The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 7th Edition

Aug 1, 2010
900 Pages - Pub ID: KLI2613362
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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. 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)
  • Core Lab (General Chemistries, Workstations, Analyzers)
  • Immunoassays (Blood Gases, Urinalysis, Critical Care)
  • Molecular Assays (Infectious Disease, Blood Screening, Inherited Diseases, Oncology, Pharmacodiagnostics, Tissue Typing, Prenatal)
  • Hematology
  • Coagulation (Lab-Based, POC, Genetic Markers)
  • Microbiology and Virology
  • Blood Banking (Grouping, Immunoassay Screens, NAT Screens)
  • Histology and Cytology (Pap, ISH, IHC, traditional non-pap, HPV)

For each of these sections, Shara Rosen reviews the key products dominating the market, the innovations that are occurring, and the trends that are impacting the segments. 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 2009, with projections given through 2014.

Kalorama Information’s Report - ‘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. These are the numbers that it is very likely competitive companies will be using in their planning.

This 900+ 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)
  • Eastern Europe
  • South America
  • Asia (China and India as subsegments)
  • Rest of World

A Report Designed for a Changing Industry

In this seventh edition of The Worldwide Market for In Vitro Diagnostic Tests Kalorama Information has reorganized the presentation of the IVD market in a manner that better reflects how the industry has evolved.

  • In the past, molecular testing was a small emerging discipline that related to chlamydia, gonorrhea, TB, and some inherited diseases. Now molecular technologies are impacting several areas of diagnostics. Molecular diagnostics has its own chapter but also is present in those other areas. Trends such as pharmacodiagnostics, molecular poc and test services are put in a context.

  • The report's approach reflects the increasing use of automation in the lab; core lab section includes both workstation and automated panel revenues.

  • 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.

  • We track ‘laggards’ - companies from the past few years that have failed due to financing or product failure.

  • IVD Companies have been busy. The report examines the major mergers as well as partnerships, distribution agreements.

  • A comparison and contrast of India and China - important emerging markets for IVD. But not always well-understood ones.

  • There is discussion of the role of the new government focus on EMR and how it impacts IVD devices.

  • Healthcare statistics for various countries -healthcare spending as a percent of GDP, new hospitals, cost increases and other information.

  • Tables that document the innovative products being developed in each area of IVD.

  • Country-level Breakout of IVD market for major European and Asian countries.

  • The Impact of US Health Care Reform

  • The Spread of Wireless Diagnostics and Remote Monitoring

  • New Screening Guidelines and Market Impact

  • Chronic vs. Infectious Disease

  • Strange Bedfellows? Analysis fn the IVD Industry Consolidation

  • The Continued Molecularization of Devices

  • The Current Economic Situation: Recession: Post-Recession?

  • The report looks at where non-Invasive Sampling

  • PGx and SNP Testing

  • IVD and the Promise of Personalized Medicine has been a discussion for years. Now it is closer to reality.

  • The report provides an Update on the Regulation of Novel Devices

  • Focus on the Continued Fight against Nosocomial Infections

  • Innovations in Blood Banking

  • Histology/Cytology innovations; the role of FISH testing and Digital Images

Extensive IVD Company Profiles

The report covers companies that are established leaders in in vitro diagnostics, companies that dominate a specialty area and those that have very innovative or promising approaches. Over two hundred companies are profiled in the The Worldwide Market for In Vitro Diagnostics; among those companies profiled:

