Breast Cancer Therapies Markets

  • ID: 2142428
  • November 2012
  • Region: Global
  • 271 Pages
  • TriMark Publications
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Breast cancer therapies are entering a new era as game-changers emerge for each of the major breast cancer patient populations. New market entrants must possess drug profiles and a savvy clinical development program to overcome such barriers to entry as a stringent regulatory environment and the incursion of cost containment within oncology.

This TriMark Publications report provides comprehensive information on major and minor shapers of the breast cancer drug treatment landscape. The study includes detailed discussions on the impact of critical factors, such as genericization, patent cliffs, drug shortages, reimbursement, predictive testing and personalized medicine, to help current and contemplative drug sponsors navigate the breast cancer pharmacotherapeutic market.

Moreover, this report contains a detailed analysis of each of the seven main modalities of breast cancer therapies, i.e., hormone therapy, surgery, radiation, molecular targeted therapy, chemotherapy, hormone treatment and targeted drug therapy. Additionally, this study examines prescribing trends and the arrival of the first biosimilar agents and electronic records in post-marketing surveillance.


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1. Overview
1.1 About This Report
1.2 Scope of This Report
1.3 Objectives
1.4 Methodology
1.5 Drugs Covered in This Report
1.6 Summary of Major Findings

2. About Breast Cancer
2.1 Tumorigenesis
2.2 Classification of Breast Cancer
2.3 Risk Factors of Breast Cancer
2.3.1 Gender, Age and Reproductive Status
2.3.2 Genetic Mutation and Family History
2.3.3 Environmental Factors
2.3.4 Breast Density
2.4 The Various Options for Treating Breast Cancer
2.4.1 Prevention of Breast Cancer
2.4.2 Chemoprevention
2.4.3 Prophylactic Surgery
2.4.4 Radiation Therapy
2.4.5 Systemic Therapy
2.4.6 Targeted Therapy
2.4.7 Chemotherapy
2.4.8 Hormone Therapy

3. Global and Regional Data on Breast Cancer
3.1 Global Breast Cancer Statistics, 2012
3.2 Breast Cancer in the U.S.
3.2.1 U.S. Breast Cancer Statistics at a Glance
3.2.2 Breast Cancer Occurrence in the U.S.
3.2.3 Geographic Differences in Breast Cancer Rates in the U.S.
3.2.4 Breast Cancer Mortality Rate in the U.S.
3.2.5 Breast Cancer in the U.S. by Age
3.2.6 Changing Trends in In Situ Breast Cancer
3.2.7 Changing Trends in Invasive Breast Cancer in the U.S.
3.2.8 Breast Cancer in the U.S. by Tumor Size
3.2.9 Breast Cancer by Age and Ethnicity in the U.S.
3.2.10 U.S.: Early Detection of Breast Cancer Breast Cancer Screening in the U.S.
3.3 Breast Cancer in Canada
3.4 Breast Cancer Screening, Survival and Mortality in OECD Countries
3.5 Breast Cancer in U.K.
3.5.1 Female Breast Cancer by Age in U.K.
3.6 Breast Cancer in Australia
3.7 Breast Cancer in China
3.7.1 Treatment Patterns in China for Breast Cancer
3.8 Burden of Breast Cancer in India
3.9 Overview of Breast Cancer Incidence in Seven Major Markets

4. Pharmaceutical Drugs Used in Breast Cancer Treatment
4.1 Selected Classes of Chemotherapies
4.1.1 Chemotherapies Available as Generics
4.1.2 Branded Chemotherapies
4.2 Hormone Treatments
4.3 Targeted Drug Therapy

