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2048098

液態生物檢體市場－全球產業規模、佔有率、趨勢、機會和預測：按適應症、類型、地區和競爭格局分類，2021-2031年

Fluid Biopsy Market - Global Industry Size, Share, Trends, Opportunity & Forecast, Segmented By Indication By Type, 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

全球液體切片檢查市場預計將從 2025 年的 119.2 億美元成長到 2031 年的 238.2 億美元，複合年成長率達到 12.23%。

也稱為液態生物檢體，該市場涵蓋了分析血液和尿液等生物體液以檢測循環性腫瘤細胞和腫瘤衍生標記（包括DNA）的診斷技術。推動該市場發展的關鍵因素包括臨床上對微創方法的需求（作為手術組織取樣的替代方案）以及需要重複取樣以監測疾病進展。這些技術使臨床醫生能夠獲得即時基因組數據並調整治療方案，而無需為患者帶來傳統固態組織切片檢查相關的風險和恢復期。

市場概覽
預測期 2027-2031
市場規模：2025年 119.2億美元
市場規模：2031年 238.2億美元
複合年成長率：2026-2031年 12.23%
成長最快的細分市場 乳癌
最大的市場 北美洲

全球癌症發生率的上升進一步推動了該領域的擴張，催生了對擴充性、高效診斷解決方案的需求。例如，美國癌症協會預測，到2025年，美國將新增約2,041,910例癌症病例。儘管需求如此明確，但由於報銷範圍和支付方政策的不一致，市場成長仍面臨巨大挑戰。這些挑戰不僅為醫療服務提供者帶來了經濟障礙，也限制了患者獲得這些關鍵診斷檢測的機會。

市場促進因素

全球液體切片檢查市場正受到精準醫療和伴隨診斷日益普及的顯著推動。這是因為醫療機構擴大利用血液檢測來指導標靶治療的選擇。這包括將循環腫瘤DNA (ctDNA) 分析整合到常規臨床工作流程中，因此無需進行侵入性組織切片檢查即可實現精準的患者分層。產業營運指標也印證了對這些診斷方法日益成長的需求。例如，Natera公司報告稱，其在2024年處理了約528,200例腫瘤檢測，年增54.9%，凸顯了液態生物檢體在檢測微量殘存疾病和最佳化治療方案方面發揮的關鍵作用。

同時，公共和私人資金籌措的大幅成長正在推動研發活動，這對於提高檢測靈敏度和實現新型篩檢方法的商業化至關重要。這種強勁的資金支持使診斷公司能夠進行關鍵的臨床試驗，並擴大業務規模以滿足全球需求。例如，Geneoscopy公司獲得了1.05億美元的C輪資金籌措，用於支持其非侵入性大腸癌篩檢測試的商業性推出。 Guardant Health公司2024年的總營收達到7.39億美元，年增31%，這主要得益於臨床檢測量的成長，進一步凸顯了該產業的良好財務狀況。

市場挑戰

保險報銷範圍和支付機構政策的不一致給醫療服務提供者和私人檢測實驗室帶來了巨大的財務不確定性，直接阻礙了全球液態生物檢體市場的成長。儘管液態生物檢體具有明顯的臨床優勢，但由於次世代定序和基因組分析高成本，強而有力的保險支持至關重要。當私人保險公司將這些診斷測試歸類為「臨床實驗」或將承保範圍限制在有限的臨床適應症時，醫療服務提供者將面臨拒絕和拒絕付款的風險。這阻礙了體液切片檢查方案在常規實踐中的廣泛應用，導致人們不得不依賴更可靠的傳統侵入性組織取樣方法。

此外，支付方政策的差異阻礙了市場擴張，因為病患取得醫療服務往往基於地理位置或保險類型，而非臨床必要性。缺乏標準化的保險覆蓋範圍常常導致患者面臨高昂的自付費用，從而放棄檢測，縮小了潛在市場規模。美國癌症協會癌症行動網路的最新政策數據凸顯了這種障礙的嚴重性。數據顯示，截至2025年6月，僅有18個州立法強制要求州監管的醫療保險計劃涵蓋全面的生物標記檢測，導致報銷分散，阻礙了診斷服務的市場滲透和擴充性。

市場趨勢

多重癌症早期檢測 (MCED) 技術的出現正在從根本上改變市場格局，將診斷方式從單一器官篩檢轉變為多癌症同步分析。與傳統的篩檢有症狀患者的方法不同，這些檢測利用甲基化模式和循環 DNA (cfDNA)，僅需一份血液樣本即可對無症狀人群進行多種癌症篩檢。這項技術有效填補了目前尚無標準化篩檢方案的癌症的臨床空白，從而顯著擴大了目標患者群體。該領域的商業性發展勢頭在近期公佈的財務業績中得到了體現。 GRAIL 公司報告稱，2024 年第三季 Galleri 檢測的銷售額達到 2,540 萬美元，比去年同期成長 52%。

同時，市場正經歷著向非腫瘤領域，特別是神經病學和器官移植監測領域的顯著擴張。開發商正日益檢驗血液衍生生物標記在檢測阿茲海默症神經退化性疾病和評估同種異體移植器官健康狀況方面的應用，從而將液態生物檢體的應用範圍擴展到傳統腫瘤學之外。這種多元化使製造商能夠降低與癌症診斷相關的周期性風險，並充分利用對非侵入性神經系統評估日益成長的需求。 Quanterix 公司就是一個典型的例子，該公司在 2024 年第三季的總收入達到 3,570 萬美元，這主要得益於其專注於神經病學的診斷服務的擴張。

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：全球液態生物檢體市場展望

  • 市場規模及預測
    • 按金額
  • 市佔率及預測
    • 依適應症（肺癌、乳癌、大腸癌、其他）
    • 依類型（循環性腫瘤細胞、循環腫瘤DNA、遊離DNA）
    • 按地區
    • 按公司（2025 年）
  • 市場地圖

第6章：北美液態生物檢體市場展望

  • 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：歐洲液態生物檢體市場展望

  • 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：亞太地區液態生物檢體市場展望

  • 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：中東和非洲液態生物檢體市場展望

  • 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：南美洲液態生物檢體市場展望

  • 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 全球液態生物檢體市場：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

  • Bio-Rad Laboratories
  • Guardant Health Inc.
  • Illumina, Inc.
  • Qiagen NV
  • Laboratory Corporation of America Holdings
  • F. Hoffmann-La Roche AG
  • Thermo Fisher Scientific Inc.
  • Johnson & Johnso
  • Biocept Inc.
  • Bio-Rad Laboratories, Inc.

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: 16097

The Global Fluid Biopsy Market is projected to grow from USD 11.92 Billion in 2025 to USD 23.82 Billion by 2031, achieving a compound annual growth rate (CAGR) of 12.23%. This market, also known as liquid biopsy, encompasses diagnostic technologies that analyze biological fluids like blood or urine to detect tumor-derived markers, including circulating tumor cells and DNA. Key drivers for this market include the clinical demand for minimally invasive alternatives to surgical tissue extraction and the crucial requirement for repeated sampling to monitor disease progression. These capabilities enable clinicians to acquire real-time genomic data and adjust therapeutic plans without exposing patients to the risks and recovery periods associated with conventional solid tissue biopsies.

Market Overview
Forecast Period2027-2031
Market Size 2025USD 11.92 Billion
Market Size 2031USD 23.82 Billion
CAGR 2026-203112.23%
Fastest Growing SegmentBreast Cancer
Largest MarketNorth America

The expansion of this sector is further propelled by the increasing global incidence of cancer, necessitating scalable and efficient diagnostic solutions; for instance, the American Cancer Society anticipates approximately 2,041,910 new cancer cases in the United States in 2025. Despite this clear demand, market growth is significantly challenged by inconsistencies in reimbursement coverage and payer policies, which establish financial barriers for healthcare providers and limit widespread patient access to these crucial diagnostic tests.

