The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 9th Edition

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Date: 13-Aug-2014
No. of pages: 1200
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This single volume covers the entirety of the clinical testing market and all of its segments, providing customers with a tremendous value.

Used by Top IVD Companies For Business Planning.

This year, Kalorama has published its ninth edition of this informative volume based on the market events of 2013 and early 2014. New entrants, new technologies have entered the stage and all important events are cataloged in this report. The idea behind Kalorama's unique report is that the entire market can be captured in one volume. Published every two years, this volume includes market estimates for 2013 base year and forecasts to 2018 for the most important aspects of all of the major segments of clinical lab testing, including:


  • Core Lab (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)

  • Histology and Cytology (Pap, ISH, IHC, HPV)

  • Lab-based Infectious Disease Immunoassays, by Test (Hepatitis, HIV, STDs, TORCH, Respiratory, Sepsis, Parasitology, Mycology, Others)

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

  • Hematology

  • Molecular Test Sales, Infectious Diseases (HAI, HIV, Hepatitis, GC/Chlamydia, Respiratory, Organism ID, Mycobacteria, TB, Others

  • Lab-based 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 (Lab-Based, POC, Genetic Markers)

  • 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)


The Worldwide Market for In Vitro Diagnostic Tests is a testament to the Kalorama methodology. It is the result of months of painstaking work by an IVD industry veteran, who has tracked hundreds of companies for developments, trends and financial results. This research is compiled along with the opinion, observations and insights of industry experts to produce an unparalleled vision of the industry as it is in 2014. The report includes data in a sizeable number of IVD segments and detailed discussion of the trends that are impacting the industry. The report also provides a realistic forecast five years into the future for companies already participating in or considering entry into this growing industry.

Independent Perspective. Authoritative Coverage.

At 1200 pages, this is the most comprehensive report on the in vitro diagnostic industry available. No surprise that it has been called the 'Bible of the IVD Industry' by past users of the report. Many of the top IVD companies use this product for business planning, which means that this volume can provide a uniform standard for in vitro diagnostic market numbers. This edition greatly expands coverage of the field and tracks the most important developments.

Understand areas of the market that might not be available in your company's internal resources. View the industry from an independent point of view. Learn about competitors in a way that may be invisible to internal personnel. Know the market players - your potential partners, your existing or potential competitors, in proper context. Save countless hours of staff time and other research expenses with the authoritative guide for IVD market estimates and forecasts.

Worldwide Coverage, Including Emerging Markets.

From the first edition, this report has been intended to create a global picture for readers. Clinical testing is a worldwide business. This has always been true, but today emerging markets are part of the growth strategy of companies large and small. Kalorama has adjusted to these industry trends with enhanced geographic segmentation. While the US is a large healthcare market, many of the most interesting opportunities for companies are occurring in emerging markets.

As part of its coverage, the report breaks down the entire IVD market for the following regions:


  • North America

  • Europe (with total IVD market sizes for EU countries)

  • Asia (China, Japan, India)

  • Latin America

  • Rest of World


Not Just "What" Happened in the Industry, But "Why?"

The report does not merely report figures absent context. It describes the competitive workings of the diagnostics industry, combining a competitor, product, regulatory and payor decision analysis. In addition to providing authoritative market estimates for IVD market segments, this unique report seeks to explain why market events are occurring. The report delves into fast- breaking trends in in vitro diagnostics and distinguishes between company PR and actual market reality.

As part of its coverage, the following trends are detailed in the report:


  • Sample to Insight: IT Makes It Possible

  • The Lure of IVD – Companies Mix and Match

  • Distribution Agreements

  • Emerging Market Growth

  • Licenses and Collaboration Agreements

  • Test Services Commercialization

  • Top Suppliers and Niche Players

  • Selected Test Innovations from Non-Commercial Facilities

  • Sequencing Moves To The Clinic

  • LDTs

  • Personalized Precision Medicine Advances and Barriers

  • LOCs Enable Mobile Health (mHealth)

  • Digital PCR

  • Exomes

  • Omics and BIG Data


Superior Company Profiling - Understand How Companies Rank and Where They Compete.

The report contains detailed profiles of the top players in IVD. Profiling in this report describes the developments in each significant division of their business. A number of secondary players are also extensively profiled, as well as specialty companies with expertise in one testing area.


  • Abbott Diagnostics

  • Alere Inc.

  • Arkray

  • Beckman Coulter, Inc.

  • Becton, Dickinson and Company (BD)

  • bioMérieux Inc.

  • Bio-Rad Laboratories, Inc.

  • Danaher Corporation

  • Hologic, Inc.

