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Cancer Bundle

TriMark Publications
May 1, 2011
1470 Pages - SKU: TRI6282637

Abstract Table of Contents Related Reports

The Cancer Reports Bundle includes the following TriMark Publications reports at a 15% discount off the individual reports being purchased separately:

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

Below are summaries of each report.

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.

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 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.

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.

Cancer vaccines have the potential to become a significant force in future cancer treatments. In 2010, Dendreon's Provenge became the first cancer vaccine approved by the FDA, generating renewed interest and support for this type of cancer immune therapy. Cancer vaccines can be divided into six main categories: antigen/adjuvant vaccines, DNA vaccines, vector-based vaccines, tumor cell vaccines, dendritic cell vaccines and anti-idiotype vaccines. This relatively new commercial market for cancer vaccines is poised to dramatically increase to over $7 billion by 2015. The purpose of this TriMark Publications report is to supply comprehensive information on the developing market for cancer vaccines. This study surveys almost all of the companies known to be marketing, manufacturing, or developing cancer vaccines in the world, providing in-depth analysis of the current and emerging technologies in the cancer vaccines market. Each company is extensively examined, with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company's market position. Moreover, this report provides detailed discussions of cancer vaccines funding trends, intellectual property, market opportunities, research collaborations, partnership activities, regulatory issues and guidelines for establishing new ventures. Detailed tables and charts with sales forecasts and market share data are also included.

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.

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.

Molecular diagnostics is a rapidly-advancing area of research and medicine, with new technologies and applications being continually added. The technologies that come under the umbrella of molecular diagnostics include first-generation amplification, DNA probes, fluorescent in-situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors and molecular labels, and gene expression profiling using microarrays. These technologies are improving the discovery of therapeutic molecules for cancer, the screening, diagnosis and classification of cancer patients, and the optimization of drug therapy. This TriMark Publications report describes the specific segment of the in vitro diagnostics (IVD) market known as molecular diagnostics (MD), with a specialization in the MD tests for cancer. In the current medical diagnostics market, molecular diagnostics for cancer testing offers one of the brightest areas for growth and innovation. The confluence of breakthroughs in genomics, proteomics, and the development of microarray devices to measure analytes in the blood and various body tissues, has led to this revolutionary market segment offering the power of advanced analytical techniques to the diagnosis and treatment of cancer. This report analyzes the size and growth of the molecular diagnostics market in its applications for cancer detection and therapy, examining the factors that influence the various market segments and the dollar volume of sales, both in the United States and worldwide.

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; 2.2 Cancer Detection and Treatment with Biomarkers; 2.3 Cancer: The Disease; 2.4 Drivers of the Biotech and Diagnostics Industry; 2.5 Outlook for Tumor Markers; 2.6 Focus on Proteomics; 2.7 Epigenic Markers for Cancer; 2.8 Molecular Diagnostics Testing for Cancer; 2.9 Market Opportunities
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; 3.4 Cancer Biomarker Market Estimates by Tissue of Origin; 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 AmpliChip®-based Personalized Medicine
5. Breast Cancer: 5.1 Overview of Breast Cancer Disease; 5.2 BRCA1 and BRCA2 Genes; 5.3 Estrogen Receptors and Breast Cancer; 5.4 HER2 Gene and Protein; 5.5 Herceptin® Treatment; 5.6 Tumor Assays for Adjuvant Chemotherapy; 5.7 Use of Genomics to Understand Breast Cancer; 5.8 Genetic Analysis Solution; 5.9 Gene Expression Microarrays and Recurrence Prediction; 5.10 Economic Benefits of Oncotype DX; 5.11 Increased Clinical Utility of Oncotype DX; 5.12 Second Generation Oncotype DX; 5.13 MammaPrint; 5.14 Rotterdam Signature 76-Panel; 5.15 Summary of Microarray Technologies; 5.16 Mass Spectrometry-based Approaches; 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; 6.3 Serum Protein Biomarkers for Ovarian Cancer; 6.4 Ovarian Cancer Triage Testing
