+91 9425150513 (Asia) support@24lifesciences.com
Size, Share & Industry Analysis, By Type (Circulating Tumor DNA (ctDNA) Analysis, Circulating Tumor Cells (CTCs) Detection), By Application (Treatment Response Monitoring, Early Cancer Detection, Minimal Residual Disease Detection, Others), By End User (Hospitals and Diagnostic Laboratories, Biopharmaceutical Companies, Academic and Research Institutes), By Technology (Next-Generation Sequencing (NGS), PCR-based Technologies, Other Technologies), and Global Forecast, 2026-2034
Explore the report section by section.
The global Liquid Biopsy Diagnostic Tool Market reached USD 2.0 billion in 2025 and is estimated at USD 2.4 billion in 2026. Revenue is forecast to reach USD 10.9 billion by 2034, reflecting a 21.0% CAGR during 2026–2034.
Liquid biopsy diagnostic tools analyze biomarkers in blood or other body fluids without requiring a new tissue biopsy for each molecular assessment. Oncology applications include genomic treatment selection, molecular residual disease surveillance, therapy-response monitoring and selected cancer screening tests. Revenue covers dedicated diagnostic devices, laboratory assays, collection and processing kits, and testing services used for liquid-biopsy analysis; it excludes cancer medicines, unrelated routine blood chemistry and general-purpose equipment not sold for these workflows.
The U.S. FDA approved Guardant Shield in July 2024 for colorectal cancer screening among average-risk adults aged 45 and older. Guardant reported that Medicare assigned advanced diagnostic laboratory test status in March 2025, with an initial payment rate of USD 1,495 from April through December 2025. Regulatory authorization and reimbursement create a defined route for eligible patients, but a positive screening result still requires follow-up evaluation and the test does not replace diagnostic colonoscopy.
Circulating tumor DNA tests are also used in treatment selection and disease monitoring. NHS England began wider liquid biopsy testing for eligible lung and breast cancer patients in 2025, and an April 2026 implementation letter instructed hospitals to procure collection kits locally. Foundation Medicine and Guardant have FDA-authorized plasma companion diagnostics for specific oncology medicines, while Natera, Exact Sciences and Quest offer molecular residual disease tests with varying coverage and regulatory status.
Population-scale screening remains scientifically distinct from testing patients with diagnosed cancer. GRAIL reported in May 2026 that the NHS-Galleri randomized trial did not meet its primary combined stage III/IV endpoint, although reductions in stage IV diagnoses appeared in secondary analyses. Clinical evidence, false-positive management and downstream imaging costs therefore remain important constraints on multi-cancer screening adoption. Oncology treatment selection and MRD testing have different performance requirements and payer pathways.
Source: FDA Shield; NHS ctDNA implementation; GRAIL NHS-Galleri trial.
Included revenue comprises liquid biopsy diagnostic devices, dedicated assays and consumables, and related testing services, principally for oncology biomarker analysis and other fluid-based molecular applications.
| Report Attribute | Coverage |
|---|---|
| Base Year | 2025 |
| Estimated Year | 2026 |
| Forecast Period | 2026–2034 |
| Market Measurement | Revenue, USD million/billion |
| By Type | Circulating Tumor DNA (ctDNA) Analysis; Circulating Tumor Cells (CTCs) Detection |
| By Application | Early Cancer Detection; Treatment Response Monitoring; Minimal Residual Disease Detection; Others |
| By End User | Hospitals and Diagnostic Laboratories; Biopharmaceutical Companies; Academic and Research Institutes |
| By Technology | Next-Generation Sequencing (NGS); PCR-based Technologies; Other Technologies |
| By Region | North America; Europe; Asia-Pacific; Latin America; Middle East & Africa |
| Selected Countries | United States; Canada; United Kingdom; Germany; Japan; China; Australia; Brazil; Saudi Arabia |
| Key Market Players | Guardant Health; Natera; Foundation Medicine; Exact Sciences; GRAIL; Quest Diagnostics; Roche Diagnostics; QIAGEN; Bio-Rad Laboratories; Sysmex Corporation; Illumina; Thermo Fisher Scientific; Foresight Diagnostics; Tracer Biotechnologies; Labcorp |
ctDNA includes tumor-derived DNA fragments detected in plasma for treatment selection, recurrence assessment or screening. Circulating Tumor Cells covers intact malignant cells isolated from blood. Application revenue is assigned to the primary clinical purpose of each test, so a sample used for MRD surveillance is not also counted as early screening or treatment monitoring. Tests for patients with a known diagnosis are distinguished from asymptomatic population screening.
