Pediatric Cancer Biomarkers Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Indication (Leukemia, Neuroblastoma, CNS Tumors, Lymphoma, Others), By Type (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), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 815.53 Million
CAGR (2026-2031)	9.34%
Fastest Growing Segment	Leukemia
Largest Market	North America
Market Size (2031)	USD 1393.78 Million

Market Overview

The Global Pediatric Cancer Biomarkers Market will grow from USD 815.53 Million in 2025 to USD 1393.78 Million by 2031 at a 9.34% CAGR. Pediatric cancer biomarkers define biological molecules or genetic alterations indicative of malignant processes, utilized to diagnose, prognose, and monitor therapeutic responses in childhood cancers. The market is primarily driven by the increasing integration of precision oncology, which necessitates accurate molecular profiling to tailor treatments and mitigate lasting adverse effects in developing physiologies. Additionally, the rising emphasis on minimally invasive diagnostic methods, such as liquid biopsies, propels the demand for biomarker platforms that offer rapid testing alternatives compared to traditional tissue biopsies.

Despite the sector's potential, market expansion is significantly challenged by the scarcity of pediatric tumor samples and the inherent biological heterogeneity of childhood cancers, which complicate extensive clinical validation. Statistical data highlights the critical need for these diagnostic solutions. According to the American Association for Cancer Research, in 2025, approximately 400,000 children worldwide are estimated to develop cancer annually. This substantial burden emphasizes the urgency for robust biomarker development, yet the difficulties in recruiting sufficient pediatric cohorts for regulatory approval remain a substantial barrier to rapid commercialization.

Key Market Drivers

The accelerated shift toward precision medicine is fundamentally reshaping the Global Pediatric Cancer Biomarkers Market by prioritizing molecular profiling over broad-spectrum treatments. As clinicians increasingly rely on genomic data to identify actionable alterations, the demand for assays that can guide the selection of immunotherapies and kinase inhibitors has surged. This transition addresses the critical need to reduce the toxicity associated with conventional chemotherapy while improving outcomes in young patients with relapsed or refractory malignancies. Validating this trend, according to the American Association for Cancer Research, December 2025, in the 'AACR Pediatric Cancer Progress Report 2025', the FDA approved more than 20 molecularly targeted therapies and over 10 immunotherapies for pediatric cancers between 2015 and 2025. Such regulatory milestones underscore the growing commercial and clinical reliance on biomarkers to match patients with these newly available, life-saving interventions.

Concurrently, increased government funding and academic research grants are providing the essential capital required to de-risk the development of pediatric-specific diagnostic tools. Because the pediatric oncology market is smaller than the adult sector, public sector support is crucial for sustaining the high costs of biomarker discovery and clinical validation. According to the National Institutes of Health, September 2025, the agency announced a doubling of the annual budget for the Childhood Cancer Data Initiative to $100 million to accelerate data generation and analysis. This influx of resources directly supports the creation of robust data infrastructure needed to identify novel biomarkers. Furthermore, these investments aim to bridge global disparities in care quality. According to the World Health Organization, in 2025, while survival rates in high-income countries exceed 80%, less than 30% of children with cancer in low- and middle-income nations are cured, highlighting the urgent need for cost-effective biomarker solutions to improve early diagnosis worldwide.

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Key Market Challenges

The scarcity of pediatric tumor samples and the inherent biological heterogeneity of childhood cancers constitute a significant barrier to the growth of the Global Pediatric Cancer Biomarkers Market. Unlike adult malignancies, pediatric cancers are rare and biologically distinct, often driven by unique genetic alterations that differ vastly between patients. This diversity necessitates large-scale studies to establish the clinical validity of new biomarkers. However, the limited availability of high-quality tissue samples makes it exceptionally difficult for researchers to generate the statistically significant data required for regulatory submissions. Consequently, diagnostic companies face prolonged development timelines and elevated costs, which discourages investment and delays the commercial launch of precision testing platforms.

This fundamental constraint restricts the ability of market players to rapidly expand their portfolios. The difficulty in recruiting adequate study cohorts is underscored by the low incidence rates of these malignancies compared to adult cancers. According to the American Cancer Society, in 2024, an estimated 9,620 children between birth and 14 years of age were diagnosed with cancer in the United States. This relatively small patient population creates a bottleneck for clinical trial recruitment, directly hampering the validation of new biomarkers and stalling overall market expansion.

Key Market Trends

The Proliferation of Minimal Residual Disease (MRD) Testing Applications is becoming a pivotal trend in the market, driven by the critical need to assess treatment efficacy and predict relapse with high sensitivity. Unlike traditional morphological assessments, advanced MRD assays are now integral to clinical trials and regulatory approvals, serving as primary endpoints for validating novel therapeutics. This shift is exemplified by the increasing reliance on MRD status to guide therapeutic decisions in hematologic malignancies. According to Ascentage Pharma, December 2025, in the 'FDA and EMA Clear Phase 3 POLARIS-1 Trial in Newly Diagnosed Ph+ ALL' press release, the company reported that its combination therapy achieved a molecular MRD-negativity rate of approximately 65% after three treatment cycles, highlighting the test's central role in demonstrating the clinical benefit of new drug candidates for pediatric and adult patients.

