The Preterm Birth and PROM Testing Market was valued at USD 1.5 billion in 2023 and is projected to reach USD 2.93 billion by 2032, expanding at a compound annual growth rate (CAGR) of 7.7% over the forecast period from 2024 to 2032.s

This substantial growth reflects increasing global awareness of maternal and neonatal health, rising rates of preterm births, and the adoption of advanced diagnostic techniques for early detection and risk assessment of pregnancy complications.

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Understanding the Market Landscape

Preterm birth—defined as childbirth before 37 weeks of gestation—is one of the leading causes of neonatal mortality and long-term health complications in infants. Premature rupture of membranes (PROM), especially preterm PROM (PPROM), significantly increases the risk of preterm labor and infection. As such, accurate and timely diagnostic testing is critical to managing risks and improving outcomes for both mother and child.

With healthcare systems across the globe placing a stronger emphasis on prenatal care and early intervention, the demand for reliable and non-invasive testing solutions is witnessing a notable surge

Key Market Drivers

  1. Rising Global Preterm Birth Rates: The World Health Organization (WHO) estimates that around 15 million babies are born prematurely each year, with the numbers steadily rising due to lifestyle changes, late pregnancies, and increased use of fertility treatments.
  2. Advancements in Biomarker-Based Testing: Biomarker-based assays such as fetal fibronectin (fFN), insulin-like growth factor-binding protein-1 (IGFBP-1), and placental alpha-microglobulin-1 (PAMG-1) have enhanced the accuracy and reliability of preterm labor and PROM diagnostics.
  3. Increased Adoption of Point-of-Care Testing (POCT): Hospitals and clinics are increasingly adopting rapid, bedside testing kits to accelerate diagnosis and guide timely clinical decisions, particularly in low-resource settings.
  4. Government and NGO Support: Public health initiatives and funding programs aimed at reducing neonatal mortality are further driving adoption of preterm birth and PROM testing solutions, especially in emerging economies

Key Market Segments:

By Test Type

  • Ultrasound
  • Pelvic exam
  • Biochemical Markers
    • Interleukin (IL)-6
    • Corticotropin-Releasing Hormone (CRH)
    • C-Reactive Protein (CRP)
    • IL-1, IL-2, IL-8, TNF-a
    • Alpha-fetoprotein (AFP)
  • Uterine Monitoring
  • Nitazine Test
  • Ferning Test
  • IGFBP Test
  • Pooling
  • PAMG-1 Immunoassay
  • Fetal Fibronectin (fFN)
  • Others

By Application

  • PROM
  • Preterm Labor
  • Chorioamnionitis

 

Key Players in the Preterm Birth and PROM Testing Market

Key Service Providers/Manufacturers

  • Hologic, Inc. (Rapid fFN Test, AmniSure ROM Test)
  • Abbott Laboratories (i-STAT System, ARCHITECT Clinical Chemistry)
  • Sera Prognostics Inc. (PreTRM Test)
  • CooperSurgical Inc. (ROM Plus, AmnioTest)
  • IQ Products (Actim PROM, Actim Partus)
  • Qiagen N.V. (PartoSure Test, AmniSure ROM Test)
  • Biosynex (PREMAQUICK, Amnioquick)
  • LifeCell International Pvt. Ltd. (Maternal Blood Test, Fetal Monitoring Services)
  • Clinical Innovations, LLC (ROM Plus, Koala Intrauterine Pressure Catheter)
  • NX Prenatal, Inc. (NeXosome Assay)
  • Medixbiochemica (Actim PROM, Actim Partus)
  • Medtronic (InSync III, Reveal LINQ)
  • Fisher & Paykel Healthcare Limited (Airvo 2, Optiflow)
  • FUJIFILM Holdings Corporation (SonoSite Ultrasound Systems, Synapse PACS)
  • Nonin Medical, Inc. (Onyx Vantage 9590, SenSmart Model X-100)

 Challenges and Opportunities

While the market shows robust growth potential, challenges such as limited awareness in rural and underdeveloped areas, and variability in test accuracy can hinder adoption. Moreover, the cost of advanced biomarker tests may limit accessibility in lower-income regions.

On the other hand, ongoing technological innovations, the rise of telehealth-integrated prenatal monitoring, and the development of AI-powered diagnostic tools present immense opportunities for market expansion

Future Outlook

The coming decade is poised to reshape maternal-fetal medicine through precision diagnostics and personalized care. The integration of molecular diagnostics, wearable technologies, and remote testing platforms will redefine how clinicians detect, monitor, and manage preterm labor risks.

Stakeholders across healthcare systems, diagnostic labs, and medical device companies are expected to play a pivotal role in making affordable and accessible prenatal testing a global standard, reducing preterm-related complications and improving neonatal survival rates.

About the Report

This analysis is based on a comprehensive evaluation of historical data, current trends, and forecasted growth from 2024 to 2032. The report provides strategic insights into market opportunities, challenges, regional trends, and technological advancements.

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