轉移性大腸直腸癌：新型療法、未滿足的需求和TPP洞察報告，2026年

市場概覽

• 預計到 2025 年，mCRC 市場將達到 43 億美元，到 2035 年將達到 61 億美元，複合年成長率為 3.5-4%。
• 推動市場成長的因素如下：符合藥物治療條件的患者人數增加（從 87,000 人增加到 91,000 人），標靶治療和生物製藥的應用範圍擴大，以及多線治療方案的改進。

對轉移性大腸直腸癌新興治療方法和治療策略的深入了解

Thelansis 發布的「轉移性結直腸癌新興治療方法、未滿足需求和 TPP 洞察報告 - 2026」全面分析了該適應症的關鍵新興治療方法和主要藥物發現機會，包括新興的競爭格局、未滿足的需求、目標產品概況 (TPP)、試驗設計和關鍵意見領袖 (KOL) 的見解。

轉移性大腸直腸癌概述

轉移性大腸直腸癌（mCRC），也稱為IV期大腸直腸癌，是指起源於結腸或直腸的惡性細胞轉移到遠處器官（最常見的是肝臟和肺，較少見的是腹膜、腦和骨骼）。這種轉移的進展是大腸直腸癌患者死亡的主要原因。

儘管晚期疾病的根治性治療效果仍然有限，但治療方法的進步已顯著提高了患者的整體存活率和生活品質。治療方案高度個人化，取決於腫瘤的生物學特徵、分子譜和先前治療方案，並結合以下幾種治療方法：

• 化療（FOLFOX、FOLFIRI方案）
• 標靶治療（EGFR抑制劑、VEGF抑制劑、BRAF抑制劑）
• 免疫療法（尤其適用於 MSI-H/dMMR 患者）

對於某些患者而言，切除術轉移性病灶和治療肝臟（消融、栓塞）在控制疾病和實現長期緩解方面起著至關重要的作用。

主要亮點

• mCRC 是一種醫療負擔沉重的癌症領域，因為相當一部分大腸直腸癌患者會發展為轉移性疾病。
• 由於診斷率和存活率的提高，大量患者仍然符合藥物治療的條件，而且這一數字還在不斷成長。
• 治療模式很大程度上依賴生物標記，並根據以下標準進行分類：腫瘤側別（左側與右側）和分子狀態（RAS/BRAF 突變、MSI 狀態）。
• RAS 突變佔患者的 45-50%，而 BRAF 突變（8-10%）則代表了一個較小但高風險的亞群。
• 治療方案包括多條線：
• 第一線治療方案：化療+標靶治療（EGFR/VEGF）
• 二線治療方案：根據抗藥性模式更換治療方法
• 三線和四線治療：晚期標靶治療和補救性治療

基於對醫生和關鍵意見領袖（KOL）的調查得出的結論：

• 透過對關鍵意見領袖 (KOL) 的訪談，我們獲得了更多見解，從而進一步完善了調查結果。
• 調查問卷將根據客戶的要求進行客製化。

交付成果格式：

• PowerPoint簡報
• MS Excel

主要問題

• 詳細的競爭格局分析
• 管道分析
• 符合新興治療方法的患者
• 大公司
• 主要作用機制
• 發布日期等的預測
• 臨床試驗趨勢分析
• 目標患者群
• 試驗終點
• 測試設計
• 受試者招募標準等。
• 未滿足的需求和機遇
• 目前主要治療方法的有效性
• 未滿足需求的關鍵領域
• 估算主要未滿足需求的市場規模
• 目標產品概況
• 屬性和級別
• 醫生開立的處方
• 預期患者佔有率
• 關鍵KOL洞察對領先新興治療方法的見解
• 意識
• 預期用途/處理線
• 對主要未滿足需求的滿意度
• KOL評論

目標國家

• G8
  • 美國
  • EU5
    • 法國
    • 德國
    • 義大利
    • 西班牙
    • 英國
  • 日本
  • 中國

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.

目錄

第1章：主要調查結果及分析師說明

• 主要趨勢：市場概況、SWOT分析、商業性利益與風險等。

第2章：疾病背景

• 疾病定義、分類、病因和病理生理學、藥物標靶等。

第3章：流行病學

• 重點
• 發病率/盛行率
• 已確診並接受藥物治療的患者人數
• 合併症
• 其他相關患者群

第4章 市場規模及預測

• 重點
• 市場促進因素與限制因素
• 按藥物類別分類的趨勢
• 各國具體趨勢

第5章 競爭情勢

• 目前的治療方法
• 重點
• 診斷和治療過程/演算法
• 主要治療方法概述及KOL洞察
• 新興治療方法
• 重點
• 值得關注的後期新治療方法－概述、市場上市預期及KOL洞察
• 值得關注的早期研發管線

第6章：未滿足的需求與目標產品分析

• 主要未滿足的需求及其未來透過新興治療方法實現的可能性
• TPP分析與KOL展望

第7章 監理與報銷環境

第8章附錄

Metastatic Colorectal Cancer Emerging Therapy and TPP Insights

Thelansis's "Metastatic Colorectal Cancer Emerging Therapy, with Unmet Needs and TPP Insights Report - 2026" provides a comprehensive analysis of the emerging competitive landscape, unmet needs, target product profiles (TPPs), trial designs, and KOL insights on key emerging therapies and key drug development opportunities in the indication.

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 surveys with physician / key opinion leaders:

• Survey findings are corroborated and enriched by insights from interviews with leading KOLs
• Survey is customized based on client requirements

Deliverables format:

• PowerPoint presentation
• MS Excel

Key business questions answered:

• Detailed emerging competitive landscape
• Pipeline analysis
• Target patients for emerging therapies
• Key companies
• Key mechanism of actions
• Launch date estimates, etc.
• Clinical trial landscape analysis
• Target patient segments
• Trial endpoints
• Trial design
• Recruitment criteria, etc.
• Unmet Needs and Opportunities
• Performance of key current therapies
• Top areas of unmet needs
• Opportunity sizing for key unmet needs
• Target Product Profiles
• Attributes and levels
• Physician likelihood of prescribing
• Expected patient shares
• KOL insights on key emerging therapies
• Level of awareness
• Expected use / line of therapy
• Extent to fulfil key unmet needs
• KOL quotes

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 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)