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The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 9th Edition


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

The in vitro diagnostics  (IVD) market attracts considerable interest.  There are hundreds of participating companies, competing in multiple areas of testing.  Each IVD segment could be said to function as an industry in and of itself.  There are companies who specialize in one area and companies who participate across segments.  There are myriad products, from routine blood tests to complicated molecular assays and new sequencing based technologies.  It's often necessary for competitors to know about all of the segments of testing as different technologies can often compete.  This single volume Kalorama Information report has been written and updated for over a decade in nine editions, with the purpose of keeping readers informed about developments in clinical testing.  It covers the entirety of the clinical testing market, reports on hundreds of competitors, details deals and acquisitions and computes market size statistics for important segments.   Published every two years, this volume includes recent market size and forecasts to 2018 for the most important aspects of all of the major segments of clinical lab testing, including

  • Clinical Chemistry and "Core Lab" Markets (including sub segment revenues for General Chemistries, Workstations, Analyzers Blood Gases, Urinalysis, Critical Care)
  • Near-Patient and 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)
  • Tissue-Based Testing - Histology and Cytology (Pap, ISH, IHC, HPV)
  • Microbiology Immunoassay Testing  (Hepatitis, HIV, STDs, TORCH, Respiratory, Sepsis, Parasitology, Mycology, Others)
  • Molecular Assays (Infectious Disease, Blood Screening, Inherited Diseases, Oncology, Pharmacodiagnostics, Tissue Typing, Prenatal)
  • Hematology
  • 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)
  • 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)
No other report provides an similar sense of the world diagnostics market.   Shara Rosen (MBA, RT)  has edited nine editions of this superior work intended to provide IVD market coverage in a world perspective.  A month's long research effort creates authoritative market estimates and forecasted growth models for in vitro diagnostic (IVD) testing products throughout the world.

This is a global report.  The following IVD markets are included:

  • North America
  • Europe (with total IVD market sizes for EU countries)
  • Asia (China, Japan, India)
  • Latin America
  • Emerging Markets
  • Rest of World


Not Just "Who Did What?"  This Report Answers "What are the Reasons Behind the Results"

The report does just report on deals, events in the industry, laboratory trends and corporate results.  It provides that information, but it also analyzes why trends are occurring, and what readers can expect in the future.   

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 IVD industry veteran, who has tracked hundreds of 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 industry as it is in 2014. The report includes data in a sizeable number of IVD segments and detailed discussion of the trends that are impacting the industry. The report also provides a realistic forecast five years into the future for companies already participating in or considering entry into this growing industry.  Many top IVD companies have purchase this volume and use the data within for their business planning efforts. 

The same business intelligence top companies possess is available to purchasers of this unique report.

The report contains detailed profiles of the top players in IVD. Profiling in this report describes the developments in each significant division of their business. A number of secondary players are also extensively profiled, as well as specialty companies with expertise in one testing area.
  • Abbott Diagnostics
  • Alere Inc.
  • Arkray
  • Beckman Coulter, Inc.
  • Becton, Dickinson and Company (BD)
  • bioMérieux Inc.
  • Bio-Rad Laboratories, Inc.
  • Danaher Corporation
  • Hologic, Inc.
  • Ortho Clinical Diagnostics (OCD)
  • QIAGEN N.V.
  • Siemens Healthcare Diagnostics
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.
  • Affymetrix Inc.
  • Cepheid
  • Eiken Chemical Co., Ltd
  • ERBA Diagnostics, Inc.
  • DiaSorin S.p.A
  • Fujirebio Diagnostics, Inc.
  • Illumina
  • LabCorp
  • Luminex Corporation
  • Roche Diagnostics
  • Wako Pure Chemical Industries
And hundreds of other companies...
All market data are based on factory sales to the end user and not retail pricing or reimbursement payments. Data for the in vitro diagnostic market are presented in U.S. dollar market size for categories of tests, and for specific analytes where possible. The dollar value of a market segment is directly proportional to the number of tests performed, because the cost of the instrumentation is generally buried in the per test price.

The information presented in this report is derived on publicly available information sources such as company, government, and medical organization reports. The analysis is based on the author's industry knowledge combined with literature searches and interviews with industry professionals and experts in the IVD industry.


New Report Says In Vitro Diagnostic Market Reaches 54.6Billion 

NEW YORK, N.Y. - The world marketfor diagnostics is estimated at $54.6 billion in 2013, according to KaloramaInformation.  The market is expected to grow 4% annually and reach $65billion by 2018.  This includes all laboratory and hospital-basedproducts, and OTC product sales.  Kalorama revealed the market estimatesin its biennial survey of the IVD industry, The Worldwide Market for In Vitro DiagnosticTests, 9th Edition. 

 New technology is leading thecharge, according to Kalorama.  Diagnostic laboratory technology haschanged dramatically in the past few years, due to the publication of the humangenome project and advances in functional genomics, bioinformatics,miniaturization and microelectronics. 

“Not three years ago it would havebeen almost inconceivable to see research technologies such as genomesequencing and mass spectroscopy play a pivotal role in improving labmedicine,” said Shara Rosen, Kalorama’s lead diagnostic analyst and the authorof the report.  “Their influence is felt in personalized medicine,inherited diseases, pathogen detection, antibiotic resistance testing, bloodbanking and much more to come.”

 According to the report, thisphenomenon has seen the major vendors of these technologies enter the IVDmarket.  Life Technologies, Illumina, Affymetrix, Bruker Daltonics,PerkinElmer/Caliper and others have all launched clinical tests and testservices.

Commentary on LDT Regulatory changes

The 8th edition of this report published in 2012 discussed the possible regulation of lab developed tests (LDTs).  Well in 2014, the possible is a reality.  In the beginning …. September 2006, the FDA issued a draft guidance on analyte specific reagents (ASRs), which are commercially available reagents used in lab developed tests (LDTs).  The FDA decided to use enforcement discretion and excluded laboratory-developed tests from the ASR rule based on confidence in a high-complexity laboratory’s ability to use them.