7. Prostate Cancer: 7.1 Overview; 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; 8.2 Bladder Cancer Tests; 8.3 UroVysion Bladder Cancer Kit; 8.4 Ikoniscope® Robotic Digital Microscopy Platform; 8.5 Nuclear Matrix Protein Markers; 8.6 ImmunoCyt™/uCyt+™; 8.7 Cangen Microsatellite DNA; 8.8 Bladder Cancer Market
9. Colorectal Cancer: 9.1 Overview; 9.2 Screening for CRC; 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; 10.2 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
12. Lung Cancer
13. Enabling Technologies for Oncology Biomarker Discovery: 13.1 Automated Cellular Imaging System (ACIS®); 13.2 DNA Methylation; 13.3 Proteomics; 13.4 Secreted Proteins as Cancer Biomarkers; 13.5 Noncodings RNA as Potential Tumor Markers; 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: AlphaScreen®, AequoScreen®, DELFIA® and LANCE® 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; 15.9 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; 15.11 Companion Diagnostics and Personalized Medicine: Qualitative and Quantitative Market Analysis; 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; 17.4 Strategic Business and Marketing Considerations; 17.5 Commercial Opportunities in Cancer Markers; 17.6 Moderators of Growth; 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; 17.12 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; 17.21 Genetic Tests and Medical Records; 17.22 Medicare Reimbursement; 17.23 Global Drivers of Clinical Laboratory Testing; 17.24 Global Outlook for Cancer Biomarkers; 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 bioMérieux; 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 InterGenetics®; 18.54 Ipsogen; 18.55 LabCorp®; 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; A7.4 Submission of Pharmacogenomic Data; 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 BRACAnalysis® 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; 2.2 Adult Stem Cell-based Therapies (ASCs); 2.3 Stem Cell-based Cellular Therapies; 2.4 Clinical Uses of HSC; 2.5 What are the Challenges and Barriers to the Development of New and Improved Treatments Using HSCs?; 2.6 Cancer Stem Cells; 2.7 Cellular Immunotherapy with DCs in 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; 2.11 Cancer/Testis Antigens (CTAs): A Novel Cancer Marker?; 2.12 Minimal Residual Disease (MRD) Post-Bone Marrow Transplantation for Hemato-Oncological Diseases; 2.13 Clinical Implications of Minimal Residual Disease; 2.14 Genetic Engineering of Tumor Cells; 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; 3.2 Vaccines in Development; 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; 3.8 Vaccine for Non-Hodgkin’s Lymphoma; 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; 4.4 Antigens that are Commonly Found in Cancer Vaccines under Investigation Today; 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
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
7. Government Regulation of Cell Therapy Products: 7.1 Pharmaceutical Product Regulation; 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 Performed Worldwide; Table 3.5: Clinical Studies Utilizing MSCs; Table 3.6: Distribution of MSC-based Cancer Clinical Studies being Performed Worldwide; 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; 2.2 The Drivers of the Biotech and Diagnostics Industry; 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 IHC; 3.11 In Vivo Detection Cancer Products; 3.12 Radionuclides and X-Ray Detection Products; 3.13 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; 4.2 Clinical Laboratory Methods for Measuring Tumor Markers; 4.3 New Technologies for Cancer Diagnostics; 4.4 Clinical Methods for Diagnosis of Cancer
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 Ambrilia Biopharma, Inc.; 6.5 AMDL, Inc.; 6.6 Asuragen, Inc.; 6.7 Aureon Laboratories, Inc.; 6.8 Bard Diagnostics, Inc.; 6.9 Beckman, Dickinson and Company (BD) Diagnostics - TriPath; 6.10 Beckman Coulter, Inc.; 6.11 Biocode S.A.; 6.12 BioCurex; 6.13 Biomedical Diagnostics; 6.14 Biomerica; 6.15 bioMerieux; 6.16 BioModa, Inc.; 6.17 Bruker Daltonics; 6.18 Byk Gulden; 6.19 Cepheid; 6.20 Clarient, Inc.; 6.21 Correlogic Systems, Inc.; 6.22 CytoCore (formerly Molecular Diagnostics, Inc.); 6.23 Cytogen Corporation (now EUSA Pharma); 6.24 diaDexus, Inc.; 6.25 DiagnoCure, Inc.; 6.26 Diagnostic Automation / Cortez Diagnostics, Inc.; 6.27 DRG International, Inc.; 6.28 Eisai Co., Ltd.; 6.29 Enigma Diagnostics Ltd.; 6.30 Epigenomics AG; 6.31 Exact Sciences Corporation; 6.32 Exagen Diagnostics, Inc.; 6.33 Fujirebio Diagnostics, Inc.; 6.34 Gene Logic, Inc.; 6.35 Gen-Probe, Inc.; 6.36 Genomic Health; 6.37 Geron Corporation; 6.38 Hologic, Inc. (formerly Cytyc Corporation); 6.39 Immunicon Corporation (now Veridex, LLC); 6.40 Immunomedics, Inc.; 6.41 Incyte Pharmaceuticals, Inc.; 6.42 Ipsogen; 6.43 LabCorp; 6.44 Matritech; 6.45 Mitsubishi Kagaku Medical; 6.46 Molecular Devices (formerly Arcturus Bioscience, Inc.); 6.47 Myriad Genetics, Inc.; 6.48 Nexell Therapeutics, Inc.; 6.49 Northwest Biotherapeutics, Inc.; 6.50 Nuvelo, Inc.; 6.51 Oncotech, Inc.; 6.52 Oncothyreon, Inc. (formerly Biomira); 6.53 Panacea Pharmaceuticals, Inc.; 6.54 Poniard Pharmaceuticals, Inc.; 6.55 Polymedco, Inc.; 6.56 Princeton BioMeditech Corporation; 6.57 Qiagen; 6.58 Roche (F. Hoffman-La Roche, Ltd.); 6.59 Sanko Junyaku Co., Ltd.; 6.60 Siemens Heathcare Diagnostics; 6.61 Tosoh Corporation (Bioscience division); 6.62 Ventana Medical Systems, Inc.; 6.63 Veridex, LLC; 6.64 Vermillion, Inc.; 6.65 Worldwide Medical Corporation; 6.66 Xenomics, Inc. (TrovaGene, 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 Commercial Opportunities in Cancer Markers; 7.5 Moderators of Growth; 7.6 Biotechnology Industry Trends; 7.7 Pharmaceutical Industry Trends; 7.8 Sales and Marketing Strategies for Tumor Marker Tests
