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Preterm Birth Prom Testing Market

ID: MRFR/HC/41657-HCR
200 Pages
Rahul Gotadki
October 2025

Preterm Birth and PROM Testing Market Research Report By Test Type (Amniotic Fluid Test, Cervical Swab Test, Biochemical Marker Test, Ultrasound Test), By Indication (Preterm Birth, Premature Rupture of Membranes, Gestational Diabetes, Intrauterine Infection), By End User (Hospitals, Diagnostic Laboratories, Clinics, Home Care Settings), By Distribution Channel (Direct Sales, Online Sales, Distributors, Retail Pharmacies) and By Regional (North America, Europe, South America, Asia Pacific, Middle East and Africa) - Forecast to 2035

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Preterm Birth Prom Testing Market Summary

As per MRFR analysis, the Preterm Birth and PROM Testing Market Size was estimated at 2.3 USD Billion in 2024. The Preterm Birth and PROM Testing industry is projected to grow from 2.444 USD Billion in 2025 to 4.49 USD Billion by 2035, exhibiting a compound annual growth rate (CAGR) of 6.27 during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The Preterm Birth and PROM Testing Market is experiencing notable growth driven by technological advancements and increased maternal health focus.

  • Technological advancements in testing are enhancing the accuracy and efficiency of preterm birth diagnostics.
  • North America remains the largest market, while Asia-Pacific is emerging as the fastest-growing region in this sector.
  • The amniotic fluid test segment holds the largest market share, whereas the biochemical marker test segment is witnessing rapid growth.
  • Rising incidence of preterm births and increased awareness and education are key drivers propelling market expansion.

Market Size & Forecast

2024 Market Size 2.3 (USD Billion)
2035 Market Size 4.49 (USD Billion)
CAGR (2025 - 2035) 6.27%

Major Players

Hologic (US), Fisher Scientific (US), Thermo Fisher Scientific (US), Roche (CH), Siemens Healthineers (DE), PerkinElmer (US), BD (US), Abbott Laboratories (US), Medtronic (IE)

Preterm Birth Prom Testing Market Trends

The Preterm Birth and PROM Testing Market is currently experiencing notable developments driven by advancements in medical technology and increasing awareness regarding maternal and neonatal health. The rise in preterm births globally has prompted healthcare providers to seek effective testing solutions to identify risk factors associated with premature labor. This market appears to be influenced by a growing emphasis on early diagnosis and intervention, which may lead to improved outcomes for both mothers and infants. Furthermore, the integration of innovative diagnostic tools and methodologies is likely to enhance the accuracy and reliability of tests, thereby fostering greater adoption among healthcare professionals. In addition, the Preterm Birth and PROM Testing Market seems to be shaped by evolving healthcare policies and initiatives aimed at reducing preterm birth rates. Governments and health organizations are increasingly prioritizing maternal health, which could result in increased funding for research and development in this field. As a consequence, the market may witness a surge in the introduction of novel testing products and services designed to address the complexities of preterm labor. Overall, the landscape of this market appears dynamic, with various factors converging to create opportunities for growth and innovation in the coming years.

Technological Advancements in Testing

The Preterm Birth and PROM Testing Market is witnessing a surge in technological innovations that enhance the accuracy and efficiency of diagnostic tests. New methodologies, such as biomarker identification and point-of-care testing, are emerging, potentially transforming how healthcare providers assess the risk of preterm labor. These advancements may lead to quicker results and improved patient management.

Increased Focus on Maternal Health

There is a growing emphasis on maternal health within healthcare systems worldwide, which appears to be influencing the Preterm Birth and PROM Testing Market. Initiatives aimed at reducing preterm birth rates are gaining traction, suggesting that healthcare providers are prioritizing early detection and intervention strategies. This trend may drive demand for effective testing solutions.

Regulatory Support and Funding

The Preterm Birth and PROM Testing Market seems to benefit from enhanced regulatory support and funding initiatives aimed at improving maternal and neonatal health outcomes. Governments and health organizations are likely to invest in research and development, which could facilitate the introduction of innovative testing products. This support may create a favorable environment for market expansion.

Preterm Birth Prom Testing Market Drivers

Increased Awareness and Education

The growing awareness and education surrounding maternal health issues are pivotal in shaping the Preterm Birth and PROM Testing Market. Campaigns aimed at educating expectant mothers about the risks associated with preterm births and the importance of early detection are gaining traction. This heightened awareness is likely to lead to increased demand for testing services, as more women seek proactive measures to ensure healthy pregnancies. Furthermore, healthcare providers are increasingly prioritizing patient education as part of their standard care protocols, which may further drive the adoption of PROM testing. As awareness continues to rise, the Preterm Birth and PROM Testing Market is expected to benefit from a more informed patient population that actively engages in their prenatal care.