5. Game Changers for Her2+ Breast Cancer for the Current Decade
5.1 Targeted Her2 Therapies in their Prime
5.2 About Her2+ Carcinoma
5.3 Molecular Targeted Agents
5.3.1 Herceptin Mechanism of Action of Herceptin Drug Profile of Herceptin Herceptin Resistance Herceptin Product Positioning Herceptin in the Adjuvant Setting Herceptin Biosimilars in Development Herceptin SC Reformulation
5.4 Predictive Testing for Her2+ Breast Cancer
5.5 New and Emerging Her2 Targeted Options
5.5.1 Pertuzumab
5.5.2 T-DM: Chemotherapy with Fewer Side Effects to Win the Patients
5.6 Roche's Her2 Portfolio and Oncology Pipeline
5.7 Data Prediction of Tykerb Utility after Failure of Herceptin Monotherapy
5.7.1 ALTTO and NEO-ALTTO: Drive Her2+ Tumors into Adjuvant Setting
5.7.2 TEACH Trial
5.7.3 Tykerb Product Positioning
5.7.4 GSK's Oncology Pipeline
5.8 Emerging Diagnostics to Aid Her2 Targeted Drug Selection
5.9 The More Distant Future of Her2 Targeted Therapy
5.9.1 Afinitor
5.9.2 Afatinib
5.9.3 Neratinib

6. Game Changers for Estrogen Receptor Positive Breast Cancer for Current Decade
6.1 About ER+ Breast Cancer
6.1.1 Standard of Care for the Treatment of ER+ Breast Cancer
6.2 Adjuvant Chemotherapy in ER+ Breast Cancer
6.3 Adjuvant Hormone Therapy in ER+ Breast Cancer
6.4 Afinitor Expected to be a Game Changer in ER+ Breast Cancer
6.4.1 mTOR/PI3k Resistance
6.5 Novartis' Oncology Pipeline
6.6 Biphosphonates Shown to Reduce Bone Metastases

7. Triple Negative Breast Cancer (TNBC)
7.1 Avastin
7.2 Angiogenesis Drugs in Development
7.3 PARP Inhibitors

8. Advances in Chemotherapy
8.1 Standard of Care for Chemotherapy
8.1.1 Physician Preference
8.2 New and Emerging Chemotherapies
8.3 Using Existing Chemotherapies in Novel Ways
8.4 Chemotherapies Reformulations
8.5 Chemotherapies and Drug Shortage Crisis
8.6 Future Trends: Tailoring Care
8.7 Elderly Patients
8.8 Adjuvant Chemotherapy in ER+ Breast Cancer
8.9 Adjuvant Chemotherapy in Her2+ Breast Cancer

9. Biomarkers, Molecular Diagnostics and Personalized Medicine in Breast Cancer Treatment
9.1 Overview of Markers and Diagnostics as Game Changers in Breast Cancer Treatment
9.2 Personalized Medicine: Applied Biomarkers and Companion Diagnostics
9.3 Multigene Diagnostic Tests
9.4 Biomarkers: Drug Tolerability and Toxicity
9.5 Personalized Medicine and Companion Diagnostic Tests in Breast Cancer
9.6 Her2 and Herceptin
9.7 Bayer's Advia Centaur Her2 Assay
9.8 Epidermal Growth Factor Receptor Companions
9.9 Companies Marketing Her2 Assays
9.9.1 Myriad's BRCA Companion Diagnostics Testing for BioMarin's PARP Inhibitor BMN 673
9.10 Biomarkers as Endpoints in Drug Discovery
9.11 Risks and Uncertainties of Companion Diagnostics
9.12 Biomarkers, Companion Diagnostics and Regulatory Environment

10. Drug Development for the Treatment of Breast Cancer
10.1 Targeted Drugs of the PI3k/mTOR Pathway
10.2 Her2 Targeted Agents
10.2.1 Neratinib
10.2.2 Afatinib
10.3 VEGF Modulators
10.4 Biologics
10.5 Vaccines
10.6 Overview of Safety Profiles of Pipeline Agents

11. Regulatory Trends: How Authorities May Change the Game
11.1 Introduction to Regulatory Trends
11.2 Case Study Avastin: Regulators Look to Overall Survivor Data
11.3 Case Study: T-DMI and Unmet Need
11.4 Case Study: Halaven and Trial Design
11.5 Postmarketing Surveillance
11.6 Regulators Look Towards Longer Term Outcomes
11.7 Regulatory Trends for Combination Therapies
11.8 Austerity Measures
11.9 Reimbursement
11.10 U.S. Healthcare Reform and its Potential Impact on Regulation
11.11 New PDUFA V Recommendations
11.12 Generics and Drug Shortages
11.13 Biomarker, Companion Diagnostics and the Regulatory Pathway
11.13.1 Regulatory Perspectives on Pharmacogenomics and Biomarker Validation
11.13.2 Role of Governmental Agencies in Driving the Adoption of Companion Diagnostics
11.13.3 Role of Insurance Industry in Driving Adoption of Pharmacogenomics
11.13.4 Role of Pharma Industry in Driving Adoption of Pharmacogenomics
11.13.5 FDA Guidance Document on Co-Development
11.13.6 Role of Diagnostic Industry in Driving the Adoption of Pharmacogenomics
11.14 2012 Regulatory Guidance for Biosimilars
11.15 Off-Label Use and Good Publication Practices
11.16 The Future Regulatory Environment for Oncology

12. Breast Cancer Therapies: Market Analysis
12.1 Growth in Breast Cancer Drug Market and the New Entrants
12.1.1 Market for Her2+ Drugs
12.1.2 Global Market for Breast Cancer Hormonal Therapies
12.1.3 Declining Revenue for Aromatase Inhibitors
12.1.4 Market for Targeted Therapy in Breast Cancer
12.1.5 Shortage of Chemotherapy Drugs
12.2 Breast Cancer Market in the U.S.
12.2.1 Growth in Inpatient Breast Cancer Services in the U.S.
12.2.2 Outpatient Breast Cancer Services in the U.S.
12.2.3 Chemotherapy Market in the U.S.
12.2.4 Number of Chemotherapy Patients with Breast Cancer in the U.S.
12.2.5 Number of Breast Cancer Surgeries in the U.S.
12.2.6 U.S. Market for Conventional Breast Cancer Treatments
12.2.7 U.S. Market for Standard Imaging Procedures in Breast Cancer
12.2.8 U.S. Market for Advanced Breast Imaging Procedures

Appendix 1: Breast Cancer Drug Therapies: Marketed and Development
Appendix 2: A Woman's Guide to Breast Cancer
Appendix 2.1: Breast Biopsy
Appendix 2.2: Staging of Breast Cancer
Appendix 2.3: Treatment Options
Appendix 3: Cancer Treatment and Survivorship
Appendix 3.1: Female Breast Cancer
Appendix 3.1.1: Treatment and Survival After Breast Cancer
Appendix 3.1.2: Special Concerns of Breast Cancer Survivors
Appendix 3.2: Childhood Cancer
Appendix 3.2.1: Treatment and Survival for Childhood Cancer
Appendix 3.3: Colon and Rectum Cancer
Appendix 3.3.1: Treatment and Survival for Colon and Rectum Cancer Patients
Appendix 3.4: Leukemia and Lymphomas
Appendix 3.4.1: Treatment and Survival for Leukemia and Lymphoma Patients
Appendix 3.5: Lung and Bronchus Cancer
Appendix 3.5.1: Treatment and Survival for Lung and Bronchus Cancer Patients
Appendix 3.6: Melanoma
Appendix 3.6.1: Treatment and Survival for Melanoma Patients
Appendix 3.7: Prostate Cancer
Appendix 3.7.1: Treatment and Survival Rate for Prostate Cancer Patients
Appendix 3.8: Testicular Cancer
Appendix 3.8.1: Treatment and Survival for Testicular Cancer Patients
Appendix 3.9: Thyroid Cancer
Appendix 3.9.1: Treatment and Survival Rate for Thyroid Cancer Patients
Appendix 3.10: Urinary Bladder Cancer
Appendix 3.10.1: Treatment and Survival Rate for Urinary Bladder Cancer Patients
Appendix 3.11: Uterine Corpus
Appendix 3.11.1: Treatment and Survival of Uterine Corpus Patients
Appendix 4: U.S. Spending on Cancer
Appendix 5: Oncology Drugs and Companion Diagnostics
Appendix 6: References


