Table of Contents
ONE: EXECUTIVE SUMMARY
Scope and Methodology
Size and Growth of the Market
Market Trends
TWO: INTRODUCTION
Report Design
Lab Medicine Disciplines and Applications
Market Analysis of IVD Market Segments
IVD Companies Mix and Match
Distribution Agreements
Licenses and Collaboration agreements
Test Services
Top Suppliers and Niche Players
IVDs Then and Now – A 20 Year Perspective
In the Beginning to Now
Surprises and Disappointments
Future
Point of View
THREE: OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC MARKETS
Background
Population and Disease Demographics Worldwide
Emerging Markets as a Market Driver
World Segments of the IVD Market and IVD Market Evolution
Specific Country Information
The United States of America
Japan
Europe: Slow Growth – Effects of Austerity
IVD Directive Update
China
India
Brazil
Russia
Canada
Saudi Arabia
Asia Review
FOUR: TRENDS AND INNOVATION
Background
Personal Genomics – A Work in Progress
Sequencing Enters the Clinic
Digital Technology, IT, BIG Data
Gene Editing
Wearables
Breath Test Advances
FIVE: POINT-OF-CARE TESTS
Overview and Trends
Professional POC
OTC Self Testing
Colon Cancer Screening
Lipid Testing
The Major POC Test Players
Diabetes Testing – Blood Glucose Monitoring
Glucose Testing in Tight Economics
IT to Aid Diabetes Management
Diabetes Market Analysis
Blood Glucose Self-Testing
Noninvasive Testing Devices
Continuous Self Testing en Route to the Artificial Pancreas
Blood Glucose Testing by Professionals
Diabetes Testing – Glycated Hemoglobin
Genes and Other Markers of Diabetes
SIX: THE CORE LAB
Core Lab Overview and Trends
Connectivity
Overview of Chemistry Tests
Lab Automation
Market Analysis
Rapid Response Systems
Critical Care Analysis
User Apps
Urinalysis
The Commercial Outlook for Chemistry Tests
SEVEN: IMMUNOASSAYS
Overview and Trends
Immunoassay Technology Continues to Evolve
Mass Spectrometry
Immunoassays in the Core Lab
Radioimmunoassays
Market Analysis
Leading Suppliers and Growth Potential
Mature Assay Segment
Thyroid Function
Therapeutic Drug Monitoring
Anemia
Toxicology/DAU
Allergy
Maturing Immunoassays
Proteins
Growth Immunoassays
Vitamin D
Tumor Markers
Cardiac Markers
Autoimmune
Rheumatoid Arthritis
Gastrointestinal Disorders
Transplant Management
Women’s Health
Alzheimer’s Disease
Miscellaneous
Point-of-Care OTC and Professional Use
Pregnancy Testing
Cardiovascular Diagnostics
Drugs of Abuse/Therapeutic Drug Monitoring
The Commercial Outlook for Immunoassays
EIGHT: MOLECULAR ASSAYS
Overview
Sample Preparation and Quality Control
Advanced Molecular Tests and Technologies
Exosome Sequencing
Liquid Biopsy
Metabolomic Profiling
Information Technology for Test Value
Forensic Studies – An Emerging Opportunity
Test Platforms
Major Players
Market Analysis
Oncology
Inherited Diseases
Prenatal and Newborn Testing
Tissue Typing
The Commercial Outlook for Molecular Tests
NINE: HEMATOLOGY
Overview of Hematology and Trends
Digital Image Analysis
Digital Evolution
Decentralized Hematology Testing
Hemoglobin/Hematocrit at the POC
Market Analysis: Leading Suppliers
The Commercial Outlook for Hematology Tests
TEN: COAGULATION
Overview and Trends of Coagulation and Immunohematology Tests
Special Topics
Direct Oral Anticoagulants (DOACs)
D-dimer
Market Analysis
Lab-based Testing
Genetic Markers of Hypercoagulopathies
Decentralized Coagulation Testing – Professional Use
Decentralized Coagulation Testing – OTC
Platelet Testing
Leading Suppliers
The Commercial Market for Coagulation Tests
ELEVEN: MICROBIOLOGY AND VIROLOGY
