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市場調查報告書
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1963805

膽道癌市場－全球產業規模、佔有率、趨勢、機會、預測：按癌症類型、最終用戶、地區和競爭格局分類，2021-2031年

Biliary Tract Cancers Market - Global Industry Size, Share, Trends, Opportunity, & Forecast, Segmented By Cancer Type, By End-User, By Region & Competition, 2021-2031F
出版日期: | 出版商: TechSci Research | 英文 180 Pages | 商品交期: 2-3個工作天內

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簡介目錄

全球膽道癌市場預計將從 2025 年的 6.7569 億美元成長到 2031 年的 8.9263 億美元，複合年成長率為 4.75%。

此領域涵蓋專門用於診斷膽管和膽囊惡性腫瘤（例如膽管癌和膽囊癌）的診斷設備和治療方法。推動該市場發展的關鍵因素包括慢性肝病盛行率的上升、全球人口結構向老化轉變，以及用於分子譜分析以發現新治療途徑的資金投入增加。根據美國癌症協會估計，到2025年，美國預計將新增約12,610例膽囊癌及鄰近膽管癌病例。

市場概覽
預測期 2027-2031
市場規模：2025年 6.7569億美元
市場規模：2031年 8.9263億美元
複合年成長率：2026-2031年 4.75%
成長最快的細分市場 肝外膽管癌（EHC）
最大的市場 北美洲

然而，由於疾病確診時常已處於晚期，市場面臨許多重大障礙。由於症狀通常只在癌症發展到相當晚期時才會出現，因此對大多數患者而言，根治性手術並非現實之選，許多現有療法的療效也有限。這個問題使得臨床研發複雜化，並限制了早期療育療法的商業性可行性，阻礙了整體市場擴張。

市場促進因素

新型標靶治療和免疫療法的引入，克服了傳統化療的局限性，正強勁推動全球膽道癌市場成長。製藥公司正利用基因組數據開發針對分子突變（例如HER2擴增和FGFR2融合）的藥物。 2024年11月，Jazz Pharmaceuticals發布的新聞稿「FDA核准Zanidatamab用於治療膽道癌」重點介紹了雙特異性抗體zanidatamab取得的顯著進展，該抗體在HER2陽性膽道癌患者中獲得了52%的確認客觀緩解率。這些進展將改善臨床療效，減少對安寧療護的依賴，並鼓勵對精準腫瘤學進行更多投資。

同時，全球膽道惡性腫瘤發生率的上升是主要促進因素，持續推動先進診斷和治療方案的需求。這種日益加重的疾病負擔歸因於人口老化和慢性肝病盛行率上升等因素。根據Astra Zeneca2024年4月發布的新聞稿《英夫利西單抗化療總生存期翻倍》，全球每年約有21萬人被診斷出患有膽道癌，因此對有效的臨床治療方案的需求十分迫切。預期這一趨勢還將持續，多學科數位出版研究所（MDNI）2024年的報告預測，到2029年，肝內膽管癌的發生率將達到每10萬人2.13例，凸顯了開發可擴展治療方法的迫切性。

市場挑戰

全球膽道癌市場面臨的主要障礙之一是晚期診斷率高。由於惡性腫瘤發展到相當晚期之前，症狀往往不明顯或難以察覺，絕大多數患者已不適合接受根治性手術，從而限制了輔助性治療的應用。這限制了商業性前景，迫使藥廠優先研發安寧療護方案，而安寧療護方案的療程較短，成功率也低於早期介入措施。因此，缺乏有效的早期檢測方法導致高價值根治性藥物的市場萎縮，直接減緩了該行業的成長。

診斷延誤造成的嚴重後果體現在轉移性疾病預後不良上，這大幅減少了符合長期治療條件的患者族群。 2024年，美國臨床腫瘤學會（ASCO）報告稱，遠端轉移期肝內膽管癌的5年相對存活率僅為3%。這項統計數據凸顯了晚期患者群體面臨極高的死亡率，限制了治療效果和產生收入機會，也使得維持治療方法市場的穩定變得困難。

市場趨勢

為了避免因患者群體較小而帶來的監管障礙，並加速膽道癌新療法的研發，製藥公司正日益積極地尋求孤兒藥資格認定。這項策略使研發者能夠獲得市場獨佔權和經濟獎勵，這對於降低針對預後不良的罕見惡性腫瘤的風險至關重要。脂質體製劑的研發便是此趨勢的例證，旨在增強難治性病例的藥物傳遞。根據BioSpace於2025年7月發布的新聞稿《FF-10832獲得FDA孤兒藥資格認定，用於治療膽道癌》，FDA授予在臨床實驗藥物FF-10832孤兒藥資格認定，是出於緊急應變不可切除或轉移性疾病患者高達50-70%的複發率這一問題。