FDA approval applies only to specific products and indications. Guardant Shield is approved for primary colorectal screening in eligible average-risk adults, while FoundationOne Liquid CDx and Guardant360 Liquid CDx have authorized companion diagnostic uses. GRAIL Galleri and some laboratory-developed MRD assays have different regulatory status and must not be described as FDA-approved merely because they are commercially offered or used in research.
Drivers Impact Analysis*
| Market Drivers | Impact Rank | CAGR Contribution (%) | 2026–2028 | 2029–2031 | 2032–2034 |
|---|---|---|---|---|---|
| Expanded clinical coverage for ctDNA oncology testing | High | +6.60% | High | High | High |
| Molecular residual disease surveillance adoption | High | +5.70% | High | High | High |
| Targeted cancer therapies requiring plasma genotyping | Medium-High | +4.60% | High | High | Medium |
| More efficient sequencing and digital PCR workflows | Medium | +3.70% | Medium | High | High |
| Hospital and laboratory network integration | Low-Medium | +2.10% | High | Medium | Medium |
| Others (research trials, kit formats, emerging regions) | Low | +1.30% | Low | Medium | High |
Restraints Impact Analysis*
| Market Restraints | Impact Rank | CAGR Contribution (%) | 2026–2028 | 2029–2031 | 2032–2034 |
|---|---|---|---|---|---|
| Clinical utility uncertainty for broad screening | High | -1.20% | High | High | Medium |
| Variable payer coverage and test pricing | Medium-High | -0.90% | High | Medium | Medium |
| Low tumor DNA fractions and false-negative risk | Medium | -0.60% | High | High | Medium |
| Others (sample transport, follow-up costs, data analysis) | Low | -0.30% | Medium | Medium | Low |
*CAGR contribution shows the percentage points each factor adds to or removes from the 21.0% CAGR for 2026–2034; driver contributions less restraint contributions equal the market CAGR. Period columns rate the strength of each factor in that window.
The FDA approved Guardant Shield in July 2024 for average-risk colorectal cancer screening among adults aged 45 and older. Guardant subsequently received Medicare ADLT status and reported an initial USD 1,495 reimbursement rate beginning in April 2025. Foundation Medicine and Guardant also hold plasma companion diagnostic authorizations for specified targeted therapies. Clear regulatory indications allow physicians to order validated tests for defined patients, while laboratory networks and payers determine how widely testing can be implemented.
Natera announced Medicare coverage for its genome-based Signatera MRD assay in June 2025 across previously covered indications. Exact Sciences gained Medicare coverage for Oncodetect in eligible colorectal cancer patients in July, while Quest advanced Haystack MRD studies. MRD tests may be repeated during surveillance, creating recurring service revenue rather than a single diagnostic transaction. Clinical utility still varies by cancer and setting, so coverage decisions and evidence on treatment changes affect utilization. Quest Haystack research also tests whether ctDNA results can guide post-surgical care.
NHS England expanded ctDNA testing for lung and breast cancer patients in May 2025. Its April 2026 implementation letter specified testing for suspected non-small cell lung cancer and selected breast cancer genomic alterations, and asked trusts to fund collection kits locally. The letter cited annual collection-kit spending near GBP 625,000 and potential savings elsewhere in the care pathway. Integration with hospital workflows can reduce time to molecular results, but reliable phlebotomy, specimen transport and interpretation remain essential.
The FDA Shield review reported colorectal cancer sensitivity of 83% in a study of 7,861 participants, with false positives among people without advanced neoplasia. GRAIL reported that the 142,250-participant NHS-Galleri trial did not meet its combined stage III/IV primary endpoint in May 2026. Population screening must balance earlier detection against missed cancers, unnecessary investigations and downstream costs. These evidence requirements are more demanding than demonstrating that a plasma assay can detect a known mutation in a diagnosed cancer patient.
Guardant, Foundation Medicine and Roche use sequencing workflows to analyze multiple genomic alterations from plasma, while QIAGEN and Bio-Rad support digital PCR approaches for selected targets. Deep sequencing improves sensitivity for low-frequency variants but increases library preparation, computational analysis and quality-control demands. Digital PCR can offer targeted quantification with simpler workflows when the mutation is known. Laboratories must choose methods based on specimen volume, turnaround, clinical indication and reimbursement rather than maximum analytical breadth alone.
Sources: FDA; Guardant Health; Natera; Exact Sciences; NHS England; GRAIL; Roche; QIAGEN.
NHS England expanded plasma testing for suspected lung cancer and selected breast cancer patients in 2025. Its April 2026 letter listed ESR1 and PIK3CA/AKT/PTEN testing pathways under the National Genomic Test Directory. Blood sampling can be faster than obtaining sufficient tumor tissue for sequencing, allowing some patients to reach targeted therapy sooner. However, a negative plasma result may still require tissue testing when tumor DNA shedding is low or an actionable alteration is not detected.