Figure 3.1: Breast Cancer Burden by Geography, 2009
Figure 3.2: Breast Cancer Incidence Worldwide
Figure 3.3: Lifetime Risk of Breast Cancer Worldwide
Figure 3.4: Breast Cancer Death Rate in the U.S. by Race and Ethnicity, 1975-2007
Figure 3.5: Age-Specific Female Breast Cancer Incidence and Mortality Rates in the U.S.
Figure 3.6: Incidence Rates of In Situ Breast Cancer by Age in the U.S., 1975-2008
Figure 3.7: Incidence Rates of Invasive Breast Cancer by Age, 1975-2008
Figure 3.8: Breast Cancer Incidence Rates by Tumor Size (= 2.0 cm) and Race, 1989-2008
Figure 3.9: Breast Cancer Rate (Tumor Size = 2.1-5.0 cm) in the U.S., 1989-2008
Figure 3.10: Localized Breast Cancer Rates in the U.S. by Race, 1976-2008
Figure 3.11: Female Breast Cancer Incidence and Mortality Rates by Race and Ethnicity in the U.S.
Figure 3.12: Percent of All Estimated Cancer Cases in Canadian Women, 2012
Figure 3.13: Breast Cancer Screening in women Aged 50-69 in OECD Countries, 2000 and 2009
Figure 3.14: Breast Cancer Five-Year Relative Survival Rate in OECD Countries, 1997-2009
Figure 3.15: Female Breast Cancer Mortality in OECD Countries, 2000 and 2009
Figure 3.16: Number of New Cases per Year and AS Rate in U.K., 2009
Figure 3.17: Estimated Breast Cancer Incidence in Australia, 2006-2015
Figure 3.18: Age-Standardized Incidence and Mortality Rates of the Most Common Cancers in India
Figure 5.1: Schematic Representation of Mechanism of Action of Herceptin
Figure 5.2: Blocking of Her2 Dimerization by Herceptin
Figure 5.3: Design of Herceptin H0648g Pivotal Trial
Figure 5.4: Increased Response Rate by the Addition of Xeloda to Herceptin Therapy
Figure 5.5: Extended Survival by 4.8 Months in Herceptin plus Xeloda Therapy
Figure 5.6: Herceptin's Black Box Warning
Figure 5.7: Clinical Benefit of Herceptin Shown in Four Pivotal Trials
Figure 5.8: Example of Her2 ICH and FISH
Figure 5.9: Her2 Expression via the Inform Dual ISH Assay
Figure 5.10: Interception of EGF Pathway at Different Points by Herceptin, Tykerb and Pertuzumab
Figure 5.11: CLEOPATRA Trial Design
Figure 5.12: CLEOPATRA Study Progression Free Survival
Figure 5.13: CLEOPATRA Safety Study
Figure 5.14: T-DM1 Study Design
Figure 5.15: T-DM1 Results, Phase II Evaluations
Figure 5.16: Complimentary Mechanisms of Action of Roche's 3 Her2 Agents
Figure 5.17: Roche's HER Targeted Therapy Clinical Development Program
Figure 5.18: Roche's Oncology Pipeline, Phase II and Later
Figure 5.19: Tykerb/Tyverb: The Oral Her2 Blocking Agent
Figure 5.20: Tykerb/Tryverb Works Differently than Herceptin, but on the Same Target
Figure 5.21: EGF100151 Study Design
Figure 5.22: Efficacy of Tykerb in the EGF100151 Study
Figure 5.23: Tykerb Safety and Tolerability: The EGF100151 Study
Figure 5.24: ALTTO Study Designs
Figure 5.25: NEO-ALTTO Study Design
Figure 5.26: Strong Efficacy for the Combination of Herceptin and Tykerb in NEO-ALTTO
Figure 5.27: Benefit in Hormone Receptor Negative and -Positive Her2 Tumors
Figure 5.28: GSK's Oncology Pipeline Includes Expanded and New Indications for Tykerb