  • Ortho Clinical Diagnostics (OCD)

  • QIAGEN N.V.

  • Siemens Healthcare Diagnostics

  • Sysmex Corporation

  • Thermo Fisher Scientific Inc.

  • Affymetrix Inc.

  • Cepheid

  • Eiken Chemical Co., Ltd

  • ERBA Diagnostics, Inc.

  • DiaSorin S.p.A

  • Fujirebio Diagnostics, Inc.

  • Illumina

  • LabCorp

  • Luminex Corporation

  • Menarini Diagnostics

  • Myriad Genetics

  • PerkinElmer, Inc. (PE)

  • Quest Diagnostics

  • Quidel Corporation

  • Randox Laboratories Ltd.

  • TOSOH Corporation

  • Wako Pure Chemical Industries

  • And hundreds of other companies...


All market data are based on factory sales to the end user and not retail pricing or reimbursement payments. Data for the in vitro diagnostic market are presented in U.S. dollar market size for categories of tests, and for specific analytes where possible. The dollar value of a market segment is directly proportional to the number of tests performed, because the cost of the instrumentation is generally buried in the per test price.

The information presented in this report is derived on publicly available information sources such as company, government, and medical organization reports. The analysis is based on the author's industry knowledge combined with literature searches and interviews with industry professionals and experts in the IVD industry.

The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 9th Edition

Table of Contents

Chapter One: Executive Summary
Doing More with Less
Scope and Methodology
Size and Growth of the Market
Market Trends

Chapter Two: Introduction
Background
Report Design
Lab Medicine Disciplines and Applications
Market Analysis of IVD Market Segments
The Lure of IVD – Companies Mix and Match
Distribution Agreements
Licenses and Collaboration Agreements
Test Services
Top Suppliers and Niche Players
Selected Test Innovations from Non-Commercial Facilities
Baylor Research Institute, Dallas, TX
Boston University, Boston, MA
Brown University, Providence, RI
California Institute of Technology, Pasadena, CA
California NanoSystems Institute
Cedars Sinai Medical Center, Los Angeles, CA
Cleveland Clinic, Cleveland, OH
Duke University, Durham, NC
Hartford Hospital, Hartford, CT
Johns Hopkins University School of Medicine, Baltimore, MD
MedStar Washington Hospital Center, Washington, DC
Mount Sinai's Samuel Lunenfeld Research Institute, Toronto, ON
Northeastern University, Boston, MA
Peking University, Beijing, China
Queensland Institute of Medical Research, Brisbane, Australia
Schneider Children's Medical Center of Israel, Tel Aviv, Israel
Stockholm University, Sweden
Tokyo Medical and Dental University, Tokyo, Japan
University of British Columbia, Vancouver, BC
University of California, Davis, CA
University of California, Urvine, Urvine, CA
University of Cincinnati, Cincinnati, OH
University of Cologne, Cologne, Germany
University of Washington, Seattle, WA
Vanderbilt University, Nashville, TN
Weill Cornell Medical College, New York, NY
Yonsei University Health System, Seoul, S. Korea

Chapter Three: Overview of Global In Vitro Diagnostic Markets
Background
Population and Disease Demographics, Worldwide
Emerging Markets as a Market Driver
World Segments of the IVD Market and IVD Market Evolution
Specific Country Information
The United States of America – a World in Flux
Japan
Europe: Negative Growth - Effects of Austerity
China
India
Brazil
Russia
Canada

Chapter Four: Trends and Innovation
Background
IT Enables Sample to Insight
Omics and BIG Data
Sequencing Moves to the Clinic
Personalized Precision Medicine Advances and Barriers
LOCs Enable Mobile Health (mHealth)

Chapter Five: Point-Of-Care Tests
Overview
Professional POC
OTC Self Testing
Colon Cancer Screening
The Major POC Test Players
Diabetes Testing – Blood Glucose Monitoring
Glucose Market Shakeup
Diabetes Market Analysis
Blood Glucose Self-Testing
Continuous Self-Testing
Blood Glucose Testing by Professionals
New Technologies
Diabetes Testing – Glycated Hemoglobin
The Genetics of Diabetes

Chapter Six: the Core Lab
Core Lab Overview
Overview of Chemistry Tests
Lab Automation
Market Analysis
Lab-based Chemistries
Critical Care Analysis
User Apps
Urinalysis
The Commercial Outlook for Chemistry Tests

