不可切除復发性大肠直肠癌：市场展望、流行病学、竞争格局、市场预测报告（2025-2035年）

市场概览

• 预计到 2025 年，mCRC 市场将达到 43 亿美元，到 2035 年将达到 61 亿美元，复合年增长率为 3.5-4%。
• 推动市场成长的因素如下：符合药物治疗条件的患者人数增加（从 87,000 人增加到 91,000 人），标靶治疗和生物製药的应用范围扩大，以及多线治疗方案的改进。

不可切除復发性大肠直肠癌概述

不可切除的复发性结直肠癌（mCRC），也称为IV期结直肠癌，是指起源于结肠或直肠的恶性细胞转移到远处器官（最常见的是肝臟和肺，较少见的是腹膜、脑和骨骼）。这种转移的进展是大肠直肠癌患者死亡的主要原因。

儘管晚期疾病的根治性治疗效果仍然有限，但治疗方法的进步已显着提高了患者的整体存活率和生活品质。治疗方案高度个人化，取决于肿瘤的生物学特征、分子谱和先前治疗方案，并结合以下几种治疗方法：

• 化疗（FOLFOX、FOLFIRI方案）
• 标靶治疗（EGFR抑制剂、VEGF抑制剂、BRAF抑制剂）
• 免疫疗法（尤其适用于 MSI-H/dMMR 患者）

对于某些患者而言，转移性切除术和肝臟标靶治疗（消融、栓塞）在疾病控制和长期缓解的可能性中起着至关重要的作用。

主要亮点

• mCRC 是一种医疗负担沉重的癌症领域，因为相当一部分大肠直肠癌患者会发展为转移性疾病。
• 由于诊断率和存活率的提高，能够接受药物治疗的患者人数仍然很多，而且还在增加。
• 治疗模式很大程度上依赖生物标记，根据以下标准对患者进行分类：肿瘤侧别（左侧与右侧）和分子状态（RAS/BRAF 突变、MSI 状态）。
• RAS 突变占患者的 45-50%，而 BRAF 突变（8-10%）虽然不太常见，但却构成了一个高风险亚群。
• 治疗方案包括多条线：
• 第一线治疗方案：化疗+标靶治疗（EGFR/VEGF）
• 二线治疗方案：根据抗药性模式更换治疗方法
• 三线/四线治疗：晚期分子标靶治疗与补救性治疗

格式化和更新讯息

• 详细报告（PDF）
• 市场预测模型（基于微软Excel）
• 流行病学数据（MS Excel，互动式工具）
• 高阶主管洞察（PPT简报）
• 其他功能：定期更新、自订和顾问支援。
• 根据 Thelansis 的政策，我们确保所有最新更新在发布前都反映在报告内容和市场模型中。

主要问题

• 我们如何优化 G8 市场（美国、欧盟 5 国、日本、中国）的药物开发与生命週期管理策略？
• 从发病率、盛行率、人群组成以及接受药物治疗的患者人数来看，患者数量分别是多少？
• 未来十年市场收入和病患份额的预测是多少？
• 哪些因素对市场趋势影响最大？
• 受访专家对目前和新兴的治疗方法有何看法？
• 哪款在研发线产品最有前景？其上市潜力及未来市场定位如何？
• 主要未被满足的需求是什么？ KOL 对目标受众有何期望？
• 为确保药物核准并顺利进入市场，必须满足哪些关键的监管和支付方要求？

目标国家

• G8
  • 我们
  • EU5
    • 法国
    • 德国
    • 义大利
    • 西班牙
    • 英国
  • 日本
  • 中国

大公司

• Mirati Therapeutics Inc.
• Buzzard Pharmaceuticals
• Parabilis Medicines, Inc.
• Astellas Pharma Inc
• Mirror Biologics, Inc.
• Shanghai Kechow Pharma, Inc.
• Suzhou Teligene Ltd.
• AstraZeneca
• Novartis Pharmaceuticals
• Carina Biotech Limited
• Treos Bio Limited
• Cardiff Oncology
• Alethia Biotherapeutics
• Shanghai EpimAb Biotherapeutics Co., Ltd.
• AbbVie
• Hoffmann-La Roche
• Menarini Group
• Akeso
• Riboscience, LLC.
• Amgen
• Qilu Pharmaceutical Co., Ltd.
• Pfizer
• BioNTech SE
• Arcus Biosciences, Inc.
• BeyondBio Inc.
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Agenus Inc.
• Bristol-Myers Squibb
• Taizhou Mabtech Pharmaceutical Co.,Ltd
• Incyte Biosciences International
• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
• Hutchison Medipharma Limited
• Hansoh BioMedical R&D;Company
• Jiangsu Simcere Pharmaceutical Co., Ltd.
• Luye Pharma Group Ltd.
• Shanghai JMT-Bio Inc.
• Summit Therapeutics
• Erasca, Inc.
• STCube, Inc.
• CytoDyn, Inc.
• Anbogen Therapeutics, Inc.
• Isofol Medical AB
• MedImmune LLC
• Beijing Biotech
• Vedanta Biosciences, Inc.
• Pierre Fabre Medicament
• Compass Therapeutics
• Amal Therapeutics
• MedPacto, Inc.
• PureTech
• IDEAYA Biosciences
• Wugen, Inc.
• Stingray Therapeutics
• Evopoint Biosciences Inc.

目录

第一章：主要调查结果及分析师说明

• 主要趋势：市场概况、SWOT分析、商业性利益与风险等。

第二章：疾病背景

• 疾病定义、分类、病因和病理生理学、药物标靶等。

第三章：流行病学

• 重点
• 发病率/盛行率
• 已确诊并接受药物治疗的患者人数
• 合併症
• 其他相关患者群

第四章 市场规模及预测

• 重点
• 市场驱动因素与限制因素
• 按药物类别分類的趋势
• 各国具体趋势

第五章 竞争情势

• 目前疗法
  • 重点
  • 诊断和治疗过程/演算法
  • 主要治疗方法概述及KOL洞察
• 新兴疗法
  • 重点
  • 值得关注的后期新治疗方法－概述、市场上市预期及KOL洞察
  • 值得关注的早期管道

第六章：未满足的需求与目标产品分析

• 主要未满足的需求以及透过新兴疗法实现的未来可能性
• TPP分析与KOL展望

第七章 监理与报销环境

第八章附录

Metastatic Colorectal Cancer Market Outlook

Thelansis's "Metastatic Colorectal Cancer Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report - 2025 To 2035" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Metastatic Colorectal Cancer treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Metastatic Colorectal Cancer Overview

Metastatic colorectal cancer (mCRC), or Stage IV colorectal cancer, occurs when malignant cells originating in the colon or rectum spread to distant organs-most commonly the liver and lungs, and less frequently the peritoneum, brain, and bones. This metastatic progression is the primary driver of mortality in colorectal cancer.

While curative outcomes remain limited in advanced disease, therapeutic advancements have significantly improved overall survival and quality of life. Treatment is highly personalized and guided by tumor biology, molecular profile, and line of therapy, incorporating combinations of:

• Chemotherapy (FOLFOX, FOLFIRI-based regimens)
• Targeted therapies (EGFR inhibitors, VEGF inhibitors, BRAF inhibitors)
• Immunotherapies (particularly in MSI-H/dMMR populations)

In select patients, metastasectomy and liver-directed therapies (ablation, embolization) play a critical role in disease control and potential long-term remission.

Key Highlights

• mCRC represents a high-burden oncology segment, with a substantial proportion of colorectal cancer patients progressing to metastatic disease.
• The drug-treatable patient population remains large and growing, supported by increasing diagnosis rates and improved survival outcomes.
• Treatment paradigm is highly biomarker-driven, with segmentation based on: Tumor sidedness (left vs right) & Molecular status (RAS/BRAF mutations, MSI status)
• RAS mutations account for 45-50% of patients, while BRAF mutations (8-10%) represent a smaller but high-risk subgroup.
• Treatment is structured across multiple lines:
• 1st line: chemo + targeted therapy (EGFR/VEGF)
• 2nd line: therapy switch based on resistance patterns
• 3rd/4th line: later-line targeted agents and salvage therapies

Market Overview

• The mCRC market is valued at $4.3Bn in 2025, projected to reach $6.1Bn by 2035, reflecting a CAGR of 3.5-4%.
• Market growth is driven by: Increasing drug-treatable population (87K to 91K patients), Expanded use of targeted therapies and biologics, Improved treatment sequencing across multiple lines

Insights driven by robust research, including:

• In-depth interviews with leading KOLs and payers
• Physician surveys
• RWE analysis for claims and EHR datasets
• Secondary research (e.g., peer-reviewed journal articles, third-party research databases)

Deliverables format and updates*:

• Detailed Report (PDF)
• Market Forecast Model (MS Excel-based automated dashboard)
• Epidemiology (MS Excel; interactive tool)
• Executive Insights (PowerPoint presentation)
• Others: regular updates, customizations, consultant support
• As per Thelansis's policy, we ensure that we include all the recent updates before releasing the report content and market model.

