癌症治療市場相關報告輯

Abstract

• Biomarker Technology Platforms for Cancer Diagnoses and Therapies.
• Cancer Cell Therapy Markets.
• Cancer Diagnostic Testing World Markets.
• Cancer Therapeutics Markets.
• Companion Diagnostics in Personalized Medicine and Cancer Therapy.
• Cytology and HPV Testing World Markets.

Biomarker Technology Platforms for Cancer Diagnoses and Therapies

Until superior therapeutic treatments are developed to prevent, treat and cure cancer, the best means of reducing mortality and morbidity in a disease this complex is early detection and diagnosis. In the major solid cancer types such as lung, breast, colon and prostate, long-term survival rates drop precipitously once metastatis has occurred. The case is clear for development of biomarkers for early detection and screening tests for diseases such as breast, colon, ovarian and lung cancer. In addition, diagnostic measurement of cancer disease progression is essential to successful disease management. For these reasons, development of new and effective biomarkers for cancer detection and diagnosis is central to the cancer problem. The use of nucleic acid biomarker diagnostics have begun to answer these questions. Protein biomarkers are also useful. The purpose of this TriMark Publications report is to describe the specific segment of the cancer diagnostics market which develops new biomarker technology platforms for diagnosing and treating cancer. Biomarkers are useful in following the course of cancer and evaluating which therapeutic regimes are most effective for a particular type of cancer, as well as determining long-term susceptibility to cancer or recurrence. This study particularly examines those clinical measurement devices, and their reagents and supplies, which are meant to be used in hospitals, clinics, commercial laboratories and doctor' s offices to diagnose and monitor cancer. The examination also provides an in-depth discussion of the application of biomarkers in developing novel targeted cancer therapeutics, their predication response and efficacy, as well as their use in diagnosis of cancer.

• Which companies are utilizing cutting-edge technologies to develop, validate, and implement cancer biomarkers for clinical use?
• What impediments still exist to incorporating promising research into clinical practice?
• Which cancer biomarkers show the most promise for approval?
• What are the economic challenges to approval?
• How can regulatory oversight drive approval and adoption of new technologies?
• Which alliances show the greatest synergy in bringing valid biomarkers to market?
• Which shared technologies are driving the most encouraging development?

Cancer Cell Therapy Markets

Traditionally, treatment of disease is carried out by small molecules that target specific cell types. In diseases such as cancer, the treatment is meant to kill cancer cells, leading to the removal or at least the inhibition of cancer cell proliferation. In other circumstances, a variety of therapeutic molecules have been utilized lead the disease cells to perform a specific function that they normally do not. These include small molecules, peptides, proteins, antibodies, anti-sense RNAs and ribozymes. In the case of cell therapy, as the name indicates, treatment is carried out with cells instead of small molecules. In cell therapy, cells are given to the patient as the therapeutic delivery system for a specific disease to achieve therapeutic benefit. The purpose of this TriMark Publications report is to describe the market segment of the cell therapy market aimed specifically at cancer therapy. Moreover, a review of cellular agents that are related to the chemical and cellular constituents of blood or other tissues for cancer care of the patient is addressed in this study. The two most important areas where such agents are used are in the hospital and the clinic. Emphasis is on those companies and products that are actively developing and marketing cell therapeutic agents and supplies for treating cancer patients.

Cancer Diagnostic Testing World Markets

Cancer testing is one of the most important growth opportunities for the next three to five years in the diagnostics segment. The National Cancer Institute estimates that about ten million Americans have or have had some form of cancer. Overall costs of the disease are $126 billion annually. Pharmaceutical companies are developing more than 300 new medicines for cancer, some of which are in development for more than one type of the disease, for a total of more than 500 ongoing R&D projects. The goal of this TriMark Publications report is to review the market for tumor marker testing equipment and supplies using screening reagents and instruments for analysis of individual components in blood, serum or plasma. It defines the dollar volume of sales, both worldwide and in the U.S., and analyzes the factors that influence the size and the growth of the market segments. Also examined are the subsections of each market segment, including: the physician office labs, hospital labs and commercial laboratories. Additionally, the numbers of institutions using this type of testing and the factors that influence purchases are discussed. The report surveys almost all of the companies known to be marketing, manufacturing or developing instruments and reagents for the clinical point-of-care market in the U.S. Each company is discussed in depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company' s market position.

• What are the near-term business opportunities in the cancer diagnostics market?
• What are the current and forecasted sizes of the cancer diagnostics market?
• What are the business models currently used by companies in cancer diagnostics?
• How will manufacturers, researchers, physicians, patients and payers influence the cancer diagnostics market?
• What are the drivers and bottlenecks influencing the cancer diagnostics market?
• What are the technologies used in the cancer diagnostics sector?
• Who holds the proprietary rights to cancer diagnostics market technology?
• What are current applications of this technology?
• What regulatory processes must cancer diagnostics undergo in the United States, Japan and Europe?
• How will new cancer diagnostics change treatment and payment paradigms?
• How will cancer diagnostic testing reduce healthcare expenditures?

Cancer Therapeutics Markets

Cancer is the second leading cause of death by disease in the United States, exceeded only by heart disease. Traditionally cancer has been treated with surgery, chemotherapy, hormones and radiation therapy, alone or in combination. Emerging technologies include photodynamic therapy, gene therapy, biological therapy (immunotherapy) and angiogenesis inhibitors. Pharmaceutical and biotechnology companies are investing billions of dollars to search out and develop weapons for the arsenal in the war against cancer. This TriMark Publications report provides an overview of the global market for cancer therapeutics. The examination focuses on the efforts of biotechnology companies and pharmaceutical firms to incorporate new technologies for developing anti-cancer drugs into their corporate strategies. This study examines cancer therapeutic products now on the market, as well as those currently under development that might be commercialized in the near future. Additionally, the report profiles a number of firms that are actively involved in marketing and developing of products to be used in the treatment of cancer-both large multinational corporations. The analysis also provides an overview of the disease and data on cancers by site or type. It provides incidence and mortality data for different types of the disease. In addition, the report provides a summary of each of the therapies that are being used to treat cancer.

Companion Diagnostics in Personalized Medicine and Cancer Therapy

A near-term market opportunity for cancer companion diagnostic tests exists in drug selection for cancer therapy. Co-development of molecular diagnostics and targeted therapeutics has already been proven to be a successful strategy in the development of novel anti-cancer drugs. Adoption of biomarker development in clinical research provides great opportunities to identify patient subpopulations with differential drug responses and to uncover the underlying mechanisms. These data could help to explain if clinical trials of new drugs are adequate, and offer the possibility of creating a clear prescription path based on predictive biomarkers. The purpose of this TriMark Publications report is to describe the specific segment of the diagnostics market that develops new technology platforms for evaluating the metabolism of therapeutic agents, or for evaluating which therapeutic regimes are most effective for a particular type of disease. The term companion diagnostic means that the particular diagnostic test under evaluation is specifically linked to a known therapeutic drug. This linkage could be important in the therapeutic application and clinical outcome of a drug (personalized medicine), or an important component of the drug development process. This report focuses on the former linkage, i.e., the use of companion diagnostic tests in personalized medicine.

Cytology and HPV Testing World Markets

Cancer is a group of diseases characterized by uncontrolled growth and spread of abnormal cells. If the spread is not controlled, it can result in death. Cancer is caused by both external (chemicals, radiation and viruses) and internal (hormones, immune conditions and inherited mutations) factors. Causal factors may act together or in sequence to initiate or promote carcinogenesis. Ten or more years often pass between exposures or mutations and detectable cancer. Cancer is treated by surgery, radiation, chemotherapy, hormones and immunotherapy. The purpose of this TriMark Publications report is to describe the specific segment of the diagnostic market aimed at analysis cytology (the examination of cells using optical microscopy methods) specimens derived from the human female reproductive tract. It examines the measurement devices and their reagents and supplies used in hospitals, clinics, commercial laboratories and research institutions to detect cells and proteins for the diagnosis and monitoring of disease. The study describes the analytical methods used to separate, isolate, characterize and quantitate cells, DNA and proteins complex in biological systems related to the diagnosis and treatment of disease of the female reproductive tract, such as the cervix and vagina. The emphasis is on those companies and products that are actively developing and marketing laboratory instrumentation, reagents and supplies for performing cytology and related molecular diagnostic tests, such as human papillomavirus (HPV) and other inflammatory and sexually-transmitted diseases.

Table of Contents

Biomarker Technology Platforms for Cancer Diagnoses and Therapies

1. Overview

• 1.1 Statement of Report
• 1.2 About This Report
• 1.3 Scope of the Report
• 1.4 Objectives
• 1.5 Methodology
• 1.6 Executive Summary

2. Introduction to Cancer Biology and the Diagnostic Industry

• 2.1 Biomarkers
  • 2.1.1 The Biomarker Market Drivers
    • 2.1.1.1 The Sector
    • 2.1.1.2 The Critical Path Opportunities
    • 2.1.1.3 The Capital Markets
• 2.2 Cancer Detection and Treatment with Biomarkers
  • 2.2.1 The Problem
• 2.3 Cancer: The Disease
  • 2.3.1 Metastasis
  • 2.3.2 Demographics and Statistics of Cancer
• 2.4 Drivers of the Biotech and Diagnostics Industry
  • 2.4.1 Venture Funding of Biotech Sector
  • 2.4.2 Technological Innovation
  • 2.4.3 Government Funding
  • 2.4.4 Pharmaceutical Development and Bioanalytical Services
  • 2.4.5 The War on Cancer
  • 2.4.6 Current Oncology Drug Development
• 2.5 Outlook for Tumor Markers
• 2.6 Focus on Proteomics
  • 2.6.1 Scientific Background
  • 2.6.2 The Relationship between Proteins and Diseases
  • 2.6.3 Limitations of Existing Diagnostic Approaches
  • 2.6.4 Addressing the Heterogeneity of Cancer
  • 2.6.5 Validation of Biomarkers Through Proper Study Design
  • 2.6.6 Exploiting the Power of Mass Spectrometry to Improve Assay Specificity
  • 2.6.7 Creating and Maintaining a Multi-Disease Product Pipeline
  • 2.6.8 Partnerships for Developing Proteomic Biomarkers
• 2.7 Epigenic Markers for Cancer
• 2.8 Molecular Diagnostics Testing for Cancer
• 2.9 Market Opportunities
  • 2.9.1 Industry Overview
  • 2.9.2 Medical Indications and Medically Useful Information
  • 2.9.3 Research Market
  • 2.9.4 Competition
  • 2.9.5 Diagnostic Services
  • 2.9.6 Clinical Image Analysis
  • 2.9.7 Research Imaging Market
  • 2.9.8 Genomic Disease Management and In Vitro Diagnostic Multivariate Index Assays (IVDMIA)
  • 2.9.9 Predictive Expression Profiles

3. Market Analysis of the Cancer Biomarkers Space

• 3.1 Scope of this Chapter
• 3.2 The Overall Market Opportunity and Segmentation of the Total Cancer Biomarkers Marketplace
• 3.3 Potential Cancer Biomarker Commercial Applications
  • 3.3.1 Market for Routine Tumor Markers
  • 3.3.2 Market for Genomic Cancer Biomarkers
  • 3.3.3 Market Size and Forecasts for Companion Diagnostic Tests for Cancer Therapeutics
  • 3.3.4 SWOT Analysis of the Major Cancer Biomarker Market Segments
    • 3.3.4.1 Traditional Serum Cancer Biomarkers
    • 3.3.4.2 Proteomic Cancer Biomarkers
    • 3.3.4.3 Companion Diagnostic Cancer Biomarkers
• 3.4 Cancer Biomarker Market Estimates by Tissue of Origin
  • 3.4.1 Colorectal
  • 3.4.2 Prostate
  • 3.4.3 Lung
  • 3.4.4 Breast
  • 3.4.5 Ovarian
• 3.5 Challenges Facing Cancer Biomarker Developers
• 3.6 Unmet Product Needs in the Cancer Biomarkers Space
• 3.7 Competitive Landscape of the Cancer Biomarkers Marketplace

4. Major Clinical Applications of Cancer Biomarkers

• 4.1 Launched Products and Pipeline
• 4.2 CYP2C9 Pharmacogenetics and Role in Personalized Medicine
• 4.3 Personalized Breast Cancer Therapy
• 4.4 Personalized NSCLC Therapy
• 4.5 AmpliChipR-based Personalized Medicine

5. Breast Cancer

• 5.1 Overview of Breast Cancer Disease
• 5.2 BRCA1 and BRCA2 Genes
  • 5.2.1 Types of Genetic Testing Available for Breast Cancer
    • 5.2.1.1 DNA Sequencing
    • 5.2.1.2 Multi-Site Analysis
    • 5.2.1.3 Single-Site Analysis
  • 5.2.2 BRCA Test Results
    • 5.2.2.1 What Does a Positive BRCA1 or BRCA2 Test Result Mean?
    • 5.2.2.2 What Does a Negative BRCA1 or BRCA2 Test Result Mean?
    • 5.2.2.3 What Does an Ambiguous BRCA1 or BRCA2 Test Result Mean?
    • 5.2.2.4 What are the Options for a Person Who Tests Positive?
  • 5.2.3 What are Some of the Benefits of Genetic Testing for Breast Cancer Risk?
  • 5.2.4 What Are Some of the Risks of Genetic Testing for Breast and Ovarian Cancer Risk?
• 5.3 Estrogen Receptors and Breast Cancer
  • 5.3.1 Expression and Prognostic Value of ER
  • 5.3.2 Progesterone Receptors and Breast Cancer
  • 5.3.3 ER and PR Predict Response to Endocrine Therapy
• 5.4 HER2 Gene and Protein
  • 5.4.1 HER2 Tests
    • 5.4.1.1 IHC Test
    • 5.4.1.2 FISH Test
    • 5.4.1.3 Questions About Testing
    • 5.4.1.4 HER2 Tumor Status
• 5.5 HerceptinR Treatment
• 5.6 Tumor Assays for Adjuvant Chemotherapy
• 5.7 Use of Genomics to Understand Breast Cancer
• 5.8 Genetic Analysis Solution
  • 5.8.1 The Use of Proteomics in Breast Cancer
  • 5.8.2 Tissue Microarrays
  • 5.8.3 Protein Microarrays
• 5.9 Gene Expression Microarrays and Recurrence Prediction
  • 5.9.1 Oncotype DX
  • 5.9.2 Oncotype DX for Breast Cancer
  • 5.9.3 Risk Assessment
  • 5.9.4 Use of Chemotherapy
  • 5.9.5 Utility of the Oncotype Test
  • 5.9.6 Clinical Development and Validation of Oncotype DX
    • 5.9.6.1 Clinical Development of the Oncotype DX Recurrence Score
    • 5.9.6.2 Clinical Validation of Prediction of Recurrence and Survival in N-, ER+ Patients Treated with Tamoxifen
    • 5.9.6.3 Oncotype DX Predicts the Likelihood of Recurrence
    • 5.9.6.4 Oncotype DX Predicts the Likelihood of Breast Cancer Survival in a Community Hospital Setting
    • 5.9.6.5 Oncotype DX Predicts both Prognosis and Tamoxifen Benefit
• 5.10 Economic Benefits of Oncotype DX
• 5.11 Increased Clinical Utility of Oncotype DX
• 5.12 Second Generation Oncotype DX
  • 5.12.1 Recurrence and Benefit Test for N-, ER- Breast Cancer
  • 5.12.2 Taxane Benefit Test
• 5.13 MammaPrint
• 5.14 Rotterdam Signature 76-Panel
• 5.15 Summary of Microarray Technologies
• 5.16 Mass Spectrometry-based Approaches
  • 5.16.1 Gel-based Approaches
  • 5.16.2 Non-Gel-based Approaches
    • 5.16.2.1 SELDI-TOF MS
    • 5.16.2.2 SELDI and Prognosis
    • 5.16.2.3 SELDI and Treatment Monitoring
  • 5.16.3 Limitations of Mass Spectroscopy
• 5.17 Outlook
• 5.18 Future Perspectives
• 5.19 Breast Cancer Program (NMP66)
• 5.20 Myriad Genetics
• 5.21 Veridex GeneSearch"! Breast Lymph Node
• 5.22 OncoVue Cancer Risk Test
• 5.23 Research Biomarkers for Breast Cancer
• 5.24 Protein Biomarkers for Breast Cancer Prevention
• 5.25 Biomarker Prognosis of Breast Cancer Treated with Doxorubicin

