Non-Invasive Liquid Biopsy Market Size, Share and Trends Analysis, By Product and Service (Instruments, Software and Service, and Consumable Kits and Assays), By Sample Type (Urine, Saliva, Stool, and Blood, By Technology (Single Gene Analysis and Multi-gene-parallel Analysis (NGS), By Circulating Biomarker, By Application, By End-Use, and By Region, Forecast 2025-2032

Non-Invasive Liquid Biopsy Market Overview and Key Insights:

The non-invasive liquid biopsy market size reached USD 8.77 billion in 2024 and is expected to register a revenue CAGR of 11.5% during the forecast period. Liquid biopsy is a new precision medicine technology that examines biological fluids, including blood, to learn more about a patient’s health. It is a non-invasive method of detecting and evaluating biomarkers such circulating tumour cells (CTCs), cell-free DNA (cfDNA), and exosomes.

Market Drivers:

Increase in prevalence of cancer is a key driver of revenue growth in the non-invasive liquid biopsy market. According to the American Cancer Society, the number of colorectal cancers in the United States in 2025 are approximately 107,320 new cases of colon cancer (54,510 in males and 52,810 in women). Approximately 46,950 new cases of rectal cancer (27,950 men and 19,000 women). Colorectal cancer is the third-leading cause of cancer-related deaths in men and the fourth-leading cause in women in the United States, but it ranks second when men and women are combined. It is estimated to kill approximately 52,900 people by 2025.

Growing preference for non-invasive diagnostics is another key driver driving the market growth over the forecasted period. Liquid biopsies have substantially changed the area of clinical oncology by making tumor collection easier, allowing for continuous monitoring through repeated sampling, developing customized therapy regimens, and screening for therapeutic resistance. Liquid biopsies are less intrusive to the patient than tissue biopsies, making them ideal for continuous monitoring of tumor growth.

On November 2023, Illumina Inc., a global pioneer in DNA sequencing and array-based technologies, has introduced a new version of their distributed liquid biopsy assay for genomic profiling. The new TruSight Oncology 500 ctDNA v2 (TSO 500 ctDNA v2) is a research assay that allows for noninvasive comprehensive genomic profiling (CGP) of circulating tumor DNA (ctDNA) from blood when tissue testing is not possible or to supplement tissue-based testing.

Market Opportunity:

Advancements in AI & bioinformatics acts as an opportunity for the non-invasive liquid biopsy market. AI improves diagnostic accuracy in liquid biopsies using advanced algorithms such as Convolutional Neural Networks (CNNs) and Natural Language Processing (NLP). These AI algorithms examine complex biomedical data, providing greater sensitivity and specificity in cancer diagnosis. The combination of AI and liquid biopsies promises earlier detection, improved disease monitoring, and individualized treatment regimens.

On November 2024, Illumina Inc., a global pioneer in DNA sequencing and array-based technologies, has introduced a new version of their distributed liquid biopsy assay for genomic profiling. The new TruSight Oncology 500 ctDNA v2 (TSO 500 ctDNA v2) is a research assay that allows for noninvasive comprehensive genomic profiling (CGP) of circulating tumor DNA (ctDNA) from blood when tissue testing is not possible or to supplement tissue-based testing.

Recent Trends:

Emerging trends include non-invasive prenatal testing, mass population screening and point-of-care, RNA therapeutics and treatment monitoring, topical use for skincare, and precision oncology.

Non-invasive prenatal testing (NIPT) is a revolutionary method for detecting fetal cfDNA in maternal plasma during pregnancy, and it is used to check for fetal chromosomal disorders. The NIPT-based liquid biopsy has been proven to be a particularly sensitive and specific technique for chromosomal abnormalities resulting from undetected maternal primitive cancers.

On February 2025, Yourgene Health (part of the Novacyt group of enterprises), a leading international molecular diagnostics company, has announced the launch of IONA Care+, a fully comprehensive non-invasive prenatal screening service for genetic diseases, in the UK. The service will use Yourgene’s IONA Nx NIPT Workflow to provide safe, quick, and accurate non-invasive prenatal testing (NIPT) findings. This lowers the need for intrusive diagnostics and their accompanying hazards, while also lowering stress and anxiety for expectant parents.

Restraints & Challenges:

Variability in sensitivity & specificity is a key restraint limiting the growth of the market. The accuracy of liquid biopsies varies depending on the kind and stage of cancer, with possible problems detecting low quantities of ctDNA in early-stage tumours. The inclusion of ctDNA from non-tumor sources, such as clonal haematopoiesis with indeterminate potential (CHIP), can make results difficult to interpret. Liquid biopsies provide essential genetic and molecular information, but they may not provide the same level of detail as tissue biopsies do.

