액체생검 시장 : 바이오마커, 샘플, 유형, 기술, 적응증, 최종사용자, 용도별 - 세계 전망(2025-2030년)

The Liquid Biopsy Market was valued at USD 6.72 billion in 2024 and is projected to grow to USD 7.52 billion in 2025, with a CAGR of 12.24%, reaching USD 13.44 billion by 2030.

An authoritative introduction to liquid biopsy and its transformative potential in precision medicine and oncology diagnostics for industry stakeholders

Liquid biopsy represents a paradigm shift in diagnostic medicine by offering a minimally invasive window into tumor biology through the analysis of circulating biomarkers in bodily fluids. Unlike conventional tissue biopsies that necessitate surgical extraction and carry procedural risks, liquid biopsy harnesses circulating tumor DNA, cells, and vesicles to capture dynamic molecular information in real time. This approach aligns with the growing emphasis on precision oncology, where tailoring therapeutic regimens to individual molecular profiles can dramatically improve patient outcomes.

As cancer incidence continues to rise globally, healthcare systems are under pressure to deliver cost-effective, rapid diagnostics that minimize patient discomfort without compromising accuracy. Liquid biopsy addresses these demands by enabling serial monitoring of disease progression, early detection of minimal residual disease, and the identification of actionable mutations that guide targeted therapies. Moreover, its application extends beyond oncology into transplant medicine, prenatal screening, and infectious disease monitoring, positioning liquid biopsy as a versatile tool for modern clinical practice.

Stakeholders across pharmaceutical, diagnostic, and research sectors are now evaluating how to integrate liquid biopsy into existing workflows and regulatory pathways. With technological advances driving down assay time and costs, liquid biopsy is poised to become a standard component of patient management. In the following sections, we explore the transformative forces reshaping this landscape, the implications of recent policy changes, and the strategic insights that will guide industry leaders forward.

Exploring the pivotal shifts redefining the liquid biopsy landscape through technological breakthroughs regulatory progress and strategic industry collaborations

The liquid biopsy landscape is evolving at an unprecedented pace, propelled by breakthroughs in next-generation sequencing, digital PCR, and novel bioinformatics pipelines. These technological advancements have significantly increased the sensitivity and specificity of analyte detection, enabling the identification of rare circulating tumor DNA fragments at early stages of cancer. Concurrently, regulatory agencies across key markets have begun to issue more streamlined approval pathways for companion diagnostics, reflecting confidence in the clinical utility and reproducibility of liquid biopsy assays.

At the same time, strategic collaborations between diagnostic manufacturers, academic centers, and pharmaceutical firms are accelerating assay validation and broadening the scope of clinical studies. Such partnerships are fostering the co-development of targeted panels aligned with emerging targeted therapies, thereby integrating diagnostics directly into the drug development lifecycle. Meanwhile, decentralized testing models-ranging from point-of-care platforms to patient-collected sampling kits-are democratizing access and supporting remote monitoring initiatives.

Collectively, these forces are redefining the competitive dynamics of the liquid biopsy domain. Incumbent laboratory providers are investing in proprietary platforms to maintain differentiation, while nimble start-ups continue to innovate assay chemistries and data analytics. Looking ahead, convergence around multi-omics integration and standardized reporting frameworks will further solidify liquid biopsy's role as a cornerstone of personalized care.

Assessing the cumulative repercussions of the 2025 United States tariffs on liquid biopsy supply chains pricing structures and global research collaborations

On January 1, 2025, new U.S. tariffs on imported diagnostic reagents and instrumentation took effect, introducing a layer of complexity for cross-border supply chains. The added duties have increased landed costs for core consumables, prompting manufacturers and laboratory partners to reassess sourcing strategies and inventory models. For companies reliant on specialized reagents, securing alternative domestic suppliers or negotiating long-term contracts has become a critical objective to contain margins and avoid service disruptions.

The ripple effects extend into pricing structures, as laboratories pass incremental expenses to payers and patients, potentially impacting adoption rates in price-sensitive segments. To mitigate these pressures, several industry players have begun exploring localized manufacturing solutions, including establishing regional production hubs and partnering with contract development organizations. In parallel, increased collaboration with customs authorities and trade associations has enabled more efficient classification and duty minimization, offering relief to stakeholders navigating the evolving tariff landscape.

Despite these headwinds, many organizations view the 2025 tariffs as a catalyst to strengthen domestic supply resilience and foster innovation in reagent design. By investing in robust regional capabilities and diversifying supplier networks, the industry anticipates a more balanced cost structure over the long term, ultimately supporting sustainable growth and uninterrupted patient access.

Deriving critical insights from multifaceted segmentation of biomarkers samples assay types technologies indications applications and end-user dynamics

Segmentation by biomarker class reveals the interplay between mature and emerging analytes. Cell-free DNA continues to anchor clinical assays due to its well-established correlation with tumor burden and mutational profiling, while circulating tumor cells unlock opportunities for phenotypic analysis. The advent of circulating tumor DNA technologies enables real-time monitoring of resistance mutations, and the exploration of extracellular vesicles is opening new research frontiers around RNA cargo and proteomic signatures.

When considering sample origin, blood-based tests dominate current workflows because of established venipuncture protocols and high analyte yield. However, urine-based assays are gaining traction as a noninvasive alternative for longitudinal screening, particularly in urological and genitourinary indications. Advances in sample stabilization and extraction methods are narrowing performance gaps, setting the stage for wider clinical adoption of diversified fluid matrices.

In terms of product taxonomy, assay kits form the backbone of commercial offerings by delivering standardized workflows that simplify laboratory implementation. Instruments add value through automation and throughput optimization, while services encompass bespoke assay development, data interpretation, and clinical reporting. On the technology front, multi-gene parallel analysis using next-generation sequencing is prized for its multiplexing capacity and depth of coverage, whereas single-gene analysis via PCR microarrays maintains a strong presence in targeted mutation detection due to rapid turnaround.

Indication-driven segmentation underscores the primacy of cancer applications, with breast, colorectal, lung, melanoma, and prostate cancers accounting for the majority of clinical validation studies. Non-cancer indications are expanding into areas such as organ transplant rejection monitoring and prenatal aneuploidy screening. Among end-users, academic and research centers spearhead exploratory studies, while clinical diagnostic laboratories, hospitals, and physician office labs drive routine testing volumes. Finally, application segmentation reveals a balanced portfolio of early cancer screening initiatives, recurrence monitoring protocols, therapy selection assays, and treatment monitoring programs, reflecting the multifaceted utility of liquid biopsy in patient management.

Uncovering regional dynamics shaping liquid biopsy adoption and innovation across the Americas Europe Middle East Africa and Asia Pacific markets

The Americas continue to lead with advanced regulatory frameworks and high-volume clinical adoption. Government initiatives focusing on cancer screening and value-based care have accelerated reimbursement discussions, enabling broader uptake in both academic medical centers and community hospitals. Moreover, strategic partnerships between local diagnostic companies and international technology providers have fortified supply chains and expanded regional access to cutting-edge assays.

Europe, Middle East, and Africa present a heterogeneous landscape marked by diverse regulatory regimes and reimbursement environments. In Western Europe, centralized health technology assessments and national screening programs drive standardization, whereas emerging markets in Eastern Europe, the Middle East, and Africa are gradually integrating liquid biopsy into oncology networks through pilot projects and center-of-excellence collaborations. Cross-border data sharing and harmonized clinical guidelines remain key enablers of sustainable growth across these jurisdictions.

Asia-Pacific is characterized by rapid market expansion underpinned by significant public health investments and rising cancer incidence. Government funding for cancer genomics and domestic manufacturing incentives have catalyzed indigenous assay development. Collaborative research between regional academic institutions and global diagnostic firms is intensifying, while the rollout of digital pathology and telemedicine platforms supports remote sample collection and result dissemination, extending the reach of liquid biopsy solutions.

Analyzing strategic positioning competitive strengths and market contributions of leading corporations in the rapidly evolving liquid biopsy ecosystem

Leading diagnostic and biotechnology companies are positioning themselves through differentiated platforms, strategic acquisitions, and expansive intellectual property portfolios. Legacy players with established laboratory networks are leveraging deep clinical validation data to extend their assay menus, while pure-play innovators focus on proprietary chemistries and advanced bioinformatics to achieve early market entry.

Collaborative alliances between pharmaceutical companies and diagnostic developers are accelerating the co-development of companion diagnostics tailored to specific targeted therapies. Start-ups are forging partnerships with contract research organizations to streamline multicenter clinical trials, ensuring robust evidence generation and regulatory alignment. At the same time, instrument manufacturers are integrating connectivity features and cloud-based data analytics into their platforms, enhancing operational efficiency and facilitating seamless integration with laboratory information systems.

Beyond technology differentiation, corporate strategies are increasingly oriented toward geographic expansion through regional sales networks and production hubs. By aligning global R&D pipelines with localized commercialization strategies, leading companies are building scalable models that address diverse regulatory requirements and market access challenges.

