Paediatric & Neonatal Testing Kits Market Outlook

The paediatric & neonatal testing kits market is estimated to secure a valuation of US$ 3.5 Billion in 2023 and is estimated to rise to US$ 6.7 Billion by 2033. The market is anticipated at a CAGR of 6.7% during the forecast period. The factors accelerating the demand for paediatric & neonatal testing kits are as follows-

  • Advancement in paediatric & neonatal intensive care sector
  • Increased rate of newborn screening
  • Increased birth rate and increased newborn healthcare spending
  • Surging cases of infant disorders
  • Rising organ transplant and increased number of donors.
  • Increased prevalence of genetic and metabolic disorders among new-borns
  • Availability of a wide range of paediatric & neonatal testing kits
  • North America dominates the paediatric & neonatal testing kits market due to the forecast period.

The paediatric & neonatal testing kits market is majorly driven by increased birth rates across the major developing and developed nations. Also, the increased rate of paediatric and other infant-related disorders is expected to spur the demand for paediatric & neonatal testing kits during the forecast period.

The increasing demand for early diagnostics, advancement in point-of-care diagnostics, and growing new-born screening are likely to boost the paediatric & neonatal testing kits market

Another factor likely to drive the market growth includes the advancement in the healthcare sector and increased demand for advanced. Also, the increased cases of allergies in infants and the high risk of the physical problem and mental retardation are expected to boost the sales of paediatric & neonatal testing kits throughout the forecast period.

North America dominates the paediatric & neonatal testing kits market during the forecast period owing to the increased prevalence of congenital disorders in new-born. The favourable reimbursement policies and rising research and innovative activity dominate the paediatric & neonatal testing kits market in the region. Additionally, the availability of a wide range of paediatric & neonatal testing kits in the region is supporting the market growth during the forecast period.

On the other hand, the paediatric & neonatal testing kits market in Europe is witnessing significant growth in recent years. The market players in Europe are providing innovative products to meet the growing demand. Asia Pacific’s paediatric & neonatal testing kits market is expected to rise at a significant CAGR during the forecast period.

Some of the key players supplying paediatric & neonatal testing kits are Perkin Elmer Inc, Medtronic plc, Thermo Fisher Scientific Inc, Trivitron Healthcare, Natus Medical Incorporated, Bio-Rad Laboratories, GE Healthcare, ZenTech SA, MP BIOMEDICAL, Baebies Inc, Masimo Care Dx Inc, QUIGEN, Hologic Inc, Eurofins Inc, JETA Molecular BV, among others. To gain a good share of the market, the leading payers are following strategies like partnerships, mergers, and acquisitions.

The market for paediatric & neonatal testing kits is expected to flourish during the forecast period owing to the increase in incidences of critical congenital heart defects like pulmonary atresia and tricuspid atresia. With the increased demand for paediatric & neonatal testing products, start-ups are entering the paediatric & neonatal testing kits market with innovative products and services.

For instance, founded in 2001- ZenTech is the developer of prenatal, neonatal, and pediatric IVD kits. Their product range includes prenatal immunoassay kits for the detection of Edward's syndrome, Down's syndrome, and neural tube defect, prenatal FISH assays for the detection of microdeletions, and neonatal screening assays for assessing levels of thyroid stimulating hormone (TSH) and galactose, cystic fibrosis, phenylketonuria, maple syrup urine disorder and biotinidase deficiency.

Data Point Key statistics
Expected Market Value in 2023 US$ 3.5 Billion
Projected Market Value in 2033 US$ 6.7 Billion
Growth Rate (2023 to 2033) CAGR of 6.7%

The Paediatric & Neonatal Testing Kits will show growth due to the rising organ transplants globally and an increased number of donors to support the recipients’ transplantation. Therefore, growth at a significantly high CAGR will be expected soon.

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What is Driving the Demand for Paediatric & Neonatal Testing Kits

Paediatric & Neonatal testing refers to the process of taking a blood sample from and testing the sample to identify specific illnesses or conditions. The illnesses that are tested are genetic, metabolic, or endocrine disorders.

The specific conditions included in a new-born screening test are typically illnesses that are serious and rare and may not have symptoms right away. The purpose of testing is to identify these illnesses early before the baby develops symptoms and becomes sick and to treat the disease so that the baby remains healthy.

The test is usually done twice, once before the baby leaves the hospital after being born and then a second time in the baby’s physician’s office in the first 2 weeks of life.

According to a study, each year, almost all of the 4 million babies born in the United States experience new-born screening. Of these babies who undergo screening, about 4000 will test positive for a condition.

