The global preterm birth and PROM testing market size was estimated at USD 1.1 billion in 2018. Factors such as growing incidence of preterm births, increasing geographical foothold of market players, high demand for effective preterm diagnosis, and improvement in point-of-care (PoC) diagnostics are anticipated to drive the market.
Premature rupture of membranes (PROM) cause approximately 4.5 Million preterm births each year, worldwide. Globally, premature birth is among the most frequent causes of death among neonates within the first month of life. The approval of preterm birth and PROM testing diagnostic kits has introduced a highly efficacious yet cost-effective option for testing premature rupture of membranes in symptomatic patients. These tests are increasingly replacing traditional standard-of-care tests (Fern and Nitrazine) supported by their ease of use and high sensitivity.
The approval of improved diagnostic test PartaSure (Parsagen Diagnostics, Inc. and Qiagen) in April 2018 has introduced a highly efficacious yet cost-effective option for PROM testing in symptomatic patients. The PartaSure test can help predict spontaneous premature delivery within seven days of testing in symptomatic women. The Positive Predictive Value (PPV) of PartoSure test is 19.0% compared to 6.5% of fFN. The Actim PROM rapid test (Medixbiochemica) gives 97% accuracy in results compared to 16% and 56%, respectively from a Nitrazine test. Moreover, unlike traditional methods, the improved PROM detection test is not affected by urine, semen, or blood discharge.
In North America, 3.9 Million babies are born annually, of which 12.0% are born premature. In the EU, Germany has one of the highest preterm birth rates with 9.0% of 670,000 annual births being preterm. According to the March of Dimes, a nonprofit organization focused on improving maternal and infant health, premature birth rate in U.S. has increased for the third consecutive year in 2018 and the country is among the worst of developed nations in terms of premature births. Such factors demonstrate the need for development of highly accurate yet cost-effective methods for diagnosis of premature rupture of membranes.
With the help of these diagnostic kits, doctors and nurses can obtain an accurate diagnosis within five minutes of conducting the test to initiate necessary treatment measures early on. This allows delivery of immediate care as risk of infection increases exponentially within a few hours of PROM.
Increasing adoption of biomarker test kits is expected to drive the market over the forecast period. High accuracy of these tests results in early diagnosis of preterm labor, decreases the chance of neonatal morbidity and mortality, reduces the length of stay of high-risk patients, and minimizes unnecessary treatment costs. Increasing demand for improved healthcare, high treatment costs, and rising global population are anticipated to further propel the market for point-of-care testing, in turn boosting the adoption of preterm birth and PROM testing.
Conventional methods of preterm birth testing include sterile speculum examination (pooling), pelvic examination, blood test, ultrasound, and fetal fibronectin (fFN) test. To diagnose preterm labor, doctors review symptoms such as pelvic pressure, vaginal spotting or bleeding, cramps or regular contractions, vaginal discharge, and fluid leakage. A pelvic exam is performed multiple times over a period of few hours to monitor contractions and detect changes in the cervix. Pelvic examination is the first-line exam conducted by doctors to measure the changes in the cervix. The segment is expected to contribute approximately USD 200.0 Million in sales to the global preterm birth and PROM testing market in 2025.
PROM testing methods include nitrazine and ferning test, ultrasound, biomarker tests such as Placental alpha microglobulin-1 (PAMG-1), Insulin-like growth factor binding protein 1 (IGFBP-1), and Alpha-fetoprotein (AFP) test. Traditional methods such as nitrazine and ferning tests are rapidly being replaced by improved biochemical marker detection kits. Clinical studies suggest that PAMG-1 based tests provide improved diagnostic accuracy and sensitivity compared to traditional tests for detection of premature rupture of membranes. This key factor is poised to contribute to growth in the segment’s sales in 2025.
Geographically, the market is segmented into Europe, North America, Asia Pacific, Middle East and Africa, and Latin America. North America dominated the market in 2018. Rising incidence of premature births, poor lifestyle choices, and increasing maternal age are driving the market in this region.
Asia Pacific is expected to witness the fastest CAGR of 2.8% during the forecast period. Key factors attributable to the growth of the region include high prevalence of premature births, rise in awareness regarding maternal health, increase in healthcare spending, and supportive government initiatives in developing economies.
The global market is a developing one, with manufacturers focused on development of technologically advanced products, diversifying their product portfolio, and expanding geographic presence through mergers and acquisitions. Key participants include Qiagen, Hologic, Cooper Surgical, Abbott Laboratories, Medixbiochemica, Sera Prognostics, Biosynex, and IQ Products.
Base year for estimation
Actual estimates/Historical data
2014 - 2017
2019 - 2025
Revenue in USD Million and CAGR from 2019 to 2025
North America, Europe, Asia Pacific, Latin America, Middle East & Africa
U.S., Canada, U.K., Germany, France, Italy, Greece, Denmark, Spain, Austria, Switzerland, Russia China, India, Japan, South Korea, Australia, Singapore, Thailand, Mexico, Brazil, Argentina, South Africa, Saudi Arabia, U.A.E, Turkey,
Revenue forecast, company share, competitive landscape, growth factors and trends
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This report forecasts revenue growth at global, regional, and country levels and provides an analysis on latest industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global preterm birth and PROM testing market report on the basis of test type and region:
Test Type Outlook (Revenue, USD Million, 2014 - 2025)
Pooling (Speculum Exam)
IL-1, IL-2, IL-8, TNF-a
AFP (Alpha fetoprotein)
Regional Outlook (Revenue, USD Million, 2014 - 2025)
Middle East & Africa
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With Covid-19 infections rising globally, the apprehension regarding a shortage of essential life-saving devices and other essential medical supplies in order to prevent the spread of this pandemic and provide optimum care to the infected also widens. In addition, till a pharmacological treatment is developed, ventilators act as a vital treatment preference for the COVID-19 patients, who may require critical care. Moreover, there is an urgent need for a rapid acceleration in the manufacturing process for a wide range of test-kits (antibody tests, self-administered, and others). The report will account for Covid19 as a key market contributor.