Non-invasive Prenatal Testing Global Market Report 2024

The non-invasive prenatal testing market size has grown rapidly in recent years. It will grow from $4.73 billion in 2023 to $5.44 billion in 2024 at a compound annual growth rate (CAGR) of 15.1%. The growth observed during the historical period can be attributed to factors such as enhanced accuracy, decreased risk, the trend of increasing maternal age, heightened awareness, and the influence of clinical guidelines.

The non-invasive prenatal testing market size is expected to see rapid growth in the next few years. It will grow to $9.43 billion in 2028 at a compound annual growth rate (CAGR) of 14.7%. The anticipated growth in the forecast period can be linked to the expansion of test offerings, increased accessibility, a rising trend in maternal age, the enhanced detection of fetal anomalies, and the influence of telemedicine and digital health. Prominent trends in this forecast period include the broadening of test panels, the widespread adoption of non-invasive prenatal testing (NIPT), technological advancements, and the development of non-invasive fetal aneuploidy diagnosis (NIFAD).

The high incidence rate of Down syndrome is a significant factor propelling the growth of the non-invasive prenatal testing (NIPT) market, especially with the increasing trend of older maternal age, which raises concerns about fetal well-being. Down syndrome, a chromosomal condition resulting from an error in cell division, leads to an extra chromosome 21 and can impact the cognitive and physical development of the fetus. NIPT screening tests offer a safe and non-invasive means of detecting Down syndrome, posing no harm to the mother or baby and carrying no risk of miscarriage. These tests can identify over 99% of Down syndrome cases. In the USA, the National Down Syndrome Society and the Centers for Disease Control and Prevention report that 1 in every 700 babies is born with Down syndrome, and 80% of children with Down syndrome are born to older mothers. The increased risk associated with advanced maternal age is a driving force behind the growth of the NIPT market.

The key categories of non-invasive prenatal testing encompass consumables and instruments. Consumables refer to products that are used and depleted during their application. Instruments include NGS systems, PCR instruments, microarrays, ultrasound devices, and other equipment like centrifuges, UV systems, incubators, and microscopes. Various consumables comprise assay kits and reagents, as well as disposables. These applications pertain to the detection of conditions such as trisomy, microdeletion, genetics, and the Rh factor, and are typically employed by hospitals and diagnostic laboratories.

The non-invasive prenatal testing market research report is one of a series of new reports that provides non-invasive prenatal testing market statistics, including non-invasive prenatal testing industry global market size, regional shares, competitors with a non-invasive prenatal testing market share, detailed non-invasive prenatal testing market segments, market trends and opportunities, and any further data you may need to thrive in the non-invasive prenatal testing industry. This non-invasive prenatal testing market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The increasing maternal age is expected to be a key driver of the non-invasive prenatal testing market's expansion in the foreseeable future. Factors such as pursuing education, career opportunities, financial stability, personal choices, delayed marriage, improved contraception, and societal changes have led to women delaying childbirth. This delay increases the risk of chromosomal abnormalities, prompting more expectant mothers to opt for NIPT to assess their pregnancy's health. For example, data from the Centers for Disease Control and Prevention in June 2023 indicates a 2% increase in the provisional birth rate for women aged 35-39 from 2021 to 2022, with a 2% rise in the number of births to women in their late 30s. Additionally, the provisional birth rate for women aged 40-44 increased by 4% from 2021 to 2022, with a 6% rise in the number of births to these women. The provisional birth rate for women aged 45-49 (including those aged 50 and older) increased by 1.1 births per 1,000 women in 2022, up from 0.9 in 2021, marking the first change in this rate since 2015 and a 12% increase in the number of births to women in this age group. Therefore, increasing maternal age will continue to drive the growth of the non-invasive prenatal testing market.

The non-invasive prenatal testing (NIPT) market faces ethical challenges, particularly concerning issues related to sex selection and the abortion of fetuses with chromosomal abnormalities. Determining the sex of the fetus or identifying abnormalities at an early stage has raised ethical concerns, leading to stricter regulations on the use of such diagnostic tools. In the UK, a record 214,869 abortions were performed in England and Wales in 2021, the highest number since abortion became legal in 1967. These ethical dilemmas can pose constraints on the non-invasive prenatal testing market.

The integration of next-generation sequencing technology has significantly enhanced the capabilities of researchers, enabling them to conduct a wide range of applications and study biological systems at a higher level. Next-generation sequencing allows for the simultaneous sequencing of thousands to millions of DNA molecules, reducing both time and cost while optimizing results for genome and DNA testing. Major companies like Illumina, Eurofins, Natera, Roche, and Annoroad have adopted this technology for non-invasive prenatal testing. The China Food and Drug Administration (CFDA) has approved the medical instrument product registration for Annoroad's NGS instrument NextSeq 550AR.

The non-invasive prenatal testing market is subject to strict regulation by various international and country-specific agencies. For instance, the US Food and Drug Administration (FDA) issues certifications for Laboratory Developed Tests (LDTs) and Clinical Laboratory Improvement Amendments (CLIA). Manufacturers must obtain a 510(k) premarket notification for in vitro diagnostic tests, with LDTs and CLIA certification based on the number of tests conducted during clinical trials. For instance, for trisomy 21 (Down syndrome), with an incidence rate of 1/1000, at least 100,000 samples would need to be tested to meet the requirements of a 510(k). A 510(k) premarket notification ensures that the new product is as safe and effective as other legally-marketed devices, and manufacturers must register such notifications before commercially marketing new products.

In May 2021, Echelon Diagnostics, a US-based leader in genomic healthcare AI imaging analysis and big data solutions, signed a collaboration agreement with Cradle Genomics for an undisclosed amount. This partnership aims to accelerate the development of Cradle's cellular-based non-invasive prenatal diagnostic (NIPD) products. Cradle Genomics, a US-based company specializing in non-invasive prenatal testing services, offers diagnostic solutions.

Major companies operating in the non-invasive prenatal testing market include F. Hoffmann-La Roche AG, Illumina Inc., Laboratory Corporation of America Holdings, Natera Inc., PerkinElmer Inc., Quest Diagnostics Inc., Agilent Technologies Inc., BGI Diagnosis Co Ltd., Berry Genomics Co, LifeCodexx AG, Myriad Genetics Inc., NIPD Genetics Co Ltd., Sequenom Inc., Annoroad Gene Technology Co Ltd., Centogene AG, Counsyl Inc., EUROFINS Genoma Group, Eurofins Scientific SE, Next Biosciences, Premaitha Health PLC, Ariosa Diagnostics Inc., Beijing Genomics Institute, Yourgene Health PLC, GE Healthcare Technologies Inc., Koninklijke Philips NV, Thermo Fisher Scientific Inc., Pacific Biosciences of California Inc., QIAGEN NV, MedGenome Labs Ltd., Progenity Inc.

North America was the largest region in the non-invasive prenatal testing market in 2023. Western Europe was the second largest region in the non-invasive prenatal testing market. The regions covered in the non-invasive prenatal testing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa

The countries covered in the non-invasive prenatal testing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Italy, Spain, Canada

The non-invasive prenatal testing market includes revenue earned by ultrasound detection, fetal cells in maternal blood tests, cell-free DNA in maternal plasma tests, and biochemical screening tests. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.


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