Global Noninvasive Prenatal Testing Market Overview
The key driver impacting the noninvasive prenatal testing market is the rising incidence of gene-related disorders and chromosomal abnormalities. For instance, As per NCBI, Sickle cell disease (SCD) is one of the most common genetic hematological diseases. It accounts for 305000 births in 2010, with millions of people affected globally in 2018. As per the Center for Disease Control and Prevention (CDC), Sickle Cell Disease has an effect on over 100,000 Americans. Around one in all 365 African-American babies is born with Sickle Cell Disease in the U.S., whereas one in every 16,300 Hispanic-American babies is diagnosed with sickle cell disease. The other most widespread genetic disorder is Cystic Fibrosis. As to the Cystic Fibrosis Foundation, More than 30,000 people living with cystic fibrosis in the United States, more than 70,000 globally, and approximately 1,000 new CF cases are diagnosed each year. Moreover, high risk of chromosomal abnormalities with rising maternal age and growing preference for noninvasive methods over invasive methods, contributing to market growth.
According to Value Market Research, the global noninvasive prenatal testing market size was valued at around USD 2750 million in 2020 and is estimated to grow at a CAGR of about 10.9% during the forecast period 2021 to 2027.
The improving reimbursement policies for average and low-risk pregnancies are estimated to augment noninvasive prenatal testing demand in the forecast period. For instance, Natera declared extended coverage from the U.S. largest Health Plan Aetna, meant for its non-invasive prenatal testing (NIPT) for all pregnancies. This coverage was the outcome of the guidelines on aneuploidy screening options published by the Society for Maternal-Fetal Medicine (SMFM) in partnership with the American College of Obstetricians and Gynecologists (ACOG). The growing technological advancement in the existing tests in terms of improved chemistry, advanced functions, detection of monogenic diseases, and bioinformatics analysis. For instance, in April 2019, Progenity, Inc. launched the Resura prenatal test for the monogenic disease through sequencing-based noninvasive cell-free DNA technology to improve its portfolio than competitive tests available in the market. However, the high costs of noninvasive prenatal testing may hamper the global noninvasive prenatal testing market in the long run. Also, the unfavorable government regulations and reliability issues-particularly in obese women, negatively impact the market. The current industry trends, such as the increased maternal age, growing product usage in new applications, and technological advancement in the field of genetic and chromosomal disorder analysis, are expected to provide market players with new market opportunities.
The noninvasive prenatal testing market is vast, with many local and global players. The noninvasive prenatal testing market is extensive, with many local and international players. The key leaders follow numerous strategies to increase their market position, such as extending product portfolio, contracts, amalgamation, expanding product portfolio, product advancement, and acquisitions to improve their market share across the globe. The known players studied in the report are Genesis Genetics (CooperSurgical, Inc.), Centogene N.V., Eurofins LifeCodexx GmbH, F. Hoffmann-La Roche Ltd (Ariosa Diagnostics), Progenity, Inc., Laboratory Corp. of America Holdings, Natera, Inc., Illumina, Inc. (Verinata Health, Inc.), MedGenome Labs Ltd., Myriad Women’s Health, Inc. (Myriad Genetics Inc/Counsyl, Inc.), QiagenQuest Diagnostics, Inc.
In this research report, the noninvasive prenatal testing market is segmented by gestation period, risk type, method, technology, product, end-user, and region.
Analysis by Gestation period:
By gestation period, the report is segmented into 0-12 Weeks, 13-24 Weeks, 25-36 Weeks. The 13-24 Weeks dominate the gestation period segment with a 45% share in 2020. It is due to maximum noninvasive prenatal diagnosis is carried out in the second trimester of the pregnancy, and analysis of cffDNA in a sample of maternal blood collected in the first trimester develop a more accurate and reliable NIPT. Moreover, these tests also cover major complementary tests, such as ultrasound and serum screening for alpha-fetoproteins creates more testing in a 13-24 Weeks gestation period.
Analysis by Risk Type:
By risk type, the report is segmented into high & average risk and low risk. The high & average risk dominate the risk type segment with a 90% share in 2020. It is due to the increased adoption of these tests in high-risk cases in patients aged 35 years and above. Moreover, the presence of favorable payer reimbursement in this segment with growing awareness regarding prevention of chromosomal anomalies, such as Down syndrome, contributes to high & average risk segment growth in the forecast period.
Analysis by the Method:
By the method, the report is categorized into ultrasound detection, biochemical screening tests, and cell-free DNA in maternal plasma tests. The cell-free DNA-based NIPT method segment dominates the application segment with a 42.5% share in 2020. It is because cell-free DNA-based NIPT progressively more employed in foreseeing the risk of genetic conditions in prenatal care through diverse genetic analyses. Moreover, numerous research studies are being done to advance the usage of tests presented through this segment, thus contributing to the cell-free DNA-based NIPT method segment's growth in the forecast period.
Analysis by Technology:
By technology, the report is categorized into NGS, array technology, PCR, and other technologies. The NGS technology segment dominates the technology segment with a 57% share in 2020. It is due to the extensive use of NGS technology, such as targeted genome sequencing, whole-genome sequencing, and whole-exome sequencing, for prenatal cfDNA testing. Moreover, the NGS technology leads in various aspects such as availability, efficiency, penetration, and technology, thus contributing to the NGS technology segment's growth in the forecast period.
Analysis by Product:
By product, the report is segmented into reagents & consumables, and instruments. The reagents & consumables dominate the product segment with a 76% share in 2020. It is due to the high adoption of NGS-based prenatal test that needs several reagents and assays to run sequencing process and existence of a significant number of suppliers that provides advanced solutions to isolate cell-free DNA. Moreover, easy to use than conventional methods create more demands for consumables and reagents segments in the coming years.
Analysis by End-User:
By end-use, the report is categorized into diagnostic laboratories, hospitals & clinics. The Diagnostic laboratories segment dominates the end-user segment with a 59% share in 2020. It is because of well-drafted laboratory standards for NIPT in developed regions and the high volume of NIPT tests conducted in diagnostic laboratories. Moreover, the growing trend of outsourcing testing services to diagnostic laboratories as labs operates in agreement with quality-assurance regulations to safeguard the test reproducibility and quality thus, contribute to the diagnostic laboratories segment's growth in the forecast period.
Analysis by Region:
In the regional outlook of the global non invasive prenatal testing market, the North America region dominates with the most significant market share of 45% during the forecast period. It is due to the recent addition of NIPT in coverage plans of major insurance companies and the growing volume of chromosome abnormality cases leading to various genetic disorders. Also, the launch of new products by key players and a surge in healthcare infrastructure enhancement in the United States generates more revenue. Moreover, the growing awareness of NIPT with the high preference of couples for noninvasive prenatal testing tests during IVF and other artificial insemination procedures contributes to the market's growth across North America.
Market Segmentation covered in the Report:
By Gestation Period
By Risk Type
- 0-12 Weeks
- 13-24 Weeks
- 25-36 Weeks
- High & Average Risk
- Low Risk
- Ultrasound Detection
- Biochemical Screening Tests
- Cell-Free DNA in Maternal Plasma Tests
- Array Technology
- Other Technologies
- Consumables & Reagents
- Hospitals & Clinics
- Diagnostic Laboratories
- North America
- Asia Pacific
- Latin America
- Middle East and Africa
This market research report has been produced by gathering information on the basis of primary and secondary research. Secondary research has been done by using various sources which include (but not limited to) Company Websites, Paid Data Sources, Technical Journals, Financial Reports, SEC Filings, and other different industry publications.
If specific information is required which is not currently within the scope of the report, it can be provided as a part of customization.