In seven best-selling editions, Shara Rosen has provided a total view of every
aspect of the market for in vitro diagnostic (IVD) testing in one complete
volume. The report, The Worldwide Market for In Vitro Diagnostic Tests, is a
testament to the Kalorama methodology. Real industry knowledge combined with
an exhaustive review of the medical, business, and company literature. Market
numbers for business planning matched with a discovery of the trends that are
impacting the industry. A realistic forecast five years into the future for
companies already participating in or considering entry into this growing
industry.
This year, Kalorama will complete its eighth edition of this informative
volume based on the market events of 2011. The idea behind Kalorama's unique
report is that the entire market can be captured in one volume and business
planners can use it as a key reference. Published every two years, this volume
includes coverage of the most important aspects of all of the major segments
of clinical lab testing, including:
Point of Care (POC), (Professional and Self-Testing)
Histology and Cytology (Pap, ISH, IHC, traditional non-pap, HPV)
Market sizes, forecasts and shares are provided, as well as a geographic
breakdown of the segments, where possible. Changes in technology development,
regulatory and reimbursement issues, clinical care, and business environments
are discussed. Current market numbers are presented for 2011, with projections
given through 2016.
The Bible of the IVD Industry
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 800+ page edition greatly expands coverage of the field
and tracks the most important developments.
A Global Report
IVD is a worldwide business. While the US is a large healthcare market, much
of the dynamism occurs in other areas. Many of the most interesting
developments 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 (EU countries)
Eastern Europe
South America
Asia (China and India)
Rest of World
A Report Designed for a Changing Industry
In this eighth edition of The Worldwide Market for In Vitro Diagnostic Tests
Kalorama Information addresses the key issues affecting the diagnostic
industry in 2012 and how competitors are faring. Among the topics tackled in
this report:
Molecular diagnostics including infectious disease mdx, pharmacodiagnostics,
molecular poc and test services are put in a context.
Technology: How EMR, mobile apps and handhelds impacts IVD devices.
New Screening Guidelines and Market Impact
The status of automation in the lab; core lab section includes both
workstation and automated panel revenues.
Hospital Infection Testing - the latest
Hundreds of company profiles. Top tier companies but also smaller
innovators. The report's profiles distinguish between companies that are
leaders in all aspects of IVD, those that lead in one particular area or a
few, and those that are innovative but not yet large.
Major mergers as well as partnerships, distribution agreements.
Brazil, India and China - important emerging markets for IVD. But not
always well-understood ones.
Innovations in Blood Banking
Histology/Cytology innovations; the role of FISH testing and Digital Images
Healthcare statistics for various countries -healthcare spending as a
percent of GDP, new hospitals, cost increases and other information.
Tables that document the most competitive products on the market and under
development in each area of IVD.
Country-level Breakout of IVD market for major European and Asian
countries.
The Current Economic Situation
Update on the Regulation of Novel Devices
Table of Contents
CHAPTER ONE: EXECUTIVE SUMMARY
Introduction - 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 - new majors and entrants
Licenses and distribution agreements
Test Services
Top Suppliers and Niche players
Point of View
CHAPTER THREE: OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC MARKETS
Background
Population and Disease Demographics, Worldwide
Chronic Diseases as a Market Driver
Cancer
Diabetes
Allergy
The BRIC Effect
World Segments of the IVD Market and IVD Market Evolution
Specific Country Information
The United States of America - a world in flux
RUO/IUO Issues
The Patient Protection and Affordable Care Act
Accountable Care Organizations
LDT Oversight
Accent on Preventative Care
In Patient Bundling
Molecular test reimbursement
Japan
Europe - effects of austerity
