Preterm Birth And PROM Testing Market Size, Share & Trends Analysis Report By Type, By Application (PROM, Preterm Labor, Chorioamnionitis), By Region, And Segment Forecasts, 2025 - 2033
Description
Preterm Birth And PROM Testing Market Summary
The global preterm birth and PROM testing market size was estimated at USD 1.56 billion in 2024 and is projected to reach USD 3.26 billion by 2033, growing at a CAGR of 8.6% from 2025 to 2033. Increasing advancements in point-of-care diagnostics are expected to have a positive impact on the preterm birth and PROM testing market.
The increasing average age of pregnant women, leading to an exponential rise in the number of early births, and the delay in parenthood due to sociodemographic factors, including education/career goals, the growing impact of women’s empowerment movements, and financial barriers, are key factors driving the adoption of tests in the market. According to research conducted by a group of researchers in Southern Ethiopia in December 2021, hypertension during pregnancy and a history of either abortion or cesarean section are the major causes of complications during childbirth. The study recommended that early identification tests and treatment can minimize the risk of premature rupture of fetal membranes. Other factors that raise the probability of PROM in pregnant women are low socioeconomic conditions, sexually transmitted infections, and cigarette smoking during pregnancy.
According to UNICEF, India accounts for 25.0 million births each year and witnesses the death of one child every minute, with the mortality rate due to premature birth at 35.0%. While substantial development in Special Newborn Care Units (SNCUs) has led to a decline in neonatal mortality, the socio-cultural barriers in healthcare access for female infants remain a major factor behind higher female premature deaths. However, India has witnessed a consistent reduction in child mortality rates, driven by initiatives prioritizing newborn and maternal safety.
Governments and regulatory bodies are taking considerable measures to increase access to PROM testing across several regions. For instance, in March 2022, Sera Prognostics Inc. announced that the Centers for Medicare & Medicaid Services established a Medicare payment rate of USD 750 for its PreTRM test, a proteomic blood test designed to measure preterm birth risk. The test has gained additional traction, with ongoing commercial collaboration between Sera and Elevance Health regarding coverage for its PreTRM test, which improves affordability for high-risk pregnant women and encourages broader adoption among hospitals and maternal-fetal medicine specialists.
Similarly, Actim PROM is a U.S. FDA-approved POC rapid test, to detect PROM. It provides rapid accurate results for preterm births. More than 7 million tests have been distributed in over 70 countries since they are highly reliable with 97% sensitivity and specificity. Actim Prom helps detect the protein biomarker Insulin-like Growth Factor Binding Protein-1 (IGFBP - 1). The advancements in POC diagnostics for PROM can encourage pregnant women to test for PROM more frequently when compared to a long procedure of testing held in hospitals and clinics.
Global Preterm Birth And PROM Testing Market Report Segmentation
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global preterm birth and PROM testing market report based on type, application, and region:
The global preterm birth and PROM testing market size was estimated at USD 1.56 billion in 2024 and is projected to reach USD 3.26 billion by 2033, growing at a CAGR of 8.6% from 2025 to 2033. Increasing advancements in point-of-care diagnostics are expected to have a positive impact on the preterm birth and PROM testing market.
The increasing average age of pregnant women, leading to an exponential rise in the number of early births, and the delay in parenthood due to sociodemographic factors, including education/career goals, the growing impact of women’s empowerment movements, and financial barriers, are key factors driving the adoption of tests in the market. According to research conducted by a group of researchers in Southern Ethiopia in December 2021, hypertension during pregnancy and a history of either abortion or cesarean section are the major causes of complications during childbirth. The study recommended that early identification tests and treatment can minimize the risk of premature rupture of fetal membranes. Other factors that raise the probability of PROM in pregnant women are low socioeconomic conditions, sexually transmitted infections, and cigarette smoking during pregnancy.
According to UNICEF, India accounts for 25.0 million births each year and witnesses the death of one child every minute, with the mortality rate due to premature birth at 35.0%. While substantial development in Special Newborn Care Units (SNCUs) has led to a decline in neonatal mortality, the socio-cultural barriers in healthcare access for female infants remain a major factor behind higher female premature deaths. However, India has witnessed a consistent reduction in child mortality rates, driven by initiatives prioritizing newborn and maternal safety.
Governments and regulatory bodies are taking considerable measures to increase access to PROM testing across several regions. For instance, in March 2022, Sera Prognostics Inc. announced that the Centers for Medicare & Medicaid Services established a Medicare payment rate of USD 750 for its PreTRM test, a proteomic blood test designed to measure preterm birth risk. The test has gained additional traction, with ongoing commercial collaboration between Sera and Elevance Health regarding coverage for its PreTRM test, which improves affordability for high-risk pregnant women and encourages broader adoption among hospitals and maternal-fetal medicine specialists.
