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Nintedanib (Colorectal Cancer) - Forecast and Market Analysis to 2023

Published: Nov-2014 | Format: PDF | GlobalData | Number of pages: 70 | Code: MRS - 3114


GlobalData has released its new PharmaPoint Drug Evaluation report, “Nintedanib (Colorectal Cancer) - Forecast and Market Analysis to 2023”. Colorectal cancer (CRC) is the second leading cause of mortality among cancer patients in the world and is the third most diagnosed cancer globally, and thus represents a huge burden on healthcare systems. This report focuses on the current treatment landscape, unmet needs, current pipeline, and commercial opportunities in the colorectal cancer market, with coverage of multiple settings of the disease including neoadjuvant/adjuvant, first-, second-, third-line KRAS wild-type and mutation-positive, and fourth-line metastatic. In terms of targeted treatments, the metastatic CRC treatment landscape is mature, including the branded treatments Avastin (bevacizumab), Erbitux (cetuximab), and Vectibix (panitumumab), treatments that have extended the survival of metastatic patients compared to chemotherapy-only regimens. However, high unmet needs remain for the extension of survival of metastatic patients, and particularly those with KRAS mutation-positive disease, for whom the epidermal growth factor receptor (EGFR) inhibitors Erbitux and Vectibix are not recommended.

Boehringer Ingelheim is developing nintedanib (BIBF-1120), an orally available anti-VEGF inhibitor, for the treatment of refractory CRC in the US, Europe, and Japan. The drug is being investigated in a placebo-controlled, double-blind, randomized Phase III study in 764 metastatic CRC patients. To be eligible for the trial, patients must be refractory to multiple previous treatments for metastatic disease, including 5-FU, oxaliplatin, irinotecan, Avastin or Zaltrap, and anti-EGFR therapy if KRAS wild-type. Previous treatment with Stivarga is allowed. The trial has a primary endpoint of PFS, with secondary endpoints including OS, ORR, and disease control. The trial is due to report data for PFS in the second half of 2016.


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

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 Colorectal 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 Nintedanib performance
- Obtain sales forecast for Nintedanib from 2013-2023 in top seven countries (the US, France, Germany, Italy, Spain, the UK and Japan)

Table of Contents

1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 8
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 14
3.2 Clinical Staging 15
3.3 Symptoms 16
4 Disease Management 18
4.1 Diagnosis and Treatment Overview 18
4.1.1 Screening and Diagnosis 18
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 21
4.1.3 Clinical Practice 25
5 Competitive Assessment 32
5.1 Overview 32
6 Unmet Need and Opportunity 34
6.1 Overview 34
6.2 Therapies That Provide Substantial Overall Survival Benefit for Metastatic Patients 35
6.2.1 Unmet Need 35
6.2.2 Gap Analysis 37
6.2.3 Opportunity 37
6.3 Targeted Treatments for KRAS and BRAF Mutaton-Positive Patients 39
6.3.1 Unmet Need 39
6.3.2 Gap Analysis 40
6.3.3 Opportunity 40
6.4 Effective Neoadjuvant/Adjuvant Therapies for High Risk Resectable Disease 41
6.4.1 Unmet Need 41
6.4.2 Gap Analysis 42
6.4.3 Opportunity 42
6.5 Tolerable Later-Line Therapies For Chemotherapy-Resistant Patients 43
6.5.1 Unmet Need 43
6.5.2 Gap Analysis 43
6.5.3 Opportunity 44
7 Pipeline Assessment 45
7.1 Overview 45
7.2 Promising Drugs in Clinical Development 46
8 Nintedanib (BIBF-1120) 48
8.1 Overview 48
8.2 Efficacy 49
8.3 Safety 49
8.4 Dosing and Formulation 50
8.5 Potential Clinical and Commercial Positioning 50
8.6 SWOT Analysis 51
8.7 Forecast 51
9 Appendix 52
9.1 Bibliography 52
9.2 Abbreviations 57
9.3 Methodology 61
9.4 Forecasting Methodology 61
9.4.1 Diagnosed Colorectal Cancer Patients 61
9.4.2 Percent Drug-Treated Patients 62
9.4.3 General Pricing Assumptions 62
9.4.4 Average Body Weight and Surface Area Across the 8MM 63
9.4.5 Generic Erosion 63
9.4.6 Pricing of Pipeline Agents 63
9.5 Primary Research - KOLs Interviewed for this Report 64
9.6 Primary Research - Prescriber Survey 66
9.7 About the Authors 67
9.7.1 Analyst 67
9.7.2 Global Head of Healthcare 68
9.8 About GlobalData 69
9.9 Disclaimer 69

List of Tables

Table 1: TNM and Staging Classification System for CRC 16
Table 2: Symptoms of Colorectal Cancer 17
Table 3: Treatment Guidelines for CRC 22
Table 4: Most-Prescribed Neoadjuvant/Adjuvant Regimens for Early-Stage CRC in the Global Markets, 2013 23
Table 5: Most Prescribed Targeted Therapies for Metastatic CRC by Segment in the Global Markets, 2013 24
Table 6: Leading Treatments for CRC, 2014 33
Table 7: Unmet Need and Opportunity in CRC 35
Table 8: Product Profile - Nintedanib 49
Table 9: Nintedanib SWOT Analysis, 2014 51
Table 10: Global Sales Forecasts ($m) for Nintedanib, 2013-2023 51
Table 11: Average Body Weight and Surface Area Across the 8MM 63
Table 12: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 66

List of Figures

Figure 1: CRC - Phase III Pipeline 46
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in CRC, 2013-2023 47
Figure 3: Clinical and Commercial Positioning of Nintedanib 50

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