Crafting forward-looking strategies and practical recommendations for industry stakeholders to capitalize on liquid biopsy advancements and market opportunities

To navigate the evolving liquid biopsy environment, industry stakeholders should prioritize investment in flexible assay architectures that support both targeted and broad-panel applications. This approach ensures agility in responding to emerging biomarkers and regulatory shifts. Integrating multi-omics capabilities into existing workflows will enhance diagnostic accuracy and provide richer insights into tumor heterogeneity.

Building resilient supply chains through regional manufacturing partnerships and dual-sourcing agreements can mitigate exposure to trade policy fluctuations. Organizations should also establish cross-functional teams that unite regulatory, commercial, and scientific experts to streamline product approvals and reimbursement negotiations. Collaborative initiatives with payers and healthcare providers will strengthen the value proposition by demonstrating real-world clinical utility and cost savings.

Digital transformation should remain a strategic priority, with investments in cloud-native analytics, artificial intelligence-driven variant interpretation, and telehealth-enabled sample collection. These technologies will support decentralized testing models and personalized patient engagement. Finally, fostering open innovation through consortiums and public-private partnerships will accelerate the validation of novel analytes and drive the harmonization of reporting standards, reinforcing liquid biopsy's role in precision medicine.

Outlining rigorous research methodology encompassing data collection analysis validation to ensure comprehensive coverage of the liquid biopsy domain

This report's methodology integrates a rigorous blend of secondary and primary research to ensure robustness and credibility. Initially, extensive secondary research was conducted, encompassing peer-reviewed journals, clinical trial registries, patent filings, regulatory publications, and white papers to establish a comprehensive foundation of technical and clinical understanding.

Primary research was conducted through in-depth interviews with senior executives, laboratory directors, and key opinion leaders across diagnostics, pharmaceutical, and academic sectors. These expert dialogues provided nuanced perspectives on assay development, regulatory strategy, and commercialization challenges. Data triangulation techniques validated qualitative insights against proprietary databases and financial disclosures to reinforce accuracy.

Quantitative analysis involved mapping product pipelines, technology adoption metrics, and regional deployment patterns. Key variables were cross-referenced with public health statistics and reimbursement schedules to contextualize application potential. Validation workshops with external advisors and technical specialists were organized to resolve discrepancies and refine assumptions.

Collectively, this multi-layered approach delivers a holistic view of the liquid biopsy domain, balancing empirical evidence with expert interpretation to guide strategic decision-making.

Summarizing the strategic significance future outlook and enduring value of liquid biopsy innovations for advancing precision diagnostics and patient care

Liquid biopsy has emerged as a cornerstone of modern diagnostic practice, bridging the gap between molecular insights and personalized patient management. Its capacity to detect and monitor disease through noninvasive sampling unlocks new avenues for early intervention, treatment optimization, and long-term surveillance. As technology platforms mature, liquid biopsy is transitioning from niche research applications to mainstream clinical adoption.

Strategically, stakeholders who align their portfolios with the evolving landscape-incorporating flexible assay designs, resilient supply chains, and digital innovation-will be best positioned to capitalize on market opportunities. Continued collaboration across industry, academia, and regulatory bodies will drive the standardization of workflows and reimbursement frameworks, further reducing barriers to implementation.

Looking ahead, the integration of liquid biopsy with complementary diagnostics and therapeutic modalities promises to accelerate the shift toward truly individualized medicine. By embracing a data-driven, patient-centered approach, industry leaders can unlock significant clinical and commercial value, reinforcing liquid biopsy's role as a transformative force in healthcare.

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

• 4.1. Introduction
• 4.2. Market Sizing & Forecasting

5. Market Dynamics

• 5.1. Adoption of ultra-high sensitivity digital PCR techniques for minimal residual disease monitoring in oncology
• 5.2. Integration of multi-omic liquid biopsy assays combining ctDNA methylation and protein biomarkers for early disease screening
• 5.3. Emergence of decentralized point-of-care liquid biopsy platforms enabling rapid at-home cancer monitoring
• 5.4. Use of artificial intelligence-driven algorithms for comprehensive interpretation of circulating tumor cell heterogeneity
• 5.5. Expansion of noninvasive prenatal testing with fetal aneuploidy and microdeletion screening through cell-free DNA fragmentation analysis
• 5.6. Strategic collaborations between diagnostic developers and pharmaceutical companies to accelerate biomarker discovery and companion diagnostic development

6. Market Insights

• 6.1. Porter's Five Forces Analysis
• 6.2. PESTLE Analysis

7. Cumulative Impact of United States Tariffs 2025

8. Liquid Biopsy Market, by Biomarkers

• 8.1. Introduction
• 8.2. Cell-free DNA
• 8.3. Circulating Tumor Cells
• 8.4. Circulating Tumor DNA
• 8.5. Extracellular Vesicles

