Precision Oncology Market Size & Share Analysis - Growth Trends and Forecast (2026 - 2031)

Global Precision Oncology Market Trends and Insights

Advancements in NGS & AI-Driven Analytics

AI now reduces whole-genome interpretation from days to hours, allowing real-time therapeutic decisions in acute leukemia and aggressive solid tumors.^{[1]Illumina Investor Relations, “Q4 2025 Earnings Call Transcript,” illumina.com} Illumina’s DRAGEN platform is deployed at more than 1,200 clinical sites and processes a genome in under 90 minutes with high accuracy. FoundationOne CDx expanded into additional tumor types in early 2025 and integrates machine-learning models trained on more than 500,000 de-identified records, yielding a 78% positive predictive value for immunotherapy response. Oxford Nanopore’s adaptive sampling further reduces the per-sample reagent cost by 40% while maintaining diagnostic sensitivity above 99%. These efficiency gains convert molecular profiling from an academic add-on into a routine decision-support tool across community oncology. 

Rising Cancer Incidence & Favorable Reimbursement

New cancer cases reached 20.4 million globally in 2024, up 15% from 2020, an increase driven by aging populations and better detection in low- and middle-income nations. Medicare lifted prior-authorization hurdles and now pays up to USD 3,200 per comprehensive genomic profile, boosting test utilization by 60% in Q1 2025 alone.^{[2]Centers for Medicare & Medicaid Services, “National Coverage Determinations for Genomic Testing,” cms.gov} Germany, Japan, and the United Kingdom followed with similar reimbursement upgrades in 2025, sending a clear market signal that molecular information is now the standard of care. As a result, insurers worldwide are increasingly covering upfront profiling for lung, colorectal, and ovarian cancers, where actionable mutations have a prevalence exceeding 60%. 

Companion-Diagnostic Approvals Accelerating Commercialization

The FDA cleared a record 18 companion diagnostics in 2025, including liquid-biopsy assays that eliminate the need for tissue re-biopsy in patients with scant archival specimens. Roche’s Ventana PD-L1 SP263 assay secured expanded approval with durvalumab in early-stage non-small cell lung cancer, opening access for roughly 200,000 eligible U.S. patients each year. Guardant360 CDx became the first blood-based pan-tumor companion diagnostic, shortening test-to-treatment time and widening clinical adoption. Parallel review pathways in Europe and streamlined review processes in China further reduce approval lags, creating synchronized global launches and enabling drugmakers to reach broader markets more quickly. 

Rapid Adoption of Liquid Biopsy Platforms

Liquid biopsy test volumes expanded by 85% in 2025 as oncologists utilized circulating tumor DNA assays for minimal residual disease surveillance across colorectal and breast cancers. GRAIL’s Galleri test screens for more than 50 tumors through cell-free DNA methylation and shows 67% sensitivity at 99.5% specificity in asymptomatic adults, a landmark performance that prompted England’s National Health Service to launch a 140,000-person pilot in late 2025. Natera’s Signatera now guides adjuvant therapy by detecting relapse six to twelve months before imaging, and Chinese demand is climbing as two provinces added circulating-tumor-DNA coverage to reimbursement schedules. 

High Cost of Personalized Therapeutics & Testing

Targeted drugs, such as antibody-drug conjugates, regularly exceed USD 200,000 annually, far outstripping the health budget capacity in emerging economies. Comprehensive genomic profiling remains self-funded in India, Indonesia, and Brazil, where household income cannot absorb a USD 3,000 test. Even within high-income countries, payers demand real-world evidence proving cost-effectiveness at a level below USD 150,000 per quality-adjusted life year, which muddies coverage decisions for new therapies. Patent exclusivity on next-generation inhibitors delays biosimilar entry until after 2030, keeping drug prices elevated and curbing uptake. 

Regulatory & Payer Uncertainties

Fragmented global regulations require separate validation studies for the same assay, extending development time and expense.^{[3]European Commission, “In Vitro Diagnostic Regulation Guidance,” ec.europa.eu} Europe’s In Vitro Diagnostic Regulation imposed performance-study mandates that add more than a year to many submissions. At the same time, some U.S. insurers still reimburse molecular tests only after first-line therapy has failed, thereby diminishing the clinical value of early profiling. The inconsistent stance on polygenic risk scores and tumor-mutational-burden panels introduces forecasting risk for laboratories and investors. 

Segment Analysis

By Type: Diagnostics Momentum Overtakes Therapeutics

Diagnostics are expected to post a 10.06% CAGR from 2026 to 2031, even as therapeutics held 58.81% precision oncology market share in 2025. Continuous monitoring through circulating tumor DNA (ctDNA) turns testing into a recurring service, raising lifetime revenue per patient and making the diagnostics segment a structural growth driver within the broader precision oncology market. Liquid biopsy platforms, such as Signatera and Guardant360, deliver molecular insights every three to six months, creating new billing events and embedding laboratories deeper in care pathways. Exact Sciences processed over 2 million Cologuard liquid-biopsy colorectal screens within six months of its launch in 2025, demonstrating that non-invasive tests can reach a population scale when insurers reimburse first-line use. 

Therapeutics growth faces mature classes and patent expiries yet still benefits from rising biomarker-defined patient pools. Twelve precision oncology therapeutics gained FDA clearance in 2025, fewer than in 2024, reflecting the maturation of the EGFR and ALK franchises. Drug developers increasingly co-develop diagnostics from early clinical phases, which improves payer confidence but lengthens timelines. Nevertheless, label expansions into adjuvant and neoadjuvant settings will support the precision oncology market as broader patient cohorts become eligible for biomarker-guided treatment. 

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

By Technology: FISH Rebounds on Spatial Biology Needs

Fluorescence in situ hybridization is projected to grow at a 10.72% CAGR to 2031, as spatial biology demands gene-locus visualization that next-generation sequencing cannot provide. Expanded FDA clearance of Abbott’s digital-pathology-compatible ALK Break-Apart probe cuts turnaround times to less than two days, a key advantage for time-sensitive lung cancer cases. FISH also anchors multi-omics spatial platforms such as Visium HD, which overlay transcriptomic maps onto tissue architecture to decode immune-cell positioning. 

Next-generation sequencing remains the mainstay, accounting for 36.73% of the precision oncology market size in 2025, with a dominant presence in academic centers. Growth now depends on adopting community practices that run far lower sample volumes yet collectively care for the majority of patients. PCR-based hotspot panels continue to serve as a rapid method for detecting EGFR or KRAS mutations, where a sub-24-hour response influences emergency therapy. Microarray and other technologies retain niche roles in germline testing and gene-expression signatures, sustaining diversified demand across the precision oncology market. 

By Biomarker Type: Epigenomic Signatures Gain Share

Genomic variants still accounted for 31.48% of the precision oncology market size in 2025, but epigenomic assays are projected to expand at a 8.79% CAGR through 2031. Methylation-based liquid biopsy detects cancer signal in early stages with sensitivity that eclipses traditional tumor markers, pushing adoption beyond high-risk populations. The USPSTF now recommends Cologuard’s combined methylation and mutation panel as a first-line colorectal screening option, potentially opening a vast asymptomatic segment. 

Proteomic, transcriptomic, and metabolomic markers provide complementary layers that refine therapy decisions. Mass-spectrometry cytokine panels forecast immunotherapy response more reliably than PD-L1 staining. Gene-expression signatures guide chemotherapy omission in hormone-receptor-positive breast cancer, sparing thousands from cytotoxic regimens each year. Metabolomics remains research-oriented, yet early data suggest tumor lactate and glutamine levels could soon inform eligibility for metabolic-pathway inhibitors. The multidimensional trend reinforces the precision oncology market pursuit of holistic tumor characterization. 

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

By Cancer Type: Prostate Growth Outstrips Breast Dominance

Breast cancer contributed 49.26% of 2025 revenue, anchoring the precision oncology market with mature HER2, hormone-receptor, and BRCA testing pathways. Market saturation tempers its forward CAGR, whereas prostate cancer is set to experience a 11.53% CAGR through 2031, following Medicare's decision to reimburse germline testing for every new diagnosis, which has led to a 150% increase in testing volume within six months. PARP-inhibitor companion diagnostics extend molecular targeting beyond BRCA into ATM and CHEK2 defects, further broadening precision eligibility. 

Lung and colorectal cancers continue to benefit from the expansion of EGFR, ALK, and KRAS panels, particularly in Asia, where mutation frequencies are high. Caris Life Sciences profiled more than 100,000 tumors in 2025, with lung and colorectal cancers accounting for 45% of volume. Rare tumors such as cholangiocarcinoma gain new targeted options as fibroblast growth factor receptor fusions are routinely screened. Broader genomic interrogation continues to bring small-population cancers into the revenue fold, supporting the overall expansion of the precision oncology market. 

By End-User: Laboratories Capture Outsourced Volume

Hospitals and cancer centers owned 69.16% of the precision oncology market share in 2025, thanks to the integration of tumor boards and on-site pathology. Yet, independent diagnostic laboratories will outpace the market with a 12.27% CAGR through 2031, as decentralized testing lowers capital barriers for community practices. Labcorp and Quest jointly processed more than 1.5 million precision oncology tests in 2025, a 70% surge from 2024. 

Research institutions drive the development of cutting-edge single-cell and spatial methods, but their commercial share remains below 5%. Drug developers increasingly outsource biomarker screening to reference labs for trial enrollment, adding another growth leg. Direct-to-consumer liquid biopsies enter routine preventive care as payers cover early detection for high-risk cohorts, expanding the addressable testing pool well beyond hospital walls and sustaining momentum in the precision oncology market. 