Figure 6.1: Response Rates to Endocrine Manipulation in ER+ Patients, Based on Receptor Type
Figure 6.2: Adjuvant Chemotherapy in ER+ Breast Cancer
Figure 6.3: Novartis' BOLERO Registrational Program for Afinitor in Breast Cancer
Figure 6.4: BOLERO-2 Study Design
Figure 6.5: BOLERO-2 Progression Free Survival, Local
Figure 6.6: BOLERO-2 Progression Free Survival, Central
Figure 6.7: BOLERO-2 Progression Free Survival, Subgroups
Figure 6.8: BOLERO-2 Overall Survival
Figure 6.9: BOLERO-2 Safety
Figure 6.10: Intersection of mTOR and Estrogen Receptor Growth Pathways
Figure 6.11: Novartis' Oncology Pipeline and pl3k Modulators in Development
Figure 6.12: Novartis' Planned Filings 2012 and Later
Figure 6.13: Novartis' Candidate PI3k Modulators
Figure 8.1: Halavan's EMBRACE Trial: Improved Survival in Heavily Pretreated Patients
Figure 8.2: Halaven's EMBRACE Trial: Improved Overall Survival
Figure 8.3: Halaven Effective Largely Irrespective of Prior Chemotherapy Experience
Figure 8.4: Halaven Safety
Figure 8.5: Access and Rationale for Adjuvant Chemotherapy in ER+ Breast Cancer
Figure 9.1: Personalized Drug Treatment
Figure 9.2: Approaches to Personalized Medicine
Figure 9.3: The Oncotype DX Assay Provides an Individualized Recurrence Score Result
Figure 9.4: Mammaprint Genes by Biological Function
Figure 9.5: Mammaprint Gene Signature Predicts Survival
Figure 9.6: ASCO-CAP Guidelines for Her2 Testing in Breast Cancer: Equivocal Results with IHC
Figure 9.7: ASCO-CAP Guidelines for Her2 Testing in Breast Cancer: Results by FISH
Figure 9.8: Personalized Medicine Drugs in Development
Figure 10.1: EGF and Her2 Receptors
Figure 10.2: Afatinib PFS Results in NSCCL
Figure 11.1: Healthcare Spending in the U.S. and Selected OECD Countries, 1970-2008
Figure 12.1: Growth of Breast Cancer Drug Sales in Major Markets, 2011-2018
Figure 12.2: Growth of Her2+ Drug Sales, 2011-2018
Figure 12.3: Declining Revenue for Branded Hormonal Therapies, 2011-2018
Figure 12.4: Declining Revenue for Aromatase Inhibitors, 2011-2018
Figure 12.5: The Her2-/Her2+ Drug Sales in the Major Seven Markets, 2011-2018
Figure 12.6: U.S. Shortages of Chemotherapy Drugs, 2005-2010
Figure 12.7: U.S. Market: Inpatient Breast Cancer Services, 2011-2021
Figure 12.8: U.S. Market: Outpatient Breast Cancer Services, 2011-2021
Figure 12.9: U.S. Market: Number of Chemotherapy Utilization, 2011-2021
Figure 12.10: Number of Chemotherapy Patients with Breast Cancer in the U.S., 2010-2020
Figure 12.11: Number of Breast Cancer Surgeries in the U.S., 2010-2020
Figure 12.12: U.S. Outpatient Breast Cancer Services Utilization Growth Rate, 2011-2021
Figure 12.13: Percent Growth for Standard Imaging Procedures in U.S. for Breast Cancer, 2011-2021
Figure 12.14: U.S. Market: Percent Growth fore Advanced Imaging in Breast Cancer, 2011-2021
Figure A2.1: Tumor Sizes
Figure A3.1: Breast Cancer in the U.S. by Race and Stage at Diagnosis
Figure A3.2: Female Breast Cancer Treatment Patterns by Stage
Figure A3.3: Five-Year Survival Rates for Breast Cancer Patients by Race and Stage at Diagnosis
