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Cancer Biomarkers: Adoption Is Driving Growth

Published by: CHI Insight Pharma Reports

Published: Jul. 1, 2008 - 126 Pages


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 Hernán, 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

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.



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