Global Newborn Screening Market is anticipated to witness a decent growth rate of ~6-8% by 2027

Newborn screening aims to identify infants at risk of genetic, hormonal and metabolic conditions. These screens are used to confirm a diagnosis and allow for early intervention in the hope of prevention or amelioration of the disease. These tests are mostly performed for medical conditions which are not clinically evident in the neonatal period but are likely to be treatable with early intervention.

Commonly covered medical conditions include congenital hypothyroidism (CH), Phenylketonuria (PKU), congenital adrenal hyperplasia (CAH), cystic fibrosis (CF), galactosemia (GAL), tyrosinemia type I (HT1), sickle cell anaemia, G6PD-Deficiency, hearing problems (congenital deafness) and congenital heart problems. These are tested through three standard methods: Blood spot, hearing test and pulse oximetry.

Quick Population Growth, Growing Levels of Birth Defects and Favourable Government Initiatives are some of the key drivers responsible for the growth of the Newborn Screening Market

The global population is projected to grow to 9.7 billion people by 2050 from 8 billion in 2022 and improving access to primary care (evidenced by significant global improvements in life expectancy from 46.5 in 1950 to 71 in 2021) are the key driving factors in the growth of newborn screening market.

Globally, an estimated 8 million newborns are born with a birth defect every year. As per CDC, birth defects affect one in every 33 babies (about 3% of all babies) born in United States each year. In the WHO South-East Asia Region, between 2010 and 2019, birth defects increased as a proportion of child mortality in the region, from 6.2% to 9.2%. The most common birth defects are heart defects, neural tube defects and Down syndrome, among others. These can be caused by one or more genetic, infectious, nutritional or environmental factors. To curb the growing birth defects, health organizations across the world are taking necessary actions to prevent, detect, manage and care for birth defects.

An Increasing Use of Next-Generation Sequencing (NGS) is Set to Drive the Growth of Newborn Screening Market in Developed Countries

NGS approaches are slowly being adopted in hospitals for use in newborn screening for rare genetic disorders. The costs of sequencing whole exomes has fallen rapidly since its invention and continues to decline – in USA, bioinformatics companies can provide sequencing for ~$500-$900. Pilot studies are being conducted in USA, UK, China and other countries into the suitability for the widespread application of NGS technology in newborn screening programmes as well as in neonatal wards.?

Competitive Landscape Analysis: Newborn Screening Market

The global newborn screening market is marked by the presence of well-established market players such as SCIEX , 安捷伦 , Bio-Rad Laboratories , Covidien (Medtronic Minimally Invasive Therapies Group) , GE医疗 , 珀金埃尔默企业管理（上海）有限公司 , Masimo , Natus Medical Incorporated , Trivitron Healthcare , Waters Corporation , Labsystems Diagnostics Oy , LifeCell International Pvt.Ltd , ArcherDX, Inc. and others.

China is Projected to Hold the Highest Share of the Newborn Screening Market – Followed by North America

While China is the largest newborn screening market - 9.56 million babies were born in China in 2022, down from 17.86 million in 2016. Approximately 93% of newborns are reported to undergo screening in China – the availability of the various range of tests available differs between urban and rural regions. The penetration of newborn screening in China is poised to grow in the upcoming years due to government initiatives, rising number of newborn screening centers and establishment of well-developed newborn screening network system.

The Chinese government recognizes newborn screening as a public health project and by the end of 2018, there were ~238 newborn screening centers in the China, with screening rates exceeding 97.5%. ?China newborn screening has established a complete network system, from sample collection and delivery, laboratory testing, results reporting, clinical diagnosis to follow-up which has also played an important role in its penetration. Meanwhile, India has become the most populated country on earth – ~23 million babies were born in 2022, however, there is no active national NBS programme in India.

The costs of performing standardized tests is declining slowly, increasing the feasibility of performing population-wide screening exercises in developing nations. Programmes already exist for the majority of developing nations and the cost-effectiveness of these campaigns due to an increasing efficiency in lab operations, increased IVD manufacturing capacity post-COVID and economies of scale make them highly attractive to governments.

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