LDTs are developed within the laboratory and do not currently require FDA clearance. They are currently regulated under CLIA as highly complex tests and thus are subject to in-house validation and cGMP quality documentation requirements.

August 1, 2014, the FDA announced plans to implement a risk-based regulation of laboratory-developed tests over the course of nine years.  The FDA also said it plans to release its draft guidance in 60 days.  The FDA’s announcement comes out at a time when the agency has come under increasing pressure from congressional and federal advisory committees, consumer groups and the industry to expand its oversight of in-house developed testing.  The FDA announcement stated that LDTs have become an intrinsic part of personalized medicine and that inaccurate test results could cause patients to seek unnecessary treatment, or delay and sometimes forgo treatment altogether.  Further the policy change “demonstrates the agency's commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient.”

The statement also stated that the FDA would implement the regulations over a nine-year period and would focus on tests where a wrong result would pose the highest risk for patients.  It also said it would exempt tests for which there is no approved alternative and tests for rare diseases.

The FDA says it intends to require pre-market review for higher-risk LDTs, such as those that have the same intended use as FDA-approved or cleared companion diagnostics currently on the market.  The draft guidance also proposed that LDTs would be classified as Class I, II, or III depending on risk.  The agency will first focus on high-risk devices that have the same intended use as cleared or approved companion diagnostics. 

It is expected that the classification may take the form of a proposal submitted by the American College of Medical Genetics and Genomics.  In 3013, the American College of Medical Genetics and Genomics (ACMG, www.acmg.net/) released a framework to standardize risk classification of laboratory developed tests (LDTs) for inherited conditions. The approach represents a regulatory context that the group hopes will be used to assist federal agencies and policymakers.  The ACMG presented risk-based classification that aligns risk with the medical decisions made based on the test results and how an incorrect result or interpretation might impact patients. 

