United States Liquid Biopsy Market Analysis

Apelo Consulting has released a report on “United States Liquid Biopsy Market (By Circulating Biomarker, Product, Application, Cancer Types, Non-Cancer Application Types, Clinical Application, End User and Sample Type), Initiatives, Company Profiles, Recent Developments and Market Dynamics – Forecast to 2030”

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1. 2024-2030 Comprehensive Report Prepared by Apelo Consulting 1 United States Liquid Biopsy Market Analysis Apelo Consulting United States Liquid Biopsy Market Analysis Strategic Insights & Growth Trends
2. Apelo Consulting | Page 2 Market Overview GROWTH & OUTLOOK 2024-2030 US$ 1,376.6 US$ 3,264.4 Million Million Market Value (2024) Projected Value (2030) CAGR ~15.5% 2.04 Million Projected US Cancer Burden (2025) 618,120 New Cases Deaths Source: National cancer Institute
3. Apelo Consulting | Page 3 What is Liquid Biopsy? A revolutionary minimally invasive test that analyzes tumor-derived material—such as circulating tumor DNA (ctDNA), cells (CTCs), and extracellular vesicles—in blood and other body fluids to reveal the molecular characteristics of cancer. Advantages Over Traditional Tissue Biopsy SAMPLE SOURCES Simple blood draw reduces patient risk, pain, and recovery time compared to surgical procedures. Minimally Invasive Captures a comprehensive molecular profile from multiple tumor sites, overcoming single-site bias. Tumor Heterogeneity Enables longitudinal tracking of treatment response and early detection of drug resistance. Repeatable Monitoring Crucial when tumor tissue is physically inaccessible or insufficient for genomic analysis. High Accessibility Standard for ctDNA & CTCs Blood (Plasma) Urine Emerging for bladder/prostate Other Fluids CSF, Saliva, Pieural Effusions
4. Apelo Consulting | Page 4 Market Segmentation by Circulating Biomarkers Key Drivers & Biologicl Targets Holds the largest market share. CTCs are intact tumor cells shed into the bloodstream, crucial for understanding metastatic potential. Their isolation enables direct analysis of the whole cell. Circulating Tumor Cells (CTCs) Broad non-invasive screening method. While inclusive of ctDNA, general cfDNA analysis is vital for detecting graft rejection, fetal chromosomal abnormalities, and infectious diseases. Cell-Free DNA (cfDNA) Fragments of DNA shed by tumor cells. This segment follows CTCs closely in market size and is the gold standard for genomic profiling and identifying specific actionable mutations. Circulating Tumor DNA (ctDNA) Small lipid-bound particles containing proteins, RNA, and DNA. EVs are the fastest-growing segment due to their stability and rich cargo, offering a new layer of molecular insight beyond DNA alone. Extracellular Vesicles (EVs)
5. Apelo Consulting | Page 5 Market Segmentation Product Landscape & End User Adoption Dominated the market share in 2024. Driven by the expansion of basic research, rising test volumes, and the critical need for highly reliable, specific diagnostic assays. Kits & Consumables Projected to experience the highest growth rate. Advanced automated platforms enable precise, high-throughput detection of CTCs and ctDNA in blood samples. Instruments Includes testing services and data analysis support provided by specialized vendors to healthcare providers and research institutions. Services Represents the largest and fastest-growing segment. Driven by outsourcing of complex samples to facilities with specialized capabilities and advanced infrastructure. Reference Laboratories Increasing adoption of in-house liquid biopsy testing to speed up diagnosis and integrate results directly into patient care workflows. Hospitals & Physician Labs Focused on developing novel biomarkers, refining assay sensitivity, and conducting large-scale clinical validation studies. Academic & Research Centers By Product By End User
6. Apelo Consulting | Page 6 Market Applications Oncology & Non-Cancer Utilization Lung and Breast cancers represent the dominant areas of application. Market growth is fuelled by rising incidence and research volume. Dominant Cancers Expanding rapidly across multiple cancer types: Other Key Indications Primary driver of growth. Uses cfDNA to detect chromosomal trisomies (13, 16, 18), fetal sex, monosomy X, and microdeletions. Non-Invasive Prenatal Testing Utilized for non-invasive monitoring of graft health and early detection of rejection via donor-derived cell-free DNA. Organ Transplantation Emerging application for identifying pathogens and analyzing host immune response through liquid biopsy techniques. Infectious Disease Testing Oncology Application Non-Cancer Application
7. Apelo Consulting | Page 7 Clinical Applications & Sample Types Market Segmentation By Usage & Source Critical for identifying actionable mutations in advanced stages (III & IV) to guide personalized treatment Therapy Selection Real-time tracking of tumor response and emerging resistance mechanisms during therapy. Treatment Monitoring Clinical Applications (Oncology) Sample Types Growing focus on multi-cancer early detection (MCED) to catch malignancy before symptoms appear. Early Cancer Screening Post-treatment surveillance (MRD) to detect residual disease earlier than imaging. Recurrence Monitoring The most common source (plasma/serum) for current FDA- approved liquid biopsy tests. Blood Sample Significant expansion expected due to complete non- invasiveness and ease of home collection. Urine Sample Includes saliva, CSF, and pleural effusions for specific niche applications and research. Other Fluids
8. Apelo Consulting | Page 8 Key Market Drivers Forces Accelerating Growth & Adoption Offers superior clinical utility through minimally invasive sampling, faster turnaround times, repeatability for monitoring, and the ability to capture comprehensive tumor heterogeneity. Advantages Over Tissue Biopsy An escalating public health challenge with over 2 million new cases projected in 2025, creating an urgent demand for efficient, scalable diagnostic solutions. Rising Cancer Burden Growing preference among patients and clinicians for blood-based tests (liquid biopsies) that significantly reduce procedural risks, pain, and recovery time. Demand for Minimally Invasive Procedures Surging capital influx from both public and private sectors is fueling innovation, validating new biomarkers, and expanding commercial applications. Increased Investment in R&D
9. Apelo Consulting | Page 9 Recent Developments Strategic Milestones & Regulatory Approvals (2024-2025) FoundationOne Liquid CDx received FDA approval as a companion diagnostic for TEPMETKO (tepotinib), enhancing precision treatment options for metastatic non-small cell lung cancer patients. FDA Approval Granted Partnership aimed at supporting the development and commercialization of Pfizer’s oncology portfolio utilizing the Guardant Infinity smart liquid biopsy platform to accelerate drug development. Strategic Collaboration LungLife AI entered a conditional exclusive license with Circulogene Theranostics for the commercial distribution of the LungLB test in the United States, expanding access to advanced lung cancer diagnostics. Exclusive License Agreement 2025 2025 2024 Nov Apr Apr
10. Apelo Consulting | Page 10 Key Players & Conclusion Major Market Players $3.26B Market Growth Forecast Projected value by 2030, growing from $1.38B in 2024 driven by widespread clinical adoption. Key Outlook Points Advanced instruments will enhance sensitivity for early detection. Innovation & Automation Broader Applications Expansion beyond oncology into NIPT and infectious disease testing. Emerging Modalities High growth expected in EV analysis and urine-based assays.