Cancer Biomarker Testing Market Analysis: FDA Approvals, Technology Shifts & Competitive Landscape

Cancer-Biomarker-Testing Market Size and Forecast

DataM Intelligence has published a new research report on "Cancer-Biomarker-Testing Market Size 2025". The report explores comprehensive and insightful Information about various key factors like Regional Growth, Segmentation, CAGR, Business Revenue Status of Top Key Players and Drivers. The purpose of this report is to provide a telescopic view of the current market size by value and volume, opportunities, and development status.

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➢ Recent FDA Approvals:

✦ The FDA approved Guardant360 CDx, a liquid biopsy for comprehensive genomic profiling, as a companion diagnostic for BRAF V600E-mutant metastatic colorectal cancer to guide treatment with Braftovi, Erbitux, and chemotherapy; this marks its 25th indication across tumor types.

✦ This blood-based test enables non-invasive detection when tissue is unavailable, supported by phase 3 BREAKWATER trial data showing improved response rates, progression-free survival, and overall survival.​

➢ Technological Advances:

✦ Liquid biopsies, including ctDNA analysis, are improving for early detection and monitoring, with machine learning reducing false positives; challenges remain in tumor localization.​

✦ Experts forecast multimodal precision tools beyond DNA sequencing, incorporating RNA, proteomics, and AI-driven digital pathology for better tumor phenotyping in 2026.

➢ Recent Developments:

✅ In January 2026, Roche Diagnostics expanded its next-generation sequencing (NGS) oncology portfolio in the U.S. with an updated comprehensive genomic profiling test. The launch improves detection of rare and actionable cancer biomarkers across solid tumors. It supports broader adoption of precision medicine in community oncology settings.

✅ In December 2025, Thermo Fisher Scientific announced a strategic investment to scale up liquid biopsy-based biomarker testing at its California facility. The expansion focuses on minimally invasive cancer diagnostics for lung and colorectal cancers. Commercial rollout is targeted for early 2026.

✅ In November 2025, Guardant Health partnered with leading U.S. cancer centers to accelerate real-world adoption of blood-based biomarker testing. The collaboration aims to integrate liquid biopsy data into routine clinical workflows. It strengthens evidence generation for early cancer detection.

➢ Key Players:

Illumina, Inc., F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., Abbott, QIAGEN, Siemens Healthineers AG, Bio-Rad Laboratories, Inc., Agilent Technologies, BioMérieux, and Foundation Medicine, Inc., among others.

Growth Forecast Projected:

The Global Cancer-Biomarker-Testing Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2032. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Cancer-Biomarker-Testing Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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➢ Key Segments:

✦ By Test Type:
The market is segmented by test type into genetic biomarker testing, protein biomarker testing, circulating tumor DNA (ctDNA) testing, polymerase chain reaction (PCR), next-generation sequencing (NGS), and others. Genetic and protein biomarker testing are widely used for identifying disease-specific molecular signatures and guiding precision medicine. ctDNA testing is gaining strong traction as a non-invasive liquid biopsy approach for early detection and disease monitoring. PCR remains a standard technique due to its high sensitivity and rapid turnaround, while NGS is increasingly adopted for comprehensive genomic profiling. The "others" segment includes emerging molecular and multi-omics testing approaches.

✦ By Product Type:
Based on product type, the market is divided into instruments and kits & reagents. Instruments include PCR machines, NGS platforms, mass spectrometers, ctDNA detection devices, and others, which are essential for high-throughput and accurate molecular analysis. Kits & reagents account for a significant share due to their recurring usage, standardized protocols, and compatibility with multiple platforms, supporting routine diagnostics and research applications.

✦ By Cancer Type:
By cancer type, the market includes lung cancer, prostate cancer, breast cancer, leukemia, and others. Lung and breast cancer represent major segments due to high global incidence and extensive biomarker-driven research. Prostate cancer testing is widely used for risk stratification and treatment selection, while leukemia benefits from advanced molecular diagnostics for disease classification and monitoring. The "others" category covers colorectal, ovarian, and other solid and hematological malignancies.

✦ By Application:
In terms of application, the market is segmented into drug discovery and development, disease screening, treatment planning, and others. Drug discovery and development dominate as biomarker testing supports target identification, patient stratification, and clinical trial optimization. Disease screening is expanding with the adoption of early detection and liquid biopsy technologies. Treatment planning leverages biomarker insights to personalize therapies, while the "others" segment includes prognosis, therapy monitoring, and companion diagnostics.

➢ Regional Analysis for 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)

Benefits of the Report:

Chapter 1: Lays the foundation by defining the scope of the report, highlighting core market segments across regions, product types, and applications. It delivers a clear snapshot of current market size, growth potential, and how the industry is expected to evolve in both the near and long term.

Chapter 2: Spotlights the most impactful market insights, unveiling the transformative trends and forces shaping the future of the industry.

Chapter 3: Provides a deep dive into the competitive landscape of , covering revenue shares, strategic initiatives, and notable mergers & acquisitions that are reshaping the market.

Chapter 4: Presents detailed company profiles of leading players featuring financial performance, product portfolios, profit margins, and key milestones that set them apart in the industry.

Chapters 5 & 6: Break down revenue analysis at both regional and country levels, offering precise data on market size, growth drivers, and expansion opportunities across global markets.

Chapter 7: Analyzes the market by product type, spotlighting segment-specific opportunities and helping stakeholders identify untapped, high-growth areas.

Chapter 8 :Explores the market through application-based segmentation, assessing demand across industries and pinpointing downstream sectors with the strongest potential for growth.

Chapter 9: Maps the industry's supply chain in detail, tracing upstream and downstream activities to provide clarity on value creation across the ecosystem.

Chapter 10: Wraps up with a concise summary of the report's key insights distilling the most critical findings and strategic takeaways for decision-makers and stakeholders.

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FAQ

Q1: What is the current size of the Cancer-Biomarker-Testing Market?

A: The global cancer biomarker testing market was valued at US$ 29.83 Billion in 2023. The market size reached US$ 33.37 Billion in 2024 and is expected to reach US$ 96.53 Billion by 2032.

Q2: How rapidly will the Market expand?

A: The Cancer-Biomarker-Testing market is projected to grow at a CAGR of 22.1% between 2025 and 2032.

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