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Gilotrif (Non-Small Cell Lung Cancer) - Forecast and Market Analysis to 2022

Published By :

GlobalData

Published Date : Jun 2013

Category :

Cancer

No. of Pages : 71 Pages


Non-Small Cell Lung Cancer (NSCLC) is the most common lung cancer, and the second-most common cancer in men and women. Historically, the treatment paradigm has centered around chemotherapy. However, the launch of targeted therapies for patients with specific biomarkers has begun to fragment the NSCLC treatment landscape into smaller niche patient populations. Over the forecast period, this trend will continue with the launch of multiple new drugs in several new drug classes to address the high unmet need among NSCLC patients, and provide new treatment options for previously underserved populations. Launch of premium-priced drug candidates combined with increasing incident cases of the disease will be major drivers of growth in the major markets.

Gilotrif is an irreversible inhibitor of the ErbB family of receptors, which include EGFR and HER2, and it has TKI activity against the wild-type as well as the mutant EGFR receptor. This distinguishes it from Tarceva and Iressa, which are reversible TKIs that only target the mutant receptor. Boehringer Ingelheim received FDA marketing approval for Gilotrif in July 2013 for the first-line treatment of EGFR-mutant NSCLC patients.

Scope

  • Overview of NSCLC, including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
  • Detailed information on Gilotrif including product description, safety and efficacy profiles as well as a SWOT analysis.
  • Sales forecast for Gilotrif for the top nine countries from 2012 to 2022.
  • Sales information covered for the US, France, Germany, Italy, Spain, the UK, Japan, India 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 NSCLC
  • 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 Gilotrif performance
  • Obtain sales forecast for Gilotrif from 2012-2022 in top nine countries (the US, France, Germany, Italy, Spain, the UK, Japan, India and China)
Table of Contents

1 Table of Contents
1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 7

2 Introduction 8
2.1 Catalyst 8
2.2 Related Reports 9
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 and Histology 12
3.1.3 NSCLC Biomarkers 13
3.1.4 Quality of Life 14
3.2 Symptoms 15

4 Disease Management 17
4.1 Treatment Overview 17
4.1.1 Diagnosis 19
4.1.2 Clinical Staging 19
4.1.3 Screening and Early Detection 22
4.1.4 Localized Procedures and Therapies 23
4.1.5 Systemic Chemotherapy 24
4.1.6 Targeted Therapy 25

5 Competitive Assessment 28
5.1 Overview 28
5.2 Strategic Competitor Assessment 29

6 Opportunity and Unmet Need 32
6.1 Overview 32
6.2 Improved Overall Survival and Less Toxicity 33
6.3 Treatments for Patients with Acquired TKI Resistance 34
6.4 Better Treatment Options for Squamous Patients 35
6.5 Preventing Relapse or Recurrence 35
6.6 More Efficacious Second-Line Therapies 36
6.7 Increased Availability of Mutation Testing 36
6.8 More Cost-Effective Therapies 37
6.9 Unmet Needs Gap Analysis 38

7 Pipeline Assessment 42
7.1 Overview 42
7.2 Promising Drugs in Clinical Development 42

8 Gilotrif (afatinib) 46
8.1 Overview 46
8.2 Efficacy 47
8.3 Safety 48
8.4 Dosing and Formulation 48
8.5 Potential Clinical Positioning 48
8.6 Potential Commercial Positioning 50
8.7 Pricing and Reimbursement 51
8.8 SWOT Analysis 51
8.9 Forecast 52

9 Appendix 53
9.1 Bibliography 53
9.2 Abbreviations 58
9.3 Methodology 61
9.4 Forecasting Methodology 61
9.4.1 Number of NSCLC Patients Currently Seeking Treatment 61
9.4.2 Percent Drug-treated Patients 62
9.4.3 General Pricing Assumptions 62
9.4.4 Individual Drug Assumptions 65
9.4.5 Generic Erosion 65
9.4.6 Pricing of Pipeline Agents 65
9.5 Physicians and Specialists Included in This Study 66
9.6 Survey of Prescribing Physicians 67
9.7 About the Authors 68
9.7.1 Author 68
9.7.2 Epidemiologist 68
9.7.3 Global Head of Healthcare 69
9.8 About GlobalData 70
9.9 Disclaimer 70

List of Table


Table 1: Symptoms of Disease NSCLC 16
Table 2: Treatment Guidelines for NSCLC 18
Table 3: Stage Definitions for NSCLC 21
Table 4: Treatment Overview by Stage of Diagnosis for NSCLC 27
Table 5: Leading Treatments for NSCLC 31
Table 6: Overall Unmet Needs Current Level of Attainment 33
Table 7: Clinical Unmet Needs Gap Analysis, 2013 39
Table 8: Non-Small Cell Lung Cancer Phase I-II Pipeline, 2013 43
Table 9: NSCLC Phase III Pipeline, 2013 44
Table 10: NSCLC Advantages and Disadvantages of Therapeutic Classes 45
Table 11: Product Profile Gilotrif (afatinib) 47
Table 12: Gilotrif SWOT Analysis, 2013 51
Table 13: Global Sales Forecasts ($m) for Gilotrif, 2012-2022 52
Table 14: Five Year Prevalence 62
Table 15: Physicians Surveyed by Country 67

List of Chart


Figure 1: Competitive Assessment of Late-Stage Pipeline Agents in NSCLC, 20122022 45

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