PUBLISHER: Grand View Research | PRODUCT CODE: 1869724
PUBLISHER: Grand View Research | PRODUCT CODE: 1869724
The global cancer and tumor biomarker-based assay market size was estimated at USD 10.97 billion in 2024 and is projected to reach USD 26.81 billion by 2033, growing at a CAGR of 10.50% from 2025 to 2033, driven by the growing demand for early diagnosis, personalized treatment, and precision oncology. Biomarker assays-covering genomic, proteomic, and metabolomic markers-enable clinicians to detect cancers earlier, predict disease progression, and guide therapy selection with higher accuracy.
Advances in technologies such as next-generation sequencing (NGS), liquid biopsy, and multiplex immunoassays are enhancing assay sensitivity and throughput while reducing turnaround times. Pharmaceutical companies increasingly collaborate with diagnostic developers to create companion diagnostics for targeted therapies, further fueling market growth.
Rapid advances in analytic platforms are transforming biomarker testing. Next-generation sequencing (NGS) platforms have become faster, cheaper and more flexible, enabling broad genomic panels, tumor profiling and discovery of rare variants at scale - which drives demand for assay development and clinical adoption. Meanwhile, liquid biopsy (cfDNA, CTCs, exosomes) allows minimally invasive serial monitoring, early detection and therapy resistance tracking; its convenience expands testing volumes beyond tissue-only workflows. Multiplex PCR/immunoassay platforms and digital pathology/imaging biomarkers further enable simultaneous measurement of multiple markers from limited samples, improving diagnostic yield and cost per actionable result. Together these technologies lower per-test costs, shorten time-to-result for certain workflows, and unlock new clinical use cases (screening, MRD, monitoring), all of which expand total addressable market and invite investment from diagnostics firms and pharma co-development partners.
The shift to targeted oncology therapeutics has created a tight coupling between drugs and the biomarker tests that identify eligible patients. As more targeted therapies and immunotherapies receive approvals tied to specific genomic, proteomic or immunologic signatures, pharma companies increasingly require validated companion diagnostics for clinical trials and regulatory approval. This raises demand for clinically validated biomarker assays across indications and supports higher price-per-test economics when tests are linked directly to expensive therapies. Furthermore, broader adoption of comprehensive genomic profiling and tumor-agnostic approvals increases use of multiplex assays and panel testing, concentrating spend on assays that can guide multiple treatment decisions. These dynamics fuel M&A and partnerships between diagnostic companies and drug developers, accelerating commercial rollouts of biomarker assays globally.
Biomarker assays used for treatment selection-especially companion diagnostics-face stringent regulatory pathways that affect time-to-market and commercialization costs. Regulatory agencies require rigorous analytical validation, clinical validation, and often co-submission or alignment with therapeutic approvals; novel biomarkers or rare variants complicate sample accrual for validation studies. Varying regional frameworks (e.g., FDA, EMA, and evolving IVD rules) create complexity for global launches and can force iterative studies or label differences across geographies. Additionally, regulators increasingly scrutinize clinical utility and real-world performance, pushing manufacturers to generate post-market evidence and to adopt quality systems (IVDR compliance, clinical evidence generation), which raises development timelines and CAPEX but ultimately improves clinical confidence and payer acceptance.
Global Cancer And Tumor Biomarker-based Assay Market Segmentation
This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global cancer and tumor biomarker-based assay market based on cancer type, biomarker type, end use, and region: