Preterm Birth And PROM Testing Market Size, Share & Trends Report

Preterm Birth And PROM Testing Market Size, Share & Trends Analysis Report By Test Type (Pelvic Exam, Ultrasound, Biochemical Markers, Uterine Monitoring), By Application (PROM, Preterm Labor), By Region, And Segment Forecasts, 2023 - 2030

  • Report ID: GVR-3-68038-055-2
  • Number of Pages: 120
  • Format: Electronic (PDF)
  • Historical Range: 2018 - 2021
  • Industry: Healthcare

Market Segmentation

  • Preterm Birth and PROM Testing Type Outlook (Revenue, USD Million, 2018 - 2030)
    • Pelvic exam
    • Ultrasound
    • Biochemical Markers
      • Interleukin (IL)-6
      • C-Reactive Protein (CRP)
      • IL-1, IL-2, IL-8, TNF-a
      • Corticotropin-Releasing Hormone (CRH)
      • Alpha-fetoprotein (AFP)
    • Uterine Monitoring
    • Nitazine Test
    • Ferning Test
    • Pooling
    • PAMG-1 Immunoassay
    • IGFBP Test
    • Fetal Fibronectin (fFN)
    • Others
  • Preterm Birth and PROM Testing Application Type Outlook (Revenue, USD Million, 2018 - 2030)
    • PROM
    • Preterm Labor
    • Chorioamnionitis
  • Preterm Birth and PROM Testing Regional Outlook (Revenue, USD Million, 2018 - 2030)
    • North America
      • North America Preterm Birth and PROM Testing Market, By Test Type
        • Pelvic exam
        • Ultrasound
        • Biochemical Markers
          • Interleukin (IL)-6
          • C-Reactive Protein (CRP)
          • IL-1, IL-2, IL-8, TNF-a
          • Corticotropin-Releasing Hormone (CRH)
          • Alpha-fetoprotein (AFP)
        • Uterine Monitoring
        • Nitazine Test
        • Ferning Test
        • Pooling
        • PAMG-1 Immunoassay
        • IGFBP Test
        • Fetal Fibronectin (fFN)
        • Others
      • North America Preterm Birth and PROM Testing Market, By Application Type
        • PROM
        • Preterm Labor
        • Chorioamnionitis
      • U.S.
        • U.S. Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • U.S. Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
      • Canada
        • Canada Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • Canada Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
    • Europe
      • Europe Preterm Birth and PROM Testing Market, By Test Type
        • Pelvic exam
        • Ultrasound
        • Biochemical Markers
          • Interleukin (IL)-6
          • C-Reactive Protein (CRP)
          • IL-1, IL-2, IL-8, TNF-a
          • Corticotropin-Releasing Hormone (CRH)
          • Alpha-fetoprotein (AFP)
        • Uterine Monitoring
        • Nitazine Test
        • Ferning Test
        • Pooling
        • PAMG-1 Immunoassay
        • IGFBP Test
        • Fetal Fibronectin (fFN)
        • Others
      • Europe Preterm Birth and PROM Testing Market, By Application Type
        • PROM
        • Preterm Labor
        • Chorioamnionitis
      • Germany
        • Germany Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • Germany Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
      • U.K.
        • U.K. Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • U.K. Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
      • France
        • France Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • France Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
      • Italy
        • Italy Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • Italy Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
      • Spain
        • Spain Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • Spain Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
      • Denmark
        • Denmark Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • Denmark Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
      • Sweden
        • Sweden Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • Sweden Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
      • Norway
        • Norway Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • Norway Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
    • Asia Pacific
      • Asia Pacific Preterm Birth and PROM Testing Market, By Test Type
        • Pelvic exam
        • Ultrasound
        • Biochemical Markers
          • Interleukin (IL)-6
          • C-Reactive Protein (CRP)
          • IL-1, IL-2, IL-8, TNF-a
          • Corticotropin-Releasing Hormone (CRH)
          • Alpha-fetoprotein (AFP)
        • Uterine Monitoring
        • Nitazine Test
        • Ferning Test
        • Pooling
        • PAMG-1 Immunoassay
        • IGFBP Test
        • Fetal Fibronectin (fFN)
        • Others
      • Asia Pacific Preterm Birth and PROM Testing Market, By Application Type
        • PROM
        • Preterm Labor
        • Chorioamnionitis
      • Japan
        • Japan Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • Japan Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
      • China
        • China Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • China Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
      • India
        • India Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • India Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
      • Australia
        • Australia Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • Australia Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
      • South Korea
        • South Korea Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • South Korea Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
      • Thailand
        • Thailand Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • Thailand Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
    • Latin America
      • Latin America Preterm Birth and PROM Testing Market, By Test Type
        • Pelvic exam
        • Ultrasound
        • Biochemical Markers
          • Interleukin (IL)-6
          • C-Reactive Protein (CRP)
          • IL-1, IL-2, IL-8, TNF-a
          • Corticotropin-Releasing Hormone (CRH)
          • Alpha-fetoprotein (AFP)
        • Uterine Monitoring
        • Nitazine Test
        • Ferning Test
        • Pooling
        • PAMG-1 Immunoassay
        • IGFBP Test
        • Fetal Fibronectin (fFN)
        • Others
      • Latin America Preterm Birth and PROM Testing Market, By Application Type
        • PROM
        • Preterm Labor
        • Chorioamnionitis
      • Brazil
        • Brazil Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • Brazil Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
      • Mexico
        • Mexico Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • Mexico Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
      • Argentina
        • Argentina Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • Argentina Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
    • Middle East and Africa (MEA)
      • Middle East and Africa Preterm Birth and PROM Testing Market, By Test Type
        • Pelvic exam
        • Ultrasound
        • Biochemical Markers
          • Interleukin (IL)-6
          • C-Reactive Protein (CRP)
          • IL-1, IL-2, IL-8, TNF-a
          • Corticotropin-Releasing Hormone (CRH)
          • Alpha-fetoprotein (AFP)
        • Uterine Monitoring
        • Nitazine Test
        • Ferning Test
        • Pooling
        • PAMG-1 Immunoassay
        • IGFBP Test
        • Fetal Fibronectin (fFN)
        • Others
      • Middle East and Africa Preterm Birth and PROM Testing Market, By Application Type
        • PROM
        • Preterm Labor
        • Chorioamnionitis
      • South Africa
        • South Africa Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • South Africa Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
      • Saudi Arabia
        • Saudi Arabia Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • Saudi Arabia Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
      • UAE
        • UAE Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • UAE Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis
      • Kuwait
        • Kuwait Preterm Birth and PROM Testing Market, By Test Type
          • Pelvic exam
          • Ultrasound
          • Biochemical Markers
            • Interleukin (IL)-6
            • C-Reactive Protein (CRP)
            • IL-1, IL-2, IL-8, TNF-a
            • Corticotropin-Releasing Hormone (CRH)
            • Alpha-fetoprotein (AFP)
          • Uterine Monitoring
          • Nitazine Test
          • Ferning Test
          • Pooling
          • PAMG-1 Immunoassay
          • IGFBP Test
          • Fetal Fibronectin (fFN)
          • Others
        • Kuwait Preterm Birth and PROM Testing Market, By Application Type
          • PROM
          • Preterm Labor
          • Chorioamnionitis