Overview
Special Topics
Some Disease Facts
Pregnancy Infections – Beyond Zika
Emerging Disease Threats
Antimicrobial Drug Resistance
Mass Spectrometry Not a Pipedream
Infection Screening Serology
Microbiome – Bacteria in Disease Processes
Market Analysis
Supplies
Chromogenic Media
Microbial Identification and Antimicrobial Sensitivity Tests
Automated Microbiology
Blood Culture
Rapid Tests
Immunoassays – Lab-based
Immunoassays – Rapid
Molecular Tests
The Commercial Outlook for Microbiology / Virology Tests
TWELVE: BLOOD BANKING SERVICES
Overview and Trends
are all these transfusions good medicine
Artificial blood
Pathogen Alerts
Platelet Safety
Market Analysis
Blood Grouping and Typing
Immunoassays
Nucleic Acid Testing (NAT)
The Commercial Outlook for Blood Banking
THIRTEEN: HISTOLOGY AND CYTOLOGY
Overview
Special Topics
Histology Automation
Advanced Analysis Solutions
HPV Goes Core Lab
Market Analysis
Histology/Cytology
Immunohistochemistry and In Situ Hybridization
Pharmacodiagnostic Histology
Digital Imaging and Computational Pathology
Circulating Tumor Cells
Flow Cytometry
The Commercial Outlook for Histology and Cytology Tests
FOURTEEN: COMPANY PROFILES: THE TOP TIER
Abbott Diagnostics
Recent Revenue History:
2014/2015 Business Highlights
Core Lab
Immunoassays
Hematology
Coagulation
Blood Bank
Point of Care
Diabetes
Molecular
IntelligentMDx Alliance
Iridica
Histology
Alere Inc
Recent Revenue History:
Alere in Africa
Product News
Microbiology
Molecular
Arkray
Recent Revenue History:
Urinalysis
Diabetes
Molecular
Beckman Coulter, Inc. / Danaher
Recent Revenue History:
Core Lab
Hematology
Immunoassays
Iris International
Microbiology
Molecular
Sequencing
Genomics
Information Technology
Flow Cytometry
Becton, Dickinson and Company (BD)
Recent Revenue History:
Traditional Microbiology
Blood Culture
Mass Spectrometry
Veritor System – Immunoassays
Histology
HPV
Molecular
The BD MAX Enterprise
Sequencing
Flow Cytometry
bioMérieux Inc
Recent Revenue History:
Traditional Microbiology
Blood Culture
Immunoassays
Rapid Tests
Oncology
Mass Spectrometry
Molecular Strategy
Sequencing Service
Expansion
Bio-Rad Laboratories, Inc
Recent Revenue History
Controls
Diabetes
Blood Bank
Immunoassays
Flow Cytometry
Digital PCR
Danaher Corporation
Recent Revenue History
Hologic, Inc
Recent Revenue History:
The Gen-Probe/PANTHER Business
Blood Bank
Quest Contract
Instrumentation Laboratory (IL)
Recent Revenue History: ($ millions)
Coagulation
Direct Oral Anticoagulant Testing (DOAC)
Coagulation Automation
Critical Care
Ortho Clinical Diagnostics (OCD)
Recent Revenue History:
Blood Bank
QIAGEN N.V
Recent Revenue History
Tuberculosis
Infectious Disease Testing
Transplant Medicine and HAIs
Personalized Healthcare
Companion Diagnostics
Liquid Biopsy/CTC
Instrumentation Base
Rotor-Gene Q – Clinical Diagnostics
Sequencing
Exosomes
Information Technology
Collaborations
Forensics
Radiometer A/S
Recent Revenue History:
Immunoassays
Hemocue AB
Roche Diagnostics
Recent Revenue History
New Enterprises
Global Access Program for HIV
Core Lab
Hematology
Immunoassays
Transplant Medicine
Diabetes
Point of Care
Core Molecular Tests
Virology
STDs
A POC Enterprise – Liat
Prenatal and cfDNA
HPV
Blood Bank
Liquid Biopsy
Personalized Medicine
Sequencing – Putting the Pieces Together
Siemens Healthcare Diagnostics
Recent Revenue History:
Core Lab
Immunoassays
Urinalysis
Critical Care
POC Connectivity
Hematology
Histology
Coagulation
Molecular
Companion Diagnostics
China
Sysmex Corporation
Recent Revenue History:
Hematology
Coagulation
