Gastric and Gastroesophageal Junction Adenocarcinoma - Japan Drug Forecast and Market Analysis to 2024

1 Table of Contents
1.1 List of Tables
1.2 List of Figures
2 Introduction
2.1 Catalyst
2.2 Related Reports
2.3 Upcoming Related Reports
3 Disease Overview
3.1 Etiology and Pathophysiology
3.1.1 Etiology
3.1.2 Pathophysiology
3.1.3 Biomarkers/Targets of Interest
3.2 Staging
3.3 Symptoms
3.4 Prognosis
3.5 Quality of Life
4 Disease Management
4.1 Diagnosis and Treatment Overview
4.1.1 Screening
4.1.2 Diagnosis
4.1.3 Treatment Guidelines and Leading Prescribed Drugs
4.1.4 Clinical Practice
4.2 Japan
4.2.1 Screening and Diagnosis
4.2.2 Clinical Practice
5 Competitive Assessment
5.1 Overview
5.2 HER2-Targeted Therapy
5.2.1 Herceptin (trastuzumab)
5.3 Angiogenesis Inhibitors
5.3.1 Cyramza (ramucirumab)
5.3.2 Aitan (apatinib)
5.4 Chemotherapies
5.4.1 TS-1 (tegafur, gimeracil, oteracil)
5.4.2 Abraxane (nab-paclitaxel)
6 Unmet Need and Opportunity
6.1 Overview
6.2 First-Line Therapy for HER2-Negative Patients
6.2.1 Unmet Need
6.2.2 Gap Analysis
6.2.3 Opportunity
6.3 New Molecular Targets for Targeted Therapies
6.3.1 Unmet Need
6.3.2 Gap Analysis
6.3.3 Opportunity
6.4 Effective Perioperative and Postoperative Therapies
6.4.1 Unmet Need
6.4.2 Gap Analysis
6.4.3 Opportunity
6.5 More Efficacious HER2-Targeted Therapies
6.5.1 Unmet Need
6.5.2 Gap Analysis
6.5.3 Opportunity
6.6 Peritoneal Metastases
6.6.1 Unmet Need
6.6.2 Gap Analysis
6.6.3 Opportunity
6.7 Better Clinical Trial Design
6.7.1 Unmet Need
6.7.2 Gap Analysis
6.7.3 Opportunity
6.8 Early Detection of Gastric and Gastroesophageal Adenocarcinomas
6.8.1 Unmet Need
6.8.2 Gap Analysis
6.8.3 Opportunity
7 Pipeline Assessment
7.1 Overview
7.2 Promising Drugs in Phase III Clinical Development
7.3 HER2-Targeted Therapies
7.3.1 Kadcyla (T-DM1; trastuzumab emtansine)
7.3.2 Perjeta (pertuzumab)
7.4 Immune Checkpoint Inhibitors
7.4.1 Keytruda (pembrolizumab)
7.4.2 Opdivo (nivolumab)
7.5 Further Strategies for G/GEJAC Treatment
7.5.1 Napabucasin
7.5.2 Lynparza (olaparib)
7.5.3 Nimotuzumab
7.5.4 TAS-118
7.6 Early/Near-Phase III Pipeline Drugs
7.6.1 GS-5745
7.6.2 Masitinib
7.7 Promising Drugs in Early-Stage Development
7.7.1 Immune Checkpoint Inhibitors
7.7.2 MET-Targeting Drugs
7.7.3 Antibody-Drug Conjugates
7.8 Biosimilars
8 Market Outlook
8.1 Japan
8.1.1 Forecast
8.1.2 Key Events
8.1.3 Drivers and Barriers - Japan
9 Appendix
9.1 Bibliography
9.2 Abbreviations
9.3 Methodology
9.4 Forecasting Methodology
9.4.1 Diagnosed G/GEJAC Patients
9.4.2 Percent of Drug-Treated Patients
9.4.3 Drugs Included in Each Therapeutic Class
9.4.4 Launch and Patent Expiry Dates
9.4.5 General Pricing Assumptions
9.4.6 Individual Drug Assumptions
9.4.7 Generic Erosion
9.4.8 Pricing of Pipeline Agents
9.5 Primary Research - Key Opinion Leaders Interviewed for this Report
9.6 Primary Research - High-Prescriber Survey
9.7 About the Authors
9.7.1 Analyst
9.7.2 Therapy Area Director
9.7.3 Epidemiologist
9.7.4 Global Head of Healthcare
9.8 About GlobalData
9.9 Disclaimer

1.1 List of Tables
Table 1: Stage Definitions for Gastric Cancer
Table 2: Symptoms of Gastric Cancer
Table 3: Prognosis of Gastric Cancer in the US and UK
Table 4: Clinical Guidelines for Gastric Cancer
Table 5: Generic Chemotherapy Regimens Indicated for Gastric Cancer
Table 6: Country Profile - Japan
Table 7: Leading Treatments for G/GEJAC, 2015
Table 8: Product Profile - Herceptin
Table 9: Summary of Results from the ToGA Trial of Herceptin plus FC
Table 10: Summary of the Results of the Analysis of the HER2 IHC3+ or IHC2+/FISH+ Subgroup
Table 11: Summary of AEs from the ToGA Trial of Herceptin plus FC
Table 12: Herceptin SWOT Analysis, 2015
Table 13: Global Sales Forecasts ($m) for Herceptin, 2014-2024
Table 14: Product Profile - Cyramza
Table 15: Summary of the Results from the REGARD of Cyramza
Table 16: Summary of the Results from the RAINBOW Trial of Cyramza plus Paclitaxel
Table 17: Summary of Trial Results of Cyramza in Combination with mFOLFOX6 in the First-Line Setting
Table 18: Summary of AEs from the REGARD Trial of Cyramza Monotherapy
Table 19: Summary of AEs from the RAINBOW Trial of Cyramza plus Paclitaxel
Table 20: Cyramza SWOT Analysis, 2015
Table 21: Global Sales Forecasts ($m) for Cyramza, 2014-2024
Table 22: Product Profile - Aitan
Table 23: Summary of Aitan Trial Results
Table 24: Summary of AEs from Phase III Trial of Aitan
Table 25: Aitan SWOT Analysis, 2015
Table 26: Global Sales Forecasts ($m) for Aitan, 2014-2024
Table 27: Product Profile - TS-1
Table 28: Summary of the Results of Three Studies of TS-1 Monotherapy
Table 29: Summary of the Results from the ACTS-GC Study of TS-1
Table 30: Summary of TS-1 in the DIGEST trial
Table 31: Summary of AEs from ACTS=GS Trial of TS-1 Adjuvant Treatment
Table 32: Summary of AEs from Trial of TS-1 plus Cisplatin
Table 33: TS-1 SWOT Analysis, 2015
Table 34: Global Sales Forecasts ($m) for TS-1, 2014-2024
Table 35: Product Profile - Abraxane
Table 36: Summary of Results from a Phase II Trial of Abraxane
Table 37: Safety of Abraxane
Table 38: Abraxane SWOT Analysis, 2015
Table 39: Global Sales Forecasts ($m) for Abraxane, 2014-2024
Table 40: Unmet Needs and Opportunities in G/GEJAC
Table 41: Product Profile - Kadcyla
Table 42: Kadcyla SWOT Analysis, 2015
Table 43: Product Profile - Perjeta
Table 44: Summary of the Results of the Phase IIa Trial of the Herceptin/Perjeta-CX Combination
Table 45: Safety of the Herceptin/Perjeta-CX Combination
Table 46: Perjeta SWOT Analysis, 2015
Table 47: Global Sales Forecasts ($m) for Perjeta, 2014-2024
Table 48: Product Profile - Keytruda
Table 49: Summary of the Results of the KEYNOTE-012 Trial of Keytruda
Table 50: Keytruda SWOT Analysis, 2015
Table 51: Global Sales Forecasts ($m) for Keytruda, 2014-2024
Table 52: Product Profile - Opdivo
Table 53: Opdivo SWOT Analysis, 2015
Table 54: Global Sales Forecasts ($m) for Opdivo, 2014-2024
Table 55: Product Profile - Napabucasin
Table 56: Summary of the Results from the Phase Ib/II Trial of Napabucasin
Table 57: Napabucasin SWOT Analysis, 2015
Table 58: Global Sales Forecasts ($m) for Napabucasin, 2014-2024
Table 59: Product Profile - Lynparza
Table 60: Summary of Results of the Phase II Trial of Lynparza
Table 61: Summary of AEs from Phase II Trial of Lynparza
Table 62: Lynparza SWOT Analysis, 2015
Table 63: Global Sales Forecasts ($m) for Lynparza, 2014-2024
Table 64: Product Profile - Nimotuzumab
Table 65: Summary of the Results of the Phase II Trial of Nimotuzumab in Unselected Patients
Table 66: Summary of the Results of the Subgroup Analysis of Nimotuzumab in EGFR-Positive Patients
Table 67: Summary of AEs from the Phase II Trial of Nimotuzumab in Combination with Irinotecan
Table 68: Nimotuzumab SWOT Analysis, 2015
Table 69: Global Sales Forecasts ($m) for nimotuzumab, 2014-2024
Table 70: Product Profile - TAS-118
Table 71: TAS-118 SWOT Analysis, 2015
Table 72: Global Sales Forecasts ($m) for TAS-118, 2014-2024
Table 73: Product Profile - GS-5745
Table 74: GS-5745 SWOT Analysis
Table 75: Product Profile - Masitinib
Table 76: Summary of the Results of the Phase II Trial of the Masitinib-Chemotherapy Combinations
Table 77: Summary of AEs from the Phase II Trial of the Masitinib-Chemotherapy Combinations
Table 78: Masitinib SWOT Analysis, 2013
Table 79: Early-Stage Immune Checkpoint Inhibitors
Table 80: Early-Stage MET-Targeting Drugs
Table 81: Early-Stage Antibody-Drug-Conjugates
Table 82: Marketed or Phase III Trastuzumab Biosimilars
Table 83: Sales Forecast ($m) for Gastric Cancer in Japan, 2014-2024
Table 84: Key Events Impacting Sales for Gastric Cancer in Japan, 2014-2024
Table 85: Gastric Cancer Market in Japan - Drivers and Barriers, 2015
Table 86: Key Launch Dates
Table 87: Key Patent Expiries
Table 88 Average Body Weight and Surface Area Across the 8MM
Table 89: Average Cost of Therapy of Herceptin
Table 90: Average Cost of Therapy of Cyramza
Table 91: Average Cost of Therapy of TS-1
Table 92: Average Cost of Therapy of Abraxane
Table 93: High-Prescribing Physicians Surveyed by Country

1.2 List of Figures
Figure 1: Treatment Flowchart for Localized Gastric Cancer
Figure 2: Treatment Flowchart for Locoregional Gastric cancer
Figure 3: Treatment Flowchart for Metastatic Gastric Cancer
Figure 4: Herceptin’s Development in G/GEJAC
Figure 5: Development of Cyramza in G/GEJAC
Figure 6: Development of TS-1 in G/GEJAC
Figure 7: Development of Abraxane in Gastric Cancer
Figure 8: G/GEJAC - Phase III Pipeline, 2015
Figure 9: Competitive Assessment of Late-Stage Pipeline Agents in G/GEJAC, 2014-2024
Figure 10: Kadcyla’s Development in G/GEJAC
Figure 11: Clinical and Commercial Positioning of Kadcyla
Figure 12: Perjeta’s Development in G/GEJAC
Figure 13: Clinical and Commercial Positioning of Perjeta
Figure 14: Keytruda’s Development in G/GEJAC
Figure 15: Clinical and Commercial Positioning of Keytruda
Figure 16: Opdivo’s Development in G/GEJAC
Figure 17: Clinical and Commercial Positioning of Opdivo
Figure 18: Napabucasin ’s Development in G/GEJAC
Figure 19: Clinical and Commercial Positioning of Napabucasin
Figure 20: Lynparza’s Development in G/GEJAC
Figure 21: Clinical and Commercial Positioning of Lynparza
Figure 22: Nimotuzumab’s Development in Gastric Cancer
Figure 23: Clinical and Commercial Positioning of Nimotuzumab
Figure 24: TAS-118’s Development in Gastric Cancer
Figure 25: Clinical and Commercial Positioning of TAS-118
Figure 26: GS-5745 ’s Development in G/GEJAC
Figure 27: Clinical and Commercial Positioning of GS-5745
Figure 28: Clinical and Commercial Positioning of masitinib
Figure 29: Sales for Gastric Cancer in Japan by Drug Class, 2014-2024