What Are Cancer Biomarkers and Why Are They Critical?

At their core, cancer biomarkers are biological molecules—genes, proteins, or genetic fragments like circulating tumor DNA (ctDNA)—found in blood, other body fluids, or tissues that signal the presence of cancer or provide insight into its behavior. They serve as the "fingerprints" of a tumor. However, cancer biomarkers market value lies in their utility. They effectively segment the patient population, allowing clinicians to identify who will respond to expensive immunotherapies, thereby saving costs and lives. For instance, the demand is so acute that the National Cancer Institute (NCI) requested a budget of USD 7.839 billion for fiscal year 2025, with USD 716 million specifically allocated to the Cancer Moonshot to accelerate these biomarker-driven discoveries.

Where Are Biomarkers Delivering the Most Value?

The application of cancer biomarkers market is bifurcated primarily into drug development and clinical diagnostics. In drug development, biomarkers reduce trial failure rates by ensuring the right patients are enrolled. Labcorp, a giant in this space, supported more than 75% of new FDA-approved drugs in 2024, proving that biomarker data is now a prerequisite for regulatory success.

In clinical diagnostics, the focus is on Companion Diagnostics (CDx) and screening. The utility here is measurable in volume; Exact Sciences, for example, screened over 1 million people with Cologuard in a single quarter of 2024. Furthermore, the shift toward non-invasive testing is palpable, with Guardant Health processing approximately 206,700 clinical oncology tests in 2024, largely driven by the need for blood-based genomic profiling.

What Are the Most Prominent Developments and Milestones?

The period between late 2024 and 2025 has been defined by regulatory breakthroughs that have expanded cancer biomarkers market access. A pivotal moment occurred on October 18, 2024, when Roche received FDA approval for the VENTANA Claudin 18 (43-14A) RxDx Assay, opening a new frontier in gastric cancer treatment. Similarly, Illumina solidified its infrastructure dominance with the FDA approval of TruSight Oncology Comprehensive on August 27, 2024, a kit capable of profiling 500 distinct genes.

On the screening front, the FDA approval of Exact Sciences' Cologuard Plus in late 2024 set a new standard for sensitivity. Simultaneously, the approval of Roche's HPV self-collection solution in May 2024 marked a significant milestone in democratizing access to biomarker-based prevention, moving testing from the clinic to the patient’s home.

What Does the Current Product Pipeline Look Like?

The pipeline in global cancer biomarkers market as of 2025 is dominated by "pan-tumor" liquid biopsies and Multi-Cancer Early Detection (MCED) platforms. The industry is moving beyond single-gene tests toward comprehensive genomic profiling (CGP). For example, N-Power Medicine secured USD 72 million in Series B funding in July 2024 specifically to expand trial networks that utilize these complex biomarker panels.

Innovation is also surging in AI-integrated discovery. AstraZeneca’s USD 247 million commitment to Absci in 2024 to co-develop generative AI antibody drugs highlights how the pipeline is evolving from manual discovery to AI-predicted biomarker targets. Additionally, with the NCI supporting 1,353 competing Research Project Grants in FY 2025, the academic pipeline is robust, feeding early-stage discoveries into commercial validation.

How is the Investment Landscape Shaping Up in 2025?

Capital flow in cancer biomarkers market remains aggressive, favoring established players and late-stage innovators. Venture capital investment in the healthcare sector, including diagnostics, reached a staggering USD 23 billion in 2024, providing a massive war chest for 2025 operations. BioAge Labs, for instance, secured USD 170 million in Series D financing, while Freenome raised USD 254 million to push its early-detection assays toward commercialization.

Strategic consolidation is another defining feature of the current landscape of the cancer biomarkers market. Tempus AI’s acquisition of Ambry Genetics in 2024 for a total deal value of USD 600 million exemplifies the trend of merging data companies with wet-lab genomic providers. Furthermore, AstraZeneca’s planned capital investment of USD 50 billion in the US by 2030 underscores the long-term confidence pharmaceutical giants have in a biomarker-led future.

Who Are the Top 5 Players Ruling the Domain?

The cancer biomarkers market is concentrated among entities that control both the testing infrastructure and the data.

1. Roche: A dominant force in tissue diagnostics and CDx, evident by its aggressive IP strategy with 75 healthcare patents filed in Q3 2024 alone.
2. Exact Sciences: The leader in screening, generating USD 709 million in Q3 2024 revenue, with its screening segment contributing USD 545 million.
3. Guardant Health: The pioneer of liquid biopsy, reporting preliminary 2024 revenue of USD 737 million and achieving an Average Selling Price (ASP) of over USD 3,000.
4. Labcorp: The infrastructure backbone, employing 70,000 people and completing 10 acquisitions in 2024 to widen its testing net.
5. Thermo Fisher Scientific: The enabler of the ecosystem, generating USD 10.54 billion in Q2 2024 revenue, largely through the instrument bases that run these biomarker tests.

