United States Cancer Biomarkers Market Size & Share Analysis - Growth Trends & Forecasts (2025 - 2030)

The United States Cancer Biomarkers Market is Segmented by Disease (Breast Cancer, Lung Cancer, Prostate Cancer, and More), Biomolecule Type (Protein Biomarkers and More), Profiling Technology (Omics Technologies, Imaging Technologies, and More), and End User (Hospitals & Clinics, and More). The Market and Forecasts are Provided in Terms of Value (USD).

United States Cancer Biomarkers Market Size and Share

United States Cancer Biomarkers Market (2025 - 2030)
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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.

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.

United States Cancer Biomarkers Market: Market Share by Disease
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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.

United States Cancer Biomarkers Market: Market Share by Profiling Technology
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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

  1. Abbott Laboratories Inc.

  2. Thermo Fisher Scientific

  3. Biomerieux

  4. Illumina Inc.

  5. F. Hoffmann-La Roche Ltd

  6. *Disclaimer: Major Players sorted in no particular order
United States Cancer Biomarkers Market
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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.

Table of Contents for United States Cancer Biomarkers Industry Report

1. Introduction

  • 1.1 Study Assumptions & Market Definition
  • 1.2 Scope of the Study

2. Research Methodology

3. Executive Summary

4. Market Landscape

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Rising cancer prevalence and ageing population
    • 4.2.2 Precision-medicine push & FDA approvals for companion diagnostics
    • 4.2.3 Surge in liquid-biopsy adoption for early, minimally-invasive detection
    • 4.2.4 Federal Cancer Moonshot & NIH funding uptick for biomarker research
    • 4.2.5 AI-enabled multi-omic biomarker discovery from integrated EHR-omics datasets
    • 4.2.6 CMS "Transitional Coverage for Emerging Technologies fast-track" for novel tests
  • 4.3 Market Restraints
    • 4.3.1 High diagnostic costs & fragmented private-payer reimbursement
    • 4.3.2 Complex multi-agency regulatory pathway
    • 4.3.3 Genomic-privacy and data-ownership concerns among patients
    • 4.3.4 Under-represented minority biospecimen availability in US biobanks
  • 4.4 Regulatory Landscape
  • 4.5 Technological Outlook
  • 4.6 Porters Five Forces Analysis
    • 4.6.1 Threat of New Entrants
    • 4.6.2 Bargaining Power of Buyers
    • 4.6.3 Bargaining Power of Suppliers
    • 4.6.4 Threat of Substitutes
    • 4.6.5 Intensity of Competitive Rivalry

5. Market Size & Growth Forecasts (Value, USD)

  • 5.1 By Disease
    • 5.1.1 Breast Cancer
    • 5.1.2 Lung Cancer
    • 5.1.3 Prostate Cancer
    • 5.1.4 Colorectal Cancer
    • 5.1.5 Cervical Cancer
    • 5.1.6 Other Cancers
  • 5.2 By Biomolecule Type
    • 5.2.1 Protein Biomarkers
    • 5.2.2 Genetic Biomarkers
    • 5.2.3 Others
  • 5.3 By Profiling Technology
    • 5.3.1 Omics Technologies
    • 5.3.2 Imaging Technologies
    • 5.3.3 Immunoassays
    • 5.3.4 Others
  • 5.4 By End User
    • 5.4.1 Hospitals & Clinics
    • 5.4.2 Clinical & Reference Laboratories
    • 5.4.3 Pharma & Biotech Companies
    • 5.4.4 Others

6. Competitive Landscape

  • 6.1 Market Concentration
  • 6.2 Market Share Analysis
  • 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
    • 6.3.1 Abbott Laboratories
    • 6.3.2 Agilent Technologies
    • 6.3.3 BioMerieux
    • 6.3.4 Bio-Rad Laboratories
    • 6.3.5 Caris Life Sciences
    • 6.3.6 Exact Sciences
    • 6.3.7 F. Hoffmann-La Roche
    • 6.3.8 Foundation Medicine
    • 6.3.9 Guardant Health
    • 6.3.10 GRAIL
    • 6.3.11 Hologic
    • 6.3.12 Illumina
    • 6.3.13 Myriad Genetics
    • 6.3.14 Natera
    • 6.3.15 NeoGenomics
    • 6.3.16 Qiagen
    • 6.3.17 Quest Diagnostics
    • 6.3.18 Thermo Fisher Scientific
    • 6.3.19 23andMe
    • 6.3.20 Adaptive Biotechnologies
    • 6.3.21 Somalogic

7. Market Opportunities & Future Outlook

  • 7.1 White-space & Unmet-need Assessment
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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
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
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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

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