Preterm Birth and PROM Testing Market to Reach USD 562.1 Million by 2034, Growing at 8.6% CAGR Due to Rising Preterm Birth Rates – Analysis by TMR
The global Preterm Birth and PROM Testing Market was valued at USD 227.8 million in 2023 and is projected to expand at a CAGR of 8.6% from 2024 to 2034, reaching USD 562.1 million by the end of the forecast period. Growth in the market is driven by an increasing prevalence of preterm births, advancements in diagnostic technology, and rising investments in point-of-care testing solutions.
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The Preterm Birth and PROM (Premature Rupture of Membranes) Testing Market plays a critical role in prenatal care by enabling early detection and management of risks associated with preterm labor and membrane rupture. These diagnostic tests help healthcare providers assess the likelihood of preterm birth, allowing for timely intervention to prevent complications for both the mother and newborn.
Preterm birth occurs when a baby is delivered before 37 weeks of gestation, often leading to severe health complications such as respiratory distress syndrome, neurological impairments, and developmental delays. PROM, characterized by the early rupture of the amniotic sac before labor begins, increases the risk of infections and premature delivery, necessitating accurate and rapid diagnostic solutions.
With the rise in maternal age, changing lifestyles, and an increase in chronic health conditions among pregnant women, the demand for preterm birth and PROM testing is surging globally. Additionally, socioeconomic factors and disparities in healthcare access contribute to the prevalence of preterm births, further emphasizing the need for advanced and accessible diagnostic solutions.
The market is witnessing continuous advancements in diagnostic technologies, including biomarker-based tests, next-generation sequencing (NGS), and AI-powered predictive analytics, which enhance accuracy, safety, and speed. Healthcare providers are increasingly adopting point-of-care testing devices and non-invasive screening methods to improve prenatal care and reduce neonatal mortality rates.
As healthcare investments and awareness regarding maternal-fetal health grow worldwide, the preterm birth and PROM testing market is expected to expand significantly, driven by technological innovations, increasing preterm birth rates, and improved access to prenatal diagnostics.
Key Market Insights and Trends
- Prevalence of Preterm Births Driving Market Expansion
The growing number of preterm births globally is a major factor fueling demand for preterm birth and PROM testing. According to the World Health Organization (WHO), nearly 13.4 million babies are born preterm annually, with preterm birth rates ranging from 4% to 16% across countries. Timely intervention enabled by diagnostic tests could prevent up to three-quarters of these deaths, further reinforcing the importance of PROM and preterm birth testing. - Technological Advancements Enhancing Diagnostic Capabilities
Rapid innovations in diagnostic tools, including next-generation sequencing (NGS), AI-powered risk assessment algorithms, and 3D ultrasound imaging, are improving test accuracy, safety, and efficiency. The integration of machine learning algorithms in prenatal diagnostics is expected to enhance early detection rates and optimize maternal-fetal care strategies. - Increased Healthcare Spending Supporting Market Growth
Rising healthcare investments, particularly in diagnostic and maternal-fetal health technologies, are fueling market expansion. According to the Advanced Medical Technology Association (AdvaMed), medical technology expenditure in the U.S. reached USD 199.1 billion, with diagnostic tests accounting for nearly USD 25 billion annually.
Regional Outlook
- North America Leads with Strong Healthcare Infrastructure
In 2023, North America accounted for the largest market share, driven by an advanced healthcare system, increased awareness of prenatal care, and a growing number of preterm births. The National Center for Health Statistics (NCHS) reported 380,548 preterm births in the U.S. in 2022, representing 10.4% of all live births. - Asia Pacific to Witness Rapid Growth from 2024 to 2034
Asia Pacific is anticipated to grow steadily due to improving access to prenatal healthcare services, particularly in China and India, where rising birth rates and increasing healthcare spending are driving demand for early diagnostic solutions.
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Competitive Landscape
Leading companies in the preterm birth and PROM testing market are focusing on product development, strategic collaborations, and geographic expansion to strengthen their market presence. Prominent players include:
QIAGEN
Hologic, Inc.
Medix Biochemica
Biosynex SA
Abbott
Laborie
Sera Prognostics
The Cooper Companies, Inc.
NX Prenatal, Inc.
IQ Products
In May 2022, Sera Prognostics and the Newborn Foundation launched the Every Mother, Every Baby Project to promote the use of biomarker-driven preterm birth risk assessment tests. The initiative aims to improve newborn health outcomes by integrating predictive testing into routine prenatal care.
Market Segmentation
The preterm birth and PROM testing market is segmented based on:
By Test Type:
Preterm Birth Tests: Pelvic Exam, Ultrasound, Uterine Monitoring, Biomarker Tests
PROM Tests: Nitrazine Test, Ferning Test, Pooling, Ultrasound, Fetal Fibronectin Test, Biomarker Test, Others
By End-user:
Hospitals, Diagnostic Laboratories, Others
By Region:
North America (U.S., Canada)
Europe (U.K., France, Germany, Italy, Spain)
Asia Pacific (China, India, Japan, Australia)
Latin America (Brazil, Mexico)
Middle East & Africa (GCC Countries, South Africa)
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Market Outlook
The preterm birth and PROM testing market is set for significant growth over the next decade, with early detection technologies, AI-driven diagnostic tools, and increasing awareness of maternal-fetal health playing key roles in market expansion. With continued investments in advanced prenatal testing, the industry is poised to enhance pregnancy outcomes and reduce infant mortality worldwide.
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