The Worldwide Market for In Vitro Diagnostic Tests - 3rd Edition

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Published Apr 1, 2002 | 398 Pages | Pub ID: KLI691381

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This comprehensive report is a thorough overview of the in vitro diagnostics (IVD) industry worldwide, covering the breadth of traditional IVD testing (Kalorama released a report dedicated to the molecular diagnostics segment in the Fall of 2001). The Worldwide Market for In Vitro Diagnostic Tests will contain complete market statistics and analysis for all areas of IVD, including:
  • Point-of-Care
  • Clinical Chemistry
  • Immunoassays
  • Molecular Assays
  • Hematology
  • Coagulation
  • Microbiology and Virology
  • Blood Banking
  • Tissue Banking and Transplantation, and
  • Histology and Cytology

Market size, growth, share, and geographic distribution, as well as trends in technology development, regulatory and reimbursement issues, clinical care, and business environments will be discussed.

Chapter One: Executive Summary


    Scope and Methodology
    Size and Growth of the Market
    Market Trends

Chapter Two: Introduction


    Background
    Lab Medicine Disciplines and Applications
    Market Analysis of IVD Market Segments
    Top Suppliers and Niche Players
    Tests, Bioinformatics, and Drugs—The 21st Century Diagnostics Paradigm
    Point of View

Chapter Three: Overview of Global In Vitro Diagnostic Markets


    Background
    World Segments of the IVD Market—Healthcare and Geography
    Population Trends and IVD Market Evolution
    IVD Market Growth—Emerging and Developed Country Potentials
    • The United States
    • Japan
    • Western Europe
    • China
    • India
    • The Tiger Economies

    Privatization To Spur Demand For IVD Products
    End-Users of Clinical IVD Products
    End-Users of IVD Products Outside the Healthcare System

Chapter Four: Trends in Healthcare Delivery and In Vitro Diagnostics


    Background
    Outpatient/Inpatient Product Mix
    Miniaturization and Chip Progress
    Non-Invasive Techniques and Alternative Samples
    Nearer-the-Patient Testing and Decentralization
    Commercialization Issues: Globalization and Distribution Channels
    Consumer Power
    Provider Group Consolidations
    Outcomes-Based Medicine
    Emergence of New Technologies
    Test Implications from The Human Genome Project
    Growing Globalization of Public Health Crises
    Regulatory and Reimbursement Issues and Novel Devices

Chapter Five: Point-of-Care Tests


    Overview
    POC Test Segments
    Market Analysis: Leading Suppliers
    Cost Pressures and Perceived Barriers for POC Tests
    Institutional Users of POC Tests
    The Commercial Outlook for POC Tests

Chapter Six: Clinical Chemistry


    Overview
    Market Analysis: Leading Suppliers and Growth Potential
    Lab Automation and Workstation Consolidation
    The Commercial Outlook for Chemistry Tests

Chapter Seven: Immunoassays


    Overview of Immunoassays
    Market Analysis: Leading Suppliers and Growth Potential
    Immunoassay Test Segments-Mature and Emerging
    New Antibodies, Labels, and Homogeneous Assay Designs
    Growth Opportunities Derived from Trends in Functional Genomics
    The Commercial Outlook for Immunoassays

Chapter Eight: Molecular Assays


    Overview
    Market Analysis: Leading Suppliers and Growth Potential
    Genomic Medicine and the Role of In Vitro Diagnostics
    Molecular Testing Initiatives- Technology and Players
    Biochips, Arrays, and Instrumentation
    The Commercial Outlook for Molecular Tests

Chapter Nine: Hematology


    Overview
    Market Analysis: Leading Suppliers and Growth Potential
    Rare Event Cell Counting Techniques
    Decentralized Hematology Testing
    The Commercial Outlook for Hematology Tests

Chapter Ten: Coagulation


    Overview
    Market Analysis: Leading Suppliers and Growth Potential
    Hypercoagulopathies and Cardiac Disease
    POC and Self-Testing Coagulation Systems
    The Commercial Market for Coagulation Tests

Chapter Eleven: Microbiology and Virology


    Overview
    Market Analysis: Leading Suppliers and Growth Potential
    Antimicrobial Resistance Testing
    Tradition Is Challenged by Molecular Techniques
    The Commercial Outlook for Microbiology/Virology Tests

Chapter Twelve: Blood Banking Services


    Overview
    Market Analysis: Leading Suppliers and Growth Potential
    • Blood Grouping and Typing Reagents
    • Immunoassays
    • Nucleic Acid Testing

    Artificial Blood Products Begin to Appear
    The Commercial Outlook for Blood Banking

Chapter Thirteen: Histology and Cytology


    Overview
    Market Analysis: Leading Suppliers and Growth Potential
    • Traditional Testing
    • Immunohistochemical Stains and In Situ Hybridization

    New Technologies for Monolayer and Sample Preparation
    Genomic Medicine Fuels Automated Techniques and FISH
    The Commercial Outlook for Histology and Cytology Tests

Chapter Fourteen: Company Profiles, Top 15 Competitors


    Roche Diagnostics
    Abbott Laboratories
    Ortho Clinical Diagnostics & LifeScan
    Bayer Corporation, Diagnostics Division
    Beckman Coulter Inc.
    Dade Behring Inc.
    BD Biosciences
    bioMérieux-Pierre Fabre
    Bio-Rad Laboratories Inc.
    Sysmex Corporation
    Instrumentation Laboratory (IL)
    Diagnostic Product Corporation (DPC)
    Fujirebio, Inc.
    Olympus America Inc.
    Thermo Electron Corp.

