Newborn Screening Market - By Product Type (Instruments, Consumables), Technology (Tandem Mass Spectrometry, Oximetry, Enzyme-Based Assays, DNA Assays), Test Type (Dried Blood Spot, Hearing Screening, CCHD), End-use – Global Forecast, 2024 – 2032

Newborn Screening Market Size

Newborn Screening Market size was valued at around USD 950.5 million in 2023 and is estimated to grow at 7.7% CAGR from 2024 to 2032. Newborn screening is a systematic public health program that involves testing newborn infants for certain genetic, metabolic, and congenital disorders shortly after birth.
 

The primary objective of newborn screening is to detect conditions that may not be immediately apparent but have the potential to cause serious health issues if left untreated. As per statistics, the global birth rate in 2023 stood at 17.46 births per 1000 individuals. Consequently, a rise in childbirth rates is expected to yield a favorable impact on the market.
 

Furthermore, the expansion of newborn screening panels represents a strategic shift towards a more inclusive and detailed assessment of a newborn's health. This initiative involves screening of conditions that occurs in the early stages of life, with a particular focus on rare diseases, metabolic disorders, and genetic abnormalities. This expansion aims to create more comprehensive screening panels that can detect a broader range of potential health concerns in early infancy, fuelling its increasing demand in the healthcare industry.
 

Newborn Screening Market Trends

The rising incidence of genetic and metabolic disorders has significantly contributed to an escalating demand for newborn screening. This heightened demand stems from the pressing need to identify and address these disorders at the earliest stages of life. Growing awareness among healthcare professionals and the general public about the benefits of newborn screening has fuelled its demand. As understanding of the importance of early detection grows, more parents are likely to opt for screening for their newborns.
 

• Governments and healthcare organizations worldwide are recognizing the importance of newborn screening in public health initiatives. Efforts are being made to expand screening programs to cover a broader range of disorders, reflecting a commitment to addressing the increasing prevalence of genetic and metabolic conditions.
   
• Early detection of genetic and metabolic disorders provides families with valuable information for family planning and decision-making. It allows for informed choices and facilitates genetic counseling to help families understand the implications of such conditions.
   
• Moreover, technological advancements, such as the incorporation of advanced genetic testing methods, have enhanced the accuracy and scope of newborn screening. These innovations contribute to the identification of a wider array of genetic and metabolic disorders.
   

Newborn Screening Market Analysis

Based on product type, the market is segmented into instruments and consumables. The instruments segment is poised for significant growth at a CAGR of 7.8% during the forecast period. The segment is further bifurcated into dried blood spot puncher, hearing screening devices, analyzers, electrophoresis unit, pulse oximetry and other instruments.
 

• This growth is fueled by ongoing technological advancements are enhancing the capabilities of newborn screening instruments. This includes improvements in the accuracy, speed, and efficiency of analyzers and other devices used in the screening process.
   
• There is a growing emphasis on point-of-care testing instruments within the market. Point-of-care devices, such as handheld analyzers, are gaining popularity for their ability to deliver rapid results, facilitating immediate clinical decisions.
   
• The market is witnessing a trend towards diversification of instruments. This includes a broad spectrum of devices such as dried blood spot punchers, hearing screening devices, electrophoresis units, and pulse oximetry tools, catering to various aspects of newborn health assessment.

Based on technology, the newborn screening market is segmented into tandem mass spectrometry, oximetry, enzyme-based assays, DNA assays, and other technologies. The tandem mass spectrometry segment accounted for a revenue share of 26.7% in 2023 and is estimated to follow similar trend over the coming years.
 

• The persistent revenue share and the projected continuation of the trend suggest a sustained and growing adoption of tandem mass spectrometry in the market. This could be attributed to its effectiveness in providing precise and detailed analytical results.
   
• Since, tandem mass spectrometry is known for its capability in high-throughput screening, allowing for the rapid analysis of a large number of samples. The trend may indicate an increasing demand for efficient and fast analytical processes in applications such as newborn screening or clinical diagnostics.
   
• Furthermore, it plays a crucial role in metabolomics and proteomics research. The trend may indicate an increasing demand for these applications, driven by the need for detailed insights into metabolic pathways and protein structures.
   

The newborn screening market by test type is categorized into dried blood spot, hearing screening, critical congenital heart defect (CCHD), and other test types. The dried blood spot segment accounted for around USD 412.5 million revenue size in 2023.
 

• A heightened focus on hearing screening, indicating an increasing awareness of the importance of early detection and intervention for hearing impairments in newborns. This may lead to the integration of advanced technologies in hearing screening processes.
   
• The inclusion of multiple test types in newborn screening suggests a growing demand for comprehensive screening panels that cover a wide spectrum of disorders. This trend aligns with efforts to identify and address various health conditions in newborns from different aspects.
   

The newborn screening market by end-use is categorized into hospitals, diagnostic centers, and other end-users. The hospital segment accounted for around USD 433.4 million revenue size in 2023.
 

• The trend of hospitals establishing and expanding in-house newborn screening programs is likely to grow. This allows for immediate testing and intervention for infants born within the hospital.
   
• Hospitals may increasingly adopt point-of-care testing newborn screening technologies, allowing for rapid testing and immediate decision-making within the hospital setting.
   
• Increasing emphasis on training hospital staff, including neonatal nurses and pediatricians, to enhance awareness and understanding of newborn screening protocols and technologies.
   
• Collaboration between hospitals and diagnostic centers to leverage specialized testing capabilities. Hospitals may send samples to diagnostic centers for more advanced and extensive newborn screening.

North America newborn screening market accounted for USD 431.3 million revenue in 2023 and is predicted to witness substantial market expansion.
 

• The U.S. has been at the forefront of adopting advanced genetic testing technologies, such as next-generation sequencing (NGS), for newborn screening. This enhances the precision and scope of screening efforts.
   
• Integration of newborn screening data with electronic health records is a trend in the U.S. This facilitates seamless information sharing among healthcare providers and ensures that screening results are part of the infant's comprehensive health record.
   
• The U.S. is a hub for research and development in healthcare. Trends include ongoing research to discover new biomarkers and conditions for inclusion in newborn screening programs.
   

Newborn Screening Market Share

The newborn screening industry is competitive in nature, with several large multinationals and small and mid-sized companies competing in the industry. The development and launch of novel advanced products based on different technologies is among a key market strategy. Some of the leading industry players including Bio-Rad Laboratories, Inc., GE Healthcare, Masimo Corporation, Natus Medical Incorporated, Thermo Fisher Scientific Inc., among others have a notable presence in the market.
 

Newborn Screening Market Companies

Some of the eminent market participants operating in the newborn screening industry include:

• Agilent Technologies, Inc.
• Bio-Rad Laboratories, Inc.
• GE Healthcare
• Masimo Corporation
• Medtronic plc
• Natus Medical Incorporated
• PerkinElmer, Inc.
• Thermo Fisher Scientific Inc.
• Trivitron Healthcare
• Waters Corporation

Newborn Screening Industry News:

• In January 2023, Masimo revealed its state-of-the-art baby monitoring system. This newly introduced system enables caregivers to monitor infants' data in real time.
   
• In November 2023, Trivitron Healthcare launched EkSahiShuruat, an initiative aimed at raising awareness about newborn screening in India. The initiative strived to create awareness at scale regarding the critical importance of newborn screening in the country.
   

Newborn screening market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 to 2032 for the following segments:

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Market, By Product Type

• Instruments  
  • Dried blood spot puncher
  • Hearing screening devices
  • Analyzers
  • Electrophoresis unit
  • Pulse oximetry
  • Other instruments 
• Consumables

Market, By Technology

• Tandem mass spectrometry
• Oximetry
• Enzyme-based assays
• DNA assays
• Other technologies

Market, By Test Type

• Dried blood spot
• Hearing screening
• Critical congenital heart defect (CCHD)
• Other test types

Market, By End-use

• Hospitals
• Diagnostic centers
• Other end-users

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• Middle East and Africa
  • Saudi Arabia
  • South Africa
  • UAE
  • Rest of Middle East and Africa