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

Summary

GlobalData has released its new PharmaPoint Country Evaluation report, “PharmaPoint: Colorectal Cancer - Japan 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.

Japan represents the second-largest market for CRC across the countries covered in this report. Japan is a major CRC market, due to the high incidence of the disease and high drug treatment rates. 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 metastases 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 Japan including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in Japan from 2013-2023.
- Analysis of the impact of key events as well the drivers and restraints affecting the Japan 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 Japan.

Table Of Contents

PharmaPoint: Colorectal Cancer - Japan 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 Japan 30
4.2.1 Screening and Diagnosis 32
4.2.2 Clinical Practice 32
5 Competitive Assessment 34
5.1 Overview 34
5.2 Product Profiles — Major Brands 35
5.2.1 Avastin (Bevacizumab) 35
5.2.2 Erbitux (Cetuximab) 39
5.2.3 Vectibix (Panitumumab) 43
5.2.4 Stivarga (Regorafenib) 47
5.2.5 Zaltrap (Ziv-Aflibrcept) 51
5.2.6 Lonsurf (TAS-102) 54
5.2.7 TS-1 (Tegafur, Gimeracil, Oteracil) 58
5.2.8 Xeloda (Capecitabine) 61
6 Unmet Need and Opportunity 65
6.1 Overview 65
6.2 Therapies That Provide Substantial Overall Survival Benefit for Metastatic Patients 66
6.2.1 Unmet Need 66
6.2.2 Gap Analysis 68
6.2.3 Opportunity 68
6.3 Targeted Treatments for KRAS and BRAF Mutaton-Positive Patients 70
6.3.1 Unmet Need 70
6.3.2 Gap Analysis 71
6.3.3 Opportunity 71
6.4 Effective Neoadjuvant/Adjuvant Therapies for High Risk Resectable Disease 72
6.4.1 Unmet Need 72
6.4.2 Gap Analysis 73
6.4.3 Opportunity 73
6.5 Tolerable Later-Line Therapies For Chemotherapy-Resistant Patients 74
6.5.1 Unmet Need 74
6.5.2 Gap Analysis 74
6.5.3 Opportunity 75
7 Pipeline Assessment 76
7.1 Overview 76
7.2 Promising Drugs in Clinical Development 77
7.2.1 Cyramza (Ramucirumab) 78
7.2.2 Nintedanib (BIBF-1120) 83
7.3 Promising Approaches in Early-Stage Development 87
7.3.1 Anti-Angiopoietin-2 Inhibitors 87
7.3.2 Strategies for BRAF Mutation-Positive Disease 90
7.3.3 Strategies for KRAS-Mutation Positive Disease 96
7.3.4 Immune Checkpoint Inhibitors 99
8 Market Outlook 104
8.1 Japan 104
8.1.1 Forecast 104
8.1.2 Key Events 108
8.1.3 Drivers and Barriers - Global Issues 108
8.1.4 Drivers and Barriers 111
9 Appendix 114
9.1 Bibliography 114
9.2 Abbreviations 134
9.3 Methodology 139
9.4 Forecasting Methodology 139
9.4.1 Diagnosed Colorectal Cancer Patients 139
9.4.2 Percent Drug-Treated Patients 140
9.4.3 Drugs Included in Each Therapeutic Class 140
9.4.4 Launch and Patent Expiration Dates 140
9.4.5 General Pricing Assumptions 141
9.4.6 Average Body Weight and Surface Area 142
9.4.7 Individual Drug Assumptions 142
9.4.8 Generic Erosion 146
9.4.9 Pricing of Pipeline Agents 146
9.5 Primary Research - KOLs Interviewed for this Report 147
9.6 Primary Research - Prescriber Survey 149
9.7 About the Authors 150
9.7.1 Analyst 150
9.7.2 Global Head of Healthcare 151
9.8 About GlobalData 152
9.9 Disclaimer 152

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 - Japan 31
Table 7: Leading Treatments for CRC, 2014 35
Table 8: Product Profile — Avastin 37
Table 9: Avastin SWOT Analysis, 2014 39
Table 10: Product Profile — Erbitux 41
Table 11: Erbitux SWOT Analysis, 2014 43
Table 12: Product Profile - Vectibix 45
Table 13: Vectibix SWOT Analysis, 2014 46
Table 14: Product Profile - Stivarga 49
Table 15: Stivarga SWOT Analysis, 2014 50
Table 16: Product Profile - Zaltrap 52
Table 17: Zaltrap SWOT Analysis, 2014 54
Table 18: Product Profile - Lonsurf 56
Table 19: Lonsurf SWOT Analysis, 2014 58
Table 20: Product Profile - TS-1 59
Table 21: TS-1 SWOT Analysis, 2014 61
Table 22: Product Profile - Xeloda 62
Table 23: Unmet Need and Opportunity in CRC 66
Table 24: Product Profile - Cyramza 81
Table 25: Cyramza SWOT Analysis, 2014 83
Table 26: Product Profile - Nintedanib 85
Table 27: Nintedanib SWOT Analysis, 2014 87
Table 28: Anti-Angiopoietin-2 Inhibitors in Development 88
Table 29: Early-stage Strategies for BRAF Mutation-Positive CRC 91
Table 30: Early-stage Strategies for KRAS Mutation-Positive CRC 97
Table 31: Anti-PD1 and Anti-PDL1 Drugs in Early-Stage Development for CRC 101
Table 32: Sales Forecasts ($m) for Colorectal Cancer in Japan, 2013-2023 106
Table 33: Key Events Impacting Sales for CRC in Japan, 2014 108
Table 34: CRC Market Drivers and Barriers, 2014 108
Table 35: Japan CRC Market - Drivers and Barriers, 2014 111
Table 36: Key Launch Dates 140
Table 37: Key Patent Expiries 141
Table 38: Average Body Weight and Surface Area 142
Table 39: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 149

1.2 List of Figures
Figure 1: CRC - Phase III Pipeline 77
Figure 2: Competitive Assessment of Late-Stage Pipeline Agents in CRC, 2013-2023 78
Figure 3: Clinical and Commercial Positioning of Cyramza 82
Figure 4: Clinical and Commercial Positioning of Nintedanib 86
Figure 5: Sales for Colorectal Cancer in Japan by Drug Class, 2013-2023 107

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