Cell-Free DNA (cfDNA) Kits Market Report 2025

The cell-free DNA (cfDNA) kits market size has grown rapidly in recent years. It will grow from $1.6 billion in 2024 to $1.8 billion in 2025 at a compound annual growth rate (CAGR) of 12.6%. Growth in the historic period was driven by the increasing number of diagnostic laboratories, greater adoption of oncology applications, wider use in transplantation and gynecology applications, and rising integration of artificial intelligence in diagnostics.

The cell-free DNA (cfDNA) kits market size is expected to see rapid growth in the next few years. It will grow to $2.86 billion in 2029 at a compound annual growth rate (CAGR) of 12.3%. Growth in the forecast period is expected to be supported by rising adoption of digital polymerase chain reaction, increased use of real-time polymerase chain reaction, expanding applications in other disease areas, growth in the number of diagnostic laboratories, and higher demand for non-invasive prenatal testing. Key trends anticipated for the forecast period include advancements in single-cell genomics, integration of automated laboratory workflows, progress in proteomics-based diagnostics, innovation in metabolomics analysis, and the development of enzyme-free nucleic acid detection methods.

The increasing prevalence of genetic disorders is expected to drive the growth of the cell-free DNA (cfDNA) kits market in the coming years. Genetic disorders are medical conditions caused by alterations in a person’s DNA, which can result from mutations in one or more genes, or chromosomal abnormalities. The rising occurrence of these disorders is largely due to lifestyle changes and environmental factors such as pollution and poor diet, which can either cause genetic mutations or worsen inherited conditions. Cell-free DNA (cfDNA) kits enable early, non-invasive detection of genetic abnormalities by analyzing DNA fragments present in blood or other body fluids. This technology facilitates quicker diagnoses and allows healthcare providers to make accurate treatment decisions. For example, the Centers for Disease Control and Prevention (CDC), a U.S.-based government agency, reported in November 2024 that about 1 in every 33 newborns in the U.S. is born with a birth defect, many of which are genetically related. As a result, the increasing prevalence of genetic disorders is fueling demand for cfDNA kits.

Leading companies in the cfDNA kits market are concentrating on developing innovative products that use digital polymerase chain reaction (PCR)-based absolute quantification to enhance the sensitivity and accuracy of cfDNA analysis. Digital PCR-based absolute quantification allows for the precise detection of low-frequency genetic variants with improved consistency, making it suitable for critical applications such as cancer diagnostics, prenatal testing, and monitoring transplant rejection. For example, in June 2024, Omixon, a molecular diagnostics company based in Hungary, introduced HoloGRAFT ONE, a research-use-only kit designed to monitor donor-derived cell-free DNA (dd-cfDNA) post-transplant. This kit utilizes proprietary genetic markers and digital PCR to differentiate donor DNA from the recipient’s DNA, measuring both absolute and relative amounts of dd-cfDNA through copy-number variants. The goal of this innovative test is to enable the early detection of transplant rejection, improve patient monitoring, and support personalized post-transplant care by providing clinicians with precise cfDNA data.

In February 2022, Labcorp Holdings Inc., a U.S.-based life sciences company, acquired Personal Genome Diagnostics Inc. for an undisclosed amount. This acquisition allows Labcorp to integrate Personal Genome Diagnostics’ advanced genomic technologies to enhance its cancer diagnostic offerings and bolster its precision medicine capabilities. Personal Genome Diagnostics Inc. is a U.S.-based company specializing in cell-free DNA (cfDNA) kits, with a focus on circulating tumor DNA (ctDNA) for cancer research and diagnostics.

Major players in the cell-free DNA (cfDNA) kits market are F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., Agilent Technologies Inc., Illumina Inc., Bio-Rad Laboratories Inc., QIAGEN N.V, Natera Inc., Myriad Genetics Inc., Guardant Health Inc., Bioneer Corporation, Streck Inc., Freenome Holdings Inc., GRAIL Inc., Zymo Research Corporation, Geneseeq Technology Inc, Covaris LLC, Active Motif Inc., Norgen Biotek Corp, AMSBIO LLC, EpiGentek Group Inc., Paragon Genomics Inc., Suzhou Beaver Biomedical Engineering.

North America was the largest region in the cell-free DNA (cfDNA) kits market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in cell-free DNA (cfDNA) kits report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the cell-free DNA (cfDNA) kits market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The fast surge in U.S. tariffs and the trade tensions that followed in spring 2025 are heavily affecting the medical equipment sector, particularly for imported imaging machine components, surgical-grade stainless steel, and plastic disposables. Hospitals and clinics resist price hikes, pressuring manufacturers’ margins. Regulatory hurdles compound the problem, as tariff-related supplier changes often require re-certification of devices, delaying time-to-market. Companies are mitigating risks by dual-sourcing critical parts, expanding domestic production of commoditized items, and accelerating R&D in cost-efficient materials.

Cell-free DNA (cfDNA) kits are laboratory tools designed to isolate and analyze fragmented DNA circulating in blood or other body fluids. They support non-invasive genetic testing by providing high-quality DNA for applications such as prenatal screening, cancer diagnostics, and transplant monitoring. These kits simplify sample preparation and enhance accuracy in downstream molecular analysis.

The primary product types in the cell-free DNA (cfDNA) kits market include plasma cfDNA kits, serum cfDNA kits, urine cfDNA kits, and others. Plasma cfDNA kits are designed to isolate and analyze DNA fragments circulating in plasma, the liquid component of blood. Key technologies include next-generation sequencing (NGS), polymerase chain reaction (PCR), microarray technology, and digital PCR. Major applications encompass cancer diagnostics, prenatal testing, transplant rejection monitoring, and non-invasive disease detection. Distribution channels consist of direct sales, retail pharmacies, online platforms, and distributors, while end users include hospitals, research laboratories, diagnostic laboratories, and academic institutions.

The cell-free DNA (cfDNA) market research report is one of a series of new reports that provides cell-free DNA (cfDNA) market statistics, including cell-free DNA (cfDNA) industry global market size, regional shares, competitors with a cell-free DNA (cfDNA) market share, detailed cell-free DNA (cfDNA) market segments, market trends and opportunities, and any further data you may need to thrive in the cell-free DNA (cfDNA) industry. The cell-free DNA (cfDNA) market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The cell-free DNA (cfDNA) kits market consists of revenues earned by entities by providing services such as purification services, bulk services, quality control (QC) services, data integration services, and custom biomarker discovery services. The market value includes the value of related goods sold by the service provider or included within the service offering. The cell-free DNA (cfDNA) kits market also includes sales of plasma separation consumables, liquid biopsy assay kits, serum preparation kits, concentration kits, and bisulfite conversion and methylation kits. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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