NON-INVASIVE PRENATAL TESTING (NIPT) MARKET ANALYSIS

Non-invasive Prenatal Testing (NIPT) Market Size and Forecast – 2024 to 2031

The Global Non-invasive Prenatal Testing (NIPT) Market is estimated to be valued at USD 4.60 Bn in 2024 and is expected to reach USD 9.11 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 10.2% from 2024 to 2031.

Key Takeaways of the Non-invasive Prenatal Testing (NIPT) Market:

• By product & service, the product segment is expected to contribute the highest share of the market with 55.1% in 2024.
• By application, the trisomy detection segment is expected to contribute the highest share of the market with 42.4% in 2024.
• By technology, the Next-Generation Sequencing (NGS)segment is expected to contribute the highest share of the market with 39.1% in 2024.
• North America is projected to top the global market with 37.3% share, followed by Asia Pacific with 27.7% share in 2024.

Market Overview:

The global non-invasive prenatal testing (NIPT) market is witnessing high growth rate owing to rising awareness about NIPT and increasing focus of key players on new product launches and approvals. Growing prevalence of Down’s syndrome and other genetic disorders in babies and rapid expansion of application areas of non-invasive prenatal testing are expected to drive the market growth during the forecast period. Furthermore, increasing preference of non-invasive techniques over invasive methods and reimbursement for NIPT in many countries have been supporting the growth of this market. However, availability of alternative diagnostic techniques and ethical concerns regarding NIPT are expected to hamper the market growth to some extent.

Segmental Insights

To learn more about this report, Request sample copy

Product & Service Insights - Rising demand for rapid and accurate screening and diagnosis drives product segment growth

In terms of product & service, the product segment is expected to contribute the highest share of the market with 55.1% in 2024 owing to the growing need for rapid and accurate non-invasive screening and diagnosis solutions among expectant mothers and healthcare providers. Products such as instruments and equipment that facilitate quick and reliable detection of fetal chromosomal abnormalities without invasive procedures have seen rising uptake. Continuous technological advancements enabling high-volume testing with improved accuracy have boosted product demand. Ultrasound devices with innovative features for detailed fetal scanning without risk of pregnancy loss are widely adopted. Likewise, next-generation sequencing platforms that can efficiently analyze cell-free DNA for various genetic parameters gain popularity.

Application Insights - Prevalence of common aneuploidies drives trisomy detection segment growth

In terms of application, the trisomy detection segment is expected to contribute the highest share of the market with 42.4% in 2024 owing to the high prevalence and health impact of common fetal trisomies. Trisomy 13, 18 and 21 which cause Patau, Edwards, and Down’s syndromes respectively are among the major aneuploidies detected via non-invasive prenatal testing. As these conditions are leading genetic causes of miscarriages and developmental disabilities, expectant mothers opt for early screening. Rising public health awareness about availability of NIPT and its efficacy in trisomy risk assessment compared to older tests has raised demand. Government initiatives promoting routine testing have further aided segment revenue. Likewise, increasing pregnancies in high risk groups and advancing maternal age where chances of trisomy rise bolster uptake. Comprehensive profiling with precision has made trisomy detection the major application area.

Technology Insights - Technological superiority of NGS platforms drives next-generation sequencing segment growth

In terms of technology, the next-generation sequencing (NGS) is expected to contribute the highest share of the market with 39.1% in 2024 owing to the technological advantages it offers over legacy methods. NGS platforms have played a key role in establishing the non-invasiveness of NIPT through high-throughput analysis of cell-free DNA from maternal plasma. Tests based on NGS achieve higher resolution and sensitivity in genome screening. The massive parallel sequencing capability enables faster and more efficient detection of multiple chromosomal regions simultaneously. Continuous refinement of NGS technologies has improved analytical accuracy while bringing down costs. Vendors have also launched automated NGS workflows with simplified sample-to-result times attracting more laboratories and clinics. Additionally, expanding applications of NGS-based NIPT like microdeletion screening and investigation of other genetic factors drive segment revenue. Its rising acceptance as the gold standard for reliable and detailed prenatal screening sustains segment leadership.

Regional Insights

To learn more about this report, Request sample copy

North America Non-invasive Prenatal Testing (NIPT) Market Trends

In North America, the dominance in the non-invasive prenatal testing (NIPT) market with a share of 37.3% in 2024 can be attributed to the increasing awareness about NIPT tests, growing focus on early disease detection, presence of advanced healthcare infrastructure, and easy access to healthcare facilities. The region is home to various pioneers offering advanced testing solutions, while government policies focus on improving maternal and child healthcare.

Asia Pacific Non-invasive Prenatal Testing (NIPT) Market Trends

Meanwhile, the Asia Pacific exhibits the fastest growth in the non-invasive prenatal testing (NIPT) market with a share of 27.7% in 2024. This can be credited to the rising healthcare spending of developing countries, growing initiatives to enhance prenatal care, and increasing investments by international players looking to tap potential markets.

Non-invasive Prenatal Testing (NIPT) Market Outlook for Key Countries

United States Non-invasive Prenatal Testing (NIPT) Market Trends

Enhanced reimbursement policies for average and low-risk pregnancies are anticipated to boost the adoption of non-invasive prenatal screening tests. In the U.S., Medicaid programs provide coverage for NIPT for high-risk patients following first-trimester screening. Additionally, NIPT is covered by insurers for approximately 114 million women with average-risk singleton pregnancies in the country.

Germany Non-invasive Prenatal Testing (NIPT) Market Trends

The Germany non-invasive prenatal testing (NIPT) market is supported by favorable healthcare policies. In January 2023, the German Federal Joint Committee announced new guidelines that include NIPT as a standard prenatal screening option, which is expected to enhance its adoption among expectant parents.

China Non-invasive Prenatal Testing (NIPT) Market Trends

The China non-invasive prenatal testing (NIPT) market is expanding rapidly due to government support and a high birth rate. The Chinese government has implemented policies such as National Prenatal and Newborn Screening Guidelines & Funding for Genetic Testing Infrastructure to promote prenatal screening, contributing to market growth.

India Non-invasive Prenatal Testing (NIPT) Market Trends

The India non-invasive prenatal testing (NIPT) market is expanding due to the rising burden of genetic disorders. In October 2023, the Indian Council of Medical Research (ICMR) launched a national initiative to promote non-invasive prenatal testing, aiming to improve maternal and fetal health outcomes across the country.

Market Players, Key Devlopment, and Competitive Intelligence

Get actionable strategies to beat competition: Request sample copy

Key Developments:

• In October 2024, Yourgene Health, a part of the Novacyt Group and a leader in molecular diagnostics, partnered with Genetix, a high-tech genetic diagnostics organization, to launch Colombia's first local non-invasive prenatal testing (NIPT) service. Utilizing Yourgene’s IONA Nx NIPT Workflow, Genetix's NipTest offers safe, fast, and accurate prenatal testing, reducing turnaround times and eliminating shipping challenges for expectant parents in the region.
• In September 2023, Yourgene Health plc, a leading provider of genomic solutions, launched the Yourgene MagBench Automated DNA Extraction Instrument and Kit for Sage customers in Asia Pacific and the Middle East. This cost-effective bench-top robotic workstation, designed for the Sage 32 NIPT Workflow, enables clinical labs to offer precise and efficient NIPT services.
• In August 2022, Natera, Inc., a pioneer in cell-free DNA testing, announced at the Canaccord Genuity Growth Conference that it had initiated the U.S. FDA pre-submission process for its Panorama NIPT. The filing targets fetal chromosomal aneuploidies and 22q11.2 deletion syndrome, highlighting Natera's commitment to regulatory compliance and advanced prenatal diagnostics.
• In September 2022, Yourgene Health plc, a leader in genomic and diagnostic solutions, received Health Sciences Authority (HSA) approval in Singapore for its IONA Nx NIPT Workflow. This approval enables clinical laboratories to offer advanced non-invasive prenatal testing (NIPT) services.
• In September 2022, Eurofins Genoma, a pioneer in advanced genetic diagnostics, introduced a non-invasive preimplantation genetic aneuploidy screening test (niPGT-A). This innovative solution provides IVF centers with a precise and reliable alternative to traditional genetic testing, meeting diverse reproductive genetic diagnostic needs.

Top Strategies Followed by Global Non-invasive Prenatal Testing (NIPT) Market Players

• Established Players: Leading companies are heavily investing in research and development to innovate high-performance NIPT products.
  • For instance, Illumina has been at the forefront of advancing sequencing technologies to enhance the accuracy and efficiency of NIPT. Their continuous R&D efforts have led to the development of more reliable and comprehensive prenatal testing solutions.
• Mid-Level Players: Mid-level players focus on delivering quality, budget-friendly NIPT products targeting price-sensitive consumers. A notable example is the introduction of more affordable NIPT options by companies like Natera, aiming to make prenatal testing accessible to a wider demographic.
• Small-Scale Players: Small players often target niche markets with unique features or innovative products.
  • For instance, Cradle Genomics focuses on developing advanced NIPT solutions that can be administered earlier in pregnancy, catering to specific market needs.

Emerging Startups - Non-invasive Prenatal Testing (NIPT) Industry Ecosystem

• Innovative Technologies: DNAscript is developing programmable molecular assemblers to synthesize personalized molecular circuits for compact sequencing. This could miniaturize NIPT devices. Cygenica uses graph neural networks for structural variant detection in NIPT, improving diagnostic accuracy.
• Sustainable Solutions: Cradle Genomics aims to make NIPT disposables plastic-free and fully recycled/compostable to reduce medical waste. It uses biodegradable substrates and vegetable-based inks for kits. Prelude Genetics captures fetal cells from maternal blood through microfluidic-based separation without centrifugation, lowering energy usage 50%. Their technologies set sustainability standards.
• Market Contribution: Startups like Juno Diagnostics are addressing unique market needs by developing NIPT solutions that are more accessible and affordable, targeting underserved populations. Partnerships with other companies or institutions drive technological and sustainable innovation. For instance, in February 2023, Juno Diagnostics partnered with Labcorp to expand the availability of its NIPT solutions, enhancing market reach and technological advancements.

Market Report Scope

Market Dynamics

Discover market dynamics shaping the industry: Request sample copy

Market Driver - Increasing prevalence of chromosomal abnormalities among newborns

The prevalence of chromosomal abnormalities in newborns has been increasing over recent decades. Conditions such as Down syndrome, Trisomy 18, Trisomy 13, and Turner syndrome can severely impact a child’s health and development while placing significant emotional and financial strain on families. The risk of these abnormalities rises with parental age at conception. As more people delay parenthood to prioritize their careers, the average age of new parents has risen worldwide, increasing the likelihood of serious chromosomal defects in babies. For instance, in December 2022, according to Springer Nature, a study in Zhejiang Province, China (2014–2020), showed rising chromosomal abnormalities (CAs), with sex chromosomal abnormalities increasing from 1.70 to 7.30 per 10,000 births and microdeletions/duplications from 0.30 to 6.81. The prenatal diagnosis rate for trisomy 21 improved from 20.8% to 70.1%. Elevated maternal age (≥35 years) and advances in prenatal diagnostics contributed to these trends.

Market Challenge - High costs associated with NIPT procedures

One of the key challenges faced by the global non-invasive prenatal testing (NIPT) market is the high costs associated with NIPT procedures. NIPT tests analyze cell-free DNA from a maternal blood sample to screen for fetal chromosome abnormalities such as Down syndrome, without risking the health of the fetus. However, the procedures and techniques involved in extracting and analyzing fetal cell-free DNA are highly complex and require sophisticated laboratory equipment and genetic expertise. This makes NIPT tests quite expensive, with an average cost ranging from US$ 1,000-2,000 per test. The high costs pose affordability issues, restricting NIPT to high-income groups, and developed regions of the world. Several developing and underdeveloped markets have low acceptance and adoption rates of NIPT due to the high expenditure required.

Market Opportunities - Technological advancements in genomic testing

One of the key opportunities for the global non-invasive prenatal testing (NIPT) market lies in the ongoing technological advancements in the field of genomic testing. Continuous research and development is helping refine NIPT methodologies and optimize associated laboratory processes. Improvements in next generation sequencing (NGS) technologies have enabled more accurate and efficient analysis of cell-free DNA from smaller sample sizes. Advanced analytics and machine learning applications are also aiding the interpretation of NIPT results. Portable and decentralized testing solutions are being innovated to facilitate POINT-of-CARE NIPT outside conventional laboratory settings. Such technological upgrades are helping reduce the costs and complexities of NIPT. As tests become more affordable and accessible, demand for NIPT is expected to tremendously increase across different global regions.

Analyst Opinion (Expert Opinion)

• Increased awareness about NIPT and its benefits among expectant mothers across regions is a key driver. Growing preference for non-invasive procedures during pregnancy will further propel market expansion. Additionally, continuous technological developments are enabling NIPT to identify an extensive number of genetic abnormalities at an early gestational age. This factor will aid in cementing NIPT's position as a primary screening method globally.
• Strict regulatory norms and reimbursement policies pose challenges to market players in various countries. Different regulatory pathways also result in delay in test approval, restricting market access. On the other hand, higher test costs compared to traditional screening techniques could deter certain segments. Nevertheless, rising healthcare expenditures are facilitating the incorporation of NIPT in national healthcare programs, offering new opportunities.
• Among regions, North America currently dominates the NIPT landscape owing to accessibility to advanced healthcare facilities and supportive insurance coverage. However, Asia Pacific is likely to emerge as the most lucrative market in the long run. Factors such as the increasing accessibility of NIPT, rising healthcare infrastructure, and growing medical tourism will majorly support the regional market growth over the coming decade.

Market Segmentation

• By Product & Service Insights (Revenue, USD Bn, 2019 - 2031)
• • Product
    • Consumables
    • Assay Kits and Reagents
    • Instruments
  • Services
• By Application Insights (Revenue, USD Bn, 2019 - 2031)
• • Trisomy Detection
  • Microdeletion Detection
  • Sex Chromosome Aneuploidy Detection
• By Technology Insights (Revenue, USD Bn, 2019 - 2031)
• • Next-Generation Sequencing (NGS)
  • Polymerase Chain Reaction (PCR)
  • Array Technology
  • Rolling Circular Amplification
• By Period Insights (Revenue, USD Bn, 2019 - 2031)
• • 0-12 Weeks
  • 13-24 Weeks
  • 25-36 Weeks
• By End User Insights (Revenue, USD Bn, 2019 - 2031)
• • Hospitals
  • Diagnostic Laboratories
  • Home Care Settings
  • Others
• Regional Insights (Revenue, USD Bn, 2019 - 2031)
• • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
• • Illumina, Inc.
  • Natera, Inc.
  • Roche Diagnostics
  • Ariosa Diagnostics
  • Verinata Health, Inc.
  • Yourgene Health
  • Centogene N.V.
  • Eurofins Scientific
  • Hoffmann-La Roche Ltd.
  • LabCorp
  • Quest Diagnostics
  • BGI Genomics
  • MedGenome Labs
  • Genetic Technologies Limited
  • Myriad Genetics, Inc.