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PharmaPoint: Colorectal Cancer - US Drug Forecast and Market Analysis to 2023

Summary

GlobalData has released its new PharmaPoint Country Evaluation report, “PharmaPoint: Colorectal Cancer - US Drug 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), Avastin (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 Avastin and Vectibix are not recommended.

The US represents the largest market for CRC across the countries covered in this report. In 2013, GlobalData’s forecast estimates that sales of branded therapies were $2.23 billion. The US is the largest CRC market due to the high incidence of the disease, high drug treatment rate, and higher drug prices compared with the 5EU, Japan, and China. Increased sales of CRC therapies over the forecast period will be driven by increasing disease incident cases as the population ages, label extension of Stivarga as an adjuvant treatment for resected liver metastasis patients, and the launch of expensive new therapies that provide further treatment options for patients in later-line settings, replacing cheaper, generic chemotherapy-only regimens.

Scope

- Overview of CRC including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.
- Detailed information on the key drugs in the US including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in the US from 2013-2023.
- Analysis of the impact of key events as well the drivers and restraints affecting the US CRC market.

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 CRC
- 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 drug performance
- Obtain sales forecast for drugs from 2013-2023 in the US

Table Of Contents

PharmaPoint: Colorectal Cancer - US Drug Forecast and Market Analysis to 2023
1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 8
1.2 List of Figures 10
2 Introduction 11
2.1 Catalyst 11
2.2 Related Reports 12
2.3 Upcoming Related Reports 13
3 Disease Overview 14
3.1 Etiology and Pathophysiology 14
3.1.1 Etiology 14
3.1.2 Pathophysiology 16
3.2 Clinical Staging 17
3.3 Symptoms 19
4 Disease Management 20
4.1 Diagnosis and Treatment Overview 20
4.1.1 Screening and Diagnosis 20
4.1.2 Treatment Guidelines and Leading Prescribed Drugs 23
4.1.3 Clinical Practice 24
4.2 US 30
4.2.1 Screening and Diagnosis 32
4.2.2 Clinical Practice 33
5 Competitive Assessment 36
5.1 Overview 36
5.2 Product Profiles — Major Brands 37
5.2.1 Avastin (Bevacizumab) 37
5.2.2 Erbitux (Cetuximab) 41
5.2.3 Vectibix (Panitumumab) 45
5.2.4 Stivarga (Regorafenib) 49
5.2.5 Zaltrap (Ziv-Aflibrcept) 53
5.2.6 Lonsurf (TAS-102) 56
5.2.7 Xeloda (Capecitabine) 60
6 Unmet Need and Opportunity 64
6.1 Overview 64
6.2 Therapies That Provide Substantial Overall Survival Benefit for Metastatic Patients 65
6.2.1 Unmet Need 65
6.2.2 Gap Analysis 67
6.2.3 Opportunity 67
6.3 Targeted Treatments for KRAS and BRAF Mutaton-Positive Patients 69
6.3.1 Unmet Need 69
6.3.2 Gap Analysis 70
6.3.3 Opportunity 70
6.4 Effective Neoadjuvant/Adjuvant Therapies for High Risk Resectable Disease 71
6.4.1 Unmet Need 71
6.4.2 Gap Analysis 72
6.4.3 Opportunity 72
6.5 Tolerable Later-Line Therapies For Chemotherapy-Resistant Patients 73
6.5.1 Unmet Need 73
6.5.2 Gap Analysis 73
6.5.3 Opportunity 74
7 Pipeline Assessment 75
7.1 Overview 75
7.2 Promising Drugs in Clinical Development 76
7.2.1 Cyramza (Ramucirumab) 77
7.2.2 Imprime PGG 82
7.2.3 Nintedanib (BIBF-1120) 87
7.3 Promising Approaches in Early-Stage Development 91
7.3.1 Anti-Angiopoietin-2 Inhibitors 91
7.3.2 Strategies for BRAF Mutation-Positive Disease 94
7.3.3 Strategies for KRAS-Mutation Positive Disease 100
7.3.4 Immune Checkpoint Inhibitors 103
8 Market Outlook 108
8.1 United States 108
8.1.1 Forecast 108
8.1.2 Key Events 112
8.1.3 Drivers and Barriers - Global Issues 112
8.1.4 Drivers and Barriers 115
9 Appendix 118
9.1 Bibliography 118
9.2 Abbreviations 138
9.3 Methodology 143
9.4 Forecasting Methodology 143
9.4.1 Diagnosed Colorectal Cancer Patients 143
9.4.2 Percent Drug-Treated Patients 144
9.4.3 Drugs Included in Each Therapeutic Class 144
9.4.4 Launch and Patent Expiration Dates 144
9.4.5 General Pricing Assumptions 145
9.4.6 Average Body Weight and Surface Area 145
9.4.7 Individual Drug Assumptions 146
9.4.8 Generic Erosion 150
9.4.9 Pricing of Pipeline Agents 150
9.5 Primary Research - KOLs Interviewed for this Report 151
9.6 Primary Research - Prescriber Survey 152
9.7 About the Authors 153
9.7.1 Analyst 153
9.7.2 Global Head of Healthcare 154
9.8 About GlobalData 155
9.9 Disclaimer 155

