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The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 10th Edition (Core Lab, POC, Glucose, Infectious Disease Testing, Histology, Hematology, NGS, Blood Screening/Typing, Coagulation Tests, Other Markets and Trends)

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SKU: KLI15067157 Categories: Clinical Chemistry, Diagnostics Market Research, Immunoassays, Point-of-Care Diagnostics Pages:
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Description

This Kalorama Information report, The Worldwide Market for In Vitro Diagnostic Tests, represents the 10th edition of this comprehensive look at the IVD industry.   At 1,600 pages report provides market size estimates and projections for the entirety of the clinical diagnostics testing market.  It also profiles hundreds of competitors, notes significant acquisitions and other deals, discusses trends and breaks out regional and country markets.   The report provides market size and forecasts to 2021 for defined segments of the IVD market and various sub-segments, including: 

Molecular Assays (Infectious Disease, Blood Screening, Inherited Diseases, Oncology, Pharmacodiagnostics, Tissue Typing, Prenatal)

Clinical Chemistry  (General Chemistries, Workstations, Analyzers Blood Gases, Urinalysis, Critical Care)

Point-of-Care  (POC), (Professional and Self-Testing, Glucose Testing, Pregnancy Tests, drugs of abuse, HIV, H. pylori, Other, OTC/Self Total, Professional POC, Cardiac Markers, Drugs of Abuse, HbA1c, Pregnancy, Other)

Microbiology and Virology by Test Type (Immunoassays, ID/AST, Infectious Diseases – DNA; ID/AST: Panels and Reagents, automated; Panels and Reagents, manual; Blood Culture; Chromogenic Media; Rapid Micro; Supplies)

Blood Banking (Grouping, Immunoassay Screens, NAT Screens)

Tissue-Based Testing – Histology and Cytology (Pap, ISH, IHC, HPV)

Microbiology Immunoassay Testing  (Hepatitis, HIV, STDs, TORCH, Respiratory, Sepsis, Parasitology, Mycology, Others)

Hematology

Molecular Tests in Infectious Diseases (HAI, HIV, Hepatitis, GC/Chlamydia, Respiratory, Organism ID, Mycobacteria, TB, Others

Non-Infectious Disease Immunoassay Sales by Analyte Type (Cardiac markers, Tumor markers, Diabetes/HbA1c, Autoimmune, Allergy, Thyroid, Proteins, Anemia, Fertility, Therapeutic drugs, Tox/Drugs of abuse, Vitamin D)

Coagulation Tests (Lab-Based, POC, Genetic Markers)

No other report provides similar understanding of the world diagnostics market.  For  each of the listed   segments, 2016 market size, 2021 projection and compound annual growth rate is provided, as well as   significant companies in the market and product innovations.  The market data is put into a context with   real-world industry and medical practice trends.

Included in the analysis is IVD market sizes and forecasts for the overall IVD markets of the US, Europe (including Germany, UK, France, Spain, Italy, Netherlands and Other Countries), China, Japan, Russia, Saudi Arabia, India, Canada, Turkey, Poland and other regions and countries.

