According to FutureWise analysis the market for cell-free DNA (cDNA) testing in 2025 is US$ 10.87 billion, and is expected to reach US$ 23.61 billion by 2033 at a CAGR of 10.18%. The growth of non-invasive diagnostic techniques in prenatal screening, oncology, and transplant medicine is driven by the increasing prevalence of cancer and genetic disorders. This has led to a rising demand for cfDNA-based liquid biopsies due to their accuracy and convenience. Furthermore, advancements in next-generation sequencing (NGS) and bioinformatics are enhancing test sensitivity, enabling earlier disease detection and personalized treatments.
Cell-free DNA (cfDNA) testing is a groundbreaking approach that analyzes short, fragmented DNA found in blood plasma. This DNA is primarily released from cells undergoing apoptosis and necrosis. The phenomenon of cfDNA was first documented in 1948 by Mandel and Metais, but it gained significant clinical relevance in 1997 when Lo et al. discovered fetal DNA circulating in maternal plasma. This discovery paved the way for non-invasive prenatal testing (NIPT). Today, cfDNA assays are utilized in various medical fields, including oncology, transplantation, and prenatal care, largely thanks to advancements in next-generation sequencing (NGS), digital PCR (dPCR), and targeted methylation panels.
In the context of cancer diagnostics, liquid biopsies focusing on tumor-derived circulating tumor DNA (ctDNA) account for approximately 0.01% to 50% of total cfDNA. Assays such as Guardant360, FoundationOne Liquid, and Signatera are designed to detect single nucleotide variations (SNVs), insertions/deletions (indels), copy number variations (CNVs), and gene fusions from less than 10 mL of blood. These tests play a critical role in guiding treatment decisions for conditions like non-small cell lung cancer (NSCLC), colorectal cancer, and breast cancer. The sensitivity of these assays for advanced disease typically ranges from 70% to 90%, although it may fall below 50% when assessing early-stage patients or minimal residual disease (MRD).
From a technical standpoint, cfDNA is isolated from plasma through a double-spin process that removes leukocytes, yielding about 5 to 50 ng/mL of cfDNA. Techniques such as bisulfite conversion, the use of unique molecular identifiers (UMIs), and bioinformatics error correction are employed to address potential PCR and sequencing artifacts. Regulatory aspects include FDA-cleared in vitro diagnostics (IVDs), like the cobas EGFR Mutation Test v2, as well as laboratory-developed tests (LDTs) regulated under CLIA. Projections suggest that by 2025, more than 20 million NIPT tests and over 500,000 cancer cfDNA tests will be conducted annually on a global scale.
Despite its potential, cfDNA testing faces challenges, including pre-analytical variability due to factors like hemolysis and delayed processing, as well as biological confounders such as inflammation or recent physical activity. The cost of testing can also range from $500 to $3,000. However, advancements in long-read sequencing, epigenomic profiling, and AI-driven variant calling indicate a future trend toward broader adoption. Overall, cfDNA testing is revolutionizing diagnostics, moving away from invasive tissue biopsies to more routine and less invasive blood draws, which facilitate real-time disease monitoring and population-scale studies.
FutureWise Market Research has instantiated a report that provides an intricate analysis of Cell-Free DNA (cfDNA) Testing Market trends that shall affect the overall market growth. Furthermore, it includes detailed information on the graph of profitability, SWOT analysis, market share and regional proliferation of this business. Moreover, the report offers insights on the current stature of prominent market players in the competitive landscape analysis of this market.
According to the research study conducted by FutureWise research analysts, the Cell-Free DNA (cfDNA) Testing Market is anticipated to attain substantial growth by the end of the forecast period. The report explains that this business is predicted to register a noteworthy growth rate over the forecast period. This report provides crucial information pertaining to the total valuation that is presently held by this industry and it also lists the segmentation of the market along with the growth opportunities present across this business vertical.