Table of Contents
ONE: EXECUTIVE SUMMARY
The Global In Vitro Diagnostics Market Outlook
Scope And Methodology
Size And Growth of The Market
IVD Product Sales
Table 1-1: Global IVD Product (Reagent, Instruments, Other Supplies) Sales by Test Type In $ Millions, 2016-2021
IVD Procedure Volume
Figure 1-1: IVD Procedure Volumes by Type, 2016
Table 1-2: Global IVD Procedural Volume by Test Type In Millions, 2016-2021
Figure 1-2: IVD Procedures by Type, 2016-2021
Figure 1-3: IVD Procedures by Type, percentage
Figure 1-4: IVD Product Sales by Type, percentage
Unit Test Prices
Table 1-3: Global IVD Product Sales per Procedure by Test Type In Dollars, 2016-2021
TWO: INTRODUCTION
IVD Testing Trends
IVD Testing Venues
Global Market Environment
Demographic Patterns
World Healthcare Trends
THREE: REGIONAL MARKET TEST PROCEDURE VOLUME ANALYSIS
Global Overview
Table 3-1: Global IVD Procedural Volume by Country/Region In Millions, 2016-2021
United States
Canada
Healthcare Environment
Mexico
Healthcare Environment
Western Europe
Healthcare Environment
France
Germany
Italy
Spain
United Kingdom
Other Western Europe
Asia/Pacific
Healthcare Environment
Australia
China
India
Japan
Other Asia/Pacific
Brazil
Healthcare Environment
Other Central & South America
Healthcare Environment
Russia
Healthcare Environment
Other Eastern Europe
Healthcare Environment
Africa/Mideast
Healthcare Environment
FOUR: POINT OF CARE TEST VOLUME AND PRICING ANALYSIS
Global POC Procedure Volume by Test Type
Glucose
Pregnancy/Ovulation
Colorectal Cancer Screening
Coagulation
Drugs of Abuse
Cholesterol
HIV
- Pylori
OTC POC
Professional POC
Table 4-1: Global Point-of-Care (Poc) IVD Procedural Volume In Millions, 2016-2021
Types of Tests
Otc Poc Tests
Table 4-2: Global Over-The-Counter (Otc) Procedural Volume by Test Type In Millions, 2016-2012
FIVE: CORE LABORATORY TEST VOLUME AND PRICING ANALYSIS
Types of Tests
Blood Gas Analysis
Urinalysis
Cardiac Markers
Allergy
Tumor Markers
Proteins
Vitamin D
Autoimmune
Diabetes/HbA1c
Thyroid
Anemia
Drugs of Abuse
Therapeutic Drug Monitoring
Fertility
Table 5-1: Global Core Laboratory Procedural Volume by Test Type In Millions, 2016-2021
Clinical Chemistry Procedures
Immunoassay Procedures
Applications
Core Laboratory IVD Product Sales
Table 5-2: Global Core Laboratory IVD Product Sales by Test Type In $ Million, 2016-2021
Worldwide In Vitro Diagnostic Market: Procedure Volumes And Pricing Analysis
Cost & Pricing Trends
Table 5-3: Global Core Laboratory – IVD Product Sales per Procedure by Test Type In Dollars, 2016-2021
SIX: MOLECULAR ASSAYS
Table 6-1: Molecular Assay Procedural Volume by Test Type In Millions, 2016-2021
Types of Test
Testing Technologies
Infectious Diseases
Table 6-2: Global Molecular Infectious Disease Assay Procedural Volume by Test Type In Millions, 2016-2021
Healthcare-Associated Infections
Hepatitis
HIV
Sexually Transmitted Diseases
Respiratory Infections
Other
NAT Blood Screening
Cancer
Transplant Matching
Inherited Diseases
Other Molecular Assays
Global Sales by Test Type & Market
Table 6-3: Global Molecular Assay IVD Product Sales by Test Type In $ Million, 2016-2021
Pricing Trends
Table 6-4: Global Molecular Assays – IVD Product Sales per Procedure In Dollars, 2016-2019
SEVEN: HEMATOLOGY TEST VOLUME AND PRICING ANALYSIS
Complete Blood Count (CBCs)
Other Hematology Tests
Table 7-1: Global Hematology Procedural Volume by Test Type In Millions, 2016-2021
Types of Tests
Global Sales of Hematology Products
Table 7-2: Global Hematology IVD Product Sales by Test Type In $ Million, 2016-2021
Pricing Trends
Table 7-3: Global Hematology IVD Product Sales per Procedure In Dollars, 2016-2021
EIGHT: COAGULATION TEST VOLUME AND PRICING ANALYSIS
Table 8-1: Global Coagulation Procedural Volume by Test Type In Millions, 2016-2021
Types of Tests
Prothrombin Time (PT/INR)
Other Coagulation Tests
Global Sales of Coagulation Products
Table 8-2: Global Coagulation IVD Products by Test Type In $ Million, 2016-2021
Pricing Trends
Table 8-3: Global Coagulation Procedures – IVD Product Sales per Procedure In Dollars, 2016-2021
NINE: MICROBIOLOGY TEST VOLUME AND PRICING ANALYSIS
Table 9-1: Global Microbiology Procedural Volume by Test Type In Millions, 2016-2021
Types of Tests
Chromogenic Media
Automated Panels & Reagents
Manual Panels & Reagents
Worldwide In Vitro Diagnostic Market: Procedure Volumes And Pricing Analysis
Blood Culture
Rapid Microbiological Tests
Global Sales of IVD Microbiology Products
Table 9-2: Global Microbiology Procedures IVD Product Sales by Test Type In $ Million, 2016-2021
Pricing Trends
Table 9-3: Global Microbiology Procedures – IVD Product Sales per Procedure by Test Type In Dollars, 2016-2021
TEN: BLOOD TYPING / GROUPING TEST VOLUME AND PRICING ANALYSIS
Type of Tests
Table 10-1: Global Blood Grouping Procedural Volume In Millions, 2016-2021
Global Abo Blood Grouping Product Sales
Table 10-2: Global IVD Blood Grouping Sales In $ Million, 2016-2021
Pricing Trends
Table 10-3: Blood Grouping Procedures – IVD Products per Procedure, 2016-2021
ELEVEN: HISTOLOGY AND CYTOLOGY TEST VOLUME AND PRICING ANALYSIS
Table 11-1: Global Histology/Cytology Procedural Volume by Test Type In Millions, 2016-2021
Types of Tests
Pap Tests
Immunohistochemistry Tests
In Situ Hybridization
Other Histology/Cytology Tests
Histology/Cytology IVD Product Sales
Table 11-2: Global Histology/Cytology IVD Product Sales by Test Type In $ Millions, 2016-2021
Pricing Trends
Table 11-3: Global Histology/Cytology – IVD Sales per Procedure by Test Type In Dollars, 2016-2021
TWELVE: CORPORATE PROFILES AND COMPANY TEST PROCEDURE VOLUME SHARES
Introduction
Table 12-1 Global Sales And Procedural Volumes of Leading IVD Manufacturers, 2016
ROche
Overview
Diabetes Care
Molecular Diagnostics
Tissue Diagnostics
Table 12-2: Roche Estimated Global IVD Product Sales by Product Group In $ Million, 2016
Table 12-3: Roche Estimated Global IVD Procedural Volume by Product Group In Millions, 2016
Centralized and Point of Care Solutions
Abbott Laboratories
Overview
Core Laboratory Products
Molecular Products
Point of Care Products
Diabetes Care Products
Worldwide In Vitro Diagnostic Market: Procedure Volumes And Pricing Analysis
Table 12-4: Abbott Laboratories Estimated Global IVD Product Sales by Product Group In $ Million, 2016 183
Table 12-5: Abbott Laboratories Estimated Global IVD Procedural Volume by Product Group In Millions
Siemens AG
Overview
Clinical Chemistry
Drug Testing Immunoassays
Hematology
Hemostasis
Urinanalysis
Molecular Diagnostics
Point-of-Care Testing
Table 12-6: Siemens Healthineers Estimated Global IVD Product Sales by Product Group In $ Million, 2016
Table 12-7: Siemens Healthineers Estimated Global Share of IVD Procedural Volume by Product Group In Millions, 2016
Danaher
Beckman Coulter
Cepheid
Leica Biosystems
Radiometer
Table 12-8: Danaher Estimated Global IVD Product Sales by Product Group In $ Million, 2016
Table 12-9: Danaher Estimated Global IVD Procedural Volume by Product Group In Millions, 2016
Thermo Fisher Scientific
Clinical Diagnostics
Immunodiagnostics
Microbiology
Anatomical Pathology
Transplant Diagnostics
Table 12-10: Thermo Fisher Scientific Estimated Global IVD Product Sales by Product Group In $ Million, 2016
Table 12-11 Thermo Fisher Scientific Estimated IVD Procedural Volume by Product Group In Millions, 2016
Alere
Table 12-12: Alere Estimated Global IVD Product Sales by Product Group In $ Million, 2016
Table 12-13: Alere Estimated Global IVD Procedural Volume by Product Group In Millions, 2016
Professional Diagnostics
Worldwide In Vitro Diagnostic Market: Procedure Volumes And Pricing Analysis
Consumer Diagnostics
BD Becton, Dickinson and Company
Table 12-14: Becton Dickinson Estimated Global IVD Product Sales by Product Group In $ Million, 2016 . 217
Table 12-15: Becton Dickinson Estimated Global IVD Procedural Volume by Product Group In Millions, 2016
Bd Diagnostic Systems
Bd Biosciences
Sysmex
Table 12-16: Sysmex Estimated Global IVD Product Sales by Product Group In $ Million, 2016
Table 12-17 Sysmex Estimated Global IVD Procedural Volume by Product Segment In Millions, 2016
Hematology
Coagulation
Other IVD Products & Services
Biomerieux
Table 12-18: Biomérieux Estimated Global IVD Product Sales
by Product Group In $ Million, 2016
Table 12-19: Biomérieux Estimated Global IVD Procedural Volume by Product Segment In Millions, 2016
Blood Culture
Immunoassay
Rapid Tests
Mass Spectrometry
Molecular
Bio-Rad Laboratories
Blood Virus
Diabetes Testing
Hemaglobinopathies
Immunohematology
Microbiology
Newborn Screening
Other Clinical Diagnostic Products
Table 12-20: Bio-Rad Laboratories Estimated Global IVD Product Sales
by Product Group In $ Million, 2016
Table 12-21: Bio-Rad Laboratories Estimated Global IVD Procedural
Volume by Product Group In $ Million, 2016
Autoimmune
Bioplex 2200 Multiplex Testing
Ortho Clinical Diagnostics
Clinical Chemistry/Immunoassay
Transfusion Medicine
Table 12-22: Ortho Clinical Diagnostics Estimated Global IVD Product Sales
by Product Group In $ Million, 2016
Worldwide In Vitro Diagnostic Market: Procedure Volumes And Pricing Analysis
Table 12-23: Ortho Clinical Diagnostics Estimated Global IVD Procedural Volume by Product Group, 2016
Hologic
Table 12-24: Hologic Estimated Global IVD Product Sales by Product Group In $ Million, 2016
Hologic Procedure Share
Table 12-25: Hologic Estimated Global IVD Procedural Volume by Product Group In Millions, 2016
Molecular Assays And Instruments
Thinprep System
Qiagen
Molecular Infectious Disease
Cancer Diagnostics
Transplant Diagnostics
Next-Generation Sequencing
Circulating Tumor Cells
Table 12-26: Qiagen Estimated IVD Product Sales by Product Segment In $ Million, 2016
Table 12-27: Qiagen Estimated IVD Procedural Volume by Product Segment In Millions, 2016
THIRTEEN: OTHER IVD COMPETITORS
Agilent Technologies
Eiken Chemical Company
Erba Diagnostics
Diasorin
Fujirebio Diagnostics
Molecular
Illumina
Sequencing
Sequencing Kits
Sample Prep
IVD Business
Oncology
HLA Typing
Information Technology
CRISPR
Forensics
CLIA Lab Service
Sample to Insight
Labcorp, Laboratory Corporation of America
Luminex Corporation
Menarini Diagnostics
Mindray Medical
Core Lab
Hematology
Coagulation
Myriad Genetics
Molecular Product News
Perkin Elmer
Newborn Testing
Prenatal Testing
Histology
Information Technology
India
China
Quest Diagnostics
Oncology
Infectious Diseases
Prenatal And Women’s Health
Quest Partners for Market Accessibility
Information Technology
Quidel Corporation
Immunoassays
Randox Laboratories
Royal Philips
Tosoh Corporation
Immunoassays
Trinity Biotech
Wako Pure Chemical Industries
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
