Non-invasive Prenatal Testing (NIPT) Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028, Segmented By Product Type (Consumables, Instruments), By Test Type (Materni 21, Harmony, Panaroma, Verifi, NIFTY, Others), By Method (Ultrasound Detection, Biochemical Screening Testing, Cell-Free DNA Maternal Plasma Tests, Fetal Cells in Maternal Blood Tests, Others), By Application (Trisomy, Microdeletion Syndrome, Others), By End User (Diagnostic Laboratories, Hospitals, Others), By Region and Competition Forecast

Market Overview

Global Non-invasive Prenatal Testing (NIPT) Market has valued at USD 4.03 Billion in 2022 and is anticipated to project robust growth in the forecast period with a CAGR of 7.38% through 2028. Noninvasive prenatal testing (NIPT) is a prenatal screening method performed on a pregnant woman's blood sample to identify fetal abnormalities. This test is primarily used for diagnosing genetic disorders like Down syndrome (trisomy 21), Edwards syndrome (trisomy 18), Patau syndrome (trisomy 13), and Turner syndrome by analyzing DNA fragments in the mother's blood. By eliminating the need for invasive procedures such as chorionic villus sampling (CVS), NIPT offers a safer alternative. It can be conducted after nine weeks of pregnancy.

Key Market Drivers

Increased Emphasis on Early Detection and Prevention

Increased emphasis on early detection and prevention has had a significant impact on the demand for Non-Invasive Prenatal Testing (NIPT). NIPT is a revolutionary advancement in prenatal screening that allows for the detection of certain genetic abnormalities in a fetus through a simple blood test taken from the mother. This approach contrasts with traditional invasive methods like amniocentesis or chorionic villus sampling (CVS), which carry a risk of miscarriage. Traditional invasive prenatal tests like amniocentesis or CVS involve physically extracting samples from the amniotic fluid or placenta, which carries a small risk of complications, including miscarriage. NIPT, on the other hand, requires only a blood sample from the mother, making it a much safer option for early genetic screening. The non-invasive nature of NIPT is particularly appealing to expectant parents. The procedure is as simple as having a blood test, eliminating the need for any invasive procedures that could potentially harm the fetus. NIPT can detect certain genetic abnormalities, such as Down syndrome (trisomy 21), Edwards syndrome (trisomy 18), and Patau syndrome (trisomy 13), as well as sex chromosome abnormalities and other genetic disorders. Detecting these conditions early allows parents and healthcare providers to make informed decisions about their pregnancy and plan for potential medical interventions after birth. NIPT is highly accurate in identifying the risk of these genetic conditions. While it is not a diagnostic test, it provides a strong indication of whether further diagnostic testing is necessary, thereby reducing unnecessary invasive procedures.

Availability of Advanced Screening Technologies

Advancements in genome sequencing technologies have led to reduced turnaround time and simplified diagnosis through next-generation sequencing (NGS). The utilization of NGS technology presents numerous opportunities for the development of non-invasive diagnostic procedures, enabling early and precise detection of various genetic disorders. The life science industry is currently experiencing significant growth in NGS-based NIPT tests, as several biotechnology companies are actively engaged in researching and developing such products. Moreover, the integration of genome sequencing technologies in the life science industry has empowered companies to detect genetic diseases at an early stage, delivering accurate results to maintain competitiveness in the market. Advances in DNA sequencing technology have significantly improved the accuracy and reliability of NIPT. This has further bolstered its appeal among healthcare providers and patients alike. Advanced screening technologies, such as Next-Generation Sequencing (NGS), have significantly improved the accuracy and reliability of NIPT results. NGS allows for the detection of fetal genetic material in the maternal bloodstream with high precision, leading to more reliable screening outcomes. As advanced technologies improve the sensitivity of NIPT, the test can now detect a broader range of genetic conditions beyond chromosomal trisomies. This expanded scope, which includes sex chromosome aneuploidies and microdeletion syndromes, makes NIPT even more attractive to expectant parents seeking comprehensive information about their baby's health. With advanced screening technologies, NIPT can identify genetic abnormalities at an earlier stage of pregnancy. This early detection allows parents and healthcare providers to make timely and informed decisions about medical interventions and care plans. Advanced technologies have contributed to a decrease in the rate of false-positive results in NIPT. This reduction helps alleviate unnecessary stress and anxiety for expectant parents and minimizes the need for follow-up invasive procedures.

Healthcare Shifting of Reimbursement Policies Toward More Genetics Coverage

Reimbursement policies have a direct impact on the affordability and accessibility of medical services, and changes that make NIPT more financially feasible for patients can lead to increased adoption. Traditional prenatal tests such as amniocentesis and chorionic villus sampling (CVS) are often covered by insurance when there's a medical indication, but they also carry risks. NIPT, being non-invasive and accurate, is a preferred alternative for many patients. When reimbursement policies cover NIPT costs, it becomes a financially viable option for a broader range of expectant parents. Shifting reimbursement policies can lead to lower out-of-pocket expenses for patients undergoing NIPT. This reduction in cost burden encourages more individuals to opt for the test, as they are more likely to pursue testing when it's economically feasible. When NIPT is covered by insurance, it becomes accessible to a wider population, including those who might not have considered it due to financial constraints. This expanded access can lead to a higher demand for NIPT services.