Core Lab
Inostics GmbH
Flow Cytometry
Thermo Fisher Scientific Inc
Recent Revenue History:
Sequencing
Microbiology
Microbiology IT
Transplant
Quality Control
Mass Spectrometry
Point of Care
Molecular
Oncology
Forensic
Werfen Group S.A
FIFTEEN: Company Profiles: The Second Tier
Affymetrix Inc
Recent Revenue History
Axiom Genotyping Applications
Agilent Technologies
Recent Revenue History:
Agilent in Genomics
PCR
Sequencing
Arrays
Cepheid
Recent Revenue History:
Hospital Acquired Infections (HAI)
TB
Infectious Diseases
Virology
Oncology
Eiken Chemical Co., Ltd
Recent Revenue History:
ERBA Mannheim
ERBA Diagnostics, Inc
Recent Revenue History:
Product Expansion
DiaSorin S.p.A
Recent Revenue History:
Immunoassays
Molecular
Fujirebio Diagnostics, Inc
Recent Revenue History:
Molecular
Illumina
Recent Revenue History:
Understand Your Genome Symposium
Sequencing
Sequencing Kits
Sample Prep
IVD Business
Oncology
HLA Typing
Information Technology
CRISPR
Forensics
CLIA Lab Service
Sample to Insight
Making a Market
Expansion in China
LabCorp, Laboratory Corporation of America
Recent Revenue History:
Infectious Diseases
Prenatal
Sequencing
Oncology
Information Technology
Forensic
Expanding Food Testing
Luminex Corporation
Recent Revenue History: $ million
Business Expansion
MAGPIX Multiplexing
Next Generation NxTag
Menarini Diagnostics
Recent Revenue History:
Mindray Medical International Limited
Recent Revenue History:
Core Lab
Hematology
Coagulation
Myriad Genetics
Recent Revenue History: (millions)
Molecular Product News
Beyond Cancer
IP Update
PerkinElmer, Inc. (PE)
Recent Revenue History: ($ million, estimated)
Newborn Testing
Prenatal Testing
Histology
Information Technology
India
China
Quest Diagnostics
Recent Revenue History:
Oncology
Infectious Diseases
Prenatal and Women’s Health
Market Expansion
Insurance and Wellness Business
Quest Partners for Market Accessibility
Information Technology
Quidel Corporation
Recent Revenue History:
Point of Care
Immunoassays
Molecular
Lyra Product Line
Solana Molecular System
AmpliVue Product Line
Savanna (formerly Wildcat)
Randox Laboratories Ltd
Recent Revenue History:
Controls
Immunoassays
Molecular
Prenatal
POC
Royal Philips
Histology
Point of Care
TOSOH Corporation
Recent Revenue History
Immunoassays
Transasia Bio-Medicals Ltd
Trinity Biotech plc
Recent Revenue History
Wako Pure Chemical Industries, Ltd
Recent Revenue History
SIXTEEN: COMPANY PROFILES: BLOOD BANK SPECIALISTS
BloodSource
Cerus Corporation
Grifols
Clinical Analysis
Blood Transfusion Business
International Programs
Molecular
Haemokinesis Pty Ltd
Immucor, Inc
Transfusion Medicine
Transplant Diagnostics
IMMUCOR DX Laboratory Service
Micro Typing Concepts (MTC)
Quotient Limited
Traditional Blood Grouping
MosaiQ Platform
SEVENTEEN: COMPANY PROFILES: COAGULATION SPECIALISTS
Diagnostica Stago, S.A.S
Recent Revenue History
Instrumentation
Test Kits
Microvisk Technologies
EIGHTEEN: COMPANY PROFILES: CORE LAB AND OTHER COMPANIES
AB SCIEX Pte Ltd
Bruker BioSciences Corporation
Recent Revenue History
Microbiology
Tissue Analysis
EKF Diagnostics Holdings Plc
Recent Revenue History
Lab-based Assays
Molecular
EliTech Group S.A.S
MedTest DX
Microsaic Systems plc
Nova Biomedical
Diabetes
Scienion AG
Sekisui Diagnostics
Shimadzu Scientific Instruments
Tecan Group
Recent Revenue History
NINETEEN: COMPANY PROFILES: CTC & LIQUID BIOPSY TEST PROVIDERS
Angle plc
ApoCell, Inc
Biocept, Inc
Recent Revenue History
Menu Expansion
Reimbursement
Biodesix, Inc
Celsee Diagnostics (formerly DeNovo Sciences, Inc.)
