소화기계 암 치료제 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the gastrointestinal cancer drugs market size was valued at USD 23.14 billion in 2025 and is estimated to grow from USD 24.18 billion in 2026 to reach USD 30.13 billion by 2031, at a CAGR of 4.5% during the forecast period (2026-2031).

Global Gastrointestinal Cancer Drugs Market Trends and Insights

Precision Oncology and Biomarker Defined Treatment Adoption

The gastrointestinal cancer drugs market is increasingly driven by biomarker-based treatment decisions rather than tumor location alone. Colorectal, gastric, and pancreatic cancer care uses KRAS G12C, BRAF V600E, HER2, CLDN18.2, MSI-H/dMMR, MET amplification, and NRG1 fusions. Commercially relevant targets have nearly tripled since 2020. Patients can transition to another biomarker-eligible regimen after disease progression, extending treatment across multiple lines of care. In 2026, the FDA approved Guardant360 CDx as a companion diagnostic for the BRAFTOVI combination in BRAF V600E-mutant metastatic colorectal cancer, supporting liquid biopsy adoption and testing access in community oncology settings.

First Line Immunotherapy Combination Expansion

First-line checkpoint inhibitor combinations are replacing chemotherapy alone across several gastrointestinal cancers. In March 2025, the FDA approved pembrolizumab with trastuzumab and platinum-based chemotherapy for HER2-positive gastric or gastroesophageal junction adenocarcinoma with PD-L1 CPS of 1 or higher. In April 2025, nivolumab plus ipilimumab received regular approval for first-line MSI-H/dMMR unresectable or metastatic colorectal cancer. These regimens require biomarker testing at the start of care and can extend maintenance treatment for 24 months or longer. The FDA approval of the Idylla CDx MSI Test for nivolumab in dMMR colorectal cancer also supported an automated workflow with results in under three hours.

Cost and Reimbursement Friction for Biomarker Selected Regimens

Biomarker-selected combinations are among the highest-cost treatment options in gastrointestinal oncology. First-line treatment for HER2-positive gastric adenocarcinoma can combine HER2-targeted therapy, PD-1 or PD-L1 inhibition, and chemotherapy. Health technology assessment bodies assess these combinations against incremental survival gains, which may be measured in weeks rather than months. In several European countries, reimbursement for medicines does not always cover companion diagnostics, discouraging testing and limiting biomarker-eligible prescribing. China's 2025 National Reimbursement Drug List process included several gastrointestinal cancer biologics and required price cuts of 40% to 60% for inclusion. Wider coverage can improve access, but lower prices can reduce manufacturer margins and favor domestic products with lower starting prices.

Other drivers and restraints analyzed in the detailed report include:

1. Rising Gastrointestinal Cancer Burden and Earlier Diagnosis
2. Perioperative and Adjuvant Drug Treatment
3. Biosimilar, Generic, and Mandatory Price Reduction Pressure

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Colorectal cancer held 34.22% of the gastrointestinal cancer drugs market share in 2025, supported by established treatment pathways across biomarker-defined groups, including MSI-H/dMMR, BRAF V600E, KRAS G12C, and HER2-amplified disease. Gastric, gastroesophageal junction, and esophageal cancers formed the next-largest group, with treatment use increasing following HER2-directed and PD-1 inhibitor approvals in 2025 and 2026. Pancreatic cancer is the fastest-growing category, with the segment projected to grow at a 5.36% CAGR through 2031. In August 2026, the FDA is expected to approve daraxonrasib for metastatic pancreatic adenocarcinoma after prior systemic therapy or for patients unable to receive multi-agent chemotherapy. The Phase III RASolute 302 trial showed a 60% reduction in the risk of death versus chemotherapy.

