
United States Cancer Biomarkers Market Analysis by Mordor Intelligence
The United States cancer biomarkers market stands at USD 7.62 billion in 2025 and is on course to reach USD 11.23 billion by 2030, translating into an 8.06% CAGR. The growth trajectory reflects federal funding from the Cancer Moonshot, streamlined reimbursement through CMS’s Transitional Coverage pathway, and rapid clinical uptake of liquid-biopsy platforms. Rising cancer incidence in aging cohorts, especially in Sun Belt states, sustains volume demand, while 17 state-level coverage mandates reduce out-of-pocket risk for patients [1]Grace A. Lin, "The State of State Biomarker Testing Insurance Coverage Laws," JAMA Network, jamanetwork.com. The FDA’s final rule on laboratory-developed tests (LDTs) creates a clearer regulatory runway that lowers commercialization risk for novel multi-omic assays. Alongside these top-down reforms, hospital systems continue to invest in centralized genomics laboratories that cut turnaround times and ease clinician adoption.
Key Report Takeaways
- By disease type, breast cancer led with 36.33% of United States cancer biomarkers market share in 2024, whereas prostate cancer is projected to expand at a 9.02% CAGR through 2030.
- By biomolecule, protein biomarkers accounted for 50.41% revenue in 2024; genetic biomarkers are advancing fastest at a 9.11% CAGR.
- By profiling technology, omics platforms captured 33.58% revenue in 2024, while immunoassays are registering an 8.96% CAGR.
- By end user, hospitals and clinics held 43.44% revenue share in 2024; clinical and reference laboratories are growing quickest at 9.08% CAGR.
United States Cancer Biomarkers Market Trends and Insights
Drivers Impact Analysis
Driver | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
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Rising cancer prevalence and ageing population | +1.8% | National, concentrated in Sun Belt states | Long term (≥ 4 years) |
Precision-medicine push and FDA approvals for companion diagnostics | +2.1% | National, early adoption in academic centers | Medium term (2-4 years) |
Surge in liquid-biopsy adoption for minimally invasive detection | +1.5% | National, urban centers leading adoption | Medium term (2-4 years) |
Federal Cancer Moonshot and NIH funding uptick | +1.2% | National, research hubs | Short term (≤ 2 years) |
AI-enabled multi-omic biomarker discovery | +0.9% | National, major health systems | Long term (≥ 4 years) |
CMS Transitional Coverage fast-track for novel tests | +0.5% | National, Medicare beneficiaries | Short term (≤ 2 years) |
Source: Mordor Intelligence
Rising Cancer Prevalence and Ageing Population
Cancer incidence now tops 2 million diagnoses each year, with mortality clustering in nonmetropolitan counties where biomarker access remains sparse. Population migration toward the Sun Belt magnifies demand in Florida, Texas, and Arizona, creating a dual market dynamic: urban centers pull premium multi-omic panels, whereas rural counties present large untapped test volumes. CDC geospatial mapping shows mortality hot spots in the Midwest, confirming unmet diagnostic need. As the national median age rises, comorbidity complexity pushes providers to order broader panels, lifting average revenue per patient. Point-of-care liquid-biopsy pilots in community hospitals cut logistic barriers, but insufficient lab infrastructure still limits reach. These demographics ensure durable revenue upside well beyond the forecast horizon.
Precision-Medicine Push and FDA Approvals for Companion Diagnostics
The FDA cleared multiple high-impact companion tests in 2024, including broader indications for FoundationOne CDx. Tissue-agnostic guidance now lets drug developers target molecular alterations rather than tumor sites, expanding testable patient pools. Parallel ctDNA draft guidance validates minimal residual disease endpoints, encouraging payers to reimburse serial monitoring. Academic flagships like Mayo Clinic report that comprehensive genomic profiling doubles trial-matching odds relative to narrow panels. The regulatory momentum cascades through hospital networks, driving enterprise-wide adoption. Standardized order sets embedded in electronic health records further normalize testing and shorten decision cycles, reinforcing the virtuous adoption loop [2]Yiqing Zhao, "Real-world Trends, Rural-urban Differences, and Socioeconomic Disparities in Utilization of Narrow versus Broad Next-generation Sequencing Panels," Cancer Research Communications, aacrjournals.org.