Circulogene Theranostics
Clearbridge BioMedics
Cynvenio Biosystems, Inc
Epic Sciences Inc
Collaborations
Exosome Diagnostics, Inc
Fluxion Biosciences, Inc
Genyo – Centre for Genomics
Janssen Diagnostics, LLC (formerly Veridex, LLC)
Recent Revenue History
Menarini-Silicon Biosystems
Qiagen Hanover
Recent Revenue History
ScreenCell
WaveSense LLC
TWENTY: COMPANY PROFILES: DIABETES SPECIALISTS
Animas Corporation
Recent Revenue History
Ascensia Diabetes Care (formerly Bayer Diabetes Care)
Recent Revenue History
Bigfoot Biomedical
Cellnovo Group
Recent Revenue History
Debiotech SA
DexCom, Inc
Recent Revenue History
Dexcom Product Overview
Collaborations
Diasend AB
Recent Revenue History
Gentag, Inc
Gentag’s Patent Position
Glucosense Diagnostics Ltd
Glysure Limited
Glytec Inc
iHealth Lab Inc
Insulet Corporation
Recent Revenue History
Neighborhood Diabetes Inc
Integrity Applications Inc
LabStyle Innovations Corp
Recent Revenue History
Lifescan Inc
Recent Revenue History
IP Issues
Medtronic Inc
Recent Revenue History
Nemaura Medical, Inc
Nightscout
Nipro Diagnostics, Inc
Recent Revenue History:
Sanofi Diabetes
Recent Revenue History
Tandem Diabetes Care, Inc
Recent Revenue History
TypeZero Technologies
Verily (formerly Google Life Sciences)
TWENTY-ONE: COMPANY PROFILES: HEMATOLOGY (CELL ANALYSIS) SPECIALISTS
CellaVision AB
Recent Revenue History
Horiba Medical
Recent Revenue History
Chemistry
Medica Corporation
Oncascan Limited
West Medica
Zyomyx Inc
TWENTY-TWO: COMPANY PROFILES: HISTOPATHOLOGY SPECIALISTS
Advanced Cell Diagnostics (ACD)
Amoy Diagnostics Co. Ltd
Applied Spectral Imaging Inc. (ASI)
BioGenex Laboratories Inc
BioView Ltd
Recent Revenue History
Circulomics Inc
Dako A/S
Recent Revenue History
Special Stains
Immunohistochemistry (ICH)
Companion Diagnostics
Flow Cytometry
Automation
Alliances
Definiens
EMD Millipore
HTG Molecular Diagnostics
Recent Revenue History
Kapa Biosystems Inc
Leica Biosystems
Collaborations
Omnyx LLC
Ventana Medical Systems Inc
Recent Revenue History
Digital Pathology
Virtuoso Software Update
Product News
Automation
Partnerships
Visiopharm
TWENTY-THREE: COMPANY PROFILES: IMMUNOASSAY SPECIALISTS
BG Medicine, Inc
Recent Revenue History
Binding Site Group Ltd. (The)
Recent Revenue History
Biohit Oyj
Recent Revenue History
Market Expansion
Biomerica Inc
Recent Revenue History
Bio-Techne Corporation
Recent Revenue History
Corgenix Medical Corporation
Critical Diagnostics
Diaxonhit
Recent Revenue History
Euroimmun AG
Recent Revenue History
Hob Biotech
Immunodiagnostic Systems (IDS)
Recent Revenue History
INOVA Diagnostics, Inc
Integrated Diagnostics (Indi)
One Lambda
Recent Revenue History
Orgentec Diagnostika
Recent Revenue History
Protagen Diagnostics
Quanterix Corporation
Response Biomedical Corp
Recent Revenue History
Singulex, Inc
Theradiag
Recent Revenue History
VolitionRx Limited
TWENTY-FOUR: COMPANY PROFILES: INFORMATION TECHNOLOGY SPECIALISTS
Advaita Bioinformatics
Apple Inc
Cartagenia
Cerner Corp
CLC bio
Cypher Genomics Inc
Dell Healthcare and Life Sciences
Desktop Genetics, Ltd
DNAnexus
Edico Genome
Euformatics Oy
GENALICE
GenomOncology
Google Genomics (Alphabet)
IBM Healthcare
Intel Corporation
Knome Inc
Collaborations
N-of-One
PierianDx
Rennova Health, Inc
Sophia Genetics
Sunquest Information Systems
Tute Genomics
WuXi NextCODE Genomics
TWENTY-FIVE: COMPANY PROFILES: MICROBIOLOGY SPECIALISTS
Accelerate Diagnostics, Inc
Advanced Biological Laboratories, S.A. (ABL)
AdvanDx, Inc
altona Diagnostics
ArcDia International Oy Ltd
BioFire Diagnostics, Inc
Recent Revenue History
Copan Diagnostics Inc
Lab Automation
Partnerships
