조산 및 조기양막파수 검사 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the preterm birth and PROM testing market size is expected to grow from USD 1.65 billion in 2025 to USD 1.78 billion in 2026 and is forecast to reach USD 2.59 billion by 2031 at 7.81% CAGR over 2026-2031.

This report is Segmented by Test Type (Pelvic Examination, and More), Biomarker Category (Fetal Fibronectin (fFN), Placental Alpha-Microglobulin-1 (PAMG-1), and More), Setting (Laboratory-Based Testing and Point-Of-Care/Emergency Dept. ), Geography (North America, Europe, Asia-Pacific, The Middle East and Africa, and South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Preterm Birth And PROM Testing Market Trends and Insights

Rising Global Preterm Birth Incidence

Annual preterm births already exceed 15 million and continue climbing despite medical advances. Asia accounts for more than half of those births, intensifying diagnostic demand in high-population regions. Preterm complications cost the United States health system over USD 25 billion each year, spurring payer investment in early detection technologies that reduce neonatal intensive care stays. Reduction of neonatal mortality has become a central performance metric in national maternal-child health plans, ensuring that budget allocations favor evidence-based diagnostic tools. Advanced maternal age, increasingly common in developed economies, raises baseline risk and keeps demand elevated over the long term.

Technological Advancements in Point-of-Care Diagnostics

Hand-held and bedside analyzers now deliver results within minutes, eliminating laboratory delays during acute obstetric evaluations. Quantitative ultrasound that maps cervical microstructure predicts preterm risk as early as week 23, a notable improvement over history-based assessments. Wearable sensors capturing heart-rate variability supply real-time data feeds that machine-learning models convert into 82% accurate risk scores. Combining artificial intelligence with established biomarkers increases diagnostic specificity while minimizing false positives. Such converged platforms strengthen the role of point-of-care testing within the preterm birth and PROM testing market.

Limited Accessibility in Low-Resource Settings

Diagnostics uptake lags in regions with fragile health infrastructure where preterm birth rates are highest. Shortages of trained personnel and laboratory equipment restrict biomarker testing coverage. The cessation of fetal fibronectin supply in remote Australian clinics forced costly patient transfers and highlighted supply chain fragility. Persistent digital divides hamper telehealth solutions, and cold-chain requirements add logistical hurdles. These systemic barriers slow penetration of the preterm birth and PROM testing market in underserved regions.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion of Prenatal Screening Programs
2. Increasing Healthcare Expenditure on Maternal Care
3. High Cost of Advanced Diagnostic Tests

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Ultrasound retained a 38.12% revenue share in 2025, securing its place as the primary modality for cervical-length assessment and fetal surveillance. Quantitative ultrasound now detects microstructural cervical changes that forecast preterm birth risk several weeks earlier than legacy imaging approaches. Biochemical markers, accounting for a smaller 2025 base, exhibit the fastest 9.96% CAGR as clinicians seek objective molecular readouts that complement imaging. Pelvic examination and uterine monitoring continue to serve supportive roles but lack the predictive power of combined biomarker panels. Emerging digital biomarkers and AI-powered analytics promise integrated solutions, signaling longer-term evolution of the preterm birth and PROM testing market.

The widening preference for multimodal assessment underscores a shift toward comprehensive risk profiling. Ultrafast imaging plus biomarker quantification delivers actionable probabilities that drive early interventions such as antenatal steroids. Remote ultrasound systems linked to specialist review extend capability to community settings, while disposable biochemical cartridges simplify bedside workflows. These converging trends strengthen future demand within the preterm birth and PROM testing market size for hybrid platforms that merge imaging with molecular diagnostics.

Fetal fibronectin (fFN) commands 41.88% share and remains clinically entrenched due to robust guideline support. Negative fFN results give clinicians 96% confidence that delivery will not occur within two weeks, allowing safe discharge and cost avoidance. Placental alpha-microglobulin-1 (PAMG-1) is growing at a 10.07% CAGR and demonstrates superior predictive performance for delivery within seven days. IGFBP-1 gains traction in low-resource environments because it delivers 91% sensitivity and 82.6% specificity using minimally invasive collection. Cytokines and cell-free RNA represent frontier categories undergoing clinical validation.

Competitive dynamics within the biomarker space are intensifying as novel targets enter multi-analyte panels. Assay developers emphasize high positive predictive value to minimize unnecessary interventions. Laboratories leverage digital PCR for quantitative reads that refine cutoffs and stratify risk tiers, thereby expanding the preterm birth and PROM testing market size for advanced biomarker panels.

Complete Report Scope:

• By Test Type
  • Pelvic Examination
  • Ultrasound
  • Biochemical Markers
  • Uterine Monitoring
  • Other Test Types
• By Biomarker Category
  • Fetal Fibronectin (fFN)
  • Placental Alpha-Microglobulin-1 (PAMG-1)
  • Insulin-Like Growth Factor-Binding Protein-1 (IGFBP-1)
  • Interleukins & Other Cytokines
• By Setting
  • Laboratory-Based Testing
  • Point-Of-Care / Emergency Dept.
• By End User
  • Hospitals & Maternity Centers
  • Diagnostic Laboratories
  • Ambulatory & Freestanding Birth Centers
  • Home-Care & Remote Monitoring
• Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 42.76% of 2025 revenue due to near-universal insurance coverage for key biomarker assays, including new CPT payment for at-home fetal monitoring that removed a traditional access barrier. The United States leads global direct-to-consumer uptake, reflecting strong digital health maturity and patient engagement. Canada's single-payer system funds national screening programs, ensuring consistent demand. Mexico's public-private partnerships extend testing to rural areas, though logistic bottlenecks remain. While urban centers showcase high penetration, Indigenous and remote communities still report lower utilization, indicating pockets of unmet need within the preterm birth and PROM testing market.

