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US Liquid Biopsy Market

US Liquid Biopsy Market Size, Trend and Growth Forecast by Product Type, by Application, by Biomarker, by End User, and by Zone for 2024-2031

US Liquid Biopsy Market Size and Share Analysis

The US market for liquid biopsy is estimated to value at US$10.5 Bn by the end of 2031 from US$4.1 Bn anticipated in 2024. The market is expected to secure a CAGR of 14.3% from 2024 to 2031.

Market Attributes

Key Insights

Market Size (2024E)

US$4.1 Bn

Projected Market Value (2031F)

US$10.5 Bn

Projected Growth Rate (CAGR 2024 to 2031)

14.3%

Historical Growth Rate (CAGR 2019 to 2023)

11.5%

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US Liquid Biopsy Market Introduction

In recent years, the US liquid biopsy sector has grown significantly due to breakthroughs in technology as well as a rise in the prevalence of cancer and chronic disorders. As a result, liquid biopsies are being used and are becoming more common. These non-invasive screenings have generated a great lot of enthusiasm and advice for treatment programs because they may accurately offer information on a patient's cancer condition.

Due to its ability to provide information on the cancer's stage and spread, track the effects of treatment, determine the root causes of treatment resistance, and identify potential recurrences early on, liquid biopsies are becoming more and more important in the United States.

At over 1.8 million new diagnoses and over 0.6 million cancer deaths annually, cancer continues to be the second greatest cause of death in the US. Reducing treatment costs and improving survival rates are dependent on early cancer diagnosis.

To promptly stratify patients according to the most suitable therapy, there is a great demand for minimally invasive, early detection techniques that can offer a molecular diagnosis.

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Historical Growth and Course Ahead

From 2018 to 2023, the US liquid biopsy market had a compound annual growth rate of 11.5%. The growth rate is expected to climb by decimals during the projection period, reaching 14.3% by 2031.

Since new and effective technologies are being researched, it is anticipated that the demand for cancer detection tests like liquid biopsy will have a practical application if cancer continues to impact many people, with current statistics forecast to rise over the next seven years.

It is anticipated that more government-led programs in the US will inspire cancer experts to establish research objectives in cancer treatments, with an emphasis on practicality, cost, and the best possible patient care. Increased financing is expected to enable specialists to form research partnerships to promote advancements against several cancer outcomes.

Rapid approvals of non-invasive cancer diagnostic technologies by regulatory agencies such as the US Food and Drug Administration (FDA) are opening doors for major players in the industry. These initiatives and support mechanisms are likely to drive significant progress in cancer treatment and diagnostics within the US market.

Key Trends and Innovations Shaping the Market

  • Increasing regulatory approvals and reimbursement
  • Advancements in next-generation sequencing (NGS)
  • Development of multi-analyte tests
  • Liquid biopsy for monitoring minimal residual disease (MRD)

Increasing regulatory approvals and efforts to establish clear reimbursement pathways are critical for the adoption of liquid biopsies. Positive regulatory endorsements enhance the credibility and clinical acceptance of liquid biopsy tests, while reimbursement policies make these tests more accessible to patients.

These trends and innovations highlight the dynamic nature of the US liquid biopsy market and its potential to transform cancer diagnostics and personalized medicine. The continued advancements in technology, combined with strategic industry partnerships and regulatory support, are likely to drive significant growth and adoption of liquid biopsy tests in the coming years.

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Key Growth Drivers

Advantages of Liquid Biopsy over Traditional Biopsy Techniques

Liquid biopsy has becoming widely used by end users due to its advantages over conventional incisional biopsy methods, including its non-invasiveness, cost-effectiveness, ease of disease monitoring, and early cancer identification.

The use of liquid biopsy is becoming more widespread in many medical specialties as people become more aware of its advantages. The advantages of liquid biopsy over traditional biopsy techniques are becoming more widely acknowledged, which is driving the quick development and growth of liquid biopsy goods and services.

Liquid biopsies allow for frequent and real-time monitoring of tumor dynamics. This is particularly useful for assessing treatment response and detecting recurrence or metastasis earlier than traditional methods, which are often limited by the feasibility of repeated tissue sampling.