Swabs
Curetis AG
Fast-Track Diagnostics
Focus Diagnostics, Inc
Genetic Analysis AS
GeneWeave Biosciences, Inc
About Smarticle Technology
Great Basin Scientific, Inc
Greiner Bio-One International GmbH
Preanalytical Products
Hain Lifescience GmbH
Meridian Bioscience, Inc
Recent Revenue History
Immunoassays
illumigene
Meridian Life Science
Sample Collection
Mobidiag Ltd
Nanosphere, Inc
Recent Revenue History
Market Expansion
PositiveID Corporation
Recent Revenue History
Seegene, Inc
Recent Revenue History
Instrumentation
Collaborations
Specific Technologies
Synbiosis Ltd
T2 Biosystems
Recent Revenue History
ViroCyt, LLC
TWENTY-SIX: COMPANY PROFILES: MOLECULAR TEST SPECIALISTS
Agena Bioscience
Market Expansion
Asuragen Inc
Controls
Sample Collection
Sequencing
AutoGenomics Inc
BGI (formerly Beijing Genome Institute)
Prenatal Testing
Liquid Biopsy
With Complete Genomics
BGI Projects
Biocartis Group
Recent Revenue History
Connectivity
DMAT Instrumentation – MyCartis
Idylla News
Infectious Diseases
Building the Future
Collaborations
Enzo Biochem Inc
Recent Revenue History
IP Situation
Epigenomics
Exosome Diagnostics, Inc
Fluidigm Corporation
Recent Revenue History
GenMark Diagnostics
Recent Revenue History
Genome Diagnostics BV (GenDx)
Life Technologies Corporation
Instrumentation and Applications
Liquid Biopsy
Sequencing
Life Technologies an IVD company
Emerging Pathogens
Bacterial Typing
Forensic
Nanostring Technologies, Inc
Recent Revenue History
Immunohistochemistry
Alliances
LDTs
Oxford Nanopore Technologies Ltd
Pacific Biosciences of California, Inc. (PacBio)
Recent Revenue History
QuanDx Inc
RainDance Technologies, Inc
Recent Revenue History
Market Expansion
Rubicon Genomics, Inc
Transgenomic, Inc
Alliances
Lab Services
Diagnostic Tools Division
TrovaGene, Inc
Vela Diagnostics
WaferGen Bio-systems, Inc
Recent Revenue History
TWENTY-SEVEN: COMPANY PROFILES: POINT OF CARE TEST SPECIALISTS
Abaxis, Inc
Recent Revenue History
Abingdon Health Ltd
Atlas Genetics Ltd
Biomeme, Inc
Chembio Diagnostic Systems, Inc
Recent Revenue History
DNA Electronics Ltd (DNAe)
Enigma Diagnostics Limited
Entopsis
Epistem Holdings plc
FABPulous B.V
Fio Corporation
Hema Diagnostic Systems (HDS)
Imec
InSilixa Inc
MedMira Inc
OraSure Technologies, Inc
Recent Revenue History
The Genotek Business
PTS Diagnostics
QloudLab SA
QuantuMDx Group Limited
Rheonix, Inc
Samsung Healthcare
Scanadu, Inc
Theranos, Inc
Veredus Laboratories Pte Ltd
Xagenic
TWENTY-EIGHT: COMPANY PROFILES: PRENATAL TEST SERVICE PROVIDERS
Ariosa Diagnostics, Inc
Berry Genomics Co. Ltd
Combimatrix Corp
Recent Revenue History
Good Start Genetics, Inc
Illumina
IP Issues
Cytogenetics
Inex Innovations Exchange
LifeCodexx AG
MAP Diagnostics Ltd
Multiplicom N.V
Natera
Recent Revenue History
Oncology – Planning for the Future
Premaitha Health plc
Sequenom Inc
Recent Revenue History
Market Expansion
Product Expansion
IP Issues
Oncology
Coagulation
TWENTY-NINE: COMPANY PROFILES: QUALITY CONTROL & SAMPLE PRETREATMENT SPECIALISTS
Horizon Discovery Group plc
Recent Revenue History
Collaborations
MO BIO Laboratories, Inc
Oasis Diagnostics Corporation
PreAnalytiX GmbH
SeraCare Life Sciences, Inc
Streck Inc
THIRTY: COMPANY PROFILES: TEST SERVICE PROVIDERS
23andMe
The Move to Building a Research Company
Therapeutics Group
Ancestry
Outside the U.S
Agendia BV
Recent Revenue History
Ambry Genetics
Epilepsy
Oncology
Cardiac
Prenatal
Information Technology
ARUP Laboratories
Assurex Health
BioCollective (The)
Bio-Reference Laboratories, Inc. (BRLI)
bioTheranostics
BluePrint Genetics Oy
Boston Heart Diagnostics
CareDx, Inc. (Formerly XDx, Inc.)
Recent Revenue History
Sequencing
Cleveland HeartLab Inc
Counsyl
Eurofins Genomics
Exact Sciences Corp
Recent Revenue History
Foundation Medicine Inc
Recent Revenue History
Collaborations
Genomic Health, Inc
Recent Revenue History
Market Uptake
Liquid Biopsy
Service Spin-off
Genomic Vision
Recent Revenue History
Helomics Corporation (formerly Precision Therapeutics, Inc)
Mayo Medical Laboratories
Information Technology
MDxHealth SA
Recent Revenue History
OPKO Diagnostics
Pathway Genomics Corporation
Rosetta Genomics Ltd
Recent Revenue History
Expansion
Sonic Healthcare
Recent Revenue History
Veracyte, Inc
Recent Revenue History
Vermillion Inc
Recent Revenue History
————————————-List of Exhibits—————————————-
ONE: EXECUTIVE SUMMARY
Table 1-1
Exchange Rate Fluctuations, 2012–2016
Table 1-2
Worldwide In Vitro Diagnostic Reagent Sales by Market Segment, 2016-2021
TWO: INTRODUCTION
Table 2-1
Worldwide In Vitro Diagnostic Sales by Product Market, 2016-2021
Table 2-2
Selected Diagnostics Industry Acquisitions, 2014, 2015 and H2 2016
Table 2-3
Selected Diagnostics Industry Distribution Agreements, 2014, 2015, H2 2016
Table 2-4
Selected IVD collaboration/Licensing Agreements, 2014, 2015, H2 2016
Table 2-5
Selected Test Services, Sales 2012-2016
Table 2-6
Lab Market Segmentation, Worldwide, 2016
Table 2-7
Revenues for a Selection of U.S.-based Reference Labs, 2012-2016
Table 2-8
Selected Company sponsored Labs Established in 2014 and 2015
Table 2-9
Revenues of Selected Top IVD Companies, 2012-2016
Table 2-10
Revenues of Selected Niche Players, 2012-2016
Table 2-11 IVD Test Segment Sales 1995-2015
THREE: OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC MARKETS
Table 3-1
World Population Distribution, 2016
Table 3-2
Selected Disease Statistics, Worldwide
Table 3-3
Elderly Support Ratio in Selected Countries (2050)
Table 3-4
Available Market Data, 2016
Table 3-5
Worldwide In Vitro Diagnostic Reagent Sales by Country/Region, 2016-2021
Figure 3-1: EU IVD Revenue Stream 2007-2016
Table 3-6
European Union (EU14) IVD Sales by Country 2014
Table 3-7
Per Capita IVD Expenditure
FOUR: TRENDS AND INNOVATION
Table 4-1
Selected Sequencing Platforms
Table 4-2
Selected IVD industry IT Investments
Table 4-3
Selected Gene Editing Research Kits
Table 4-4
Selected Wearable Devices
Table 4-5
Selected Disease Markers in Exhaled Breath
Table 4-6
Selected Breath Test Innovations
FIVE: POINT-OF-CARE TESTS
Table 5-1
Professional POC Test Sales by Category, Worldwide, 2016-2021
Table 5-2
Hospital POC Test Usage, U.S
Table 5-3
Selected Profession POC Test Innovations
Table 5-4
POC Self Test Sales by Category, Worldwide, 2016-2021
Table 5-5
POC Test Revenues of Selected IVD Companies, 2013-2015
Table 5-6
Selected Apps and Glucose Management IT
Table 5-7
Diabetes Sales by Test Category, Worldwide, 2016-2021
Table 5-8
World Glucose Monitoring Sales, Major Companies, 2012-2016
Table 5-9
Selected Glucose Self-Test Meter Innovations
Table 5-10
Selected Noninvasive Glucose Monitoring Devices
Table 5-11
Selected Continuous BGM Sales, 2013 – 2016
Table 5-12
Selected Continuous Blood Glucose System Developments
Table 5-13
Selected Innovations in Hospital-based Glucose Monitoring
