Non-invasive prenatal testing (NIPT) is an innovative way of screening pregnancies for fetal chromosomal aneuploidies by analyzing fetal cell-free DNA circulating in maternal blood. It involves the testing for particular diseases or birth defects in a fetus or embryo before it is born

1. Non-invasive Prenatal Testing (NIPT) Market – Global
Industry Insights, Trends, Outlook, and Opportunity
Analysis, 2017–2025
Non-invasive prenatal testing (NIPT) is an innovative way of screening pregnancies for fetal
chromosomal aneuploidies by analyzing fetal cell-free DNA circulating in maternal blood. It
involves the testing for particular diseases or birth defects in a fetus or embryo before it is born.
Statistics:
The global non-invasive prenatal testing market is estimated to account for US$ 1,936.4 Mn in
terms of value by the end of 2027.
Global Non-Invasive Prenatal Testing Market: Drivers
High prevalence of chromosomal disorders is expected to propel growth of the global non-invasive
prenatal testing market over the forecast period. For instance, according to the study, ‘Estimating
Nationwide Prevalence of Live Births with Down Syndrome and Their Medical Expenditures in
Korea’, published in Journal of Korean Medical Science in August 2019, the prevalence of live
births with Down’s syndrome was 5.03 per 10,000 births between 2007 and 2016.
Moreover, high awareness regarding benefits of non-invasive testing methods is also expected to
aid in growth of the global non-invasive prenatal testing market. Obstetricians are increasingly
recommending patients to undergo non-invasive tests as an alternative to invasive methods and
initial diagnostic screening in the first trimester of a pregnancy.

2. Statistics:
North America held dominant position in the global non-invasive prenatal testing market in 2019,
accounting for 45% share in terms of value, followed by Europe and Asia Pacific, respectively.
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Global Non-Invasive Prenatal Testing Market: Restraints
Uncertain reimbursement policies and insurance coverage is expected to hinder growth of the
global non-invasive prenatal testing market. Changes in the American Medical Association’s
Current Procedural Terminology, or CPT codes for non-invasive tests along with other molecular
diagnostic testing have led to uncertainties in reimbursement and insurance coverage for these tests.
Given the high costs for these tests, most vendors enjoy limited success due to limited or no
coverage for these tests.
Moreover, tests are patented by select few vendors, which is also expected to limit growth of the
market. A very select few vendors hold patents and exclusive licenses to technologies used in
non-invasive prenatal tests. As a result, there is limited market competition and limited incentive
to reduce cost of testing, as well as quality assurance.
Global Non-Invasive Prenatal Testing Market: Opportunities
Obtaining reimbursement for tests from payers is expected to offer lucrative growth opportunities
for players in the global non-invasive prenatal testing market. Vendors may focus on obtaining
insurance coverage for NIPT tests offered by them, considering the high costs of these tests.
Moreover, attention towards health education, subsidies for NIPT, and genetic counseling is also
expected to aid in growth of the market. For instance, in September 2020, researchers from Fudan
University, China, and University College London, U.K., reported that, in China, compared with
Zhengzhou participants, a higher proportion of Shenzhen women had heard of NIPT (87.30% vs.
64.03%), were willing to receive NIPT (91.80% vs. 80.43%) and had taken NIPT (83.12% vs.
54.54%), while their satisfaction level was lower.

3. Statistics:
The global non-invasive prenatal testing market was valued at US$ 882.9 Mn in 2019 and is
forecast to reach a value of US$ 1,936.4 Mn by 2027 at a CAGR of 10.3% between 2020 and
2027.
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Market Trends/Key Takeaways
Recommendation of new guidelines is expected to propel growth of the global non-invasive
prenatal testing market over the forecast period. For instance, in August 2020, American College
of Obstetricians and Gynecologists recommend new guidelines for Non-Invasive Prenatal Testing
(NIPT).

4. Major players in the global non-invasive prenatal testing market are focused on raising funds to
enhance their market share. For instance, in March 2020, BillionToOne, Inc. raised US$ 15
million to support the commercial expansion of UNITY, a prenatal screen that directly assesses the
baby’s risk for common and severe inherited disorders such as cystic fibrosis, spinal muscular
atrophy, and hemoglobinopathies, to all US states as well as the research and development (R&D)
of future diagnostics tests including liquid biopsy products.
Regulations
Europe
A national screening program for congenital anomalies or aneuploidies is strictly avoided in
Europe, because doctors and the national health service are NOT interested in terminating as many
handicapped individuals as possible
But pregnant women are informed in time by the obstetricians about the existence of all the
prenatal tests available, mentioning the advantages, the related risks and possible difficult decisions
arising from these tests
All these non-invasive / risk calculation tests and invasive / diagnostic tests are offered on request
of the pregnant women and are not compulsory. Since Combined Tests are increasingly requested,
the number of invasive tests is significantly declining.
Reimbursement Scenario for NIPT - Health insurer Anthem Blue Cross Blue Shield changed its
medical policy regarding non-invasive prenatal testing as such screening technology is considered
medically necessary for most pregnancies regardless of the risk status. According to Anthem's new
policy, cell-free DNA-based prenatal screening for trisomy 21, 18, and 13 is medically necessary
for women carrying a single fetus using NIPT as a screening tool for fetal aneuploidies regardless
of risk status.
Global Non-Invasive Prenatal Testing Market: Competitive Landscape

5. Major players operating in the global non-invasive prenatal testing market include, Ariosa
Diagnostics, Inc., BGI Diagnosis Co., Ltd., Berry Genomics Corporation, Illumina, Inc.,
LifeCodexx AG, Natera, Inc., Sequenom, Inc., Natera, Inc., Axia Women’s Health, Eluthia,
BillionToOne, Inc., and Quest Diagnostics Incorporated.
Global Non-Invasive Prenatal Testing Market: Key Developments
Major players in the global non-invasive prenatal testing market are focused on launching new
products to expand their product portfolio. For instance, in August 2019, Axia Women’s Health, a
U.S. based independent women’s healthcare group, launched non-invasive prenatal testing (NIPT)
in U.S.
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