Figure A3.4: Distribution of Colon and Rectum Cancer by Race and Stage at Diagnosis
Figure A3.5: Colon Cancer Treatment Patterns by Stage
Figure A3.6: Rectal Cancer Treatment Patterns by Stage
Figure A3.7: Five-Year Survival Rates for Colon and Rectal Cancer Patients by Race and Stage at Diagnosis
Figure A3.8: Distribution (%) of Non-Hodgkin Lymphoma Patients by Race and Stage at Diagnosis
Figure A3.9: Chemotherapy Use among Leukemia Patients by Age
Figure A3.10: Non-Hodgkin Lymphoma Treatment Patterns
Figure A3.11: Distribution (%) of Lung and Bronchus Cancer by Race and Stage at Diagnosis
Figure A3.12: Non-Small Cell Lung Cancer Treatment Patterns by Stage
Figure A3.13: Five-Year Survival Rates for Lung and Bronchus Cancer Patients
Figure A3.14: Distribution (%) of Melanoma by Race and Stage
Figure A3.15: Five-Year Survival Rates for Melanoma Patients by Race and Stage
Figure A3.16: Distribution of Prostate Cancer by Race and Stage
Figure A3.17: Prostate Cancer Primary Treatment Patterns by Age
Figure A3.18: Five-Year Survival Rates for Prostate Patients by Race and Stage
Figure A3.19: Distribution of Testicular Cancer by Race and Stage
Figure A3.20: Treatment Patterns for Testicular Cancer Patients
Figure A3.21: Treatment Patterns for Non-Seminomatous Testicular Cancer
Figure A3.22: Five-Year Survival Rates for Testicular Cancer Patients by Race and Stage
Figure A3.23: Distribution of Thyroid Cancer by Race and Stage
Figure A3.24: Five-Year Survival Rates for Thyroid Cancer Patients by Race and Stage
Figure A3.25: Distribution of Urinary Bladder Cancer by Race and Stage
Figure A3.26: Muscle Invasive Bladder Cancer Treatment Patterns
Figure A3.27: Five-Year Survival Rates for Urinary Bladder Cancer Patients by Race and Stage
Figure A3.28: Distribution of Uterine Corpus Cancer by Race and Stage
Figure A3.29: Uterine Cancer Treatment Patterns by Stage
Figure A3.30: Five-Year Survival Rates for Uterine Corpus Cancer Patients by Race and Stage
Figure A3.31: Domains of Quality of Life
Figure A3.32: Observed-to-Expected Ratios for Subsequent Cancers by Site, Sex and Age 20 and Older
Figure A3.33: Observed-to-Expected Ratios for Subsequent Cancers by Primary Site
Figure A3.34: Unmet Caregiver Needs by Time Since Diagnosis
Figure A4.1: Estimates of National Expenditures for Cancer Care in 2010 by Site
Figure A4.2: National Expenditure for Cancer Care in 2010 by Site and Phase of Care
Figure A4.3: Proportion of National Expenditure for Cancer Care in 2010 by Site and Phase of Care
Figure A4.4: Percentage of Medicare Payments in the First Year Following Diagnosis for Cancer Care by Type of Service in 2002
Figure A5.1: Oncology Drugs and CDX Launches, 1995-2011
Figure A5.2: Major Oncology Firms' R&D Budgets, 2012
Figure A5.3: Oncology Pipeline-Drug Development Strategy
Figure A5.4: Oncology Drugs in Development and Future Launches
Figure A5.5: Launches, Launch Position and Drugs with CDX, 2012-2017
Figure A5.6: Past Oncology Launches vs. Forecast, 1997-2016