Table of Contents

ONE: EXECUTIVE SUMMARY

Scope and Methodology

Size and Growth of the Market

Market Trends

TWO: INTRODUCTION

Report Design

Lab Medicine Disciplines and Applications

Market Analysis of IVD Market Segments

IVD Companies Mix and Match

Distribution Agreements

Licenses and Collaboration agreements

Test Services

Top Suppliers and Niche Players

IVDs Then and Now – A 20 Year Perspective

In the Beginning to Now

Surprises and Disappointments

Future

Point of View

THREE: OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC MARKETS

Background

Population and Disease Demographics Worldwide

Emerging Markets as a Market Driver

World Segments of the IVD Market and IVD Market Evolution

Specific Country Information

The United States of America

Japan

Europe: Slow Growth – Effects of Austerity

IVD Directive Update

China

India

Brazil

Russia

Canada

Saudi Arabia

Asia Review

FOUR: TRENDS AND INNOVATION

Background

Personal Genomics – A Work in Progress

Sequencing Enters the Clinic

Digital Technology, IT, BIG Data

Gene Editing

Wearables

Breath Test Advances

FIVE: POINT-OF-CARE TESTS

Overview and Trends

Professional POC

OTC Self Testing

Colon Cancer Screening

Lipid Testing

The Major POC Test Players

Diabetes Testing – Blood Glucose Monitoring

Glucose Testing in Tight Economics

IT to Aid Diabetes Management

Diabetes Market Analysis

Blood Glucose Self-Testing

Noninvasive Testing Devices

Continuous Self Testing en Route to the Artificial Pancreas

Blood Glucose Testing by Professionals

Diabetes Testing – Glycated Hemoglobin

Genes and Other Markers of Diabetes

SIX: THE CORE LAB

Core Lab Overview and Trends

Connectivity

Overview of Chemistry Tests

Lab Automation

Market Analysis

Rapid Response Systems

Critical Care Analysis

User Apps

Urinalysis

The Commercial Outlook for Chemistry Tests

SEVEN: IMMUNOASSAYS

Overview and Trends

Immunoassay Technology Continues to Evolve

Mass Spectrometry

Immunoassays in the Core Lab

Radioimmunoassays

Market Analysis

Leading Suppliers and Growth Potential

Mature Assay Segment

Thyroid Function

Therapeutic Drug Monitoring

Anemia

Toxicology/DAU

Allergy

Maturing Immunoassays

Proteins

Growth Immunoassays

Vitamin D

Tumor Markers

Cardiac Markers

Autoimmune

Rheumatoid Arthritis

Gastrointestinal Disorders

Transplant Management

Women’s Health

Alzheimer’s Disease

Miscellaneous

Point-of-Care OTC and Professional Use

Pregnancy Testing

Cardiovascular Diagnostics

Drugs of Abuse/Therapeutic Drug Monitoring

The Commercial Outlook for Immunoassays

EIGHT: MOLECULAR ASSAYS

Overview

Sample Preparation and Quality Control

Advanced Molecular Tests and Technologies

Exosome Sequencing

Liquid Biopsy

Metabolomic Profiling

Information Technology for Test Value

Forensic Studies – An Emerging Opportunity

Test Platforms

Major Players

Market Analysis

Oncology

Inherited Diseases

Prenatal and Newborn Testing

Tissue Typing

The Commercial Outlook for Molecular Tests

NINE: HEMATOLOGY

Overview of Hematology and Trends

Digital Image Analysis

Digital Evolution

Decentralized Hematology Testing

Hemoglobin/Hematocrit at the POC

Market Analysis: Leading Suppliers

The Commercial Outlook for Hematology Tests

TEN: COAGULATION

Overview and Trends of Coagulation and Immunohematology Tests

Special Topics

Direct Oral Anticoagulants (DOACs)

D-dimer

Market Analysis

Lab-based Testing

Genetic Markers of Hypercoagulopathies

Decentralized Coagulation Testing – Professional Use

Decentralized Coagulation Testing – OTC

Platelet Testing

Leading Suppliers

The Commercial Market for Coagulation Tests

ELEVEN: MICROBIOLOGY AND VIROLOGY

Overview

Special Topics

Some Disease Facts

Pregnancy Infections – Beyond Zika

Emerging Disease Threats

Antimicrobial Drug Resistance

Mass Spectrometry Not a Pipedream

Infection Screening Serology

Microbiome – Bacteria in Disease Processes

Market Analysis

Supplies

Chromogenic Media

Microbial Identification and Antimicrobial Sensitivity Tests

Automated Microbiology

Blood Culture

Rapid Tests

Immunoassays – Lab-based

Immunoassays – Rapid

Molecular Tests

The Commercial Outlook for Microbiology / Virology Tests

TWELVE: BLOOD BANKING SERVICES

Overview and Trends

are all these transfusions good medicine

Artificial blood

Pathogen Alerts

Platelet Safety

Market Analysis

Blood Grouping and Typing

Immunoassays

Nucleic Acid Testing (NAT)

The Commercial Outlook for Blood Banking

THIRTEEN: HISTOLOGY AND CYTOLOGY

Overview

Special Topics

Histology Automation

Advanced Analysis Solutions

HPV Goes Core Lab

Market Analysis

Histology/Cytology

Immunohistochemistry and In Situ Hybridization

Pharmacodiagnostic Histology

Digital Imaging and Computational Pathology

Circulating Tumor Cells

Flow Cytometry

The Commercial Outlook for Histology and Cytology Tests

FOURTEEN: COMPANY PROFILES: THE TOP TIER

Abbott Diagnostics

  Recent Revenue History:

  2014/2015 Business Highlights

  Core Lab

  Immunoassays

  Hematology

  Coagulation

  Blood Bank

  Point of Care

  Diabetes

  Molecular

  IntelligentMDx Alliance

  Iridica

  Histology

Alere Inc

  Recent Revenue History:

  Alere in Africa

  Product News

  Microbiology

  Molecular

Arkray

  Recent Revenue History:

  Urinalysis

  Diabetes

  Molecular

Beckman Coulter, Inc. / Danaher

  Recent Revenue History:

  Core Lab

  Hematology

  Immunoassays

Iris International

  Microbiology

  Molecular

  Sequencing

  Genomics

  Information Technology

  Flow Cytometry

Becton, Dickinson and Company (BD)

  Recent Revenue History:

  Traditional Microbiology

  Blood Culture

  Mass Spectrometry

  Veritor System – Immunoassays

  Histology

  HPV

  Molecular

  The BD MAX Enterprise

  Sequencing

  Flow Cytometry

bioMérieux Inc

   Recent Revenue History:

   Traditional Microbiology

   Blood Culture

   Immunoassays

   Rapid Tests

   Oncology

   Mass Spectrometry

   Molecular Strategy

   Sequencing Service

   Expansion

Bio-Rad Laboratories, Inc

   Recent Revenue History

   Controls

   Diabetes

   Blood Bank

   Immunoassays

   Flow Cytometry

   Digital PCR

Danaher Corporation

   Recent Revenue History

Hologic, Inc

   Recent Revenue History:

   The Gen-Probe/PANTHER Business

   Blood Bank

   Quest Contract

Instrumentation Laboratory (IL)

   Recent Revenue History: ($ millions)

   Coagulation

   Direct Oral Anticoagulant Testing (DOAC)

   Coagulation Automation

   Critical Care

Ortho Clinical Diagnostics (OCD)

   Recent Revenue History:

   Blood Bank

QIAGEN N.V

   Recent Revenue History

   Tuberculosis

   Infectious Disease Testing

   Transplant Medicine and HAIs

   Personalized Healthcare

   Companion Diagnostics

   Liquid Biopsy/CTC

   Instrumentation Base

   Rotor-Gene Q – Clinical Diagnostics

   Sequencing

   Exosomes

   Information Technology

   Collaborations

   Forensics

Radiometer A/S

   Recent Revenue History:

   Immunoassays

   Hemocue AB

Roche Diagnostics

   Recent Revenue History

   New Enterprises

   Global Access Program for HIV

   Core Lab

   Hematology

   Immunoassays

   Transplant Medicine

   Diabetes

   Point of Care

   Core Molecular Tests

   Virology

   STDs

   A POC Enterprise – Liat

   Prenatal and cfDNA

   HPV

   Blood Bank

   Liquid Biopsy

   Personalized Medicine

   Sequencing – Putting the Pieces Together

Siemens Healthcare Diagnostics

   Recent Revenue History:

   Core Lab

   Immunoassays

   Urinalysis

   Critical Care

   POC Connectivity

   Hematology

   Histology

   Coagulation

   Molecular

   Companion Diagnostics

   China

Sysmex Corporation

   Recent Revenue History:

   Hematology

   Coagulation

   Core Lab

   Inostics GmbH

   Flow Cytometry

   Thermo Fisher Scientific Inc

   Recent Revenue History:

   Sequencing

   Microbiology

   Microbiology IT

   Transplant

   Quality Control

   Mass Spectrometry

   Point of Care

   Molecular

   Oncology

   Forensic

Werfen Group S.A

FIFTEEN: Company Profiles: The Second Tier

Affymetrix Inc

    Recent Revenue History

    Axiom Genotyping Applications

    Agilent Technologies

    Recent Revenue History:

    Agilent in Genomics

    PCR

    Sequencing

    Arrays

Cepheid

    Recent Revenue History:

    Hospital Acquired Infections (HAI)

    TB

    Infectious Diseases

    Virology

    Oncology

Eiken Chemical Co., Ltd

    Recent Revenue History:

ERBA Mannheim

ERBA Diagnostics, Inc

    Recent Revenue History:

    Product Expansion

DiaSorin S.p.A

    Recent Revenue History:

    Immunoassays

    Molecular

Fujirebio Diagnostics, Inc

    Recent Revenue History:

    Molecular

Illumina

    Recent Revenue History:

    Understand Your Genome Symposium

    Sequencing

    Sequencing Kits

    Sample Prep

    IVD Business

    Oncology

    HLA Typing

    Information Technology  

    CRISPR

    Forensics

    CLIA Lab Service

    Sample to Insight

    Making a Market

    Expansion in China

LabCorp, Laboratory Corporation of America

    Recent Revenue History:

    Infectious Diseases

    Prenatal

    Sequencing

    Oncology

    Information Technology

    Forensic

    Expanding Food Testing

Luminex Corporation

    Recent Revenue History: $ million

    Business Expansion

    MAGPIX Multiplexing

    Next Generation NxTag

Menarini Diagnostics

    Recent Revenue History:

Mindray Medical International Limited

     Recent Revenue History:

     Core Lab

    Hematology

    Coagulation

Myriad Genetics

     Recent Revenue History: (millions)

     Molecular Product News

     Beyond Cancer

     IP Update

PerkinElmer, Inc. (PE)

     Recent Revenue History: ($ million, estimated)

     Newborn Testing

     Prenatal Testing

     Histology

     Information Technology

     India

     China

Quest Diagnostics

     Recent Revenue History:

     Oncology

     Infectious Diseases

     Prenatal and Women’s Health

     Market Expansion

     Insurance and Wellness Business

Quest Partners for Market Accessibility

     Information Technology

Quidel Corporation

     Recent Revenue History:

     Point of Care

     Immunoassays

     Molecular

     Lyra Product Line

     Solana Molecular System

     AmpliVue Product Line

     Savanna (formerly Wildcat)

Randox Laboratories Ltd

     Recent Revenue History:

     Controls

     Immunoassays

     Molecular

     Prenatal

     POC

Royal Philips

     Histology

     Point of Care

TOSOH Corporation

     Recent Revenue History

     Immunoassays

     Transasia Bio-Medicals Ltd

Trinity Biotech plc

     Recent Revenue History

Wako Pure Chemical Industries, Ltd

     Recent Revenue History

SIXTEEN: COMPANY PROFILES: BLOOD BANK SPECIALISTS

BloodSource

Cerus Corporation

Grifols

Clinical Analysis

Blood Transfusion Business

International Programs

Molecular

Haemokinesis Pty Ltd

Immucor, Inc

Transfusion Medicine

Transplant Diagnostics

IMMUCOR DX Laboratory Service

Micro Typing Concepts (MTC)

Quotient Limited

Traditional Blood Grouping

MosaiQ Platform

SEVENTEEN: COMPANY PROFILES: COAGULATION SPECIALISTS

Diagnostica Stago, S.A.S

     Recent Revenue History

    Instrumentation

    Test Kits

Microvisk Technologies

EIGHTEEN: COMPANY PROFILES: CORE LAB AND OTHER COMPANIES

AB SCIEX Pte Ltd

Bruker BioSciences Corporation

    Recent Revenue History

    Microbiology

    Tissue Analysis

EKF Diagnostics Holdings Plc

    Recent Revenue History

    Lab-based Assays

    Molecular

EliTech Group S.A.S

MedTest DX

Microsaic Systems plc

Nova Biomedical

Diabetes

Scienion AG

Sekisui Diagnostics

Shimadzu Scientific Instruments

Tecan Group

    Recent Revenue History

NINETEEN: COMPANY PROFILES: CTC & LIQUID BIOPSY TEST PROVIDERS

Angle plc

ApoCell, Inc

Biocept, Inc

    Recent Revenue History

    Menu Expansion

    Reimbursement

Biodesix, Inc

Celsee Diagnostics (formerly DeNovo Sciences, Inc.)

Circulogene Theranostics

Clearbridge BioMedics

Cynvenio Biosystems, Inc

Epic Sciences Inc

Collaborations

Exosome Diagnostics, Inc

Fluxion Biosciences, Inc

Genyo – Centre for Genomics

Janssen Diagnostics, LLC (formerly Veridex, LLC)

    Recent Revenue History

Menarini-Silicon Biosystems

Qiagen Hanover

    Recent Revenue History

ScreenCell

WaveSense LLC

TWENTY: COMPANY PROFILES: DIABETES SPECIALISTS

Animas Corporation

    Recent Revenue History

Ascensia Diabetes Care (formerly Bayer Diabetes Care)

Recent Revenue History

Bigfoot Biomedical

Cellnovo Group

    Recent Revenue History

Debiotech SA

DexCom, Inc

    Recent Revenue History

Dexcom Product Overview

    Collaborations

Diasend AB

    Recent Revenue History

Gentag, Inc

Gentag’s Patent Position

Glucosense Diagnostics Ltd

Glysure Limited

Glytec Inc

iHealth Lab Inc

Insulet Corporation

    Recent Revenue History

Neighborhood Diabetes Inc

Integrity Applications Inc

LabStyle Innovations Corp

    Recent Revenue History

Lifescan Inc

    Recent Revenue History

    IP Issues

    Medtronic Inc

    Recent Revenue History

Nemaura Medical, Inc

Nightscout

Nipro Diagnostics, Inc

    Recent Revenue History:

Sanofi Diabetes

    Recent Revenue History

Tandem Diabetes Care, Inc

    Recent Revenue History

TypeZero Technologies

Verily (formerly Google Life Sciences)

TWENTY-ONE: COMPANY PROFILES: HEMATOLOGY (CELL ANALYSIS) SPECIALISTS

CellaVision AB

Recent Revenue History

Horiba Medical

Recent Revenue History

Chemistry

Medica Corporation

Oncascan Limited

West Medica

Zyomyx Inc

TWENTY-TWO: COMPANY PROFILES: HISTOPATHOLOGY SPECIALISTS

Advanced Cell Diagnostics (ACD)

Amoy Diagnostics Co. Ltd

Applied Spectral Imaging Inc. (ASI)

BioGenex Laboratories Inc

BioView Ltd

Recent Revenue History

Circulomics Inc

Dako A/S

Recent Revenue History

Special Stains

Immunohistochemistry (ICH)

