Non-Invasive Prenatal Testing Market Analysis

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.

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.

Figure 1: Global Non-Invasive Prenatal Testing Market Share (%) Value, By Region, 2019

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.

Non-Invasive Prenatal Testing Market Report Coverage

Report Coverage	Details
Base Year:	2019	Market Size in 2020:	US$ 971.9 Mn
Historical Data for:	2016 to 2019	Forecast Period:	2020 to 2027
Forecast Period 2020 to 2027 CAGR:	10.3%	2027 Value Projection:	US$ 1,936.4 Mn
Geographies covered:	North America: U.S., Canada Latin America: Brazil, Argentina, Mexico, Rest of Latin America Europe: Germany, U.K., France, Spain, Italy, Russia, Rest of Europe Asia Pacific: China, Japan, India, Australia, South Korea, ASEAN, Rest of Asia Pacific Middle East: GCC Countries, Israel, Rest of Middle East Africa: North Africa, Central Africa, South Africa
Segments covered:	By Test Type: Panel 1 Test, Panel 2 Test, Panel 3 Test. By End User: Hospitals, Diagnostic Laboratories, Maternity Centers.
Companies covered:	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
Growth Drivers:	Increasing prevalence of chromosomal disorders Approval and launch of new products
Restraints & Challenges:	Lack of reimbursement

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.

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.

Figure 2: Global Non-Invasive Prenatal Testing Market Value (US$ Mn), 2016 – 2027

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).

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

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.