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Factors Impeding the Market Growth

Lower Specificity and Sensitivity of Some Liquid Biopsy Techniques

A significant challenge in identifying circulating tumor DNA (ctDNA) is the reduced sensitivity reported by several liquid biopsy methods. As a result, it is possible that ctDNA will remain undiscovered in the patient sample, which could produce false-negative results and compromise the validity of the liquid biopsy test for the diagnosis of cancer.

According to the sampling statistics, each plasma sample may include more than one detectable copy of the ctDNA with the cancer mutation. When ctDNA is present in the plasma, even at a low level, it might not be found in the patient sample.

This affects the informative value of the liquid biopsy test for cancer and leads to false-negative results, where ctDNA is not found even though it is there. False-negative results can occasionally result in the early detection of tumor recurrence.

Regulatory Challenges, and Reimbursement Issues

Obtaining regulatory approval from agencies like the FDA can be time-consuming and costly. Stringent regulatory requirements for clinical validation and quality assurance may delay market entry for new liquid biopsy tests, hindering innovation and adoption.

Reimbursement policies and coverage decisions by payers can significantly impact market uptake. Lack of reimbursement or inadequate reimbursement rates for liquid biopsy tests may limit patient access and healthcare provider adoption, particularly for tests with higher costs.

Future Opportunities for Liquid Biopsy Companies in the US

Companion Diagnostics are Becoming Increasingly Significant

Liquid biopsy tests have the potential to guide personalized treatment decisions by identifying actionable mutations or biomarkers. Developing companion diagnostics that match patients with targeted therapies or immunotherapies could create substantial market opportunities, especially as precision medicine becomes more prevalent.

As liquid biopsy technologies improve in sensitivity and specificity, they can become powerful tools for early cancer detection and monitoring. Companies that develop highly accurate liquid biopsy tests for various cancer types could see significant demand, particularly for screening in high-risk populations.

Liquid biopsies offer a non-invasive method for monitoring minimal residual disease (MRD) after cancer treatment. Companies that develop assays capable of detecting and quantifying residual tumor DNA or circulating tumor cells could play a vital role in post-treatment surveillance and improving patient outcomes.

Category-wise Analysis

Category

Projected CAGR through 2031

Product Type - Assay Kits

13.1%

Biomarkers - Circulating Tumor Cells

14.6%

Assay Kits Continue to be the Bestseller Category

Among product, the US liquid biopsy market is divided into assay kits, instruments, and services. The assay kits market segment became the market leader in 2023. Because of their affordability, adaptability, simplicity, and ongoing technological developments, assay kits continue to rule the market.

The necessity for precise and dependable assay kits, as well as the growing body of research and commercial applications for liquid biopsy, are some of the factors that are anticipated to propel this market's expansion in the upcoming years.

Assay kits are designed for ease of use and standardization, making them highly accessible for clinical laboratories and research institutions. They provide ready-to-use solutions that streamline the process of detecting and analysing biomarkers, facilitating quick and accurate results?.  

Assay kits offer a cost-effective solution for liquid biopsy testing. Their standardized format reduces the need for extensive laboratory setup and specialized equipment, lowering the overall cost of testing. This affordability makes them attractive options for many healthcare providers.

Circulating Tumor Cells Set to Explore Excellent Prospects

Circulating tumor cells (CTCs) are set to explore excellent prospects in the liquid biopsy market due to several key factors. CTCs provide valuable information for the early detection of cancer. Detecting these cells in the bloodstream can help identify malignancies at an early stage, improving the chances of successful treatment.

The presence and quantity of CTCs can serve as prognostic markers, offering insights into disease progression and patient outcomes. Recent technological advancements have significantly improved the ability to capture, isolate, and analyse CTCs.

Techniques such as microfluidics, advanced imaging, and molecular characterization have enhanced the sensitivity and specificity of CTC detection, making it a more viable option for clinical use.

Competitive Landscape Analysis

The US liquid biopsy market is characterized by a small number of key competitors and high fragmentation. In 2023, both established businesses and newly formed startups are competing for dominance in the highly competitive US market.

The market is predominantly led by companies based in the United States and Europe, with a growing number of participants from Asia. The competitive environment is dynamic, with new entrants continually emerging and others exiting. The US market is particularly significant, given its robust healthcare infrastructure and substantial investments in cancer research?.

Top Industry Players Profiled in the US Liquid Biopsy Market Report

  • Biocept, Inc.
  • Qiagen N.V.
  • Illumina, Inc.
  • Myriad Genetics, Inc.
  • Thermo Fisher Scientific, Inc.
  • Guardant Health
  • F. Hoffmann-La Roche Ltd
  • ANGLE plc.
  • BIODESIX
  • NeoGenomics Laboratories, Inc.
  • Others

Recent Developments in the Liquid Biopsy Market

February 2024

A formal deal was signed by Myriad Genetics, Inc. (US) to purchase certain assets from Intermountain Health. The Precise Tumor Test, the Precise Liquid Test, and the CLIA-certified laboratory of Intermountain Precision Genomics (IPG) were among the assets possessed by the company.

November 2022

Thermo Fisher Scientific introduced digital PCR liquid-biopsy assays for the Applied Biosystems absolute Q dPCR system, along with a custom design tool to streamline cancer research in academia and clinical settings.

US Liquid Biopsy Market - Report Scope & Segmentation

Attributes

Details

Forecast Period

2024 to 2031

Historical Data Available for

2018 to 2023

Market Analysis

US$ Billion for Value

Key Zone Covered

  • Northeast
  • Midwest
  • Southeast
  • Southwest
  • West

Key Market Segments Covered

  • By Product Type
  • By Biomarkers
  • By Application
  • By End User
  • By Zone

Key Companies Profiled in the Report

  • Biocept, Inc.
  • Qiagen N.V.
  • Illumina, Inc.
  • Myriad Genetics, Inc.
  • Thermo Fisher Scientific, Inc.
  • Guardant Health
  • F. Hoffmann-La Roche Ltd
  • ANGLE plc.
  • BIODESIX
  • NeoGenomics Laboratories, Inc.
  • Others

Report Coverage

  • Market Forecast and Trends
  • Company Share Analysis
  • Competitive Intelligence
  • DROT Analysis
  • Market Dynamics and Challenges
  • Strategic Growth Initiatives  

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US Liquid Biopsy Market Segmentation

By Product Type

  • Assay Kits
  • Services
  • Instruments

By Biomarker

  • Cell-free DNA Circulating
  • Cell-Free RNA
  • Circulating Tumor Cells (CTCs)
  • Exosomes and Extracellular Vesicles
  • Others

By Application

  • Cancer Application
    • Lung Cancer
    • Breast Cancer
    • Colorectal Cancer
    • Prostate Cancer
    • Others
  • Non-cancer Application

By End User

  • Academic and Research Institutions
  • Clinical Laboratories
  • Pharmaceutical and Biotechnology Companies
  • Other

By Zone

  • Northeast
  • Midwest
  • Southeast
  • Southwest
  • West

- Companies Covered in This Report -

- Frequently Asked Questions -

The demand for Liquid Biopsy is being driven by several key factors US The rising incidence of various types of cancer has significantly increased the need for effective diagnostic and monitoring tools. Liquid biopsies offer a non-invasive, quicker, and more comfortable alternative to traditional tissue biopsies, which is particularly beneficial for cancer patients who require frequent monitoring.

Some of the key players operating in the market are Biocept, Inc., Qiagen N.V., Illumina, Inc., Myriad Genetics, Inc., and Thermo Fisher Scientific, Inc.

The increasing incidence of cancer significantly boosts the demand for liquid biopsies, as these non-invasive tests offer a safer and more comfortable alternative to traditional tissue biopsies.

Future liquid biopsy tests are likely to incorporate multiple analytes, such as circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), and exosomes, in a single assay. This approach can provide comprehensive insights into the molecular landscape of tumors, improving diagnostic accuracy and patient management.

The circulating tumor cells (CTCs) segment hold the largest share in the US liquid biopsy market.

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