-2017 vs. 2017-2022
  - Table Eastern Europe In Vitro Diagnostic Sales by Country, 2018-2023 ($ millions) (Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Russia, Slovakia, Slovenia, Ukraine, Other Eastern Europe, Total)
- Japan: Second-Largest Country Market
- China: Largest High-Growth Market
  - Table Total Midyear Population by Broad Age Group: China (million persons), 2010-2050
  - Clinical Laboratory Tests in China
    - Table 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
  - Table 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 IVD Market
  - South Africa IVD Market
  - Turkey IVD Market
    - Table Selected Emerging Growth in Health Expenditure, 20012-2017 vs. 2017-2022
  - Columbia IVD Market
  - United Arab Emirates (UAE) IVD Market
  - South Korea IVD Market.
  - Other Markets to Watch
Company and Industry Trends
- Introduction
- Gene Editing
  - Table Selected Gene Editing / CRISPR Innovations
- Microbiome
  - Table Selected Microbiome Test Innovations
- Liquid Biopsy
  - Table Liquid Biopsy: Selected Liquid Biopsy Innovations
- Information Technology Takes Center Stage
  - Table Selected IT Innovations
- Exosome Sequencing
  - Table Selected Exosome Test Innovations
- Biotin Interference in Immunoassay Detection Errors
  - Table 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
- Regulators Clear a Path for Diagnostic Next Generation Sequencing
  - The FDA Released Regulatory Guidance
  - More NGS Tests Are Getting FDA Approval
  - 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 $2 Million Boost
- Traumatic Brain Injury and IVD
- Blockchain
- Substance Abuse
  - Opiod Epidemic
  - Biomarkers and Substance Abuse
  - Clinical Laboratory Testing for Drugs of Abuse
    - Table Global Drug Abuse Statistics
  - Urine
  - Blood
  - Oral
  - Hair
    - Table Selected Opioid FDA Approvals, 2015-2018
Point-of-Care Tests
- Overview and Trends
  - Professional POC
    - Table Professional POC Test Sales by Category, Worldwide 2018 -2023 ($million)
    - Table Hospital POC Test Usage, U.S. (% of hospital using; % of hospitals not using)
    - Table POC Test Use among Survey Respondents, Current and Desired
    - Table Selected Profession POC Test Innovations
  - OTC Self Testing
    - Table POC Self-Test Sales by Category, Worldwide, 2018-2023 ($million)
  - Colon Cancer Screening
  - Lipid Testing
- The Major POC Test Players
  - Table POC Test Revenues of Selected IVD Companies, 2013-2015 ($ million, estimated)
- POC Infectious Disease Testing
  - Table 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 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 Selected Apps and Glucose Management IT
  - Diabetes Market Analysis
    - Table Diabetes Sales by Test Category, Worldwide, 2018-2023 (Glucose, OTC; Glucose, professional;
  - Blood Glucose Self-Testing
    - Table Selected Glucose Self-Test Meter Innovations
  - Noninvasive Testing Devices
    - Table Selected Noninvasive Glucose Monitoring Devices
  - Continuous Self Testing en Route to the Artificial Pancreas
    - Table Selected Continuous Blood Glucose System Developments
  - Blood Glucose Testing by Professionals
    - Table Selected Innovations in Hospital-based Glucose Monitoring
  - Diabetes Testing – Glycated Hemoglobin
    - Table Selected POC HbA1c Devices
  - Genes and Other Markers of Diabetes
    - Table Selected POC Diabetes Monitoring Tests
- Drug of Abuse Testing
  - Products
    - Table Drugs of Abuse Tests on the Market
The Core Lab
- Core Lab Overview and Trends
  - Table Workstation Sales, 2018-2023 (General Chemistries, Immunos on workstations; $ millions)
  - Table Core Lab Sales of the Top Five Manufacturers, 2014-2017 ($ millions, estimated)
  - Table Selected New Analytes for the Core Lab, 2016-2018
- Connectivity
- Overview of Chemistry Tests
  - Lab Automation
    - Table Selected Lab Automation Innovations
  - Service Plans
- Market Analysis
  - Table Worldwide Clinical Chemistry Sales by Test Category, 2018-2023 ($millions)
  - Table Major Clinical Chemistry Companies
  - Table Selected Clinical Chemistry Innovations
  - Rapid Response Systems
    - Table Major Whole Blood Chemistry Analyzers
  - Critical Care Analysis
  - User Apps
    - Table Selected Apps, Critical Care and Urinalysis IT Innovations, 2016
  - Urinalysis
    - Table Selected Urinalysis Innovations, 2016
- Sleep Apnea Testing: Core Lab Solution?
