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Size, Share & Industry Analysis, By Type (CTCs and ctDNA, Exosomes and RNA), By Application (Hospitals, Clinics, Others), By End User (Diagnostic Laboratories, Pharmaceutical & Biotech Companies, Academic & Research Institutes), By Biomarker Target (EGFR Mutations, ALK Rearrangements, Other Genomic Alterations), and Global Forecast, 2026-2034
Explore the report section by section.
The global Lung Cancer Liquid Biopsy Market was valued at USD 584 million in 2025 and is estimated at USD 657 million in 2026. Revenue is projected to reach USD 1.683 billion by 2034, a 12.5% CAGR over the 2026–2034 forecast period.
Lung cancer liquid biopsy uses a blood or other fluid sample to identify tumor-derived molecular signals, especially circulating tumor DNA (ctDNA), circulating tumor cells and selected RNA or exosomal markers. Revenue includes lung-cancer-attributable clinical testing, in-scope diagnostic reagents and related assay services. A pan-cancer test contributes only the portion used for lung cancer, not its entire oncology revenue. Conventional tissue biopsy, low-dose CT screening and therapeutic drug sales are outside the defined market.
The World Health Organization reported 2.5 million new lung cancer cases and 1.8 million deaths globally in 2022. Many patients present with advanced disease and require molecular profiling before targeted treatment. Plasma testing can be useful when tissue is insufficient, a biopsy is difficult or rapid results are needed. However, a negative plasma result may miss a mutation because some tumors shed little DNA; tissue testing remains important when feasible and clinically appropriate.
NHS England announced a national blood-test-first pathway in May 2025 for up to 15,000 patients with suspected lung cancer annually. Its pilot found that relevant molecular results sometimes arrived 16 days sooner than with conventional tissue pathways, potentially advancing targeted treatment. In the United States, the FDA has authorized blood-based companion diagnostics for specific lung cancer therapies, including FoundationOne Liquid CDx for MET exon 14 skipping and Guardant360 CDx for HER2-mutant disease. FDA authorizations specify the exact mutation and associated therapeutic indication for each companion diagnostic.
Clinical uptake depends on actionable mutations, test turnaround time, payer coverage and availability of confirmatory tissue sampling. Guardant Health reported about 74,000 oncology tests in the third quarter of 2025 across its broader portfolio, a company-volume indicator rather than a lung-specific market count. Manufacturers are adding larger sequencing panels and epigenomic features, but clinical utility must be assessed for the relevant disease and indication. Liquid biopsy does not replace low-dose CT as the established screening approach for people at high lung-cancer risk.
Source: WHO disease burden; NHS England liquid biopsy rollout; FDA authorized companion diagnostics.
The market covers lung-cancer-specific blood-based molecular testing, associated laboratory services and reagents used for treatment selection or monitoring; pan-cancer sales are allocated only to relevant lung indications.
| Report Attribute | Coverage |
|---|---|
| Base Year | 2025 |
| Estimated Year | 2026 |
| Forecast Period | 2026–2034 |
| Market Measurement | Revenue, USD million/billion |
| By Type | Exosomes and RNA; CTCs and ctDNA |
| By Application | Hospitals; Clinics; Others |
| By End User | Diagnostic Laboratories; Pharmaceutical & Biotech Companies; Academic & Research Institutes |
| By Biomarker Target | EGFR Mutations; ALK Rearrangements; Other Genomic Alterations |
| By Region | North America; Europe; Asia-Pacific; Latin America; Middle East & Africa |
| Selected Countries | United States; Canada; United Kingdom; Germany; France; Japan; China; Australia; Brazil; Mexico; United Arab Emirates |
| Key Market Players | Guardant Health; Foundation Medicine; F. Hoffmann-La Roche Ltd; QIAGEN; Thermo Fisher Scientific; NeoGenomics Laboratories; Illumina; Sysmex Inostics; Menarini Silicon Biosystems; Labcorp; Quest Diagnostics; Natera |
By Type, CTCs and ctDNA combines established circulating-cell and cell-free tumor-DNA testing; Exosomes and RNA captures alternative fluid biomarkers and emerging workflows. By Application, Hospitals are care institutions ordering or integrating testing, Clinics are outpatient oncology services, and Others includes reference-only ordering channels. By End User, Diagnostic Laboratories process clinical tests, Pharmaceutical & Biotech Companies commission trials or biomarker services, and Academic & Research Institutes develop and validate assays. Each clinical order is assigned to one commercial end user to prevent duplication of assay revenue.