Chapter Seven: Immunoassays
Overview of Immunoassays
Immunoassay Technology Continues to Evolve
Immunoassays in the Core Lab
Special Topic – Metabolite Testing
Market Analysis
Leading Suppliers and Growth Potential
Assay Segments
Thyroid Function
Therapeutic Drug Tests
Anemia
Toxicology/DAU
Allergy
Proteins
Vitamin D
Tumor Markers
Cardiac Markers
Autoimmune
Diabetes
Transplant Management
Women’s Health
Gastrointestinal Disorders
Miscellaneous
Point-of-Care OTC and Professional Use
Patient Self-Tests (OTC)
Pregnancy Testing
Cardiovascular Diagnostics
Drugs of Abuse/Therapeutic Drug Monitoring
The Commercial Outlook for Immunoassays

Chapter Eight: Molecular Assays
Overview
Advanced Molecular Tests and Technologies
Digital PCR
Exomes
Major Players
Market Analysis
Oncology
Inherited Diseases
Prenatal Analysis
Tissue Typing
The Commercial Outlook for Molecular Tests

Chapter Nine: Hematology
Overview of Hematology
Digital Image Analysis
Digital Evolution
Decentralized Hematology Testing
Hemoglobin/Hematocrit at the POC
Market Analysis: Leading Suppliers
The Commercial Outlook for Hematology Tests

Chapter Ten: Coagulation
Overview of Coagulation and Immunohematology Tests
Genetics and Personalized Medicine
Warfarin
Plavix
Market Analysis
Lab-based Testing
Genetic Markers of Hypercoagulopathies
Decentralized Coagulation Testing – Professional Use
Decentralized Coagulation Testing – OTC
Platelet Testing
Leading Suppliers
The Commercial Market for Coagulation Tests

Chapter Eleven: Microbiology and Virology
Overview
Special Topics
Some Disease Facts
Emerging Disease Threats
Antimicrobial Drug Resistance
Mass Spectrometry Not a Pipedream
Sepsis Serology
Market Analysis
Supplies
Microbial Identification and Antimicrobial Sensitivity Tests
Blood Culture
Rapid Tests
Immunoassays – Lab-based
Immunoassays – Rapid
Molecular Tests
The Commercial Outlook for Microbiology / Virology Tests

Chapter Twelve: Blood Banking Services
Overview
Blood Banking Gets a Shakeup
Blood Management – Are All These Transfusions Good Medicine?
Pathogen Alerts
Platelet Safety
Market Analysis
Blood Grouping and Typing
Immunoassays
Nucleic Acid Testing (NAT)
The Commercial Outlook for Blood Banking
chapter thirteen
Histology and Cytology
Overview
Special Topics
Advanced Analysis Solutions
HPV Goes Core Lab
Market Analysis

Chapter Thirteen: Histology/Cytology
Immunohistochemistry and In Situ Hybridization
Pharmacodiagnostic Histology
Digital Imaging
Circulating Tumor Cells
Flow Cytometry
The Commercial Outlook for Histology and Cytology Tests

Chapter Fourteen: Company Profiles: the Top Tier
Abbott Diagnostics
Recent Revenue History
Highlights
Core Lab
Immunoassays
Molecular
Hematology
Histology
Blood Bank
Point of Care
Diabetes
IntelligentMDx Alliance
PLEX-ID
Alere Inc.
Recent Revenue History
HIV
Lab-based
Blood Gases
Hematology
Microbiology
Toxicology
Cardiology
Mail Order Glucose Meters
Molecular
Alere Medical India
Arkray
Recent Revenue History
Molecular
Beckman Coulter, Inc. / Danaher
Recent Revenue History
Core Lab
Hematology
Immunoassays
Histology
Flow Cytometry
Molecular
Lab Services
Becton, Dickinson and Company (BD)
Recent Revenue History:
Initiatives
Traditional Microbiology
Blood Culture
The BD MAX Enterprise
HPV
Veritor System - Immunoassays
Continuous Blood Glucose
Flow Cytometry
Histology
Mass Spectrometry
bioMérieux Inc.
Recent Revenue History
Expansion
Immunoassays
Blood Culture
Molecular Strategy
Mass Spectrometry
Bio-Rad Laboratories, Inc.
Recent Revenue History
Controls
Digital PCR
Blood Bank
Flow Cytometry
Lab Automation
Danaher Corporation
Recent Revenue History
Hologic, Inc.
Recent Revenue History
Product News
Blood Bank
Quest Contract
The Gen-Probe Business
Panther System
Instrumentation Laboratory (IL)
Recent Revenue History
New Products
Direct Sales
Ortho Clinical Diagnostics (OCD)
Recent Revenue History
Blood Bank
QIAGEN N.V.
Recent Revenue History
Personalized Healthcare
TB Testing
HPV
Oncology
Automation for the Future
Rotor-Gene Q
Exosomes
Sequencing
Information Technology
Point of Care
Collaborations
Radiometer A/S
Recent Revenue History
Immunoassays
Hemocue AB
Roche Diagnostics
Recent Revenue History
Reorganization
The PCR Enterprise
Core Lab
Molecular Core Lab IT
Immunoassays
Diabetes
Point of Care
Coagulation
HPV
Blood Bank
Liquid Biopsy
Molecular
Sequencing
Siemens Healthcare Diagnostics
Core Lab
Immunoassays
Hematology
Microbiology
Point of Care
Coagulation
Histology
Urinalysis
Critical Care
Molecular
Companion Diagnostics
Sequencing
Sysmex Corporation
Recent Revenue History
Hematology
Coagulation
Clinical Chemistry
Inostics GmbH
Intraoperative Test
Flow Cytometry
Thermo Fisher Scientific Inc.
Recent Revenue History
Sepsis
Histology
Allergy
Therapeutic Drug Monitoring
Mass Spectrometry
Microbiology
Werfen Group S.A.

