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
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.
Europe (EU countries)
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
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
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
CHAPTER TWO: INTRODUCTION
Lab Medicine Disciplines And Applications
Market Analysis of IVD Market Segments
The lure of IVD - new majors and entrants
Licenses and distribution agreements
Top Suppliers and Niche players
Point of View
CHAPTER THREE: OVERVIEW OF GLOBAL IN VITRO DIAGNOSTIC MARKETS
Population and Disease Demographics, Worldwide
Chronic Diseases as a Market Driver
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
The Patient Protection and Affordable Care Act
Accountable Care Organizations
Accent on Preventative Care
In Patient Bundling
Molecular test reimbursement
Europe - effects of austerity
IVD Directive Update
CHAPTER FOUR: TRENDS AND INNOVATION
Looking to the East
Looking Past the Hospital ER
Telemedicine and Home Care Trends
Commercialization of Novel Tests
Wireless Connectivity and Healthcare Efficiencies
The search for non-invasive tools
CHAPTER FIVE: POINT-OF-CARE TEST PLATFORMS
Overview of POC Tests
The Major POC Test Players
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
Critical Care Analysis
The Commercial Outlook for the Core Lab
CHAPTER SEVEN: IMMUNOASSAYS
Overview of Immunoassays
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
Molecular Technologies And Players
Prenatal Chromosome Analysis
The Commercial Outlook for Molecular Tests
CHAPTER NINE: HEMATOLOGY
Overview of Hematology
Automation and IT
Decentralized Hematology Testing
Market Analysis : Leading Suppliers
The Commercial Outlook for Hematology Tests
CHAPTER TEN: COAGULATION
Overview of Coagulation / Immunohematology Tests
Genetics and Personalized Medicine
Genetic markers of hypercoagulopathies
Decentralized Coagulation testing - Professional Use
Decentralized Coagulation testing - OTC
The Commercial Outlook for Coagulation Tests
CHAPTER ELEVEN: MICROBIOLOGY AND VIROLOGY
Overview of Microbiology / Virology Tests
Antimicrobial Drug Resistance
Genome Sequencing and Mass Spectrometry
Microbial Identification and Antimicrobial Sensitivity Tests
Immunoassays - lab based
Immunoassays - rapid
The Commercial Outlook for Microbiology / Virology Tests
CHAPTER TWELVE: BLOOD BANKING SERVICES
Overview of Blood Banking
Blood Management - are all these transfusions good medicine
Nucleic Acid Testing Continues to Grow
The Commercial Outlook for Blood Banking
CHAPTER THIRTEEN: HISTOLOGY AND CYTOLOGY
Overview of Histology / Cytology
Companies expand with test services
Pap and HPV Tests
Immunochemistry and In Situ Hybridization
Circulating Tumor Cells
The Commercial Outlook for Histology and Cytology Tests
The Top Tier
Beckman Coulter Inc.
Becton, Dickinson and Company (BD)
Bio-Rad Laboratories Inc.
Instrumentation Laboratory (IL)
Ortho Clinical Diagnostics
Siemens Healthcare Diagnostics
Thermo Fisher Scientific Inc.
The Second Tier
Agilent Technologies Inc.
Bruker BioSciences Corporation
China Medical Technologies
Eiken Chemical Co., Ltd
Fujirebio Diagnostics, Inc.
General Electric - GE Healthcare
IRIS International, Inc.
A. Menarini Diagnostics
Mindray Bio-Medical Electronics Co., Ltd
Randox Laboratories Ltd.
Transasia Bio-Medicals Ltd.
Trinity Biotech plc
Ventana Medical Systems Inc.
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.
Idaho Technology Inc.
International Technidyne Corp (ITC)
Intrinsic Bioprobes Inc.
Ivax Diagnostics Inc.
Linkage Biosciences, Inc.
Millipore - EMD Millipore
Mitsubishi Chemical Medience Corporation
OPTI Medical Systems
Radient Pharmaceuticals Corporation
Spartan Bioscience Inc.
TrimGen Genetic Technology
Blood Bank Specialists
BIO-key International, Inc.,
BloodCenter of Wisconsin
Mediware Information Systems, Inc.
Quotient Biodiagnostics Inc.
Transfusion Management Services, Inc. (TxMS)
Verax Biomedical Inc.
Gamma Therapeutics, Inc.
ALR Technologies Inc.
Bayer Diabetes Care
Breath Testing at Home
Diagnostic Devices, Inc.
Echo Therapeutics, Inc.
Entra Health Systems
Epinex Diagnostics, Inc.
Infopia Co Ltd
Integrity Applications Ltd.
Luminous Medical, Inc.:
Nipro Diagnostics/Home Diagnostics, Inc.
OptiScan Biomedical Corporation
Oxford Medical Diagnostics (OMD)
Solianis Monitoring AG
Tandem Diabetes Care, Inc.
Constitution Medical, Inc.
Guava Technologies, Inc.
QBC Diagnostics, Inc.
Companies Specializing in Circulating Tumor Cells
Advanced Cell Diagnostics
Aperio Technologies, Inc.
Biocare Medical, LLC
BioGenex Laboratories, Inc.
Cambridge Research & Instrumentation, Inc.
Cancer Genetics, Inc.
Foundation Medicine Inc.
Genetix Applied Imaging
Horizon Discovery Ltd
HTG Molecular Diagnostics
Massachusetts General Hospital
Maven Biotechnologies histo
OvaGene Oncology Inc.
