Preterm Birth and PROM Testing Market - Growth, Trends, Covid-19 Impact, And Forecasts (2022 - 2027)

The Global Preterm Birth and PROM Testing Market is segmented by Test Type (Pelvic exam, Ultrasound, Biochemical Markers, Uterine Monitoring, and Others), and Geography (North America, Europe, Asia-Pacific, Middle East, and Africa, South America). The report offers the value (in USD million) for the above segments.

Market Snapshot

Preterm Birth and PROM Testing Market Size
Study Period: 2019-2027
Base Year: 2021
Fastest Growing Market: Asia-Pacific
Largest Market: North America
CAGR: 3.35 %

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Market Overview

The Preterm Birth and PROM testing market is projected to grow with a CAGR of 3.35% during the forecast period (2022 - 2027).

The COVID-19 pandemic has significantly impacted the preterm birth and PROM testing market. According to a study published in the International Journal of Gynecology and Obstetrics, in October 2020, titled "The effect of the COVID-19 pandemic on maternal health due to delay in seeking health care: Experience from a tertiary center," inadequate prenatal visits were observed in one-third of the women. Lockdown and fear of infection were the leading causes of delayed health-seeking, with 44.7% of pregnancies ending in complications. Also, according to a report published in the Gynecologic and Obstetric Investigation in July 2020, infection with COVID-19 during pregnancy raises the risk of pregnancy complications such as preterm birth, preterm premature rupture of the membranes, and, in rare circumstances, maternal mortality. As a result, preterm and PROM testing have been increased to detect and prevent prenatal births and reduce complications. Thus, the market is predicted to rise due to the increased need for care.

The factors propelling the growth of the market are the rising number of preterm and low-weight births worldwide, growing advancements in point-of-care diagnostics and technological advancements in PROM testing tools, and increasing awareness regarding preterm birth and PROM testing availability.

The incidences of premature birth and increasing death among children due to preterm birth are the key driving factors for the growth of the market over the forecast period. According to the data published by the Centers for Disease Control, in 2021, the rate of preterm delivery among African-American women was 14.9%, which is 50% higher than the rate among whites (9.1%) and Hispanic women (9.8%). Similarly, according to the statistics published by the March of Dimes, in 2021, it has been observed that the preterm birth rates rose from 14.25% to 14.36% among Black women and from 11.55% to 11.61% among American Indian/Alaska Native mothers. Additionally, an article published by the Centers for Disease Control and Prevention in 2021, titled 'Preterm Birth,' reported that in 2020, in the United States, one in every ten infants born were premature.

Furthermore, the increasing number of people visiting diagnostic labs and healthcare units for testing, particularly in emerging regions, is fueling market expansion over the forecast period. Diagnostic centers are becoming more popular and widely used due to their increased reliability, cost-effectiveness, speed of results, and delivering precise diagnosis results at a low cost.

However, the lack of availability of PROM testing services and economic constraints in under-der developed countries are likely to hinder the growth of the market.

Scope of the Report

As per the scope of the report, preterm birth is the birth of the baby before completion of the 37 weeks. Preterm babies are prone to various medical complications and have weakened immunity. PROM testing is a type of test that detects the premature rupturing of the fetal membranes. The Global Preterm Birth and PROM Testing Market is segmented by test type (Pelvic exam, Ultrasound, Biochemical Markers, Uterine Monitoring, and Others) and geography (North America, Europe, Asia-Pacific, Middle East, and Africa, South America). The market report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (in USD million) for the above segments.

By Test Type
Pelvic exam
Biochemical Markers
Uterine Monitoring
North America
United States
United Kingdom
Rest of Europe
South Korea
Rest of Asia-Pacific
Middle East and Africa
South Africa
Rest of Middle East and Africa
South America
Rest of South America

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Key Market Trends

Ultrasound Segment Expects to Register a High CAGR in the Forecast Period

The ultrasound segment is witnessing significant growth in the forecast period owing to the factors such as increased incidences of preterm birth, increasing company research and development activities, and technological advancements to detect and predict preterm births.

Ultrasound can be used to check cervical tissue, as it generates images of the uterus and the baby, which can be used to identify if the cervix has dilated or effaced, as well as to improve diagnosis and forecast premature births.

With increased incidences of preterm births and associated consequences, pregnant women are more likely to engage in preterm testing during pregnancy for reassurance and monitoring of preterm birth symptoms and to avoid preterm deaths. For instance, according to an article published by the American Family Physician, in 2020, it has been observed that about 3% of pregnancies are complicated by preterm PROM, and one-third of preterm deliveries are caused by it. It raises the risk of preterm and causes several other perinatal and neonatal issues, including a 1% to 2% chance of fetal death.

The increasing company focus on developing tests and devices to predict preterm birth is also contributing to the growth of the ultrasound segment, thereby increasing the market growth. For instance, in March 2022, Ultrasound AI Inc. will use ultrasound technology and artificial intelligence to anticipate preterm birth and allow for earlier interventions. In addition, in May 2021, DC Medical developed a portable preterm diagnostic device, EveryBaby, after researching Electrical Impedance Spectroscopy (EIS) at the University of Sheffield, which could potentially improve the prediction of preterm birth. In August 2020, PulseNmore, an Israeli startup, launched a handheld tele-ultrasound device that allows pregnant women to conduct ultrasound exams at home and receive feedback from a physician or sonographer.

