Innovations in Oncology Diagnostics: Technological advances, growth opportunities and future market outlook

Despite public policy measures to prevent cancer, such as tobacco control and vaccination against HPV, cancer is sure to remain a significant public health problem throughout the 21st century. Indeed, the global demographic shift towards an ageing population and the spread of high tech modern medicine throughout the emerging economies of Asia and (maybe later) Africa, will expand the market for cancer diagnostics globally. Major developments are likely in both the IVD market and in imaging-based modalities, like computed tomography, with the emphasis being upon the personalized medicine approach, where demand will come from physicians, patients and payors – all of whom want more effective treatments and value for money.

This report analyzes the latest innovations in oncology diagnostics and identifies the most exciting new technologies and trends, ranging from body imaging and cytology to molecular diagnostics and pharmacogenomics. The report also identifies the key challenges facing innovative diagnostics companies.

Key Features of this report

•Analysis the latest innovations in diagnostics imaging in the oncology sector, covering Magnetic Resonance Imaging (MRI), x-ray, Computed Tomography (CT), ultrasound, Positron Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT) and Flow Cytometry.
•Analyzes the latest innovations in molecular diagnostics and how they impact the diagnostics market. The report covers technology including fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), HPV testing, immunoassays & biomarkers, microarrays and comparative genomic hybridization (CGH).
•Analyzes the latest innovations in pharmacogenomics and covers the major applications for familial cancer, breast cancer, colon cancer and lung cancer. Also, the report provides an overview of the regulatory and intellectual property environment for genetic-based tests.
•Looks at the key commercial challenges for innovative diagnostics companies, including the impact of the recession, reimbursement, regulatory changes, pharmacoeconomics and the relationship between industry and academia.
The report Includes in-depth case studies on the potential technologies available in core areas of un-met need such as ovarian cancer and colorectal cancer.

Key benefits of this report

•Understand the latest innovations in the oncology diagnostics market in the core areas – diagnostic imaging, molecular diagnostics and pharmacogenetics. This includes market information and an analysis of the scientific literature so as to identify what is really innovative.
•Identify what the key areas of unmet need are in the oncology diagnostics market and understand which products have the greatest potential over the next decade.
•Understand what the greatest challenges are for oncology diagnostics and what the best strategies are for coping with these obstacles.
•Understand the competitive landscape and what companies are leading the way in terms of innovation, and what the latest partnerships regarding companion diagnostics.
•Business Insights has identified five key areas of innovation in the diagnostics markets, use this to help guide company strategy.

Key findings from this report

Molecular diagnostics and biomarkers are the key drivers of the oncology diagnostics market.

Despite the deep economic recession, R&D spending has held up for oncology diagnostics companies. However, M&A activity has been impacted with the value of deals conducted in 2009 far below the peak year of 2007.

Partnerships between diagnostic firms and pharmaceutical firms represents the future of the industry and the number of companion deals has been increasing in the past few years.

Virtual colonoscopy - using CT scans to build a picture of the colon - is becoming an increasingly accepted alternative to invasive colonoscopy for colorectal screening in high risk groups and the general population. This presents a sizeable market opportunity.

Interesting research is being conducted in both ovarian cancer and for prostate cancer, which could have wide-market implications. Specifically, companies are looking to validate new biomarkers to create more accurate tests.

Key questions answered by this report

What is the market potential for in vitro diagnostic products?
What is the market forecast for oncology diagnostics?
What are the key innovations in diagnostic testing and diagnostic imaging?
What are the major areas of unmet need in oncology diagnostics?
What are the most promising technology areas in oncology diagnostics, and which companies are exploiting these?
What will be the key trends impacting the market in the long-term?
How can big pharma fully exploit the opportunities in the oncology diagnostics sector?



Companies mentioned in the report

Abbott Diagnostics
Affymetrix
Beckman Coulter
Beckton Dickinson
Bio-Rad
Gen-Probe
Johnson & Johnson
Luminex
Nanogen
Roche Diagnostics
Siemens
Sysmex

