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Non-invasive Prenatal Testing Global Market Report 2021: COVID-19 Growth And Change To 2030

Non-invasive Prenatal Testing Global Market Report 2021: COVID-19 Growth And Change To 2030

  • September 2021
  • 175 pages
  • ID: 6151568
  • Format: PDF
  • The Business Research Company

Summary

Table of Contents

Major players in the non-invasive prenatal testing market are F. Hoffmann-La Roche AG, Illumina, Inc., Laboratory Corporation of America Holdings, Natera, Inc. and PerkinElmer Inc.

The global non-invasive prenatal testing market is expected to grow from $2.17 billion in 2020 to $2.43 billion in 2021 at a compound annual growth rate (CAGR) of 12%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $4.02 billion in 2025 at a CAGR of 13.4%.

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 fetus in 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 non-invasive prenatal testing market covered in this report is segmented by type into consumables, instruments. It is also segmented by end user into hospital, diagnostic labs; by instruments into NGS systems, PCR instruments, microarrays, ultrasound devices, others(centrifuges, UV systems, incubators, microscopes); by consumables into assay kits &reagents, disposables and by application into trisomy, microdeletion, genetics, Rh factor.

The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

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 Department of Health (UK), there were 3,213 abortions in England and Wales from which 37% of the total abortions consisted of chromosomal abnormality and 80% of the abortions were performed under 10 weeks of pregnancy. 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 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, 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.

In June 2019, Invitae, a USA based medical genetics company acquired Singular Bio for $55M.This acquisition will further strengthen Invitae’s ability to bring genetic information into mainstream medical care.

Singular Bio, a USA based company specializing in single-molecule, cell-free DNA analysis that it is developing for non-invasive prenatal testing.

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 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.

The countries covered in the market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA.

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