Preterm Birth and PROM Testing Market Size & Outlook, 2025-2033

Preterm Birth and PROM Testing Market Overview

The global preterm birth and prom testing market size was valued at USD 2.25 billion in 2024 and is expected to grow from USD 2.61 billion in 2025 to reach USD 8.76 billion by 2033, exhibiting a CAGR of 16.33% during the forecast period (2025–2033).

Key Market Indicators

• North America dominated the market and accounted for 40% of the USD 2.25 billion global market in 2024.
• Europe accounted for nearly 30% of the global market in 2024, supported by high maternal health awareness and strong adoption of novel tests.
• Asia-Pacific captured around 22% of the market in 2024 and is projected to grow at the fastest CAGR of 3.4% during the forecast period.
• Based on test type, the ultrasound segment dominated the global preterm birth and PROM testing market in 2024, holding the largest share and projected to grow at a CAGR of 2.9%, driven by its reliability as a first-line, non-invasive imaging method for assessing cervical changes, amniotic fluid levels, and fetal health.

Market Size & Forecast

• 2024 Market Size: USD 2.25 Billion
• 2033 Projected Market Size: USD 8.76 Billion
• CAGR (2025–2033): 16.33%
• North America: Largest market in 2024
• Asia-Pacific: Fastest-growing region

Pregnant women are more likely to sign up for PROM testing during their pregnancy for reassurance and monitoring of preterm birth symptoms as preterm births and their consequences become more well-known, stimulating preterm birth and prom testing market growth.

Premature Rupture of Membrane is referred to as PROM. It is one of the primary causes of preterm deliveries and a usual pregnancy difficulty. Preterm birth and premature rupture of membrane (PROM) tests are combined into preterm birth and PROM testing. Hospitalization and expectant management are two possible care and therapy options for premature membrane rupture. Very rarely, the membrane may close and stop leaking fluid. Gynaecologists look for signs of premature labour, including pelvic pressure, vaginal spotting or bleeding, cramping or frequent contractions, vaginal discharge, and fluid leaking.

Over a few hours, a pelvic exam is repeatedly carried out to track contractions and identify cervix changes. Due to these tests' high degree of accuracy, preterm labour can be detected early, reducing the risk of infant morbidity and death, reducing the length of stay for high-risk patients, and avoiding unnecessary medical costs. Traditional preterm birth testing methods include fetal fibronectin (fFN), pelvic examination, blood test, ultrasound, and sterile speculum inspection (pooling).

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Market Growth Factors

Improvement in Point-of-Care Diagnostics

Point-of-care (POC) diagnostics have substantially changed the testing approach in several domains. Devices can evaluate the analytes in a given sample using cutting-edge technology. Companies are putting more effort into R&D to make equipment more sensitive and specialized, which reduces mistake rates. As a result, attention is placed on lowering the sample amount needed for different types of medical testing.

In 2016, American Society of Microbiology researchers thoroughly investigated POC for PROM testing. They discovered certain proteins and bacterial components in the vagina that can be used to gauge the likelihood of preterm delivery. POC testing is becoming more popular because of its low cost, high dependability, and quick response time. According to Stanford research, many expectant mothers worldwide, particularly in developing nations, lack access to prenatal ultrasound exams. However, a quick, low-cost, reliable test can enhance prenatal care. For instance, Actim PROM is a POC fast test for PROM authorized by the US FDA. For premature deliveries, it offers quick, precise findings. Since it has a 97% sensitivity and specificity, it has been delivered in more than 70 countries, totaling more than 7 million tests. Insulin-like Growth Factor Binding Protein-1 (IGFBP-1) is an easier protein biomarker to find using Actim PROM. When compared to a drawn-out process of testing performed in hospitals and clinics, improvements in POC diagnostics for PROM may encourage pregnant women to test for PROM more regularly.

