Prenatal Testing & Newborn Screening Market - Forecast(2024 - 2030)

Prenatal Testing & Newborn Screening Market Size is forecast to reach $15,729.00 Million by 2030, at a CAGR of 11.20% during forecast period 2024-2030. Prenatal Testing and Newborn Screening is one of the advanced techniques that is used in the healthcare industry to identify the defects at a very early stage. It is also used for checking the presence of genetic disorders that includes Tay-Sachs disease, cystic fibrosis, sickle cell anaemia and Down’s syndrome among others. Screening is further continued after a baby is born, called newborn genetic testing to check for genetically inherited diseases or congenital anomalies such as phenylketonuria (PKU), muscular spinal atrophy, critical congenital heart disease, hearing loss, and others. The growing awareness towards pediatric diseases and efforts laid by organizations such as Save Babies Through Screening Inc. and National Health Service for screening programmes are the major factors driving the growth of the market. The development of advanced technologies such as tandem mass spectrometry that allows screening of above 50 disorders and increasing demand for prenatal testing is set to further enhance the overall market developments of the Prenatal Testing & Newborn Screening Market for the period 2024-2030.

The report: “Prenatal Testing & Newborn Screening Market Forecast (2024-2030)”, by Industry ARC, covers an in-depth analysis of the following segments of the Prenatal Testing & Newborn Screening Market. 

By Product: Instruments, Reagents, Assay Kits, and Others

By Diagnosing Technique: Non Invasive (Ultrasonography, Pre-implementation Genetic Diagnosis, Fetal Cells in Maternal Circulation, and Fetus Free Fetal DNA), and Invasive ( Amniocentesis, Chronic Villus Sampling, Fetal Blood Sampling, and Embryoscopy % Fetoscopy)

By Screening Option: First Trimester (Nuclear Translucency, and Serum Screening), and Second Trimester (Triple Screen, Quadruple Screen, Genetic Sonograms, Extended Sonograms, Sequential Screening, and Ultrasonography)

By Technology: Tandem Mass Spectrometry, Electrophoresis, Enzymes & Immuno Assays, DNA Based Assays, Pulse Oximetry Technology, and Hearing Screen Technology

By Geography: North America (U.S., Canada, Mexico), South America (Brazil, Argentina, Chile, Columbia, and Rest of South America), Europe (Germany, France, U.K. (United Kingdom), Italy, Spain, Russia, and Rest of Europe), Asia Pacific (China, Japan, South Korea, India, Australia & New Zealand, and Rest of Asia Pacific), and Rest of the World (Middle East, and Africa)

• North America dominated the Prenatal Testing & Newborn Screening Market in 2021 owing to the increasing need of new testing techniques and increasing usage of non-invasive diagnose method that is being widely adopted as the growing number of women are choosing to become pregnant at an advanced maternal age. The Prenatal Testing & Newborn Screening Market scope for different regions will be provided in the final report.
• Increasing demand for detecting genetic abnormalities in the prenatal and newborn population are likely to aid the market growth of the Prenatal Testing & Newborn Screening Market report.
• Detailed analysis of the Strength, Weakness, and Opportunities of the prominent players operating in the market will be Prenatal Testing & Newborn Screening Market report.
• Several ethical concerns related to prenatal and new-born testing & lack of standardization of newborn testing policies and procedures is poised to create the hurdles for the Prenatal Testing & Newborn Screening Market.

 

Amniocentesis held the largest share in the Prenatal Testing & Newborn Screening Market in 2021 and is estimated to grow at a CAGR 12.3% during the forecast period 2022-2027. Amniocentesis is generally done after an abnormal triple test result. It helps to determine the fetal anemia severity in babies with Rh disease, and assists the physician to decide on the need for lifesaving blood transfusions of fetus. It is also used to diagnose chromosomal conditions, blood disorders, neural tube defects, musculoskeletal disorders and other genetic conditions. Potential risks and side effects such as miscarriage and others associated with the amniocentesis diagnosis are anticipated to hinder the growth of the number of amniocentesis diagnosis procedure. However, strict precautions taken by the healthcare provider is poised to exhibit an overall positive growth by reducing the instances of potential risks and side effects associated with amniocentesis diagnosis. Ultrasonography technique is used for identifying the abnormalities in the size of the fetus and placenta and also the amount of amniotic fluid during 16 to 20 weeks gestation. Ultrasonography is estimated to register the higher CAGR over the period 2022-2027.