EGFR Mutations, ALK Rearrangements and Other Genomic Alterations partition the biomarker-target dimension by the primary result guiding clinical use. Other Genomic Alterations includes KRAS, MET, RET, ROS1, ERBB2/HER2 and broad multi-gene panels without a single primary EGFR or ALK claim. Liquid biopsy screening for cancer in asymptomatic individuals is not treated as an established substitute for low-dose CT; exploratory early-detection revenue is limited to genuine commercial lung-specific tests, not unrelated multi-cancer screening.
The FDA lists companion diagnostic indications linking molecular tests to targeted drugs, including blood-based platforms for specific non-small cell lung cancer mutations. FoundationOne Liquid CDx gained a 2024 indication for MET exon 14 skipping in patients considered for tepotinib. Guardant360 CDx received a 2026 authorization for HER2-mutant lung cancer with zongertinib. Each drug-diagnostic pairing can create a new testing pathway, but the relevant assay must be validated for the specimen and mutation. Testing revenue therefore follows approved therapies rather than lung cancer incidence alone.
NHS England began expanding a blood-test-first pathway in May 2025 after a pilot showed some lung cancer patients obtained actionable results 16 days sooner than with a conventional tissue-first approach. The service planned capacity for up to 15,000 patients annually. Faster molecular results can reduce delays before starting targeted therapy, particularly when obtaining tumor tissue is difficult. The benefit depends on coordinated oncology ordering, laboratory processing and clear reflex rules for negative plasma results, rather than simply substituting one specimen type for another.
Plasma tests detect DNA fragments shed into blood, so early-stage tumors and some disease sites may yield too little ctDNA for reliable detection. Foundation Medicine advises that a negative plasma result does not exclude a genomic alteration and recommends tissue confirmation where feasible for relevant companion-diagnostic decisions. This limitation restrains use as a stand-alone early-detection test and creates demand for high-sensitivity sequencing, error suppression and complementary tissue workflows. Assay quality controls and clinical interpretation remain important cost components for laboratories.
Guardant Health reported 74,000 oncology tests in the third quarter of 2025, showing substantial demand for molecular testing across cancer types. Yet patients may face payer authorization, sample logistics or uneven access to molecular tumor boards. The American Lung Association reported that 23% of lung cancer patients received chemotherapy or radiation before full biomarker testing, identifying an implementation gap. Health systems that embed early molecular orders into routine pathways can increase testing volumes without assuming every diagnosed patient will require repeated plasma assays.
Sources: FDA companion diagnostic list; Foundation Medicine METex14 announcement; NHS England liquid biopsy rollout; American Lung Association biomarker campaign; Guardant Health Q3 2025 results.
Guardant Health received FDA approval in May 2026 for an expanded Guardant360 Liquid CDx platform combining genomic and epigenomic information. Broad panels can identify several actionable alterations from one blood sample, potentially reducing sequential single-gene testing. However, the presence of many reported variants does not make each one an approved companion diagnostic indication. Laboratories must distinguish validated treatment-selection claims from additional research or professional-service findings. Payers also assess whether broad profiling changes management enough to justify its cost.
NHS England planned nationwide use of liquid biopsy for suspected lung cancer in May 2025, following pilot evidence of earlier molecular results. This model requires coordination among radiology, pathology, oncology and central genomic laboratories because tissue still supplies histologic diagnosis and confirmation when blood findings are uninformative. Faster processing may benefit patients with advanced disease who cannot wait for repeated procedures. The commercial opportunity includes assay kits, reference laboratory services and logistics, but not the value of the resulting anticancer medicines.
Circulating tumor DNA can be sampled serially to investigate acquired resistance during targeted therapy, unlike a single invasive biopsy taken at diagnosis. Clinical adoption depends on evidence that detecting a resistance mutation leads to a beneficial treatment change. The FDA has authorized blood-based companion diagnostics for several actionable lung cancer mutations, but these approvals do not automatically validate every longitudinal monitoring use. Research programs are examining minimal residual disease and relapse detection, which could create new orders if clinical benefit and reimbursement are established.
Japan reimbursed Guardant360 CDx for comprehensive genomic profiling in 2023 and approved additional lung cancer companion-diagnostic indications. Europe is expanding personalized cancer medicine through EU4Health programs that include molecular diagnostics and liquid biopsy. The United States has a comparatively developed FDA pathway for biomarker-linked tests, but access still varies across health plans and care settings. Manufacturers need local regulatory claims, laboratory capacity and specimen transport arrangements before a test can become routine outside its original market.