Asia-Pacific is the fastest-growing region at 9.28% CAGR through 2031. China channels substantial public funds into maternal-child health and conducts cohort studies across 60 neonatal intensive care units that help validate diagnostics. India's private providers integrate cost-efficient assays into large antenatal camps, while policy reforms aim to lower out-of-pocket costs. Japan and South Korea drive premium-segment demand for high-sensitivity biomarker panels, supported by advanced hospital networks. Australia's supply disruptions underscore ongoing infrastructure challenges that vendors must address to capture rural opportunities. Diverse income profiles in the region create segmented pricing strategies across the preterm birth and PROM testing market.

Europe maintains steady expansion on the strength of harmonized clinical guidelines and stable reimbursement. NICE recommendations standardize biomarker use across the United Kingdom, which speeds hospital adoption. Germany and France allocate public budgets for preventive screening, integrating tests into bundled antenatal packages. Italy and Spain deploy point-of-care kits in midwife-led clinics to reduce referral delays. Regulatory clarity encourages innovation, though value assessments remain stringent. Meanwhile, Middle East & Africa and South America register rising attention from multilateral aid programs. Limited infrastructure slows immediate growth, yet unmet clinical need remains pronounced, signaling longer-term upside for the preterm birth and PROM testing market.

1. Hologic
2. Abbott Laboratories
3. QIAGEN
4. Sera Prognostics
5. The Cooper Companies
6. Biosynex
7. Intelligent Implants
8. NX Prenatal
9. Clinical Innovations
10. LifeCell International
11. Medix Biochemica
12. Hangzhou Singclean Medical
13. Shuwen Biotech
14. Creative Diagnostics
15. LabCorp
16. Quest Diagnostics
17. Eurofins
18. Genova Diagnostics
19. Sysmex
20. Randox Laboratories

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Global Preterm Birth Incidence
  • 4.2.2 Technological Advancements In Point-Of-Care Diagnostics
  • 4.2.3 Expansion Of Prenatal Screening Programs
  • 4.2.4 Increasing Healthcare Expenditure On Maternal Care
  • 4.2.5 Favorable Reimbursement And Regulatory Support
  • 4.2.6 Growing Adoption Of Telehealth And Home Testing
• 4.3 Market Restraints
  • 4.3.1 Limited Accessibility In Low-Resource Settings
  • 4.3.2 High Cost Of Advanced Diagnostic Tests
  • 4.3.3 Stringent Regulatory Approval Processes
  • 4.3.4 Competition From Alternative Monitoring Modalities
• 4.4 Regulatory Landscape
• 4.5 Porter's Five Forces Analysis
  • 4.5.1 Threat Of New Entrants
  • 4.5.2 Bargaining Power Of Buyers/Consumers
  • 4.5.3 Bargaining Power Of Suppliers
  • 4.5.4 Threat Of Substitute Products
  • 4.5.5 Intensity Of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Test Type
  • 5.1.1 Pelvic Examination
  • 5.1.2 Ultrasound
  • 5.1.3 Biochemical Markers
  • 5.1.4 Uterine Monitoring
  • 5.1.5 Other Test Types
• 5.2 By Biomarker Category
  • 5.2.1 Fetal Fibronectin (fFN)
  • 5.2.2 Placental Alpha-Microglobulin-1 (PAMG-1)
  • 5.2.3 Insulin-Like Growth Factor-Binding Protein-1 (IGFBP-1)
  • 5.2.4 Interleukins & Other Cytokines
• 5.3 By Setting
  • 5.3.1 Laboratory-Based Testing
  • 5.3.2 Point-Of-Care / Emergency Dept.
• 5.4 By End User
  • 5.4.1 Hospitals & Maternity Centers
  • 5.4.2 Diagnostic Laboratories
  • 5.4.3 Ambulatory & Freestanding Birth Centers
  • 5.4.4 Home-Care & Remote Monitoring
• 5.5 Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East & Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East & Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Business Segments, Financials, Headcount, Key Information, Market Rank, Market Share, Products and Services, and analysis of Recent Developments)
  • 6.3.1 Hologic, Inc.
  • 6.3.2 Abbott
  • 6.3.3 QIAGEN
  • 6.3.4 Sera Prognostics
  • 6.3.5 CooperSurgical
  • 6.3.6 Biosynex
  • 6.3.7 Intelligent Implants
  • 6.3.8 NX Prenatal
  • 6.3.9 Clinical Innovations
  • 6.3.10 LifeCell International
  • 6.3.11 Medix Biochemica
  • 6.3.12 Hangzhou Singclean Medical
  • 6.3.13 Shuwen Biotech
  • 6.3.14 Creative Diagnostics
  • 6.3.15 Labcorp
  • 6.3.16 Quest Diagnostics
  • 6.3.17 Eurofins Scientific
  • 6.3.18 Genova Diagnostics
  • 6.3.19 Sysmex
  • 6.3.20 Randox Laboratories

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment