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

Published by	Business Insights
Published	June, 2009	Product code	92691
Content info	134 pages
Price	US $ 3835 PDF by E-mail (Single User License) US $ 14381 PDF by E-mail (Global Site License)

Introduction
Related Reports

Innovations in In-Vitro Diagnostics: New technologies, growth opportunities, and the future market outlook published by Business Insights in June, 2009. This report consists of 134 pages and the price starts from US $ 3835.

Introduction

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.

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