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

Summary

GlobalData has released its new PharmaPoint Drug Evaluation report, “Tykerb (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.

GSK’s Tykerb (lapatinib ditosylate monohydrate) is a small-molecule inhibitor of the intracellular tyrosine kinase domain of EGFR and HER2. Tykerb was approved by the FDA in 2007, and by the European Medicines Agency (EMA) in 2008, for use in locally-advanced or metastatic breast cancer, in combination with Xeloda (capecitabine). In 2010, the FDA and EMA approved Tykerb for use in HR positive locally advanced or metastatic breast cancer in combination with letrozole.

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 Tykerb including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for Tykerb 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 Tykerb performance
- Obtain sales forecast for Tykerb from 2013-2023 in top eight countries (the US, France, Germany, Italy, Spain, the UK, Japan and China)

Table Of Contents

Tykerb (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 Tykerb (lapatinib) 29
6.1 Overview 29
6.2 Efficacy 30
6.3 Safety 32
6.4 SWOT Analysis 32
6.5 Forecast 33
7 Appendix 34
7.1 Bibliography 34
7.2 Abbreviations 42
7.3 Methodology 45
7.4 Forecasting Methodology 45
7.4.1 Diagnosed HER2-Positive Breast Cancer Patients 45
7.4.2 Percent Drug-Treated Patients 46
7.4.3 General Pricing Assumptions 46
7.4.4 Individual Drug Assumptions 48
7.5 Primary Research - KOLs Interviewed for this Report 49
7.6 Primary Research - Prescriber Survey 51
7.7 About the Authors 52
7.7.1 Analyst 52
7.7.2 Therapy Area Director 52
7.7.3 Global Head of Healthcare 53
7.8 About GlobalData 54
7.9 Disclaimer 54

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: Product Profile - Tykerb 30
Table 5: Tykerb SWOT Analysis, 2013 32
Table 6: Global Sales Forecast ($m) for Tykerb, 2013-2023 33
Table 7: HER2-Positive Breast Cancer Incidence, 2013-2023 46
Table 8: Average Body Weight and Surface Area Across the 8MM 47
Table 9: Average Annual Cost of Therapy ($) - Tykerb, First Line 48
Table 10: Physicians Surveyed by Country 51

1.2 List of Figures

Figure 1: Basic Breast Anatomy, Including Key Lymph Nodes 14
Figure 2: Primary Completion Dates of Active Phase III Clinical Trials for Tykerb 29

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