North America Liquid Biopsy Market By Product Type (Assays and Kits, Instruments, and Services), By Application (Early Cancer Detection, Recurrence Monitoring, Prenatal Testing, Organ Transplant Monitoring, and Others), By Biomarker Type (Circulating Tumor Cells (CTCs), Circulating Tumor DNA (ctDNA), Microvesicles, and Others), By Technology (Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), Microarray, and Others), By Indication (Lung Cancer, Breast Cancer, Colorectal Cancer, Prostate Cancer, Pancreatic Cancer, Prenatal Testing, and Others), and By End-User (Hospitals and Clinics, Diagnostic Laboratories, Pharma & Biotech Companies, and Research Institutes), Global Market Size, Segmental analysis, Country Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

Industry Outlook

North America Liquid Biopsy market accounted for USD 3.36 Billion in 2024 and is expected to reach USD 13.8 Billion by 2035, growing at a CAGR of around 13.7% between 2025 and 2035. North America liquid biopsy is the region characterizing the segment associated with new minimally non-invasive diagnostic tools based on biomarkers present in body fluids, blood, and cancer cells. It facilitates the evaluation of early cancer, control of treatment outcomes, and identification of cancer relapse without invasive tissue biopsies. Prominent drivers include growth in the sophistication of genomic technologies, rising incidence of cancer, and a focus shift towards personalized care. Applicable to various cancer types, the liquid biopsy market will have great potential for growth and the ability to advance the way they treat patients.

Report Scope:

Market Dynamics

Pediatric liquid biopsy applications address an underserved patient population.

The North American liquid biopsy market is expanding due to several factors. The issue of pediatric cancer persists, evident by a rise in cases attributed to the advent of new diagnostic methods that examine tissue biopsy, which is shown to be difficult for pediatric patients. Liquid biopsies are a much safer option because they do not involve invasive surgeries that compromise patients’s health in terms of pain sensations. Many molecular methods, such as digital droplet PCR or next-generation sequencing, are employed for early disaggregation and detection of circulating tumor DNA and have improved the specificity and sensitivity of these tests. Furthermore, the emergence of a patient care model contributes to market expansion since liquid biopsies provide doctors with real-time tumor dynamics and enable them to modify their therapy accordingly.

Supportive government funding and the right regulatory policies boost advancements in cancer research and fuel market growth. The continued increase in healthcare provider knowledge about the effectiveness of liquid biopsies will contribute to the increased use of this technology in pediatric oncology to meet the urgent demands of the targeted population.

Rising cancer incidence boosts demand for non-invasive diagnostic tools.

There is a high demand for noninvasive diagnostic instruments like liquid biopsies since cancer cases increasing in North America. Such approaches make it easier to diagnose and screen for cancer through blood tests and are preferable and less painful than a biopsy. The market is expanding because of advancements in genetic technology and rising awareness of customized treatment. The development and approval of liquid biopsy tests are being strengthened by the support of regulatory agencies including the US Food and Drug Administration. New cancer registrations for 2023 alone are estimated to be 1.9 million by the National Cancer Institute. This shows a need for better and less invasive diagnostic tools. This viewpoint follows the general trend of current healthcare management that emphasizes the needs of patients, which ensures the market growth of liquid biopsy.

Patient preference for traditional biopsies may limit liquid adoption.

The major factor that hinders the North America liquid biopsy market is the general inclination of patients toward traditional biopsy techniques. Many individuals and healthcare professionals are used to these conventional methods considered to be correct due to the normal evolution of tissue biopsies. Owing to these restrictions on liquid biopsies, there is uncertainty about the procedure's ability to fully diagnose a tumor or precisely identify specific mutations. Furthermore, there is little patient understanding and adoption knowledge about the benefits of liquid biopsies, such as the non-invasive nature of diagnosis and the possibility of tracking treatment outcomes over time. Therefore, slower adoption of liquid biopsies than traditional methods may slow market growth, even though the technology used is better than traditional methods.

Pharma collaborations can drive mutual growth in companion diagnostics.

The current opportunity in the North America liquid biopsy market is enormous because of the new and developing technologies and the increasing rate of cancer incidences. Liquid biopsies are a non-invasive way to analyze biomarkers in fluids that can help in early diagnosis and assessment of treatment outcomes. The connection between pharma enterprises and diagnostics creators can improve the transformation between types of products, making innovative and targeted treatments prominent. These partnerships may reduce the time for approvals, encourage invention, and benefit the patients by coordinating the drug with tests. Value-based care is expected to be a major trend in healthcare environments. North America will become a global leader in cutting-edge solutions as demand for solutions like liquid biopsies rises rapidly.

Home testing kits broaden appeal and convenience for consumers.

The North American Liquid Biopsy Market is expected to have major growth prospects in the future attributed to the increasing use of home testing kits that make it convenient for users. For patients looking for novel ways to avoid invasive techniques for diagnosis, liquid biopsy is a more attractive option than conventional tissue biopsy used to identify early cancer detection. The growth of telemedicine and digitally customized healthcare means that at-home tests are easily incorporated into the sphere of provider supervision and guidance. Furthermore, technological advancements make liquid biopsies more effective than in the past, increasing their appeal to patients and medical professionals equally. These indicate a sufficiently large potential for market players to increase their share in the growing market through innovation.

Industry Experts Opinion

“Our updated test provides much broader gene panel coverage and analyzes both currently actionable and emerging biomarkers not available on any other liquid biopsy test. This upgrade will mark the beginning of a new chapter of tumor profiling that will be as profound as the original introduction of comprehensive profiling, informing cancer care teams about the optimal treatment strategy for their patients by giving them many more precision treatment options that can help improve their outcomes.”

• Helmy Eltoukhy, co-founder and chairman of Guardant Health.

“Less than 6% of pancreatic cancer cases are detected today in early stages, when they can be removed with surgery, if we manage to double or even quadruple this percentage, more patients will survive. That’s why we want to detect pancreatic cancer years before symptoms appear. Symptoms occur at late stages.”

• Klaus Pantel, coordinator of PANCAID and director of the Institute of Tumor Biology at the University Medical Center Hamburg-Eppendorf.

Segment Analysis

Based on the product type, the North America Liquid Biopsy Market is classified into Assays and Kits, Instruments, and Services. In the North America Liquid Biopsy Market, the Assays and Kits segment is dominant because it plays a crucial role in non-invasive cancer detection and tracking. These products help identify circulating tumor DNA (ctDNA) and other biomarkers that are crucial to understanding tumor and treatment kinetics. Lifestyle-related factors increase cancer incidence, and the development of genomic technologies are the main reasons for the necessity of these assays, supported by the role of these methods in precision medicine. Furthermore, expanding a role in the practice of liquid biopsy raises their market visibility as an element of personalized medicine.

Based on the application, the North America Liquid Biopsy Market is classified into Early Cancer Detection, Recurrence Monitoring, Prenatal Testing, Organ Transplant Monitoring, and Others. In the North America Liquid Biopsy Market, the business opportunity that one can identify as most promising is Early Cancer Detection. This trend is easily explained by the occurrence of cancer on the rise and the constant search for non-invasive diagnostic techniques. Liquid biopsy is a radical shift from conventional ones, making it easier for doctors to diagnose cancer at an early stage and then recommend appropriate treatments to manage the disease. This includes the enhanced technological developments in liquid biopsy, giving a strong basis for this market segment's dominance. Liquid biopsies are expected to play greater parts in early cancer detection as supporting data from these studies become available and emphasize their significance in the market as stated.

Regional Analysis

The liquid biopsy market is expanding in the United States due to improved technology, a focus on early detection of cancer, and the utilization of targeted therapy. This market is remarkably heterogeneous, with large businesses and ground-breaking novices across the entire liquid biopsy spectrum, including ctDNA analysis and exosome analysis. Silicon points like California and Massachusetts are already there, given that both have an impressive foundation in biotechnology and access to research. Moreover, there is increased academic-industry collaboration on the development of new technologies and the discovery of clinical uses.

In the future, liquid biopsy will continue to expand its market based on the increasing knowledge of its advantages among doctors and patients. Many patients and their doctors will seek approval of liquid biopsy-based diagnostic and therapeutic approaches. Mobile health will play a key role in liquid biopsy approval and reimbursement over the next five years as providers and payers seek to implement policies governing mobile health-related diagnostic testing.

Canada is the fastest-growing country in the North America liquid biopsy market, with high growth rates driven by the enhancement of new technologies and the growing focus on individualized medicine. The demand for a diagnostic technique that is used in conjunction with treatment to evaluate treatment outcomes is growing as the cancer rate rises.

Industry leaders like Illumina and Guardant Health drive innovation, and regulatory activities such as Health Canada respond accordingly with their measures to safeguard the legitimate use of the technology. There are obstacles in this market, such as reimbursement problems and high demand for clinical trials, but the market is expanding. Further prospects emerge from uses in other fields apart from oncology, setting the country to be central in the emerging shifts in liquid biopsies.

Competitive Landscape

This North American liquid biopsy market is highly dynamic, with plenty of new developments and competition from leading companies like Guardant Health, Foundation Medicine, and Freenome Holdings. Such firms are investing in new technology and products to improve the accuracy of early cancer diagnosis and individualized approaches. The test for tracking early detection, called Guardant Reveal, is a new addition to Guardant Health's product line. Foundation Medicine focuses on using the complementary properties of complete genetic profiling and liquid biopsy to enhance its position in precision oncology. Furthermore, Freenome raised a significant amount of capital to improve the AI system that can identify colorectal cancer at an early stage. Collaborations and partnerships to leverage advancements in artificial intelligence and genomic technology to push the industry toward improved patient outcomes increase market growth.

North America Liquid Biopsy Market, Company Shares Analysis, 2024

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Recent Developments:

• In July 2024, Guardant Health's Shield™ Blood Test received FDA approval as a primary screening option for colorectal cancer. This approval facilitated Medicare reimbursement, improved patient access, and marked a new era in colorectal cancer screening focused on early detection and better outcomes.

Report Coverage:

By Product Type

• Assays and Kits
• Instruments      
• Services

By Application

• Early Cancer Detection 
• Recurrence Monitoring 
• Prenatal Testing
• Organ Transplant Monitoring     
• Others

By Biomarker Type

• Circulating Tumor Cells (CTCs)
• Circulating Tumor DNA (ctDNA)
• Microvesicles   
• Others 

By Technology

• Polymerase Chain Reaction (PCR)        
• Next-Generation Sequencing (NGS)      
• Microarray                    
• Others

By Indication

• Lung Cancer
• Breast Cancer  
• Colorectal Cancer
• Prostate Cancer            
• Pancreatic Cancer        
• Prenatal testing
• Others

By End-User

• Hospitals and Clinics
• Diagnostic Laboratories
• Pharma & Biotech Companies
• Research Institutes

By Region

North America

• U.S.
• Canada

List of Companies:

• Guardant Health, Inc.
• Foundation Medicine, Inc.
• Biocept, Inc.
• Freenome Holdings, Inc.
• Cynvenio Biosystems, Inc.
• NeoGenomics Laboratories, Inc.
• Exosome Diagnostics, Inc.
• Personal Genome Diagnostics (PGDx)
• Strata Oncology, Inc.
• Trovagene, Inc.
• GRAIL, Inc.
• Chronix Biomedical, Inc.
• Liquid Biopsy, Inc.
• OncoOne, Inc.
• MediSapiens

Frequently Asked Questions (FAQs)

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