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Preterm Birth and PROM Testing Market Report: Trends, Forecast and Competitive Analysis to 2031

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    Report

  • 150 Pages
  • April 2025
  • Region: Global
  • Lucintel
  • ID: 5993725
The global preterm birth and PROM testing market is expected to reach an estimated $2 billion by 2031, with a CAGR of 3.0% from 2025 to 2031. The major drivers for this market are the rising prevalence of preterm birth cases, increasing progress in point-of-care diagnostics, and growing development of innovative and accurate pregnancy testing methods.

The future of the global preterm birth and PROM testing market looks promising, with opportunities in the PROM, preterm labor, and chorioamnionitis markets.
  • Within the test type category, the ultrasound segment will remain the largest segment over the forecast period.
  • Within the application category, preterm labor will remain the largest segment over the forecast period.
  • In terms of regions, North America will remain the largest region over the forecast period.

Emerging Trends in the Preterm Birth and PROM Testing Market

Emerging trends in the preterm birth and PROM testing market are driving innovations in diagnostics and patient care. These trends reflect advancements in technology and increasing emphasis on personalized healthcare solutions.
  • Advancement in Biomarker Discovery: Research is focusing on discovering new biomarkers that improve the accuracy of preterm birth and PROM predictions. This trend enhances early detection and enables more targeted interventions.
  • Integration of Point-of-Care Testing: The adoption of point-of-care testing solutions is on the rise, allowing for rapid and convenient testing in various settings. This trend improves accessibility and timely management of preterm birth and PROM.
  • Growth of Telemedicine and Remote Monitoring: Telemedicine is becoming more prevalent, providing remote monitoring and consultations for preterm birth and PROM management. This trend improves access to care, especially in underserved areas.
  • Personalized Medicine Approaches: Personalized medicine is gaining traction, with tests tailored to individual risk profiles. This approach ensures that interventions are based on specific patient needs, enhancing treatment effectiveness.
  • Increased Focus on Maternal Health Education: There is a growing emphasis on maternal health education and awareness programs. These initiatives aim to improve the understanding and management of preterm birth and PROM, leading to better outcomes.
Emerging trends such as advancements in biomarker discovery and the integration of point-of-care testing are reshaping the preterm birth and PROM testing market. These trends are enhancing diagnostic accuracy, accessibility, and personalized care.

Recent Developments in the Preterm Birth and PROM Testing Market

Recent developments in the preterm birth and PROM testing market reflect advancements in technology and shifts in healthcare approaches. These key developments are transforming the landscape of prenatal care.
  • Introduction of Advanced Biomarkers: New biomarkers for preterm birth and PROM have been identified, improving diagnostic accuracy. These advancements enable earlier detection and better management strategies.
  • Development of Rapid Testing Kits: The launch of rapid testing kits for preterm birth and PROM has enhanced the speed and convenience of diagnosis. These kits are increasingly used in both clinical and home settings.
  • Advancements in Molecular Diagnostics: Molecular diagnostic technologies have advanced, offering more precise and reliable testing for preterm birth and PROM. These innovations contribute to improved patient outcomes.
  • Expansion of Point-of-Care Testing: The expansion of point-of-care testing solutions allows for immediate results and timely interventions. This development is particularly beneficial for managing preterm birth and PROM in diverse settings.
  • Enhanced Maternal Health Programs: The implementation of comprehensive maternal health programs has improved access to preterm birth and PROM testing. These programs include education, support, and advanced diagnostic tools.
Key developments in the preterm birth and PROM testing market, such as advanced biomarkers and rapid testing kits, are improving diagnostic capabilities and patient care. These advancements are making prenatal care more effective and accessible.

