Table of Contents
K a l o r a m a 2 0 1 7 I V D M a r k e t B u n d l e
—THE WORLDWIDE MARKET FOR IN VITRO DIAGNOSTICS —
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
PLEX-ID
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: $ million
Wako Pure Chemical Industries, Ltd
Recent Revenue History
SIXTEEN: COMPANY PROFILES: BLOOD BANK SPECIALISTS
BloodSource
Cerus Corporation
Recent Revenue History
Grifols
Recent Revenue History:
Clinical Analysis
Blood Transfusion Business
International Programs
Molecular
Haemokinesis Pty Ltd
Immucor, Inc
Recent Revenue History
Transfusion Medicine
Transplant Diagnostics
IMMUCOR DX Laboratory Service
Micro Typing Concepts (MTC)
Quotient Limited
Recent Revenue History
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
–UNITED STATES IVD MARKET —
1: Executive Summary
Introduction
Market Metrics – Utilization
Market Metrics – Aging
Market Metrics – Disease
Market Metrics – U.S. Total Health and Clinical Lab Expenditures and Payers
Market Metrics – U.S. Clinical Testing by Channel
Impacts of the Affordable Care Act
Impacts of PAMA and LDT Reform
U.S. IVD Market
Top Tier U.S. IVD Market Participants and Rankings
Conclusions
2: Introduction to U.S. Health Care
The United States and In Vitro Diagnostics
U.S. Patient Population
Healthcare System Utilization
Aging
Disease Prevalence and Incidence
Health Insurance in the United States and the Affordable Care Act
U.S. Health Expenditure
U.S. Clinical Lab Expenditure
Affordable Care Act (ACA)
Clinical Testing under Medicare – Reimbursement Cuts and Market-Based Pricing 55
Protecting Access to Medicare Act of 2014 (PAMA)
Molecular Diagnostics and Medicare Policy
Laboratory-Developed Tests (LDTs) Invigorate Market, Challenge Regulators
U.S. Healthcare Infrastructure and Testing Channels
Hospitals
Independent Labs
Physician Office Laboratories
Self-Testing
Retail Clinics
Conclusions
3: U.S. IVD Market Analysis
Clinical Chemistry
Microbiology and Virology – ID/AST and Molecular
Point-of-Care Testing
Immunoassays
Urinalysis
Molecular Diagnostics
Coagulation
Histology
Hematology
Blood Testing and Typing
Flow Cytometry
Total U.S. IVD Market
4: Top Tier U.S. IVD Market Players
Abbott Diagnostics
Core Lab
Hematology
Molecular
Blood Testing
Mass Spectrometry ID/AST
Diabetes Testing
Point-of-Care (POC) Diagnostics
Alere
Critical Care
Lipids and Cardiac Markers
Diabetes Testing
Coagulation
Toxicology / Drugs of Abuse
Infectious Diseases
Beckman Coulter (Danaher)
Immunoassays
Clinical Chemistry
Hematology
Microbiology
Urinalysis
Flow Cytometry
Molecular
Becton, Dickinson and Company (BD)
Microbiology
Mass Spectrometry
Immunoassays
Molecular
Histology/Cytology
Flow Cytometry
bioMérieux
Microbiology
Mass Spectrometry
Immunoassays
Molecular
Sequencing
Bio-Rad Laboratories
Microbiology
Hemoglobinopathy and Diabetes Testing
Immunoassays
Blood Typing and Testing
Tissue Typing
Sequencing
Cepheid
Molecular Hospital-Acquired Infection (HAI) Testing
Molecular Sexual Health and Women’s Health Testing
Molecular Critical Infectious Disease Testing
Molecular Oncology Testing
Danaher Corporation
Histology
Point-of-Care Testing
Hologic
Molecular Cytology / Histology (HPV)
Other Molecular (STIs, HIV, HCV, TB, Respiratory)
Microbiology (AccuProbe Molecular Culture ID Tests)
Blood Testing (Molecular PROCLEIX Tests)
Johnson & Johnson (Incl. Janssen Diagnostics)
Ortho-Clinical Diagnostics
Core Lab
Blood Testing and Typing
QIAGEN
Molecular Infectious Disease
Companion Diagnostics
Immunoassays
Next-Generation Sequencing
Roche Diagnostics
Professional Diagnostics
Immunoassays
Point-of-Care Diagnostics
Diabetes Care
Tissue Diagnostics
Molecular Diagnostics
Blood Testing
Sequencing
Microbiology (GeneWeave)
Siemens Healthcare Diagnostics
Clinical Chemistry
Immunoassays
Hematology
Molecular Diagnostics and Histology
Urinalysis
Coagulation
Point-of-Care Diagnostics
Sysmex Corporation
Hematology
Coagulation
Urinalysis
Thermo Fisher Scientific
Immunoassays
Drug Testing
Histology
Mass Spectrometry
Microbiology
Molecular
Sequencing
L I S T O F E X H I B I T S
CHAPTER ONE: EXECUTIVE SUMMARY
- Table 1-1: U.S. Commercially Insured Members’ Encounters with Ambulatory Physicians (per 1,000 Members) (2005-2014)
- Table 1-2: Historical and Projected U.S. Aged Populations (60+) (% Share of Total Population, Population in Millions) (1950-2050)
- Table 1-3: U.S. IVD Market by Segment (2015/2020)
- Table 1-4: U.S. IVD Market Rankings by Estimated 2015 Revenue – Top 15 Companies
- CHAPTER TWO: INTRODUCTION
- Figure 2-1: U.S. IVD Market (2015/2020)
- Table 2-1: U.S. Hospital Inpatient Admissions and Outpatient Visits Per 1,000 Persons (1994-2013)
- Table 2-2: U.S. Commercially Insured Members’ Encounters with Ambulatory Physicians (per 1,000 Members) (2005-2014)
- Table 2-3: Historical and Projected U.S. Aged Populations (60+) (% Share of Total Population, Population in Millions) (1950-2050)
- Table 2-4: U.S. Cancer Incidence – Aggregate, Lung, Colon, Prostate, Breast (per 100,000 persons) (2002-2012)
- Table 2-5: Selected Notifiable Infectious Disease Incidences in the United States (per 100,000 persons) (2003-2013)
- Table 2-6: U.S. National Health Expenditure by Payer (Out-of-Pocket, Private Health Insurance, Medicare, Medicaid) (2013-2020)
- Table 2-7: U.S. Clinical Laboratory Market by Segment – Hospital, Independent, Physician Office (2013-2020)
- Figure 3-1: U.S. Clinical Chemistry Market (2015/2020)
- Figure 3-2: U.S. ID/AST Microbiology Market (2015/2020)
- Figure 3-3: U.S. Molecular Microbiology / Virology Market (2015/2020)
- CHAPTER THREE: MARKET ANALYSIS
- Table 3-1: U.S. ID/AST Microbiology Market – Automated ID/AST, Manual/Semi-Auto ID/AST, Blood Culture, Chromogenic Media, Rapid Micro (2015/2020)
- Table 3-2: U.S. Molecular Microbiology / Virology Market – HAIs/BSIs, HIV, Hepatitis, CT/NG, HPV, Respiratory, Mycobacteria/TB, Other (2015/2020)
- Figure 3-4: U.S. Point-of-Care (POC) Diagnostics Markets – Professional, OTC Diabetes, OTC Other (2015/2020)
- Table 3-3: U.S. Point-of-Care (POC) Diagnostics Markets – Professional (Drugs of Abuse, Infectious Disease, Pregnancy, Glucose, HbA1c, Lipids, Cardiac Markers, FOB, Critical Care, Coagulation, Hematology, Other), OTC Diabetes, OTC Other (2015/2020)
- Figure 3-5: U.S. Immunoassays Markets – Infectious and Non-Infectious (2015/2020)
- Table 3-4a: U.S. Immunoassays Market – Non Infectious (Cardiac Markers, Tumor Markers, HbA1c, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic Drugs, Drugs of Abuse, Vitamin D) (2015/2020)
- Table 3-4b: U.S. Immunoassays Market – Infectious (Hepatitis, HIV, STDs, ToRCH, Respiratory, HAIs/Sepsis, Parasitology, Mycology, Others)
- Figure 3-6: U.S. Urinalysis Lab Diagnostics Market (2015/2020)
- Figure 3-7: U.S. Molecular Diagnostics Market (2015/2020)
- Figure 3-8: U.S. Coagulation Diagnostics Market (2015/2020)
- Figure 3-9: U.S. Histology and Cytology Diagnostics Market (2015/2020)
- Figure 3-10: U.S. Hematology Diagnostics Market (2015/2020)
- Figure 3-11: U.S. Blood Testing and Typing Diagnostics Market (2015/2020)
- Figure 3-12: U.S. Clinical Flow Cytometry Market (2015/2020)
- Table 3-5: U.S. IVD Market by Segment (2015/2020)
- CHAPTER FOUR: COMPANY PROFILES
- Table 4-1: Abbott Diagnostics Revenue (2012-2015)
- Table 4-2: Alere Revenue (2012-2015)
- Table 4-3: Beckman Coulter Revenue (2012-2015)
- Table 4-4: BD Revenue (FY 2012-FY 2015)
- Table 4-5: bioMérieux Revenue (2012-2015)
- Table 4-6: Bio-Rad Laboratories Revenue (2012-2015)
- Table 4-7: Cepheid Revenue (2012-2015)
- Table 4-8: Danaher Diagnostics Group Subsidiary Revenue (Beckman Coulter, Radiometer, Leica Biosystems) (2012-2015)
- Table 4-9: Hologic Revenue (FY 2012-FY 2015)
- Table 4-10: Johnson & Johnson Diagnostics Revenue (2012-2015)
- Table 4-11: QIAGEN Revenue (2012-2015)
- Table 4-12: Roche Diagnostics Revenue (2012-2015)
- Table 4-13: Siemens Healthcare Diagnostics Revenue (FY 2012-FY 2015)
- Table 4-14: Sysmex Corporation Revenue (FY 2012-FY 2015)
- Table 4-15: Thermo Fisher Scientific Revenue (2012-2015)
–COMPANION DIAGNOSTIC TESTING —
ONE: EXECUTIVE SUMMARY
Overview
Scope and Methodology
Market Overview
Prognosis for Growth
TWO: INTRODUCTION
Terms Used in Companion Diagnostics and Personalized Medicine
Definitions of Companion Diagnostics and Personalized Medicine Used in This Report
Types of Tests Included in Personalized Medicine