Preterm Babies Are Rising Exponentially Due to Older Mothers

Preterm births happen before the full 37 weeks of pregnancy and are the main cause of infant mortality. Several reasons cause preterm birth. The delay in pregnancy till age 34 or older is one of the main factors. Preterm delivery is more likely when the mother is older, which raises the chance of an ill kid. According to U.S. research, the risk of preterm birth is highest for the youngest and oldest moms. Preterm birth rates ranged from 9.5% for women aged 20 to 29 to 14.5% for those over 40 between 2017 and 2019. The lowest rate was 10.3%.

As a result, preterm births have been identified as a global issue that is not unique to any one region. With rising average prenatal ages, the risk of preterm deliveries normally rises. Pregnant women are more likely to sign up for Premature Rupture of Membranes (PROM) testing during their pregnancy for reassurance and monitoring of preterm birth symptoms as preterm births and their consequences become more well-known. These factors will drive the global market.

Market Restraint

Product Recalls and Adverse Effects

Government rules, like those of the US FDA, regulate product recalls. To carry out their responsibility to safeguard the public against items that pose a danger of injury, blatant deceit, or defection, the FDA-regulated businesses can either start a recall themselves or heed an FDA lead. Approximately 39,000 AmniSure ROM tests were recalled by Qiagen Sciences LLC in May 2018, which the U.S. FDA classified as a class I recall. This test determines whether a pregnant woman has a Rupture of Membranes (ROM). The test's results are not meant to serve as the only basis for making any decisions; instead, they are frequently combined with other clinical tests, such as physical examinations and other diagnostic procedures. An error was seen in the control line's display due to a manufacturing flaw, which caused the test findings to be misinterpreted. This misunderstanding might have severe negative effects, including the embryo's death and the mother's health issues. Qiagen Sciences LLC removed the test kit from sale after receiving several consumer complaints.

Similarly, in 2020, the same organizations issued a class II recall for the same item due to an error in the polybag's printing of the rinse time. The FDA classified it as an employee error, and the market recall of 1,654 kits was approved. Consumers lose faith in the test's capacity to produce reliable findings due to such instances, which can reduce market demand and harm a manufacturer's image in the marketplace.

Market Opportunity

Technology Advancement

The market is expected to expand quickly due to the coordinated efforts of manufacturers and rising R&D expenditures. Several import-dependent nations are formulating plans to improve domestic manufacturing capacity and reduce healthcare expenses. Healthcare professionals may remotely monitor high-risk pregnancies using telemedicine systems, which eliminates the need for frequent in-person visits. The constant surveillance of vital signs and fetal movements made possible by remote monitoring technologies, such as wearable sensors and home monitoring systems, immediately alerts medical personnel to potential problems. It will open many opportunities.

Regional Insights

North America Market Trend

North America is the most significant global preterm birth and prom testing market shareholder and is estimated to exhibit a CAGR of 3.5% over the forecast period. This is due to the high prevalence of pregnancies in the 35+ age group and the infrastructure's readiness to handle high-risk pregnancies. Premature births are on the rise in the United States due to changes in lifestyle variables such as excessive alcohol intake and sedentary behaviour. Several awareness campaigns and efforts by nonprofit organisations in the United States and Canada are addressing the difficulties experienced by preterm newborns and their families. For instance, to address the growing preterm birth rates and ongoing health disparities in the United States, the March of Dimes organised the Prematurity Campaign Collaborative in 2017.

Asia-Pacific Market Growth

Asia-Pacific is anticipated to exhibit a CAGR of 3.4% over the forecast period. The existence of a sizable population in China and India is the cause of this rise. Additionally, the growing rate of preterm births in the region's emerging nations is considered to expand a potential market in these nations and fuel the industry's rapid expansion. Rapid technical progress, the availability of a well-established healthcare system, a growth in awareness campaigns, and nonprofit organisations that help preterm newborns and their families are some of the key elements favourably influencing the market.

European Market Trends

Europe has emerged as one of the fastest-growing regions in the global market. High maternal health awareness and higher uptake of novel tests in nations like Germany, the U.K., Italy, and France are to blame for expanding the markets in Europe. The regional market is also anticipated to increase because of the presence of major companies locally and ongoing R&D projects in the fields of preterm births and PROM testing. The high frequency of alcohol misuse and cigarette use among pregnant women in the region is also anticipated to increase the risk of preterm deliveries and PROM, increasing the demand for testing solutions. The developed healthcare system and high rate of prenatal care adoption of cutting-edge preterm birth and PROM testing technologies may be credited for the market's success. Additionally, the nation's favourable reimbursement regulations for pricey testing solutions foster a good atmosphere for business expansion. The need for its testing solutions is also anticipated to increase due to the country's high risk of perinatal death and morbidity and significant prevalence of preterm births.

Latin America Market Trend

In Latin America, the market has huge room to develop. Due to the high occurrence of preterm births in Latin American nations, there may be a demand for preterm birth testing. These elements are projected to fuel market expansion in the area. An improved healthcare reimbursement structure has enhanced access to appropriate healthcare services for the region's underprivileged population. Growing consumer knowledge of numerous obstetric and prenatal care issues is another factor promoting market expansion in the area. Another element contributing to the market expansion in Latin America is rising healthcare spending. Brazil, Mexico, and Argentina are powerful nations that are categorised as being in Latin America.

In the Middle East and Africa, expanding the preterm birth and PROM testing industry may be ascribed to ongoing government efforts to provide regional access to cutting-edge preterm birth and PROM testing solutions. Additionally, there will be a large need for preterm birth and PROM testing solutions due to the rising risk of preterm birth and PROM caused by maternal malnutrition, infectious illnesses, bad living circumstances, and smoking in African nations. Uncertain reimbursement situations, a lacklustre healthcare system, and the high cost of pricey tests in several Middle East and African nations are anticipated to pose a serious challenge to the market's expansion.

Market Segmentation

Test Type Insights

The market is bifurcated into Pelvic Examination, Ultrasound, Biochemical Markers, Uterine Monitoring, Nitazine Test, Ferning Test, Pooling, PAMG-1 Immunoassay, IGFBP Test, Fetal Fibronectin (fFN), and Others. The ultrasound segment dominates the global market share and is projected to exhibit a CAGR of 2.9% over the forecast period. One of the traditional techniques for determining preterm labour is ultrasound imaging. To evaluate if the cervix has dilated or effaced, doctors frequently do an ultrasound to get pictures of the uterus and the developing baby. To capture pictures of the pelvic area, transvaginal or endovaginal ultrasonography employs a transducer that produces sound waves painlessly. The transducer is greased before being placed into the vagina to record photos for viewing on a computer screen. One of the initial examinations a doctor or nurse performs is an ultrasound imaging test to determine the baby's weight, measure the amount of amniotic fluid present, and visually inspect the embryo's location. Key players are also making deliberate moves to broaden their product offerings.

• For instance, Hologic and the Canadian business Clarius Mobile Health struck a development and distribution deal in November 2017. The portable ultrasound scanner from Clarius is one of the rights transferred under the deal. The goal of this program was to increase the company's ultrasound business.

List of key players in Preterm Birth and PROM Testing Market

1. Qiagen N.V.
2. Hologic Inc.
3. Coopersurgical Inc.
4. Abbott
5. Medix Biochemica
6. Sera Prognostics
7. Clinical Innovations LLC
8. Biosynex
9. NX Prenatal
10. I.Q. Products

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Recent Developments

• September 2025: NX Prenatal announced progress in its R&D program to validate early pregnancy biomarker panels for predicting spontaneous preterm birth, with plans for clinical trials in late 2025.
• September 2025: Hologic Inc. Launches New Fetal Fibronectin Test Version
• August 2025: Sera Prognostics Partners with Diagnostic Lab for PreTRM Distribution
• May 2025: Abbott launched the Actim® PROM test, a reliable bedside test for quickly and easily detecting premature rupture of fetal membranes (PROM) in all patients.