Table of Contents for Innovations in Diagnostics
Innovations in Diagnostics
Executive Summary 10
Introduction to diagnostics 10
Challenges and opportunities in diagnostic innovation 11
Molecular technology innovations 12
Innovation in infectious disease diagnostics 13
Personalized medicine 13
Point-of-care testing 15
Competitive landscape 16
Chapter 1 Introduction to diagnostics 18
Summary 18
Introduction 19
The global IVD market 20
Market segments 20
Market dynamics 22
Market growth 23
Key IVD players 24
Industry profile 25
Overview of diagnostic technologies 26
Immunoassays 26
Nucleic acid (NA) assays 27
Biosensors 27
Microarrays 28
Future trends 28
Chapter 2 Challenges and opportunities in diagnostic innovation 32
Summary 32
Introduction 33
A changing healthcare environment 33
Challenges & opportunities 34
Regulatory hurdles 35
Reimbursement 37
Technology requirements 38
Connectivity 38
Communication 39
New partnerships/new players 40
Chapter 3 Molecular technology innovations 44
Summary 44
Introduction 45
IVD technologies 47
PCR 47
FISH 48
Arrays 49
Nanotechnology 50
DNA methylation 51
DNA biosensors 53
Chapter 4 Innovation in infectious disease diagnostics 56
Summary 56
Introduction 57
Emerging infections 58
Avian influenza H5N1 58
SARS 59
Multiple detection of infectious agents 60
Future challenges 62
Hospital-acquired infections 62
Gonorrhea 62
Early onset sepsis 63
Other infections 63
Chapter 5 Personalized medicine 66
Summary 66
Introduction 67
Imaging: part of the Dx+PGx+Rx equation 68
Pharmacogenomics 70
Clinical application of pharmacogenomics 71
Pharmacogenetic tests 72
Case Study: AmpliChip CYP450 73
Other pharmacogenetic tests 73
Biomarkers 75
Case study: Diabetes 76
Case study: Heart disease 76
Oncology 77
Breast cancer 79
Colorectal cancer 80
Leukemia 81
Lung cancer 82
Prostate cancer 82
Future challenges 83
Chapter 6 Point-of-care testing 86
Summary 86
Introduction 87
Blood glucose tests 88
Case study: Scout test for diabetes screening 89
Infectious diseases 90
Rapid Step B test 90
Urinary tract infection (UTI) biosensor 90
Active tuberculosis (TB) 91
Cardiac diagnostics 91
Blood coagulation 91
Cardiac markers 91
Direct LDL cholesterol test 92
Stroke 92
Bladder cancer rapid test 93
HIV home tests 93
Future challenges 94
Chapter 7 Competitive landscape 98
Summary 98
Introduction 99
Key mergers & acquisitions 99
Competitive landscape 101
Pharma companies with Dx divisions 101
Roche Diagnostics 102
Diabetes Care 102
Centralized Diagnostics 103
Molecular Diagnostics 103
Near Patient Testing 104
Applied Science 104
Product Pipeline 104
Abbott 105
Diabetes Care 105
Immunodiagnostics, clinical chemistry and hematology 105
Molecular Diagnostics 106
Point-of-Care 107
MedTech companies with Dx divisions 107
Becton Dickinson 107
Diagnostics 108
Biosciences 108
Dx Specialists 109
Gen-Probe 109
Clinical Diagnostics 110
Blood Screening 111
Molecular Diagnostics 111
Inverness Medical Innovations (IMI) 113
Consumer Diagnostics Products 113
Professional Diagnostics Products 114
Research & Development 115
Acquisitions 115
Tm Bioscience 116
Human Genetics 116
Infectious disease 117
PGx 117
Technology specialists 118
Affymetrix 118
Collaborations 119
Competition 119
Nanogen 120
Chapter 8 Appendix 124
Index 124
List of Figures
Figure 1.1: IVD market segments, 2005 21
Figure 1.2: IVD market segments projected growth, 2004-2010 23
Figure 3.3: Orion Genomics’ Second Code technology 52
Figure 5.4: The healthcare model of the future: Personalized medicine 67
Figure 5.5: Breast cancer management in the future 69
Figure 5.6: From diagnostic market candidate to a product: Three development phases 75
Figure 5.7: Potential roles of genomics in cancer 77
Figure 7.8: New cancer marker launches 104
Figure 7.9: Gen-Probe leads US STD market, 2002-05 110
Figure 7.10: IMI product sales by business segment, 2005 113
Figure 7.11: IMI’s leading market position in consumer diagnostics 114
List of Tables
Table 1.1: Top 15 IVD companies, 2005 24
Table 2.2: Development costs and timeframes to produce a new IVD in the US, 2006 36
Table 5.3: Cancer markers used in Dx tests 78
Table 7.4: Pure-play diagnostic companies and ownership of IVD companies by medical device and pharmaceutical companies 101
Table 7.5: Roche Diagnostics sales, H1 2006 102
Table 7.6: Gen-Probe product sales, 2005 110
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