Similarly, Actim PROM is a U.S. FDA-approved POC rapid test, to detect PROM. It provides rapid accurate results for preterm births. More than 7 million tests have been distributed in over 70 countries since they are highly reliable with 97% sensitivity and specificity. Actim Prom helps detect the protein biomarker Insulin-like Growth Factor Binding Protein-1 (IGFBP - 1). The advancements in POC diagnostics for PROM can encourage pregnant women to test for PROM more frequently when compared to a long procedure of testing held in hospitals and clinics.
Global Preterm Birth And PROM Testing Market Report Segmentation
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global preterm birth and PROM testing market report based on type, application, and region:
- Type Outlook (Revenue, USD Million, 2021 - 2033)
- Pelvic Exam
- Ultrasound
- Biochemical Markers
- Interleukin (IL)-6
- C-Reactive Protein (CRP)
- IL-1, IL-2, IL-8, TNF-a
- Corticotropin-Releasing Hormone (CRH)
- AFP (Alpha fetoprotein)
- Uterine Monitoring
- Nitazine Test
- Ferning Test
- Pooling
- PAMG-1 Immunoassay
- IGFBP Test
- Fetal Fibronectin (fFN)
- Others
- Application Outlook (Revenue, USD Million, 2021 - 2033)
- PROM
- Preterm Labor
- Chorioamnionitis
- Regional Outlook (Revenue, USD Million, 2021 - 2033)
- North America
- U.S.
- Canada
- Mexico
- Europe
- UK
- Germany
- France
- Italy
- Spain
- Russia
- Denmark
- Sweden
- Norway
- Asia Pacific
- Japan
- China
- India
- Australia
- South Korea
- Singapore
- Thailand
- Latin America
- Brazil
- Argentina
- Middle East & Africa
- South Africa
- Saudi Arabia
- UAE
- Kuwait
Table of Contents
90 Pages
- Chapter 1. Methodology and Scope
- 1.1. Market Segmentation & Scope
- 1.2. Segment Definitions
- 1.2.1. Type
- 1.2.2. Application
- 1.3. Estimates and Forecast Timeline
- 1.4. Research Methodology
- 1.5. Information Procurement
- 1.5.1. Purchased Database
- 1.5.2. GVR’s Internal Database
- 1.5.3. Secondary Sources
- 1.5.4. Primary Research
- 1.6. Information Analysis
- 1.6.1. Data Analysis Models
- 1.7. Market Formulation & Data Visualization
- 1.8. Model Details
- 1.8.1. Commodity Flow Analysis
- 1.9. List of Secondary Sources
- 1.10. Objectives
- Chapter 2. Executive Summary
- 2.1. Market Snapshot
- 2.2. Segment Snapshot
- 2.3. Competitive Landscape Snapshot
- Chapter 3. Preterm Birth and PROM Testing Market Variables, Trends, & Scope
- 3.1. Market Lineage Outlook
- 3.2. Market Dynamics
- 3.2.1. Market Driver Analysis
- 3.2.2. Market Restraint Analysis
- 3.2.3. Market Opportunity Analysis
- 3.3. Business Environment Analysis
- 3.3.1. Industry Analysis - Porter’s Five Forces Analysis
- 3.3.1.1. Supplier Power
- 3.3.1.2. Buyer Power
- 3.3.1.3. Substitution Threat
- 3.3.1.4. Threat of New Entrants
- 3.3.1.5. Competitive Rivalry
- 3.3.2. PESTLE Analysis
- 3.3.3. Unmet Need and Gap Analysis
- 3.3.4. Case Studies
- Chapter 4. Preterm Birth and PROM Testing Market: Type Business Analysis
- 4.1. Type Market Share, 2024 & 2033
- 4.2. Type Segment Dashboard
- 4.3. Market Size & Forecasts and Trend Analysis, by Type, 2021 to 2033 (USD Million)
- 4.4. Pelvic Exam
- 4.4.1. Pelvic Exam Market, 2021 - 2033 (USD Million)
- 4.5. Ultrasound
- 4.5.1. Ultrasound Market, 2021 - 2033 (USD Million)
- 4.6. Biochemical Markers
- 4.6.1. Biochemical Markers Market, 2021 - 2033 (USD Million)
- 4.6.2. Interleukin (IL)-6
- 4.6.2.1. Interleukin (IL)-6 Market, 2021 - 2033 (USD Million)
- 4.6.3. C-Reactive Protein (CRP)
- 4.6.3.1. C-Reactive Protein (CRP) Market, 2021 - 2033 (USD Million)
- 4.6.4. IL-1, IL-2, IL-8, TNF-a
- 4.6.4.1. IL-1, IL-2, IL-8, TNF-a Market, 2021 - 2033 (USD Million)
- 4.6.5. Corticotropin-Releasing Hormone (CRH)
