Table of Contents
One: Executive Summary
Introduction – Doing More with Less
Scope and Methodology
Size and Growth of the Market
Market Trends
Two: Introduction
Background
Report Design
Lab Medicine Disciplines and Applications
Market Analysis of IVD Market Segments
The Lure of IVD – Companies Mix and Match
Distribution Agreements
Licenses and Collaboration Agreements
Test Services
Top Suppliers and Niche Players
Selected Test Innovations from Non-Commercial Facilities
Baylor Research Institute, Dallas, TX
Boston University, Boston, MA
Brown University, Providence, RI
California Institute of Technology, Pasadena, CA
California NanoSystems Institute at the UCLA Henry Samueli School of Engineering and
Applied Science, Los Angeles, CA
Cedars Sinai Medical Center, Los Angeles, CA
Cleveland Clinic, Cleveland, OH
Duke University, Durham, NC
Hartford Hospital, Hartford, CT
Johns Hopkins University School of Medicine, Baltimore, MD
MedStar Washington Hospital Center, Washington, DC
Mount Sinai’s Samuel Lunenfeld Research Institute, Toronto, ON
Northeastern University, Boston, MA
Peking University, Beijing, China
Queensland Institute of Medical Research, Brisbane, Australia
Schneider Children’s Medical Center of Israel, Tel Aviv, Israel
Stockholm University, Sweden
Tokyo Medical and Dental University, Tokyo, Japan
University of British Columbia, Vancouver, BC
University of California, Davis, CA
University of California, Urvine, Urvine, CA
University of Cincinnati, Cincinnati, OH
University of Cologne, Cologne, Germany
University of Washington, Seattle, WA
Vanderbilt University, Nashville, TN
Weill Cornell Medical College, New York, NY
Yonsei University Health System, Seoul, S. Korea
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 – a World in Flux
Japan
Europe: Negative Growth – Effects of Austerity
China
India
Brazil
Russia
Canada
Four: Trends and Innovation
Background
IT Enables Sample to Insight
Omics and BIG Data
Sequencing Moves to the Clinic
Personalized Precision Medicine Advances and Barriers
LOCs Enable Mobile Health (mHealth)
Five: Point-of-Care Tests
Overview
Professional POC
OTC Self Testing
Colon Cancer Screening
The Major POC Test Players
Diabetes Testing – Blood Glucose Monitoring
Glucose Market Shakeup
Diabetes Market Analysis
Blood Glucose Self-Testing
Continuous Self-Testing
Blood Glucose Testing by Professionals
New Technologies
Diabetes Testing – Glycated Hemoglobin
The Genetics of Diabetes
Six: The Core Lab
Core Lab Overview
Overview of Chemistry Tests
Lab Automation
Market Analysis
Lab-based Chemistries
Critical Care Analysis
User Apps
Urinalysis
The Commercial Outlook for Chemistry Tests
Seven: Immunoassays
Overview of Immunoassays
Immunoassay Technology Continues to Evolve
Immunoassays in the Core Lab
Special Topic – Metabolite Testing
Market Analysis
Leading Suppliers and Growth Potential
Mature Assay Segment
Thyroid Function
Therapeutic Drug Tests
Anemia
Toxicology/DAU
Allergy
Maturing Immunoassays
Proteins
Growth Immunoassays
Vitamin D
Tumor Markers
Cardiac Markers
Autoimmune
Diabetes
Transplant Management
Women’s Health
Gastrointestinal Disorders
Miscellaneous
Point-of-Care OTC and Professional Use
Patient Self-Tests (OTC)
Pregnancy Testing
Cardiovascular Diagnostics
Drugs of Abuse/Therapeutic Drug Monitoring
The Commercial Outlook for Immunoassays
Eight: Molecular Assays
Overview
Advanced Molecular Tests and Technologies
Digital PCR
Exomes
Major Players
Market Analysis
Oncology
Inherited Diseases
Prenatal Analysis
Tissue Typing
The Commercial Outlook for Molecular Tests
Nine: Hematology
Overview of Hematology
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 of Coagulation and Immunohematology Tests
Genetics and Personalized Medicine
Warfarin
Plavix
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
Emerging Disease Threats
Antimicrobial Drug Resistance
Mass Spectrometry Not a Pipedream
Sepsis Serology
Market Analysis
Supplies
Microbial Identification and Antimicrobial Sensitivity Tests
Blood Culture
Rapid Tests
Immunoassays – Lab-based
Immunoassays – Rapid
Molecular Tests
The Commercial Outlook for Microbiology / Virology Tests
Twelve: Blood Banking Services
Overview
Blood Banking Gets a Shakeup
Blood Management – Are All These Transfusions Good Medicine?
