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

Summary

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

Kadcyla (ado-trastuzumab) is Roche’s third HER2-targeted mAb, approved by the FDA in February 2013, by the Japanese MHLW in September 2013, and by the EMA in November 2013, for the second-line treatment of metastatic HER2-positive breast cancer. Kadcyla is an antibody-drug conjugate consisting of trastuzumab covalently linked to the microtubule inhibitor, DM1 (mertansine) via a non-reducible thioether linkage (MCC).

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

Table Of Contents

Kadcyla (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 Kadcyla (ado-trastuzumab emtansine, T-DM1) 29
6.1 Overview 29
6.2 Efficacy 31
6.3 Safety 32
6.4 SWOT Analysis 32
6.5 Forecast 33
7 Appendix 34
7.1 Bibliography 34
7.2 Abbreviations 41
7.3 Methodology 44
7.4 Forecasting Methodology 44
7.4.1 Diagnosed HER2-Positive Breast Cancer Patients 44
7.4.2 Percent Drug-Treated Patients 45
7.4.3 General Pricing Assumptions 45
7.4.4 Individual Drug Assumptions 47
7.5 Primary Research - KOLs Interviewed for this Report 48
7.6 Primary Research - Prescriber Survey 50
7.7 About the Authors 51
7.7.1 Analyst 51
7.7.2 Therapy Area Director 51
7.7.3 Global Head of Healthcare 52
7.8 About GlobalData 53
7.9 Disclaimer 53

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 - Kadcyla 30
Table 5: Kadcyla SWOT Analysis, 2013 32
Table 6: Global Sales Forecast ($m) for Kadcyla, 2013-2023 33
Table 7: HER2-Positive Breast Cancer Incidence, 2013-2023 45
Table 8: Average Body Weight and Surface Area Across the 8MM 46
Table 9: Average Annual Cost of Therapy ($) - Kadcyla, Second Line 47
Table 10: Physicians Surveyed by Country 50

1.2 List of Figures

Figure 1: Basic Breast Anatomy, Including Key Lymph Nodes 14
Figure 2: Active Phase III Clinical Trials for Kadcyla 30

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