Cancer Biomarkers: Players, products and prospects
Volume I
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| Overview: | |
| 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. |
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By Dr Cheryl L Barton / Publication Date: 28th August 2008
Contents:
EXECUTIVE SUMMARY.1
Figure1: Growth in biomarker market 2007-20151
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 Criteria7
Biomarker technology & platforms7
Association/clinical studies8
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 players11
Figure 3: Top 10 oncology players (2007 revenues)..11
CANCER EPIDEMIOLOGY, DIAGNOSIS, SCREENING & TREATMENT 12
Epidemiology12
Table 1: Cancer Statistics for four most common cancers, 2008.12
Diagnosis..12
Screening .13
Table 2: Cancer screening13
Current & future treatment..14
Future treatment..14
Figure 4: Anticancer drugs in clinical development15
CANCER BIOMARKERS .. 16
Cancer biomarker R&D..16
Table 3: Types of biomarker..17
Known cancer biomarkers17
Table 4: Commercially available known cancer biomarker diagnostics17
Probable and possible valid cancer biomarkers18
Table 5: Probable cancer biomarkers diagnostics19
Table 6: Possible cancer biomarkers diagnostics19
CANCER BIOMARKER OPPORTUNITIES & CHALLENGES21
Opportunities..21
Challenges21
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 TRENDS27
Table 7: Recent deals in oncology biomarkers27
Pharma and specialty pharma deals 29
Collaborations with service providers29
Collaborations with academics and consortia 29
BIOMARKER ANALYSIS30
DNA biomarkers 30
RNA and microRNA biomarkers30
Proteomic biomarkers30
KEY BIOMARKER COMPANIES ANALYSED..31
KEY BIOMARKER EVALUATION CRITERIA32
CANCER BIOMARKER- COMPANY ANALYSIS33
Abbott Diagnostics33
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 Criteria39
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 Programme48
Application & market potential. 48
Biomarker analysis.. 48
Beckman Coulter50
Biomarker novelty & technology platform.. 50
Association studies/clinical data.50
Management strategy. 50
Application & market potential.51
Biomarker analysis51
BioCurex.52
Biomarker novelty & technology platform..52
Association studies/clinical data..52
Management strategy..52
Application & market potential.53
Biomarker analysis..53
Biomedical Diagnostics54
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 Daltonics58
Biomarker novelty & technology platform 58
Association studies/clinical data. 58
Management strategy. 58
Application & market potential. 58
Biomarker analysis.. 58
Caprion Proteomics60
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, Inc78
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 cancer80
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 Genetics85
Biomarker novelty & technology platform.. 85
Association studies/clinical data 85
Management strategy. 85
Application & market potential. 85
Biomarker analysis. 86
InterGenetics87
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 cancer90
Application & market potential. 90
Biomarker analysis. 90
Laboratory Corporation of America91
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 Biosciences95
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 MethylScope98
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 analysis101
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 analysis110
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 strategy112
Application & market potential113
Biomarker analysis113
SuperArray Bioscience Corporation. 114
Biomarker novelty & technology platform.114
Association studies/clinical data..114
Management strategy114
Application & market potential114
Biomarker analysis114
Third Wave Technologies. 116
Biomarker novelty & technology platform.116
Association studies/clinical data..116
Management strategy116
Application & market potential116
Biomarker analysis117
Upstream Biosciences. 118
Biomarker novelty & technology platform.118
Association studies/clinical data..118
Management strategy118
Application & market potential118
Biomarker analysis119
Veridex, LLC120
Biomarker novelty & technology platform.120
Association studies/clinical data..120
Management strategy120
Application & market potential121
Biomarker analysis121
Vermillion.122
Biomarker novelty & technology platform.122
Association studies/clinical data..122
Management strategy122
Application & market potential123
Biomarker analysis123
CAncer biomarker APPENDIX 1 124
Table 8: Global biomarker sales 2007-20015E..124
CAncer biomarker APPENDIX 2 125
Table 8: Global cancer biomarker sales 2007-20015E125
CAncer biomarker APPENDIX 3 126
Company Analysis Criteria..126
Biomarker technology & platforms126
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
List of Tables:
Table 1: Cancer Statistics for four most common cancers, 2008.12
Table 2: Cancer screening13
Table 3: Types of biomarker..17
Table 4: Commercially available known cancer biomarker diagnostics17
Table 5: Probable cancer biomarkers diagnostics19
Table 6: Possible cancer biomarkers diagnostics19
Table 7: Recent deals in oncology biomarkers27
Table 7: Comparison of UroVysion vs Cystoscopy/Histology for Detection of Bladder
Table 8: Global biomarker sales 2007-20015E..124
Table 8: Global cancer biomarker sales 2007-20015E125
Table 9: Key cancer biomarker companies..128
Figure 1: Global cancer drugs sales (2007).9
Figure 2: Leading cancer brands (2007).10
Figure 3: Top 10 oncology players (2007 revenues)..11
Figure 8: Global biomarker sales in 2007..23
Figure 9: Global cancer biomarker sales in 2007.24
Figure 10: Global biomarker sales in 2015.25
Figure 11: Global cancer biomarker sales in 2015.26
Figure 12: Abbott’s UroVysion bladder cancer test..33
Figure 13: Affymetrix’ approach to biomarker discovery, validation and clinical utility applications..36
Figure 14: MammaPrint Profile vs NIH Consensus Criteria39
Figure 16: Epistem’s Biomarker Drug Development Programme..72
Figure 17: GeneNews’ Sentinel Principle.75
Figure 18: Oncotype Dx test for invasive breast cancer80
Association studies/clinical data 80
Figure 19: Oncotype Dx test for invasive breast cancer90
Figure 20: VeraTag Assay.95
Figure 21: VeraTag Clinical Data: Bordet Cohort..96
Figure 22: Orion’s MethylScope98
Figure 23: Powder3’s business strategy.103
Figure 24: Diagnostic marker candidate to a product 111
Figure 25: Biomarkers distinguish Leukaemia subclasses.. 112
Figure 26: Leading Cancer Biomarker Companies – Service providers, Technology