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
AXA Diagnostics Srl
Axela Biosensors, Inc.
Binding Site (The)
BioSystems International (BSI)
B" R" A" H" M" S Aktiengesellschaft
Corgenix Medical Corporation
Correlogic Systems, Inc.
Gold Standard Diagnostics, Corporation
Hycor Biomedical, Inc.
IMMCO Diagnostics, Inc.
ostic Systems Ltd. (IDS)
Inova Diagnostics Inc.
Innovative Health Diagnostics
Neogenix Oncology, Inc.
Oasis Diagnostics Corporation
Proteomics International Pty Ltd.
Saladax Biomedical, Inc.
Sera Prognostics, Inc.
Shanghai Kehua Bio-engineering
SQI Diagnostics Inc.
Wistar Institute, The
Accelr8 Technology Corporation
Advanced Biological Laboratories (ABL)
ABS Advanced Biomedical Systems (ABS
Akonni Biosystems Inc.
Biomagnetics Diagnostics Corporation
Calypte Biomedical Corporation
Canon US Life Sciences
Catalysis Foundation for Health
Chembio Diagnostic Systems, Inc.
Cooperative Diagnostics, LLC
Copan Diagnostics Inc.
Diagnostic HYBRIDS, Inc. (DHI)
Don Whitley Scientific
Enigma Diagnostics Limited
Focus Diagnostics, Inc.
Great Basin Scientific, Inc.
Hain Lifescience GmbH
InBios International, Inc.
Intelligent Medical Devices, Inc. (IMDx)
MBio Diagnostics, Inc.
Miacom Diagnostics GmbH
Micro Identification Technologies, Inc. (MIT)
Microgen Bioproducts Ltd.
Mo Bio Laboratories
Molecular Detection Inc. (MDI)
Molzym GmbH & Co. KG
MP Biomedicals LLC
Next Dimension Technologies, Inc.
OraSure Technologies, Inc.
Oxford Immunotec Ltd.
Phthisis Diagnostics Inc.
QuantuMDx Group Limited
QuickCheck Health Inc.
Renishaw Diagnostics Ltd
Signature Mapping Medical Sciences, Inc.
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.
Beijing Genome Institute (BGI)
biOasis Technologies Inc.
Dimerix Bioscience Pty Ltd
DNA Genotek Inc.
DxTerity Diagnostics Inc.
EraGen Biosciences Inc.
EXACT Sciences Corporation
Exosome Diagnostics Inc.
Falcon Genomics Inc.
Foundation Medicine. Inc.
Genetic Technologies Limited
GenMark Diagnostics Inc.
Genomic Expression, Inc.
Great Basin Corporation
LifeGen Technologies, LLC
Linkage Biosciences, Inc.
Med BioGene, Inc. (MBI)
Microsaic Systems plc
Nanostring Technologies, Inc.
NIPD Genetics LTD
Norgen Biotek Corp.
Nuvera Biosciences, Inc.
Oxford Gene Technology
Population Diagnostics, Inc.
RainDance Technologies, Inc.
Skyline Diagnostics B.V.
Sony DADC Biosciences
SpotOn Clinical Diagnostics Ltd
Stratos Genomics Inc.
TcLand Expression SA
WaferGen Biosystems, Inc.
ZyGEM Corp. Ltd.
Company Profiles: Point-of-Care Specialists
3M Health Care
Acon Laboratories, Inc.
Alfa Scientific Designs, Inc.
CardioGenics Holdings Inc.
Claros Diagnostics, Inc.
Clearbridge BioLoc Pte Ltd
EKF Diagnostics Holdings plc
Hai Kang Life Corporation
Hema Diagnostic Systems (HDS)
Helena Laboratories USA
MycroLab Pty Ltd.
OPKO Health, Inc.
QuantRx Biomedical Corporation
Response Biomedical Corp.
Samsung Electronics Co., Ltd.
SensiVida Medical Technologies, Inc.
Sphere Medical Ltd.
SuperNova Diagnostics, Inc.
T2 Biosystems, Inc.
True Diagnostics, Inc.
Test Service Providers
AltheaDx Diagnostics, Inc.
Atherotech Diagnostic Lab
Atossa Genetics, Inc.
BioReference Laboratories, Inc. (BRLI)
Cancer Treatment Centers of America
Caris Life Sciences
Castle Biosciences Inc.
Chronix Biomedical Inc.
Clinical Reference Laboratory, Inc. (CRL)
CombiMatrix Molecular Diagnostics, Inc.
Crescendo Bioscience, Inc.
Diatherix Laboratories Inc.
Exagen Diagnostics, Inc.
Gene Security Network Inc. (GSN)
Genetadi Biotech SL
Genetic Disease Foundation
Genomic Health, Inc.
Genoptix Medical Laboratory
Good Start Genetics, Inc.
Interleukin Genetics, Inc.
Iverson Genetic Diagnostics, Inc.
Laboratory Corporation of America Holdings (LabCorp)
Mayo Medical Laboratories
MDxHealth SA (formerly Oncomethylome Sciences)
Medco Health Solutions Inc.
Medical Diagnostic Laboratories, L.L.C. (MDL)
Myriad Genetics, Inc.
OvaGene Oncology, Inc.
Pacific Edge Biotechnology Limited (PEB)
Partners HealthCare Center for Personalized Genetic Medicine (PCPGM)