조산 및 PROM 검사 시장 : 유형, 샘플, 최종사용자별 - 세계 예측(2025-2030년)

The Preterm Birth & PROM Testing Market was valued at USD 1.55 billion in 2023 and is projected to grow to USD 1.64 billion in 2024, with a CAGR of 6.20%, reaching USD 2.36 billion by 2030.

Executive Summary Introduction: Setting the Stage for Preterm Birth & PROM Testing

In today's rapidly evolving healthcare environment, the early detection and management of preterm birth and PROM (premature rupture of membranes) have emerged as critical focal points for clinicians, researchers, and decision-makers alike. This report delves into the intricate landscape of diagnostic and prognostic testing approaches, shedding light on both traditional and emerging methodologies that shape patient care. The introduction explores the clinical importance of early detection and timely intervention, underlining how advanced testing techniques contribute to better neonatal outcomes and reduce associated health risks. As we navigate through the comprehensive insights provided herein, the reader will develop an understanding of how technological innovations, regulatory shifts, and evolving clinical practices are converging to transform the landscape of preterm birth and PROM testing. Emphasizing data-driven analysis and actionable intelligence, this report leverages robust market research to identify trends that have the potential to redefine clinical protocols and diagnostic accuracy. By establishing a holistic view of the current state and prospective trends, the content is tailored to both industry experts and key decision-makers seeking to optimize patient management strategies and drive forward the standards of care.

Transformative Shifts in the Landscape: Innovations and Evolving Practices in Preterm Birth & PROM Testing

The landscape of preterm birth and PROM testing is undergoing transformative shifts fueled by innovative diagnostic technologies and evolving clinical practices. Over recent years, the integration of advanced diagnostic tools with improved imaging techniques and biochemical testing has significantly enhanced the detection rates and accuracy of identifying risks associated with premature birth. Driven by research breakthroughs and cross-disciplinary collaborations, clinicians are increasingly incorporating novel biomarkers and more precise screening tests into routine practice. Moreover, regulatory bodies across various geographies have updated guidelines to accommodate these technological advances, fostering an environment that encourages rapid adoption of innovative testing methods. As a consequence, stakeholders across the healthcare continuum are witnessing accelerated developments in test sensitivity and specificity, leading to improved patient outcomes. Additionally, the convergence of digital health solutions and real-time data analytics has enabled practitioners to make swift, informed decisions, thereby reinforcing the value of early diagnostics. These transformative shifts collectively reflect a commitment to reducing the morbidity and mortality associated with preterm birth and PROM, while also opening new avenues for personalized and predictive healthcare interventions.

Key Segmentation Insights: A Detailed Look into Diagnostic Modalities and Sample Types in Testing

Our analysis identifies distinct segmentation trends that provide a clearer picture of the market's structure and evolution. When examining the landscape based on type, the market is evaluated across an array of diagnostic modalities including biochemical markers, the ferning test, fetal fibronectin, the nitazine test, pelvic exam, pooling, ultrasound, and uterine monitoring. Of particular note are biochemical markers, which have been further dissected into several sub-categories such as alpha-fetoprotein, C-reactive protein, corticotropin-releasing hormone, IL-1, IL-2, IL-8, TNF-a, insulin-like growth factor binding protein-1, interleukin (IL)-6, and placental alpha microglobulin-1. In addition to the technology-based segmentation, the analysis also considers sample-based divisions, focusing on diagnostic samples derived from amniotic fluid, blood, urine, and vaginal secretions, each of which provides unique insights into the diagnostic process. Furthermore, a critical end-user segmentation delineates the market into diagnostic laboratories, hospitals and clinics, and specialty centers. These segmentation insights collectively underscore the complexity and interconnectivity of the various testing approaches, sample sources, and application settings that are coalescing to form the drivers of current market trends.

Based on Type, market is studied across Biochemical Markers, Ferning Test, Fetal Fibronectin, Nitazine Test, Pelvic exam, Pooling, Ultrasound, and Uterine Monitoring. The Biochemical Markers is further studied across Alpha-fetoprotein, C-Reactive Protein, Corticotropin-Releasing Hormone, IL-1, IL-2, IL-8, TNF-a, Insulin-like Growth Factor Binding Protein-1, Interleukin (IL)-6, and Placental Alpha Microglobulin-1.

