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Cancer Biomarkers: Players, Products and Prospects (Volume I)


Description: Part of our new 3-volume report on Cancer, CNS and Cardiovascular Biomarkers, this volume provides a comprehensive analysis of the cancer biomarker sector, along with a critical assessment of the companies involved.

The cancer biomarker market represents one of the largest segments of biomarkers in terms of revenue. In 2007, the estimated cancer biomarker market accounted for around 55% of biomarker revenues at over US$3 billion, with the majority of revenues derived from biomarker discovery and molecular diagnostics.

This market is relatively mature due to researchers’ comprehensive understanding of the underlying genetic and proteomic components of the disease. It has been the focus for the majority of the early biomarker research which was aimed at the discovery and identification of biomarkers that guided the development of targeted therapies (companion diagnostics) and has been stimulated by advances in technology platforms for the analysis of biological samples (blood, serum and tissue).

Collaborative working is essential
During the last two years, the leading pharma companies such as Abbott, AstraZeneca, Eisai, Merck & Co, sanofi-aventis, Solvay, Pfizer, Roche and Wyeth have been forming strategic alliances with a variety of companies, including Caprion Proteomics, Celera, Epigenomics, EpiStem, Monogram BioSciences (formerly ViroLogic) and Vermillion which are all actively involved in biomarker discovery and validation.

Many of these agreements have been established in the last 12 months and pursue the identification of multiple oncology biomarkers that complement pharma product pipelines. For example, in March 2008 Abbott established a collaboration with Genentech, Roche and OSI to develop an EGFR FISH based test for NSCLC testing. Similarly, specialty pharma companies such as Amgen, Myriad and OSI Pharmaceuticals have formed collaborations to utilise biomarkers in drug discovery and development programmes.

Increasingly, the industry is establishing relationships with leading academic institutes to clinically validate biomarkers prior to their use in clinical drug development programmes. For example, in the US, the Eastern Virginia Medical School, the Johns Hopkins University, The University of Kentucky, the Mayo Clinic, and the MD Anderson Cancer Center and, in Europe, the Institut Curie in France and the University of Oxford in the UK are all assessing new cancer biomarkers and technology platforms for biomarker discovery and validation.

Questions, Questions
- What will the global cancer biomarker market be worth in 2015?
- What developments in proteomic biomarkers are proving fruitful in the cancer sector and which companies are developing them?
- Why might drug discovery companies be interested in Dutch diagnostic company Agendia BV?
- How is Beckman Coulter strengthening its presence in the cancer biomarker arena?

Focus on...opportunities
The cancer biomarker sector will be driven by...
Increases in the number of new cases of a range of cancers due to an aging population, e.g. prostate, breast and ovarian cancers. These will continue to drive growth and research interest in cancer therapies and investigation into the underlying mechanisms of the disease.

Improvements in diagnostic tests and technology platforms to direct treatment and surgery which instil confidence and renewed interest in developing PoC diagnostics, e.g. EPCA/PSA tests for prostate cancer and HER-2 for breast cancer.

The development of easy-to-use and rapid PoC diagnostics that may help to increase the number of cancer patients treated with first line therapy.


Contents: EXECUTIVE SUMMARY 1
Figure1: Growth in biomarker market 2007-2015 1
What are biomarkers? 2
Why are they important? 2
Figure 2: Potential impact of biomarkers on disease pathways 2
What technologies are involved? 3
What impact will biomarkers have on R&D? 3
Figure 3: Potential impact of biomarkers on R&D 3
Who are the major biomarker players and in what research area? 4
Cancer biomarker companies 5
Cardiovascular biomarker companies 6
CNS biomarkers companies 7
Company Analysis Criteria 7
Biomarker technology & platforms 7
Association/clinical studies 8
Management strategy 8
Application & potential 8

CANCER MARKET & REVENUES 9
Market revenues - global 9
Figure 1: Global cancer drugs sales (2007) 9
Market revenues – leading brands 10
Figure 2: Leading cancer brands (2007) 10
Market revenues – leading players 11
Figure 3: Top 10 oncology players (2007 revenues) 11

CANCER EPIDEMIOLOGY, DIAGNOSIS, SCREENING & TREATMENT 12
Epidemiology 12
Table 1: Cancer Statistics for four most common cancers, 2008 12
Diagnosis 12
Screening 13
Table 2: Cancer screening 13
Current & future treatment 14
Future treatment 14
Figure 4: Anticancer drugs in clinical development 15

CANCER BIOMARKERS 16
Cancer biomarker R&D 16
Table 3: Types of biomarker 17
Known cancer biomarkers 17
Table 4: Commercially available known cancer biomarker diagnostics 17
Probable and possible valid cancer biomarkers 18
Table 5: Probable cancer biomarkers diagnostics 19
Table 6: Possible cancer biomarkers diagnostics 19

CANCER BIOMARKER OPPORTUNITIES & CHALLENGES 21
Opportunities 21
Challenges 21
BIOMARKER MARKET 23
Biomarker market revenues - global 23
Figure 8: Global biomarker sales in 2007 23
Cancer biomarker market revenues - global 24
Figure 9: Global cancer biomarker sales in 2007 24
Future biomarker market revenues – global 24
Figure 10: Global biomarker sales in 2015 25
Future cancer biomarker market revenues - global 25
Figure 11: Global cancer biomarker sales in 2015 26

CANCER BIOMARKER TRENDS 27
Table 7: Recent deals in oncology biomarkers 27
Pharma and specialty pharma deals 29
Collaborations with service providers 29
Collaborations with academics and consortia 29

BIOMARKER ANALYSIS 30
DNA biomarkers 30
RNA and microRNA biomarkers 30
Proteomic biomarkers 30

KEY BIOMARKER COMPANIES ANALYSED 31
KEY BIOMARKER EVALUATION CRITERIA 32
CANCER BIOMARKER- COMPANY ANALYSIS 33
Abbott Diagnostics 33
Biomarker novelty & technology platform 33
Figure 12: Abbott’s UroVysion bladder cancer test 33
Association studies/clinical data 34
Pivotal Trial 34
Table 7: Comparison of UroVysion vs Cystoscopy/Histology for Detection of Bladder Cancer Recurrence by Stage and Grade* 34
Management strategy 34
Application & market potential 34
Biomarker analysis 35
Affymetrix 36
Biomarker novelty & technology platform 36
Figure 13: Affymetrix’ approach to biomarker discovery, validation and clinical utility applications 36
Association studies/clinical data 37
Management strategy 37
Application & market potential 37
Biomarker analysis 37
Agendia BV 39
Biomarker novelty & technology platform 39
Association studies/clinical data 39
Figure 14: MammaPrint Profile vs NIH Consensus Criteria 39
Management strategy 40
Application & market potential 40
Biomarker analysis 40
AltheaDx 41
Biomarker novelty & technology platform 41
Association studies/clinical data 41
Management strategy 41
Application & market potential 41
Biomarker analysis 41
AVEO Pharmaceuticals 43
Biomarker novelty & technology platform 43
Association studies/clinical data 43
Management strategy 43
Application & market potential 43
Biomarker analysis 44
AviaraDx 45
Biomarker novelty & technology platform 45
Association studies/clinical data 45
Management strategy 45
Application & market potential 46
Biomarker analysis 46
BG Medicine 47
Biomarker novelty & technology platform 47
Association studies/clinical data 47
Management strategy 47
Figure 15: BG Medicines Biomarker Programme 48
Application & market potential 48
Biomarker analysis 48
Beckman Coulter 50
Biomarker novelty & technology platform 50
Association studies/clinical data 50
Management strategy 50
Application & market potential 51
Biomarker analysis 51
BioCurex 52
Biomarker novelty & technology platform 52
Association studies/clinical data 52
Management strategy 52
Application & market potential 53
Biomarker analysis 53
Biomedical Diagnostics 54
Biomarker novelty & technology platform 54
Association studies/clinical data 54
Management strategy 54
Application & market potential 54
Biomarker analysis 55
Biomerica 56
Biomarker novelty & technology platform 56
Association studies/clinical data 56
Management strategy 56
Application & market potential 56
Biomarker analysis 57
Bruker Daltonics 58
Biomarker novelty & technology platform 58
Association studies/clinical data 58
Management strategy 58
Application & market potential 58
Biomarker analysis 58
Caprion Proteomics 60
Biomarker novelty & technology platform 60
Association studies/clinical data 60
Management strategy 60
Application & market potential 60
Biomarker analysis 60
Clinical Data 62
Biomarker novelty & technology platform 62
Association studies/clinical data 62
Management strategy 62
Application & market potential 62
Biomarker analysis 63
Celera 64
Biomarker novelty & technology platform 64
Association studies/clinical data 64
Management strategy 64
Application & market potential 65
Biomarker analysis 65
Dako Denmark A/S 66
Biomarker novelty & technology platform 66
Association studies/clinical data 66
Management strategy 66
Application & market potential 66
Biomarker analysis 67
DxS Ltd 68
Biomarker novelty & technology platform 68
Association studies/clinical data 68
Management strategy 68
Application & market potential 68
Biomarker analysis 69
Epigenomics AG 70
Biomarker novelty & technology platform 70
Association studies/clinical data 70
Management strategy 70
Application & market potential 71
Biomarker analysis 71
Epistem Plc 72
Biomarker novelty & technology platform 72
Figure 16: Epistem’s Biomarker Drug Development Programme 72
Association studies/clinical data 73
Management strategy 73
Application & market potential 73
Biomarker analysis 73
GeneNews 75
Biomarker novelty & technology platform 75
Figure 17: GeneNews’ Sentinel Principle 75
Association studies/clinical data 76
Management strategy 76
Application & market potential 76
Biomarker analysis 76
Fujirebio Diagnostics, Inc 78
Biomarker novelty & technology platform 78
Association studies/clinical data 78
Management strategy 78
Application & market potential 79
Biomarker analysis 79
Genomic Health 80
Biomarker novelty & technology platform 80
Figure 18: Oncotype Dx test for invasive breast cancer 80
Association studies/clinical data 80
Management strategy 81
Application & market potential 81
Biomarker analysis 81
Gen-Probe 83
Biomarker novelty & technology platform 83
Association studies/clinical data 83
Management strategy 83
Application & market potential 84
Biomarker analysis 84
Genzyme Genetics 85
Biomarker novelty & technology platform 85
Association studies/clinical data 85
Management strategy 85
Application & market potential 85
Biomarker analysis 86
InterGenetics 87
Biomarker novelty & technology platform 87
Association studies/clinical data 87
Management strategy 87
Application & market potential 87
Biomarker analysis 88
Ipsogen Therapeutics 89
Biomarker novelty & technology platform 89
Association studies/clinical data 89
Management strategy 89
Figure 19: Oncotype Dx test for invasive breast cancer 90
Application & market potential 90
Biomarker analysis 90
Laboratory Corporation of America 91
Biomarker novelty & technology platform 91
Association studies/clinical data 91
Management strategy 91
Application & market potential 91
Biomarker analysis 91
Matritech 93
Biomarker novelty & technology platform 93
Association studies/clinical data 93
Management strategy 93
Application & market potential 93
Biomarker analysis 94
Monogram Biosciences 95
Biomarker novelty & technology platform 95
Figure 20: VeraTag Assay 95
Association studies/clinical data 95
Figure 21: VeraTag Clinical Data: Bordet Cohort 96
Management strategy 96
Application & market potential 96
Biomarker analysis 97
Orion Genomics 98
Biomarker novelty & technology platform 98
Figure 22: Orion’s MethylScope 98
Association studies/clinical data 98
Management strategy 99
Application & market potential 99
Biomarker analysis 99
Oxford Genome Biosciences (UK) Ltd 100
Biomarker novelty & technology platform 100
Association studies/clinical data 100
Management strategy 100
Application & market potential 100
Biomarker analysis 101
Power3 Medical Products 102
Biomarker novelty & technology platform 102
Association studies/clinical data 102
Management strategy 102
Figure 23: Powder3’s business strategy 103
Application & market potential 103
Biomarker analysis 103
Predictive Biosciences 105
Biomarker novelty & technology platform 105
Association studies/clinical data 105
Management strategy 105
Application & market potential 105
Biomarker analysis 106
Provista Life Sciences 107
Biomarker novelty & technology platform 107
Association studies/clinical data 107
Management strategy 107
Application & market potential 108
Biomarker analysis 108
Quest Diagnostics 109
Biomarker novelty & technology platform 109
Association studies/clinical data 109
Management strategy 109
Application & market potential 109
Biomarker analysis 110
Roche Diagnostics 111
Biomarker novelty & technology platform 111
Figure 24: Diagnostic marker candidate to a product 111
Association studies/clinical data 112
Figure 25: Biomarkers distinguish Leukaemia subclasses 112
Management strategy 112
Application & market potential 113
Biomarker analysis 113
SuperArray Bioscience Corporation 114
Biomarker novelty & technology platform 114
Association studies/clinical data 114
Management strategy 114
Application & market potential 114
Biomarker analysis 114
Third Wave Technologies 116
Biomarker novelty & technology platform 116
Association studies/clinical data 116
Management strategy 116
Application & market potential 116
Biomarker analysis 117
Upstream Biosciences 118
Biomarker novelty & technology platform 118
Association studies/clinical data 118
Management strategy 118
Application & market potential 118
Biomarker analysis 119
Veridex, LLC 120
Biomarker novelty & technology platform 120
Association studies/clinical data 120
Management strategy 120
Application & market potential 121
Biomarker analysis 121
Vermillion 122
Biomarker novelty & technology platform 122
Association studies/clinical data 122
Management strategy 122
Application & market potential 123
Biomarker analysis 123

