Table of Contents
1.Introduction
2.Definition of newborn screening
3.History of newborn screening
4.Importance of newborn screening
5.Disorders screened in newborn screening
6.Newborn screening tests
7.Market segmentation of newborn screening
8.Market size of newborn screening
9.Growth rate of newborn screening market
10.Drivers of newborn screening market growth
11.Challenges of newborn screening market
12.Regulatory environment of newborn screening
13.Competitive landscape of newborn screening
14 Key players in the newborn screening market
15.Future outlook of newborn screening market
16.Conclusion
17.FAQs
1.Introduction
Newborn screening is a vital component of public health programs that aim to prevent and manage serious health conditions. It is estimated that about 1 in 300 newborns has a disorder that can be detected through newborn screening, and early detection and treatment can save lives and prevent disabilities. The newborn screening market is driven by technological advancements, government initiatives, and rising awareness among parents and healthcare providers. In this article, we will provide an overview of the newborn screening market, including its size, growth rate, and future outlook.
2.Definition of Newborn Screening
Newborn screening is a set of tests that are performed shortly after birth to identify infants who may have certain disorders that can affect their health and development. The tests are usually done by taking a few drops of blood from the baby's heel and analysing them in a laboratory. The tests are designed to detect disorders that may not be apparent at birth but can cause serious health problems later in life if left untreated.
3.History of Newborn Screening
Newborn screening has been in use for over 50 years and has undergone significant changes since its inception. The first newborn screening test was developed in the 1960s to detect phenylketonuria (PKU), a metabolic disorder that can cause intellectual disability if left untreated. Over time, the number of disorders screened in newborn screening has increased, and the methods used to perform the tests have become more sophisticated.
4.Importance of Newborn Screening
Newborn screening is important because it can help identify infants with serious health conditions before they become symptomatic. Early detection and treatment can prevent or reduce the severity of the conditions and improve outcomes for affected infants. Newborn screening is also cost-effective, as it can reduce the need for expensive medical interventions later in life.
5.Disorders Screened in Newborn Screening
The disorders screened in newborn screening vary by country and region. In the United States, the Recommended Uniform Screening Panel (RUSP) includes 35 core conditions that are screened for in all states. These conditions include metabolic disorders, hemoglobinopathies, cystic fibrosis, hearing loss, and critical congenital heart disease. Some states also screen for additional disorders, such as severe combined immunodeficiency (SCID) and spinal muscular atrophy (SMA).
6.Newborn Screening Tests
Newborn screening tests are typically performed by taking a few drops of blood from the baby's heel and analysing them in a laboratory. The tests can detect levels of certain substances in the blood that may indicate the presence of a disorder.
Depending on the disorder being screened for, additional tests may be required, such as a urine test, hearing screening, or echocardiogram. Newborn screening tests are typically performed within 24-48 hours of birth, although some conditions may require repeat testing at a later time.
7.Market Segmentation of Newborn Screening
The newborn screening market can be segmented based on the type of test, the technology used, and the end-user. The type of test can include metabolic screening, haemoglobin screening, hearing screening, and pulse oximetry screening. The technology used can include tandem mass spectrometry (MS/MS), DNA microarrays, and next-generation sequencing (NGS). The end-users of newborn screening tests can include hospitals, clinics, and diagnostic laboratories.
8.Market Size of Newborn Screening
The newborn screening market is expected to grow significantly in the coming years due to the increasing prevalence of genetic and metabolic disorders worldwide. According to a report by Market Research Future, the global newborn screening market is expected to reach a value of USD 1,782.4 million by 2023, growing at a CAGR of 10.6% during the forecast period (2017-2023).
9.Growth Rate of Newborn Screening Market
The growth rate of the newborn screening market is expected to remain strong in the coming years due to various factors such as increasing awareness about the benefits of early detection and treatment of disorders, rising healthcare expenditure, and government initiatives to expand the scope of newborn screening programs. In addition, advancements in technology, such as the development of NGS-based tests and digital microfluidics, are expected to further drive market growth.