Company Profiles: the Second Tier
Affymetrix Inc.
Recent Revenue History
Agilent Technologies
Recent Revenue History
Arrays
Sample Management
Mass Spectrometry
Expansion
Cepheid
Recent Revenue History:
Hospital Acquired Infections (HAI)
TB
Infectious Diseases
Oncology
Eiken Chemical Co., Ltd
Recent Revenue History
ERBA Diagnostics, Inc.
Recent Revenue History
ERBA Mannheim
DiaSorin S.p.A.
Recent Revenue History
Molecular
Immunoassays
Fujirebio Diagnostics, Inc.
Recent Revenue History
Molecular
Illumina
Recent Revenue History:
Sequencing
Cytogenetics
Prenatal Testing
CLIA Lab Service
Nanopore Sequencing
Sample to Insight
IP Situation
LabCorp, Laboratory Corporation of America
Recent Revenue History
Collaborations
BRCA Saga
Life Technologies Corporation
Recent Revenue History
Life Technologies as an IVD Company
Partnerships Worldwide
Life and Quidel Develop Diagnostics on the Fast Dx
Sepsis
HIV
Emerging Pathogens
Bacterial Typing
Personalized Medicine
Instrumentation and Applications
Luminex Corporation
Recent Revenue History:
Business Expansion
MAGPIX Multiplexing
Next Generation NxTag
Product News
Menarini Diagnostics
Recent Revenue History:
Myriad Genetics
Recent Revenue History:
Product News
The U.S. Market
IP Update
PerkinElmer, Inc. (PE)
Recent Revenue History:
Newborn Testing
Prenatal Testing
Histology
Sequencing
Mass Spectrometry
Information Technology
China
Quest Diagnostics
Recent Revenue History:
Quidel Corporation
Recent Revenue History:
Acquisitions
Point of Care
Immunoassays
Molecular
Savanna (formerly Wildcat)
Randox Laboratories Ltd.
Recent Revenue History:
Controls
Immunoassays
Molecular
TOSOH Corporation
Recent Revenue History:
Immunoassays
Transasia Bio-Medicals Ltd.
Recent Revenue History
Trinity Biotech plc
Recent Revenue History:
Product News
Wako Pure Chemical Industries, Ltd.
Recent Revenue History:

Sixteen: Company Profiles: Blood Bank Specialists
Cerus Corporation
Grifols
Haemonetics Corporation
Immucor, Inc.
Immunetics Inc.
Novartis Molecular Diagnostics
International Programs
Quotient Limited
Terumo BCT
Verax Biomedical Inc.

Seventeen: Company Profiles: Coagulation Specialists
Accriva Diagnostics
Atherotech Diagnostics Lab
Diagnostica Stago, S.A.S.
Gamma Therapeutics, Inc.
Microvisk Technologies

Eighteen: Company Profiles: Core Lab and Other Companies
Elektronika Kft
AB SCIEX Pte Ltd.
Bruker BioSciences Corporation
Diatron MI Plc
EliTech Group S.A.S.
IRIS International, Inc.
Medica Corporation
MedTest DX
Mindray Medical International Limited
Nova Biomedical

Nineteen: Company Profiles: Ctc Test Providersabnova
AdnaGen AG
Angle plc
ApoCell, Inc.
Biocept, Inc.
Clearbridge BioMedics
Cynvenio Biosystems, Inc.
Epic Sciences Inc.
Fluxion Biosciences, Inc.
Icellate AB
ProKyma Technologies
RareCyte, Inc.
ScreenCell
Veridex, LLC
WaveSense LLC

Twenty: Company Profiles: Diabetes Specialists
AgaMatrix, Inc.
ALR Technologies Inc.
Animas Corporation
Bayer Diabetes Care
DexCom, Inc.
Echo Therapeutics, Inc.
Entra Health Systems
iHealth Lab Inc.
Infopia Co Ltd
Insulet Corporation
U.S. Medicare Effects
Integrity Applications Inc.
LabStyle Innovations Corp.
Lifescan Inc.
IP Issues
Medtronic Inc.
Newomics Inc.
Prodigy Diabetes Care, LLC
Sanofi Diabetes
Senseonics, Incorporated
Tandem Diabetes Care, Inc.
TelCare Inc.

