EV-Based Liquid Biopsy Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Offering (Kits & Assays, Services, Instruments), By Workflow (Sample Preparation, Sequencing, Data Analysis), By Technology (Isolation Technologies, Analysis Technologies), By Sample Type (Blood, Urine, Saliva, and Others), By End user (Academic and Research Institutes, Pharmaceutical and Biotechnology Companies, Clinical Laboratories), By Region and Competition, 2020-2030F

Market Overview

The Global EV-Based Liquid Biopsy Market , valued at USD 91.12 Million in 2024, is projected to experience a CAGR of 9.74% to reach USD 159.14 Million by 2030. Extracellular vesicle (EV)-based liquid biopsy involves the non-invasive analysis of disease-specific biomarkers encapsulated within extracellular vesicles, such as exosomes, circulating in bodily fluids like blood or urine. These vesicles carry molecular cargoes including proteins, nucleic acids, and lipids, providing insights into the physiological and pathological state of originating cells. The market's expansion is significantly driven by the increasing global burden of chronic diseases, particularly cancer, and the rising demand for early, non-invasive diagnostic solutions. The inherent stability and abundance of EVs in biofluids, offering advantages over other circulating biomarkers, also act as key growth facilitators.

A substantial challenge impeding market expansion is the ongoing technical complexity associated with isolating and comprehensively characterizing EVs from complex biofluids. This variability in isolation methods and subsequent characterization often leads to issues with reproducibility and consistent clinical validation, thereby hindering broader clinical adoption and regulatory approvals. According to the American Cancer Society, in 2024, 20 million new cases of cancer were identified globally, highlighting the urgent clinical need that advanced diagnostic platforms like EV-based liquid biopsies seek to address.

Key Market Drivers

The escalating global cancer burden fundamentally drives the EV-based liquid biopsy market. Traditional diagnostic methods often face limitations in early detection and continuous monitoring, areas where the non-invasive nature of EV liquid biopsies offers significant advantages. As cancer incidence continues its upward trajectory, the urgency for advanced, accessible diagnostic tools intensifies. According to the International Agency for Research on Cancer (IARC), in 2022, there were close to 20 million new cases of cancer worldwide. This pervasive health crisis necessitates innovative solutions that can accurately identify malignancies at earlier stages and monitor treatment efficacy without the invasiveness of tissue biopsies, directly propelling the adoption and development of EV-based platforms.

Concurrently, increasing demand for non-invasive diagnostic solutions across medical disciplines reflects a widespread patient and clinician preference for less burdensome procedures. Patients consistently prioritize diagnostic methods that reduce physical discomfort and procedural risks. According to a study published in the Journal of Patient-Reported Outcomes in February 2022, "Patient and physician preferences for non-invasive diagnostic cardiovascular imaging technologies: a discrete choice experiment", patients assigned the risks and side effects attribute the most importance, at 30%, when considering diagnostic imaging choices. This preference directly translates to the oncology space, where EV-based liquid biopsies offer an attractive alternative. Research and development efforts in this field are further demonstrated by the College of American Pathologists (CAP) Newsroom reporting in July 2025 that combining exosomal ribonucleic acid with circulating tumor DNA led to a nearly 10-fold increase in detectable EGFR mutation copies in a lung cancer study. These advancements highlight the significant potential for non-invasive EV solutions in clinical practice.

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Key Market Challenges

A substantial challenge impeding the growth of the Global EV-Based Liquid Biopsy Market is the ongoing technical complexity associated with isolating and comprehensively characterizing extracellular vesicles (EVs) from complex biofluids. This inherent variability in isolation methods and subsequent characterization protocols often leads to significant issues with reproducibility and consistent clinical validation. The lack of standardized procedures across different laboratories and platforms directly compromises the reliability of test results, creating skepticism among clinicians and delaying the widespread adoption of EV-based diagnostic solutions.

This absence of consistency directly hampers broader clinical uptake and necessary regulatory approvals. When results from different studies or even within the same study are not easily comparable, it becomes difficult for regulatory bodies to establish clear guidelines for test performance and for healthcare providers to trust the diagnostic utility of these assays. According to the International Society for Extracellular Vesicles (ISEV), in a 2023 global inter-laboratory comparison study involving 39 flow cytometers across 24 laboratories, EV concentration measurements were found to be incomparable. This fundamental issue with measurement comparability underscores the pervasive standardization problem, directly impeding the progression of EV-based liquid biopsies from research to routine clinical practice and constraining market expansion.

Key Market Trends

The emergence of novel EV biomarkers is significantly shaping the global EV-based liquid biopsy market by enhancing diagnostic precision and expanding application areas. Research into disease-specific cargo within extracellular vesicles, such as proteins and nucleic acids, is uncovering new targets for early detection and disease monitoring across various pathologies. This focus on biomarker discovery drives the development of more sensitive and specific diagnostic assays. According to the International Society for Extracellular Vesicles, its MISEV2023 guidelines, published in March 2024, garnered consensus from approximately 97% of surveyed members, reflecting a widespread scientific commitment to standardizing and advancing EV research which underpins biomarker identification. This collective effort is crucial for translating promising biomarker candidates into validated clinical tools. Furthermore, a review article in *Biology (Basel)* in September 2024, highlighted the therapeutic opportunity of tumor-derived extracellular vesicles, emphasizing their capacity to harbor cancer-derived cargo reflective of their cell-of-origin and their superior stability in blood for diagnostic and prognostic insights.

Concurrently, the integration of AI-enhanced EV liquid biopsy platforms represents a transformative trend, improving the efficiency and accuracy of data analysis in this complex field. Artificial intelligence algorithms can process vast amounts of EV-derived molecular data, identify subtle patterns, and accelerate the discovery of diagnostic signatures that might be missed by conventional methods. This technological advancement directly contributes to more robust and reliable diagnostic solutions. The American Association for Cancer Research Annual Meeting in April 2024, for instance, attracted over 22,000 researchers and clinicians, where liquid biopsies and artificial intelligence were prominently featured as key topics, underscoring the substantial industry focus on these integrated technologies. Such platforms are pivotal for moving EV diagnostics from research settings to widespread clinical adoption. For example, Mursla Bio commercially launched its AI Precision Medicine Platform in June 2025, which is built on organ-specific EV isolation and multi-omics data to enable differentiated AI-powered biomarker discovery from plasma samples.

Segmental Insights

The Kits & Assays segment is a rapidly expanding area within the Global EV-Based Liquid Biopsy Market, primarily driven by the increasing demand for standardized and efficient diagnostic tools. This growth stems from the critical need for non-invasive early disease detection and continuous monitoring, particularly in oncology, where extracellular vesicles offer promising biomarker insights. Advancements in molecular diagnostic technologies have significantly enhanced the sensitivity and specificity of EV-based liquid biopsy tests, making these kits and assays essential for accurate analysis. Furthermore, sustained investment in research and development by various institutions is fueling innovation, leading to the broader adoption of these accessible and effective diagnostic solutions in clinical and research settings.

Regional Insights

North America holds a dominant position in the Global EV-Based Liquid Biopsy Market due to a convergence of advantageous factors. The region benefits from a robust healthcare infrastructure and substantial investments in cancer research and precision medicine, fostering an environment conducive to innovation. Furthermore, North America features a strong presence of leading biotechnology and diagnostics companies, alongside a comprehensive biomedical research ecosystem involving prominent academic institutions. Favorable and well-established regulatory frameworks, notably from bodies like the U. S. Food and Drug Administration, accelerate the adoption and commercialization of advanced diagnostic technologies. This regulatory clarity, coupled with high demand for non-invasive solutions and significant R&D funding, underpins North America's leadership.

Recent Developments

• In September 2025, Myriad Genetics and SOPHiA GENETICS announced a strategic collaboration aimed at developing an innovative global liquid biopsy companion diagnostic test for pharmaceutical companies. The partnership intends to combine Myriad's laboratory expertise in the U.S. with SOPHiA GENETICS' extensive international testing network. This initiative will initially focus on the MSK-ACCESS® platform powered by SOPHiA DDM™. The collaboration seeks to advance precision medicine by expanding access to data-driven diagnostic solutions within the global EV-Based Liquid Biopsy Market.

• In June 2025, Guardant Health's Shield multi-cancer detection (MCD) test was granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). This designation recognizes the potential of the methylation-based blood test to provide a more effective diagnosis for life-threatening diseases like cancer, particularly for individuals aged 45 or older at average risk. The Shield test is designed to screen for multiple cancer types with a single blood draw, representing a significant advancement in non-invasive early detection within the global EV-Based Liquid Biopsy Market.

• In April 2024, researchers at City of Hope presented significant findings at the American Association for Cancer Research (AACR) Annual Meeting. The breakthrough research detailed an investigational exosome-based liquid biopsy that demonstrated high accuracy, detecting 97% of stage 1-2 pancreatic cancers when integrated with the CA 19-9 biomarker. This development suggests an improved, more sensitive, and less invasive method for the early detection and monitoring of aggressive tumors, directly enhancing the capabilities of the global EV-Based Liquid Biopsy Market for critical oncology applications.

• In April 2024, EXO Biologics, a biotechnology company based in Belgium, successfully completed a Series A funding round, securing up to €16 million. This substantial investment is designated to fuel the development and clinical supply of the company's exosome-based therapeutics. The funding will also support the expansion of manufacturing capabilities, including enhancements to its ExoPulse™ production platform. This financial milestone underscores increasing investor confidence in extracellular vesicle (EV) technologies, which are foundational to advancements in both therapeutic applications and EV-based liquid biopsy diagnostics.

Key Market Players

• Horiba Ltd.
• Thermo Fisher Scientific, Inc.
• Lonza Group AG
• Takara Bio Inc.
• Abcam plc
• Qiagen N.V.
• Malvern Panalytical Ltd.
• Revvity, Inc. (PerkinElmer, Inc)
• Norgen Biotek Corp.
• Bio-Techne Corporation

Report Scope:

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

• EV-Based Liquid Biopsy Market , By Offering:

o   Kits & Assays

o   Services

o   Instruments

• EV-Based Liquid Biopsy Market , By Workflow:

o   Sample Preparation

o   Sequencing

o   Data Analysis

• EV-Based Liquid Biopsy Market , By Technology:

o   Isolation Technologies

o   Analysis Technologies

• EV-Based Liquid Biopsy Market , By Sample Type:

o   Blood

o   Urine

o   Saliva

o   Others

• EV-Based Liquid Biopsy Market , By End User:

o   Academic and Research Institutes

o   Pharmaceutical & Biotechnology Companies

o   Clinical Laboratories

• EV-Based Liquid Biopsy Market , By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global EV-Based Liquid Biopsy Market .

Available Customizations:

Global EV-Based Liquid 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).

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