(MENAFN- GlobeNewsWire - Nasdaq) U.S. Market Shows Robust Momentum, Accounting for Significant Global Share as Hospitals, Research Institutes, and Biotech Firms Accelerate Biomarker-Driven Cancer CareAustin, Sept. 05, 2025 (GLOBE NEWSWIRE) -- Pediatric Cancer Biomarker Market Size & Growth Analysis
According to SNS Insider, the global pediatric cancer biomarker market was valued at USD 830.41 million in 2023 and is projected to reach USD 1,635.68 million by 2032, growing at a CAGR of 7.84% during the forecast period of 2024–2032. This growth is underpinned by the rising global burden of pediatric cancer, increased focus on precision oncology, and greater availability of non-invasive diagnostic tools.
Biomarkers are critical in improving early detection, guiding therapeutic decisions, and monitoring disease progression in children. In the U.S., which holds a substantial share of the global market, adoption is fueled by strong R&D investment, collaborative research initiatives, and government-backed pediatric oncology programs.
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Market Overview
Pediatric cancers, though rare compared to adult cancers, remain one of the leading causes of disease-related mortality among children worldwide. The need for early, accurate, and minimally invasive diagnostic tools has spurred significant innovation in biomarker research. Pediatric cancer biomarkers, including genomic, proteomic, and metabolomic signatures, are revolutionizing how clinicians approach diagnosis, risk stratification, and treatment selection.
From liquid biopsy platforms that detect circulating tumor DNA to advanced imaging biomarkers that identify disease recurrence, the field is rapidly evolving. The market's momentum is also supported by regulatory initiatives such as the U.S. RACE for Children Act, which encourages the development of oncology drugs and diagnostics for pediatric populations.
Major Companies in the Pediatric Cancer Biomarker Market Include:
F. Hoffmann-La Roche Ltd – Cobas EGFR Mutation Test, FoundationOne Liquid Abbott Laboratories – Vysis ALK Break Apart FISH Probe Kit, RealTime IDH1 Assay Siemens Healthineers – ADVIA Centaur AFP Assay, IMMULITE Tumor Marker Assays Thermo Fisher Scientific Inc. – Oncomine Childhood Cancer Research Assay, Ion AmpliSeq Panels QIAGEN N.V. – QIAseq Targeted DNA Panels, ipsogen JAK2 RGQ PCR Kit Myriad Genetics, Inc. – MyRisk Hereditary Cancer Test Beckman Coulter, Inc. – Access AFP Assay, Flow Cytometry Panels Bio-Rad Laboratories, Inc. – Bio-Plex Pro Cancer Biomarker Panels Agilent Technologies, Inc. – SureSelect Cancer All-In-One Panels, ALK FISH Probe BIOMÉRIEUX SA. – VIDAS Tumor Markers, NephroCheck Biomarker Test RayBiotech, Inc. – Human Cancer Biomarker Array, ELISA Kits for Oncology Randox Laboratories Ltd. – Evidence Investigator Tumor Marker Array, Biochip Technology Illumina, Inc. – TruSight Oncology 500, NGS Panels for Pediatric Cancer AstraZeneca PLC – Companion Diagnostics for Targeted Therapies Guardant Health, Inc. – Guardant360 CDx Liquid Biopsy ICON Public Limited Company – Biomarker Discovery & Validation Services Merck Sharp & Dohme Corp. – Oncology Biomarker Partnerships
Segment Analysis
By Indication
In 2023, the leukemia segment dominated the pediatric cancer biomarker market with a share of 41.2%. Leukemia is the most prevalent pediatric cancer, and highly specific biomarkers are needed for early detection and successful treatment. The need for biomarkers like minimal residual disease (MRD) markers has grown, enabling improved monitoring of the disease and personalized treatment.
Conversely, the segment of CNS tumors is witnessing the fastest growth. CNS tumors like gliomas and medulloblastomas are some of the most difficult childhood cancers to treat and diagnose. The enhanced focus on the cerebrospinal fluid (CSF)-based biomarkers and genetic analysis has improved the detection at the earliest stages, thereby making the segment the most growing in the industry.