Which Cancers Are Witnessing Significant Adoption in the Global Cancer biomarkers market?

Adoption is highest in cancers where targeted therapies are most mature. Colorectal cancer is a prime driver, evidenced by the 6,400 Shield blood tests performed in Q4 2024 immediately post-launch. Gastric cancer has seen a resurgence in biomarker interest following Roche’s Claudin 18 approval.

Melanoma remains a high-value segment. Wherein,  the Clinical Laboratory Fee Schedule in 2025 priced cutaneous melanoma profiling (CPT 81529) at a premium USD 7,193. Furthermore, pan-tumor applications are growing, with Medicare pricing Caris Life Sciences’ pan-tumor panel (CPT 0211U) at USD 8,455 for 2025, signaling high payer willingness to fund complex profiling for metastatic cancers regardless of primary origin.

What Recent Trends Are Shaping Demand?

The most significant trend in the cancer biomarkers market is the "liquid-first" approach. Liquid biopsy is no longer a backup but a primary tool, with Medicare setting reimbursement for the Guardant Shield test at USD 920 effective August 2024. Another trend is the integration of clinical research into routine care. Tempus AI, for example, delivered 66,500 NGS tests in Q2 2024 specifically to match patients to trials, blurring the line between diagnosis and recruitment.

High-value reimbursement is also shaping product development. With Rapid Whole Genome Sequencing (CPT 0094U) priced at USD 7,582, companies are incentivized to develop more comprehensive, data-rich tests rather than simple single-gene assays.

What Key Challenges Are Shaping the Growth Trajectory?

Despite the optimism, cost remains a formidable barrier behind the cancer biomarkers market growth. The 2025 fee schedule lists exome sequence analysis (CPT 84116) at USD 12,000, a price point that challenges healthcare budget sustainability. Additionally, operational costs for providers are high; NeoGenomics reported an adjusted EBITDA of only USD 13 million on USD 146 million revenue in Q3 2024, highlighting the thin margins in pure-play diagnostics.

Regulatory complexity also persists. While approvals are happening, the documentation required is immense, and the European IVDR certification process continues to slow down product launches in the EU compared to the US. Furthermore, while patent activity is high—10,990 healthcare patents were granted in Q3 2024—this creates a "thicket" of IP rights that can hinder smaller innovators from entering the market without facing litigation.

 Segmental Analysis 

Breast Cancer is Set to Enjoy the Highest Market Share and Dominance in the Years to Come 

The breast cancer segment secured the largest market share in cancer biomarkers market by fundamentally redefining the scope of the addressable patient population through two pivotal clinical shifts. The most transformative event occurred in June at the ASCO Annual Meeting, where data from the DESTINY-Breast06 trial validated the efficacy of Enhertu in patients classified as "HER2-Ultralow." This seemingly minor classification change had massive operational implications. It meant that a population previously dismissed as HER2-negative and untreated with targeted agents was now eligible for therapy. This created an immediate, retroactive mandate for pathology departments to re-evaluate millions of metastatic samples with high-sensitivity immunohistochemistry assays. Laboratories could no longer default to a negative report but were forced to adopt complex scoring workflows to distinguish "Ultralow" from "Null," driving a significant spike in assay volume and billable hours.

In parallel, the cancer biomarkers market saw the full clinical operationalization of the AKT pathway following the late 2023 approval of Truqap. Unlike previous therapies that hinged on a single biomarker, the label for Truqap required a comprehensive evaluation of the PIK3CA, AKT1, and PTEN triplet. This regulatory requirement effectively rendered single-gene PCR tests obsolete for this indication, forcing oncologists to transition toward larger, more expensive Next-Generation Sequencing panels that check all three genes simultaneously. This shift from low-cost single markers to high-value multiplex panels significantly increased the revenue captured per breast cancer patient, ensuring the segment’s dominance over other disease indications that rely on simpler diagnostic tools.

Diagnostics Segment: The Shift to "Subscription" Economics

The diagnostics segment captured the highest revenue share in cancer biomarkers market because the industry successfully transitioned from a transactional business model to one resembling a recurring subscription service. This economic evolution was catalyzed in February 2024, when CMS expanded coverage for Natera’s Signatera test to include ovarian cancer surveillance and neoadjuvant breast cancer monitoring. This policy change was critical because it shifted the utility of diagnostics from a one-time event at diagnosis to a serial necessity. Under this new paradigm, "surveillance" implies testing a patient every three to six months to detect recurrence. Consequently, a single patient who historically generated revenue once now generates revenue four to five times annually. This compounding revenue stream allowed the diagnostics segment to significantly outpace drug discovery applications, which rely on lower-volume, sporadic testing.

