Innovations In In-Vitro Diagnostics: New Technologies, Growth Opportunities, And The Future Market Outlook
Published By: Business Insights
June 2009
R162-964
Online Download $3,835.00
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Description
Innovations in In-Vitro Diagnostics
New technologies, growth opportunities and the future market outlook
Report Overview
Clinical diagnostics is an attractive and growing industry, with the majority of major diagnostic companies experiencing sales growth of over 10% in 2008, 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 propsects 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.
Key Findings
MRSA screening is the single most important new market for molecular diagnostics. The market is currently valued at $1.2 billion in the US alone, and could extend to $2.2 billion if screening technologies can be applied in smaller hospitals, out-patients facilities and long-term care facilities.
Novel multiplex assays for respiratory viruses may become widely adopted if effective antivirals become available, especially for the treatment of respiratory syncytial virus infections in the elderly.
The growing prevalence of common chronic conditions will increase immunoassay testing volumes. It is notable that one of the most promising new markets is for troponin, a cardiac biomarker which was originally approved in the US in 1996.
Novel technologies with enhanced sensitivities will open up new areas of research, although the clinical applications are still to be determined. Conventional immunoassays and polymerase chain reaction are likely to remain the most commercially significant technologies for the foreseeable future.
Negative pressure on growth is a barrier to the development of novel immunoassays. New test approvals by the FDA have fallen from a peak of 867 in 1997 to 248 in 2008.
Use this report to...- Identify which novel diagnostics offer the greatest potential clinical advances within the cardiovascular, viral, and bacterial markets and compare their efficacy against conventional diagnostic techniques.
- Understand the market dynamics that are shaping the in-vitro diagnostics market with this report’s analysis of key issues including pricing, barriers to innovation, factors driving testing volumes, regulatory changes and trends in 510(k) approvals.
- Evaluate the growth prospects of key new markets such as nosocomial infections and respiratory virus multiplex panels, with this report’s estimates of potential market sizes and drivers/resistors to market growth.
- Assess the competitive positions of leading diagnostics companies with this report’s analysis of the performances, market presence and R&D focus of Roche, Siemens Healthcare Diagnostics, Abbott, Ortho-Clinical Diagnostics, Beckman Coulter, Becton Dickinson, Bio-Rad, bioMérieux and Inverness Medical Solutions.
Explore issues including
Incremental improvements in coronary heart disease detection. Novel markers in development, such as PAPP-A and PGF, may add incremental improvements in risk stratification and prognostic assessment. It is possible that new cardiac panels will emerge, which combine markers of inflammation, ischemia, plaque instability and necrosis.
Limited adoption of respiratory virus multiplex panels. Although several multiplex RVPs have been launched, it appears unlikely that they will become widely adopted until additional evidence demonstrates their cost-effectiveness. The market for RVPs may expand more rapidly if effective anti-virals become available, especially for respiratory syncytial virus.
Growth prospects in mature markets. The molecular diagnostic market has shown steady growth since the start of the decade, serving a high unmet clinical need. However, all the major existing submarkets, such as blood screening, sexually transmitted disease testing and clinical virology are now mature with modest growth prospects.
Discover- What are the future growth prospects for the in-vitro diagnostics market?
- Which areas offer the most promising growth?
- Which segments promise the most innovation?
- Which companies are in the strongest position?
- Which smaller companies are attractive?
- What are the current unmet needs in the market?
- What are the greatest areas of market uncertainty?
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Table of Contents
- Innovations in In-Vitro Diagnostics
- 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
- bioMérieux
- 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
- 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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