Preterm Birth Diagnostic Test Kits Market Size, Share, Opportunities, And Trends By Product Type (Fetal Fibronectin Test Kits (fFN), Placental Alpha Micro-globulin-1 Test Kits (PAMG-1), Insulin-like Growth Factor Binding Protein-1 Test Kits (IGFBP-1), Others), By Sample Type (Blood Sample, Urine Sample, Vaginal Discharge Sample), By End-User (Hospitals, Diagnostic Centers, Clinics, Others), And By Geography - Forecasts From 2024 To 2029

The preterm birth diagnostic test kit market is projected to show steady growth during the forecast period.

A preterm birth diagnostic kit is a medical device that, by measuring specific biomarkers found in blood or urine samples, helps healthcare professionals better predict the likelihood of a preterm birth. Diagnostic test kits for preterm delivery are classified into different categories, including placental alpha microglobulin-1 test (PAMG-1) and fetal fibronectin test (fFN) kits. These kits provide quick and easy results for preterm labor and premature rupture of the membranes. Increasing circumstances of preterm births, rise in diagnosis regime for preterm births, and increased focus on personalized medicine are driving the preterm birth diagnostic kits market growth.

Market Drivers:

• Increasing circumstances of preterm birth drive the preterm birth diagnostic kits market growth.

A premature birth occurs when a baby is born before 37 weeks of pregnancy. These babies often face health issues due to their underdeveloped state, and early detection can improve outcomes. According to the National Vitals for Statistics published report in 2024, in recent years, there has been a slight increase in the rate of premature births. From 2014 to 2022, the percentage of premature births rose from 7.7% to 8.7%. This indicates a consistent annual increase of almost 2% from 2014 to 2019. However, the rate has fluctuated in recent years, with a slight decline in 2020 and 2022, and a slight increase in 2021. Despite some variation, the overall trend suggests a minor rise in the rate of premature births.

• The rise in diagnosis regimes for preterm birth propels the market growth.

Advancements in biomarker research and diagnostic technology are leading to the development of more precise, reliable, and non-invasive clinical test kits. According to a Cleveland Clinic report it is stated that, when a woman is pregnant, the body produces a protein called fetal fibronectin. This protein plays a crucial role in keeping the amniotic sac attached to the lining of the uterus. Doctors can conduct a fFN test to measure the amount of fFN present in vaginal fluid. This test helps to determine the likelihood of preterm birth.

• Increased focus on personalized medicine projects the preterm birth diagnostic kits market growth.

Personalized medicine aims to customize interventions and treatments to each individual, causing a paradigm shift in healthcare. According to the National Institute of Health published an article on precision medicine in gynecology, precision medicine is an area of research that has the potential to revolutionize how to diagnose and treat illnesses. By using the principles of molecular medicine, nanotechnology, and precision medicine, therapeutic compounds can be delivered directly to specific cells and organs, thus improving treatment outcomes while minimizing side effects. The field of obstetrics offers numerous opportunities to leverage precision medicine as a diagnostic and therapeutic tool. Moreover, there is scope to develop innovative approaches to address the challenges associated with fetal growth restriction, preterm birth, and fetal abnormalities, among other things.

North America is projected to grow significantly.

North America is projected to account for a significant share of the preterm birth diagnostic kits market due to the increasing preterm birth rates coupled with favorable government initiatives to prevent the same in the major countries in the region. According to the March of Dimes Report Card 2023, in the United States, over 380,000 babies, which is equivalent to 10.4% of all births, were born prematurely in the year 2022. Additionally, in May 2023, congress reauthorized the PREEMIE ACT for five years, which is an initiative to continue addressing preterm birth through federal research, promoting established therapies, and encouraging community initiatives.

Market Restraints

• Inappropriate accuracy and reliability tests with respective diagnostic kits obstruct the preterm birth diagnostic kit market.

The accuracy of the respective kit is not 100% correct and reliable. False positive results can cause unnecessary concern and interventions for pregnant women. Additionally, false negative results may impede early detection and necessary action.

Key Developments:

• June 2022: Pregnolia announced the building of a new diagnostic tool that estimates the probability of preterm birth using cervical tissue stiffness. It is twice as efficient as standard ultrasound technology, safe, and easy to use. In November 2023, the company secured a second round of funding for its device.

Company Products:

• Preterm Birth Diagnostic Kit PartoSure Test: Preterm birth diagnostic kit PartoSure test is a quick, non-instrumented, qualitative immunochromatographic test for detecting placental alpha microglobulin-1 in pregnant women's vaginal secretions offered by Qiagen. The gadget is intended to assist in quickly determining the likelihood of an early birth within 7 or 14 days after the cervicovaginal sample is taken from a pregnant woman exhibiting early labor symptoms, intact amniotic membranes, and minimal cervical dilatation (≤ 3 cm). The sample must be taken between 20 weeks, 0 days, and 36 weeks, 6 days of gestation.
• Preterm Birth Diagnostic Kit Amnioquick: Amnioquick, a quick and simple in vitro test offered by Biosynex, can determine whether a pregnant woman has a premature rupture of the membranes around her fetus (PROM). Preterm prelabour rupture of membranes (P-PROM) occurs when the membranes rupture before the commencement of labor in a patient who is less than 37 weeks pregnant.
• Preterm Birth Diagnostic Kit Actim PROM: The Actim prom test kit is a fast test for detecting premature rupture of membranes, which is the breakdown of the amniotic sac before childbirth. PROM is a dangerous disorder that can cause infection and other issues for both the mother and the baby.

Segmentation

• By Product Type
  • Fetal fibronectin test kits (fFN)
  • Placental alpha micro-globulin-1 test kits (PAMG-1)
  • Insulin-like growth factor binding protein-1 test kits (IGFBP-1)
  • Others
• By Sample Type
  • Blood sample
  • Urine sample
  • Vaginal discharge sample
• By End-User
  • Hospitals
  • Diagnostic centers
  • Clinics
  • Others
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • South America
    • Brazil
    • Argentina
    • Others
  • Europe
    • United Kingdom
    • Germany
    • France
    • Italy
    • Spain
    • Others
  • Middle East and Africa
    • Saudi Arabia
    • UAE
    • Others
  • Asia Pacific
    • Japan
    • China
    • India
    • South Korea
    • Taiwan
    • Thailand
    • Indonesia
    • Others