Regulatory Support and Guidelines

Regulatory support and the establishment of guidelines for prenatal care are influential factors in the Preterm Birth and PROM Testing Market. Governments and health organizations are increasingly recognizing the need for standardized protocols to address the challenges associated with preterm births. This regulatory framework not only encourages the adoption of best practices in maternal care but also fosters innovation in testing methodologies. For example, guidelines that promote the use of specific biomarkers for early detection of PROM can lead to increased investment in research and development. As regulatory bodies continue to advocate for improved maternal health outcomes, the Preterm Birth and PROM Testing Market is likely to experience growth driven by compliance with these evolving standards.

Rising Incidence of Preterm Births

The increasing incidence of preterm births is a critical driver for the Preterm Birth and PROM Testing Market. Recent statistics indicate that approximately 15 million infants are born preterm each year, which represents a significant public health concern. This rise in preterm births necessitates the development and implementation of effective testing methods to identify at-risk pregnancies. As healthcare providers seek to mitigate the risks associated with preterm deliveries, the demand for reliable PROM testing solutions is likely to grow. This trend underscores the importance of investing in innovative technologies and methodologies that can enhance prenatal care and improve outcomes for both mothers and infants. Consequently, the Preterm Birth and PROM Testing Market is poised for expansion as stakeholders respond to this pressing need.

Advancements in Diagnostic Technologies

Technological advancements in diagnostic tools are transforming the landscape of the Preterm Birth and PROM Testing Market. Innovations such as point-of-care testing and non-invasive methods are enhancing the accuracy and speed of diagnosing preterm labor and premature rupture of membranes. For instance, the introduction of biomarkers and molecular diagnostics has shown promise in identifying at-risk pregnancies earlier than traditional methods. This evolution in testing technology not only improves patient outcomes but also streamlines clinical workflows, making it easier for healthcare providers to manage high-risk cases. As these technologies continue to evolve, they are expected to drive growth in the Preterm Birth and PROM Testing Market, as more healthcare facilities adopt these advanced solutions to enhance maternal and fetal health.

Growing Investment in Maternal Health Research

The surge in investment directed towards maternal health research is a significant driver for the Preterm Birth and PROM Testing Market. Funding from both public and private sectors is increasingly being allocated to studies focused on understanding the causes and consequences of preterm births. This financial support is crucial for developing new testing methods and improving existing ones, thereby enhancing the overall quality of prenatal care. Research initiatives that explore innovative approaches to predict and manage preterm labor are likely to yield valuable insights, which can subsequently be translated into practical applications within the healthcare system. As investment in maternal health research continues to grow, the Preterm Birth and PROM Testing Market stands to benefit from the advancements and discoveries that emerge from these efforts.

Market Segment Insights

By Test Type: Amniotic Fluid Test (Largest) vs. Biochemical Marker Test (Fastest-Growing)

The Preterm Birth and PROM Testing Market exhibits a diverse landscape across its test types, where the Amniotic Fluid Test stands out as the largest segment. This test has been widely adopted due to its direct correlation with pregnancy outcomes, enabling healthcare professionals to make informed decisions. Following this, the Cervical Swab Test and Ultrasound Test hold significant shares, but they do not match the prevalent dominance of the Amniotic Fluid Test. Meanwhile, the Biochemical Marker Test has gained attention for its innovative approach, showing increasing relevance in clinical settings. In terms of growth trends, the market for these tests is evolving with advancements in technology and increasing awareness about preterm birth risks. The Biochemical Marker Test, in particular, is highlighted as the fastest-growing segment as research continues to unveil its potential in early detection, aided by the rise of personalized medicine. These developments are supported by an upward shift in healthcare spending and a push for early diagnosis to improve maternal and neonatal health outcomes. The overall segment shows robust dynamics driven by both established practices and emerging technologies.

Amniotic Fluid Test (Dominant) vs. Biochemical Marker Test (Emerging)

The Amniotic Fluid Test remains the dominant choice in the Preterm Birth and PROM Testing Market, recognized for its effectiveness in assessing risk levels associated with preterm births and PROM. This test is typically administered in clinical settings and has a well-established protocol, making it a preferred option for many healthcare providers. On the other hand, the Biochemical Marker Test is emerging rapidly within this landscape, showcasing its innovative nature that attracts both clinicians and researchers. Its ability to assess biochemical markers for risk prediction is revolutionizing how healthcare professionals approach screenings. Though it is currently smaller in volume compared to the Amniotic Fluid Test, increasing research and clinical validation are expected to enhance its adoption, positioning it as a key player in future testing methodologies.

