U.S. Preterm Birth Diagnostic Test Kit Market Set to Reach US$74.4 Mn by 2032, Growing at 6.3% CAGR

According to the latest analysis by Persistence Market Research, the U.S. Preterm Birth Diagnostic Test Kit Market is projected to witness strong growth over the coming years. The market size is estimated to be US$48.5 million in 2025 and is expected to reach US$74.4 million by 2032, expanding at a steady CAGR of 6.3% during the forecast period (2025-2032).

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Rising Demand for Early Detection of Preterm Birth Risks
Preterm birth-defined as childbirth before 37 weeks of pregnancy-remains a significant public health concern in the United States. With rising awareness about maternal and neonatal health, the demand for reliable and rapid diagnostic test kits has surged. These kits help healthcare providers identify high-risk pregnancies early, enabling timely medical interventions and improving newborn survival outcomes.
The increasing prevalence of preterm births, coupled with advancements in diagnostic technologies and growing adoption of point-of-care (POC) testing, is driving consistent market growth. Moreover, initiatives to reduce neonatal mortality and healthcare costs are further supporting market expansion.

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Key Market Insights

• Market Size (2025): US$48.5 million
• Forecast (2032): US$74.4 million
• CAGR (2025-2032): 6.3%
• Key Segment: Fetal Fibronectin (fFN) Test Kits
• Primary End Users: Hospitals, Diagnostic Laboratories, and Point-of-Care Clinics
Fetal Fibronectin-based diagnostic kits continue to lead the market, thanks to their proven accuracy and clinical reliability. Additionally, innovations in non-invasive biomarkers-such as cell-free RNA (cfRNA) and protein-based assays-are expected to open new growth opportunities for manufacturers.

Growth Drivers

• Rising Preterm Birth Rates: The increasing incidence of premature deliveries in the U.S. is fueling the need for effective risk assessment tools.
• Advances in Point-of-Care Testing: POC kits enable faster diagnosis and immediate medical response, reducing unnecessary hospital admissions.
• Integration with Digital Health Platforms: AI and digital analytics are being integrated into test kits to enhance predictive accuracy.
• Supportive Healthcare Policies: Growing focus on maternal health programs and insurance coverage for prenatal diagnostics is boosting market adoption.

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Top Key Players:

• Creative Diagnostics
• QIAGEN Sciences LLC
• Actim Oy
• Hysen Biotech
• Hologic, Inc.
• Sera
• Biomatik
• Laborie
• Elabscience® Bionovation Inc.
• CUSABIO TECHNOLOGY LLC
• IQ Products
• Biosynex SA

Market Segmentation

By Product
• Fetal Fibronectin Test Kits
• Placental Alpha Micro-Globulin-1 Test Kits
• Insulin Like Growth Factor Binding Protein-1 (iGFBP-1) Test Kits
By Sample
• Blood
• Urine
• Vaginal Discharge
By Technology
• Lab-based Testing
• POC Testing
By End-user
• Hospitals
• Outpatient Clinics
• Diagnostic Centers
• Others
By Region
• U.S.

Market Challenges

Despite strong potential, some challenges persist-such as variations in diagnostic accuracy, high costs of advanced test kits, and limited awareness among healthcare providers in certain regions. Addressing these gaps through education and improved accessibility remains crucial for sustained market growth.

Future Outlook

The U.S. preterm birth diagnostic test kit market is entering a transformative phase, driven by innovation and preventive healthcare trends. With ongoing investments in research and the integration of biomarker-based technologies, the market is expected to witness strong partnerships between medical device companies, hospitals, and research institutions.
As healthcare shifts toward predictive and personalized care, early detection tools for preterm birth will play a vital role in reducing risks, enhancing maternal well-being, and improving neonatal survival rates

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