  • Executive Summary
    • INTRODUCTION – DOING MORE WITH LESS
    • SCOPE AND METHODOLOGY
      • Table Exchange Rate Fluctuations, 2009-2013
    • SIZE AND GROWTH OF THE MARKET
      • Table Worldwide In Vitro Diagnostic Reagent Sales by Market Segment 2013-2018 (Clinical Chemistry, Immunoassays - non isotopic, Infectious Diseases, Other Immunos, Blood Bank Screening, Diabetes HbA1c, Lab, Hematology, Microbiology (ID/AST), Microbiology - molecular, Radioimmunoassays, Coagulation, Histology/Cytology, HPV - molecular, Nucleic Acid Assays, Blood Grouping/Typing, Blood Bank Molecular, Flow Cytometry, Circulating Tumor Cells, POC - OTC diabetes, POC - OTC other, POC - Professional/Hospital)
    • MARKET TRENDS
  • Introduction
    • BACKGROUND
    • REPORT DESIGN
    • LAB MEDICINE DISCIPLINES AND APPLICATIONS
    • MARKET ANALYSIS OF IVD MARKET SEGMENTS
      • Table Worldwide In Vitro Diagnostic Sales by Product Market (Clinical Chemistry, Immunoassays - non isotopic, Infectious Diseases, Other Immunos, Blood Bank Screening, Diabetes HbA1c, Lab, Hematology, Microbiology (ID/AST), Microbiology - molecular, Radioimmunoassays, Coagulation, Histology/Cytology, HPV - molecular, Nucleic Acid Assays, Blood Grouping/Typing, Blood Bank Molecular, Flow Cytometry, Circulating Tumor Cells, POC – OTC diabetes, POC - OTC other, POC - Professional/Hospital) 2013-2018, $ million
    • THE LURE OF IVD - COMPANIES MIX AND MATCH
      • Table Selected Diagnostics Industry Acquisitions, 2012 and 2013
    • DISTRIBUTION AGREEMENTS
      • Table Selected Diagnostics Industry Distribution Agreements, 2012 and 2013
    • LICENSES AND COLLABORATION AGREEMENTS
      • Table Selected IVD Licensing Agreements, 2012-2013
      • Table Selected IVD Collaboration Agreements, 2012-2013
      • Table New IVD Company Developments, 2012-2013
    • TEST SERVICES
      • Table Selected Test Services, Sales 2009-2013 ($ millions, estimated)
      • Table Lab Market Segmentation (Hospital Labs, Independent Labs, Physician Office Labs), Worldwide, 2013 (estimated)
      • Table Revenues for a Selection of U.S.-based Reference Labs, 2009-2013 $ million (estimated)
      • Table Selected CLIA-certified Labs Established in 2012 and 2013
      • Table Selected International Lab Developments, 2013
    • TOP SUPPLIERS AND NICHE PLAYERS
      • Table Revenues of Selected Top IVD Companies, 2009-2013 ($ million, estimated)
      • Table Revenues of Selected Niche Players, 2009-2013, $ million
      • Table Selected IVD Market Laggards, 2012-2014
    • SELECTED TEST INNOVATIONS FROM NON-COMMERCIAL FACILITIES
      • Baylor Research Institute, Dallas, TX
      • Boston University, Boston, MA
      • Brown University, Providence, RI
      • California Institute of Technology, Pasadena, CA
      • California NanoSystems Institute at the UCLA Henry Samueli School of Engineering and Applied Science, Los Angeles, CA
      • Cedars Sinai Medical Center, Los Angeles, CA
      • Cleveland Clinic, Cleveland, OH
      • Duke University, Durham, NC
      • Hartford Hospital, Hartford, CT
      • Johns Hopkins University School of Medicine, Baltimore, MD
      • MedStar Washington Hospital Center, Washington, DC
      • Mount Sinai's Samuel Lunenfeld Research Institute, Toronto, ON
      • Northeastern University, Boston, MA
      • Peking University, Beijing, China
      • Queensland Institute of Medical Research, Brisbane, Australia
      • Schneider Children's Medical Center of Israel, Tel Aviv, Israel
      • Stockholm University, Sweden
      • Tokyo Medical and Dental University, Tokyo, Japan
      • University of British Columbia, Vancouver, BC
      • University of California, Davis, CA
      • University of California, Urvine, Urvine, CA
      • University of Cincinnati, Cincinnati, OH
      • University of Cologne, Cologne, Germany
      • University of Washington, Seattle, WA
      • Vanderbilt University, Nashville, TN
      • Weill Cornell Medical College, New York, NY
      • Yonsei University Health System, Seoul, S. Korea
    • POINT OF VIEW
  • Overview of Global In Vitro Diagnostic Markets
    • BACKGROUND
    • POPULATION AND DISEASE DEMOGRAPHICS,WORLDWIDE
      • Table World Population Distribution, August 2014
      • Table Selected Disease Statistics, Worldwide
      • Table Elderly Support Ratio in Selected Countries (2050)
    • EMERGING MARKETS AS A MARKET DRIVER
      • Table Available Market Data, 2013
      • Table Healthcare Spending as a % of GDP Growth, Selected Developed Countries
      • Table Healthcare Spending as a % of GDP Growth, Selected Emerging Markets
    • WORLD SEGMENTS OF THE IVD MARKET AND IVD MARKET EVOLUTION
      • Table Worldwide In Vitro Diagnostic Reagent Sales by Country/Region 2013-2018, $ million
    • SPECIFIC COUNTRY INFORMATION
      • The United States of America - a World in Flux
      • Japan
      • Europe: Negative Growth - Effects of Austerity
        • Table European Union (EU14) IVD Sales by Country 2012, million
      • China
      • India
      • Brazil
      • Russia
      • Canada
  • Trends and Innovation
    • BACKGROUND
    • IT ENABLES SAMPLE TO INSIGHT
      • Table Selected IT Enabled Sample to Result Innovations
    • OMICS AND BIG DATA
    • SEQUENCING MOVES TO THE CLINIC
      • Table Major Sequencing Platforms
      • Table Selected Sequencing-based Innovations, 2012-2013
    • PERSONALIZED PRECISION MEDICINE ADVANCES AND BARRIERS
      • Table Diseases with Drug Labels
      • Table Selected Drug/Biomarker Targets in the U.S.
      • Table Selected Drugs That Recommend PGx Testing in Europe
    • LOCS ENABLE MOBILE HEALTH (MHEALTH)
      • Table Selected Cellphone Enabled Test Devices
  • Point-of-Care Tests