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

Geography Analysis

North America commanded 42.83% of the revenue in 2025, following the expansion of Medicare's genomic test coverage and the FDA's acceleration of companion diagnostic reviews. The region maintains leadership through widespread payer reimbursement and a dense sequencing infrastructure, yet its CAGR trails that of the Asia-Pacific region because penetration already exceeds 70% of eligible patients. 

Asia-Pacific is forecast to post a 13.27% CAGR from 2026 to 2031, the fastest of any region, buoyed by China’s 12 companion-diagnostic approvals in 2025 and provincial insurance that reimburses up to CNY 20,000 (USD 2,800) per comprehensive profile. BGI Genomics processed 800,000 oncology samples in 2025 and plans a 50% increase in capacity for 2026. Japan increased the payment for genomic profiling to JPY 800,000 (approximately USD 5,300), aligning with global benchmarks and encouraging domestic labs to adopt high-throughput sequencers. 

Implementation of the In Vitro Diagnostic Regulation adds cost but harmonizes quality, ensuring reliable data across borders. Whole-genome sequencing within the U.K. Genomic Medicine Service doubled test volume in a year, and France launched regional molecular-tumor-board networks that mandate comprehensive profiling for advanced tumors. 

South America and the Middle East & Africa together contribute less than 10% of the spend due to limited public coverage. Brazil cleared six companion diagnostics in 2025; however, without broad reimbursement, fewer than 20% of eligible patients receive the tests. South African private insurers now cover comprehensive genomic profiling, whereas government programs lag, leaving the majority excluded and limiting growth. 

Precision Oncology Market in Europe

Europe represents a significant market for precision oncology, demonstrating robust growth over the forecast period. The region's market expansion is driven by strong healthcare systems and increasing government support for precision medicine initiatives. The European market benefits from extensive collaboration between academic institutions, healthcare providers, and pharmaceutical companies, fostering innovation in personalized cancer treatments. Countries like Germany, France, and the UK lead the regional market with their advanced healthcare infrastructure and significant investments in genomic research. The region's commitment to healthcare digitalization and the integration of artificial intelligence in cancer diagnostics has enhanced the adoption of precision oncology solutions. Furthermore, the presence of well-established biotech clusters and research centers has created an ecosystem conducive to developing innovative cancer treatments. The European Union's initiatives to standardize genetic testing and biomarker analysis across member states have also contributed to market growth.

Precision Oncology Market in Asia Pacific

The Asia Pacific precision oncology market is poised for remarkable expansion and is projected to grow at a notable pace. The region's growth trajectory is supported by rapidly evolving healthcare infrastructure and increasing investment in advanced medical technologies. Countries like Japan, China, and South Korea are leading the regional market with their significant investments in healthcare technology and research facilities. The large patient population and increasing healthcare awareness have created substantial opportunities for market expansion. Growing private sector participation and government initiatives to promote precision medicine have strengthened the market foundation. The region's emerging economies are witnessing increased adoption of next-generation sequencing technologies and molecular diagnostics. Additionally, the rising number of cancer research centers and clinical laboratories has enhanced the accessibility of precision oncology solutions. The growing collaboration between international pharmaceutical companies and local healthcare providers has further accelerated market development.

Precision Oncology Market in Middle East and Africa

The Middle East and Africa region presents an emerging market for precision oncology, characterized by growing healthcare investments and increasing focus on advanced medical technologies. The region's market is driven by significant healthcare infrastructure development, particularly in GCC countries. Major medical hubs in countries like Saudi Arabia and the UAE are leading the adoption of precision oncology solutions through substantial investments in healthcare technology and research facilities. The region benefits from increasing government initiatives to improve cancer care and rising private sector participation in healthcare delivery. Growing awareness about personalized medicine and improving access to advanced diagnostic facilities have created new opportunities for market expansion. The establishment of specialized cancer treatment centers and partnerships with international healthcare providers has enhanced the quality of cancer care. Additionally, medical tourism initiatives and improving healthcare insurance coverage have contributed to market growth.

Precision Oncology Market in South America

South America's precision oncology market is experiencing steady growth, driven by improving healthcare infrastructure and increasing awareness about personalized medicine approaches. The region is witnessing a gradual shift towards more sophisticated cancer treatment methodologies, supported by growing investment in healthcare technology. Countries like Brazil and Argentina are leading the regional market with their expanding healthcare facilities and increasing adoption of advanced diagnostic technologies. The region benefits from growing partnerships between international pharmaceutical companies and local healthcare providers, facilitating knowledge transfer and technology adoption. Rising healthcare expenditure and improving access to advanced cancer treatments have created new opportunities for market expansion. Furthermore, the increasing focus on medical tourism and the establishment of specialized cancer treatment centers have contributed to market development. The region's growing middle class and improving insurance coverage for advanced treatments are also driving market growth.