Thus, with the increased incidence and risk associated with preterm births and the technological advancements, the demand for the ultrasound segment is likely to increase in the forecast period.

Preterm Birth and PROM Testing Market Share

North America is Expected to Have the Significant Market Share

North America is anticipated to have a significant share in the market owing to the factors such as increased demand for pre-birth testing due to the increased incidence of preterm births, rising technical breakthroughs, and well-established healthcare facilities in the region.

In addition, the company, as well as non-profit organizations, are focusing on developing tests and devices for evaluating and detecting preterm births in the region and contributing to the market's growth. For instance, In January 2021, Sera Prognostics, Inc. partnered with HealthCore, Inc. and Anthem, Inc. to launch the PRIME study to evaluate the effectiveness of the PreTRM test with clinical interventions to improve neonatal outcomes. In addition, In May 2021, Sera Prognostics announced a novel strategic commercial partnership with Anthem to make PreTRM Tests available to pregnant members as part of a multi-year contract. Through this partnership, many physicians and patients in the United States will have access to early and accurate preterm birth predictions, allowing them to make more informed decisions during pregnancy. Similarly, in October 2021, the researchers at the March of Dimes Prematurity Research Center at Imperial College London developed a first-of-its-kind testing device that may help advance the diagnosis and treatment of preterm birth.

Moreover, increased intake of alcohol and illicit drugs is also contributing to a rise in the incidence of preterm births in the United States. According to the data published by the Centers for Disease Control, in 2022, 14% of pregnant females reported current drinking, and 5% reported binge drinking.

Thus, increasing rates of preterm births and companies and organizations focusing on developing testing kits and devices are likely to increase the market growth in the region over the forecast period.

Preterm Birth and PROM Testing Market Analysis

Competitive Landscape

The market is highly competitive with many global and local players. The major companies are adopting different growth strategies such as new product development, product differentiation strategies, and expansion to withhold the market position. Some players are Hologic, Inc., Abbott, Sera Prognostics Inc., CooperSurgical Inc., and IQ Products.

Recent Development

  • In May 2022, Sera Prognostics and the Newborn Foundation announced the launch of the Every mother, every Baby Project. Its goal is to raise awareness among clinicians, policymakers, and public health stakeholders about the essential role validated biomarker-based preterm risk assessment tests like Sera's PreTRM test can play in improving newborn and maternal health outcomes.
  • In November 2021, Sera Prognostics announced a partnership with PreemieWorld, GLO Preemies, and the Alliance for Black NICU Families to empower and support families impacted by preterm birth.
  • In June 2021, Nuvo Group received the United States Food and Drug Administration approval for the expanded utility of its INVU, a prescription-initiated remote pregnancy monitoring platform to add a new uterine activity module that enables remote monitoring of uterine activity.

Table of Contents


    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study




    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Increasing Incidence of Preterm and Low-weight Births

      2. 4.2.2 Increasing Awareness and Technological Advancements in Point-Of Care and PROM Testing

    3. 4.3 Market Restraints

      1. 4.3.1 Lack of Awareness and Economic Constraints in Under-developed Countries

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value - USD million)

    1. 5.1 By Test Type

      1. 5.1.1 Pelvic exam

      2. 5.1.2 Ultrasound

      3. 5.1.3 Biochemical Markers

      4. 5.1.4 Uterine Monitoring

      5. 5.1.5 Others

    2. 5.2 Geography

      1. 5.2.1 North America

        1. United States

        2. Canada

        3. Mexico

      2. 5.2.2 Europe

        1. Germany

        2. United Kingdom

        3. France

        4. Italy

        5. Spain

        6. Rest of Europe

      3. 5.2.3 Asia-Pacific

        1. China

        2. Japan

        3. India

        4. Australia

        5. South Korea

        6. Rest of Asia-Pacific

      4. 5.2.4 Middle East and Africa

        1. GCC

        2. South Africa

        3. Rest of Middle East and Africa

      5. 5.2.5 South America

        1. Brazil

        2. Argentina

        3. Rest of South America


    1. 6.1 Company Profiles

      1. 6.1.1 Hologic, Inc

      2. 6.1.2 Abbott

      3. 6.1.3 Sera Prognostics Inc.

      4. 6.1.4 CooperSurgical Inc.

      5. 6.1.5 IQ Products

      6. 6.1.6 Qiagen N.V.

      7. 6.1.7 Biosynex

      8. 6.1.8 LifeCell International Pvt. Ltd.

      9. 6.1.9 Clinical Innovations, Inc.

      10. 6.1.10 NX Prenatal, Inc.

    2. *List Not Exhaustive

**Subject to Availability
**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments

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Frequently Asked Questions

The Global Preterm Birth and PROM Testing Market market is studied from 2019 - 2027.

The Global Preterm Birth and PROM Testing Market is growing at a CAGR of 3.35% over the next 5 years.

Asia-Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2021.

Hologic, Inc., Abbott, Sera Prognostics, CooperSurgical Inc., IQ Products are the major companies operating in Global Preterm Birth and PROM Testing Market.

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