Preterm Birth And PROM Testing Market Size, Share, Opportunities, And Trends By Preterm Birth Tests (Pelvic Exam, Ultrasound, Others), By PROM Tests (Nitrazine Test, Ferning Test, Others), By End-User (Diagnostic Laboratories, Hospitals, Others), And By Geography - Forecasts From 2023 To 2028

  • Published : Dec 2023
  • Report Code : KSI061615710
  • Pages : 140

The preterm birth and PROM testing market is expected to grow at a CAGR of 5.03% from US$1.510 billion in 2021 to US$2.129 billion in 2028.

Preterm birth and PROM testing aid in identifying fetal membrane rapture in pregnant women. The patient can be treated and a preterm birth can be avoided by identifying the ruptured fetal membrane. The rising cases of preterm birth and PROM due to several factors such as bad lifestyle, and stress are a major growth driver in the preterm birth and PROM testing market. Moreover, the increasing adolescent pregnancies and preeclampsia cases among pregnant women are further expected to positively impact the preterm birth and PROM testing market. Additionally, government efforts coupled with product launches and research projects by the market players are also contemplated to boost the preterm birth and PROM testing market. 

Rising Cases of Preterm Birth

The increasing number of preterm births due to several factors such as bad lifestyle indicates the widening of the preterm birth and PROM testing market. In 2020, there were reportedly 13.4 million preterm births (births that occurred before 37 full weeks of pregnancy) according to the WHO, and Preterm birth rates in 2020 ranged from 4 to 16% across all nations. Moreover, preterm birth rates are highest in southern Asia and sub-Saharan Africa, and preterm infants in these areas have the highest mortality rates. More than 65% of preterm births worldwide are concentrated in these two areas. The study conducted by the Department of Obstetrics and Gynecology (University of Addis Ababa) in December 2022 revealed that the preterm PROM rate was 2.2% with a perinatal mortality rate of 206/1000.

Adverse Effects of Preterm Birth

There are numerous complications associated with preterm births and PROM which indicates the requirement of early detection and prevention of preterm births thereby propelling the preterm birth and PROM testing market. For instance, the primary factor in the death of children under the age of five is preterm birth problems, which accounted for almost 900,000 deaths in 2019. Breathing issues brought on by an underdeveloped respiratory system, heart issues including patent ductus arteriosus and low blood pressure, and other brief consequences are possible in people born preterm. Bleeding inside the head complications with the digestive system that can lead to necrotizing enterocolitis, anemia, and neonatal jaundice, hypoglycemia, cerebral palsy, learning disabilities, dental troubles, and chronic health conditions like infections, asthma, and feeding difficulties are examples of long-term repercussions that can affect the people born preterm.

Increasing Adolescent Pregnancy and Preeclampsia Cases

Preterm deliveries are closely associated with maternal health hazards, such as adolescent pregnancy and pre-eclampsia. The rising number of adolescent pregnancies and increasing preeclampsia cases are therefore contemplated to augment the preterm birth and PROM testing market. Preeclampsia complications cause 50,000 maternal deaths and 500,000 fetal deaths annually, according to NCBI. The chances of eclampsia, puerperal endometritis, and systemic infections are higher for adolescent mothers (10–19 years old) than for women (20–24 years old), and the risks of low birth weight, preterm birth, and severe neonatal conditions are higher for their offspring. According to the WHO, the anticipated global adolescent birth rate for females aged 10 to 14 in 2022 was 1.5 per 1000 women.

Government Efforts and Research Projects

The government efforts and research projects are encouraging the advancement and adoption of PROM testing thereby propelling the preterm birth and PROM testing market. For instance, in low- and middle-income nations, the WHO conducts research to improve care for pregnant women and preterm infants. These studies include the WHO ACTION Trials (Antenatal Corticosteroids for Improving Outcomes in Preterm Newborns), the Nutritional Management of Growth Flapping in Early Infancy Trial, and an implementation research trial to scale-up immediate kangaroo mother care (KMC). Moreover, the International Federation of Gynecology and Obstetrics (FIGO) launched a special section in the October 2021 issue of the International Journal of Gynecology and Obstetrics. This special section contains nine FIGO good practice recommendations for the effective management and monitoring of preterm birth.

North America is expected to grow Significantly

The North American region is expected to hold a significant share of the preterm birth and PROM testing market during the forecast period. Various factors attributed to such a share are the rising rate of preterm births, and technological advancements coupled with increased awareness. For instance, the preterm birth rate increased by 4% in 2021 as compared to 2020 which is the highest since 2007 as per the CDC data, and around one in 10 babies born in the US in 2021 suffered from preterm birth. Moreover, the presence of major market players such as Hologic, Abbott Laboratories, and Sera Prognostics Inc. is further expected to boost the preterm birth and PROM testing market in the region through enhanced accessibility.

Major Market Players

  • Hologic Inc. is a US-based multinational company focused on women’s health. Perinatal testing called Rapid fFN® assesses a pregnant woman's risk of having a preterm birth. Other preterm and PROM kits offered by the company are the QuikCheck fFN® Test kit, Rapid fFN® 10Q Cassette Kit.
  • Sera Prognotics Inc. is one of the leading women’s health companies headquartered in the US. In February 2023, the company announced the positive top-line data from Avert Preterm Trial in the reduction of neonatal morbidity or neonatal death. It was conducted at ChristianaCare in Wilmington.

Key Market Developments


  • In January 2023, to advance maternal health equity, the March of Dimes established a new preterm research centre at the University of Pennsylvania. It focuses on resolving the persistent racial inequities and poor health outcomes that make the United States the riskiest developed country for giving birth.
  • In August 2022, March of Dimes launched a new prematurity research hum at the University of California which focuses on using big data to gain insights into diagnostic and therapeutic tools to combat prematurity.

Preterm Birth And PROM Testing Market Scope:


Report Metric Details
Market Size Value in 2021 US$1.510 billion
Market Size Value in 2028 US$2.129 billion
Growth Rate CAGR of 5.03% from 2021 to 2028
Base Year 2021
Forecast Period 2023 – 2028
Forecast Unit (Value) USD Billion
Segments Covered Preterm Birth Tests, PROM Tests, End-User, and Geography
Regions Covered North America, South America, Europe, Middle East and Africa, Asia Pacific
Companies Covered Hologic, Inc, Abbott, Sera Prognostics Inc., CooperSurgical Inc., IQ Products, Qiagen N.V., BHR Pharmaceuticals, LifeCell International Pvt. Ltd., NX Prenatal, Inc.
Customization Scope Free report customization with purchase



  • By Preterm Birth Tests
    • Pelvic exam
    • Ultrasound
    • Others
  • By PROM Tests
    • Nitrazine Test
    • Ferning Test
    • Others
  • By End-User
    • Diagnostic Laboratories
    • Hospitals
    • Others
  • By Geography
    • North America
      • United States
      • Canada
      • Mexico
    • South America
      • Brazil
      • Argentina
      • Others
    • Europe
      • United Kingdom
      • Germany
      • France
      • Spain
      • Others
    • Middle East and Africa
      • Saudi Arabia
      • UAE
      • Israel
      • Others
    • Asia Pacific
      • Japan
      • China
      • India
      • South Korea
      • Indonesia
      • Thailand
      • Others


1.1. Market Overview

1.2. Market Definition

1.3. Scope of the Study

1.4. Market Segmentation

1.5. Currency

1.6. Assumptions

1.7. Base, and Forecast Years Timeline


2.1. Research Data

2.2. Research Process


3.1. Research Highlights


4.1. Market Drivers

4.2. Market Restraints

4.3. Porter’s Five Force Analysis

4.3.1. Bargaining Power of Suppliers

4.3.2. Bargaining Power of Buyers

4.3.3. Threat of New Entrants

4.3.4. Threat of Substitutes

4.3.5. Competitive Rivalry in the Industry

4.4. Industry Value Chain Analysis


5.1. Introduction

5.2. Pelvic exam

5.3. Ultrasound

5.4. Others


6.1. Introduction

6.2. Nitrazine Test

6.3. Ferning Test

6.4. Others


7.1. Introduction

7.2. Diagnostic Laboratories

7.3. Hospitals

7.4. Others


8.1. Introduction

8.2. North America

8.2.1. United States

8.2.2. Canada

8.2.3. Mexico

8.3. South America

8.3.1. Brazil

8.3.2. Argentina

8.3.3. Others

8.4. Europe

8.4.1. United Kingdom

8.4.2. Germany

8.4.3. France

8.4.4. Spain

8.4.5. Others

8.5. The Middle East and Africa

8.5.1. Saudi Arabia

8.5.2. UAE

8.5.3. Israel

8.5.4. Others

8.6. Asia Pacific

8.6.1. Japan

8.6.2. China

8.6.3. India

8.6.4. South Korea

8.6.5. Indonesia

8.6.6. Thailand

8.6.7. Others


9.1. Major Players and Strategy Analysis

9.2. Market Share Analysis

9.3. Mergers, Acquisitions, Agreements, and Collaborations


10.1. Hologic, Inc

10.2. Abbott

10.3. Sera Prognostics Inc.

10.4. CooperSurgical Inc.

10.5. IQ Products

10.6. Qiagen N.V.

10.7. BHR Pharmaceuticals

10.8. NX Prenatal, Inc.

Hologic, Inc


Sera Prognostics Inc.

CooperSurgical Inc.

IQ Products

Qiagen N.V.

BHR Pharmaceuticals

NX Prenatal, Inc.