Cancer biomarker APPENDIX 1 124
Table 8: Global biomarker sales 2007-20015E 124
Cancer biomarker APPENDIX 2 125
Table 8: Global cancer biomarker sales 2007-20015E 125
Cancer biomarker APPENDIX 3 126
Company Analysis Criteria 126
Biomarker technology & platforms 126
Association studies 126
Management strategy 126
Application & potential 126
Table 9: Key cancer biomarker companies 128
Figure 26: Leading Cancer Biomarker Companies – Service providers, Technology Providers, Biomarker Discovery & Diagnostic Developers 130

GLOSSARY 131
ACRONYMS 133
BIBLIOGRAPHY & end NOTES 138


Companies Mentioned - Abbott Diagnostics - Affymetrix - Agendia BV - AltheaDx - AVEO Pharmaceuticals - AviaraDx - BD Medicine - Beckman Coulter Inc - BioCurex Inc - Biomedical Diagnostics - Biomerica - Bruker Daltonics - Caprion Proteomics - Celera - Clinical Data Inc - Dako Denmark A/S - DxS Ltd. - Epigenomics AG - EpiStem - Fujirebio Diagnostics - Gen-Probe Inc - Genomics Health Inc - GeneNews - Genzyme Genetics - InterGenetics Inc - Ipsogen Therapeutics - Laboratory Corporation of America - Matritech Inc - Monogram Biosciences Inc - Orion Genomics Inc - Oxford Genome Sciences (UK) Ltd - Power3 Medical Products - Predictive Biosciences - Provista Life Sciences - Quest Diagnostics Inc - Roche Diagnostics - SuperArray Bioscience Corporation - Third Wave Technologies - Upstream Biosciences Inc - Veridex - Vermillion


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