1.1 List of Tables
Table 1: TNM and Staging Classification System for CRC 18
Table 2: Symptoms of Colorectal Cancer 19
Table 3: Treatment Guidelines for CRC 23
Table 4: Most-Prescribed Neoadjuvant/Adjuvant Regimens for Early-Stage CRC in the US Markets, 2013 24
Table 5: Most Prescribed Targeted Therapies for Metastatic CRC by Segment in the US Markets, 2013 24
Table 6: Country Profile - US 31
Table 7: Leading Treatments for CRC, 2014 37
Table 8: Product Profile — Avastin 39
Table 9: Avastin SWOT Analysis, 2014 41
Table 10: Product Profile — Erbitux 43
Table 11: Erbitux SWOT Analysis, 2014 45
Table 12: Product Profile - Vectibix 47
Table 13: Vectibix SWOT Analysis, 2014 48
Table 14: Product Profile - Stivarga 51
Table 15: Stivarga SWOT Analysis, 2014 52
Table 16: Product Profile - Zaltrap 54
Table 17: Zaltrap SWOT Analysis, 2014 56
Table 18: Product Profile - Lonsurf 58
Table 19: Lonsurf SWOT Analysis, 2014 60
Table 20: Product Profile - Xeloda 61
Table 21: Unmet Need and Opportunity in CRC 65
Table 22: Product Profile - Cyramza 80
Table 23: Cyramza SWOT Analysis, 2014 82
Table 24: Product Profile - Imprime PGG 84
Table 25: Imprime PGG SWOT Analysis, 2014 87
Table 26: Product Profile - Nintedanib 89
Table 27: Nintedanib SWOT Analysis, 2014 91
Table 28: Anti-Angiopoietin-2 Inhibitors in Development 92
Table 29: Early-stage Strategies for BRAF Mutation-Positive CRC 95
Table 30: Early-stage Strategies for KRAS Mutation-Positive CRC 101
Table 31: Anti-PD1 and Anti-PDL1 Drugs in Early-Stage Development for CRC 105
Table 32: Sales Forecasts ($m) for Colorectal Cancer in the United States, 2013-2023 110
Table 33: Key Events Impacting Sales for CRC in the US, 2014 112
Table 34: CRC Market Drivers and Barriers, 2014 112
Table 35: US CRC Market Drivers and Barriers, 2014 115
Table 36: Key Launch Dates 144
Table 37: Key Patent Expiries 145
Table 38: Average Body Weight and Surface Area 146
Table 39: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 152

1.2 List of Figures
Figure 1: CRC - Phase III Pipeline 76
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in CRC, 2013-2023 77
Figure 3: Clinical and Commercial Positioning of Cyramza 81
Figure 4: Clinical and Commercial Positioning of Imprime PGG 86
Figure 5: Clinical and Commercial Positioning of Nintedanib 90
Figure 6: Sales for Colorectal Cancer in the United States by Drug Class, 2013-2023 111

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