Preterm Birth And PROM Testing Market (2026 - 2033)

Preterm Birth And PROM Testing Market Summary

The global preterm birth and PROM testing market size was valued at USD 1.7 billion in 2025 and is projected to grow from USD 1.8 billion in 2026 to USD 3.3 billion by 2033, at a CAGR of 8.7% from 2026 to 2033. North America dominated the market with the largest revenue share of 38.3% in 2025. Increasing advancements in point-of-care diagnostics are expected to have a positive impact on the preterm birth and PROM testing market.

The increasing average age of pregnant women, leading to an exponential rise in the number of early births, and the delay in parenthood due to sociodemographic factors, including education/career goals, the growing impact of women’s empowerment movements, and financial barriers, are key factors driving the adoption of tests in the market. According to research conducted by a group of researchers in Southern Ethiopia in December 2021, hypertension during pregnancy and a history of either abortion or cesarean section are the major causes of complications during childbirth. The study recommended that early identification tests and treatment can minimize the risk of premature rupture of fetal membranes. Other factors that raise the probability of PROM in pregnant women are low socioeconomic conditions, sexually transmitted infections, and cigarette smoking during pregnancy.

According to UNICEF, India accounts for 25.0 million births each year and witnesses the death of one child every minute, with the mortality rate due to premature birth at 35.0%. While substantial development in Special Newborn Care Units (SNCUs) has led to a decline in neonatal mortality, the socio-cultural barriers in healthcare access for female infants remain a major factor behind higher female premature deaths. However, India has witnessed a consistent reduction in child mortality rates, driven by initiatives prioritizing newborn and maternal safety.

Governments and regulatory bodies are taking considerable measures to increase access to PROM testing across several regions. For instance, in March 2022, Sera Prognostics Inc. announced that the Centers for Medicare & Medicaid Services established a Medicare payment rate of USD 750 for its PreTRM test, a proteomic blood test designed to measure preterm birth risk. The test has gained additional traction, with ongoing commercial collaboration between Sera and Elevance Health regarding coverage for its PreTRM test, which improves affordability for high-risk pregnant women and encourages broader adoption among hospitals and maternal-fetal medicine specialists.

Similarly, Actim PROM is a U.S. FDA-approved POC rapid test, to detect PROM. It provides rapid accurate results for preterm births. More than 7 million tests have been distributed in over 70 countries since they are highly reliable with 97% sensitivity and specificity. Actim Prom helps detect the protein biomarker Insulin-like Growth Factor Binding Protein-1 (IGFBP - 1). The advancements in POC diagnostics for PROM can encourage pregnant women to test for PROM more frequently when compared to a long procedure of testing held in hospitals and clinics.

Market Dynamics

The preterm birth and PROM testing market is experiencing growth due to the increasing incidence of preterm births and the rising emphasis on early identification of pregnancy related complications that can adversely affect maternal and neonatal outcomes. Healthcare providers are increasingly incorporating biomarker-based diagnostics, fetal fibronectin testing, PAMG 1 immunoassays, and advanced prenatal monitoring tools into routine obstetric care to support timely clinical decision making. The market is also benefiting from expanding access to prenatal healthcare services and the growing adoption of risk assessment strategies aimed at reducing preterm delivery associated complications. Industry participants are focusing on developing predictive diagnostic solutions that enable earlier intervention and more effective pregnancy management. For instance, in February 2025, Sera Prognostics reported positive outcomes supporting the commercialization of its PreTRM Test, reinforcing the clinical adoption of blood-based biomarker testing for assessing spontaneous preterm birth risk. Increasing integration of evidence based diagnostic approaches into maternal healthcare pathways is expected to support continued demand for preterm birth and PROM testing solutions during the forecast period.

Type Insights

Based on test type, the ultrasound segment led the market with the largest revenue share of 31.5% in 2025. Ultrasound imaging remains one of the most widely adopted modalities for assessing the risk of preterm childbirth, particularly through transvaginal measurement of cervical length. Recent market progression is shaped by digital innovation, as clinical researchers and companies increasingly integrate AI analytics with ultrasound platforms. In March 2022, Ultrasound AI Inc. received its first patent for Preterm AI, software that combines ultrasound data and machine learning to improve preterm birth prediction.

The PAMG-1 immunoassay segment is projected to register the fastest CAGR of 9.5% during the forecast period. Placental Alpha Microglobulin-1 (PAMG-1) is a highly specific biomarker used to confirm membrane rupture, where concentrations rise sharply (2,000-25,000 ng/mL) in the case of PROM or PPROM. Recent literature shows PAMG-1 may be useful as part of preterm-birth risk pathways (combined with cervical length, clinical risk) - creating new use cases beyond the classic PROM indication. That improves the addressable market.

Application Insights

Based on application, the preterm birth segment led the market with the largest revenue share of 42.5% in 2025. According to a Lancet publication (September 2021), China has the second-highest burden of preterm births, with a 1.3% annual increase in preterm rate from 2012 to 2018. Approximately 29.5% of preterm births originate from spontaneous preterm labor, while 27.8% are associated with preterm premature rupture of the fetal membranes (PPROM).

The Premature Rupture of Membranes (PROM) application segment is estimated to register a significant CAGR during the forecast period. According to data published in the NCBI in June 2021, the PROM condition occurs in 8% to 10% of pregnancies worldwide. For accurate and timely management of PROM, it is important to emphasize efficient diagnosis.

Regional Insights

North America dominated the preterm birth and PROM testing market with the largest revenue share of 38.3% in 2025 due to the changes in lifestyle factors such as excessive alcohol consumption & sedentary lifestyles, and high prevalence of preterm births in the region. The market is supported by strong institutional adoption of advanced prenatal diagnostics and well-established maternal healthcare systems.

U.S. Preterm Birth And PROM Testing Market Trends

The preterm birth and PROM testing market in the U.S. held the largest share in the North America region in 2025, driven by a high clinical burden of preterm births and the rapid integration of innovative biomarker-based tests in routine obstetric care. Broader insurance coverage for diagnostic solutions, including risk-prediction assays and PROM POC kits, has improved patient access while supporting earlier clinical intervention.

Europe Preterm Birth And PROM Testing Market Trends

The Europe preterm birth and PROM testing market represented a significant market growth in 2024, supported by widespread use of established screening practices and stringent clinical management guidelines for high-risk pregnancies. Countries such as Germany, Italy, and the UK demonstrate strong uptake of PAMG-1 and IGFBP-1 biomarker testing as part of standardized care pathways.

Asia Pacific Preterm Birth And PROM Testing Market Trends

The Asia Pacific preterm birth and PROM testing market is expected to grow at the fastest CAGR of 9.2% over the forecast period, driven by the presence of a large population in India and China. Moreover, the rising number of preterm births in developing countries of the region is creating a significant potential market, thereby leading to high market growth. Rapid technological advancements and an increase in the number of awareness campaigns & nonprofit organizations supporting preterm infants and their families are some of the vital factors positively impacting the market.

The China preterm birth and PROM testing market held the largest revenue share in the Asia-Pacific region, driven by its high preterm birth burden, large patient population, and expanding network of advanced maternity hospitals. According to a Lancet publication (September 2021), China has the second-highest burden of preterm births, with a 1.3% annual increase in preterm rate from 2012 to 2018.

The India preterm birth and PROM testing market is emerging as a significant market within the Asia Pacific due to its high newborn population and ongoing efforts to reduce preventable preterm complications. Preterm births are one of the major causes of neonatal death in India. India enhanced high-risk pregnancy screening through programs such as LaQshya and SUMAN in 2023, expanding diagnostic access at district and community health levels.

Latin America Preterm Birth And PROM Testing Market Trends

Latin America presents steady growth opportunities driven by increasing utilization of point-of-care diagnostics in maternity emergency units and tertiary obstetric hospitals. Countries such as Brazil and Mexico are strengthening maternal-fetal health policies, encouraging the shift from traditional examinations toward more accurate biomarker testing for suspected membrane rupture.

Middle East & Africa Preterm Birth And PROM Testing Market Trends

MEA preterm birth and PROM testing market represents significant opportunities over the forecast period owing to a notable burden of risk factors such as maternal malnutrition, infectious diseases, and other socio-economic challenges in parts of Africa, which could increase preterm birth and PROM incidence. In addition, the rising awareness of preterm birth complications in selected African markets and GCC countries is pushing the demand for early detection and interventions.

Key Preterm Birth And PROM Testing Company Insights

The market is highly competitive with the presence of many international and local players. The major companies are focusing on strategies such as new product development, product enhancements, and regional expansion in an attempt to capture a large share of the market. For instance, in February 2023, Sera Prognostics announced positive results for its PreTRM Preterm Birth Test, a biomarker test based on blood used for predicting the risk of preterm birth. The individuals were managed with the test-and-treat approach, which resulted in a reduction of neonatal death and decreased length of hospital stay. 

Competitive Benchmarking

Recent Developments

• In May 2025, Mirvie launched Encompass, a predictive solution that uses a novel blood test analyzing cell-free RNA to identify personalized preeclampsia risk months before symptoms appear.

Preterm Birth And PROM Testing Market Report Scope

Global Preterm Birth And PROM Testing Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global preterm birth and PROM testing market report based on type, application, and region:

• Type Outlook (Revenue, USD Million, 2021 - 2033)

  • Pelvic Exam

  • Ultrasound

  • Biochemical Markers

    • Interleukin (IL)-6

    • C-Reactive Protein (CRP)

    • IL-1, IL-2, IL-8, TNF-a

    • Corticotropin-Releasing Hormone (CRH)

    • AFP (Alpha fetoprotein)

  • Uterine Monitoring

  • Nitazine Test

  • Ferning Test

  • Pooling

  • PAMG-1 Immunoassay

  • IGFBP Test

  • Fetal Fibronectin (fFN)

  • Others

• Application Outlook (Revenue, USD Million, 2021 - 2033)

  • PROM

  • Preterm Labor

  • Chorioamnionitis

• Regional Outlook (Revenue, USD Million, 2021 - 2033)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Russia

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Singapore

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait

Research Methodology

The preterm birth and PROM testing market figures in this report are based on a proven research process that combines executive interviews with secondary research from proprietary databases, company filings, and recognized regulatory and institutional sources. Market size is built through value-chain sizing - reconciling supply-side and demand-side estimates - and triangulated with bottom-up and top-down approaches. Every estimate passes multiple levels of expert validation before publication, with each preterm birth and PROM testing segment quantified using the revenue-capture definitions in the table below.

Segment Definition

Estimation Model 

The Preterm Birth and PROM Testing Market was estimated using a bottom-up methodology that involved identifying key market participants and evaluating their diagnostic product portfolios related to preterm birth risk assessment and premature rupture of membranes testing. Revenue generated from major testing technologies, including fetal fibronectin assays, PAMG 1 immunoassays, IGFBP tests, ultrasound-based assessments, biochemical marker tests, and other diagnostic solutions, was analyzed to determine segment level market estimates. These estimates were further validated through assessment of technology adoption trends, patient utilization rates, and the market presence of leading manufacturers across key regions to derive the overall market size.

Delivered Customizations

This report has been delivered with the following In-depth customizations