- The Commercial Outlook for Chemistry Tests
Immunoassays
- Overview and Trends
  - Immunoassay Technology Continues to Evolve
    - Table Selected Immunoassay Technologies 2017
  - Mass Spectrometry
    - Table Selected Innovation in Mass Spectrometry for Routine Analyses
  - Immunoassays in the Core Lab
    - Table Selected Immunoassay Innovations on Core Lab Instruments
  - Radioimmunoassays
- Market Analysis
  - Leading Suppliers and Growth Potential
    - Table Worldwide Lab-based Immunoassay Sales by Analyte Type, 2018-2023
    - Table Selected Immunoassay Quality Control Products
    - Table 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 Selected Vitamin D Immunoassays 2015-2017
  - Tumor Markers
    - Table Selected Tumor Marker Innovations 2015-2017
  - Cardiac Markers
    - Table Selected Cardiac Marker Innovations
  - Autoimmune
    - Table Selected Autoimmune Test Innovations
  - Rheumatoid Arthritis
    - Table Selected Arthritis Immunoassay Innovations
  - Gastrointestinal Disorders
    - Table Selected Inflammatory Bowel Disease Test Innovations
  - Transplant Management
    - Table Selected Immunoassays for Transplant Medicine
  - Women's Health
    - Table Selected Women's Health Innovations
  - Alzheimer's Disease
    - Table Selected Innovations for Alzheimer's Disease Immunoassays
  - Sleep Apnea
  - Miscellaneous
    - Table Selected Immunoassay Innovations
  - Point-of-Care OTC and Professional Use
    - Table POC Immunoassay Test Sales by Test Category, 2018-2023 (millions $)
    - Table Selected Self-Test Immunoassay Innovations
  - Pregnancy Testing
  - Cardiovascular Diagnostics
  - Drugs of Abuse/Therapeutic Drug Monitoring
    - Table Selected POC Test Innovations
    - Table Selected POC Immunoassay Test Platforms
- The Commercial Outlook for Immunoassays
Molecular Assays
- Overview
  - Table Common Next Generation Molecular Test Traits
- Sample Preparation and Quality Control
  - Table Selected Molecular Test Sample Preparation and QC Innovations
- Advanced Molecular Tests and Technologies
  - Exosome Sequencing
    - Table Selected Exosome Test Innovations
  - Liquid Biopsy
    - Table Selected Liquid Biospy Innovations
  - Metabolomic Profiling
  - Information Technology for Test Value
    - Table Selected IT Innovations in Molecular Diagnostics
  - Forensic Studies – An Emerging Opportunity
    - Table Selected Innovations in Forensic DNA Testing
  - Test Platforms
    - Table Key Molecular Technologies and Major Players
    - Table Selected Molecular Test Platform Innovations
- Major Players
  - Table Molecular Test Revenues of Selected IVD Vendors, 2013-2017 (in millions $)
- Market Analysis
  - Table Worldwide Molecular Test Sales by Type 2018-2023
  - Oncology
  - Pharmacodiagnostics
    - Table Selected Molecular Tumor Marker Test Innovations
  - Inherited Diseases and Thrombophilia SNPs
    - Table Most Frequently Requested Genetic Tests
    - Table Selected Genomic Tests for Inherited Diseases
  - Prenatal and Newborn Testing
    - Table Prenatal Services Provided
    - Table Selected Molecular Tests for Prenatal Analysis
  - Tissue Typing
    - Table Selected HLA Typing Test Innovations
- The Commercial Outlook for Molecular Tests
Hematology
- Overview of Hematology and Trends
  - Digital Image Analysis
    - Table CellaVision Placement Data by Hematology Vendor (as of February 2017)
    - Table Selected Hematology Image Analysis Innovations, 2014-2018
  - Digital Evolution
  - Quality Control Measurement Programs
- Laboratory-based Hematology Testing
  - Table Selected Hematology Innovations, 2014-2018
  - Table Laboratory-based Hematology Test and Instrument Market, 2018 and 2023 ($ millions)
  - Regional Laboratory-based Hematology Test and Instrument Market
    - Table Laboratory-based Hematology Test and Instrument Market, Regional Analysis, 2017
- Decentralized Hematology Testing
  - Hemoglobin/Hematocrit at the POC
    - Table Selected POC Hematology Innovations, 2016-2018
    - Table Decentralized Hematology Test and Instrument Market, 2018 and 2023 ($ millions)
  - Regional Decentralized Hematology Test and Instrument Market
    - Table Decentralized Hematology Test and Instrument Market, Regional Analysis, 2017
- Market Analysis: Leading Suppliers