Technology Used in Personalized Medicine
Point of View
THREE: CURRENT AND EMERGING APPLICATIONS OF PERSONALIZED MEDICINE
Oncology (Solid Tumors and Hematological Cancers)
Cardiovascular Disease
Neurological Disorders
Autoimmune and Inflammatory Disorders; Other Immune Related Conditions
Infectious Disease
Antibiotic Resistance
Other Infectious Disease Personalized Medicine Tests
Therapeutic Drug Monitoring
Drug Metabolism
Other Applications of Personalized Medicine Tests
FOUR: BUSINESS MODELS AND DEALS – PERSONALIZED MEDICINE AND COMPANION DIAGNOSTICS
Business Models
Business Models for Pharmaceutical Companies in Personalized Medicine
Business Models for Diagnostic Companies in Personalized Medicine
Investments and Financing Agreements
Mergers and Acquisitions
Collaborations between Pharmaceutical and Diagnostic Companies
Other Pharmaceutical Company Agreements
Diagnostic Company Collaborations with Other (Non-Pharmaceutical) Companies
Diagnostic Company Collaborations with Universities and Non-Profit Research
Institutes
FIVE: PERSONALIZED MEDICINE AND COMPANION DIAGNOSTICS – MARKET DRIVERS AND CHALLENGES
Cancer Diagnostic Market Drivers
Companion Diagnostic Tests in Drug Development – Opportunities and Challenges
Clinical Validation of Novel Biomarkers or Genetic Signatures
Regulation of Companion Diagnostics
Complexities of Companion Diagnostic Tests and Corresponding Therapeutic
Products; Harmonization of Companion Diagnostic Tests across a Class of Targeted
Therapies
Guidelines
Laboratory Developed Tests and the FDA
Limited Tissue from Biopsies for Growing Number of Cancer Tests
Advances in Technology Changing the Future of Personalized Medicine Diagnostics .. 277
Reimbursement
Physician Education, Acceptance, and Use of Novel Personalized Medicine Tests
Competition
Working Together on Personalized Medicine – Alliances, Consortiums, and Other
Groups
Future Prospects
SIX: PERSONALIZED MEDICINE AND COMPANION DIAGNOSTICS – MARKET ANALYSIS
Global Personalized Medicine and Companion Diagnostic Test Market by
Geographical Region
Personalized Medicine and Companion Diagnostic Test Market by Disease
Indication
Personalized Medicine Testing Services Market
SEVEN: COMPANY PROFILES: PHARMACEUTICAL COMPANIES (FOCUSINGON COMPANION DIAGNOSTIC ACTIVITIES)
AbbVie Inc.
Recent Revenue History
Companion Diagnostics/Personalized Medicine Activities
Acumen Pharmaceuticals, Inc.
Adaptimmune Therapeutics plc
Recent Revenue History
Company Overview
Amgen Inc.
Recent Revenue History
Companion Diagnostics/Personalized Medicine Activities
ARCA biopharma, Inc.
Recent Revenue History
Company Overview
ARIAD Pharmaceuticals, Inc.
Recent Revenue History
Companion Diagnostics/Personalized Medicine Activities
Arno Therapeutics, Inc.
Recent Revenue History
Company Overview
Array BioPharma Inc.
Recent Revenue History
Company Overview
Astellas Pharma Inc.
Recent Revenue History
Companion Diagnostics/Personalized Medicine Activities
AstraZeneca
Recent Revenue History
Companion Diagnostics/Personalized Medicine Activities
Athera Biotechnologies AB
AVEO Oncology
Recent Revenue History
Company Overview
Bayer AG
Recent Revenue History
Companion Diagnostics/Personalized Medicine Activities
Boehringer Ingelheim
Recent Revenue History
Companion Diagnostics/Personalized Medicine Activities
Bristol-Myers Squibb Company
Recent Revenue History
Companion Diagnostics/Personalized Medicine Activities
Celldex Therapeutics, Inc.
Recent Revenue History
Company Overview
Clovis Oncology, Inc.
Recent Revenue History
Companion Diagnostics/Personalized Medicine Activities
Eli Lilly
Recent Revenue History
Companion Diagnostics/Personalized Medicine Activities
Galena Biopharma, Inc.
Recent Revenue History
Company Overview
GlaxoSmithKline plc
Recent Revenue History
Companion Diagnostics/Personalized Medicine Activities
Idera Pharmaceuticals, Inc
Recent Revenue History
Company Overview
Janssen Pharmaceutical Companies of Johnson & Johnson
Merck & Co., Inc.
Recent Revenue History
Companion Diagnostics/Personalized Medicine Activities
Merck KGaA (EMD Serono)
Novartis AG
Recent Revenue History
Companion Diagnostics/Personalized Medicine Activities
Pfizer Inc.