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 MS in Sequencing; 9.9 High-Throughput Organic Synthesis
10. New Cancer Markers in Basic Research: 10.1 Genetics of Cancer; 10.2 DNA Mismatch Repair Genes (MMRs); 10.3 Telomeres; 10.4 Diseases; 10.5 Tumor Markers; 10.6 Technology; 10.7 Disease-specific Technology
11. Market Trends and Forecasts: 11.1 Ultrasensitive Cancer Tests; 11.2 Mergers and Acquisitions (M&As) of Diagnostic Companies; 11.3 Reverse transcriptase-polymerase chain reaction (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
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 CRC Development; Figure 4.2: Progression of CRC Development; Figure 4.3: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC; Figure 4.4: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH; Figure 4.5: The BTA stat Test vs. Cytology; Figure 10.1: PCA3 Test Volume in U.S., 2005-2008
INDEX OF TABLES: Table 2.1: Organ-Specific Medicines in Development for Cancer; Table 2.2: Leading Sites of New Cancer Cases and Deaths in 2010 in the U.S. by Sex; Table 2.3: Worldwide Number of New Cancer Cases and Deaths by Type of Cancer; Table 2.4: Number of New Cancer Cases and Deaths by Region; Table 2.5: Cancer-Associated Genes; Table 2.6: Carcinogens in the Workplace; Table 2.7: Private Funding Levels for the Biotechnology Segment, 1995-2010; Table 2.8: Herceptin Worldwide Sales, 2000-2015; Table 2.9: Classes of Drugs Used to Treat Breast Cancer; Table 3.1: Tumor Biomarkers Currently in Common Use; Table 3.2: Global IVD Cancer Tumor Marker Testing Market Segments Growth Rates, 2005-2015; Table 3.3: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2015; Table 3.4: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2015; Table 3.5: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015; Table 3.6: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015; Table 3.7: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015; Table 3.8: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2015; Table 3.9: Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market; Table 3.10: Major Presence in Cancer Tumor Marker Diagnostics Markets; Table 3.11: Worldwide PSA Sales, 2000-2015; Table 3.12: U.S. PSA Sales, 2000-2015; Table 3.13: Serum Markers Used Clinically; Table 3.14: Drivers of IHC Growth; Table 3.15: Bladder Cancer Testing Efforts in the U.S. and Germany; Table 3.16: Worldwide Bladder Cancer Marker Sales, 2001-2015; Table 3.17: U.S. Bladder Cancer Marker Sales, 2001-2015; Table 3.18: Worldwide NMP22 Sales, 2001-2015; Table 3.19: Current Breast Cancer Products and Product Opportunities; Table 3.20: Products in Various Stages of Development for Cancers Other than Breast Cancer; Table 4.1: CRC Stages; Table 4.2: Worldwide CEA Sales, 2001-2015; Table 4.3: U.S. CEA Sales, 2001-2015; Table 4.4: Population Statistics of Serum Levels of PSA in Men Over 50 Years of Age; Table 4.5: Cell Doubling Time and Time to Reach PSA Level of 1,000 ng/mL; Table 4.6: Worldwide CA 19-9 Sales, 2001-2015; Table 4.7: U.S. CA 19-9 Sales, 2001-2015; Table 4.8: CA 19-9 Levels in Management of Pancreatic Cancer; Table 4.9: Worldwide CA 15-3 Sales, 2001-2015; Table 4.10: U.S. CA 15-3 Sales, 2001-2015; Table 4.11: TPA Marker Sensitivity; Table 4.12: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: How to Interpret Test Results; Table 4.13: Siemens Oncogene Science Biomarker Group Reagents; Table 4.14: Worldwide CA-125 Sales, 2001-2015; Table 4.15: U.S. CA-125 Sales, 2001-2015; Table 4.16: Number of Pap Smears Performed by Country; Table 4.17: Lung Cancer Survival Rates; Table 4.18: American Cancer Society Lung Cancer Facts; Table 4.19: Tests Identifying Molecular Markers in Urine; Table 4.20: Patient Category Applications; Table 4.21: Worldwide AFP Marker Sales, 2001-2015; Table 4.22: U.S. AFP Cancer Marker Sales, 2001-2015; Table 4.23: Potential Uses of Molecular Diagnostics in Cancer Management; Table 4.24: Markers Frequently Used to Identify Adult Stem Cells in the Prostate, Breast and Intestine; Table 4.25: CRC mAb Imaging Kits; Table 4.26: MammaPrint: Key Features; Table 6.1: Tumor Marker Tests; Table 6.2: Tumor Diagnosis Immunoassays; Table 6.3: Tumor Diagnosis Radioimmunoassays; Table 6.4: Summary of Matritech's Product Development Programs; Table 6.5: 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: Categories of Oncogenes; Table 10.2: Familial Cancer Syndromes and Tumor Suppressor Genes; 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; 3.3 The Pharmaceutical Industry; 3.4 Cancer Therapies; 3.5 New Product Trends