Product and Service Segment Insights and Analysis:

Based on the product and service, the non-invasive liquid biopsy market is segmented into instruments, software and service, and consumable kits and assays.

Instruments segment contributed the largest market share in 2024. In recent years, there has been a boost in cancer knowledge, as well as technical advancements that have given rise to medical oncology. Examples of molecular biology techniques: Q-PCR, BEAMing, Safe-SeqS, CAPP-Seq, and TAmSeq use one or a few known tumor-specific mutations of the primary tumor to monitor residual disease in peripheral blood. This allows for extremely sensitive targeted monitoring, as mutations can be detected at an allele frequency of up to 0.01% with high specificity and at a fast and cost-effective pace.

On January 2024, Ultima Genomics, Inc., an innovator of a groundbreaking new ultra-high throughput sequencing architecture, has announced the debut and full commercial availability of the UG 100 at the upcoming Advances in Genome Biology and Technology (AGBT) conference. This commercial version of Ultima’s sequencing platform will also contain a new ppmSeq technology, which enables industry-leading raw read accuracy for detecting single nucleotide variations (SNVs) in rare event detection applications such as low-level circulating tumor DNA.

The consumable kits and assays segment is expected to grow at the highest rate throughout the forecasted period. CLIA-certified labs offer approximately ten different ctDNA laboratory-developed tests (LDTs) for patient care. Most kits use next-generation sequencing to test patients with advanced cancer for the presence or absence of about 70 different genetic mutations (such as those in genes p53, EGFR, BRCA1, BRCA2, BRAF, and KRAS) that provide actionable insights.

On February 2024, Twist Bioscience Corporation, a company that helps companies thrive by providing high-quality synthetic DNA on its silicon platform, has launched the cfDNA Library Preparation Kit to facilitate liquid biopsy research. The Twist cfDNA Library Preparation Kit was designed to increase the number of unique cfDNA molecules caught during library preparation, resulting in greater confidence in the accuracy and sensitivity of liquid biopsy testing.

Circulating Biomarker Segment Insights and Analysis:

Based on the circulating biomarker, the non-invasive liquid biopsy market is segmented into Circulating Tumor Cells (CTCs), circulating tumor DNA, circulating proteins, and Extracellular Vesicles (EV).

Circulating Tumor Cells (CTCs) segment contributed the largest market share in 2024. CTCs are cancer cells that break away from the primary tumour and enter the bloodstream. Technological advances in CTC detection and isolation, including as microfluidics, immunomagnetic separation, and improved imaging, have not only increased the sensitivity and specificity of CTC analysis, but also opened new paths for their characterization. 

On June 2024, Bio-Rad Laboratories, Inc., a global leader in life science research and clinical diagnostics products, announced the availability of Celselect Slides 2.0, which improves rare cell and circulating tumor cell (CTC) capture. The current version of Celselect Slides, which is compatible with Bio-Rad’s Genesis Cell Isolation System, allows for the processing of larger volumes of liquid biopsy samples while also capturing and recovering a greater number of CTCs for enumeration or usage in downstream applications.

Extracellular vesicles (EV) are expected to have the highest market growth rate throughout the forecasted period. EVs have emerged as key mediators of intercellular communication in cancer. DNA fragments in EVs remain more stable than cfDNA. Studies have shown that cfDNA has a short half-life of 2–2.5 hours. Furthermore, EVs may reflect their cell of origin and indicate the body’s physiological and pathological status. Given these benefits, researchers have suggested EV-DNA as an alternative resource for gene detection and screening. Many research has investigated the possibility of EV-DNA-based liquid biopsy for the treatment of cancers such as lung cancer, pancreatic cancer, bladder cancer, and nervous system tumours.

On October 2024, researchers at the University of Rochester described a new method for employing ultrathin membranes to quickly identify EVs for liquid biopsies. The technology, known as catch and display for liquid biopsy (CAD-LB), has the potential to diagnose cancer rapidly and economically, as well as track the progress of illness treatments. In addition to describing the CAD-LB approach, the study revealed its ability to detect important immune modulatory proteins on EVs. These proteins help the body fight malignancies and can indicate how a patient will respond to immunotherapies.

Application Segment Insights and Analysis:

Based on the application, the non-invasive liquid biopsy market is segmented into cancer and non-cancer. Cancer is further sub-segmented into lung cancer, breast cancer, colorectal cancer, melanoma, prostate cancer, leukemia, and others. Non-cancer is further sub-segmented into non-invasive prenatal testing, organ transplantation, infectious disease testing, and others.

Cancer segment contributed the largest market share in 2024. According to the American Cancer Society, breast cancer is the most frequent cancer in women in the United States, except for skin cancers. It accounts for around 30% (or one in every three) of all new female malignancies each year. There will be around 316,950 new instances of invasive breast cancer in women, 59,080 new cases of ductal carcinoma in situ (DCIS), and 42,170 deaths from breast cancer. In the United States, the average risk of a woman obtaining breast cancer at some point in her life is about 13%, which means she has a one-in-eight chance of developing the disease and a seven-in-eight chance of never getting it.

On May 2023, Labcorp, a global leader in life sciences, has introduced Labcorp Plasma Focus, a new liquid biopsy test that allows patients with advanced or metastatic solid tumors to select a tailored therapy. 

Non-cancer segment is expected to have the highest growth rate throughout the forecasted period. The global usage of NIPT has expedited research into plasma DNA’s additional diagnostic applications. NIPT has been shown to detect genetic abnormality risk more accurately than ultrasound results or family history information, providing vital insights into the pregnancy’s health and informing future treatment options. NIPT provides parents and physicians with a safe and uncomplicated tool for early detection and management of predicted fetal abnormalities before delivery, especially in high-risk or complicated pregnancies.

Geographical Outlook:

Non-invasive liquid biopsy market is strategically segmented by geography to provide a comprehensive understanding of regional market dynamic. Discover demand analysis, emerging trends, and growth opportunities shaping market performance across different region and countries.

North America Non-Invasive Liquid Biopsy Market:

North America is registered to have highest market share in non-invasive liquid biopsy market in 2024. This is mainly due to the rising prevalence of cancer and a growing preference for non-invasive diagnostics. Lung cancer is the leading cause of cancer-related death in both men and women, with a substantially higher death rate than prostate or breast cancer. According to the National Cancer Institute, approximately 234,580 people will be diagnosed with lung and bronchus cancer in the United States in 2024, with an estimated 125,070 people dying from the disease—65,790 men and 59,280 women. The 5-year survival rate for these tumors is 26.7%.

On September 2024, SOPHiA GENETICS, a cloud-native healthcare technology business and global pioneer in data-driven medicine, has announced a significant milestone in the global rollout of the liquid biopsy test MSK-ACCESS powered by SOPHiA DDM, which was initially announced in October 2023. The solution combines the SOPHiA DDM Platform’s powerful analytics, cutting-edge algorithms, and decentralized, cloud-based solutions with MSK’s scientific and clinical experience in cancer genomics to create a best-in-class liquid biopsy solution.

Asia Pacific Non-Invasive Liquid Biopsy Market:

Asia Pacific is registered the fastest growth rate during the forecasted period. Precision medicine in the Asia-Pacific area has made tremendous advances. Countries such as Singapore, China, and South Korea have made advances in genomic sequencing, biomarker discovery, and the establishment of large-scale biobanks, and there is an increasing emphasis on generating companion diagnostics to identify patients who will benefit most from specific medications. In India, the incidence of cancer cases is expected to rise from 1.46 million in 2022 to 1.57 million in 2025. Lung and breast cancers continue to be the most common types of cancer in both genders.

On April 2024, Guardant Health Japan Corp., a leading precision oncology company, announced that the Japanese Ministry of Health, Labour, and Welfare (MHLW) has approved Guardant360 CDx as a companion diagnostic to identify EGFR exon 20 insertion mutations in patients with inoperable or recurrent non-small cell lung cancer (NSCLC) for treatment with amivantamab-vmjw combined with chemotherapy.

Europe Non-Invasive Liquid Biopsy Market:

Europe is to register a considerable market share during the forecasted period. The growing preference for non-invasive diagnostics and the increased adoption of personalized medicine and targeted therapy mainly drive this trend. In February 2023, Euformatics, in collaboration with ViennaLab Diagnostics and Oncompass Medicine, secured a contract to investigate and develop an end-to-end liquid biopsy solution for eight major European oncology centers. The newly formed bidding consortium was able to submit a solid offer due to the combination of an existing cancer kit NGS assay, intellectual property, and competence in areas such as genetic variant detection, variant interpretation, NGS data quality control, and precision oncology.