By Indication: Preterm Birth (Largest) vs. Premature Rupture of Membranes (Fastest-Growing)

In the Preterm Birth and PROM Testing Market, the indication of Preterm Birth commands the largest market share. It is the primary focus of diagnostic tests due to the significant health implications associated with its early detection. This segment's existing dominance is strengthened by increasing awareness among healthcare providers and expectant mothers, which drives demand for effective testing solutions. In contrast, the segment related to Premature Rupture of Membranes is emerging rapidly, supported by advances in diagnostic technologies and growing knowledge among clinicians about the importance of early detection for improving maternal and neonatal outcomes.

Indication: Preterm Birth (Dominant) vs. Intrauterine Infection (Emerging)

Preterm Birth remains the dominant indication within testing protocols, driven by its critical impact on neonatal health and the associated healthcare costs for managing preterm deliveries. This category is characterized by established clinical pathways and robust research backing its testing requirements, leading to consistent investments and innovations. Conversely, Intrauterine Infection is considered an emerging indication, garnering attention as maternal infectious diseases are increasingly recognized as significant contributors to adverse pregnancy outcomes. This segment is witnessing growth driven by new diagnostic capabilities and a deeper understanding of the infection’s implications during pregnancy, creating opportunities for novel products and approaches in testing.

By End User: Hospitals (Largest) vs. Diagnostic Laboratories (Fastest-Growing)

The Preterm Birth and PROM Testing Market is primarily segmented by end users, where hospitals hold the largest market share. Hospitals are integral to maternal and neonatal care, providing comprehensive services that include advanced diagnosis and management of preterm birth and PROM. Diagnostic laboratories follow closely, serving a critical role in confirming diagnoses and facilitating timely interventions. Growth in the hospitals segment is driven by increasing awareness of maternal health issues and rising hospitalization rates for preterm births. Meanwhile, diagnostic laboratories are emerging as the fastest-growing segment, fueled by advancements in diagnostic technologies and the demand for more precise testing solutions. The focus on early diagnosis to improve neonatal outcomes enhances the market potential for laboratories, making them a key player in this evolving landscape.

Hospitals (Dominant) vs. Home Care Settings (Emerging)

Hospitals are the dominant end user in the Preterm Birth and PROM Testing Market due to their capacity to handle complex cases and provide a wide range of necessary services for pregnant women at risk. Equipped with specialized personnel and technology, hospitals play a vital role in managing preterm labor and complications associated with PROM. Conversely, home care settings represent an emerging segment, driven by trends toward patient-centered care and the increasing implementation of telemedicine solutions. Home care allows for monitoring and support in a more comfortable environment for patients, catering to those who prefer to manage their conditions outside traditional healthcare facilities. As technology continues to advance, home care settings are likely to expand, offering innovative solutions for monitoring maternal health remotely.

By Distribution Channel: Direct Sales (Largest) vs. Online Sales (Fastest-Growing)

In the Preterm Birth and PROM Testing Market, the distribution of sales channels reveals that Direct Sales holds the largest share, driven by strong relationships with healthcare providers and hospitals that prefer traditional purchasing methods. Online Sales, while currently smaller in share, is gaining traction due to the increasing convenience and expanded reach it offers, particularly to a wider audience of healthcare practitioners and facilities that prioritize efficiency in their purchasing processes.

Direct Sales (Dominant) vs. Online Sales (Emerging)

Direct Sales dominates the Preterm Birth and PROM Testing Market primarily due to its established network and face-to-face interactions that foster trust and reliability among buyers. This channel is particularly effective within hospital environments where purchasing decisions often involve clinical evaluations. Conversely, Online Sales represents an emerging avenue characterized by its rapid adoption, particularly among smaller practices and rural healthcare providers seeking cost-effective and accessible testing solutions. The trend towards e-commerce reflects a shift in purchasing behavior, with many healthcare professionals appreciating the convenience of ordering supplies online, leading to a consistent growth trajectory for this sales channel.

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Regional Insights

The Regional segment of the  Preterm Birth and PROM Testing Market presents a diverse landscape of growth and development across various territories. In 2024, North America is projected to hold the majority share with a revenue of 0.95 USD Billion, significantly leading the market, driven by advanced healthcare infrastructure and increased awareness regarding preterm complications. Europe follows with a notable valuation of 0.65 USD Billion, reflecting strong healthcare systems and research capabilities focusing on maternal and infant health.

The APAC region is also gaining traction, with an expected revenue of 0.5 USD Billion, supported by rising healthcare expenditure and population growth. Meanwhile, South America and MEA demonstrate smaller market figures at 0.1 USD Billion and 0.05 USD Billion, respectively. The growth potential in these regions lies in improving healthcare access and awareness. Overall, the Preterm Birth and PROM Testing Market segmentation reveals a strategic opportunity for expansion, particularly in underserved regions, where increased investment and innovations can significantly impact health outcomes.