Chapter Fifteen: Company Profiles: Niche Player Summaries


    AccuMed International, Inc.
    Affymetrix, Inc.
    AstraZeneca Diagnostics
    Avitar Inc.
    Avocet Medical Inc.
    Beacon Diagnostics Inc.
    Biosite Diagnostics Incorporated
    Caliper Technologies Corporation
    Calypte Biomedical Corporation
    Cholestech Corporation
    Cygnus, Inc.
    Cytyc Corporation
    DiagnoCure Inc.
    Digene Corporation
    Enzo Diagnostics
    Epitope, Inc.
    Genicon Sciences Corporation
    Gen-Probe Inc.
    Genzyme Diagnostics
    Igen, Inc.
    International Remote Imaging Systems, Inc. (IRIS)
    i-STAT Corporation
    Luminex Corporation
    LungCheck Inc. / CellMetrix
    Matritech, Inc.
    Mediators Diagnostika
    Motorola Life Sciences
    Myriad Genetics, Inc.
    Nanogen Inc.
    National Genetics Institute (NGI)
    Non-Invasive Monitoring Systems, Inc. (NIMS)
    OraSure Technologies, Inc.
    PharmaNetics, Inc.
    PicoQuant GmbH
    Quantum Dot Corporation
    Rapigene Inc.
    Saliva Diagnostic Systems Inc.
    Spectral Diagnostics Inc.
    SpectRx, Inc.
    Third Wave Technologies Inc.
    Visible Genetics Inc.
    Vysis Inc.
    World Diagnostics Inc. (WDI)
    Xtrana, Inc.



List of Exhibits


    Table 1-1: Worldwide In Vitro Diagnostic Sales by Product Market, 2000-2005
    Table 2-1: Worldwide In Vitro Diagnostic Sales by Product Market, 2000-2005
    Table 2-2: Revenues of Selected IVD Companies, 1999-2001
    Table 3-1: Worldwide In Vitro Diagnostics Sales by Geographic Region, 2000-2005
    Table 3-2: Selected Companies Involved in International Collaborations
    Table 3-3: Selected Company Product Collaborations
    Table 4-1: Percent of Selected Surgical Procedures to be Performed by Minimally Invasive Methods
    Table 4-2: Selected Clinical Biochip Systems
    Table 4-3: Selected Tests using Alternative Samples
    Table 4-4: Selected Non-Invasive Devices (Nonglucose)
    Table 4-5: Selected International Distribution Agreements
    Table 4-6: Selected OTC Self-Test Types Available, 2001
    Table 4-7: Selected Home Test Products, Non-glucose
    Table 4-8: Selected IVD Company Mergers and Acquisitions, 1998-2001
    Table 4-9: Selected POC Infectious Disease Tests
    Table 5-1: Selected POC Connectivity Solutions
    Table 5-2: POC Sales by Test Category, Worldwide 2000-2005
    Table 5-3: World Rapid Infectious Disease Sales by Test, 2000
    Table 5-4: Selected New Professional POC Devices
    Table 6-1: Worldwide Clinical Chemistry Sales by Test Category, 2000-2005
    Table 6-2: General Chemistry Sales for Top Competitors, 2000-2001
    Table 6-3: Selected Clinical Chemistry Innovations
    Table 7-1: Worldwide Lab-Based Immunoassay Sales, 2000-2005
    Table 7-2: Worldwide Immunoassays Average Cost per Test, 2000
    Table 7-3: Selected Cancer Immunoassays
    Table 7-4: Selected Immunoassay Innovations
    Table 8-1: Worldwide Molecular Test Sales, 2000-2005
    Table 8-2: Molecular Assays Currently Available
    Table 8-3: Selected Molecular Assay Innovations
    Table 9-1: Selected Hematology and Flow Cytometry Innovations
    Table 10-1: Worldwide Coagulation Sales, 2000-2005
    Table 10-2: Selected Procoagulation and Thrombolytic Markers
    Table 10-3: Selected Coagulation Test Innovations
    Table 11-1: Worldwide Microbiology/Virology Sales, 2000-2005
    Table 11-2: Selected Prion Test Innovations
    Table 11-3: Selected Biowarfare Agent Tests
    Table 12-1: Selected Artificial Blood Products
    Table 12-2: Selected Blood Bank Product Innovations
    Table 13-1: Worldwide Histology and Cytology Sales, 2000-2005
    Table 13-2: Selected Histology Stains
    Table 13-3: Companies Marketing Fluorescent and Colorimetric Labeled Probes for ISH
    Table 13-4: Selected Histology/Cytology Innovations
    Figure 5-1: Competitive Share or the Flushable Fecal Occult
    Blood Test Market, 2001
    Figure 9-1: Share of the Hematology Market by Competitor

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