Natera Signatera uses patient-specific tumor variants to identify residual or recurrent disease, and Exact Sciences launched Oncodetect in April 2025 for several solid tumors. Quest Haystack MRD is also being evaluated in post-surgical oncology cohorts. Serial sampling can provide molecular information between imaging visits, creating demand for repeat laboratory tests and personalized assay design. Coverage and clinical decisions must remain indication-specific because detecting residual DNA does not automatically prove that changing treatment improves outcomes. Exact Sciences reported Medicare coverage for serial Oncodetect testing in colorectal cancer.
QIAGEN announced partnerships with Tracer Biotechnologies and Foresight Diagnostics in June 2025 for digital PCR and NGS MRD applications. Bio-Rad launched additional ddPCR systems in July 2025, including QX Continuum and QX700. Targeted digital PCR may be attractive when clinicians need sensitive measurement of a defined alteration, while broad NGS panels identify many possible variants. Kit-based formats can support local laboratories, but assay transfer requires documented sensitivity and quality controls. QIAGEN plans kit-based versions of the Foresight CLARITY assay for lymphoma testing.
GRAIL presented full NHS-Galleri results in May 2026 from a randomized trial of more than 142,000 participants. The combined stage III/IV primary endpoint was not met, despite favorable stage IV trends in secondary analyses. Such findings make it important to distinguish screening sensitivity from evidence that a test improves patient outcomes. Widespread population testing may require additional follow-up and health-economic data before national payers support routine adoption. GRAIL reported a positive predictive value of 52.0% in the trial, so confirmatory workups remain relevant.
Sysmex announced Japanese approval of its OncoGuide PlasmaSeq oncology panel in June 2026 for ctDNA mutation analysis. NHS England continued implementing commissioned ctDNA pathways during 2026, and QIAGEN pursued MRD assay partnerships across international laboratories. Regional expansion depends on local device authorization, reimbursement and specimen logistics. A laboratory-developed service that operates in the United States may need additional validation or registration before it can be sold as a kit in Japan or Europe. PMDA maintains separate approved companion diagnostic listings for drug-linked uses.
Oncology liquid biopsy uses plasma-derived nucleic acids, circulating tumor cells and specialized molecular assays. Clinical applications differ substantially between screening asymptomatic people, selecting treatment in known cancer and monitoring recurrence after surgery.
| Method | Example | Primary Clinical Use | Important Limitation |
|---|---|---|---|
| Broad NGS plasma profiling | Guardant360 Liquid CDx; FoundationOne Liquid CDx | Targeted therapy selection | Low shedding can yield false negatives |
| Tumor-informed ctDNA MRD | Signatera; Oncodetect; Haystack | Post-treatment surveillance | Evidence and coverage vary by indication |
| Blood cancer screening | Guardant Shield; Galleri | CRC or multi-cancer screening | Different approval and outcome evidence |
| Digital PCR | QIAGEN QIAcuity; Bio-Rad QX700 | Targeted mutation or MRD quantification | Requires a known target or selected assay |
Broad plasma NGS tests analyze many genomic alterations from a single blood draw. FoundationOne Liquid CDx received an FDA companion diagnostic indication in June 2026 for HRR-mutated prostate cancer, while Guardant360 Liquid CDx supports several therapy-linked indications. These tests are most useful when a clinician needs to identify a mutation that can change treatment, but negative results may not exclude a mutation in tumor tissue.
MRD assays are designed to detect very small quantities of tumor-associated DNA after surgery or systemic treatment. Natera Signatera, Exact Sciences Oncodetect and Quest Haystack use different designs and validation strategies. Repeated tests may identify molecular recurrence before imaging, but treatment decisions and reimbursement depend on the disease and clinical setting. Some marketed MRD tests are laboratory-developed services rather than FDA-approved devices.
Screening tests address patients without a prior cancer diagnosis and must demonstrate acceptable false-positive rates, sensitivity and clinical utility. Guardant Shield is FDA-approved for average-risk colorectal screening, whereas GRAIL Galleri was evaluated in the NHS-Galleri randomized trial and had not achieved its primary combined late-stage endpoint by May 2026. Both tests require appropriate clinical follow-up rather than replacing standard diagnostic pathways. The FDA Shield label specifically excludes surveillance colonoscopy for high-risk patients.
Two specimen-derived biomarker categories define the type split: ctDNA fragments and intact circulating tumor cells. The approaches require different isolation methods, analytical instruments and downstream interpretation. Guardant and Foundation Medicine plasma panels use DNA fragments, whereas intact-cell analysis depends on capturing scarce malignant cells from blood and preserving measurable cell features. Plasma DNA testing dominates routine genomic treatment selection and many MRD programs.
Circulating Tumor DNA represented an estimated ~78% of 2025 revenue. Guardant360, FoundationOne Liquid CDx and Natera Signatera analyze plasma-derived tumor DNA for different oncology decisions. NGS and digital PCR can detect mutations or residual disease without repeated tissue sampling. Clinical utility depends on assay sensitivity, tumor shedding and the intended use.
Circulating Tumor Cells are intact cancer cells isolated from blood, allowing cell counts or phenotypic analysis. The workflow differs from ctDNA because viable or fixed cells must be captured before molecular assessment. CTC testing can support research into metastasis and treatment response, but routine use is more limited than plasma genomic profiling.
The two types serve different clinical and research questions and are counted by the primary biomarker measured in each test. ctDNA is expected to remain the largest category as molecular profiling and MRD surveillance expand. Guardant and Foundation Medicine also offer therapy-linked plasma tests for advanced cancers.
Clinical application determines the patient population, test frequency and evidentiary standard. Monitoring known cancer, screening asymptomatic people and detecting residual disease after treatment should not be combined in one transaction or treated as interchangeable indications.
Treatment Response Monitoring represented an estimated ~36% of 2025 revenue. Plasma assays can identify emerging resistance mutations or evaluate response during systemic therapy. Guardant and Foundation Medicine offer genomic profiling relevant to treatment selection, while NHS England uses ctDNA testing in selected lung and breast cancer pathways. Natera Signatera repeat sampling can provide molecular data between imaging appointments for eligible patients.
Guardant Shield received FDA approval in July 2024 for average-risk colorectal screening, while GRAIL Galleri has been studied for multi-cancer detection. Screening requires follow-up diagnostic pathways and evidence that benefits outweigh false positives and missed cases. The NHS-Galleri primary endpoint was not met in 2026, limiting claims about proven population benefit.
Natera Signatera, Exact Sciences Oncodetect and Quest Haystack use ctDNA to investigate residual or recurrent cancer after treatment. Medicare coverage expanded for selected MRD indications during 2025. Repeat testing can generate longitudinal revenue, but evidence and reimbursement remain cancer-specific.
Other oncology liquid biopsy applications include clinical trial stratification, research on metastatic biology and exploration of drug resistance mechanisms. Pharmaceutical sponsors may purchase plasma assays to evaluate candidate biomarkers, but research-use results should not be presented as approved clinical treatment-selection tests.
FDA and Medicare policies specify distinct intended uses and patient groups for oncology blood tests. A test validated for targeted therapy selection cannot automatically be assumed suitable for early cancer screening or MRD surveillance without additional evidence.
The end-user model separates clinical testing sites, biopharmaceutical sponsors and research institutes by the organization purchasing the liquid biopsy test or service. Clinical laboratories account for the largest share because patient testing is repeated across diagnosis and follow-up.
Hospitals and Diagnostic Laboratories form the leading end-user group. NHS England commissioned ctDNA testing for selected cancers and required local blood collection kit procurement in April 2026. U.S. laboratories process FDA-authorized companion assays and covered MRD tests. Clinical demand depends on physicians ordering tests, specimen logistics and reimbursement.
Biopharmaceutical sponsors use plasma genomic profiling to select trial participants, measure response and investigate resistance. QIAGEN partnered with Tracer and Foresight on MRD tools intended to support pharmaceutical development. Sponsor contracts may include longitudinal samples and assay validation alongside research testing.
Research institutes study ctDNA biology, circulating tumor cells and multi-cancer screening performance. The NHS-Galleri randomized trial demonstrates the large cohorts needed to assess screening utility. Academic laboratories may also compare plasma results with tissue and imaging to identify situations where blood testing misses disease.
Clinical testing is expected to account for most incremental revenue because approved and reimbursed uses create repeat orders. Research and biopharma programs remain important sources of evidence and new assay development.
Sequencing, PCR and specialized cell-based or epigenetic technologies differ in mutation breadth, analytical sensitivity and cost. NGS dominates broad plasma profiling, while targeted PCR can be effective for known variants and decentralized monitoring.
NGS is the largest technology category in the 2025 model. Guardant360 Liquid CDx and FoundationOne Liquid CDx analyze many genes in plasma, while Natera and Exact Sciences use sequencing for tumor-informed MRD. Broader panels can identify actionable variants, but deep sequencing and bioinformatics add cost.
Digital PCR detects selected mutations or small DNA quantities with high analytical sensitivity. QIAGEN QIAcuity and Bio-Rad QX platforms support molecular oncology research and MRD assay development. PCR is attractive when the target is already known, although it does not replace broad genomic discovery panels.