Salient features of Market Forecast model:

• 10-year market forecast (2025-2035)
• Bottom-up patient-based market forecasts validated through the top-down sales methodology
• Covers clinically and commercially-relevant patient populations/ line of therapies
• Annualized drug-level sales and patient share projections
• Utilizes our proprietary Epilansis and Analog tool (e.g., drug uptake and erosion) datasets and conjoint analysis approach
• Detailed methodology/sources & assumptions
• Graphical and tabular outputs
• Users can customize the model based on requirements

Key business questions answered:

• How can drug development and lifecycle management strategies be optimized across G8 markets (US, EU5, Japan, and China)?
• How large is the patient population in terms of incidence, prevalence, segments, and those receiving drug treatments?
• What is the 10-year market outlook for sales and patient share?
• Which events will have the greatest impact on the market's trajectory?
• What insights do interviewed experts provide on current and emerging treatments?
• Which pipeline products show the most promise, and what is their potential for launch and future positioning?
• What are the key unmet needs and KOL expectations for target profiles?
• What key regulatory and payer requirements must be met to secure drug approval and favorable market access?

Countries Covered

• G8
  • United States
  • EU5
    • France
    • Germany
    • Italy
    • Spain
    • U.K.
  • Japan
  • China

Apart from the G8 Market, adding any additional country data to the dashboard/report will cost USD 1,750 per country

Companies Mentioned

• Mirati Therapeutics Inc.
• Buzzard Pharmaceuticals
• Parabilis Medicines, Inc.
• Astellas Pharma Inc
• Mirror Biologics, Inc.
• Shanghai Kechow Pharma, Inc.
• Suzhou Teligene Ltd.
• AstraZeneca
• Novartis Pharmaceuticals
• Carina Biotech Limited
• Treos Bio Limited
• Cardiff Oncology
• Alethia Biotherapeutics
• Shanghai EpimAb Biotherapeutics Co., Ltd.
• AbbVie
• Hoffmann-La Roche
• Menarini Group
• Akeso
• Riboscience, LLC.
• Amgen
• Qilu Pharmaceutical Co., Ltd.
• Pfizer
• BioNTech SE
• Arcus Biosciences, Inc.
• BeyondBio Inc.
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Agenus Inc.
• Bristol-Myers Squibb
• Taizhou Mabtech Pharmaceutical Co.,Ltd
• Incyte Biosciences International
• Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
• Hutchison Medipharma Limited
• Hansoh BioMedical R&D Company
• Jiangsu Simcere Pharmaceutical Co., Ltd.
• Luye Pharma Group Ltd.
• Shanghai JMT-Bio Inc.
• Summit Therapeutics
• Erasca, Inc.
• STCube, Inc.
• CytoDyn, Inc.
• Anbogen Therapeutics, Inc.
• Isofol Medical AB
• MedImmune LLC
• Beijing Biotech
• Vedanta Biosciences, Inc.
• Pierre Fabre Medicament
• Compass Therapeutics
• Amal Therapeutics
• MedPacto, Inc.
• PureTech
• IDEAYA Biosciences
• Wugen, Inc.
• Stingray Therapeutics
• Evopoint Biosciences Inc.

Table of Contents

1. Key Findings and Analyst Commentary

• Key trends: market snapshots, SWOT analysis, commercial benefits and risks, etc.

2. Disease Context

• Disease definition, classification, etiology and pathophysiology, drug targets, etc.

3. Epidemiology

• Key takeaways
• Incidence / Prevalence
• Diagnosed and Drug-Treated populations
• Comorbidities
• Other relevant patient segments

4. Market Size and Forecast

• Key takeaways
• Market drivers and constraints
• Drug-class specific trends
• Country-specific trends

5. Competitive Landscape

• Current therapies
  • Key takeaways
  • Dx and Tx journey/algorithm
  • Key current therapies - profiles and KOL insights
• Emerging therapies
  • Key takeaways
  • Notable late-phase emerging therapies - profiles, launch expectations, KOL insights
  • Notable early-phase pipeline

6. Unmet Need and TPP Analysis

• Top unmet needs and future attainment by emerging therapies
• TPP analysis and KOL expectations

7. Regulatory and Reimbursement Environments (by country and payer insights)

8. Appendix (e.g., bibliography, methodology)