Table 5-14
Selected POC HbA1c Devices
Table 5-15
Selected POC Diabetes Monitoring Tests
SIX: THE CORE LAB
Table 6-1
Workstation Sales, 2016-2021 (General Chemistries, Immunos on workstations)
Table 6-2
Core Lab Sales of the Top Five Manufacturers, 2012-2016
Table 6-3
Selected New Analytes for the Core Lab, 2014-2015
Table 6-4
Selected Lab Automation Innovations
Table 6-5
Worldwide Clinical Chemistry Sales by Test Category, 2016-2021
Table 6-6
Major Clinical Chemistry Companies
Table 6-7
Selected Clinical Chemistry Innovations
Table 6-8
Major Whole Blood Chemistry Analyzers
Table 6-9
Selected Apps, Critical Care and Urinalysis IT Innovations, 2016
Table 6-10
Selected Urinalysis Innovations, 2016
SEVEN: IMMUNOASSAYS
Table 7-1
Selected New Immunoassay Technologies, 2016
Table 7-2
Selected Innovation in Mass Spectrometry for Routine Analyses
Table 7-3
Selected Immunoassay Innovations on Core Lab Instruments
Table 7-4
Worldwide Lab-based Immunoassay Sales by Analyte Type, 2016-2021
Table 7-5
Selected Immunoassay Quality Control Products
Table 7-6
Revenue History of Leading Immunoassay Vendors, 2012-2016
Table 7-7
Selected New Vitamin D Immunoassays, 2014-2016
Table 7-8
Selected Tumor Marker Innovations, 2014-2016
Table 7-9
Selected Cardiac Marker Innovations
Table 7-10
Selected Autoimmune Test Innovations
Table 7-11
Selected Arthritis Immunoassay Innovations
Table 7-12
Selected Inflammatory Bowel Disease Test Innovations
Table 7-13
Selected Immunoassays for Transplant Medicine
Table 7-14
Selected Women’s Health Innovations
Table 7-15
Selected Innovations for Alzheimer’s Disease Immunoassays
Table 7-16: Selected Immunoassay Innovations
Table 7-17
POC Immunoassay Test Sales by Test Category, 2016-2021
Table 7-18
Selected Self-Test Immunoassay Innovations
Table 7-19
Selected Professional POC Test Innovations, 2016
Table 7-20
Selected POC Immunoassay Test Platforms
EIGHT: MOLECULAR ASSAYS 310
Table 8-1
Common Next Generation Molecular Test Traits
Table 8-2
Selected Molecular Test Sample Preparation and QC Innovations
Table 8-3
Selected Exosome Test Innovations
Table 8-4
Selected Liquid Biopsy Innovations
Table 8-5
Selected IT Innovations in Molecular Diagnostics
Table 8-6
Selected Innovations in Forensic DNA Testing
Table 8-7
Key Molecular Technologies and Major Players
Table 8-8
Selected Molecular Test Platform Innovations
Table 8-9
Molecular Test Revenues of Selected IVD Vendors, 2012-2016
Table 8-10
Worldwide Molecular Test Sales by Type, 2016-2021
Table 8-11
Selected Molecular Tumor Marker Test Innovations
Table 8-12
Most Frequently Requested Genetic Tests
Table 8-13
Selected Genomic Tests for Inherited Diseases
Table 8-14
Revenue Stream of Selected NIPT Service Companies, 2012-2015
Table 8-15
Prenatal Services Provided
Table 8-16
Selected Molecular Tests for Prenatal Analysis
Table 8-17
Selected HLA Typing Test Innovations
NINE: HEMATOLOGY
Table 9-1
CellaVision Placement Data by Hematology Vendor
Table 9-2
Selected Hematology Image Analysis Innovations, 2014-2015
Table 9-3
Selected POC Hematology Innovations
Table 9-4
Revenue History of the Major Hematology Vendors, 2012-2016
Table 9-5
