Newborn Screening Market Analysis And Forecast To 2031: By Product (Instruments, Reagents), By Technology (Tandem Mass Spectrometry, Pulse Oximetry, Enzyme Based Assay, DNA Assay, Electrophoresis), By Test Type (Dry Blood Spot Test, CCHD, Hearing Screen)

Newborn Screening Market Analysis And Forecast To 2031: By Product (Instruments, Reagents), By Technology (Tandem Mass Spectrometry, Pulse Oximetry, Enzyme Based Assay, DNA Assay, Electrophoresis), By Test Type (Dry Blood Spot Test, CCHD, Hearing Screen) And Region

The global newborn screening market was valued at USD 1.7 billion in 2021 and it is anticipated to grow up to USD 3.7 billion by 2031, at a CAGR of 8.0% during the forecast period.

Newborn screening identifies conditions that can affect a childs long-term health or survival. This screening technology includes a series of tests essential for timely detection, early diagnosis, and health management to prevent overall disability and avert death of a child. These tests are performed shortly after the baby is born, and detect genetic, developmental, and metabolic disorders in newborn babies. Newborn screening is done by using a few drops of blood from the newborn’s heel, for certain genetic, endocrine, and metabolic disorders, and are tested for hearing loss and critical congenital heart defects (CCHDs) prior to discharge from a hospital or birthing center.

Market Trends and Drivers

The prevalence of newborn diseases has risen in recent years, prompting providers to raise awareness and support the demand for advanced screening instruments. Hearing, metabolic, and hormonal disorders and critical congenital heart disease are the major newborn disorders; most are treatable if diagnosed early. For instance, according to the US CDC, during 2015–2017, the prevalence of newborn disorders was 34 per 10,000 live births in the US. Approximately 12,900 infants are expected to be identified each year with a disorder. Moreover, according to the same source, the most prevalent disorders are hearing loss (16.5 per 10,000), congenital hypothyroidism (6.0 per 10,000), sickle-cell disease (4.9 per 10,000), and cystic fibrosis (1.8 per 10,000). Such scenario will propel the industry growth.

Market Restraints and Challenges

Several ethical concerns related to prenatal and new-born testing may hamper the market progression. Prenatal and new-born genetic testing raises complex ethical issues further limiting the development of clinical services and implementation of public policy related to access and funding. The use of screening in selective abortion has raised several concerns. The rising occurrence of false results in prenatal and new-born genetic testing might decrease the adoption of genetic testing. For instance, around 5% of women are tested false-positive during prenatal testing for Down syndrome.

Global Newborn Screening Market Segmental Overview

The report analyses the global newborn screening market based on product, technology, test type, and region.

Global Newborn Screening Market by Product

Based on product, it is segmented into instrument and reagents. Among these, removable brace segment accounted for significant market share in 2021. The instruments market segment is expected to experience growth owing to increasing demand for newborn screening across the globe. Instruments used for newborn screening include mass spectrometers, pulse oximeters, fractionators, and others. Further, the launch of improved performance instruments of mass spectroscopy and oximeters is also expected to assist market growth. For instance, PerkinElmer’s TDQ screening system utilizes tandem quadrupole analysis which provides regular robust screening along with higher sensitivity and faster scanning. The rising prevalence of congenital disorders is also likely to boost market growth over the forecast period.

Global Newborn Screening Market by Technology

Based on technology, it is segmented into tandem mass spectrometry, pulse oximetry, enzyme based assay, DNA assay, electrophoresis and others. Among them, tandem mass spectrometry segment is expected to experience the fastest growth rate during the forecast period. Tandem mass spectrometry (TMS) is an advanced analytical instrument used in the laboratories which can analyze body fluids and other body contaminants. Tandem mass spectrometry dominated the overall market in 2014 owing to high demand due to cost-effectiveness, higher applicability, and technological upgrades. Tandem spectroscopy (MS/MS) is also likely to grow at a CAGR of 11.1% over the forecast period, due to its high function in diagnosing an array of conditions in a single procedure. It helps in concurrent recognition of amino acids, carnitine conjugates, and other compounds. Federal Agencies promoting mandatory testing of 50 conditions that can be easily screened using MS/MS technology is a major driving factor for this segment.

Global Newborn Screening Market Test Type

Based on test type, it is segmented into dry blood spot test, CCHD, hearing screen. Dry blood spot segment is anticipated to witness the fastest CAGR over the forecast period. The collection of blood from newborn’s heel within 24-48 hours of birth on the screening card for diagnosis of over 50 conditions is termed as a heel stick or dried blood spot test (DBS). These screening cards are labeled using unique codes and contain no additional identity information. Autisms, Lymphomas, and leukemia, and many other metabolic conditions can be diagnosed through this test. The card used for testing is provided free in North America as a plan to promote higher procedure volume.

Geographical Analysis of Global Newborn Screening Market

Region-wise, it is studied across North America, Europe, Asia Pacific, and the Rest of the World. North America held the largest share of the newborn screening market owing to the growing prevalence of congenital disorders and enforced testing in all the 50 states of the nation. The newborn screening program is diligently followed in all the states of North America. According to statistics published by CDC’s in 2013, more than four million babies born annually are screened for various possible conditions. Conditions for screening was provided through extensive research by the American College of Medical Genetics (ACMG) under the supervision of the U.S. Department of Health and Human Services (HHS). Recently, ACMG has deviated from the traditional screening criteria and added new conditions to the list. Hearing screen was added in 2011.

Major Players in the Global Newborn Screening Market

COVID-19 Impact

COVID-19 has impacted many sectors of the medical devices and diagnostics industry, it has had a limited impact on the market. Legislation in important markets has already emphasized the need for newborn screening; stringent regulations have been implemented to oversee newborn health and protect babies from COVID-19 or exposure to similar diseases. Many screening laboratories and government organizations provide health awareness to parents. On the other hand, the supply and sales operations of major companies in the market, such as Natus (US), PerkinElmer (US), and Masimo (US), were affected during Q2 2020 due to COVID-19. However, operations resumed in Q3 as countries ended lockdowns and permitted the transportation of medical goods

Recent Developments

• In April 2022, Waters launched new tandem quadrupole mass spectrometer Xevo TQ Absolute
• In November 2021, Thermo Fisher launched new mass spectrometry and chromatography solutions
• In September 2020, PerkinElmer (US) recevied CE-IVD approval for EONIS screening assay used to screen SMA (spinal muscular atrophy), SCID (severe combined immunodeficiency), and XLA (X-linked agammaglobulinemia) in newborns
• In December 2019, PerkinElmer (US) received US FDA approval for GSP Neonatal Creatine Kinase –MM (CK-MM) kit for screening newborns affected by Duchenne muscular dystrophy (DMD)
• In October 2019, Demant A/S (Denmark) has lancuehd its easyScreen BERAphone, a hearing screening device, at the 64th International Congress of Hearing Aid Acousticians in Nuremberg, Germany
• In January 2018, Demant A/S (Denmark) has launched GSI Novus, a handheld newborn hearing screener

Frequently Asked QuestionsQ1. How big is the orthopedic braces & supports market?Ans. The global newborn screening market size was USD 1.7 billion in 2021 and is anticipated to reach USD 3.7 billion in 2031, growing at a rate of 8.0% from 2022 to 2031.Q2. What is the newborn screening market growth rate?Ans. The growth rate of the newborn screening market is 8.0%.Q3. Which region holds a major market share for the market?Ans. North America holds a major market share of the newborn screening market in 2021.Q4. Which segment accounted for the largest newborn screening market share?Ans. By end user, the healthcare segment accounted for the largest newborn screening market share.Q5. Who are the key players in the orthopedic braces & supports market?Q6. What are the factors driving the newborn screening market growth?Ans. The major factors driving the growth of the market are the increasing demand for new born screening across the globeQ7. What are the key growth strategies of newborn screening market players?Ans. The key growth strategies of newborn screening market players are product launch and product approval.Q8. Which region will provide more business opportunities for the newborn screening market during the forecast period?Ans. The Asia-Pacific region will provide more business opportunities for the newborn screening market during the forecast period.

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