Cell-Free DNA are fragments of DNA which circulate in the blood fluid and can be utilized as valuable biomarkers. It is a new technology in which small quantity of liquid sample (saliva, urine, or blood) from the patient is collected to examine the freely flowing DNA. Cell-Free DNA (cfDNA) is a noninvasive screening test used to help detect graft rejection, identify mutations in cancer patients and detect various chromosomal abnormalities in the fetus, in order to know the gender of fetus. The discovery of cfDNA has opened up to new potentials in the field of oncology, gynecology, transplantation and infectious diseases.
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The cell-free DNA testing market is segmented on basis of its application, types and region. On basis of application the market is segmented into oncology, gynecology and transplantation. By type, the market is further segmented into donor derived cell free DNA (ddcfDNA), circulating cell-free tumor DNA (ctDNA) and cell-free fetal DNA (NIPT). Donor-derived cell-free DNA testing examines the graft rejection in transplanted patient by recognizing the absence or presence of donor DNA in the bloodstream. In ctDNA testing, circulating tumor DNA in urine, saliva or blood of tumor patients is examined to detect mutation. In prenatal testing, the chromosomal abnormality is identified in the fetus by collection of blood sample from pregnant women who carry DNA of that fetus.
The cell-free fetal DNA market has a major share in the market due to increased number of pregnancies following to it is the circulating cell-free tumor DNA market and later the donor derived cell-free DNA market. In the region wise segmentation, North America region had the largest revenue in 2015 due to majority of tests launched and adaptation of advanced technologies in screening techniques. Following North America is Europe and Asia Pacific which are also the fastest growing market due to blooming economy and improving healthcare infrastructure and rising prevalence of diseases in these regions. The potential of cell-free DNA testing market has attracted many biotechnology and pharmaceutical firms by acquiring other major firms or by launching novel tests.
Increased incidences of diseases like chromosomal abnormalities due to increase in maternal age, changing lifestyle, unhealthy diet habits and rising prevalence of cancer, also in addition to it increasing healthcare expenditure and rising healthcare awareness are the reasons driving the cell-free DNA market. However, there are some other factors such as lack of skilled healthcare professionals, high test cost, non-affordability in low income countries, ethical issues related to genetic testing, lack of standardization, unfavorable reimbursement policies and legal and regulatory guidelines some of the reasons hampering the growth of the market.
Various companies are coming up with new software’s and improved sequencing technologies which has improved the test quality with accurate and rapid results. Some of the leading players in cell-free DNA testing market are Agilent Technology, Allenex AB, Biocept, Inc., Biodesix, Inc., CareDx, Inc. Guardant Health, Inc., Illumania, Inc., Inivated Limited, Natera, Inc., Quest Diagnostics, Roche Holdings AG, Sequenom, Inc. and Trovagene, Inc. The global cell-free DNA testing market is a competitive market and all the players are involved in developing new assays by mergers and acquisitions In order to sustain themselves in the market and maintain their market share.
For instance, Roche Holdings AG received U.S. FDA approval for its newly launched ctDNA test Cobas which is approved for blood based genetic tests. Roche also entered the NIPT market with acquisition of Ariosa diagnostics. CareDx, Inc., acquired Allenex AB for its new developments in donor derived Cell-Free DNA tests for kidney and heart transplant patients.
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