Abstract
Part of Espicom' s 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.
Companies Analysed
- 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
Table of Contents
EXECUTIVE SUMMARY
- Figure1: Growth in biomarker market 2007-2015
- What are biomarkers?
- Why are they important?
- Figure 2: Potential impact of biomarkers on disease pathways
- What technologies are involved?
- What impact will biomarkers have on R&D?
- Figure 3: Potential impact of biomarkers on R&D
- Who are the major biomarker players and in what research area?
- Cancer biomarker companies
- Cardiovascular biomarker companies
- CNS biomarkers companies
- Company Analysis Criteria
- Biomarker technology & platforms
- Association/clinical studies
- Management strategy
- Application & potential
CANCER MARKET & REVENUES
- Market revenues - global
- Figure 1: Global cancer drugs sales (2007)
- Market revenues - leading brands
- Figure 2: Leading cancer brands (2007)
- Market revenues - leading players
- Figure 3: Top 10 oncology players (2007 revenues)
- CANCER EPIDEMIOLOGY, DIAGNOSIS, SCREENING & TREATMENT
- Epidemiology
- Table 1: Cancer Statistics for four most common cancers, 2008
- Diagnosis
- Screening
- Table 2: Cancer screening
- Current & future treatment
- Future treatment
- Figure 4: Anticancer drugs in clinical development
- CANCER BIOMARKERS
- Cancer biomarker R&D
- Table 3: Types of biomarker
- Known cancer biomarkers
- Table 4: Commercially available known cancer biomarker diagnostics
- Probable and possible valid cancer biomarkers
- Table 5: Probable cancer biomarkers diagnostics
- Table 6: Possible cancer biomarkers diagnostics
- CANCER BIOMARKER OPPORTUNITIES & CHALLENGES
- Opportunities
- Challenges
- BIOMARKER MARKET
- Biomarker market revenues - global
- Figure 8: Global biomarker sales in 2007
- Cancer biomarker market revenues - global
- Figure 9: Global cancer biomarker sales in 2007
- Future biomarker market revenues - global
- Figure 10: Global biomarker sales in 2015
- Future cancer biomarker market revenues - global
- Figure 11: Global cancer biomarker sales in 2015
- CANCER BIOMARKER TRENDS
- Table 7: Recent deals in oncology biomarkers
- Pharma and specialty pharma deals
- Collaborations with service providers
- Collaborations with academics and consortia
- BIOMARKER ANALYSIS
- DNA biomarkers
- RNA and microRNA biomarkers
- Proteomic biomarkers
- KEY BIOMARKER COMPANIES ANALYSED
- KEY BIOMARKER EVALUATION CRITERIA
CANCER BIOMARKER- COMPANY ANALYSIS
- Abbott Diagnostics
- Biomarker novelty & technology platform
- Figure 12: Abbott' s UroVysion bladder cancer test
- Association studies/clinical data
- Pivotal Trial
- Table 7: Comparison of UroVysion vs Cystoscopy/Histology for Detection of Bladder Cancer Recurrence by Stage and Grade*
- Management strategy
- Application & market potential
- Biomarker analysis
- Affymetrix
- Biomarker novelty & technology platform
- Figure 13: Affymetrix' approach to biomarker discovery, validation and clinical utility applications
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Agendia BV
- Biomarker novelty & technology platform
- Association studies/clinical data
- Figure 14: MammaPrint Profile vs NIH Consensus Criteria
- Management strategy
- Application & market potential
- Biomarker analysis
- AltheaDx
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- AVEO Pharmaceuticals
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- AviaraDx
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- BG Medicine
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Figure 15: BG Medicines Biomarker Programme
- Application & market potential
- Biomarker analysis
- Beckman Coulter
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- BioCurex
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Biomedical Diagnostics
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Biomerica
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Bruker Daltonics
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Caprion Proteomics
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Clinical Data
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Celera
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Dako Denmark A/S
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- DxS Ltd.
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Epigenomics AG
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Epistem Plc
- Biomarker novelty & technology platform
- Figure 16: Epistem' s Biomarker Drug Development Programme
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- GeneNews
- Biomarker novelty & technology platform
- Figure 17: GeneNews' Sentinel Principle
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Fujirebio Diagnostics, Inc
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Genomic Health
- Biomarker novelty & technology platform
- Figure 18: Oncotype Dx test for invasive breast cancer
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Gen-Probe
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Genzyme Genetics
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- InterGenetics
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Ipsogen Therapeutics
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Figure 19: Oncotype Dx test for invasive breast cancer
- Application & market potential
- Biomarker analysis
- Laboratory Corporation of America
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Matritech
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Monogram Biosciences
- Biomarker novelty & technology platform
- Association studies/clinical data
- Figure 21: VeraTag Clinical Data: Bordet Cohort
- Management strategy
- Application & market potential
- Biomarker analysis
- Orion Genomics
- Biomarker novelty & technology platform
- Figure 22: Orion' s MethylScope
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Oxford Genome Biosciences (UK) Ltd
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Power3 Medical Products
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Figure 23: Powder3' s business strategy
- Application & market potential
- Biomarker analysis
- Predictive Biosciences
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Provista Life Sciences
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Quest Diagnostics
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Roche Diagnostics
- Biomarker novelty & technology platform
- Figure 24: Diagnostic marker candidate to a product
- Association studies/clinical data
- Figure 25: Biomarkers distinguish Leukaemia subclasses
- Management strategy
- Application & market potential
- Biomarker analysis
- SuperArray Bioscience Corporation
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Third Wave Technologies
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Upstream Biosciences
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Veridex, LLC
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
- Vermillion
- Biomarker novelty & technology platform
- Association studies/clinical data
- Management strategy
- Application & market potential
- Biomarker analysis
CANCER biomarker APPENDIX 1
- Table 8: Global biomarker sales 2007-20015E
CANCER biomarker APPENDIX 2
- Table 8: Global cancer biomarker sales 2007-20015E
CAncer biomarker APPENDIX 3
- Company Analysis Criteria
- Biomarker technology & platforms
- Association studies
- Management strategy
- Application & potential
- Table 9: Key cancer biomarker companies
- Figure 26: Leading Cancer Biomarker Companies - Service providers, Technology Providers, Biomarker Discovery & Diagnostic Developers
GLOSSARY
ACRONYMS
BIBLIOGRAPHY & end NOTES
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