6. Ovarian Cancer

• 6.1 Serum Markers
• 6.2 Biomarkers
  • 6.2.1 Strategies for Discovering New Cancer Biomarkers
• 6.3 Serum Protein Biomarkers for Ovarian Cancer
  • 6.3.1 Clinical Proteomics
• 6.4 Ovarian Cancer Triage Testing
  • 6.4.1 Vermillion' s Ovarian Cancer Triage Diagnostic Program

7. Prostate Cancer

• 7.1 Overview
  • 7.1.1 Prevalence
  • 7.1.2 Prostate Cancer Progression and Recurrence Test
  • 7.1.3 Current Market Size
• 7.2 Genes Involved in Prostate Cancer
• 7.3 Androgen Independence
• 7.4 Gene Markers in Prostate Cancer
• 7.5 Microarray Gene Identification of Prostate Biomarkers
• 7.6 GEArray DNA Microarrays
• 7.7 Vermillion' s Cancer Diagnostic Program
• 7.8 Hepsin
• 7.9 Matritech' s Prostate Cancer Program (NMP48)
• 7.10 Gen-Probe' s PCA3 Assay
• 7.11 Early Prostate Cancer Antigen-2 (EPCA-2)
• 7.12 Mass Spectrometry
• 7.13 Summary

8. Bladder Cancer

• 8.1 Overview
  • 8.1.1 Prevalence
  • 8.1.2 Progression and Recurrence
  • 8.1.3 Bladder Cancer Risk Factors
  • 8.1.4 Bladder Cancer Symptoms
• 8.2 Bladder Cancer Tests
• 8.3 UroVysion Bladder Cancer Kit
• 8.4 IkoniscopeR Robotic Digital Microscopy Platform
  • 8.4.1 The CellOptics Platform
  • 8.4.2 Cell Staining and Genetic Characterization
  • 8.4.3 Ikoniscope/IkoniLAN Automated Microscopy
• 8.5 Nuclear Matrix Protein Markers
• 8.6 ImmunoCyt"!/uCyt+"!
• 8.7 Cangen Microsatellite DNA
• 8.8 Bladder Cancer Market
  • 8.8.1 Urologist Market
  • 8.8.2 Clinical Lab Market
  • 8.8.3 Primary Care Market
  • 8.8.4 Private and Public Sector Markets
  • 8.8.5 POC Market
  • 8.8.6 Market Distribution
  • 8.8.7 Reimbursement

9. Colorectal Cancer

• 9.1 Overview
  • 9.1.1 Prevalence
  • 9.1.2 Progression and Recurrence
• 9.2 Screening for CRC
  • 9.2.1 Stool-based DNA (sDNA) Screening
• 9.3 Almac Diagnostics DSA
• 9.4 Colon Cancer Program (NMP35)
• 9.5 Myriad Genetics Colaris AP Risk Assessment
• 9.6 Summary

10. Genetic Diagnostics Set to Revolutionize Cancer Diagnostic Testing

• 10.1 Overview
  • 10.1.1 Clinicians Need for More Information with Regard to Therapeutic Treatment Drives Demand for Pharmacogenomic Testing
  • 10.1.2 Predictive Medicine Shows Potential for Genetic Diagnostics
  • 10.1.3 Different Rates of Growth
  • 10.1.4 Effective Competitive Strategies
  • 10.1.5 Improvements in Marketing Effectiveness
  • 10.1.6 Emerging Technologies Imply Start of a New Era and Offer Tremendous Growth Opportunities
  • 10.1.7 Increased Market Share
  • 10.1.8 Technologies Used in Genetic Testing
• 10.2 AMAS Test
• 10.3 Corixa Antibodies as Tumor Markers
• 10.4 Cytovision
• 10.5 Ariol System
• 10.6 Mammaglobin Protein Expression
• 10.7 L523S or KOC RNA Binding Protein
• 10.8 CA1-18 from EDP Biotech

11. Leukemia Biomarkers

• 11.1 Overview
  • 11.1.1 Prevalence
    • 11.1.1.1 Progression and Recurrence

12. Lung Cancer

13. Enabling Technologies for Oncology Biomarker Discovery

• 13.1 Automated Cellular Imaging System (ACISR)
  • 13.1.1 ACIS for HER2 Protein Expression Testing
  • 13.1.2 ACIS for ER Protein Expression Testing
  • 13.1.3 ACIS for PR Protein Expression Testing
  • 13.1.4 ACIS for Cell Proliferation Expression
  • 13.1.5 ACIS for Protein Expression
  • 13.1.6 ACIS for Protein Micrometastases in Bone Marrow
  • 13.1.7 ACIS for Protein Micrometastases in Tissue
  • 13.1.8 ACIS for Tissue Microarray
  • 13.1.9 ACIS for DNA Ploidy
  • 13.1.10 ACIS for HPV
• 13.2 DNA Methylation
  • 13.2.1 Differential Methylation Hybridization (DMH)
  • 13.2.2 MIRA-Assisted Microarrays for DNA Methylation Analysis and Cancer Diagnosis
• 13.3 Proteomics
  • 13.3.1 Proteomics Technologies for Cancer Marker Discovery
  • 13.3.2 Validation of Candidate Biomarkers
  • 13.3.3 Requirements Bringing a New Marker into the Market
  • 13.3.4 Value Chain in the Development of New Cancer Biomarkers
• 13.4 Secreted Proteins as Cancer Biomarkers
  • 13.4.1 Markers of Known Tissue Origin
  • 13.4.2 Secreted Proteins as Low Abundance Markers
  • 13.4.3 Secreted Proteins in Tissue and Blood
• 13.5 Noncodings RNA as Potential Tumor Markers
  • 13.5.1 miRNA Meets Microarray
  • 13.5.2 Mimetics and Inhibitors
  • 13.5.3 Clinical Patterns in Cancer
• 13.6 Architect TIMP-1 (Tissue Inhibitor of Metalloproteinases-1) Immunoassay for Colorectal Cancer Detection
• 13.7 Companies Developing Automated Microscope-based Analysis Systems
• 13.8 Companies Developing Research Products for Tumor Cell Isolation
• 13.9 Companies Supplying Fluorescently Labeled Antibodies to Characterize Tumor Cells
• 13.10 PerkinElmer High Throughput Platforms: AlphaScreenR, AequoScreenR, DELFIAR and LANCER Technologies

14. Biomarker Tests Co-developed with Cancer Therapeutics as Companion Diagnostics

• 14.1 Sector Overview
• 14.2 Companion Diagnostics
• 14.3 EGFR for Colorectal Cancer and Camptostar (Irinotecan)
• 14.4 EGFR Express and Erbitux (Cetuximab)
• 14.5 HER2 and Heceptin
• 14.6 Myriad' s TheraGuide 5-FU
• 14.7 TheraScreen: EGFR29
• 14.8 Drivers and Barriers to Companion Diagnostics
• 14.9 Partnerships with Pharma Companies to Identify Therapeutic Targets
• 14.10 Future Developments for Companion Diagnostics

15. Companion Diagnostics and Personalized Medicine: Biology, Approaches, Pipeline and Regulatory Trends

• 15.1 Scope of this Chapter
• 15.2 Introduction to Companion Diagnostics and Personalized Medicine
• 15.3 The Compelling Case for Personalized Medicine
• 15.4 Drug Metabolism and Implications for Companion Diagnostics and Personalized Medicine
• 15.5 Examples of Personalized Medicine
• 15.6 Personalized Medicine and Companion Diagnostics Testing Product Pipeline
• 15.7 The Personalized Medicine Coalition
• 15.8 Regulatory Trends and Guidelines in the Personalized Medicine Space
  • 15.8.1 The Changing Regulatory Landscape for Personalized Medicine
• 15.9 Patenting Personalized Medicine
• 15.10 The Leading Edge of Personalized Medicine: Specific Examples of Clinical Situations Where Personalized Medicine and Companion Diagnostics is Appropriate and Being Deployed
  • 15.10.1 EGFR Assay
  • 15.10.2 Individualized Warfarin Therapy
  • 15.10.3 UGT1A1 Molecular Assay for Camptosar
  • 15.10.4 Response to Gleevec in Gastrointestinal Stromal Tumors
  • 15.10.5 LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases
  • 15.10.6 Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Push into Companion Diagnostics
• 15.11 Companion Diagnostics and Personalized Medicine: Qualitative and Quantitative Market Analysis
  • 15.11.1 Market Analysis of Molecular Diagnostics and Companion Diagnostics and Personalized Medicine
  • 15.11.2 Diagnostics vs. Pharmaceuticals
  • 15.11.3 Molecular Diagnostic Market
  • 15.11.4 Molecular Diagnostics Technology Platforms and their Impact on Personalized Medicine
• 15.12 Snapshot of Companion Diagnostics Industry Structure
• 15.13 The Case for Theranostics (Therapeutic/Companion Diagnostic)
• 15.14 Personalized Medicine Market Analysis-Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters
• 15.15 How the Market Segregates Today
• 15.16 Timeline for Impact of Various Segments in Personalized Medicine
• 15.17 Challenges for Personalized Therapeutics and Companion Diagnostics Development
• 15.18 Macro Trends in Personalized Medicine
• 15.19 Personalized Medicine and Companion Diagnostics: Industry SWOT Analysis

16. Cancer Biomarker Testing Sector and Company Analysis

• 16.1 Abbott Molecular, Inc. (Formerly Vysis, Inc.)
• 16.2 Agendia
• 16.3 AMDL, Inc.
• 16.4 Aureon Laboratories, Inc.
• 16.5 BioCurex
• 16.6 Biomarker Technologies
• 16.7 Biomedical Diagnostics LLC
• 16.8 Biomerica
• 16.9 Biomira, Inc.
• 16.10 Biomoda
• 16.11 Byk Gulden
• 16.12 Clarient
• 16.13 Correlogic Systems, Inc.
• 16.14 Cytogen Corporation
• 16.15 Dako (Formerly Dako Cytomation)
• 16.16 diaDexus
• 16.17 Diagnocure, Inc. (ImmunoCyt"!/uCyt+"!)
• 16.18 DxS Ltd.
• 16.19 Epigenomics
• 16.20 Exagen Diagnostics, Inc.
• 16.21 Genesis Genomics
• 16.22 Health Discovery Corporation
• 16.23 Immunicon
• 16.24 Ipsogen
• 16.25 InterGenetics
• 16.26 Miraculins, Inc.
• 16.27 Molecular Devices Inc. (Formerly Arcturus Bioscience, Inc.)
• 16.28 Myriad Genetics, Inc.
• 16.29 Orion Genomics
• 16.30 Power3 Medical Products
• 16.31 Qiagen N.V.
• 16.32 SuperArray Bioscience Corporation
• 16.33 Upstream Biosciences, Inc.
• 16.34 Ventana Medical Systems, Inc.
• 16.35 Veridex
• 16.36 Vermillion

17. Business Trends in the Industry

• 17.1 Industry Consolidation
• 17.2 Breadth of Product Offering and Pricing
• 17.3 Government Regulation of Medical Devices
  • 17.3.1 FDA Guidance on Drug Test Co-development
• 17.4 Strategic Business and Marketing Considerations
• 17.5 Commercial Opportunities in Cancer Markers
  • 17.5.1 Licensing and Intellectual Property (IP) Constraints and how they will Impact New Product Development
• 17.6 Moderators of Growth
  • 17.6.1 Roadblocks to Integrating Cancer Biomarkers into Clinical Practice
• 17.7 Biotechnology Industry Trends
• 17.8 Pharmaceutical Industry Trends
• 17.9 Acquisition, License Agreement, Partnerships
• 17.10 Legal Developments
• 17.11 Sales and Marketing Strategies for Tumor Marker Tests
  • 17.11.1 North American Market
  • 17.11.2 International Markets
    • 17.11.2.1 Europe
    • 17.11.2.2 Central and South America
    • 17.11.2.3 Asia/Pacific
• 17.12 Product Commercialization
• 17.13 Reimbursement
• 17.14 Self Referral Rules
• 17.15 Health Insurance Portability and Accountability Act
• 17.16 Clinical Laboratory Improvement Amendments (CLIA)
• 17.17 In-Vitro Diagnostic Directive (IVDD) and Medical Device Regulations
• 17.18 FDA' s Quality System Regulation (QSR)
• 17.19 FDA' s OIVD on IVDMIAs
• 17.20 FDA' s Qualification of Cancer Biomarkers
  • 17.20.1 Regulatory Perspectives of Biomarker Validation
• 17.21 Genetic Tests and Medical Records
  • 17.21.1 Laws against Genetic Discrimination
• 17.22 Medicare Reimbursement
  • 17.22.1 Medicare Part B Spending Trends
• 17.23 Global Drivers of Clinical Laboratory Testing
• 17.24 Global Outlook for Cancer Biomarkers
  • 17.24.1 Which Companies are Utilizing Cutting-Edge Technologies to Develop, Validate and Implement Cancer Biomarkers for Clinical Use?
  • 17.24.2 What Impediments Still Exist to Incorporating Promising Research into Clinical Practice?
  • 17.24.3 Which Biomarkers Show the Most Promise for Approval?
  • 17.24.4 How can Regulatory Oversight Drive Approval and Adoption of New Technologies?
  • 17.24.5 Which Alliances Show the Greatest Synergy in Bringing Valid Biomarkers to Market?
  • 17.24.6 Which Shared Technologies are Driving the Most Encouraging Development?
  • 17.24.7 How Strategic Alliances and Interdisciplinary Involvement Drive Development and Implementation of Emerging Biomarker Technologies
• 17.25 Oncology Biomarker Qualification Initiative
• 17.26 FDA Critical Path
• 17.27 FDA Criteria for a Valid Biomarker