IVD Directive Update
China
India
Brazil
Russia
CHAPTER FOUR: TRENDS AND INNOVATION
Background
Looking to the East
Looking Past the Hospital ER
Telemedicine and Home Care Trends
Commercialization of Novel Tests
EMR Update
Wireless Connectivity and Healthcare Efficiencies
Apps everywhere
The search for non-invasive tools
CHAPTER FIVE: POINT-OF-CARE TEST PLATFORMS
Overview of POC Tests
The Major POC Test Players
Market Analysis
Blood Glucose Monitoring
Blood Glucose Self Testing
Continuous Self Testing
Blood Glucose Testing by Professionals
Diabetes Testing - Glycated Hemoglobin
The Genetics of Diabetes
The Commercial Outlook for POC Tests
CHAPTER SIX: THE CORE LAB
Core Lab Overview
Overview of Chemistry Tests
Market Analysis : Leading Suppliers and Growth Potential
Lab-based Chemistries
Critical Care Analysis
Urinalysis
The Commercial Outlook for the Core Lab
CHAPTER SEVEN: IMMUNOASSAYS
Overview of Immunoassays
Market Analysis
Immunoassay Test Segments - Mature and Emerging
Point-of-care OTC and Professional Use
The Commercial Outlook for Immunoassays
CHAPTER EIGHT: MOLECULAR ASSAY PLATFORMS
Overview of Molecular Assays
Worldwide Opportunities for Molecular Tests
Molecular Test User Markets
Next generation Sequencing
Mass Spectroscopy
Molecular Technologies And Players
Market Analysis
Oncology
Inherited Diseases
Pharmacodiagnostics
Prenatal Chromosome Analysis
Tissue Typing
The Commercial Outlook for Molecular Tests
CHAPTER NINE: HEMATOLOGY
Overview of Hematology
Automation and IT
Digital Evolution
Decentralized Hematology Testing
Market Analysis : Leading Suppliers
The Commercial Outlook for Hematology Tests
CHAPTER TEN: COAGULATION
Overview of Coagulation / Immunohematology Tests
Special Topic
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 Outlook for Coagulation Tests
CHAPTER ELEVEN: MICROBIOLOGY AND VIROLOGY
Overview of Microbiology / Virology Tests
Special Topics
Antimicrobial Drug Resistance
Genome Sequencing and Mass Spectrometry
Sepsis Serology
Market Analysis
Supplies
Chromogenic Media
Microbial Identification and Antimicrobial Sensitivity Tests
Liquid Microbiology
Blood Culture
Immunoassays - lab based
Immunoassays - rapid
Molecular Tests
The Commercial Outlook for Microbiology / Virology Tests
CHAPTER TWELVE: BLOOD BANKING SERVICES
Overview of Blood Banking
Blood Management - are all these transfusions good medicine
Blood Tracking
Chagas Disease
Platelet Safety
Market Analysis
Blood Grouping
Immunoassay Screens
Nucleic Acid Testing Continues to Grow
Leading Suppliers
The Commercial Outlook for Blood Banking
CHAPTER THIRTEEN: HISTOLOGY AND CYTOLOGY
Overview of Histology / Cytology
Special Topics
Companies expand with test services
Market Analysis
Histology/Cytology
Traditional Stains
Pap and HPV Tests
Immunochemistry and In Situ Hybridization
Pharmacodiagnostic Histology
Digital Imaging
Tissue Microarrays
Circulating Tumor Cells
Chromosome Analysis
Flow Cytometry
The Commercial Outlook for Histology and Cytology Tests
COMPANIES PROFILED
The Top Tier
Abbott Diagnostics
Alere
Arkray
Beckman Coulter Inc.
Becton, Dickinson and Company (BD)
bioMerieux Inc.
Bio-Rad Laboratories Inc.
Danaher Corporation
Gen-Probe Inc.
Hologic, Inc.
Horiba Medical
Instrumentation Laboratory (IL)
Ortho Clinical Diagnostics
QIAGEN N.V.
Radiometer A/S
Roche Diagnostics
Siemens Healthcare Diagnostics
Sysmex Corporation
Thermo Fisher Scientific Inc.
The Second Tier
Affymetrix, Inc.
Agilent Technologies Inc.
Axis-Shield plc
Bruker BioSciences Corporation
Celera Diagnostics
Cepheid
China Medical Technologies
Dako A/S
DiaSorin S.p.A.
Eiken Chemical Co., Ltd
ELITech Group
Fujirebio Diagnostics, Inc.
General Electric - GE Healthcare
Grifols, S.A.
Illumina Inc.
IRIS International, Inc.
Life Technologies
Luminex Corporation
Magellan Biosciences
A. Menarini Diagnostics
Mindray Bio-Medical Electronics Co., Ltd
Nanosphere, Inc.
Nova Biomedical
Novartis Diagnostics
PerkinElmer, Inc.
Phadia AB
Quidel Corporation
Randox Laboratories Ltd.
Sequenom
Tosoh Corporation
Transasia Bio-Medicals Ltd.
Trinity Biotech plc
Ventana Medical Systems Inc.
Veridex, LLC
Wako Pure Chemical Industries, Ltd.
Werfen Group S.A
The Third Tier
Arrayit Diagnostics Inc.
Astra Biotech GmbH
BG Medicine, Inc.
Caliper Life Sciences
Enzo Biochem Inc.
Epigenomics AG
Idaho Technology Inc.
Innogenetics NV
International Technidyne Corp (ITC)
Intrinsic Bioprobes Inc.
