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Afinitor (Breast Cancer) ' Analysis and Forecasts to 2020
Published on October 2011

                                                                                                                Report Summary

Afinitor (Breast Cancer) ' Analysis and Forecasts to 2020


Summary


GlobalData's pharmaceuticals report, 'Afinitor (Breast Cancer) ' Analysis and Forecasts to 2020' provides Afinitor sales estimates for
US, EU5 and Japan. In addition, it covers detailed clinical assessment of the drug, factors impacting drug sales, competitive
landscape, and analysis of sales performance during the forecast period (2013-2020). The report also includes information on Breast
Cancer market. This report is built using data and information sourced from GlobalData's proprietary databases, primary and
secondary research using Company's corporate website, SEC filings, investor presentations and featured press releases, both from
company and industry-specific third party sources, put together with in-house analysis, by GlobalData's team of industry experts.


Note: This is a on-demand report and will be delivered within 7 business days (excluding weekends) of the purchase.


Scope


- Therapy area profile including patient population for the US, EU5 and Japan (seven major markets)
- Analysis and review of Afinitor including sales data
- Qualitative and quantitative assessment of market space
- Analysis of the trends, drivers and restraints shaping and defining the markets
- In-depth analysis of Afinitor including efficacy, safety, pricing, competition and other details which influence its sales potential
- Detailed sales forecast for 2013-2020 for Afinitor in the seven major markets


Reasons to buy


- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of competition by understanding the changing competitive landscape
- Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential
- Make more informed business decisions from insightful and in-depth analysis of the drug's performance
- Examine the historical sales performance of a drug in seven major markets
- Obtain sales forecast for currently marketed/pipeline drug for 2011-2020 for all seven major markets




                                                                                                                 Table of Content

1 Table of Contents 2
1.1 List of Tables 3
1.2 List of Figures 3
2 Introduction 5
2.1 Breast Cancer Market 5



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2.2 Epidemiology 5
2.3 GlobalData Report Guidance 7
3 Breast Cancer: Market Characterization 8
3.1 Breast Cancer Market 8
3.2 Breast Cancer Market Forecasts and CAGR 8
3.3 Drivers of Breast Cancer Market 9
3.3.1 High Prevalence 9
3.3.2 Breast Cancer: Most Frequent Cancer in Women 9
3.3.3 Increasing Breast Cancer Incidence Rate 10
3.3.4 Decreasing Breast Cancer Mortality Rate 11
3.3.5 High Survival Rates of Breast Cancer 13
4 Staging of Breast Cancer: Introduction 15
4.1 Distribution of Patients by Stages 15
4.1.1 Stages 15
5 Predictive Biomarker in the Treatment of Breast Cancer 18
6 Treatment Options of Breast Cancer 20
6.1 Stage 0 Breast Cancer: Treatment Options 20
6.2 Early Stage Breast Cancer (Excluding Stage 0) 21
6.3 Metastatic Breast Cancer (MBC) 23
6.3.1 Endocrine Treatment: Adjuvant, First Line and Second Line 23
6.3.2 Cytotoxic Chemotherapy 25
6.3.3 Management of Patients with HER-2 Positive Patients 27
7 Afinitor 29
7.1 Introduction 29
7.2 Mechanism of Action 29
7.3 Clinical Studies 29
7.3.1 Phase I/II trial to Determine the Safety and Efficacy of everolimus (E) plus trastuzumab (T) in Patients with T-resistant
Metastatic Breast Cancer 29
7.3.2 Everolimus in Combination with trastuzumab and paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic
Breast Cancer (BOLERO-1) 30
7.3.3 Everolimus in Combination with exemestane in the Treatment of Postmenopausal Women with ER Positive Locally Advanced or
Metastatic Breast Cancer who are Refractory to letrozole or anastrozole (BOLERO-2) 30
7.3.4 Daily everolimus in Combination with trastuzumab and vinorelbine in HER2 Positive women with Locally Advanced or Metastatic
Breast Cancer (BOLERO-3) 30
7.4 Approval Status of Afinitor 30
7.5 Factors Affecting Sales of Afinitor 30
7.5.1 Absence of Competition from Neratinib in Japan 30
7.5.2 Patent Expiry of Aromasin before Launch of Afinitor for Breast Cancer 30
7.5.3 High Cost of Afinitor 31
7.6 Drug Risk Benefit Score 31
7.6.1 Efficacy 31
7.6.2 Safety 31
7.6.3 Compliance 31
7.6.4 Dosing Convenience 32
7.7 Intensity of Competition 32
7.8 Sales Forecasts 32
7.8.1 Target Patient Pool of Afinitor 32
7.8.2 Dosing 33



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7.8.3 Market Penetration 33
7.8.4 Annual Cost of Therapy 34
7.8.5 Sales Projections of Afinitor 34
8 Appendix 44
8.1 Market Definitions 44
8.2 Abbreviations 44
8.3 Research Methodology 44
8.3.1 Coverage 44
8.3.2 Secondary Research 45
8.3.3 Forecasting 45
8.3.4 Number of Patients Approved to take the Drug 45
8.3.5 Net Penetration of Drug 46
8.3.6 Net Annual Dosing 47
8.3.7 Annual Cost of Therapy 47
8.3.8 Primary Research 47
8.3.9 Expert Panels 47
8.4 Contact Us 48
8.5 Disclaimer 48
8.6 Sources 48


1.1 List of Tables


Table 1: Breast Cancer, Incidences and Mortality, By Country, 2008-2030 5
Table 2: Breast Cancer, Global, Market Size Forecasts ($bn), 2010'2020 8
Table 3: Five-Year Relative Survival Rates, By Stages 14
Table 4: Approval Status of Afinitor 30
Table 5: Drug Risk Benefit Score of Afinitor 31
Table 6: Annual Cost of Therapy of Afinitor 34
Table 7: Afinitor, Breast Cancer, Global, Sales Forecasts ($m), 2013'2020 35
Table 8: Afinitor, Breast Cancer, the US, Sales Forecasts ($m), 2013'2020 36
Table 9: Afinitor, Breast Cancer, the UK, Sales Forecasts ($m), 2013'2020 37
Table 10: Afinitor, Breast Cancer, France, Sales Forecasts ($m), 2013'2020 38
Table 11: Afinitor, Breast Cancer, Germany, Sales Forecasts ($m), 2013'2020 39
Table 12: Afinitor, Breast Cancer, Italy, Sales Forecasts ($m), 2013'2020 40
Table 13: Afinitor, Breast Cancer, Spain, Sales Forecasts ($m), 2013'2020 41
Table 14: Afinitor, Breast Cancer, Japan, Sales Forecasts ($m), 2013'2020 42


1.2 List of Figures


Figure 1: Distribution by Incidence and Mortality, Most Commonly Diagnosed Cancers, Worldwide, 2010 6
Figure 2: Breast Cancer, Global, Market Size Forecasts ($bn), 2010'2020 8
Figure 3: Top 10 Most Frequent Cancers on Incidence-Mortality Matrix, Worldwide, 2010 9
Figure 4: Incidence per 100,000, Breast Cancer, Selected Countries, 1975-2005 10
Figure 5: Incidence per 100,000, Breast Cancer, Selected Countries, 1975-2005 10
Figure 6: Breast Cancer, Incidence, Worldwide, 2008-2030 11
Figure 7: All Cancers, Incidence, Worldwide, 2008-2030 11
Figure 8: Mortality per 100,000, Breast Cancer, Selected Countries, 1975-2005 12
Figure 9: Mortality per 100,000, Breast Cancer, Selected Countries, 1975-2005 12