10.Drivers of Newborn Screening Market Growth
Several factors are driving the growth of the newborn screening market, including increasing prevalence of genetic and metabolic disorders, rising demand for point-of-care testing, increasing adoption of NGS technology, and increasing government initiatives to expand newborn screening programs. In addition, rising awareness among parents and healthcare providers about the benefits of early detection and treatment of disorders is expected to further drive market growth.
11.Challenges of Newborn Screening Market
Despite the many advantages of newborn screening, there are also several challenges that need to be addressed. These include the high cost of testing, the need for specialised equipment and trained personnel, and the potential for false-positive or false-negative results. In addition, there is a need for better communication and education about the significance of test results and the potential implications for the affected infants and their families.
12.Regulatory Environment of Newborn Screening
Newborn screening is regulated by various agencies, depending on the country and region. In the United States, the Centers for Disease Control and Prevention (CDC) and the Health Resources and Services Administration (HRSA) provide guidance and oversight for newborn screening programs. The Food and Drug Administration (FDA) regulates the approval and clearance of diagnostic tests used in newborn screening.
13.Competitive Landscape of Newborn Screening
The newborn screening market is highly competitive, with several companies offering a range of tests and technologies. Some of the key players in the market include PerkinElmer, Natus Medical, Bio-Rad Laboratories, Agilent Technologies, and GE Healthcare. These companies are focused on developing innovative tests and technologies, expanding their product portfolios, and collaborating with healthcare providers to expand the scope of newborn screening programs.
14.Key Players in the Newborn Screening Market
PerkinElmer, Natus Medical, Bio-Rad Laboratories, Agilent Technologies, and GE Healthcare are some of the key players in the newborn screening market. These companies offer a range of tests and technologies for newborn screening, including MS/MS-based tests, DNA microarrays, and NGS-based tests. They are also focused on expanding their product portfolios and collaborating with healthcare providers to improve the accuracy and efficiency of newborn
screening. For instance, PerkinElmer offers a comprehensive newborn screening solution that includes MS/MS-based tests, DNA microarrays, and digital microfluidics. Natus Medical offers a range of hearing screening devices for newborns, while Bio-Rad Laboratories offers a range of tests for haemoglobin screening.
15.Future of Newborn Screening Market
The future of the newborn screening market looks promising, with the continued development of innovative tests and technologies, expanding government initiatives to expand newborn screening programs, and rising awareness among parents and healthcare providers about the benefits of early detection and treatment of disorders. In addition, the increasing prevalence of genetic and metabolic disorders is expected to drive market growth in the coming years.
16.Conclusion
The newborn screening market is expected to grow significantly in the coming years due to various factors such as the increasing prevalence of genetic and metabolic disorders, rising demand for point-of-care testing, and government initiatives to expand newborn screening programs. Although there are several challenges that need to be addressed, the advantages of early detection and treatment of disorders make newborn screening an essential component of paediatric care.
17.FAQs
What is newborn screening, and why is it important?
Newborn screening is a process of testing newborn babies for certain genetic and metabolic disorders that may not be apparent at birth but can cause significant health problems if left untreated. Early detection and treatment of these disorders can prevent serious complications and improve long-term health outcomes.
What disorders are included in newborn screening tests?
Newborn screening tests can include metabolic screening, haemoglobin screening, hearing screening, and pulse oximetry screening. The specific tests performed can vary depending on the state, country, or region.
How are newborn screening tests performed?
Newborn screening tests are typically performed by collecting a small blood sample from the baby's heel within 24-48 hours of birth. Depending on the disorder being screened for, additional tests may be required, such as a urine test, hearing screening, or echocardiogram.
How accurate are newborn screening tests?
Newborn screening tests have a high degree of accuracy, but false-positive or false-negative results can occur. Follow-up testing and evaluation are necessary to confirm the diagnosis and determine the appropriate course of treatment.
Who is responsible for regulating newborn screening programs?
Newborn screening is regulated by various agencies, depending on the country and region. In the United States, the Centers for Disease Control and Prevention (CDC), the Health Resources and Services Administration (HRSA), and the Food and Drug Administration (FDA) provide guidance and oversight for newborn screening programs.