4. The Disease of Cancer: 4.1 Incidence of Cancer; 4.2 Causes of Cancer; 4.3 Risk Factors; 4.4 Cancer Costs
5. Specific Cancers: 5.1 Bladder Cancer; 5.2 Brain Cancer; 5.3 Breast Cancer; 5.4 Cervical Cancer; 5.5 Colon Cancer; 5.6 Leukemia; 5.7 Lymphoma; 5.8 Lung Cancer; 5.9 Ovarian Cancer; 5.10 Prostate Cancer
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: Estimated 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
Cancer Vaccines 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. Overview of Cancer: 2.1 Cancer Statistics; 2.2 The Cost of Cancer; 2.3 Cancers Being Targeted by Vaccine Therapies: Overview of Disease and Market
3. Introduction to Cancer Vaccines: 3.1 Overview of the Types of Cancer Vaccines; 3.2 Antigen/Adjuvant Vaccines; 3.3 DNA Vaccines; 3.4 Vector-based Vaccines; 3.5 Tumor Cell Vaccines; 3.6 Dendritic Cell (DC) Vaccines; 3.7 Anti-Idiotype Vaccines
4. Prophylactic Vaccines on the Market and in Development: 4.1 Cervical Cancer (HPV); 4.2 Prophylactic Breast Cancer Vaccine in Development
5. Therapeutic Vaccines on the Market and in Development: 5.1 Breakthroughs in the Cancer Vaccine Market: Vaccines on the Market; 5.2 Vaccines in Development (by Type of Vaccine)
6. Challenges and Issues in Cancer Vaccine Development: 6.1 Eliciting Appropriate Immune Response Against Cancer; 6.2 Clinical Trial Design; 6.3 Combination Therapies
7. Regulatory Issues: 7.1 Pharmaceutical Product Regulation; 7.2 New Drug Application (NDA) or Biologics License Application (BLA); 7.3 Post-Approval Phase; 7.4 Fast-Track Review; 7.5 Orphan Drug Designation and Exclusivity; 7.6 What Regulatory Guidance Is Needed for Companion Biomarkers?; 7.7 Oncology Biomarker Qualification Initiative; 7.8 IRB Approval in Clinical Trials; 7.9 U.S. Patent and Trademark Office (USPTO)
8. Trends Affecting the Cancer Vaccine Market: 8.1 Screening and Cancer Detection; 8.2 Public Perception of Vaccines; 8.3 Insurance Issues; 8.4 New Technological and Scientific Developments; 8.5 Personalized Medicine; 9. Business Landscape; 9.1 Technology and Market Trends; 9.2 M&A Activity; 9.3 Partnering; 9.4 Competitive Situation; 9.5 Intellectual Property Rights 97; 9.6 Industry Challenges and Strategic Recommendations for Commercialization; 9.7 Opportunities and Strategic Recommendations; 9.8 Requirements for a Successful Cancer Vaccine Products Industry
10. Company Profiles: 10.1 Advaxis; 10.2 Agenus (formerly Antigenics); 10.3 AlphaVax; 10.4 Antigen Express; 10.5 Apthera; 10.6 Argos Therapeutics; 10.7 AVAX Technologies; 10.8 Bavarian Nordic; 10.9 Bellicum Pharmaceuticals; 10.10 BioSante Pharmaceuticals; 10.11 Biovest International; 10.12 Celldex Therapeutics; 10.13 CG Therapeutics; 10.14 CureVac; 10.15 DanDrit Biotech; 10.16 Dendreon; 10.17 EMD Serono; 10.18 Geron; 10.19 GlaxoSmithKline; 10.20 GlobeImmune; 10.21 Immatics Biotechnologies; 10.22 ImmunoCellular Therapeutics; 10.23 Immunovaccine; 10.24 Inovio Pharmaceuticals; 10.25 KAEL-Gemvax; 10.26 MannKind; 10.27 Mologen AG; 10.28 NewLink Genetics Corporation; 10.29 Northwest Biotherapeutics; 10.30 NovaRx; 10.31 Oxford BioMedica; 10.32 Prima BioMed; 10.33 Scancell; 10.34 Transgene; 10.35 Trimed Biotech; 10.36 Vaccinogen; 10.37 Vical
INDEX OF FIGURES: Figure 2.1: Estimates of National Expenditures for Cancer Care in 2006 by Cancer Site; Figure 2.2: Person-Years of Life Lost (PYLL) in the U.S. Due to Cancer, Male, 2006; Figure 2.3: Person-Years of Life Lost (PYLL) in the U.S. Due to Cancer, Female, 2006; Figure 3.1: Antigen Presentation; Figure 3.2: Antigen/Adjuvant Cancer Vaccine Immunotherapy Process; Figure 3.3: DNA Cancer Vaccine Immunotherapy Process; Figure 3.4: Viral Vector Cancer Vaccine Immunotherapy Process; Figure 3.5: Modified Tumor Cell Cancer Vaccines; Figure 3.6: Dendritic Cell Vaccination Process; Figure 3.7: Schematic of Anti-idiotype Antibodies for Cancer Vaccines; Figure 5.1: New Therapeutic Cancer Vaccines Entering Clinical Study Per Year During 1990-2006
INDEX OF TABLES: Table 2.1: Estimated New Cancer Cases and Deaths in the U.S. by Sex for all Cancer Sites, 2010; Table 2.2: Estimated New Cancer Cases and Deaths for Ten Leading Cancer Sites in the U.S. in 2010, by Sex; Table 2.3: Worldwide Number of New Cancer Cases and Deaths by Leading Cancer Sites and by Level of Economic Development, 2008; Table 2.4: Number of New Cancer Cases and Deaths by World Area, 2008; Table 2.5: Estimated Annual Costs of Cancer in the U.S. in Billions, 2008; Table 2.6: Cancer Vaccines in the Pipeline, by Cancer Type; Table 3.1: Infectious Agents Involved in Cancer; Table 3.2: Cancer Vaccine Technologies; Table 3.3: Antigens Commonly Found in Cancer Vaccines; Table 3.4: Adjuvants Commonly Found in Cancer Vaccines; Table 4.1: Cervical Cancer Vaccines on the Market; Table 5.1: Therapeutic Vaccines on the Market; Table 5.2: Pipeline of Therapeutic Cancer Vaccines, by Type of Vaccine; Table 5.3: Antigen/Adjuvant Vaccines in Development; Table 5.4: DNA