Increasing Prevalence of Genetic and Congenital Disorders

The increasing prevalence of genetic and congenital disorders is a significant factor driving the demand for Non-Invasive Prenatal Testing (NIPT). As the awareness of these disorders grows and their impact on families becomes more apparent, expectant parents are seeking ways to ensure the health and well-being of their unborn children. NIPT offers a non-invasive and accurate method for early detection of certain genetic abnormalities, making it an attractive option for those at higher risk. The rising prevalence of genetic and congenital disorders has increased awareness among expectant parents about the potential risks their pregnancies might face. This heightened awareness prompts individuals to seek comprehensive and accurate screening methods like NIPT to identify potential issues early.

As medical advancements enable early detection of genetic disorders, parents are recognizing the value of early intervention and medical planning. NIPT provides information that allows parents and healthcare providers to make informed decisions about pregnancy management and future care. The rising prevalence of genetic and congenital disorders has led to heightened awareness and concern among expectant parents. This, in turn, has driven the demand for accurate and non-invasive prenatal screening options like NIPT. As the medical community continues to emphasize the importance of early detection and intervention, NIPT is likely to remain a sought-after tool for assessing the genetic health of unborn children.

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Key Market Challenges

Limitations of NIPT

Although NIPT is highly accurate, there is still a possibility of false-positive or false-negative results. False positives can lead to unnecessary anxiety and additional invasive testing, while false negatives might provide a false sense of security. These uncertainties can make some patients hesitant to fully rely on NIPT. NIPT is a screening test, not a diagnostic one. Positive NIPT results require confirmation through invasive diagnostic tests like amniocentesis or CVS. The need for follow-up invasive procedures can deter some individuals from pursuing NIPT. NIPT mainly focuses on chromosomal abnormalities and may not provide insight into functional genetic disorders or certain rare conditions. This limitation can be frustrating for parents seeking a comprehensive understanding of their baby's health. While the cost of NIPT has decreased over time, it can still be relatively expensive, especially for individuals without insurance coverage. Cost considerations may lead some people to explore alternative screening methods or forgo genetic testing altogether. NIPT's accuracy for detecting rare genetic conditions or those caused by de novo mutations may not be as high as for common aneuploidies. This uncertainty can affect decisions for families with specific genetic concerns.

Alternative Screening and Testing Methods

Traditional serum screening tests, like the first trimester combined test (which includes ultrasound and blood tests), have been used for years to assess the risk of chromosomal abnormalities. Some individuals may opt for these tests due to familiarity or recommendations from healthcare providers, despite the fact that NIPT offers higher accuracy and earlier detection. Sequential screening involves combining first-trimester serum screening with second-trimester maternal serum markers. While this approach provides more information than traditional screening alone, it might still be less accurate than NIPT for certain conditions. Some patients might choose this route over NIPT due to a lack of awareness about the benefits of NIPT. Some individuals might prefer invasive diagnostic tests like amniocentesis or chorionic villus sampling (CVS) over NIPT, even though they carry a small risk of miscarriage. This could be due to concerns about the accuracy of NIPT, a desire for a definitive diagnosis, or personal beliefs.

Key Market Trends

Availability of Direct-to-Consumer Tests

The availability of Direct-to-Consumer (DTC) tests for Non-Invasive Prenatal Testing (NIPT) has the potential to significantly boost its demand in the future. DTC testing allows individuals to access genetic testing services without involving a healthcare provider as an intermediary. While there are both advantages and concerns associated with DTC testing, it can play a role in increasing awareness, accessibility, and utilization of NIPT.  DTC testing eliminates the need for a healthcare provider's referral or prescription. This can make NIPT more accessible to individuals who might not have easy access to medical facilities or who prefer a more convenient testing process. DTC NIPT can encourage individuals to consider early genetic screening, even before consulting with a healthcare provider. This emphasis on early detection aligns with the current trend of proactive healthcare management. DTC testing allows individuals to make their own decisions about genetic testing, potentially leading to more proactive and informed choices about prenatal care.

Focus on Pre-Implantation Genetic Diagnosis

The combination of PGD and NIPT can provide a comprehensive assessment of genetic health, both before implantation and during pregnancy. Expectant parents who have undergone IVF with PGD might also choose to utilize NIPT to monitor the genetic health of the pregnancy, enhancing their confidence in the overall health of their baby. NIPT can serve as a validation tool for the results obtained through PGD. Parents who have used PGD to select embryos free of genetic conditions might choose NIPT to confirm that the selected embryos have indeed resulted in pregnancies free of the targeted genetic disorders. The combination of PGD and NIPT can provide dual assurance regarding the genetic health of the pregnancy. This could be particularly appealing to parents who are highly concerned about genetic disorders due to personal or family history.

Segmental Insights

Product Type Insights

Based on the application, the market is segmented into trisomy, microdeletion syndrome, and others. Trisomy is a prevalent condition. Non-invasive prenatal testing (NIPT) is a highly effective and secure method for prenatal screening of trisomy 21, 18, and 13 in the average-risk or general population. Moreover, non-invasive prenatal testing (NIPT) is strongly recommended for pregnancies resulting from in-vitro fertilization (IVF). Additionally, NIPT serves as an excellent screening tool for pregnant women following an IVF procedure, demonstrating exceptional sensitivity and specificity in detecting fetal aneuploidy.

End User Insights

Based on the end-user segment, the diagnostic laboratories category continues to dominate the global non-invasive prenatal testing market in 2022. The increasing preference for non-invasive prenatal testing among patients and healthcare professionals is driving the expansion of this segment. Moreover, diagnostic labs are experiencing a surge in test volumes due to their well-equipped facilities and qualified laboratory staff, thereby contributing to the market share growth. Furthermore, the projected increase in the number of initiatives implemented by diagnostic laboratories to ensure safe and accurate prenatal testing over the forecast period is expected to further drive the growth of the non-invasive prenatal testing market.

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Regional Insights

In 2022, North America held the largest market share, followed by Europe. The significant demand for genetic testing in North America, high R&D expenditures, a higher preterm birth rate, a well-established research framework, and increased rates of complicated births are projected to support the expansion of the non-invasive prenatal testing market in North America. Additionally, the robust reimbursement system in the region further supports the demand for non-invasive prenatal testing. The Europe non-invasive prenatal testing (NIPT) market is influenced by factors such as the high incidence of Down syndrome. According to estimates by Contact A Family in March 2022, one in every 1,000 children in the United Kingdom is born with Down syndrome. This increasing prevalence raises concerns among expectant parents and drives the adoption of non-invasive prenatal testing in Europe. Moreover, the growing trend of childbearing at advanced maternal ages (35 or older) contributes to the demand for NIPT in the region. The Asia Pacific region is projected to experience rapid growth in the coming years, driven by a large number of pregnancies resulting in children with Down syndrome. Additionally, government initiatives in some regions are also influencing market growth.

Recent Developments

• In September 2022, Yourgene Health plc, a prominent global molecular diagnostics group, announced the acquisition of Health Sciences Authority (HSA) approval for its IONA NX NIPT Workflow in Singapore. The IONA Nx NIPT Workflow stands as an in vitro diagnostic (IVD) tool meticulously crafted to provide unparalleled flexibility, simplicity, and scalability for prenatal screening.
• In January 2022, QIAGEN entered into a collaboration with Atila BioSystems to provide non-invasive prenatal testing (NIPT) solutions to QIAGEN's dPCR business.
• In July 2021, Pacific Biosciences executed a definitive merger agreement to acquire Omniome, a San Diego-based company that specializes in developing a highly distinctive, proprietary short-read sequencing platform capable of delivering exceptional accuracy. The decision to choose Omniome was driven by its innovative approach to swiftly deploying a precise short-read sequencing platform in rapidly expanding clinical application areas such as oncology, transcriptomics, metagenomics, and non-invasive prenatal testing (NIPT).

Key Market Players

• YOURGENE HEALTH Plc
• Illumina, Inc.
• Natera, Inc.
• F.Hoffman La Roche Ltd.
• Perkin Elmer Inc.
• Laboratory Corporation of America Holdings
• Eurofins LifeCodex GmbH
• Progenity, Inc.
• Genesis Genetics
• Quest Diagnostics Incorporated

Report Scope:

In this report, the Global Non-invasive Prenatal Testing (NIPT) Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

            ·         Non-invasive Prenatal Testing (NIPT) Market, By Product Type:

o   Consumables

o   Instruments

            ·         Non-invasive Prenatal Testing (NIPT) Market, By Test Type:

o   Materni 21

o   Harmony

o   Panaroma

o   Verifi

o   NIFTY

o   Others

            ·         Non-invasive Prenatal Testing (NIPT) Market, By Method:

o   Ultrasound Detection

o   Biochemical Screening Testing

o   Cell-Free DNA Maternal Plasma Tests

o   Fetal Cells in Maternal Blood Tests

o   Others

            ·         Non-invasive Prenatal Testing (NIPT) Market, By Application:

o   Trisomy

o   Microdeletion Syndrome

o   Others

            ·         Non-invasive Prenatal Testing (NIPT) Market, By End User:

o   Diagnostic Laboratories

o   Hospitals

o   Others

            ·         Non-invasive Prenatal Testing (NIPT) Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia-Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

§  Kuwait

§  Turkey

§  Egypt

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Non-invasive Prenatal Testing (NIPT) Market.

Available Customizations:

Global Non-invasive Prenatal Testing (NIPT) market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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