United States Liquid Biopsy Market

United States Liquid Biopsy Market Size and Share:

The United States liquid biopsy market size was valued at USD 563.6 Million in 2024. Looking forward, IMARC Group estimates the market to reach USD 1,775.8 Million by 2033, exhibiting a CAGR of 13.6% from 2025-2033. The market is primarily driven by the increasing preference for non-invasive diagnostic methods, the widespread adoption of personalized medicine and targeted treatments, and the expanding use of liquid biopsy in areas beyond cancer, including cardiovascular, neurodegenerative, and infectious diseases, driving broader clinical usage.

The 2024 Global Cancer Statistics report released by the American Cancer Society highlights that 20 million new cases of cancer were identified globally, leading to 9.7 million deaths. By 2050, it is anticipated that there will be 35 million new cases of cancer. The increasing prevalence of cancer and genetic conditions is resulting in a greater demand for customized treatment and early detection. Liquid biopsies are becoming more crucial for early detection and customized treatment, offering faster and more accurate outcomes with minimal invasiveness. The ongoing improvements in technology are increasing the accuracy and use of liquid biopsy, leading to substantial market expansion, and supporting the shift towards personalized medicine.

The region's market is mostly driven by strategic alliances, joint ventures, and acquisitions that improve a company's capabilities and visibility. The impact of quick NGS-based liquid biopsy solutions is demonstrated by Pillar Biosciences' collaboration with AstraZeneca on September 10, 2024, which enables nearby labs to do accurate, efficient, and in-house tumor profiling in a matter of days for prompt diagnosis and individualized treatment. These partnerships increase access to cutting-edge technologies, improve research, and broaden product options. By maintaining high standards and facilitating the creation of reliable diagnostic solutions, regulatory support, and developments in NGS and PCR platforms also propel market expansion. Innovation is fostered by sustained research and development (R&D) spending, which improve accuracy and broaden applications.

United States Liquid Biopsy Market Trends:

Growing Demand for Non-Invasive Diagnostic Solutions

One of the main factors propelling the market is the rising need for non-invasive diagnostic alternatives, especially for cancer. Traditional biopsy techniques, which frequently include surgery, have hazards, and can cause discomfort for patients. On the other hand, liquid biopsy offers a more convenient and less invasive method of detecting cancer biomarkers by using bodily fluids such as blood or urine. As patients look for faster, more comfortable therapies that don't involve hospitalization or lengthy recovery periods, the transition to non-invasive procedures is essential. As a result, the market presence of liquid biopsy in the US is increasing due to its increasing acceptance. Advances in liquid biopsy technologies are being driven by the growing need for earlier and more effective cancer detection, augmenting its use in the healthcare sector.

Rising Adoption of Precision Medicine and Targeted Therapies

The United States liquid biopsy market forecast is profoundly influenced by the rise of precision medicine, which tailors’ treatments based on genetic traits. Liquid biopsy aids in rapidly examining the molecular features of tumors, which enables the detection of mutations and alterations that inform decisions regarding targeted treatment. Research conducted at Memorial Sloan Kettering Cancer Center (MSK) examined 47,271 tumor samples and found that 164 out of 198 recent oncology medications (52%) were aimed at specific targets, with 86 (52%) of them being precision oncology treatments. Out of these, 69 (80%) showed identifiable biomarkers using next-generation sequencing, qualifying them as perfect candidates for liquid biopsy. The FDA approved 23 new drugs and 18 follow-up drugs targeting specific population using new biomarkers, with a notable increase in approvals, including 12 drugs in 2020 alone. Due to the ability to detect biomarkers and monitor disease progression, liquid biopsy's market potential is significantly increasing with the progress of precision medicine.

Expansion of Applications Beyond Oncology

The rise of liquid biopsy utilization in healthcare settings is also impacting the United States liquid biopsy market trends. Although oncology is still the main area of interest, there is an increasing interest in utilizing the technology to potentially detect and monitor diseases such as heart conditions, brain disorders, and infections. Liquid biopsy allows for the detection of biomarkers associated with diseases including heart disease or Alzheimer's, which could lead to early diagnosis of conditions typically diagnosed using more invasive procedures or imaging techniques. Research in new diagnostic fields is being encouraged by the expanding range of applications in the market. Due to technological advancements, an increased array of diseases can now be detected using new products and solutions. It is expected to have a significant effect on market growth, enhancing its clinical utility and increasing its acceptance across different medical sectors.

United States Liquid Biopsy Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the United States liquid biopsy market, along with forecasts at the regional levels from 2025-2033. The market has been categorized based on product and service, circulating biomarker, cancer type, and end user.

Analysis by Product and Service:

• Kits and Reagents
• Platforms and Instruments
• Services
   

Kits and reagents are essential in the liquid biopsy market in the United States, enabling accurate detection of biomarkers in blood or other bodily fluids. These items consist of the necessary substances, proteins, and substances needed for extracting, amplifying, and examining DNA/RNA. The precision and sensitivity of liquid biopsy results are essential for accurate cancer detection, monitoring, and treatment planning.

Platforms and tools found in the US market offer the necessary technological framework for analyzing and managing liquid biopsy samples. NGS systems and PCR machines enable accurate genetic profiling and efficient high-throughput analysis. The advancement of these technologies ensures enhanced accuracy, faster processing rates, and the ability to detect mutations present in small amounts, further encouraging their application in medical settings.

Diagnostic testing and data analysis services are essential in assisting healthcare providers. Included in these services are gathering samples, analyzing biomarkers, and interpreting of genetic data, offering valuable insights for personalized treatment plans. With growing complexity in genomic data, specialized services ensure that clinicians can effectively integrate liquid biopsy results into clinical decision-making, enhancing patient care and treatment outcomes.

Analysis by Circulating Biomarker:

• Circulating Tumor Cells
• Extracellular Vesicles
• Circulating Tumor DNA
• Others
   

As per the United States liquid biopsy market analysis, circulating tumor cells (CTCs) play a pivotal role in the United States market, as they are directly shed from primary or metastatic tumors into the bloodstream. CTCs serve as valuable biomarkers for cancer detection, progression, and treatment monitoring. Their ability to reflect the tumor's genetic and phenotypic characteristics renders them crucial for personalized oncology, driving growth in liquid biopsy applications.

Extracellular vesicles (EVs), including exosomes, are emerging as key players in the United States liquid biopsy market. These nano-sized vesicles, secreted by cancer cells, contain genetic material, proteins, and lipids that reflect the tumor's molecular profile. As a non-invasive biomarker, EVs provide insights into tumor heterogeneity, resistance mechanisms, and therapeutic responses, fostering increased interest and market potential in liquid biopsy.

Circulating tumor DNA (ctDNA) is one of the most widely used biomarkers in the market, offering a highly sensitive method for detecting tumor mutations, gene amplifications, and other genetic alterations. ctDNA, found in blood plasma, is particularly valuable for monitoring minimal residual disease, tracking treatment responses, and detecting early recurrences, significantly contributing to the growth of liquid biopsy technologies in oncology.

Analysis by Cancer Type:

• Lung Cancer
• Breast Cancer
• Colorectal Cancer
• Prostate Cancer
• Liver Cancer
• Others
   

Lung cancer holds significant importance in the market due to its high incidence and mortality rates. Liquid biopsy enables the detection of genetic mutations and alterations in non-small cell lung cancer (NSCLC) and other subtypes, allowing for early diagnosis, treatment monitoring, and detection of resistance mutations. This non-invasive approach is transforming lung cancer care by offering more personalized and timely therapeutic options.

Breast cancer is a major driver in the Market, as liquid biopsy helps monitor tumor progression, detect minimal residual disease, and identify specific genetic alterations in breast cancer cells. Liquid biopsy’s ability to provide real-time insights into treatment response, resistance, and relapse is increasing its adoption in clinical practice, enabling more tailored and effective treatment strategies for patients.

Colorectal cancer (CRC) is another critical area in the United States market. Liquid biopsy facilitates the early detection of CRC by identifying specific genetic mutations and biomarkers, such as KRAS mutations, in blood samples. It also enables monitoring of disease progression and treatment response, offering a non-invasive alternative to traditional methods, which augments patient compliance and supports more personalized care approaches in CRC management.

Prostate cancer is a key focus in the market, with liquid biopsy playing an essential role in detecting genetic alterations, such as those in the androgen receptor gene. This technology allows for monitoring tumor mutations and evaluating treatment responses in metastatic prostate cancer, offering a less invasive method compared to traditional biopsies. Liquid biopsy is increasingly being used to guide therapeutic decisions and monitor for recurrence or resistance.

Liver cancer, particularly hepatocellular carcinoma (HCC), is an emerging area in the United States liquid biopsy market, as liquid biopsy aids in detecting genetic mutations, such as those in the TP53 and CTNNB1 genes. Liquid biopsy offers a non-invasive method for early liver cancer detection and monitoring, especially in high-risk populations such as individuals with cirrhosis or hepatitis. This technology has the potential to improve early diagnosis and treatment outcomes for liver cancer patients.

Analysis by End User:

• Hospitals and Laboratories
• Academic and Research Centers
• Others
   

Hospitals and diagnostic laboratories are central to the market, as they are the primary settings for performing liquid biopsy tests and interpreting results. These institutions use liquid biopsy to offer non-invasive cancer screenings, monitor treatment progress, and detect minimal residual disease in various cancers. With advanced diagnostic tools and a growing emphasis on precision medicine, hospitals and labs are critical players in expanding the adoption of liquid biopsy, helping clinicians provide more personalized and timely care to patients.

Academic and research centers play a pivotal role in driving innovation within the United States liquid biopsy market. These institutions are at the forefront of studying new biomarkers, developing advanced liquid biopsy technologies, and conducting clinical trials. Their research efforts contribute significantly to the validation and standardization of liquid biopsy methods for cancer detection and monitoring. Strategic collaborations between universities, research organizations, and biotech companies are accelerating advancements, making academic and research centers essential in shaping the future of liquid biopsy in clinical oncology.

Regional Analysis:

• Northeast 
• Midwest 
• South 
• West
   

The Northeast region holds a prominent position in the United States liquid biopsy market due to its concentration of major academic institutions, leading hospitals, and biotech companies. Cities including New York, Boston, and Philadelphia are hubs for cancer research, clinical trials, and the development of innovative diagnostic technologies. The region's strong healthcare infrastructure and high adoption rates of advanced medical technologies contribute significantly to the market's growth, particularly in personalized oncology.

The Midwest, with its robust healthcare network and prominent medical research institutions, represents a growing market for liquid biopsy solutions. Cities such as Chicago, Cleveland, and Minneapolis are home to leading academic and medical centers that are increasingly adopting liquid biopsy for early cancer detection and treatment monitoring. The region’s emphasis on research collaborations, affordable healthcare access, and expanding clinical trials is helping drive the adoption of liquid biopsy technologies in this area.

The South is anticipated to see notable growth in the market, driven by major healthcare systems and research institutions located in states such as Texas, Florida, and Georgia. With a large and diverse population, the region presents opportunities for liquid biopsy applications in early cancer detection and personalized treatment. The expansion of clinical trial networks and healthcare initiatives to address cancer care disparities is fueling market growth, particularly in underserved and high-risk populations.

The West is expected to lead the market, due to its concentration of technology companies, academic research centers, and healthcare giants. Silicon Valley and Los Angeles are key areas where biotech innovations and liquid biopsy technologies are rapidly advancing. The region’s emphasis on precision medicine, coupled with its strong healthcare infrastructure, accelerates the adoption of liquid biopsy for cancer diagnosis and treatment, establishing the West as a major driver of market growth.

Competitive Landscape:

The United States liquid biopsy market is highly competitive, with established and emerging companies driving technological advancements using NGS and PCR-based platforms. Companies are focused on diversifying product portfolios, enhancing test accuracy, and securing regulatory approvals. On May 21, 2024, Predicine, Inc. showcased data from nine ctDNA studies at ASCO 2024, highlighting its innovative liquid biopsy solutions, PredicineBEACON™ and PredicineALERT™ MRD, for patient selection, disease monitoring, biomarker discovery, and therapy resistance analysis. Strategic partnerships, acquisitions, and collaborations with academic institutions are prevalent as companies aim to solidify their market presence and augment the adoption of liquid biopsy technologies across clinical and research applications.

The report provides a comprehensive analysis of the competitive landscape in the United States liquid biopsy market with detailed profiles of all major companies.

Latest News and Developments:

• August 7, 2024: Guardant Health's Shield blood test for colorectal cancer (CRC) screening FDA-approved for individuals aged 45 and older at average risk, marks the first blood test approved as a primary CRC screening option. With 83% sensitivity and 90% specificity for advanced neoplasia, Shield offers a non-invasive, convenient alternative to traditional screening methods such as colonoscopy. The test is also Medicare-covered. This approval addresses low CRC screening rates in the U.S., providing a promising tool to increase early detection and improve treatment outcomes in the liquid biopsy market.
• November 18, 2024: Foundation Medicine, Inc. received FDA approval for its FoundationOne Liquid CDx as a companion diagnostic for TEPMETKO (tepotinib), a treatment for metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations (METex14). This approval marks FoundationOne Liquid CDx as the first FDA-approved liquid biopsy for TEPMETKO, helping identify patients eligible for targeted treatment. NSCLC, which accounts for 85% of lung cancer cases, is 3-4% associated with METex14 alterations. With this approval, Foundation Medicine expands its leadership in FDA-approved liquid biopsy diagnostics, offering critical genomic insights for precision medicine.

United States Liquid Biopsy Market Report Scope:

Key Benefits for Stakeholders:

• IMARC’s report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the United States liquid biopsy market from 2019-2033.
• The research study provides the latest information on the market drivers, challenges, and opportunities in the United States liquid biopsy market.
• Porter's Five Forces analysis assists stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the United States liquid biopsy industry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.