The Type dimension distinguishes established CTCs and ctDNA assays from Exosomes and RNA workflows. Both use minimally invasive samples, but their clinical evidence and diagnostic claims differ considerably.
CTCs and ctDNA represented an estimated ~93% of 2025 revenue. FDA-authorized liquid companion diagnostics rely heavily on circulating tumor DNA to identify alterations in EGFR, MET, HER2 and other genes. Guardant360 and FoundationOne Liquid CDx are commercially deployed examples. Circulating tumor cells support specialized analysis, while ctDNA dominates routine molecular profiling because sequencing and digital PCR can detect multiple actionable variants from a blood sample.
Exosomes and RNA assays explore vesicle-associated nucleic acids and circulating transcripts that may complement DNA-based profiling. They could reveal tumor activity not captured by a limited mutation panel, but sample preparation, stability and clinical validation are less standardized. These technologies are more prominent in research and selected laboratory workflows than in FDA-authorized lung cancer companion diagnostics. Wider commercialization requires reproducible performance and evidence that results change treatment decisions.
ctDNA will retain the largest commercial share as new targeted therapies receive biomarker-linked approvals. Exosome and RNA methods may expand in resistance research or early detection, but they must demonstrate accuracy against tissue and established plasma tests before routine reimbursement. Reference laboratories will need reproducible sample handling and validated interpretation before these biomarkers become routine clinical orders.
Hospitals, Clinics and Others are differentiated by the institution ordering and incorporating results into patient care. The same test is allocated to its primary ordering setting rather than counted again at the processing laboratory.
Hospitals accounted for an estimated ~56% of 2025 revenue. Multidisciplinary lung cancer programs combine imaging, pathology, molecular testing and treatment planning, so they can use plasma results quickly when tissue is limited. NHS England’s blood-test-first pathway illustrates how centralized testing can be embedded into hospital oncology services. Hospital laboratories also coordinate reflex tissue testing when a plasma assay is negative or lacks sufficient tumor signal.
Clinics include community oncology practices and specialist ambulatory cancer centers. They may order liquid biopsy when treatment must start promptly or an additional tissue procedure would be difficult. External laboratories handle sequencing and report interpretation, making specimen logistics and electronic ordering important. Coverage documentation and physician education influence use because community clinics may have less immediate access to molecular tumor boards than major academic hospitals.
Others covers research networks and non-hospital ordering programs that do not fit the two clinical categories. Academic trials may collect repeated plasma samples to track resistance, while tele-oncology services can coordinate tests through licensed laboratories. Revenue is included only when an actual lung-specific diagnostic service is delivered, not for unrelated multi-cancer screening subscriptions.
Hospitals remain the largest channel for initial molecular workups, but community clinics can increase their share as turnaround times improve and insurers accept appropriate blood-based companion diagnostics. Workflow integration is necessary to avoid redundant testing between institutions.
Diagnostic Laboratories, Pharmaceutical & Biotech Companies and Academic & Research Institutes purchase or use assays for different objectives. Clinical tests and research services are counted separately without assigning the same sample to multiple end users.
Diagnostic Laboratories lead the commercial end-user segment because high-complexity sequencing, quality control and interpretation are usually performed in specialist facilities. Guardant Health and Foundation Medicine operate clinically deployed plasma platforms, while hospital laboratories and reference networks route specimens into validated workflows. Laboratories benefit from repeat orders but must meet regulatory, accreditation and turnaround expectations. Their revenue reflects actual tests and assay services rather than the full price of downstream oncology treatment.
Pharmaceutical and biotechnology sponsors commission ctDNA assays for trial eligibility, pharmacodynamic endpoints and exploratory resistance analyses. Biomarker-linked drug programs can create a companion diagnostic pathway, as seen in recent MET and HER2 approvals for non-small cell lung cancer. Clinical development work may precede commercial launch by years, so trial service revenue should not be confused with approved patient-testing volume.
Academic institutes study circulating tumor biology, minimum detectable allele fractions and clinical utility in early-stage disease. Their projects may combine plasma, tissue and imaging to establish when blood testing adds useful information. Research spending is smaller than clinical laboratory revenue, but evidence from well-designed studies can support future guidelines and reimbursement decisions.
Accredited laboratory networks connect oncology clinics with validated blood-based molecular assays and timely interpretation. Pharmaceutical partnerships can supply development work and new diagnostic claims, while research institutes help determine which emerging applications warrant larger clinical validation programs.
EGFR Mutations, ALK Rearrangements and Other Genomic Alterations are allocated by the principal clinical question for each test order. Broad-panel orders are assigned to one category, preventing double counting of multiple detected genes.
EGFR Mutations remain a leading lung cancer liquid biopsy target because EGFR-directed medicines require molecular selection and resistance can emerge during therapy. Plasma assays can detect sensitizing mutations and selected resistance alterations, although a negative result may require tissue testing. The relevance of EGFR varies across patient populations and treatment lines, so assay selection should follow the current drug label and clinical pathway rather than a generic positive result.
ALK Rearrangements identify a smaller molecular subset with approved targeted therapies. Detecting rearrangements in circulating DNA can be technically challenging because fusions may require broad coverage and adequate tumor DNA shedding. Tissue or RNA testing may remain necessary after an uninformative plasma result. The segment benefits from expanding sequencing panels but does not equal the total market for ALK inhibitor drugs.
Other Genomic Alterations include MET exon 14 skipping, ROS1, RET, KRAS, HER2 and additional actionable or resistance markers. FoundationOne Liquid CDx received a MET-related companion diagnostic indication in November 2024, while Guardant360 CDx gained a HER2-mutant lung cancer claim in June 2026. Multiplex assays reduce the need to order separate tests for each possible mutation and support wider therapy matching.
Other Genomic Alterations is likely to expand as new medicines require additional biomarkers, but EGFR remains a high-volume individual testing target. Clinical utility and assay validation govern whether a reported alteration can guide a labelled therapy.
Molecular testing adoption is concentrated in health systems with funded targeted therapy, specialist pathology and validated genomic laboratories. Reimbursement and national clinical pathways determine whether blood-based profiling reaches patients outside major cancer centers.
North America represented an estimated ~51% of global lung cancer liquid biopsy revenue in 2025. U.S. FDA authorization of plasma companion diagnostics, Medicare and commercial coverage for eligible testing, and strong oncology laboratory networks support the region. Guardant Health reported 74,000 oncology tests in third-quarter 2025 across its broader portfolio, demonstrating substantial demand for blood and tissue molecular services. Yet the American Lung Association identified incomplete biomarker testing before treatment in many patients, indicating that diagnostic access remains uneven. Canada shares advanced oncology infrastructure but follows provincial reimbursement and laboratory procurement decisions.
The FDA maintains a list of authorized companion diagnostics, including FoundationOne Liquid CDx and Guardant360 indications for selected lung cancer therapies. Guardant360 CDx received a HER2-mutant non-small cell lung cancer claim in June 2026. These authorizations give oncologists validated blood-based options, while a negative result may still require tissue confirmation depending on the test and drug label.
Source: FDA companion diagnostic list.
Canadian oncology programs use genomic profiling through provincial cancer agencies and specialist laboratories. Blood-based tests must fit local funding decisions, sample transport and laboratory quality requirements. The commercial opportunity is strongest when an approved targeted medicine and validated biomarker assay can be offered together, rather than when a plasma test is promoted independently of treatment access.
Source: WHO lung cancer burden.
European adoption reflects national health technology assessment, pathology infrastructure and access to targeted lung cancer medicines. NHS England announced a blood-test-first pathway for up to 15,000 suspected lung cancer patients each year, illustrating a system-level commitment to faster molecular results. The European Commission’s personalized cancer medicine initiatives also include liquid biopsy and molecular tumor boards, but countries differ in funding and implementation. Under the EU IVDR, companion diagnostics require conformity assessment and consultation procedures tied to the associated medicinal product. Laboratories must balance broad-panel sensitivity, tissue confirmation and turnaround targets within public budgets.
NHS England expanded a blood-test-first pathway in May 2025 after a pilot found that some lung cancer patients obtained relevant genomic results 16 days earlier. The service aims to accelerate targeted treatment and reduce unnecessary repeat procedures. Its implementation requires central laboratory capacity and close coordination with tissue pathology, rather than replacement of histologic diagnosis.
Source: NHS England announcement.
German oncology centers participate in European precision medicine networks and use molecular tumor boards to interpret actionable cancer variants. Plasma testing offers a less invasive option for selected patients, but reimbursement and laboratory validation remain separate from EU device conformity. The European Commission’s JA PCM program seeks to improve equitable access to molecular diagnostics across participating health systems.
Source: European Commission JA PCM.