  - Table Top Hematology, including d-dimer, Company Revenues, (laboratory and POC), 2017 ($ millions)
- The Commercial Outlook for Hematology Tests
Coagulation
- Overview and Trends of Coagulation and Immunohematology Tests
- Special Topics
  - Direct Oral Anticoagulants (DOACs)
  - D-dimer
- Market Analysis
  - Table Global Coagulation Sales by Segment, 2018-2023 ($millions)
  - Table Global Coagulation Test and Instrument Market, Regional Analysis, 2017
- Lab-based Testing
  - Table Selected Lab-based Coagulation Innovations, 2015-2018
  - Genetic Markers of Hypercoagulopathies
    - Table Selected Molecular Coagulation Test Innovations
- Leading Suppliers: Laboratory Systems
  - Table Top Coagulation Company Revenues, Laboratory-based - 2017 ($ millions)
- Decentralized Coagulation Testing – Professional Use
  - Decentralized Coagulation Testing – OTC
    - Table Selected POC Coagulation Test Innovations
  - Platelet Testing
    - Table Selected Platelet Activity Test Innovations
- Leading Suppliers: POC Systems
  - Table Top Coagulation Company Revenues, POC - 2017 ($ millions)
- The Commercial Market for Coagulation Tests
  - Table Major Anticoagulants Uses and Tests
Microbiology and Virology
- The Burden of Infectious Disease
  - Table 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 Selected Companies Developing Faster Identification, Some Also with Antimicrobial Susceptibility/Resistance Tests
- Traditional Microbiology and Its Limits
- New Microbiology - Innovations
  - Liquid Based Microbiology and Automation Innovations
  - Post-Blood Culture Microbial ID
  - PCR and Other NAAT-Based Tests for Infectious Diseases
    - Table Selected Nucleic Acid Amplification Test and Other Molecular Companies in Microbiology
  - Microbiome-Related Microbiology Tests
    - Table Selected Microbiome-Based Tests
  - Next Generation Sequencing-Based Microbiology Approaches
    - Table Selected Companies Applying DNA/RNA Sequencing to Microbiology
  - Syndromic Testing
- Emerging Infectious Disease Threats
  - Table 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 Microbiology ID/AST Market, 2018-2023 (in millions USD)
  - ID/AST
  - Blood Culture
    - Table 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 Selected Infectious Disease Immunoassay Innovations
    - Table World Clinical Laboratory Based Microbiology/Infectious Disease Immunoassay Market by Pathogen, 2018
  - Hepatitis Testing
  - Sepsis
  - HIV Immunoassay Testing
    - Table Selected HIV Assays
  - Sexually Transmitted Diseases (STDs)
  - TORCH
  - Lyme Disease
  - Rapid Immunoassay Tests
- Market Analysis - Molecular Microbiology
  - Table Worldwide Molecular Microbiology Market, by Pathogen/Disease Indication, 2018-20223
  - Molecular Respiratory Infection Testing
    - Table 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 Frequency of the Most Common Nosocomial Infections
  - Clostridium Difficile
  - MRSA
  - Molecular TB Testing
  - Limitations of Molecular Microbiology Testing
- Mass Spectrometry
  - Table Selected Companies Marketing Mass Spectrometers and/or Assays for the Clinical Laboratory [CE-Marked and/or 510(k) cleared]
- The Future Outlook for Microbiology
Blood Banking Services
- Introduction
  - Table History of Blood Testing
- The Current Status of Global Blood Collection
  - Table Distribution of Blood Units Collected
- Global Blood Safety
  - Table Laboratory Screening of Blood Donations for Transfusion-Transmissible Infections, Number of Countries
  - Table Prevalence of TTIs in Blood Donations [Median (Interquartile range)], by Income Group Income group HIV HBV HCV Syphilis
  - Zika Virus
- Blood and Component Collection
  - Table Blood Component Usage for Selected Conditions
  - Table Red Blood Cell and Platelet Use by Hospital Services
- Reevaluating Blood Transfusions
  - Table Impact of Alloimmunization (% of Patients Screening Positive for One or More Antibodies)
- Blood Typing and Grouping Market
  - Table Blood Typing Market, 2018-2023 (Typing)
  - Manual Blood Typing Methods
  - Automated Blood Typing and Screening Methods
  - Molecular Methods
  - Reducing Blood Typing Errors
    - Table Selected Blood Typing and Grouping Innovations
  - Size and Growth of Typing Markets
- Blood Testing Market
  - Table Selected Blood Testing Innovations
