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Market Research Report

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

Published by Kalorama Information Product code 567992
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The Top 25 IVD Companies: Revenue Performance, Products, Strategies, Market Activities
Published: October 5, 2017 Content info: 235 Pages
Description

From the IVD Experts: Who's Winning, Who's Growing, Who's Launching Products, Who's Buying Whom?

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.

Authored by Shara Rosen, senior IVD analyst at Kalorama Information and author of The Worldwide Market for In Vitro Diagnostics Test, this report, IVD Market Top 25 Companies presents advancements in in vitro diagnostics (IVD) by the Top 25 companies in the industry and provides an overview of the most recent trends and developments.

Companies Profiled Include:

  • Abbott Diagnostics
  • Alere Inc.
  • Arkray
  • Beckman Coulter / Danaher
  • Becton Dickinson
  • Bio-Rad Laboratories
  • bioMe' rieux
  • 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

NOTABLE OTHER COMPANY EVENTS

This report examines the major companies 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

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.

MARKET TRENDS

While assembling the company information found in IVD Market Top 25 Companies: Revenue Performance, Products, Competitive Activity, several trends became apparent. The report reviews these trends. . . .

Gene Editing

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.

Liquid Biopsy

The report presents selected liquid biopsy innovations. For example, QIAGEN has been pioneering innovation in molecular testing and has recently put new muscle in the diagnosis and monitoring of cancer with non-invasive circulating tumor cell and cell free DNA (liquid biopsy). The potential of these technologies has attracted other major IVD companies to enter the market for these tests.

Microbiome

Intense research into the relationship of a person's population of normal flora and pathogenic invaders with the etiology and progression of disease states has been developed into microbiome-based molecular testing. At this time, most testing is available from service providers and for research.

Patient Service Center Revival

In 2017, various news reports have indicated that Quest Diagnostics (Quest) and Laboratory Corporation of America (LabCorp) have become more active and have been opening more patient service centers in grocery stores and retail pharmacies.

IVD Companies Mix and Match: Menu Expansion by Partnering and Acquisitions

Human genome research is providing areas of expansion for molecular testing. Decreases in life science funding in the U.S. has encouraged companies active in this space to migrate their technologies for clinical applications. The result is the entry of companies such as Illumina, Thermo Fisher Scientific, PerkinElmer and Affymetrix (now part of Thermo Fisher Scientific) to the diagnostics market. They have made investments to become “clinical” companies. These companies join expansion activity into new market segments by companies already involved in the IVD industry. The report provides a sampling of the initiatives that selected companies have taken to expand their product portfolio, particularly in molecular testing.

Direct to Consumer Genomics

The U.S. FDA has slowly relaxed its strict stance in the area of direct to consumer genome services and a number of new offerings have been commercialized.

Looking to the East

The repercussions of recent economic instability in North America and Europe are still very obvious at this time. In an effort to maintain growth, IVD companies have begun to look to markets outside their home and traditional geographies. The major IVD companies have been active in Asia, Africa, and Latin America for some time and have increased their efforts there.

IVD Market Top 25 Companies also presents highlights of IVD industry developments as demonstrated by a selection of small and niche companies in 2016 and the first half of 2017. Small companies are also 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.

Quantitative company data is provided in U.S. dollars for the years 2016 and the first half of 2017. No adjustments have been made to the market data for the effects of currency exchange fluctuations or inflation. Kalorama has decided to use a constant exchange rate because this provides a more accurate reflection of actual revenue growth in dollars rather than growth due to exchange rate fluctuations.

Table of Contents
Product Code: KLI15498064

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)
  • 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
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