Selected Hematology Innovations, 2016
TEN: COAGULATION
Table 10-1
Worldwide Coagulation Sales by Segment, 2016-2021
Table 10-2
Selected Lab-based Coagulation Innovations, 2016
Table 10-3
Selected Molecular Coagulation Test Innovations
Table 10-4
Selected POC Coagulation Test Innovations
Table 10-5
Top Coagulation Company Revenues, Lab & POC, 2012 – 2016
Table 10-6
Major Anticoagulants Uses and Tests
ELEVEN: MICROBIOLOGY AND VIROLOGY
Table 11-1
Global Deaths from Communicable Diseases, 2010
Table 11-2
Selected Tests for Emerging Pathogens
Table 11-3
Selected Tests for Antibiotic Resistance
Table 11-4
Selected Microbiology Mass Spec Innovations
Table 11-5
Selected Microbiome-based Tests
Table 11-6
Worldwide Microbiology/Virology Sales by Type, 2016-2021
Table 11-7
Selected Innovations in Microbiology Pre-Analytical Products
Table 11-8
Selected Innovations in Bacterial Identification
Table 11-9
Selected Antibiotic Sensitivity Test Innovations
Table 11-10
Revenue of Selected Microbiology Companies, 2013, 2016
Table 11-11
Selected Advanced Techniques for Positive Blood Cultures
Table 11-12
Lab-based Infectious Disease Immunoassays, by Test, 2016
Table 11-13
Selected Infectious Disease Immunoassay Innovations
Table 11-14
Selected Professional Use POC Tests for Infectious Diseases
Table 11- 15: Selected Molecular Test Platform Innovations, 2014-2016
Table 11-16
Selected Microbiology Sequencing Innovations
Table 11-17
Molecular Test Sales, Infectious Diseases, 2016
Table 11-18
Selected Molecular HAI Test Innovations
Table 11-19
Selected Molecular Tests for STDs
Table 11-20
Selected Molecular Respiratory Disease Innovations
Table 11-21
Selected Molecular HIV Test Innovations
Table 11-22
Selected Infectious Disease Molecular Test Innovations
Table 11-23
Selected Molecular POC Device Innovations
TWELVE: BLOOD BANKING SERVICES
Table 12-1
Blood Donation, Key Facts
Table 12-2
Distribution of Blood Units Collected
Table 12-3
Laboratory Screening of Blood Donations for Transfusion-Transmissible Infections, Number of Countries (Syphilis, HCV, HBV, HIV)
Table 12-4
Blood Component Usage (Liver Transplant, Adult Open Heart Surgery, Automobile Accident, Leukemia, Sickle Cell Disease, Cancer Chemotherapy)
Table 12-5
Impact of Alloimmunization (% of Patients Screening Positive for One or More Antibodies)
Table 12-6
Worldwide Blood Bank Sales, 2016-2021
Table 12-7
Selected Blood Grouping Innovations
Table 12-8
Selected New Blood Screen NAT Tests and Systems
THIRTEEN: HISTOLOGY AND CYTOLOGY
Table 13-1
Selected Histology Lab Automation
Table 13-2
Histology Information Technology Tools
Table 13-3
Selected Advanced Histology Techniques
Table 13-4
Selected HPV Test Innovations
Table 13-5
Worldwide Histology/Cytology Sales by Type, 2016-2021
Table 13-6
Revenues of the Major Histology Companies, 2012-2016
Table 13-7
Selected Vendors Of Traditional Histology Stains
Table 13-8
Selected In Situ Hybridization-based Tests
Table 13-9
Selected IHC Test Innovations
Table 13-10
Major Pharmacodiagnostic Markers
Table 13-11
Selected Pharmacodiagnostic Histology Tests
Table 13-12
Selected Digital Imaging Innovations
Table 13-13
Selected Innovations in CTC Technology
