Gastric Cancer: From H. pylori Prevention to Precision Treatment | Market Intelligence

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List of Tables

Gastric cancer is the disease Japan taught the world to see coming. Decades of endoscopic screening culture, national H. pylori eradication reimbursement since 2013, and ABC risk stratification have bent incidence in ways no other country has replicated, and Japanese surgeons and endoscopists built the early-detection and ESD resection standards the rest of Asia adopted. Yet the disease remains a leading cause of cancer death at home, and the patients who still present with advanced disease now enter the most biomarker-fragmented treatment landscape in oncology: HER2, CLDN18.2, PD-L1, FGFR2b, and MSI status each carve the same diagnosis into different drug pathways.

The tension runs in both directions along the disease timeline. At the prevention end, eradication coverage has created a growing population of post-eradication patients whose residual cancer risk is real but whose surveillance is unstructured - a managed segment in search of a manager. At the treatment end, Japan approved Vyloy first-in-world in March 2024, hosts Japan-led Enhertu gastric data, and runs first-line immunotherapy through Opdivo and Keytruda, while Amgen's bemarituzumab and a Chinese CLDN18.2 ADC and CAR-T wave press from behind. Which biomarker is tested, in what order, on which specimen, and which targeted agent takes which line are live sequencing disputes with direct commercial stakes.

This report follows gastric cancer in Japan from eradication policy to precision treatment. It maps the prevention infrastructure - screening participation, ABC stratification, eradication therapy, and post-eradication surveillance practice - then reconstructs the advanced-disease armamentarium program by program: CheckMate-649 and ATTRACTION-4 for Opdivo, KEYNOTE-811 and KEYNOTE-859 for Keytruda, SPOTLIGHT and GLOW for Vyloy, DESTINY-Gastric for Enhertu, FORTITUDE-101 for bemarituzumab, and the Chinese assets led by Innovent's IBI343, Akeso, RemeGen, and CARsgen. A dedicated chapter covers the biomarker-testing cascade that makes any of this actionable.

The report serves GI oncology BD teams, diagnostics firms building multi-marker panels and pathology services, payers tracking biomarker-defined spending, and investors comparing gastric programs. It provides the end-to-end view - prevention economics through line-of-therapy sequencing - that single-modality analyses miss.

Scope and Coverage: The report covers gastric cancer prevention, screening, and treatment in Japan, including H. pylori programs, endoscopic early detection, perioperative and metastatic therapy, biomarker testing, and pipeline assets. It profiles Astellas, Daiichi Sankyo, Ono, Bristol Myers Squibb, Merck, Amgen, Innovent, Akeso, RemeGen, Zai Lab, and CARsgen.

Report Highlights:

Maps Japan's H. pylori eradication and ABC stratification prevention infrastructure
Analyzes the unmanaged post-eradication residual-risk surveillance segment
Profiles first-line immunotherapy, Vyloy, Enhertu, and bemarituzumab programs
Covers the Chinese CLDN18.2 ADC, bispecific, and CAR-T wave in gastric cancer
Dissects the multi-biomarker testing cascade and pathology workflow
Frames sequencing and line-of-therapy questions with commercial stakes

Product Code: JPH-035

Table of Content

1. Executive Summary

2. Gastric Cancer: Overview and Clinical Background

3. Epidemiology and Patient Population: US, EU5, Japan, and China

4. Current Treatment Landscape and Standard of Care

5. Pipeline and Development Activity

6. Regulatory Pathways: FDA, EMA, PMDA, and NMPA Considerations

7. Reimbursement and Pricing Analysis with a Focus on Japan's NHI System

8. Competitive Landscape and Key Companies

9. Unmet Needs and Commercial Opportunities in Japan

10. Appendix: Methodology and Sources

Companies Mentioned

Astellas (JP) - Vyloy (zolbetuximab) first-in-world CLDN18.2 approval in Japan
Daiichi Sankyo (JP) - Enhertu HER2 ADC with Japan-led gastric cancer data
Ono Pharmaceutical (JP) - Opdivo first-line gastric cancer in Japan
Bristol Myers Squibb (US) - Opdivo global partner; CheckMate gastric program
Merck & Co (US) - Keytruda gastric and GEJ indications
Amgen (US) - bemarituzumab FGFR2b mAb program
Innovent (CN) - IBI343 CLDN18.2 ADC for gastric cancer
Akeso (CN) - cadonilimab and CLDN18.2 bispecific programs
RemeGen (CN) - disitamab vedotin approved in China for HER2-expressing gastric cancer
Zai Lab (CN) - bemarituzumab China rights
CARsgen (CN) - satricabtagen autoleucel CLDN18.2 CAR-T in gastric cancer

