The global Newborn Screening market was valued at USD 0.9 Billion in 2022 and is projected to reach USD 1.6 Billion by 2030, registering a CAGR of 7.51% for the forecast period 2023-2030.
Market Definition
The newborn screening can be defined as the public health initiative aimed at identifying specific genetic, metabolic, and congenital disorders in infants shortly after birth. The process typically involves collecting a small amount of blood from a baby's heel, which is then analyzed for the presence of specific markers or substances associated with these conditions. This early screening is essential because many of these disorders may not exhibit immediate symptoms but, if left undiagnosed and untreated, can lead to severe health problems, developmental issues, or even fatalities in infants. These factors raised the demand for the newborn screening market.
For instance, according to the WHO in February 2023, globally 240,000 newborns died within 28 days of birth due to congenital disorders. These disorders further caused 170,000 death of newborns who are in between 1month and 5 months of age. Congenital disorders can contribute to long-term disability, which takes a significant toll on individuals, families, health care systems and societies.
Market Size:
- 2022: USD 0.9 billion
- 2030: USD 1.6 billion
- CAGR (2023-2030): 7.51%
Newborn Screening Market Dynamics
Drivers : Rising incidence of disorders in newborns:
With the global population growing, particularly in regions with high birth rates. With more infants being born, the absolute number of babies at risk of congenital disorders is also on the rise. Healthcare systems are under pressure to address the health needs of this expanding newborn population, and newborn screening is a critical tool to identify and manage potential health issues. The growing number of births and the awareness of congenital disorders have collectively driven the market for newborn screening to counter to this expanding demand, making it an essential component of modern healthcare. Additionally, the increasing average maternal age is associated with a higher risk of certain congenital disorders, and as family planning trends evolve, more couples are having children later in life. This demographic shift has led to a higher incidence of newborn disorders, further underscoring the importance of early detection through newborn screening.
For instance, according to WHO in May 2023, around 4.5 million women and babies die every year during pregnancy, childbirth or the first weeks after birth equivalent to 1 death happening every 7 seconds.
Recent Developments
In March 2023, Demant opened new diagnostic facility at Rosówek, Poland.
In April 2023, waters launched IVD system a most sensitive benchtop tandem quadrupole mass spectrometer for clinical applications.
Restraint : Cost effectiveness can restrain the newborn screening market:
The advancement in technology and continuous innovations may offer improved products and services with more accuracy and a wider range of diagnostic capabilities, these advancement’s often come with higher upfront costs, including the purchase of sophisticated screening instruments and the training of healthcare professionals to operate them. Additionally, the cost of screening reagents and consumables can be elevated for advanced tests. Advanced tests may lead to earlier disease detection and intervention, potentially reducing the overall healthcare costs associated with treating affected newborns, the economic impact is not always immediately evident. Healthcare decision-makers may be cautious about investing in new screening technologies without concrete evidence of their long-term cost-effectiveness may restrain the newborn screening market.
Challenges : Resistance in adoption of new technologies:
With the rapid evolution of medical technology, an abundance of new screening methods and diagnostic tools become available, making it essential to keep healthcare professionals and families updated on the latest advancements. Healthcare professionals, including pediatricians and neonatologists, may be accustomed to existing screening protocols, and introducing new tests may require them to invest time and effort in learning about the latest developments. This resistance to change can slow down the adoption of advanced screening methods, potentially delaying the implementation of more comprehensive and accurate screening procedures. Additionally, educating families about new tests can be challenging due to varying levels of health literacy and cultural factors. Some families may not fully understand the importance and benefits of the new screening methods or may have concerns about the potential costs, invasiveness, or implications of these tests. To overcome these challenges effective communication and some educational strategies for informing families about these new screening technologies can be implemented.
Opportunities : NGS & Data Analysis offering new opportunities for the market:
Emerging technologies, such as next-generation sequencing (NGS) and advanced mass spectrometry, are revolutionizing the way screening is conducted. NGS, for instance, allows for the simultaneous analysis of multiple genes, enabling the screening of a broader range of genetic disorders with a single test. This not only enhances the scope of newborn screening but also improves the efficiency of the process, as it requires smaller sample volumes and reduces the need for repeat testing. In addition to it, the vast amount of data generated through newborn screening, especially with the expansion of test panels, can be harnessed to develop predictive models and personalized healthcare plans. AI-driven algorithms can analyze screening results in real-time, identifying patterns and potential health risks more effectively than manual interpretation. This not only aids in the early diagnosis of disorders but also allows for the customization of treatment plans, optimizing healthcare outcomes for newborns with specific needs.
Snapshot:
| Attributes | Details |
| Market Size in 2022 | USD 0.9 billion |
| Market Forecast in 2030 | USD 1.6 billion |
| Compound Annual Growth Rate (CAGR) | 7.51% |
| Unit | Revenue (USD Million) and Volume (Kilo Tons) |
| Segmentation | By Product, By Test Type, By Technology, By End-User, & By Region |
| By Product Type |
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| By Test Type |
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| By Technology |
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| By End-User |
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| By Region |
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| Base Year | 2022 |
| Historical Year | 2018 - 2022 |
| Forecast Year | 2023 - 2030 |
Segment Analysis of the Newborn Screening Market
The newborn screening market is segmented by product, by test type, by technology, by end-user, & by region.
By Test Type : The Dry Blood Spot Test segment dominated the market in 2022:
Based on the test type segment the market for newborn screening is classified into CCHD, dry blood spot test, hearing screen and others. The dry blood spot test segment dominated the market in 2022 and is expected expansion at highest CAGR during the forecasted period. The factors for the segment’s dominations are due to the practical advantages of these tests. These tests involve collection of blood samples from newborn’s heel which is further dried on special absorbent paper card. This method offers several benefits over others such as easy sample collection, cost-effectiveness, and ability to transport and store sample without the need for refrigeration. These tests are used on large scale making it convenient and efficient choice.
By Product
The newborn screening market based on the segment product is classified into instruments and reagents. The instruments segment dominated the market in 2022. With the rise in birth rate gave rise to the screening of these newborns for early detection of the diseases. This gave an opportunity for the instruments segment to grow. In addition to it advancement in the technologies produced highly advanced and efficient screening instruments which are capable of rapid and accurate analysis of blood samples, making this process more essential. All these factors contributed to the segment’s growth.
Regional Analysis
Asia-Pacific accounted for largest market share during the forecasted period:
The Asia-Pacific accounted for largest market share during the forecasted period. Newborn screening is becoming more popular because of better roads, healthcare plans, and new chances for growth. In the future, these things are likely to make more people want newborn screening. In the Asia Pacific region, with the growing population, & higher rate of babies being born, and the possibility of babies having diseases from birth raised concerns for the governments and healthcare systems to prioritize newborn screening, leading to high investments and support for the market. For instance, according to UN the birth rate in India is quite high as compared to rest of the world. Around one-fifth of the global annual child births i.e. 25 million yearly this high birth rate and the gave raise to the demand for the newborn screening products and services.
List of the prominent players in the Newborn Screening Market:
- Perkinelmer
- Parseq Lab
- Trivitron Healthcare
- Medtronic
- Bio-Rad Laboratories
- Ge Lifesciences
- Ab Sciex
- Agilent Technologies
- Masimo
- Natus Medical
Segmentation Analysis of the Newborn Screening Market
By Product
- Instruments
- Reagents
- CCHD
- Dry Blood Spot Test
- Hearing Screen
- Pulse Oximetry
- Electrophoresis
- DNA Assay
- Enzyme Based Assay
- Tandem Mass Spectrometry
- Others
- Clinical Laboratories
- Hospitals
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East and Africa
Impact of the COVID-19 Pandemic on the Newborn Screening Market:
The COVID-19 pandemic had a significant impact on the newborn screening market in multiple ways. Firstly, it disrupted routine healthcare services including newborn screening programs as healthcare resources were diverted to address the surge in covid-19 cases. This resulted in delayed or reduce screening effects, potentially leading to missed early diagnoses of genetic and metabolic disorders in infants. Resource constraints strained the capacity of healthcare systems affecting the timely analysis of blood samples.
The pandemic has had both negative and positive effects on the newborn screening market. However, it also accelerated the adoption of telehealth and remote monitoring, enabling some healthcare providers to continue aspects of newborn screening remotely. In conclusion, the pandemic highlighted the need for adaptable healthcare systems to ensure that essential screening programs can be maintained even during crises, underscoring the importance of safeguarding the health of newborns.