Competition Analysis:

The non-invasive liquid biopsy market is characterized by a fragmented structure, with several players competing across various segments and regions. List of major players included in the non-invasive liquid biopsy market report are:

• QIAGEN
• Exact Sciences Corporation
• Thermo Fisher Scientific Inc.
• Freenome Holdings, Inc.
• Hoffmann-La Roche Ltd.
• Illumina, Inc.
• Epigenomics AG
• Guardant Health
• Myriad Genetics, Inc.
• Biocept, Inc.
• Lucence Health Inc.
• OraSure Technologies Inc.
• Norgen Biotek Corp
• Zymo Research Corporation
• Oasis Diagnostics Corporation

Strategic Developments in Non-Invasive Liquid Biopsy Market:

• In January 2025, Oxford Cancer Analytics, a medtech startup that develops blood tests for early cancer diagnosis using sophisticated proteomics and AI, has announced that it has raised USD 11 million in Series A funding from global investors, including disease detection and diagnostics experts. Using advanced proteomics and AI, it answers an unmet need in the liquid biopsy market by providing a protein-based blood test with excellent accuracy for detecting malignancies with the highest mortality burden.
• In December 2024, PanGIA Biotech, a pioneer in liquid biopsy technology, has announced its first worldwide collaboration with Canary Oncoceutics (Canary Oncoceutics, Inc., Phoenix, AZ and Canary Oncoceutics India Pvt Ltd, Tamil Nadu, India). This collaboration introduces the PanGIA Prostate Assay, the world’s first AI-integrated urine-based liquid biopsy for prostate cancer detection, which will make its commercial debut in India. 
• In September 2024, PreAnalytiX GmbH, a joint venture between QIAGEN N.V. and BD, has announced the release of the PAXgene Urine Liquid Biopsy Set, which allows for the reliable analysis of cell-free DNA (cfDNA) from urine using most molecular testing technologies, such as qPCR, digital PCR, and next-generation sequencing. QIAGEN will commercialize the new set. The PAXgene Urine Liquid Biopsy Set solves the difficulty of extracting cfDNA from urine using an integrated preservation solution. 

Key Advantages for Stakeholders:

Navistrat Analytics’ industry report provides an in-depth quantitative analysis of various market segments, historical and current trends, market forecasts, and dynamics within the global market. The historical years covered in this report are 2022 to 2023, with 2024 serving as the base year for market size calculations. The forecast period extends from 2025 to 2032.

The report includes an executive summary and a comprehensive overview of market drivers, restraints, opportunities, and challenges (DROC), along with insights into regulatory standards. It features detailed analyses such as PORTER’s Five Forces, SWOT, and PESTLE, as well as assessments of technological trends and the competitive landscape.

PORTER’s Five Forces analysis helps stakeholders evaluate the impact of new entrants, competitive rivalry, supplier power, buyer power, and substitution threats, enabling them to assess the level of competition and the attractiveness of the global market. The competitive landscape provides stakeholders with a clear understanding of the current market positions of key players, offering valuable insights into their competitive environment.

Scope And Key Highlights Of The Non-Invasive Liquid Biopsy Market Report:

The Non-Invasive Liquid Biopsy market report offers a detailed analysis of market size, including historical revenue (in USD Billion) data for 2022-2023 and revenue forecasts for 2025-2032 across the following segments:

• Product and Service Outlook (Revenue, USD Billion; 2022-2032)
  • Instruments
  • Software and Service
  • Consumable Kits and Assays

• Sample Type Outlook (Revenue, USD Billion; 2022-2032)
  • Urine
  • Saliva
  • Stool
  • Blood

• Technology Outlook (Revenue, USD Billion; 2022-2032)
  • Single Gene Analysis
  • Multi-gene-parallel Analysis (NGS)

• Circulating Biomarker Outlook (Revenue, USD Billion; 2022-2032)
  • Circulating Tumor Cells (CTCs)
  • Circulating Tumor DNA
  • Circulating Proteins
  • Extracellular Vesicles

• Application Outlook (Revenue, USD Billion; 2022-2032)
  • Cancer
    • Lung Cancer
    • Breast Cancer
    • Colorectal Cancer
    • Melanoma
    • Prostate Cancer
    • Leukemia
    • Others
  • Non-Cancer
    • Non-Invasive Prenatal Testing
    • Organ Transplantation
    • Infectious Disease Testing
    • Others

• End-Use Outlook (Revenue, USD Billion; 2022-2032)
  • Hospitals and Laboratories
  • Specialty Clinics
  • Academic and Research Centers
  • Others

• Regional Outlook (Revenue, USD Billion; 2022-2032)
  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • France
    • U.K.
    • Italy
    • Spain
    • Benelux
    • Nordic Countries
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Oceania
    • ASEAN Countries
    • Rest of APAC
  • Latin America
    • Brazil
    • Rest of LATAM
  • Middle East & Africa
    • GCC Countries
    • South Africa
    • Israel
    • Turkey
    • Rest of MEA

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