Furthermore, the operational dynamics of testing were revolutionized by the FDA’s approval of Illumina’s TruSight Oncology Comprehensive kit on August 27, 2024. As the first distributable IVD kit with pan-cancer claims approved for use within local hospital laboratories, it decentralized high-value genomic profiling. Hospitals in the US cancer biomarkers market were incentivized to internalize revenue that was previously outsourced to central reference labs. By bringing these tests in-house, institutions were able to integrate testing more tightly into their clinical workflows, leading to more aggressive and frequent testing protocols. This democratization of access, combined with the recurring nature of surveillance testing, cemented the diagnostics segment as the primary revenue engine of the global biomarkers market.

Genetic Biomarkers: The "Liquid-First" Necessity

Genetic biomarkers, specifically DNA, dominated over protein and RNA segments in cancer biomarkers market because they became the indispensable currency for managing treatment resistance in real-time. The primary driver of this trend was the widespread adoption of Orserdu for ER-positive, HER2-negative breast cancer, which solidified the clinical necessity of liquid biopsy. The drug targets ESR1 mutations, a genetic alteration that is rarely present at primary diagnosis but is acquired after the failure of aromatase inhibitor therapy. This biological reality rendered archived tissue samples from a patient’s original diagnosis clinically useless, as they cannot reveal mutations that evolved years later under treatment pressure. Clinicians were therefore forced to order blood-based genetic testing, or ctDNA analysis, at the time of disease progression to guide therapy.

This shift created a distinct, high-volume market for genetic markers in the cancer biomarkers market that traditional protein-based immunohistochemistry on old tissue slides simply could not address. The reliance on DNA was further entrenched by the standardization of Homologous Recombination Deficiency (HRD) scoring in 2024. As HRD status became the standard-of-care gatekeeper for prescribing PARP inhibitors in ovarian and breast cancer, the industry saw a consolidation around DNA sequencing workflows. Unlike protein expression, which can fluctuate, DNA signatures provided the robust, reproducible data required for these high-stakes therapeutic decisions. By serving as the only viable method to navigate the complexities of acquired resistance and synthetic lethality, genetic biomarkers established themselves as the most critical and lucrative biomolecule segment of the year.

 Regional Analysis 

North America (35.89% Share): The "Regulatory Moat" & Reimbursement Stabilization

North America’s commanding 35.89% market share in cancer biomarkers market was not merely a product of advanced infrastructure but the result of a deliberate structural realignment that centralized value within the United States. The most decisive factor was the FDA’s issuance of the Final Rule on Laboratory Developed Tests on April 29, 2024. By reclassifying these tests under the medical device framework, the regulator effectively constructed a high barrier to entry. While this move introduced significant compliance burdens, it paradoxically strengthened the position of large, well-capitalized US incumbents like LabCorp, Quest Diagnostics, and Foundation Medicine. These entities possessed the financial resilience to navigate the new "IVD-like" environment, creating a regulatory moat that prevented smaller international laboratories from capturing high-value testing volumes. Consequently, revenue recognition remained tightly concentrated within North American borders rather than fragmenting globally.

Simultaneously, the financial architecture of the regional cancer biomarkers market was fortified by the Centers for Medicare & Medicaid Services during the early months of the year. After a 2023 characterized by hesitation and uncertainty regarding payment rates for expanded genomic panels, Medicare Administrative Contractors successfully finalized "gapfill" pricing for CPT codes 81457 through 81459. This resolution provided the reimbursement certainty required for major US hospital systems to abandon limited "hotspot" testing in favor of Comprehensive Genomic Profiling. With the risk of claim denials minimized, the volume of high-cost tests surged, directly inflating the revenue per patient in North America compared to European or APAC markets, where reimbursement remains capped or bundled.

Europe: Regulatory Clarity Fueling Cancer Biomarkers Market Adoption
The European landscape for the market is entering a phase of rapid maturity, driven by the stabilization of the In Vitro Diagnostic Regulation (IVDR). The 2024 achievement of Class C IVDR certification by Agilent Technologies for its PD-L1 assay serves as a critical precedent, streamlining the approval pathway for high-risk cancer biomarkers across the continent. This regulatory certainty is directly accelerating the reimbursement and clinical adoption of complex immuno-oncology markers within national health systems. Furthermore, the region is solidifying its role as a logistical hub for biomarker-driven research. 

