Preterm Birth and PROM Testing Market - Forecast from 2026 to 2031

The preterm birth and PROM testing market, with a 6.3% CAGR, is expected to grow to USD 2.521 billion in 2031 from USD 1.748 billion in 2025.

The preterm birth and PROM testing market is experiencing rising demand driven by increasing global cases of preterm births and premature rupture of membranes (PROM). These diagnostic tools enable early detection of fetal membrane rupture in pregnant women, facilitating timely interventions to mitigate complications and potentially prevent preterm delivery.

Key growth drivers include escalating preterm birth incidences influenced by factors such as unhealthy lifestyles and stress. Additionally, rising adolescent pregnancies and preeclampsia cases among pregnant women are expected to positively influence market expansion. Preeclampsia complications contribute to significant maternal and fetal mortality annually, while adolescent mothers face elevated risks of preterm delivery and associated neonatal conditions.

The adverse health effects of preterm birth underscore the need for early detection. Preterm births are associated with numerous short- and long-term complications, including respiratory distress, cardiovascular issues, intracranial hemorrhage, necrotizing enterocolitis, anemia, jaundice, hypoglycemia, cerebral palsy, developmental delays, and chronic conditions such as infections and asthma.

Government initiatives and ongoing clinical research projects support market advancement. Organizations like the WHO conduct studies in low- and middle-income countries to enhance care for pregnant women and preterm infants, including trials on antenatal corticosteroids, nutritional management, and immediate kangaroo mother care. Collaborative efforts, such as those from the International Federation of Gynecology and Obstetrics, provide good practice recommendations for preterm birth management.

Geographically, North America is poised for significant growth, holding a substantial market share during the forecast period. Contributing factors include technological advancements, heightened awareness, and the presence of major industry players such as Hologic, Abbott Laboratories, and Sera Prognostics Inc., which enhance accessibility and innovation.

Leading companies in the sector include Hologic Inc., a multinational focused on women's health, offering perinatal testing solutions like the Rapid fFN(R) test to assess preterm birth risk, along with kits such as QuikCheck fFN(R) and Rapid fFN(R) 10Q Cassette Kit. Sera Prognostics Inc., a prominent women's health company, reported positive top-line results in February 2023 from the AVERT Preterm Trial, demonstrating reductions in neonatal morbidity or death when conducted at ChristianaCare.

Overall, the market is expanding rapidly due to these clinical, demographic, and supportive factors, addressing critical needs in maternal-fetal medicine through improved diagnostic capabilities.

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Report Coverage:

• Historical data from 2021 to 2025 & forecast data from 2026 to 2031
• Growth Opportunities, Challenges, Supply Chain Outlook, Regulatory Framework, and Trend Analysis
• Competitive Positioning, Strategies, and Market Share Analysis
• Revenue Growth and Forecast Assessment of segments and regions including countries
• Company Profiling (Strategies, Products, Financial Information, and Key Developments among others.)

Preterm Birth and PROM Testing Market Segmentation

• By Preterm Birth Tests
• Pelvic Exam
• Ultrasound
• Others
• By PROM Tests
• Nitrazine Test
• Ferning Test
• Others
• By End-User
• Diagnostic Laboratories
• Hospitals
• Others
• By Geography
• North America
• USA
• Canada
• Mexico
• South America
• Brazil
• Argentina
• Others
• Europe
• Germany
• France
• United Kingdom
• Spain
• Others
• Middle East and Africa
• Saudi Arabia
• UAE
• Others
• Asia Pacific
• China
• India
• Japan
• South Korea
• Indonesia
• Thailand
• Others