Newborn Screening LC-MS Reagent Kits Market

Market Overview

Global newborn screening LC-MS reagent kits market was valued at USD 233.86 million in 2019 and is expected to grow at a CAGR 6.8% during the forecast period 2019–2029

Newborn screening is the practice of testing babies in their first days of life for developmental, genetic, metabolic disorders, and conditions that can deter their normal development. Early detection and treatment can help prevent intellectual and physical disabilities and life-threatening illnesses. LC-MS/MS method is primarily employed for the detection of amino acids and acylcarnitine in blood. Tandem mass spectrometry can efficiently detect even a low concentration of the compounds that can be used to determine if the baby has any inborn metabolic disease or not.

Market Dynamics

The rising neonatal population coupled with the increasing prevalence of congenital disordersis driving the market growth. A congenital anomaly is one of the leading causes of neonatal morbidity and mortality, especially in developing countries. According to the report published by the United Nations, about 250 babies are born every minute and more than 130 million in a year. Out of this, over 330,000 newborns die during their first 28 days of life due to congenital disorders. It has been found that neural tube defects, heart defects, and Down syndrome are the most common and severe congenital irregularities in newborns; however, newborn screening can help in bringing down the overall mortality and improve living.

In the last few years, the overall number of favorable government policies supporting newborn screening programs such as Newborn bloodspot screening (NBS) programs have expanded significantly with the emergence of genetic technologies. Both federal and state governments are responsible for governing newborn screening and approving the screening tests for public use, which further ensures that laboratories processing the screening tests meet the set standards.

Segmental Analysis

Non-derivatized Test: Most Preferred Newborn Screening

Non-derivatized method is rapid and cost-effective as well as need minimum preventive maintenancethan the derivatized method.It is frequently used in the initial stage of newborn screening, and derivatized reagent kits are used only for confirming the test. Therefore, theconsumption of non-derivatized reagents is higherthan the derivatized. In line with this, several key market players are launching new non-derivatized MSMS kits in the market. For instance, in January 2018, Perkin Elmer announced the launch of its NeoBase 2 non-derivatized MSMS kit for the semi-quantitative measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid concentrations. The kit evaluates newborn heel prick blood samples dried on filter paper and is used with a tandem mass spectrometer.

Chemical derivatization is frequently used to enhance the mass spectroscopy detectability. It improves the separation and ionization efficiency. Moreover, the generated derivatives offer particular productions by CID (collision-induced dissociation), which allow for sensitive detection. Derivatized assay provides more accurate results than non-derivatized assay. Therefore, it is used forconfirming the results of newborn specimens in the second tier.However, high cost and complex extraction process act as a growth barrier for the product. Apart from this, ancillary equipment such as evaporator, plate sealer, fume blood, and gas supply systems are additionally required in this process, which further increases the overall operational cost, making it less likely preferred type in the first tier.

Application of the Newborn Screening LC-MS Reagent Kits

By application, the market is segmented into protein metabolism, fatty acid metabolism, organic acid metabolism, and others. In the last few years, protein acid metabolism has emerged as the largest newborn screening LC-MS reagent kits and is projected to growat a CAGR of 7.5% over the forecast period. Fatty acid metabolism is another remarkable segment in terms of revenue. Some of the key fatty acid disorders detected during newborn screening are Short-chain acyl-CoA dehydrogenase deficiency (SCAD) and Multiple acyl-CoA dehydrogenase deficiency (MADD).

Protein metabolism segment dominated the new-born screening LC-MS market in 2019 and was valued at USD 108.28 million.

Medium chain acyl-CoA dehydrogenase deficiency is the most common fatty acid oxidation disorders with an occurrence of one in 10,000 to 20,000 births. Long chain 3 hydroxyacyl-CoA dehydrogenase and very-long-chain acyl-CoA dehydrogenase deficiency are some of the rare disorders with a prevalence of 1 in 100,000 births.

Regional Analysis

Based on Region,

The global Newborn Screening LC-MS Reagent Kit market is segmented into Asia Pacific, Europe, North America, Central, South America, and Caribbean, MEA.

Currently, North America is leading the global newborn screening LC-MS market,owing to the well-developed newborn screening program being followed across all the U.S. states. As perthe CDC, more than 4 million babies were screened for various possible conditions in 2017. Precise conditions for the newborn 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). To increase awareness regarding newborn screening, the U.S. health department has published free data to aid parents in managing these conditions. In December 2014, members of Congress in the U.S. passed the Newborn Screening Saves Lives Reauthorization Act bill to renew and upgrade the federal initiatives for newborn screening.

In the U.S., newborn screening related programs by the state governments have upgraded child healthcare. The Research Triangle Institute (RTI) in alliance with the CDC and National Center on Birth Defects and Developmental Disabilities is conducting research studies and programs to advance awareness about newborn screening policy practices. These prompt initiatives are adding fuel to the market growth. PerkinElmer and Tech. Dev. Pte are some of the key players present in the U.S., whichare further contributing toregional market growth. PerkinElmer offers advanced LC-MS reagent kits such as NeoLSD MSMS kit and NeoBase 2 Non-derivatized MSMS kit.

Central, South America, and Caribbean newborn screening market is likely to experience modest evolution over the forecast period. Several companies and laboratories have signed distribution agreements with test providers for offering advanced products and services to the regional patients. Every year, around 11 million infants are born in this region, and only about 70% are likely to have access to newborn screening benefits. Regardless of such disparities, continual and momentous growth in newborn screening activities has become evident in the last decade, highlighted by the employment of new programs, upsurge in coverage, expansion of newborn screening panels, and the significant surge in the involvement of government and public health authorities.

The Middle East and Africa newborn screening LC-MS reagent kit market is projected to grow at a moderate CAGR during the forecast period. The population in the region is around 400 million, with high birth rate and isassessed 10 million newborns annually. In line with this, the region offers favorable growth opportunities for the product. However, socio-economic barriers are hampering the adoption of newborn screening tests. In the past few decades, countries like Saudi Arabia, Qatar, and Lebanon have become regional as well as international pioneers for newborn screening applications by tandem mass spectrometry. National NBS programs with extensive screening coverage are now present in Bahrain, Egypt, Iran, Israel, Kuwait, Oman, Qatar, the State of Palestine, Saudi Arabia, and the United Arab Emirates. Increasing efforts by the government to spread awareness regarding newborn screening procedures will upsurge its adoption to some extent.

Newborn Screening LC-MS Reagent Kits Market Segmentation