Table of Contents
1: EXECUTIVE SUMMARY
Table 1-1: Exchange Rate Fluctuations, 2012–2016
MARKET TRENDS
Gene Editing
Liquid Biopsy
Table 1-2: Selected Liquid Biopsy Innovations
Microbiome
Patient Service Center Revival
IVD Companies Mix and Match
Table 1-3: Selected Menu Expansion by Partnering and Acquisitions
Direct to the Consumer Genomics
Looking to the East
2: TOP 25 IVD COMPANIES – CORPORATE PROFILES
ABBOTT DIAGNOSTICS
Table 2-1: Abbott Recent Revenue History, 2013-2017 ($ million)
Table 2-2: 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 2-3: Alere Recent Revenue History, 2013-2017 (total Dx, $ million)
Table 2-4: 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 2-5: Beckman Coulter, Inc. / Danaher Recent Revenue History, 2011-2017 ($ million, estimated)
Table 2-6: 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 2-7: Becton, Dickinson and Company (BD) Recent Revenue History, 2013-2017 (diagnostic systems, $ million)
Table 2-8: BD’s Revenue in Selected IVD Test Segments ($ million, estimated), 2013 (Molecular, Microbiology ID/AST, Microbiology media, Rapid Tests, Blood Culture)
Table 2-9: 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 2-10: Bio-Rad Laboratories Recent Revenue History, 2013-2017 (all diagnostics, $ million, estimated)
Table 2-11: 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 2-12: bioMérieux Recent Revenue History, 2013-2017 (Total IVDs, $ million)
Table 2-13: 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 2-14: Cepheid Recent Revenue History, 2013-2017 (clinical product sales, $ million)
Tuberculosis
Microbiology
Influenza
POC HIV
Cancer
DANAHER CORPORATION
Table 2-15: Danaher Corp. Recent Revenue History, 2014-2017 ($ million – diagnostics – most recent years for which data is available, estimated)
Table 2-16: 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 2-17: Radiometer Recent Revenue History, 2012-2016 (estimated, core products, $ million)
Radiometer, POC
Radiometer, Critical Care
Radiometer, Immunoassays
GRIFOLS
Recent Revenue History
Table 2-18: 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 2-19: Hologic Recent Revenue History, 2013-2017 (total Dx; $ million)
Table 2-20: 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 2-21: 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 2-22: Instrumentation Laboratory (IL) Recent Revenue History, 2012-2016 ($ million)
Table 2-23: 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 2-24: LabCorp Recent Revenue History, 2013-2017 ($ millions)
LabCorp Buys Sequenom
Diagnostics Services
Prenatal
Retail Outlets
LUMINEX CORPORATION
Table 2-25: Luminex Recent Revenue History, 2013-2016 ($ million)
Assay Development
Verigene Business
Business Expansion
ORTHO CLINICAL DIAGNOSTICS (OCD)
Table 2-26: Ortho Clinical Diagnostics (OCD) Recent Revenue History, 2012-2016 ($ million, estimated) .. 122
Table 2-27: 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 2-28: PerkinElmer Recent Revenue History, 2014-2017 ($ million, estimated)
Diagnostics
Sequencing
Histology
Prenatal Business
Lab Services
Expansion
QIAGEN N.V.
Table 2-29: QIAGEN Recent Revenue History, 2013-2017 ($ million)
Table 2-30: 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 2-31: 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 2-32: Quidel Recent Revenue History, 2013-2016 ($ million)
Immunoassays
The Solana Business
ROCHE DIAGNOSTICS
Table 2-33: Roche Diagnostics Recent Revenue History, 2011-2017 ($ millions)
Table 2-34: 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 2-35: Ventana Recent Revenue History, 2013-2017 ($ million)
PHILIPS
Histology
Cancer Genomics
Patient Monitoring
Point of Care
Wearable Self Monitor
SIEMENS HEALTHINEERS
Table 2-36: Siemens Recent Revenue History, 2012-2015 (total IVD; $ million)
Table 2-37: 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 2-38: Sysmex Recent Revenue History, 2012-2017 ($ million)
Table 2-39: 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 2-40: Thermo Fisher Recent Revenue History, 2013-2016 (clinical diagnostics, $ million)
Table 2-41: Thermo Fisher Product Sales in Selected Test Segments, 2015-2016 ($ million) (Clinical products, Immunoassays, Microbiology, Histology)
Immunoassays
Microbiology
Molecular Test Business
Oncology Companion Diagnostics
Zika
Transplant Medicine
Quality Control IT
Point of Care
Mass Spectrometry
Forensic
Expansion
Research
3: OTHER IVD COMPANY NOTABLE
EVENTS
Table 3-1: Selected New Products