Enzymes & Immuno Assays held the largest share in the Prenatal Testing & Newborn Screening Market in 2021 and is estimated to grow at a CAGR 8.7% during the forecast period 2022-2027. This is owing to the fact that it is primarily used in immunology to detect the presence of an antibody or an antigen in a sample. It is also used for the quantitative determination of Immunoreactive Trypsin (IRT) in human newborn blood spot samples and also for neonatal screening of cystic fibrosis (CF). Increasing demand for detecting genetic abnormalities in the prenatal and new-born population is also contributing to the market expansion. Additionally, heavy investment in research activities, extensive research associated with proteomics and genomics have led to significant developments in technology. Woman infected with the rubella virus during pregnancy can transmit the disease to her baby and leads to serious birth defects such as cataracts and other eye problems, hearing impairment, and heart disease. Miscarriage and stillbirth are also possible consequences for pregnant women thus to eradicate these concerns growth of enzyme immunoassay screening tool is witnessed. Prenatal and new-born genetic testing is significant in determination of various options during pregnancy to improvise the health outlook for the baby. Enzymes and Immunoassays helps in prevention of infant mortalities and enhances patient outcomes. Pulse Oximetry Technology are estimated to register the higher CAGR over the period 2022-2027.

North America dominated the Prenatal Testing & Newborn Screening Market with a major share of 41.4% in 2021. This is owing to the fact that prenatal testing and newborn screening testing are very accurate and effective and for several disorders only single test is required and this reason has led to the growth of the market in U.S. As prenatal testing and newborn screening provides various diagnostic techniques such as Ultrasonography, Pre-implementation Genetic Diagnose, Amniocentesis, Cvs and other diagnostic methods that uses advanced technologies has led to the demand of prenatal testing in U.S. 

However, Asia Pacific is estimated to grow at a higher CAGR during the forecast period 2021-2026 owing to the presence of a well-developed healthcare infrastructure. The Japanese healthcare system is one of the most advanced in the Asia Pacific region. This ensures that both urban and rural regions of the country receive access to high quality prenatal testing and newborn screening. Besides, the public health insurance system of Japan that covers most of the country’s citizens pays around 70% of the medical costs. This has led to a high demand for prenatal testing and newborn screening as the services are can be availed at low costs. 

The technological progressions and introduction of advanced products fuels the market growth, thereby increasing the growth of the Prenatal Testing & Newborn Screening Market. With the emergence of advanced technologies such as next generation sequencing, high throughput screening, and cell free fetal DNA, there has been a steady growth in the overall demand of the newly developed prenatal diagnosis and newborn screening tests. The newborn screening has been a great example of how technology and research advance health, from the past six decades. In the early 2000s, disorders were screening for, on average, 4 conditions. Today, most states screen for over 30 conditions. This increase is due to advancements in technology and the advocacy efforts of families. With rising incidence of diseases, rapid innovations in technology in medical field, and government initiative in spending for research and development, the newborn screening market is expected to have tremendous growth. Thus, increasing the demand of market during the forecast period 2022-2027.

Ethical concerns related to prenatal and new-born testing & lack of standardization of newborn testing policies and procedures 

Some of the factors that are set to impede the growth of the Prenatal Testing & Newborn Screening Market are the several ethical concerns related to prenatal and new-born testing & lack of standardization of newborn testing policies and procedures. Newborn screening programs is one of the most successful public health initiatives of modern times. The number of tests included in the nationally recommended uniform screening panel (RUSP) has grown steadily to 34, with some states screening for as many as 58 conditions. Despite this, newborn screening has some disadvantages. Many countries have different procedures for how babies blood gets collected and transported from hospitals to state labs, different testing methods and turnaround times, and different approaches for interpreting results, including setting cutoffs. These differences, were brought into sharp focus via a series of media reports. Medicare funds only a small number of genetic tests and this may act as a barrier to implementing some screening programs and as a disincentive to preventive screening in general practice. Children may have particular problems dealing with the psychosocial effects of knowing that they have a genetic. Thus, hindering the growth of the market during the forecast period 2024-2030.

Product launches, mergers and acquisitions, joint ventures, and R&D activities are key strategies adopted by players in the Prenatal Testing & Newborn Screening Market. In 2021, the Prenatal Testing & Newborn Screening Market share is consolidated by the top ten players present in the market. The Prenatal Testing & Newborn Screening Market, top 10 companies are-

1. Perkin Elmer
2. Progenity
3. Laboratory Corporation of America Holdings
4. Natera
5. Invitae
6. Centogene
7. Roche Diagnostics
8. Quest Diagnostics
9. Eluthia
10. Agilent

• In March 2020, Agilent introduced Agilent GenetiSure Cyto microarrays that includes three novel microarrays to meet the requirements of institutions and laboratories engaged in prenatal and postnatal research. This launch helped the company to gain competitive advantage and strengthen its industrial position.
• In June 2019, BGI Genomics and Eluthia launched non-invasive prenatal test in Germany, providing prenatal diagnosis for 96 genetic conditions. This geographical expansion assisted the company in driving the product sales in Germany.

Key Market Players:

The Top 5 companies in the Prenatal Testing & Newborn Screening Market are:

1. Perkin Elmer
2. Laboratory Corporation of America Holdings 
3. Natera, Inc.
4. Invitae Corporation
5. CENTOGENE N.V

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