同時，液態生物檢體作為一種非侵入性基因組分析方法，在臨床實踐中的應用日益廣泛，使得精準檢測治療標靶突變（例如FGFR2融合基因）成為可能，而無需承擔侵入性組織取樣的風險。這種常規分子譜分析的整合，使腫瘤科醫師能夠即時監測腫瘤的演變和治療抗藥性，並在整個治療過程中最佳化標靶治療的選擇。隨著醫療機構採用基於血液的檢測方法，這些工具的商業性價值顯而易見。 Guardant Health在其2025年4月發布的新聞稿《Guardant Health公佈2025年第一季業績》中預測，2025年腫瘤檢測量將成長超過25%，這反映出進行性固態腫瘤管理中對全面基因組譜分析的需求激增。

目錄

第1章概述

第2章：調查方法

第3章執行摘要

第4章：客戶心聲

第5章：全球膽道癌市場展望

  • 市場規模及預測
    • 按金額
  • 市佔率及預測
    • 癌症類型（肝內膽管癌（ICC）、肝外膽管癌、膽囊癌）
    • 按最終使用者（醫院、專科癌症中心、門診手術中心等）
    • 按地區
    • 按公司（2025 年）
  • 市場地圖

第6章：北美膽道癌市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 北美洲：國別分析
    • 美國
    • 加拿大
    • 墨西哥

第7章：歐洲膽道癌市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 歐洲：國別分析
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙

第8章：亞太地區膽道癌市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 亞太地區：國別分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲

第9章：中東和非洲膽道癌市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 中東與非洲：國別分析
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 南非

第10章：南美洲膽道癌市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 南美洲：國別分析
    • 巴西
    • 哥倫比亞
    • 阿根廷

第11章 市場動態

  • 促進因素
  • 任務

第12章 市場趨勢與發展

  • 併購
  • 產品發布
  • 近期趨勢

第13章：全球膽道癌市場：SWOT分析

第14章：波特五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的議價能力
  • 顧客權力
  • 替代品的威脅

第15章 競爭格局

  • Bristol-Myers Squibb
  • Eli Lilly and Company
  • F. Hoffmann-La Roche Ltd.
  • Johnson & Johnson Services, Inc
  • Merck & Co., Inc.
  • Novartis AG
  • Pfizer Inc.
  • Sanofi SA
  • Bayer AG
  • AstraZeneca plc

第16章 策略建議

第17章：關於研究公司及免責聲明

簡介目錄
Product Code: 17636

The Global Biliary Tract Cancers Market is projected to expand from USD 675.69 Million in 2025 to USD 892.63 Million by 2031, achieving a compound annual growth rate (CAGR) of 4.75%. This sector comprises diagnostic instruments and therapeutic agents tailored for malignancies originating in the bile ducts and gallbladder, such as cholangiocarcinoma and gallbladder carcinoma. Key factors driving this market trajectory include the rising prevalence of chronic liver diseases and global demographic shifts toward an aging population, alongside increased funding for molecular profiling to discover new treatment pathways. The American Cancer Society estimates that approximately 12,610 new cases of gallbladder and adjacent large bile duct cancers will be diagnosed in the United States in 2025.

Market Overview
Forecast Period2027-2031
Market Size 2025USD 675.69 MIllion
Market Size 2031USD 892.63 MIllion
CAGR 2026-20314.75%
Fastest Growing SegmentExtrahepatic Cholangiocarcinoma (EHC)
Largest MarketNorth America

However, the market faces significant obstacles due to the high frequency of diagnoses occurring at advanced disease stages. Symptoms typically appear only after the cancer has progressed substantially, making curative surgery unviable for most patients and limiting the effectiveness of many current treatments. This issue complicates clinical development and restricts the commercial viability of early intervention therapies, thereby hindering the overall expansion of the market.

