Abstract
Clinical diagnostics is an attractive and growing industry, with the majority
of major diagnostic companies experiencing sales growth of over 10% in2008,
despite significant pricing pressures. However, achieving market growth is
becoming increasingly challenging due to the difficulty in developing novel
diagnostics for new high value markets, or which can add appreciable clinical
benefit in existing markets. ' Innovations in In-Vitro Diagnostics' is a new
report published by Business Insights that provides an in-depth analysis of
emerging opportunities and potential clinical advances across the diagnostics
markets of coronary heart disease, heart failure, bacterial infections and
viral infections. This report explores the major trends and issues that are
shaping the development of novel diagnostics and assesses the future prospects
of leading innovations. The market segments with the greatest growth
opportunities are identified and the competitive landscape of the market is
also assessed, with profiles of nine major diagnostics companies, based on
market presence, R&D focus, acquisitions, historical sales and number of
immunoanalyzers.
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
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