18. Companies Entering the Cancer Diagnostics Market with Novel Technology Platforms

• 18.1 Abbott Diagnostics
• 18.2 Affymetrix, Inc.
• 18.3 Agendia BV
• 18.4 Agensys, Inc.
• 18.5 Almac Group
• 18.6 AMDL, Inc.
• 18.7 Aureon Laboratories, Inc.
• 18.8 Bayer Diagnostics Corporation
• 18.9 Beckman Coulter, Inc.
• 18.10 Biocode S.A.
• 18.11 BioCurex, Inc.
• 18.12 Biomarker Technologies LLC
• 18.13 Biomedical Diagnostics LLC
• 18.14 Biomerica
• 18.15 bioMerieux
• 18.16 Biomira, Inc.
• 18.17 Biomoda, Inc.
• 18.18 Bruker Daltonics, Inc.
• 18.19 Byk Gulden
• 18.20 Cangen Biotechnologies, Inc.
• 18.21 Caprion Proteomics
• 18.22 Celera Diagnostics
• 18.23 Cepheid
• 18.24 Clarient, Inc.
• 18.25 Claros Diagnostics, Inc.
• 18.26 Clinical Data, Inc.: PGxHealth and Cogenics
• 18.27 Correlogic Systems, Inc.
• 18.28 CytoCore (Formerly Molecular Diagnostics, Inc.)
• 18.29 Cytogen Corporation
• 18.30 Dako (Formerly Dako Cytomation)
• 18.31 diaDexus LLC
• 18.32 DiagnoCure, Inc.
• 18.33 Diagnostic Products Corporation
• 18.34 Diagnostic Systems Laboratories, Inc.
• 18.35 Digene Corporation
• 18.36 DRG International, Inc.
• 18.37 DxS Ltd.
• 18.38 EDP Biotech Corporation
• 18.39 Eisai Co., Ltd.
• 18.40 Epigenomics
• 18.41 Exact Sciences Corporation
• 18.42 Exagen Diagnostics, Inc.
• 18.43 Gene Logic, Inc.
• 18.44 Genesis Genomics, Inc.
• 18.45 Genomic Health, Inc.
• 18.46 Gen-Probe, Inc.
• 18.47 Health Discovery Corporation
• 18.48 Hologic, Inc. (Formerly Cytyc Corporation)
• 18.49 Ikonisys, Inc.
• 18.50 Immunicon Corporation
• 18.51 Immunomedics, Inc.
• 18.52 Incyte Pharmaceuticals, Inc.
• 18.53 InterGeneticsR
• 18.54 Ipsogen
• 18.55 LabCorpR
• 18.56 Matritech, Inc.
• 18.57 Miraculins, Inc.
• 18.58 Mitsubishi Kagaku Medical
• 18.59 Molecular Devices (Formerly Arcturus Biosciences, Inc.)
• 18.60 Myriad Genetics, Inc.
• 18.61 NimbleGen Systems, Inc.
• 18.62 Northwest Biotherapeutics, Inc.
• 18.63 Oncotech, Inc.
• 18.64 Orion Genomics
• 18.65 Oxford Genome Sciences
• 18.66 Panacea Pharmaceuticals, Inc.
• 18.67 Phenomenone Discoveries
• 18.68 Polymedco, Inc.
• 18.69 Power3 Medical Products
• 18.70 Proteome Systems Ltd.
• 18.71 Qiagen N.V.
• 18.72 Sanko Junyaku Co., Ltd.
• 18.73 SensiGen LLC
• 18.74 SuperArray Bioscience Corporation
• 18.75 Third Wave Technologies, Inc.
• 18.76 Tosoh Medics, Inc.
• 18.77 TriPath Imaging, Inc.
• 18.78 Upstream Biosciences, Inc.
• 18.79 Ventana Medical Systems, Inc.
• 18.80 Veridex LLC
• 18.81 Vermillion, Inc. (Formerly Ciphergen)

Appendix 1: Cancer Biomarker Centers of Research

Appendix 2: Myriad Patents on Genes BRAC1 and BRAC2

Appendix 3: Common Laboratory Tests for Cancer

Appendix 4: Questions/Issues in the Cancer Biomarkers Space

Appendix 5: Cancer Markers Currently in Common Clinical Use

Appendix 6: International Federation of Gynecology and Obstetrics (FIGO) Staging System for Primary Carcinoma of the Ovary

Appendix 7: FDA Guidance for Industry: Pharmacogenomic Data Submission

• A7.1 Introduction
• A7.2 Background
• A7.3 Submission Policy
  • A7.3.1 General Principles
  • A7.3.2 Specific Uses of Pharmacogenomic Data in Drug Development and Labeling
  • A7.3.3 Benefits of Voluntary Submissions to Sponsors and FDA
• A7.4 Submission of Pharmacogenomic Data
  • A7.4.1 Submission of Pharmacogenomic Data During the IND Phase
  • A7.4.2 Submission of Pharmacogenomic Data to a New NDA, BLA, or Supplement
  • A7.4.3 Submission to a Previously Approved NDA or BLA
  • A7.4.4 Compliance with 21 CFR Part 58
  • A7.4.5 Submission of Voluntary Genomic Data from Application-Independent Research
• A7.5 Format and Content of a VGDS
• A7.6 Process for Submitting Pharmacogenomic Data
• A7.7 Agency Review of VGDSs

Glossary

INDEX OF FIGURES

• Figure 3.1: Potential Market for Cancer Biomarkers, 2006
• Figure 3.2: Segmentation of the Cancer biomarkers Marketplace Based Upon Commercial Offerings-Products and Services
• Figure 3.3: Geographical Distribution of Cancer Tumor Diagnostic Testing
• Figure 3.4: Cancer Biomarkers Research Market, 2006-2011
• Figure 3.5: Breast Cancer Biomarker Market Potential, 2005
• Figure 3.6: Challenges in the Study or Utilization of Proteomic Cancer Biomarkers
• Figure 3.7: Challenges in the Study or Utilization of Companion Diagnostic Cancer Biomarkers
• Figure 3.8: Challenges in the Study or Utilization of Serum Cancer Markers
• Figure 3.9: Top Unmet Needs in Commercial Products in the Cancer Biomarkers Space
• Figure 5.1: Hybridization Process
• Figure 5.2: FISH Test Procedure
• Figure 5.3: Gene Expression Profiling
• Figure 15.1: Phase I and II Processes of Drug Metabolism
• Figure 15.2: Human Phase I Enzymes
• Figure 15.3: Human Phase II Enzymes
• Figure 15.4: Hepatic Distribution of Human CYP450
• Figure 15.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism
• Figure 15.6: Genetic Components Determine Drug Metabolism
• Figure 15.7: From Genetic Content to Personalized Medicine
• Figure 15.8: Remuneration for Diagnostics
• Figure 15.9: Breakout of the Molecular Diagnostics Marketplace
• Figure 15.10: Molecular Diagnostics Market Segmentation
• Figure 15.11: Molecular Diagnostics Market Segmentation by Technology
• Figure 15.12: Market Survey Respondent Demographics
• Figure 15.13: Breakout of the Respondent Pool by Affiliation
• Figure 15.14: Segmentation of the Personalized Medicine Market
• Figure 15.15: Personalized Medicine Market Drivers
• Figure 15.16: Challenges in the Personalized Medicine Space
• Figure 16.1: Epigenomics Product Development Pipeline
• Figure 17.1: Medicare Part B Spending on Clinical Laboratory Services, 1991-2005

INDEX OF TABLES

• Table 2.1: Cancer Biomarkers at the Nexus Point
• Table 2.2: Drug Development by Type of Cancer
• Table 2.3: Organ Specific Medicines in Development for Cancer, 2006
• Table 2.4: Estimates for the Leading Sites of New Cancer Cases and Deaths in the U.S. by Sex, 2007
• Table 2.5: Estimated Worldwide Number of New Cancer Cases and Deaths by Type of Cancer
• Table 2.6: Estimated Number of New Cancer Cases and Deaths by Region
• Table 2.7: Cancer Death Rates per 100,000 Population (and Rank) for All Cancer Sites by Country
• Table 2.8: Cancer Associated Genes
• Table 2.9: Carcinogens in the Workplace
• Table 2.10: Cancer Biomarker Markets
• Table 2.11: Private Funding Levels for the Biotechnology Segment, 1995-2006
• Table 2.12: Global Pharmaceutical Industry R&D Spending, 1995-2006
• Table 2.13: U.S. Government NIH Research Budget, 1995-2007
• Table 2.14: Tumor Markers Currently in Common Use
• Table 2.15: Herceptin Worldwide Sales, 1999-2007
• Table 2.16: Classes of Drugs Used to Treat Breast Cancer
• Table 2.17: Solutions to Biomarker Developments
• Table 2.18: Vermillion Collaborations
• Table 2.19: Uses of Molecular Diagnostics in Detection and Management of Cancer
• Table 2.20: U.S. Cancer Diagnostic Testing Market Size, 2005-2012
• Table 2.21: Market Opportunities for Cancer Biomarker Technology Platforms
• Table 3.1: Characteristics of Different Cancer Biomarker Types and Associated Market Opportunities
• Table 3.2: Segmentation of the Cancer Biomarker Market by Type/Lineage of Cancer Biomarkers and Market Size
• Table 3.3: In Vitro Cancer Marker Market Segments Worldwide, 2001 and 2007
• Table 3.4: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010
• Table 3.5: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010
• Table 3.6: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
• Table 3.7: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
• Table 3.8: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
• Table 3.9: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
• Table 3.10: Global Distribution of IVD Cancer Tumor Marker Diagnostic Testing, 2005
• Table 3.11: Estimated Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market
• Table 3.12: Major Presence in Cancer Tumor Marker Diagnostics Markets
• Table 3.13: Worldwide CEA Sales, 2001-2010
• Table 3.14: U.S. CEA Sales, 2001-2010
• Table 3.15: Cancer Genomic Biomarker Markets, 2002-2012
• Table 3.16: Cancer Biomarkers Research Market Forecast, 2006-2011
• Table 3.17: Cancer Biomarker Market Estimates by Tissue of Origin
• Table 3.18: Companies Developing New Proteomic Cancer Biomarker Technology Platforms
• Table 4.1: Cancer Biomarkers Used to Maximize Likelihood of Response
• Table 4.2: Biomarkers for Monitoring Therapeutic Effectiveness and Resistance
• Table 4.3: Biomarkers for Dose Response of Therapy
• Table 4.4: Decision on Optimal Duration of Therapy
• Table 5.1: U.S. Breast Cancer Rate Decline, 2002-2006
• Table 5.2: BRCA Development Model
• Table 5.3: BRCA Test Development and Commercialization
• Table 5.4: BRAC Analysis
• Table 5.5: Revenue for BRACAnalysisR Risk Assessment Test, 2002-2006
• Table 5.6: GEArray DNA Microarrays and RT2 Profiler PCR Arrays
• Table 5.7: Product Development Opportunities in Breast Cancer
• Table 5.8: Concentration of Some Abundant Proteins, New Cancer Biomarkers Identified by SELDI-TOF, and Classical Cancer Biomarkers in Serum
• Table 5.9: Questions Related to Diagnostic SELDI-TOF Technology
• Table 6.1: Worldwide CA-125 Sales, 2001-2010
• Table 6.2: U.S. CA-125 Sales, 2001-2010
• Table 6.3: Some Clinically Established Cancer Serum Markers Currently in Use for Cancer
• Table 6.4: Pathophysiology of Ovarian Cancer and Characterization of Ovarian Epithelial Tumors
• Table 7.1: Worldwide PSA Sales, 2000-2010
• Table 7.2: U.S. PSA Sales, 2000-2010
• Table 7.3: Molecular Gene Markers for Prostate Cancer
• Table 8.1: Worldwide Bladder Cancer Marker Sales, 2001-2010
• Table 8.2: U.S. Bladder Cancer Marker Sales, 2001-2010
• Table 8.3: Worldwide NMP22 Sales, 2001-2010
• Table 8.4: Summary of Matritech' s Product Development Programs
• Table 8.5: Opportunities for Bladder Cancer Biomarkers
• Table 9.1: TNM Staging for Colorectal Cancer
• Table 10.1: Genetic Diagnostics Market, 2004-2012
• Table 13.1: Genomic and Proteomic Technologies
• Table 14.1: Potential Benefits of Biomarkers as Companion Diagnostics
• Table 14.2: Utility of Biomarker as Companion Diagnostics to Drug Development
• Table 14.3: Device Submission Elements for the FDA
• Table 14.4: Summary of Biomarker Use in the Commercialization of Novel Oncology Pharmacotherapeutics
• Table 14.5: Pharmacoeconomic Challenges to the Implementation of Biomarkers as Companion Diagnostic Tests
• Table 15.1: Percentage of Non-Responders in Various Drug Classes
• Table 15.2: High Profile Drug Withdrawals from the Marketplace
• Table 15.3: Drug Metabolism Drives Drug Efficacy/Toxicity
• Table 15.4: Population Frequency of the Various Cytochromes
• Table 15.5: Selected List of Personalized Medicine Tests
• Table 15.6: Personalized Medicine and Companion Diagnostics Product Pipeline
• Table 15.7: Marketed Personalized Therapies, 2006
• Table 15.8: Various Molecular Diagnostics Technologies: Timeline for Impact
• Table 15.9: Various Molecular Diagnostics Technologies: Impact on Different Therapeutic Areas in Personalized Medicine
• Table 15.10: Various Molecular Diagnostics Technologies: Technical Challenges in the Deployment for Personalized Medicine
• Table 15.11: Classification of Diagnostics by Risk
• Table 15.12: Areas in Personalized Medicine-Timeline of Impact
• Table 15.13: Impact of Personalized Medicine on Various Therapeutic Areas
• Table 15.14: Hurdles in Personalized Medicine and Companion Diagnostics Development in Various Therapeutic Areas
• Table 15.15: Market Opportunities in Personalized Medicine
• Table 15.16: Challenges for Market Adoption of the Various Personalized Medicine Tests
• Table 15.17: Personalized Medicine Industry SWOT
• Table 16.2: Clarient Revenue, 2002-2006
• Table 16.3: Clarient Percentage of Revenue, 2004-2006
• Table 16.4: Opportunities for Biomarkers in Cancer Diagnosis and Treatment
• Table 16.5: Myriad Biomarker Revenue, 2002-2006
• Table 17.1: List and Discounted Prices for Abbott Tumor Marker Tests
• Table 17.2: Hospital Laboratory Share of Part B Medicare Spending, 1996-2005
• Table 17.3: Medicare Spending on Clinical Lab Services, 1991-2005
• Table 17.4: Medicare Part B Spending Per Medicare Enrollee, 1998-2005
• Table 18.1: Tumor Diagnosis Immunoassay
• Table 18.2: Tumor Diagnosis Radioimmunoassay
• Table 18.3: Summary of Matritech' s Product Development Programs
• Table A1: Team Descriptions
• Table A5: Cancer Markers in Use

