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

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Published Date : Nov 2014

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No. of Pages : 56 Pages

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

Bayer/Onyxs Stivarga (regorafenib) is an orally administered multi-targeting kinase inhibitor that was approved by the FDA in September, 2012 for the treatment of metastatic CRC patients who have not, or are no longer, responding to chemotherapy and an anti-VEGF therapy or, if KRAS wild-type, Erbitux and Vectibix (FDA, press release, September 27, 2012). Stivarga was approved under FDA priority review, allowing approval within six months of submission. Approvals for Stivarga in Europe and Japan followed in 2013 (Onyx Pharmaceuticals, press release, August 30, 2013; Onyx Pharmaceuticals, press release, March 25, 2013).


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

1 Table of Contents 6
1.1 List of Tables 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 Stivarga (Regorafenib) 34
6.1 Overview 34
6.2 Efficacy 36
6.3 Safety 37
6.4 SWOT Analysis 37
6.5 Forecast 38

7 Appendix 39
7.1 Bibliography 39
7.2 Abbreviations 44
7.3 Methodology 47
7.4 Forecasting Methodology 47
7.4.1 Diagnosed Colorectal Cancer Patients 47
7.4.2 Percent Drug-Treated Patients 48
7.4.3 General Pricing Assumptions 48
7.4.4 Average Body Weight and Surface Area Across the 8MM 49
7.4.5 Individual Drug Assumptions 50
7.4.6 Generic Erosion 50
7.5 Primary Research - KOLs Interviewed for this Report 51
7.6 Primary Research - Prescriber Survey 52
7.7 About the Authors 53
7.7.1 Analyst 53
7.7.2 Global Head of Healthcare 54
7.8 About GlobalData 55
7.9 Disclaimer 55

List of Table

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: Product Profile - Stivarga 36
Table 8: Stivarga SWOT Analysis, 2014 37
Table 9: Global Sales Forecasts ($m) for Stivarga, 2013-2023 38
Table 10: Average Body Weight and Surface Area Across the 8MM 49
Table 11: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 52

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