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SMA Newborn Screening Market

SMA Newborn Screening Market

The market for SMA Newborn Screening was estimated at $483 million in 2024; it is anticipated to increase to $823 million by 2030, with projections indicating growth to around $1.28 billion by 2035.

Report ID:DS1801354
Author:Debadatta Patel - Senior Consultant
Published Date:July 2025
Datatree
Life Science
Medical Device
SMA Newborn Screening
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Report Summary
Table of Contents
Methodology
Market Data

Global SMA Newborn Screening Market Outlook

Revenue, 2024

$483M

Forecast, 2034

$1.17B

CAGR, 2024 - 2034

9.3%
The SMA Newborn Screening industry revenue is expected to be around $527.5 million in 2025 and expected to showcase growth with 9.3% CAGR between 2025 and 2034. The strong expansion in the SMA Newborn Screening market is influenced by a variety of factors. One of the notable factors is the increasing understanding of the significance of early identification of Spinal Muscular Atrophy in newborn babies. The rising occurrence of this condition and the crucial importance of prompt action in enhancing patient results have established SMA Newborn Screening as a vital component of infant care. Additionally progressions, in genetic testing methods and positive government initiatives are playing a role in maintaining the markets significance and growth.

Newborn Screening for Spinal Muscular Atrophy (SMA) is a genetic examination designed to detect the condition in infants shortly after birth to support prompt intervention and enhance the well being and chances of survival, for the child. In the few years the need for SMA Newborn Screening has increased due to progress, in genetic testing tools, better comprehension of the illness and the development of new therapies.

SMA Newborn Screening market outlook with forecast trends, drivers, opportunities, supply chain, and competition 2024-2034

Market Key Insights

  • The SMA Newborn Screening market is projected to grow from $482.6 million in 2024 to $1.17 billion in 2034. This represents a CAGR of 9.3%, reflecting rising demand across Early Detection of Spinal Muscular Atrophy, Carrier Testing and Prenatal Diagnosis.
  • PerkinElmer Inc., Thermo Fisher Scientific Inc., Bio-Rad Laboratories Inc. are among the leading players in this market, shaping its competitive landscape.
  • U.S. and Germany are the top markets within the SMA Newborn Screening market and are expected to observe the growth CAGR of 6.8% to 9.8% between 2024 and 2030.
  • Emerging markets including Brazil, India and South Africa are expected to observe highest growth with CAGR ranging between 8.9% to 11.6%.
  • Transition like Advancement in Genetic Testing is expected to add $96.4 million to the Sma Newborn Screening market growth by 2030
  • The SMA Newborn Screening market is set to add $692 million between 2024 and 2034, with manufacturer targeting MLPA & NGS Technology Type projected to gain a larger market share.
  • With The rising prevalence of spinal muscular atrophy, and Advancements in genetic testing technologies, SMA Newborn Screening market to expand 143% between 2024 and 2034.
sma newborn screening market size with pie charts of major and emerging country share, CAGR, trends for 2025 and 2032

Opportunities in the SMA Newborn Screening

The emergence of cutting edge technologies in the sector has paved the way for advancements in SMA Newborn Screening methods. The incorporation of intelligence and ML in diagnostic procedures could enhance precision and speed of outcomes consequently driving up the need, for SMA Newborn Screening services.

Growth Opportunities in North America and Asia-Pacific

North America Outlook

In North America and specifically the United States there is a demand for SMA Newborn Screening due in partto the widespread prevalence of Spinal Muscular Atrophy and the well developed healthcare system in place. This region stands out with its tier medical diagnostics companies. creating a competitive environment that also drives innovation and growth in the SMA Newborn Screening sector. The primary force behind these developments, in this region is the growing awareness of the significance of detection of SMA supported by government programs and regulations mandating newborn screening.

Asia-Pacific Outlook

The Asia Pacific region is showing promising growth potential for SMA Newborn Screening with an increase in cases of SMA in populous nations such as China and India driving this trend forward. The competition is currently minimal in this region because the market is still in its stages – making it an attractive space for new players looking for opportunities. The key factor fuelinA the growth in this region is the increased spending on healthcare and the enhancement of healthcare facilities that are making it easier, for newborn screening techniques adoption. The growing recognition of conditions and the value of early detection are likely factors driving the need for SMA Newborn Screening, in the region.

Market Dynamics and Supply Chain

01

Driver: The Rising Prevalence of Spinal Muscular Atrophy, and Government Initiatives and Policies

The rising prevalence of Spinal Muscular Atrophy on a scale plays a crucial role in the expansion of the SMA Newborn Screening market sector. The early identification facilitated by screening has also a substantial impact on enhancing the outlook for patients affected by this severe ailment making it an essential asset, in combating this debilitating condition. Governments around the world are also realizing more and more the significance of detecting genetic disorders such as SMA early onset diseases in infants and newborns. The inclusion of newborn screening initiatives within public health strategies is also fuelng the need for SMA Newborn Screening services. Playing a role, in the growth of the market.
The swift progress, in genetic testing tools has also enhanced the accuracy and dependability of SMA Newborn Screening significantly which is also anticipated to drive market expansion as an increasing number of healthcare providers embrace these screening techniques.
02

