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

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 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?

Table of Contents

• Innovations in In-Vitro Diagnostics

Executive summary 10

• Overview 10
• Market analysis 11
• Coronary heart disease 11
• Heart failure 12
• Viral infectious 13
• Bacterial infections 14
• Market outlook 15

Chapter 1 Overview 18

• Summary 18
• Introduction 19
• Classification of clinical diagnostics 19
• Market segments 22
• Clinical chemistry 22
• Immunoassays 22
• Estimated number of immunoassay analyzers by company 23
• Molecular diagnostics 25
• Point of care 27
• Pricing 28
• Regulation 29
• Increasing regulatory oversight 31

Chapter 2 Market analysis 34

• Summary 34
• Introduction 35
• Sales by company 35
• Sales by market segment 38
• Acquisition activity 39
• Company profiles 40
• Roche 40
• Siemens Healthcare Diagnostics 42
• Abbott 43
• Ortho-Clinical Diagnostics 44
• Beckman Coulter 45
• Becton Dickinson 46
• Bio-Rad 46
• bioMérieux 47
• Inverness Medical Solutions 48

Chapter 3 Coronary heart disease 50

• Summary 50
• Introduction 51
• Diagnosis of coronary heart disease 51
• Cardiac specific markers 53
• High-sensitive troponin assays 55
• Novel ultra-sensitive assays 56
• Potential clinical advances of novel assays 58
• Novel markers of coronary heart disease 60
• Cardiac ischemia 61
• Plaque instability 62
• Inflammation 63
• Future outlook 66
• Impact of novel troponin assays 67
• Incremental improvements 67
• Biomarkers for the early detection of disease 68

Chapter 4 Heart failure 72

• Summary 72
• Introduction 73
• Diagnosis of heart failure 73
• Natriuretic peptides 74
• Novel markers of heart failure 74
• MR-proANP 74
• Soluble ST2 75
• Troponin 76
• MR-proADM 77
• Future outlook 77
• Screening of asymptomatic patient populations 78

Chapter 5 Viral infections 80

• Summary 80
• Introduction 81
• Blood screening 81
• Major companies in the blood screening market 82
• Blood screening market size 84
• Quantitative viral diagnostics 85
• Treatment of viral infections 85
• Respiratory viral panels 86
• Novel multiplex assays 87
• RSV in the elderly 89
• Future outlook 91
• Existing market growth 92
• Emerging markets 93
• Need for effective therapies 94

Chapter 6 Bacterial infections 96

• Summary 96
• Introduction 97
• Sexually transmitted diseases 97
• Market size and key companies 100
• Healthcare associated infections 101
• Clostridium difficile 101
• Novel NAT based tests 105
• Market size for C.diff tests 107
• Methicillin-resistant Staphylococcus aureus 108
• Universal screening 110
• NAT based technologies 111
• Other rapid detection methods 112
• Universal screening market size 113
• Countries investing in MRSA screening 114
• Cost comparison of tests 115
• Future outlook 120

Chapter 7 Market outlook 122

• Summary 122
• Introduction 123
• Trends in 510(k) approvals 123
• Barriers to innovation 125
• Immunoassays 127
• Factors driving testing volumes 127
• Molecular diagnostics 130
• Demonstration of clinical need 130
• Novel technologies 131
• Appendix 134
• Methodology 134
• Glossary 134

List of Figures

• Figure 1.1: Estimated number of immunoassay analyzers sold since launch, by company, 2008 24
• Figure 1.2: Existing and emerging markets for molecular diagnostics 27
• Figure 1.3: Cost of tests by technology and clinical application, 2009, US 29
• Figure 2.4: Clinical diagnostics sales, by company, 2008 37
• Figure 2.5: Clinical diagnostic sales, by sector, 2008 38
• Figure 3.6: Diagnosis of myocardial infarction 54
• Figure 3.7: High sensitive troponin assays, comparison of lower limit of detection 59
• Figure 3.8: Novel cardiac biomarkers 65
• Figure 3.9: Potential US market for diagnosis of coronary heart disease 69
• Figure 5.10: Deaths due to respiratory syncytial virus infection, by age, US, 2003 90
• Figure 6.11: C. trachomatis and N. gonorrhoeae incidence rates, US, 1984-2007 99
• Figure 6.12: Deaths due to CDAD as underlying cause of death, US, 1999-2006 104
• Figure 6.13: CDAD infections in patients aged 65 years or older, England, 2006-2008 107
• Figure 6.14: Cost breakdown of universal admission MRSA screening program 117
• Figure 6.15: Comparison of PCR and chromogenic media cost for universal admission MRSA screening program 118
• Figure 7.16: 510(k) approvals by medical specialty, 2006-2008 124
• Figure 7.17: 510(k) approvals, 1997-2008 125
• Figure 7.18: Number of Clinical Laboratory Fee Schedule Codes, 2003 and 2009 126
• Figure 7.19: Hospital charges, by disease, 2006 128
• Figure 7.20: Prevalence of self-reported cardiovascular disease by age, US 129

List of Tables

• Table 1.1: Examples of commonly used in vivo and in vitro diagnostics 20
• Table 1.2: Number of clinical laboratories by type, US, 2008 21
• Table 1.3: Estimated number and sales of immunoassay analyzers, by company, 2008 25
• Table 2.4: Clinical diagnostics sales, by company, 2006-2008 36
• Table 2.5: Acquisitions by company, 2007-2009 39
• Table 2.6: Roche patenting activity 41
• Table 3.7: High sensitive troponin assays, comparison of lower limit of detection 57