Preterm Birth And PROM Testing Market Dynamics

Drivers: Increasing average age of pregnant women, leading to exponential rise in the number of preterm births

Preterm births are when childbirth occurs before completion of 37 weeks of pregnancy, which is a leading cause of infant death. Several factors have been identified for preterm birth. One of the significant causes is a delay in pregnancy to the age of 34 and above. Advanced maternal age is a risk factor for unhealthy children and increases the probability of preterm birth. As per a study conducted in the U.S., the youngest and oldest mothers have a high risk of preterm birth. From 2017 to 2019, on average, preterm birth rates were 14.5% for women aged 40 and older, followed by 10.3% for ages 30 to 39, and the lowest rate was 9.5% for the age of 20 to 29. The study assessed the average percentage of women in the U.S. who gave birth between 30 and 39 years as 40.9% from 2014 to 2016. The delay in motherhood can be due to various social causes, such as women pursuing higher education, focus on careers, unemployment, and economic uncertainty. Similarly, in the European Union, the mean age of pregnant women increased from 28.8 years in 2013 to 29.3 years in 2018. As a result, approximately 500,000 babies are born prematurely in Europe every year.

Hence, preterm births are not specific to a particular geography and have been recognized as a worldwide concern. The risk of preterm births typically escalates with increasing average age of pregnant women. In light of growing awareness about preterm births and their consequences, pregnant women are more likely to enroll in Premature Rupture of Membranes (PROM) testing during pregnancy as a means of reassurance and monitoring symptoms of preterm birth. 

Drivers: Improvement in point-of-care diagnostics

Point-of-Care (POC) diagnostics have drastically altered the testing methodology in various fields. With the help of advanced technology, devices can assess analytes in a given sample. Companies are focusing on R&D to increase specificity and sensitivity of devices, which lowers the error rate. Hence, emphasis is being given to reducing the sample size required for other medical testing. Researchers from the American Society of Microbiology conducted an extensive study on POC in 2016 for PROM testing. They identified specific components of proteins and bacteria in the vagina, which can assess the level of risk for preterm birth. The adoption of POC tests is gaining momentum owing to their low cost, high reliability, and faster turnaround time. As per Stanford's study, many pregnant women around the globe, specifically in low-income countries, do not have access to prenatal ultrasound scans. However, a simple, inexpensive, and accurate test can improve prenatal care.

For instance, Actim PROM is a US. FDA-approved POC rapid test to detect PROM. It provides fast, accurate results for preterm births. More than 7 million tests have been distributed in over 70 countries since it is highly reliable with a 97% sensitivity and specificity. Actim Prom helps detect the protein biomarker Insulin-like Growth Factor Binding Protein-1 (IGFBP - 1). The advancements in POC diagnostics for PROM can encourage pregnant women to test for PROM more frequently when compared to a long procedure of testing held in hospitals and clinics. 

Restraints: Product recalls and adverse effects.

Government regulations, such as the U.S. FDA, control product recalls. The FDA-regulated firms can initiate a recall or follow a lead provided by the FDA to fulfill their duty to protect the public from products that are associated with the risk of injuries, gross deception, or any defection. In May 2018, Qiagen Sciences LLC recalled approximately 39,000 tests of AmniSure ROM, which the U.S. FDA identified as a class I recall. This test is used to diagnose a Rupture of Membranes (ROM) in pregnant women. Results from the test are not intended as the primary basis for any decision but are most often accompanied by other clinical tests, such as physical examination and other diagnostic assessments. Owing to a manufacturing defect, a glitch in the display of the control line was observed, leading to misinterpretation of test results. This misinterpretation could lead to serious adverse consequences, such as embryonic deaths and health complications for the mother. After receiving multiple customer complaints, Qiagen Sciences LLC withdrew the test kit from the market. Similarly, in 2020, the same organizations recalled the same device under class II, for misprinting the rinse time on the polybag. The FDA categorized it as employee error and permitted recall of 1,654 kits from the market. Such incidents do not just affect a manufacturer’s reputation in the market, but consumers also lose their confidence in the ability of the test to provide accurate results, which can impede market demand.

What Does This Report Include?

This section will provide insights into the contents included in this preterm birth and PROM testing market report and help gain clarity on the structure of the report to assist readers in navigating smoothly.

Preterm birth and PROM testing market qualitative analysis

  • Industry overview

  • Industry trends

  • Market drivers and restraints

  • Market size

  • Growth prospects

  • Porter’s analysis

  • PESTEL analysis

  • Key market opportunities prioritized

  • Competitive landscape

    • Company overview

    • Financial performance

    • Product benchmarking

    • Latest strategic developments

Preterm birth and PROM testing market quantitative analysis

  • Market size, estimates, and forecast from 2018 to 2030

  • Market estimates and forecast for product segments up to 2030

  • Regional market size and forecast for product segments up to 2030

  • Market estimates and forecast for application segments up to 2030

  • Regional market size and forecast for application segments up to 2030

  • Company financial performance

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