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Neratinib (HER2-Positive Breast Cancer) - Forecast and Market Analysis to 2023

Summary

GlobalData has released its new PharmaPoint Drug Evaluation report, “Neratinib (HER2-Positive Breast Cancer) - Forecast and Market Analysis to 2023”. HER2-positive breast cancer is the second most common cancer in the world and the most common cancer in women worldwide. This report focuses on the current treatment landscape, unmet needs, current pipeline, and commercial opportunities in the HER2-positive breast cancer market, with coverage of multiple settings of the disease including neoadjuvant, adjuvant, first-, second-, third, and fourth-line metastatic.

Puma Biotechnology’s neratinib is an orally-administered TKI that binds irreversibly, targeting HER1, HER2, and HER4. Neratinib inhibits HER2 at a different site than the currently marketed HER2-targeted therapies, which Puma believes will make it effective in patients who have developed resistance to these other treatments.

Scope

- Overview of HER2-Positive Breast Cancer, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on Neratinib including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Neratinib for the top eight countries from 2013 to 2023.
- Sales information covered for the US, France, Germany, Italy, Spain, the UK, Japan and China.

Reasons to buy

- Understand and capitalize by identifying products that are most likely to ensure a robust return
- Stay ahead of the competition by understanding the changing competitive landscape for HER2-Positive Breast Cancer
- 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 Neratinib performance
- Obtain sales forecast for Neratinib from 2013-2023 in top eight countries (the US, France, Germany, Italy, Spain, the UK, Japan and China)

Table Of Contents

Neratinib (HER2-Positive Breast Cancer) - Forecast and Market Analysis to 2023
1 Table of Contents

2 Introduction 9
2.1 Catalyst 9
2.2 Related Reports 10
2.3 Upcoming Related Reports 11
3 Disease Overview 12
3.1 Etiology and Pathophysiology 12
3.1.1 Etiology 12
3.1.2 Pathophysiology 12
3.2 Basic Breast Anatomy 14
3.3 Breast Cancer Staging 15
3.4 Prognosis 16
3.5 Quality of Life 17
3.6 Symptoms 19
4 Disease Management 20
4.1 Treatment Overview 20
4.1.1 Treatment of Early-Stage Breast Cancer (Stage 0 to Stage IB) 20
4.1.2 Treatment of Locally-Advanced and Regional Breast Cancer (Stage IB to IIIA) 21
4.1.3 Treatment of Metastatic HER2-Positive Breast Cancer (Stage IV) 24
5 Competitive Assessment 27
5.1 Overview 27
6 Unmet Need and Opportunity 29
6.1 Overview 29
6.2 Brain Metastases 30
6.2.1 Unmet Need 30
6.2.2 Gap Analysis 30
6.2.3 Opportunity 32
6.3 Resistance to HER2-Targeting Therapies 32
6.3.1 Unmet Need 32
6.3.2 Gap Analysis 33
6.3.3 Opportunity 34
7 Pipeline Assessment 36
7.1 Overview 36
7.2 Promising Drugs in Clinical Development 37
8 Neratinib 38
8.1 Overview 38
8.2 Efficacy 39
8.3 Safety 40
8.4 Dosing and Formulation 41
8.5 Potential Clinical and Commercial Positioning 41
8.6 SWOT Analysis 42
8.7 Forecast 42
9 Appendix 43
9.1 Bibliography 43
9.2 Abbreviations 51
9.3 Methodology 54
9.4 Forecasting Methodology 54
9.4.1 Diagnosed HER2-Positive Breast Cancer Patients 54
9.4.2 Percent Drug-Treated Patients 55
9.4.3 General Pricing Assumptions 55
9.4.4 Generic Erosion 57
9.4.5 Pricing of Pipeline Agents 57
9.5 Primary Research - KOLs Interviewed for this Report 59
9.6 Primary Research - Prescriber Survey 61
9.7 About the Authors 62
9.7.1 Analyst 62
9.7.2 Therapy Area Director 62
9.7.3 Global Head of Healthcare 63
9.8 About GlobalData 64
9.9 Disclaimer 64

1.1 List of Tables

Table 1: AJCC Stage Definitions for Breast Cancer 16
Table 2: Prognosis for Breast Cancer in the US 17
Table 3: Treatment Guidelines for HER2-Positive Breast Cancer 26
Table 4: Unmet Need and Opportunity in HER2-Positive Breast Cancer 29
Table 5: Product Profile - Neratinib 39
Table 6: Neratinib SWOT Analysis, 2013 42
Table 7: Global Sales Forecast ($m) for Neratinib, 2013-2023 42
Table 8: HER2-Positive Breast Cancer Incidence, 2013-2023 55
Table 9: Average Body Weight and Surface Area Across the 8MM 56
Table 10: Average Annual Cost of Therapy ($) - Neratinib, Third Line 58
Table 11: Physicians Surveyed by Country 61

1.2 List of Figures

Figure 1: Basic Breast Anatomy, Including Key Lymph Nodes 14
Figure 2: HER2-Positive Breast Cancer - Phase II-III Pipeline, 2013 37
Figure 3: Neratinib's Clinical Development 39
Figure 4: Clinical and Commercial Positioning of neratinib. 41

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