Biomarker Technology Platforms for Cancer Diagnoses and Therapies

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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. 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.

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.

This report provides an in depth insight into cancer biomarkers including a detailed 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.

The main objectives of this analysis are:

This analysis emphasizes companies that are actively developing and marketing new reagents and supplies for performing cancer biomarker diagnostics tests. It discusses the various market trends and opportunities using new biomarkers, while providing an in-depth analysis of market share, revenue forecasts, and market drivers and restraints. The comprehensive focus of the study, backed by strategic recommendations, enables companies to position their growth strategies to benefit from the changing market conditions and obtain maximum return on investment.

This study surveys biotech companies known for marketing, manufacturing or developing instruments and reagents for the clinical cancer diagnostics market, both in the U.S. and the world.

Leading companies are discussed in-depth, with sections on the companies\' histories, product lines, business and marketing analyses, and subjective commentary on the companies\' market positions.This report answers the questions:

Table of Contents

  • Appendix 1: Cancer Biomarker Centers of Research330

  • Appendix 2: Myriad Patents on Genes BRAC1 and BRAC2331

  • Appendix 3: Common Laboratory Tests for Cancer332

  • Appendix 4: Questions/Issues in the Cancer Biomarkers Space339

  • Appendix 5: Cancer Markers Currently in Common Clinical Use341

  • Appendix 6: International Federation of Gynecology and Obstetrics (FIGO) Staging System for Primary Carcinoma of the Ovary342

  • Appendix 7: FDA Guidance for Industry: Pharmacogenomic Data Submission343
  • A7.1Introduction343
  • A7.2Background343
  • A7.3Submission Policy344
  • A7.3.1General Principles344
  • A7.3.2Specific Uses of Pharmacogenomic Data in Drug Development and Labeling346
  • A7.3.3Benefits of Voluntary Submissions to Sponsors and FDA347
  • A7.4Submission of Pharmacogenomic Data348
  • A7.4.1Submission of Pharmacogenomic Data During the IND Phase348
  • A7.4.2Submission of Pharmacogenomic Data to a New NDA, BLA, or Supplement349
  • A7.4.3Submission to a Previously Approved NDA or BLA350
  • A7.4.4Compliance with 21 CFR Part 58350
  • A7.4.5Submission of Voluntary Genomic Data from Application-Independent Research351
  • A7.5Format and Content of a VGDS351
  • A7.6Process for Submitting Pharmacogenomic Data352
  • A7.7Agency Review of VGDSs352

  • Glossary354


  • INDEX OF FIGURES

  • Figure 3.1: Potential Market for Cancer Biomarkers, 200648
  • Figure 3.2: Segmentation of the Cancer biomarkers Marketplace Based Upon Commercial Offerings-Products and Services51
  • Figure 3.3: Geographical Distribution of Cancer Tumor Diagnostic Testing55
  • Figure 3.4: Cancer Biomarkers Research Market, 2006-201160
  • Figure 3.5: Breast Cancer Biomarker Market Potential, 200566
  • Figure 3.6: Challenges in the Study or Utilization of Proteomic Cancer Biomarkers67
  • Figure 3.7: Challenges in the Study or Utilization of Companion Diagnostic Cancer Biomarkers67
  • Figure 3.8: Challenges in the Study or Utilization of Serum Cancer Markers68
  • Figure 3.9: Top Unmet Needs in Commercial Products in the Cancer Biomarkers Space69
  • Figure 5.1: Hybridization Process86
  • Figure 5.2: FISH Test Procedure87
  • Figure 5.3: Gene Expression Profiling97
  • Figure 15.1: Phase I and II Processes of Drug Metabolism179
  • Figure 15.2: Human Phase I Enzymes180
  • Figure 15.3: Human Phase II Enzymes180
  • Figure 15.4: Hepatic Distribution of Human CYP450181
  • Figure 15.5: Relative Contribution of CYP450 Enzymes to Drug Metabolism181
  • Figure 15.6: Genetic Components Determine Drug Metabolism182
  • Figure 15.7: From Genetic Content to Personalized Medicine198
  • Figure 15.8: Remuneration for Diagnostics198
  • Figure 15.9: Breakout of the Molecular Diagnostics Marketplace199
  • Figure 15.10: Molecular Diagnostics Market Segmentation200
  • Figure 15.11: Molecular Diagnostics Market Segmentation by Technology201
  • Figure 15.12: Market Survey Respondent Demographics205
  • Figure 15.13: Breakout of the Respondent Pool by Affiliation206
  • Figure 15.14: Segmentation of the Personalized Medicine Market206
  • Figure 15.15: Personalized Medicine Market Drivers210
  • Figure 15.16: Challenges in the Personalized Medicine Space211
  • Figure 16.1: Epigenomics Product Development Pipeline225
  • Figure 17.1: Medicare Part B Spending on Clinical Laboratory Services, 1991-2005259