Cancer Cell Therapy Markets

1. Overview

• 1.1 About this Report
• 1.2 Scope of the Report
• 1.3 Objectives
• 1.4 Methodology
• 1.5 Executive Summary

2. Biology of Cellular Therapy for Cancer: Different Cell Types Deployed and Disease Areas Addressed

• 2.1 Components of the Hematopoietic System that can be Leveraged for Cancer Cellular Therapy
  • 2.1.1 Dendritic Cells
  • 2.1.2 Cytotoxic T Lymphocytes (CTLs)
  • 2.1.3 Natural Killer (NK) Cells
  • 2.1.4 Tumor Infiltrating Lymphocytes (TILs) also known as Lymphokine-activated Killers (LAKs)
  • 2.1.5 Hematopoietic Stem Cells (HSCs)
• 2.2 Adult Stem Cell-based Therapies (ASCs)
• 2.3 Stem Cell-based Cellular Therapies
  • 2.3.1 Effectiveness in Transplants of Peripheral Versus Bone Marrow Stem Cells
  • 2.3.2 What do HSCs do and what Factors are Involved in these Activities?
  • 2.3.3 Self-renewal of HSCs
  • 2.3.4 Differentiation of HSCs into Components of the Blood and Immune System
  • 2.3.5 Migration of HSCs Into and Out of Marrow and Tissues
  • 2.3.6 Apoptosis and Regulation of HSC Populations
• 2.4 Clinical Uses of HSC
  • 2.4.1 Leukemia and Lymphoma
  • 2.4.2 Inherited Blood Disorders
  • 2.4.3 HSC Rescue in Cancer Chemotherapy
  • 2.4.4 Graft-Versus-Tumor Treatment of Cancer
  • 2.4.5 Other Clinical Applications of HSCs
• 2.5 Challenges and Barriers to the Development of New and Improved Treatments Using HSCs
  • 2.5.1 Boosting the Numbers of HSCs
  • 2.5.2 The Immune System in Host, Graft and Pathogen Attacks
  • 2.5.3 Understanding the Differentiating Environment and Developmental Plasticity
• 2.6 Cancer Stem Cells
  • 2.6.1 The Microenvironment
  • 2.6.2 3-D Cultures and Spheres
• 2.6.3 Targeted Therapies
• 2.7 Cellular Immunotherapy with DCs in Cancer
  • 2.7.1 Routes of DC Delivery
    • 2.7.1.1 Autologous Tumor Cell Vaccines and DC Therapy
    • 2.7.1.2 The Use of DCs for Cancer Vaccination
  • 2.7.2 Immune Response to Vaccination
  • 2.7.3 Clinical Studies with DCs
  • 2.7.4 Future of DC Therapy for Cancer
• 2.8 Tumor Immunotherapy Using DCs Pulsed with Tumor-derived Peptides
• 2.9 Recent Advances on the Use of Stem Cells in Cancer Therapies
• 2.10 Growth Factor Signaling Inhibitors
  • 2.10.1 EGFR Family Member Inhibitors
  • 2.10.2 Hedgehog, Wnt/s-Catenin and Notch Signaling Inhibitors
  • 2.10.3 Combination Therapies
  • 2.10.4 High-dose Cancer Therapy Plus HSCs
• 2.11 Cancer/Testis Antigens (CTAs): A Novel Cancer Marker?
• 2.12 Minimal Residual Disease Post-Bone Marrow Transplantation for Hemato-Oncological Diseases
  • 2.12.1 Methods for Detection of MRD
    • 2.12.1.1 Nonmolecular Methods
    • 2.12.1.2 Immunophenotyping
    • 2.12.1.3 Restriction Fragment Length Polymorphism (RFLP)
    • 2.12.1.4 Southern Blotting for Detection of Clonal Genetic Markers
    • 2.12.1.5 PCR for Detection of Clonal Genetic Markers
    • 2.12.1.6 PCR of Minisatellite (VNTR) Sequences
    • 2.12.1.7 PCR of Microsatellite Sequences
    • 2.12.1.8 Y Chromosome-specific PCR
    • 2.12.1.9 PCR-Amelogenin: Improved Single-step PCR Assay for Gender Identification
    • 2.12.1.10 Quantitative PCR
    • 2.12.1.11 Two-color Fluorescence In situ Hybridization (FISH): BCR/ABL Fusion Gene Detection
    • 2.12.1.12 FISH in Sex-Mismatch Transplantation
• 2.13 Clinical Implications of Minimal Residual Disease
  • 2.13.1 Upfront Transplantation Decision Based on MRD Findings
  • 2.13.2 Prediction of Relapse Post-BMT
  • 2.13.3 Adoptive Immunotherapy for CML Patients Relapsing after BMT
  • 2.13.4 Mixed Allogeneic Chimerism as an Approach to Transplantation Tolerance
  • 2.13.5 BMT in Thalassemia and SAA and Detection of MRD
  • 2.13.6 Organ Transplantation
• 2.14 Genetic Engineering of Tumor Cells
  • 2.14.1 Hybridoma Process
  • 2.14.2 Hollow-fiber Perfusion
  • 2.14.3 Heat Shock Protein Technology
  • 2.14.4 Stem Cells Used as Platforms in Anticancer Therapies
  • 2.14.5 Stem Cell Transplantation in Cancer
  • 2.14.6 Bone Marrow Stem Cell Transplantation
  • 2.14.7 Cellular Immunotherapy Ex vivo Mobilization of Immune Cells
  • 2.14.8 Peripheral Blood Stem Cell Transplantation
  • 2.14.9 Autologous Stem Cell Transplantation
  • 2.14.10 Complications of Stem Cell Transplants in Cancer
  • 2.14.11 Umbilical Cord Blood Transplant for Leukemia
  • 2.14.12 MSC Transplantation in Cancer
  • 2.14.13 hESC-derived NK Cells for Treatment of Cancer Long-term Results of HSC Transplantation
• 2.15 The Human Immune System
• 2.16 Cell Therapy Commercialization

3. Current Status of Cellular Therapies for Cancer

• 3.1 Introduction to the Cancer Vaccine Space
  • 3.1.1 Tumor Cell Vaccines
  • 3.1.2 Antigen Vaccines
  • 3.1.3 DC Vaccines
    • 3.1.3.1 Dendritic/Tumor Cell Fusion
    • 3.1.3.2 Limitations of DC Vaccines for Cancer
    • 3.1.3.3 The Future of Cell Therapy with DCs
  • 3.1.4 Anti-Idiotype Vaccines
  • 3.1.5 Vector-based Vaccines
  • 3.1.6 Heat Shock Protein-based Vaccines
  • 3.1.7 Autologous Tumor Cell Vaccines
  • 3.1.8 Lymphocyte-based Cancer Therapies
    • 3.1.8.1 Adoptive Immunotherapy
    • 3.1.8.2 Rescue of CD8+ T Cells for Use in Tumor Immunotherapy
    • 3.1.8.3 Expansion of Antigen-specific CTLs
    • 3.1.8.4 Genetically Targeted T Cells for Treating B Cell Malignancies
    • 3.1.8.5 LAK Cell Therapy
    • 3.1.8.6 Tumor-infiltrating Lymphocyte (TIL) Therapy
• 3.2 Vaccines in Development
  • 3.2.1 GVAX Immunotherapies (Cell Genesys)
  • 3.2.2 Oncophage (Antigenics)
  • 3.2.3 Provenge (P-11) (Dendreon)
  • 3.2.4 Sipuleucel-T (Dendreon)
  • 3.2.5 DCVaxR (Northwest Biotherapeutics)
  • 3.2.6 StimuvaxR (EMD Pharmaceuticals)
  • 3.2.7 JuvImmune"! (Juvaris BioTherapeutics)
  • 3.2.8 Allovectin-7R (Vical)
  • 3.2.9 BiovaxID (Biovest)
  • 3.2.10 BLP25 Liposome Vaccine (Merck & Co.)
  • 3.2.11 Cervarix (GlaxoSmithKline)
  • 3.2.12 CollidemR DC Vaccine (IDM Pharma)
  • 3.2.13 EP-2101 Lung Cancer Vaccine (IDM Pharma)
  • 3.2.14 FavId (Favrille)
• 3.3 Clinical Trials Pipeline for Various Types of Cellular Therapy for Cancer
• 3.4 Cancer Therapy Based on Natural Killer Cells
• 3.5 Cancer Stem Cells
• 3.6 ESC Vaccine for Prevention of Lung Cancer
• 3.7 Cell-based Therapies for Malignant Brain Tumors
  • 3.7.1 DC Therapy for Brain Tumors
  • 3.7.2 Targeting Stem Cells in Brain Tumors
  • 3.7.3 Conclusions
• 3.8 Vaccine for Non-Hodgkin' s Lymphoma
  • 3.8.1 Non-Hodgkin' s Lymphoma
  • 3.8.2 Monoclonal Antibody Treatment
  • 3.8.3 Development of Patient-specific Vaccine for NHL
  • 3.8.4 BiovaxID Active Immunotherapy
  • 3.8.5 BiovaxID Treatment and Production Process
  • 3.8.6 FavId
  • 3.8.7 MyVax
  • 3.8.8 Sector Competition
• 3.9 Bone Marrow Transplants
• 3.10 The Market Opportunity for the Use of Stem Cells in the Cancer Therapy Marketplace

4. Tumor Antigens, Cancer Vaccines and Cellular Therapy

• 4.1 Scope of this Chapter
• 4.2 Tumor Antigens and Classes
• 4.3 Classes of Cancer Vaccines Based on Tumor Antigens
  • 4.3.1 Antigen/Adjuvant Vaccines
  • 4.3.2 Whole Cell Tumor Vaccines
  • 4.3.3 DC Vaccines
  • 4.3.4 Viral Vectors and DNA Vaccines
  • 4.3.5 Idiotype Vaccines
• 4.4 Antigens that are Commonly Found in Cancer Vaccines under Investigation Today
  • 4.4.1 Treatment Vaccines
  • 4.4.2 Prevention Vaccines
• 4.5 Cancer Vaccines that have Reached Phase III Trials
• 4.6 Selected Companies in the Tumor Antigens and Vaccines Space with Novel Technology Platforms
  • 4.6.1 Antigenics
  • 4.6.2 AlphaVax
  • 4.6.3 Argonex
  • 4.6.4 Bavarian Nordic
  • 4.6.5 Biomira
  • 4.6.6 CancerVax Corp. (Micromet, Inc.)
  • 4.6.7 Corixa (Acquired by GlaxoSmithKline)
  • 4.6.8 CTL Immunotherapies
  • 4.6.9 Dendreon
  • 4.6.10 GenEra
  • 4.6.11 GeneMax Pharmaceuticals
  • 4.6.12 Genzyme Molecular Oncology
  • 4.6.13 IDM

5. Other Competing Antibody Technologies

• 5.1 Competition
• 5.2 Companies Developing Human Antibodies
• 5.3 Antibody Sequence Libraries
• 5.4 Recombinant DNA Sequences
• 5.5 Companies with Antibody Products in Clinical Trials
• 5.6 Immunoconjugates
• 5.7 Protein Products

6. The Future of Cell Therapy Against Cancer

• 6.1 Innovations in Cell-based Therapy of Cancer
  • 6.1.1 Cancer Therapy-based on NK-92 Cells
  • 6.1.2 Myoblast-mediated Gene Therapy
  • 6.1.3 Cancer Stem Cells
  • 6.1.4 MSCs for the Treatment of Gliomas

7. Government Regulation of Cell Therapy Products

• 7.1 Pharmaceutical Product Regulation
  • 7.1.1 Preclinical Phase
  • 7.1.2 Biologics
  • 7.1.3 Clinical Phase
• 7.2 New Drug Application (NDA) or Biologics License Application (BLA)
• 7.3 Fast-Track Review
• 7.4 Post-Approval Phase
• 7.5 Hatch-Waxman Act
• 7.6 Abbreviated New Drug Applications (ANDAs)
• 7.7 505(b)(2) Applications
• 7.8 Patent Term Restoration
• 7.9 ANDA and 505(b)(2) Applicant Challenges to Patents and Generic Exclusivity
• 7.10 Non-Patent Marketing Exclusivities
• 7.11 Orphan Drug Designation and Exclusivity
• 7.12 Cell Debris Therapy Ban

8. Companies involved in Cancer Cell Therapy

• 8.1 Companies Involved in Cell-based Cancer Therapy

9. Company Profiles

• 9.1 Accentia Biopharmaceuticals, Inc.
• 9.2 Antigenics, Inc.
• 9.3 Biomira, Inc.
• 9.4 Biovest International, Inc.
• 9.5 Cell Genesys, Inc.
• 9.6 Dendreon Corp.
• 9.7 EMD Serono (Parent Company is Merck KGaA, Darmstadt, Germany)
• 9.8 Favrille, Inc.
• 9.9 Genitope Corporation
• 9.10 Genzyme Molecular Oncology
• 9.11 GlaxoSmithKline
• 9.12 IDM Pharma, Inc.
• 9.13 Juvaris BioTherapeutics, Inc.
• 9.14 Medarex, Inc.
• 9.15 Merck & Co., Inc.
• 9.16 Micromet, Inc.
• 9.17 Northwest Biotherapeutics, Inc.
• 9.18 Titan Pharmaceuticals, Inc.
• 9.19 Vical, Inc.
• 9.20 Cyclacel Pharmaceuticals, Inc.

Appendix I: List of Human Clusters of Differentiation (CD) Antigens

Appendix II: Glossary of Terms in the Stem Cells Space

Appendix III: Markers Commonly Used to Identify Stem Cells and to Characterize Differentiated Cell Types(Hematopoietic-focused)

INDEX OF FIGURES

• Figure 2.1: Autologous Process for Cancer Vaccination
• Figure 2.2: Patient Treatment Schedule for Second Line Caner Cell Therapy
• Figure 2.3: Cell Maturation Process
• Figure 2.4: CTL Cell Division
• Figure 2.5: Prostate Specific Membrane Antigen
• Figure 2.6: Exosomes
• Figure 2.7: Current End-user Utilization Category of CSCs
• Figure 2.8: Current End-user Utilization Category of Adult Stem Cells (ASCs)
• Figure 2.9: Current End-user Utilization Category of hESCs
• Figure 2.10: Current End-user Utilization Category of Human Cord Blood Stem Cells
• Figure 3.1: Cancer Vaccine Active Immune-Therapy Process
• Figure 3.2: Current End-user Utilization Category of CSCs

INDEX OF TABLES

• Table 2.1: TC Cell Activation
• Table 2.2: Innate Versus Adaptive Immunity
• Table 2.3: Proposed Cell-Surface Markers of Undifferentiated HSCs
• Table 3.1: Clinical Trials for Autologous Tumor Cell Vaccines
• Table 3.2: Pipeline of Cancer Vaccines
• Table 3.3: List of Cell Therapy Clinical Trials
• Table 3.4: Distribution of Adoptive Immunotherapy of Cancer Clinical Studies being PerformedWorldwide
• Table 3.5: Clinical Studies Utilizing MSCs
• Table 3.6: Distribution of MSC-based Cancer Clinical Studies being PerformedWorldwide
• Table 3.7: HSC-based Cancer Therapy
• Table 3.8: Distribution of HSC-based Cancer Clinical Studies Being Performed Worldwide
• Table 3.9: Characteristics of Different Stem Cell Types and Associated Market Opportunity
• Table 3.10: Segmentation of the Stem Cell Market by Type/Lineage of Stem Cell
• Table 4.1: Classes of Tumor Antigens
• Table 4.2: Cancer Vaccines in Phase III Clinical Trials
• Table 9.1: Cell Genesys Clinical Pipeline
• Table 9.2: Favrille Development Programs

Cancer Diagnostic Testing World Markets

1. Overview

• 1.1 Statement of Report
• 1.2 About This Report
• 1.3 Scope of the Report
• 1.4 Objectives
• 1.5 Methodology
• 1.6 Executive Summary

2. Introduction to Cancer Biology and the Diagnostic Industry

• 2.1 Cancer
  • 2.1.1 The Disease
  • 2.1.2 Metastasis
  • 2.1.3 Demographics and Statistics of Cancer
• 2.2 The Drivers of the Biotech and Diagnostics Industry
  • 2.2.1 Technological Innovation
  • 2.2.2 Government Funding
• 2.3 Outlook for Tumor Markers

3. Tumor Markers Market Segment Analysis: Size, Growth and Share

• 3.1 Market Description
• 3.2 Clinical Diagnostic Serum Based Cancer Markers
• 3.3 PSA Testing Market Size
• 3.4 DNA Markers
• 3.5 Serum Proteins
• 3.6 Enzymes
• 3.7 Occult Blood
• 3.8 Histology and In Situ Hybridization (ISH)
• 3.9 Cervical Cytology
• 3.10 Immunohistochemistry
• 3.11 In Vivo Detection Cancer Products
• 3.12 Radionuclides and X-Ray Detection Products
• 3.13 Human Papillomavirus (HPV) Testing
• 3.14 Bladder Cancer Testing
• 3.15 Tumor Assays for Adjuvant Chemotherapy

4. Diagnostic Methods for Cancer Detection

• 4.1 Organ Specific Tumor Markers
  • 4.1.1 Colon Cancer
  • 4.1.2 Prostate Cancer
  • 4.1.3 Pancreatic Cancer
  • 4.1.4 Breast Cancer
  • 4.1.5 Ovarian Cancer
  • 4.1.6 Cervical Cancer
  • 4.1.7 Lung Cancer
  • 4.1.8 Testicular Cancer
  • 4.1.9 Bladder Cancer
  • 4.1.10 Hepatic Cancer
  • 4.1.11 Stomach Cancer
  • 4.1.12 Malignant Melanoma
  • 4.1.13 Acute Myeloid Leukemia (AML) and Acute Lymphoblastoid Leukemia (ALL)
  • 4.1.14 Lymphoma
• 4.2 Clinical Laboratory Methods for Measuring Tumor Markers
  • 4.2.1 Abbott Diagnostics AxSYM
  • 4.2.2 Roche Diagnostics Elecsys
  • 4.2.3 Beckman Coulter Diagnostics Access
  • 4.2.4 Bayer Diagnostics ADVIA Centaur
  • 4.2.5 Dade Diagnostics Stratus
  • 4.2.6 Diagnostic Products Corporation Immulite
  • 4.2.7 Tosoh Medics A1A
  • 4.2.8 CIS bio International Kryptor
  • 4.2.9 Ortho-Clinical Diagnostics Vitros ECiQ
  • 4.2.10 Fujirebio Diagnostics, Inc.
  • 4.2.11 bioMerieux Vidas
  • 4.2.12 Eisai Picolumi
  • 4.2.13 Tosoh Medics, Inc.
• 4.3 New Technologies for Cancer Diagnostics
  • 4.3.1 New and Improved Immunoassays
  • 4.3.2 Immunohistochemical Tests
  • 4.3.3 Molecular (DNA and Genomic) Diagnostic Assays
  • 4.3.4 Genomics and Genetic Markers
  • 4.3.5 Proteomics and New Protein Markers
    • 4.3.5.1 Inside the ProteinChip System
    • 4.3.5.2 Rapid Biological Assays on a Chip
    • 4.3.5.3 Proteome Pattern Recognition
  • 4.3.6 New Platform Technologies Including Flow Cytometry
  • 4.3.7 Stem Cell Markers
  • 4.3.8 Monoclonal Antibodies
  • 4.3.9 Proteomics and Cancer Antibodies
  • 4.3.10 Pharmacogenomics and Oncology Diagnostics
  • 4.3.11 DNA Microarrays
  • 4.3.12 In Vitro Diagnostic Multivariate Index Assays (IVDMIA)
  • 4.3.13 Prostate PX Score
  • 4.3.14 Prostate-63
  • 4.3.15 Future Directions
• 4.4 Clinical Methods for Diagnosis of Cancer
  • 4.4.1 Screening
  • 4.4.2 Sigmoidoscopy
  • 4.4.3 Imaging
  • 4.4.4 Theranostics

5. Implications of Molecular Biology for New Diagnostic Cancer Tests

6. Companies Entering the Cancer Diagnostics Market with Novel Technology Platforms

• 6.1 Abbott Diagnostics
• 6.2 Affymetrix, Inc.
• 6.3 Agendia BV
• 6.4 Agensys, Inc.
• 6.5 Ambrilla Biopharma, Inc.
• 6.6 AMDL, Inc.
• 6.7 Asuragen, Inc.
• 6.8 Aureon Biosciences Corporation
• 6.9 Bard Diagnostics, Inc.
• 6.10 Bayer Diagnostics
• 6.11 Beckman Coulter, Inc.
• 6.12 Biocode S.A.
• 6.13 BioCurex
• 6.14 Biomedical Diagnostics
• 6.15 Biomerica
• 6.16 bioMerieux
• 6.17 Biomira
• 6.18 BioModa, Inc.
• 6.19 Bruker Daltonics
• 6.20 Byk Gulden
• 6.21 Cepheid
• 6.22 Clarient, Inc.
• 6.23 CytoCore (Formerly known as Molecular Diagnostics, Inc.)
• 6.24 Correlogic Systems, Inc.
• 6.25 Cytogen Corporation
• 6.26 diaDexus, LLC
• 6.27 DiagnoCure, Inc.
• 6.28 Diagnostic Products Corporation
• 6.29 Diagnostic Systems Laboratories, Inc.
• 6.30 DRG International, Inc.
• 6.31 Eisai Co., Ltd.
• 6.32 Enigma Diagnostics Ltd.
• 6.33 Epigenomics
• 6.34 Exact Sciences Corporation
• 6.35 Exagen Diagnostics, Inc.
• 6.37 Gene Logic, Inc.
• 6.38 Gen-Probe, Inc.
• 6.39 Genomic Health
• 6.40 Geron Corporation
• 6.42 Immunicon Corporation
• 6.43 Immunomedics, Inc.
• 6.44 Incyte Pharmaceuticals, Inc.
• 6.45 Ipsogen
• 6.46 LabCorp
• 6.47 Matritech
• 6.48 Mitsubishi Kagaku Medical
• 6.49 Molecular Devices (Formerly known as Arcturus Bioscience, Inc.)
• 6.50 Myriad Genetics, Inc.
• 6.51 Poniard Corporation
• 6.52 Nexell Therapeutics, Inc.
• 6.53 Northwest Biotherapeutics, Inc.
• 6.54 Nuvelo, Inc.
• 6.55 Panacea Pharmaceuticals, Inc.
• 6.56 Oncotech, Inc.
• 6.57 Polymedco, Inc.
• 6.58 Princeton BioMeditech Corporation
• 6.59 Qiagen
• 6.60 Sanko Junyaku Co., Ltd.
• 6.61 Tosoh Medics, Inc.
• 6.62 TriPath Imaging, Inc.
• 6.63 UroCor, Inc.
• 6.64 Ventana Medical Systems, Inc.
• 6.65 Veridex
• 6.66 Vermillion, Inc. (Formerly known as Ciphergen)
• 6.67 Worldwide Medical Corporation
• 6.68 Xenomics, Inc.

7. Business Trends in the Industry

• 7.1 Industry Consolidation
• 7.2 Breadth of Product Offering and Pricing
• 7.3 Government Regulation of Medical Devices
• 7.4 Strategic Business and Marketing Considerations
• 7.5 Commercial Opportunities in Cancer Markers
• 7.6 Moderators of Growth
• 7.7 Biotechnology Industry Trends
• 7.8 Pharmaceutical Industry Trends
• 7.9 Acquisition, License Agreement, Partnerships
• 7.10 Legal Developments
• 7.11 Sales and Marketing Strategies for Tumor Marker Tests
  • 7.11.1 North American Market
  • 7.11.2 International Markets
    • 7.11.2.1 Europe
    • 7.11.2.2 Central and South America
    • 7.11.2.3 Asia/Pacific

8. Tumor Marker Testing: Important Issues

• 8.1 Trends in Patient Care and Reimbursement
• 8.2 Trends in Reimbursement Practice
• 8.3 Clinical Laboratory Improvement Act (CLIA)
• 8.4 Unmet Needs in Tumor Markers

9. Important New Technology Areas

• 9.1 Proteins
• 9.2 DNA Sequencing
• 9.3 The Human Genome Project (HGP)
• 9.4 Liquid Phase Chromatography
• 9.5 Polymerase Chain Reaction (PCR)
• 9.6 Capillary Electrophoresis
• 9.7 Proteomics
• 9.8 Use of Mass Spectroscopy in Sequencing
• 9.9 High-Throughput Organic Synthesis

10. New Cancer Markers in Basic Research

• 10.1 Genetics of Cancer
• 10.2 Telomerase
• 10.3 Stomach Cancer
• 10.4 Head and Neck Cancer
• 10.5 Breast Cancer
• 10.6 Prostate Cancer: p27 (Kip1) A New Molecular Marker for Prostate Cancer
• 10.7 PSMA
• 10.8 Cervical Cancer: NMPI79
• 10.9 Pancreatic Cancer: Peritoneal Cytology
• 10.10 Colorectal Cancer: CEA Doubling Time
• 10.11 Uterine and Kidney Cancer: MN/CA9
• 10.12 MMSC1 Scaffold Gene
• 10.13 p16 Tumor Suppressor Gene
• 10.14 MTS2 and p19 Cell Cycle Genes
• 10.15 Complement Factor H Related Proteins
• 10.16 MUC 2, 3, 4
• 10.17 Cytokeratins
• 10.18 Colon Cancer: Serum VEGF
• 10.19 Ras Oncogenes
• 10.20 Lung Cancer: Ribonucleoprotein A2/B1
• 10.21 BCLA-4 Matrix Protein
• 10.22 RAK Antigens
• 10.23 Serum Urokinase Receptors
• 10.24 Chips
• 10.25 Survivin
• 10.26 Human Endometrial Specific Steroid Binding Factor (hESF1)
• 10.27 Reg-4 Protein
• 10.28 Nox-1
• 10.29 PSP94 Binding Protein
• 10.30 Ettan DIGE Technology
• 10.31 YKL-40
• 10.32 AFP-L3
• 10.33 DNA Methylation Technology
• 10.34 Transthyretin and Apolipoprotein A1
• 10.35 ADAM 12
• 10.36 Ovarian Cancer: Vermillion' s SELDI-based ProteinChip
• 10.37 Lung Cancer: Labeled Porphyrin Binding
• 10.38 C-MAP, A Cervical Cancer Screening System
• 10.39 Lung Cancer: Pro-Gastrin-Releasing Peptide (ProGRP)
• 10.40 Prostate Cancer: PCA3
• 10.41 Bladder Cancer: ImmunoCyt"!/uCyt+"!
• 10.42 Shc Proteins
• 10.43 Oncology Biomarker Qualification Initiative
• 10.44 Anti-Glycan Antibodies

11. Market Trends and Forecasts

• 11.1 Ultrasensitive Cancer Tests
• 11.2 Mergers and Acquisitions of Diagnostic Companies
• 11.3 RT-PCR
• 11.4 Genetic Tests of Hereditary Cancer Risk
• 11.5 DNA Measurements
• 11.6 Technical and Practical Issues for Potential New Markers
• 11.7 Genetic Profiling
• 11.8 Ploidy
• 11.9 Advances in Sputum Analysis for Screening and Early Detection of Lung Cancer
• 11.10 Pharmacogenetic Tests for Cancer
• 11.11 Worldwide Healthcare Spending
• 11.12 R&D Expenditures

Appendix 1: Web Links

Appendix 2: Cancer Information Resources

Appendix 3: Colon Cancer Staging

Appendix 4: Reimbursement for Tumor Marker Testing

Appendix 5: The Pathology of Prostate Cancer

Appendix 6: Government Regulation of Tumor Marker Tests

Appendix 7: The Clinical Laboratory Improvement Act (CLIA)