Simultaneously, the Emergence of Functional Precision Medicine Assays is advancing beyond static genomic profiling to evaluate dynamic therapeutic responses, such as drug exposure levels and sensitivity. These functional biomarkers allow clinicians to optimize dosing regimens and mitigate relapse risks caused by suboptimal drug concentration. The push to validate these functional markers is supported by substantial investments in translational research. For instance, according to Memorial Sloan Kettering Cancer Center, December 2024, in the 'MSK Kids 2024: Highlights of Clinical and Research Advances for Pediatric Cancers' report, the center secured a $4.4 million grant from the U.S. Department of Defense to launch the INFLUENCE Trial, which utilizes functional assays to address relapse risks in pediatric leukemia patients.

Segmental Insights

The leukemia segment represents the fastest growing category within the global pediatric cancer biomarkers market, primarily driven by the high prevalence of this malignancy among children. This rapid expansion is supported by the increasing adoption of precision medicine, which necessitates specific biomarkers for accurate risk stratification and the application of targeted therapies. Furthermore, regulatory agencies such as the U.S. Food and Drug Administration have actively authorized companion diagnostics essential for leukemia treatment protocols. This reliance on molecular characterization to optimize clinical outcomes continues to fuel the demand for leukemia-specific biomarkers.

Regional Insights

North America dominates the Global Pediatric Cancer Biomarkers Market due to extensive investments in precision medicine and a highly developed healthcare infrastructure. The region benefits from the active presence of leading pharmaceutical companies and robust government support for oncology research. Notably, the National Cancer Institute (NCI) drives innovation through programs such as the Molecular Characterization Initiative, which significantly enhances biomarker discovery. Furthermore, the U.S. Food and Drug Administration (FDA) fosters market growth by implementing regulatory policies that incentivize the development of targeted pediatric therapies. These factors collectively ensure the rapid adoption of advanced diagnostic technologies across the region.

Recent Developments

• In January 2025, Foundation Medicine, Inc. announced that the U.S. Food and Drug Administration (FDA) approved FoundationOne CDx as a companion diagnostic for a targeted therapy used in pediatric oncology. The approval allows the comprehensive genomic profiling test to be used to identify patients with pediatric low-grade glioma (pLGG) who harbor a BRAF fusion, rearrangement, or BRAF V600 mutation and may benefit from treatment with tovorafenib. This milestone marked the first time the diagnostic was approved specifically for a pediatric central nervous system tumor indication, expanding access to precision medicine for children with this common form of brain cancer.
• In August 2024, Illumina, Inc. received approval from the FDA for its TruSight Oncology (TSO) Comprehensive test, a distributable in vitro diagnostic kit that profiles over 500 genes. The approval included a companion diagnostic indication to identify pediatric and adult patients with solid tumors harboring neurotrophic tyrosine receptor kinase (NTRK) gene fusions who may benefit from a specific targeted therapy. This development provided a decentralized solution for comprehensive genomic profiling, enabling laboratories to perform testing in-house and facilitating the identification of rare, actionable biomarkers in pediatric cancer patients globally.
• In July 2024, Thermo Fisher Scientific announced a strategic collaboration with the National Cancer Institute (NCI) to support the myeloMATCH precision medicine clinical trial. Under this partnership, the company agreed to provide its next-generation sequencing technology to rapidly screen bone marrow and blood samples for specific genetic biomarkers in adult and pediatric patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The initiative aims to accelerate the enrollment of patients into sub-studies matched to their molecular profiles, thereby advancing the research and development of biomarker-driven treatments for these aggressive pediatric and adult blood cancers.
• In April 2024, Day One Biopharmaceuticals announced that the FDA granted accelerated approval for its oral type II RAF inhibitor for the treatment of patients six months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG). This regulatory milestone introduced the first systemic therapy approved for children with pLGG that harbor a BRAF fusion or rearrangement, or a BRAF V600 mutation. The launch highlighted the critical role of biomarker testing in pediatric oncology, as the therapy is specifically indicated for patients whose tumors exhibit these specific genetic alterations, driving demand for accurate molecular diagnostic tools in this market.

Key Market Players

• Roche Diagnostics
• Thermo Fisher Scientific
• Qiagen
• Abbott
• Illumina
• Bio-Rad
• Myriad Genetics
• Agilent
• Roche
• Takara Bio

By Indication	By Type	By End-Use	By Region
Leukemia Neuroblastoma CNS Tumors Lymphoma Others	Alpha-fetoprotein (AFP) Neuron-specific enolase (NSE) CD19 CD20 CD22 ALK (anaplastic lymphoma receptor tyrosine kinase gene) Others	Hospital Diagnostic Laboratories Oncology Centers Research Institutions	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Pediatric Cancer Biomarkers Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Pediatric Cancer Biomarkers Market, By Indication:

• Leukemia
• Neuroblastoma
• CNS Tumors
• Lymphoma
• Others

• Pediatric Cancer Biomarkers Market, By Type:

• Alpha-fetoprotein (AFP)
• Neuron-specific enolase (NSE)
• CD19
• CD20
• CD22
• ALK (anaplastic lymphoma receptor tyrosine kinase gene)
• Others

• Pediatric Cancer Biomarkers Market, By End-Use:

• Hospital
• Diagnostic Laboratories
• Oncology Centers
• Research Institutions

• Pediatric Cancer Biomarkers Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE