Reports

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Reports

  1. 1. PipelineReview.com is powered by La Merie Business Intelligence La Merie S.L | Passatge Jordi Ferran, 20 | E-08028 Barcelona | T +34 93 342 91 97 | F +34 93 342 91 98 | Email info@lamerie.com | Internet www.lamerie.com Online Store: www.pipelinereview.com Reports Innovations in Oncology Diagnostics: Technological advances, growth opportunities and future market outlook 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
  2. 2. PipelineReview.com is powered by La Merie Business Intelligence La Merie S.L | Passatge Jordi Ferran, 20 | E-08028 Barcelona | T +34 93 342 91 97 | F +34 93 342 91 98 | Email info@lamerie.com | Internet www.lamerie.com Online Store: www.pipelinereview.com Reports 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
  3. 3. PipelineReview.com is powered by La Merie Business Intelligence La Merie S.L | Passatge Jordi Ferran, 20 | E-08028 Barcelona | T +34 93 342 91 97 | F +34 93 342 91 98 | Email info@lamerie.com | Internet www.lamerie.com Online Store: www.pipelinereview.com Reports 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 List of Figures 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 ($bn), 2007-14 30 Figure 2.5: Example of the use of 3D tomosynthesis imaging 39 Figure 2.6: Number of CT scans in the US, 1995-2008 43
  4. 4. PipelineReview.com is powered by La Merie Business Intelligence La Merie S.L | Passatge Jordi Ferran, 20 | E-08028 Barcelona | T +34 93 342 91 97 | F +34 93 342 91 98 | Email info@lamerie.com | Internet www.lamerie.com Online Store: www.pipelinereview.com Reports Figure 2.7: Women having mammograms (%) in the US, 2004* 45 Figure 2.8: Global flow cytometry market forecast ($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 ($) per patient relative to HER2 testing 87 Figure 5.16: Decline in S&P global sector indices (%), 12 months to December 2008 96 Figure 5.17: IV diagnostics risk-based classification 100 Figure 5.18: FDA validated biomarkers by therapeutic area, September 2009 102 Figure 5.19: Roche Diagnostics regional sales (CHFm), 2008 105 Figure 5.20: Leading diagnostic firms increase in R&D spend (%) y-o-y, 2008 107 List of Tables Table 1.1: WHO cancer mortality forecasts by region (‘000), 2008-30 21 Table 1.2: In vitro diagnostics market forecast ($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

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