Restraint: High Cost of SMA Newborn Screening

The significant expense linked with screening for spinal muscular atrophy poses a challenge in the market sector for these tests. The high costs involved can deter demand for these screenings in developing nations. Are exacerbated by insurance companies often failing to cover them completely or partially; making them financially burdensome for numerous families. This situation ultimately affects market dynamics by restricting access due, to the cost barrier and hinders the markets growth.
03

Opportunity: Evolving Consumer Needs and Strategic Collaborations

As people become more informed about conditions and the significance of detecting them early on is recognized increasingly important there is a rising call for SMA Newborn Screening. The shifting customer preference creates an opportunity, for market expansion. Through meeting this demand with notch and dependable screening services providers can capture a greater portion of the market share.
Collaborations between healthcare organizations and SMA Newborn Screening providers have the potential for market growth impact. These partnerships play a role, in extending the availability of SMA Newborn Screening services and ensuring that a greater number of infants undergo screening for this inherited condition. Ultimately driving market penetration efforts forward.
04

Challenge: Lack of Awareness

There is a lack of understanding regarding SMA and the significance of newborn screening in various areas around the world. This lack of awareness frequently leads to overlooked diagnoses that can greatly impact the health of children affected by it. Such circumstances directly affect market demand since the lack of knowledge decreases the number of individuals who pursue or choose SMA screening. This decrease in demand can hinder market development. Restrict opportunities, for growth.

Supply Chain Landscape

1
Raw Material Suppliers

Thermo Fisher Scientific

Roche Diagnostics

2
Test Developers

PerkinElmer

Illumina

3
Distribution & Logistics

FedEx

UPS

4
End Users

Hospitals

Diagnostic Laboratories

*The illustration highlights the key stakeholders within the supply chain ecosystem.

Applications of SMA Newborn Screening in Early Detection of Spinal Muscular Atrophy, Carrier Testing & Prenatal Diagnosis

Early Detection of Spinal Muscular Atrophy

The SMA Newborn Screening is commonly utilized for detecting Spinal Muscular Atrophy on in infants lives. The screening process mainly relies on testing at a molecular level that pinpoints mutations in the SMN1 gene. A key factor in SMA development. This method is crucial as it enables intervention for better patient care and quality of life improvements. The leading experts in this region are Genzyme Corporation and PerkinElmer owing their reputation for cutting edge genetic testing services and solid presence, in the market.

Carrier Testing

SMA Newborn Screening also plays a role in carrier testing which benefits couples preparing for parenthood by providing insights into their chances of having a child with SMA through genetic testing identifying SMN1 gene deletions or mutations that companies such as LabCorp and Quest Diagnostics excel in offering comprehensive screening tests, for carriers.

Prenatal Diagnosis

Newborn Screening for Spinal Muscular Atrophy is also employed for purposes where the fetus is tested for SMA during pregnancy using procedures like amniocentesis or chorionic villus sampling to gather fetal cells, for genetic testing purposes. The companies Illumina and Natera play roles in this field by providing advanced solutions for prenatal diagnostics.

Recent Developments

December 2024

PerkinElmer released a screening test, in the SMA Newborn Screening sector that promises better accuracy and fewer false positive outcomes.

October 2024

Quest Diagnostics unveiled a cutting edge SMA Newborn Screening technology designed for detection and better patient results.

August 2024

Bio R​a​d Laborato​​ries recei​ved approval from the FDA for their SMA Newborn Screening test​, a notable achievement, in the field.

Spinal Muscular Atrophy is a genetic condition that impacts the nerve cells, in the spinal cord causing muscle loss and mobility challenges. It has become crucial in care as it allows for early identification and treatment of this incapacitating illness.

Impact of Industry Transitions on the SMA Newborn Screening Market

As a core segment of the Medical Device industry, the SMA Newborn Screening market develops in line with broader industry shifts. Over recent years, transitions such as Advancement in Genetic Testing and Integration of AI and ML have redefined priorities across the Medical Device sector, influencing how the SMA Newborn Screening market evolves in terms of demand, applications and competitive dynamics. These transitions highlight the structural changes shaping long-term growth opportunities.
01

Advancement in Genetic Testing

The field of SMA Newborn Screening has undergone changes due the progress in genetic testing methods. A These advancements have enhanced the precision and effectiveness of screening for Spinal Muscular Atrophy in infants. A For example A next generation sequencing has transformed the sector by enabling detection of SMA, A leading revolution, in healthcare. A Early identification facilitates treatment A enhancing outcomes and enhancing the well being of afflicted newborns. This industry transition is expected to add $96.4 million in the industry revenue between 2024 and 2030.
02

Integration of AI and ML

In the field of SMA Newborn Screening industry there has been a shift towards incorporating AI and ML into the screening process. These modern technologies have improved the analysis and data processing functions result in quicker and more precise outcomes. For instance AI algorithms are capable of examining volumes of genetic data rapidly enabling the identification of the SMA gene mutation, with increased accuracy.

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