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
Advanced Analysis Solutions
HPV Goes Core Lab
Market Analysis
Histology/Cytology
Immunohistochemistry and In Situ Hybridization
Pharmacodiagnostic Histology
Digital Imaging
Circulating Tumor Cells
Flow Cytometry
The Commercial Outlook for Histology and Cytology Tests
Fourteen: Company Profiles: The Top Tier
Abbott Diagnostics
Recent Revenue History
2013 Highlights
Core Lab
Immunoassays
Molecular
Hematology
Histology
Blood Bank
Point of Care
Diabetes
IntelligentMDx Alliance
PLEX-ID
Alere Inc.
Recent Revenue History
HIV
Lab-based
Blood Gases
Hematology
Microbiology
Toxicology
Cardiology
Mail Order Glucose Meters
Molecular
Alere Medical India
Arkray
Recent Revenue History
Molecular
Beckman Coulter, Inc. / Danaher
Recent Revenue History
Core Lab
Hematology
Immunoassays
Histology
Flow Cytometry
Molecular
Lab Services
Becton, Dickinson and Company (BD)
Recent Revenue History
Initiatives
Traditional Microbiology
Blood Culture
The BD MAX Enterprise
HPV
Veritor System – Immunoassays
Continuous Blood Glucose
Flow Cytometry
Histology
Mass Spectrometry
bioMérieux Inc.
Recent Revenue History
Expansion
Immunoassays
Blood Culture
Molecular Strategy
Mass Spectrometry
Bio-Rad Laboratories, Inc.
Recent Revenue History
Controls
Digital PCR
Blood Bank
Flow Cytometry
Lab Automation
Danaher Corporation
Recent Revenue History
Hologic, Inc.
Recent Revenue History
Product News
Blood Bank
Quest Contract
The Gen-Probe Business
Panther System
Instrumentation Laboratory (IL)
Recent Revenue History
New Products
Direct Sales
Ortho Clinical Diagnostics (OCD)
Recent Revenue History
Blood Bank
QIAGEN N.V.
Recent Revenue History
Personalized Healthcare
TB Testing
HPV
Oncology
Automation for the Future
Rotor-Gene Q
Exosomes
Sequencing
Information Technology
Point of Care
Collaborations
Radiometer A/S
Recent Revenue History
Immunoassays
Hemocue AB
Roche Diagnostics
Recent Revenue History
Reorganization
The PCR Enterprise
Core Lab
Molecular Core Lab IT
Immunoassays
Diabetes
Point of Care
Coagulation
HPV
Blood Bank
Liquid Biopsy
Molecular
Sequencing
Siemens Healthcare Diagnostics
Core Lab
Immunoassays
Hematology
Microbiology
Point of Care
Coagulation
Histology
Urinalysis
Critical Care
Molecular
Companion Diagnostics
Sequencing
Sysmex Corporation
Recent Revenue History
Hematology
Coagulation
Clinical Chemistry
Inostics GmbH
Intraoperative Test
Flow Cytometry
Thermo Fisher Scientific Inc.
Recent Revenue History
Sepsis
Histology
Allergy
Therapeutic Drug Monitoring
Mass Spectrometry
Microbiology
Werfen Group S.A
Fifteen: Company Profiles: The Second Tier
Affymetrix Inc.
Recent Revenue History
Agilent Technologies
Recent Revenue History
Arrays
Sample Management
Mass Spectrometry
Expansion
Cepheid
Recent Revenue History
Hospital Acquired Infections (HAI)
TB
Infectious Diseases
Oncology
Eiken Chemical Co., Ltd
Recent Revenue History
ERBA Diagnostics, Inc.
