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市場調查報告書
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1678781

全球液體活體組織切片市場 - 2025 - 2033

Global Liquid Biopsy Market - 2025-2033

出版日期: | 出版商: DataM Intelligence | 英文 220 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

2024 年全球液體切片市場規模達到 90.7 億美元,預計到 2033 年將達到 251.9 億美元,2025-2033 年預測期內的複合年成長率為 10.7%。

執行摘要

液體活體組織切片是一種微創測試,可檢測血液、尿液、精液或唾液等體液中的細胞或分子生物標記物,提供診斷、預後或預測疾病資訊。此外,液體活體組織切片在臨床環境中用於早期癌症檢測、局部癌症患者的腫瘤分期和監測、預測晚期癌症患者的轉移進展以及監測治療效果,儘管篩檢仍然具有挑戰性。

市場動態:

促進因素與約束因素

癌症發生率上升

由於全球癌症負擔不斷增加,液體活體組織切片市場的需求日益增加,需要早期檢測和即時監測以改善患者的治療效果。傳統方法具有侵入性且耗時,因此液體活體組織切片成為一種非侵入性替代方法。它可以從血液樣本中檢測循環腫瘤 DNA、CTC 和其他生物標記物,有助於早期診斷、治療監測和個人化治療選擇。例如,美國癌症協會(ACS)公佈了2025年癌症統計數據,預計今年美國將診斷出超過200萬例新發癌症,超過60萬人死於癌症。

研究人員預測,到 2025 年,美國將有 2,041,910 例新癌症診斷病例,相當於每天新增近 5,600 例病例。其中男性癌症病例 1,053,250 例,女性癌症病例 988,660 例。

標準化和監管挑戰

保留全球液體活體組織切片市場的主要問題之一是缺乏標準和監管機構的嚴格規則。液體活體組織切片技術的檢測方法複雜,當篩檢方法改變時,檢測結果可能會不一致。目前還沒有任何普遍認可的規則來驗證測試、處理樣本以及弄清楚結果的含義,這使得它很難被廣泛採用。

此外,FDA 和 EMA 等監管機構需要大量臨床支援液體活體組織切片測試,這使得核准過程花費更長的時間。這些問題導致新產品進入市場所需的時間更長,也使得小型企業更難將新的液體活體組織切片產品推向市場。

目錄

第 1 章:方法與範圍

第 2 章:定義與概述

第 3 章:執行摘要

第 4 章:動態

  • 影響因素
    • 驅動程式
      • 癌症發生率上升
      • 基於眼部生物力學的客製化雷射手術興起
    • 限制
      • 標準化和監管挑戰
      • 治療費用高昂
    • 機會
      • 拓展新興市場
    • 影響分析

第5章:戰略洞察與產業展望

  • 市場領導者和先驅者
    • 新興先鋒和傑出參與者
    • 擁有最大銷售品牌的成熟領導者
    • 擁有成熟產品的市場領導者
  • CXO 觀點
  • 最新進展與突破
  • 案例研究/正在進行的研究
  • 監管和報銷情況
    • 北美洲
    • 歐洲
    • 亞太地區
    • 拉丁美洲
    • 中東和非洲
  • 波特五力分析
  • 管道分析
  • 供應鏈分析
  • 專利分析
  • SWOT 分析
  • 未滿足的需求和差距
  • 市場進入和擴張的推薦策略
  • 情境分析:最佳情況、基本情況和最壞情況預測
  • 定價分析和價格動態
  • 關鍵意見領袖

第 6 章:依產品類型

  • 試劑盒和試劑
  • 儀器
  • 服務

第 7 章:透過循環生物標記

  • 循環腫瘤細胞
  • 循環腫瘤 DNA (ctDNA)
  • 遊離 DNA (cfDNA)
  • 細胞外囊泡

第 8 章:按應用

  • 癌症應用
  • 非癌症應用

第 9 章:按技術

  • 多基因平行分析(NGS)
  • 單基因分析(PCR 微陣列)

第 10 章:按最終用戶

  • 醫院和醫生實驗室
  • 研究中心
  • 其他

第 11 章:按地區

  • 北美洲
    • 美國
    • 加拿大
  • 歐洲
    • 德國
    • 英國
    • 法國
    • 西班牙
    • 義大利
    • 歐洲其他地區
  • 拉丁美洲
    • 墨西哥
    • 巴西
    • 阿根廷
    • 南美洲其他地區
  • 亞太
    • 中國
    • 印度
    • 日本
    • 韓國
    • 亞太其他地區
  • 中東和非洲

第 12 章:競爭格局

  • 競爭格局
  • 市場定位/佔有率分析
  • 併購分析

第 13 章:公司簡介

  • Exosome Sciences Inc
    • 公司概況
    • 產品組合
      • 產品描述
      • 產品關鍵績效指標 (KPI)
      • 歷史和預測產品銷售量
      • 產品銷售量
    • 財務概覽
      • 公司收入
      • 地區收入佔有率
      • 收入預測
    • 主要進展
      • 合併與收購
      • 關鍵產品開發活動
      • 監管部門批准等
    • SWOT 分析
  • Illumina, Inc
  • Guardant Health
  • Thermo Fisher Scientific Inc
  • NeoGenomics Laboratories
  • Qiagen
  • BioChain Institute Inc
  • Sysmex Europe SE
  • Eurofins Genomics
  • Goffin Molecular Technologies
  • Similar data will be provided for each market player.
  • 精確科學
    • 管道產品描述
    • 產品關鍵績效指標 (KPI)
    • 主要活動
    • 市場進入時間表
    • 產品滲透率
    • 銷售估計和預測
  • 坦帕斯
  • 深圳市迪科威科技有限公司
  • 將為每個市場參與者提供類似的資料。

第 12 章:附錄

簡介目錄
Product Code: CD320

The global liquid biopsy market reached US$ 9.07 billion in 2024 and is expected to reach US$ 25.19 billion by 2033, growing at a CAGR of 10.7% during the forecast period 2025-2033.

Executive Summary

Liquid biopsy is a minimally invasive test that detects cellular or molecular biomarkers in body fluids like blood, urine, semen, or saliva, providing diagnostic, prognostic, or predictive disease information. Moreover, Liquid biopsy is utilized in clinical settings for early cancer detection, tumor staging and monitoring of localized cancer patients, predicting metastatic progression in advanced cancer patients, and monitoring treatment efficacy, although screening remains challenging.

Market Dynamics: Drivers & Restraints

Rising Prevalence of Cancer

The liquid biopsy market is gaining demand due to the rising global cancer burden, which necessitates early detection and real-time monitoring for improved patient outcomes. Traditional methods are invasive and time-consuming, making liquid biopsy a non-invasive alternative. It allows for the detection of circulating tumor DNA, CTCs, and other biomarkers from blood samples, facilitating early diagnosis, treatment monitoring, and personalized therapy selection. For instance, the American Cancer Society (ACS) has revealed cancer statistics for 2025, estimating that more than 2 million new occurrences of cancer will be diagnosed in the United States this year, with over 600,000 people dying from cancer.

Researchers predict that in 2025, there will be 2,041,910 new cancer diagnoses in the United States, which equates to almost 5600 new cases every day. The figure comprises 1,053,250 cancer cases in males and 988,660 in women.

Standardization and Regulatory Challenges

One of the main things about retaining the global liquid biopsy market is the lack of standards and strict rules from regulators. Liquid biopsy technologies use complicated testing methods, and test results can be inconsistent when screening methods are changed. There aren't any generally agreed upon rules for validating tests, handling samples, and figuring out what the results mean, which makes it hard for broad adoption.

Also, regulatory bodies like the FDA and EMA need a lot of clinical support for liquid biopsy tests, which makes the approval process take longer. These problems make it take longer for new goods to reach the market and make it harder for smaller businesses to bring new liquid biopsy options to market.

Segment Analysis

The global liquid biopsy market is segmented based on product type, circulating biomarker, application, technology, end user and region.

Product Type:

Kits and reagents in product type segment is expected to dominate with highest market share

Kits and reagents play a crucial role in liquid biopsy, a minimally invasive test that analyzes body fluids, such as blood, to detect circulating tumor cells(CTCs), cell-free DNA (cfDNA), and extracellular vesicles (EVs). These components are essential for the extraction, purification, and analysis of the target molecules. Extraction kits, these kits are designed to isolate specific molecules, such as cfDNA, from bodily fluids.

Owing to the various factors like, novel product launches, increasing demand for this segment and other facotrs help the kits and reagents segment is expected to grow during the forecast period. For instance, in February 2024, Twist Bioscience Corporation, a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, launched the cfDNA Library Preparation Kit to enable liquid biopsy research.

Moreover, in October 2024, QIAGEN has announced significant updates to its sample technologies solutions for non-invasive liquid biopsy applications, aimed at research and clinical applications in oncology, prenatal care, and organ transplantation.

Geographical Analysis

North America is expected to hold a significant position in the Liquid Biopsy market

North America holds a substantial position in the liquid biopsy market and is expected to hold most of the market due to novel tests innovations, advanced healthcare infrastructure, high cancer prevalence, and investment in precision medicine. For instance, in July 2024, Guardant Health, Inc., a leading precision oncology company, announced the launch of a major upgrade to its market-leading Guardant360 liquid biopsy test. The new enhanced test evaluates biomarkers in 739 genes in total, which is 10 times more cancer biomarkers than the previous version of Guardant360 evaluated. The test can also identify an extensive array of emerging biomarkers to precisely characterize cancer and can quantify disease burden at much higher sensitivity.

Moreover, the rising incidence of cancer in the U.S. and Canada drives demand for early, non-invasive diagnostic solutions. FDA regulatory support and increased cancer research funding accelerate the development of liquid biopsy technologies. Leading biotechnology and pharmaceutical companies and collaborations in biomarker research and clinical trials further strengthen North America's market growth.

Competitive Landscape

The major global players in the liquid biopsy market include Exosome Sciences Inc., Illumina, Inc., Guardant Health, Thermo Fisher Scientific Inc., NeoGenomics Laboratories, Qiagen, BioChain Institute Inc., Sysmex Europe SE, Eurofins Genomics, and Goffin Molecular Technologies among others.

Key Developments

  • In February 2025, SOPHiA GENETICS, a leader in AI healthcare technology and data-driven medicine, has achieved a milestone in the global adoption of its cancer testing applications MSK-ACCESS powered with SOPHiA DDM and MSK-IMPACT powered with SOPHiA DDM. 37 prominent institutions, including top researchers and opinion leaders, have already adopted the Liquid Biopsy and Solid Tumor applications.
  • In October 2024, GeneCentric Therapeutics has launched its EXpressCTSM liquid biopsy platform, allowing tissue RNA expression and epigenomics to be realized in liquid biopsy. The platform expands the application of the company's RNA-based gene expression signatures and diagnostic tests to cell-free DNA (cfDNA) liquid biopsy samples, including blood and urine.

Why Purchase the Report?

  • Technological Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
  • Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
  • Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
  • Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
  • Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
  • Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
  • Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
  • Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
  • Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
  • Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
  • Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
  • Post-market Surveillance: Uses post-market data to enhance product safety and access.
  • Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

Target Audience 2024

  • Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
  • Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
  • Product Type & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
  • Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
  • Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
  • Supply Chain: Distribution and Supply Chain Managers.
  • Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
  • Academic & Research: Academic Institutions.

The global liquid biopsy market report delivers a detailed analysis with 61 key tables, more than 59 visually impactful figures, and 220 pages of expert insights, providing a complete view of the market landscape.

Table of Contents

1. Methodology and Scope

  • 1.1. Research Methodology
  • 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

  • 3.1. Snippet by Product Type
  • 3.2. Snippet by Circulating Biomarker
  • 3.3. Snippet by Application
  • 3.4. Snippet by Technology
  • 3.5. Snippet by End User
  • 3.6. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Rising Prevalence of Cancer
      • 4.1.1.2. Rise in Customized Laser Surgery Based on Eye Biomechanics
    • 4.1.2. Restraints
      • 4.1.2.1. Standardization and Regulatory Challenges
      • 4.1.2.2. High Cost of Treatment Procedures
    • 4.1.3. Opportunity
      • 4.1.3.1. Expansion into Emerging Markets
    • 4.1.4. Impact Analysis

5. Strategic Insights and Industry Outlook

  • 5.1. Market Leaders and Pioneers
    • 5.1.1. Emerging Pioneers and Prominent Players
    • 5.1.2. Established leaders with largest selling Brand
    • 5.1.3. Market leaders with established Product
  • 5.2. CXO Perspectives
  • 5.3. Latest Developments and Breakthroughs
  • 5.4. Case Studies/Ongoing Research
  • 5.5. Regulatory and Reimbursement Landscape
    • 5.5.1. North America
    • 5.5.2. Europe
    • 5.5.3. Asia Pacific
    • 5.5.4. Latin America
    • 5.5.5. Middle East & Africa
  • 5.6. Porter's Five Force Analysis
  • 5.7. Pipeline Analysis
  • 5.8. Supply Chain Analysis
  • 5.9. Patent Analysis
  • 5.10. SWOT Analysis
  • 5.11. Unmet Needs and Gaps
  • 5.12. Recommended Strategies for Market Entry and Expansion
  • 5.13. Scenario Analysis: Best-Case, Base-Case, and Worst-Case Forecasts
  • 5.14. Pricing Analysis and Price Dynamics
  • 5.15. Key Opinion Leaders

6. By Product Type

  • 6.1. Introduction
    • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 6.1.2. Market Attractiveness Index, By Product Type
  • 6.2. Kits & Reagents*
    • 6.2.1. Introduction
    • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 6.3. Instruments
  • 6.4. Services

7. By Circulating Biomarker

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Circulating Biomarker
    • 7.1.2. Market Attractiveness Index, By Circulating Biomarker
  • 7.2. Circulating Tumor Cells*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Circulating Tumor DNA (ctDNA)
  • 7.4. Cell-free DNA (cfDNA)
  • 7.5. Extracellular Vesicles

8. By Application

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 8.1.2. Market Attractiveness Index, By Application
  • 8.2. Cancer Applications*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Non-Cancer Applications

9. By Technology

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 9.1.2. Market Attractiveness Index, By Technology
  • 9.2. Multi-gene-parallel Analysis (NGS)*
    • 9.2.1. Introduction
    • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 9.3. Single Gene Analysis (PCR Microarrays)

10. By End User

  • 10.1. Introduction
    • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 10.1.2. Market Attractiveness Index, By End User
  • 10.2. Hospitals and Physician Laboratories*
    • 10.2.1. Introduction
    • 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 10.3. Research Centers
  • 10.4. Others

11. By Region

  • 11.1. Introduction
    • 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 11.1.2. Market Attractiveness Index, By Region
  • 11.2. North America
    • 11.2.1. Introduction
    • 11.2.2. Key Region-Specific Dynamics
    • 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Circulating Biomarker
    • 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 11.2.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.2.8.1. U.S.
      • 11.2.8.2. Canada
  • 11.3. Europe
    • 11.3.1. Introduction
    • 11.3.2. Key Region-Specific Dynamics
    • 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Circulating Biomarker
    • 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 11.3.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.3.8.1. Germany
      • 11.3.8.2. U.K.
      • 11.3.8.3. France
      • 11.3.8.4. Spain
      • 11.3.8.5. Italy
      • 11.3.8.6. Rest of Europe
  • 11.4. Latin America
    • 11.4.1. Introduction
    • 11.4.2. Key Region-Specific Dynamics
    • 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Circulating Biomarker
    • 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 11.4.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.4.8.1. Mexico
      • 11.4.8.2. Brazil
      • 11.4.8.3. Argentina
      • 11.4.8.4. Rest of South America
  • 11.5. Asia-Pacific
    • 11.5.1. Introduction
    • 11.5.2. Key Region-Specific Dynamics
    • 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Circulating Biomarker
    • 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 11.5.8. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 11.5.8.1. China
      • 11.5.8.2. India
      • 11.5.8.3. Japan
      • 11.5.8.4. South Korea
      • 11.5.8.5. Rest of Asia-Pacific
  • 11.6. Middle East and Africa
    • 11.6.1. Introduction
    • 11.6.2. Key Region-Specific Dynamics
    • 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
    • 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Circulating Biomarker
    • 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Technology
    • 11.6.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

12. Competitive Landscape

  • 12.1. Competitive Scenario
  • 12.2. Market Positioning/Share Analysis
  • 12.3. Mergers and Acquisitions Analysis

13. Company Profiles

Key Market Players

  • 13.1. Exosome Sciences Inc*
    • 13.1.1. Company Overview
    • 13.1.2. Product Portfolio
      • 13.1.2.1. Product Description
      • 13.1.2.2. Product Key Performance Indicators (KPIs)
      • 13.1.2.3. Historic and Forecasted Product Sales
      • 13.1.2.4. Product Sales Volume
    • 13.1.3. Financial Overview
      • 13.1.3.1. Company Revenue's
      • 13.1.3.2. Geographical Revenue Shares
      • 13.1.3.3. Revenue Forecasts
    • 13.1.4. Key Developments
      • 13.1.4.1. Mergers & Acquisitions
      • 13.1.4.2. Key Product Development Activities
      • 13.1.4.3. Regulatory Approvals etc.
    • 13.1.5. SWOT Analysis
  • 13.2. Illumina, Inc
  • 13.3. Guardant Health
  • 13.4. Thermo Fisher Scientific Inc
  • 13.5. NeoGenomics Laboratories
  • 13.6. Qiagen
  • 13.7. BioChain Institute Inc
  • 13.8. Sysmex Europe SE
  • 13.9. Eurofins Genomics
  • 13.10. Goffin Molecular Technologies
  • Similar data will be provided for each market player.

Emerging Market Players

  • 13.11. Exact Sciences*
    • 13.11.1. Pipeline Products Description
    • 13.11.2. Product Key Performance Indicators (KPIs)
    • 13.11.3. Key Activities
    • 13.11.4. Market Entry Timelines
    • 13.11.5. Product Penetration Rate
    • 13.11.6. Sales Estimation and Projections
  • 13.12. Tempus
  • 13.13. Dxcover Limited
  • Similar data will be provided for each market player.

LIST NOT EXHAUSTIVE

12. Appendix

  • 12.1 About Us and Services
  • 12.2 Contact Us