Surging Cancer Rates and Demand for Minimally Invasive Testing Fuel Growth in U.S. Liquid Biopsy Industry – Renub Research

According to Renub Research, the United States Liquid Biopsy Market is forecast to grow significantly from US$ 1.21 Billion in 2024 to US$ 4.25 Billion by 2033, expanding at a robust CAGR of 14.99% during the forecast period from 2025 to 2033.

This rapid growth highlights a transformative shift in how diseases—especially cancer—are being diagnosed and monitored. Liquid biopsy, a non-invasive method that detects circulating tumor DNA (ctDNA), cell-free DNA (cfDNA), and exosomes in blood and other body fluids, is revolutionizing oncology by enabling early detection, real-time monitoring, and personalized treatment strategies.

Rising Cancer Incidence Accelerates Market Growth

Cancer continues to be a leading health burden in the United States. According to the American Cancer Society, over 1.9 million new cancer cases are expected to be diagnosed in the U.S. in 2024 alone. The increased prevalence of lung, breast, prostate, and colorectal cancers necessitates more accurate, non-invasive, and timely diagnostics.

Liquid biopsies are particularly well-suited for:

  • Early cancer detection

  • Treatment response monitoring

  • Recurrence surveillance

  • Detection of minimal residual disease (MRD)

These capabilities are pushing liquid biopsy into mainstream clinical settings, replacing or supplementing traditional tissue biopsies, which are often invasive, painful, and costly.

Technological Advancements Enhance Sensitivity and Accessibility

Recent breakthroughs in next-generation sequencing (NGS), digital PCR, and bioinformatics have dramatically improved the sensitivity and specificity of liquid biopsy assays. These innovations allow for the detection of rare mutations, gene fusions, and copy number variations from minimal sample volumes.

Moreover, ongoing research is expanding the applications of liquid biopsies to include:

  • Epigenetic profiling

  • RNA sequencing

  • Methylation analysis

The integration of AI and machine learning in biomarker analysis is further accelerating diagnostic accuracy, transforming liquid biopsy into a cornerstone of precision oncology.

Precision Medicine Initiatives Driving Adoption

The growth of personalized medicine—where treatments are tailored to a patient’s genetic profile—relies heavily on diagnostic tools like liquid biopsy. The U.S. government’s Cancer Moonshot and All of Us initiatives, along with increasing support from the NIH and private sector, are promoting widespread adoption of these technologies.

Pharmaceutical companies and oncology researchers use liquid biopsies to:

  • Identify eligible patients for targeted therapies

  • Monitor therapeutic resistance

  • Adapt treatment plans based on real-time tumor evolution

This dynamic approach improves patient outcomes while reducing unnecessary treatments and healthcare costs.

Expanding Applications Beyond Oncology

While oncology remains the dominant use case, liquid biopsy is gaining traction in non-cancer applications such as:

  • Non-invasive prenatal testing (NIPT) for detecting chromosomal abnormalities

  • Transplant rejection monitoring through donor-derived cell-free DNA (dd-cfDNA)

  • Infectious disease detection and neurological condition assessment (under research)

This diversification broadens the total addressable market and attracts investments from multiple healthcare verticals.

U.S. Leads the Global Liquid Biopsy Market

The United States is the global frontrunner in the adoption of liquid biopsy due to:

  • Advanced healthcare infrastructure

  • Robust clinical research environment

  • High cancer awareness and screening programs

  • Regulatory support for breakthrough diagnostics

  • Presence of leading biotechnology firms and diagnostic players

Major U.S. healthcare providers are integrating liquid biopsy into routine diagnostic pathways, particularly for high-risk patients and those unable to undergo tissue biopsies.

Market Segmentation: Oncology Segment Leads with Strong Momentum

By Biomarker Type:

  • Circulating Tumor DNA (ctDNA)

  • Cell-Free DNA (cfDNA)

  • Exosomes

  • Circulating Tumor Cells (CTCs)

ctDNA-based assays account for the largest share due to their widespread use in monitoring treatment response and detecting tumor mutations.

By Application:

  • Cancer Diagnosis

  • Treatment Monitoring

  • Screening and Early Detection

  • Non-Oncology Applications (Prenatal, Transplant, etc.)

Cancer diagnosis and treatment monitoring remain the top revenue generators, while early detection and screening applications are expected to grow fastest with ongoing FDA approvals and clinical guideline updates.

By End User:

  • Hospitals and Clinics

  • Academic and Research Institutes

  • Diagnostic Laboratories

  • Biopharmaceutical Companies

Hospitals and diagnostic labs dominate due to the growing integration of liquid biopsy into standard-of-care protocols, while research institutes are at the forefront of developing next-generation applications.

Competitive Landscape: Innovation and Strategic Partnerships Propel Market Leadership

The U.S. liquid biopsy market is highly competitive, driven by continuous innovation, strategic collaborations, and large-scale investments. Leading companies focus on product development, clinical trials, FDA clearances, and partnerships with cancer centers and hospitals.

Key Players Include:

  • Guardant Health

  • Exact Sciences Corporation

  • Freenome

  • Biocept Inc.

  • Foundation Medicine (a Roche company)

  • Natera Inc.

  • Illumina Inc.

  • Grail (owned by Illumina, pending legal outcomes)

These companies are pushing the boundaries of early cancer detection and driving commercial adoption of blood-based testing solutions for various indications.

Challenges and Considerations

Despite robust growth, the U.S. liquid biopsy market faces challenges such as:

  • Regulatory hurdles for test validation and clinical utility

  • Reimbursement constraints from private payers and Medicare

  • Clinical interpretation complexity of results in early detection scenarios

  • Data privacy and interoperability concerns in decentralized testing models

Overcoming these obstacles will require stronger evidence from longitudinal studies, improved standardization of protocols, and continued investment in education for providers and patients.

Future Outlook: Transforming Cancer Diagnosis and Beyond

As research progresses and clinical adoption expands, liquid biopsy will likely evolve into a routine, first-line diagnostic tool for multiple cancers and conditions. Coupled with telemedicine, home sample collection kits, and AI-driven analytics, liquid biopsy will make personalized, preventive, and precision healthcare more accessible than ever before.

By 2033, the U.S. liquid biopsy market is expected to play a pivotal role in:

  • Reducing cancer mortality through early detection

  • Enabling cost-effective, non-invasive disease monitoring

  • Powering clinical trials with real-time biomarker tracking

  • Supporting decentralized, patient-centered care models

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Last Update: July 4, 2025

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