Liquid Biopsy Market

How big is the Liquid Biopsy Market in 2026?

The Liquid Biopsy Market is projected to reach USD 29.2 billion by 2036, expanding at a 14.8% CAGR from 2026 to 2036. FMI estimates the market at USD 7.3 billion in 2026. The market was valued at USD 6.4 billion in 2025. The market is expanding faster than the wider diagnostics category, because blood tests now enter several points of the cancer pathway at once.

Treatment selection is the established use. NHS England now offers circulating tumor DNA testing to all eligible lung and breast cancer patients. In the United States, SEER data show that a substantial share of lung cancers are diagnosed at a distant stage, when genotyping determines first-line therapy, when genotyping decides first-line therapy. Large diagnostics groups are now buying into monitoring and screening. Abbott completed its acquisition of Exact Sciences in March 2026, which added a residual disease test and a multi-cancer blood test.

Screening evidence is the main limitation. The NHS-Galleri trial missed its primary endpoint on stage III and IV cancers, according to its ASCO 2026 abstract. Demand therefore depends on payer coverage, which follows guideline listings and drug labels more closely than performance claims.

Key Market Trends & Insights

• Laboratory platform demand is rising as hospital and reference laboratories expand in-house testing. QIAGEN reported growth in sample technologies and QIAcuity digital PCR in its June 2026 quarter. Bio-Rad's digital PCR instrument revenue grew more than 20.0% in the same quarter. Platform suppliers therefore gain from test growth regardless of which test brand secures the clinical claim.
• Drug labels are beginning to require serial blood testing, which multiplies tests per patient. FDA approved Guardant360 CDx as the companion test for camizestrant, with retesting every three months to detect ESR1 mutations before scans show progression [7]. The company estimates that about 37,000 US women could benefit. This use connects to the ESR1 mutated metastatic breast cancer diagnostics market.
• Residual disease testing has entered treatment selection, which ties a formerly prognostic test to an approved therapy decision. FDA approved Natera's Signatera CDx in May 2026 to guide adjuvant atezolizumab in muscle-invasive bladder cancer. The company describes it as the first companion diagnostic approval for blood-based residual disease testing. Japan's PMDA approved the same use in September 2026.

Regional Highlights

• In North America, legislation is widening access to blood-based screening. The Medicare Multi-Cancer Early Detection Screening Coverage Act became law on 3 February 2026 and covers FDA-approved tests from 2028. Coverage therefore follows regulatory approval directly, which raises the commercial value of an FDA label for screening developers.
• In East Asia, regulators are opening faster routes for residual disease kits that hospital laboratories can run locally. Two whole-exome residual disease kits from Burning Rock entered China's NMPA special review procedure in August and September 2026. Kit formats shift revenue toward reagent supply and away from central laboratory services, which suits public hospital procurement.

Liquid Biopsy Market Size and Forecast

Table 1: Liquid Biopsy Market Size and Forecast

Market size and forecast	Value
Market size in 2025	USD 6.4 billion
Estimated market size in 2026	USD 7.3 billion
Projected market size by 2036	USD 29.2 billion
CAGR from 2026 to 2036	14.8%

Source: Future Market Insights analysis of the liquid biopsy market, 2026.

Analyst Perspective

“Oncologists order a blood test when it returns an actionable result before the first treatment decision. Payers fund it when a guideline or drug label names it. Supplier competitive advantage rests on regulatory claims, turnaround time and the share of samples that give a usable result. Low tumor DNA shedding is the main qualification risk. A negative blood result often still sends the patient back for a tissue biopsy.”

- Anurag Sharma, Principal Consultant, FMI

How is the Liquid Biopsy Market segmented?

