Europe Preterm Birth and Premature Rupture of Membranes (PROM) Testing Market to Witness 8.3% CAGR by 2031

Europe Preterm Birth and Premature Rupture of Membranes (PROM) Testing Market Size, Trends, Potential | 2025 - 2031

Executive Summary

The Preterm Birth and PROM Testing Market is poised for substantial growth between 2025 and 2031, driven by increasing incidences of preterm labor, technological advancements in biomarker diagnostics, and rising maternal healthcare awareness across emerging markets. The global market size was valued at approximately USD 1.4 billion in 2023 and is expected to reach around USD 2.45 billion by 2030, growing at a CAGR of 8.3%​

grandviewresearch.com

.

Access full Report Description, TOC, Table of Figure, Chart, etc. @ https://www.marketreportsinsights.com/industry-forecast/preterm-birth-and-premature-rupture-of-membranes-prom-testing-market-2022-129203

2. Market Definition and Scope

2.1 Definition

Preterm birth refers to childbirth that occurs before 37 completed weeks of gestation, while PROM is the rupture of the amniotic sac before labor onset. Early detection is critical to managing both conditions effectively. The market comprises diagnostic tools, kits, reagents, and digital technologies to detect biomarkers, monitor uterine activity, and assess cervical changes.

2.2 Scope

• Test Types: Biomarker testing, pelvic exams, ultrasound, pooling, nitrazine and ferning tests, uterine monitoring.
  
  

• Products: Kits, reagents, consumables, and instruments.
  
  

• End Users: Hospitals, diagnostic labs, outpatient clinics, research institutions.
  
  

3. Market Dynamics

3.1 Drivers

• Rising Preterm Birth Rates: Globally, preterm births are increasing, particularly in Asia Pacific and North America. Factors include lifestyle changes, maternal age, and medical conditions​
  growthmarketreports.com
  .
  
  

• Technology Advancements: Innovative non-invasive prenatal testing (NIPT), point-of-care (POC) diagnostics, and remote monitoring tools improve screening efficiency​
  coherentmarketinsights.com
  .
  
  

• Awareness & Government Support: Public and private initiatives in maternal health are promoting early diagnostic interventions, especially in developing economies​
  grandviewresearch.com
  .
  
  

3.2 Restraints

• High Testing Costs: Advanced diagnostics like NIPT remain expensive in many regions, limiting access in low-income populations.
  
  

• Regulatory Challenges: Complex regulatory pathways and approval processes slow the adoption of newer diagnostic tools.
  
  

• Skilled Personnel Shortage: Developing countries often lack trained healthcare professionals to administer and interpret diagnostic tests.
  
  

3.3 Opportunities

• Home-Based Testing Models: Growing preference for decentralized, self-testing models offers scope for market expansion.
  
  

• Multiplex Biomarker Panels: Integration of multiple biomarkers for improved predictive accuracy enhances test reliability.
  
  

• Digital Health Integration: AI-powered apps and wearable devices with diagnostic capabilities present untapped potential.
  
  

4. Market Trends

• Rise of Point-of-Care and Home Diagnostics: Self-administered tools and mobile diagnostics are gaining prominence for PROM and preterm risk assessment​
  coherentmarketinsights.com
  .
  
  

• Shift Toward Multiplex Testing: Combining biomarkers like PAMG-1, fetal fibronectin (fFN), and clinical data improves early diagnosis.
  
  

• Digital Health & Remote Monitoring: Tools like uterine activity trackers and remote monitoring platforms like INVU show promising results​
  growthmarketreports.com
  .
  
  

• Geographic Expansion of Diagnostic Access: Efforts to penetrate underserved markets in Asia Pacific and Africa continue to grow, driven by global health initiatives.
  
  

5. Segmentation Analysis

5.1 By Test Type

• Biochemical Markers (High CAGR): Includes PAMG-1, fetal fibronectin, and interleukins. These offer high sensitivity and early detection.
  
  

• Ultrasound: Conventional method to assess cervical length but lower sensitivity compared to biomarkers.
  
  

• Pelvic Exams & Others: Still in use but gradually replaced by more accurate tests.
  
  

5.2 By Product

• Kits & Reagents: Dominant in terms of market share due to the frequency of use and consumable nature.
  
  

• Instruments: Includes ultrasound and monitoring devices. Capital-intensive but essential in hospital settings.
  
  

5.3 By End User

• Hospitals: Hold the majority market share due to their access to advanced diagnostic infrastructure.
  
  

• Diagnostic Laboratories: Gaining traction with the rise of outsourced testing.
  
  

• Research Centers & Clinics: Smaller share but important for innovation and specialty care.
  
  

6. Regional Insights

6.1 North America

• Market Share Leader (38.2% in 2022): High awareness, strong insurance coverage, and access to cutting-edge diagnostics.
  
  

• Challenges: Healthcare disparities in rural regions persist.
  
  

6.2 Asia Pacific

• Fastest Growing Region: Driven by rising birth rates, increasing awareness, and investments in maternal care.
  
  

• Key Markets: India and China, both experiencing a surge in preterm birth rates and neonatal complications​
  grandviewresearch.com
  .
  
  

6.3 Europe

• Steady Growth: Universal healthcare systems and favorable reimbursement drive adoption.
  
  

• Focus Areas: Integrating prenatal testing into routine pregnancy checkups.
  
  

6.4 Latin America and MEA

• Emerging Markets: Expanding healthcare infrastructure and NGO support help bridge diagnostic gaps.
  
  

7. Competitive Landscape (Excluding Companies)

While not naming companies, the market is characterized by innovation, with numerous diagnostic developers focusing on:

• Biomarker Innovation: Emphasis on identifying and validating novel biomarkers.
  
  

• Digital Expansion: Mobile apps and wearable uterine monitors are being introduced to support remote care.
  
  

• Collaborations: Strategic alliances to expand product portfolios and market reach.
  
  

8. Regulatory Landscape

• FDA & CE Approvals: New tests require validation through extensive clinical trials.
  
  

• Harmonization Needed: Variability in regional regulations often slows global product rollout.
  
  

9. Investment & R&D

Substantial investments in R&D are channeled into developing:

• Rapid Diagnostic Tests (RDTs)
  
  

• AI-driven Clinical Decision Tools
  
  

• Affordable Screening Solutions for LMICs
  
  

Academic partnerships and government-funded trials further support innovation in this space.

10. Forecast: 2025–2031

10.1 Market Size Projections

• 2025 Estimated Market Value: ~$1.65 billion
  
  

• 2031 Estimated Market Value: ~$2.95 billion
  
  

• CAGR (2023–2030): 8.3%, with potential for continued growth beyond 2030​
  grandviewresearch.com
  .
  Request Sample Report @ https://www.marketreportsinsights.com/sample/129203

10.2 Segment Growth Highlights

• Biochemical Testing: To grow at the highest CAGR among test types.
  
  

• Asia Pacific: Expected to contribute most significantly to new market revenue.