Recent Revenue History
Companion Diagnostics/Personalized Medicine Activities
Roche (F. Hoffmann-La Roche Ltd.) and Genentech (A Member of the
Roche Group)
Recent Revenue History
Companion Diagnostics/Personalized Medicine Activities
EIGHT: COMPANY PROFILES: DIAGNOSTIC COMPANIES AND CLINICAL LABORATORIES
20/20 GeneSystems, Inc
A&G Pharmaceutical, Inc.
Abacus Diagnostica Oy
Abbott Laboratories
Recent Revenue History
Company Overview – Focusing on Personalized Medicine and Companion
Diagnostics
Agreements with Pharmaceutical Companies
Acquisitions and Other Agreements with Other Companies
Accelerate Diagnostics, Inc.
Recent Revenue History
Company Overview
Acobiom
ACT Genomics Co., Ltd.
Adaptive Biotechnologies Corporation
Admera Health (A GENEWIZ Company)
Advanced Cell Diagnostics
Products
Services for Pharmaceutical Companies
Companion Diagnostics Agreements
Aelan Cell Technologies
Affymetrix, Inc. (Acquired by Thermo Fisher Scientific)
Recent Revenue History
Company Overview
eBioscience
Affymetrix Core
Selected Affymetrix Agreements
Agena Bioscience Inc.
Agendia NV
Almac Group Limited
AltheaDx, Inc.
Amarantus BioScience Holdings, Inc.
Amarantus Diagnostics
Amoy Diagnostics Co., Ltd.
ANGLE plc
ARKRAY, Inc.
Assurex Health, Inc.
Asuragen, Inc.
Diagnostic Products
Translational/Companion Diagnostics
Agreements
Atlas Genetics Ltd
AutoGenomics, Inc.
Avant Diagnostics, Inc.
BacterioScan, Inc.
Beckman Coulter, Inc. (Subsidiary of Danaher Corporation)
Recent Revenue History
Company Overview
Flow Cytometry
Beckman Coulter Genomics
Other Tests and Services
Agreements
Becton, Dickinson and Company (BD)
Recent Revenue History
Company Overview
Microbiology and Molecular Diagnostic Testing for Infectious Diseases
Fluorescence-Activated Cell Sorters and Analyzers
Oncology
BG Medicine, Inc.
Recent Revenue History
Company Overview
Biocartis
Recent Revenue History
Company Overview
Startup History
Technology/Products
Investors/Financings and IPO
Pharmaceutical Company Agreements
Other Agreements
Biocept, Inc.
Recent Revenue History
Company Overview
Financings
Agreements with Pharmaceutical Companies
Other Agreements
Biodesix, Inc.
Investors/Financings
Other Agreements
BioFire Diagnostics, LLC. (Acquired by bioMérieux)
Recent Revenue History and Other Financial Information
Company Overview
BioGenex
Biological Dynamics, Inc.
BioMarker Strategies
bioMérieux SA
Recent Revenue History
Company Overview
Traditional Microbiology
Immunodiagnostics for Lab Professionals (Clinical Laboratories)
Mass Spectrometry for Clinical Laboratories
Molecular Diagnostics
Selected Pharmaceutical Company Agreements
Other Agreements
BioMosaics Inc.
BioReference Laboratories, Inc. (BRLI) (Part of OPKO Health, Inc.)
Recent Revenue History
Company Overview
bioTheranostics, Inc.
Biotype Diagnostic GmbH
Cancer Genetics, Inc.
Recent Revenue History
Company Overview
Pharmaceutical Company Agreements
Other Agreements
Caprion, Inc.
CardioDx, Inc.
CardioGenics Holdings Inc.
CareDx, Inc.
Recent Revenue History
Company Overview
Caris Life Sciences
Castle Biosciences, Inc.
Cepheid
Recent Revenue History
Company Overview
Clarient Diagnostic Services, Inc. (A NeoGenomics Company)
Recent Revenue History
Company Overview
CompanionDx
Crescendo Bioscience (A Myriad Company)
Cube Dx GmbH
Curetis AG
Recent Revenue History
Company Overview
Cynvenio Biosystems, Inc.
Dako A/S (An Agilent Company)
Recent Revenue History
Company Overview
Danaher Corporation
Recent Revenue History
Company Overview
Definiens AG (Acquired by MedImmune, Part of AstraZeneca)
DiaCarta, Inc.
DiamiR, LLC
Diatech Pharmacogenetics srl
Diaxonhit
Recent Revenue History
Company Overview
DNA Electronics Ltd. (DNAe)
EntroGen, Inc.
Enzo Biochem, Inc./Enzo Life Sciences, Inc./Enzo Clinical Labs, Inc.
Recent Revenue History
Company Overview
Epic Sciences, Inc.
Eutropics Pharmaceuticals
Exosome Diagnostics, Inc.
Selected Agreements
Foundation Medicine, Inc.
Recent Revenue History
Company Overview
Pharmaceutical Company Agreements
Agreement with Contract Research Organization
Agreements with Universities and Other Non-Profit Institutions
Agreements with Other (Non-Diagnostic) Companies
GeneCentric Diagnostics, Inc.
Genection, Inc. (An Invivoscribe Company)
Genelex Corporation
GeneNews Limited and Innovative Diagnostic Laboratory
Genomas, Inc.