    • OVERVIEW
      • Table POC Sales by Test Category(Glucose, Glucose continuous, Pregnancy/Ovulation, Coagulation/PT, Fecal Occult Blood, Drugs of abuse, H. pylori, HIV, Cholesterol, Other, Glucose, Critical Care, Pregnancy, Infectious Diseases, Cardiac Markers, Cholesterol/Lipids, Coagulation/PT ACT, HbA1c, Hematology, Fecal occult blood, Drugs of Abuse, Other) , Worldwide 2013-2018 ($ millions)
      • Professional POC
        • Table Hospital POC Test Usage (glucose, blood gas/electrolytes, coagulation, urinalysis, co-oximetry, cardiac markers, HbA1c), U.S.
      • OTC Self Testing
      • Colon Cancer Screening
    • THE MAJOR POC TEST PLAYERS
      • Table POC Test Revenues of Selected IVD Companies, 2013 ($ million, estimated)
    • DIABETES TESTING - BLOOD GLUCOSE MONITORING
      • Glucose Market Shakeup
    • DIABETES MARKET ANALYSIS
      • Table World Glucose Monitoring Sales, Major Companies, 2009-2013 ($ million, estimated)
      • Blood Glucose Self-Testing
        • Table Selected Glucose Self-Test Meter Innovations, 2012 and 2013
        • Table Selected Apps and Glucose Management IT, 2012 and 2013
        • Table Selected Noninvasive Glucose Monitoring Devices
      • Continuous Self-Testing
        • Table Selected Continuous BGM Sales, 2013
        • Table Selected Continuous Blood Glucose System Developments, 2013
      • Blood Glucose Testing by Professionals
      • New Technologies
        • Table Selected Innovations in Hospital-based Glucose Monitoring
      • Diabetes Testing - Glycated Hemoglobin
        • Table Selected POC HbA1c Devices
      • The Genetics of Diabetes
  • The Core Lab
    • CORE LAB OVERVIEW
      • Table Workstation Sales (General Chemistries, Immunos on Workstations), 2013-2018, $ million
      • Table Core Lab Sales of the Top Five Manufacturers, 2009-2013 $ millions, estimated
      • Table Selected New Analytes for the Core Lab, 2012-2013
    • OVERVIEW OF CHEMISTRY TESTS
    • LAB AUTOMATION
      • Table Selected Lab Automation Innovations, 2012-2013
    • MARKET ANALYSIS
      • Table Worldwide Clinical Chemistry Sales by Test Category (General Chem, Blood Gases, Urinalysis, Critical Care POC) 2013-2018, $ million
      • Table Major Clinical Chemistry Companies
      • Table Major Whole Blood Chemistry Analyzers
    • LAB-BASED CHEMISTRIES
      • Table Selected Clinical Chemistry Innovations, 2012-2013
      • Table Selected Rapid Chemistry Analyzers and Test Innovations, 2012-2013
    • CRITICAL CARE ANALYSIS
    • USER APPS
      • Table Selected Apps, Critical Care and Urinalysis Innovations, 2012-2013
    • URINALYSIS
    • THE COMMERCIAL OUTLOOK FOR CHEMISTRY TESTS
  • Immunoassays
    • OVERVIEW OF IMMUNOASSAYS
      • Immunoassay Technology Continues to Evolve
      • Immunoassays in the Core Lab
        • Table Selected Immunoassays on Core Lab Instruments
        • Table Selected New Immunoassay Technologies, 2013
    • SPECIAL TOPIC - METABOLITE TESTING
    • MARKET ANALYSIS
      • Leading Suppliers and Growth Potential
        • Table Worldwide Lab-based 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), 2013-2018
        • Table Revenue History of Leading Immunoassay Vendors, 2009-2013 $ million (estimated*)
    • MATURE ASSAY SEGMENT
      • Thyroid Function
      • Therapeutic Drug Tests
      • Anemia
      • Toxicology/DAU
      • Allergy
    • MATURING IMMUNOASSAYS
      • Proteins
        • Table Selected Immunoassays Based on Mass Spectrometry
    • GROWTH IMMUNOASSAYS
      • Vitamin D
        • Table Selected New Vitamin D Immunoassays, 2013
      • Tumor Markers
        • Table Selected Tumor Marker Innovations, 2013
      • Cardiac Markers
        • Table Selected Cardiac Marker Innovations, 2013
      • Autoimmune
        • Table Selected Autoimmune Immunoassay Innovations, 2013
      • Diabetes
        • Table Selected Diabetes Test Innovations, 2013
      • Transplant Management
      • Women's Health
        • Table Selected Women's Health Innovations, 2013
      • Gastrointestinal Disorders
        • Table Selected Gastrointestinal Disease Immunoassays, 2013
      • Miscellaneous
        • Table Selected Immunoassay Innovations, 2013
    • POINT-OF-CARE, OTC AND PROFESSIONAL USE
      • Table POC Immunoassay Test Sales by Test Category (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), 2013-2018 $ million
      • Patient Self-Tests (OTC)
      • Pregnancy Testing
      • Cardiovascular Diagnostics
      • Drugs of Abuse/Therapeutic Drug Monitoring
        • Table Selected Professional POC Test Innovations, 2013
    • THE COMMERCIAL OUTLOOK FOR IMMUNOASSAYS
  • Molecular Assays
    • OVERVIEW
      • Table Selected Molecular Test Sample Preparation Innovations, 2013
    • ADVANCED MOLECULAR TESTS AND TECHNOLOGIES
      • Digital PCR
      • Exomes
        • Table Selected Exosome Test Innovations
      • Cell-free DNA (cfDNA)
    • MAJOR PLAYERS
      • Table Molecular Test Revenues of Selected IVD Vendors, 2009-2013 $ million* (estimated)
      • Table Selection Molecular Platform Innovations for Genomic Testing
    • MARKET ANALYSIS
      • Table Worldwide Molecular Test Sales by Type, $million 2013-2018
      • Oncology
        • Table Selected Molecular Tumor Marker Test Innovations
      • Inherited Diseases
        • Table Most Frequently Requested Genetic Tests
        • Table Selected Genomic Tests for Inherited Diseases, 2013
      • Prenatal Analysis
        • Table Selected Molecular Tests for Prenatal Analysis
      • Tissue Typing
        • Table Selected HLA Typing Test Innovations, 2013
    • THE COMMERCIAL OUTLOOK FOR MOLECULAR TESTS
      • Table Selected Molecular Test Innovations, 2013
