Cell-free DNA is used to detect chromosomal abnormalities in the foetuses for specific mutations, in cancer patients and graft rejection.
Online PR News – 11-June-2016 – Boston, Massachuesetts – Cell-free DNA testing refers to the non-invasive screening test used in the various fields like gynecology, oncology and transplantation to detect chromosomal abnormalities in the foetus, specific mutations in cancer patients and to detect graft rejection. This process involves collection of patient’s sample with cell-free DNA in different forms such as fetal DNA, circulating tumour DNA and donor derived cell-free DNA respectively using various modern sequencing techniques and software algorithms to analyze the data to give rapid and accurate results for early disease diagnosis. Cell-free DNA testing is a fast emerging market with a high growth rate, as estimated by IQ4I Research is valued $XX million in 2015 and expected to grow at a CAGR of XX% to reach $8,988 million by 2022.
Increased incidences of diseases like cancer due to change in lifestyle, unhealthy food habits is expected to propel the growth of this market. Genetic abnormalities among infants are also rising across the globe because of advanced maternal age. This projected increasing incidence along with the increasing income in the developing countries and the need for safer diagnostic methods provides an opportunity for molecular diagnostics company to come up with more number of tests. On the other side there are some issues like high test cost, lack of skilled healthcare professional and ethical issues related to genetic testing are hindering the growth of cfDNA market. However, there is huge potential market for molecular diagnostic companies to come up with new tests focusing on transplantation rejection cases like lung, liver etc using cell-free DNA in coming years. Also emerging applications for cell-free DNA include infectious diseases which can revolutionize the market. For instance, Cornell investors have developed Ultrashort circulating cell-free DNA for non-invasive testing of infectious disease to pathogens such as CMV and Herpes virus.
The cell-free DNA testing global market is segmented by type, into three main divisions such as non-invasive prenatal test (NIPT), circulating tumour DNA (ctDNA) and donor DNA market. NIPT market holds the largest market revenue of $XX million in 2015 and expected to reach $XX million in 2022 at a CAGR of XX% and Circulating tumour DNA segment is expected to grow at a CAGR of XX% from 2015 to 2022 due to increase in early diagnosis, non-invasive test procedures, technological advancements and rising incidence of cancer. The ¬¬¬donor DNA segment product is projected to grow at a highest CAGR of XX% from 2017 to 2022 to reach revenue of $XX million due to increasing incidence of chronic diseases along with the advancement in transplantation technology and growing awareness towards organ donation among the public.
The cell-free DNA testing global market by applications is segmented into three major divisions such as gynecology, oncology and transplantation. Among these, gynecology account for XX% share and is growing strongly at a CAGR of XX%. The transplantation product is expected to launch by 2017 and is projected grow rapidly at a highest CAGR of XX% to reach $XX million by 2022.
The huge potential of cell-free DNA testing market has attracted many pharmaceutical and biotechnology firms either by launching their new tests or by acquiring with other major firms. For instance in June 2016, Roche Holdings AG received U.S. FDA approval for its newly launched ctDNA test named cobas EGFR mutation test V2, first FDA-approved blood based genetic test that detect EGFR gene mutation in NSCLC patients. Roche also entered the NIPT market with the acquisition of Ariosa Diagnostics for $650 million in January 2015. In January 2016, Illumina announced the formation of a new company, GRAIL with a funding of over $100 million. The company also acquired prenatal test maker Verinata Health for $350 million in January 2013. Baltimore based Personal Genome Diagnostics raised $21 million in October 2015 to develop new tests. TAI diagnostics raised $8.2 million in October 2015 to commercialize blood test for heart transplant patients. CareDx, Inc., a molecular diagnostics company which offers high-value diagnostic surveillance solutions for transplant patients, completed acquisition of Allenex AB in April 2016 for the developments of its new donor derived cell-free DNA tests for kidney and heart transplant patients. Similarly, many academic institutes are also involved in developing new tests.
Sequenom, Inc. (U.S.), Illumina, Inc. (U.S.), Natera, Inc. (U.S.), Roche Holdings AG (Switzerland), Trovagene (U.S.), Biocept, Inc. (U.S.), Personal Genome Diagnostics (U.S.), Guardant Health (U.S.), Inivata Limited (U.K.), Berry Genomics Co. Ltd (China), Laboratory Corp. Of America Holdings (U.S.), Lifecodexx AG (Germany), Quest Diagnostics (U.S.) are few major companies with their tests clinically available in cell-free DNA testing market.