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Diagnostics

World Market for In Vitro Diagnostics 2005; The


Publication Date   January 2005
Publisher   Visiongain
Product Type   Strategic Report
Pages   129
ISBN Number   not applicable
Product Code   VIS018
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Summary


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This year, the world market in 2005 for In Vitro Diagnostics will be in excess of $20bn - but what will it be next year, or in 2009? visiongain's brand new management report has the answers. The largest market is for Molecular Diagnostics, but will it continue to grow? The US currently dominates the market, whilst Germany has the largest market in Europe, but is also the third in the world.

Visiongain's senior-level report tackles these topics, in-depth:

  • Regulation
  • Molecular Technologies
  • Nucleic Acid Testing
  • Protein Chip Technologies
  • In Vitro Diagnostics at Point of Care Use
  • Personal use of In Vitro Diagnostics
  • Future Use of In Vitro Diagnostics in Diabetes
  • Future Use of In Vitro Diagnostics in Cancer
  • In Vitro Diagnostics in Cardiac Monitoring
  • Genetic Testing
  • Future Markets
  • Future Growth Areas

PLUS MUCH MUCH more...
This in-depth 120+ page report contains over 30 tables, news, insights, the latest developments, and a complete survey of the World Market for In Vitro Diagnostics. This report is a vital addition in the understanding of this lucrative and fast growing market arena. You can not afford to do without this latest report from visiongain.

This report is packed with industry data, brought together from primary and secondary sources. With company analysis, country breakdowns, government findings, and visiongain analysis, this annual report is regarded as the leading in its field. The rapid growth of molecular diagnostics has increased as the proliferation of information concerning the human genome have paved the way for commercial diagnostic protocols based on developing technologies. You need to remain aware of changes and developments in this market and only one report can do this for you. visiongain's report is only available now and only by ordering it today can you stay fully informed and up-to-date. I look forward to receiving your order, today.

Companies mentioned in this report:

  • Abbott Labs
  • Aclara
  • Adaptive Screening
  • Bayer Diagnostics
  • Bayer Healthcare
  • BD Logics
  • Becton Dickinson
  • Biacore
  • bioMerieux
  • Biosite Diagnostics
  • Biotest Diagnostics
  • Boehringer Mannheim
  • Bruker Daltonics
  • Caliper/Agilent Technologies
  • Cambridge Antibody
  • Celera Diagnostics
  • Ciphergen Biosystems
  • Cytometrics
  • Datex Ohmeda
  • DexCom
  • Digene Corporation
  • Exact Sciences
  • Gen Probe
  • Genentech
  • GenoSpectra
  • Gryphus Diagnostics
  • IMI
  • Infectio Diagnostics
  • Intrinsic Bioprobes
  • iSense
  • Johnson & Johnson
  • Logics Laboratory Corporation of America
  • Micro. Systems LifeTrac Systems
  • Medtronic MiniMed
  • Metracor Technologies
  • Metrigenix
  • National Genetics Institute
  • Mannheim NextGen
  • Pacific Biometrics
  • Pel-Freez Clinical Systems
  • Phylos
  • Protiveris
  • Quantum Dot Corp
  • Roche Diagnostics
  • Sensys Medical
  • SomaLogic
  • Sontra Medical Corporation
  • SurroMed
  • Therasense
  • VIA Medical
  • Visible Genetics
  • Zyomyx

Content


  • 1. In Vitro Diagnostics
    • 1.1 Regional Markets for In Vitro Diagnostic Technologies
  • 2. An Overview of the Regulatory Environment Surrounding In Vitro Diagnostics
    • 2.1 How are In Vitro Diagnostic Technologies Regulated by the FDA?
    • 2.2 How are IVDs Classified?
      • 2.2.1 Class I - General Controls
      • 2.2.2 Class II - Special Controls
      • 2.2.3 Class III - Premarket Approval
    • 2.3 The Regulatory Exemption of General Purpose Reagents by the FDA
    • 2.4 The Regulatory Exemption of Analyte Specific Reagents by the FDA
    • 2.5 The Clinical Laboratory Improvement Amendments of 1988 (CLIA)
    • 2.6 CLIA Waiving and In Vitro Diagnostics
    • 2.7 Premarket Notification [510(k)]
    • 2.8 Substantial Equivalence
    • 2.9 Who is Required to Make a 510(k) Submission?
    • 2.10 When is a 510(k) is Submission Required?
    • 2.11 When is 510(k) Submission Not Required?
    • 2.12 The "Pre-IDE" Process for IVDs
    • 2.13 The Fee Structure for 510(k) Pre-Market Notifications
    • 2.14 What is the Anticipated Impact of the Introduction of the Review Fee for Medical Devices?
    • 2.15 Will the MDUFMA Address the Current Limitations in the FDA Review Process for Medical Devices?
    • 2.15.1 Limitations in the FDA Review Process
    • 2.16 Premarket Approval (PMA)
    • 2.17 Bypassing the FDA with In Vitro Diagnostics
    • 2.17.1 ASRs and Home Brews
    • 2.18 An Overview of ASR Regulation by the FDA
    • 2.17.1Critical Requirements of ASR Regulation
    • 2.19 The Benefits of an FDA Approved Status for In Vitro Diagnostic Technologies
    • 2.19.1 HIV Gentoyping by Visible Genetics
    • 2.19.2 PreGen-Plus by Exact Sciences
    • 2.20 Will Regulatory Changes Affect ASRs and 'Home Brews' In Vitro Diagnostics?
    • 2.21 A New Alternative to 510(k) Filing for Analytical IVD Technologies?
  • 3.Molecular Technologies
    • 3.1 The Growing Role of Molecular Technologies in the Future Healthcare Markets
    • 3.2 Molecular Medicine and The Changing Face of Disease Diagnosis
    • 3.3 The Developing Role of Molecular Technologies in Clinical Diagnostics
    • 3.4 The Evolution of Molecular Medicine and the Role of Molecular Diagnostics in the Future of Healthcare
    • 3.5 The Emerging Market for Molecular Diagnostics
    • 3.6 The Growing Market for Molecular Diagnostic Technologies
    • 3.7 The Growing Clinical Application of Molecular Diagnostic Technologies
  • 4. In Vitro Molecular Diagnostic Technologies Approved for use in the United States
  • 5. Nucleic Acid Testing
    • 5.1 Nucleic Acid Testing in a Point-of-Care Scenario
    • 5.2 Key Elements of Point-of-Care Nucleic Acid Testing
    • 5.3 Clinical Genetic Testing
    • 5.3 Therapeutic Diagnostics and Nucleic Acid Testing
  • 6. Protein Chip Technologies as Diagnostic Devices
    • 6.1 Protein Chip Technologies in Molecular Diagnostics
    • 6.2 What are the Advantages and Limitations of Protein Chip Technologies in Clinical Diagnostics?
    • 6.3 Diagnostic Applications of Protein ChipTechnologies
    • 6.4 Cancer Diagnostics - The Key Field in the Future of Protein Chip Assays in Clinical Diagnosis
    • 6.5 Key Companies and Technologies in Protein Chip Technologies for Clinical Diagnosis
      • 6.5.1 ProteinChip by Ciphergen
      • 6.5.2 The SELDI Process
      • 6.5.3 The Trinectin Proteome Chip by Phylos
      • 6.5.4 Microfluidic Chip-Based Immunoassays
      • 6.5.5 Triage by Biosite
      • 6.5.7 Tissue Microarray Technology
      • 6.5.8 Molecular Diagnostics and Antigen-Antibody Interactions
    • 6.6 Which System Will Lead the Way for Diagnostic Protein Chip Technologies?
  • 7. In Vitro Diagnostics at the Point of Care
    • 7.1 Point of Care IVD Technologies and Acute Disease
    • 7.2 Point of Care IVD Technologies in Chronic Disease
    • 7.3 What Hurdles Must be Overcome if Point of Care IVD Technologies are to Become Established in Primary Care
  • 8. Personal Use In Vitro Diagnostic Technologies
    • 8.1 Anemia
    • 8.2 Bone Loss
    • 8.3 Drug Side-Effect Monitoring
    • 8.4 Hyperlipidemia
    • 8.5 Malnutrition
    • 8.6 Micronutrient Status
    • 8.7 Therapeutic Drug Levels
  • 9. The Future of In Vitro Diagnostic Technologies in Diabetes Testing
    • 9.1 The Role of IVD Testing in Diabetes Management
      • 9.1.1 Blood Glucose Testing
      • 9.1.2 HbAIc Haemoglobin A1c or Glycated Haemoglobin Testing
      • 9.1.3 Urinary Glucose Test
      • 9.1.4 Urine test for 'Microalbuminuria'
    • 9.2 Invasive or Noninvasive Glucose Monitoring?
    • 9.3 Transdermal Glucose Sampling and Detection
    • 9.4 Biosensor-Based Monitoring
      • 9.4.1 Implantable Systems
      • 9.4.2 Near Infrared Glucose Monitoring
    • 9.5 Nanotechnologies in Glucose Monitoring
  • 10. The Future of In Vitro Diagnostic Technologies in Cancer Diagnosis
    • 10.1 The Growing Market for In Vitro Cancer Diagnostics
      • 10.1.1 Rapid Diagnostics Technologies Set to Overshadow Routine Tests by 2008
    • 10.2 Cancer Diagnostics Will Lead the Market for Genetic Testing Technologies
      • 10.2.1 What Will Emerge as the Dominant Technology Platforms in Cancer Screening?
    • 10.3 Genetic Predisposition in Cancer and Diagnostic Opportunity
      • 10.3.1 Breast Cancer and the BRCA Genes
      • 10.3.2 Burkitt Lymphoma and the Myc Gene
      • 10.3.3 Colon Cancer and the MSH Genes
      • 10.3.4 Chronic Myeloid Leukemia and the BCR-ABL Gene
      • 10.3.5 Malignant Melanoma and CDKN2
      • 10.3.6 The p53 Tumor Suppressor Protein
  • 11. Cardiac Monitoring and In vitro Diagnosis
    • 11.1 The Global Market for Cardiac Monitoring
      • 11.1.1 The High Cost of Unnecessay Cardiac Monitoring in the US
      • 11.1.2 Early Diagnosis and Intervention Leads the Way to Cost Effective Therapy
    • 11.2 Leading IVD Technologies for Use in Cardiac Monitoring
      • 11.2.1 Lactate Monitoring by Nova Medical
      • 11.2.2 Multi-Disciplinary Monitoring by Datex-Ohmeda
      • 11.2.3 Tissue Perfusion Monitoring by Cytometrics
      • 11.2.4 Metracor Technologies and TNO Biomedical's RODA Monitor
  • 12. Future Growth in Genetic Testing
    • 12.1 Cancer Screening and Predisposition Testing Will Lead the Sector for Genetic Testing Technologies
    • 12.2 US State Legislation and Genetic Testing
  • 13. Key Future Growth Areas for In Vitro Diagnostic Technologies
    • 13.1 Molecular Diagnostics and the Future of the Market for IVD Technologies
    • 13.2 Primary Care or Personal Use IVDs?
    • 13.3 The Role of IVD Technologies in Drug Discovery
  • 14. Key Aspects of the Future Market
  • List of Boxes
    • Box 1 What are In Vitro diagnostic (IVD) Tests?
    • Box 2 CLIA Waived Guidelines for In Vitro Diagnostic Test
    • Box 3 Potential Diagnostic Applications of Protein Biochip Technologies
  • List of Tables
    • Table 1 The US Market for In Vitro Diagnostic Technologies, 2001-2002
    • Table 2 The Global Market for In Vitro Diagnostic Technology by Country Region, 2003
    • Table 3 Number of FDA Cleared/Approved In Vitro Diagnostic Devices 2003
    • Table 4 Number of Original 510(k) Filings 1999 - 2002
    • Table 5 510(k) Review User Fees
    • Table 6 Fee Exemptions and Waivers
    • Table 7 Number of PMA Approvals 1999 - 2002
    • Table 8 Existing Medicines Based on the Molecular Targeting, 2004
    • Table 9 Molecular Diagnostics vs Molecular Therapeutics as % Realization of Potential Market Outcome, 990-2010
    • Table 10 Estimated Worldwide Molecular Diagnostics Markets by Diagnostic Technique in $ Million, 2000-2010
    • Table 11 Estimated Worldwide Molecular Diagnostics Markets ($m) by Clinical Setting, 2000-2010
    • Table 12 In Vitro Molecular Diagnostic Technologies in Bacteriology, 2003
    • Table 13 In Vitro Molecular Diagnostic Technologies in Virology, 2003
    • Table 14 In Vitro Molecular Diagnostic Technologies in Clinical Disease, 2003
    • Table 15 Companies Actively Involved in Diagnostic Protein Chip Technologies, 2003
    • Table 16 Market Growth for IVD Technologies in Diabetes, 2000-2008
    • Table 17 The Growing Market ($m) for In Vitro Cancer Diagnostic Technologies, 2002-2008
    • Table 18 Compound Annual Growth Rates (%) to 2008 for In Vitro Cancer Diagnostics Technologies
    • Table 19 The Market Value ($m) for Genetic Tests for Cancer Predisposition, 2000-2008
    • Table 20 Recognized Predisposing Genetic Factors in Cancer
    • Table 21 The Increasing Cost ($m) of Cardiac Therapy in the US, 2000-2008
    • Table 22 The US Market ($m) for Cardiac Monitoring Devices, 2000-2008
    • Table 23 The Market for Genetic Testing Technologies ($m), 2000-2008
  • List of Graphs
    • Graph 1 The Global Market for In Vitro Diagnostic Devices by Technology, 2003
    • Graph 2 The Global Market for In Vitro Diagnostic Technology by Country Region, 2003
    • Graph 3 Number of FDA Cleared/Approved In Vitro Diagnostic Devices 2003
    • Graph 4 Number of Original 510(k) Filings 1999 - 2002
    • Graph 5 Number of PMA Approvals 1999 - 2002
    • Graph 6 Molecular Diagnostics vs Molecular Therapeutics as % Realization of Potential Outcome, 1990-2010
    • Graph 7 The Global Market ($m) for Molecular Diagnostics Technologies, 2000-2010
    • Graph 8 The Market for Molecular Diagnostics Technologies, 2000
    • Graph 9 The Market for Molecular Diagnostic Technologies, 2010
    • Graph 10 Market Growth for IVD Technologies in Diabetes, 2000-2008
    • Graph 11 The Growing Market ($m) for In Vitro Cancer Diagnostics, 2002-2008
    • Graph 12 Cancer Diagnosis Leads the Way in Genetic Screening, 2002
    • Graph 14 The Increasing Cost ($m) of Cardiac Therapy in the US,, 2000-2008
    • Graph 15 The US Market ($m) for Cardiac Monitoring Devices, 2000-2008
    • Graph 16 The Market for Genetic Testing Technologies ($m), 2000-2008
  • List of Figures
    • Figure 1 The SELDI Process