In Vitro Diagnostics in the Global Market Report 2005

Table of Contents

1. In Vitro Diagnostics

1.1 Regional Markets for In Vitro Diagnostic Technologies

Box 1 What are In Vitro diagnostic (IVD) Tests?

Table 1 The US Market for In Vitro Diagnostic Technologies, 2001-2002

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

Table 2 The Global Market for In Vitro Diagnostic Technology by Country Region, 2003

2. An Overview of the Regulatory Environment Surrounding In Vitro Diagnostics

2.1 How are In Vitro Diagnostic Technologies Regulated by the FDA?

Graph 3 Number of FDA Cleared/Approved In Vitro Diagnostic Devices 2003

Table 3 Number of FDA Cleared/Approved In Vitro Diagnostic Devices 2003

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

Graph 4 Number of Original 510(k) Filings 1999 - 2002

Table 4 Number of Original 510(k) Filings 1999 - 2002

2.13 The Fee Structure for 510(k) Pre-Market Notifications

Table 5 510(k) Review User Fees

Table 6 Fee Exemptions and Waivers

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)

Graph 5 Number of PMA Approvals 1999 - 2002

Table 7 Number of PMA Approvals 1999 - 2002

Box 2 CLIA Waived Guidelines for In Vitro Diagnostic Test

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

2.18.1Critical 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

Table 8 Existing Medicines Based on the Molecular Targeting, 2004

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

Graph 6 Molecular Diagnostics vs Molecular Therapeutics as % Realization of Potential Outcome, 1990-2010

Table 9 Molecular Diagnostics vs Molecular Therapeutics as % Realization of Potential Market Outcome, 990-2010

3.6 The Growing Market for Molecular Diagnostic Technologies

Graph 7 The Global Market ($m) for Molecular Diagnostics Technologies, 2000-2010

Table 10 Estimated Worldwide Molecular Diagnostics Markets by Diagnostic Technique in $ Million, 2000-2010

3.7 The Growing Clinical Application of Molecular Diagnostic Technologies

Table 11 Estimated Worldwide Molecular Diagnostics Markets ($m) by Clinical Setting, 2000-2010

Graph 8 The Market for Molecular Diagnostics Technologies, 2000

Graph 9 The Market for Molecular Diagnostic Technologies, 2010

4. In Vitro Molecular Diagnostic Technologies Approved for use in the United States

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

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

5.4 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

Box 3 Potential Diagnostic Applications of Protein Biochip Technologies

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

Figure 1 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?

Table 15 Companies Actively Involved in Diagnostic Protein Chip Technologies, 2003

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

Graph 10 Market Growth for IVD Technologies in Diabetes, 2000-2008

Table 16 Market Growth for IVD Technologies in Diabetes, 2000-2008

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

Graph 11 The Growing Market ($m) for In Vitro Cancer Diagnostics, 2002-2008

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

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?

Graph 12 Cancer Diagnosis Leads the Way in Genetic Screening, 2002

Table 19 The Market Value ($m) for Genetic Tests for Cancer Predisposition, 2000-2008

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

Table 20 Recognized Predisposing Genetic Factors in Cancer

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

Graph 14 The Increasing Cost ($m) of Cardiac Therapy in the US,, 2000-2008

Table 21 The Increasing Cost ($m) of Cardiac Therapy in the US, 2000-2008

Graph 15 The US Market ($m) for Cardiac Monitoring Devices, 2000-2008

Table 22 The US Market ($m) for Cardiac Monitoring Devices, 2000-2008

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 Biomedicals RODA Monitor

12. Future Growth in Genetic Testing

12.1 Cancer Screening and Predisposition Testing Will Lead the Sector for Genetic Testing Technologies

Graph 16 The Market for Genetic Testing Technologies ($m), 2000-2008

Table 23 The Market for Genetic Testing Technologies ($m), 2000-2008

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

• 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