Newborn Screening Market Size, Share, and Trends 2024 to 2034

Newborn Screening Market Size and Forecast 2024 to 2034

The global newborn screening market size accounted for USD 909.18 million in 2024 and is expected to reach around USD 1,882.59 million by 2034, with a CAGR of 7.55% from 2024 to 2034. The rapid increase in the number of neonatal population is playing a crucial role in the demand for the newborn screening market. This helps in early intervention by examining them for rare illnesses and early detection of any disability.

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Newborn Screening Market Key Takeaways

• Asia Pacific dominated the global newborn screening market and contributed the highest market share of 33.1% in 2023.
• North America is anticipated to register the fastest growth during the forecast period.
• By product, the instruments segment generated the highest market share of 77% in 2023.
• By product, the reagents segment is expected to register significant growth in the market during the forecast period of 2024 to 2034.
• By technology, the tandem mass spectrometry segment recorded the biggest market share of 26% in 2023.
• By technology, the electrophoresis segment is anticipated to grow at the fastest CAGR of 8.10% during the forecast period.
• By test type, the dry blood spot test segment accounted for the highest market share of 47% in 2023.
• By test type, the hearing screen segment is anticipated to stand out with significant growth in the market from 2024 to 2034.

Asia Pacific Newborn Screening Market Size and Growth 2024 to 2034

The Asia Pacific newborn screening market size is exhibited at USD 300.94 million in 2024 and is projected to be worth around USD 624.08 million by 2034, registering a notable CAGR of 7.56% from 2024 to 2034.

Asia Pacific dominated the global newborn screening market in 2023. The dominance of the region is attributed to the higher birth rate in countries like India and China, which generates the need for newborn screening in the region. Their governments are also focusing on adopting these technologies in their healthcare infrastructure, which would allow the public to access these screening tests for their newborn children. The rising internet penetration and increasing social media usage in the region are also playing a vital role in the market. Additionally, the region is witnessing rapid urbanization, which attracts multiple investments that will help it improve its healthcare infrastructure.

North America is anticipated to register the fastest growth in the newborn screening market during the forecast period from 2024 to 2034. The reason behind the rapid growth of the region is attributed to the availability of advanced technologies in countries like the United States and Canada, which focus on improving newborn screening equipment. The governments in the region are also among the major reasons behind the rapid growth as they impose rules and regulations.

• The United States implemented the Newborn Screening Saves Lives Reauthorization Act of 2014 to extend funding for programs that detect and treat inherited disorders in newborns, emphasizing timely screenings and training for healthcare professionals.

Market Overview

Newborn screening refers to a health screening program designed to identify the health conditions of newborns. The purpose of this test is to detect any health condition in the newborn that can be treated before they show any symptoms. These conditions can include hormonal, metabolic, and genetic disorders, which can also lead to death if not cured within time. These tests are mostly conducted 24-48 hours after the birth of the child and include taking blood samples from the newborn's heel and then testing it in the laboratory.

• According to the WHO, 2.3 million newborns died in 2022, with leading causes including premature birth, birth complications, infections, and congenital anomalies, accounting for 4 in every 10 under-5 deaths, a proportion unchanged since 2000 despite declining rates globally.

How can AI Help in the Newborn Screening Market?

The emergence of artificial intelligence (AI) in the healthcare sector has significantly helped the growth of the newborn screening market. AI analyses huge datasets that can help detect potential health conditions according to symptoms. AI has also improved the audio and visual equipment used during newborn screening. The emergence is also expected to eliminate the human need without affecting the productivity of the work.

• A report published by the National Library of Medicine in 2022 stated that an artificial intelligence algorithm was applied for screening inborn errors of metabolism, analyzing 94,648 newborns in China and reducing false-positive rates by over 24.9%.

Newborn Screening Market Growth Factors

• The newborn screening market is growing significantly due to multiple factors like rising disease prevalences among the neonatal population, leading to increasing awareness among individuals.
• The increasing public-private partnerships towards improving healthcare facilities stand out as a major growth factor of the newborn screening market.
• Increasing technologies have led to the need for personalized healthcare, which includes treatments according to the individuals and plays a crucial role in market growth.
• The rise in healthcare tourism is increasing the need for newborn screening, which stands out as a market growth factor. 
• Increasing focus from health insurance companies on newborn testing is crucial to market growth.

Market Scope

Market Dynamics

Drivers

Increasing birthrates in developing countries

The rising birth rate in developing countries is one of the major drivers for the newborn screening market. This is leading to attention to improving health screening for newborns, which will lead to an increase in the adoption of equipment and workforce. The increasing availability of these technologies is expected to drive the attention of the public.

Rising prevalence of neonatal disorders

There has been an increase in the number of genetic and metabolic disorders in newborns, like cystic fibrosis and congenital hypothyroidism, which is influencing the adoption of the newborn screening market services. Many companies are focusing on advancements that help detect neonatal disorders, which has led to the increasing demand for newborn screening. These advancements have led to increasing market growth due to the broader screening processes.

Restraint

Higher screening costs due to limited availability

The newborn screening market has marked significant growth in the developed regions, but there are still some factors that could potentially hamper the market growth. Many states in underdeveloped and developed countries have limited availability of healthcare infrastructure, which makes screening unaffordable for low-income families due to the higher costs.