Twenty-One: Company Profiles: Hematology (Cell Analysis) Specialists
CellaVision AB
Constitution Medical, Inc.
DVS Sciences, Inc.
Horiba Medical
OrSense Ltd.
Partec GmbH

Twenty-Two: Company Profiles: Histopathology Specialists
Advanced Cell Diagnostics (ACD)
Amoy Diagnostics Co. Ltd.
Applied Spectral Imaging Inc. (ASI)
Biocare Medical, LLC
Biodis Biotechnology
BioMarker Strategies
BioView Ltd.
Dako A/S
Definiens
DxTerity Diagnostics Inc.
Leica Biosystems
Norchip
Ventana Medical Systems Inc.

Twenty-Three: Company Profiles: Immunoassay Specialists
ALPCO Diagnostics
BG Medicine, Inc.
Biohit Oyj
Market Expansion
Corgenix Medical Corporation
Critical Diagnostics
Diazyme Laboratories
Euro Diagnostica AB
Genalyte Inc.
Gold Standard Diagnostics
INOVA Diagnostics, Inc.
Matrix-Bio Inc.
Oasis Diagnostics Corporation
OPKO Diagnostics
Pronota NV
Quanterix Corporation
Tests in Development
Response Biomedical Corp.
Sera Prognostics, Inc.

Twenty-Four: Company Profiles: Information Technology Specialists
Cartagenia
Cerner Corp.
CLC bio
CollabRx Inc.
ConnectedHealth Pte. Ltd.
IBM Healthcare
Intel Corporation
Kaiser Permanente
MediSapiens Ltd.
Personalis Inc.

Twenty-Five: Company Profiles: Microbiology Specialists
AdvanDx, Inc.
Co-Diagnostics HBDC
Copan Diagnostics Inc.
Curetis AG
DxNA, LLC
Enigma Diagnostics Limited
Epistem Holdings plc
Focus Diagnostics, Inc.
Great Basin Scientific, Inc.
Hain Lifescience GmbH
Hutman Diagnostics AG
Immunexpress Group
InBios International, Inc.
Intelligent Medical Devices, Inc. (IMDx)
Laboratorios CONDA
Liofilchem s.r.l.
Lophius Biosciences GmbH
Lumora
MAST GROUP Ltd.
ID/AST
Immunoassays
Molecular
MBio Diagnostics, Inc.
Meridian Bioscience, Inc.
Immunoassays
illumigene Molecular
Meridian Life Science
Miacom Diagnostics GmbH
Mobidiag Ltd
Nanosphere, Inc.
Pathogenica
Seegene, Inc.

Twenty-Six: Company Profiles: Molecular Test Specialists
Amoy Diagnostics Co. Ltd.
Asuragen Inc.
BGI Projects
Biocartis SA
Idylla News
Biofortuna Ltd.
DiaCarta Inc.
Enzo Biochem Inc.
Epigenomics
Exosome Diagnostics
Genia Technologies Inc.
GenMark Diagnostics
HTG Molecular Diagnostics
IncellDx, Inc.
Inform Genomics
Nanostring Technologies, Inc.
QuantuMDx Group Limited
RainDance Technologies, Inc.
Selventa
TessArae, LLC
TrovaGene, Inc.

Twenty-Seven: Company Profiles: Point of Care Test Specialists
1st Health Products Ltd.,
Abaxis, Inc.
Aerocrine AB
Arbor Vita Corporation
Atomo Diagnostics
bioLytical Laboratories
Chembio Diagnostic Systems, Inc.
Counsyl Consumer
DiAssess Inc
EKF Diagnostics Holdings Plc
Gentle Laboratories
GlysBy s.n.c.
IntraMed Diagnostics, LLC
LeucoDx
Luoxis Diagnostics Inc.
Maxim Biomedical, Inc.
MedMira Inc.
Mode Diagnostics, Ltd
NEC Corporation
OraSure Technologies, Inc.
Pixie Scientific
Radisens Diagnostics Ltd.
Samsung Healthcare
STDcheck.com
UDoTest

Twenty-Eight: Company Profiles: Prenatal Test Service Providers
Ariosa Diagnostics, Inc.
Berry Genomics Co. Ltd
CellScape Corporation
GenePeeks, Inc.
Genomed AG
Good Start Genetics, Inc.
Illumina
INEX (Innovations Exchange Pte Ltd)
Kellbenx Inc.
Natera
NIPD Genetics Ltd
Sequenom Inc.
Sera Prognostics, Inc.