  • Abbott Diagnostics
  • Becton, Dickinson and Company (BD)
  • Beckman Coulter Inc.
  • bioMérieux Inc.
  • Bio-Rad Laboratories Inc.
  • Gen-Probe Inc.
  • Hologic, Inc.
  • Instrumentation Laboratory (IL)
  • Inverness Medical Innovations
  • Ortho Clinical Diagnostics
  • Radiometer A/S
  • Roche Diagnostics
  • Siemens Healthcare Diagnostics
  • Sysmex Corporation
  • Thermo Fisher Scientific Inc.
  • Affymetrix, Inc.
  • Agendia BV
  • Axis-Shield plc
  • Bio-Reference Laboratories, Inc. (BRLI)
  • Bruker BioSciences Corporation
  • Celera Diagnostics
  • Cepheid
  • Clarient Inc.
  • Clinical Data, Inc.
  • Danaher Corporation
  • DiaSorin S.p.A.
  • Eiken Chemical Co., Ltd
  • ELITech Group
  • Fujirebio Diagnostics, Inc.
  • Genomic Health, Inc.
  • Genzyme Genetics
  • Innogenetics NV
  • International Technidyne Corp (ITC)
  • IRIS International, Inc.
  • Laboratory Corporation of America Holdings (LabCorp)
  • Life Technologies
  • Luminex Corporation
  • Magellan Biosciences
  • A. Menarini Diagnostics
  • Mindray Bio-Medical Electronics Co., Ltd
  • Monogram Biosciences, Inc.
  • Myriad Genetics, Inc.
  • Nanosphere, Inc.
  • Nova Biomedical
  • PerkinElmer, Inc.
  • Phadia AB
  • Quest Diagnostics
  • Quidel Corporation
  • Randox Laboratories Ltd.
  • Rosetta Genomics Ltd.
  • Sequenom
  • Third Wave Technologies Inc.
  • TOSOH Corporation
  • Trinity Biotech plc
  • Veridex, LLC
  • Werfen Group S.A.
  • 3M Medical Diagnostics
  • AcroMetrix
  • Advanced Liquid Logic, Inc.
  • AltheaDx Technologies, Inc.
  • AMDL Diagnostics, Inc. (ADI)
  • Arrayit Diagnostics Inc.
  • AviaraDx (formerly Arcturus Biosciences)
  • Biocare Medical LLC
  • Biotage AB
  • bioTheranostics
  • BioTrove, Inc.
  • China Medical Technologies, Inc.
  • DxS Ltd.
  • Envision ALR
  • Epigenomics AG
  • Exosome Diagnostics Inc.
  • Grifols, S.A.
  • Idaho Technology Inc.
  • iKaryos Diagnostics
  • Interleukin Genetics, Inc.
  • Intrinsic Bioprobes Inc.
  • Ionian Technologies, Inc.
  • Linkage Biosciences, Inc
  • Millipore Corporation
  • Nanogen Inc.
  • OncoMethylome Sciences S.A.
  • OPTI Medical Systems
  • OptiGene Ltd
  • Polymedco, Inc.
  • Saladax Biomedical, Inc. (SBI)
  • SensiGen LLC
  • Source MDx
  • Spartan Bioscience Inc.
  • SQI Diagnostics Inc.
  • TessArae, LLC
  • Transgenomic Inc.
  • TrimGen Corporation
  • TrovaGene, Inc.
  • Vermillion Inc.
  • Wako Pure Chemical Industries, Ltd.
  • AbSorber AB
  • Arteriocyte, Inc.
  • Biotest AG
  • CaridianBCT Inc.
  • Cerus Corporation
  • Daxor Corporation
  • Fenwal Inc.
  • Immucor, Inc.
  • IntelliDOT Corp.
  • Novartis Vaccines and Diagnostics/Chiron
  • Progenika Inc.
  • Quotient Biodiagnostics Inc.
  • Verax Biomedical Inc.
  • Accumetrics
  • Corgenix Medical Corporation
  • Diagnostica Stago
  • AgaMetrix, Inc.
  • Bayer Diabetes Care
  • Animas Corporation
  • Bionime Corporation
  • BodyTel Scientific, Inc.
  • DexCom, Inc.
  • Diabetech, LP
  • Diagnostic Devices, Inc.
  • Entra Health Systems
  • Fora Care
  • Home Diagnostics, Inc.
  • Insulet Corporation
  • Lifescan Inc.
  • Medtronic Inc.
  • OrSense Ltd.
  • Smiths Medical MD, Inc.
  • Solianis Monitoring AG
  • Burnet Institute
  • CellaVision AB
  • Chempaq A/S
  • Guava Technologies, Inc.
  • Horiba Medical
  • Partec GmbH
  • PointCare Technologies
  • QBC Diagnostics, Inc.
  • Zyomyx Inc.
  • Aperio Technologies, Inc.
  • BioImagene
  • Celerus Diagnostics
  • Compucyte Corporation
  • CytoCore, Inc.
  • Dako A/S
  • Expression Pathology Inc.
  • Genetix Applied Imaging
  • HistoRx, Inc.
  • Ikonisys, Inc.
  • InterGenetics Inc.
  • mtm laboratories AG
  • Pathwork Diagnostics
  • Vision BioSystems Ltd
  • Adlyfe, Inc.
  • Akers Biosciences, Inc.
  • Amorfix Life Sciences Ltd.
  • Atherotech
  • Avioq, Inc.
  • Axela Biosensors, Inc.
  • BG Medicine Inc.
  • Biomerica Inc.
  • BioPorto A/S
  • BioSystems International
  • B•R•A•H•M•S Aktiengesellschaft
  • CeMines, Inc.
  • Concateno Plc
  • Cylex Incorporated
  • Decision Biomarkers Inc.
  • Immunodiagnostic Systems Ltd.
  • Innotrac Diagnostics Oy
  • Inova Diagnostics Inc.
  • IVAX Diagnostics, Inc.
  • LifeAssays AB
  • Meridian Bioscience, Inc.
  • Miraculins Inc.
  • Ridge Diagnostics, Inc.
  • Shanghai Kehua Bio-engineering
  • SpectraCell Laboratories, Inc.
  • 3QBD
  • Accelr8 Technology Corporation
  • Advanced Analytical Technologies Inc.
  • AdvanDx, Inc.
  • bioLytical Laboratories
  • BioVei Incorporated
  • Cellestis Ltd
  • Chembio Diagnostic Systems, Inc.
  • Copan Diagnostics Inc.
  • Diagnostic HYBRIDS, Inc.
  • Dynacon Inc.
  • eGenomics, Inc.
  • Enigma Diagnostics Limited
  • Focus Diagnostics, Inc.
  • GlysBy
  • Hain Lifescience GmbH
  • Innovotech Inc.
  • Liofilchem s.r.l.
  • MicroPhage, Inc.
  • Mobidiag Oy
  • Molzym GmbH & Co. KG
  • Myconostica, Ltd.
  • Oxoid
  • Pocared Diagnostics Ltd
  • Prodesse Inc.
  • SIRS-Lab
  • SmartGene GmbH
  • TheraDoc
  • TREK Diagnostic Systems
  • Tyrian Diagnostics Limited
  • Veredus Laboratories Pte
  • ViraCor Laboratories
  • Advanced Analytical Technologies, Inc.
  • Arcxis Biotechnologies
  • AutoGenomics, Inc.
  • BioHelix Corporation
  • CyGene Laboratories Inc.
  • DioGenix, Inc.
  • DNage
  • GeneNews Limited
  • Ipsogen
  • KREATECH Biotechnology B.V.
  • Med BioGene, Inc.
  • Microchip Biotechnologies, Inc.
  • OncoMethylome Sciences S.A.
  • Orchid Cellmark
  • Orion Genomics
  • Psynomics Incorporated
  • Rubicon Genomics, Inc.
  • Tepnel Life Sciences
  • TwistDx, Ltd.
  • WaferGen Biosystems, Inc.
  • Xceed Molecular
  • 77 Elektronika Kft.
  • A/C Diagnostics
  • Acon Laboratories, Inc.
  • Acrongenomics Inc.
  • Amic AB
  • BioIQ
  • ContraVac, Inc.
  • HemoCue AB
  • Identa Corporation
  • Philips Electronics NV
  • QuantRx Biomedical Corporation
  • Screening Devices Canada, Inc.
  • Sphere Medical Ltd.
  • Soar BioDynamics, Ltd.
  • VeriChip Corporation
  • Vital Diagnostics