- 4.6.5.1. Corticotropin-Releasing Hormone (CRH) Market, 2021 - 2033 (USD Million)
- 4.6.6. AFP (Alpha fetoprotein)
- 4.6.6.1. AFP (Alpha fetoprotein) Market, 2021 - 2033 (USD Million)
- 4.7. Uterine Monitoring
- 4.7.1. Uterine Monitoring Market, 2021 - 2033 (USD Million)
- 4.8. Nitazine Test
- 4.8.1. Nitazine Test Market, 2021 - 2033 (USD Million)
- 4.9. Ferning Test
- 4.9.1. Ferning Test Market, 2021 - 2033 (USD Million)
- 4.10. Pooling
- 4.10.1. Pooling Market, 2021 - 2033 (USD Million)
- 4.11. PAMG-1 Immunoassay
- 4.11.1. PAMG-1 Immunoassay Market, 2021 - 2033 (USD Million)
- 4.12. IGFBP Test
- 4.12.1. IGFBP Test Market, 2021 - 2033 (USD Million)
- 4.13. Fetal Fibronectin (fFN)
- 4.13.1. Fetal Fibronectin (fFN) Market, 2021 - 2033 (USD Million)
- 4.14. Others
- 4.14.1. Others Market, 2021 - 2033 (USD Million)
- Chapter 5. Preterm Birth and PROM Testing Market: Application Business Analysis
- 5.1. Application Market Share, 2024 & 2033
- 5.2. Application Segment Dashboard
- 5.3. Market Size & Forecasts and Trend Analysis, by Application, 2021 to 2033 (USD Million)
- 5.4. PROM
- 5.4.1. PROM Market, 2021 - 2033 (USD Million)
- 5.5. Preterm Labor
- 5.5.1. Preterm Labor Market, 2021 - 2033 (USD Million)
- 5.6. Chorioamnionitis
- 5.6.1. Chorioamnionitis Market, 2021 - 2033 (USD Million)
- Chapter 6. Preterm Birth and PROM Testing Market: Regional Estimates & Trend Analysis
- 6.1. Regional Market Share Analysis, 2024 & 2033
- 6.2. Regional Market Dashboard
- 6.3. Market Size & Forecasts Trend Analysis, 2021 to 2033:
- 6.4. North America
- 6.4.1. North America Preterm Birth and PROM Testing Market Estimates and Forecasts, By Country, 2021 - 2033 (USD Million)
- 6.4.2. U.S.
- 6.4.2.1. Key Country Dynamics
- 6.4.2.2. Regulatory Framework
- 6.4.2.3. U.S. Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.4.3. Canada
- 6.4.3.1. Key Country Dynamics
- 6.4.3.2. Regulatory Framework
- 6.4.3.3. U.S. Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.4.4. Mexico
- 6.4.4.1. Key Country Dynamics
- 6.4.4.2. Regulatory Framework
- 6.4.4.3. Mexico Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5. Europe
- 6.5.1. Europe Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.2. UK
- 6.5.2.1. Key Country Dynamics
- 6.5.2.2. Regulatory Framework
- 6.5.2.3. UK Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.3. Germany
- 6.5.3.1. Key Country Dynamics
- 6.5.3.2. Regulatory Framework
- 6.5.3.3. Germany Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.4. France
- 6.5.4.1. Key Country Dynamics
- 6.5.4.2. Regulatory Framework
- 6.5.4.3. France Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.5. Italy
- 6.5.5.1. Key Country Dynamics
- 6.5.5.2. Regulatory Framework
- 6.5.5.3. Italy Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.6. Spain
- 6.5.6.1. Key Country Dynamics
- 6.5.6.2. Regulatory Framework
- 6.5.6.3. Spain Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.7. Russia
- 6.5.7.1. Key Country Dynamics
- 6.5.7.2. Regulatory Framework
- 6.5.7.3. Russia Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.8. Denmark
- 6.5.8.1. Key Country Dynamics
- 6.5.8.2. Regulatory Framework
- 6.5.8.3. Denmark Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.9. Sweden
- 6.5.9.1. Key Country Dynamics
- 6.5.9.2. Regulatory Framework
- 6.5.9.3. Sweden Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.5.10. Norway
- 6.5.10.1. Key Country Dynamics
- 6.5.10.2. Regulatory Framework
- 6.5.10.3. Norway Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.6. Asia Pacific
- 6.6.1. Asia Pacific Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.6.2. Japan
- 6.6.2.1. Key Country Dynamics
- 6.6.2.2. Regulatory Framework
- 6.6.2.3. Japan Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.6.3. China