9. Liquid Biopsy Market, by Sample

• 9.1. Introduction
• 9.2. Blood Based
• 9.3. Urine Based

10. Liquid Biopsy Market, by Type

• 10.1. Introduction
• 10.2. Assay Kits
• 10.3. Instruments
• 10.4. Services

11. Liquid Biopsy Market, by Technology

• 11.1. Introduction
• 11.2. Multi-gene Parallel Analysis using NGS
• 11.3. Single-gene Analysis using PCR Microarrays

12. Liquid Biopsy Market, by Indication

• 12.1. Introduction
• 12.2. Cancer Indication
  • 12.2.1. Breast Cancer
  • 12.2.2. Colorectal Cancer
  • 12.2.3. Lung Cancer
  • 12.2.4. Melanoma
  • 12.2.5. Prostate Cancer
• 12.3. Non-Cancer Indication

13. Liquid Biopsy Market, by End-User

• 13.1. Introduction
• 13.2. Academic & Research Centers
• 13.3. Clinical Diagnostic Laboratories
• 13.4. Hospitals
• 13.5. Physician's Office Laboratories

14. Liquid Biopsy Market, by Application

• 14.1. Introduction
• 14.2. Early Cancer Screening
• 14.3. Recurrence Monitoring
• 14.4. Therapy Selection
• 14.5. Treatment Monitoring

15. Americas Liquid Biopsy Market

• 15.1. Introduction
• 15.2. United States
• 15.3. Canada
• 15.4. Mexico
• 15.5. Brazil
• 15.6. Argentina

16. Europe, Middle East & Africa Liquid Biopsy Market

• 16.1. Introduction
• 16.2. United Kingdom
• 16.3. Germany
• 16.4. France
• 16.5. Russia
• 16.6. Italy
• 16.7. Spain
• 16.8. United Arab Emirates
• 16.9. Saudi Arabia
• 16.10. South Africa
• 16.11. Denmark
• 16.12. Netherlands
• 16.13. Qatar
• 16.14. Finland
• 16.15. Sweden
• 16.16. Nigeria
• 16.17. Egypt
• 16.18. Turkey
• 16.19. Israel
• 16.20. Norway
• 16.21. Poland
• 16.22. Switzerland

17. Asia-Pacific Liquid Biopsy Market

• 17.1. Introduction
• 17.2. China
• 17.3. India
• 17.4. Japan
• 17.5. Australia
• 17.6. South Korea
• 17.7. Indonesia
• 17.8. Thailand
• 17.9. Philippines
• 17.10. Malaysia
• 17.11. Singapore
• 17.12. Vietnam
• 17.13. Taiwan

18. Competitive Landscape

• 18.1. Market Share Analysis, 2024
• 18.2. FPNV Positioning Matrix, 2024
• 18.3. Competitive Analysis
  • 18.3.1. Illumina, Inc.
  • 18.3.2. Labcorp Holdings Inc.
  • 18.3.3. ANGLE PLC
  • 18.3.4. Bio-Rad Laboratories, Inc.
  • 18.3.5. Bio-Techne Corporation
  • 18.3.6. Biocartis NV
  • 18.3.7. Danaher Corporation
  • 18.3.8. DiaCarta, Inc.
  • 18.3.9. Dxcover Limited
  • 18.3.10. Epic Sciences Inc.
  • 18.3.11. Exact Sciences Corporation
  • 18.3.12. F. Hoffmann-La Roche Ltd.
  • 18.3.13. GENCURIX
  • 18.3.14. Guardant Health, Inc.
  • 18.3.15. Laboratory Dr. med. Pachmann
  • 18.3.16. Lucence Health Inc.
  • 18.3.17. LungLife AI, Inc.
  • 18.3.18. MDxHealth SA
  • 18.3.19. Menarini Silicon Biosystems SpA
  • 18.3.20. Merck KGaA
  • 18.3.21. Myriad Genetics, Inc.
  • 18.3.22. Natera, Inc.
  • 18.3.23. NeoGenomics Laboratories, Inc.
  • 18.3.24. OncoDNA SA
  • 18.3.25. PerkinElmer, Inc.
  • 18.3.26. Personalis, Inc.
  • 18.3.27. QIAGEN N.V.
  • 18.3.28. SAGA Diagnostics AB
  • 18.3.29. Strand Life Sciences Pvt Ltd.
  • 18.3.30. Sysmex Corporation
  • 18.3.31. Tempus AI, Inc.
  • 18.3.32. Thermo Fisher Scientific Inc.

19. ResearchAI

20. ResearchStatistics

21. ResearchContacts

22. ResearchArticles

23. Appendix