Daraxonrasib is expected to become the first targeted RAS inhibitor approved for pancreatic cancer, expanding targeted therapy in an indication previously dominated by chemotherapy. Merus received FDA accelerated approval for zenocutuzumab in NRG1 fusion-positive pancreatic adenocarcinoma in December 2024. In May 2026, the FDA expanded the use of zenocutuzumab to NRG1 fusion-positive cholangiocarcinoma following prior systemic therapy. Liver, anal, and other gastrointestinal cancers retain smaller shares but have approved systemic treatment options.

Oncology departments accounted for 68.76% of gastrointestinal cancer drug spending in 2025, reflecting the use of infusion-based immunotherapy and chemotherapy in established oncology settings. Radiology and nuclear medicine are projected to grow at a 6.33% CAGR through 2031, the fastest rate across the application segment. Radioligand therapies require specialized administration environments beyond standard infusion services. These therapies require radiation safety certification, shielded preparation areas, and waste-disposal procedures subject to nuclear regulations. Such requirements limit early expansion to centers with established infrastructure. The other application category, including supportive care drugs, dose-limiting agents, and radiation-sensitizing compounds, retains a comparatively stable share.

The gastrointestinal cancer drugs market is adding distribution, training, and access requirements as radioligand programs advance. Manufacturers need programs tailored to nuclear medicine settings rather than only infusion centers. Approved radioligand approaches in neuroendocrine tumors provide a foundation for future expansion across other gastrointestinal malignancies. Investigational programs could increase radiology activity as additional indications receive regulatory clearance. The FDA's accelerated review pathways for breakthrough-designated radioligand therapies can reduce the time from clinical results to adoption in care settings. However, specialized infrastructure remains a practical constraint on near-term patient volumes.

Complete Report Scope:

• By Cancer Type
  • Colorectal Cancer
  • Gastric and Gastroesophageal Junction Cancer
  • Esophageal Cancer
  • Pancreatic Cancer
  • Liver Cancer
  • Biliary Tract Cancer
  • Anal Cancer
  • Other Cancers
• By Application
  • Oncology
  • Radiology
  • Others
• By Therapy
  • Chemotherapy
  • Immunotherapy
  • Targeted Therapy
  • Hormone Therapy
  • Radioligand Therapy
  • Cellular and TIL Therapy
  • Others
• By End User
  • Hospitals
  • Oncology Clinics
  • Ambulatory Surgical Centers
  • Cancer Research Institutes
  • Others
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held a 39.44% share of the gastrointestinal cancer drugs market in 2025. The region benefited from more than 10 FDA clearances for gastrointestinal cancer therapies between January 2025 and August 2026. The United States led the region due to higher drug prices, stronger biomarker testing rates, and formulary systems that rapidly cover new approvals. Canada and Mexico held smaller but growing positions, while the Inflation Reduction Act price negotiation framework may pressure U.S. pricing advantages as eligible oncology medicines reach nine years after approval.

Europe held a significant market share, led by Germany, France, the United Kingdom, Italy, and Spain. The EU IVDR framework increased compliance requirements and concentrated companion diagnostic activity among larger certified suppliers. Roche's VENTANA MMR RxDx Panel received IVDR approval in June 2026 for several gastrointestinal cancer indications. The European approval of durvalumab with FLOT added a perioperative treatment option for resectable gastric and gastroesophageal junction cancer, although health technology assessment decisions may delay access in Germany and France.

Asia-Pacific is projected to expand at a CAGR of 6.98% through 2031, making it the fastest-growing geographic segment. Rising cancer incidence, investments in domestic biologics production, and faster regulatory reviews support growth. China approved VYLOY for CLDN18.2-positive gastric cancer in January 2025 and Enhertu for second-line HER2-positive gastric cancer in January 2026. Japan approved sotorasib with panitumumab in September 2025 and updated the Enhertu label in March 2026. The Middle East and Africa and South America remain smaller contributors, although Africa's projected 157% increase in cancer incidence indicates long-term potential.

1. Amgen
2. Astellas Pharma
3. AstraZeneca
4. Bayer
5. BeiGene, Ltd.
6. BeOne Medicines Ltd.
7. Bristol-Myers Squibb
8. Eli Lilly and Company
9. Exelixis, Inc.
10. Roche
11. Incyte
12. Ipsen
13. Jazz Pharmaceuticals plc
14. Merck
15. Merus N.V.
16. Novartis
17. Pfizer
18. Regeneron Pharmaceuticals
19. Revolution Medicines, Inc.
20. Sanofi
21. Taiho Pharmaceutical Co., Ltd.
22. Takeda Pharmaceuticals

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 INTRODUCTION

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET LANDSCAPE

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Precision-Oncology and Biomarker-Defined Treatment Adoption
  • 4.2.2 Expansion of First-Line Immunotherapy Combinations
  • 4.2.3 Rising Gastrointestinal Cancer Burden and Earlier Diagnosis
  • 4.2.4 Wider Use of Companion Diagnostics
  • 4.2.5 Shift Toward Perioperative and Adjuvant Drug Treatment
  • 4.2.6 Regionalization of Oncology Biologics Manufacturing
• 4.3 Market Restraints
  • 4.3.1 High Cost and Reimbursement Friction for Biomarker-Selected Regimens
  • 4.3.2 Biosimilar, Generic, and Mandatory-Price-Reduction Pressure
  • 4.3.3 Limited Molecular-Testing, Infusion, and Cell-Therapy Capacity
  • 4.3.4 Manufacturing, Cold-Chain, and Injectable Supply Vulnerability
• 4.4 Value/Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Bargaining Power of Suppliers
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 MARKET SIZE AND GROWTH FORECASTS (VALUE, USD)

• 5.1 By Cancer Type
  • 5.1.1 Colorectal Cancer
  • 5.1.2 Gastric and Gastroesophageal Junction Cancer
  • 5.1.3 Esophageal Cancer
  • 5.1.4 Pancreatic Cancer
  • 5.1.5 Liver Cancer
  • 5.1.6 Biliary Tract Cancer
  • 5.1.7 Anal Cancer
  • 5.1.8 Other Cancers
• 5.2 By Application
  • 5.2.1 Oncology
  • 5.2.2 Radiology
  • 5.2.3 Others
• 5.3 By Therapy
  • 5.3.1 Chemotherapy
  • 5.3.2 Immunotherapy
  • 5.3.3 Targeted Therapy
  • 5.3.4 Hormone Therapy
  • 5.3.5 Radioligand Therapy
  • 5.3.6 Cellular and TIL Therapy
  • 5.3.7 Others
• 5.4 By End User
  • 5.4.1 Hospitals
  • 5.4.2 Oncology Clinics
  • 5.4.3 Ambulatory Surgical Centers
  • 5.4.4 Cancer Research Institutes
  • 5.4.5 Others
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 India
    • 5.5.3.3 Japan
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.3.1 Amgen Inc.
  • 6.3.2 Astellas Pharma Inc.
  • 6.3.3 AstraZeneca PLC
  • 6.3.4 Bayer AG
  • 6.3.5 BeiGene, Ltd.
  • 6.3.6 BeOne Medicines Ltd.
  • 6.3.7 Bristol-Myers Squibb Company
  • 6.3.8 Eli Lilly and Company
  • 6.3.9 Exelixis, Inc.
  • 6.3.10 F. Hoffmann-La Roche Ltd
  • 6.3.11 Incyte Corporation
  • 6.3.12 Ipsen Biopharmaceuticals, Inc.
  • 6.3.13 Jazz Pharmaceuticals plc
  • 6.3.14 Merck & Co., Inc.
  • 6.3.15 Merus N.V.
  • 6.3.16 Novartis AG
  • 6.3.17 Pfizer Inc.
  • 6.3.18 Regeneron Pharmaceuticals, Inc.
  • 6.3.19 Revolution Medicines, Inc.
  • 6.3.20 Sanofi
  • 6.3.21 Taiho Pharmaceutical Co., Ltd.
  • 6.3.22 Takeda Pharmaceutical Company Limited

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment