Newborn Metabolic Screening Market

Newborn Metabolic Screening Market Outlook (2024 to 2034)

The newborn metabolic screening market size is anticipated to hit US$ 355.1 million in 2024. A promising compound annual growth rate (CAGR) of 9.2% is projected to boost the market through 2034. This upward motion is estimated to lead the market to a significant valuation of US$ 857.4 million by 2034.

As understanding of metabolic issues affecting newborns has grown, so has the application of newborn metabolic screening tests. This is due to its ability to accurately assess a baby's health and identify a range of conditions or birth abnormalities, allowing for the provision of the necessary medical care and possibly even the baby's survival. As a result, throughout the forecast period, there is likely to be a rise in the demand for neonatal metabolic screening.

The World Health Organization estimates that birth abnormalities prompt the deaths of around 240,000 newborns in the first 28 days after birth yearly throughout the globe, and an additional 170,000 children aged one month to five years. These estimates are based on data from February 2022.

Key Newborn Metabolic Screening Market Growth Factors

• Rising global birth rates and expanding neonatal care facilities create a larger pool of potential consumers for newborn metabolic screening services.
• The increasing prevalence of metabolic disorders in newborns amplifies the demand for efficient screening methods, fostering market development.
• Growing awareness among healthcare professionals and parents about the importance of early detection of metabolic disorders fuels the demand for screening services.
• Initiatives by several governments to implement comprehensive newborn screening programs also contribute to market expansion.
• To halt the rise in infant mortality, organizations such as the WHO, CDC, Healthy Newborn Network, etc., are educating parents about possible issues and related testing procedures.
• Advances in technology have significantly improved the accuracy and efficiency of newborn metabolic screening, driving newborn metabolic screening market revenue.

Report Attributes	Details
Estimated Market Value (2024E)	US$ 355.1 million
Forecasted Market Value (2034F)	US$ 857.4 million
Global Market Growth Rate (2024 to 2034)	9.2% CAGR
Tyrosinemia Segment Growth Rate (2024 to 2034)	13.6%
Hospital Segment Growth Rate (2024 to 2034)	10.0%
North America Market Share (2024)	31.0%
East Asia Market Share (2024)	11.3%
Key Companies Profiled	PerkinElmer Bio-Rad Laboratories Trivitron Healthcare Private Limited BioMedomics, Inc. Luminex Corporation MP BIOMEDICALS Synergy Medical Systems LLP Agilent Technologies, Inc. Thermo Fisher Scientific, Inc. Zivak Technologies Covidien Plc AB Sciex LLC Waters Corp. Masimo Corp. Natus Medical Inc.

What are the Key Dynamics Encouraging the Newborn Metabolic Screening Market Growth?

“Rising Rates of Metabolic Disorders Propel Surge in Newborn Metabolic Screening Demand”

The increasing prevalence of metabolic disorders and genetic conditions in newborns drives the market's growth. As the incidence of these disorders rises, the demand for comprehensive newborn metabolic screening continues to surge. For instance, 44 boys and 27 girls out of 300,849 neonates in China had neonatal metabolic illness diagnostics in 2021.

Neonate metabolic screening is becoming ever more necessary because of the increased risk of sickle cell disease, phenylketonuria, galactosemia, maple syrup urine illness, and cystic fibrosis.

Newborn screening has advanced, going from a simple blood and urine test to a more comprehensive and intricate screening method that can identify over 50 distinct abnormalities. As healthcare providers recognize the value of early detection and intervention, the demand for comprehensive screening solutions continues to rise, directing the newborn metabolic screening market statistic upward.

“Newborn Metabolic Screening Mandates Gain Traction Amid Global Shift toward Early Intervention”

Governments and private groups have recognized that these medical conditions can pose a threat to a newborn's life if left untreated. They are thus making an effort to put metabolic screening programs into place to address the issues at hand. For example, Ayushman Bharat, one of the top people-centered initiatives, was launched in India.

Governments and organizations are carrying out different strategies and developments to deal with issues in the newborn and maternal health sector in India. Moreover, newborn screening has been mandated in several countries. For instance, Italy has directed newborn screening for over 40 congenital metabolic disorders since 2016.

The 2004 Newborn Screening Act in the Philippines mandates newborn screening as a fundamental component of newborn care. The implementation of such policies ensures that a larger proportion of newborns undergo screening, contributing to the market expansion.

“Advanced Technologies like Next-generation Sequencing are Transforming Newborn Metabolic Screening”

The market is projected to grow as a result of the release of advanced newborn metabolic screening technologies. Newborn metabolic screening market trends are shaping the future of personalized care for infants. In recent advances, next-generation sequencing (NGS) has revolutionized genetic analysis, rapidly sequencing numerous genes or entire genomes.

Widely applied in medical contexts, NGS enhances disease diagnosis, prognosis, and therapeutic decision-making, offering unparalleled accuracy and enabling early detection of previously overlooked disorders.

Another crucial technique is mass spectrometry (MS). Identifying and quantifying various therapeutically important analytes is possible with the use of MS, a potent qualitative and quantitative analytical method. Multiple biomarkers can be measured simultaneously using MS for newborn metabolic screening.

This testing approach improves the identification of several illnesses. These advancements show a path toward transformation and emphasize how important these tests are to the direction that pediatric healthcare is taking.

Which Factors Pose Challenges to the Development of the Newborn Metabolic Screening Market?

“Lack of Healthcare Modernization and Skilled Professionals Impact the Market Negatively”

The primary constraints obstructing the newborn screening market expansion are the healthcare sector's lack of modernization of infrastructure and a scarcity of people with the education and experience needed. For example, since newborn screening is still not widely employed in the Asia Pacific, further study and tutoring are required.

Developing countries with sizable populations and a dearth of skilled workers are present. Improved healthcare systems in developing countries are hampered by high population densities, low and intermediate income levels, and inadequate medical treatment.

“False Test Findings and Standardization Issues Limit the Newborn Metabolic Screening Industry Expansion”

The newborn metabolic screening market is also expected to be hindered throughout the forecast period by a high percentage of false positive and false negative test findings, as well as a lack of global standardization in newborn metabolic screening policies and procedures.

The lack of follow-up data for screening diseases and the lack of knowledge on the long-term implications of newly discovered illnesses make it difficult for medical professionals to make decisions. Furthermore, the availability of reconditioned products, such as automated manual equipment and immunoassay systems, is expected to restrict the market expansion to a certain extent throughout 2034.

Country-wise Insights

The North America newborn metabolic screening market is gearing up for promising growth, prophesying a steady CAGR of 9.4% through 2034. This is because of the high rate of birth abnormalities in the region, strict local government regulations, an excellent healthcare system, and recent innovations in newborn metabolic screening technologies made by regional players. In this region, the United States is set to take the lead in the newborn metabolic screening industry, holding a substantial regional market share of 78.7% in 2024.

The newborn metabolic screening market in East Asia is poised for average advancement, aiming at a 9.6% CAGR until 2034. An increase in newborn screening engagement programs by different government healthcare regulatory organizations and their implementation for a larger population base principally supports the market growth here. In 2024, China is likely to take the limelight as a key player in the newborn metabolic screening industry, boasting an estimated regional share of 67.2%.

What Factors Contribute to the United State’ Supremacy in the Global Newborn Metabolic Screening Market?

“Government-driven Newborn Screening Programs Set to Transform Market Dynamics in the United States”

The United States is well aware of newborn metabolic problems. The country has significantly changed its metabolic screening procedures. The government has made newborn metabolic screening mandatory before hospital discharge. So, government-run newborn screening programs are anticipated to have an important effect on market expansion. In the United States, the states administer newborn screening programs, including metabolic screening. For example, the March of Dimes (MoD) report from 2021 states that every infant in the United States undergoes newborn screening before exiting the hospital, with an estimated 4 million babies screened each year.

Attributes	Details
United States Market Size (2024E)	US$ 87 million
United States Market Size (2034F)	US$ 220 million
United States Market CAGR (2024 to 2034)	9.8%

Companies like Danaher Corporation and PerkinElmer are proactively offering a range of newborn screening services. As the very first approved test for spinal muscular atrophy (SMA) screening in neonates, PerkinElmer reported in December 2022 that the EONISTM SCID-SMA Kit has been granted marketing authorization by the United States Food and Drug Administration.

What Factors Contribute to China’s Eminence as a Booming Market for Newborn Metabolic Screening Providers?

“Rising Incidence of Congenital Illnesses and Stress-free Insurance Coverage Boost China's Newborn Screening Industry Expansion”

Increased financing for newborn screening from government sectors is the primary factor driving the China newborn metabolic screening market. In 1981, the country launched a program for screening newborns. Newborn screening is becoming increasingly important to the government. The program for screening newborns run by the government includes collecting samples, laboratory testing, clinical diagnosis, reporting of results, follow-up, and delivery. The market expansion has been significantly aided by the coverage of some tests by regional medical insurance plans and initiatives for charitable organizations.

Attributes	Details
China Market Size (2024E)	US$ 27 million
China Market Size (2034F)	US$ 70 million
China Market CAGR (2024 to 2034)	9.9%

An increase in the incidence of congenital illness, expanding newborn screening programs, and technological developments in newborn metabolic screening are some of the other crucial factors driving the expansion of the newborn screening market. As per the findings of a research paper released in April 2022, ‘Epidemiology of Congenital Heart Disease in Jinan, China From 2005 to 2020: A Time Trend Analysis,’ the overall incidence of congenital heart disease increased by 157.45% and 316.03%, correspondingly, in both urban and rural areas from 2005 to 2020. In towns and cities, the frequency of coronary artery diseases was 4.81 per 1,000 births, while it was 3.17 per 1,000 births in the countryside.

Category-wise Insights

In 2024, the sickle cell disease test type segment is projected to be at the forefront, claiming a substantial 32.5% share of the market. On the other hand, the hospital segment is set to assert its dominance in the newborn metabolic screening industry, commanding a notable 40.3% market share in 2024.

Why is the Sickle Cell Disease Test Type Preferred in the Newborn Metabolic Screening Industry?

“Sickle Cell Disease Screening Gains Momentum with Innovative Tests and Community Outreach”

The sickle cell disease segment is estimated to hold a 30.3% share of the newborn metabolic screening market by 2034. The adoption of the sickle cell disease test type is projected to upsurge at a CAGR of 8.4% through 2034. Sickle cell disease is more common in newborns. In the United States, sickle cell disease affects about 2,000 newborns annually. This makes screening crucial for early assessment.

Increased development of new types of tests for sickle cell disease screening are also responsible for this. For example, to increase newborn screening for sickle cell disease (SCD) in sub-Saharan Africa, Revvity Inc. (PerkinElmer Inc.) partnered with Novartis AG, a renowned global pharmaceutical firm, in June 2022.

Expanding grassroots campaigns to raise awareness among patients, caregivers, and communities about the value of early intervention with hydroxyurea (HU) and other SCD medications, as well as newborn screening, is the goal of Revvity and Novartis.

During the forecast period, however, the tyrosinemia test type is anticipated to witness rapid adoption. Transient tyrosinemia, or momentarily high tyrosine levels in infants, affects around 1 in 10 infants, as reported by the National Organization for Rare Disorders.

Since tyrosinemia testing can identify this rare genetic condition early on, it is becoming ever more common in newborn screenings. This test facilitates early intervention and therapy by assisting in the identification of increased tyrosine levels.

What Factors Drive the Swift Embrace of Newborn Metabolic Screening in Hospital Settings?

“Hospitals Emerged as Prime Hubs for Newborn Screening Given their Specialized Staff and Location Appeal”

The hospital segment is likely to grip 43.4% of the newborn metabolic screening market share by 2034. The adoption of newborn metabolic screening in hospitals is anticipated to rise at a CAGR of 10.0% through 2034. This marks the maximum growth rate among end users, underscoring the increasing recognition of the screening's significance in hospitals.

Hospitals are the preferred location for giving birth. Their superior infrastructure, use of cutting-edge medical procedures, and availability of highly qualified personnel represent a few of the factors that account for this segment's substantial growth.

Parents choose hospitals for the reason that they have convenient locations near housing developments and have physicians on hand when required. Since hospital staff members are more demanding and have specialized training, people tend to favor them for screening and detection. They also provide a range of metabolic screening tests for your newborn baby.

Competitive Landscape

Key players in the newborn metabolic screening market include PerkinElmer, Bio-Rad Laboratories, Trivitron Healthcare Private Limited, BioMedomics, Inc., Luminex Corporation, MP BIOMEDICALS, Synergy Medical Systems LLP, Agilent Technologies, Inc., Thermo Fisher Scientific, Inc., Zivak Technologies, Covidien Plc, AB Sciex LLC, Waters Corp., Masimo Corp., and Natus Medical Inc.

Companies are purposefully aligning themselves to gain a competitive edge, anticipating the lucrative opportunities presented by the newborn metabolic screening market forecast. Some concentrate on recent advanced technology, applying sophisticated screening techniques to improve precision and increase the spectrum of illnesses that may be identified.

Some place a higher priority on pricing to reach a wider audience for screening. To be at the forefront of medical innovations, many players establish calculated connections with research institutes and healthcare providers. Businesses try to quickly adjust to new trends by maintaining a constant level of investment in research and development. In general, the competitive field is distinguished by a dedication to technological excellence, usability, and strategic partnerships.

Recent Developments

• In September 2023, Mylab Discovery Solutions unveiled MyNeoShield for Newborns, a patent-pending point-of-care device representing a revolutionary leap in newborn screening. This tool is going to change the face of newborn healthcare by lowering the cost, increasing accessibility, and speeding up screening.
• In June 2022, through a collaboration with the American Society of Hematology (ASH), Novartis AG began supplying six more African countries with the same technology now being utilized in Ghana to record and distribute sickle cell disease diagnostic data for infants. Through this collaboration, the present newborn screening consortium is going to reach new regions.
• In September 2020, top organizations dedicated to rare medical conditions, such as Orchard Therapeutics, Sarepta Therapeutics, Inc., BioMarin Pharmaceutical Inc., Retrophin, Inc., and the EveryLife Foundation for Rare Diseases, joined forces to assess how well newborn screening in the United States can diagnose all babies who received assistance from new therapies in the right way.

Segmentation of Newborn Metabolic Screening Market Analysis

• By Test Type :

  • Galactosemia
  • Sickle Cell Disease
  • Cystic Fibrosis
  • Toxoplasmosis
  • Phenylketonuria
  • Methylmalonic Acidemia
  • Maple Syrup Urine Disease
  • Tyrosinemia
  • Citrullinema, Medium Chain Acyl CoA Dehydrogenase Deficiency

• By Sample :

  • Coronary Artery Diseases
  • Chronic Heart Failure

• By End User :

  • Hospitals
  • Ambulatory Surgical Centers
  • Independent Catherization Labs

• By Region :

  • North America
  • Latin America
  • East Asia
  • South Asia and Pacific
  • Western Europe
  • Eastern Europe
  • The Middle East and Africa