リキッドバイオプシーの世界市場 (2025年～2033年)

世界のリキッドバイオプシー（液体生検）市場は、2024年に90億7,000万米ドルに達し、2033年には251億9,000万米ドルに達すると予測され、予測期間2025年～2033年のCAGRは10.7%で成長する見込みです。

エグゼクティブサマリー

リキッドバイオプシーは、血液、尿、精液、唾液などの体液中の細胞バイオマーカーや分子バイオマーカーを検出する低侵襲検査であり、診断、予後予測、疾患予測情報を提供します。さらに、リキッドバイオプシーは、早期がんの発見、局所がん患者の腫瘍ステージングとモニタリング、進行がん患者の転移性進行の予測、治療効果のモニタリングのために臨床現場で利用されていますが、スクリーニングは依然として困難です。

市場力学：

促進要因と抑制要因

がんの有病率の上昇

リキッドバイオプシー市場は、世界のがん罹患率の上昇により需要が高まっており、患者の予後を改善するために早期発見とリアルタイムのモニタリングが必要となっています。従来の方法は侵襲的で時間がかかるため、リキッドバイオプシーは非侵襲的な代替手段となります。リキッドバイオプシーは、血液サンプルから循環腫瘍DNA、CTC、その他のバイオマーカーを検出し、早期診断、治療モニタリング、個別化治療の選択を容易にします。例えば、米国がん協会（ACS）は2025年のがん統計を発表し、米国では今年200万人以上が新たにがんと診断され、60万人以上ががんで死亡すると推定しています。

調査によると、2025年に米国で新たにがんと診断される患者は204万1910人で、これは毎日ほぼ5600人が新たにがんと診断されることに相当します。この数字は、男性では105万3,250人、女性では98万8,660人のがん患者数です。

標準化と規制の課題

世界のリキッドバイオプシー市場を維持する主な要因の一つは、規制当局による標準化と厳格なルールがないことです。リキッドバイオプシー技術は複雑な検査方法を使用しており、スクリーニング方法が変更されると検査結果に一貫性がなくなることがあります。テストの検証、サンプルの取り扱い、結果の意味の把握について、一般的に合意されたルールがないため、広く採用されにくいです。

また、FDAやEMAのような規制機関は、リキッドバイオプシー検査に多くの臨床的裏付けを必要とするため、承認プロセスに時間がかかります。このような問題により、新商品が市場に出回るまでに時間がかかり、中小企業が新しいリキッドバイオプシーオプションを市場に投入することが難しくなっています。

目次

第1章 分析手法と分析範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
    • がん罹患率の上昇
    • 眼の生体力学に基づくカスタマイズされたレーザー手術の増加
  • 抑制要因
    • 標準化と規制上の課題
    • 治療手順の高額な費用
  • 機会
    • 新興市場への進出
  • 影響分析

第5章 戦略的洞察と業界展望

• 市場のリーダーと先駆者
  • 新たな先駆者と主要企業
  • 最大の売上を誇るブランドを確立したリーダー
  • 確立された製品を持つ市場リーダー
• CXOの視点
• 最新の開発とブレークスルー
• ケーススタディ/進行中の研究
• 規制と償還の情勢
  • 北米
  • 欧州
  • アジア太平洋
  • ラテンアメリカ
  • 中東・アフリカ
• ポーターのファイブフォース分析
• サプライチェーン分析
• 特許分析
• SWOT分析
• アンメットニーズとギャップ
• 市場参入と拡大のための推奨戦略
• シナリオ分析：ベストケース・ベースケース・ワーストケースの予測
• 価格分析と価格市場力学
• キーオピニオンリーダー (KOL)

第6章 製品種類別

• キット・試薬
• 装置
• サービス

第7章 循環バイオマーカー別

• 循環腫瘍細胞
• 循環腫瘍DNA（ctDNA）
• 遊離DNA（cfDNA）
• 細胞外小胞

第8章 用途別

• がん用途
• 非がん用途

第9章 技術別

• マルチ遺伝子並列解析（NGS）
• 単一遺伝子解析（PCRマイクロアレイ）

第10章 エンドユーザー別

• 病院・開業医
• 研究センター
• その他

第11章 地域別

• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • スペイン
  • イタリア
  • その他欧州地域
• ラテンアメリカ
  • メキシコ
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• 中東・アフリカ

第12章 競合情勢

• 競合シナリオ
• 市況・シェア分析
• 企業合併・買収 (M&A) 分析

第13章 企業プロファイル

• Exosome Sciences Inc
  • 企業概要
  • 製品ポートフォリオ
    • 製品説明
    • 製品の主要業績評価指標（KPI）
    • 製品販売の実績・予測
    • 製品販売量
  • 財務概要
    • 企業の収益
    • 収益シェア：地域別
    • 収益予測
  • 主な動向
    • 企業合併・買収 (M&A)
    • 主な製品開発活動
    • 規制当局の承認等
  • 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.
• Exact Sciences
  • パイプライン製品の説明
  • 製品の主要業績評価指標（KPI）
  • 主な活動
  • 市場参入のタイムライン
  • 製品普及率
  • 売上予測と予測
• Tempus
• Dxcover Limited
• 各市場参入企業に対しても同様のデータが提供されます。

第12章 付録

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