The Top 25 IVD Companies: Revenue Performance, Products, Strategies, Market Activities

IVD Market Top 25 Companies: Revenue Performance, Products, Competitive Activity


IVD Market Top 25 Companies presents advancements in in vitro diagnostics (IVD) by the Top 25 firms in the industry and provides an overview of the most recent trends and developments.   Companies included are:
  •  Alere Inc.
  •  Arkray
  •  Beckman Coulter / Danaher
  •  Becton Dickinson
  •  Bio-Rad Laboratories
  •  bioMérieux
  •  Cepheid / Danaher
  •  Danaher Corp. (including Radiometer A/S)
  •  Grifols
  •  Hologic
  •  Illumina
  •  Instrumentation Laboratory / Werfen
  •  LabCorp, Laboratory Corporation of America
  •  Luminex
  •  Ortho Clinical Diagnostics
  •  PerkinElmer
  •  Qiagen N.V.
  •  Quest Diagnostics
  •  Quidel
  •  Roche Diagnostics (including Ventana Medical Systems)
  •  Philips
  •  Siemens Healthineers
  •  Sysmex Corporation
  •  Thermo Fisher Scientific

 The report examines the major manufacturers in the IVD industry in terms of
  • Recent Revenue History and Commentary
  • Business Overview 
  • Revenue in Selected Test Segments
  • Current and New Products
  • Competitive Activity: M&A, Partnerships and Other Moves
In addition to the in-depth company information, the report examines market trends, including those involving gene editing, liquid biopsy, microbiome, patient service center revival, partnering and acquisitions, direct to consumer genomics, and growing IVD company activity in Asia, Africa, and Latin America.

IVD Market Top 25 Companies also presents highlights of IVD industry developments as demonstrated by a selection of small and niche firms in 2016 and the first half of 2017, which are preparing for the future with the development of next generation systems, informatics to help labs manage and retrieve test data, new infectious disease diagnostics, and gene-based oncology tests for targeted therapeutics.

This report on the advancements in in vitro diagnostics at the hands of the major companies provides an overview of the most recent trends and developments in the industry.  It is not a comprehensive review of the diagnostics industry in general.  

Clinical laboratory technology has changed dramatically in the past few years, due to the publication of the human genome project and advances in functional genomics, bioinformatics, miniaturization and microelectronics.  Not five years ago it would have been almost inconceivable to see research technologies such as genome sequencing and mass spectroscopy play a pivotal role in improving lab medicine.  Their influence is felt in personalized medicine, inherited diseases, pathogen detection, antibiotic resistance testing, blood banking and much more to come. 

The top five majors continue to bring innovations to clinical diagnostics.  However, of particular interest in the past year or so are the efforts made by companies such as Bio-Rad Laboratories, Illumina and Thermo Fisher Scientific.  These and other companies are translating their portfolio of research-based molecular solution to clinical tools. 
A review of the advancements reported by the major IVD companies included in this report shows innovations in CRISPR gene editing that is being adapted to the diagnosis of problematic diseases and the development of new therapeutics. 