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Figure 10: Breast Cancer, Mortality, Worldwide, 2008-2030 13
Figure 11: All Cancers, Mortality, Worldwide, 2008-2030 13
Figure 12: Broad Classification of Breast Cancer, By Type 15
Figure 13: Classification of Non-Invasive Breast Cancer, By CIS 15
Figure 14: Classification of Invasive Breast Cancer, By Stages 16
Figure 15: Classification of Invasive Breast Cancer, By Treatment 16
Figure 16: Classification of Metastatic or Advanced Breast Cancer 16
Figure 17: Classification of Early Stage Breast Cancer (Excluding Stage 0) 17
Figure 18: Classification of Locally Advanced Breast Cancer 17
Figure 19: Metastatic Breast Cancer Classification 17
Figure 20: Current Molecular Biomarkers used in the Clinical Management of Breast Cancer 18
Figure 21: Breast Cancer Intrinsic Sub Types used for Deciding Treatment Options for MBC 19
Figure 22: Breast Cancer Types in Decreasing Order of their Aggressiveness 19
Figure 23: Treatment Options, DCIS Breast Cancer 20
Figure 24: Treatment Options, LCIS Breast Cancer 21
Figure 25: Treatment Options, Stages I, II and IIIA 21
Figure 26: Treatment Options, Stages I, II and IIIA (HR Positive and Premenopausal Breast Cancer) 22
Figure 27: Treatment Options, Stages I, II and IIIA (HR Negative, Pre and Postmenopausal Breast Cancer) 22
Figure 28: Treatment Options, Stages I, II and IIIA (HR Positive Postmenopausal Breast Cancer) 23
Figure 29: Adjuvant Therapy for HR Positive, HER2 Negative Metastatic Breast Cancer 24
Figure 30: Hormonal Therapy in Adjuvant Setting in HR Positive, HER2 Negative MBC 24
Figure 31: Adjuvant and First Line Therapy for HR Negative, HER2 Negative Metastatic Breast Cancer 26
Figure 32: Treatment Options, HR Negative and HER2 Positive Metastatic Breast Cancer 27
Figure 33: Drug Model Diagram of Afinitor in the US, EU and Japan 33
Figure 34: Afinitor, Breast Cancer, Global, Sales Forecasts ($m), 2013'2020 35
Figure 35: Afinitor, Breast Cancer, the US, Sales Forecasts ($m), 2013'2020 36
Figure 36: Afinitor, Breast Cancer, the UK, Sales Forecasts ($m), 2013'2020 37
Figure 37: Afinitor, Breast Cancer, France, Sales Forecasts ($m), 2013'2020 38
Figure 38: Afinitor, Breast Cancer, Germany, Sales Forecasts ($m), 2013'2020 39
Figure 39: Afinitor, Breast Cancer, Italy, Sales Forecasts ($m), 2013'2020 40
Figure 40: Afinitor, Breast Cancer, Spain, Sales Forecasts ($m), 2013'2020 41
Figure 41: Afinitor, Breast Cancer, Japan, Sales Forecasts ($m), 2013-2020 42
Figure 42: Afinitor, Breast Cancer, Global, Sales Distribution by Country ($m), 2020 43
Figure 43: Drug Model Diagram 46
Figure 44: Patients Approved to take the Drug 47




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Afinitor (Breast Cancer) ' Analysis and Forecasts to 2020

  • 1. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! Afinitor (Breast Cancer) ' Analysis and Forecasts to 2020 Published on October 2011 Report Summary Afinitor (Breast Cancer) ' Analysis and Forecasts to 2020 Summary GlobalData's pharmaceuticals report, 'Afinitor (Breast Cancer) ' Analysis and Forecasts to 2020' provides Afinitor sales estimates for US, EU5 and Japan. In addition, it covers detailed clinical assessment of the drug, factors impacting drug sales, competitive landscape, and analysis of sales performance during the forecast period (2013-2020). The report also includes information on Breast Cancer market. This report is built using data and information sourced from GlobalData's proprietary databases, primary and secondary research using Company's corporate website, SEC filings, investor presentations and featured press releases, both from company and industry-specific third party sources, put together with in-house analysis, by GlobalData's team of industry experts. Note: This is a on-demand report and will be delivered within 7 business days (excluding weekends) of the purchase. Scope - Therapy area profile including patient population for the US, EU5 and Japan (seven major markets) - Analysis and review of Afinitor including sales data - Qualitative and quantitative assessment of market space - Analysis of the trends, drivers and restraints shaping and defining the markets - In-depth analysis of Afinitor including efficacy, safety, pricing, competition and other details which influence its sales potential - Detailed sales forecast for 2013-2020 for Afinitor in the seven major markets Reasons to buy - Understand and capitalize by identifying products that are most likely to ensure a robust return - Stay ahead of competition by understanding the changing competitive landscape - Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential - Make more informed business decisions from insightful and in-depth analysis of the drug's performance - Examine the historical sales performance of a drug in seven major markets - Obtain sales forecast for currently marketed/pipeline drug for 2011-2020 for all seven major markets Table of Content 1 Table of Contents 2 1.1 List of Tables 3 1.2 List of Figures 3 2 Introduction 5 2.1 Breast Cancer Market 5 Afinitor (Breast Cancer) ' Analysis and Forecasts to 2020 (From Slideshare) Page 1/6
  • 2. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! 2.2 Epidemiology 5 2.3 GlobalData Report Guidance 7 3 Breast Cancer: Market Characterization 8 3.1 Breast Cancer Market 8 3.2 Breast Cancer Market Forecasts and CAGR 8 3.3 Drivers of Breast Cancer Market 9 3.3.1 High Prevalence 9 3.3.2 Breast Cancer: Most Frequent Cancer in Women 9 3.3.3 Increasing Breast Cancer Incidence Rate 10 3.3.4 Decreasing Breast Cancer Mortality Rate 11 3.3.5 High Survival Rates of Breast Cancer 13 4 Staging of Breast Cancer: Introduction 15 4.1 Distribution of Patients by Stages 15 4.1.1 Stages 15 5 Predictive Biomarker in the Treatment of Breast Cancer 18 6 Treatment Options of Breast Cancer 20 6.1 Stage 0 Breast Cancer: Treatment Options 20 6.2 Early Stage Breast Cancer (Excluding Stage 0) 21 6.3 Metastatic Breast Cancer (MBC) 23 6.3.1 Endocrine Treatment: Adjuvant, First Line and Second Line 23 6.3.2 Cytotoxic Chemotherapy 25 6.3.3 Management of Patients with HER-2 Positive Patients 27 7 Afinitor 29 7.1 Introduction 29 7.2 Mechanism of Action 29 7.3 Clinical Studies 29 7.3.1 Phase I/II trial to Determine the Safety and Efficacy of everolimus (E) plus trastuzumab (T) in Patients with T-resistant Metastatic Breast Cancer 29 7.3.2 Everolimus in Combination with trastuzumab and paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer (BOLERO-1) 30 7.3.3 Everolimus in Combination with exemestane in the Treatment of Postmenopausal Women with ER Positive Locally Advanced or Metastatic Breast Cancer who are Refractory to letrozole or anastrozole (BOLERO-2) 30 7.3.4 Daily everolimus in Combination with trastuzumab and vinorelbine in HER2 Positive women with Locally Advanced or Metastatic Breast Cancer (BOLERO-3) 30 7.4 Approval Status of Afinitor 30 7.5 Factors Affecting Sales of Afinitor 30 7.5.1 Absence of Competition from Neratinib in Japan 30 7.5.2 Patent Expiry of Aromasin before Launch of Afinitor for Breast Cancer 30 7.5.3 High Cost of Afinitor 31 7.6 Drug Risk Benefit Score 31 7.6.1 Efficacy 31 7.6.2 Safety 31 7.6.3 Compliance 31 7.6.4 Dosing Convenience 32 7.7 Intensity of Competition 32 7.8 Sales Forecasts 32 7.8.1 Target Patient Pool of Afinitor 32 7.8.2 Dosing 33 Afinitor (Breast Cancer) ' Analysis and Forecasts to 2020 (From Slideshare) Page 2/6
  • 3. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! 7.8.3 Market Penetration 33 7.8.4 Annual Cost of Therapy 34 7.8.5 Sales Projections of Afinitor 34 8 Appendix 44 8.1 Market Definitions 44 8.2 Abbreviations 44 8.3 Research Methodology 44 8.3.1 Coverage 44 8.3.2 Secondary Research 45 8.3.3 Forecasting 45 8.3.4 Number of Patients Approved to take the Drug 45 8.3.5 Net Penetration of Drug 46 8.3.6 Net Annual Dosing 47 8.3.7 Annual Cost of Therapy 47 8.3.8 Primary Research 47 8.3.9 Expert Panels 47 8.4 Contact Us 48 8.5 Disclaimer 48 8.6 Sources 48 1.1 List of Tables Table 1: Breast Cancer, Incidences and Mortality, By Country, 2008-2030 5 Table 2: Breast Cancer, Global, Market Size Forecasts ($bn), 2010'2020 8 Table 3: Five-Year Relative Survival Rates, By Stages 14 Table 4: Approval Status of Afinitor 30 Table 5: Drug Risk Benefit Score of Afinitor 31 Table 6: Annual Cost of Therapy of Afinitor 34 Table 7: Afinitor, Breast Cancer, Global, Sales Forecasts ($m), 2013'2020 35 Table 8: Afinitor, Breast Cancer, the US, Sales Forecasts ($m), 2013'2020 36 Table 9: Afinitor, Breast Cancer, the UK, Sales Forecasts ($m), 2013'2020 37 Table 10: Afinitor, Breast Cancer, France, Sales Forecasts ($m), 2013'2020 38 Table 11: Afinitor, Breast Cancer, Germany, Sales Forecasts ($m), 2013'2020 39 Table 12: Afinitor, Breast Cancer, Italy, Sales Forecasts ($m), 2013'2020 40 Table 13: Afinitor, Breast Cancer, Spain, Sales Forecasts ($m), 2013'2020 41 Table 14: Afinitor, Breast Cancer, Japan, Sales Forecasts ($m), 2013'2020 42 1.2 List of Figures Figure 1: Distribution by Incidence and Mortality, Most Commonly Diagnosed Cancers, Worldwide, 2010 6 Figure 2: Breast Cancer, Global, Market Size Forecasts ($bn), 2010'2020 8 Figure 3: Top 10 Most Frequent Cancers on Incidence-Mortality Matrix, Worldwide, 2010 9 Figure 4: Incidence per 100,000, Breast Cancer, Selected Countries, 1975-2005 10 Figure 5: Incidence per 100,000, Breast Cancer, Selected Countries, 1975-2005 10 Figure 6: Breast Cancer, Incidence, Worldwide, 2008-2030 11 Figure 7: All Cancers, Incidence, Worldwide, 2008-2030 11 Figure 8: Mortality per 100,000, Breast Cancer, Selected Countries, 1975-2005 12 Figure 9: Mortality per 100,000, Breast Cancer, Selected Countries, 1975-2005 12 Afinitor (Breast Cancer) ' Analysis and Forecasts to 2020 (From Slideshare) Page 3/6
  • 4. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! Figure 10: Breast Cancer, Mortality, Worldwide, 2008-2030 13 Figure 11: All Cancers, Mortality, Worldwide, 2008-2030 13 Figure 12: Broad Classification of Breast Cancer, By Type 15 Figure 13: Classification of Non-Invasive Breast Cancer, By CIS 15 Figure 14: Classification of Invasive Breast Cancer, By Stages 16 Figure 15: Classification of Invasive Breast Cancer, By Treatment 16 Figure 16: Classification of Metastatic or Advanced Breast Cancer 16 Figure 17: Classification of Early Stage Breast Cancer (Excluding Stage 0) 17 Figure 18: Classification of Locally Advanced Breast Cancer 17 Figure 19: Metastatic Breast Cancer Classification 17 Figure 20: Current Molecular Biomarkers used in the Clinical Management of Breast Cancer 18 Figure 21: Breast Cancer Intrinsic Sub Types used for Deciding Treatment Options for MBC 19 Figure 22: Breast Cancer Types in Decreasing Order of their Aggressiveness 19 Figure 23: Treatment Options, DCIS Breast Cancer 20 Figure 24: Treatment Options, LCIS Breast Cancer 21 Figure 25: Treatment Options, Stages I, II and IIIA 21 Figure 26: Treatment Options, Stages I, II and IIIA (HR Positive and Premenopausal Breast Cancer) 22 Figure 27: Treatment Options, Stages I, II and IIIA (HR Negative, Pre and Postmenopausal Breast Cancer) 22 Figure 28: Treatment Options, Stages I, II and IIIA (HR Positive Postmenopausal Breast Cancer) 23 Figure 29: Adjuvant Therapy for HR Positive, HER2 Negative Metastatic Breast Cancer 24 Figure 30: Hormonal Therapy in Adjuvant Setting in HR Positive, HER2 Negative MBC 24 Figure 31: Adjuvant and First Line Therapy for HR Negative, HER2 Negative Metastatic Breast Cancer 26 Figure 32: Treatment Options, HR Negative and HER2 Positive Metastatic Breast Cancer 27 Figure 33: Drug Model Diagram of Afinitor in the US, EU and Japan 33 Figure 34: Afinitor, Breast Cancer, Global, Sales Forecasts ($m), 2013'2020 35 Figure 35: Afinitor, Breast Cancer, the US, Sales Forecasts ($m), 2013'2020 36 Figure 36: Afinitor, Breast Cancer, the UK, Sales Forecasts ($m), 2013'2020 37 Figure 37: Afinitor, Breast Cancer, France, Sales Forecasts ($m), 2013'2020 38 Figure 38: Afinitor, Breast Cancer, Germany, Sales Forecasts ($m), 2013'2020 39 Figure 39: Afinitor, Breast Cancer, Italy, Sales Forecasts ($m), 2013'2020 40 Figure 40: Afinitor, Breast Cancer, Spain, Sales Forecasts ($m), 2013'2020 41 Figure 41: Afinitor, Breast Cancer, Japan, Sales Forecasts ($m), 2013-2020 42 Figure 42: Afinitor, Breast Cancer, Global, Sales Distribution by Country ($m), 2020 43 Figure 43: Drug Model Diagram 46 Figure 44: Patients Approved to take the Drug 47 Afinitor (Breast Cancer) ' Analysis and Forecasts to 2020 (From Slideshare) Page 4/6
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