  • Hematology
    • OVERVIEW OF HEMATOLOGY
      • Digital Image Analysis
        • Table Cellavision Placement Data by Hematology Vendor
        • Table Selected Hematology Image Analysis Innovations, 2012-2013
      • Digital Evolution
    • DECENTRALIZED HEMATOLOGY TESTING
      • Hemoglobin/Hematocrit at the POC
        • Table Selected POC Hematology Systems
    • MARKET ANALYSIS: LEADING SUPPLIERS
      • Table Revenue History of the Major Hematology Vendors 2009-2013, $ millions (estimated)
      • Table Selected Hematology Innovations, 2012-2013
    • THE COMMERCIAL OUTLOOK FOR HEMATOLOGY TESTS
  • Coagulation
    • OVERVIEW OF COAGULATION AND IMMUNOHEMATOLOGY TESTS
    • GENETICS AND PERSONALIZED MEDICINE
      • Warfarin
      • Plavix
    • MARKET ANALYSIS
      • Table Worldwide Coagulation Sales by Segment (PT/INR - lab, Molecular - lab, POC - professional, POC - self testing), 2013-2018
      • Lab-based Testing
        • Table Selected Coagulation Innovations, 2012-2013
      • Genetic Markers of Hypercoagulopathies
        • Table Selected Molecular Coagulation Test Innovations
      • Decentralized Coagulation Testing - Professional Use
        • Table World POC Coagulation Sales, 2013 (million, estimated)
        • Table Selected Lab-based and POC Coagulation Innovations, 2012-2013
      • Decentralized Coagulation Testing - OTC
      • Platelet Testing
        • Table Selected Platelet Activity Test Innovations, 2012-2013
      • Leading Suppliers
        • Table Top Coagulation Company Revenues 2013 - 2018, $ million estimated
    • THE COMMERCIAL MARKET FOR COAGULATION TESTS
      • Table Major Anticoagulants Uses and Tests
  • Microbiology and Virology
    • OVERVIEW
    • SPECIAL TOPICS
      • Some Disease Facts
      • Emerging Disease Threats
      • Antimicrobial Drug Resistance
        • Table Selected Tests for Antibiotic Resistance
      • Mass Spectrometry Not a Pipedream
        • Table Selected Microbiology Mass Spec Innovations, 2013
      • Sepsis Serology
    • MARKET ANALYSIS
      • Table Worldwide Microbiology/Virology Sales by Type (Infectious Diseases - Immunos, Infectious Diseases - Rapid, ID/AST, Infectious Diseases - DNA; ID/AST: Panels and Reagents, automated; Panels and Reagents, manual; Blood Culture; Chromogenic Media; Rapid Micro; Supplies) 2013-2018, $ millions
      • Supplies
        • Table Selected Microbiology Media Innovations, 2013
      • Microbial Identification and Antimicrobial Sensitivity Tests
        • Table Revenue of Selected Microbiology Companies, 2013 (estimated)
        • Table Selected Microbiology ID/AST Innovations, 2013
        • Table Selected ID/AST Innovations, 2013
      • Blood Culture
        • Table Selected Advanced Techniques for Positive Blood Cultures
      • Rapid Tests
      • Immunoassays - Lab-based
        • Table Lab-based Infectious Disease Immunoassays, by Test (Hepatitis, HIV, STDs, TORCH, Respiratory, Sepsis, Parasitology, Mycology, Others), 2013, $ Million
        • Table Selected Infectious Disease Immunoassay Innovations
      • Immunoassays - Rapid
        • Table Selected Professional-Use POC Tests for Infectious Diseases
      • Molecular Tests
        • Table Selected Microbiology Sequencing Innovations, 2013
        • Table Selected New Instruments for Molecular Infectious Disease Testing, 2013
        • Table Molecular Test Sales, Infectious Diseases (HAI, HIV, Hepatitis, GC/Chlamydia, Respiratory, Organism ID, Mycobacteria, TB, Others), 2013-2018, $ million
        • Table Selected Molecular HAI Test Innovations, 2013
        • Table Selected Molecular STD Innovations, 2013
        • Table Selected Molecular Respiratory Disease Innovations, 2013
        • Table Selected Molecular HIV Test Innovations, 2013
        • Table Selected Molecular POC Device Innovations, 2013
    • THE COMMERCIAL OUTLOOK FOR MICROBIOLOGY / VIROLOGY TESTS
      • Table Selected Infectious Disease Molecular Test Innovations
  • Blood Banking Services
    • OVERVIEW
      • Table Laboratory Screening of Blood Donations for Transfusion-Transmissible Infections, Number of Countries
      • Table Blood Component Usage
    • BLOOD BANKING GETS A SHAKEUP
    • BLOOD MANAGEMENT - ARE ALL THESE TRANSFUSIONS GOOD MEDICINE?
      • Table Impact of Alloimmunization
    • PATHOGEN ALERTS
    • PLATELET SAFETY
    • MARKET ANALYSIS
      • Table Worldwide Blood Bank Sales, 2013-2018 (Sales $ millions)
      • Blood Grouping and Typing
      • Immunoassays
        • Table Selected New Blood Screening Immunoassays, 2012-2013
      • Nucleic Acid Testing (NAT)
        • Table Selected New Blood Screen NAT Tests and Systems, 2012-2013
    • THE COMMERCIAL OUTLOOK FOR BLOOD BANKING
  • Histology and Cytology
    • OVERVIEW
      • Table Selected Histology Lab Automation, 2013
    • SPECIAL TOPICS
      • 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, 2013-2018, Sales, $ million
      • Histology/Cytology
        • Table Revenues of the Major Histology Companies, 2009-2013 $ million, estimated
        • Table Selected Vendors of Traditional Histology Stains
      • Immunohistochemistry and In Situ Hybridization
        • Table Selected Molecular Tissue-based Tests, 2013
        • Table Selected IHC Test Innovations 2013
      • Pharmacodiagnostic Histology
        • Table Major Pharmacodiagnostic Markers
        • Table Selected Pharmacodiagnostic Histology Tests
      • Digital Imaging
        • Table Selected Digital Imaging Innovations, 2013
      • Circulating Tumor Cells
        • Table Selected Innovations in CTC Technology, 2013
      • Flow Cytometry
        • Table Selected Innovations in Flow Cytometry, 2013
    • THE COMMERCIAL OUTLOOK FOR HISTOLOGY AND CYTOLOGY TESTS
  • Company Profiles: The Top Tier
    • ABBOTT DIAGNOSTICS
      • Recent Revenue History
      • 2013 Highlights
      • Core Lab
      • Immunoassays
      • Molecular
      • Hematology
      • Histology
      • Blood Bank
      • Point of Care
      • Diabetes
      • IntelligentMDx Alliance
      • PLEX-ID
    • ALERE INC.
      • Recent Revenue History
      • HIV
      • Lab-based
      • Blood Gases
      • Hematology
      • Microbiology
      • Toxicology
      • Cardiology
      • Mail Order Glucose Meters
      • Molecular
      • Alere Medical India
    • ARKRAY
      • Recent Revenue History
      • Molecular
    • BECKMAN COULTER, INC. / DANAHER
      • Recent Revenue History
      • Core Lab
      • Hematology
      • Immunoassays
      • Histology
      • Flow Cytometry
      • Molecular
      • Lab Services
    • BECTON, DICKINSON AND COMPANY (BD)
      • Recent Revenue History
      • Initiatives
      • Traditional Microbiology
      • Blood Culture
      • The BD MAX Enterprise
      • Veritor System – Immunoassays
      • Continuous Blood Glucose
      • Flow Cytometry
      • Histology
      • Mass Spectrometry
    • BIOMÉRIEUX INC.
      • Recent Revenue History
      • Expansion
      • Immunoassays
      • Blood Culture
      • Molecular Strategy
      • Mass Spectrometry
    • BIO-RAD LABORATORIES, INC.
      • Recent Revenue History
      • Controls
      • Digital PCR
      • Blood Bank
      • Flow Cytometry
      • Lab Automation
    • DANAHER CORPORATION
      • Recent Revenue History
    • HOLOGIC, INC.
      • Recent Revenue History
      • Product News
      • Blood Bank
      • Quest Contract
      • The Gen-Probe Business
      • Panther System
    • INSTRUMENTATION LABORATORY (IL)
      • Recent Revenue History:
      • New Products
      • Direct Sales
    • ORTHO CLINICAL DIAGNOSTICS (OCD)
      • Recent Revenue History
      • Blood Bank
    • QIAGEN N.V.
      • Recent Revenue History:
      • Personalized Healthcare
      • TB Testing
      • HPV
      • Oncology
      • Automation for the Future
      • Rotor-Gene Q
      • Exosomes
      • Sequencing
      • Information Technology
      • Point of Care
      • Collaborations
    • RADIOMETER A/S
      • Recent Revenue History
      • Immunoassays
      • Hemocue AB
    • ROCHE DIAGNOSTICS
      • Recent Revenue History
      • Reorganization
      • The PCR Enterprise
      • Core Lab
      • Molecular Core Lab IT
      • Immunoassays
      • Diabetes
      • Point of Care
      • Coagulation
      • HPV
      • Blood Bank
      • Liquid Biopsy
      • Molecular
      • Sequencing
    • SIEMENS HEALTHCARE DIAGNOSTICS
      • Core Lab
      • Immunoassays
      • Hematology
      • Microbiology
      • Point of Care
      • Coagulation
      • Histology
      • Urinalysis
      • Critical Care
      • Molecular
      • Companion Diagnostics
      • Sequencing
    • SYSMEX CORPORATION
      • Recent Revenue History
      • Hematology
      • Coagulation
      • Clinical Chemistry
      • Inostics GmbH
      • Intraoperative Test
      • Flow Cytometry
    • THERMO FISHER SCIENTIFIC INC.
      • Recent Revenue History
      • Sepsis
      • Histology
      • Allergy
      • Therapeutic Drug Monitoring
      • Mass Spectrometry
      • Microbiology
    • WERFEN GROUP S.A.
  • Company Profiles: The Second Tier
    • AFFYMETRIX INC.
      • Recent Revenue History
    • AGILENT TECHNOLOGIES
      • Recent Revenue History
      • Arrays
      • Sample Management
      • Mass Spectrometry
      • Expansion
    • CEPHEID
      • Recent Revenue History
      • Hospital Acquired Infections (HAI)
      • TB
      • Infectious Diseases
      • Oncology
    • EIKEN CHEMICAL CO., LTD
      • Recent Revenue History
    • ERBA DIAGNOSTICS, INC.
      • Recent Revenue History
    • ERBA MANNHEIM
    • DIASORIN S.P.A.
      • Recent Revenue History
      • Molecular
      • Immunoassays
    • FUJIREBIO DIAGNOSTICS, INC.
      • Recent Revenue History:
      • Molecular
    • ILLUMINA
      • Recent Revenue History
      • Sequencing
      • Cytogenetics
      • Prenatal Testing
      • CLIA Lab Service
      • Nanopore Sequencing
      • Sample to Insight
      • IP Situation
    • LABCORP, LABORATORY CORPORATION OF AMERICA
      • Recent Revenue History
      • Collaborations
      • BRCA Saga
    • LIFE TECHNOLOGIES CORPORATION
      • Recent Revenue History
      • Life Technologies as an IVD Company
      • Partnerships Worldwide
      • Life and Quidel Develop Diagnostics on the 7500 Fast Dx
      • Sepsis
      • HIV
      • Emerging Pathogens
      • Bacterial Typing
      • Personalized Medicine
      • Instrumentation and Applications
    • LUMINEX CORPORATION
      • Recent Revenue History
      • Business Expansion
      • MAGPIX Multiplexing
      • Next Generation NxTag
      • Product News
    • MENARINI DIAGNOSTICS
      • Recent Revenue History
    • MYRIAD GENETICS
      • Recent Revenue History
      • Product News
      • The U.S. Market
      • IP Update
    • PERKINELMER, INC. (PE)
      • Recent Revenue History
      • Newborn Testing
      • Prenatal Testing
      • Histology
      • Sequencing
      • Mass Spectrometry
      • Information Technology
      • China
    • QUEST DIAGNOSTICS
      • Recent Revenue History
    • QUIDEL CORPORATION
      • Recent Revenue History
      • Acquisitions
      • Point of Care
      • Immunoassays
      • Molecular
      • Savanna (formerly Wildcat)
    • RANDOX LABORATORIES LTD.
      • Recent Revenue History
      • Controls
      • Immunoassays
      • Molecular
    • TOSOH CORPORATION
      • Recent Revenue History
      • Immunoassays