Product Code: JPH-035

List of Tables

Table 1. Gastric Cancer Burden in Japan: Epidemiological Framework and Data Sources
Table 2. H. pylori Infection Biology and Carcinogenesis Pathway
Table 3. NHI-Reimbursed H. pylori Eradication: Eligibility Expansion Since 2013
Table 4. Eradication Regimens: First-Line, Second-Line, and Vonoprazan-Based Protocols
Table 5. ABC Risk Stratification: Serology-Based Screening Design
Table 6. Population Endoscopic Screening Programs and Participation Data
Table 7. Early Detection and ESD Resection Standards in Japanese Practice
Table 8. Post-Eradication Residual Risk: Evidence Base and Surveillance Gap
Table 9. Surveillance Protocol Options for Post-Eradication Patients
Table 10. Gastric Cancer Staging and Surgical Standards in Japan
Table 11. Perioperative and Adjuvant Treatment Framework: ACTS-GC and SOX Heritage
Table 12. MATTERHORN and Perioperative Immunotherapy Program Designs
Table 13. Biomarker Map of Advanced Gastric Cancer: HER2, CLDN18.2, PD-L1, FGFR2b, MSI
Table 14. Opdivo First-Line Gastric Position: CheckMate-649 Design
Table 15. ATTRACTION-4: Japan-Asia Immunotherapy Combination Evidence
Table 16. Keytruda Gastric and GEJ Programs: KEYNOTE-811 and KEYNOTE-859 Designs
Table 17. Vyloy (Zolbetuximab): SPOTLIGHT and GLOW Programs and Japan Label
Table 18. Enhertu in Gastric Cancer: DESTINY-Gastric01 Japan-Led Design
Table 19. DESTINY-Gastric02 and Western Confirmatory Context
Table 20. Bemarituzumab (Amgen): FORTITUDE-101 Program and FGFR2b Testing
Table 21. Zai Lab Bemarituzumab China Rights and Regional Strategy
Table 22. Innovent IBI343: CLDN18.2 ADC Gastric Program
Table 23. Akeso Cadonilimab and CLDN18.2 Bispecific Gastric Programs
Table 24. RemeGen Disitamab Vedotin: China HER2 Gastric Approval and Programs
Table 25. CARsgen Satricabtagene Autoleucel Gastric CAR-T Program
Table 26. Ramucirumab and Legacy Second-Line VEGFR2 Positioning
Table 27. Trifluridine/Tipiracil and Later-Line Chemotherapy Framework
Table 28. MSI-High and EBV Gastric Subtypes: Immunotherapy Implications
Table 29. HER2 Testing Standards in Japanese Gastric Pathology
Table 30. CLDN18.2 IHC Testing Integration into Gastric Workflow
Table 31. PD-L1 CPS Scoring Practices and Reimbursement Context
Table 32. Multi-Biomarker Cascade Design: Order, Specimen, and Turnaround
Table 33. Line-of-Therapy Sequencing Framework for Biomarker-Defined Gastric Cancer
Table 34. NHI Pricing and Cost-Effectiveness Treatment of Gastric Regimens
Table 35. Hospital Adoption Requirements for New Biomarker-Defined Regimens
Table 36. Regional Variation in Screening and Treatment Infrastructure
Table 37. China Gastric Pipeline Density and Japan Spillover Dynamics
Table 38. Competitive Positioning Matrix: Gastric Assets by Target and Line
Table 39. Deal Benchmarks for Gastric Oncology Licensing
Table 40. Trial-Enrollment Competition in Japanese Gastric Studies
Table 41. Scenario Framework: Gastric Treatment Architecture Paths
Table 42. Risk Register: Screening Erosion, Biomarker Crowding, and Pricing Pressure
Table 43. Indicator Dashboard for Gastric Cancer Market Monitoring
Table 44. Due-Diligence Checklist for Gastric Assets and Diagnostics
Table 45. Residual-Risk Surveillance Business Models: Feasibility Framework
Table 46. Stakeholder Position Map: Societies, Municipalities, Payers, and Sponsors
Table 47. Real-World Data Sources: Registries and Claims for Gastric Cancer
Table 48. Patient Journey from Screening to Advanced-Disease Care
Table 49. Horizon Scan: MRD-Guided Adjuvant Decisions in Gastric Cancer
Table 50. Analytical Appendix: Guidelines, Registries, and Trial Sources

List of Figures

Figure 1. Gastric Cancer Epidemiological Framework
Figure 2. H. pylori Carcinogenesis Pathway Diagram
Figure 3. Eradication Eligibility Expansion Timeline
Figure 4. Eradication Regimen Decision Flow
Figure 5. ABC Stratification Screening Design
Figure 6. Endoscopic Screening Program Structure
Figure 7. Early Detection and ESD Pathway
Figure 8. Post-Eradication Residual Risk Framework
Figure 9. Surveillance Protocol Option Map
Figure 10. Staging and Surgical Standards Diagram
Figure 11. Perioperative Treatment Framework Timeline
Figure 12. MATTERHORN Program Schematic
Figure 13. Advanced-Disease Biomarker Map
Figure 14. CheckMate-649 and ATTRACTION-4 Design Schematics
Figure 15. KEYNOTE-811 and KEYNOTE-859 Program Trees
Figure 16. Vyloy SPOTLIGHT and GLOW Schematics
Figure 17. DESTINY-Gastric Program Family Tree
Figure 18. FORTITUDE-101 and FGFR2b Testing Flow
Figure 19. IBI343 Gastric Program Diagram
Figure 20. Akeso Bispecific Program Map
Figure 21. Disitamab Vedotin China Context Diagram
Figure 22. Satricabtagene Autoleucel Gastric Program Map
Figure 23. Second-Line and Later-Line Framework
Figure 24. MSI-High and EBV Subtype Diagram
Figure 25. HER2 Testing Standards Flow
Figure 26. CLDN18.2 IHC Integration into Gastric Pathology
Figure 27. PD-L1 CPS Scoring Practice Framework
Figure 28. Multi-Biomarker Cascade Design Diagram
Figure 29. Biomarker-Defined Sequencing Framework
Figure 30. NHI Pricing Pathway for Gastric Regimens
Figure 31. Hospital Adoption Requirement Checklist
Figure 32. Regional Infrastructure Variation Framework
Figure 33. China Pipeline Density and Spillover Map
Figure 34. Competitive Positioning Map by Target and Line
Figure 35. Gastric Licensing Deal Benchmarks
Figure 36. Enrollment Competition Dynamics
Figure 37. Scenario Tree: Treatment Architecture Paths
Figure 38. Risk Map: Screening, Biomarkers, and Pricing
Figure 39. Gastric Market Monitoring Dashboard
Figure 40. Asset Due-Diligence Flow
Figure 41. Residual-Risk Surveillance Business Model Framework
Figure 42. Stakeholder Position Map
Figure 43. Real-World Data Source Map
Figure 44. Patient Journey from Screening to Advanced Care
Figure 45. MRD-Guided Adjuvant Horizon Diagram
Figure 46. Endoscopy Capacity and Screening Channel Map
Figure 47. Investor KPI Dashboard for the Gastric Theme
Figure 48. Sponsor Positioning Options Across Biomarker Segments
Figure 49. Synthesis: What Decides Gastric Segment Leadership in Japan
Figure 50. Report Roadmap: Chapter Linkages to Reader Decisions

Gastric Cancer: From H. pylori Prevention to Precision Treatment | Market Intelligence | US, EU5, Japan & China

Description

Table of Contents

List of Tables

Table of Content

1. Executive Summary

2. Gastric Cancer: Overview and Clinical Background

3. Epidemiology and Patient Population: US, EU5, Japan, and China

4. Current Treatment Landscape and Standard of Care

5. Pipeline and Development Activity

6. Regulatory Pathways: FDA, EMA, PMDA, and NMPA Considerations

7. Reimbursement and Pricing Analysis with a Focus on Japan's NHI System

8. Competitive Landscape and Key Companies

9. Unmet Needs and Commercial Opportunities in Japan

10. Appendix: Methodology and Sources

Companies Mentioned

List of Tables

List of Figures