cfDNA Testing Research:CAGR of 11.30% during the forecast period

QY Research Inc. (Global Market Report Research Publisher) announces the release of 2025 latest report "cfDNA Testing- Global Market Share and Ranking, Overall Sales and Demand Forecast 2026-2032". Based on current situation and impact historical analysis (2020-2024) and forecast calculations (2026-2032), this report provides a comprehensive analysis of the global cfDNA Testing market, including market size, share, demand, industry development status, and forecasts for the next few years.

The global market for cfDNA Testing was estimated to be worth US$ 1500 million in 2024 and is forecast to a readjusted size of US$ 3165 million by 2031 with a CAGR of 11.3% during the forecast period 2025-2031.

【Get a free sample PDF of this report (Including Full TOC, List of Tables & Figures, Chart)】
https://www.qyresearch.com/reports/5491259/cfdna-testing

1. cfDNA Testing Market Summary

cfDNA testing is an advanced molecular diagnostic technology that uses the analysis of extracellular DNA fragments in the blood for disease screening, diagnosis, and monitoring. These DNA fragments primarily originate from genetic material released during cell apoptosis or necrosis, and their length is typically between 160 and 180 base pairs. In healthy individuals, cfDNA remains at a relatively stable low level, but its content and characteristics change significantly under specific physiological or pathological conditions such as pregnancy, organ transplantation, and tumors. Core applications of this technology include non-invasive prenatal testing, which screens for fetal chromosomal aneuploidy by analyzing fetal-derived cfDNA in maternal blood; tumor liquid biopsy, which detects ctDNA carrying specific gene mutations released by tumor cells for early cancer screening, companion diagnostics, efficacy evaluation, and recurrence monitoring; and post-transplant rejection monitoring, which assesses the transplanted organ's condition by analyzing the proportion of donor-derived cfDNA. Compared to traditional tissue biopsies, cfDNA testing offers advantages such as being minimally invasive, highly reproducible, and capable of reflecting tumor heterogeneity, making it an important tool in precision medicine. With the continuous development of sequencing technology and bioinformatics analysis, its application in clinical practice is constantly expanding.

According to the latest research report from QYResearch, in terms of market size, the global cfDNA Testing market size is projected to grow from USD 1.5 billion in 2024 to USD 3.2 billion by 2031, at a CAGR of 11.30% during the forecast period.

Figure00001. Global cfDNA Testing Market Revenue Growth Rate, 2020-2031

cfDNA Testing

Above data is based on report from QYResearch: Global cfDNA Testing Market Report 2025-2031 (published in 2024). If you need the latest data, plaese contact QYResearch.

2 Introduction of Major Manufacturers of cfDNA Testing

Serial Number

Company

1

Illumina

2

Onco-Genomics

3

Revvity

4

CareDx

5

Natera

6

BillionToOne, Inc.

7

Yourgene Health

8

ARUP Laboratories

9

Roche

Source: Third-party data, QYResearch Research Team

According to a survey by QYResearch's Leading Enterprise Research Center, global cfDNA Testing manufacturers include Illumina, Onco-Genomics, Revvity, CareDx, Natera, etc. By 2024, the top five global manufacturers will hold approximately 62% of the market share.

Introduction to Key Companies

Company 1

Illumina

Description

Company Introduction

Illumina is a leading global gene sequencing and microarray technology company headquartered in the United States. Since its public listing in 2000, the company has continuously driven the development of genomics technologies through a series of strategic acquisitions and technological innovations. Its products are widely used in key medical fields such as oncology, reproductive health, genetic diseases, and infectious diseases, and the company continues to advance precision medicine through collaborations with research and clinical institutions worldwide.

Product Introduction

Illumina's cfDNA (cell-free DNA) assay product line provides efficient and sensitive solutions, particularly suitable for cancer research and liquid biopsy applications. Its core product, TruSight Oncology 500 ctDNA v2, is a pan-cancer NGS assay that enables comprehensive panoramic variant analysis (CGP) of circulating tumor DNA (ctDNA) in plasma. This protocol targets 523 genes, assessing major variant categories such as single nucleotide variants (SNVs), insertions/deletions (indels), and copy number variations (CNVs), as well as key immuno-oncology genetic features such as tumor mutational burden (TMB) and microsatellite instability (MSI). This assay requires only a low starting amount of 20 ng cfDNA and utilizes unique molecular marker (UMI)-based hybridization capture library preparation and deep sequencing technology to achieve accurate detection of low-frequency mutations (such as SNVs with a detection sensitivity of up to 0.2% VAF).

Source: Third-party data, QYResearch Research Team

Company 2

Onco-Genomics

Description

Company Introduction

Onco-Genomics is a biotechnology company focused on cancer genomics, dedicated to providing solutions for precision medicine in cancer through next-generation sequencing (NGS) technology. Such companies typically offer comprehensive genomic analysis services, helping clinicians develop personalized treatment strategies by detecting gene variations in tumor tissue or blood samples. Their core businesses generally encompass cancer genome sequencing services, bioinformatics analysis, clinical interpretation reports, and collaborations with pharmaceutical companies to develop biomarkers and companion diagnostics (CDx).

Product Introduction

Onco-Genomics' cfDNA testing product is a non-invasive cancer gene testing solution based on liquid biopsy technology. This product collects peripheral blood from patients, extracts circulating tumor DNA (ctDNA) from the plasma, and uses high-throughput sequencing technology to perform deep sequencing on a range of genes closely related to cancer development and progression. Furthermore, this test is usually combined with automated data analysis workflows and professional clinical interpretation reports, providing physicians with clear, direct, and relevant genomic information for medication guidance and clinical trial enrollment, offering crucial reference information for the comprehensive management of cancer patients.

Source: Third-party data, QYResearch Research Team

Company 3

Revvity

Description

Company Introduction

Revvity is a US-based health science solutions provider with a balanced business across life sciences and diagnostics. Revvity focuses on translational multi-omics technologies, biomarker identification, imaging, and informatics platforms, providing end-to-end solutions from drug discovery and disease screening to precision medicine. Its clients include pharmaceutical and biotechnology companies, diagnostic laboratories, research institutions, and government agencies.

Product Introduction

Revity offers several innovative products in the cfDNA testing field, primarily for non-invasive prenatal testing (NIPT). Its Vanadis® NIPT system is a groundbreaking non-sequencing, non-PCR technology platform that targets and circularizes specific chromosomal fragments in cfDNA, combining fluorescent labeling with nanofiltration imaging for quantitative analysis, enabling trisomy risk screening and fetal sex determination. This system supports a fully automated workflow, allowing a single technician to process up to 20,000 samples annually, significantly improving testing efficiency and cost-effectiveness. Furthermore, Revvity's Horizon Discovery NIPT reference standards utilize immortalized cell lines to simulate real clinical samples, providing laboratories with a stable and traceable cfDNA quality control solution. The accompanying ChemagicTM cfDNA 5K kit and automated nucleic acid extractor enable rapid separation of plasma into high-purity cfDNA, ensuring the accuracy and reliability of downstream analyses. These technologies and products together constitute Revvity's complete solution for cfDNA detection, from sample pretreatment and quality control to final diagnosis.

Source: Third-party data, QYResearch Research Team

3 cfDNA Testing Industry Chain Analysis

Industry Chain

Description

Upstream

The upstream segment of cfDNA testing is the core of technological research and development and raw material supply, laying the technological foundation for the entire industry. This stage focuses on cutting-edge technological breakthroughs in life sciences and molecular diagnostics, mainly including the development of high-sensitivity sequencing platforms, efficient and accurate testing kits, and original research and development of key bioinformatics analysis algorithms. Participants are mostly international giants with strong technological barriers, such as sequencer manufacturers like Illumina and Oncogenomics, as well as various biotechnology companies specializing in the research and development of specific target probes or enzyme preparations. Its core value lies in continuously reducing testing costs, improving testing accuracy and throughput through continuous technological iteration, thereby pushing the technological boundaries of the entire industry forward and providing unlimited possibilities for subsequent clinical applications.

Midstream

The midstream segment of cfDNA testing is the main body of clinical application development and testing services, undertaking the crucial task of transforming upstream technologies into standardized, scalable products. The core of this stage is to design and validate clinically significant testing items based on different clinical needs, such as non-invasive prenatal testing (NIPT) for screening chromosomal aneuploidy, liquid biopsy for tumors for companion diagnostics, efficacy monitoring, and recurrence early warning. Midstream companies establish standardized operating procedures and quality control systems through self-built central laboratories or collaborations with large hospitals. They receive clinical samples from downstream partners and complete the entire wet laboratory process, from sample processing, DNA extraction, library construction, sequencing, to generating raw data. They act as a bridge connecting cutting-edge technology with end-user medical applications, and their service capabilities and quality directly determine the reliability and clinical value of the test results.

Downstream

The downstream link in cfDNA testing is the end-user application and data interpretation terminal, directly serving medical institutions, doctors, and patients to realize the ultimate clinical value of this technology. At this stage, the massive amounts of raw gene sequencing data generated by the midstream need to be deeply mined by a professional bioinformatics team using advanced algorithms. This involves sequence alignment, variant identification, annotation, and interpretation, ultimately generating a test report that clinicians can understand and that includes clear diagnostic and treatment recommendations. Doctors then comprehensively interpret the report in conjunction with the patient's complete clinical information, applying it to specific scenarios such as auxiliary diagnosis, medication guidance, prognostic assessment, and personalized health management. In addition, the downstream sector also involves market education, medical insurance payment discussions, and consumer-oriented health management services, which is the last mile for cfDNA technology to truly empower precision medicine and improve patient clinical outcomes.

Source: Third-party data, QYResearch Research Team

4 cfDNA Testing Industry Development Trends, Opportunities, Obstacles and Industry Barriers

Development Opportunities:

1. Early Cancer Screening Holds Immense Market and Social Value

cfDNA-based liquid biopsy technology offers a revolutionary solution for early cancer detection, particularly significant in areas where traditional testing methods are ineffective. Multiple clinical trials have confirmed the potential of cfDNA testing in the early screening of various cancers, including lung and liver cancer. With the empowerment of technologies such as artificial intelligence, the vision of "detecting cancer with a single drop of blood" is expected to be realized in the future. This represents not only a market with enormous potential but also significant public health benefits.

2. Continued Penetration and New Application Development in Non-invasive Prenatal Testing

Non-invasive prenatal testing (NIPT), as the most mature application area of ​​cfDNA technology, has a market far from saturated and still has room for continued growth and penetration. Furthermore, this technology provides crucial information in fetal sex determination, RhD blood type compatibility assessment, and shows potential for application in areas such as preeclampsia risk assessment.

3. Transplant Medicine Monitoring Opens a New Track for Precision Management

cfDNA testing provides a novel tool for post-organ transplant management, non-invasively monitoring rejection and damage to transplanted organs by detecting donor-derived cfDNA. This application has expanded from single organ transplants such as kidneys and hearts to more complex scenarios like combined heart-kidney and pancreas-kidney transplants. Automated platforms facilitate frequent longitudinal monitoring, enabling doctors to detect rejection signs earlier than traditional indicators and adjust immunosuppression regimens in a timely manner. This opens up a high-value professional medical market for cfDNA testing companies.

4. Technological Innovation and Collaborative Ecosystem Drive Continuous Expansion of Application Boundaries Emerging technologies are constantly pushing the boundaries of cfDNA testing capabilities, su

About Us:
QYResearch founded in California, USA in 2007, which is a leading global market research and consulting company. Our primary business include market research reports, custom reports, commissioned research, IPO consultancy, business plans, etc. With over 18 years of experience and a dedicated research team, we are well placed to provide useful information and data for your business, and we have established offices in 7 countries (include United States, Germany, Switzerland, Japan, Korea, China and India) and business partners in over 30 countries. We have provided industrial information services to more than 60,000 companies in over the world.

Contact Us:
If you have any queries regarding this report or if you would like further information, please contact us:
QY Research Inc.
Add: 17890 Castleton Street Suite 369 City of Industry CA 91748 United States
EN: https://www.qyresearch.com
Email: global@qyresearch.com
Tel: 001-626-842-1666(US)
JP: https://www.qyresearch.co.jp

This release was published on openPR.