Non-invasive prenatal testing (NIPT) is a new method of detecting fetal chromosomal aneuploidies in pregnancies by evaluating fetal cell-free DNA circulating in the mother’s blood. It includes screening a baby or embryo for specific diseases or birth abnormalities before the child is born.
Statistics:
The global non-invasive prenatal testing market is expected to be worth US$ 1,936.4 million by 2027.
Global Non-Invasive Prenatal Testing Market: Drivers
The rising incidence of chromosomal diseases is expected to propel the global non-invasive prenatal testing market growth during the forecast period. For instance, according to a study published in the Journal of Korean Medical Science in August 2019 titled ‘Estimating Nationwide Prevalence of Live Births with Down Syndrome and Their Medical Expenditures in Korea,’ the incidence of live births with Down syndrome was estimated to be 5.03 for every 10,000 births during 2007 – 2016.
Furthermore, increased awareness of the advantages of non-invasive testing methods is expected to surge in the growth of the global non-invasive prenatal testing market. In the first trimester of pregnancy, obstetricians are progressively suggesting non-invasive diagnostics as a substitute to invasive procedures and first diagnostic screening.
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Statistics:
In 2019, North America accounted for the largest share in the global non-invasive prenatal testing market, representing 45 % of the market revenue, followed by Europe and the Asia Pacific, respectively.
Global Non-Invasive Prenatal Testing Market: Restraints
Irregular reimbursement rules and insurance coverage are expected to hamper the global non-invasive prenatal testing market growth during the forecast period. Updates in the American Medical Association’s Current Procedural Terminology, or CPT codes, for non-invasive procedures and other molecular diagnostic testings, have caused uncertainty in reimbursement and insurance coverage. Owing to the increased expenses of these tests, many vendors have limited success as a result of little or no cover for such tests.
Furthermore, Tests are copyrighted by a small range of suppliers, which is expected to hinder the global non-invasive prenatal testing market growth during the forecast period. Patents and exclusive licenses to the technology used in non-invasive prenatal diagnostics are controlled by a few suppliers. As a result, there is no market rivalry and few incentives to lower testing and quality assurance costs.
Global Non-Invasive Prenatal Testing Market: Opportunities
Obtaining payers’ reimbursement for tests is expected to provide attractive growth prospects for players in the global non-invasive prenatal testing market. Due to the high cost of such tests, vendors may prioritize getting insurance coverage for NIPT tests supplied by them.
Furthermore, concentration on genetic counseling, health education, and NIPT subsidies are expected to boost the global non-invasive prenatal testing market growth during the forecast period. For instance, researchers from Fudan University in China and University College London in the U.K. in September 2020 reported that, in China, a higher percentage of Shenzhen women had noticed NIPT (87.30 % vs. 64.03 %), were ready to accept NIPT (91.80 % vs. 80.43 %) and had received NIPT (83.12 % vs. 54.54 %), while their level of satisfaction was relatively low.
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Statistics:
The global non-invasive prenatal testing market was worth US$ 882.9 million in 2019 and is expected to increase to US$ 1,936.4 million by 2027 growing at a CAGR of 10.3% during the forecast period 2020 – 2027.
Market Trends/Key Takeaways
The implementation of new guidelines is expected to drive the global non-invasive prenatal testing market growth during the forecast period. For instance, the American College of Obstetricians and Gynecologists had issued new guidelines for non-invasive prenatal testing in August 2020.
Key players in the global non-invasive prenatal testing market are concentrating their efforts on raising finance in order to increase their market share. For instance, BillionToOne, Inc. raised US$15 million in March 2020 to assist the commercial expansion of UNITY, a prenatal screen that directly evaluates the baby’s risk for common and serious inherited disorders such as Hemoglobinopathies, cystic fibrosis, and spinal muscular atrophy, to all the states in the U.S., and the research and development of potential diagnostics tests such as liquid biopsy products.
Regulations
Europe
- A national screening program for congenital anomalies or aneuploidies is strictly avoided in Europe, because doctors and the national health service are NOT interested in terminating as many handicapped individuals as possible
- But pregnant women are informed in time by the obstetricians about the existence of all the prenatal tests available, mentioning the advantages, the related risks and possible difficult decisions arising from these tests
- All these non-invasive / risk calculation tests and invasive / diagnostic tests are offered on request of the pregnant women and are not compulsory. Since Combined Tests are increasingly requested, the number of invasive tests is significantly declining.
- Reimbursement Scenario for NIPT – Health insurer Anthem Blue Cross Blue Shield changed its medical policy regarding non-invasive prenatal testing as such screening technology is considered medically necessary for most pregnancies regardless of the risk status. According to Anthem’s new policy, cell-free DNA-based prenatal screening for trisomy 21, 18, and 13 is medically necessary for women carrying a single fetus using NIPT as a screening tool for fetal aneuploidies regardless of risk status.
Global Non-Invasive Prenatal Testing Market: Competitive Landscape
Some of the key players contributing to the global non-invasive prenatal testing market are Axia Women’s Health, Berry Genomics Corporation, Quest Diagnostics Inc., BGI Diagnosis Co., Ltd., Sequenom, Inc., Illumina, Inc., BillionToOne, Inc., LifeCodexx AG, Eluthia, Ariosa Diagnostics, Inc., and Natera, Inc.
Global Non-Invasive Prenatal Testing Market: Key Developments
Key players in the global non-invasive prenatal testing market are focusing on the launch of innovative products in order to diversify their product offerings. For instance, Axia Women’s Health, an independent women’s healthcare business located in the U.S., released non-invasive prenatal testing in the U.S. in August 2019.
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Table of Contents
- Research Objectives and Assumptions
- Research Objectives
- Assumptions
- Abbreviations
- Market Purview
- Report Description
- Market Definition and Scope
- Executive Summary
- Market Snippet, By Test Type
- Market Snippet, By End User
- Market Snippet, By Region
- Coherent Opportunity Map (COM)
- Report Description
- Market Dynamics, Regulations, and Trends Analysis
- Market Dynamics
- Drivers
- Restraints
- Market Opportunities
- Impact Analysis
- Key Highlights
- Product launch
- PEST Analysis
- Technological Advancements
- Regulatory Scenario
- Mergers and Acquisitions
- COVID19 Impact on the market
- Market Dynamics
- Global Non-Invasive Prenatal Testing Market, By Test Type, 2016 – 2027, (US$ Mn)
- Introduction
- Market Share Analysis, 2020 and 2027 (%)
- Y-o-Y Growth Analysis, 2017 – 2027
- Segment Trends
- Panel 1 Test
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
- Panel 2 Test
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
- Panel 3 Test
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
- Introduction
- Global Non-Invasive Prenatal Testing Market, By End User, 2016 – 2027, (US$ Mn)
- Introduction
- Market Share Analysis, 2020 and 2027 (%)
- Y-o-Y Growth Analysis, 2017 – 2027
- Segment Trends
- Hospitals
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
- Diagnostic Laboratories
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
- Maternity Centers
- Introduction
- Market Size and Forecast, and Y-o-Y Growth, 2016 – 2027, (US$ Mn)
- Introduction
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