and RNA Vaccines in Development; Table 5.5: Vector-based Vaccines in Development; Table 5.6: Autologous Tumor Cell Vaccines in Development; Table 5.7: Allogeneic Tumor Cell Vaccines in Development; Table 5.8: Dendritic Cell Vaccines in Development; Table 5.9: Anti-Idiotype Vaccines in Development; Table 5.10: Competitors with Phase III Cancer Vaccine Candidates in Their Pipelines; Table 6.1: Mechanisms of Immune Evasion by Cancers; Table 6.2: Key Recommendations for Cancer Vaccine Clinical Trial Design; Table 6.3: Challenges and Strategic Recommendations for Clinical Trial Design; Table 6.4 Combination Strategies to Enhance a Vaccine's Anti-Tumor T-Cell Response; Table 7.1: Focus Areas for the FDA Critical Path Initiative; Table 9.1: Industry Challenges and Strategic Recommendations for Commercialization; Table 9.2: Required Elements of a Manufacturing Facility; Table 9.3: CMO Qualification Audit-Points to Investigate; Table 9.4: Strategies for Marketing Cancer Vaccines
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; 2.8 Companion Diagnostics Play an Increasing Role in Cancer Care; 2.9 Specific Examples of Clinical Situations Where Companion Diagnostics Are Being Deployed; 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; 5.2 Companion Diagnostics on the Market; 5.3 Epidermal Growth Factor Receptor Companions; 5.4 Myriad’s TheraGuide 5-FU; 5.5 Companions for Tyrosine Kinase Inhibitors: Erlotinib and Gefitinib; 5.6 Irinotecan and UGT1A1; 5.7 Gleevec (Imatinib) Companions; 5.8 Companion Diagnostics Involving Metabolizing Enzymes; 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; 5.14 Blood-Based Technologies; 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; 6.4 Strategic Business and Marketing Considerations; 6.5 Commercial Opportunities in Companion Markers; 6.6 Moderators of Growth; 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; 6.12 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; 6.21 Genetic Tests and Medical Records; 6.22 Medicare Reimbursement; 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
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; 2.2 The Drivers of the Biotech and Diagnostics Industry; 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
4. Human Papillomavirus Testing Overview: 4.1 Market Overview; 4.2 Hybrid Capture 2 Technology; 4.3 Histology Market Overview
5. Cytology Market Structure: 5.1 Key Players; 5.2 BD-TriPath Products; 5.3 Hologic Products; 5.4 CytoCore, Inc. Products and Services; 5.5 Marketing and Sales Strategies
6. Human Papillomavirus Testing Market Structure: 6.1 Key Players; 6.2 QIAGEN Products; 6.3 Sales and Marketing; 6.4 Competition; 6.5 HPV Vaccines; 6.6 Ventana (A Member of the Roche Group)
7. Business Trends in the Industry: 7.1 Industry Consolidation; 7.2 Breadth of Product Offering; 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 Sales and Marketing Strategies for Tumor Marker Tests
8. Product Regulation: 8.1 Government Regulation; 8.2 U.S. FDA Approval
9. Third-Party Reimbursement: 9.1 Limited Reimbursements by Third-Party Payers Obstruct Sales; 9.2 Hologic ThinPrep; 9.3 CPT Codes and Healthcare Common Procedure Coding System (HCPCS) Codes; 9.4 Reimbursement Codes Classification; 9.5 Cervical Cytology Product Line; 9.6 Molecular Diagnostic Products and Imaging Systems
10. Barriers in Business: 10.1 Barriers in the Business Section
11. Acquisition Activity: 11.1 Acquisition; 11.2 Hologic, Inc. Acquires Cytyc Corporation; 11.3 Becton, Dickinson and Company (BD) Diagnostics Acquires TriPath Imaging, Inc.; 11.4 QIAGEN Acquires Digene Corporation
12. Research & Development Activity: 12.1 Hologic In-Process R&D and Developed Technology; 12.2 BD-TriPath R&D; 12.3 QIAGEN (and Formerly Digene) R&D; 12.4 Ventana (Subsidiary of the Roche Group) R&D
13. Intellectual Property: 13.1 BD-TriPath Proprietary Technology and Intellectual Property; 13.2 QIAGEN Intellectual Property; 13.3 Ventana (Now a Member of the Roche Group) Patents and Proprietary Rights
14 Industry/Market Landscape: 14.1 Industry Overview; 14.2 Outlook on the Industry; 14.3 Trends, Issues, Challenges and Opportunities: An Analysis; 14.4 Competitive Landscape; 14.5 Products/Business Segments
15. Analytical Section: 15.1 Company Strategies; 15.2 SWOT Analysis
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: Organ-specific Medicines in Development for Cancer; Table 2.3: Estimates for the Leading Types of New Cancer Cases and Deaths in the U.S. by Sex, 2010; Table 2.4: Estimated New Cancer Cases and Deaths by Sex for All Types of Cancer; Table 2.5: Estimated Number of Cancer Cases and Deaths by World Area; 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, 1995-2009; Table 2.10: Global Pharmaceutical Industry R&D Spending, 1995-2010; Table 2.11: U.S. Government NIH Research Budget, 1995-2010; Table 2.12: Herceptin Worldwide Sales, 2000-2015; Table 2.13: Classes of Drugs Used to Treat Breast Cancer; Table 2.14: Women's Cancers in the U.S., 2010; Table 2.15: Five-Year Relative Survival Rates by Stage at Diagnosis; Table 3.1: Number of Pap Smears Performed by Country, 2009; Table 3.2: Global Market for HPV Molecular Diagnostic Testing, 2007-2015; Table 3.3: U.S. Market for HPV Diagnostic Testing, 2007-2015; Table 5.1: Pap Tests in Top European Markets; Table 5.2: Pap Tests in Top Asian Markets; Table 6.1: HPV Market Size, 2003-2015; 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 9.1: CPT and HCPCS Codes; Table 9.2: National Limitation Amounts (NLAs); Table 9.3: NLAs for Various CPT Codes; Table 13.1: HPV Types Status and Patents; Table 14.1: QIAGEN's Diagnostic Test Kit Products, Instrumentation and Markets