Appendix 8: Marketers of Occult Blood Diagnostic Test Kits

INDEX OF FIGURES

• Figure 4.1: Model of Colorectal Cancer Development
• Figure 4.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC
• Figure 4.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH
• Figure 4.4: The BTA stat Test vs. Cytology
• Figure 6.1: Qiagen Global Sales
• Figure 10.1: Estimates for PCA3 Test Volume in U.S., 2005-2008

INDEX OF TABLES

• Table 2.1: Organ-Specific Medicines in Development for Cancer, 2007
• Table 2.2: Estimates for the Leading Sites of New Cancer Cases and Deaths in the U.S. by Sex
• Table 2.3: Estimated Worldwide Number of New Cancer Cases and Deaths by Type of Cancer
• Table 2.4: Estimated Number of New Cancer Cases and Deaths by Region
• Table 2.5: Cancer Death Rates per 100,000 Population (and Rank) for all Cancer Sites by Country
• Table 2.6: Cancer Associated Genes
• Table 2.7: Carcinogens in the Workplace
• Table 2.8: Private Funding Levels for the Biotechnology Segment, 1995-2006
• Table 2.9: Herceptin Worldwide Sales, 2000-2007
• Table 2.10: Classes of Drugs Used to Treat Breast Cancer
• Table 3.1: In Vitro Cancer Marker Market Segments Worldwide, 2001 and 2007
• Table 3.2: Tumor Markers Currently in Common Use
• Table 3.3: Global IVD Cancer Tumor Marker Testing Market Segments Projected Growth Rates, 2005-2010
• Table 3.4: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010
• Table 3.5: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010
• Table 3.6: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
• Table 3.7: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
• Table 3.8: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
• Table 3.9: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010
• Table 3.10: Global Distribution of IVD Cancer Tumor Marker Diagnostic Testing, 2005
• Table 3.11: Estimated Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market
• Table 3.12: Major Presence in Cancer Tumor Marker Diagnostics Markets
• Table 3.13: Worldwide PSA Sales, 2000-2010
• Table 3.14: U.S. PSA Sales, 2000-2010
• Table 3.15: Serum Markers Used Clinically
• Table 3.16: ASCO-CAP Guidelines for HER-2 Testing in Breast Cancer
• Table 3.17: Drivers of IHC Growth
• Table 3.18: Bladder Cancer Testing Efforts in the U.S. and Germany
• Table 3.19: Worldwide Bladder Cancer Marker Sales, 2001-2010
• Table 3.20: U.S. Bladder Cancer Marker Sales, 2001-2010
• Table 3.21: Worldwide NMP22 Sales, 2001-2010
• Table 3.22: Current Breast Cancer Product and Product Opportunities
• Table 3.23: Products in Various Stages of Development for Cancers Other than Breast Cancer
• Table 4.1: Colorectal Cancer Stages
• Table 4.2: Worldwide CEA Sales, 2001-2010
• Table 4.3: U.S. CEA Sales, 2001-2010
• Table 4.4: Population Statistics of Serum Levels of PSA in Men Over 50 Years of Age
• Table 4.5: PSA Doubling Time and Time to Reach PSA of 1,000
• Table 4.6: PSA Doubling Times
• Table 4.7: Worldwide CA-19-9 Sales, 2001-2010
• Table 4.8: U.S. CA-19-9 Sales, 2001-2010
• Table 4.9: CA-19-9 Levels in Management of Pancreatic Cancer
• Table 4.10: Worldwide CA-15-3 Sales, 2001-2010
• Table 4.11: U.S. CA-15-3 Sales, 2001-2010
• Table 4.12: TPA Marker Sensitivity
• Table 4.13: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results
• Table 4.14: Siemens Oncogene Science Biomarker Group Reagents
• Table 4.15: Worldwide CA-125 Sales, 2001-2010
• Table 4.16: U.S. CA-125 Sales, 2001-2010
• Table 4.17: Number of Pap Smears Performed by Country
• Table 4.18: Lung Cancer Survival Rates
• Table 4.19: Lung Cancer Facts
• Table 4.20: Patient Category Applications
• Table 4.21: Worldwide AFP Marker Sales, 2001-2010
• Table 4.22: U.S. AFP Cancer Marker Sales, 2001-2010
• Table 4.23: Potential Uses of Molecular Diagnostics in Cancer Management
• Table 4.24: Colorectal Cancer Monoclonal Antibody Imaging Kits
• Table 6.1: Product Sales as a Percent of Total Product Sales, 2004-2006
• Table 6.2: Tumor Diagnosis Immunoassay
• Table 6.3: Tumor Diagnosis Radioimmunoassay
• Table 6.4: Summary of Matritech' s Product Development Programs
• Table 6.5: Statements of Operations Data for Matritech, 2002-2006
• Table 6.6: Results of Operations of Matritech, 2005 and 2006
• Table 6.7: PBM Product List
• Table 7.1: List and Discounted Prices for Abbott Tumor Marker Tests
• Table 8.1: CPT Codes for Tumor Markers
• Table 10.1: Familial Cancer Syndromes and Tumor Suppressor Genes
• Table 10.2: Oncogenes and Anti-oncogenes
• Table A3: TNM Classification
• Table A7: Financial Comparison for Moderate and Waived CLIA Labs
• Table A8: List of Marketers of Occult Blood Diagnostic Test Kits

Cancer Therapeutics Markets

1. Overview

• 1.1 Introduction
• 1.2 Goals and Objectives
• 1.3 Study, Scope and Format
• 1.4 Methodology
• 1.5 Summary of Major Findings

2. Introduction to the Cancer Therapeutic Market

3. Cancer Therapeutics Market Overview

• 3.1 Cancer Therapeutics in the Pharmaceutical and Biotech Industry
• 3.2 Business Analysis of the Cancer Market
  • 3.2.1 Growth Potential
  • 3.2.2 Demographics of Cancer
  • 3.2.3 The Global Market for Cancer Therapies
    • 3.2.3.1 European Cancer Market
    • 3.2.3.2 The Environment in the U.K. for Clinical Research into New Anti-Cancer Therapies
    • 3.2.3.3 The Suitability of Current U.K. and E.U. Regulatory Regimes
    • 3.2.3.4 Comments on the Current E.U. Regulatory Environment
• 3.3 The Pharmaceutical Industry
• 3.4 Cancer Therapies
  • 3.4.1 Market Size
• 3.5 New Product Trends
  • 3.5.1 Chemotherapy
  • 3.5.2 Hormone Therapy
  • 3.5.3 Photodynamic Therapy and Photosensitizers
  • 3.5.4 Gene Therapy
    • 3.5.4.1 Tumor-Suppressor Gene Therapy
    • 3.5.4.2 Immunomodulatory Gene Therapy
    • 3.5.4.3 Suicide Gene Therapy
  • 3.5.5 Radiation Therapy
  • 3.5.6 Farnesyl Transferase Inhibitors (FTIs)
  • 3.5.7 Genetic Screening
  • 3.5.8 Biological Therapies
  • 3.5.9 Interferons
  • 3.5.10 Interleukins
  • 3.5.11 Tumor Necrosis Factor (TNF)
  • 3.5.12 Colony-Stimulating Factors (CSFs)
  • 3.5.13 Monoclonal Antibodies (MAbs)
  • 3.5.14 Cancer Vaccines
  • 3.5.15 Anti-Sense Therapy
  • 3.5.16 Adjuvants
  • 3.5.17 Angiogenesis Inhibitors
  • 3.5.18 Hyperthermia
  • 3.5.19 Transplants
    • 3.5.19.1 Bone Marrow Transplants
    • 3.5.19.2 Stem Cell Transplants

4. The Disease of Cancer

• 4.1 Incidence of Cancer
  • 4.1.1 U.S. Statistics
  • 4.1.2 Global Statistics
• 4.2 Causes of Cancer
• 4.3 Risk Factors
  • 4.3.1 Smoking
  • 4.3.2 Diet
  • 4.3.3 Radiation
  • 4.3.4 Occupational Risks
  • 4.3.5 Medicine and Infection
  • 4.3.6 Environmental Pollution
  • 4.3.7 Reproductive Factors
  • 4.3.8 Socio-Economic Factors
• 4.4 Cancer Costs

5. Specific Cancers

• 5.1 Bladder Cancer
  • 5.1.1 Overview of the Disease
  • 5.1.2 Diagnosis and Staging
  • 5.1.3 Therapy
  • 5.1.4 Test for Bladder Cancer Analyzes DNA in Urine
  • 5.1.5 Drugs in Development
• 5.2 Brain Cancer
  • 5.2.1 Overview of the Disease
  • 5.2.2 Treatment Options
• 5.3 Breast Cancer
  • 5.3.1 Overview of the Disease
  • 5.3.2 Therapeutic Drugs
  • 5.3.3 Market Overview for Breast Cancer Therapeutics
• 5.4 Cervical Cancer
  • 5.4.1 Overview of the Disease
  • 5.4.2 Treatment Options
• 5.5 Colon Cancer
  • 5.5.1 Overview of the Disease
  • 5.5.2 Treatment Options
  • 5.5.3 Market Overview for Colon Cancer Therapeutics
• 5.6 Leukemia
  • 5.6.1 Overview of the Disease
  • 5.6.2 Treatment Options
• 5.7 Lymphoma
  • 5.7.1 Overview of the Disease
  • 5.7.2 Treatment Options
• 5.8 Lung Cancer
  • 5.8.1 Overview of the Disease
  • 5.8.2 Treatment Options
  • 5.8.3 Breakthrough Treatments for Lung Cancer
  • 5.8.4 Market Overview for Lung Cancer Therapeutics
• 5.9 Ovarian Cancer
  • 5.9.1 Overview of the Disease
  • 5.9.2 Treatment Options
• 5.10 Prostate Cancer
  • 5.10.1 Overview of the Disease
  • 5.10.2 Treatment Options

6. Corporate Profiles

• 6.1 AstraZeneca Plc
• 6.2 Biogen Idec, Inc.
• 6.3 Bristol-Myers Squibb
• 6.4 Genentech, Inc.
• 6.5 Genta, Inc.
• 6.6 Genzyme Oncology
• 6.7 GlaxoSmithKline Plc
• 6.8 ImClone Systems, Inc.
• 6.9 Medarex
• 6.10 Millennium Pharmaceuticals, Inc.
• 6.11 Novartis AG
• 6.12 Onyx Pharmaceuticals, Inc.
• 6.13 OSI Pharmaceuticals, Inc.
• 6.14 Pfizer
• 6.15 Regeneron Pharmaceuticals, Inc.
• 6.16 Roche
• 6.17 Sanofi-Aventis

7. References

• 7.1 Online References for Cancer
• 7.2 Print Sources
• 7.3 Product Approvals for Cancer Indications

INDEX OF TABLES

• Table 2.1: The 646 Medicines in Development for Cancer, 2006
• Table 2.2: Drug Approvals for Cancer Indications, 1996-2007
• Table 3.1: Opportunities for Molecular-Targeting Therapeutics for Cancer
• Table 3.2: Top U.S. Biotechnology Companies by Market Capitalization
• Table 3.3: Top Pharmaceutical Companies by Market Capitalization
• Table 3.4: Clinical Development for some of Hoffman-La Roche Products
• Table 3.5: Global Pharmaceutical Industry R&D Spending, 1995-2006
• Table 3.6: U.S. Government NIH Research Budget, 1995-2007
• Table 3.7: Health Spending as Percentage of GDP by Country
• Table 3.8: Spending on Health by Country
• Table 3.9: Annual Spending on Cancer Drugs Per Person
• Table 3.10: Patients Per Cancer Specialist
• Table 3.11: World Healthcare Cancer Therapeutics Markets by Region
• Table 3.12: U.S. Market for Cancer Therapeutics, 1998-2006
• Table 3.13: European Market for Cancer Therapeutics, 1998-2006
• Table 3.14: Japanese Market for Cancer Therapeutics, 1998-2006
• Table 3.15: Cancer Vaccines Approved or in Phase III Clinical Trials
• Table 3.16: Anti-Angiogenic Drugs in Clinical Trial for Cancer
• Table 4.1: New Cancer Cases and Deaths in the U.S. by Sex for all Cancer Sites, 2007
• Table 4.2: New Cancer Cases and Deaths for Ten Leading Cancer Sites in the U.S., by Sex, 2007
• Table 4.3: Worldwide Number of New Cancer Cases and Deaths by Leading Cancer Sites and by Level of Economic Development, 2007
• Table 4.4: Number of New Cancer Cases and Deaths by World Area, 2007
• Table 4.5: Cancer Death Rates per 100,000 Population (and Rank) for all Cancer Sites by Country, 2006
• Table 4.6: Genes and Cancer Risk
• Table 4.7: Carcinogens in the Workplace
• Table 5.1: Drugs Used in Bladder Cancer Therapy
• Table 5.2: Drugs in Development for Bladder Cancer
• Table 5.3: Medicines in Development for Brain Cancer
• Table 5.4: Classes of Chemotherapy Drugs Used to Treat Breast Cancer
• Table 5.5: U.S. Sales of Doxorubicin, 2001-2009
• Table 5.6: New Therapeutics for Breast Cancer
• Table 5.7: Other Classes of Drugs Used to Treat Breast Cancer
• Table 5.8: Worldwide AstraZeneca' s Nolvadex Sales, 2000-2005
• Table 5.9: Aromatase Inhibitors
• Table 5.10: Worldwide Sales Estimates for Arimidex, 2000-2008
• Table 5.11: Worldwide Herceptin Sales, 1999-2005
• Table 5.12: Innovative Drug Therapies applied to the Breast Cancer Market Sector
• Table 5.13: Treatment Regimens for Advanced Breast Cancer
• Table 5.14: Medicines in Development for Cervical Cancer
• Table 5.15: New Therapies for Colon Cancer
• Table 5.16: Worldwide Sales for Xeloda, 2001-2005
• Table 5.17: Worldwide Sales of Tomudex, 1998-2005
• Table 5.18: Medicines in Development for Leukemia
• Table 5.19: Pricing of Novartis' Gleevec in Various Strengths in the U.S.
• Table 5.20: Medicines in Development for Lymphoma
• Table 5.21: U.S. Sales of Rituxan, 1999-2005
• Table 5.22: Cytotoxics for Lung Cancer Therapy
• Table 5.23: Anti-Angiogenics for Lung Cancer
• Table 5.24: Drugs in Development for Lung Cancer
• Table 5.25: Current Therapies for Ovarian Cancer
• Table 5.26: Emerging Therapies for Ovarian Cancer
• Table 5.27: New Development Therapies for Ovarian Cancer
• Table 5.28: New Drug Types for Ovarian Cancer
• Table 5.29: Medicines in Development for Prostate Cancer
• Table 6.1: Potential Therapeutic Indications and Development Stages
• Table 6.2: Products in Clinical Development in Phase II and III (Including Additional Indications)
• Table 7.1: Drugs Currently Approved for the Treatment of Cancer

