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Non-invasive Prenatal Testing Global Market Report 2023
Major players in the non-invasive prenatal testing market are F. Hoffmann-La Roche AG, IlluminaInc., Laboratory Corporation of America Holdings, NateraInc., PerkinElmerInc., Quest Diagnostics Incorporated, Agilent TechnologiesInc, BGI Diagnosis, Berry Genomics Co.
New York, Feb. 23, 2023 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Non-invasive Prenatal Testing Global Market Report 2023" - https://www.reportlinker.com/p06229163/?utm_source=GNW
, Ltd, LifeCodexx AG, Myriad GeneticsInc., NIPD Genetics, SequenomInc., Annoroad Gene Technology, Centogene AG, CounsylInc., EUROFINS Genoma Group, Eurofins Scientific, Next Biosciences, Premaitha Health Plc, Ariosa Diagnostics (Roche), Premaitha Health, Beijing Genomics Institute, Yourgene Health PLC, GE Healthcare, Koninklijke Philips N.V., Thermo Fisher ScientificInc., Pacific Biosciences of CaliforniaInc., and QIAGEN N.V.
The global non-invasive prenatal testing market will grow from $4.21 billion in 2022 to $4.84 billion in 2023 at a compound annual growth rate (CAGR) of 14.9%. The Russia-Ukraine war disrupted the chances of global economic recovery from the COVID-19 pandemic, at least in the short term. The war between these two countries has led to economic sanctions on multiple countries, surge in commodity prices, and supply chain disruptions, causing inflation across goods and services effecting many markets across the globe. The non-invasive prenatal testing market is expected to grow to $8.36 billion in 2027 at a CAGR of 14.7%.
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.
Non-invasive prenatal testing is a test in which blood from the mother is drawn and tested for possible abnormalities in the patients. Non-invasive prenatal testing kits and equipment are used to diagnose genetic abnormalities, mainly chromosome defects in fetuses in the first trimester of pregnancy.
North America was the largest region in the non-invasive prenatal testing market in 2022.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 and Africa.
The non-invasive prenatal testing market consists of sales of non-invasive prenatal testing kits, instruments and related services.Non-invasive prenatal testing kits and equipment are used to diagnose genetic abnormalities, mainly chromosome defects in fetuses in the first trimester of pregnancy.
Non-invasive prenatal testing includes ultrasound detection, fetal cells in maternal blood tests, cell-free DNA in maternal plasma tests, and biochemical screening tests.
The main types of non-invasive prenatal testing are consumables, and instruments.Consumables are products that are used up or depleted throughout their use.
The various instrument used are NGS systems, PCR instruments, microarrays, ultrasound devices, and others (centrifuges, UV systems, incubators, microscopes) and the different consumables include assay kits and reagents, disposables. The applications involve trisomy, microdeletion, genetics, Rh factor that are used by hospitals and diagnostic labs.
High incidence rate of Down syndrome is one major factor driving non-invasive prenatal testing (NIPT) market with increase in average maternal age which has led to a concern on the safety about the growth of the fetus.Down syndrome is a chromosomal condition that occurs when an error in cell division results in an extra chromosome 21 and can affect the fetus cognitive ability and physical growth.
The NIPT screening tests do not harm the mother or baby, carries no risk of miscarriage as they are non-invasive, and can detect more than 99% of cases of Down syndrome.According to National Down Syndrome Society and Centres for Disease control and Prevention, in the USA, 1 in every 700 babies are born with Down syndrome and 80% of children with Down syndrome are born to older mothers.
The increased risk of having babies with Down syndrome among older women drives the non-invasive prenatal testing market.
The ethical hurdles in the non-invasive prenatal testing (NIPT) market have led to a range of ethical issues in terms of sex selection or aborting babies with chromosomal abnormality.Determining the sex of the fetus or knowing if the baby has an abnormality at an earlier stage led to abortions and resulted as an ethical issue which further led to strict regulations on using such devices.
According to the official statistics provided by the UK government, a record 214,869 abortions were performed in the Englan and Wales in 2021 which was the highest sinch abortion became legal in 1967. . These hurdles will restrain the non-invasive prenatal testing market.
Next-generation sequencing has increased the throughput, scalability, and speed, and further enables researchers to perform a wide range of applications and study biological systems at a higher level.Next-generation sequencing is a platform that has enabled the sequencing of thousands to millions of DNA molecules simultaneously.
The manufacturers have introduced this technology to reduce the time and money required and optimizes the output to generate results regarding genome, and DNA testing.Major companies such as Illumina, Eurofins, Natera, Roche, and Annoroad have implemented this technology in non-invasive prenatal testing.
CFDA (China Food and Drug Administration) has approved the medical instrument product registration of NGS instrument NextSeq 550AR produced by Annoroad.
The non-invasive prenatal testing market is regulated by several regulations that are governed by multiple international and country-specific agencies.For instance, the US Food and Drug Administration (FDA) that issues Laboratory Developed Tests (LDTs) certification and Clinical Laboratory Improvement Amendments (CLIA) certification.
The manufacturer needs to obtain a 510(k) premarket notification for in vitro diagnostic test.LDTs and CLIA certification are based on number of tests done during clinical trials.
For example: For trisomy 21 (Down syndrome), there is an incidence of 1/1000.Given a target of 100 positive results, at least 100,000 samples would have to be tested to meet the requirements of a 510k.
A 510k premarket notification demonstrates that the new product is at least as safe and effective as another legally-marketed device. It is mandatory for manufacturers to register a premarket notification before a new product can be certified as fit for market commercially.
In August 2021, BioReference Laboratories, a New-York-based medical laboratories company, acquired Ariosa centralized laboratory prenatal testing business from Roche.The acquisition will compliment the current offerings of BioReference and will help it improve its offerings.
Ariosa Diagnostics is a US-based non-invasive prenatal screening business owned by Roche.
The countries covered in the non-invasive prenatal testing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, and USA.
The market value is defined as the revenues that enterprises gain from goods and/or services sold within the specified market and geography through sales, grants, or donations in terms of currency (in USD ($) unless otherwise specified).
The revenues for a specified geography are consumption values – that is, they are revenues generated by organizations in the specified geography within the specified market, irrespective of where they are produced. It does not include revenues from resales either further along the supply chain or as part of other products.
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.
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