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HEALTHCARE & PHARMACEUTICAL

U.S. Non-invasive Prenatal Testing Market Segmentation By Product (Elisa Kits, Next Generation Sequencing Systems and Microarray Analysis Systems); By Application (Aneuploidy, Micro-deletion, Trisomy and Others); By End User (Hospitals, Diagnostic Labs, Clinics and Others) – United States Industry Analysis & Opportunity Outlook 2018-2027

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IN THE NEWS
  • On 28 June, 2017, Roche announced the addition of 22q11.2 deletion testing to the Harmony Prenatal Test. The test is a non-invasive prenatal screening method that examines the possibility of Down syndrome along with other chromosomal abnormalities in the fetus. The 22q11.2 deletion syndrome is a health disorder associated with heart conditions, weak immune system as well as delayed physical development. After this development, the Harmony prenatal testing service will be used for detection of this syndrome as well.
  • On 25 April, 2019, Yourgene Health PLC., an international company for molecular diagnosis which commercializes gene-related products and services, announced the completion of its acquisition of Elucigene Diagnostics (UK) Limited. Elucigene is a manufacturer of molecular diagnostics and mainly focuses on oncology and reproductive health, including non-invasive prenatal testing solutions.

Market Overview and Growth Highlights – 2018-2027

Non-invasive prenatal testing includes a simple blood test that determines the presence of any genetic abnormality in the fetus. The test is performed by screening the maternal blood and analyzing the cell-free DNA present. These fragments of DNA come from the placenta, which contains the same DNA as that of the fetus, thereby making early detection of any genetic defects in the fetus possible. The genetic defects might consist of aneuploidy, Down syndrome, trisomy 18, trisomy 13 and others. These are mainly caused by deletion of duplication of the chromosomes. The market for non-invasive prenatal testing in the United States is predicted to grow by a CAGR of 12.52% during the forecast period, i.e., 2020-2027. Further, the market is anticipated to reach USD 2,318.81 million by the end of this period. On the other hand, the global non-invasive prenatal testing market was valued at USD 2,168.79 million in 2018 and is projected to reach a market value of USD 6,406.77 million by the end of 2027. Out of all the regions globally, the market in the U.S. region is estimated to witness the highest growth in the upcoming years.

Market Segmentation Synopsis

By Product

Based on product, the market is segmented into Elisa kits, next generation sequencing systems and microarray analysis systems. Out of these, the next generation sequencing systems segment is anticipated to hold the majority of share in the non-invasive prenatal testing market in the United States. Next generation sequencing systems refer to the new method of sequencing genome with greater speed and reduced cost. This is predicted to significantly raise the demand for this technique in the market. CLICK TO DOWNLOAD SAMPLE REPORT 

U.S. Non-invasive Prenatal Testing Market

By Application

The U.S. non-invasive prenatal testing market is segmented on the basis of application into aneuploidy, micro-deletion, trisomy and others, out of which, the trisomy segment is estimated to hold the largest share in the market and grow at the highest rate during the forecast period. This screening method is increasingly being used for the determination of any fetal trisomy which increases the demand for this segment in the market.

By End User

On the basis of end user, the market is segmented into hospitals, diagnostic labs, clinics and others. The hospital segment is estimated to hold the largest share in the market in the upcoming years as a result of higher patient population along with the rising demand for better care and treatment. However, the highest growth rate over the forecast period is anticipated to be observed by the diagnostic labs segment on account of presence of specialized staff and advanced medical equipment.

U.S. Non-invasive Prenatal Testing Market Size

Market Drivers and Challenges

Growth Indicators

According to the United Nations, approximately 3,000 to 5,000 children are born with Down syndrome every year. The chromosome 21 disorder has affected around 250,000 families in the United States. The growing number of chromosomal abnormalities that lead to genetic disorders are estimated to drive the demand for prenatal screening in order to ensure early detection of any such disorder. The chromosomal aberration might result in miscarriages or health disorders in the children such as heart diseases. In order to prevent any serious health issues, the demand for prenatal testing techniques is predicted to rise in the coming years. Another major factor contributing towards the market growth is the introduction of non-invasive prenatal testing techniques. The non-invasive technique, higher safety and accuracy as compared to invasive testing methods are some features of this procedure which raise its demand in the market.

Restraints

The prenatal screening is done in the first and second trimester in order to ensure primary prevention for Down syndrome. As NIPT is not reimbursed, the testing becomes highly costly for people which is hence estimated to become a restraining factor for the market growth. Another factor hampering the market growth is the inaccuracy of NIPT testing methods. In this technique, false-positive and false-negative results might be possible which is predicted to slow the market growth down. Further, the strict government policies in the United States are anticipated to hinder the growth of non-invasive prenatal testing market. This can be attributed to prenatal testing being a highly expensive procedure and for which the costs are not covered by the insurance companies.

Competitive Landscape

Some of the affluent industry leaders in the U.S. non-invasive prenatal testing market are Natera Inc., F. Hoffmann La Roche Ltd., Yourgene Health plc., Illumina, Inc., Agilent Technologies, Inc., Laboratory Corporation of America Holdings, Quest Diagnostics and Myriad Genetics. Moreover, other key and niche players are working towards the expansion of product portfolio along with investing in high quality R&D in the healthcare sector to develop highly engineered and innovative technologies for non-invasive prenatal testing techniques in order to gain competitive edge in the U.S. non-invasive prenatal testing market.

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