Strategic Growth Opportunities for Preterm Birth and PROM Testing Market

The preterm birth and PROM testing market presents various growth opportunities across applications. These opportunities are driven by advancements in technology and increasing demand for comprehensive prenatal care solutions.
  • Expansion of Diagnostic Testing Services: There is an opportunity to expand diagnostic testing services for preterm birth and PROM. Increased service availability can enhance early detection and management.
  • Development of Home Testing Kits: The market for home testing kits is growing, offering convenience and accessibility for at-risk pregnant women. This development supports early intervention and reduces the need for frequent clinical visits.
  • Integration of Digital Health Solutions: Integrating digital health solutions, such as mobile apps and remote monitoring, presents growth opportunities. These solutions facilitate continuous monitoring and timely interventions.
  • Focus on Maternal Health Education Programs: Investing in maternal health education programs can drive growth by increasing awareness and understanding of preterm birth and PROM. These programs help in early detection and prevention.
  • Advancements in Genomic Testing: The development of genomic testing for risk assessment provides opportunities for personalized care. This approach allows for tailored interventions based on individual genetic profiles.
Strategic growth opportunities in the preterm birth and PROM testing market, such as expanding diagnostic services and developing home testing kits, are enhancing access to care and improving patient outcomes. These opportunities are driving innovation and growth in the market.

Preterm Birth and PROM Testing Market Drivers and Challenges

The preterm birth and PROM testing market is influenced by various drivers and challenges, including technological advancements, economic factors, and regulatory issues. Understanding these elements is crucial for market growth and development.

The factors responsible for driving the preterm birth and PROM testing market include:

  • Technological Advancements: Innovations in diagnostic technologies, such as advanced biomarkers and rapid testing kits, are driving market growth by improving accuracy and efficiency.
  • Increased Awareness: Growing awareness of preterm birth and PROM risks is leading to higher demand for testing and early intervention, contributing to market expansion.
  • Government Support: Government initiatives and funding for maternal health programs are enhancing access to preterm birth and PROM testing, supporting market growth.
  • Rising Maternal Health Concerns: Increased focus on maternal health and prenatal care is driving the demand for advanced testing solutions and comprehensive management strategies.
  • Growth in Healthcare Infrastructure: Expansion of healthcare facilities and services, particularly in emerging markets, is improving access to preterm birth and PROM testing.

Challenges in the preterm birth and PROM testing market are:

  • High Costs: The high cost of advanced testing technologies and diagnostic services can be a barrier to widespread adoption and access.
  • Regulatory Hurdles: Navigating regulatory requirements and approvals for new testing technologies can be complex and time-consuming.
  • Limited Access in Rural Areas: Access to advanced testing and maternal health services may be limited in rural or underserved regions, affecting overall market growth.
Major drivers, such as technological advancements and increased awareness, are fueling growth in the preterm birth and PROM testing market. However, challenges related to cost, regulatory issues, and access disparities must be addressed to ensure broader adoption and improved patient outcomes.

List of Preterm Birth and PROM Testing Companies

Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. Through these strategies, preterm birth and PROM testing companies cater to increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base.

Some of the preterm birth and PROM testing companies profiled in this report include:

  • Qiagen
  • Hologic
  • Cooper Surgical
  • Abbott
  • Medix Biochemica
  • Sera Prognostics
  • Clinical Innovations
  • Biosynex
  • NX Prenatal
  • IQ Products

Preterm Birth and PROM Testing by Segment

The study includes a forecast for the global preterm birth and PROM testing market by test type, application, and region.

Test Type [Analysis by Value from 2019 to 2031]:

  • Pelvic Exam
  • Ultrasound
  • Biochemical Markers
  • Uterine Monitoring
  • Nitazine Test
  • Ferning Test
  • Pooling
  • PAMG-1 Immunoassay
  • IGFBP Test
  • Others

Application [Analysis by Value from 2019 to 2031]:

  • PROM
  • Preterm Labor
  • Chorioamnionitis
  • Others

Region [Analysis by Value from 2019 to 2031]:

  • North America
  • Europe
  • Asia Pacific
  • The Rest of the World

Country-Wise Outlook for the Preterm Birth and PROM Testing Market

Major players in the market are expanding their operations and forming strategic partnerships to strengthen their positions. The image below highlights recent developments by major preterm birth and PROM testing producers in key regions: the USA, China, India, Japan, and Germany.
  • United States: In the U.S., advancements include the introduction of highly sensitive biomarkers and rapid testing methods for preterm birth and PROM. New technologies, such as point-of-care tests, have improved the early detection and management of these conditions.
  • China: China is witnessing growth in the market due to increased adoption of advanced diagnostic tools and government support for maternal health. The development of cost-effective testing solutions has improved accessibility in both urban and rural areas.
  • Germany: Germany's market is characterized by the integration of advanced molecular diagnostics and comprehensive prenatal care programs. Innovations in testing technology have enhanced the precision of preterm birth and PROM detection, contributing to better patient outcomes.
  • India: In India, the focus is on improving the accessibility and affordability of preterm birth and PROM tests. Recent developments include the introduction of affordable diagnostic kits and increased awareness programs to support early diagnosis and intervention.
  • Japan: Japan's market is marked by advancements in genetic testing and personalized medicine for preterm birth and PROM. The integration of these technologies into routine prenatal care is enhancing early detection and tailored management strategies.

Features of this Global Preterm Birth and PROM Testing Market Report

  • Market Size Estimates: Preterm birth and PROM testing market size estimation in terms of value ($B).
  • Trend and Forecast Analysis: Market trends (2019 to 2024) and forecast (2025 to 2031) by various segments and regions.
  • Segmentation Analysis: Preterm birth and PROM testing market size by test type, application, and region in terms of value ($B).
  • Regional Analysis: Preterm birth and PROM testing market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
  • Growth Opportunities: Analysis of growth opportunities in different test types, applications, and regions for the preterm birth and PROM testing market.
  • Strategic Analysis: This includes M&A, new product development, and competitive landscape of the preterm birth and PROM testing market.
Analysis of the competitive intensity of the industry based on Porter’s Five Forces model.

This report answers the following 11 key questions:

Q.1. What are some of the most promising, high-growth opportunities for the preterm birth and PROM testing market by test type (pelvic exam, ultrasound, biochemical markers, uterine monitoring, nitrazine test, ferning test, pooling, PAMG-1 immunoassay, IGFBP test, and others), application (PROM, preterm labor, chorioamnionitis, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
Q.2. Which segments will grow at a faster pace and why?
Q.3. Which region will grow at a faster pace and why?
Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
Q.5. What are the business risks and competitive threats in this market?
Q.6. What are the emerging trends in this market and the reasons behind them?
Q.7. What are some of the changing demands of customers in the market?
Q.8. What are the new developments in the market? Which companies are leading these developments?
Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
Q.10. What are some of the competing products in this market, and how big of a threat do they pose for loss of market share by material or product substitution?
Q.11. What M&A activity has occurred in the last 5 years, and what has its impact been on the industry?