Market Driver

The Global Fluid Biopsy Market is considerably advanced by the rising adoption of precision medicine and companion diagnostics, as healthcare providers increasingly utilize blood-based tests to guide targeted therapy selection. This involves integrating circulating tumor DNA analysis into routine clinical workflows, enabling precise patient stratification without invasive tissue biopsies. The escalating demand for these diagnostics is evident in industry operational metrics; for example, Natera reported processing approximately 528,200 oncology tests in 2024, marking a substantial 54.9% increase over the previous year, underscoring liquid biopsy's vital role in detecting minimal residual disease and optimizing treatment.

Concurrently, a significant surge in both public and private funding is fueling the research and development efforts essential for enhancing assay sensitivity and commercializing novel screening modalities. This robust financial backing empowers diagnostic companies to conduct pivotal clinical trials and scale operations to meet global demand; for instance, Geneoscopy, Inc., secured $105 million in Series C funding to support the commercial launch of its non-invasive colorectal cancer screening test. Further highlighting the sector's financial health, Guardant Health's total revenue for 2024 reached $739 million, reflecting a 31% increase driven by expanding clinical test volumes.

Market Challenge

Inconsistent reimbursement coverage and payer policies directly impede the growth of the Global Fluid Biopsy Market by introducing substantial financial uncertainty for healthcare providers and commercial laboratories. Despite the clear clinical advantages of liquid biopsy, the high costs associated with next-generation sequencing and genomic analysis necessitate strong insurance support. When commercial payers categorize these diagnostic tests as investigational or restrict coverage to limited clinical indications, healthcare facilities face potential claim denials and non-payment, which deters the widespread adoption of fluid biopsy protocols in routine practice, prompting reliance on traditional, invasive tissue sampling methods that are more reliably reimbursed.

Moreover, this disparity in payer policies curtails market expansion by restricting patient access based on geographical location and insurance type rather than clinical necessity. Without standardized coverage mandates, patients frequently encounter prohibitive out-of-pocket expenses, leading to declined testing and a reduction in potential market volume. The gravity of this obstacle is underscored by recent policy data from the American Cancer Society Cancer Action Network, which noted that as of June 2025, only 18 states had enacted legislation mandating coverage for comprehensive biomarker testing by state-regulated health plans, thereby fragmenting the reimbursement landscape and hindering broader market penetration and scalability of diagnostic services.

Market Trends

The emergence of Multi-Cancer Early Detection (MCED) tests is fundamentally transforming the market by shifting diagnostics from single-organ screening to simultaneous pan-cancer analysis. Unlike conventional methods that examine symptomatic patients, these assays leverage methylation patterns and circulating cell-free DNA to screen asymptomatic populations for numerous malignancies through a single blood draw. This capability effectively addresses the clinical gap for cancers lacking standard screening protocols, thereby significantly expanding the eligible patient population. The commercial momentum of this segment is reflected in recent financial performance, with GRAIL, Inc., reporting its Galleri test revenue reaching $25.4 million in the third quarter of 2024, a 52% increase year-over-year.

Simultaneously, the market is undergoing a crucial expansion into non-oncology applications, particularly within neurology and organ transplant monitoring. Developers are increasingly validating blood-based biomarkers to detect neurodegenerative conditions, such as Alzheimer's disease, and to evaluate allograft health, thereby extending liquid biopsy beyond its traditional oncology focus. This diversification enables manufacturers to mitigate the cyclical risks associated with the cancer diagnostics sector and capitalize on the growing demand for non-invasive neurological assessments, as exemplified by Quanterix Corporation's total revenue of $35.7 million in Q3 2024, largely driven by the acceleration of its neurology-focused diagnostic services.

Key Market Players

  • Bio-Rad Laboratories
  • Guardant Health Inc.
  • Illumina, Inc.
  • Qiagen NV
  • Laboratory Corporation of America Holdings
  • F. Hoffmann-La Roche AG
  • Thermo Fisher Scientific Inc.
  • Johnson & Johnso
  • Biocept Inc.
  • Bio-Rad Laboratories, Inc.

