Preterm Birth and PROM Testing

Global Preterm Birth and PROM Testing Market to Reach US$2.3 Billion by 2030

The global market for Preterm Birth and PROM Testing estimated at US$1.5 Billion in the year 2024, is expected to reach US$2.3 Billion by 2030, growing at a CAGR of 7.4% over the analysis period 2024-2030. Pelvic Exam Test, one of the segments analyzed in the report, is expected to record a 8.8% CAGR and reach US$701.7 Million by the end of the analysis period. Growth in the Fetal Fibronectin Test segment is estimated at 8.1% CAGR over the analysis period.

The U.S. Market is Estimated at US$405.0 Million While China is Forecast to Grow at 11.7% CAGR

The Preterm Birth and PROM Testing market in the U.S. is estimated at US$405.0 Million in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$485.9 Million by the year 2030 trailing a CAGR of 11.7% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 3.6% and 7.2% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 4.9% CAGR.

Global Preterm Birth and PROM Testing Market – Key Trends & Drivers Summarized

How Is Preterm Birth and PROM Testing Improving Maternal and Neonatal Care?

Preterm birth and premature rupture of membranes (PROM) testing have become essential tools in maternal healthcare, enabling early diagnosis and risk assessment for complications that can impact fetal development and neonatal survival. Preterm birth, defined as delivery before 37 weeks of gestation, is one of the leading causes of neonatal mortality and morbidity worldwide. Premature rupture of membranes, the spontaneous breaking of the amniotic sac before labor begins, significantly increases the risk of infection, preterm delivery, and neonatal complications. Advanced diagnostic methods, including biomarker-based assays, fetal fibronectin (fFN) tests, and point-of-care (POC) testing solutions, are transforming the way clinicians predict and manage preterm labor. The integration of rapid diagnostic tools in obstetric care has led to improved decision-making, timely interventions, and better pregnancy outcomes. As healthcare systems focus on reducing preterm birth rates and improving neonatal survival, preterm birth and PROM testing are becoming indispensable in maternity hospitals, clinics, and high-risk pregnancy monitoring programs.

What Challenges Are Affecting the Adoption of Preterm Birth and PROM Testing?

Despite its importance, the adoption of preterm birth and PROM testing faces several challenges that impact market expansion and accessibility. One of the primary concerns is the cost associated with advanced diagnostic tests, making them less accessible in low-resource settings where maternal healthcare infrastructure is limited. Additionally, the variability in test accuracy and false-positive rates can lead to unnecessary hospitalizations, administration of steroids or tocolytics, and increased healthcare costs. The lack of standardized guidelines for the universal implementation of these tests further complicates clinical decision-making, as different healthcare systems adopt varying protocols for managing preterm labor risk. Another challenge is the limited awareness among expectant mothers regarding the availability of preterm birth and PROM tests, leading to delayed diagnosis and intervention. Moreover, regulatory approvals and stringent clinical validation requirements slow down the commercialization of innovative testing solutions, delaying widespread market adoption. Addressing these challenges requires continuous research, cost-effective test development, and targeted awareness campaigns to enhance healthcare provider and patient education.

How Are Innovations in Diagnostic Technologies Transforming Preterm Birth and PROM Testing?

Technological advancements in maternal-fetal diagnostics are revolutionizing preterm birth and PROM testing, improving accuracy, efficiency, and accessibility. The development of non-invasive and biomarker-based assays, such as placental alpha-microglobulin-1 (PAMG-1) and insulin-like growth factor-binding protein-1 (IGFBP-1) tests, has enhanced the ability to detect PROM with high sensitivity and specificity. AI-powered predictive analytics and machine learning algorithms are also being integrated into maternal health monitoring, allowing clinicians to assess preterm birth risk using patient history, physiological data, and real-time biomarker tracking. Portable and point-of-care testing devices are making diagnostics more accessible in remote and underdeveloped regions, enabling early intervention in at-risk pregnancies. The rise of telemedicine and digital health platforms is further enhancing the reach of preterm birth diagnostics, allowing pregnant women to access real-time consultations and personalized risk assessments. As precision medicine gains traction in obstetric care, preterm birth and PROM testing are expected to become more sophisticated, enabling tailored treatment strategies and improved perinatal outcomes.

What Is Driving the Growth of the Preterm Birth and PROM Testing Market?

The growth in the preterm birth and PROM testing market is driven by several factors, including increasing global preterm birth rates, advancements in maternal healthcare diagnostics, and the rising adoption of point-of-care testing solutions. The growing focus on reducing neonatal mortality and morbidity has accelerated the demand for early and accurate preterm birth detection methods, leading to increased investment in innovative diagnostic technologies. The expansion of maternal-fetal medicine programs and high-risk pregnancy clinics has further fueled market growth, as healthcare providers prioritize early screening and intervention strategies. Additionally, government initiatives and funding for maternal health improvement are promoting the adoption of advanced testing solutions in public healthcare systems. The rapid digitalization of healthcare and the integration of AI in pregnancy monitoring are also creating new market opportunities, enabling more precise and accessible risk assessment tools. As demand for personalized maternal healthcare continues to rise, the preterm birth and PROM testing market is expected to experience sustained growth, transforming prenatal care through early diagnosis and targeted interventions.

SCOPE OF STUDY:

The report analyzes the Preterm Birth and PROM Testing market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Test Type (Pelvic Exam Test, Ultrasound Test, Biochemical Markers, Uterine Monitoring Test, Nitazine Test, Ferning Test, Pooling Test, PAMG-1 Immunoassay Test, IGFBP Test, Fetal Fibronectin Test, Other Test Types); Application (PROM Application, Preterm Labor Application, Chorioamnionitis Application)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Select Competitors (Total 32 Featured) -

• Abbott Laboratories
• Biosynex
• Clinical Innovations, LLC
• CooperSurgical Inc.
• Creative Diagnostics
• ELITechGroup
• Hologic, Inc.
• IQ Products
• LifeCell International Pvt. Ltd.
• Luminex Corporation
• Medix Biochemica
• Natera Inc.
• NX Prenatal Inc.
• PerkinElmer Inc.
• Promega Corporation
• QIAGEN N.V.
• Randox Laboratories Ltd.
• Sera Prognostics
• SeraCare Life Sciences
• The Cooper Companies Inc.

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by artificially increasing the COGS, reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

We are diligently following expert opinions of leading Chief Economists (14,949), Think Tanks (62), Trade & Industry bodies (171) worldwide, as they assess impact and address new market realities for their ecosystems. Experts and economists from every major country are tracked for their opinions on tariffs and how they will impact their countries.

We expect this chaos to play out over the next 2-3 months and a new world order is established with more clarity. We are tracking these developments on a real time basis.

As we release this report, U.S. Trade Representatives are pushing their counterparts in 183 countries for an early closure to bilateral tariff negotiations. Most of the major trading partners also have initiated trade agreements with other key trading nations, outside of those in the works with the United States. We are tracking such secondary fallouts as supply chains shift.

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APRIL 2025: NEGOTIATION PHASE

Our April release addresses the impact of tariffs on the overall global market and presents market adjustments by geography. Our trajectories are based on historic data and evolving market impacting factors.

JULY 2025 FINAL TARIFF RESET

Complimentary Update: Our clients will also receive a complimentary update in July after a final reset is announced between nations. The final updated version incorporates clearly defined Tariff Impact Analyses.

Reciprocal and Bilateral Trade & Tariff Impact Analyses:

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CHINA
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JAPAN
INDIA
176 OTHER COUNTRIES.

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