Pre-term Diagnostic Market Size, Share, Growth, Trends, and Global Industry Analysis: By Diagnostic Method (Foetal Fibronectin Testing, Cervical Length Measurement, Biomarker-Based Tests, Electrohysterography, Genetic and Epigenetic Testing, Digital Risk Assessment Tools), By Technology (Immunoassay, Ultrasound, Molecular Diagnostics, AI-Powered Predictive Platforms, Point-of-Care Devices), By End Use (Hospitals, Diagnostic Laboratories, Maternity & Birthing Centres, Research & Academic Institutes, Community Health Clinics), and Region Forecast 2020-2031

Pre-term Diagnostic Market size was valued at US$ 870 million in 2024 and is expected to reach US$ 1,300 million by 2031, growing at a significant CAGR of 5.8% from 2025-2031. Moreover, the U.S. Pre-term Diagnostic Market is projected to grow significantly, reaching an estimated value of US$ 500 million by 2031. The market is gaining essential momentum as the medical world comes towards anticipatory prenatal care. Preterm birth remains a dominant cause of neonatal deaths and long-term developmental problems, so the early and accurate determination of risk becomes a clinical necessity. The market is no longer screening; it's about making intervention feasible on an individual basis and transforming obstetric decision-making.

From foetal fibronectin (fFN) cervicovaginal screening to transvaginal performed ultrasounds and biomarker panels, diagnostics are more sensitive, less intrusive, and real-time relevant. In this high-stakes maternal-foetal health space, diagnostics are no longer merely a portal to care, but a gate barrier, allowing clinicians to act ahead of the risk too far along. What is notable about the new market direction is a loud call for accessibility, digitization, and evidence-based testing. Startups and diagnostic firms are investing in low-cost point-of-care technologies that are capable of functioning effectively in low-resource settings, especially where prenatal care is not regular.

Clinical studies, however, are improving the knowledge around biomarkers of preterm labour, which is fuelling new product pipelines by multinational firms. Governments and NGOs are investing in maternal health programs that include early diagnostic screening as a measure of preventing instances. The goal is changing: no longer just to identify high-risk pregnancies, but to integrate diagnostics into routine care systems globally. This change is incorporating the market as a component of modern prenatal healthcare systems, not as an auxiliary support system.

Facts & Figures

• Preterm birth remains the leading cause of child death under the age of five, and over 15 million preterm infants are born annually across the world, sustaining a widespread unmet demand for earlier diagnosis technology.
• Clinical trials have proven that the use of quantitative foetal fibronectin testing and cervical length measurement together increases predictive probability of spontaneous preterm birth by over 50% over single-screening strategies.
• Over 30% of global maternal health spending invested by multilateral donor organizations in 2024 was spent on diagnostic or early detection centre funds in high-risk pregnancy schemes.
• AI startup firms targeting maternal health doubled in 2021 with an utmost interest in developing smart triage platforms for preterm labour prediction and intervention planning.

Key Developments:

• In July 2025, Sera Prognostics announced initial findings from the AVERT PRETERM TRIAL, proving the clinical utility of serum biomarker testing in the assessment of the risk of preterm birth, complementing its predictive, personalized obstetric care strategy.
• In April 2025, A study published in PLOS Medicine discovered that testing for cell-free DNA (cfDNA), done routinely in early pregnancy screening tests, may be a cost-effective and non-invasive method for detecting risk of preterm birth, pre-empting inclusion in routine prenatal care.
• In June 2021, Medix Biochemical launched MedixMDx, a molecular diagnostics business segment offering tailored reagent solutions, positioning itself as a strategic ally for biomarker-directed preterm diagnostic innovation.

Pre-term Diagnostic Market Segmentation:

Based on the Diagnostics Methods:

• Foetal Fibronectin Testing
• Cervical Length Measurement
• Genetic and Epigenetic Testing

Testing for foetal fibronectin (fFN) is the most clinically valid and practiced technique for preterm labour risk assessment. It detects a protein in the maternal-foetal interface which, under normal circumstances, dissolves in the second or third trimester between 22–35 weeks of pregnancy. Detection of a positive fFN result during this time reflects an impaired barrier, hence elevated risk of preterm labour. Why it is effective is that it has a high negative predictive value, if the test is negative, there is a 99% probability that the patient won't deliver within two weeks. This spares clinicians from unnecessary interventions, hospitalization, or steroid treatment. Its strength, its ease of use, and its strong incorporation into clinical practice position fFN testing as a cornerstone of managing preterm birth uncertainty.

Based on the technology:

• Immunoassay
• Ultrasound, Molecular Diagnostics
• AI-Powered Predictive Platforms
• Point-of-Care Devices

Point-of-care (POC) technology is transforming the diagnosis of preterm by bringing rapid, reliable testing to maternity wards and rural clinics. POC instruments enable clinicians to assess preterm risk in real time, without standing by for lab processing in a distant location. Easy to carry and simple to operate, these devices are well suited to resource-poor settings, where delays in diagnosis mean lost opportunities for intervention. Microfluidics and platform advances in lateral flow assay are propelling low-cost but high-performance kits for the detection of biomarkers like foetal fibronectin or markers of cervical inflammation. With healthcare systems decentralizing globally, POC diagnostics offer a nimble, scalable solution, allowing for earlier, more equal maternal risk assessment, irrespective of geography or infrastructure.

Based on the end user:

• Hospital
• Diagnostic Laboratories
• Academic and Research Institutes
• Maternity & Birthing Centres
• Community Health Clinics

Hospitals remain the most critical centre of preterm diagnostic technologies due to having access to laboratory, imaging, and specialist obstetric care. They offer the setting for clinicians to combine the diagnostic tests, cervical length ultrasound, biomarker assays, and patient history, into an integrated risk profile. Specifically, emergency obstetric departments rely on diagnostics to guide timely decisions on steroid administration, tocolytic therapy, or induction of labour. Hospitals are also in better position to adopt innovations earlier due to budgetary latitude and academic ties, participating in clinical trials which feed back into future guidelines. Their ability to deploy diagnostics throughout triage, antenatal wards, and labour rooms allows for continuity of care and prompt response, positioning them as both front and referral sites in preterm risk management.