The preterm birth diagnostic test kit market is projected to show steady growth during the forecast period.
A preterm birth diagnostic kit is a medical device that, by measuring specific biomarkers found in blood or urine samples, helps healthcare professionals better predict the likelihood of a preterm birth. Diagnostic test kits for preterm delivery are classified into different categories, including placental alpha microglobulin-1 test (PAMG-1) and fetal fibronectin test (fFN) kits. These kits provide quick and easy results for preterm labor and premature rupture of the membranes. Increasing circumstances of preterm births, rise in diagnosis regime for preterm births, and increased focus on personalized medicine are driving the preterm birth diagnostic kits market growth.
Market Drivers:
A premature birth occurs when a baby is born before 37 weeks of pregnancy. These babies often face health issues due to their underdeveloped state, and early detection can improve outcomes. According to the National Vitals for Statistics published report in 2024, in recent years, there has been a slight increase in the rate of premature births. From 2014 to 2022, the percentage of premature births rose from 7.7% to 8.7%. This indicates a consistent annual increase of almost 2% from 2014 to 2019. However, the rate has fluctuated in recent years, with a slight decline in 2020 and 2022, and a slight increase in 2021. Despite some variation, the overall trend suggests a minor rise in the rate of premature births.
Advancements in biomarker research and diagnostic technology are leading to the development of more precise, reliable, and non-invasive clinical test kits. According to a Cleveland Clinic report it is stated that, when a woman is pregnant, the body produces a protein called fetal fibronectin. This protein plays a crucial role in keeping the amniotic sac attached to the lining of the uterus. Doctors can conduct a fFN test to measure the amount of fFN present in vaginal fluid. This test helps to determine the likelihood of preterm birth.
Personalized medicine aims to customize interventions and treatments to each individual, causing a paradigm shift in healthcare. According to the National Institute of Health published an article on precision medicine in gynecology, precision medicine is an area of research that has the potential to revolutionize how to diagnose and treat illnesses. By using the principles of molecular medicine, nanotechnology, and precision medicine, therapeutic compounds can be delivered directly to specific cells and organs, thus improving treatment outcomes while minimizing side effects. The field of obstetrics offers numerous opportunities to leverage precision medicine as a diagnostic and therapeutic tool. Moreover, there is scope to develop innovative approaches to address the challenges associated with fetal growth restriction, preterm birth, and fetal abnormalities, among other things.
North America is projected to grow significantly.
North America is projected to account for a significant share of the preterm birth diagnostic kits market due to the increasing preterm birth rates coupled with favorable government initiatives to prevent the same in the major countries in the region. According to the March of Dimes Report Card 2023, in the United States, over 380,000 babies, which is equivalent to 10.4% of all births, were born prematurely in the year 2022. Additionally, in May 2023, congress reauthorized the PREEMIE ACT for five years, which is an initiative to continue addressing preterm birth through federal research, promoting established therapies, and encouraging community initiatives.
Market Restraints
The accuracy of the respective kit is not 100% correct and reliable. False positive results can cause unnecessary concern and interventions for pregnant women. Additionally, false negative results may impede early detection and necessary action.
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Segmentation