Twenty-Nine: Company Profiles: Test Service Providers
23andMe
Adaptive Biotechnologies Corporation
Agendia BV
Ambry Genetics
ARUP Laboratories
Assurex Health
Athena Diagnostics
BioReference Laboratories, Inc. (BRLI)
Boulder Diagnostics Inc.
Cancer Genetics, Inc. (CGI)
CardioDx, Inc.
Clarient Diagnostic Services, Inc.
Combimatrix Corp.
Diatherix Laboratories Inc.
Genomic Health, Inc.
Imugen Inc.
LipoScience Inc.
Mayo Medical Laboratories
MDxHealth SA
Medical Diagnostic Laboratories L.L.C. (MDL)
Metabolistics Inc.
Metabolon, Inc.
Metamark Genetics Inc.
OncoPlexDx
Rosetta Genomics Ltd.
Sengenics International Pte Ltd
Veracyte, Inc.

List of Exhibits

One: Executive Summary
Table 1-1: Exchange Rate Fluctuations, 2009–2013
Table 1-2: Worldwide In Vitro Diagnostic Reagent Sales by Market Segment 2013-2018 (Clinical Chemistry, Immunoassays - non isotopic, Infectious Diseases, Other Immunos, Blood Bank Screening, Diabetes HbA1c, Lab, Hematology, Microbiology (ID/AST), Microbiology - molecular, Radioimmunoassays, Coagulation, Histology/Cytology, HPV - molecular, Nucleic Acid Assays, Blood Grouping/Typing, Blood Bank Molecular, Flow Cytometry, Circulating Tumor Cells, POC - OTC diabetes, POC - OTC other, POC - Professional/Hospital)

Two: Introduction
Table 2-1: Worldwide In Vitro Diagnostic Sales by Product Market (Clinical Chemistry, Immunoassays - non isotopic, Infectious Diseases, Other Immunos, Blood Bank Screening, Diabetes HbA1c, Lab, Hematology, Microbiology (ID/AST), Microbiology - molecular, Radioimmunoassays, Coagulation, Histology/Cytology, HPV - molecular, Nucleic Acid Assays, Blood Grouping/Typing, Blood Bank Molecular, Flow Cytometry, Circulating Tumor Cells, POC - OTC diabetes, POC - OTC other, POC - Professional/Hospital) 2013-2018
Table 2-2: Selected Diagnostics Industry Acquisitions, 2012 and 2013
Table 2-3: Selected Diagnostics Industry Distribution Agreements, 2012 and 2013
Table 2-4: Selected IVD Licensing Agreements, 2012-2013
Table 2-5: Selected IVD Collaboration Agreements, 2012-2013
Table 2-6: New IVD Company Developments, 2012-2013
Table 2-7: Selected Test Services, Sales 2009-2013
Table 2-8: Lab Market Segmentation (Hospital Labs, Independent Labs, Physician Office Labs), Worldwide, 2013
Table 2-9: Revenues for a Selection of U.S.-based Reference Labs, 2009-2013
Table 2-10: Selected CLIA-certified Labs Established in 2012 and 2013
Table 2-11: Selected International Lab Developments, 2013
Table 2-12: Revenues of Selected Top IVD Companies, 2009-2013
Table 2-13: Revenues of Selected Niche Players, 2009-2013
Table 2-14: Selected IVD Market Laggards, 2012-2014

Three: Overview of Global In Vitro Diagnostic Markets
Table 3-1: World Population Distribution, August 2014
Table 3-2: Selected Disease Statistics, Worldwide
Table 3-3: Elderly Support Ratio in Selected Countries (2050)
Table 3-4: Available Market Data, 2013
Table 3-5: Healthcare Spending as a % of GDP Growth, Selected Developed Countries
Table 3-6: Healthcare Spending as a % of GDP Growth, Selected Emerging Markets
Table 3-7: Worldwide In Vitro Diagnostic Reagent Sales by Country/Region 2013-2018
Table 3-8: European Union (EU14) IVD Sales by Country 2012

Four: Trends and Innovation
Table 4-1: Selected IT Enabled Sample to Result Innovations
Table 4-2: Major Sequencing Platforms
Table 4-3: Selected Sequencing-based Innovations, 2012-2013
Table 4-4: Diseases with Drug Labels
Table 4-5: Selected Drug/Biomarker Targets in the U.S.
Table 4-6: Selected Drugs That Recommend PGx Testing in Europe
Table 4-7: Selected Cellphone Enabled Test Devices

Five: Point-Of-Care Tests
Table 5-1: POC Sales by Test Category(Glucose, Glucose continuous, Pregnancy/Ovulation, Coagulation/PT, Fecal Occult Blood, Drugs of abuse, H. pylori, HIV, Cholesterol, Other, Glucose, Critical Care, Pregnancy, Infectious Diseases, Cardiac Markers, Cholesterol/Lipids, Coagulation/PT ACT, HbA1c, Hematology, Fecal occult blood, Drugs of Abuse, Other) , Worldwide 2013-2018
Table 5-2: Hospital POC Test Usage (glucose, blood gas/electrolytes, coagulation, urinalysis, co-oximetry, cardiac markers, HbA1c), U.S.
Table 5-3: POC Test Revenues of Selected IVD Companies, 2013
Table 5-4: World Glucose Monitoring Sales, Major Companies, 2009-2013
Table 5-5: Selected Glucose Self-Test Meter Innovations, 2012 and 2013
Table 5-6: Selected Apps and Glucose Management IT, 2012 and 2013
Table 5-7: Selected Noninvasive Glucose Monitoring Devices
Table 5-8: Selected Continuous BGM Sales, 2013
Table 5-9: Selected Continuous Blood Glucose System Developments, 2013
Table 5-10: Selected Innovations in Hospital-based Glucose Monitoring
Table 5-11: Selected POC HbA1c Devices

Six: the Core Lab
Table 6-1: Workstation Sales (General Chemistries, Immunos on Workstations), 2013-2018
Table 6-2: Core Lab Sales of the Top Five Manufacturers, 2009-2013
Table 6-3: Selected New Analytes for the Core Lab, 2012-2013
Table 6-4: Selected Lab Automation Innovations, 2012-2013
Table 6-5: Worldwide Clinical Chemistry Sales by Test Category (General Chem, Blood Gases, Urinalysis, Critical Care POC) 2013-2018
Table 6-6: Major Clinical Chemistry Companies
Table 6-7: Major Whole Blood Chemistry Analyzers
Table 6-8: Selected Clinical Chemistry Innovations, 2012-2013
Table 6-9: Selected Rapid Chemistry Analyzers and Test Innovations, 2012-2013
Table 6-10: Selected Apps, Critical Care and Urinalysis Innovations, 2012-2013

Seven: Immunoassays
Table 7-1: Selected Immunoassays on Core Lab Instruments
Table 7-2: Selected New Immunoassay Technologies, 2013
Figure 7-1: Metabolites as Biomarkers of Disease
Table 7-3: Worldwide Lab-based 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), 2013-2018
Table 7-4: Revenue History of Leading Immunoassay Vendors, 2009-2013
Table 7-5: Selected Immunoassays Based on Mass Spectrometry
Table 7-6: Selected New Vitamin D Immunoassays, 2013
Table 7-7: Selected Tumor Marker Innovations, 2013
Table 7-8: Selected Cardiac Marker Innovations, 2013
Table 7-9: Selected Autoimmune Immunoassay Innovations, 2013
Table 7-10: Selected Diabetes Test Innovations, 2013
Table 7-11: Selected Women’s Health Innovations, 2013
Table 7-12: Selected Gastrointestinal Disease Immunoassays, 2013
Table 7-13: Selected Immunoassay Innovations, 2013
Table 7-14: POC Immunoassay Test Sales by Test Category (OTC/Self Tests, pregnancy/ovulation, drugs of abuse, HIV, H. pylori, Other, OTC/Self Total, Professional POC, Cardiac Markers, Drugs of Abuse, HbA1c, Pregnancy, Other, Professional Total), 2013-2018
Table 7-15: Selected Professional POC Test Innovations, 2013

Eight: Molecular Assays
Table 8-1: Selected Molecular Test Sample Preparation Innovations, 2013
Table 8-2: Selected Exosome Test Innovations
Table 8-3: Molecular Test Revenues of Selected IVD Vendors, 2009-2013
Table 8-4: Selection Molecular Platform Innovations for Genomic Testing
Table 8-5: Worldwide Molecular Test Sales by Type, 2013-2018
Table 8-6: Selected Molecular Tumor Marker Test Innovations
Table 8-7: Most Frequently Requested Genetic Tests
Table 8-8: Selected Genomic Tests for Inherited Diseases, 2013
Table 8-9: Selected Molecular Tests for Prenatal Analysis
Table 8-10: Selected HLA Typing Test Innovations, 2013
Table 8-11: Selected Molecular Test Innovations, 2013

