Lung Cancer Liquid Biopsy Market Size & Share Analysis - Growth Trends and Forecast (2026 - 2031)

Global Lung Cancer Liquid Biopsy Market Trends and Insights

Regulatory and Clinical Guideline Endorsements for Liquid Biopsy in Lung Cancer

Publication of the FDA draft guidance in November 2024 set explicit analytic validity thresholds for circulating tumor DNA minimal residual disease assays, catalyzing investment in ultra-deep sequencing platforms. ASCO’s 2024 living guideline and NCCN’s version 4.2024 now recommend comprehensive blood-based genomic profiling when tissue is inadequate, expanding the eligible patient pool by 20-30%^{[1]American Society of Clinical Oncology, “Living Guideline v2024.3,” asco.org}. ESMO’s 2024 consensus statements added plasma testing for resistance-mechanism identification after targeted therapy failure, reinforcing payer confidence across Europe. Collectively, these endorsements normalize liquid biopsy as standard of care, reduce payer push-back, and shorten hospital committee approval cycles.

Expansion of Reimbursement Coverage for Liquid Biopsy-Based Genomic Profiling

CMS in 2025 placed Guardant360 CDx at USD 5,000, FoundationOne Liquid CDx at USD 3,500, and Signatera at USD 3,500 on its Advanced Diagnostic Laboratory Test list, instantly setting a de facto national floor for commercial insurers. Germany, the United Kingdom, and France followed with procedure codes that reimburse plasma testing when tissue biopsy is contraindicated, raising European access by 10-15% in one year. Japan’s health insurance system began covering liquid biopsy for high-risk tissue sampling, boosting domestic uptake despite historically conservative coverage policies. These moves improve vendor cash flow visibility and prompt hospital laboratories to invest in on-site sequencing infrastructure.

Rising Incidence of Lung Cancer and Growing Preference for Minimally Invasive Diagnostics

GLOBOCAN projects global lung-cancer incidence will rise from 2.48 million cases in 2022 to 4.62 million by 2050, a demographic wave that expands the testing addressable market. High pneumothorax rates associated with transthoracic biopsy drive patient and physician preference toward blood draws, reducing median diagnostic turnaround time from 24 days to under 10 days in a U.S. community oncology practice. Surveys in 2024 show 78% of advanced-stage patients would choose a blood test over re-biopsy when accuracy is equivalent. This persistent demand supports double-digit growth even if payer policy fluctuates.

Continued Launch of Targeted and Immuno-Oncology Therapies Requiring Molecular Monitoring

Eight novel targeted regimens approved between 2024-2026 depend on accurate mutation status, propelling serial liquid-biopsy orders throughout a patient’s therapy arc. Plasma monitoring detects resistance mechanisms such as C797S and MET amplification months before imaging progression, guiding timely second-line treatments and reinforcing clinical utility. Pharma trials embed circulating tumor DNA endpoints to accelerate drug registration, adding thousands of research samples annually and anchoring vendor-pharma alliances.

Analytical Sensitivity Limitations in Early-Stage Disease and Low Tumor Shedding

Stage I detection rates hover at 50-70%, well below those of radiologic modalities, due to variant-allele fractions below the 0.05% assay threshold^{[2]Nature Reviews Clinical Oncology, “ctDNA Sensitivity in Early Lung Cancer,” nature.com}. Shedding heterogeneity, clonal hematopoiesis artifacts, and pre-analytical inconsistencies further erode accuracy, so clinicians still prioritize tissue confirmation to avoid false reassurance. Vendors are countering with molecular barcoding chemistries that reduce limits of detection to 0.01%, but broad validation remains a work in progress.

Inconsistent Global Reimbursement Policies for Screening and MRD Applications

CMS’s refusal to cover multicancer early detection and its stance on minimal residual disease in evidence development create revenue bottlenecks in the United States. Elsewhere, coverage differs by province or insurer, compelling vendors to mount dozens of country-level health-economic dossiers and delaying scale.

Segment Analysis

By Analyte: Exosome Uptake Strengthens Beyond ctDNA Dominance

The lung cancer liquid biopsy market size for circulating tumor DNA commands the lion’s share, but exosome-based assays are expanding the fastest, growing at a 14.54% CAGR as investigators leverage cell-free RNA and protein cargo to illuminate resistance mechanisms. Vendors such as Exosome Diagnostics and academic spin-outs are aligning with pharma partners to validate exosomal programmed death-ligand 1 expression, addressing the tissue-complementary gap. Although exosome workflows require ultracentrifugation or immuno-capture steps that lengthen processing, automated microfluidic kits launched in 2026 promise to cut hands-on time by half, encouraging hospital adoption. The lung cancer liquid biopsy market is therefore likely to evolve toward dual-analyte panels that couple ctDNA mutations with exosomal RNA for a richer biological context.

Note: Segment shares of all individual segments available upon report purchase

By Technology: Fragmentomics Challenges Next-Generation Sequencing

Next-generation sequencing dominated 54.32% of 2025 revenue, yet fragmentomics and methylation analytics are surging at a 14.22% CAGR. These low-coverage assays trim sequencing depth by 20x, enabling 80-90% cost cuts and same-week turnaround, appealing to budget-sensitive health systems in Latin America and Southeast Asia. Illumina’s NovaSeq X compatibility has prompted tertiary hospitals to internalize 500-gene ctDNA panels and retain billing margin. Conversely, the polymerase chain reaction and droplet-digital polymerase chain reaction segments continue to shrink as clinical guidelines shift away from single-gene reflex testing.

By Clinical Use Case: MRD Surveillance Tops Growth Tables

Therapy-selection testing led to 2025 revenue of 41.54%, but minimal residual disease surveillance is rising fastest at a 14.88% CAGR, as trials show that post-operative circulating tumor DNA status predicts benefit from adjuvant immunotherapy. Real-time resistance monitoring during targeted therapy extends assay cadence to every 6–8 weeks across an entire treatment continuum, effectively doubling per-patient lifetime test counts. Early detection and screening remain exploratory until CMS reverses its coverage stance, yet results from the SUMMIT cohort in 2028 could unlock a vast new population of risk-screened individuals.

By Cancer Subtype: Small Cell Momentum Emerges

Non-small cell histologies represented 82.45% of the 2025 volume, but small cell cases will show a market-leading 14.67% CAGR through 2031. Rapid tumor doubling and high shedding make small cell disease ideally suited to liquid biopsy for real-time chemotherapy response tracking, even though actionable mutations remain scarce. DLL3-targeted conjugates and PARP inhibitors under development may soon tie drug eligibility to plasma biomarkers, further boosting small-cell test demand.

By End User: Hospitals Repatriate Testing for Speed and Margin

Independent reference laboratories still account for 46.76% of 2025 revenue, but hospital labs are expanding at a 15.43% CAGR as capital budgets fund NovaSeq X and TSO500-ctDNA setups. Academic centers seek to cut report turnaround time to under 7 days, improving the precision of therapy initiation during first-line treatment windows. Community hospitals lacking test volume continue to outsource, thereby sustaining reference-lab-scale economics in the medium term.

Note: Segment shares of all individual segments available upon report purchase

By Specimen: Serum Revival Driven by Legacy Biobanks

Plasma captured 78.65% of 2025 samples on the back of Streck and PAXgene stabilization tubes, yet serum is growing at 15.11% CAGR as researchers unlock two-decade serum archives to validate fragmentomics signatures. Vendors now market extraction kits optimized for degraded serum DNA, positioning the format for retrospective discovery and low-resource clinical settings.

Geography Analysis

North America led the lung cancer liquid biopsy market with a 43.56% revenue contribution in 2025 as Medicare payment cemented commercial price floors and fifteen of the top twenty vendors based their operations in the United States. Vendor–pharma collaborations, a mature clinical-trial ecosystem, and hospital investment in onsite sequencing sustain double-digit domestic growth despite payer limits on screening coverage.

Europe exhibits mixed momentum; Germany, the United Kingdom, and France now reimburse plasma testing for advanced disease, but divergent coding policies fragment adoption across other member states. The lung cancer liquid biopsy market size for leading European laboratories remains tethered to therapy-selection cases while IVDR compliance costs delay the launch of innovative assays.

Asia-Pacific is the fastest-growing region at a 13.45% CAGR to 2031. China’s National Medical Products Administration approval of multiple ctDNA panels and provincial pilot reimbursement boost domestic uptake, while Japan’s insurers cover liquid biopsy when tissue sampling risks complications. Local champions Burning Rock and Singlera replicate Guardant’s and Natera’s business models at lower price points, accelerating penetration into tier-2 Chinese hospitals.