Market Driver

The introduction of novel targeted therapies and immunotherapies is aggressively driving growth in the Global Biliary Tract Cancers Market by overcoming the historical limitations of standard chemotherapy. Pharmaceutical companies are utilizing genomic data to develop agents that specifically address molecular alterations like HER2 amplification and FGFR2 fusions. A major breakthrough was highlighted by Jazz Pharmaceuticals in a November 2024 press release titled 'FDA Approves Zanidatamab for Biliary Tract Cancer,' where the bispecific antibody zanidatamab achieved a confirmed objective response rate of 52% in patients with HER2-positive biliary tract cancer. These advancements improve clinical outcomes, decreasing reliance on palliative care and encouraging further investment in precision oncology.

Simultaneously, the rising global incidence of biliary tract malignancies serves as a primary driver, generating sustained demand for advanced diagnostic and therapeutic solutions. This growing disease burden results from factors such as aging populations and the increasing prevalence of chronic liver conditions. According to AstraZeneca's April 2024 press release, 'Imfinzi Plus Chemotherapy Doubled Overall Survival Rate,' roughly 210,000 individuals worldwide are diagnosed with biliary tract cancer annually, creating a significant need for effective clinical management. This trend is expected to continue, with the Multidisciplinary Digital Publishing Institute reporting in 2024 that incidence rates for intrahepatic cholangiocarcinoma are projected to reach 2.13 per 100,000 by 2029, emphasizing the urgent need for scalable therapies.

Market Challenge

A primary barrier to the Global Biliary Tract Cancers Market is the high rate of diagnosis at advanced disease stages. Since symptoms are often vague or undetected until the malignancy has significantly progressed, the vast majority of patients are ineligible for curative surgery, which restricts the use of adjuvant therapies. This limits the commercial landscape, forcing pharmaceutical developers to prioritize palliative care regimens that usually offer shorter treatment durations and lower success rates compared to early-stage interventions. Consequently, the lack of effective early detection methods diminishes the addressable market for high-value curative drugs, directly slowing sector growth.

The severe impact of these diagnostic delays is demonstrated by the poor prognosis for metastatic disease, which drastically reduces the patient pool eligible for long-term therapy. In 2024, the American Society of Clinical Oncology reported that the five-year relative survival rate for intrahepatic cholangiocarcinoma diagnosed at a distant stage is only 3 percent. This statistic highlights the difficulty in maintaining a robust market for therapies, as the advanced-stage patient population faces extremely high mortality rates, thereby limiting the window for therapeutic efficacy and revenue generation.

Market Trends

Pharmaceutical companies are increasingly seeking Orphan Drug Designations to expedite the development of new therapeutics for biliary tract cancers, bypassing regulatory hurdles associated with small patient populations. This strategy allows developers to obtain market exclusivity and financial incentives, which are essential for mitigating the risks of targeting rare malignancies with poor prognoses. An example of this trend is the development of liposomal formulations to enhance drug delivery in refractory cases; according to a BioSpace press release from July 2025 titled 'FF-10832 Granted FDA Orphan Drug Designation for the Treatment of Biliary Tract Cancer,' the FDA's designation for the investigational agent FF-10832 was based on the urgent need to address high recurrence rates of 50% to 70% in patients with unresectable or metastatic disease.

At the same time, clinical practice is shifting toward using liquid biopsies for non-invasive genomic characterization, enabling the precise detection of actionable mutations like FGFR2 fusions without the risks of invasive tissue sampling. This integration of routine molecular profiling allows oncologists to monitor tumor evolution and treatment resistance in real time, optimizing targeted therapy selection throughout care. The commercial appeal of these tools is evident as providers adopt blood-based assays; Guardant Health's April 2025 press release, 'Guardant Health Reports First Quarter 2025 Financial Results,' projected that oncology test volumes would grow by more than 25% in 2025, reflecting surging demand for comprehensive genomic profiling in advanced solid tumor management.

Key Market Players

  • Bristol-Myers Squibb
  • Eli Lilly and Company
  • F. Hoffmann-La Roche Ltd.
  • Johnson & Johnson Services, Inc
  • Merck & Co., Inc.
  • Novartis AG
  • Pfizer Inc.
  • Sanofi SA
  • Bayer AG
  • AstraZeneca plc

Report Scope

In this report, the Global Biliary Tract Cancers Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Biliary Tract Cancers Market, By Cancer Type

  • Intrahepatic Cholangiocarcinoma (ICC)
  • Extrahepatic Cholangiocarcinoma
  • Gallbladder Cancer

Biliary Tract Cancers Market, By End-User

  • Hospitals
  • Specialty Cancer Centres
  • Ambulatory Surgical Centres
  • Others

Biliary Tract Cancers Market, By Region

  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • United Kingdom
    • Italy
    • Germany
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Biliary Tract Cancers Market.

Available Customizations:

Global Biliary Tract Cancers Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Biliary Tract Cancers Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Cancer Type (Intrahepatic Cholangiocarcinoma (ICC), Extrahepatic Cholangiocarcinoma, Gallbladder Cancer)
    • 5.2.2. By End-User (Hospitals, Specialty Cancer Centres, Ambulatory Surgical Centres, Others)
    • 5.2.3. By Region
    • 5.2.4. By Company (2025)
  • 5.3. Market Map

6. North America Biliary Tract Cancers Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Cancer Type
    • 6.2.2. By End-User
    • 6.2.3. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Biliary Tract Cancers Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Cancer Type
        • 6.3.1.2.2. By End-User
    • 6.3.2. Canada Biliary Tract Cancers Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Cancer Type
        • 6.3.2.2.2. By End-User
    • 6.3.3. Mexico Biliary Tract Cancers Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Cancer Type
        • 6.3.3.2.2. By End-User

7. Europe Biliary Tract Cancers Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Cancer Type
    • 7.2.2. By End-User
    • 7.2.3. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany Biliary Tract Cancers Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Cancer Type
        • 7.3.1.2.2. By End-User
    • 7.3.2. France Biliary Tract Cancers Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Cancer Type
        • 7.3.2.2.2. By End-User
    • 7.3.3. United Kingdom Biliary Tract Cancers Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Cancer Type
        • 7.3.3.2.2. By End-User
    • 7.3.4. Italy Biliary Tract Cancers Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Cancer Type
        • 7.3.4.2.2. By End-User
    • 7.3.5. Spain Biliary Tract Cancers Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Cancer Type
        • 7.3.5.2.2. By End-User

8. Asia Pacific Biliary Tract Cancers Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Cancer Type
    • 8.2.2. By End-User
    • 8.2.3. By Country
  • 8.3. Asia Pacific: Country Analysis
    • 8.3.1. China Biliary Tract Cancers Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Cancer Type
        • 8.3.1.2.2. By End-User
    • 8.3.2. India Biliary Tract Cancers Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Cancer Type
        • 8.3.2.2.2. By End-User
    • 8.3.3. Japan Biliary Tract Cancers Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Cancer Type
        • 8.3.3.2.2. By End-User
    • 8.3.4. South Korea Biliary Tract Cancers Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Cancer Type
        • 8.3.4.2.2. By End-User
    • 8.3.5. Australia Biliary Tract Cancers Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Cancer Type
        • 8.3.5.2.2. By End-User

9. Middle East & Africa Biliary Tract Cancers Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Cancer Type
    • 9.2.2. By End-User
    • 9.2.3. By Country
  • 9.3. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia Biliary Tract Cancers Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Cancer Type
        • 9.3.1.2.2. By End-User
    • 9.3.2. UAE Biliary Tract Cancers Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Cancer Type
        • 9.3.2.2.2. By End-User
    • 9.3.3. South Africa Biliary Tract Cancers Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Cancer Type
        • 9.3.3.2.2. By End-User

10. South America Biliary Tract Cancers Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Cancer Type
    • 10.2.2. By End-User
    • 10.2.3. By Country
  • 10.3. South America: Country Analysis
    • 10.3.1. Brazil Biliary Tract Cancers Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Cancer Type
        • 10.3.1.2.2. By End-User
    • 10.3.2. Colombia Biliary Tract Cancers Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Cancer Type
        • 10.3.2.2.2. By End-User
    • 10.3.3. Argentina Biliary Tract Cancers Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Cancer Type
        • 10.3.3.2.2. By End-User

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Merger & Acquisition (If Any)
  • 12.2. Product Launches (If Any)
  • 12.3. Recent Developments

13. Global Biliary Tract Cancers Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Products

15. Competitive Landscape

  • 15.1. Bristol-Myers Squibb
    • 15.1.1. Business Overview
    • 15.1.2. Products & Services
    • 15.1.3. Recent Developments
    • 15.1.4. Key Personnel
    • 15.1.5. SWOT Analysis
  • 15.2. Eli Lilly and Company
  • 15.3. F. Hoffmann-La Roche Ltd.
  • 15.4. Johnson & Johnson Services, Inc
  • 15.5. Merck & Co., Inc.
  • 15.6. Novartis AG
  • 15.7. Pfizer Inc.
  • 15.8. Sanofi SA
  • 15.9. Bayer AG
  • 15.10. AstraZeneca plc

16. Strategic Recommendations

17. About Us & Disclaimer