GenomeDx Biosciences
Genomic Health, Inc.
Recent Revenue History
Company Overview
Genomica S.A.U.
Genomind
Genoptix (A Novartis Company)
GenPath Oncology
Grifols, S.A.
Recent Revenue History
Company Overview
Guardant Health, Inc.
HalioDx
Harmonyx Diagnostics
Helomics Corporation
HTG Molecular Diagnostics, Inc.
Recent Revenue History
Company Overview
Products
Pharmaceutical Company Agreements
Selected Other Agreements
Illumina, Inc.
Recent Revenue History
Company Overview
Products and Services – Overview
Investing in the Future
Companion Diagnostics
Agreements with Pharmaceutical Companies
Other Companion Diagnostic/Personalized Medicine Agreements
Inform Genomics, Inc.
Financings
Other Agreements
Inivata Ltd.
Insight Genetics, Inc.
Selected Agreements
InSilixa, Inc.
IntegraGen SA
Recent Revenue History
Company Overview
Invivoscribe Technologies, Inc.
Iris BioTechnologies Inc.
Recent Revenue History
Company Overview
Janssen Diagnostics/Janssen Diagnostics BVBA/Janssen Diagnostics, LLC
Infectious Disease
Oncology
Lab 21 (Part of the Novacyt Group of Companies)
Laboratory Corporation of America (LabCorp)
Recent Revenue History
Company Overview
Selected Examples of Companion Diagnostic/Personalized Medicine Agreements between LabCorp or Covance and Other Diagnostic Companies
Leica Biosystems Inc. (A Danaher Company)
Pharmaceutical Company Agreements in Companion Diagnostics and Personalized Medicine
Other Companion Diagnostic/Personalized Medicine Agreements
Luminex Corporation
Recent Revenue History
Company Overview
Mayo Medical Laboratories and Mayo Clinic
Medical & Biological Laboratories Co., Ltd. (MBL)/MBL International
Corporation
Recent Revenue History
Company Overview
Metabolon, Inc.
Metamark Genetics, Inc.
MIODx
MolecularMD Corporation
Monogram Biosciences (LabCorp Specialty Testing Group)
Multiplicom NV
Myriad Genetics, Inc./Myriad RBM, Inc.
Recent Revenue History
Company Overview
Myriad RBM
Pharmaceutical Company Agreements
NanoString Technologies, Inc.
Recent Revenue History
Company Overview
NantOmics (Member of the NantWorks ecosystem of companies)
NeoGenomics, Inc./NeoGenomics Laboratories
Recent Revenue History
Company Overview
NewGene Ltd.
New Oncology AG
NovellusDx
Nuclea Biotechnologies, Inc.
OncoDNA SA
Oncompass GmbH
OncoPlex Diagnostics (OncoPlexDx)(Part of NantOmics)
Oncospire Genomics
One Way Liver S.L. (OWL Metabolomics)
OPKO Health, Inc./OPKO Diagnostics
Recent Revenue History
Company Overview
BioReference Laboratories
OPKO Lab and 4Kscore™ Test
Point-of-Care Diagnostics – Claros 1 Analyzer and Sangia Microfluidic Assay Cassettes 728
OvaGene Oncology Inc.
Oxford Cancer Biomarkers Ltd
Oxford Gene Technology
Panagene Inc.
Personal Genome Diagnostics, Inc.
Protagen AG
QIAGEN N.V.
Recent Revenue History
Company Overview
QuanDx Inc.
Quest Diagnostics
Recent Revenue History
Company Overview
Qvella Corporation
RiboMed Biotechnologies, Inc.
Roche
Recent Revenue History
Company Overview
Roche Professional Diagnostics
Molecular Diagnostics
Tissue Diagnostics
Next-Generation Sequencing
Rosetta Genomics Ltd.
Recent Revenue History
Company Overview
Selected Agreements
Siemens Healthcare Diagnostics/Siemens Clinical Laboratory/Siemens
Recent Revenue History
Company Overview
Symbiodx
Sysmex Corporation
Recent Revenue History
Company Overview
Theranostics Health Inc. (Acquired by Avant Diagnostics, Inc.)
Thermo Fisher Scientific, Inc.
Recent Revenue History
Company Overview
Transgenomic, Inc.
Recent Revenue History
Company Overview
TrimGen Corporation
Trovagene, Inc.