Table of Contents

1. Executive Summary
2. Global Preterm Birth and PROM Testing Market: Market Dynamics
2.1: Introduction, Background, and Classifications
2.2: Supply Chain
2.3: Industry Drivers and Challenges
3. Market Trends and Forecast Analysis from 2019 to 2031
3.1. Macroeconomic Trends (2019-2024) and Forecast (2025-2031)
3.2. Global Preterm Birth and PROM Testing Market Trends (2019-2024) and Forecast (2025-2031)
3.3: Global Preterm Birth and PROM Testing Market by Test Type
3.3.1: Pelvic Exam
3.3.2: Ultrasound
3.3.3: Biochemical Markers
3.3.4: Uterine Monitoring
3.3.5: Nitazine Test
3.3.6: Ferning Test
3.3.7: Pooling
3.3.8: PAMG-1 Immunoassay
3.3.9: IGFBP Test
3.3.10: Others
3.4: Global Preterm Birth and PROM Testing Market by Application
3.4.1: PROM
3.4.2: Preterm Labor
3.4.3: Chorioamnionitis
3.4.4: Others
4. Market Trends and Forecast Analysis by Region from 2019 to 2031
4.1: Global Preterm Birth and PROM Testing Market by Region
4.2: North American Preterm Birth and PROM Testing Market
4.2.1: North American Preterm Birth and PROM Testing Market by Test Type: Pelvic Exam, Ultrasound, Biochemical Markers, Uterine Monitoring, Nitazine Test, Ferning Test, Pooling, PAMG-1 Immunoassay, IGFBP Test, and Others
4.2.2: North American Preterm Birth and PROM Testing Market by Application: PROM, Preterm Labor, Chorioamnionitis, and Others
4.3: European Preterm Birth and PROM Testing Market
4.3.1: European Preterm Birth and PROM Testing Market by Test Type: Pelvic Exam, Ultrasound, Biochemical Markers, Uterine Monitoring, Nitazine Test, Ferning Test, Pooling, PAMG-1 Immunoassay, IGFBP Test, and Others
4.3.2: European Preterm Birth and PROM Testing Market by Application: PROM, Preterm Labor, Chorioamnionitis, and Others
4.4: APAC Preterm Birth and PROM Testing Market
4.4.1: APAC Preterm Birth and PROM Testing Market by Test Type: Pelvic Exam, Ultrasound, Biochemical Markers, Uterine Monitoring, Nitazine Test, Ferning Test, Pooling, PAMG-1 Immunoassay, IGFBP Test, and Others
4.4.2: APAC Preterm Birth and PROM Testing Market by Application: PROM, Preterm Labor, Chorioamnionitis, and Others
4.4: APAC Preterm Birth and PROM Testing Market
4.4.1: APAC Preterm Birth and PROM Testing Market by Test Type: Pelvic Exam, Ultrasound, Biochemical Markers, Uterine Monitoring, Nitazine Test, Ferning Test, Pooling, PAMG-1 Immunoassay, IGFBP Test, and Others
4.4.2: APAC Preterm Birth and PROM Testing Market by Application: PROM, Preterm Labor, Chorioamnionitis, and Others
5. Competitor Analysis
5.1: Product Portfolio Analysis
5.2: Operational Integration
5.3: Porter’s Five Forces Analysis
6. Growth Opportunities and Strategic Analysis
6.1: Growth Opportunity Analysis
6.1.1: Growth Opportunities for the Global Preterm Birth and PROM Testing Market by Test Type
6.1.2: Growth Opportunities for the Global Preterm Birth and PROM Testing Market by Application
6.1.3: Growth Opportunities for the Global Preterm Birth and PROM Testing Market by Region
6.2: Emerging Trends in the Global Preterm Birth and PROM Testing Market
6.3: Strategic Analysis
6.3.1: New Product Development
6.3.2: Capacity Expansion of the Global Preterm Birth and PROM Testing Market
6.3.3: Mergers, Acquisitions, and Joint Ventures in the Global Preterm Birth and PROM Testing Market
6.3.4: Certification and Licensing
7. Company Profiles of Leading Players
7.1: Qiagen
7.2: Hologic
7.3: Cooper Surgical
7.4: Abbott
7.5: Medix Biochemica
7.6: Sera Prognostics
7.7: Clinical Innovations
7.8: Biosynex
7.9: NX Prenatal
7.10: IQ Products

Companies Mentioned

The leading players profiled in this Preterm Birth and PROM Testing market report include:
  • Qiagen
  • Hologic
  • Cooper Surgical
  • Abbott
  • Medix Biochemica
  • Sera Prognostics
  • Clinical Innovations
  • Biosynex
  • NX Prenatal
  • IQ Products

Methodology

The analyst has been in the business of market research and management consulting since 2000 and has published over 600 market intelligence reports in various markets/applications and served over 1,000 clients worldwide. Each study is a culmination of four months of full-time effort performed by the analyst team. The analysts used the following sources for the creation and completion of this valuable report:

  • In-depth interviews of the major players in the market
  • Detailed secondary research from competitors’ financial statements and published data
  • Extensive searches of published works, market, and database information pertaining to industry news, company press releases, and customer intentions
  • A compilation of the experiences, judgments, and insights of professionals, who have analyzed and tracked the market over the years.

Extensive research and interviews are conducted in the supply chain of the market to estimate market share, market size, trends, drivers, challenges and forecasts.

Thus, the analyst compiles vast amounts of data from numerous sources, validates the integrity of that data, and performs a comprehensive analysis. The analyst then organizes the data, its findings, and insights into a concise report designed to support the strategic decision-making process.

 

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