Ivax Diagnostics Inc.
Linkage Biosciences, Inc.
Millipore - EMD Millipore
Mitsubishi Chemical Medience Corporation
Nanosphere, Inc.
OPTI Medical Systems
OptiGene Ltd
Polymedco, Inc.
Radient Pharmaceuticals Corporation
Seegene, Inc.
SensiGen LLC
Spartan Bioscience Inc.
TessArae, LLC
Transgenomic, Inc.
TrimGen Genetic Technology
TrovaGene, Inc.
Vermillion Inc
Blood Bank Specialists
AbSorber AB
Alien Technology
AXO Science
BIO-key International, Inc.,
BloodCenter of Wisconsin
Cerus Corporation
Core Dynamics
CytoSorbents Corporation
Fenwal Inc.
GMS Biotech
Haemonetics Corporation
Immucor, Inc.
Immunetics Inc.
Mediware Information Systems, Inc.
Monash University
Progenika Inc.
Quotient Biodiagnostics Inc.
Terumo Corporation
Transfusion Management Services, Inc. (TxMS)
Verax Biomedical Inc.
Coagulation Specialists
Accumetrics
Diagnostica Stago
Gamma Therapeutics, Inc.
Microvisk Technologies
Novo Nordisk
TCoag
Diabetes Specialists
AgaMatrix, Inc.
ALR Technologies Inc.
Animas Corporation
Bayer Diabetes Care
Breath Testing at Home
C8 MediSensors
Cellnovo, Inc.
DexCom, Inc.
Diagnostic Devices, Inc.
Echo Therapeutics, Inc.
Entra Health Systems
Epinex Diagnostics, Inc.
Glycomark
GlySens Incorporated
HealthPartners
Infopia Co Ltd
Insulet Corporation
Integrity Applications Ltd.
Lifescan Inc.
Luminous Medical, Inc.:
Mayo Clinic
Medtronic Inc.
MicroCHIPS, Inc.
Nipro Diagnostics/Home Diagnostics, Inc.
OptiScan Biomedical Corporation
OrSense Ltd.
Oxford Medical Diagnostics (OMD)
PositiveID Corporation
Solianis Monitoring AG
Tandem Diabetes Care, Inc.
TelCare Inc.
VeraLight, Inc.
Hematology Specialist
Accuri Cytometers
Burnet Institute
CellaVision AB
Constitution Medical, Inc.
Guava Technologies, Inc.
Partec GmbH
PointCare Technologies
QBC Diagnostics, Inc.
Zyomyx Inc.
CHAPTER 20A
Companies Specializing in Circulating Tumor Cells
ApoCell, Inc.
Clearbridge BioMedics
NaturalNano, Inc.
On-Q-ity
RareCyte, Inc.
ScreenCell
Histology Specialists
Advanced Cell Diagnostics
Almac Diagnostics
Aperio Technologies, Inc.
Biocare Medical, LLC
BioGenex Laboratories, Inc.
BioImagene
BioMarker Strategies
Biomoda Inc.
Cambridge Research & Instrumentation, Inc.
Cancer Genetics, Inc.
Celerus Diagnostics
Cernostics, Inc.
ChipDX, LLC
CytoCore, Inc.
Definiens
Foundation Medicine Inc.
Genetix Applied Imaging
HistoRx, Inc.
Holomic LLC
Horizon Discovery Ltd
HTG Molecular Diagnostics
Ikonisys, Inc.
Leica Microsystems
Massachusetts General Hospital
Maven Biotechnologies histo
OvaGene Oncology Inc.
Immunoassay Specialists
Abkine Pharmaceuticals
Acumen Pharmaceuticals, Inc.
Akers Biosciences, Inc.
Arbor Vita Corporation
ARK Diagnostics Inc.
AspenBio Pharma, Inc.
Associates of Cape Cod, Inc. (ACC)
Augurex Life Sciences Corp.
Avantra Biosciences Corporation
Autobio Group
AXA Diagnostics Srl
Axela Biosensors, Inc.
Binding Site (The)
BioCurex, Inc.
Biomedical Diagnostics
Biomerica Inc.
Biophor Diagnostics
BioPorto A/S
BioSystems International (BSI)
B" R" A" H" M" S Aktiengesellschaft
Cellmid Ltd.
Corgenix Medical Corporation
Correlogic Systems, Inc.
Critical Diagnostics
Cylex, Inc.
diaDexus, Inc.
Diagnosticum Inc.