Companion Diagnostics in Personalized Medicine and Cancer Therapy

1. Overview

• 1.1 Statement of Report
• 1.2 About This Report
• 1.3 Scope of the Report
• 1.4 Objectives
• 1.5 Methodology
• 1.6 Executive Summary

2. Companion Diagnostics and Personalized Medicine

• 2.1 Scope of this Section
• 2.2 Introduction to Companion Diagnostics and Personalized Medicine
• 2.3 Drug Metabolism and Companion Diagnostics and Personalized Medicine
• 2.4 Examples of Personalized Medicine and Companion Diagnostic Tests
• 2.5 Personalized Medicine and Companion Diagnostic Testing Product Pipeline
• 2.6 The Personalized Medicine Coalition (PMC)
• 2.7 Regulatory Trends and Guidelines in the Personalized Medicine Space
  • 2.7.1 The Changing Regulatory Landscape for Personalized Medicine
• 2.8 Companion Diagnostics Play an Increasing Role in Cancer Care
• 2.9 Specific Examples of Clinical Situations Where Companion Diagnostics Are Being Deployed
  • 2.9.1 Epidermal Growth Factor Receptor (EGFR) Assay
  • 2.9.2 Individualized Warfarin Therapy
  • 2.9.3 UGT1A1 Molecular Assay for Camptosar
  • 2.9.4 Response to Gleevec in GIST
  • 2.9.5 LabCorp, ARCA Personalized Medicine Deal for Cardiovascular Diseases
  • 2.9.6 Osmetech Licenses Epidauros Biotechnologie AG CYP2D6 Biomarker to Enter Companion Diagnostics
• 2.10 Diagnostic Tests for Personalized Analysis of Cancer Therapy Effectiveness

3. Companion Diagnostics: Qualitative and Quantitative Market Analysis

• 3.1 Market Analysis of Molecular Diagnostics and Companion Diagnostics
• 3.2 Costs of Companion Diagnostics in Healthcare Expenditures
• 3.3 Molecular Diagnostic Market
• 3.4 Molecular Diagnostics Technology Platforms and Their Impact on Clinical Medicine
• 3.5 Snapshot of Companion Diagnostics Industry Structure
• 3.6 The Case for Theranostics
• 3.7 Companion Diagnostics Market Analysis-Market Survey Data Characterizing the Qualitative and Quantitative Industry Parameters

4. Trends and Overview

• 4.1 Companion Diagnostics: Industry SWOT Analysis
• 4.2 Macro Trends in Companion Diagnostics
• 4.3 Challenges for Companion Diagnostics Development
• 4.4 Timeline for Impact of Various Segments in Companion Diagnostics
• 4.5 Use of Proteomics to Develop Individualized Tests
• 4.6 The Market Problem: Finding Value with Diagnostics for Personalized Medicine

5. Biomarker Tests Co-developed with Cancer Therapeutics as Companion Diagnostics

• 5.1 Sector Overview
  • 5.1.1 Impact of New Technology Platforms
  • 5.1.2 Impact on Drug Discovery
  • 5.1.3 Biomarkers as Endpoints in Drug Discovery
  • 5.1.4 Targeted Therapy
• 5.2 Companion Diagnostics on the Market
• 5.3 Epidermal Growth Factor Receptor Companions
  • 5.3.1 Bevacizamab (Avastin)
  • 5.3.2 EGFR for Colorectal Cancer and Camptosar (Irinotecan)
  • 5.3.3 EGFR Express and Erbitux (Cetuximab)
  • 5.3.4 HER2 and Heceptin (Trastuzumab)
  • 5.3.5 Iressa and Tarceva Companion Test
  • 5.3.6 Tykerb (GSK), and Vectibix"! (Amgen) Companion Tests
  • 5.3.7 EGFRx Assay
  • 5.3.8 Monogram eTag
  • 5.3.9 Veripath OncoDiagnostics EGFR PharmDX
• 5.4 Myriad' s TheraGuide 5-FU
• 5.5 Companions for Tyrosine Kinase Inhibitors: Erlotinib and Gefitinib
  • 5.5.1 TheraScreen: EGFR29
  • 5.5.2 The K-RAS Mutation Detection Kit
• 5.6 Irinotecan and UGT1A1
• 5.7 Gleevec (Imatinib) Companions
  • 5.7.1 DakoCytomation' s c-Kit (9.7) pharmDx
• 5.8 Companion Diagnostics Involving Metabolizing Enzymes
  • 5.8.1 Companions for TMPT, CYP2C9, and UGT1A1 Enzymes
  • 5.8.2 Companions for Aromatase Inhibitors
  • 5.8.3 Companions for Actos and Avandia
• 5.9 Drivers and Barriers to Companion Diagnostics
• 5.10 Partnerships with Pharma Companies to Identify Therapeutic Targets
• 5.11 Circulating Tumor Cell Assay: Prognostic and Predictive Factors for Breast Cancer
• 5.12 Companion Diagnostics Used by Clinical Service Laboratories
• 5.13 New Technologies and Products under Development
  • 5.13.1 OncoMethylome
• 5.14 Blood-Based Technologies
  • 5.14.1 Oncotech
• 5.15 Monogram Biosciences HIV Personalized Platform
• 5.16 Wako LBA¥AFP Test for Liver Cancer
• 5.17 Future Developments for Companion Diagnostics

6. Business and Regulatory Trends in the Companion Biomarker Testing Sector

• 6.1 Industry Consolidation
• 6.2 Breath of Product Offering and Pricing
• 6.3 Government Regulation of Medical Devices
  • 6.3.1 FDA Guidance on Drug Test Co-development
  • 6.3.2 Device Classes
  • 6.3.3 Investigational Use of IVDM Assays
  • 6.3.4 Post-market Requirements
• 6.4 Strategic Business and Marketing Considerations
• 6.5 Commercial Opportunities in Companion Markers
• 6.6 Moderators of Growth
  • 6.6.1 Roadblocks to Integrating Companion Biomarkers into Clinical Practice
  • 6.6.2 Management of Targeted Therapeutics by Third-Party Payers
• 6.7 Biotechnology Industry Trends
• 6.8 Pharmaceutical Industry Trends
• 6.9 Acquisition, License Agreement, Partnerships
• 6.10 Legal Developments
• 6.11 Sales and Marketing Strategies for Tumor Marker Tests
  • 6.11.1 International Markets
• 6.12 Product Commercialization
• 6.13 Reimbursement
• 6.14 Self-Referral Rules
• 6.15 Health Insurance Portability and Accountability Act
• 6.16 Clinical Laboratory Improvement Amendments (CLIA)
• 6.17 In Vitro Diagnostic Directive (IVDD) and Medical Device Regulations
• 6.18 FDA' s Quality System Regulation (QSR)
• 6.19 FDA' S OIVD on IVDMIAs
• 6.20 FDA' s Qualification of Cancer Biomarkers
  • 6.20.1 Regulatory Perspectives of Biomarker Validation
• 6.21 Genetic Tests and Medical Records
  • 6.21.1 Laws against Genetic Discrimination
• 6.22 Medicare Reimbursement
  • 6.22.1 Medicare Part B Spending Trends
• 6.23 Global Drivers of Clinical Laboratory Testing
• 6.24 Global Outlook
• 6.25 Oncology Biomarker Qualification Initiative
• 6.26 FDA Critical Path
• 6.27 Biomarkers and FDA' s Voluntary Genomic Data Submission
• 6.28 From Personalized to Predictive Medicine
• 6.29 Analysis of Cost-Effectiveness at the Individual Level
• 6.30 The Patient and Advocate Perspective: An Evolution of Influence
• 6.31 Real-World Experiences Translating the Vision of Personalized Medicine into Practice

7. Companies Entering the Companion Diagnostics Market

• 7.1 Industry Overview
• 7.2 Representative Companion Diagnostic Development Companies
  • 7.2.1 20/20 GeneSystems
  • 7.2.2 Abbott Diagnostics
  • 7.2.3 Affymetrix
  • 7.2.4 Agendia BV
  • 7.2.5 Agensys
  • 7.2.6 Almac Group
  • 7.2.7 AMDL
  • 7.2.8 Arcturus Bioscience (acquired by Molecular Devices)
  • 7.2.9 Aureon Laboratories
  • 7.2.10 BD
  • 7.2.11 Beckman Coulter
  • 7.2.12 Biocode Hycel
  • 7.2.13 BioCurex
  • 7.2.14 Biomarker Technologies
  • 7.2.15 Biomedical Diagnostics
  • 7.2.16 Biomerica
  • 7.2.17 bioMerieux
  • 7.2.18 BioModa
  • 7.2.19 Bruker Daltonics
  • 7.2.20 Cangen Biotechnologies
  • 7.2.21 Caprion Proteomics
  • 7.2.22 Celera Diagnostics
  • 7.2.23 Cepheid
  • 7.2.24 Claros Diagnostics
  • 7.2.25 Clinical Data: PGxHealth and Cogenics
  • 7.2.26 Ciphergen Biosystems renamed Vermillion, Inc.
  • 7.2.27 Clarient
  • 7.2.28 Correlogic Systems
  • 7.2.29 CytoCore
  • 7.2.30 Cytogen
  • 7.2.31 Cytyc Corporation
  • 7.2.32 Dako (formerly DakoCytomation)
  • 7.2.33 DiaDexus
  • 7.2.34 Digene (acquired by Qiagen)
  • 7.2.35 DiagnoCure
  • 7.2.36 Diagnostic Systems Laboratories (acquired by Beckman Coulter)
  • 7.2.37 DRG International
  • 7.2.38 DxS
  • 7.2.39 EDP Biotech
  • 7.2.40 Epigenomics
  • 7.2.41 EXACT Sciences Corporation
  • 7.2.42 Exagen Diagnostics
  • 7.2.43 Gene Logic
  • 7.2.44 Genesis Genomics
  • 7.2.45 Genomic Health
  • 7.2.46 Gen-Probe
  • 7.2.47 Health Discovery Corporation
  • 7.2.48 Ikonisys
  • 7.2.49 Immunicon
  • 7.2.50 Immunomedics
  • 7.2.51 Incyte
  • 7.2.52 InterGenetics
  • 7.2.53 Ipsogen
  • 7.2.54 LabCorp
  • 7.2.55 Matritech
  • 7.2.56 Miraculins
  • 7.2.57 Mitsubishi Kagaku latron
  • 7.2.58 Monogram Biosciences
  • 7.2.59 Myriad Genetics
  • 7.2.60 NimbleGen Systems
  • 7.2.61 Northwest Biotherapeutics
  • 7.2.62 Nycomed
  • 7.2.63 Oncotech
  • 7.2.64 Oncothyreon (formerly known as Biomira)
  • 7.2.65 Orion Genomics
  • 7.2.66 Oxford Genome Sciences
  • 7.2.67 Panacea Pharmaceuticals
  • 7.2.68 Perlegen Sciences
  • 7.2.69 Polymedco
  • 7.2.70 Power3 Medical Products
  • 7.2.71 Prometheus
  • 7.2.72 Proteome Systems
  • 7.2.73 Qiagen
  • 7.2.74 Sanko Junyaku
  • 7.2.75 SensiGen
  • 7.2.76 SuperArray Bioscience
  • 7.2.77 Third Wave Technologies
  • 7.2.78 Tosoh Biosciences
  • 7.2.79 TrimGen
  • 7.2.80 TriPath Imaging (acquired by BD)
  • 7.2.81 Upstream Biosciences
  • 7.2.82 Ventana Medical Systems
  • 7.2.83 Veridex

Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submission (March 2005)

Appendix 2: Histochemical Markers for Cancer

LIST OF TABLES

• Table 2.1: Timeline for Development of Companion Diagnostics
• Table 2.2: Personalized Medicine at the Nexus Point
• Table 2.3: Percentage of Non-Responders in Various Drug Classes
• Table 2.4: High-Profile Drug Withdrawals from the Marketplace
• Table 2.5: Metabolism of Drugs by Hepatic Enzymes
• Table 2.6: Drug Metabolism Drives Drug Efficacy/Toxicity
• Table 2.7: Population Frequency of the Various Cytochromes
• Table 2.8: Selected List of Personalized Medicine Tests
• Table 2.9: Personalized Medicine Product Pipeline
• Table 2.10: Marketed Personalized Therapies in 2006
• Table 2.11: Typical Response Rates in Therapeutic Areas
• Table 2.12: Prevalence of People Taking Medications Metabolized by Liver Enzymes
• Table 2.13: UGT1A1 Helps to Determine Risks Associated with Irinotecan
• Table 2.14: Current Product Labels: Enzyme Metabolism
• Table 3.1: Timeline for Impact of Various Molecular Diagnostics Technologies on Personalized Medicine
• Table 3.2: Impact of Molecular Diagnostics Technologies on Therapeutic Areas in Personalized Medicine
• Table 3.3: Challenges of Various Molecular Diagnostics Technology Platforms in Personalized Medicine
• Table 3.4: FDA Classification of Diagnostics by Risk
• Table 4.1: Personalized Medicine Industry SWOT Analysis
• Table 4.2: Market Opportunities in Personalized Medicine
• Table 4.3: Challenges for Market Adoption of Various Personalized Medicine Tests
• Table 4.4: Hurdles to Personalized Medicine and Companion Diagnostics Development
• Table 4.5: Timeline of Impact in Areas of Personalized Medicine
• Table 4.6: Impact of Personalized Medicine on Various Therapeutic Areas
• Table 5.1: Potential Benefits of Biomarkers as Companion Diagnostics
• Table 5.2: Utility of Biomarker as Companion Diagnostics to Drug Development
• Table 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results
• Table 5.4: Device Submission Elements for the FDA
• Table 6.1: List and Discounted Prices for Abbott Tumor Marker Tests
• Table 6.2: Medicare Spending on Clinical Lab Services, 1996 to 2005
• Table 6.3: Hospital Laboratory Share of Part B Medicare Spending, 1996 to 2005
• Table 6.4: Medicare Part B Lab Spending Per Medicare Enrollee, 1998 to 2005
• Table 6.5: Summary of Biomarker Use in the Commercialization of Novel Oncology Pharmacotherapeutics
• Table 6.6: Pharmacoeconomic Challenges to the Implementation of Biomarkers as Companion Diagnostic Tests
• Table 7.1: Major Players in Companion Diagnostic Sector
• Table 7.2: Tumor Diagnosis Immunoassay
• Table 7.3: Tumor Diagnosis Radioimmunoassay
• Table 7.4: Summary of Matritech' s Product Development Programs