Molecular Diagnostics in Cancer Testing
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 Molecular Diagnostics: 2.1 Opening-up of Opportunities in Molecular Diagnostics; 2.2 Impact of the Human Genome Project on Molecular Diagnostics; 2.3 Considerations for Molecular and Clinical Diagnostics; 2.4 Molecular Diagnostics in the Post-Genomic Era; 2.5 Advances in Molecular Diagnostics Technologies; 2.6 Oligonucleotide Array Platforms; 2.7 Emerging Cancer Personalized Medicine Market; 2.8 Companion Tests for Drug Development; 2.9 Opportunities for IVDMIA Companies
3. Cancer Diagnostics Molecular Testing Market: 3.1 Market Description
4. Molecular Diagnostic Tests for Cancer: 4.1 Cancer Diagnostic Tests; 4.2 Breast Cancer; 4.3 Colorectal Cancer Molecular Diagnostics Market; 4.4 Prostate Cancer Molecular Diagnostics Market; 4.5 Other Cancer Molecular Diagnostic Markets; 4.6 Molecular Diagnostic Screening Test for Cancer; 4.7 Companion Diagnostic Tests for Cancer Therapeutics
5. Business: 5.1 Technology and Market Trends; 5.2 M&A Activity; 5.3 Partnerships; 5.4 Competitive Analysis; 5.5 SWOT Comparison of Business Models for Cancer Diagnostic Testing; 5.6 Intellectual Property Rights
6. Reimbursement and Billing: 6.1 Overview; 6.2 Trends in Reimbursement Practice; 6.3 Breast Cancer Tests; 6.4 Colon Cancer Tests; 6.5 Trends in Patient Care and Reimbursement; 6.6 Revenue Threats; 6.7 Billing
7. Government Regulation: 7.1 U.S. Food and Drug Administration; 7.2 CLIA Regulations; 7.3 Clinical Laboratory Improvement Act (CLIA); 7.4 State Licensing for Service Laboratories; 7.5 FDA Treatment of Multivariate Index Assays (IVDMIAs); 7.6 510(k) Clearance; 7.7 Pre-Market Approval (PMA); 7.8 ASRs; 7.9 What Regulatory Guidance is Needed for Companion Biomarkers?; 7.10 U.S. Patent and Trademark Office (USPTO); 7.11 IRB Approval in Clinical Trials; 7.12 Oncology Biomarkers Qualification Initiative Project; 7.13 FDA Clearance Picture for Insight Dx, MammaPrint, and Oncotype DX; 7.14 FDA Packaging Requirements for Erbitux; 7.15 Micoarray Quality Control (MAQC); 7.16 CAP Evidence-based Recommendations to Improve the Accuracy of ER and PR Testing; 7.17 ER and PR Proficiency Testing
8. Business Decisions Using Molecular Diagnostic Tests in Drug Development: 8.1 Advantages of a Pharmacogenomic Assessment of Genetic Biomarkers to Determine Clinical Dose; 8.2 What are Key Opportunities in Biomarker Discovery, Development and Commercialization?; 8.3 What are the Current Obstacles in Biomarker Implementation?; 8.4 How do Business Strategies, such as those Relating to Acquisition, Drive Biomarker Strategies?; 8.5 What is the Right Balance between External Partnerships and Internal Infrastructure?; 8.6 How might Novel Biomarker Development Lead to Acquisition Strategies?; 8.7 Which Types of Genetic Biomarkers should be Developed by Diagnostic Companies?; 8.8 What Strategies Help Translate Genetic biomarkers from Preclinical to Clinical Development?; 8.9 In what Class of Drugs is the Value of Using Genetic biomarkers in Decision making the Highest?; 8.10 How can Regulatory Oversight Drive Approval and Adoption of New Technologies?; 8.11 How can Big Pharma Co-develop Genetic Biomarkers for Regulatory Acceptance?; 8.12 How are Genetic Biomarkers being Used to reduce the Attrition Rate in Drug Development?; 8.13 How is ROI Measured Using Genetic Biomarkers in Drug Development?; 8.14 How might Organizational Structures Limit the Use of Genetic Biomarkers in; Drug Development and How Should R&D Organizations Address This Problem?; 8.15 How to Maximize Business Development through Biomarker Strategies?; 8.16 What is the Best Type of Business Model for Developing Genetic Biomarkers?; 8.17 What are Organizational Impediments in Genetic Biomarkers in Drug Development?; 8.18 What are Internal Capabilities for Novel Biomarker Development and Application?; 8.19 How can Key Biomarker Technical Expertise be Applied across a Complex and Highly-Stratified R&D Value Chain?; 8.20 At what Stage of Drug Development have Genetic Biomarkers Provided the Most Benefit?; 8.21 What Companies are the most Innovative in Development of Genetic Biomarkers?; 8.22 Best Values for Genetic Biomarkers in Drug Development and in Diagnostics; 8.23 Molecular Diagnostic Tests can Increase Value in an Associated Drug