Report Scope

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

Fluid Biopsy Market, By Indication

  • Lung Cancer
  • Breast Cancer
  • Colorectal Cancer
  • Other

Fluid Biopsy Market, By Type

  • Circulating Tumor Cells
  • Circulating Tumor DNA
  • Cell-free DNA

Fluid Biopsy 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 Fluid Biopsy Market.

Available Customizations:

Global Fluid Biopsy 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 Fluid Biopsy Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Indication (Lung Cancer, Breast Cancer, Colorectal Cancer, Other)
    • 5.2.2. By Type (Circulating Tumor Cells, Circulating Tumor DNA, Cell-free DNA)
    • 5.2.3. By Region
    • 5.2.4. By Company (2025)
  • 5.3. Market Map

6. North America Fluid Biopsy Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Indication
    • 6.2.2. By Type
    • 6.2.3. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Fluid Biopsy 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 Indication
        • 6.3.1.2.2. By Type
    • 6.3.2. Canada Fluid Biopsy 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 Indication
        • 6.3.2.2.2. By Type
    • 6.3.3. Mexico Fluid Biopsy 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 Indication
        • 6.3.3.2.2. By Type

7. Europe Fluid Biopsy Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Indication
    • 7.2.2. By Type
    • 7.2.3. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany Fluid Biopsy 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 Indication
        • 7.3.1.2.2. By Type
    • 7.3.2. France Fluid Biopsy 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 Indication
        • 7.3.2.2.2. By Type
    • 7.3.3. United Kingdom Fluid Biopsy 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 Indication
        • 7.3.3.2.2. By Type
    • 7.3.4. Italy Fluid Biopsy 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 Indication
        • 7.3.4.2.2. By Type
    • 7.3.5. Spain Fluid Biopsy 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 Indication
        • 7.3.5.2.2. By Type

8. Asia Pacific Fluid Biopsy Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Indication
    • 8.2.2. By Type
    • 8.2.3. By Country
  • 8.3. Asia Pacific: Country Analysis
    • 8.3.1. China Fluid Biopsy 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 Indication
        • 8.3.1.2.2. By Type
    • 8.3.2. India Fluid Biopsy 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 Indication
        • 8.3.2.2.2. By Type
    • 8.3.3. Japan Fluid Biopsy 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 Indication
        • 8.3.3.2.2. By Type
    • 8.3.4. South Korea Fluid Biopsy 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 Indication
        • 8.3.4.2.2. By Type
    • 8.3.5. Australia Fluid Biopsy 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 Indication
        • 8.3.5.2.2. By Type

9. Middle East & Africa Fluid Biopsy Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Indication
    • 9.2.2. By Type
    • 9.2.3. By Country
  • 9.3. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia Fluid Biopsy 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 Indication
        • 9.3.1.2.2. By Type
    • 9.3.2. UAE Fluid Biopsy 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 Indication
        • 9.3.2.2.2. By Type
    • 9.3.3. South Africa Fluid Biopsy 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 Indication
        • 9.3.3.2.2. By Type

10. South America Fluid Biopsy Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Indication
    • 10.2.2. By Type
    • 10.2.3. By Country
  • 10.3. South America: Country Analysis
    • 10.3.1. Brazil Fluid Biopsy 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 Indication
        • 10.3.1.2.2. By Type
    • 10.3.2. Colombia Fluid Biopsy 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 Indication
        • 10.3.2.2.2. By Type
    • 10.3.3. Argentina Fluid Biopsy 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 Indication
        • 10.3.3.2.2. By Type

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 Fluid Biopsy 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. Bio-Rad Laboratories
    • 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. Guardant Health Inc.
  • 15.3. Illumina, Inc.
  • 15.4. Qiagen NV
  • 15.5. Laboratory Corporation of America Holdings
  • 15.6. F. Hoffmann-La Roche AG
  • 15.7. Thermo Fisher Scientific Inc.
  • 15.8. Johnson & Johnso
  • 15.9. Biocept Inc.
  • 15.10. Bio-Rad Laboratories, Inc.

16. Strategic Recommendations

17. About Us & Disclaimer