Table 2.1: Factors That Increase the Risk of Breast Cancer in Women
Table 2.2: Age-Specific Probabilities of Developing Invasive Breast Cancer
Table 3.1: Worldwide Number of New Cancer Cases and Deaths by Leading Cancer Sites, 2008
Table 3.2: Number of New Cancer Cases and Deaths by Geography, 2008
Table 3.3: Estimated New Female Breast Cancer Cases and Death by Age in the U.S., 2011
Table 3.4: Female Breast Cancer Incidence and Mortality Rates by Race, Ethnicity and State
Table 3.5: Five-Year Cause Specific Survival Rate by Race/Ethnicity
Table 3.6: Mammography Screening Prevalence by Age and Poverty Status in the U.S., 1987-2010
Table 3.7: Breast Cancer Incidence Rates per 100,000 Populations in U.K., 2009
Table 3.8: Number of Breast Cancer Patients in U.K., 2009-2010
Table 3.9: Metastatic Breast Cancer Patients Who Receive Later Lines of Chemotherapy in China
Table 3.10: Top-Three Chemotherapy Regimens for Breast Cancer in China
Table 3.11: Top-Three Stage IV Hormone Therapies in China
Table 3.12: Breast Cancer Drugs Available in China
Table 3.13: Utilization of Traditional Chinese Medicine for Breast Cancer
Table 3.14: Incident Breast Cancer Cases in Seven Major Markets, 2010-2019
Table 4.1: Selected, Partial List of Chemotherapies
Table 4.2: Currently Available Drugs for the Treatment of Breast Cancer
Table 5.1: Key Points About Herceptin
Table 5.2: Incidence of Congestive Heart Failure in Adjuvant Breast Cancer Studies
Table 5.3: Incidence of Cardiac Disfunction in Metastatic Breast Cancer Studies
Table 5.4: Selected Ongoing Pertuzumab Studies
Table 5.5: Key Points about Pertuzumab (Omnitarg)
Table 5.6: Key Efficacy Results from Tykerb's EGF100151 Study
Table 5.7: Tykerb: Recommendations for Diarrhea Management
Table 5.8: Tykerb (Lapatinib): Key Points
Table 7.1: Drugs Targeting Angiogenesis
Table 8.1: Selected Chemotherapies in Breast Cancer
Table 8.2: Currently Available Chemotherapies
Table 8.3: Chemotherapies Reformulations
Table 9.1: Timeline for Development of Companion Diagnostics
Table 9.2: Personalized Medicine at Nexus Point
Table 9.3: Percentage of Non-Responders in Various Drug Classes
Table 9.4: High-Profile Drug Withdrawals from the Marketplace
Table 9.5: Selected List of Personalized Medicine Tests
Table 9.6: ASCO-CAP Guidelines for Her2 Testing in Breast Cancer: Interpretation of Results
Table 9.7: Potential Benefits of Biomarkers as Companion Diagnostics
Table 9.8: Utility of Biomarker as Companion Diagnostics to Drug Development
Table 10.1: Selected Drugs and Classes in Development, Agents in Phase II or Later
Table 10.2: PI3k/mTOR Targeted Drugs in Development
Table 10.3: Breast Cancer Vaccines in Development
Table 10.4: Emerging Drugs and Selected Side Effect Profiles
Table A2.1: Staging of Breast Cancer
Table A3.1: Estimated Number of Cancer Survivors in the U.S. as of January 1, 2012
Table A3.2: Estimated Numbers of U.S. Cancer Survivors by Site as of January 1, 2012
Table A3.3: Estimated U.S. Cancer Survivors by Sex and Time since Diagnosis as of January 1, 2012
Table A3.4: Estimated U.S. Cancer Survivors by Sex and Age as of January 1, 2012
Table A5.1: Annual Revenue of Top Oncology Franchises, 2011

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The author of this report holds a Ph.D. in physiology. Trained at the University of California and seasoned with many decades of experience as a pharmaceutical industry analyst, the author also has had first-hand experience with drug development, product launches and medical communications. Company-specific information is obtained mainly from industry trade publications, academic journals, news and research articles, press releases and corporate websites, as well as annual reports for publicly-held firms. Additional sources of information include nongovernmental organizations (NGOs) such as the World Health Organization (WHO) and governmental entities, such as the United States Department of Health and Human Services (HHS), the National Institutes of Health (NIH), the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Where possible and practicable, the most recent data available have been used.

Some of the statistical information was taken from Biotechnology Associates’ databases and from TriMark’s private data stores. The information in this study was obtained from sources that we believe to be reliable, but we do not guarantee the accuracy, adequacy or completeness of any information or omission or for the results obtained by the use of such information. Key information from the business literature was used as a basis to conduct dialogue with and obtain expert opinion from market professionals regarding commercial potential and market sizes. Senior managers from major company players were interviewed for part of the information in this report.

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