Diazyme Laboratories
Euroimmun AG
GenBio
GlysBy
Gold Standard Diagnostics, Corporation
HealthLinx Limited
Hycor Biomedical, Inc.
IMMCO Diagnostics, Inc.
Immunodiagn
ostic Systems Ltd. (IDS)
Inova Diagnostics Inc.
Innovative Health Diagnostics
Jeev Diagnostics
LifeAssays AB
MabCure Inc.
Mediomics, LLC
Miraculins Inc.
Neogenix Oncology, Inc.
Oasis Diagnostics Corporation
OJ-Bio Ltd.
OncoCyte Corp.
OncoHealth Corp.
Orgentec Diagnostika
PrognostiX Inc.
Protagen AG
Proteomics International Pty Ltd.
Saladax Biomedical, Inc.
Sera Prognostics, Inc.
Shanghai Kehua Bio-engineering
Shionogi Diagnostic
Sialix Inc.
SQI Diagnostics Inc.
Sword Diagnostics
Wistar Institute, The
Microbiology Specialists
Accelr8 Technology Corporation
Advanced Biological Laboratories (ABL)
ABS Advanced Biomedical Systems (ABS
AdvanDx, Inc.
Akonni Biosystems Inc.
Avioq, Inc.
bioLytical Laboratories
Biomagnetics Diagnostics Corporation
BioVei Incorporated
BlackBio S.L.
Calypte Biomedical Corporation
Canon US Life Sciences
CapitalBio Corporation
Catalysis Foundation for Health
Cellestis Ltd
Chembio Diagnostic Systems, Inc.
Ceeram S.A.S.
CHROMagar
Cooperative Diagnostics, LLC
Copan Diagnostics Inc.
Diagnostic HYBRIDS, Inc. (DHI)
Don Whitley Scientific
Dynacon Inc.
Enigma Diagnostics Limited
Focus Diagnostics, Inc.
Great Basin Scientific, Inc.
Hain Lifescience GmbH
Hardy Diagnostics
Ibis Biosciences
Immunexpress Inc.
Immuno-Mycologics (IMMY)
InBios International, Inc.
Ingen Biosciences
Innovotech Inc.
Intelligent Medical Devices, Inc. (IMDx)
IQuum Inc.
Lab M
MBio Diagnostics, Inc.
Miacom Diagnostics GmbH
Micro Identification Technologies, Inc. (MIT)
MicroBionetics, Inc.
Microgen Bioproducts Ltd.
MicroPhage, Inc.
Mo Bio Laboratories
Molecular Detection Inc. (MDI)
Molzym GmbH & Co. KG
MP Biomedicals LLC
Myconostica
NanoLogix, Inc.
nanoMR Inc.
NetBio
Next Dimension Technologies, Inc.
OraSure Technologies, Inc.
Oxford Immunotec Ltd.
Oxoid
PathoGene
Pathogenica
Preventx Limited
Phthisis Diagnostics Inc.
Quantalife, Inc.
QuantuMDx Group Limited
QuickCheck Health Inc.
R-Biopharm AG
Renishaw Diagnostics Ltd
Serosep Limited
Signature Mapping Medical Sciences, Inc.
SIRS-Lab
T2 Biosystems, Inc.
Company Profiles: Molecular Test Specialists
20/20 GeneSystems, Inc.
Ahram Biosystems, Inc.
Alacris Theranostics GmbH
Allegro Diagnostics Corp.
Amoy Diagnostics Co. Ltd.
Anagnostics Bioanalysis GmbH
Applied BioCode, Inc.
ArcticDx Inc.
Ariosa Diagnostics
Asuragen, Inc.
Autogenomics Inc.
Beijing Genome Institute (BGI)
biOasis Technologies Inc.
Biocartis SA
Biodesix, Inc.
Biofortuna Ltd.
BioHelix Corporation
Biomatrica, Inc.
BioNanomatrix
BJS Biotechnologies
BlueGnome
CardioDx, Inc.
Curetis AG
DiaGenic ASA
DiagnoCure
Diagenode
Dimerix Bioscience Pty Ltd
DNA Genotek Inc.
DxTerity Diagnostics Inc.
EraGen Biosciences Inc.
Eutropics Pharmaceuticals
Everist Genomics
Evotec AG
EXACT Sciences Corporation
Exosome Diagnostics Inc.
Falcon Genomics Inc.
Fluidigm Corporation
Fluoresentric, Inc.
Foundation Medicine. Inc.
GeneNews Limited
Genetic Technologies Limited
GenMark Diagnostics Inc.
GenoID Ltd.
Genomic Expression, Inc.
Genomed AG
Genomica S.A.U.