Report Highlights

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Table of Contents
Innovations in oncology diagnostics
Executive summary 10
Setting the scene 10
Innovations in diagnostic imaging 11
Innovations in molecular diagnostics 12
Innovations in pharmacogenomics 13
Challenges in the oncology diagnostics sector 14
Competitive landscape 15
Chapter 1 Setting the scene 18
Summary 18
Introduction 19
Cancer facts, current and projected 19
History of oncology diagnostics 23
Elements of a cancer diagnosis 26
Pathology 27
Oncology diagnostics market 28
Chapter 2 Innovations in diagnostic imaging 34
Summary 34
Introduction 35
Body imaging 35
Overview 35
X-ray 38
Breast cancer 38
Computed tomography 40
Lung cancer 40
Colon cancer 40
Others 42
Ultrasound 44
Magnetic resonance imaging 44
Nuclear medicine – PET & SPECT 45
Case study 47
HYPERImage 47
Cytology 47
Overview 47
Flow cytometry 48
Case study 49
CellSearch 49
Cervical screening 50
Cytogenetics 52
Chapter 3 Innovations in molecular diagnostics 56
Summary 56
Introduction 57
DNA, genes and chromosomes 59
Fluorescence in situ hybridization (FISH) 59
PCR and variants 60
Case study 61
HPV testing 61
Immunoassays and biomarkers 62
Case study 66
Ovarian cancer 66
PSA testing 68
Other areas of research 70
Epigenomics 71
Microarrays 72
Comparative genomic hybridization (CGH) 73
Case study 74
Almac 74
DiaGenic 74
Overview of clinical applications of molecular diagnostics 74
BCR-ABL 74
LOH 75
MSI 75
Chapter 4 Innovations in pharmacogenomics 78
Summary 78
Introduction 79
Familial cancer 79
Breast cancer 80
Colon cancer 81
Melanoma 81
Case study 82
IP challenge 82
Response to therapy 83
Cytochrome P450 variants 86
HER2 overexpression 86
The FDA, EMEA and PGx labeling 88
Case study 89
TheraScreen: KRAS 89
BioTheranostics: Breast cancer 89
Clarient: Breast cancer 90
Marker validation for erlotinib in lung cancer 90
Companion diagnostics 91
Chapter 5 Challenges in the oncology diagnostics sector 94
Summary 94
Introduction 95
Reimbursement funding 97
Educated patients = educated decisions 98
Regulation 99
Pharmacoeconomics 101
Emerging markets 104
Partnerships between drug companies & academia 105
Research & development 106
Mergers & acquisitions 109
Chapter 6 Competitive landscape 112
Summary 112
Introduction 113
Abbot Diagnostics 113
Affymetrix 114
Beckman Coulter 116
Becton Dickinson 117
Bio-Rad Laboratories 119
Gen-Probe 120
Johnson & Johnson (J&J) 121
Ortho Clinical Diagnostics 121
Luminex 121
Tm Bioscience 122
Nanogen 122
Roche Diagnostics 123
Siemens Healthcare Diagnostics 126
Sysmex 126
Future perspectives in the oncology diagnostics market 127
Science 127
Infrastructure 128
Adoption of innovation 130
Companion diagnostics 131
Chapter 7 Appendix 135
Glossary 135
Index 138


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Table 1.1: WHO cancer mortality forecasts by region (‘000), 2008-30 21
Table 1.2: In vitro diagnostics market forecast ($bn), 2008-14 29
Table 2.3: Overview of imaging systems 37
Table 2.4: Mortality reduction (%) attributed to FOBT screening, 1985-96 41
Table 2.5: Organ radiation data from various clinical studies 44
Table 3.6: Extensively investigated cancer biomarkers 65
Table 3.7: Market potential for Epigenomics’ cancer specialty tests 72
Table 4.8: Absent/incomplete efficacy (%) of drugs by therapeutic class 84
Table 5.9: Leading M&A deals in the diagnostics industry ($m), 2009 109
Table 6.10: Sales for the leading innovative oncology diagnostics companies ($m), 2006-08 113
Table 6.11: Beckman Coulter R&D investment ($m), 2004-08 116
Table 6.12: Bio-Rad sales ($bn) 2004-2008 119
Table 6.13: Roche Diagnostics sales by division (CHFm), H109 123
Table 6.14: Major recent Dx-Rx partnerships 132
Figure 1.1: Leading sites of new cancer US, 2009 22
Figure 1.2: Leading sites of new cancer in developing countries, 2007 23
Figure 1.3: Information required by oncologist pre/post diagnosis 27
Figure 1.4: Oncology diagnostics forecasts ($bn), 2007-14 30
Figure 2.5: Example of the use of 3D tomosynthesis imaging 39
Figure 2.6: Number of CT scans in the US, 1995-2008 43
Figure 2.7: Women having mammograms (%) in the US, 2004* 45
Figure 2.8: Global flow cytometry market forecast ($bn), 2008-14 48
Figure 3.9: IV diagnostics market forecast ($bn), 2007-2014) 58
Figure 3.10: Use of biomarkers 63
Figure 3.11: Obstacles to biomarker development 64
Figure 3.12: US 5-year survival (%) for ovarian cancer at time of diagnosis 67
Figure 4.13: Myriad: Molecular diagnostics sales ($m), 2005-09 83
Figure 4.14: Number of biologics regulated by CDER that have existing PGx information 85
Figure 4.15: Herceptin therapy cost ($) per patient 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 100
Figure 5.18: FDA validated biomarkers by therapeutic area, September 2009 102
Figure 5.19: Roche Diagnostics regional sales (CHFm), 2008 105
Figure 5.20: Leading diagnostic firms increase in R&D spend (%) y-o-y, 2008 107
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