According to WHO, it is to be expected that, at least 500,000 HIV-infected infants will be born each year, most of them in low-income countries with generalized epidemics. Mother-to-child transmission of HIV accounts for the vast majority of the 2.3 million children under the age of 15 years who are estimated to be living with HIV, almost 90% of them in sub-Saharan Africa.

As per WHO facts, in 2006, 380,000 children aged under 15 years died of AIDS-related causes. Affordable treatments for opportunistic infections are becoming increasingly available but this is of little benefit to infants unless they can be diagnosed early.

Early diagnosis of HIV allows healthcare providers to offer optimal care and treatment of HIV infected children, assists in decision-making on infant feeding and avoids needless stress in mothers and families.

Which Factors are likely to Augment the Growth of the Paediatric & Neonatal Testing Kits Market

Increasing cases of allergies in infants and children are becoming a large factor for diagnosis. Allergy-related disorders are among the leading diagnoses of chronic diseases in children.

According to one study, 8-10% have asthma and 15-25% have allergic rhinitis (hay fever). Most of these birth defects have no immediate visible effects on a baby but, unless detected and treated early, can cause physical problems, mental retardation, and, in some cases, death.

A lot of babies are found to have metabolic disorders and in these cases, only an early diagnosis and proper treatment can make the difference. For rare diseases, neonatal testing represents a weapon for early detection.

The SARS-Cov-2 pandemic necessitates tailored recommendations addressing specific procedures for neonatal and paediatric transport of suspected or positive COVID-19 patients.

Sabyasachi Ghosh
Sabyasachi Ghosh

Principal Consultant

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The USA and Canada Paediatric & Neonatal Testing Kits Market Outlook

USA and Canada will retain the top position in the market of Paediatric & Neonatal Testing Kits due to the pronounced government involvement in paediatric & neonatal testing.

According to the American Academy of Paediatrics each year, 4.1 million new-borns are screened for congenital disorders in the USA Of these, 4,000 infants are diagnosed as having a condition.

It is estimated another 1,000 infants that have conditions go undetected. The Canadian Task Force on Preventive Health recommends that all children and teens age 17 years and younger have their growth monitored during primary care visits.

According to the USA Centres for Disease Control and Prevention, TB in children is a public health concern because it is a marker for recent transmission of the bacteria, and infants and young children are more likely than older children and adults to develop life-threatening forms of the disease.

Among children, the most cases of TB are seen in those under 5 years of age and adolescents older than 10 years of age. The American Academy of Paediatrics recommends that children who are at risk of contracting TB should have a tuberculin skin test.

Europe Demand Outlook for Paediatric & Neonatal Testing Kits

Europe is seeing growth in advancement in the healthcare sector and an increase in demand for better healthcare providing opportunities will lead the Paediatric & Neonatal Testing Kits market in Europe. There has been immense involvement of the government in paediatric and neonatal screening.

In 2004, the European Cystic Fibrosis Society (ECFS) established the Neonatal Screening Working Group (NSWG) to track current practices, support implementation, and establish consensus on issues arising in new-born screening.

It has been found that there has been a substantial increase and the adoption of Cystic Fibrosis New-born screening in Europe. Similarly, there have been steps taken by associations and governments in the region to promote Paediatric & Neonatal Testing. This will give rise to the market in the forecasted period.

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Who are the Key Manufacturers and Suppliers of Paediatric & Neonatal Testing Kits

Some of the leading manufacturers and suppliers of Paediatric & Neonatal Testing Kits include

  • PerkinElmer Inc.
  • Trivitron Healthcare
  • Natus Medical Incorporated
  • Medtronic Plc
  • Thermo Fisher Scientific Inc.
  • Bio-Rad Laboratories Inc
  • GE Healthcare
  • ZenTech S.A.
  • MP BIOMEDICALS
  • Baebies, Inc.
  • Masimo CareDx Inc.
  • Thermo Fisher Scientific
  • QIAGEN
  • Hologic Inc.
  • Eurofins Scientific
  • JETA Molecular BV.
  • ELITech Group SAS, Natera, Inc.
  • F. Hoffmann-La Roche Ltd
  • Biocare Health Resources Inc.
  • Bio-Rad Laboratories, Inc.
  • Biogenuix Medsystems Pvt Ltd
  • Genome Diagnostics B.V.
  • Sanbio B.V., and others.

These companies followed certain strategies like partnership, collaboration, product launch, and mergers and acquisitions to gain a good position in the market.

The report is a compilation of first-hand information, qualitative and quantitative assessment by industry analysts, inputs from industry experts and industry participants across the value chain.

The report provides an in-depth analysis of parent market trends, macro-economic indicators and governing factors along with market attractiveness as per segments. The report also maps the qualitative impact of various market factors on market segments and geographies.

Key Segments

By Product:

  • Assay kits & reagents
  • Instruments
    • Table-top
    • Point of Care Testing

By Test Type:

  • Dried Blood Spot
  • Hearing Screening
  • Critical Congenital Heart Defect (CCHD)
  • Others

By Technology:

  • Tandem Mass Spectrometry
  • Pulse Oximetry
  • Enzyme-based assays
  • DNA based assays
  • Electrophoresis
  • Others

By End User:

  • Hospitals
  • Diagnostic Centres
  • Maternity & Specialty Clinics
  • Others

By Region:

  • North America
  • Latin America
  • Europe
  • South Asia
  • East Asia
  • Oceania
  • MEA
Table of Content
  • 1. Executive Summary
  • 2. Industry Introduction, including Taxonomy and Market Definition
  • 3. Market Trends and Success Factors, including Macro-economic Factors, Market Dynamics, and Recent Industry Developments
  • 4. Global Market Demand Analysis and Forecast, including Historical Analysis and Future Projections
  • 5. Pricing Analysis
  • 6. Global Market Analysis and Forecast
    • 6.1. Product
    • 6.2. Test Type
    • 6.3. Technology
    • 6.4. End User
  • 7. Global Market Analysis and Forecast, By Product
    • 7.1. Assay kits & reagents
    • 7.2. Instruments
    • 7.3. Table-top
    • 7.4. Point of Care Testing
  • 8. Global Market Analysis and Forecast, By Test Type
    • 8.1. Dried Blood Spot
    • 8.2. Hearing Screening
    • 8.3. Critical Congenital Heart Defect (CCHD)
    • 8.4. Others
  • 9. Global Market Analysis and Forecast, By Technology
    • 9.1. Tandem Mass Spectrometry
    • 9.2. Pulse Oximetry
    • 9.3. Enzyme-based assays
    • 9.4. DNA based assays
    • 9.5. Electrophoresis
    • 9.6. Others
  • 10. Global Market Analysis and Forecast, By End User
    • 10.1. Hospitals
    • 10.2. Diagnostic Centres
    • 10.3. Maternity & Specialty Clinics
    • 10.4. Others
  • 11. Global Market Analysis and Forecast, By Region
    • 11.1. North America
    • 11.2. Latin America
    • 11.3. Europe
    • 11.4. South Asia
    • 11.5. East Asia
    • 11.6. Oceania
    • 11.7. MEA
  • 12. North America Sales Analysis and Forecast, by Key Segments and Countries
  • 13. Latin America Sales Analysis and Forecast, by Key Segments and Countries
  • 14. Europe Sales Analysis and Forecast, by Key Segments and Countries
  • 15. South Asia Sales Analysis and Forecast, by Key Segments and Countries
  • 16. East Asia Sales Analysis and Forecast, by Key Segments and Countries
  • 17. Oceania Sales Analysis and Forecast, by Key Segments and Countries
  • 18. MEA Sales Analysis and Forecast, by Key Segments and Countries
  • 19. Sales Forecast by Product, Test Type, Technology, and End User for 30 Countries
  • 20. Competition Outlook, including Market Structure Analysis, Company Share Analysis by Key Players, and Competition Dashboard
  • 21. Company Profile
    • 21.1. PerkinElmer Inc.
    • 21.2. Trivitron Healthcare
    • 21.3. Natus Medical Incorporated
    • 21.4. Medtronic Plc
    • 21.5. Thermo Fisher Scientific Inc.
    • 21.6. Bio-Rad Laboratories Inc
    • 21.7. GE Healthcare
    • 21.8. ZenTech S.A.
    • 21.9. MP BIOMEDICALS
    • 21.10. Baebies, Inc.
    • 21.11. Masimo CareDx Inc.
    • 21.12. Thermo Fisher Scientific
    • 21.13. QIAGEN
    • 21.14. Hologic Inc.
    • 21.15. Eurofins Scientific
    • 21.16. JETA Molecular BV.
    • 21.17. ELITech Group SAS, Natera, Inc.
    • 21.18. F. Hoffmann-La Roche Ltd
    • 21.19. Biocare Health Resources Inc.
    • 21.20. Bio-Rad Laboratories, Inc.
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