Genomind, LLC
Genorama Ltd.
GenturaDx
GnuBIO, Inc.
Great Basin Corporation
Helicos BioSciences
IncellDx, Inc.
Inostics GmbH
Insight Genetics
IntegenX Inc.
Ipsogen SA
LifeCodexx AG
LifeGen Technologies, LLC
Linkage Biosciences, Inc.
Lumora Ltd.
Med BioGene, Inc. (MBI)
Microsaic Systems plc
Multiplicom N.V.
NABsys, Inc.
Nanostring Technologies, Inc.
NewGene
NIPD Genetics LTD
NobleGen Biosciences
Norgen Biotek Corp.
Nuvera Biosciences, Inc.
OptiGene Ltd
Orion Genomics
Oxford Gene Technology
Pharmigene
Population Diagnostics, Inc.
PrimeraDx
RainDance Technologies, Inc.
Rheonix Inc.
Sequenta, Inc.
Sirius Genomics
Skyline Diagnostics B.V.
Sony DADC Biosciences
SpotOn Clinical Diagnostics Ltd
Stratos Genomics Inc.
SureGene, LLC
TcLand Expression SA
VolitionRx Limited
WaferGen Biosystems, Inc.
Waters Corporation
Xagenic
ZyGEM Corp. Ltd.
Company Profiles: Point-of-Care Specialists
3M Health Care
Abaxis, Inc.
Acon Laboratories, Inc.
Alfa Scientific Designs, Inc.
Augurix Diagnostics
BBInternational
CardioGenics Holdings Inc.
CIC microGUNE
Claros Diagnostics, Inc.
Clearbridge BioLoc Pte Ltd
EKF Diagnostics Holdings plc
Gentag Inc.
Hai Kang Life Corporation
Hema Diagnostic Systems (HDS)
Helena Laboratories USA
InstantLabs
Labonfoil Consortium
Metabolomx
Micronics
MycroLab Pty Ltd.
Ohmx Corporation
OPKO Health, Inc.
QuantRx Biomedical Corporation
Response Biomedical Corp.
Rheonix, Inc.
Samsung Electronics Co., Ltd.
SensiVida Medical Technologies, Inc.
Sphere Medical Ltd.
SuperNova Diagnostics, Inc.
Systagenix
T2 Biosystems, Inc.
True Diagnostics, Inc.
Test Service Providers
23andMe
Agendia BV
AltheaDx Diagnostics, Inc.
Ambry Genetics
ARUP Laboratories
AssureRx Health
Atherotech Diagnostic Lab
Atossa Genetics, Inc.
Avesthagen Limited
Biocept, Inc.
Biophysical Corporation
BioReference Laboratories, Inc. (BRLI)
BioServe
bioTheranostics
Bostwick Laboratories
Cancer Treatment Centers of America
CardioDx
Caris Life Sciences
Castle Biosciences Inc.
Circadian Technologies
CDx Diagnostics
Chronix Biomedical Inc.
Clarient Inc.
Clinical Reference Laboratory, Inc. (CRL)
CombiMatrix Molecular Diagnostics, Inc.
Complete Genomics
Crescendo Bioscience, Inc.
DeCode Genetics
DermaGenoma, Inc.
DiaTech Oncology
Diatherix Laboratories Inc.
Exagen Diagnostics, Inc.
Existence Genetics
ExonHit Therapeutics
Gene Security Network Inc. (GSN)
Genelex Corporation
Genetadi Biotech SL
Genetic Disease Foundation
Genomas
Genomic Health, Inc.
Genoptix Medical Laboratory
GenoVive LLC
Genzyme Genetics
Good Start Genetics, Inc.
iGenix Inc.
IntegraGen SA
Interleukin Genetics, Inc.
Iverson Genetic Diagnostics, Inc.
Knome, Inc.
Lab21 Limited
Laboratory Corporation of America Holdings (LabCorp)
Lineagen Inc.
LipoScience, Inc.
Lumigenix
Mayo Medical Laboratories
MDxHealth SA (formerly Oncomethylome Sciences)
Medco Health Solutions Inc.
Medical Diagnostic Laboratories, L.L.C. (MDL)
Metabolon
MinuteClinic
Mira Dx
Mitomics, Inc.
MolecularMD Corp.
Molecular Response
Myriad Genetics, Inc.
Navigenics
Oncimmune LLC
OncoPlexDx
OralDNA Labs
OvaGene Oncology, Inc.
Pacific Edge Biotechnology Limited (PEB)
Partners HealthCare Center for Personalized Genetic Medicine (PCPGM)