- 6.6.3.1. Key Country Dynamics
- 6.6.3.2. Regulatory Framework
- 6.6.3.3. China Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.6.4. India
- 6.6.4.1. Key Country Dynamics
- 6.6.4.2. Regulatory Framework
- 6.6.4.3. India Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.6.5. Australia
- 6.6.5.1. Key Country Dynamics
- 6.6.5.2. Regulatory Framework
- 6.6.5.3. Australia Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.6.6. South Korea
- 6.6.6.1. Key Country Dynamics
- 6.6.6.2. Regulatory Framework
- 6.6.6.3. South Korea Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.6.7. Singapore
- 6.6.7.1. Key Country Dynamics
- 6.6.7.2. Regulatory Framework
- 6.6.7.3. Singapore Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.6.8. Thailand
- 6.6.8.1. Key Country Dynamics
- 6.6.8.2. Regulatory Framework
- 6.6.8.3. Thailand Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.7. Latin America
- 6.7.1. Latin America Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.7.2. Brazil
- 6.7.2.1. Key Country Dynamics
- 6.7.2.2. Regulatory Framework
- 6.7.2.3. Japan Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.7.3. Argentina
- 6.7.3.1. Key Country Dynamics
- 6.7.3.2. Regulatory Framework
- 6.7.3.3. China Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.8. Middle East and Africa
- 6.8.1. Middle East and Africa Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.8.2. South Africa
- 6.8.2.1. Key Country Dynamics
- 6.8.2.2. Regulatory Framework
- 6.8.2.3. South Africa Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.8.3. Saudi Arabia
- 6.8.3.1. Key Country Dynamics
- 6.8.3.2. Regulatory Framework
- 6.8.3.3. Saudi Arabia Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.8.4. UAE
- 6.8.4.1. Key Country Dynamics
- 6.8.4.2. Regulatory Framework
- 6.8.4.3. UAE Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- 6.8.5. Kuwait
- 6.8.5.1. Key Country Dynamics
- 6.8.5.2. Regulatory Framework
- 6.8.5.3. Kuwait Preterm Birth and PROM Testing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
- Chapter 7. Competitive Landscape
- 7.1. Participant Overview
- 7.2. Company Market Position Analysis
- 7.3. Company Categorization
- 7.4. Strategy Mapping
- 7.5. Company Profiles/Listing
- 7.5.1. QIAGEN
- 7.5.1.1. Overview
- 7.5.1.2. Financial Performance
- 7.5.1.3. Product Benchmarking
- 7.5.1.4. Strategic Initiatives
- 7.5.2. Hologic, Inc.
- 7.5.2.1. Overview
- 7.5.2.2. Financial Performance
- 7.5.2.3. Product Benchmarking
- 7.5.2.4. Strategic Initiatives
- 7.5.3. CooperSurgical Inc.
- 7.5.3.1. Overview
- 7.5.3.2. Financial Performance
- 7.5.3.3. Product Benchmarking
- 7.5.3.4. Strategic Initiatives
- 7.5.4. Abbott
- 7.5.4.1. Overview
- 7.5.4.2. Financial Performance
- 7.5.4.3. Product Benchmarking
- 7.5.4.4. Strategic Initiatives
- 7.5.5. Medix Biochemica
- 7.5.5.1. Overview
- 7.5.5.2. Financial Performance
- 7.5.5.3. Product Benchmarking
- 7.5.5.4. Strategic Initiatives
- 7.5.6. Sera
- 7.5.6.1. Overview
- 7.5.6.2. Financial Performance
- 7.5.6.3. Product Benchmarking
- 7.5.6.4. Strategic Initiatives
- 7.5.7. Laborie
- 7.5.7.1. Overview
- 7.5.7.2. Financial Performance
- 7.5.7.3. Product Benchmarking
- 7.5.7.4. Strategic Initiatives
- 7.5.8. Biosynex SA
- 7.5.8.1. Overview
- 7.5.8.2. Financial Performance
- 7.5.8.3. Product Benchmarking
- 7.5.8.4. Strategic Initiatives
- 7.5.9. NX Prenatal Inc.
- 7.5.9.1. Overview
- 7.5.9.2. Financial Performance
- 7.5.9.3. Product Benchmarking
- 7.5.9.4. Strategic Initiatives
- 7.5.10. IQ Products
- 7.5.10.1. Overview
- 7.5.10.2. Financial Performance
- 7.5.10.3. Product Benchmarking
- 7.5.10.4. Strategic Initiatives
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