Regulatory deregulation and liquid biopsy adoption pushing the rapid growth of the oncology companion diagnostic market. In addition to this, strategic pharmaceutical partnerships and widespread next-generation sequencing integration are solidifying precision medicine as the global standard of care.
Chicago, Jan. 20, 2026 (GLOBE NEWSWIRE) — The global oncology companion diagnostic market size was valued at USD 5.68 billion in 2025 and is projected to hit the market valuation of USD 12.84 billion by 2035 at a CAGR of 8.50% during the forecast period 2026–2035.
The Oncology companion diagnostic market is currently positioned at a pivotal inflection point characterized by regulatory deregulation and technological ubiquity. As of early 2026, the sector is capitalizing on the FDA’s strategic proposal to reclassify CDx tests to Class II, significantly lowering commercialization barriers. Market leaders like Foundation Medicine have solidified their dominance, achieving critical mass with over 100 approved indications.
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The competitive landscape of the market has definitively shifted from single-gene assays to comprehensive NGS panels, with liquid biopsy becoming the standard of care for monitoring resistance mutations like ESR1. While reimbursement headwinds persist due to the tightened USD 32.35 conversion factor, the introduction of specialized CPT codes helps mitigate margin pressure. Global adoption is accelerating, evidenced by recent regulatory wins in Japan and the EU, positioning the market for robust expansion driven by the mandatory integration of diagnostics into pharmaceutical prescriptions.
Key Findings
- North America accounted for 40% of the oncology companion diagnostic market share in 2025.
- Within product and services, the products category held the leading position in the market in 2025.
- On the basis of technology, the Next-generation Sequencing (NGS) segment represented the foremost share of the market in 2025.
- Considering disease type, the non-small cell lung cancer segment emerged as the largest contributor to the market in 2025.
- By end-use, hospitals remained the primary setting for oncology companion diagnostic market adoption in 2025.
By Product, Recurring Consumables Revenue and High-Volume Kit Sales Drive Product Leadership
The products segment secured the leading market share in 2025, driven primarily by the high-volume, recurring sales of consumables such as assays, reagents, and molecular testing kits. Unlike capital-intensive instruments that generate one-time revenue, consumables represent a continuous income stream essential for daily clinical workflows. The dominance is cemented by the industry’s “razor-and-blade” model; once diagnostic platforms are installed, laboratories are locked into purchasing proprietary reagents for the machine’s operational lifespan.
Furthermore, the market saw a surge in demand for regulatory-approved commercial kits—such as those for EGFR and KRAS testing—which offer standardized, compliant results preferred by oncologists over laboratory-developed tests. The rising adoption of liquid biopsy products also contributed significantly, as these require specialized, high-cost reagent kits for recurring non-invasive monitoring, ensuring the product segment remains the financial backbone of the oncology companion diagnostic market.
By Disease, Extensive Biomarker Profiles and Targeted Therapy Options Cement NSCLC Market Lead
Non-Small Cell Lung Cancer (NSCLC) dominated the oncology companion diagnostic market in 2025 due to its status as the most biomarker-driven malignancy in modern oncology. Unlike other solid tumors that may rely on one or two targets, NSCLC management mandates testing for a vast array of actionable “driver mutations,” including EGFR, ALK, ROS1, BRAF, MET, RET, and KRAS. This biological complexity forces high utilization rates of companion diagnostics, as clinical guidelines now recommend molecular profiling for virtually all patients with advanced disease.
The segment’s revenue is further amplified by the continuous approval of novel targeted therapies, such as those for KRAS G12C mutations and EGFR exon 20 insertions, which require specific, regulatory-approved companion diagnostic tests prior to prescription. This direct link between a high volume of mandated tests and a wide portfolio of approved drugs ensures NSCLC remains the largest revenue generator in the companion diagnostic space.
By End Users, Integrated Care Models and In-House Testing Demand Secure Hospital Segment Dominance
The hospitals segment led the oncology companion diagnostic market in 2025, driven by the critical clinical requirement for rapid turnaround times in cancer treatment planning. In-house hospital laboratories allow oncologists to obtain diagnostic results and initiate targeted therapies within days, bypassing the logistical delays inherent in outsourcing to external reference laboratories. As precision medicine becomes the standard of care, major hospital networks have aggressively invested in internal molecular pathology infrastructure to retain reimbursement revenue and maintain tighter control over patient data. This dominance is reinforced by the integrated nature of hospital care, where multidisciplinary tumor boards rely on immediate access to diagnostic insights for real-time decision-making.
Furthermore, the increasing availability of compact, automated diagnostic platforms has empowered even community hospitals to perform “near-patient” testing, effectively decentralizing the market and ensuring that the majority of companion diagnostic volume is captured directly at the point of care.
Liquid Biopsy Blood-Based Testing Revolutionizing Precision Cancer Detection
Liquid biopsy technology is fundamentally transforming the oncology companion diagnostic market by enabling non-invasive blood-based biomarker detection, removing the need for tissue biopsies. The detection of circulating tumor DNA (ctDNA) allows for the assessment of actionable mutations, resistance mechanisms, and minimal residual disease via a single blood draw. Significant investment is driving platform development; notably, Foundation Medicine’s FoundationOne Liquid CDx holds FDA approvals for multiple indications. Beyond stratification, applications are extending to real-time treatment monitoring and early resistance detection.
Adoption is accelerating due to clinical convenience and superior detection capabilities. Multi-analyte tests, such as CancerSEEK, combine DNA mutations, methylation profiles, and protein biomarkers to detect multiple cancer types with high sensitivity. Research advances in 2025 regarding exosome analysis and multi-omics approaches enable comprehensive tumor characterization from blood samples. Continuous technological refinement is reducing minimum DNA input requirements, expanding applicability to early-stage cancers. As FDA approvals for liquid biopsy companion diagnostics increase, this segment positions itself as a rapidly growing frontier in precision oncology.
Clinical Trial Enrollment Validates Diagnostic Utility and Adoption
Large-scale clinical studies in 2025 demonstrated the critical role of the oncology companion diagnostic market in patient selection. The SERENA-6 Phase III trial successfully enrolled 3,256 patients to assess ctDNA monitoring for ESR1 mutations. Commercial diagnostics proved vital for inclusion. Precisely 548 patients in that trial exhibited detectable ESR1 mutations identified by the Guardant360 CDx. Smaller cohorts also relied heavily on precision testing. The EMBER-3 trial treated 138 patients with imlunestrant based strictly on CDx findings. These figures prove that pharmaceutical success now hinges on robust diagnostic partnerships.
Real-world evidence further cements the value of these tests. A 2025 study utilizing the Flatiron Health database analyzed records from 7,772 patients with metastatic breast cancer. Researchers evaluated 222 of these individuals for ESR1 mutations at baseline using commercial CDx tests. Additionally, the VISION trial enrolled 313 patients to validate tepotinib efficacy alongside its companion diagnostic. Early-phase studies show similar reliance. The Beamion LUNG-1 Phase Ib trial included a specific cohort of 71 patients to validate the Oncomine Dx Target Test. Such integration across all trial phases ensures a steady pipeline for the oncology companion diagnostic market.
New Coding and Reimbursement Structures Incentivize Market Growth
Financial incentives for the oncology companion diagnostic market improved significantly through specific 2025 coding updates. CMS established a separate payment threshold for diagnostic radiopharmaceuticals with a per-day cost exceeding USD 630, effective January 1, 2025. This change allows laboratories to recover costs for high-value tests. However, general payment rates faced pressure. The final 2025 Medicare Physician Fee Schedule set the conversion factor at USD 32.35. This figure represents a decrease of USD 0.94 compared to the 2024 rate. Laboratories must now rely on volume and specialized codes to maintain profitability.
The American Medical Association introduced distinct codes to capture value for genomic testing. A new CPT code, 81515, allows for reporting specific genomic algorithm analyses in 2025. Another addition, CPT code 81558, specifically addresses post-transplant gene expression profiling. Furthermore, 1 new Multianalyte Assays with Algorithmic Analyses (MAAA) code, 0020M, was implemented for CNS tumor methylation classification. CMS also finalized 3 distinct CPT codes (38225, 38226, 38227) for CAR-T therapy preparation. These specific identifiers facilitate precise billing. Proper coding infrastructure is essential for the sustained revenue growth of the oncology companion diagnostic market.
Leading Competitors Expand Genomic Coverage and Global Reach
Key players in the oncology companion diagnostic market aggressively expanded their testing capabilities in 2025. Tempus AI launched its xT CDx test nationally in January 2025, offering a profile of 648 genes. Competitors matched this depth with their own broad panels. Illumina’s TruSight Oncology (TSO) Comprehensive test now interrogates 517 genes in a single assay. Such comprehensive profiling supports the trend toward tumor-agnostic therapies. Roche Diagnostics maintains active partnerships with over 85 pharmaceutical companies as of 2025. Their diagnostics division reports a total of 200 collaborative projects, securing a dominant industry position.