By Biomarker
The CD19, CD20, and CD22 biomarker category held the highest market share in 2023 at 30.1% of the total. The biomarkers are critical for the diagnosis and targeted therapy of hematologic cancers like B-cell leukemia and lymphoma. Their use in broad-based applications of CD-targeting immunotherapies like CAR-T cell therapies has consolidated their position in the treatment of children's cancers.
The anaplastic lymphoma receptor tyrosine kinase gene (ALK) segment is experiencing the most rapid growth. ALK-positive tumors, such as neuroblastomas and anaplastic large cell lymphomas (ALCL), are attracting more attention as a result of new targeted therapies. ALK inhibitors' approval and ongoing research on new ALK-targeted treatments are fueling this segment's growth.
By End Use
The hospital segment provided the highest percentage of 41.2% in 2023. Hospitals are the core centers of pediatric cancer diagnosis and treatment with access to new diagnostic technologies and dedicated oncology units. Availability of biomarker-based diagnostic assays in hospital pathology laboratories has provided an opportunity for early detection with resultant improved management of patients.
In contrast, the segment of research institutions is the fastest-growing. Increasing academic and clinical research into pediatric cancer biomarkers, driven by government and private funding, is heavily increasing this segment. Research institutions lead in the discovery of new biomarkers, the development of clinical trials, and translation of research to clinical application, which is fuelling the quick growth of the segment.
Regional Analysis
North America was the market leader in pediatric cancer biomarkers in 2023, holding 43.8% of the overall market share. The region's established healthcare infrastructure, advanced adoption of diagnostic technologies, and strong research support have entrenched its leadership in the market. Having top pharmaceutical and biotechnology companies and rising investments in pediatric oncology continues to fuel growth.
The Asia-Pacific region is expected to witness the highest growth in the pediatric cancer biomarker market. The growth in healthcare infrastructure, enhanced awareness regarding pediatric cancers, and heightened government efforts towards biomarker research are the primary drivers for regional growth. The use of biomarker-based diagnostic products is gaining momentum, especially in China, Japan, and India.
Recent Developments
November 2024: A newly approved pediatric leukemia-targeted therapy was released, uniquely intended for children's treatment of KMT2A-rearranged acute leukemia. The novel drug maximizes the treatment benefit with minimal side effects. September 2024: Scientists discovered a new immune-based biomarker that greatly enhances the early diagnosis of pediatric CNS tumors. The biomarker may improve diagnostic accuracy and result in more successful treatment options. July 2024: A new liquid biopsy test for pediatric solid tumors was introduced, allowing for non-invasive, real-time detection of cancer growth and response to treatment. The test is a significant step forward in precision medicine.
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Statistical Insights and Trends Reporting
In 400,000 children and adolescents aged 0-19 years, cancer was diagnosed globally, with leukemia being the most frequently reported cancer, followed by CNS tumors and lymphomas. Around 68% of childhood cancers employed biomarker-based diagnostics, with hospitals being the largest users. Research institutions experienced a 20% boost in biomarker-related research. Pediatric cancers saw the 22% growth in liquid biopsy usage during 2023, with promising advancements in detecting diseases at earlier stages and monitoring responses to therapy.
Pediatric Cancer Biomarker Market Report Scope
| Report Attributes | Details |
| Market Size in 2023 | Market Size in 2023 |
| Market Size by 2032 | Market Size by 2032 |
| CAGR | CAGR |
| Base Year | 2023 |
| Forecast Period | 2024-2032 |
| Historical Data | 2020-2022 |
| Report Coverage | Market Size, Segments Analysis, Competitive Landscape, Regional Analysis, DROC & SWOT Analysis, Forecast Outlook |
| Key Segments | . By Indication [Leukemia, Neuroblastoma, CNS Tumors, Lymphoma, Others]
. By Biomarker [Alpha-fetoprotein (AFP), Neuron-specific enolase (NSE), CD19, CD20, CD22, ALK (anaplastic lymphoma receptor tyrosine kinase gene), Others]
. By End Use [Hospital, Diagnostic Laboratories, Oncology Centers, Research Institutions] |
| Regional Analysis | North America (US, Canada, Mexico), Europe (Germany, France, UK, Italy, Spain, Poland, Turkey, Rest of Europe), Asia Pacific (China, India, Japan, South Korea, Singapore, Australia, Rest of Asia Pacific), Middle East & Africa (UAE, Saudi Arabia, Qatar, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Rest of Latin America) |
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