United States Cancer Biomarker Testing Market to Reach US$ 67.74 Billion by 2033, Driven by Precision Oncology and Advanced Genomic Profiling | Top Companies are Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., Guardant Health

The Global Cancer Biomarker Testing Market reached US$24.86 billion in 2024 and is expected to reach US$67.74 billion by 2033, growing at a CAGR of 11.5% during the forecast period 2025-2033.

The Cancer Biomarker Testing market involves diagnostic tests that detect specific genetic, protein, or cellular markers to guide cancer diagnosis, prognosis, and treatment selection. Rising adoption of precision oncology drives market growth. Technological advancements in next-generation sequencing, liquid biopsy, and multiplex assays enhance accuracy. Increasing prevalence of cancers and demand for personalized therapies fuel adoption. Supportive regulations and healthcare investments further accelerate market development.

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☛ Global Cancer Biomarker Testing Market Recent Developments 2025:

United States: Recent Industry Developments
✅ In September 2025, Exact Sciences launched CancerguardTM, a multi-cancer early detection blood test analyzing multiple biomarker classes to detect a wide range of cancers, including those often undiagnosed until later stages.

✅ In August 2025, Exact Sciences acquired exclusive rights to Freenome's blood-based colorectal cancer screening tests, aiming to enhance early detection capabilities.

✅ In May 2025, the AACR Cancer Progress Report highlighted the lifesaving impact of federal investments in cancer research, showcasing advancements in understanding blood cancers and their contribution to groundbreaking treatments.

Japan: Recent Industry Developments
✅ In May 2025, Illumina received approval from Japan's Ministry of Health, Labour and Welfare for TruSightTM Oncology Comprehensive, a genomic profiling test analyzing over 500 genes to assist in targeted therapy selection.

✅ In July 2025, Mirxes Japan and Nagawa Pharmaceutical launched a nationwide initiative to promote gastric health and early detection of gastric cancer, co-initiating a comprehensive early cancer detection ecosystem.

✅ In February 2025, HaploX Group established HaploX JAPAN K.K. in Osaka City, focusing on providing services related to life sciences, including cancer gene testing and analysis, to expand its presence in the Japanese market.

☛ Common Types of Biomarker Tests

Genetic / Genomic Biomarkers: Mutations, amplifications, deletions (e.g., EGFR, KRAS, BRAF, HER2, BRCA). Guides targeted therapy and immunotherapy.

Protein Biomarkers: Detect proteins like PSA, CA-125, CEA for diagnosis and treatment monitoring.

Epigenetic Biomarkers: Methylation patterns or histone modifications associated with cancer.

Circulating Tumor DNA (ctDNA) / Liquid Biopsies: Minimally invasive detection of tumor DNA in blood for real-time monitoring.

RNA / miRNA Biomarkers: Expression profiles used for cancer classification and prognosis.

☛ Recent Trends & Innovations
Next-Generation Sequencing (NGS): Multi-gene panels for comprehensive mutation profiling.

Liquid Biopsies: Non-invasive detection of ctDNA, circulating tumor cells, and exosomes.

Immunotherapy Biomarkers: PD-L1 expression, tumor mutational burden (TMB), microsatellite instability (MSI) guide checkpoint inhibitor therapy.

Multi-Omics Approaches: Integration of genomics, transcriptomics, proteomics, and metabolomics for detailed profiling.

AI & Machine Learning: Predictive models for biomarker discovery and personalized therapy.

Companion Diagnostics: Co-developed tests with targeted therapies to identify patients likely to benefit.

☛ Global Cancer Biomarker Testing Market Competitve Landscape:

F. Hoffmann-La Roche Ltd, Illumina, Inc., Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., Guardant Health, Agilent Technologies, Inc., Quanterix, Exact Sciences Corporation, QIAGEN and Takara Bio Inc., among others.

Research Methodology

We follow a hybrid research approach, combining qualitative insights with rigorous quantitative analysis to deliver reliable and comprehensive market intelligence. Our process begins with extensive secondary research, drawing on trusted industry reports, proprietary databases, and credible market sources. This is then reinforced through targeted primary research, including structured surveys and in-depth interviews with industry leaders, subject matter experts, and key market participants.

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☛ Segment Covered in the Global Cancer Biomarker Testing Market:

By Test Type: Genetic Biomarker Testing, Protein Biomarker Testing, Circulating Tumor DNA (ctDNA) Testing, Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Others

By Product Type: Instruments (PCR Machines, NGS Platforms, Mass Spectrometers, ctDNA Detection Devices, Others), Kits & Reagents

By Cancer Type: Lung Cancer, Prostate Cancer, Breast Cancer, Leukemia, Others

By Application: Drug Discovery and Development, Disease Screening, Treatment Planning, Others

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☛ Regional Analysis for Global Cancer Biomarker Testing Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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