Companion Diagnostics

Flow Cytometry

Automation

Alliances

Definiens

EMD Millipore

HTG Molecular Diagnostics

Recent Revenue History

Kapa Biosystems Inc

Leica Biosystems

Collaborations

Omnyx LLC

Ventana Medical Systems Inc

Recent Revenue History

Digital Pathology

Virtuoso Software Update

Product News

Automation

Partnerships

Visiopharm

TWENTY-THREE: COMPANY PROFILES: IMMUNOASSAY SPECIALISTS

BG Medicine, Inc

Recent Revenue History

Binding Site Group Ltd. (The)

Recent Revenue History

Biohit Oyj

Recent Revenue History

Market Expansion

Biomerica Inc

Recent Revenue History

Bio-Techne Corporation

Recent Revenue History

Corgenix Medical Corporation

Critical Diagnostics

Diaxonhit

Recent Revenue History

Euroimmun AG

Recent Revenue History

Hob Biotech

Immunodiagnostic Systems (IDS)

Recent Revenue History

INOVA Diagnostics, Inc

Integrated Diagnostics (Indi)

One Lambda

Recent Revenue History

Orgentec Diagnostika

Recent Revenue History

Protagen Diagnostics

Quanterix Corporation

Response Biomedical Corp

Recent Revenue History

Singulex, Inc

Theradiag

Recent Revenue History

VolitionRx Limited

TWENTY-FOUR: COMPANY PROFILES: INFORMATION TECHNOLOGY SPECIALISTS

Advaita Bioinformatics

Apple Inc

Cartagenia

Cerner Corp

CLC bio

Cypher Genomics Inc

Dell Healthcare and Life Sciences

Desktop Genetics, Ltd

DNAnexus

Edico Genome

Euformatics Oy

GENALICE

GenomOncology

Google Genomics (Alphabet)

IBM Healthcare

Intel Corporation

Knome Inc

Collaborations

N-of-One

PierianDx

Rennova Health, Inc

Sophia Genetics

Sunquest Information Systems

Tute Genomics

WuXi NextCODE Genomics

TWENTY-FIVE: COMPANY PROFILES: MICROBIOLOGY SPECIALISTS

Accelerate Diagnostics, Inc

Advanced Biological Laboratories, S.A. (ABL)

AdvanDx, Inc

altona Diagnostics

ArcDia International Oy Ltd

BioFire Diagnostics, Inc

Recent Revenue History

Copan Diagnostics Inc

Lab Automation

Partnerships

Swabs

Curetis AG

Fast-Track Diagnostics

Focus Diagnostics, Inc

Genetic Analysis AS

GeneWeave Biosciences, Inc

About Smarticle Technology

Great Basin Scientific, Inc

Greiner Bio-One International GmbH

Preanalytical Products

Hain Lifescience GmbH

Meridian Bioscience, Inc

Recent Revenue History

Immunoassays

illumigene

Meridian Life Science

Sample Collection

Mobidiag Ltd

Nanosphere, Inc

Recent Revenue History

Market Expansion

PositiveID Corporation

Recent Revenue History

Seegene, Inc

Recent Revenue History

Instrumentation

Collaborations

Specific Technologies

Synbiosis Ltd

T2 Biosystems

Recent Revenue History

ViroCyt, LLC

TWENTY-SIX: COMPANY PROFILES: MOLECULAR TEST SPECIALISTS

Agena Bioscience

Market Expansion

Asuragen Inc

Controls

Sample Collection

Sequencing

AutoGenomics Inc

BGI (formerly Beijing Genome Institute)

Prenatal Testing

Liquid Biopsy

With Complete Genomics

BGI Projects

Biocartis Group

Recent Revenue History

Connectivity

DMAT Instrumentation – MyCartis

Idylla News

Infectious Diseases

Building the Future

Collaborations

Enzo Biochem Inc

Recent Revenue History

IP Situation

Epigenomics

Exosome Diagnostics, Inc

Fluidigm Corporation

Recent Revenue History

GenMark Diagnostics

Recent Revenue History

Genome Diagnostics BV (GenDx)

Life Technologies Corporation

Instrumentation and Applications

Liquid Biopsy

Sequencing

Life Technologies an IVD company

Emerging Pathogens

Bacterial Typing

Forensic

Nanostring Technologies, Inc

Recent Revenue History

Immunohistochemistry

Alliances

LDTs

Oxford Nanopore Technologies Ltd

Pacific Biosciences of California, Inc. (PacBio)

Recent Revenue History

QuanDx Inc

RainDance Technologies, Inc

Recent Revenue History

Market Expansion

Rubicon Genomics, Inc

Transgenomic, Inc

Alliances

Lab Services

Diagnostic Tools Division

TrovaGene, Inc

Vela Diagnostics

WaferGen Bio-systems, Inc

Recent Revenue History

TWENTY-SEVEN: COMPANY PROFILES: POINT OF CARE TEST SPECIALISTS

Abaxis, Inc

Recent Revenue History

Abingdon Health Ltd

Atlas Genetics Ltd

Biomeme, Inc

Chembio Diagnostic Systems, Inc

Recent Revenue History

DNA Electronics Ltd (DNAe)

Enigma Diagnostics Limited

Entopsis

Epistem Holdings plc

FABPulous B.V

Fio Corporation

Hema Diagnostic Systems (HDS)

Imec

InSilixa Inc

MedMira Inc

OraSure Technologies, Inc

Recent Revenue History

The Genotek Business

PTS Diagnostics

QloudLab SA

QuantuMDx Group Limited

Rheonix, Inc

Samsung Healthcare

Scanadu, Inc

Theranos, Inc

Veredus Laboratories Pte Ltd

Xagenic

TWENTY-EIGHT: COMPANY PROFILES: PRENATAL TEST SERVICE PROVIDERS

Ariosa Diagnostics, Inc

Berry Genomics Co. Ltd

Combimatrix Corp

Recent Revenue History

Good Start Genetics, Inc

Illumina

IP Issues

Cytogenetics

Inex Innovations Exchange

LifeCodexx AG

MAP Diagnostics Ltd

Multiplicom N.V

Natera

Recent Revenue History

Oncology – Planning for the Future

Premaitha Health plc

Sequenom Inc

Recent Revenue History

Market Expansion

Product Expansion

IP Issues

Oncology

Coagulation

TWENTY-NINE: COMPANY PROFILES: QUALITY CONTROL & SAMPLE PRETREATMENT SPECIALISTS

Horizon Discovery Group plc

Recent Revenue History

Collaborations

MO BIO Laboratories, Inc

Oasis Diagnostics Corporation

PreAnalytiX GmbH

SeraCare Life Sciences, Inc

Streck Inc

THIRTY: COMPANY PROFILES: TEST SERVICE PROVIDERS

23andMe

The Move to Building a Research Company

Therapeutics Group

Ancestry

Outside the U.S

Agendia BV

Recent Revenue History

Ambry Genetics

Epilepsy

Oncology

Cardiac

Prenatal

Information Technology

ARUP Laboratories

Assurex Health

BioCollective (The)

Bio-Reference Laboratories, Inc. (BRLI)

bioTheranostics

BluePrint Genetics Oy

Boston Heart Diagnostics

CareDx, Inc. (Formerly XDx, Inc.)

Recent Revenue History

Sequencing

Cleveland HeartLab Inc

Counsyl

Eurofins Genomics

Exact Sciences Corp

Recent Revenue History

Foundation Medicine Inc

Recent Revenue History

Collaborations

Genomic Health, Inc

Recent Revenue History

Market Uptake

Liquid Biopsy

Service Spin-off

Genomic Vision

Recent Revenue History

Helomics Corporation (formerly Precision Therapeutics, Inc)

Mayo Medical Laboratories

Information Technology

MDxHealth SA

Recent Revenue History

OPKO Diagnostics

Pathway Genomics Corporation

Rosetta Genomics Ltd

Recent Revenue History

Expansion

Sonic Healthcare

Recent Revenue History

Veracyte, Inc

Recent Revenue History

Vermillion Inc

Recent Revenue History

————————————-List of Exhibits—————————————-

ONE: EXECUTIVE SUMMARY

Table 1-1

Exchange Rate Fluctuations, 2012–2016

Table 1-2

Worldwide In Vitro Diagnostic Reagent Sales by Market Segment, 2016-2021

TWO: INTRODUCTION

Table 2-1

Worldwide In Vitro Diagnostic Sales by Product Market, 2016-2021

Table 2-2

Selected Diagnostics Industry Acquisitions, 2014, 2015 and H2 2016

Table 2-3

Selected Diagnostics Industry Distribution Agreements, 2014, 2015, H2 2016

Table 2-4

Selected IVD collaboration/Licensing Agreements, 2014, 2015, H2 2016

Table 2-5

Selected Test Services, Sales 2012-2016

Table 2-6

Lab Market Segmentation, Worldwide, 2016

Table 2-7

Revenues for a Selection of U.S.-based Reference Labs, 2012-2016

Table 2-8

Selected Company sponsored Labs Established in 2014 and 2015

Table 2-9

Revenues of Selected Top IVD Companies, 2012-2016

Table 2-10

Revenues of Selected Niche Players, 2012-2016

Table 2-11 IVD Test Segment Sales 1995-2015

THREE: OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC MARKETS

Table 3-1

World Population Distribution, 2016

Table 3-2

Selected Disease Statistics, Worldwide

Table 3-3

Elderly Support Ratio in Selected Countries (2050)

Table 3-4

Available Market Data, 2016

Table 3-5

Worldwide In Vitro Diagnostic Reagent Sales by Country/Region, 2016-2021

Figure 3-1: EU IVD Revenue Stream 2007-2016

Table 3-6

European Union (EU14) IVD Sales by Country 2014

Table 3-7

Per Capita IVD Expenditure

FOUR: TRENDS AND INNOVATION

Table 4-1

Selected Sequencing Platforms

Table 4-2

Selected IVD industry IT Investments

Table 4-3

Selected Gene Editing Research Kits

Table 4-4

Selected Wearable Devices

Table 4-5

Selected Disease Markers in Exhaled Breath

Table 4-6

Selected Breath Test Innovations

FIVE: POINT-OF-CARE TESTS

Table 5-1

Professional POC Test Sales by Category, Worldwide, 2016-2021

Table 5-2

Hospital POC Test Usage, U.S

Table 5-3

Selected Profession POC Test Innovations

Table 5-4

POC Self Test Sales by Category, Worldwide, 2016-2021

Table 5-5

POC Test Revenues of Selected IVD Companies, 2013-2015

Table 5-6

Selected Apps and Glucose Management IT

Table 5-7

Diabetes Sales by Test Category, Worldwide, 2016-2021

Table 5-8

World Glucose Monitoring Sales, Major Companies, 2012-2016

Table 5-9

Selected Glucose Self-Test Meter Innovations

Table 5-10

Selected Noninvasive Glucose Monitoring Devices

Table 5-11

Selected Continuous BGM Sales, 2013 – 2016

Table 5-12

Selected Continuous Blood Glucose System Developments

Table 5-13

Selected Innovations in Hospital-based Glucose Monitoring

Table 5-14

Selected POC HbA1c Devices

Table 5-15

Selected POC Diabetes Monitoring Tests

SIX: THE CORE LAB

Table 6-1

Workstation Sales, 2016-2021 (General Chemistries, Immunos on workstations)

Table 6-2

Core Lab Sales of the Top Five Manufacturers, 2012-2016

Table 6-3

Selected New Analytes for the Core Lab, 2014-2015

Table 6-4

Selected Lab Automation Innovations

Table 6-5

Worldwide Clinical Chemistry Sales by Test Category, 2016-2021

Table 6-6

Major Clinical Chemistry Companies

Table 6-7

Selected Clinical Chemistry Innovations

Table 6-8

Major Whole Blood Chemistry Analyzers

Table 6-9

Selected Apps, Critical Care and Urinalysis IT Innovations, 2016

Table 6-10

Selected Urinalysis Innovations, 2016

SEVEN: IMMUNOASSAYS

Table 7-1

Selected New Immunoassay Technologies, 2016

Table 7-2

Selected Innovation in Mass Spectrometry for Routine Analyses

Table 7-3

Selected Immunoassay Innovations on Core Lab Instruments

Table 7-4

Worldwide Lab-based Immunoassay Sales by Analyte Type, 2016-2021

Table 7-5

Selected Immunoassay Quality Control Products

Table 7-6

Revenue History of Leading Immunoassay Vendors, 2012-2016

Table 7-7

Selected New Vitamin D Immunoassays, 2014-2016

Table 7-8

Selected Tumor Marker Innovations, 2014-2016

Table 7-9

Selected Cardiac Marker Innovations

Table 7-10

Selected Autoimmune Test Innovations

Table 7-11

Selected Arthritis Immunoassay Innovations

Table 7-12

Selected Inflammatory Bowel Disease Test Innovations

Table 7-13

Selected Immunoassays for Transplant Medicine

Table 7-14

Selected Women’s Health Innovations

Table 7-15

Selected Innovations for Alzheimer’s Disease Immunoassays

Table 7-16: Selected Immunoassay Innovations

Table 7-17

POC Immunoassay Test Sales by Test Category, 2016-2021

Table 7-18

Selected Self-Test Immunoassay Innovations

Table 7-19

Selected Professional POC Test Innovations, 2016

Table 7-20

Selected POC Immunoassay Test Platforms

EIGHT: MOLECULAR ASSAYS 310

Table 8-1

Common Next Generation Molecular Test Traits

Table 8-2

Selected Molecular Test Sample Preparation and QC Innovations

Table 8-3

Selected Exosome Test Innovations

Table 8-4

Selected Liquid Biopsy Innovations

Table 8-5

Selected IT Innovations in Molecular Diagnostics

Table 8-6

Selected Innovations in Forensic DNA Testing

Table 8-7

Key Molecular Technologies and Major Players

Table 8-8

Selected Molecular Test Platform Innovations

Table 8-9

Molecular Test Revenues of Selected IVD Vendors, 2012-2016

Table 8-10

Worldwide Molecular Test Sales by Type, 2016-2021

Table 8-11

Selected Molecular Tumor Marker Test Innovations

Table 8-12

Most Frequently Requested Genetic Tests

Table 8-13

Selected Genomic Tests for Inherited Diseases

Table 8-14

Revenue Stream of Selected NIPT Service Companies, 2012-2015

Table 8-15

Prenatal Services Provided

Table 8-16

Selected Molecular Tests for Prenatal Analysis

Table 8-17

Selected HLA Typing Test Innovations

NINE: HEMATOLOGY

Table 9-1

CellaVision Placement Data by Hematology Vendor

Table 9-2

Selected Hematology Image Analysis Innovations, 2014-2015

Table 9-3

Selected POC Hematology Innovations

Table 9-4

Revenue History of the Major Hematology Vendors, 2012-2016

Table 9-5

Selected Hematology Innovations, 2016

TEN: COAGULATION

Table 10-1

Worldwide Coagulation Sales by Segment, 2016-2021

Table 10-2

Selected Lab-based Coagulation Innovations, 2016

Table 10-3

Selected Molecular Coagulation Test Innovations

Table 10-4

Selected POC Coagulation Test Innovations

Table 10-5

Top Coagulation Company Revenues, Lab & POC, 2012 – 2016

Table 10-6

Major Anticoagulants Uses and Tests

ELEVEN: MICROBIOLOGY AND VIROLOGY

Table 11-1

Global Deaths from Communicable Diseases, 2010

Table 11-2

Selected Tests for Emerging Pathogens

Table 11-3

Selected Tests for Antibiotic Resistance

Table 11-4

Selected Microbiology Mass Spec Innovations

Table 11-5

Selected Microbiome-based Tests

Table 11-6

Worldwide Microbiology/Virology Sales by Type, 2016-2021

Table 11-7

Selected Innovations in Microbiology Pre-Analytical Products

Table 11-8

Selected Innovations in Bacterial Identification

Table 11-9

Selected Antibiotic Sensitivity Test Innovations

Table 11-10

Revenue of Selected Microbiology Companies, 2013, 2016

Table 11-11

Selected Advanced Techniques for Positive Blood Cultures

Table 11-12

Lab-based Infectious Disease Immunoassays, by Test, 2016

Table 11-13

Selected Infectious Disease Immunoassay Innovations

Table 11-14

Selected Professional Use POC Tests for Infectious Diseases

Table 11- 15: Selected Molecular Test Platform Innovations, 2014-2016

Table 11-16

Selected Microbiology Sequencing Innovations

Table 11-17

Molecular Test Sales, Infectious Diseases, 2016

Table 11-18

Selected Molecular HAI Test Innovations

Table 11-19

Selected Molecular Tests for STDs

Table 11-20

Selected Molecular Respiratory Disease Innovations

Table 11-21

Selected Molecular HIV Test Innovations

Table 11-22

Selected Infectious Disease Molecular Test Innovations

Table 11-23

Selected Molecular POC Device Innovations

TWELVE: BLOOD BANKING SERVICES

Table 12-1

Blood Donation, Key Facts

Table 12-2

Distribution of Blood Units Collected

Table 12-3

Laboratory Screening of Blood Donations for Transfusion-Transmissible Infections, Number of Countries (Syphilis, HCV, HBV, HIV)

Table 12-4

Blood Component Usage (Liver Transplant, Adult Open Heart Surgery, Automobile Accident, Leukemia, Sickle Cell Disease, Cancer Chemotherapy)

Table 12-5

Impact of Alloimmunization (% of Patients Screening Positive for One or More Antibodies)

Table 12-6

Worldwide Blood Bank Sales, 2016-2021

Table 12-7

Selected Blood Grouping Innovations

Table 12-8

Selected New Blood Screen NAT Tests and Systems

THIRTEEN: HISTOLOGY AND CYTOLOGY

Table 13-1

Selected Histology Lab Automation

Table 13-2

Histology Information Technology Tools

Table 13-3

Selected Advanced Histology Techniques

Table 13-4

Selected HPV Test Innovations

Table 13-5

Worldwide Histology/Cytology Sales by Type, 2016-2021

Table 13-6

Revenues of the Major Histology Companies, 2012-2016

Table 13-7

Selected Vendors Of Traditional Histology Stains

Table 13-8

Selected In Situ Hybridization-based Tests

Table 13-9

Selected IHC Test Innovations

Table 13-10

Major Pharmacodiagnostic Markers

Table 13-11

Selected Pharmacodiagnostic Histology Tests

Table 13-12

Selected Digital Imaging Innovations

Table 13-13

Selected Innovations in CTC Technology

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