9. Company Profiles: 9.1 Agendia; 9.2 ArcticDx, Inc.; 9.3 Arcxis Biotechnologies; 9.4 Aureon Laboratories; 9.5 bioTheranostics (AviaraDx); 9.6 Clarient, Inc.; 9.7 CombiMatrix Corporation; 9.8 DiagnoCure; 9.9 Epigenomics; 9.10 Exact Sciences Corporation; 9.11 Exagen Diagnostics, Inc.; 9.12 Exiqon; 9.13 Ferrer inCode; 9.14 Genomic Health, Inc.; 9.15 Genoptix, Inc.; 9.16 Gen-Probe; 9.17 InterGenetics, Inc.; 9.18 LabCorp; 9.19 Myriad Genetics, Inc.; 9.20 Nuvera Biosciences; 9.21 Orion Genomics; 9.22 QIAGEN NV; 9.23 Rosetta Genomics Ltd.; 9.24 Seegene; 9.25 Sequenom, Inc.; 9.26 SABiosciences Corporation; 9.27 Source MDx; 9.28 Targeted Molecular Diagnostics; 9.29 Xenomics, Inc.; Appendix 1: Definition of Terms for Molecular Diagnostics; Appendix 2: Standard Cancer Therapeutic Panels; Appendix 3: Menu of Specialized Technologies Used to Assess and Characterize; Cancer; Appendix 4: Technical Assessment of the KRAS Mutation Test by Several; Methodologies and Specialty Oncology Laboratories; Appendix 5: Overview of Microarrays
INDEX OF FIGURES: Figure 2.1: Finding Genes with Microassays; Figure 2.2: Use of Microassays for Studying Gene Expression; Figure 2.3: Using DNA Microarrays to Compare Cancer and Normal Cells; Figure 2.4: Microarrays for Prediction of Survival in Cancer; Figure 2.5: Finding New Drugs with Microarrays; Figure 2.6: Using Gene Expression Patterns to Chose Treatment; Figure 2.7: Segmentation of the Biomarker Development Market; Figure 3.1: Molecular Diagnostic Markets for Cancer Testing Globally, 2010; Figure 3.2: Molecular Diagnostic Markets for Cancer Testing U.S., 2010; Figure 3.3: Key Players Market Share in Global Molecular Diagnostics Cancer Testing Markets; Figure 3.4: Market Growth and Evolution of MD Cancer Biomarkers; Figure 4.1: Using DNA Microassays to Measure Gene Expression; Figure 4.2: Schematic of Molecular Diagnostics for Studying Gene Expression in Patients; Figure 4.3: HER-2/NEU Protein as a Target in Cancer Therapy; Figure 4.4: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Equivocal Results with IHC; Figure 4.5: ASCO-CAP Guidelines for HER2 Testing in Breast Cancer: Results by FISH; Figure 4.6: Action of Herceptin in Breast Cancer Patients; Figure 4.7: Analysis of Cancer Tissue by Microarray; Figure 4.8 Global Market Size and Share of Breast Cancer Molecular Diagnostic; Market, 2010; Figure 4.9 Incidence of CRC by Age Group; Figure 4.10 HNPCC Mutation Increases Risk of Cancer; Figure 4.11 APC Mutation Increases the Risk of Cancer; Figure 4.12 U.S. Market Share of Colon Cancer Molecular Diagnostic Market, 2010; Figure 4.13 Prostate-Specific Membrane Antigen; Figure 4.14 Estimates for PCA3 Test Volume in U.S., 2005-2008; Figure 4.15 U.S. Market Share of Ovarian Cancer Molecular Diagnostic Market,; 2010; Figure 5.1: FDA Co-developed Products as a Model for Collaboration; Figure 5.2: Segmentation of the Biomarker Development Market; Figure 6.1: Number of Oncotype DX Tests Performed, 1991-2006; Figure 7.1: OBQI and the Relationship of Governmental Regulatory Agencies; Figure 8.1: Discovery, Validation and Use of Genetic Biomarkers
INDEX OF TABLES: Table 2.1: Genes and Cancer Risk; Table 2.2: Use of Cancer Biomarkers to Enhance Patient Care; Table 2.3: Targeted Drug Therapies for Cancers; Table 2.4: Use of Cancer Biomarkers in Drug Development; Table 2.5: Utility of Biomarkers as Companion Diagnostics to Drug Development; Table 2.6: Time Line for Development of Companion Diagnostics; Table 3.1: Global Market for Molecular Diagnostics Cancer Testing, 2008-2016; Table 3.2: U.S. Market for Molecular Diagnostics Cancer Testing, 2008-2016; Table 3.3: Molecular Diagnostic Markets for Cancer Testing, 2010; Table 3.4: Key Players and Market Share in Global Molecular Diagnostics Cancer Testing Market; Table 3.5: Business Factors Influencing Advanced Oncology Testing Services; Table 3.6: Specific Diagnostic Products Categories Comprising the Cancer Diagnostic Market; Table 3.7: In Vitro Cancer BioMarker Market Segments Worldwide, 2007 and 2010; Table 3.8: Tumor Markers Currently in Common Use; Table 3.9: Global IVD Cancer Tumor Marker Testing Market Segments Growth Rates; Table 3.10: Worldwide Market Size in Dollar Volume for Tumor Marker Assays; Product Market, 2001-2010; Table 3.11: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-2010; Table 3.12: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010; Table 3.13: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010; Table 3.14: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010; Table 3.15: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-2010; Table 3.16: Global Distribution of IVD Cancer Tumor Marker Diagnostic Testing; Table 3.17: Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market; Table 3.18: Major Presence in Cancer Tumor Marker Diagnostics Markets; Table 3.19: Highlights of the Cancer Diagnostic Testing Segment; Table 3.20: Highlights of Certified Clinical Labs Specializing in Cancer Genetics and Molecular Diagnostic Services; Table 3.21: Strategies for Marketing Cancer Diagnostic Products; Table 3.22: Key Elements of MD Diagnostic Companies Marketing Plan; Table 4.1: Estimates for the Leading Sites of New Cancer Cases and Deaths in the U.S. by Gender; Table 4.2: Emerging Molecular Diagnostic Technologies; Table 4.3: Key Elements for Business Competition in Gene Expression Profiling for Cancer; Table 4.4: Key Elements for Future Success in the Gene Profiling for Cancer Segment; Table 4.5: Companies Marketing Products in the Cancer Molecular Diagnostics Sector; Table 4.6: Breast Cancer Overview; Table 4.7: Overview of ER/PR Testing and Response to Therapy; Table 4.8: Key Players in the Breast Cancer Molecular Diagnostic Space; Table 4.9: Commercially Available Molecular Diagnostic Products for Breast Cancer Assay; Table 4.10: Clinical Utility and Health Economic Benefits of Oncotype DX; Table 4.11: Overview of HER2/neu and Herceptin; Table 4.12: MammaPrint: Key Features; Table 4.13: Oncogene Science Biomarker Group Reagents; Table 4.14: Major Companies Marketing Breast Cancer Molecular Diagnostic Tests, 2010; Table 4.15: Global Market for Breast Cancer Molecular Diagnostic Testing, 2005-2010; Table 4.16: U.S. Market for Breast Cancer Molecular Diagnostic Testing,; 2005-2010; Table 4.17: Global Market Forecast for Breast Cancer Molecular Diagnostic Testing, 2011-2016; Table 4.18: U.S. Market Forecast for Breast Cancer Molecular Diagnostic Testing,; 2011-2016; Table 4.19: Breast Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact; Table 4.20: Breast Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact; Table 4.21: Summary of Strengths, Weaknesses, Opportunities and Threats of the Breast Cancer Molecular Diagnostic Market; Table 4.22: Colorectal Cancer Overview; Table 4.23: KRAS Mutation Assay; Table 4.24: KRAS Assays by Analytical Type; Table 4.25: KRAS Mutation Analysis Summary; Table 4.26: DxS KRAS Mutation Test Summary; Table 4.27: KRAS and BRAF in Clinical Use; Table 4.28: Product Development Opportunities in Cancer Tumor Types, 2008; Table 4.29: Key Players in the Colorectal Cancer Molecular Diagnostic Space; Table 4.30: ArcticDx Genetic Test, Colo Risk; Table 4.31: NexCourse CRC Test Offering and Treatment Direction; Table 4.32: Global Market for Molecular Diagnostic Colon Cancer Testing, 2005-2010; Table 4.33: U.S. Market for Molecular Diagnostic Colon Cancer Testing, 2005-2010; Table 4.34: Global Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2011-2016; Table 4.35: U.S. Market Forecast for Colon Cancer Molecular Diagnostic Testing, 2010-2016; Table 4.36: Colon Cancer Molecular Diagnostic Testing Market: Market Drivers Ranked in Order of Impact; Table 4.37: Colon Cancer Molecular Diagnostic Testing Market: Market Restraints Ranked in Order of Impact; Table 4.38: Summary of Strengths, Weaknesses, Opportunities and Threats of the Colon Cancer Market; Table 4.39: Players in the Prostate Cancer Molecular Diagnostic Space; Table 4.40: Players in the Bladder Cancer Molecular Diagnostic Space; Table 4.41: Commercially Available Molecular Diagnostic Products for Ovarian Caner Assay; Table 4.42: Global Market for Molecular Diagnostic Ovarian Cancer Testing, 2005-2010; Table 4.43: U.S. Market for Molecular Diagnostic Ovarian Cancer Testing, 2005-2010; Table 4.44: Global Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, 2011-2016; Table 4.45: U.S. Market Forecast for Ovarian Cancer Molecular Diagnostic Testing, 2010-2016; Table 4.46: Ovarian Cancer Molecular Diagnostic Testing Market: Market Drivers in Order of Impact; Table 4.47: Ovarian Cancer Molecular Diagnostic Testing Market: Market Restraints in Order of Impact; Table 4.48: Summary of Strengths, Weaknesses, Opportunities and Threats of the Ovarian Cancer Market; Table 4.49: Lung Cancer Survival Rates; Table 4.50: Lung Cancer Facts; Table 4.51: Potential of Cancer Biomarkers in Drug Delivery and Development; Table 4.52: Barriers to Adoption of Biomarkers in Clinical Use; Table 5.1: Technology Trends in Cancer Testing; Table 5.2: Trends in Theranostics; Table 5.3: Market Trends in Cancer Testing; Table 5.4: Molecular Diagnostics Cancer Market: Market Drivers Ranked in Order of Impact; Table 5.5: Molecular Diagnostics Cancer Market: Market Restraints Ranked in Order of Impact; Table 5.6: Companies That Offer Products to Profile Gene Expression in Breast Cancer; Table 5.7: Principal Competitive Factors in the Cancer Screening Market; Table 5.8: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of Care Market; Table 5.9: Molecular Diagnostics Cancer Market: Strategic Recommendations on Molecular Diagnostic Sector Business Functions; Table 5.10: Total Molecular Diagnostics Cancer Market: Impact of Top Industry Challenges (U.S.); Table 5.11: Utility of Biomarkers as Companion Diagnostics to Drug Development; Table 6.1: CPT Codes for Tumor Markers; Table 6.2: Genomic Health Oncotype DX Sales, 2006-2010; Table 6.3: Drivers in KRAS Testing; Table 6.4: Factors Determining Third-Party Payment for Advanced Cancer Tests; Table 7.1: Rules that Affect the Ability of a Cancer Diagnostic Service Lab to Conduct Business; Table 7.2: Focus Areas for the FDA Critical Path Initiative; Table A1: Tumor Markers Currently in Common Use 200

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