Preterm Birth and PROM Testing - Global Strategic Business Report

The global market for Preterm Birth and PROM Testing was estimated at US$1.5 Billion in 2024 and is projected to reach US$2.3 Billion by 2030, growing at a CAGR of 7.4% from 2024 to 2030. This comprehensive report provides an in-depth analysis of market trends, drivers, and forecasts, helping you make informed business decisions. The report includes the most recent global tariff developments and how they impact the Preterm Birth and PROM Testing market.

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.

Key Insights:

• Market Growth: Understand the significant growth trajectory of the Pelvic Exam Test segment, which is expected to reach US$701.7 Million by 2030 with a CAGR of a 8.8%. The Fetal Fibronectin Test segment is also set to grow at 8.1% CAGR over the analysis period.
• Regional Analysis: Gain insights into the U.S. market, estimated at $405.0 Million in 2024, and China, forecasted to grow at an impressive 11.7% CAGR to reach $485.9 Million by 2030. Discover growth trends in other key regions, including Japan, Canada, Germany, and the Asia-Pacific.

Why You Should Buy This Report:

• Detailed Market Analysis: Access a thorough analysis of the Global Preterm Birth and PROM Testing Market, covering all major geographic regions and market segments.
• Competitive Insights: Get an overview of the competitive landscape, including the market presence of major players across different geographies.
• Future Trends and Drivers: Understand the key trends and drivers shaping the future of the Global Preterm Birth and PROM Testing Market.
• Actionable Insights: Benefit from actionable insights that can help you identify new revenue opportunities and make strategic business decisions.

Key Questions Answered:

• How is the Global Preterm Birth and PROM Testing Market expected to evolve by 2030?
• What are the main drivers and restraints affecting the market?
• Which market segments will grow the most over the forecast period?
• How will market shares for different regions and segments change by 2030?
• Who are the leading players in the market, and what are their prospects?

Report Features:

• Comprehensive Market Data: Independent analysis of annual sales and market forecasts in US$ Million from 2024 to 2030.
• In-Depth Regional Analysis: Detailed insights into key markets, including the U.S., China, Japan, Canada, Europe, Asia-Pacific, Latin America, Middle East, and Africa.
• Company Profiles: Coverage of players such as Abbott Laboratories, Biosynex, Clinical Innovations, LLC, CooperSurgical Inc., Creative Diagnostics and more.
• Complimentary Updates: Receive free report updates for one year to keep you informed of the latest market developments.

Some of the 32 companies featured in this Preterm Birth and PROM Testing market report include:

• 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.

This edition integrates the latest global trade and economic shifts as of June 2025 into comprehensive market analysis. Key updates include:

• Tariff and Trade Impact: Insights into global tariff negotiations across 180+ countries, with analysis of supply chain turbulence, sourcing disruptions, and geographic realignment. Special focus on 2025 as a pivotal year for trade tensions, including updated perspectives on the Trump-era tariffs.
• Adjusted Forecasts and Analytics: Revised global and regional market forecasts through 2030, incorporating tariff effects, economic uncertainty, and structural changes in globalization. Includes segmentation by product, technology, type, material, distribution channel, application, and end-use, with historical analysis since 2015.
• Strategic Market Dynamics: Evaluation of revised market prospects, regional outlooks, and key economic indicators such as population and urbanization trends.
• Innovation & Technology Trends: Latest developments in product and process innovation, emerging technologies, and key industry drivers shaping the competitive landscape.
• Competitive Intelligence: Updated global market share estimates for 2025, competitive positioning of major players (Strong/Active/Niche/Trivial), and refined focus on leading global brands and core players.
• Expert Insight & Commentary: Strategic analysis from economists, trade experts, and domain specialists to contextualize market shifts and identify emerging opportunities.
• Complimentary Update: Buyers receive a free July 2025 update with finalized tariff impacts, new trade agreement effects, revised projections, and expanded country-level coverage.