• By biomarker type: Circulating Tumor Cells (CTCs), Circulating Tumor Nucleic Acids (ctDNA and ctRNA), and Exosomes.
• By sample type: Blood, Urine, and Others.
• By end user: Hospitals, Cancer Institutes, Academic Institutes, and Diagnostic Centers.
• By application: Cancer Diagnosis, Treatment Monitoring, and Recurrence Monitoring. Tissue and blood tests used together for diagnosis also fall within the next generation cancer diagnostics market that FMI tracks separately.
• By cancer type: Lung Cancer, Breast Cancer, Colorectal Cancer, and Others.
• By region: North America, Latin America, Western Europe, Eastern Europe, East Asia, South Asia and Pacific, and Middle East and Africa.

Why do Circulating Tumor Cells lead by Biomarker Type in the Liquid Biopsy Market in 2026?

Circulating Tumor Cells hold 70.0% of the Liquid Biopsy Market by biomarker type in 2026.

The lead reflects the analytical breadth of a captured cell. Intact tumor cells give laboratories material for counting, protein staining and molecular work from one blood draw. Clinical validation supports this use. The PREDICT pooled analysis of patients with metastatic breast cancer found a substantial survival difference between patients with no detectable tumor cells and those positive at both time points. Patients positive at both points had median survival of 17.3 months.

Commercial products are built on that prognostic value. Menarini Silicon Biosystems markets CELLSEARCH as an FDA-cleared test whose cell counts predict overall and progression-free survival in metastatic breast, prostate and colorectal cancer. The PREDICT authors still called for randomized trials to show that acting on counts improves outcomes. Cell-based tests therefore sell mainly into prognosis, research and drug trials.

Circulating Tumor Nucleic Acids and Exosomes together hold the remaining 30.0%. Nucleic acid tests attract most new regulatory approvals. Plasma-based entries on the FDA companion diagnostics list now span EGFR, KRAS G12C, HER2, MET, ALK and ROS1 targets.

Table 2: Biomarker Type, 2026 Share

Leading Share	2026 market share
Circulating Tumor Cells	70.0%
All Other Segments Combined Share	30.0%

Source: Future Market Insights analysis of the liquid biopsy market, 2026.

Why does Blood lead by Sample Type in the Liquid Biopsy Market in 2026?

By sample type, Blood holds 87.4% of the Liquid Biopsy Market in 2026.

Blood leads because a draw fits into a routine visit and needs no procedure room. That matters most in advanced lung cancer, where many patients cannot safely undergo a second biopsy. National programme data quantify the clinical benefit. The Department of Health and Social Care reports that blood-based lung results arrive 7 to 14 days earlier than tissue genotyping. NHS England reports that pilot patients started targeted therapy about two weeks earlier than with the standard tissue route.

Faster results convert into test orders, because oncologists choose the test that returns before the first treatment decision. Simple collection also makes blood the default sample for screening programmes, where completion rates decide programme cost per detected cancer.

Urine and Others together account for the remaining 12.6%. Urine suits bladder and other urinary tract cancers, where tumor material passes directly into the sample. The Others group includes saliva and cerebrospinal fluid, which serve narrower clinical questions.

Table 3: Sample Type, 2026 Share

Leading Share	2026 market share
Blood	87.4%
All Other Segments Combined Share	12.6%

Source: Future Market Insights analysis of the liquid biopsy market, 2026.

Why does Lung Cancer lead by Cancer Type in the Liquid Biopsy Market in 2026?

Lung Cancer holds 39.5% of the Liquid Biopsy Market by cancer type in FMI's 2026 assessment.

The lead rests on a large advanced-stage population that requires genotyping before first-line therapy. SEER data show that 51.0% of US lung cancers are diagnosed at a distant stage. Lung cancer remains a leading cause of US cancer deaths, with SEER projecting it to account for a substantial share of cancer mortality in 2026  . Many of these patients lack enough tissue for full profiling, which makes blood the practical sample.

Drug approvals reinforce that position. Non-small cell lung cancer accounts for most plasma-based entries on the FDA list of authorized companion diagnostics. Each approved targeted therapy therefore creates a funded reason to test. England also chose lung cancer as the first tumor type for its national blood-first service.

Breast Cancer, Colorectal Cancer and Others together represent the remaining 60.5%. Breast and colorectal cancer are the next demand pools, through serial monitoring and blood-based screening respectively.

Table 4: Cancer Type, 2026 Share

Leading Share	2026 market share
Lung Cancer	39.5%
All Other Segments Combined Share	60.5%

Source: Future Market Insights analysis of the liquid biopsy market, 2026.

What are the key drivers restraints and opportunities?

Liquid biopsy revenue depends on how many clinical decisions a blood result can support and on whether payers fund those decisions. Evidence requirements differ sharply between treatment selection, residual disease monitoring and screening.

Driver

Payer acceptance is widening funded screening volume. Guardant reported about 66,000 Shield screening tests between April and June 2026, against 16,000 a year earlier. UnitedHealth Group became the first major commercial insurer to cover Shield during that period. Coverage converts a cash-pay test into a reimbursed screening option, which allows primary care physicians to order it without passing the full price to patients.

Restraint

Tumor biology limits what a blood sample can show. Foundation Medicine notes that some tumors do not shed enough DNA into the blood for actionable alterations to be detected. Its liquid test label states that patients who test negative should be reflexed to tissue testing where feasible. Payers then fund two tests for part of the population, which weakens the cost case for blood-first pathways.

Opportunity

Residual disease testing offers a revenue pool tied directly to treatment decisions. For its approved bladder cancer claim, Natera cites about 30,000 new muscle-invasive bladder cancer diagnoses a year in the United States. Similar claims in other tumor types would make residual disease testing a required step before therapy. Developers that run trials with drug makers will reach this demand first, and the work overlaps with the companion diagnostics market.

How do approval and coverage rules affect liquid biopsy purchasing?

Regulatory status determines which tests payers fund and which claims suppliers can make. The Medicare MCED law starts coverage in 2028, limits use to one test a year and pays at parity with multi-target stool DNA tests through 2030. From 2031, CMS may reduce rates through the clinical laboratory payment system. Developers therefore have a fixed window to build volume at a known price.

Approval for multi-cancer screening is still pending. GRAIL submitted its Galleri premarket approval application on 29 January 2026. An FDA advisory committee voted 7 to 2 on 23 September 2026 that benefits outweigh risks and 6 to 4 on effectiveness. The FDA is not bound by that vote, so health systems planning population programmes should wait for the final label and its eligible age group. The same evidence test applies across the NGS solution for early cancer screening market.

What limits reliable liquid biopsy capacity and result quality?

Positive predictive value and follow-up capacity limit screening use. In NHS-Galleri, the test showed 99.6% specificity and a positive predictive value of 52.0%. Roughly half of positive results therefore led to diagnostic workups that found no cancer. Health systems must fund imaging and specialist review for each positive result, which raises programme cost per detected cancer.

Laboratory throughput is a second constraint, because most clinical-grade tests run in a small number of central laboratories. Central processing gives consistent quality but adds shipping time for samples drawn far from those sites. Platform makers are raising throughput to ease that limit. Thermo Fisher launched the Ion 560 Chip, which nearly doubles sequencing capacity on its Ion GeneStudio S5 system.

Where can test developers win additional business?

Test developers can expand through national programmes, serial monitoring and hospital kit supply. National programmes offer the clearest volume commitment. England's cancer plan commits the Genomic Medicine Service to extend ctDNA testing to other cancers by 2030, subject to efficacy and value for money. Serial monitoring multiplies tests per patient, since a quarterly retesting schedule equals about four tests a year. Hospital in-sourcing creates recurring kit and reagent demand, which favours developers that can package assays for local platforms.

Liquid Biopsy Market by Country (2026 to 2036)

Table 5: Liquid Biopsy Market Country Growth Forecast

Country	CAGR, 2026 to 2036
China	20.0%
India	18.5%
Germany	17.0%
United States	14.1%
United Kingdom	12.6%

Source: Future Market Insights analysis of the liquid biopsy market, 2026.

China

China's lung cancer burden sets the scale of demand for blood-based genotyping. A 2025 review of national data reported 4.82 million new cancer cases in China in 2022. Lung cancer made up 22.0% of those cases and 28.5% of cancer deaths. It remained the leading cause of cancer death among both men and women. Public hospitals treat most of these patients and are building their own sequencing capacity.

Hospital testing is replacing outsourced testing. Burning Rock had supported 94 hospitals in setting up in-house NGS platforms by mid-2026. Its in-hospital revenue grew in the second quarter even as total revenue declined, reflecting the shift toward hospital-based testing [12]. Regulators are also opening faster routes for new kits. Two of the company's whole-exome residual disease kits entered the NMPA special review procedure in August and September 2026. The newest kit runs on MGI's domestic high-throughput sequencer.

Hospital kit adoption and faster approvals support a 20.0% CAGR for China across 2026 to 2036, the highest in the profiled group. Price controls could slow revenue more than volume. Roche reported a continuing negative impact from healthcare pricing reforms in China in its first-half 2026 results. Volume-based tenders can cut the price per kit even as test numbers grow, so suppliers that reduce sequencing cost per sample will protect margins. Each approved kit also adds recurring reagent demand inside the hospital that installs it.

India

Recorded cancer incidence in India is rising, partly because diagnosis is improving. The Ministry of Health and Family Welfare reported to the Lok Sabha that estimated cancer cases rose from 1.39 million in 2020 to 1.53 million in 2024, with ICMR attributing part of the increase to wider diagnostic access [25]. Age-adjusted male incidence varies widely across registry districts . The North-East combines the highest incidence with weaker treatment facilities.

Cancer care is being decentralised into district hospitals. A parliamentary committee reported in August 2026 that 297 Day Care Cancer Centres were approved for 2025-26. It also urged that every district hospital gain oncology day-care facilities within three years. These centres can draw blood locally and send samples to regional laboratories. Tissue biopsy and molecular pathology are much harder to provide in district settings. Blood-based tests therefore fit the referral pattern that the new centres will create.

A distributed care network favours blood-based testing over tissue-led genotyping, which supports an 18.5% CAGR for India during 2026 to 2036. Pricing oversight could still limit margins. The same committee recommended binding standard treatment guidelines to curb unwarranted diagnostic testing and arbitrary pricing in private facilities. Suppliers will need clear clinical indications and transparent prices to secure referrals. Laboratories close to the 19 State Cancer Institutes and 20 Tertiary Care Cancer Centres can serve the densest referral flows.

Germany

Germany treats a large cancer population in hospital, which gives blood tests a defined clinical entry point. Destatis recorded about 1.45 million inpatient cancer treatment cases in 2024. Lung cancer accounted for a substantial share of inpatient cancer treatment and cancer deaths in Germany, with Destatis recording more than 45,000 lung cancer deaths in 2025 [28].

Insurer funding for genomic oncology is expanding through a national model project. BfArM reported in August 2025 that university hospitals were connected to the genome sequencing model under section 64e of the Social Code Book V, with statutory and private insurers participating . Statutory and private insurers participate, and a BfArM confirmation is required before insurers reimburse a case. The programme targets rare diseases and advanced cancers, which gives hospitals a funded route for genomic work-ups.

University centres with genomic programmes can add blood-based monitoring with little new infrastructure. That access supports a 17.0% CAGR for Germany from 2026 to 2036, above the global rate, because the model project brings genomic oncology under insurer funding. EU compliance costs weigh on kit suppliers. Bio-Rad reports incremental costs to comply with the EU In Vitro Diagnostics Regulation for previously approved products. Kit suppliers must recertify assays before hospitals can keep using them. Laboratories may also consolidate onto fewer and broader panels to limit validation work. For kit suppliers, the commercial opening lies in serial monitoring within those university centres.

United States

The United States combines a large cancer population with drug labels and payer policies that name specific blood tests. About 2.1 million people will be diagnosed with cancer in the United States in 2026, according to SEER estimates. Colorectal cancer alone accounts for 158,850 projected new cases, which makes it a direct target for blood-based screening completed during a routine visit. Most blood-based companion diagnostics on the FDA's authorized list serve non-small cell lung cancer, which ties test volume to targeted therapy prescribing.

Screening is the newest demand pool, and federal policy sets its pace. The Medicare MCED coverage law starts payment in 2028 and holds the rate at parity with stool DNA tests through 2030. CMS may cut rates from 2031, which would compress margins on screening tests. GRAIL's Galleri application still awaits an FDA decision after the September 2026 advisory committee vote. A favourable label would give the first multi-cancer test access to Medicare funding from the start of coverage.

Screening uptake and residual disease monitoring support a 14.1% CAGR for the United States between 2026 and 2036, slightly below the global rate. Therapy selection is already established in US oncology practice, so incremental growth depends on new indications and screening adoption. Suppliers with FDA labels and guideline listings will defend their prices best, since Medicare rates and commercial contracts reference those claims.

United Kingdom

England has turned liquid biopsy into a national service for lung cancer. NHS England reports that thousands of people with non-small cell lung cancer had a liquid biopsy during its pilot across approximately 176 hospitals [1]. Testing is now offered to all eligible lung and advanced breast cancer patients through the NHS Genomic Medicine Service [1].

Policy now sets a wider scope. The National Cancer Plan for England commits the Genomic Medicine Service to extend ctDNA testing to other cancers by 2030. It cites savings of about GBP 11.0 million a year from the lung pilot. The plan also aims for every patient who needs a genomic test to receive results in time to change treatment. New contracts for seven Genomic Medicine Service lead providers began in April 2026.

A single national buyer tends to hold test prices down. That pricing discipline holds UK growth to a 12.6% CAGR over 2026 to 2036, below every other profiled country. Screening adds uncertainty. NHS-Galleri missed its primary endpoint, although secondary analyses reported reductions in late-stage diagnoses and emergency presentations  . Any national screening decision will weigh those gains against the cost of following up false positives. Suppliers that meet NHS tender rules and turnaround targets are positioned to secure national volume.

Who are the notable companies in the Liquid Biopsy Market?

Liquid biopsy competition divides between test service providers, diversified diagnostics groups and platform suppliers. Guardant sells therapy-selection and screening tests from its own laboratories. Natera focuses on tumor-informed residual disease testing with Signatera. Roche reports Foundation Medicine within its Molecular Lab customer area, which grew 3.0% at constant exchange rates in the first half of 2026. Abbott entered the field by completing its purchase of Exact Sciences in March 2026.

The Abbott transaction added the Oncodetect residual disease test and the Cancerguard multi-cancer blood test. A large diagnostics group now has direct access to screening and monitoring channels. GRAIL filed the first premarket approval application for a multi-cancer early detection test. Its outcome will indicate how high the FDA sets the evidence bar for screening claims.

Platform suppliers sell instruments and reagents to hospital and reference laboratories. QIAGEN reported growth in sample technologies and QIAcuity digital PCR in its June 2026 quarter. Bio-Rad's digital PCR instrument revenue grew more than 20.0%. Thermo Fisher launched the Ion 560 Chip, which nearly doubles sequencing capacity on its Ion GeneStudio S5 system. Menarini Silicon Biosystems supplies the FDA-cleared CELLSEARCH system for tumor cell counts. For oncology buyers, the comparison across these suppliers turns on regulatory claims, turnaround and cost per sample.

Key Developments in the Liquid Biopsy Market

• On 23 March 2026, Abbott completed its acquisition of Exact Sciences for USD 105.0 per share in cash. The deal added the Oncodetect residual disease test and the Cancerguard multi-cancer blood test.
• On 15 May 2026, Natera announced FDA approval of Signatera CDx as a companion diagnostic for adjuvant atezolizumab in muscle-invasive bladder cancer.
• On 20 May 2026, Guardant Health announced FDA approval of Guardant360 Liquid CDx. The test assesses a genomic footprint 100 times wider than the earlier Guardant360 CDx.

Key Players in the Liquid Biopsy Market

• Guardant Health, Inc.
• F. Hoffmann-La Roche Ltd (Foundation Medicine)
• QIAGEN N.V.
• Bio-Rad Laboratories, Inc.
• Thermo Fisher Scientific Inc.
• Natera, Inc.
• GRAIL, Inc.
• Abbott Laboratories (Exact Sciences)
• Menarini Silicon Biosystems
• Burning Rock Biotech Limited

Liquid Biopsy Market Report Scope

Table 6: Liquid Biopsy Market Report Scope

Coverage field	Report scope
Market definition	Tests, kits and platforms that analyze tumor-derived cells, nucleic acids or vesicles in blood and other body fluids to detect cancer, select treatment and monitor response or recurrence. Tissue-only tests and non-cancer uses such as prenatal screening are excluded.
Biomarker Type	Circulating Tumor Cells (CTCs); Circulating Tumor Nucleic Acids; Exosomes
Sample Type	Blood; Urine; Others
End User	Hospitals; Cancer Institutes; Academic Institutes; Diagnostic Centers
Application	Cancer Diagnosis; Treatment Monitoring; Recurrence Monitoring
Cancer Type	Lung Cancer; Breast Cancer; Colorectal Cancer; Others
Regions covered	North America, Latin America, Western Europe, Eastern Europe, East Asia, South Asia and Pacific, Middle East and Africa
Profiled markets	China, India, Germany, United States, United Kingdom
Companies covered	Guardant Health, Inc.; F. Hoffmann-La Roche Ltd (Foundation Medicine); QIAGEN N.V.; Bio-Rad Laboratories, Inc.; Thermo Fisher Scientific Inc.; Natera, Inc.; GRAIL, Inc.; Abbott Laboratories (Exact Sciences); Menarini Silicon Biosystems; Burning Rock Biotech Limited
Quantitative Units	USD billion

Source: Future Market Insights analysis of the liquid biopsy market, 2026.

Liquid Biopsy Market Research Methodology

The liquid biopsy assessment draws on national cancer statistics, regulatory decisions, health system program data and company disclosures. FMI measures annual revenue from tests, kits and platforms that use blood and other body fluids to detect cancer and guide treatment. Segment values are classified by biomarker type, sample type and cancer type. Country forecasts reflect local cancer burden, reimbursement and laboratory capacity over the same 2026 to 2036 period. Test volumes, regulatory approvals and company revenue are reviewed as separate measures.

Liquid Biopsy Market by Segments

Liquid Biopsy Market segmented by Biomarker Type:

• Circulating Tumor Cells (CTCs)
• Circulating Tumor Nucleic Acids
• Exosomes

Liquid Biopsy Market segmented by Sample Type:

• Blood
• Urine
• Others

Liquid Biopsy Market segmented by End User:

• Hospitals
• Cancer Institutes
• Academic Institutes
• Diagnostic Centers

Liquid Biopsy Market segmented by Application:

• Cancer Diagnosis
• Treatment Monitoring
• Recurrence Monitoring

Liquid Biopsy Market segmented by Cancer Type:

• Lung Cancer
• Breast Cancer
• Colorectal Cancer
• Others

Liquid Biopsy Market by Region

• North America
  • United States
  • Canada
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Chile
• Western Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Benelux
  • Nordics
• Eastern Europe
  • Poland
  • Czech Republic
  • Romania
  • Hungary
• East Asia
  • China
  • Japan
  • South Korea
• South Asia and Pacific
  • India
  • ASEAN
  • Australia and New Zealand
• Middle East and Africa
  • GCC Countries
  • South Africa
  • Türkiye
  • Israel

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