Nine: Hematology
Table 9-1: Cellavision Placement Data by Hematology Vendor
Table 9-2: Selected Hematology Image Analysis Innovations, 2012-2013
Table 9-3: Selected POC Hematology Systems
Table 9-4: Revenue History of the Major Hematology Vendors 2009-2013
Table 9-5: Selected Hematology Innovations, 2012-2013

Ten: Coagulation
Table 10-1: Worldwide Coagulation Sales by Segment (PT/INR - lab, Molecular - lab, POC - professional, POC - self testing), 2013-2018
Table 10-2: Selected Coagulation Innovations, 2012-2013
Table 10-3: Selected Molecular Coagulation Test Innovations
Table 10-4: World POC Coagulation Sales, 2013
Table 10-5: Selected Lab-based and POC Coagulation Innovations, 2012-2013
Table 10- 6: Selected Platelet Activity Test Innovations, 2012-2013
Table 10-7: Top Coagulation Company Revenues 2013 – 2018
Table 10-8: Major Anticoagulants Uses and Tests

Eleven: Microbiology and Virology
Table 11-1: Selected Tests for Antibiotic Resistance
Table 11-2: Selected Microbiology Mass Spec Innovations, 2013
Table 11-3: Worldwide Microbiology/Virology Sales by Type (Infectious Diseases - Immunos, Infectious Diseases - Rapid, ID/AST, Infectious Diseases - DNA; ID/AST: Panels and Reagents, automated; Panels and Reagents, manual; Blood Culture; Chromogenic Media; Rapid Micro; Supplies) 2013-2018
Table 11-4: Selected Microbiology Media Innovations, 2013
Table 11-5: Revenue of Selected Microbiology Companies, 2013
Table 11-6: Selected Microbiology ID/AST Innovations, 2013
Table 11-7: Selected ID/AST Innovations, 2013
Table 11-8: Selected Advanced Techniques for Positive Blood Cultures
Table 11-9: Lab-based Infectious Disease Immunoassays, by Test (Hepatitis, HIV, STDs, TORCH, Respiratory, Sepsis, Parasitology, Mycology, Others), 2013
Table 11-10: Selected Infectious Disease Immunoassay Innovations
Table 11-11: Selected Professional-Use POC Tests for Infectious Diseases
Table 11-12: Selected Microbiology Sequencing Innovations, 2013
Table 11-13: Selected New Instruments for Molecular Infectious Disease Testing, 2013
Table 11-14: Molecular Test Sales, Infectious Diseases (HAI, HIV, Hepatitis, GC/Chlamydia, Respiratory, Organism ID, Mycobacteria, TB, Others), 2013-2018
Table 11-15: Selected Molecular HAI Test Innovations, 2013
Table 11-16: Selected Molecular STD Innovations, 2013
Table 11-17: Selected Molecular Respiratory Disease Innovations, 2013
Table 11-18: Selected Molecular HIV Test Innovations, 2013
Table 11-19: Selected Molecular POC Device Innovations, 2013
Table 11-20: Selected Infectious Disease Molecular Test Innovations

Twelve: Blood Banking Services
Table 12-1: Laboratory Screening of Blood Donations for Transfusion-Transmissible Infections, Number of Countries
Table 12-2: Blood Component Usage
Table 12-3: Impact of Alloimmunization (% of Patients Screening Positive for One or More Antibodies)
Table 12-4: Worldwide Blood Bank Sales, 2013-2018
Table 12-5: Selected New Blood Screening Immunoassays, 2012-2013
Table 12-6: Selected New Blood Screen NAT Tests and Systems, 2012-2013

Thirteen: Histology and Cytology
Table 13-1: Selected Histology Lab Automation, 2013
Table 13-2: Selected Advanced Histology Techniques
Table 13-3: Selected HPV Test Innovations
Table 13-4: Worldwide Histology/Cytology Sales by Type, 2013-2018
Table 13-5: Revenues of the Major Histology Companies, 2009-2013
Table 13-6: Selected Vendors of Traditional Histology Stains
Table 13-7: Selected Molecular Tissue-based Tests, 2013
Table 13-8: Selected IHC Test Innovations 2013
Table 13-9: Major Pharmacodiagnostic Markers
Table 13-10: Selected Pharmacodiagnostic Histology Tests
Table 13-11: Selected Digital Imaging Innovations, 2013
Table 13-13: Selected Innovations in CTC Technology, 2013
Table 13-14: Selected Innovations in Flow Cytometry, 2013

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