Newborn Screening

Global Newborn Screening Market to Reach US$1.9 Billion by 2030

The global market for Newborn Screening estimated at US$1.3 Billion in the year 2024, is expected to reach US$1.9 Billion by 2030, growing at a CAGR of 7.2% over the analysis period 2024-2030. Consumables, one of the segments analyzed in the report, is expected to record a 7.5% CAGR and reach US$1.4 Billion by the end of the analysis period. Growth in the Instruments segment is estimated at 6.3% CAGR over the analysis period.

The U.S. Market is Estimated at US$330.6 Million While China is Forecast to Grow at 10.6% CAGR

The Newborn Screening market in the U.S. is estimated at US$330.6 Million in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$467.2 Million by the year 2030 trailing a CAGR of 10.6% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 3.6% and 6.4% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 4.2% CAGR.

Global Newborn Screening Market - Key Trends & Drivers Summarized

What Is Newborn Screening and Why Is It Essential?
Newborn screening is a vital public health program that tests infants for certain genetic, metabolic, and developmental disorders shortly after birth. These screenings are essential for detecting conditions that, if left untreated, can lead to severe health problems, including developmental delays, physical disabilities, and even death. Early detection through newborn screening allows for timely interventions, such as medications, dietary changes, or surgeries, which can prevent long-term complications and improve the child’s quality of life.

Newborn screening programs typically include tests for a variety of conditions, such as phenylketonuria (PKU), congenital hypothyroidism, sickle cell disease, cystic fibrosis, and more. With the continuous advancement in technology, the range of detectable disorders is expanding, making newborn screening an indispensable tool in modern healthcare. By identifying these conditions early, newborn screening programs contribute to reducing infant mortality and improving overall public health outcomes.

How Is the Newborn Screening Market Evolving?
The newborn screening market is evolving rapidly, driven by technological advancements and the expansion of screening panels. One of the key trends shaping the market is the increasing use of tandem mass spectrometry (MS/MS), a technology that allows for the detection of multiple metabolic disorders from a single blood sample. This technology has revolutionized newborn screening by enabling faster, more accurate, and comprehensive testing. Additionally, genetic screening techniques, including next-generation sequencing (NGS), are being integrated into newborn screening programs, allowing for the detection of a broader range of genetic conditions, including rare diseases.

Another significant trend is the shift towards point-of-care testing (POCT) for newborn screening. POCT devices are portable and enable immediate testing and results at the bedside, reducing the time it takes to begin treatment for diagnosed conditions. The expansion of digital healthcare platforms is also playing a role in the evolution of the market by streamlining data collection, analysis, and reporting processes, leading to more efficient newborn screening workflows. This evolution is allowing more infants to be screened faster, particularly in regions where access to healthcare infrastructure may be limited.

Which Conditions Are Driving the Demand for Newborn Screening?
Several conditions are driving the demand for newborn screening, with metabolic disorders such as phenylketonuria (PKU) and congenital hypothyroidism being among the most commonly screened. These conditions can cause serious developmental issues if not detected early, but with appropriate interventions, their impacts can be significantly mitigated. Genetic disorders, such as cystic fibrosis and sickle cell disease, are also major drivers of screening demand, as early treatment can prevent severe complications and improve long-term health outcomes.

Additionally, lysosomal storage disorders (LSDs), which are a group of rare genetic conditions, are increasingly being included in newborn screening panels. As diagnostic technologies improve, more rare diseases are being detected, leading to early treatments that can improve the prognosis for affected children. The rise of inherited metabolic disorders, which require early dietary interventions, is also contributing to the growing demand for newborn screening programs across the globe.

What Are the Key Growth Drivers in the Newborn Screening Market?
The growth in the newborn screening market is driven by several factors, including the increasing prevalence of genetic and metabolic disorders, which necessitate early diagnosis and intervention. Government mandates and initiatives focused on expanding newborn screening programs are a key driver, as they ensure that a growing number of conditions are included in routine testing. Technological advancements, particularly in mass spectrometry and genetic sequencing, are also propelling market growth by enabling more comprehensive and accurate screening.

Another important factor is the rising awareness among healthcare providers and parents about the importance of early detection in preventing long-term health complications. As healthcare infrastructure improves, especially in developing regions, access to newborn screening is expanding, contributing to market growth. Additionally, collaborations between public health organizations and private companies are increasing, leading to more widespread adoption of advanced screening technologies and better patient outcomes.

SCOPE OF STUDY:

The report analyzes the Newborn Screening market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Product Type (Consumables, Instruments); Test Type (Dry Blood Spot Tests, Hearing Screening Tests, Critical Congenital Heart Disease (CCHD) Screening Tests); Technology (Immunoassays & Enzymatic Assays, Tandem Mass Spectrometry, Molecular Assays, Hearing Screening Technologies, Pulse Oximetry, Other Technologies)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Select Competitors (Total 11 Featured) -

• AB Sciex LLC
• Agilent Technologies, Inc.
• Bio-Rad Laboratories, Inc.
• GE Healthcare
• Masimo Corporation
• Medtronic PLC
• Natus Medical, Inc.
• PerkinElmer, Inc.
• Trivitron Healthcare
• Waters Corporation

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by artificially increasing the COGS, reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

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APRIL 2025: NEGOTIATION PHASE

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