  • Executive Summary
    • Table Exchange Rate Fluctuations, 2012-2016
    • Market Trends
      • Gene Editing
      • Liquid Biopsy
        • Table Selected Liquid Biopsy Innovations
      • Microbiome
      • Patient Service Center Revival
      • IVD Companies Mix and Match
        • Table Selected Menu Expansion by Partnering and Acquisitions
      • Direct to the Consumer Genomics
      • Looking to the East
  • Top 25 IVD Companies - Corporate Profiles
    • Abbott Diagnostics
      • Table Abbott Recent Revenue History, 2013-2017 ($ million)
      • Table Abbott's Revenue in Selected Test Segments, 2013-2017 ($ million) (Histology (Vysis), Chem/Immuno, Hematology, Molecular, Point of Care, Diabetes)
      • 2016/2017 Business Highlights
      • Alere Acquisition Update
      • Core Lab
      • Coagulation
      • Infectious Diseases - Molecular
      • Diabetes
      • iSTAT Business
      • Companion Testing
      • Zika
    • Alere Inc.
      • Table Alere Recent Revenue History, 2013-2017 (total Dx, $ million)
      • Table Alere Revenue by IVD Test Segment, 2013-2017 ($ million) (Cardiac Markers, Infectious Diseases, Toxicology, Diabetes- Arriva, Other)
      • Innovation Milestones
      • Abbott Acquisition Update
      • Diabetes
      • HIV
      • Alere Reader
      • Coagulation
      • Molecular POC
      • Market Expansion
    • Arkray
      • Recent Revenue History
      • Molecular
      • Immunoassays
      • Urinalysis
      • Diabetes
    • Beckman Coulter, Inc. / Danaher
      • Table Beckman Coulter, Inc. / Danaher Recent Revenue History, 2011-2017 ($ million, estimated)
      • Table Beckman Coulter's Revenue in Selected Test Segments ($ million, estimated), 2011-2016 (Routine Chemistry, Immunoassays, Hematology, Microbiology)
      • Hematology
      • Clinical Chemistry
      • Immunoassays
      • Coagulation
      • Lab Management
      • Flow Cytometry
      • Research
    • Becton, Dickinson and Company (BD)
      • Table Becton, Dickinson and Company (BD) Recent Revenue History, 2013-2017 (diagnostic systems, $ million)
      • Table BD's Revenue in Selected IVD Test Segments ($ million, estimated), 2013 (Molecular, Microbiology ID/AST, Microbiology media, Rapid Tests, Blood Culture) 2013
      • Table BD's Flow Cytometry Revenue ($ million, estimated), 2012-2015
      • Cytology
      • BD Max Molecular
      • ID/AST
      • POC Veritor
      • Mass Spectrometry
      • Blood Collection
      • Flow Cytometry
      • Licensing
    • Bio-Rad Laboratories, Inc.
      • Table Bio-Rad Laboratories Recent Revenue History, 2013-2017 (all diagnostics, $ million, estimated)
      • Table Bio-Rad's Revenue in Selected Product Segments ($ million, estimated), 2012-2016 (Quality Control, Immunoassays, Microbiology (all), Blood Bank)
      • Quality Control
      • Blood Bank
      • Infectious Diseases - Molecular
      • Immunoassays
      • Liquid Biopsy
      • Microbiome
      • Droplet Digital PCR
      • Sequencing
    • bioMérieux Inc.
      • Table bioMérieux Recent Revenue History, 2013-2017 (Total IVDs, $ million)
      • Table bioMérieux's Revenue in Selected IVD Test Segments ($ million), 2013-2017 (Microbiology, Immunoassays, Molecular, FilmArray)
      • Traditional Microbiology
      • Blood Culture
      • Immunoassays
      • Mass Spectrometry
      • Platelet Safety
      • Sequencing
      • Sequencing - Sample Preparation, Molecular
      • Data Analysis
      • BioFire Diagnostics Business
    • Cepheid / Danaher
      • Table Cepheid Recent Revenue History, 2013-2017 (clinical product sales, $ million)
      • Tuberculosis
      • Microbiology
      • Influenza
      • POC HIV
      • Cancer
    • Danaher Corporation
      • Table Danaher Corp. Recent Revenue History, 2014-2017 ($ million - diagnostics - most recent years for which data is available, estimated)
      • Table Danaher’s Revenue in Selected Business Segments, 2013-2017 ($ million, estimated)
      • For 2016 vs 2015, Danaher Reported
      • Beckman Coulter
      • Radiometer
      • Leica Biosystems
      • Cepheid
      • Radiometer A/S Profile
        • Table Radiometer Recent Revenue History, 2012-2016 (estimated, core products, $ million)
      • Radiometer, POC
      • Radiometer, Critical Care
      • Radiometer, Immunoassays
    • Grifols
      • Recent Revenue History
        • Table Grifols Diagnostic Product Revenues, 2012-2017 ($ million, estimated) (Core, Blood Screen, Total)
      • 2016 Summary as Reported by Grifols
      • Blood Transfusion Business
      • Blood Bank CLIA Lab
      • Coagulation
      • Acquisitions and Collaborations
    • Hologic, Inc.
      • Table Hologic Recent Revenue History, 2013-2017 (total Dx; $ million)
      • Table Hologic's Revenue in Selected Segments ($ million), 2013-2017 (HPV (legacy), ThinPrep/cytology, Molecular, Blood Bank)
      • Panther Molecular System
      • Panther Fusion
      • Blood Bank - Zika Virus
      • Collaboration
    • Illumina
      • Table Illumina Recent Revenue History, 2013-2017 ($ million - not all revenues are for clinical products and services [estimated])
      • Reported 2016 Summary
      • Sequencing
      • Microarrays
      • Project Firefly
      • Grail Liquid Biopsy
      • Forensic Medicine
      • Prenatal Testing Business
    • Instrumentation Laboratory (IL) / Werfen
      • Table Instrumentation Laboratory (IL) Recent Revenue History, 2012-2016 ($ million)
      • Table IL’s Revenue in Selected Product Segments ($ million), 2012-2016 (Coagulation, Critical Care)
      • Expansion
      • Coagulation
      • Critical Care
      • Information Technology
    • LabCorp, Laboratory Corporation of America
      • Table LabCorp Recent Revenue History, 2013-2017 ($ millions)
      • LabCorp Buys Sequenom
      • Diagnostics Services
      • Prenatal
      • Retail Outlets
    • Luminex Corporation
      • Table Luminex Recent Revenue History, 2013-2016 ($ million)
      • Assay Development
      • Verigene Business
      • Business Expansion
    • Ortho Clinical Diagnostics (OCD)
      • Table Ortho Clinical Diagnostics (OCD) Recent Revenue History, 2012-2016 ($ million, estimated)
      • Table OCD's Revenue in Selected Test Segments ($ million), 2015 (Immunoassays, Chemistry, Blood Grouping)
      • Blood Bank
      • Core Lab / Immunoassays
      • Lab Automation
      • Connectivity
    • PerkinElmer, Inc. (PE)
      • Table PerkinElmer Recent Revenue History, 2014-2017 ($ million, estimated)
      • Diagnostics
      • Sequencing
      • Histology
      • Prenatal Business
      • Lab Services
      • Expansion
    • QIAGEN N.V.
      • Table QIAGEN Recent Revenue History, 2013-2017 ($ million)
      • Table QIAGEN Molecular IVD Product Revenues ($ million), 2013-2017 (HPV, TB, Other Molecular, Total IVD)
      • Tuberculosis
      • Companion Diagnostics
      • Digital Sequencing
      • Bioinformatics
      • Liquid Biopsy
      • Cervical Cancer
      • Transplant medicine
      • Forensic
      • Expansion
    • Quest Diagnostics
      • Table Quest Diagnostics Recent Revenue History, 2010-2016 ($ million)
      • Highlights from 2016
      • Diagnostic Services
      • Oncology
      • Infectious Diseases
      • Prenatal and Women’s Health
      • Neurology
      • Retail / Direct to Consumer
    • Quidel Corporation
      • Table Quidel Recent Revenue History, 2013-2016 ($ million)
      • Immunoassays
      • The Solana Business
    • Roche Diagnostics
      • Table Roche Diagnostics Recent Revenue History, 2011-2017 ($ millions)
      • Table Roche's Revenue in Selected Test Segments, 2013-2016 ($ millions, estimated) (Chemistry/Immuno, Diabetes, Molecular, Histology)
      • 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
      • Roche’s Ventana Medical Systems Inc.
        • Table Ventana Recent Revenue History, 2013-2017 ($ million)
    • Royal Philips
      • Histology
      • Cancer Genomics
      • Patient Monitoring
      • Point of Care
      • Wearable Self Monitor
    • Siemens Healthineers
      • Table Siemens Recent Revenue History, 2012-2015 (total IVD; $ million)
      • Table Siemens’ IVD Product Sales in Selected Test Segments, 2012-2015 ($ million) (Chemistry/Immunoassays, Coagulation, Hematology, Molecular, Urinalysis, Blood Gases)
      • Business Expansion
      • Lab Automation
      • Coagulation
      • Immunoassays
      • Molecular
      • POC Connectivity
    • Sysmex Corporation
      • Table Sysmex Recent Revenue History, 2012-2017 ($ million)
      • Table Sysmex's Product Sales in Selected Test Segments, 2013-2016 ($ million) (Hematology, Coagulation, Urinalysis)
      • Business Expansion
      • Hematology
      • Coagulation
      • Urinalysis
      • Forging New Markets
      • Sysmex Inostics
    • Thermo Fisher Scientific Inc.
      • Table Thermo Fisher Recent Revenue History, 2013-2016 (clinical diagnostics, $ million)
      • Table Thermo Fisher Product Sales in Selected Test Segments, 2015-2016 ($ million) (Clinical products, Immunoassays, Microbiology, Histology) 2015 2016
      • Immunoassays
      • Microbiology
      • Molecular Test Business
      • Oncology Companion Diagnostics
      • Zika
      • Transplant Medicine
      • Quality Control IT
      • Point of Care
      • Mass Spectrometry
      • Forensic
      • Expansion
      • Research
  • Notable Other Company Events
    • Table Selected New Products

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