Asia-Pacific combines large lung cancer case numbers with very different reimbursement structures. Japan approved Guardant360 CDx for comprehensive genomic profiling and granted national reimbursement in 2023, supporting use in advanced solid tumors and specified lung cancer indications. China has substantial oncology sequencing capacity and domestic assay developers, but clinical use depends on national and provincial device and hospital rules. Australia has specialist molecular pathology and targeted therapy pathways, while other markets face cost and specimen logistics barriers. Regional expansion depends on the availability of matched medicines, not merely on disease incidence. Australian laboratories also depend on national genomic testing pathways and local reimbursement rules before broad-panel plasma assays can become standard oncology practice.
Japan’s Ministry of Health, Labour and Welfare approved Guardant360 CDx for genomic profiling and granted national reimbursement effective July 2023. A separate approval covered HER2-mutant non-small cell lung cancer selection for Enhertu. This pairing of test authorization, reimbursement and therapeutic indication offers a clearer commercial route than stand-alone research testing.
Source: Guardant Japan reimbursement.
China has a large lung cancer treatment population and a growing network of hospital molecular laboratories. Plasma NGS can reduce delays when tissue is limited, but local device authorization, hospital budgets and the availability of targeted therapies determine routine use. Domestic assay providers may compete on price and turnaround while international firms pursue clinical partnerships.
Source: IARC global lung cancer estimates.
Latin American liquid biopsy use is concentrated in private oncology networks, academic hospitals and selected public cancer programs. Brazil and Mexico have meaningful lung cancer burdens, but many patients lack timely access to comprehensive genomic profiling. Imported reagents, reference laboratory capacity and payer authorization affect whether plasma assays can be ordered before treatment. Partnerships with local laboratories may lower sample transport times, although test availability alone does not guarantee access to a matched targeted therapy. Health systems must prioritize assays with established clinical utility while building capacity for wider molecular profiling.
Brazil has advanced oncology centers and growing precision medicine activity, but public and private funding rules differ. A lung cancer liquid biopsy may be ordered through specialized laboratories when tissue is insufficient or a rapid molecular answer is needed. Wider use requires validated assays, oncology referral pathways and access to corresponding medicines, not only imported sequencing equipment.
Source: WHO disease burden.
Mexico’s mix of public and private oncology providers creates uneven access to high-complexity molecular diagnostics. Plasma testing may help patients unable to undergo repeated invasive biopsies, but costs and referral delays remain significant constraints. Expanding local sample processing and clear coverage rules could improve the use of actionable biomarkers in advanced non-small cell lung cancer.
Source: IARC lung cancer burden.
Middle East and Africa has uneven molecular oncology infrastructure. Major hospitals in Gulf countries can order advanced tumor profiling and targeted therapies, while many African cancer services face shortages of pathology specialists, sequencing facilities and affordable treatment. Plasma collection is less invasive than tissue sampling, but specimens still require validated processing, reliable transport and bioinformatics interpretation. The WHO estimates that lung cancer caused 1.8 million deaths globally in 2022, highlighting the need for improved diagnosis and treatment pathways. Commercial adoption is likely to remain concentrated where clinical laboratories can return actionable results and oncologists can prescribe the matched medicines.
The United Arab Emirates has tertiary oncology centers and international laboratory partnerships able to support selected genomic assays. Adoption depends on local registration, insurance authorization and clinician access to approved targeted therapies. Blood-based testing may reduce the need for another tissue procedure, but it cannot replace pathology confirmation or an indicated companion diagnostic where those are required.
Source: FDA companion diagnostics.
South African cancer services include specialized private and academic molecular laboratories, while many patients rely on public facilities with limited testing budgets. Prioritizing actionable biomarkers and building specimen logistics may improve access more quickly than adopting broad panels without reimbursement. Negative plasma results still require careful clinical interpretation, particularly when tumor DNA shedding is low.
Source: WHO disease burden.
Liquid biopsy spending is linked to the clinical decision supported by a validated result. A broad research panel does not automatically qualify for the reimbursement available to an authorized companion diagnostic.
| Setting | Access mechanism | Effect on demand |
|---|---|---|
| United States | FDA-authorized CDx indications plus payer medical necessity | Targeted therapy selection supports covered plasma testing |
| England | NHS blood-test-first pathway for suspected lung cancer | Centralized procurement and faster result delivery |
| Japan | National reimbursement for Guardant360 CDx genomic profiling | Broader access in advanced solid tumor pathways |
| Emerging markets | Private payment or selective hospital budgets | Price and laboratory logistics constrain routine use |
FDA companion diagnostic approvals specify the therapeutic product, specimen type and biomarker that a test may be used to identify. FoundationOne Liquid CDx and Guardant360 CDx have distinct claims for selected lung cancer medicines, and their general genomic findings are not automatically prescriptive. Coverage decisions may require evidence that a plasma result changes treatment. Laboratories must document the intended indication, sample quality and clinical interpretation to support reimbursement and avoid unnecessary repeated testing.
NHS England’s May 2025 expansion offers a practical public-sector route: blood is collected early, tested through a national genomic network and integrated with tissue pathology. The pilot reported earlier molecular results for some patients, creating a potential reduction in time to targeted therapy. Central procurement can improve volumes but also puts pressure on laboratory prices, logistics and turnaround guarantees. The pathway illustrates why integrated service delivery matters as much as the analytical chemistry of a test.
Japan’s national reimbursement decision for Guardant360 CDx demonstrates how an authorized assay can reach more patients when payment rules are defined. In markets without comparable funding, advanced plasma sequencing may remain concentrated in private hospitals and clinical trials. Clinical demand also depends on drug access: finding a rare mutation has less immediate value if the indicated medicine is unavailable or unaffordable. Companies entering new regions must coordinate registration, clinical education and local reimbursement rather than relying on disease burden alone.
Source: FDA CDx list; NHS England; Guardant Japan.
Regulatory authorization is specific to a device, specimen and associated treatment, while early-detection and minimal residual disease claims require separate clinical evidence.
| Date | Event | Clinical significance |
|---|---|---|
| November 2024 | FoundationOne Liquid CDx approved for Tepmetko selection | Plasma MET exon 14 skipping companion diagnostic |
| May 2025 | NHS England announces blood-test-first expansion | Up to 15,000 suspected lung cancer patients annually |
| May 2026 | FDA approves expanded Guardant360 Liquid CDx | Broader genomic and epigenomic profiling |
| June 2026 | Guardant360 CDx authorized for Hernexeos selection | HER2-mutant NSCLC treatment selection |
| 2026 | WHO updates lung cancer fact sheet | Global burden remains high |
An FDA-authorized companion diagnostic provides information essential to the safe and effective use of a specified medicine. The agency’s public list identifies the linked drug and biomarker, allowing clinicians to distinguish a labelled claim from a general tumor profiling result. FoundationOne Liquid CDx gained a MET exon 14 skipping indication for tepotinib in 2024, and Guardant360 CDx added HER2-mutant non-small cell lung cancer selection for zongertinib in 2026. These approvals do not authorize every possible clinical use of the underlying platform.
Guardant Health announced FDA approval of an expanded Liquid CDx platform in May 2026 that combines genomic and epigenomic information. Additional molecular information may improve tumor characterization, but its use for a particular treatment must still follow the cleared or approved indication and available clinical evidence. Similarly, a negative plasma assay cannot exclude a mutation in every patient because some tumors shed little detectable DNA. Tissue testing and multidisciplinary review remain necessary when results are incomplete or discordant.
For population screening, the American Lung Association continues to identify low-dose CT as the established approach for eligible high-risk adults. Investigational blood tests may complement future screening strategies, but they should not be described as approved replacements for CT. European IVDR procedures and national reimbursement decisions add further requirements for companion diagnostics. Commercial developers must therefore validate analytical sensitivity, clinical performance and the impact of results on patient management before seeking broader claims.
Competition in lung cancer liquid biopsy is based on clinical utility, authorized companion diagnostic claims, panel breadth, specimen logistics and turnaround time. Several suppliers operate across oncology; only lung-cancer-attributable test and service revenue belongs within the defined market.
Guardant360 CDx has multiple lung cancer companion diagnostic indications, including HER2-mutant non-small cell lung cancer selection approved in June 2026. The company reported broad oncology test volume growth during 2025 and gained approval for an expanded Liquid CDx platform in May 2026. Its wider oncology revenue is not wholly attributable to lung cancer.
FoundationOne Liquid CDx is an FDA-authorized plasma genomic profiling platform with a MET exon 14 skipping claim for Tepmetko. Roche also markets tissue companion diagnostics, enabling parallel pathology workflows. The companies compete on clinical validation and links to targeted oncology medicines rather than on blood sampling alone.
These suppliers provide molecular assay technology, sample preparation, sequencing and companion diagnostic development capabilities. Thermo Fisher Oncomine workflows support research on EGFR and other lung cancer biomarkers using tissue or plasma. Their revenue is included only where diagnostic reagents or services are attributable to lung cancer liquid biopsy.