Other technologies include circulating tumor cell capture, methylation-based multi-cancer assays and specialized molecular readouts. GRAIL Galleri analyzes methylation patterns for screening research, while CTC platforms isolate intact cells for analysis. Clinical claims depend on the specific assay and regulatory indication rather than the technology label alone. Roche AVENIO research kits analyze ctDNA with a defined extraction, library-preparation and sequencing workflow, and their research-use status differs from FDA-authorized companion diagnostic tests.
Laboratories often combine technologies: NGS identifies candidate variants, PCR can quantify selected targets, and tissue testing remains important when plasma results are negative. Medicare coverage and laboratory turnaround requirements influence whether hospitals use NGS or targeted PCR.
North America leads revenue through FDA-authorized tests, clinical laboratories and payer coverage. Europe is expanding commissioned ctDNA pathways, while Asia-Pacific includes regulated plasma profiling and growing oncology research capacity.
North America represented an estimated ~45% of 2025 global revenue. The United States hosts Guardant, Natera, Foundation Medicine, Exact Sciences, GRAIL and Quest, along with major academic cancer centers and molecular laboratories. FDA approval of Guardant Shield for colorectal screening in July 2024 established a regulated blood-based screening indication, and Medicare granted the test ADLT status in March 2025. Natera and Exact Sciences obtained additional Medicare coverage for selected MRD testing during 2025. Guardant reported second-quarter 2026 oncology revenue of USD 219.1 million and around 104,000 oncology tests, reflecting rising test volume, although its reported oncology segment includes services beyond liquid biopsy. Canada contributes oncology genomics and clinical trials, but local reimbursement determines access. Broad testing availability also depends on physicians distinguishing companion diagnostics, MRD surveillance and screening.
The FDA approved Guardant Shield in July 2024 for average-risk colorectal screening in adults aged 45 and older. Guardant received Medicare ADLT status in March 2025, with an initial USD 1,495 payment rate. Natera announced Signatera Genome Medicare coverage in June 2025, and Exact Sciences received Oncodetect coverage for eligible colorectal cancer patients in July. These decisions expand reimbursement for different oncology liquid biopsy indications, although each test has its own patient eligibility and clinical evidence.
Source: FDA.
Europe has expanding clinical demand for liquid biopsy in targeted cancer treatment, alongside regulatory and reimbursement differences between countries. NHS England expanded plasma testing for selected lung and breast cancer patients in May 2025. An April 2026 implementation letter specified ctDNA testing under the National Genomic Test Directory and required individual trusts to fund blood collection kits locally. The letter cited around GBP 625,000 in national annual collection-kit costs and potential savings in other parts of the diagnostic pathway. Germany and France host molecular oncology laboratories, while EU IVDR rules shape the authorization of diagnostic devices. Population screening remains less established than treatment-selection testing, and the NHS-Galleri randomized trial did not meet its combined stage III/IV primary endpoint in 2026. Laboratory implementation depends on transport, sequencing capacity and payer decisions.
NHS England stated in April 2026 that ctDNA testing was commissioned for suspected non-small cell lung cancer and selected breast cancer genomic alterations, including ESR1 and PIK3CA/AKT/PTEN. Hospitals were asked to procure blood collection kits locally, with annual national kit spending near GBP 625,000. The policy supports ongoing plasma testing within clinical pathways and may reduce delays to targeted treatment. NHS England has not established routine population-wide multi-cancer screening through this ctDNA commissioning letter.
Source: NHS England.
Asia-Pacific includes large oncology populations and a growing network of genomic testing laboratories, but clinical adoption differs by country. Japan-based Sysmex announced manufacturing and marketing approval for its OncoGuide PlasmaSeq oncology panel in June 2026, expanding regulated ctDNA mutation testing. PMDA maintains lists of companion diagnostics and drug-agnostic uses, helping laboratories identify which assays support specific treatments. China and South Korea have substantial oncology research activity, while Australia is investing in genomics translation and clinical trials. PacBio and other sequencing vendors supply regional laboratories with analytical platforms, but imported equipment costs and local reimbursement affect uptake. International sponsors also use plasma testing in multicountry trials to investigate treatment response and residual disease. The region is expected to gain demand as more hospitals establish validated molecular oncology workflows. The availability of specialist pathology services and local sample transport networks will influence the pace of adoption.
Sysmex reported on 11 June 2026 that its OncoGuide PlasmaSeq oncology panel had received Japanese manufacturing and marketing approval on 3 June. The test analyzes circulating tumor DNA and adds BRAF V600E detection to a molecular profiling workflow for colorectal cancer. Japan PMDA also publishes approved companion diagnostic lists, including 2026 updates. Clinical laboratories must use the approved test within its intended indication and applicable reimbursement conditions.
Source: Sysmex.
Latin America has rising cancer diagnostic demand but uneven access to advanced molecular testing. Brazil has large oncology treatment centers and a developing precision-health research base, while private laboratories offer molecular tests to selected patients. The Brazilian Genomas Brasil program supports genomic research and the longer-term integration of precision medicine, but it does not establish universal reimbursement for ctDNA screening. International testing services must also address sample export rules and data protection when serving Brazilian patients. International suppliers may serve patients through centralized testing or partner laboratories, with sample transport and foreign-currency pricing affecting access. Mexico and other countries face similar barriers where molecular oncology services are concentrated in major cities. Research partnerships can introduce new assays before routine public payment is available. Regional uptake is likely to be stronger for treatment selection in known cancer than for broad multi-cancer screening without proven clinical outcome benefit.
The Brazilian Ministry of Health established Genomas Brasil to support genomic research, scientific training and precision-health development. These capabilities can strengthen oncology biomarker studies and laboratory infrastructure. Liquid biopsy adoption still depends on validated assays, specialist interpretation and reimbursement arrangements, especially in the public SUS system. Private hospitals may adopt selected tests earlier, while population screening requires stronger clinical and economic evidence.
Source: Brazil Ministry of Health.
Middle East & Africa has a smaller liquid biopsy revenue base, with sophisticated molecular oncology concentrated in Gulf hospitals and selected reference laboratories. King Faisal Specialist Hospital in Saudi Arabia reported performing liquid biopsies to analyze about 50 cancer-related genes and more than 3,000 mutations in 2023. Saudi institutions subsequently expanded precision oncology research and genomics collaboration in 2025–2026. These programs support demand for plasma collection, targeted sequencing and bioinformatics, but regulatory approval and clinical validation remain necessary for routine treatment selection. Across many African countries, limited laboratory infrastructure, specialist staffing and payer coverage restrict access to high-complexity ctDNA testing. Partnerships with international reference laboratories can help, although sample shipping, turnaround and affordability remain challenges. The region is expected to grow from a small base as specialist cancer centers expand molecular diagnostics.
King Faisal Specialist Hospital reported in October 2023 that its liquid biopsy program could assess about 50 genes associated with cancer and more than 3,000 mutations from blood samples. Saudi Arabia also hosted the Precision Oncology Saudi Summit in February 2025, promoting molecular testing and targeted treatment. These developments show clinical and research capacity at specialized centers, while routine availability across the wider region depends on qualified laboratories and funding.
Source: Saudi Press Agency.
The competitive landscape spans clinical testing laboratories, sequencing platforms, assay developers and screening specialists. Guardant, Natera, Foundation Medicine and Exact Sciences focus on different oncology decisions, while QIAGEN, Roche and Bio-Rad supply enabling technologies.
Guardant360 Liquid CDx and FoundationOne Liquid CDx have FDA companion diagnostic uses for specified targeted therapies. Their commercial strength rests on analytical validation, clinical interpretation, laboratory scale and drug-linked indications, not on a claim that every reported variant is treatment actionable.
Natera Signatera, Exact Sciences Oncodetect and Quest Haystack address residual disease after cancer treatment. Medicare coverage expanded for selected indications in 2025, supporting repeated testing while clinical utility and reimbursement remain disease-specific.
Guardant Shield is FDA-approved for average-risk colorectal screening. GRAIL Galleri has been evaluated in a large NHS randomized trial but did not meet the combined late-stage primary endpoint in 2026. The two screening products have different regulatory status and clinical evidence.
QIAGEN partnered on digital PCR and NGS MRD assays, Roche supplies AVENIO research-use ctDNA kits, Bio-Rad expanded ddPCR hardware and Sysmex received Japanese approval for OncoGuide PlasmaSeq. Platform suppliers compete on sensitivity, workflow simplicity and consumable availability.
Guardant reported second-quarter 2026 revenue growth of 44%, including USD 219.1 million of oncology revenue and 104,000 oncology tests. Those figures indicate expanding commercial testing volumes but include broader oncology activities, so they are not a direct market-share calculation. Natera and Exact Sciences have different business models focused on personalized residual disease testing and covered clinical indications.
Guardant Shield screening, Natera MRD surveillance and FoundationOne Liquid CDx treatment selection address distinct clinical questions. A plasma companion diagnostic helps select targeted treatment, an MRD test assesses possible residual or recurrent disease, and a screening test is used before a cancer diagnosis. FDA authorizations, Medicare decisions and clinical studies differ across these uses, preventing vendors from treating every test as interchangeable or claiming that screening evidence establishes treatment benefit.
QIAGEN partnerships with Tracer and Foresight are extending assay development toward decentralized testing. QIAGEN announced collaborations with Tracer and Foresight for MRD assays in June 2025, while NHS England shifted collection-kit procurement to local trusts in 2026. Decentralized workflows can shorten transport and improve access, but they require reproducible analytical performance, specimen quality and compatible interpretation systems. Companies with validated platforms and payer relationships may be better positioned to scale repeat testing.
June 2026: Sysmex announced Japanese approval of OncoGuide PlasmaSeq for ctDNA-based cancer mutation analysis. The panel includes BRAF V600E detection and is positioned for colorectal cancer molecular profiling, expanding the set of regulated plasma assays available in Japan. Sysmex announced the manufacturing and marketing authorization on 11 June 2026. Source
May 2026: GRAIL presented the NHS-Galleri randomized trial results from 142,250 participants. The combined stage III/IV primary endpoint was not met, although stage IV reductions appeared in secondary analyses, with population screening policy still dependent on further clinical outcome evidence. GRAIL reported that participants underwent three annual screening rounds. Source
April 2026: NHS England instructed trusts to procure and fund ctDNA blood collection kits locally for commissioned lung and breast cancer pathways. Its letter estimated national annual collection-kit costs near GBP 625,000 and described potential diagnostic-pathway savings from earlier targeted treatment. The commissioned indications include suspected lung cancer and selected breast cancer variants. Source
July 2025: Exact Sciences announced Medicare coverage for Oncodetect molecular residual disease testing in eligible colorectal cancer patients. Coverage includes serial use in stage II, III and resectable stage IV disease, supporting clinical adoption of tumor-informed recurrence monitoring. The company launched the test in April 2025 for multiple solid tumors. Source
June 2025: Natera announced Medicare coverage for Signatera Genome across previously covered indications, including colorectal, breast, bladder, ovarian and lung cancer. The tumor-informed assay detects circulating tumor DNA for molecular residual disease monitoring and supports repeated clinical testing. Natera described coverage across colorectal, breast, bladder, ovarian and lung cancer uses. Source
March 2025: Guardant received CMS ADLT status for Shield colorectal cancer screening, with an initial Medicare reimbursement amount of USD 1,495 beginning April 2025. Shield had received FDA approval in July 2024 for average-risk adults aged 45 and older. The screening test is not a substitute for diagnostic colonoscopy. Source
Liquid biopsy oncology revenue is forecast to rise from USD 2.4 billion in 2026 to USD 10.9 billion in 2034, representing a 21.0% CAGR. Wider clinical indications and repeat monitoring are expected to drive the increase.
| Growth Variable | Recent Evidence | Potential Revenue Effect |
|---|---|---|
| Clinical coverage | Natera and Exact Sciences MRD Medicare decisions | Higher serial-testing utilization |
| Treatment selection | Guardant360 and FoundationOne Liquid CDx indications | More plasma genomic profiling |
| Hospital rollout | NHS England ctDNA commissioning in 2026 | Broader routine laboratory demand |
| Screening evidence | NHS-Galleri primary endpoint not met | Slower population screening adoption |
| Regional access | Sysmex Japanese plasma panel approval | Additional regulated markets |
Clinical use in patients with diagnosed cancer should remain a major revenue driver because plasma profiling can guide targeted therapy and MRD tests can be repeated during follow-up. Natera, Exact Sciences and Quest are building evidence for longitudinal testing, while Guardant and Foundation Medicine continue to expand therapy-linked plasma indications. Utilization will depend on the clinical question and payer policy rather than test availability alone.
Population screening offers a large theoretical addressable population but faces a higher evidence threshold. Guardant Shield is approved for average-risk colorectal screening, while the NHS-Galleri trial did not meet its combined stage III/IV primary endpoint in 2026. Broad multi-cancer adoption will depend on stronger evidence about health outcomes, follow-up pathways and false-positive consequences. Screening growth should therefore not be equated with the pace of reimbursed MRD testing.
Workflow innovation is expected to reduce turnaround and widen geographic access. NHS England has commissioned selected ctDNA tests and shifted collection-kit procurement to individual trusts, while QIAGEN and Bio-Rad are developing decentralized digital PCR options. Regional laboratories still need validated pre-analytical handling and robust quality controls, especially when tumor DNA levels are low or specimens travel long distances.
Asia-Pacific is positioned to expand as Japan and other markets approve new assays, and specialized Gulf centers are investing in molecular oncology. Latin America and much of Africa face more severe reimbursement and infrastructure constraints, which may favor reference-laboratory models. Across all regions, regulators and clinicians will distinguish tests that guide therapy from assays intended for screening or investigational surveillance, shaping the achievable revenue mix through 2034.
Coverage includes oncology liquid biopsy tests, clinical assay services, dedicated consumables, indications and payer pathways.
The market generated USD 2.0 billion in 2025 and is estimated at USD 2.4 billion in 2026. Revenue includes dedicated diagnostic tools, liquid-biopsy assay kits and associated laboratory testing services, but excludes the price of cancer medicines and unrelated routine blood testing.
The market is forecast to expand at a 21.0% CAGR from 2026 through 2034, reaching USD 10.9 billion. More targeted therapy selection, repeat molecular residual disease testing and wider hospital implementation support demand, while screening evidence remains a constraint.
Circulating Tumor DNA represented an estimated ~78% of 2025 revenue. Plasma DNA testing is used in Guardant360, FoundationOne Liquid CDx and multiple MRD assays, while circulating tumor cell tests address a different set of cellular research and clinical questions.
Treatment Response Monitoring represented an estimated ~36% of 2025 revenue. Clinicians use blood-based genomic information to evaluate response, progression and resistance during therapy. MRD surveillance and early cancer detection are separate applications with different validation and payer requirements.
North America represented an estimated ~45% of 2025 global revenue. The United States combines FDA-authorized plasma tests, specialized oncology laboratories and Medicare coverage for selected screening and MRD indications. Europe and Asia-Pacific are expanding regulated clinical pathways.
Guardant360 Liquid CDx and tumor tissue sequencing can differ in sensitivity when plasma contains little tumor DNA. Blood tests can identify tumor mutations without a new tissue sample, but low DNA shedding may cause false negatives. FDA-authorized plasma companion tests do not necessarily replace tissue testing when a clinically important mutation is absent from blood.
Yes. The FDA approved Guardant Shield in July 2024 for average-risk adults aged 45 and older who need colorectal screening. It does not replace diagnostic colonoscopy or surveillance colonoscopy in high-risk patients, and positive results require follow-up evaluation.
No. GRAIL reported in May 2026 that the randomized NHS-Galleri trial did not achieve a statistically significant reduction in its combined stage III/IV primary endpoint. Secondary analyses showed reductions in stage IV diagnoses, but those findings do not establish the primary trial objective.
Medicare covers selected MRD indications, not every cancer or assay. Natera announced Signatera Genome coverage in June 2025, and Exact Sciences received Oncodetect coverage for eligible colorectal cancer patients in July. Medicare coverage policies specify clinical stage, cancer indication and testing circumstances for each assay.
Companies include Guardant Health, Natera, Foundation Medicine, Exact Sciences, GRAIL, Quest Diagnostics, Roche, QIAGEN and Sysmex. Their offerings differ across companion diagnostics, MRD surveillance, screening and research kits, so product authorizations should be assessed individually.
ctDNA consists of tumor-derived DNA fragments circulating in blood, while circulating tumor cells are intact malignant cells. DNA fragments are commonly analyzed using NGS or PCR, whereas cell-based tests require capture and analysis of individual cells. Guardant plasma ctDNA assays and CTC cell-capture tests answer different clinical and research questions.
Clinical use should expand as plasma profiling and MRD tests gain evidence, reimbursement and laboratory capacity. Japan approved an additional ctDNA panel in 2026, while NHS England commissioned selected pathways. Broad screening will depend on stronger clinical outcome data and careful false-positive management.
Display logos only where use is approved. A logo does not imply a public endorsement.
The data provided by 24LifeScience was clear, well-organized, and useful for internal strategy planning. It helped us understand the competitive landscape more effectively.
We used one of their market overview reports for early-stage feasibility work. It gave us a helpful snapshot of current trends and key players in our therapeutic area.
I appreciated the team’s responsiveness and willingness to adjust the scope based on our feedback. The final report was aligned with our expectations and timelines.
Their custom report on clinical trial trends was a helpful reference as we explored new indications.
As someone working on early product planning, I found their therapeutic-area briefs useful and easy to apply in our internal discussions.
We needed dependable data and a clearly presented market structure. The research gave us a practical starting point for our assessment.
Publish named testimonials only when the individual and organization have approved disclosure.
Review the report scope, forecast timeframe, methodology, and cited evidence before deciding whether the full study fits your requirement.
Coverage, segmentation, geography, and market boundaries are stated within the report.
Readers can review the published sources and evidence referenced in this market overview.
Base, estimated, and forecast years are shown to place the market outlook in context.
Each overview displays its report identifier and latest update date.
A structured view of market size, forecast outlook, segmentation, regional dynamics, competitive activity, and the research framework behind this study.
Review the market estimate, growth outlook, forecast direction, and key factors influencing future demand.
Understand the report’s defined segments, demand drivers, applications, end users, and market opportunities.
Assess regional performance, selected country context, and factors shaping adoption across major markets.
Explore company profiles, market positioning, and selected developments relevant to the market landscape.
Review key demand drivers, challenges, emerging opportunities, technology shifts, and factors influencing market direction.
Understand the report scope, market boundaries, research approach, and evidence referenced in the published market overview.