Recent Revenue History
ERBA Mannheim
DiaSorin S.p.A.
Recent Revenue History
Molecular
Immunoassays
Fujirebio Diagnostics, Inc.
Recent Revenue History
Molecular
Illumina
Recent Revenue History
Sequencing
Cytogenetics
Prenatal Testing
CLIA Lab Service
Nanopore Sequencing
Sample to Insight
IP Situation
LabCorp, Laboratory Corporation of America
Recent Revenue History
Collaborations
BRCA Saga
Life Technologies Corporation
Recent Revenue History
Life Technologies as an IVD Company
Partnerships Worldwide
Life and Quidel Develop Diagnostics on the 7500 Fast Dx
Sepsis
HIV
Emerging Pathogens
Bacterial Typing
Personalized Medicine
Instrumentation and Applications
Luminex Corporation
Recent Revenue History
Business Expansion
MAGPIX Multiplexing
Next Generation NxTag
Product News
Menarini Diagnostics
Recent Revenue History
Myriad Genetics
Recent Revenue History
Product News
The U.S. Market
IP Update
PerkinElmer, Inc. (PE)
Recent Revenue History
Newborn Testing
Prenatal Testing
Histology
Sequencing
Mass Spectrometry
Information Technology
China
Quest Diagnostics
Recent Revenue History
Quidel Corporation
Recent Revenue History
Acquisitions
Point of Care
Immunoassays
Molecular
Savanna (formerly Wildcat)
Randox Laboratories Ltd.
Recent Revenue History
Controls
Immunoassays
Molecular
TOSOH Corporation
Recent Revenue History
Immunoassays
Transasia Bio-Medicals Ltd.
Recent Revenue History
Trinity Biotech plc
Recent Revenue History
Product News
Wako Pure Chemical Industries, Ltd.
Recent Revenue History
Sixteen: Company Profiles: Blood Bank Specialists
Cerus Corporation
Recent Revenue History
Grifols
Recent Revenue History
Haemonetics Corporation
Recent Revenue History
Immucor, Inc.
Recent Revenue History
Immunetics Inc.
Recent Revenue History
Novartis Molecular Diagnostics
Recent Revenue History
International Programs
Quotient Limited
Recent Revenue History
Terumo BCT
Recent Revenue History
Verax Biomedical Inc.
Recent Revenue History
Seventeen: Company Profiles: Coagulation Specialists
Accriva Diagnostics
Recent Revenue History
A Bit of History
Atherotech Diagnostics Lab
Recent Revenue History
Diagnostica Stago, S.A.S.
Recent Revenue History
Gamma Therapeutics, Inc.
Microvisk Technologies
Eighteen: Company Profiles: Core Lab and Other Companies
77 Elektronika Kft
AB SCIEX Pte Ltd.
Recent Revenue History
Danaher Combines Two Forces
Bruker BioSciences Corporation
Recent Revenue History
Microbiology
Menu Expansion
NMR
Diatron MI Plc
Recent Revenue History
EliTech Group S.A.S.
Recent Revenue History
IRIS International, Inc.
Recent Revenue History
Medica Corporation
Recent Revenue History
MedTest DX
Recent Revenue History
Mindray Medical International Limited
Recent Revenue History
Nova Biomedical
Recent Revenue History
Diabetes
Nineteen: Company Profiles: CTC Test Providers
Abnova
AdnaGen AG
Angle plc
ApoCell, Inc.
Biocept, Inc.
Recent Revenue History
Clearbridge BioMedics
Cynvenio Biosystems, Inc.
Epic Sciences Inc.
Fluxion Biosciences, Inc.
Recent Revenue History
Icellate AB
ProKyma Technologies
RareCyte, Inc.
ScreenCell
Veridex, LLC
Recent Revenue History
WaveSense LLC
Twenty: Company Profiles: Diabetes Specialists
AgaMatrix, Inc.
Recent Revenue History
ALR Technologies Inc.
Animas Corporation
Recent Revenue History
Bayer Diabetes Care
Recent Revenue History
DexCom, Inc.
Recent Revenue History
Echo Therapeutics, Inc.
Recent Revenue History
Entra Health Systems
Recent Revenue History
iHealth Lab Inc.
Infopia Co Ltd
Recent Revenue History
Insulet Corporation
Recent Revenue History
U.S. Medicare Effects
Integrity Applications Inc.
Recent Revenue History
LabStyle Innovations Corp
Lifescan Inc.
Recent Revenue History
IP Issues
Medtronic Inc.
Recent Revenue History
Service Expansion
Newomics Inc.
Recent Revenue History
Prodigy Diabetes Care, LLC
Recent Revenue History
Sanofi Diabetes
Recent Revenue History
Senseonics, Incorporated
Recent Revenue History
Tandem Diabetes Care, Inc.
Recent Revenue History
TelCare Inc.
Recent Revenue History
Twenty-One: Company Profiles: Hematology (Cell Analysis) Specialists
CellaVision AB
Recent Revenue History
Constitution Medical, Inc.
DVS Sciences, Inc.
Horiba Medical
Recent Revenue History
OrSense Ltd.
Partec GmbH
Recent Revenue History
Twenty-Two: Company Profiles: Histopathology Specialists
Advanced Cell Diagnostics (ACD)
Recent Revenue History
Amoy Diagnostics Co. Ltd.
Applied Spectral Imaging Inc. (ASI)
Biocare Medical, LLC
Recent Revenue History
Biodis Biotechnology
BioMarker Strategies
BioView Ltd.
Recent Revenue History
Dako A/S
Recent Revenue History
Companion Diagnostics
Digital Imaging
Flow Cytometry
Automation
Alliances
Definiens
Recent Revenue History
DxTerity Diagnostics Inc.
Recent Revenue History
Leica Biosystems
Norchip
Ventana Medical Systems Inc.
Recent Revenue History
Digital Pathology
Virtuoso Software Update
Product News
Automation
China
Partnerships
Twenty-Three: Company Profiles: Immunoassay Specialists
ALPCO Diagnostics
Recent Revenue History
BG Medicine, Inc.
Recent Revenue History
Biohit Oyj
Recent Revenue History
Market Expansion
Corgenix Medical Corporation
Recent Revenue History
Systems
Tests
Critical Diagnostics
Diazyme Laboratories
Recent Revenue History
Euro Diagnostica AB
Recent Revenue History
Market Expansion
Genalyte Inc.
Recent Revenue History
Gold Standard Diagnostics
INOVA Diagnostics, Inc.
Recent Revenue History
Matrix-Bio Inc.
Oasis Diagnostics Corporation
OPKO Diagnostics
Recent Revenue History
Pronota NV
Quanterix Corporation
Tests in Development
Response Biomedical Corp.
Recent Revenue History
Sera Prognostics, Inc.
Twenty-Four: Company Profiles: Information Technology Specialists
Cartagenia
Cerner Corp.
CLC bio
Recent Revenue History
CollabRx Inc.
ConnectedHealth Pte. Ltd.
IBM Healthcare
Intel Corporation
Kaiser Permanente
MediSapiens Ltd.
Personalis Inc.
Twenty-Five: Company Profiles: Microbiology Specialists
AdvanDx, Inc.
Recent Revenue History
Co-Diagnostics HBDC
Copan Diagnostics Inc.
Recent Revenue History
Curetis AG
DxNA, LLC
Enigma Diagnostics Limited
Epistem Holdings plc
Focus Diagnostics, Inc.
Recent Revenue History
Great Basin Scientific, Inc.
Hain Lifescience GmbH
Recent Revenue History
Hutman Diagnostics AG
Recent Revenue History
Immunexpress Group
InBios International, Inc.
Intelligent Medical Devices, Inc. (IMDx)
Recent Revenue History
Laboratorios CONDA
Liofilchem s.r.l.
Recent Revenue History
Lophius Biosciences GmbH
Lumora
MAST GROUP Ltd.
ID/AST
Immunoassays
Molecular
MBio Diagnostics, Inc
Meridian Bioscience, Inc.
Recent Revenue History
Immunoassays
illumigene Molecular
Meridian Life Science
Miacom Diagnostics GmbH
Mobidiag Ltd
Nanosphere, Inc.
Recent Revenue History
Market Expansion
Pathogenica
Seegene, Inc.
Recent Revenue History
Instrumentation
Collaborations
Specific Technologies
Twenty-Six: Company Profiles: Molecular Test Specialists
Amoy Diagnostics Co. Ltd.
Recent Revenue History
Asuragen Inc.
Recent Revenue History
Controls
Sample Collection
Sequencing
BGI
Recent Revenue History
BGI Projects
Biocartis SA
Connectivity
Instrumentation
Collaborations
Idylla News
Biofortuna Ltd.
DiaCarta Inc.
Enzo Biochem Inc.
Recent Revenue History
IP Situation
Epigenomics
Recent Revenue History
Exosome Diagnostics
Genia Technologies Inc.
GenMark Diagnostics
Recent Revenue History
HTG Molecular Diagnostics
Recent Revenue History
IncellDx, Inc.
Recent Revenue History
Inform Genomics
Nanostring Technologies, Inc.
Recent Revenue History
QuantuMDx Group Limited
RainDance Technologies, Inc.
Recent Revenue History
Collaborations
Selventa
TessArae, LLC
Recent Revenue History
TrovaGene, Inc.
Recent Revenue History
Twenty-Seven: Company Profiles: Point of Care Test Specialists
1st Health Products Ltd.,
Abaxis, Inc.
Recent Revenue History
Aerocrine AB
Arbor Vita Corporation
Atomo Diagnostics
bioLytical Laboratories
Recent Revenue History
Chembio Diagnostic Systems, Inc.
Recent Revenue History
In Brazil
Counsyl Consumer
Recent Revenue History
DiAssess Inc
EKF Diagnostics Holdings Plc
Recent Revenue History
Molecular
Gentle Laboratories
GlysBy s.n.c.
IntraMed Diagnostics, LLC
LeucoDx
Luoxis Diagnostics Inc.
Maxim Biomedical, Inc.
MedMira Inc.
Recent Revenue History
Mode Diagnostics, Ltd
Recent Revenue History
NEC Corporation
OraSure Technologies, Inc.
Recent Revenue History
Pixie Scientific
Radisens Diagnostics Ltd.
Samsung Healthcare
STDcheck.com
Recent Revenue History
UDoTest
Twenty-Eight: Company Profiles: Prenatal Test Service Providers
Ariosa Diagnostics, Inc.
Recent Revenue History
IP Status
Berry Genomics Co. Ltd
CellScape Corporation
Recent Revenue History
GenePeeks, Inc.
Genomed AG
Good Start Genetics, Inc.
Illumina
Recent Revenue History
INEX (Innovations Exchange Pte Ltd)
Kellbenx Inc.
Natera
Recent Revenue History
NIPD Genetics Ltd
Sequenom Inc.
Recent Revenue History
Market Expansion
Coagulation
IP Issues
Sera Prognostics, Inc.
Twenty-Nine: Company Profiles: Test Service Providers
23andMe
Recent Revenue History
Adaptive Biotechnologies Corporation
Agendia BV
Recent Revenue History
Ambry Genetics
Recent Revenue History
ARUP Laboratories
Recent Revenue History
Assurex Health
Recent Revenue History
Athena Diagnostics
Recent Revenue History
BioReference Laboratories, Inc. (BRLI)
Recent Revenue History
Boulder Diagnostics Inc.
Cancer Genetics, Inc. (CGI)
Recent Revenue History
CardioDx, Inc.
Clarient Diagnostic Services, Inc.
Recent Revenue History
Combimatrix Corp
Recent Revenue History
Diatherix Laboratories Inc.
Genomic Health, Inc.
Recent Revenue History
Market Uptake
Sequencing
Imugen Inc.
Lab21 Limited
Recent Revenue History
LipoScience Inc.
Recent Revenue History
Mayo Medical Laboratories
Information Technology
MDxHealth SA
Recent Revenue History
Medical Diagnostic Laboratories L.L.C. (MDL)
Metabolistics Inc.
Metabolon, Inc.
Metamark Genetics Inc.
OncoPlexDx
Rosetta Genomics Ltd.
Recent Revenue History
Sengenics International Pte Ltd
Veracyte, Inc.
Recent Revenue History