Recent Revenue History
Company Overview
Ventana Medical Systems, Inc. (Member of the Roche Group)
WOUNDCHEK Laboratories
LIST OF EXHIBITS
ONE: EXECUTIVE SUMMARY
Table 1-1: Worldwide Companion Diagnostic Market, 2015 and 2020
THREE: CURRENT AND EMERGING APPLICATIONS OF PERSONALIZED MEDICINE
Table 3-1: FDA Cleared/Approved Companion Diagnostic Tests
Table 3-2: Selected Major Biomarkers in Oncology Personalized Medicine Tests
Table 3-3: Selected Companies with Personalized Medicine Tests for Oncology
Table 3-4: Selected Companies with Personalized Medicine Tests for Cardiovascular Disease/Disorders
Table 3-5: Selected Companies with Personalized Medicine Tests for Neurological Disorders
Table 3-6: Selected Companies with Personalized Medicine Tests for Autoimmune and Inflammatory Disorders; Other Immune Related Conditions
Table 3-7: Selected Biomarkers and Other Tests for Antibiotic Resistance, and Companies Developing/Marketing these Biomarkers
Table 3-8: Selected Companies with Other Personalized Medicine Infectious Disease Tests
Table 3-9: Selected Companies with Personalized Medicine Tests for Therapeutic Drug Monitoring of Biological Drugs
Table 3-10: Pharmacogenomic Biomarkers in Drug Labeling
Table 3-11: Selected Companies with Personalized Medicine Tests for Drug Metabolism Genes
Table 3-12: Selected Companies with Other Personalized Medicine Tests
FOUR: BUSINESS MODELS AND DEALS – PERSONALIZED MEDICINE AND COMPANION DIAGNOSTICS
Table 4-1: Investments and Financings in Personalized Medicine/Companion
Diagnostics
Table 4-2: Selected Examples of Pharmaceutical Companies and Other Companies
That Invested in Diagnostic Companies in Personalized Medicine
Table 4-3: Mergers and Acquisitions in Personalized Medicine/Companion
Diagnostics
Table 4-4: Selected Examples of Pharmaceutical Companies That Acquired Diagnostic Companies or Have Diagnostic Divisions
Table 4-5: Collaborations between Pharmaceutical and Diagnostic Companies
Table 4-6: Selected Examples of Pharmaceutical That Entered into Agreements with Diagnostic Companies
Table 4-7: Selected Other Pharmaceutical Company Agreements
Table 4-8: Collaborations between Two Diagnostic Companies
Table 4-9: Diagnostic Company Agreements with Clinical Laboratories
Table 4-10: Diagnostic Company Agreements with Other Companies
Table 4-11: Diagnostic Company Collaborations with Universities and Other Non-Profit Research Institutes (Including Government)
SIX: PERSONALIZED MEDICINE AND COMPANION DIAGNOSTICS – MARKET ANALYSIS
Table 6-1: World IVD Companion Diagnostics Test Market (In Vitro Diagnostic Kits) by
Region (N. America, EU, ROW), 2015-2020
Table 6-2: World IVD Companion Diagnostics Test Market by Disease Segment, 2015(Cancer, Other)
Table 6-3: Wo.. 287
–NEXT-GENERATION SEQUENCING MARKETS —
Chapter 1: Executive Summary
Overview
Scope and Methodology
Market Overview
Future Prospects in the Sequencing Market
Chapter 2: Introduction
Overview – Next Generation Sequencing Market Is Rapidly Changing
History of DNA Sequencing
Point-of-View
Chapter 3: Sequencing Technology
Sanger Sequencing
Next-Generation Sequencing
Massively Parallel Signature Sequencing (MPSS)
Pyrosequencing
454 Technology
Sequencing by Synthesis (SBS)
Supported Oligonucleotide Ligation and Detection (SOLiD)
Ion Torrent Sequencing
Single Molecule Real Time (SMRT) Sequencing
DNA Nano Ball Sequencing
Nanopore Sequencing
Other Sequencing Technologies
Sequencing Applications/Types of Sequencing
Sample or Library Preparation
Information Technology
Sample-to-Answer (Sample-to-Insight) Workflows or Platforms
Rapid Next Generation Sequencing Testing
Chapter 4: Sequencing Applications
Research, Drug Discovery and Development
Clinical Diagnostic Applications of Sequencing
Cancer Diagnostics: NGS Based Tests for Oncology
Cancer Diagnostics: Liquid Biopsies
Genetic Analysis – Inherited Disorders, Prenatal and Postnatal Diagnostics
Infectious Disease Diagnostics
Human Leukocyte Antigen (HLA) Testing
Other Diagnostic Applications of Sequencing
Direct-to-Consumer Genetic Testing Industry
Chapter 5: Deals – Next Generation Sequencing Companies
Investments and Financing Agreements
Mergers and Acquisitions
Other Corporate Agreements and Collaborations
Collaborations/Agreements with Diagnostic Companies and/or Clinical Laboratories
Collaborations/Agreements with Pharmaceutical and Biopharmaceutical Companies
Collaborations/Agreements between Two Companies in Next Generation Sequencing
Other Company Collaborations/Agreements
Collaborations and Other Agreements with Universities, Non-Profit Research Institutes and Government
Chapter 6: Applying Sequencing to Diagnostics – Market Drivers and Challenges
Overcoming Technology Hurdles – Sample Preparation and Data Analysis
Advances in Next Generation Sequencing Platforms
Next Generation Sequencing Market Drivers
Advances in Technology
Research Market Drivers
Increasing Number of Clinical Applications for Next Generation Sequencing
Cancer Diagnostic Market Drivers
Genetic Analysis [Inherited Disorders, Prenatal and Postnatal Diagnostics] Market Drivers
Infectious Disease Diagnostic Market Drivers
Market Drivers for Other Segments of the Diagnostic Market
Issues and Hurdles Faced by NGS Companies Selling to the Research Market
Issues and Hurdles Faced by Clinical Laboratories Doing NGS
Regulation of Next Generation Sequencing-Based In Vitro Diagnostic (IVD) Tests
Regulation of Companion Diagnostics
Complexities of Companion Diagnostic Tests and Corresponding Therapeutic Products; Harmonization of Companion Diagnostic Tests Across a Class of Targeted Therapies
Cost and Reimbursement Issues
Competition
Future Prospects
Chapter 7: Sequencing Market Analysis
Sequencing Market Overview
Sequencing Market – Geographical Distribution
Brand Ownership
Sequencing Market – Research versus Clinical Use
Sequencing Methods/Applications
Clinical Sequencing Market – Disease Indications
Analysis of Deals Activity in Next Generation Sequencing
Chapter 8: Company Profiles – Next Generation Sequencing Companies
10x Genomics, Inc.
23andMe, Inc.
Abbott Laboratories
Recent Revenue History
Company Overview – With a Focus on Sequencing
ACT Genomics Co., Ltd.
Adaptive Biotechnologies Corporation
Admera Health
Advanced Biological Laboratories (ABL), S.A
Agilent Technologies Inc.
Recent Revenue History
Company Overview
AltheaDx, Inc.
Ambry Genetics Corp.
Aperiomics, Inc.
Asuragen, Inc.
Athena Diagnostics, Inc. (A Quest Diagnostics Business)
Base4 Innovation Ltd
Beckman Coulter, Inc. (Subsidiary of Danaher Corporation)
Revenue History
Company Overview
Becton, Dickinson and Company (BD)
Recent Revenue History
Company Overview
BGI
Bina Technologies, Inc. (Part of Roche Sequencing)
BioDiscovery, Inc.
Biomatters Ltd.
bioMérieux SA
Recent Revenue History
Company Overview
bioTheranostics, Inc.
Cancer Genetics, Inc.
Recent Revenue History
Company Overview
CareDx, Inc.
Recent Revenue History
Company Overview
Caris Life Sciences
CLC bio (A QIAGEN Company)
Color Genomics, Inc.
Complete Genomics (A BGI Company)
Courtagen Life Sciences, Inc.
Cynvenio Biosystems, Inc.
DNA Electronics Ltd.
Eurofins Genomics
Exosome Diagnostics, Inc.
Foundation Medicine, Inc.
Recent Revenue History
Company Overview
GATC Biotech AG
GenapSys, Inc.
GenDx
GENEWIZ Inc.
Genia Technologies, Inc. (Part of Roche Sequencing)
Genomic Health, Inc.
Recent Revenue History
Company Overview
Genoptix (A Novartis Company)
GnuBIO, Inc. (A Bio-Rad Company)
GRAIL
Guardant Health, Inc.
Helix
HTG Molecular Diagnostics
Recent Revenue History
Company Overview
Human Longevity, Inc.
Illumina, Inc.
Recent Revenue History
Company Overview
Inivata Ltd.
Invitae Corporation
Recent Revenue History
Company Overview
Invivoscribe Technologies, Inc.
Laboratory Corporation of America (LabCorp)
Recent Revenue History
Company Overview
Lasergen, Inc.
MolecularMD Corporation
Myriad Genetics, Inc.
Recent Revenue History
Company Overview
NANTOMICS (Member of the NantWorks ecosystem of companies)
Natera, Inc.
NeoGenomics, Inc./NeoGenomics Laboratories
Recent Revenue History
Company Overview
N-of-One, Inc.
OncoDNA SA
Oncospire Genomics
Oxford Nanopore Technologies Ltd.
Pacific Biosciences of California, Inc.
Recent Revenue History
Company Overview
Pathway Genomics Corporation
Personal Genome Diagnostics, Inc.
Personalis, Inc.
QIAGEN N.V.
Recent Revenue History
Company Overview
Quest Diagnostics
Recent Revenue History
Company Overview
RainDance Technologies, Inc.
Roche
Recent Revenue History
Company Overview
Siemens Healthcare Diagnostics
Recent Revenue History
Company Overview
Stratos Genomics Inc.
Sysmex Corporation
Recent Revenue History
Company Overview
Thermo Fisher Scientific, Inc.
