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Kalorama 2017 IVD Market Research Bundle (The Worldwide Market for In Vitro Diagnostic Tests, NGS, Companion, US IVD)

$7,996.00 – $15,992.00

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SKU: KLI15198514 Category: Diagnostics Market Research Pages: 2600
  • Description
  • Table of Contents
  • Latest reports

Description

This bundle of previously published Kalorama Information studies allows decision-makers and researchers to review critical information in order to be prepared for events coming in 2017.   This In Vitro Diagnostics Market bundle contains the following reports, covering a range of IVD topics.

      The World Market for In Vitro Diagnostics, 10thEdition.  Published August 2016
United States In Vitro Diagnostics Markets Published July 2016
Companion Diagnostic Testing Markets Published April 2016
Next Generation Sequencing Markets Published September 2016

These are the full PDFs, as published this year.   In addition, Kalorama Information’s White paper Top 5 Trends to Watch in 2017 is provided.  Eachis presented as the original PDF.  Each report has its own table of contents  

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)

    Worldwide Market for Point-of-Care (POC) Diagnostic Tests, 12th Edition
    May 13, 2025
    In Vitro Diagnostic (IVD) Trends and Market Update, 2025
    April 7, 2025
    In Vitro Diagnostics Business Outlook, 2025 (6 Issues)
    April 3, 2025
    Molecular Diagnostics Quarterly Datastream, 2025
    April 2, 2025

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