Market penetration metrics reveal massive reach for these diagnostic giants. Thermo Fisher’s Oncomine CDx solutions now cover a total of 550 million lives worldwide. Their NGS CDx solution also secured approval for reimbursement in 15 countries globally. Guardant Health demonstrated similar scale. The Guardant360 CDx secured coverage for 300 million covered lives in the US by September 2025. These coverage figures indicate that access to precision testing is becoming universal. Widespread insurance adoption serves as a primary catalyst for the oncology companion diagnostic market.
Emerging Biomarker Targets Define Precision Medicine Opportunities
Novel biological targets discovered in 2025 created fresh opportunities within the oncology companion diagnostic market. Guardant360 CDx received approval to detect 7 specific amino acid mutations in the ESR1 gene, including E380 and Y537. New categories of disease also require precise identification. A Mayo Clinic study re-scored 300 patients to determine HER2-ultralow prevalence. The study identified 171 of these patients as HER2-ultralow, opening a new therapeutic avenue. The FoundationOne Liquid CDx secured approval to detect MET exon 14 skipping alterations. Identifying these rare variants drives demand for high-sensitivity panels.
Technology now detects targets with unprecedented granularity. Imidex’s VisiRad XR device detects lung nodules as small as 6 millimeters. Broad-spectrum tests also gained traction. The Oncomine Dx Express Test detects variants in 46 genes for its EU and Japan indications. Furthermore, Illumina signed 2 new strategic partnerships focused specifically on KRAS companion diagnostics in September 2025. FoundationOne CDx was approved as a companion diagnostic for 1 specific pediatric condition: low-grade glioma. These diverse applications ensure the oncology companion diagnostic market remains indispensable across patient demographics.
Disease Specific Approvals Diversify Market Revenue Streams
The second quarter of 2025 saw a flurry of disease-specific approvals that benefited the oncology companion diagnostic market. The FDA granted 4 approvals for Non-Small Cell Lung Cancer (NSCLC) therapies in Q2 2025 alone. Prostate cancer also saw significant activity. Regulators granted 3 approvals for Prostate Cancer therapies in the same period. Colorectal cancer treatments matched this pace. 3 approvals were granted for Colorectal Cancer therapies in Q2 2025. These clusters of authorization drive focused demand for indication-specific testing panels.
Breast cancer remains a primary driver of diagnostic volume. 3 approvals were granted for Breast Cancer therapies in Q2 2025. Multiple Myeloma also requires complex diagnostics. 3 approvals were granted for Multiple Myeloma therapies in Q2 2025. Approvals extended to rarer indications as well. 1 approval was granted for a rare neuroendocrine tumor, specifically pheochromocytoma, in Q2 2025. Additionally, 1 approval was granted for Head and Neck Squamous Cell Carcinoma (HNSCC). Finally, the 2025 Medicare Physician Fee Schedule update spans 1 calendar year. These diverse applications ensure stability for the oncology companion diagnostic market.
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Top Companies in the Oncology Companion Diagnostic Market
- Abbott Laboratories
- Agilent Technologies
- Bio-Rad Laboratories
- Biocartis
- Exact Sciences
- Genedrive
- Genomic Health
- Guardant Health
- Illumina
- Invivoscribe
- Myriad Genetics
- QIAGEN
- Roche Diagnostics
- Sysmex Corporation
- Thermo Fisher Scientific
- Other Prominent Players
Market Segmentation Overview
By Product & Services
- Product
- Instrument
- Consumables
- Software
- Services
By Technology
- Polymerase Chain Reaction (PCR)
- Next-generation Sequencing (NGS)
- Immunohistochemistry (IHC)
- In Situ Hybridization (ISH)/Fluorescence In Situ Hybridization (FISH)
- Other Technologies
By Disease Type
- Breast Cancer
- Non-small Cell Lung Cancer
- Colorectal Cancer
- Leukemia
- Melanoma
- Prostate Cancer
- Others
By End-use
- Hospital
- Pathology/Diagnostic Laboratory
- Academic Medical Center
By Region
- North America
- Europe
- Asia Pacific
- Middle East and Africa
- South America
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