Newborn Screening Market Size, Share & Trends Analysis Report By Technology (Tandem Mass Spectrometry, Pulse Oximetry), By Type of Test (Dry Blood Spot Test, CCHD), And Segment Forecasts, 2012 - 2022

Industry Insights

The global newborn screening market size was valued at USD 783.5 million in 2016 and is expected to grow at a CAGR of 10.6% during the forecast period. Growing neonatal population base, rising cases of congenital diseases in newborns, favorable government programs & legislations, and technological advancements are anticipated to serve as vital drivers of the newborn screening market.

The rising neonatal population is one of the key market drivers. According to the world population meter, over 88 billion births were reported in 2015 resulting in about 250 births per minute. Of these, more than 2.8 million babies die within the first month due to a lack of skilled care and screening of the babies. To prevent this number from rising, efforts are being taken by organizations such as the WHO, CDC, Healthy Newborn Network, etc., to educate parents for the possible disorders and their diagnostic procedures. Moreover, North American agencies have ordered 100% screening of all children born in private sector hospitals.

In addition, government programs and legislation also create a favorable environment to foster market growth. The newborn screening program was recommended by the WHO to safeguard the health of children across the globe. Under this program, numerous policies and initiatives have been taken by the U.S. Department of Health and Human Services Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC), Japan’s Society of Obstetrics and Gynecology (JSOG), UK (PEACH), and advocacy groups like the March of Dimes.

Majority of the nations have statutes for newborn screening, wherein funding for the program, various conditions requiring screening, and exemptions are clearly stated. The demand for these procedures is expected to be influenced by the introduction of technological advancements, rising paranoia of parents, and availability of new treatment options enabling the diagnosis of about 29 possible disorders such as phenylketonuria (PKU), galactosemia (GS), congenital hypothyroidism (CH) and hearing disorders in neonates.

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.

The World Health Organization in their publications had stated that over 270,000 babies globally die of congenital disorders. Their deaths were caused within 4 weeks of their birth. As per the European Surveillance of Congenital Anomalies (EUROCAT), the occurrence of these abnormalities in every 24 births out 1,000 is currently observed. In 2010, the WHO had undertaken a resolution of preventing these deaths by developing strong surveillance systems. Such measures are likely to contribute to the growth of the market over the forecast period.

The increasing awareness and rising demand for newborn diagnoses are expected to propel demand over the forecast period. This is also expected to trigger the establishment of diagnostic institutions. For instance, Taiwan in 2009, established its first international quality assurance program for G6PD testing. According to statistics published by the CDC, over four million babies are tested annually for metabolism-related dysfunctions across all 50 states of the U.S.

In the U.S., state-run newborn related programs have improved child healthcare tremendously over the last two decades. The Research Triangle Institute (RTI) in collaboration with the CDC, National Center on Birth Defects, and Developmental Disabilities is further conducting research studies and programs to develop awareness pertaining to newborn screening policy practices. Such initiatives are bolstering the growth of the market.

Technology Insights

Key technology segments include tandem mass spectrometry, pulse oximetry; enzyme & DNA based assays, and electrophoresis. 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.

Electrophoresis is expected to witness faster growth at a lucrative CAGR of 11.2% by 2022. This growth is anticipated due to rising demand and early detection techniques.

Product and Test Insights

Dry blood spot tests dominated the overall newborn screening market accounting for over 45.0% of revenue. 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.

Critical Congenital Heart Disease (CCHD) is one of the commonly occurring disorders, which is screened using pulse oximeter based technology. It is estimated that 18 out of 10,000 infants suffer from CCHD, which may lead to death if undetected. The growth of this segment is anticipated to affect the newborn screening market substantially over the next seven years.

Instruments used for newborn screening include mass spectrometers, pulse oximeters, fractionators, and others. The instruments market segment is expected to experience growth owing to increasing demand for newborn screening across the globe.

Regional Insights

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.

To raise awareness, health departments of the states in the U.S. have published free data and created websites that are expected to help parents to cope better with these conditions. In December 2014, congressmen in the U.S. passed the Newborn Screening Saves Lives Reauthorization Act bill to renew and upgrade the federal initiatives for newborn screening.

Asia Pacific is expected to witness lucrative growth over the forecast period due to, the presence of favorable healthcare schemes drafted by government agencies. Awareness programs and quality assurance of newborn diagnostic procedures have gained importance in the developing economies of Korea, China, Taiwan, India, and Sri Lanka for the last few years.

Improving infrastructure and healthcare plans and the availability of new opportunities for expansion are expected to play a major role in driving demand over the forecast period. Moreover, owing to the high population density, higher birth rate, and the soaring prevalence of congenital diseases, Asia Pacific is expected to be the fastest-growing market for newborn screening techniques.

Newborn Screening Market Share Insights

A large portion of the newborn screening market share is held by companies like Agilent Technologies Inc., Natus Medical Inc., Covidien Plc, Trivitron Healthcare, GE Healthcare, Masimo Corp., AB Sciex LLC, Waters Corp., PerkinElmer Inc., and Bio-Rad Laboratories Inc.

The players are actively involved in strategic partnerships and mergers and acquisitions in order to ensure sustainability. For example, Trivitron Healthcare and Agilent Technologies have partnered to initiate collaboration in the area of high precision in-vitro diagnostics based on the LC-MS/MS platform.

Report Scope

Segments Covered in the Report

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2012 to 2022. For the purpose of this study, Grand View Research, Inc. has segmented the global newborn screening market report on the basis of product, technology, test type, and region:

• Product Outlook (Revenue, USD Million, 2012 - 2022)

  • Instruments

  • Reagents

• Technology Outlook (Revenue, USD Million, 2012 - 2022)

  • Tandem mass spectrometry

  • Pulse oximetry

  • Enzyme based assay

  • DNA assay

  • Electrophoresis

  • Others

• Test Type Outlook (Revenue, USD Million, 2012 - 2022)

  • Dry blood spot test

  • CCHD

  • Hearing screen

• Regional Outlook (Revenue, USD Million, 2012 - 2022)

  • North America

    • The U.S.

    • Canada

  • Europe

    • Germany

    • The U.K.

  • Asia Pacific

    • Japan

    • China

  • Latin America

    • Brazil

    • Mexico

  • The Middle East and Africa (MEA)

    • South Africa

    • Saudi Arabia