  - Preventing Bacterial Infections
  - Immunoassays
  - Nucleic Acid Testing (NAT)
  - Size and Growth of the Market
    - Table Blood Banking Diagnostics Market, 2018-2023 (Typing, Immunoassay Screen, NAT Screens)
  - Blood Testing Market by Geography
    - Table Blood Testing Market by Geography, 2018
- The Commercial Outlook for Blood Banking Testing
Histology and Cytology
- Overview
- Special Topics
  - Histology Automation
    - Table Selected Histology Lab Automation
    - Table Histology Information Technology Tools
  - Advanced Analysis Solutions
    - Table Selected Advanced Histology Techniques
  - HPV Goes Core Lab
    - Table Selected HPV Test Innovations
- Market Analysis
  - Table Worldwide Histology/Cytology Sales by Type, 2018-2023 ($ millions)
  - Histology/Cytology
    - Table Revenues of the Major Histology Companies, 2012-2017 ($ millions, estimated)
    - Table Selected Vendors of Traditional Histology Stains
  - Immunohistochemistry and In Situ Hybridization
    - Table Selected In Situ Hybridization-based Tests
    - Table Selected IHC Test Innovations
  - Pharmacodiagnostic Histology
    - Table Major Pharmacodiagnostic Markers
    - Table Selected Pharmacodiagnostic Histology Tests
  - Digital Imaging and Computational Pathology
    - Table Selected Digital Imaging Innovations
  - Circulating Tumor Cells
    - Table Selected Innovations in CTC Technology
  - Flow Cytometry
- The Commercial Outlook for Histology and Cytology Tests
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
  - Recent 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
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
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
Company Profiles: Coagulation Specialists
- Diagnostica Stago, S.A.S.
  - Instrumentation
  - Test Kits
- Microvisk Technologies
- DIAGON Kft. Hungary
Company Profiles: Core Lab and Other Companies
- AB SCIEX Pte Ltd.
- EKF Diagnostics Holdings Plc
  - Lab-based Assays
  - Molecular
- ELITech Group S.A.S.
- ERBA Diagnostics, Inc.
- MedTest DX
- Microsaic Systems plc
- Nova Biomedical
  - Diabetes
- Scienion AG
- Sekisui Diagnostics
- Shimadzu Scientific Instruments
- Snibe Co. Ltd., (Shenzhen New Industries Biomedical Engineering Co. Ltd.)
- Tecan Group
- Tosoh Bioscience
- Trinity Biotech Plc
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
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
Company Profiles: Hematology (Cell Analysis) Specialists
- CellaVision AB
  - Recent Revenue History
- Horiba Medical
  - Recent Revenue History
  - Chemistry
- Medica Corporation
- Onca Xt Ltd
- West Medica
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
  - Special Stains
  - Immunohistochemistry (ICH)
  - Companion Diagnostics
  - Flow Cytometry
  - Automation
  - Alliances
- Definiens
- HTG Molecular Diagnostics
  - Strategic Partnerships
- Kapa Biosystems Inc.
- Leica Biosystems
  - Collaborations
- MilliporeSigma (formerly EMD Millipore)
- Omnyx LLC
- Visiopharm
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
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
Company Profiles: Microbiology Specialists
- Accelerate Diagnostics, Inc.
  - Recent Revenue History
  - Company Overview
- Advanced Biological Laboratories, S.A. (ABL)
- AdvanDx, Inc.
- altona Diagnostics
- 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
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.
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
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
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
Test Service Providers
- 23andMe
  - The Move to Building a Research Company
  - Therapeutics Group
  - Ancestry
  - Outside the U.S.
- Agendia BV
- Ambry Genetics
  - Epilepsy
  - Oncology
  - Cardiac
  - Prenatal
  - Information Technology
- ARUP Laboratories
- Assurex Health
- The BioCollective
- BioReference Laboratories
- Biotheranostics
- BluePrint Genetics Oy
- Boston Heart Diagnostics
- CareDx, Inc.
  - Sequencing
- Cleveland HeartLab Inc.
- Eurofins Genomics
- Exact Sciences Corp.
- Genomic Vision
- Helomics Corporation
- Mayo Medical Laboratories
  - Information Technology
  - Reference Laboratory Services
- MDxHealth SA
- OPKO Diagnostics
- Pathway Genomics Corporation
- Sonic Healthcare
- Veracyte, Inc.
- Vermillion Inc.