  • INDEX OF TABLES

  • Table 2.1: Cancer Biomarkers at the Nexus Point19
  • Table 2.2: Drug Development by Type of Cancer22
  • Table 2.3: Organ Specific Medicines in Development for Cancer, 200623
  • Table 2.4: Estimates for the Leading Sites of New Cancer Cases and Deaths in the U.S. by Sex, 200724
  • Table 2.5: Estimated Worldwide Number of New Cancer Cases and Deaths by Type of Cancer24
  • Table 2.6: Estimated Number of New Cancer Cases and Deaths by Region25
  • Table 2.7: Cancer Death Rates per 100,000 Population (and Rank) for All Cancer Sites by Country26
  • Table 2.8: Cancer Associated Genes27
  • Table 2.9: Carcinogens in the Workplace27
  • Table 2.10: Cancer Biomarker Markets28
  • Table 2.11: Private Funding Levels for the Biotechnology Segment, 1995-200629
  • Table 2.12: Global Pharmaceutical Industry R&D Spending, 1995-200631
  • Table 2.13: U.S. Government NIH Research Budget, 1995-200731
  • Table 2.14: Tumor Markers Currently in Common Use33
  • Table 2.15: Herceptin Worldwide Sales, 1999-200734
  • Table 2.16: Classes of Drugs Used to Treat Breast Cancer34
  • Table 2.17: Solutions to Biomarker Developments36
  • Table 2.18: Vermillion Collaborations39
  • Table 2.19: Uses of Molecular Diagnostics in Detection and Management of Cancer41
  • Table 2.20: U.S. Cancer Diagnostic Testing Market Size, 2005-201243
  • Table 2.21: Market Opportunities for Cancer Biomarker Technology Platforms44
  • Table 3.1: Characteristics of Different Cancer Biomarker Types and Associated Market Opportunities50
  • Table 3.2: Segmentation of the Cancer Biomarker Market by Type/Lineage of Cancer Biomarkers and Market Size50
  • Table 3.3: In Vitro Cancer Marker Market Segments Worldwide, 2001 and 200752
  • Table 3.4: Worldwide Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-201052
  • Table 3.5: U.S. Market Size in Dollar Volume for Tumor Marker Assays Product Market, 2001-201053
  • Table 3.6: Worldwide In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-201053
  • Table 3.7: U.S. In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-201053
  • Table 3.8: Japanese In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-201054
  • Table 3.9: European In Vitro Cancer Tumor Marker Diagnostics Market Size, 2001-201054
  • Table 3.10: Global Distribution of IVD Cancer Tumor Marker Diagnostic Testing, 200554
  • Table 3.11: Estimated Market Share of Major Competitors in U.S. Cancer Tumor Marker Diagnostics Market55
  • Table 3.12: Major Presence in Cancer Tumor Marker Diagnostics Markets55
  • Table 3.13: Worldwide CEA Sales, 2001-201056
  • Table 3.14: U.S. CEA Sales, 2001-201057
  • Table 3.15: Cancer Genomic Biomarker Markets, 2002-201257
  • Table 3.16: Cancer Biomarkers Research Market Forecast, 2006-201160
  • Table 3.17: Cancer Biomarker Market Estimates by Tissue of Origin64
  • Table 3.18: Companies Developing New Proteomic Cancer Biomarker Technology Platforms72
  • Table 4.1: Cancer Biomarkers Used to Maximize Likelihood of Response74
  • Table 4.2: Biomarkers for Monitoring Therapeutic Effectiveness and Resistance74
  • Table 4.3: Biomarkers for Dose Response of Therapy74
  • Table 4.4: Decision on Optimal Duration of Therapy74
  • Table 5.1: U.S. Breast Cancer Rate Decline, 2002-200677
  • Table 5.2: BRCA Development Model79
  • Table 5.3: BRCA Test Development and Commercialization80
  • Table 5.4: BRAC Analysis80
  • Table 5.5: Revenue for BRACAnalysis® Risk Assessment Test, 2002-200680
  • Table 5.6: GEArray DNA Microarrays and RT2 Profiler PCR Arrays97
  • Table 5.7: Product Development Opportunities in Breast Cancer104
  • Table 5.8: Concentration of Some Abundant Proteins, New Cancer Biomarkers Identified by SELDI-TOF, and Classical Cancer Biomarkers in Serum111
  • Table 5.9: Questions Related to Diagnostic SELDI-TOF Technology113
  • Table 6.1: Worldwide CA-125 Sales, 2001-2010117
  • Table 6.2: U.S. CA-125 Sales, 2001-2010118
  • Table 6.3: Some Clinically Established Cancer Serum Markers Currently in Use for Cancer119
  • Table 6.4: Pathophysiology of Ovarian Cancer and Characterization of Ovarian Epithelial Tumors125
  • Table 7.1: Worldwide PSA Sales, 2000-2010127
  • Table 7.2: U.S. PSA Sales, 2000-2010127
  • Table 7.3: Molecular Gene Markers for Prostate Cancer129
  • Table 8.1: Worldwide Bladder Cancer Marker Sales, 2001-2010141
  • Table 8.2: U.S. Bladder Cancer Marker Sales, 2001-2010141
  • Table 8.3: Worldwide NMP22 Sales, 2001-2010142
  • Table 8.4: Summary of Matritech\'s Product Development Programs143
  • Table 8.5: Opportunities for Bladder Cancer Biomarkers144
  • Table 9.1: TNM Staging for Colorectal Cancer147
  • Table 10.1: Genetic Diagnostics Market, 2004-2012153
  • Table 13.1: Genomic and Proteomic Technologies165
  • Table 14.1: Potential Benefits of Biomarkers as Companion Diagnostics171
  • Table 14.2: Utility of Biomarker as Companion Diagnostics to Drug Development171
  • Table 14.3: Device Submission Elements for the FDA174
  • Table 14.4: Summary of Biomarker Use in the Commercialization of Novel Oncology Pharmacotherapeutics175
  • Table 14.5: Pharmacoeconomic Challenges to the Implementation of Biomarkers as Companion Diagnostic Tests175
  • Table 15.1: Percentage of Non-Responders in Various Drug Classes178
  • Table 15.2: High Profile Drug Withdrawals from the Marketplace178
  • Table 15.3: Drug Metabolism Drives Drug Efficacy/Toxicity183
  • Table 15.4: Population Frequency of the Various Cytochromes183
  • Table 15.5: Selected List of Personalized Medicine Tests185
  • Table 15.6: Personalized Medicine and Companion Diagnostics Product Pipeline186
  • Table 15.7: Marketed Personalized Therapies, 2006187
  • Table 15.8: Various Molecular Diagnostics Technologies: Timeline for Impact201
  • Table 15.9: Various Molecular Diagnostics Technologies: Impact on Different Therapeutic Areas in Personalized Medicine202
  • Table 15.10: Various Molecular Diagnostics Technologies: Technical Challenges in the Deployment for Personalized Medicine202
  • Table 15.11: Classification of Diagnostics by Risk204
  • Table 15.12: Areas in Personalized Medicine-Timeline of Impact207
  • Table 15.13: Impact of Personalized Medicine on Various Therapeutic Areas208
  • Table 15.14: Hurdles in Personalized Medicine and Companion Diagnostics Development in Various Therapeutic Areas209
  • Table 15.15: Market Opportunities in Personalized Medicine212
  • Table 15.16: Challenges for Market Adoption of the Various Personalized Medicine Tests213
  • Table 15.17: Personalized Medicine Industry SWOT214
  • Table 16.2: Clarient Revenue, 2002-2006219
  • Table 16.3: Clarient Percentage of Revenue, 2004-2006219
  • Table 16.4: Opportunities for Biomarkers in Cancer Diagnosis and Treatment220
  • Table 16.5: Myriad Biomarker Revenue, 2002-2006230
  • Table 17.1: List and Discounted Prices for Abbott Tumor Marker Tests238
  • Table 17.2: Hospital Laboratory Share of Part B Medicare Spending, 1996-2005259
  • Table 17.3: Medicare Spending on Clinical Lab Services, 1991-2005260
  • Table 17.4: Medicare Part B Spending Per Medicare Enrollee, 1998-2005260
  • Table 18.1: Tumor Diagnosis Immunoassay293
  • Table 18.2: Tumor Diagnosis Radioimmunoassay293
  • Table 18.3: Summary of Matritech\'s Product Development Programs310
  • Table A1: Team Descriptions330
  • Table A5: Cancer Markers in Use341

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