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 USD 950.5 million in 2023 and is estimated to grow at 7.7% CAGR from 2024 to 2032 due to the rising incidence of genetic and metabolic diseases.
 

The growing burden of congenital disorders detected at birth is driving the demand for several screening tests. Hospitals and healthcare providers are increasingly adopting advanced screening technologies to identify these disorders early for ensuring timely intervention and treatment.
 

Rapid technological advancements are improving the accuracy and efficiency of screening methods. Moreover, expanded screening programs will enhance the ability to detect and manage newborn disorders effectively. For instance, in March 2024, WHO reported that the first month is the most vulnerable for child survival, with 2.3 million newborns dead in 2022, subsequently highlighting the critical need for effective newborn screening to improve early detection and intervention.
 

The rise in government initiatives and policies for mandating newborn screening in various regions is supporting the market growth. These mandates are driving healthcare providers to adopt comprehensive screening programs for ensuring early detection and intervention for genetic, metabolic, and congenital disorders. As governments continue to recognize the importance of early diagnosis in improving child health outcomes, they are implementing and reinforcing these policies. This ongoing support through government policies will expand the reach and effectiveness of newborn screening programs to enhance public health. For instance, the Alabama Bureau of Clinical Laboratories (BCL) is conducting all newborn blood screenings in Alabama and testing around 60,000 babies annually and handling 150,000 specimens.
 

However, limited infrastructure and the shortage of skilled professionals are impeding newborn screening efforts. These challenges are continuing to hamper the widespread implementation and effectiveness of screening programs. Without adequate resources and expertise, early detection and intervention will remain compromised, potentially leading to preventable health complications and increased infant mortality rates, restricting the industry expansion to some extent.
 

Newborn Screening Market Trends

With companies increasingly launching advanced devices to improve early detection of genetic disorders in infants, the market is set to witness steady growth. These innovative screening tools are enhancing diagnostic accuracy and accessibility. The ongoing technological advancements are making way for the rising awareness among healthcare providers and parents.
 

The continuous development of more efficient and reliable screening solutions are ensuring better health outcomes for newborns worldwide. This innovation will transform newborn screening practices for making early detection and intervention more effective and widespread. For instance, in September 2023, Mylab launched MyNeoShield, a point-of-care newborn screening device for revolutionizing newborn healthcare by providing faster, more accessible, and cost-effective screening for saving lives and preventing lifelong illnesses through early detection and intervention.
 

Newborn Screening Market Analysis

On the basis of product type, the industry size from the instruments segment is poised for significant growth at 7.8% CAGR through 2032. Clinics are increasingly employing sophisticated instruments for newborn screening to detect metabolic and genetic disorders early. These instruments help analyze blood samples from newborns to identify conditions like cystic fibrosis and hypothyroidism. By utilizing advanced technology, they are enabling prompt diagnosis and intervention. Moreover, medical facilities are integrating more precise and comprehensive instruments, further adding to the segment growth.

Based on technology, the newborn screening market value from the tandem mass spectrometry segment is predicted to record USD 476 million by 2032. This expansion is due to the robust role of tandem mass spectrometry in transforming newborn screening by analyzing blood samples for metabolic disorders. It helps detect multiple conditions from a single sample for providing rapid and accurate results. This technology also assists in identifying biomarkers of rare diseases and ensuring early intervention and treatment.
 

Based on test type, the dried blood spot segment accounted for USD 412.5 million in 2023 and may exhibit 8.1% CAGR through 2032. Dried blood spot (DBS) sampling involves collecting a small amount of blood from a newborn's heel onto a special filter paper. It enables healthcare providers to conduct screenings efficiently and accurately. With its simplicity and effectiveness, DBS sampling has become indispensable in identifying a wide range of genetic disorders and metabolic conditions early on for ensuring timely intervention and better health outcomes for newborns.
 

In terms of end-users, the newborn screening market from the hospital segment is expected to reach USD 858.9 million by 2032, due to the rising implementation of newborn screening protocols to ensure early detection of potential health issues in infants. Healthcare professionals are routinely collecting samples for analysis and employing various screening methods to identify genetic disorders and metabolic conditions promptly. Moreover, hospitals are continuously prioritizing newborn screening by integrating advanced technologies and refining protocols for more accurate and comprehensive assessments. This ongoing commitment will optimize infant health outcomes for providing timely interventions and support to families while advancing the standard of care in neonatal medicine.
 

North America newborn screening market is predicted to record over USD 837 million by 2032, on account of the increasing advancements in diagnostic techniques and the expansion of screening panels. Healthcare providers in the region are integrating innovative methods for more precise and comprehensive screening of newborns. Ongoing R&D efforts are enhancing diagnostic capabilities and broadening the scope of screening panels. These advancements will enable early detection of a wider range of genetic disorders and metabolic conditions for improving health outcomes for newborns across North America through timely intervention and personalized treatment strategies.
 

Newborn Screening Market Share

Leading industry players are developing innovative technologies and solutions to expand their portfolio. They are collaborating with healthcare providers to enhance screening accuracy and accessibility. These players are also introducing advanced methods and expanding their global reach to ensure early detection and intervention for newborns worldwide.
 

Newborn Screening Market Companies

• 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 unveiled an advanced baby monitoring system for allowing caregivers to track the data of infants instantly.
   
• In November 2023, Trivitron Healthcare introduced EkSahiShuruat, a campaign dedicated to increasing awareness about newborn screening in India. The initiative is aimed at disseminating information widely and emphasizing the vital significance of newborn screening across 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