Reference laboratories connect oncologists to validated molecular testing, specimen logistics and interpretation. Broad pathology networks can increase community access to complex assays, while sponsors may contract with laboratories for biomarker-driven trials. Competitive advantage depends on accredited workflows, timely reports and payer relationships.
Specialist firms such as Sysmex Inostics and Menarini Silicon Biosystems focus on high-sensitivity molecular or circulating tumor cell approaches, while Natera develops tumor-informed molecular residual disease testing across cancers. Their clinical applications are not identical, so a platform marketed for monitoring should not be treated as interchangeable with an FDA-approved initial therapy-selection companion diagnostic. Evidence and approved indications determine the revenue attributable to lung cancer rather than a company’s total molecular diagnostics sales.
The NHS blood-test-first initiative demonstrates the importance of system integration. Laboratories that coordinate plasma collection with tissue confirmation, molecular tumor boards and targeted treatment pathways may secure larger recurring service volumes than firms offering isolated test kits. As panels broaden, payers will increasingly assess whether an additional molecular finding changes treatment or reduces repeat procedures. This creates pressure for faster turnaround, consistent quality control and transparent clinical reporting.
June 2026: Guardant360 CDx received FDA authorization as a companion diagnostic for Hernexeos (zongertinib) in HER2-mutant advanced non-small cell lung cancer. The blood test identifies a defined ERBB2 alteration for treatment selection, adding another labelled clinical use for plasma profiling. The indicated treatment is for adults with advanced non-squamous disease carrying qualifying HER2 mutations detected by an authorized test. Source
May 2026: The FDA approved Guardant360 Liquid CDx, an expanded blood-based profiling platform incorporating genomic and epigenomic information. The authorization broadened the test architecture, while individual companion diagnostic claims continue to govern use with specific lung cancer therapies. The platform incorporates a larger genomic footprint, but broader profiling does not authorize every possible clinical decision. Source
May 2025: NHS England announced a blood-test-first rollout for up to 15,000 suspected lung cancer patients annually. Pilot results indicated that some patients received actionable molecular findings 16 days earlier, supporting faster targeted treatment decisions in the national pathway. The NHS said the new approach may help some patients avoid repeat invasive procedures while retaining tissue pathology where necessary. Source
November 2024: Foundation Medicine received FDA approval for FoundationOne Liquid CDx to identify MET exon 14 skipping alterations in patients considered for Tepmetko. The decision created a defined plasma companion diagnostic option for selected metastatic non-small cell lung cancer cases. The company notes that a negative plasma result does not rule out an actionable alteration and tissue confirmation may be appropriate. Source
August 2025: The American Lung Association expanded its biomarker education campaign, highlighting gaps in testing before lung cancer treatment. Better patient and clinician awareness may increase appropriate molecular profiling, but the campaign does not establish a new diagnostic approval. It emphasized the need to improve access to molecular profiling before chemotherapy or radiation decisions are made. Source
November 2025: The European Commission began its JA PCM personalized cancer medicine initiative, including molecular diagnostics and liquid biopsy among its activities. The project runs through October 2029 and aims to improve equitable access and clinical capacity across participating countries. Activities include molecular tumor boards, advanced diagnostics and shared clinical implementation practices. Source
The Lung Cancer Liquid Biopsy Market is forecast to grow from USD 657 million in 2026 to USD 1.683 billion in 2034, an estimated 12.5% CAGR. Expanded targeted therapy testing and organized hospital pathways are expected to drive much of the increase.
| Forecast variable | Direction | Clinical or commercial mechanism |
|---|---|---|
| Targeted therapy indications | More biomarkers | New companion diagnostic testing needs |
| Blood-test-first pathways | Wider use | Earlier plasma collection and coordinated pathology |
| Repeat testing | Selective expansion | Resistance and response monitoring where evidence supports use |
| Test sensitivity | Technical improvement | Better detection at low tumor fractions |
| Reimbursement | Uneven by country | Coverage tied to validated clinical benefit |
New targeted medicines create opportunities for companion diagnostics when treatment eligibility depends on a detectable mutation. FDA authorizations for MET exon 14 skipping and HER2-mutant non-small cell lung cancer illustrate this link. Broader panels may reduce the need for sequential tests, but a large list of reported variants does not mean each finding has clinical actionability. The forecast assumes that diagnostic revenue follows approved therapeutic indications and demonstrated clinical utility rather than treating every lung cancer case as a full-panel customer.
