Innovations In Oncology Diagnostics: Technological Advances, Growth Opportunities And Future Market Outlook

Major developments are likely in both the IVD				Overview 47
market and in imaging-based modalities, like				Flow cytometry 48
computed tomography, with the emphasis being				Case study 49
upon the personalized medicine approach, where				CellSearch 49
demand will come from physicians, patients and				Cervical screening 50
payors – all of whom want more effective				Cytogenetics 52
treatments and value for money.				Chapter 3 Innovations in molecular diagnostics 56
This report analyzes the latest innovations in				Summary 56
oncology diagnostics and identifies the most				Introduction 57
exciting new technologies and trends, ranging				DNA, genes and chromosomes 59
from body imaging and cytology to molecular				Fluorescence in situ hybridization (FISH) 59
diagnostics and pharmacogenomics. The report				PCR and variants 60
also identifies the key challenges facing innovative				Case study 61
diagnostics companies.				HPV testing 61
Key Features of this report				Immunoassays and biomarkers 62
•Analysis the latest innovations in diagnostics				Case study 66
imaging in the oncology sector, covering Magnetic				Ovarian cancer 66
Resonance Imaging (MRI), x-ray, Computed				PSA testing 68
Tomography (CT), ultrasound, Positron Emission				Other areas of research 70
Tomography (PET), Single Photon Emission				Epigenomics 71
Computed Tomography (SPECT) and Flow				Microarrays 72
Cytometry.				Comparative genomic hybridization (CGH) 73
•Analyzes the latest innovations in molecular				Case study 74
diagnostics and how they impact the diagnostics				Almac 74
market. The report covers technology including				DiaGenic 74
fluorescence in situ hybridization (FISH),				Overview of clinical applications of molecular
polymerase chain reaction (PCR), HPV testing,				diagnostics 74
immunoassays & biomarkers, microarrays				BCR-ABL 74
and comparative genomic hybridization (CGH).				LOH 75
•Analyzes the latest innovations in				MSI 75
pharmacogenomics and covers the major				Chapter 4 Innovations in pharmacogenomics 78
applications for familial cancer, breast cancer, colon				Summary 78
cancer and lung cancer. Also, the report provides				Introduction 79
an overview of the regulatory and intellectual				Familial cancer 79
property environment for genetic-based tests.				Breast cancer 80
•Looks at the key commercial challenges for				Colon cancer 81
innovative diagnostics companies, including the				Melanoma 81
impact of the recession, reimbursement,				Case study 82
regulatory changes, pharmacoeconomics and the				IP challenge 82
relationship between industry and academia.				Response to therapy 83
The report Includes in-depth case studies on the				Cytochrome P450 variants 86
potential technologies available in core areas of				HER2 overexpression 86
un-met need such as ovarian cancer and				The FDA, EMEA and PGx labeling 88
colorectal cancer.				Case study 89
Key benefits of this report				TheraScreen: KRAS 89
•Understand the latest innovations in the				BioTheranostics: Breast cancer 89
oncology diagnostics market in the core areas				Clarient: Breast cancer 90
– diagnostic imaging, molecular diagnostics and				Marker validation for erlotinib in lung cancer 90
pharmacogenetics. This includes market				Companion diagnostics 91
information and an analysis of the scientific				Chapter 5 Challenges in the oncology diagnostics
literature so as to identify what is really				sector 94
innovative.				Summary 94
•Identify what the key areas of unmet need				Introduction 95
are in the oncology diagnostics market and				Reimbursement funding 97
understand which products have the greatest				Educated patients = educated decisions 98
potential over the next decade.				Regulation 99
•Understand what the greatest challenges are				Pharmacoeconomics 101
for oncology diagnostics and what the best				Emerging markets 104
strategies are for coping with these obstacles.				Partnerships between drug companies &
•Understand the competitive landscape and				academia 105
what companies are leading the way in terms of				Research & development 106
innovation, and what the latest partnerships				Mergers & acquisitions 109
regarding companion diagnostics.				Chapter 6 Competitive landscape 112
•Business Insights has identified five key areas				Summary 112
of innovation in the diagnostics markets, use this				Introduction 113
to help guide company strategy.				Abbot Diagnostics 113
Key findings from this report				Affymetrix 114
Molecular diagnostics and biomarkers are the key				Beckman Coulter 116
drivers of the oncology diagnostics market.				Becton Dickinson 117
Despite the deep economic recession, R&D				Bio-Rad Laboratories 119
spending has held up for oncology diagnostics				Gen-Probe 120
companies. However, M&A activity has been				Johnson & Johnson (J&J) 121
impacted with the value of deals conducted in				Ortho Clinical Diagnostics 121
2009 far below the peak year of 2007.				Luminex 121
Partnerships between diagnostic firms and				Tm Bioscience 122
pharmaceutical firms represents the future of the				Nanogen 122
industry and the number of companion deals has				Roche Diagnostics 123
been increasing in the past few years.				Siemens Healthcare Diagnostics 126
Virtual colonoscopy - using CT scans to build a				Sysmex 126
picture of the colon - is becoming an increasingly				Future perspectives in the oncology diagnostics
accepted alternative to invasive colonoscopy for				market 127
colorectal screening in high risk groups and the				Science 127
general population. This presents a sizeable market				Infrastructure 128
opportunity.				Adoption of innovation 130
Interesting research is being conducted in both				Companion diagnostics 131
ovarian cancer and for prostate cancer, which				Chapter 7 Appendix 135
could have wide-market implications. Specifically,				Glossary 135
companies are looking to validate new biomarkers				Index 138
to create more accurate tests.				List of Figures
Key questions answered by this report				Figure 1.1: Leading sites of new cancer US, 2009
What is the market potential for in vitro diagnostic				22
products?				Figure 1.2: Leading sites of new cancer in
What is the market forecast for oncology				developing countries, 2007 23
diagnostics?				Figure 1.3: Information required by oncologist pre
What are the key innovations in diagnostic testing				post diagnosis 27
and diagnostic imaging?				Figure 1.4: Oncology diagnostics forecasts ($bn),
What are the major areas of unmet need in				2007-14 30
oncology diagnostics?				Figure 2.5: Example of the use of 3D
What are the most promising technology areas in				tomosynthesis imaging 39
oncology diagnostics, and which companies are				Figure 2.6: Number of CT scans in the US,
exploiting these?				1995-2008 43
What will be the key trends impacting the market				Figure 2.7: Women having mammograms (%) in
in the long-term?				the US, 2004* 45
How can big pharma fully exploit the opportunities				Figure 2.8: Global flow cytometry market forecast
in the oncology diagnostics sector?				($bn), 2008-14 48
				Figure 3.9: IV diagnostics market forecast ($bn),
Abbott Diagnostics				2007-2014) 58
Affymetrix				Figure 3.10: Use of biomarkers 63
Beckman Coulter				Figure 3.11: Obstacles to biomarker development
Beckton Dickinson				64
Bio-Rad				Figure 3.12: US 5-year survival (%) for ovarian
Gen-Probe				cancer at time of diagnosis 67
Johnson & Johnson				Figure 4.13: Myriad: Molecular diagnostics sales
Luminex				($m), 2005-09 83
Nanogen				Figure 4.14: Number of biologics regulated by
Roche Diagnostics				CDER that have existing PGx information 85
Siemens				Figure 4.15: Herceptin therapy cost ($) per patient
Sysmex				relative to HER2 testing 87
				Figure 5.16: Decline in S&P global sector
				indices (%), 12 months to December 2008 96
				Figure 5.17: IV diagnostics risk-based classification
Table of Contents :				100
Innovations in oncology diagnostics				Figure 5.18: FDA validated biomarkers by
Executive summary 10				therapeutic area, September 2009 102
Setting the scene 10				Figure 5.19: Roche Diagnostics regional sales
Innovations in diagnostic imaging 11				(CHFm), 2008 105
Innovations in molecular diagnostics 12				Figure 5.20: Leading diagnostic firms increase in
Innovations in pharmacogenomics 13				R&D spend (%) y-o-y, 2008 107
Challenges in the oncology diagnostics sector 14				List of Tables
Competitive landscape 15				Table 1.1: WHO cancer mortality forecasts by
Chapter 1 Setting the scene 18				region (‘000), 2008-30 21
Summary 18				Table 1.2: In vitro diagnostics market forecast
Introduction 19				($bn), 2008-14 29
Cancer facts, current and projected 19				Table 2.3: Overview of imaging systems 37
History of oncology diagnostics 23				Table 2.4: Mortality reduction (%) attributed to
Elements of a cancer diagnosis 26				FOBT screening, 1985-96 41
Pathology 27				Table 2.5: Organ radiation data from various clinical
Oncology diagnostics market 28				studies 44
Chapter 2 Innovations in diagnostic imaging 34				Table 3.6: Extensively investigated cancer
Summary 34				biomarkers 65
Introduction 35				Table 3.7: Market potential for Epigenomics' cancer
Body imaging 35				specialty tests 72
Overview 35				Table 4.8: Absent/incomplete efficacy (%) of
X-ray 38				drugs by therapeutic class 84
Breast cancer 38				Table 5.9: Leading M&A deals in the
Computed tomography 40				diagnostics industry ($m), 2009 109
Lung cancer 40				Table 6.10: Sales for the leading innovative
Colon cancer 40				oncology diagnostics companies ($m), 2006-08 113
Others 42				Table 6.11: Beckman Coulter R&D investment
Ultrasound 44				($m), 2004-08 116
Magnetic resonance imaging 44				Table 6.12: Bio-Rad sales ($bn) 2004-2008 119
Nuclear medicine – PET & SPECT 45				Table 6.13: Roche Diagnostics sales by division
Case study 47				(CHFm), H109 123
HYPERImage 47				Table 6.
Cytology 47

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Innovations In Oncology Diagnostics: Technological Advances, Growth Opportunities And Future Market Outlook

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