Surge in Liquid-Biopsy Adoption for Minimally Invasive Detection
Guardant Shield earned FDA approval for colorectal screening with 83% sensitivity, while Cologuard Plus reached 95% sensitivity. Community hospital data from Canada show median three-day liquid-biopsy turnaround versus week-long tissue workflows. Johns Hopkins investigators detected circulating tumor DNA up to three years pre-diagnosis, underscoring public-health potential. Yet average per-test pricing of USD 2,800 restricts uptake among cost-sensitive payers. Providers are piloting bedside collection protocols that pair point-of-care draws with centralized sequencing, balancing specialization and access. The technology’s non-invasive appeal positions it for large-scale screening once cost hurdles are mitigated [3]Champica Nicholas, "Point of Care Liquid Biopsy for Cancer Treatment—Early Experience from a Community Center," MDPI, mdpi.com.
Federal Cancer Moonshot and NIH Funding Uptick for Biomarker Research
The White House allocated USD 1.5 billion to cancer initiatives, including USD 150 million specifically for biomarker grants. The National Cancer Institute is underwriting liquid-biopsy validation projects focused on early-stage tumors. Newly launched Cancer Scholars fellowships aim to close talent gaps by nurturing biomarker specialists. Grant scoring now weights health-equity plans, funneling dollars toward programs that improve test accuracy in underserved populations. Academic-industry consortia leverage these funds to accelerate assay standardization, which shrinks commercialization timelines and lowers technical risk for private investors.
Restraints Impact Analysis
Restraint | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
---|---|---|---|
High diagnostic costs and fragmented private-payer reimbursement | -1.4% | National, acute in rural and underinsured markets | Medium term (2-4 years) |
Complex multi-agency regulatory pathway | -0.8% | National, affecting smaller developers | Short term (≤ 2 years) |
Genomic-privacy and data-ownership concerns | -0.6% | National, privacy-conscious demographics | Long term (≥ 4 years) |
Limited minority biospecimen availability | -0.4% | National, diverse metro areas | Long term (≥ 4 years) |
Source: Mordor Intelligence
High Diagnostic Costs and Fragmented Private-Payer Reimbursement
Two-thirds of oncologists cite insurance denials as the top barrier to ordering biomarkers. While 17 states mandate coverage, commercial payers apply heterogeneous criteria; UnitedHealthcare and Cigna each publish distinct medical policies that create administrative friction. Health-economic models show that broad next-generation sequencing can cut per-patient costs by more than 50% compared with sequential single-gene testing, yet payers still favor narrower panels during prior authorization. This fragmentation slows market penetration for emerging assays lacking phase-III survival data. Hospital rev-cycle teams maintain biomarker “denial management” units to appeal rejections, adding overhead that discourages smaller centers from offering advanced panels.
Complex Multi-Agency Regulatory Pathway
Cancer biomarker developers must satisfy FDA device rules, CMS coverage determinations, and state CLIA licensure, a trio that lengthens launch timelines. The FDA’s 2024 final LDT rule sets a four-year glide path, yet small labs face disproportionately high compliance workload. Additional guidance on AI-enabled diagnostics and ctDNA endpoints forces iterative submission strategies, pressuring startups with limited regulatory budgets. Harmonizing test data packages for FDA approval while simultaneously gathering real-world evidence for CMS coverage creates sequencing challenges that delay revenue inflow. Larger platforms spread these compliance costs across broad menus, improving resilience, whereas single-biomarker firms remain vulnerable.
Segment Analysis
By Disease: Breast Cancer Dominance Masks Prostate Opportunity
Breast cancer generated 36.33% of United States cancer biomarkers market revenue in 2024 through well-established panels targeting HER2, ER, PR, and multi-gene expression. The United States cancer biomarkers market size for prostate testing is projected to expand at a 9.02% CAGR, underpinned by urine-based assays such as MyProstateScore 2.0 that remove invasive digital rectal examinations. Multi-cancer early detection (MCED) pilots also embed breast and prostate signatures, reinforcing volume demand. Rapid adoption of Decipher and Prolaris gene score tests among urologists signals further upside.
Innovators are leveraging high-risk germline markers and somatic mutations to enable risk-stratified screening in African-American men, a cohort with elevated mortality yet historically low biomarker utilization. Community outreach paired with at-home urine collection broadens reach into previously under-screened zip codes. Oncology groups in the Midwest now bundle prostate genomic scores with MRI triage to reduce unnecessary biopsies, validating the segment’s cost-effectiveness story. As PSA specificity limitations become more visible, guideline committees are expected to recommend multi-omic panels, catalyzing revenue.

