Overview
New York, NY – April 30, 2025 – The Global Preterm Birth and PROM Testing Market size is expected to be worth around USD 3.1 Billion by 2033 from USD 1.4 Billion in 2023, growing at a CAGR of 8.4% during the forecast period from 2024 to 2033.
The global Preterm Birth and Premature Rupture of Membranes (PROM) Testing Market is experiencing notable growth due to the increasing incidence of premature births and associated complications. Preterm birth, defined as childbirth occurring before 37 weeks of gestation, is a leading cause of neonatal morbidity and mortality worldwide. According to the World Health Organization (WHO), approximately 15 million babies are born prematurely each year, with complications from preterm birth accounting for nearly 1 million deaths annually.
PROM refers to the rupture of the amniotic sac before labor begins, posing significant risks for both the mother and fetus. Accurate and timely diagnosis using PROM and preterm birth testing tools is critical to improving clinical outcomes. These tests typically include biomarker-based kits such as fetal fibronectin (fFN), placental alpha microglobulin-1 (PAMG-1), and insulin-like growth factor binding protein-1 (IGFBP-1).
The market is being driven by rising maternal age, increased awareness of pregnancy complications, and growing healthcare investments in maternal-fetal medicine. Furthermore, technological advancements in point-of-care diagnostics and laboratory-based tests continue to support market expansion. The increasing adoption of non-invasive, rapid testing methods across hospitals and diagnostic laboratories is expected to further accelerate growth during the forecast period.
Table of Contents
Key Takeaways
- Market Overview: The global Preterm Birth and PROM Testing Market is projected to grow from USD 1.4 billion in 2023 to approximately USD 3.1 billion by 2033. This expansion reflects a compound annual growth rate (CAGR) of 8.4% over the forecast period from 2024 to 2033.
- Test Type Analysis: Ultrasound testing represents the leading segment, accounting for 32.1% of the market share in 2023. Its dominance is attributed to its diagnostic accuracy and non-invasive nature, making it the preferred choice for detecting fetal complications and signs of preterm labor.
- Application Analysis: Preterm labor, defined as labor occurring before 37 completed weeks of gestation, remains the primary application segment, holding a significant 43.2% share in 2023. The high incidence of preterm labor cases worldwide continues to drive demand for early and precise diagnostic solutions.
- End-Use Analysis: Hospitals emerged as the dominant end-use segment in 2023, capturing 62.7% of the market share. This is due to their comprehensive maternal care services and access to advanced diagnostic technologies necessary for managing preterm birth risks and PROM detection.
- Regional Analysis: North America led the global market in 2023, contributing 39.2% of the total revenue. The region’s dominance is supported by a strong healthcare infrastructure, high awareness levels regarding maternal and neonatal health, and favorable reimbursement frameworks.
- Technological Advancements: Significant improvements in diagnostic platforms, particularly in point-of-care testing devices, have enhanced the speed, precision, and accessibility of preterm birth and PROM testing. These innovations continue to strengthen diagnostic capabilities in both high- and low-resource settings.
- Government Initiatives: National health policies and maternal healthcare programs aimed at reducing the incidence of preterm births are playing a crucial role in market expansion. Government efforts to improve prenatal care access are particularly impactful in developing regions.
- Research and Development Investments: Ongoing investments by diagnostic companies in R&D are focused on improving test specificity, reliability, and turnaround times. These developments aim to minimize false positives and enhance clinical decision-making in preterm birth risk assessment.
Segmentation Analysis
- Test Type Analysis: The Preterm Birth and PROM Testing Market features diverse diagnostic methods for early detection. Ultrasound testing dominates with a 32.1% market share, valued for its accuracy in assessing fetal conditions. Biochemical markers such as PAMG-1 and IGFBP-1 are widely used to detect membrane rupture with high precision. Fetal Fibronectin (fFN) tests help predict the risk of early labor. Additional tests include pelvic exams, uterine monitoring, Nitrazine, Ferning, and pooling methods for fluid leakage confirmation.
- Application Analysis: Preterm labor testing holds the largest application share at 43.2%, driven by the critical need to manage births occurring before 37 weeks of gestation. PROM testing is also essential due to the high risk of infection and complications following early amniotic sac rupture. Chorioamnionitis, often linked with PROM, requires prompt detection to prevent severe maternal-fetal outcomes. These applications underscore the importance of accurate diagnostic tools for timely clinical intervention and improved pregnancy outcomes.