LIST OF FIGURES

• Figure 2.1: Personalizing Drug Treatment
• Figure 2.2: Approaches to Personalized Medicine
• Figure 2.3: The Phase I and II Processes of Drug Metabolism
• Figure 2.4: Hepatic Distribution of Human CYP450
• Figure 2.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism
• Figure 2.6: Genetic Components Determine Drug Metabolism
• Figure 2.7: Personalized Medicine Drugs in Development
• Figure 3.1: From Genetic Content to Personalized Medicine
• Figure 3.2: Impact of Diagnostic Testing on Healthcare Decision Making
• Figure 3.3: Impact of Diagnostic Testing on Healthcare Spending
• Figure 3.4: Breakout of the Molecular Diagnostics Marketplace by Country
• Figure 3.5: Breakout of the Molecular Diagnostics Marketplace by Vendor
• Figure 3.6: Molecular Diagnostics Market Segmentation
• Figure 3.7: Molecular Diagnostics Market Segmentation by Technology
• Figure 3.8: Market Survey Respondent Demographics
• Figure 3.9: Breakout of the Respondent Pool by Affiliation
• Figure 3.10: Segmentation of the Personalized Medicine Market
• Figure 4.1: Personalized Medicine Market Drivers
• Figure 4.2: Challenges in the Personalized Medicine Space
• Figure 5.1: Carcinogenesis Is a Multi-Step Process
• Figure 5.2: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC
• Figure 5.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH
• Figure 5.4: MGMT Methylation Status Correlates to Survival Rate
• Figure 6.1: Part B Spending on Clinical Lab Services, 1991 to 2005

Cytology and HPV Testing World Markets

1. Overview

• 1.1 Statement of Report
• 1.2 About this Report
• 1.3 Scope of the Report
• 1.4 Objectives
• 1.5 Methodology

2. Introduction to Cancer Biology and the Diagnostic Industry

• 2.1 Cancer
  • 2.1.1 The Disease
  • 2.1.2 Metastasis
  • 2.1.3 Demographics and Statistics of Cancer
• 2.2 The Drivers of the Biotech and Diagnostics Industry
  • 2.2.1 Top Ten Biotech Corporations
  • 2.2.2 Technological Innovation
  • 2.2.3 Government Funding
  • 2.2.4 Pharmaceutical Development
• 2.3 Outlook for Tumor Markers
• 2.4 The Cancer Market

3. Cervical Cytology Testing Overview

• 3.1 Sector Background
• 3.2 Market Opportunity
• 3.3 Cervical Cancer
  • 3.3.1 Screening for Cervical Cancer
  • 3.3.2 Screening Procedures and Pap Smear Technology

4. Human Papillomavirus (HPV) Testing Overview

• 4.1 Market Overview
  • 4.1.1 Human Papillomavirus
  • 4.1.2 North American Market
  • 4.1.3 European Market
  • 4.1.4 Latin American Market
• 4.2 Hybrid Capture 2 Technology
• 4.3 Histology Market Overview

5. Cytology Market Structure

• 5.1 Key Players
  • 5.1.1 BD, TriPath
  • 5.1.2 Cytyc (Acquired by Hologic)
  • 5.1.3 CytoCore, Inc. (formerly known as Molecular Diagnostics, Inc.)
• 5.2 BD, TriPath Products
  • 5.2.1. Cervical Cytology Product Line
    • 5.2.1.1 BD SurePath Pap Test
    • 5.2.1.2 BD PrepStain Slide Processor
    • 5.2.1.3 BD FocalPoint GS Imaging System
    • 5.2.1.4 BD FocalPoint Slide Profiler
    • 5.2.1.5 Molecular Oncology
    • 5.2.1.6 Molecular Imaging Systems
    • 5.2.1.7 Blood-based Reagents
  • 5.2.2 Hologic Products
    • 5.2.2.1 The ThinPrep System
      • 5.2.2.1.1 Additional Applications of the ThinPrep System
    • 5.2.2.2 The ThinPrep Process
    • 5.2.2.3 Clinical Studies Evaluating the ThinPrep Pap Test
    • 5.2.2.4 Competition
    • 5.2.2.5 Surgical Products
    • 5.2.2.6 The NovaSure System
    • 5.2.2.7 Competition
  • 5.2.3 CytoCore Inc., Products and Services
    • 5.2.3.1 SoftPAP Cervical Cell Collector
• 5.3 Marketing and Sales Strategies
  • 5.3.1 BD, TriPath Sales and Marketing
    • 5.3.1.1 Total Sales and Marketing
    • 5.3.1.2 Commercial Operations
    • 5.3.1.3 Marketing Strategy
    • 5.3.1.4 BD, TriPath' s Molecular Diagnostic Products
  • 5.3.2 Cytyc (Acquired by Hologic) Marketing and Sales
    • 5.3.2.1 Sales and Marketing Costs
    • 5.3.2.2 Hologic' s Marketing and Sales Strategy
      • 5.3.2.2.1 Domestic Strategy
      • 5.3.2.2.2 International Strategy
    • 5.3.2.3 Sales Strategy - Cervical Cytology Product Line
      • 5.3.2.3.1 Molecular Diagnostics
      • 5.3.2.3.2 Marketing and Sales Organizations
      • 5.3.2.3.3 Outside the U.S. with the Exception of Canada
• 5.4 Manufacturing BD, TriPath, BD SurePath and BD PrepStain
  • 5.4.1 Manufacturing Standards for Diagnostic Products
• 5.5 Competition
  • 5.5.1 Molecular Diagnostic Reagents

6. Human Papillomavirus (HPV) Testing Market Structure

• 6.1 Key Players
  • 6.1.1 Digene (Acquired by QIAGEN)
    • 6.1.1.1 Digene Products
  • 6.1.2 Ventana Medical Systems
• 6.2 Products
  • 6.2.1 HPV Tests
  • 6.2.2 Chlamydia and Gonorrhea Tests
  • 6.2.3 Blood Virus Tests
  • 6.2.4 Instrumentation and Accessory Products
  • 6.2.5 Vaccine
• 6.3 Sales and Marketing
  • 6.3.1 International Markets
  • 6.3.2 Europe
  • 6.3.3 Central and South America
  • 6.3.4 Asia/Pacific
  • 6.3.5 Strategy
• 6.4 Manufacturing
• 6.5 Competition
  • 6.5.1 Ventana
• 6.6 Ventana Staining Products
  • 6.6.1 Ventana Products

7. Business Trends in the Industry

• 7.1 Industry Consolidation
• 7.2 Breath of Product Offering and Pricing
• 7.3 Government Regulation of Medical Devices
• 7.4 Strategic Business and Marketing Considerations
• 7.5 Commercial Opportunities in Cancer Markers
• 7.6 Moderators of Growth
• 7.7 Biotechnology Industry Trends
• 7.8 Pharmaceutical Industry Trends
• 7.9 Acquisition, License Agreement and Partnerships
• 7.10 Legal Developments
• 7.11 Sales and Marketing Strategies for Tumor Marker Tests
  • 7.11.1 North American Market

8. Government Regulation

• 8.1 Government Regulation
• 8.2 U.S. FDA Approval
  • 8.2.1 Clinical Laboratory Improvement Act of 1988 and State Laboratory Laws
  • 8.2.2 Foreign Regulatory Approval

9. Legal Developments

• 9.1 Cytyc Legal Proceedings
• 9.2 Ventana Legal Proceedings

10. Third-Party Reimbursement

• 10.1 Limited Reimbursements by Third-party Payers Obstruct Sales
• 10.2 Cytyc ThinPrep
• 10.3 CPT Codes and HCPCS Codes
• 10.4 Professional Component Fee
• 10.5 Regional Payer Relations Managers
• 10.6 Reimbursement Codes Classification
  • 10.6.1 Reporting Screening and Diagnostic Pap Smears
  • 10.6.2 HCPCS (HCFA Common Procedure Coding System) Code Definitions
  • 10.6.3 CPT (Current Procedural Terminology) Code Definitions
• 10.7 A Note on Statutory Limitations
• 10.8 Cervical Cytology Product Line
• 10.9 Molecular Diagnostic Products and Imaging Systems

11. Barriers in Business

• 11.1 Barriers in the Business Section
  • 11.1.1 Hologic Barriers
  • 11.1.2 QIAGEN Risk Factors
  • 11.1.3 Ventana
    • 11.1.3.1 Ventana factors that could affect future results

12. Acquisition Activity

• 12.1 Acquisition
• 12.2 Hologic Acquires Cytyc

13. Research & Development Activity

• 13.1 Hologic In-Process R&D and Developed Technology
• 13.2 BD, TriPath Research & Development
  • 13.2.1 Development of Molecular Diagnostic Products
• 13.3 Digene Research & Development
• 13.4 Ventana Research & Development
  • 13.4.1 Instrumentation Development Projects
  • 13.4.2 Reagent Development Projects

14. Intellectual Property

• 14.1 BD, TriPath Proprietary Technology and Intellectual Property
• 14.2 Digene Intellectual Property
  • 14.2.1 Hybrid Capture Technology
  • 14.2.2 Rights to HPV Types
  • 14.2.3 Other Intellectual Property
• 14.3 Ventana Patents and Proprietary Rights

15. Hologic and Cytyc Profile

• 15.1 Company Information
  • 15.1.1 Contact
  • 15.1.2 About Cytyc and Hologic Together
• 15.2 Products/Business Segments
  • 15.2.1 Diagnostic Products
  • 15.2.2 The ThinPrep Process

16. Analytical Section

• 16.1 Financial Analysis
• 16.2 Company' s Strategies
• 16.3 SWOT Analysis

17. Industry/Market Landscape

• 17.1 Industry Overview
  • 17.1.1 Industry Key Players
    • 17.1.1.1 Cytology Screening Testing Market Structure
    • 17.1.1.2 Human papillomavirus (HPV) Testing Market Structure
• 17.2 Outlook on the Industry
• 17.3 Trends, Issues, Challenges and Opportunities: An Analysis
• 17.4 Molecular Diagnostics Products
  • 17.4.1 Microscopic Slide Based Reagents
  • 17.4.2 Molecular Imaging Systems
  • 17.4.3 Blood-Based Reagents
• 17.5 Competitive Landscape
• 17.6 Products/Business Segments
  • 17.6.1 Digene' s HPV Tests
  • 17.6.2 Digene' s Chlamydia and Gonorrhea Tests
  • 17.6.3 Digene' s Blood Virus Tests
  • 17.6.4 Digene' s Instrumentation and Accessory Products

18. QIAGEN

• 18.3 Analytical Section
  • 18.3.1 Financial Analysis
• 18.4 Company' s Strategies
• 18.5 SWOT Analysis

19. Industry/Market Landscape

• 19.1 Digene Industry Overview
  • 19.1.1 Industry Definition
    • 19.1.1.1 Cytology Products
  • 19.1.2 Industry Key Players
  • 19.1.3 Company' s Outlook on the Industry
• 19.2 Trends, Issues, Challenges and Opportunities - An Analysis
• 19.3 Competitive Landscape
• 19.4 Competition
  • 19.4.1 Digene' s Competitive Advantage
  • 19.4.2 Molecular Diagnostic Reagents
  • 19.4.3 BD, TriPath
• 19.5 Products/Business Segments
  • 19.5.1 Cervical Cytology Product Line (Formerly the i3 Series Product Line)
    • 19.5.1.1 BD PrepStain Slide Processor
    • 19.5.1.2 BD FocalPoint Imaging System
    • 19.5.1.3 BD SlideWizard Product Line
  • 19.5.2 Molecular Oncology Products
    • 19.5.2.1 Microscopic Slide Based Reagents
    • 19.5.2.2 Molecular Imaging Systems
    • 19.5.2.3 Blood-Based Reagents

20. Analytical Section

• 20.1 Financial Analysis
  • 20.1.2 BD, TriPath Oncology Revenues
• 20.2 Company' s Strategies
• 20.3 SWOT Analysis

21. Industry/Market Landscape

• 21.1 Industry Overview
  • 21.1.1 Industry Definition
    • 21.1.1.1 Cytology Products
    • 21.1.1.2 Molecular Diagnostic Products
  • 21.1.2 Industry Key Players
• 21.2 Company' s Outlook on the Industry
• 21.3 Trends, Issues, Challenges and Opportunities: An Analysis
• 21.4 Molecular Diagnostics Products
  • 21.4.1 Blood-Based Reagents
• 21.5 Competitive Landscape
  • 21.5.1 Competition
    • 21.5.1.2 BD, TriPath' s Competitive Advantage
    • 21.5.1.3 Molecular Diagnostic Reagents
    • 21.5.1.4 Ventana

Appendix 1: Breast Cancer

Appendix 2: Ovarian Cancer

Appendix 3: Malignant Melanoma

INDEX OF TABLES

• Table 2.1: Drug Development by Type of Cancer
• Table 2.2: The 402 Organ Specific Medicines in Development for Cancer
• Table 2.3: Leading Sites of Cancer Cases and Deaths in the U.S. by Sex
• Table 2.4: Estimated New Cancer Cases and Deaths by Type of Cancer, 2008
• Table 2.5: Estimated Number of New Cancer Cases and Deaths by World Area 2007
• Table 2.6: Cancer Death Rates per 100,000 Population (and Rank) for All Cancer Sites by Country
• Table 2.7: Cancer-Associated Genes
• Table 2.8: Carcinogens in the Workplace
• Table 2.9: Private Funding Levels for the Biotechnology Segment, 1995 to 2007
• Table 2.10: Global Pharmaceutical Industry R&D Spending, 1995 to 2007
• Table 2.11: U.S. Government NIH Research Budget, 1995 to 2008
• Table 2.12: Herceptin Worldwide Sales, 1999 to 2007
• Table 2.13: Classes of Drugs Used to Treat Breast Cancer
• Table 2.14: Women' s Cancers in the U.S., 2008
• Table 2.15: Five-Year Relative Survival Rates by Stage at Diagnosis
• Table 3.1: Number of Pap Smears Performed by Country
• Table 5.1: Pap Tests in Top European Markets
• Table 5.2: Pap Tests in Top Asian Markets
• Table 6.1: HPV Market Size, 2003 to 2011
• Table 6.2: Product, Infection and Market
• Table 6.3: Instrumentation and Accessories, Infection and Market
• Table 7.1: List and Discounted Pricing for Abbott Tumor Marker Tests
• Table 10.1: CPT and HCPCS Codes
• Table 10.2: National Limitation Amounts
• Table 10.3: NLAs for Various CPT Codes
• Table 14.1: HPV Types Status and Patents
• Table 17.1: Diagnostic Test Kit Products and Markets