Based on Sample, market is studied across Amniotic Fluid, Blood, Urine, and Vaginal Secretions.

Based on End-User, market is studied across Diagnostic Laboratories, Hospitals & Clinics, and Specialty Centers.

Key Regional Insights: Understanding Market Dynamics Across Global Territories

Regional dynamics play an essential role in shaping the market trends for preterm birth and PROM testing. The market reveals distinct characteristics and varying rates of adoption across different geographies. In the Americas, strong investments in healthcare technologies, coupled with advanced infrastructure, have positioned the region at the forefront of testing innovations. Regions encompassing Europe, the Middle East, and Africa exhibit a wide spectrum of market maturity, where the interplay of established healthcare systems and emerging economies stimulates both sophisticated testing advancements and rapid adoption of novel diagnostics. In Asia-Pacific, rising healthcare expenditure and a burgeoning patient population are driving the rapid integration of state-of-the-art diagnostics into clinical practice. These developments are further boosted by regional government initiatives focused on enhancing maternal and neonatal health outcomes. Collectively, these regional insights highlight the need for tailored market strategies that account for varying economic landscapes, regulatory environments, and cultural factors, which in turn dictate the pace at which testing methodologies are embraced and implemented.

Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

Key Companies Insights: Leading Innovators and Market Influencers in Diagnostic Testing

The market for preterm birth and PROM testing is increasingly competitive, with several leading companies driving innovation and shaping market dynamics. Industry leaders such as Abbott Laboratories, BillionToOne, Inc., Biosynex SA, Eurofins Scientific SE, and F. Hoffmann-La Roche AG have consistently pushed the boundaries in diagnostic accuracy and test efficacy. These companies are complemented by organizations like FUJIFILM Holdings Corporation, GE HealthCare Technologies, Inc., and Hologic, Inc., whose contributions in imaging and analytical solutions are pivotal in refining test protocols. Further notable players include Igenomix India Private Limited, Illumina, Inc., Koninklijke Philips N.V., Laboratory Corporation of America Holdings, and Medix Biochemica Group, all of which emphasize the importance of robust technology integration. Leaders like Nanjing Liming Bio-products Co., Ltd., Natera, Inc., NX Prenatal, Inc., Pro Lab Diagnostics Inc, and Qiagen N.V. are continuously evolving to meet clinical demands. Additional contributions from Revvity, Inc., Samsung Electronics Co., Ltd., Sekisui Diagnostics, LLC, Sera Prognostics, Inc., Siemens Healthineers AG, The Cooper Companies, Inc., and Thermo Fisher Scientific Inc. further underscore the multi-faceted competitive landscape. This competitive milieu reflects a relentless pursuit of innovation, improved patient outcomes, and operational excellence in diagnostic testing.

The report delves into recent significant developments in the Preterm Birth & PROM Testing Market, highlighting leading vendors and their innovative profiles. These include Abbott Laboratories, BillionToOne, Inc., Biosynex SA, Eurofins Scientific SE, F. Hoffmann-La Roche AG, FUJIFILM Holdings Corporation, GE HealthCare Technologies, Inc., Hologic, Inc., Igenomix India Private Limited, Illumina, Inc., Koninklijke Philips N.V., Laboratory Corporation of America Holdings, Medix Biochemica Group, Nanjing Liming Bio-products Co., Ltd., Natera, Inc., NX Prenatal, Inc., Pro Lab Diagnostics Inc, Qiagen N.V., Revvity, Inc., Samsung Electronics Co., Ltd., Sekisui Diagnostics, LLC, Sera prognostics, Inc., Siemens Healthineers AG, The Cooper Companies, Inc., and Thermo Fisher Scientific Inc.. Actionable Recommendations for Industry Leaders: Strategies to Enhance Diagnostic Value and Market Positioning

