Innovations in In-Vitro Diagnostics: New technologies, growth opportunities, and the future market outlook

Table of Contents

Executive summary

• Overview
• Market analysis
• Coronary heart disease
• Heart failure
• Viral infectious
• Bacterial infections
• Market outlook

Chapter 1 Overview

• Summary
• Introduction
• Classification of clinical diagnostics
• Market segments
• Clinical chemistry
• Immunoassays
• Estimated number of immunoassay analyzers by company
• Molecular diagnostics
• Point of care
• Pricing
• Regulation
• Increasing regulatory oversight

Chapter 2 Market analysis

• Summary
• Introduction
• Sales by company
• Sales by market segment
• Acquisition activity
• Company profiles
• Roche
• Siemens Healthcare Diagnostics
• Abbott
• Ortho-Clinical Diagnostics
• Beckman Coulter
• Becton Dickinson
• Bio-Rad
• bioMerieux
• Inverness Medical Solutions

Chapter 3 Coronary heart disease

• Summary
• Introduction
• Diagnosis of coronary heart disease
• Cardiac specific markers
• High-sensitive troponin assays
• Novel ultra-sensitive assays
• Potential clinical advances of novel assays
• Novel markers of coronary heart disease
• Cardiac ischemia
• Plaque instability
• Inflammation
• Future outlook
• Impact of novel troponin assays
• Incremental improvements
• Biomarkers for the early detection of disease

Chapter 4 Heart failure

• Summary
• Introduction
• Diagnosis of heart failure
• Natriuretic peptides
• Novel markers of heart failure
• MR-proANP
• Soluble ST2
• Troponin
• MR-proADM
• Future outlook
• Screening of asymptomatic patient populations

Chapter 5 Viral infections

• Summary
• Introduction
• Blood screening
• Major companies in the blood screening market
• Blood screening market size
• Quantitative viral diagnostics
• Treatment of viral infections
• Respiratory viral panels
• Novel multiplex assays
• RSV in the elderly
• Future outlook
• Existing market growth
• Emerging markets
• Need for effective therapies

Chapter 6 Bacterial infections

• Summary
• Introduction
• Sexually transmitted diseases
• Market size and key companies
• Healthcare associated infections
• Clostridium difficile
• Novel NAT based tests
• Market size for C.diff tests
• Methicillin-resistant Staphylococcus aureus
• Universal screening
• NAT based technologies
• Other rapid detection methods
• Universal screening market size
• Countries investing in MRSA screening
• Cost comparison of tests
• Future outlook

Chapter 7 Market outlook

• Summary
• Introduction
• Trends in 510(k) approvals
• Barriers to innovation
• Immunoassays
• Factors driving testing volumes
• Molecular diagnostics
• Demonstration of clinical need
• Novel technologies
• Appendix 134
• Methodology
• Glossary

List of Figures

• Figure 1.1: Estimated number of immunoassay analyzers sold since launch, by company, 2008
• Figure 1.2: Existing and emerging markets for molecular diagnostics
• Figure 1.3: Cost of tests by technology and clinical application, 2009, US
• Figure 2.4: Clinical diagnostics sales, by company, 2008
• Figure 2.5: Clinical diagnostic sales, by sector, 2008
• Figure 3.6: Diagnosis of myocardial infarction
• Figure 3.7: High sensitive troponin assays, comparison of lower limit of detection
• Figure 3.8: Novel cardiac biomarkers
• Figure 3.9: Potential US market for diagnosis of coronary heart disease
• Figure 5.10: Deaths due to respiratory syncytial virus infection, by age, US, 2003
• Figure 6.11: C. trachomatis and N. gonorrhoeae incidence rates, US, 1984-2007
• Figure 6.12: Deaths due to CDAD as underlying cause of death, US, 1999-2006
• Figure 6.13: CDAD infections in patients aged 65 years or older, England, 2006-2008
• Figure 6.14: Cost breakdown of universal admission MRSA screening program
• Figure 6.15: Comparison of PCR and chromogenic media cost for universal admission MRSA
• screening program
• Figure 7.16: 510(k) approvals by medical specialty, 2006-2008
• Figure 7.17: 510(k) approvals, 1997-2008
• Figure 7.18: Number of Clinical Laboratory Fee Schedule Codes, 2003 and 2009
• Figure 7.19: Hospital charges, by disease, 2006
• Figure 7.20: Prevalence of self-reported cardiovascular disease by age, US

List of Tables

• Table 1.1: Examples of commonly used in vivo and in vitro diagnostics
• Table 1.2: Number of clinical laboratories by type, US, 2008
• Table 1.3: Estimated number and sales of immunoassay analyzers, by company, 2008
• Table 2.4: Clinical diagnostics sales, by company, 2006-2008
• Table 2.5: Acquisitions by company, 2007-2009
• Table 2.6: Roche patenting activity
• Table 3.7: High sensitive troponin assays, comparison of lower limit of detection