The global newborn screening software market is expected to grow at a CAGR of 8.1% during the forecast period, 2019–2026.
Newborn screening software is an emerging concept in the healthcare sector used for the early identification of genetic metabolic or infectious conditions in newborns that can cause mental retardation or serious health problems if left untreated. It is widely adopted by hospitals and clinics for the organization, storage, and analysis of newborn information and screening test results.
| Report Metric | Details |
|---|---|
| Base Year | 2017 |
| Study Period | 2016–2026 |
| Forecast Period | 2023-2031 |
| CAGR | 8.1% |
| Market Size | 345 |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Report Coverage | Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends |
| Geographies Covered |
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The growing incidence of neonatal diseases has led to an upsurge in demand for newborn screening tests. According to the World Health Organization, 5.6 million children died before the age of five in 2016 – a decline compared to the 9.9 million figure in 2000; however, the proportion of under-five deaths in the newborn period increased from 41% to 46% during the same period. Furthermore, the proportion of neonatal deaths in under-five deaths is highest in developing economies, making it an issue of global concern. According to WHO, Southern Asia (39%) and sub-Saharan Africa (38%) account for the largest shares for newborn deaths, and five countries accounted for the highest number of new-born deaths.
The demand for newborn screening software is increasing in hospitals across developed economies as screening tests are normally included in the forms for standard medical procedures at hospitals. In grow countries such as the U.S. and U.K., the adoption rate of newborn screening is higher than 99% and hospitals are extensively adopting newborn screening software in order to track and monitor newborn screening as well as for disease diagnosis. Thus, the adoption of newborn screening in hospitals is increasing around the globe, which is positively affecting the growth of the hospitals segment in the newborn screening software market.
The U.S. to Spearhead Demand for Newborn Screening Software in North America Market
North America is projected to a significant share in the global new-born screening market, with the U.S. accounting for the largest share of the regional market. According to the CDC, around 4 million infants are born in the U.S. each year; in 2017, the country’s birth rate was 11.8 per 1,000. In order to maintain uniformity throughout the U.S., the Health Resources and Services Administration (HRSA) agreed upon a ‘Uniform Panel’ of 35 specific conditions that are currently recommended for incorporation into state screening programs and the cost for these supplemental screening tests is typically covered by insurance. As newborn screening is a law-abiding aspect in the U.S., the demand for newborn screening software is foreseen to remain strong in the country.
Europe is expected to witness significant growth in the newborn screening software market on account of high GDP expenditure on healthcare, per capita expenditure, awareness, and income. In France, newborn screening is mandatory for five congenital diseases; thus, the demand for newborn screening software is rising in the country. In the U.K., newborns are screened for at least 9 conditions, and in Germany, the new-born screening process is centralized, and 99% of newborns are tested.
Asia-Pacific is expected to grow at an accelerated pace in the global new-born screening software market. Awareness programs and quality assurance of newborn diagnostic process have gained importance in the developing economies of Asia-Pacific. Countries such as Australia, New Zealand, Japan, the Philippines, Taiwan, South Korea, India, P.R. China, and Singapore are among the key contributors to the region’s growth momentum. Developing economies in the region are extensively adopting newborn screening and initiating newborn screening programs for selected metabolic and other congenital disorders. For instance, in Singapore, The KKH Women’s & Children’s Hospital Department of Pathology & Laboratory Medicine has been moving forward with the expansion of its newborn screening program, with plans to include congenital adrenal hyperplasia and severe combined immune deficiency. Thus, favorable healthcare schemes by government agencies are driving the newborn screening software market in Asia-Pacific.
Latin America encompasses 20 countries with vast diversity in their healthcare systems. According to the World Bank, three Latin American countries are high income, and 16 are middle income while the remaining are low income. Out of 20 countries, 15 have national or regional NBS programs, only two have <3.0% coverage, and 10/15 have >75% coverage. Growing awareness about newborn screening and development of the healthcare system are accelerating the demand for newborn screening software in the region.
The Middle East and Africa region accounts for 6% of the global population. Saudi Arabia, Qatar, and Lebanon are regional pioneers for the adoption of newborn screening by tandem mass spectrometry (KSA), homocystinuria and TREC-KREK screening (QATAR), and G6PD screening. The demand for newborn screening software is, therefore, expected to remain high in specifically Saudi Arabia, Qatar, and Lebanon in the MEA market.
By type, real-time PCR newborn screening software is expected to hold a significant market share during the forecast period, 2019–2026. The technology is used to screen for various immunodeficiencies and commonly used to identify spinal muscular atrophy (SMA). According to Genetic Home References, SMA affects one per 8,000 to 10,000 births worldwide; the condition results in significant motor disabilities, respiratory and nutritional compromise, and death in infancy or childhood in more than 50% of the affected children. Thus, the demand for real-time PCR newborn screening software is expected to increase with the growing need to detect SMA and other immunodeficiencies.
Detectable disorders such as metabolic disorders, hematologic disorders, and endocrinopathies, account for approximately 3,000 new cases of potentially fatal or debilitating diseases each year in the U.S., for which outcomes are enhanced with early identification and treatment through newborn screening. The significant increase in the number of inherited metabolic disorders detectable in the newborn period because of tandem MS screening greatly extends the possibilities of early, usually presymptomatic, diagnosis, and treatment to minimize morbidity and mortality for many affected children.
Next-generation sequencing (NGS) newborn screening software is likely to grow at an accelerated pace during the forecast period, 2019–2026. It is advanced software used in the diagnosis of inherited metabolic diseases. It is used as the second-tier diagnostic test to detect gene mutations in samples after the diagnosis of high-risk infants found by MS/MS technology. Thus, the genomic sequencing technologies are experiencing rapid developments, due to which the cost of genetic analysis has decreased, and the adoption of the technology is increasing in newborn screening.
By application, the data management segment is expected to grow at the highest CAGR in the global newborn screening software market during the forecast period, 2019–2026. Newborn screening started about 50 years ago in the developed countries of North America and Europe; at the time, data was recorded manually. Nowadays, newborn screening creates a large amount of data per patient. For instance, in the U.S.,
Therefore, the amount of data created is large. Newborn screening software manages large volumes of data, from daily examinations and record-keeping; thus, the data management segment is expected to witness significant growth in years to come.
Clinics and diagnostics centers are expected to hold a strong market share in the global newborn screening market during the forecast period, 2019–2026. In recent years, home birth trends are increasing around the world; according to the CDC, in the U.S., home birth rate rose 50% during 2004–2012. Thereby, the demand for newborn screening software in clinics and hospitals is thus rising with the growing prevalence of home births around the world.
Some of the prominent players in the global newborn screening software market are
