Global Newborn Screening Market is anticipated to witness a decent CAGR of 6 to 8% by 2027

Newborn screening aims to detect infants and new born at risk of various genetic, hormonal and metabolic conditions. These screens are used to confirm a diagnosis and allow for an early intervention in the hope of the prevention or amelioration of the disease. These tests are commonly performed for medical conditions which are not clinically evident in the neonatal period but are likely to be treatable with an 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 testing methods: Blood spot, hearing test and pulse oximetry. 

Rising Population, Growing Levels of Birth Defects and Positive Government Initiatives are some of the key drivers responsible for the Growth of the Global Newborn Screening Market

The global population is anticipated to grow to 9.7 billion people by 2050 from 8 billion in 2022 and enhancing access to primary care are the key driving factors in the rapid growth of the global newborn screening market. 

Globally, an estimated 8 million newborns are born with a birth defect each year. As per CDC, birth defects affect one in every 33 babies born (about 3% of all babies) born in USA each year. In the WHO, South-East Asia Region, between 2010 and 2019, birth defects rose 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 stop the growing birth defects, leading healthcare companies across the world are taking essential steps to prevent, identify, manage and care for various birth defects.

Developing countries and regions are heavily investing in the global newborn screening market. 

For instance, 

• Brazil passed a new law in 2021, stating that all states must implement an expanded NBS programme by June 2022 – these targets have fallen short in few states, however the programme continues to steadily grow to include lysosomal diseases, immunodeficiencies, and spinal muscular atrophy.
• Additionally, Columbia, Chile & Panama are in the process of expanding their testing coverage from 70-80% to >90% of newborns as well as expanding the number of medical conditions screened for.

Rising Application of Next-Generation Sequencing Is Slated to Trigger the Growth of the Newborn Screening Market in Developed Countries

NGS approaches are being adopted in various hospital settings for application of 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 offer sequencing for $500-$900. Pilot studies are being conducted in USA, UK, China and other developed countries into the suitability for the global utilization of NGS technology in newborn screening programmes as well as in neonatal wards. 

China is Anticipated to Account for the Largest Market Share in the Global Newborn Screening Market – Followed by North America and Europe

While China is the largest new born screening market - 9.56 million babies were born in China in 2022, down from 17.86 million babies born in 2016. Approximately, 93% of newborns are reported to undergo screening in China – the availability of the various range of tests available between urban and rural regions. 

The penetration of newborn screening in China is set to surge in the upcoming years due to favourable government initiatives, rising number of newborn screening centers and establishment of well-developed network system. The Chinese government identifies newborn screening as a public health project and by the end of 2018, there were 238 newborn screening centers in China mainland with screening rates exceeding 97.5%.  China newborn screening has established a whole network system, from sample collection and delivery, laboratory testing, results reporting, clinical diagnosis to follow-up which has played a major role in its penetration. Meanwhile, India has become the highest populous nation on earth – 23 million babies were born in 2022, also, currently, there is no active national NBS programme in India. 

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

Competitive Landscape Analysis: Newborn Screening Market

The global newborn screening market is marked by the presence of some of the leading market players such as SCIEX, Agilent Technologies Inc., Bio-Rad Laboratories, Covidien, GE Healthcare, PerkinElmer, Inc., Masimo Corporation, Natus Medical Incorporated, Trivitron Healthcare, Waters Corporation, Labsystems Diagnostics Oy, LifeCell International Pvt.Ltd, Archer DX, etc.

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