U.S. Liquid Biopsy Market Size, Share & Industry Analysis, By Product (Assay Kits & Consumables, and Instruments), By Application (Oncology, Non-Invasive Prenatal Testing (NIPT), and Others), By End User (Hospitals, Clinical Laboratories, and Others), and Country Forecast, 2024-2032

The U.S. liquid biopsy market size was worth USD 4.13 billion in 2023 and is projected to grow at a CAGR of 24.1% during the forecast period.

The prevalence of chronic diseases, such as cancer, and the need for early detection of these conditions are increasing among the U.S. population.

• According to an article published by the American Cancer Society, Inc., in 2022, an estimated 1.9 million new cancer cases were diagnosed and 609,360 deaths due to cancer were reported in the U.S.

Thus, extensive clinical studies on developing new products for diagnostics and screening, and introduction of advanced tests, such as liquid biopsy are rising across the country. This has led to an increase in the adoption of these tests for disease diagnosis across the healthcare settings. Hence, the rising availability and adoption of liquid biopsy for prenatal testing and cancer screening are driving the growth of the market. The impact of the COVID-19 pandemic resulted in a decline in the market growth in 2020 owing to limited patient visits for diagnostic tests, such as cancer screening across the U.S. healthcare systems.

LATEST TRENDS

Rise in Launch of Liquid Biopsy Tests by Key Players

Liquid biopsy testing offers varied clinical applications including disease diagnosis and detection of genetic aneuploidies, among others, through a patient’s blood samples. The demand for these tests is rising owing to their several advantages over traditional methods, such as early results, high sensitivity, minimally invasive, and potential to offer screening of several genetic disorders. Thus, owing to the high demand, manufacturers are focusing on developing screening tests for the early detection of diseases with advanced technologies and extensive applications.

• In September 2021, Yourgene Health received the FDA approval for its IONA Nx NIPT workflow. The tool was designed to screen for several clinical conditions in the fetus including Edwards' Syndrome (Trisomy 18), Patau’s Syndrome (Trisomy 13), and Down’s syndrome (Trisomy 21). The test could also be used for fetal sex determination from the gestation period of 10 weeks and to screen sex-chromosome and autosomal aneuploidies.

DRIVING FACTORS

Increasing Collaborations amongst Industry Players to Propel Market Development

Major companies operating in the U.S. market are focusing on organic strategies, such as collaborations and alliances with other industry players as well as research institutions to offer evidence-based treatment options owing to the surge in disease prevalence across the country.

• In January 2023, Agilent Technologies Inc. announced an agreement with Quest Diagnostics Incorporated that will enable healthcare providers and patients throughout the U.S. to access the Agilent Resolution ctDx FIRST next-generation sequencing (NGS) test.

Therefore, such strategic initiatives by industry players are anticipated to fuel the introduction of advanced products across the country, further propelling the U.S. liquid biopsy market growth.

RESTRAINING FACTORS

Lack of Evidence of Clinical Utility of Liquid Biopsy to Restrict Market Growth

Several industry players are now investing in R&D to conduct clinical trials for the development of liquid biopsy products. However, the lack of large-scale clinical studies demonstrating their clinical use may inhibit the growth of this market. Emerging technologies to detect biomarkers, such as circulating tumor DNA (ctDNA), Circulating Tumor Cells (CTCs), or extracellular vesicles have potential applications in disease diagnosis, prediction of disease metastasis, and targeted treatment, among others. However, currently only a few assays have sufficient data to obtain the FDA approval for targeted treatment.

• Springer Nature Limited published a study in April 2021 on the five circulating tumor DNA sequencing assays for precision oncology screened at 12 labs across the U.S., Europe, Asia, and Australia. However, the U.S. Food and Drug Administration (FDA) approved none of the biomarkers for clinical use due to insufficient data on their clinical utility and accuracy for liquid biopsy.

Thus, though there is an increasing demand for these tests in the U.S. market, the lack of evidence of their clinical utility might restrict the market's growth.

Among all cancer types, the prevalence of breast cancer is highest in the U.S.

SEGMENTATION

By Product Analysis

By product, the U.S. liquid biopsy market is segmented into assay kits & consumables, and instruments.

The assay kits & consumables segment dominated this market in 2022 owing to the rise in new product launches by key players and their increasing initiatives to expand their distribution network across the U.S.

• In December 2022, Agilent Technologies Inc. announced the U.S. Food and Drug Administration (FDA) approval of its Agilent Resolution ctDx FIRST as a companion diagnostic (CDx) to identify advanced non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations.

By Application Analysis

Based on application, the U.S. market is segmented into non-invasive prenatal testing (NIPT), oncology, and others.

The non-invasive prenatal testing (NIPT) segment accounted for the largest share in 2022 due to the growing adoption of non-invasive screening tests among women. The rising approval of advanced prenatal tests launched by key players further propelled the segment share.

• According to data published by Sonic Healthcare in 2021, an estimated 25-35% of pregnant women underwent NIPT tests in the U.S.

By End User Analysis

Based on end-user, the U.S. market is divided into hospitals & clinical laboratories, research institutes, and others.

The hospitals & pathology laboratories segment dominated the market in 2022 owing to the rising number of cancer diagnostic tests at hospitals across the country.

• According to an article published by the American Lung Association in November 2022, the 2022 “State of Lung Cancer” report stated that around 5.8% of the U.S. population had been screened for lung cancer in hospital settings.

KEY INDUSTRY PLAYERS

Strategic Collaborations among Key Players to Offer Growth Opportunities for Market

In terms of the competitive landscape, the market depicts the presence of established players, such as Guardant Health, Inc., Foundation Medicine, Natera, Inc., Personalis, Inc., and others. These major companies are focusing on receiving product approvals from various regulatory bodies and expanding their existing product portfolios for new applications. These factors are responsible for helping them capture a sizeable U.S. liquid biopsy market share.

Other major players operating in the market, such as QIAGEN, Bio-Rad Laboratories, Inc., BioChain Institute Inc., Stilla, BIOCEPT, INC., and GRAIL, LLC. are focusing on key strategies, such as partnerships with other research institutions across the globe to develop effective screening & monitoring tests for patients. Moreover, high emphasis of key players on the launch of technologically advanced products for research initiatives are projected to propel the market growth by 2030.

• In April 2023, QIAGEN announced the launch of QIAseq Targeted cfDNA Ultra Panels that will enable researchers studying cancer and other diseases to turn cell-free DNA (cfDNA) liquid-biopsy samples into libraries for Next-Generation Sequencing (NGS) in less than eight hours.


• In March 2023, Exai Bio Inc. announced a collaboration with Quantum Leap Healthcare Collaborative (QLHC) to broaden the use of Exai’s novel RNA-based liquid biopsy platform to monitor patients’ treatment response and disease burden in the I-SPY 2 TRIAL.

LIST OF KEY COMPANIES PROFILED:

• Guardant Health (U.S.)


• PERSONALIS, INC. (U.S)


• FOUNDATION MEDICINE, INC. (U.S.)


• Natera, Inc. (U.S.)


• Illumina, Inc. (U.S.)


• F. Hoffmann La Roche Ltd. (Switzerland)


• Thermo Fisher Scientific Inc. (U.S.)


• QIAGEN (Germany)


• Bio-Rad Laboratories, Inc. (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• January 2023: Foundation Medicine and Natera Inc. launched an early-access program of a co-developed personalized circulating tumor DNA (ctDNA) monitoring assay for research purposes in clinical trials. The assay, called FoundationOne Tracker, is intended to enable physicians to serially monitor patients' response to cancer treatments, especially in immunotherapies.


• September 2022: Predicine, Inc., a global provider of precision medicine in oncology and infectious diseases, announced that the U.S. Food and Drug Administration (FDA) had granted the Breakthrough Device designation to its PredicineCARE cfDNA Assay, a Next-Generation Sequencing (NGS) assay for tumor mutation profiling in cfDNA isolated from liquid biopsy samples from cancer patients.


• July 2022: BillionToOne Inc., a next-generation molecular diagnostics company, announced the launch of its first oncology products Northstar Select and Northstar Response.

REPORT COVERAGE

The market report provides a detailed market analysis and focuses on crucial aspects, such as leading players, products, and major applications. Additionally, it offers insights into market trends, key industry developments, such as mergers, partnerships & acquisitions, and the impact of COVID-19 on the market. In addition to the factors mentioned above, the report includes many factors that have contributed to the market's growth in recent years with a regional analysis of different segments.

Report Scope & Segmentation