Thermo Fisher Scientific’s 2024 inauguration of a specialized clinical trial facility in the Netherlands addresses the critical logistical demand for handling temperature-sensitive biological samples. Such infrastructure investments are vital for supporting the surging volume of cancer biomarkers trials, ensuring that Europe remains a central pillar in global precision oncology development.

Asia Pacific: Disease Prevalence Driving Specific Cancer Biomarkers Demand
The Asia Pacific region represents the fastest-growing frontier for the cancer biomarkers market, primarily catalyzed by the commercialization of targeted diagnostics for regionally prevalent malignancies. Roche’s 2024 FDA approval of the VENTANA Claudin 18 (43-14A) assay acts as a significant volume driver for this region, given the disproportionately high incidence of gastric cancer in East Asian markets. Consequently, the demand for this specific cancer biomarker is projected to skyrocket as local regulatory bodies align with global standards to mandate testing. 

Simultaneously, the aggressive expansion of laboratory infrastructure by global leaders like Labcorp and Quest Diagnostics in 2024 indicates a strategic pivot to capture the Asian market. These investments are rapidly democratizing access to comprehensive genomic profiling, effectively transitioning the cancer biomarkers market in Asia from basic screening to advanced, high-value molecular diagnostics.

Top 5 Recent Developments in Cancer biomarkers market

1. BioMark Diagnostics (August 10, 2025): The company highlighted key fiscal 2025 achievements, including advancements in AI-enhanced liquid biopsy assays like ThyGeM and PancraMiR for early detection of thyroid and pancreatic cancers. They also announced plans to publish results from a landmark 6,000-patient lung cancer trial in Q3 2025, emphasizing biomarker-driven screening improvements.​
2. Guardant Health and Zephyr AI (October 27, 2025): Guardant announced a strategic partnership with Zephyr AI to integrate its comprehensive biomarker platform with Zephyr's AI models. This collaboration aims to predict patient drug responses in oncology trials, accelerating personalized cancer treatments through real-world evidence and genomic insights.​
3. Oxford Cancer Biomarkers (January 14, 2025): Oxford achieved a major milestone by dosing the first patient in a clinical study for its AI-powered OncoProg test. Targeted at colorectal cancer, the test uses biomarkers to predict chemotherapy response, enhancing precision diagnostics and patient stratification.​
4. BriaCell Therapeutics (October 20, 2025): At ESMO 2025, BriaCell presented blinded Phase 3 biomarker data from its Bria-IMT trial in metastatic breast cancer. Results showed promising immune response trends correlated with survival benefits, supporting off-the-shelf cell therapy advancements.​
5. Revvity (April 22, 2025): Revvity launched the VivoJect Image-Guided Injection System at AACR 2025. This tool improves in vivo tumor model imaging, enabling precise biomarker tracking and validation in preclinical cancer research for faster drug development.

Top Companies in the Cancer Biomarkers Market

• Axon Medchem
• Bio-Rad Laboratories, Inc.
• CENTOGENE N.V.
• Abbott
• BioVision Inc.
• F. Hoffmann-La Roche Ltd.
• Myriad RBM
• R&D System
• Sino Biological Inc.
• Thermo Fisher Scientific
• Other Prominent Players 

Market Segmentation Overview

By Type

• Breast Cancer
• Prostate Cancer
• Colorectal Cancer
• Cervical Cancer
• Liver Cancer
• Lung Cancer
• Others

By Biomolecule

• Genetic Biomarkers
• Epigenetic Biomarkers
• Metabolic Biomarkers
• Proteomic Biomarkers
• Others

By Application

• Drug Discovery and Development
• Diagnostics
• Personalized Medicine
• Others

By Profiling Technology

• Omic Technologies
• Imaging Technologies
• Immunoassays
• Cytogenetics-based Tests

By End User

• Hospitals
• Academic and Cancer Research Institutes
• Ambulatory Surgical Centres
• Diagnostic Laboratories

By Region

• North America
  • The US
  • Canada
  • Mexico
• Europe
  • Western Europe
    • The UK
    • Germany
    • France
    • Italy
    • Spain
    • Rest of Western Europe
  • Eastern Europe
    • Poland
    • Russia
    • Rest of Eastern Europe
• Asia Pacific
  • China
  • India
  • Japan
  • Australia and New Zealand
  • South Korea
  • ASEAN
  • Rest of Asia Pacific
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of MEA
• South America
  • Argentina
  • Brazil
  • Rest of South America