Recent Revenue History
Company Overview
List of Exhibits
1: Executive Summary
Table 1-1: Worldwide Sequencing Market Product Revenues (Instruments and Consumables), 2015 and 2020
3: Sequencing Technology
Table 3-1: Current and Emerging Sequencing Technologies and Platforms
Table 3-2: Selected Companies Developing/Marketing Products for NGS Sample or Library Preparation
Table 3-3: Selected Companies Developing/Marketing NGS Information Technology Solutions
Table 3-4: Selected Companies Developing NGS Sample-to-Answer(Sample-to-Insight) Platforms
Table 3-5: Selected Companies Developing Rapid NGS Assays or Platforms
4: Sequencing Applications
Table 4-1: Selected Companies Offering Products/Services for Applications of Next Generation Sequencing in Oncology
Table 4-2: Selected Companies Developing and/or Marketing Liquid Biopsy Assays
Table 4-3: Selected Companies Offering Products/Services for Applications of Next Generation Sequencing in Genetic Analysis [Inherited Disorders,Prenatal and Postnatal Diagnostics]
Table 4-4: Selected Companies Offering Products/Services for Applications of Next Generation Sequencing in Infectious Diseases
Table 4-5: Selected Companies Offering Products/Services for Applications of DNA Sequencing in Human Leukocyte Antigen (HLA) Testing
Table 4-6: Selected Companies Offering Products/Services for Applications of Next Generation Sequencing in Other Diagnostic Applications
5: Deals – Next Generation Sequencing Companies
Table 5-1: Selected Investment and Financing Agreements in Next Generation Sequencing Companies [Includes IT Companies in NGS]
Table 5-2: Selected Acquisitions of Next Generation Sequencing Companies[Includes IT Companies in NGS]
Table 5-3: Selected Agreements between Next Generation Sequencing Companies and Diagnostic Companies or Clinical Laboratories [Includes IT Companies in NGS]
Table 5-4: Examples of Diagnostic Companies and Clinical Laboratories That Have Made Agreements in Next Generation Sequencing
Table 5-5: Selected Agreements between Next Generation Sequencing Companies and Pharmaceutical or Biopharmaceutical Companies [Includes Contract Research Organizations Providing Services to Pharma Companies]
Table 5-6: Selected Pharmaceutical and Biopharmaceutical Companies Using or Active in Next Generation Sequencing
Table 5-7: Selected Company Agreements between Two Next Generation Sequencing Companies [Includes IT Companies in NGS]
Table 5-8: Selected Other Next-Generation Sequencing Company Agreements in Next Generation Sequencing [Includes IT Companies in NGS]
Table 5-9: Selected Next Generation Sequencing Company Agreements with Academic or Other Non-Profit Organizations [Includes IT Companies in NGS]
7: Sequencing Market Analysis
Table 7-1: Sequencing Market, Worldwide, 2015 and 2020 (Instrument Revenue, Consumables Revenue, Services Revenue, Total Market)
Table 7-2: Sequencing Market by Geographical Region, Worldwide, 2015 and 2020 (North America, Europe, Asia, Rest of World, Total Market)
Figure 7-2: Next Generation Sequencing System Ownership by Country, Percentage (United States, China, Germany, UK, South Korea, Spain, Canada, France, Australia, Netherlands, Italy, Taiwan, Brazil, Japan, India, Sweden, Belgium, Denmark, Switzerland, Singapore, Saudi Arabia, Others)
Figure 7-3: Next Generation Sequencing System Ownership by Brand (HiSeq2000, Genome Analyser, Roche 454, ABI SOLiD, Ion Torrent, MiSeq, Ion Proton, Pacific Biosciences, Oxford Nanopore MinION, Polonator, NextSeq)
Figure 7-5: Research Sequencing Market – Types of Sequencing: Targeted or Whole Exome Sequencing versus de novo or Whole Genome Sequencing (2015)
Figure 7-6: Clinical Sequencing Market by Disease Category, 2015, Percentage (Genetic Testing/Inherited Disorders, Other Disorders)
Figure 7-7: Clinical Sequencing Market by Disease Category, 2020, Percentage(Oncology, Genetic Testing/Inherited Disorders, Infectious Disease, Other Disorders)
Table 7-3: Investments in Next Generation Sequencing Companies, 2015 and First Half of 2016
8: Company Profiles – Next Generation Sequencing Companies
Table 8-1: Abbott Revenues (2013, 2014, 2015)
Table 8-2: Agilent Technologies Revenues (2013, 2014, 2015)
Table 8-3: Becton, Dickinson and Company (BD) Revenues (2013, 2014, 2015)
Table 8-4: bioMérieux Revenues (2013, 2014, 2015)
Table 8-5: bioMérieux Revenues (2014 and 2015) – By Region, and by Technology and Application
Table 8-6: Cancer Genetics Revenues (2013, 2014, 2015)
Table 8-7: CareDx Revenues (2013, 2014, 2015)
Table 8-8: Foundation Medicine Revenues (2013, 2014, 2015)
Table 8-9: Genomic Health Revenues (2013, 2014, 2015)
Table 8-10: HTG Molecular Diagnostics (2014 and 2015)
Table 8-11: Illumina (2013, 2014, 2015)
Table 8-12: Invitae Corporation Revenues (2013, 2014, 2015)
Table 8-13: Laboratory Corporation of America (LabCorp) Revenues (2013,2014, 2015)
Table 8-14: Myriad Genetics Revenues (2013, 2014, 2015)
Table 8-15: NeoGenomics Revenues (2013, 2014, 2015)
Table 8-16: Pacific Biosciences Revenues (2013, 2014, 2015)
Table 8-17: QIAGEN Revenues (2013, 2014, 2015)
Table 8-18: QIAGEN – Distribution of Sales in 2015
Table 8-19: Quest Diagnostics Revenues (2013, 2014, 2015)
Table 8-20: Roche Revenues (2014 and 2015)
Table 8-21: Siemens Revenues (2014 and 2015)
Table 8-22: Sysmex Revenues (2013, 2014, 2015)
Table 8-23: Thermo Fisher Scientific Revenues (2013, 2014, 2015)