Note: Segment shares of all individual segments available upon report purchase
By Biomolecule Type: Genetic Biomarkers Accelerate Despite Protein Leadership
Protein assays retained a 50.41% revenue position in 2024 because immunoassays remain embedded in analyzer workflows across most hospital laboratories. The United States cancer biomarkers market size for genetic assays is forecast to rise at a 9.11% CAGR as sequencing prices fall and companion diagnostic labeling expands. Thermo Fisher’s Proximity Extension Assay acquisition adds more than 5,000 high-specificity protein targets, blurring traditional biomolecule boundaries and enabling integrated panels.
RNA-seq and methylation signatures gain visibility as they prove earlier detection windows compared with protein markers. Yet reimbursement still favors single-analyte proteins such as CA 19-9, CEA, and PSA because of decades-long clinician familiarity. Mass-spectrometry proteomics is entering translational pipelines to overcome antibody cross-reactivity challenges, but capital-expenditure requirements slow routine adoption. Meanwhile, circulating exosomes and metabolites remain in discovery, positioning genetic and protein biomarkers as dual pillars through 2030.
By Profiling Technology: Immunoassays Gain Ground on Omics Leadership
Omics platforms—genomics, transcriptomics, proteomics, and metabolomics—held 33.58% revenue share in 2024 and anchor comprehensive clinical decision support. Immunoassays are logging an 8.96% CAGR as automated analyzers and tabletop instruments broaden cancer panel capacity in mid-tier hospitals. The Royal Marsden NHS robotic genomics laboratory doubled sample throughput via integrated liquid handlers, signaling how automation can scale precision testing.
Microfluidic biosensors under investigation promise near-patient testing within 30 minutes, but current CLIA waiver hurdles confine them to research settings. Imaging-based molecular diagnostics exploit radiopharmaceuticals to visualize marker expression, a niche expected to expand with FDA approvals of theranostic pairs. AI-curated bioinformatics pipelines now ingest multi-modal data, shortening interpretation timelines and improving report standardization, thereby solidifying omics as the backbone while immunoassays fill rapid-turnaround niches.

Note: Segment shares of all individual segments available upon report purchase
By End User: Laboratory Centralization Accelerates Market Shift
Hospitals and clinics accounted for 43.44% revenue in 2024, yet clinical and reference laboratories are projected to outpace with a 9.08% CAGR as complexity increases. Central laboratories secure economies of scale through high-volume sequencers and specialist bioinformaticians, enabling per-sample cost compression. The United States cancer biomarkers market share for reference labs rises as community hospitals outsource tissue and blood panels, reserving point-of-care immunoassays for same-day decisions.
Pharmaceutical manufacturers rely on third-party labs for trial enrollment biomarker eligibility, injecting additional growth. To maintain relevance, hospital networks adopt a hub-and-spoke model: specimens are collected locally and routed to central genomics cores, with results interfaced back into electronic records. This hybrid fosters timely physician access while exploiting centralized expertise. Telepathology advances further bridge the urban-rural divide, letting reference labs review digital slides remotely and recommend companion assays.
Geography Analysis
Academic medical centers in coastal metros act as vanguards for advanced biomarker adoption, but access gaps persist. Only 36.6% of the U.S. population resides within a one-hour drive of a National Cancer Institute-designated comprehensive center, whereas 16.4% face commutes exceeding four hours. These disparities shape a bifurcated United States cancer biomarkers market where urban clusters demand high-plex panels and rural regions gravitate toward lower-cost single analytes.
State policy divergence has material impact. Seventeen states enforce biomarker coverage mandates, boosting claim approval rates by 22 percentage points versus non-mandate states. Sun Belt markets such as Texas and Florida combine fast-growing elderly populations with favorable reimbursement, delivering above-average revenue growth. Midwest mortality hot spots underline latent demand; provider systems in Kansas and Missouri deploy mobile phlebotomy teams to collect liquid-biopsy samples in counties lacking oncology clinics, seeding future test volume.
Telehealth expansion accelerated by the COVID-19 pandemic reduces logistical barriers, allowing oncologists to mail collection kits for tests like MyProstateScore directly to patients. Uptake is strongest where broadband coverage is robust, mainly in Northeastern states. Federal Cancer Moonshot grant scoring now rewards projects that expand rural access, prompting academic centers to establish spoke laboratories in the Appalachians and Plains. Combined, these initiatives progressively equalize geographic distribution of biomarker utilization, though full convergence remains unlikely before 2035.
Competitive Landscape
The United States cancer biomarkers market features a moderate concentration. Thermo Fisher, Roche, Guardant Health, Exact Sciences, and Illumina comprise the top tier. Thermo Fisher’s USD 3.1 billion Olink acquisition strengthens its proteomics bench, enabling multiplex panels delivered on its Ion Torrent sequencers. Roche pledged USD 50 billion toward U.S. diagnostics and gene therapy capacity, signaling confidence in domestic biomarker growth.
Strategic alliances dominate go-to-market tactics. Illumina partnered with Tempus AI to enhance bioinformatics, while Thermo Fisher co-develops companion diagnostics with Bayer. Startups exploit white space in AI-optimized biomarker discovery, but regulatory sophistication and payer access remain gating factors. Moderate fragmentation persists because test complexity discourages broad product standardization; payers reimburse menu items individually rather than bundled, diluting economies of scope. As FDA oversight over LDTs tightens, well-capitalized firms are positioned to consolidate smaller labs that cannot absorb compliance costs, driving incremental concentration over the forecast horizon.
United States Cancer Biomarkers Industry Leaders
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Abbott Laboratories Inc.
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Thermo Fisher Scientific
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Biomerieux
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Illumina Inc.
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F. Hoffmann-La Roche Ltd
- *Disclaimer: Major Players sorted in no particular order

Recent Industry Developments
- June 2025: Mainz Biomed commences the next phase of its PancAlert blood test program for early pancreatic cancer detection.
- June 2025: Guardant Health receives FDA Breakthrough Device designation for Shield multi-cancer detection with 98.6% specificity.
- April 2025: Roche announces USD 50 billion U.S. investment plan encompassing diagnostics and gene therapy capacity expansion.
- January 2025: Roche announces USD 50 billion U.S. investment plan encompassing diagnostics and gene therapy capacity expansion.
United States Cancer Biomarkers Market Report Scope
As per the scope of the report, biomarkers are chemical, physical, or biological parameters, which can be used to indicate the disease states. Oncology biomarkers offer high-speed, non-invasive cancer diagnoses, and enhance cancer detection and screening. The cancer biomarkers market is segmented by disease, type, profiling technology.
By Disease | Breast Cancer |
Lung Cancer | |
Prostate Cancer | |
Colorectal Cancer | |
Cervical Cancer | |
Other Cancers | |
By Biomolecule Type | Protein Biomarkers |
Genetic Biomarkers | |
Others | |
By Profiling Technology | Omics Technologies |
Imaging Technologies | |
Immunoassays | |
Others | |
By End User | Hospitals & Clinics |
Clinical & Reference Laboratories | |
Pharma & Biotech Companies | |
Others |
Breast Cancer |
Lung Cancer |
Prostate Cancer |
Colorectal Cancer |
Cervical Cancer |
Other Cancers |
Protein Biomarkers |
Genetic Biomarkers |
Others |
Omics Technologies |
Imaging Technologies |
Immunoassays |
Others |
Hospitals & Clinics |
Clinical & Reference Laboratories |
Pharma & Biotech Companies |
Others |
Key Questions Answered in the Report
What is the current size of the United States cancer biomarkers market?
The market is valued at USD 7.62 billion in 2025 and is forecast to reach USD 11.23 billion by 2030, reflecting an 8.06% CAGR.
Which cancer type generates the most biomarker revenue?
Breast cancer leads, contributing 36.33% of revenue in 2024, supported by routine HER2 and multi-gene expression testing.
Why are liquid-biopsy tests gaining traction?
They provide less invasive sample collection, faster turnaround averaging three days, and new screening indications such as colorectal cancer, though high pricing remains a constraint.
How will the FDA’s LDT final rule affect test developers?
It phases out enforcement discretion over four years, requiring most laboratory-developed tests to obtain FDA clearance, favoring well-capitalized companies that can manage the added compliance burden.
Which end-user segment is growing fastest?
Clinical and reference laboratories are expanding at a 9.08% CAGR because centralization of complex genomic testing offers economies of scale and higher quality assurance.
Page last updated on: June 16, 2025