Hospital workflow changes may contribute as much to growth as assay innovation. NHS England’s blood-test-first rollout connects early plasma collection with national genomic laboratories and oncology decision-making. When molecular results arrive sooner, clinicians can choose targeted therapy without waiting for a second invasive procedure in suitable cases. The pathway still relies on tissue for diagnosis and for confirmation after some negative plasma results. Other health systems may adopt similar protocols when funding, laboratory capacity and clinical evidence support the investment.
Repeat ctDNA testing offers an additional revenue opportunity during therapy, particularly when resistance mutations can guide a treatment change. Research in molecular residual disease and early relapse is active, but routine payment depends on demonstrating better outcomes than existing monitoring strategies. Low DNA shedding and false-negative results remain limitations, especially in early-stage tumors. Providers will need validated thresholds, clear reporting and reflex tissue pathways before wider surveillance claims can become standard practice.
Growth will remain concentrated in regions with funded targeted medicines, molecular tumor boards and accredited laboratories. North America leads in commercial value, while England and Japan provide examples of organized public reimbursement or pathway expansion. Emerging markets may benefit from cheaper sequencing and local reference laboratories, but patient access is constrained when tests or the corresponding therapies are unaffordable. The forecast therefore assumes gradual diffusion of clinically validated testing, not immediate adoption across all diagnosed patients.
The coverage measures lung-cancer-attributable revenue from blood-based molecular profiling, diagnostic reagents and assay services without including therapeutic drug sales or low-dose CT imaging.
Global revenue attributable to lung cancer liquid biopsy is estimated at USD 584 million in 2025. The boundary includes plasma molecular tests, associated reagents and diagnostic services, but excludes oncology drug revenue and unrelated pan-cancer testing. The forecast reaches USD 1.683 billion in 2034.
The expected CAGR is 12.5% during 2026–2034, based on a USD 657 million 2026 estimate and a USD 1.683 billion endpoint. More targeted therapy biomarkers, wider hospital pathways and validated repeat testing support growth, while sensitivity and reimbursement constrain adoption.
Plasma testing does not replace tissue diagnosis in every patient with suspected lung cancer. Plasma testing can identify actionable mutations when tissue is insufficient or difficult to obtain, but negative results may miss alterations because tumor DNA shedding varies. Histologic diagnosis and tissue-based confirmation remain important when clinically feasible and required by the relevant drug or test label.
Validated assays may detect EGFR, MET, KRAS, HER2, RET and other genomic alterations, depending on the test. FoundationOne Liquid CDx has an FDA companion diagnostic indication for MET exon 14 skipping, while Guardant360 CDx supports selected HER2-mutant lung cancer treatment decisions. FDA companion diagnostic labels define which therapy and genomic alteration each assay can guide.
Guardant Health and Foundation Medicine are prominent clinical plasma profiling providers. Roche, QIAGEN, Thermo Fisher Scientific, Illumina, Labcorp and other laboratories contribute assays, sequencing technology and services. Company-wide oncology revenues should not be mistaken for sales attributable only to lung cancer blood testing.
Blood-based early detection remains under investigation and is not a general replacement for low-dose CT screening. The American Lung Association identifies low-dose CT as the established approach for eligible high-risk adults. Liquid biopsy is more widely used for molecular profiling after suspected or confirmed cancer.
North America held an estimated ~51% of 2025 revenue, supported by FDA-authorized companion diagnostics, oncology laboratories and insurance coverage for eligible testing. England is expanding blood-test-first pathways, while Japan reimburses Guardant360 CDx genomic profiling for defined advanced cancer uses.
A ctDNA assay looks for tumor-derived mutations in a blood sample. When an authorized companion diagnostic detects a biomarker linked to a targeted medicine, the result can help clinicians determine eligibility. The FDA lists the relevant test, specimen, alteration and drug indication, so results must be interpreted within the approved label.
Serial plasma samples may detect emerging resistance alterations without repeated invasive tissue procedures. Whether monitoring improves outcomes depends on an available treatment response to the finding and sufficient assay sensitivity. Routine use and reimbursement are not established for every resistance marker or treatment setting.
NHS England announced in May 2025 that up to 15,000 suspected lung cancer patients annually could benefit from early liquid biopsy testing. Pilot experience found molecular results up to 16 days sooner in some cases, potentially accelerating targeted treatment while tissue pathology remains part of care.
Some tumors release little circulating DNA, particularly when disease burden is low or the sampled blood contains too few tumor fragments. Sensitivity differs by the molecular alteration and quality of the collected plasma specimen. Foundation Medicine advises tissue confirmation where feasible after a negative result for relevant companion diagnostic decisions.
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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.
