Pediatric and Neonatal Testing Kit Global Market Report 2024

The pediatric and neonatal testing kit market size has grown strongly in recent years. It will grow from $3.7 billion in 2023 to $4.02 billion in 2024 at a compound annual growth rate (CAGR) of 8.5%. The growth witnessed during the historic period can be ascribed to several factors contributing to the advancement of pediatric and neonatal care. This includes notable progress in medical practices for infants and newborns, a heightened emphasis on child health, the expansion of healthcare infrastructure, a rising awareness regarding prenatal testing, and ongoing developments in the regulatory landscape.

The pediatric and neonatal testing kit market size is expected to see strong growth in the next few years. It will grow to $5.51 billion in 2028 at a compound annual growth rate (CAGR) of 8.2%. The anticipated growth in the forecast period is driven by various factors, including an upsurge in the demand for non-invasive testing methods, the widening application of point-of-care testing in pediatrics, heightened investments in neonatal and pediatric research, and the growing adoption of digital health solutions. Prominent trends expected during this period encompass the development of swift and precise testing kits, the integration of next-generation sequencing in pediatric diagnostics, the expansion of newborn screening programs, a heightened emphasis on metabolic testing in neonates, and the incorporation of artificial intelligence in diagnostic tools.

The pediatric and neonatal testing kit market is poised for growth due to the rising prevalence of congenital disorders in newborns. These disorders, occurring during fetal development or present at birth, underscore the importance of pediatric and neonatal screening. Early detection of congenital disabilities through such screening enables healthcare professionals to initiate prompt treatment. In February 2023, the World Health Organization (WHO) reported that approximately 240,000 babies worldwide die within the first 28 days of birth due to congenital disorders annually, with an additional 170,000 deaths occurring between the ages of 1 month to 5 years. The European Commission noted in December 2022 that anomalies were prevalent in 253.38 per 10,000 births in 2020, with 58.22 instances of termination of pregnancy for congenital anomalies (TOPFA). This emphasizes the significant impact of congenital disorders on infant mortality and underscores the need for pediatric and neonatal testing kits.

The increasing neonatal and pediatric population is another driving factor for the pediatric and neonatal testing kit market. Neonates, defined as newborns within the first 28 days of life, and pediatric patients (up to 21 years old) constitute a growing demographic with specific healthcare needs. In the United Kingdom, for example, as of 2021, there were 3.58 million children aged 0 to 4, with varying age distributions within this range. The statistics from 2021 also revealed neonatal death rates of 1.65 per 1000 live births and stillbirth rates of 3.54 per 1000 total births in the UK. This surge in the neonatal and pediatric population underscores the essential role of pediatric and neonatal testing kits in addressing the unique healthcare requirements of this demographic. As a result, the increasing prevalence of congenital disorders and the expanding neonatal and pediatric population are significant drivers propelling the growth of the pediatric and neonatal testing kit market.

A prominent trend in the pediatric and neonatal testing kits market is the development of innovative screening tests, with major companies prioritizing the creation of novel kits to enhance their market standing. Notably, companies such as Calmark are at the forefront of this trend, exemplified by the introduction of their product, Calmark Neo-Bilirubin. In April 2020, Calmark, a diagnostics company based in Sweden, announced the regulatory approval and CE mark for Neo-Bilirubin in the European Union. This point-of-care diagnostic system is designed for measuring bilirubin levels in newborns. Distinguished by its high tolerance to hemolysis and the ability to deliver accurate results even at up to 60% hematocrit, this product is tailored for hospital environments and holds NEST360 Qualified approval, ensuring enhanced quality and safety standards.

Major players in the pediatric and neonatal testing kits market are actively engaging in strategic collaborations to fortify their market positions. Collaborations, such as the one between Baebies, Inc., a US-based medical device company, and Medical Horizons s.r.l, an Italy-based medical device supplier, exemplify efforts to advance precision medicines for chronic kidney diseases. This collaboration, initiated in May 2022, aims to discover and develop innovative products facilitating early disease detection and comprehensive diagnosis. The expansion of digital microfluidics technology into new global markets is a strategic focus, offering opportunities to screen more infants and improve overall patient outcomes.

In November 2021, NeoLight LLC, a prominent medical device firm based in the United States, successfully completed the acquisition of Phoenix Technology Group for an undisclosed sum. This strategic move enhances NeoLight's existing newborn care portfolio, bolstering its capabilities in newborn testing. Phoenix Technology Group, renowned for its expertise in manufacturing ocular imaging devices for both newborn and adult testing, further augments NeoLight's comprehensive newborn testing portfolio through this acquisition.

Major companies operating in the pediatric and neonatal testing kit market report are F. Hoffmann-La Roche AG, Thermo Fisher Scientific Inc., Abbott Laboratories, Medtronic PLC, Siemens Healthineers, GE Healthcare GmbH, Eurofins Scientific SE, Trivitron Healthcare Pvt Ltd., Hologic Inc., PerkinElmer Inc., Quidel Corporation, Bio-Rad Laboratories Inc., QIAGEN NV, Masimo CareDx Inc., Natus Medical Incorporated, BioFire Diagnostics LLC, Luminex Corporation, Meridian Bioscience Inc., Advanced Instruments LLC, MP Biomedicals LLC, ELITech Group SAS, Baebies Inc., iHealth Labs Inc., Labsystems Diagnostics Oy, Advacare Pharma LLP, Beckman Coulter Inc., JETA Molecular BV, EpigenTek Group Inc., ZenTech SA, Hangzhou Testsea Biotechnology Co. Ltd.

North America was the largest region in the pediatric and neonatal testing kit market in 2023. The regions covered in the pediatric and neonatal testing kit market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the pediatric and neonatal testing kit market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Key test types featured in pediatric and neonatal testing kits include dried blood spot, hearing screening, critical congenital heart defect (CCHD), among others. The dried blood spot (DBS) test, a diagnostic technique, entails the collection of a small blood volume from individuals, allowing it to dry on a specialized filter paper. The product offerings include assay kits, reagents, and instruments employing various cutting-edge technologies such as tandem mass spectrometry, pulse oximetry, enzyme-based assays, DNA-based assays, electrophoresis, and more. These advanced testing solutions cater to a diverse range of end users, including hospitals, diagnostic centers, maternity facilities, specialty clinics, and other healthcare institutions.

The pediatric and neonatal testing kit market research report is one of a series of new reports that provides pediatric and neonatal testing kit market statistics, including pediatric and neonatal testing kit industry global market size, regional shares, competitors with a pediatric and neonatal testing kit market share, detailed pediatric and neonatal testing kit market segments, market trends and opportunities, and any further data you may need to thrive in the pediatric and neonatal testing kit industry. This pediatric and neonatal testing kit market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The pediatric and neonatal testing kit market consists of sales of maternal blood screening, ultrasound tests, amniocentesis, and glucose screening. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.


This product will be delivered within 3-5 business days.