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The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 8th Edition

July 2012 | 1400 pages | ID: TD7466AF124EN
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In eight best-selling editions, Shara Rosen has detailed the market for in vitro diagnostic (IVD) testing, throughout the world, 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.

Comprehensive Coverage of a High Interest Industry

This year, Kalorama has published its eighth edition of this informative volume based on the market events of 2011. The report is over 1400 pages, reflecting the dramatic change in IVD. New entrants, net 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 and business planners avoid multiple purchases. 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)
  • 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)

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"

Now in 8 editions, this report has become the go-to market research reference for the 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 edition greatly expands coverage of the field and tracks the most important developments. See aspects of the industry that might not be available in your company's internal resources. View the market from an independent point of view. Learn about competitors in away that may be invisible to internal personnel. Know the market players - your competitors and potential partners, in proper context and classification. Save countless hours of staff time and other research expenses with the authoritative guide for IVD market estimates and forecasts.

A Global Report

From the first edition, this report was designed as a global resource in order to give market-watchers a true picture of the industry. IVD is a worldwide business. While the US is a large healthcare market, much of the dynamism, the growth, and also competition is occurring in other areas. 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 (EU countries, incl. IVD market sizes by country)
  • Eastern Europe
  • South America
  • Asia (Japan, China and India)
  • Rest of World

A Report Designed for a Changing Industry
A number of totally disparate phenomena have come together to change the IVD industry. Human genome research is finding links between a person’s genome and several lifestyle situations such as nutrition, dieting, skin conditions and other essentially non-medical conditions. This has attracted consumer product companies such as Proctor & Gamble and Nestlé to develop products and services based on IVD technologies. Decreases in life science grants has encouraged companies active in this space to migrate their technologies for clinical applications.

The result is the entry of companies such as Caliper Life Sciences, Illumina, Affymetrix and Life Technologies to the diagnostics market with products and test services. Miniaturization of traditional immunoassay and molecular test technologies has finally matured to the point where they may be ready for scale-up and then commercialization into products. Here electronics companies such as Sony, Samsung, Dell Computers and Intel Corp. have invested in clinical diagnostics ventures. These exciting developments join expansion into new market segments by companies already involved in the IVD industry.

In 2010 and 2011, there were at least 74 acquisitions and some 36 distribution agreements. And this is only a small portion of what is really happening. There are many more deals that have not been announced. The goal is to build better tests and stronger companies. The future of the industry lies in the development of more sensitive, faster, user-friendly, IT capable devices for a host of new protein and molecular markers.

In this eighth edition of The Worldwide Market for In Vitro Diagnostic Tests Kalorama Information addresses all of 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.
  • Merging IT and IVD: Establishing the EMR Record from IVD Tests
  • Healthcare Reform and its Possible Impact on IVD.
  • The Status of Automation in the Lab; Core Lab Section Includes Both Workstation and Automated Panel Revenues.
  • Mass Spec, Next Gen Sequencing and Other Technology Entrants
  • Hospital Infection Testing - the latest
  • Several Hundred Company profiles. Top tier companies, Second and Third Tier companies but also Smaller Innovators. The report‘s profiles distinguish between companies that are leaders in all aspects of IVD, those that are Specialists in one particular area or a few.
  • Major Mergers as well as Partnerships, Distribution Agreements.
  • Brazil, India and China - Important Emerging Markets for IVD.
  • 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
  • Introduction – Doing more with less
  • Scope and Methodology
  • Size and Growth of the Market
  • Market Trends
  • 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
  • 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

  • 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
  • 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
  • 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
  • Overview of Immunoassays
  • Market Analysis
    • Immunoassay Test Segments - Mature and Emerging
    • Point-of-care OTC and Professional Use
  • The Commercial Outlook for Immunoassays
  • 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
  • Overview of Hematology
    • Automation and IT
    • Digital Evolution
  • Decentralized Hematology Testing
  • Market Analysis : Leading Suppliers
  • The Commercial Outlook for Hematology Tests
  • 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
  • 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
  • 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
  • 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

The Top Tier
    Abbott Diagnostics
  • Alere
  • Arkray
  • Beckman Coulter Inc.
  • Becton, Dickinson and Company (BD)
  • bioMérieux Inc.
  • Bio-Rad Laboratories Inc.
  • Danaher Corporation
  • Gen-Probe Inc.
  • Hologic, Inc.
  • Horiba Medical
  • Instrumentation Laboratory (IL)
  • Ortho Clinical Diagnostics
  • 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

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