Opportunities

Increasing awareness among parents

Increasing education about newborns is resulting in increasing understanding among the parents regarding the benefits of screening which helps in detecting neonatal disorders at an early stage. Digitalization is also contributing significantly towards engaging parents and individuals, which will help in the growth of the newborn screening market. Additionally, the increasing technologies in medical screening for newborns are increasing the reliability of the individuals who put their children under these tests.

Increasing government initiatives

The rising genetic disorder cases among newborns has led to the increasing focus of governments towards promoting the newborn screening market. Many governments are conducting health screening programs that focus on early diagnosis of neonatal disorders. The increasing healthcare opportunities are also attracting funding through public-private partnerships.

• A pilot newborn screening program was launched in Udupi, South India, with funding from Grand Challenges Canada, to assess the need and cost-effectiveness of a national screening initiative.
• In August 2024, the Australian government announced a USD 5.5 million investment towards a new screening platform.

Product Insights

The instruments segment stood the dominant in the newborn screening market in 2023. Instruments in newborn screening refer to the medical devices that are used for newborn screening. They include pulse oximeters, hearing screening devices, and mass spectrometers, which perform various tasks during the screening process. The dominance of these instruments is attributed to their high demand in hospitals and clinics. Healthcare professionals use these devices to treat multiple disorders in children. The rising need for these instruments in the healthcare setting is leading to a rapid expansion in production.

The reagents segment is expected to register significant growth in the newborn screening market during the forecast period of 2024 to 2034. Reagents in the market refer to chemical substances used in screening procedures mainly to detect endocrine and metabolic disorders in newborns. The rising growth of the segment is attributed to the rising cases of metabolic and endocrine disorders, which is driving the need for more reagents in newborn screening. The rising prevalence of various disorders and conditions among newborns is leading to an enhanced focus on producing solutions for the diseases.

Technology Insights

The tandem mass spectrometry segment marked its dominance over the newborn screening market in 2023. Tandem mass spectrometry refers to an analytical technique that can cover multiple compounds at a single time. It is a highly used technique for detecting metabolism errors in newborns. Covering multiple tests in this technique leads to an increasing preference for the technology due to its cost-effectiveness. The increasing consumer preference for the technology is leading to its adoption by many healthcare providers. Many companies are also increasing their focus on enhancing this technique.

The electrophoresis segment is anticipated to grow at the fastest rate in the newborn screening market during the forecast period. Electrophoresis is a lab-based technique that separates DNA and proteins, which helps diagnose genetic blood disorders like thalassemia and sickle cell anemia. The growth of the segment is also attributed to rising hemoglobin disorders that raise the need for electrophoresis. This is leading towards improving the cost-effective techniques that also provide better outcomes through these tests.

Test Type Insights

The dry blood spot test segment registered the largest share of the newborn screening market in 2023. Dry blood spot test (DBS) refers to a test that includes taking blood drops of the newborns on a filter paper, which are dried and then analyzed in the laboratory. This test helps in detecting metabolic disorders, hormonal disorders, and other genetic disorders. The dominance of the segment is attributed to the rising number of multiple disorder detections done in this test using a simple process. This is also considered to be the traditional test method for testing newborns. This also makes it affordable for low-income people, which helps target multiple audiences.

The hearing screen segment is anticipated to stand out with significant growth in the newborn screening market from 2024 to 2034. Hearing screening refers to tests like otoacoustic emissions that measure the sound waves in the ears and detect hearing conditions. Tests like auditory brainstem response detect the response of the brain and the hearing nerve to the sound. This is one of the biggest factors that is considered to be important in newborns. This has also led to an increasing focus on improving these tests, which could help enhance the test outcomes. Many governments are promoting these tests through screening programs.

Newborn Screening Market Companies

• Bio-Rad Laboratories
• Agilent Technologies
• Waters Corporation
• Natus Medical
• Trivitron Healthcare
• GE Lifesciences
• PerkinElmer Inc
• AB SCIEX
• Covidien plc
• Masimo

Recent Developments

• In July 2024, a study conducted by the Barcelona Institute for Global Health (ISGlobal) launched an innovative 3D printer-based test that enhances early detection of Chagas disease in newborns, improving screening efficiency and treatment outcomes in endemic regions. 
• In May 2024, Alberta announced USD 30 million for women's health research and expanded its newborn screening program to enhance healthcare for women and infants in the province.
• In February 2024, a research study named Early Check reached a milestone by screening 1,000 newborns in North Carolina to identify rare genetic conditions early, provide treatment, and connect families with specialists.
• In September 2023, Mylab Discovery Solutions launched MyNeoShield, a revolutionary point-of-care newborn screening device that has enabled faster, more accessible, and cost-effective testing, which also ensures timely health interventions for newborns.

Segments Covered in the Report 

By Product 

• Instruments
• Reagents

By Technology 

• Tandem Mass Spectrometry
• Pulse Oximetry
• Enzyme Based Assay
• DNA Assay
• Electrophoresis
• Others

By Test Type 

• Dry Blood Spot Test
• CCHD
• Hearing Screen

By Geography

• North America
• Asia Pacific
• Europe
• Latin America
• Middle East and Africa