Preterm Birth and PROM Testing Market, Global Sector / Industry Report & Analysis, 2025 (Includes Business Impact of COVID-19)

                                          
Abstract, Snapshot, Market Analysis & Market Definition: Global Preterm Birth and PROM Testing Market


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.

Market Segmentation, Outlook & Viewpoint: Global Preterm Birth and PROM Testing Market


Test Type Market Segmentation & Outlook (Revenue, USD Million, 2014 - 2025)

Pelvic exam

Ferning Test

Nitazine Test

Pooling (Speculum Exam)

Ultrasound

Uterine Monitoring

IL-6

CRP

IL-1, IL-2, IL-8, TNF-a

CRH

AFP (Alpha fetoprotein)

fFN

PAMG-1 Immunoassay

IGFBP Test

Others


Key Players, Recent Developments & Regional Insights: Global Preterm Birth and PROM Testing Market


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.

Regional Insights
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.
Preterm Birth and PROM Testing Market Share Insights
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.

Key Insights Covered: Global Preterm Birth and PROM Testing Market
1.  North America, Europe, Asia Pacific, Middle East & Africa, Latin America market size (sales, revenue and growth rate) of Preterm Birth and PROM Testing industry.
2. Global major manufacturers' operating situation (sales, revenue, growth rate and gross margin) of Preterm Birth and PROM Testing industry.
3. Global major countries (United States, Canada, Germany, France, UK, Italy, Russia, Spain, China, Japan, Korea, India, Australia, New Zealand, Southeast Asia, Middle East, Africa, Mexico, Brazil, C. America, Chile, Peru, Colombia) market size (sales, revenue and growth rate) of Preterm Birth and PROM Testing industry.
4. SWOT analysis, New Project Investment Feasibility Analysis, Upstream raw materials and manufacturing equipment & Industry chain analysis of Preterm Birth and PROM Testing industry.
5. Global market size (sales, revenue) forecast by regions and countries from 2019 to 2024 of Preterm Birth and PROM Testing industry.

Research Methodology: Global Preterm Birth and PROM Testing Market

Data collection and base year analysis is done using data collection modules with large sample sizes. The market data is analyzed and forecasted using market statistical and coherent models. Also market share analysis and key trend analysis are the major success factors in the market report. To know more please Request a Sample Report.
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