Report: Cancer Bundle TOC

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

Cancer Bundle

Table of Contents

Biomarker Technology Platforms for Cancer Diagnoses and Therapies

1. Overview

2. Introduction to Cancer Biology and the Diagnostic Industry

3. Market Analysis of the Cancer Biomarkers Space

4. Major Clinical Applications of Cancer Biomarkers

5. Breast Cancer

6. Ovarian Cancer

7. Prostate Cancer

8. Bladder Cancer

9. Colorectal Cancer

10. Genetic Diagnostics Set to Revolutionize Cancer Diagnostic Testing

11. Leukemia Biomarkers

12. Lung Cancer

13. Enabling Technologies for Oncology Biomarker Discovery

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

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

16. Cancer Biomarker Testing Sector and Company Analysis

17. Business Trends in the Industry

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

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

Glossary

INDEX OF FIGURES

INDEX OF TABLES

Cancer Cell Therapy Markets

1. Overview

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

3. Current Status of Cellular Therapies for Cancer

4. Tumor Antigens, Cancer Vaccines and Cellular Therapy

5. Other Competing Antibody Technologies

6. The Future of Cell Therapy Against Cancer

7. Government Regulation of Cell Therapy Products

8. Companies involved in Cancer Cell Therapy

9. Company Profiles

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

INDEX OF TABLES

Cancer Diagnostic Testing World Markets

1. Overview

2. Introduction to Cancer Biology and the Diagnostic Industry

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

4. Diagnostic Methods for Cancer Detection

5. Implications of Molecular Biology for New Diagnostic Cancer Tests

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

7. Business Trends in the Industry

8. Tumor Marker Testing: Important Issues

9. Important New Technology Areas

10. New Cancer Markers in Basic Research

11. Market Trends and Forecasts

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

INDEX OF TABLES

Cancer Therapeutics Markets

1. Overview

2. Introduction to the Cancer Therapeutic Market

3. Cancer Therapeutics Market Overview

4. The Disease of Cancer

5. Specific Cancers

6. Corporate Profiles

7. References

INDEX OF TABLES

Companion Diagnostics in Personalized Medicine and Cancer Therapy

1. Overview

2. Companion Diagnostics and Personalized Medicine