Industry leaders are encouraged to adopt proactive and innovative strategies to maintain competitive advantage in the dynamic market of preterm birth and PROM testing. Embracing technology-driven advancements is imperative in today's clinical environment. Companies should invest in continuous research and development to explore novel biomarkers and testing methodologies, ensuring that new diagnostic solutions anticipate future clinical needs. Furthermore, strategic collaborations with academic institutions and healthcare providers can expedite the translation of cutting-edge research into reliable, market-ready solutions. Emphasis should be placed on integrating digital health platforms and real-time data analytics not only to improve test turnaround times but also to enhance predictive accuracy through personalized patient profiles. In addition, expanding geographical reach into regions with emerging markets can create new revenue channels while addressing unmet clinical needs. Cost-effective operational strategies, coupled with a robust regulatory compliance framework, will aid in ensuring that testing solutions remain accessible and trustworthy. Ultimately, leaders must balance rapid innovation with patient safety and data integrity, fostering a culture of excellence that positions their organizations as pioneers in the field of preterm birth and PROM testing.

Conclusion: Synthesizing Insights to Shape the Future of Diagnostic Testing in Preterm Birth and PROM

The comprehensive insights presented in this report underscore the multifaceted nature of the preterm birth and PROM testing market. From transformative technological shifts to detailed segmentation analyses and regional dynamics, it becomes clear that the landscape is marked by both complexity and opportunity. Integrating advanced diagnostic tools with refined clinical practices has paved the way for improved patient care and better outcomes in maternal and neonatal health. As the market continues to evolve, the interplay between innovative testing methodologies and strategic industry positioning will be fundamental to driving progress and addressing unmet clinical needs. This synthesis of data, trends, and actionable strategies offers a clear vision for the future, emphasizing the importance of agility, sustained investment in research, and cross-industry partnerships. Ultimately, the shared goal remains to enhance diagnostic precision, thereby contributing to more informed decision-making and improved quality of care for patients globally.

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Market Dynamics
  • 5.1.1. Drivers
    • 5.1.1.1. Prevalence of preterm births owing to the increasing rates of diabetes and hypertension
    • 5.1.1.2. Rising focus on the development of point-of-care testing solutions
    • 5.1.1.3. Growing government and healthcare initiatives aimed at reducing preterm birth rates
  • 5.1.2. Restraints
    • 5.1.2.1. Rising concerns about false positive results of PROM tests
  • 5.1.3. Opportunities
    • 5.1.3.1. Rising investment by companies for the development of preterm birth & PROM testing solutions
    • 5.1.3.2. Emerging collaborative efforts in research and development activities for PROM tests
  • 5.1.4. Challenges
    • 5.1.4.1. Stringent regulations and varying approval processes for preterm birth & PROM tests
• 5.2. Market Segmentation Analysis
  • 5.2.1. Type: Growing use of biochemical markers for early detection and management of preterm birth & PROM
  • 5.2.2. Sample: Expanding the use of amniotic fluid testing in clinical settings owing to high specificity and sensitivity
  • 5.2.3. End-User: Growing use of preterm birth & PROM tests in diagnostic laboratories owing to accuracy and mass testing
• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental

6. Preterm Birth & PROM Testing Market, by Type

• 6.1. Introduction
• 6.2. Biochemical Markers
  • 6.2.1. Alpha-fetoprotein
  • 6.2.2. C-Reactive Protein
  • 6.2.3. Corticotropin-Releasing Hormone
  • 6.2.4. IL-1, IL-2, IL-8, TNF-a
  • 6.2.5. Insulin-like Growth Factor Binding Protein-1
  • 6.2.6. Interleukin (IL)-6
  • 6.2.7. Placental Alpha Microglobulin-1
• 6.3. Ferning Test
• 6.4. Fetal Fibronectin
• 6.5. Nitazine Test
• 6.6. Pelvic exam
• 6.7. Pooling
• 6.8. Ultrasound
• 6.9. Uterine Monitoring

7. Preterm Birth & PROM Testing Market, by Sample

• 7.1. Introduction
• 7.2. Amniotic Fluid
• 7.3. Blood
• 7.4. Urine
• 7.5. Vaginal Secretions

8. Preterm Birth & PROM Testing Market, by End-User

• 8.1. Introduction
• 8.2. Diagnostic Laboratories
• 8.3. Hospitals & Clinics
• 8.4. Specialty Centers

9. Americas Preterm Birth & PROM Testing Market

• 9.1. Introduction
• 9.2. Argentina
• 9.3. Brazil
• 9.4. Canada
• 9.5. Mexico
• 9.6. United States

10. Asia-Pacific Preterm Birth & PROM Testing Market

• 10.1. Introduction
• 10.2. Australia
• 10.3. China
• 10.4. India
• 10.5. Indonesia
• 10.6. Japan
• 10.7. Malaysia
• 10.8. Philippines
• 10.9. Singapore
• 10.10. South Korea
• 10.11. Taiwan
• 10.12. Thailand
• 10.13. Vietnam

11. Europe, Middle East & Africa Preterm Birth & PROM Testing Market

• 11.1. Introduction
• 11.2. Denmark
• 11.3. Egypt
• 11.4. Finland
• 11.5. France
• 11.6. Germany
• 11.7. Israel
• 11.8. Italy
• 11.9. Netherlands
• 11.10. Nigeria
• 11.11. Norway
• 11.12. Poland
• 11.13. Qatar
• 11.14. Russia
• 11.15. Saudi Arabia
• 11.16. South Africa
• 11.17. Spain
• 11.18. Sweden
• 11.19. Switzerland
• 11.20. Turkey
• 11.21. United Arab Emirates
• 11.22. United Kingdom

12. Competitive Landscape

• 12.1. Market Share Analysis, 2023
• 12.2. FPNV Positioning Matrix, 2023
• 12.3. Competitive Scenario Analysis
  • 12.3.1. Novocuff Inc. secures USD 26 million in Series A funding to advance pioneering device addressing preterm birth and PROM with global impact
  • 12.3.2. Clarius Mobile Health's FDA-cleared Clarius OB AI tool enhances prenatal care with automated fetal biometry in the U.S. and Canada
  • 12.3.3. Lumos Diagnostics secures an additional USD 5 million from Hologic to enhance preterm birth diagnostics with advanced fetal fibronectin test
  • 12.3.4. Samsung Medison acquires Sonio SAS to integrate advanced AI technologies with ultrasound systems
  • 12.3.5. Natera Inc. unveils revolutionary cell-free DNA RhD test improving RhD-negative pregnancy care and conserving RhIg resources
  • 12.3.6. Revvity unveils NGS panel workflow to enhance newborn screening capabilities
  • 12.3.7. BillionToOne launches a new non-invasive prenatal test for preterm birth risk and PROM testing
  • 12.3.8. Cord Blood Registry (CBR) and Fulgent Genetics introduce advanced genetic testing services
  • 12.3.9. Bloomlife and PeriGen collaborate to address maternal and fetal health needs in underserved regions
  • 12.3.10. BillionToOne and Janssen collaborate on phase 3 AZALEA clinical trial of nipocalimab for HDFN
  • 12.3.11. Hologic collaborates with AAGL and Inovus Medical to advance OB-GYN training with advanced simulation technology
  • 12.3.12. GE HealthCare receives USD 44 million Gates Foundation grant to develop AI-assisted ultrasound for improving maternal and child healthcare in low-and-middle-income countries
• 12.4. Strategy Analysis & Recommendation
  • 12.4.1. Hologic, Inc.
  • 12.4.2. Laboratory Corporation of America Holdings
  • 12.4.3. Revvity, Inc.
  • 12.4.4. Siemens Healthineers AG

Companies Mentioned

• 1. Abbott Laboratories
• 2. BillionToOne, Inc.
• 3. Biosynex SA
• 4. Eurofins Scientific SE
• 5. F. Hoffmann-La Roche AG
• 6. FUJIFILM Holdings Corporation
• 7. GE HealthCare Technologies, Inc.
• 8. Hologic, Inc.
• 9. Igenomix India Private Limited
• 10. Illumina, Inc.
• 11. Koninklijke Philips N.V.
• 12. Laboratory Corporation of America Holdings
• 13. Medix Biochemica Group
• 14. Nanjing Liming Bio-products Co., Ltd.
• 15. Natera, Inc.
• 16. NX Prenatal, Inc.
• 17. Pro Lab Diagnostics Inc
• 18. Qiagen N.V.
• 19. Revvity, Inc.
• 20. Samsung Electronics Co., Ltd.
• 21. Sekisui Diagnostics, LLC
• 22. Sera prognostics, Inc.
• 23. Siemens Healthineers AG
• 24. The Cooper Companies, Inc.
• 25. Thermo Fisher Scientific Inc.