Solid Tumor Testing Market Size & Share Analysis - Growth Trends and Forecast (2026 - 2031)

Global Solid Tumor Testing Market Trends and Insights

Aging-Driven Incidence & Precision-Medicine Adoption

Cancer incidence rises steeply with age, and populations in high-income countries are aging rapidly. Japan’s over-65 cohort reached 29% in 2024, while the United States is projected to hit 21% by 2030, sustaining test demand. Precision-medicine guidelines now mandate molecular profiling for most advanced solid tumors, embedding testing into routine care. The American Society of Clinical Oncology updated its lung-cancer guideline in 2024 to require reflex NGS or sequential assays for at least eight biomarkers before first-line therapy selection. Oncologists increasingly consider molecular reports essential, ensuring durable volume growth even when reimbursement is flat.

Falling NGS Cost Curve

Sequencing reagent prices have dropped by an order of magnitude in the past decade. Illumina’s NovaSeq X Plus targets a USD 600 genome by 2025, while BGI Genomics advertises sub-USD 100 costs at scale^{[1]Illumina Inc., “Investor Presentation Q2 2024,” illumina.com}. A 2024 costing study demonstrated that per-sample expenses fall from USD 377 to USD 128 when throughput rises from 600 to 5,000 samples, incentivizing high-volume reference labs. Cost deflation widens laboratory margins, funding automation and AI interpretation that reinforce competitive barriers.

Regulatory Approvals of Tumor-Agnostic Therapies

The FDA cleared multiple tumor-agnostic drugs in 2024, including Bizengri for NRG1-fusion tumors and repotrectinib for NTRK-positive cancers. These approvals require assays capable of detecting rare fusions, amplifying demand for broad panels. Pharma sponsors are prioritizing pan-cancer trials, creating a feedback loop in which more approvals justify wider testing, and wider testing generates real-world evidence for further approvals.

Hospital Shift to In-House CGP IVD Kits

Academic medical centers and large health systems increasingly run comprehensive panels in-house to shorten turnaround and retain pathology revenue. FDA-cleared kits such as TruSight Oncology 500 enable hospitals to operate without developing lab-developed tests under CLIA. A 2024 U.S. survey showed that 38% of cancer centers already perform NGS internally, primarily to deliver results within ten days.

High Comprehensive-Panel Cost & Patchy Reimbursement

Panels priced between USD 3,000 and USD 5,000 strain oncology budgets outside academic centers. Medicare reimburses under NCD 90.2, but many commercial payers impose prior-authorization hurdles that delay adoption. Europe remains fragmented; Germany broadened NGS coverage in 2024, whereas France still mandates case-by-case approval via molecular tumor boards. This patchwork sustains demand for single-gene assays in community settings, slowing panel-first workflows.

Shortage of Trained Molecular Pathologists

Fewer than 200 new U.S. specialists graduate each year, well below projected needs^{[2]American Society for Clinical Pathology, “Molecular Pathology Workforce Study 2024,” ascp.org}. India counts fewer than 50 certified molecular pathologists for a population of 1.4 billion, highlighting a global skills gap that lengthens turnaround times and raises labor costs.

Segment Analysis

By Technology: NGS Dominance Meets FISH Resurgence

Next-generation sequencing accounted for 54.55% of 2025 revenue, making it the largest component of the solid tumor testing market. NGS panels condense hundreds of genes into a single run, supporting targeted therapy selection, immunotherapy biomarkers, and tumor-agnostic indications. Fluorescence in-situ hybridization is projected to grow at a 10.25% CAGR through 2031 as guidelines continue to list FISH as the gold-standard confirmatory method for HER2 amplification and ALK rearrangement.

Automation is extending FISH’s lifespan; a 2025 study showed AI-assisted digital pathology reduced interpretation time by 40% and improved concordance to 96%. Should payers tighten authorization for broad panels, FISH and PCR could regain share by offering faster paths to coverage. Conversely, if comprehensive panels secure wider reimbursement, single-biomarker assays will recede to niche roles.

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

By Cancer Type: Lung Surges on Immunotherapy Tailoring

Lung cancer testing is expected to post a 10.85% CAGR, the fastest among tumor types, fueled by reflex profiling for EGFR, ALK, KRAS G12C, and PD-L1 before first-line therapy. Breast cancer maintained an 18.53% contribution to 2025 revenue through universal HER2 screening and emerging PIK3CA and ESR1 assays.

The pipeline of targeted drugs expands the solid tumor testing market by adding new biomarkers, while negative trials can slow uptake. Colorectal, prostate, and rare tumors such as cholangiocarcinoma all benefit from the expanding actionable-mutation list, supporting broader panel adoption.

By Sample Type: Liquid Biopsy’s MRD Catalyst

Tissue retained a 61.23% share of the solid tumor testing market size in 2025, benefiting from higher tumor content and clear coverage pathways. Liquid biopsy, however, is forecast to grow 15.55% annually as clinicians embrace serial ctDNA testing for minimal-residual-disease monitoring and resistance tracking. 

Sensitivity remains histology-dependent, yet FDA approval of Guardant’s Shield for colorectal-cancer screening signals regulatory confidence in blood-based assays. Pre-analytical standardization will determine how quickly liquid biopsy displaces tissue outside low-shedding tumors.

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

By End User: Reference Labs Capture Scale Economies

Diagnostic and reference laboratories are projected to expand at 10.11% annually as they pool high volumes and amortize the cost of molecular pathologists. NeoGenomics and Guardant Health reported double-digit revenue growth in 2024 by emphasizing broad menus and rapid turnaround. 

Hospitals and cancer centers hold 48.03% of 2025 revenue but exhibit divergent strategies; academic centers internalize testing, while many community hospitals outsource complex assays. Reimbursement incentives and IVDR compliance costs will shape future test-allocation models.

Geography Analysis

North America generated 42.25% of 2025 revenue, reflecting broad Medicare coverage and a mature ecosystem of reference laboratories and hospital molecular programs. The United States accounts for the bulk of regional activity, aided by per-test payment levels that exceed USD 3,000 under CPT 81455, whereas Canada and Mexico lag behind due to provincial funding variability and private-insurance dependence. Continued approvals of tumor-agnostic therapies should sustain volume growth, although commercial payers are tightening prior-authorization criteria that could temper expansion in community oncology.

Asia-Pacific posted the highest projected growth, a 12.21% CAGR, fueled by policy reforms and falling sequencing costs. China’s 2024 inclusion of NGS panels in provincial reimbursement catalogs has stimulated adoption beyond tier-1 cities, while Japan’s universal-coverage system supports genomic medicine for its rapidly aging population. India’s National Cancer Grid is scaling molecular hubs across 50 cities despite infrastructure gaps. Regional players like BGI and Macrogen leverage localized manufacturing to undercut imported assays, positioning the region for sustained uptake of liquid biopsy and AI-assisted interpretation.

Europe occupies an intermediate position. Germany broadened statutory coverage in 2024, and the U.K. expanded whole-genome sequencing through the NHS Genomic Medicine Service. Nonetheless, IVDR conformity bottlenecks slow new-test introductions, especially for smaller vendors, and reimbursement remains fragmented in southern Europe. In Latin America, Middle East, and Africa, testing volume is concentrated in private hospitals that serve affluent patients and expatriates, while public systems grapple with competing health priorities and budget constraints.