Additional Information


The IVD industry is on an upswing. For the past 15 years the number of assays introduced has been growing at a remarkable clip. At the same time, diagnostic laboratory technology is changing dramatically, due to the publication of the human genome project and advances in functional genomics, bioinformatics, miniaturization and microelectronics. Further the revolution in bioinformatics has allowed scientists to mine genetic information to derive new and hopefully better markers of some of the most pressing health problems such as cancer, cardiac disease, diabetes and autoimmune disorders. This has contributed to growth in many areas but especially in immunoassays and nucleic acid tests.

However, these tests are being launched in a time of global economic instability and rising healthcare costs. The fact is most labs continue to run established tests that account for most of the lab’s human and financial resources. The only way to add new tests into the toolbox is to do more with the same amount of resources. And with the economic downturn, for most labs it may even mean doing more with less.

There is also a lack of trained lab technologists, so there is a decreasing availability of human resources needed to run the more complex new set of molecular and histological tests and immunoassays. Therefore there has been a proliferation of test and lab automation tools launched that remove precious human resources from mundane pre-analytical and sample tracking tasks to make time for more sophisticated ones. This phenomenon was once thought to be the purview of biochemistry and immunoassays but automation is becoming a common feature in blood banking, microbiology, and histology.

This emphasis on automation has created further consolidation of laboratory testing to large core labs. In 2010, systems for urinalysis, coagulation and microbiology are ready to take their place along side the hematology, chemistry and immunoassay instruments - all located in a single core lab. In larger labs they may be linked to a common track line.

It has been some ten years since the Institute of Medicine (IOM) alerted healthcare professionals to the cost of medical errors. Most of these errors involve mistakes related to medications including administering or prescribing the wrong drug, providing the wrong dose, or using the wrong route to administer drugs to patients. But there also is an element of processing errors in the lab that include the wrong tests run on a patient sample, errors in entering a patient’s name, etc and not sending results in a timely manner. Thus barcoding, error checking and sample tracking via information systems have become a major tool to assure patient safety through a limitation of errors.

Doing more with less appears to be a continuing theme. Automation and information systems are becoming the norm for hospital labs. In today’s depressed economy, these tools help labs control costs, reduce unnecessary spending, and get more for every dollar they spend. The trend applies to small and mid-sized hospital laboratories as well as high volume labs. For the first time, established automated technology considered normal in biochemistry and hematology is now a reality for microbiology.

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