Abstract
Aggressive adoption of cancer biomarkers will accelerate the growth of
commercial markets for these products.
This new report offers in-depth analysis of:
- The current cancer biomarker products, applications, and markets
- Key validation and assessment cancer biomarker programs integrating
established “standards of care” for cancer diagnosis and treatment
- Product opportunities for improved screening and early detection, to
provide better guidance on therapy, for understanding cancer staging, response
to treatment, and prognosis
- Profile of business models behind cancer biomarker products and a SWOT
analysis associated with specific strategies
- Projections for market growth for cancer biomarker product categories
Cancer biomarkers are employed across the entire healthcare spectrum from the
cancer biological research laboratory to patient monitoring in the clinic.
Cancer biomarkers have contributed greatly to our current understanding of the
heterogeneous nature of specific cancers and have led to improvements in
treatment outcomes. Biomarker diagnostic and drug therapy combinations are the
basis of established treatment protocols in the clinic.
Cancer biomarker -"based diagnostics have applications for establishing
disease predisposition, early detection, cancer staging, therapy selection,
identifying whether or not a cancer is metastatic, therapy monitoring,
assessing prognosis, and advances in the adjuvant setting. As this report
details, full adoption of cancer biomarkers in the clinic has to date been
slow, and only a limited number of cancer biomarker products are currently in
routine use. However, several major programs have been organized to facilitate
the validation and assessment of cancer biomarkers alongside the established
“standards of care” for cancer diagnosis and treatment. These
programs are likely to be key to increasing the rate of cancer biomarker
adoption in the clinic setting. Further, the regulatory environment is
progressing as more cancer biomarker products gain approval.
Cancer Biomarkers: Adoption Is Driving Growth explores the various
applications for cancer biomarkers across the healthcare spectrum by
presenting the successful adoption of specific biomarkers. These applications
include the identification of novel therapeutic targets in cancer drug
discovery and uses of cancer biomarkers as surrogate markers for drug efficacy
in clinical trials. This report describes a number of factors providing the
driving forces behind cancer biomarker growth and commercialization. These
factors include requirements to improve screening and early detection, to
provide better guidance on therapy and the need to avoid therapy resistance
attributes, for understanding cancer staging, response to treatment, and
prognosis.
Cancer Biomarkers: Adoption Is Driving Growth reviews emerging cancer
biomarker types and the increasing interest in circulating tumor cells, as
well as data on potential DNA, RNA, and protein biomarkers under study,
including:
- Oncogenes
- Germline inheritance
- Mutations in drug targets
- Epigenetic changes
The report presents the business models behind cancer biomarker products and a
SWOT profile analysis associated with specific strategies. Also, the
intellectual property issues around cancer biomarkers are presented, since
clear ownership may be a problem in certain circumstances. Further,
projections for growth areas within the cancer biomarker markets are provided.
Cancer Biomarkers: Adoption Is Driving Growth includes summaries of interviews
with four experts from companies engaged in cancer biomarker product
commercialization. Additionally, it provides an analysis of results from a
recent Insight Pharma Reports survey, primarily aimed at the pharmaceutical
industry, relating to the research, development, and commercialization of
cancer biomarkers.
Table of Contents
Chapter - 1
- BACKGROUND
- 1.1. Cancer Staging
- 1.2. AACR/FDA/NCI Collaborative
- 1.3. Cancer Biomarkers
- 1.4. Genetics
- 1.5. Research Areas
- 1.6. Treatment Selection
- 1.7. New Biomarkers
- 1.8. Circulating Tumor Cells
- 1.9. Cancer Stem Cells
- 1.10. Classification
Chapter - 2
- THE DISCOVERY OF CANCER BIOMARKERS
- 2.1. Genetic Methods
- DNA Arrays
- Southern Blot
- Polymerase Chain Reaction (PCR)
- Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
- Fluorescent In Situ Hybridization (FISH)
- 2.2. Protein Methods
- Immunohistochemistry
- Mass Spectrometry
- 2.3. Metabolomics
- 2.4. Imaging
- Imaging Techniques
- Positron Emission Tomography (PET)
- Computed Tomography (CT)
- Magnetic Resonance Spectroscopy (MRS)
- Magnetic Resonance Imaging (MRI)
- Single-Photon Emission Computed Tomography (SPECT)
- Ultrasound
- X-ray
- Biophotonics
Chapter - 3
- IMPORTANT CANCER BIOMARKERS
- 3.1. Lung Cancer
- Proteins
- Genes and Gene Arrays
- Splice Variants (Ciz1)
- Serum L-Lactate Dehydrogenase
- Telomerase
- 3.2. Colorectal Cancer
- Early Detection
- Proteins by SELDI
- Fecal DNA
- Genes and Epigenetic Markers
- Carcinoembryonic Antigen
- 3.3. Prostate Cancer
- Prostate-Specific Antigen (PSA)
- TIMP1
- MUC1
- B7-H3
- Genetic Biomarkers
- Epigenetic Alterations
- 3.4. Breast Cancer
- Growth Factors and Receptors
- Genetic Markers
- 3.5. Ovarian Cancer
- CA125
- Lysophospholipids
- H4
- Mammaglobin-2
- 3.6. Pancreatic Cancer
- CA19-9
- Blood Proteins
- MUC1
- 3.7. Liver Cancer
- 3.8. Leukemia
- 3.9. Other Cancers
- 3.10. Outlook for the Use of Cancer Biomarkers
Chapter - 4
- COMMERCIAL MARKETS
- 4.1. Commercial Importance of Biomarkers
- Competitive Opportunities
- Cost Saving
- 4.2. Market Considerations
- Economic Importance
- Companies
Chapter - 5
- SWOT ANALYSIS
- 5.1. Strengths
- Patients
- Healthcare Payers/Reimbursers
- Healthcare Providers
- Diagnostic/Drug Development Companies
- 5.2. Weaknesses
- 5.3. Opportunities
- Patients
- Healthcare Payers/Reimbursers
- Healthcare Providers
- Diagnostic/Drug Development Companies
- 5.4. Threats
Chapter - 6
- INSIGHT PHARMA REPORTS CANCER BIOMARKERS SURVEY- FEBRUARY 2008
Chapter - 7
- INTERVIEWS WITH CANCER BIOMARKER EXPERTS
- 7.1. Mark Reynolds, PhD; Senior Director, Gen-Probe
- 7.2. Mark Chandler, PhD; Chairman and CEO, Biophysical Corporation
- 7.3. Roberto Hernan, PhD; Head of Business Development, Dominion Pharmakine
- 7.4. Michael Milburn, PhD; Chief Scientific Officer, Metabolon
Chapter - 8
- DISCUSSION AND SUMMARY OF CANCER BIOMARKER FINDINGS
- 8.1. Background
- 8.2. Studying Cancer Biomarkers
- 8.3. Important Cancer Biomarkers
- 8.4. Cancers
- Lung Cancer
- Colorectal Cancer
- Prostate Cancer
- Breast Cancer
- Other Cancers
- 8.5. Markets
References
Company Index with Web Addresses
TABLES
- Table 1.1. Current and Potential Applications of Breast Cancer Biomarkers
- Table 1.2. Examples of the Functional Classification of Cancer Biomarkers
- Table 3.1. Lung Cancer Biomarkers
- Table 3.2. Colorectal Cancer Biomarkers
- Table 3.3. Prostate Cancer Biomarkers
- Table 3.4. Breast Cancer Biomarkers
- Table 3.5. Ovarian Cancer Biomarkers
- Table 3.6. Pancreatic Cancer Biomarkers
- Table 3.7. Liver Cancer Biomarkers
- Table 3.8. Other Cancer Biomarkers
- Table 3.9. Current and Potential Applications of Cancer Biomarkers
- Table 4.1. Organizations Involved in the Development and/or
Commercialization of Cancer Biomarkers
- Table 4.2. Prominent Organizations Involved in the Study and/or
Commercialization of Cancer Biomarkers
FIGURES
- Figure 1.1. Breast Cancer Biomarker Profile
- Figure 3.1. Classification of Cancer Biomarkers by Type
- Figure 3.2. Classification of Cancer Biomarkers by Cancer
- Figure 4.1. Biomarker Patent Filings According to Indication
- Figure 4.2. Biomarker Patent Filings According to Cancer Type
- Figure 6.1. Respondents by Sector
- Figure 6.2. Respondents by Position
- Figure 6.3. Respondents by Stage of Work
- Figure 6.4. Respondents by Area of Work
- Figure 6.5. Types of Cancer Biomarkers Studied
- Figure 6.6. Views on Collaborative Biomarker Development
- Figure 6.7. Experience with Novel Cancer Biomarkers
- Figure 6.8. Means by Which Cancer Biomarker Discovery or Development Is
Done
- Figure 6.9. Technologies Used to Discover Cancer Biomarkers
- Figure 6.10. Focus of Biomarker Work
- Figure 6.11. Types of Organizations Involved with Cancer
Diagnostics/Biomarker Development
- Figure 6.12. Reasons for Organizations' Lack of Involvement with Cancer
Biomarkers
- Figure 6.13. 2008 Budget for Cancer Biomarkers
- Figure 6.14. Areas of Cancer Biomarker Development