    • TRANSASIA BIO-MEDICALS LTD.
      • Recent Revenue History
    • TRINITY BIOTECH PLC
      • Recent Revenue History
      • Product News
    • WAKO PURE CHEMICAL INDUSTRIES, LTD.
      • Recent Revenue History
  • Company Profiles: Blood Bank Specialists
    • CERUS CORPORATION
      • Recent Revenue History
    • GRIFOLS
      • Recent Revenue History
    • HAEMONETICS CORPORATION
      • Recent Revenue History
    • IMMUCOR, INC.
      • Recent Revenue History
    • IMMUNETICS INC.
      • Recent Revenue History
    • NOVARTIS MOLECULAR DIAGNOSTICS
      • Recent Revenue History
      • International Programs
    • QUOTIENT LIMITED
      • Recent Revenue History
    • TERUMO BCT
      • Recent Revenue History
    • VERAX BIOMEDICAL INC.
      • Recent Revenue History
  • Company Profiles: Coagulation Specialists
    • ACCRIVA DIAGNOSTICS
      • Recent Revenue History
      • A Bit of History
    • ATHEROTECH DIAGNOSTICS LAB
      • Recent Revenue History
    • DIAGNOSTICA STAGO, S.A.S.
      • Recent Revenue History
    • GAMMA THERAPEUTICS, INC.
    • MICROVISK TECHNOLOGIES
  • Company Profiles: Core Lab and Other Companies
    • 77 ELEKTRONIKA KFT
    • AB SCIEX PTE LTD.
      • Recent Revenue History
      • Danaher Combines Two Forces
    • BRUKER BIOSCIENCES CORPORATION
      • Recent Revenue History
      • Microbiology
      • Menu Expansion
      • NMR
    • DIATRON MI PLC
      • Recent Revenue History
    • ELITECH GROUP S.A.S.
      • Recent Revenue History
    • IRIS INTERNATIONAL, INC.
      • Recent Revenue History
    • MEDICA CORPORATION
      • Recent Revenue History
    • MEDTEST DX
      • Recent Revenue History
    • MINDRAY MEDICAL INTERNATIONAL LIMITED
      • Recent Revenue History
    • NOVA BIOMEDICAL
      • Recent Revenue History
      • Diabetes
  • Company Profiles: CTC Test Providers
    • ABNOVA
    • ADNAGEN AG
    • ANGLE PLC
    • APOCELL, INC.
    • BIOCEPT, INC.
      • Recent Revenue History
    • CLEARBRIDGE BIOMEDICS
    • CYNVENIO BIOSYSTEMS, INC.
    • EPIC SCIENCES INC.
    • FLUXION BIOSCIENCES, INC.
      • Recent Revenue History
    • ICELLATE AB (formerly Liquid Biopsy AB)
    • PROKYMA TECHNOLOGIES
    • RARECYTE, INC.
    • SCREENCELL
    • VERIDEX, LLC
      • Recent Revenue History
    • WAVESENSE LLC
  • Company Profiles: Diabetes Specialists
    • AGAMATRIX, INC.
      • Recent Revenue History
    • ALR TECHNOLOGIES INC.
    • ANIMAS CORPORATION
      • Recent Revenue History
    • BAYER DIABETES CARE
      • Recent Revenue History
    • DEXCOM, INC.
      • Recent Revenue History
    • ECHO THERAPEUTICS, INC.
      • Recent Revenue History
    • ENTRA HEALTH SYSTEMS
      • Recent Revenue History
    • IHEALTH LAB INC.
    • INFOPIA CO LTD
      • Recent Revenue History
    • INSULET CORPORATION
      • Recent Revenue History
      • U.S. Medicare Effects
    • INTEGRITY APPLICATIONS INC.
      • Recent Revenue History
    • LABSTYLE INNOVATIONS CORP.
    • LIFESCAN INC.
      • Recent Revenue History
      • IP Issues
    • MEDTRONIC INC.
      • Recent Revenue History
      • Service Expansion
    • NEWOMICS INC.,
      • Recent Revenue History
    • PRODIGY DIABETES CARE, LLC (formerly Diagnostic Devices, Inc.)
      • Recent Revenue History
    • SANOFI DIABETES
      • Recent Revenue History
    • SENSEONICS, INCORPORATED (formerly Sensors for Medicine and Science, Inc.)
      • Recent Revenue History
    • TANDEM DIABETES CARE, INC.
      • Recent Revenue History
    • TELCARE INC.
      • Recent Revenue History
  • Company Profiles: Hematology (Cell Analysis) Specialists
    • CELLAVISION AB
      • Recent Revenue History
    • CONSTITUTION MEDICAL, INC.
    • DVS SCIENCES, INC.
    • HORIBA MEDICAL
      • Recent Revenue History
    • ORSENSE LTD.
    • PARTEC GMBH
      • Recent Revenue History
  • Company Profiles: Histopathology Specialists
    • ADVANCED CELL DIAGNOSTICS (ACD)
      • Recent Revenue History
    • AMOY DIAGNOSTICS CO. LTD.
    • APPLIED SPECTRAL IMAGING INC. (ASI)
    • BIOCARE MEDICAL, LLC
      • Recent Revenue History
    • BIODIS BIOTECHNOLOGY
    • BIOMARKER STRATEGIES
    • BIOVIEW LTD.
      • Recent Revenue History
    • DAKO A/S
      • Recent Revenue History
      • Companion Diagnostics
      • Digital Imaging
      • Flow Cytometry
      • Automation
      • Alliances
    • DEFINIENS
      • Recent Revenue History
    • DXTERITY DIAGNOSTICS INC.
      • Recent Revenue History
    • LEICA BIOSYSTEMS
    • NORCHIP
    • VENTANA MEDICAL SYSTEMS INC.
      • Recent Revenue History
      • Digital Pathology
      • Virtuoso Software Update
      • Product News
      • Automation
      • China
      • Partnerships
  • Company Profiles: Immunoassay Specialists
    • ALPCO DIAGNOSTICS
      • Recent Revenue History
    • BG MEDICINE, INC.
      • Recent Revenue History
    • BIOHIT OYJ
      • Recent Revenue History
      • Market Expansion
    • CORGENIX MEDICAL CORPORATION
      • Recent Revenue History
      • Systems
      • Tests
    • CRITICAL DIAGNOSTICS
    • DIAZYME LABORATORIES
      • Recent Revenue History
    • EURO DIAGNOSTICA AB
      • Recent Revenue History
      • Market Expansion
    • GENALYTE INC.
      • Recent Revenue History
    • GOLD STANDARD DIAGNOSTICS
    • INOVA DIAGNOSTICS, INC.
      • Recent Revenue History
    • MATRIX-BIO INC.
    • OASIS DIAGNOSTICS CORPORATION
    • OPKO DIAGNOSTICS
      • Recent Revenue History
    • PRONOTA NV
    • QUANTERIX CORPORATION
      • Tests in Development
    • RESPONSE BIOMEDICAL CORP.
      • Recent Revenue History
    • SERA PROGNOSTICS, INC.
  • Company Profiles: Information Technology Specialists
    • CARTAGENIA
    • CERNER CORP.
    • CLC BIO
      • Recent Revenue History
    • COLLABRX INC.
    • CONNECTEDHEALTH PTE. LTD.
    • IBM HEALTHCARE
    • INTEL CORPORATION
    • KAISER PERMANENTE
    • MEDISAPIENS LTD.
    • PERSONALIS INC.
  • Company Profiles: Microbiology Specialists
    • ADVANDX, INC.
      • Recent Revenue History
    • CO-DIAGNOSTICS HBDC
    • COPAN DIAGNOSTICS INC.
      • Recent Revenue History
    • CURETIS AG
    • DXNA, LLC
    • ENIGMA DIAGNOSTICS LIMITED
    • EPISTEM HOLDINGS PLC
    • FOCUS DIAGNOSTICS, INC.
      • Recent Revenue History
    • GREAT BASIN SCIENTIFIC, INC.
    • HAIN LIFESCIENCE GMBH
      • Recent Revenue History
    • HUTMAN DIAGNOSTICS AG
      • Recent Revenue History
    • IMMUNEXPRESS GROUP
    • INBIOS INTERNATIONAL, INC.
    • INTELLIGENT MEDICAL DEVICES, INC. (IMDX)
      • Recent Revenue History
    • LABORATORIOS CONDA
    • LIOFILCHEM S.R.L.
      • Recent Revenue History
    • LOPHIUS BIOSCIENCES GMBH
    • LUMORA
    • MAST GROUP LTD.
      • ID/AST
      • Immunoassays
      • Molecular
    • MBIO DIAGNOSTICS, INC.
    • MERIDIAN BIOSCIENCE, INC.
      • Recent Revenue History
      • Immunoassays
      • illumigene Molecular
      • Meridian Life Science
    • MIACOM DIAGNOSTICS GMBH
    • MOBIDIAG LTD
    • NANOSPHERE, INC.
      • Recent Revenue History
      • Market Expansion
    • PATHOGENICA
    • SEEGENE, INC.
      • Recent Revenue History
      • Instrumentation
      • Collaborations
    • SPECIFIC TECHNOLOGIES
  • Company Profiles: Molecular Test Specialists
    • AMOY DIAGNOSTICS CO. LTD.
      • Recent Revenue History
    • ASURAGEN INC.
      • Recent Revenue History
      • Controls
      • Sample Collection
      • Sequencing
    • BGI (formerly Beijing Genome Institute)
      • Recent Revenue History
      • BGI Projects
    • BIOCARTIS SA
      • Connectivity
      • Instrumentation
      • Collaborations
      • Idylla News
    • BIOFORTUNA LTD.
    • DIACARTA INC.
    • ENZO BIOCHEM INC.
      • Recent Revenue History
      • IP Situation
    • EPIGENOMICS
      • Recent Revenue History
    • EXOSOME DIAGNOSTICS
    • GENIA TECHNOLOGIES INC.
    • GENMARK DIAGNOSTICS
      • Recent Revenue History
    • HTG MOLECULAR DIAGNOSTICS (formerly High Throughput Genomics)
      • Recent Revenue History
    • INCELLDX, INC.
      • Recent Revenue History
    • INFORM GENOMICS
    • NANOSTRING TECHNOLOGIES, INC.
      • Recent Revenue History
    • QUANTUMDX GROUP LIMITED
    • RAINDANCE TECHNOLOGIES, INC.
      • Recent Revenue History
      • Collaborations
    • SELVENTA
    • TESSARAE, LLC
      • Recent Revenue History
    • TROVAGENE, INC.
      • Recent Revenue History
  • Company Profiles: Point of Care Test Specialists
    • 1ST HEALTH PRODUCTS LTD.,
    • ABAXIS, INC.
      • Recent Revenue History
    • AEROCRINE AB
    • ARBOR VITA CORPORATION
    • ATOMO DIAGNOSTICS
    • BIOLYTICAL LABORATORIES
      • Recent Revenue History
    • CHEMBIO DIAGNOSTIC SYSTEMS, INC.
      • Recent Revenue History
      • In Brazil
    • COUNSYL CONSUMER
      • Recent Revenue History
    • DIASSESS INC
    • EKF DIAGNOSTICS HOLDINGS PLC
      • Recent Revenue History
      • Molecular
    • GENTLE LABORATORIES
    • GLYSBY S.N.C.
    • INTRAMED DIAGNOSTICS, LLC
    • LEUCODX
    • LUOXIS DIAGNOSTICS INC.
    • MAXIM BIOMEDICAL, INC.
    • MEDMIRA INC.
      • Recent Revenue History
    • MODE DIAGNOSTICS, LTD
      • Recent Revenue History
    • NEC CORPORATION
    • ORASURE TECHNOLOGIES, INC.
      • Recent Revenue History
    • PIXIE SCIENTIFIC
    • RADISENS DIAGNOSTICS LTD.
    • SAMSUNG HEALTHCARE
    • STDCHECK.COM
      • Recent Revenue History
    • UDOTEST
  • Company Profiles: Prenatal Test Service Providers
    • ARIOSA DIAGNOSTICS, INC.
      • Recent Revenue History
      • IP Status
    • BERRY GENOMICS CO. LTD
    • CELLSCAPE CORPORATION
      • Recent Revenue History
    • GENEPEEKS, INC.
    • GENOMED AG
    • GOOD START GENETICS, INC.
    • ILLUMINA
      • Recent Revenue History
    • INEX (INNOVATIONS EXCHANGE PTE LTD)
    • KELLBENX INC.
    • NATERA
      • Recent Revenue History
    • NIPD GENETICS LTD
    • SEQUENOM INC.
      • Recent Revenue History
      • Market Expansion
      • Coagulation
      • IP Issues
    • SERA PROGNOSTICS, INC.
  • Company Profiles: Test Service Providers
    • 23ANDME
      • Recent Revenue History
    • ADAPTIVE BIOTECHNOLOGIES CORPORATION
    • AGENDIA BV
      • Recent Revenue History
    • AMBRY GENETICS
      • Recent Revenue History
    • ARUP LABORATORIES
      • Recent Revenue History
    • ASSUREX HEALTH
      • Recent Revenue History
    • ATHENA DIAGNOSTICS
      • Recent Revenue History
    • BIOREFERENCE LABORATORIES, INC. (BRLI)
      • Recent Revenue History
    • BOULDER DIAGNOSTICS INC.
    • CANCER GENETICS, INC. (CGI)
      • Recent Revenue History
    • CARDIODX, INC.
    • CLARIENT DIAGNOSTIC SERVICES, INC.
      • Recent Revenue History
    • COMBIMATRIX CORP.
      • Recent Revenue History
    • DIATHERIX LABORATORIES INC.
    • GENOMIC HEALTH, INC.
      • Recent Revenue History
      • Market Uptake
      • Sequencing
    • IMUGEN INC.
    • LAB21 LIMITED
      • Recent Revenue History
    • LIPOSCIENCE INC.
      • Recent Revenue History
    • MAYO MEDICAL LABORATORIES
      • Recent Revenue History
    • MDXHEALTH SA
      • Recent Revenue History
    • MEDICAL DIAGNOSTIC LABORATORIES L.L.C. (MDL)
    • METABOLISTICS INC.
    • METABOLON, INC.
    • METAMARK GENETICS INC.
    • ONCOPLEXDX (formerly Expression Pathology Inc.)
    • ROSETTA GENOMICS LTD.
      • Recent Revenue History
    • SENGENICS INTERNATIONAL PTE LTD
    • VERACYTE, INC.
      • Recent Revenue History

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