- End-User Analysis: Hospitals account for a dominant 62.7% share in the Preterm Birth and PROM Testing Market due to their access to comprehensive care and emergency services. Their capacity to perform high-risk pregnancy diagnostics positions them as key players. Diagnostic laboratories follow, offering advanced biochemical and molecular testing. Other end-users, including specialty clinics and home healthcare settings, contribute by improving accessibility for patients with limited reach to hospital-based services, thus expanding diagnostic coverage.
Market Segments
Test Type
- Pelvic exam
- Ultrasound
- Biochemical Markers
- Interleukin (IL)-6
- C-Reactive Protein (CRP)
- IL-1, IL-2, IL-8, TNF-a
- Corticotropin-Releasing
- Hormone (CRH)
- Alpha-fetoprotein (AFP)
- Uterine Monitoring
- Nitazine Test
- Ferning Test
- Pooling
- PAMG-1 Immunoassay
- IGFBP Test
- Fetal Fibronectin (fFN)
- Others
Application
- PROM
- Preterm Labor
- Chorioamnionitis
End-User
- Hospitals
- Disgnostic Laboratories
- Others
Regional Analysis
In 2023, North America accounted for the largest share 39.2% of the global Preterm Birth and PROM (Premature Rupture of Membranes) Testing Market. This regional dominance can be attributed to the presence of advanced healthcare infrastructure and widespread availability of diagnostic technologies. Elevated public awareness regarding preterm birth complications further supports market expansion across the region.
Additionally, high per capita healthcare spending and robust clinical research initiatives have reinforced North America’s leadership. The strong presence of major industry players and favorable government policies aimed at improving maternal-fetal health outcomes continue to drive market growth. Rising preterm birth rates are expected to sustain demand for precise diagnostic testing across North America in the coming years.
Emerging Trends
- Integration of Artificial Intelligence (AI) and Machine Learning (ML): AI and ML are increasingly utilized to predict the risk of preterm birth by analyzing complex datasets, including patient history, biomarkers, and imaging results. These technologies facilitate early identification of at-risk pregnancies, enabling timely interventions.
- Development of Rapid Point-of-Care Diagnostic Tests: Advancements in point-of-care testing have led to the creation of rapid diagnostic tools capable of detecting PROM with high sensitivity and specificity.
- Emphasis on Biomarker Research: Research is focusing on identifying specific biomarkers associated with preterm labor and PROM. Biomarkers such as fetal fibronectin and placental alpha microglobulin-1 (PAMG-1) are being studied for their predictive value in assessing the risk of preterm birth.
- Personalized Medicine Approaches: There is a growing trend towards personalized medicine in obstetrics, where individual risk factors and genetic profiles are considered to tailor prevention and treatment strategies for preterm birth and PROM.
Use Cases
Prevalence and Impact of PROM
- PROM complicates approximately 8% to 10% of all pregnancies.
- Preterm PROM (PPROM) accounts for about 30% of all preterm births, highlighting its significant role in neonatal morbidity and mortality.
Risk Factors Associated with PROM
Several risk factors have been identified for PROM, including:
- History of PROM or preterm birth
- Short cervical length
- Second- or third-trimester vaginal bleeding
- Infections such as urinary tract infections
- Smoking and substance abuse
- Low body mass index (BMI)
- Low socioeconomic status
Management Strategies
Management of PROM involves a combination of approaches:
- Antibiotic Therapy: Administered to prevent or treat infections, thereby prolonging pregnancy and improving neonatal outcomes.
- Corticosteroids: Given to enhance fetal lung maturity when PROM occurs before 34 weeks of gestation.
- Tocolytics: Used to delay labor, allowing time for corticosteroids to take effect.
Outcomes and Prognosis
- Following PROM at term, spontaneous labor typically begins within 24 hours in 60% to 70% of patients and within 72 hours in over 95%.
- Previable and periviable PPROM, occurring before 24 weeks of gestation, is associated with high rates of neonatal morbidity and mortality, occurring in 0.3% to 0.4% of pregnancies.
Conclusion
In conclusion, the global Preterm Birth and PROM Testing Market is witnessing significant growth, driven by the increasing prevalence of preterm births and associated risks. Technological advancements, especially in rapid point-of-care diagnostics and biomarker research, are enhancing early detection and clinical outcomes.
With hospitals leading in test adoption and North America dominating regionally, the market is expected to expand further. Government initiatives, AI integration, and personalized care approaches are reinforcing this growth. As PROM complicates up to 10% of pregnancies and contributes to 30% of preterm births, timely and accurate testing remains critical to improving maternal and neonatal health outcomes worldwide.
Discuss your needs with our analyst
Please share your requirements with more details so our analyst can check if they can solve your problem(s)