Preterm Birth Prom Testing Market Regional Image

Key Players and Competitive Insights

The Preterm Birth and PROM Testing Market is characterized by its rapid growth and significant advancements in testing technologies aimed at addressing the critical public health issue of preterm birth, which can lead to serious health concerns for both infants and mothers. With rising awareness regarding the implications of preterm labor and premature rupture of membranes (PROM), healthcare providers are increasingly adopting innovative testing solutions. The competitive landscape is marked by various players striving to leverage cutting-edge research and development to introduce more effective diagnostic tools.

Key trends influencing the market include growing investment in maternal health initiatives, advancements in point-of-care testing, and shifting regulatory landscapes which together stimulate competition among beverage makers.

The need for improved monitoring, early detection, and timely intervention further drives innovation, fostering a dynamic environment where companies are constantly adapting to meet market demands. Hologic is a prominent player in the Preterm Birth and PROM Testing Market, recognized for its innovative contributions towards the detection and management of preterm labor and PROM. The company has established a strong presence through its commitment to developing reliable diagnostic tests that enable healthcare professionals to assess the risk of preterm birth accurately. Hologic's advanced testing solutions are designed to enhance clinical decision-making, supporting healthcare providers in delivering timely interventions.

The company's strengths lie in its robust R&D capabilities, allowing to stay at the forefront of technology and address the evolving needs within the maternal care segment. Moreover, Hologic's focus on quality and safety standards further solidifies its reputation as a trusted partner in improving patient outcomes .

Abbott Laboratories similarly boasts a significant role in the Preterm Birth and PROM Testing Market, where its innovative testing technologies are designed to facilitate early detection and risk assessment for potential preterm births. With a diversified portfolio that leverages scientific expertise, Abbott Laboratories effectively addresses the complexities surrounding PROM and preterm labor through reliable and user-friendly solutions. The company's strengths are evident in its strategic investments in research and partnerships that accelerate product development and enhance its market presence.

Abbott Laboratories prioritizes patient care by focusing on solutions that offer timely and accurate results, which are crucial for effective clinical interventions. This commitment to improving maternal and neonatal health reinforces its competitive advantage within the market, making it a key contender in addressing the challenges associated with preterm births.

Key Companies in the Preterm Birth Prom Testing Market market include

Industry Developments

Recent developments in the Preterm Birth and PROM Testing Market include several noteworthy advancements and ongoing trends. Companies like Hologic and Abbott Laboratories are making strides in developing advanced diagnostic tools aimed at improving early detection of preterm birth and premature rupture of membranes (PROM). Progenity has also been focused on enhancing their testing platforms with innovations that promise higher accuracy and faster results. The market has seen a growing demand for these technologies due to increased awareness of preterm birth implications and healthcare providers prioritizing prenatal care.

Mergers and acquisitions are pivotal in this landscape, with companies such as Roche and Siemens Healthineers looking to enhance their product portfolios and expand their market presence through strategic partnerships. Thermo Fisher Scientific and BD are further investing in research and development, aiming to broaden their offering of testing solutions. Moreover, the overall valuation of companies operating within this market is experiencing growth, reflecting a proactive response to the socio-economic impacts of early childbirth, which ultimately drives the development of innovative testing solutions in the field.

As the focus intensifies on maternal and infant health, these companies are positioning themselves as leaders in addressing critical diagnostics.

Future Outlook

Preterm Birth Prom Testing Market Future Outlook

The Preterm Birth and PROM Testing Market is projected to grow at a 6.27% CAGR from 2024 to 2035, driven by technological advancements and increasing awareness.

New opportunities lie in:

  • Development of portable diagnostic devices for remote testing
  • Integration of AI for predictive analytics in prenatal care
  • Expansion of telehealth services for maternal health monitoring

By 2035, the market is expected to achieve substantial growth, enhancing maternal and neonatal health outcomes.

Market Segmentation

Preterm Birth Prom Testing Market End User Outlook

  • Hospitals
  • Diagnostic Laboratories
  • Clinics
  • Home Care Settings

Preterm Birth Prom Testing Market Test Type Outlook

  • Amniotic Fluid Test
  • Cervical Swab Test
  • Biochemical Marker Test
  • Ultrasound Test

Preterm Birth Prom Testing Market Indication Outlook

  • Preterm Birth
  • Premature Rupture of Membranes
  • Gestational Diabetes
  • Intrauterine Infection

Preterm Birth Prom Testing Market Distribution Channel Outlook

  • Direct Sales
  • Online Sales
  • Distributors
  • Retail Pharmacies

Report Scope

MARKET SIZE 2024 2.3(USD Billion)
MARKET SIZE 2025 2.444(USD Billion)
MARKET SIZE 2035 4.49(USD Billion)
COMPOUND ANNUAL GROWTH RATE (CAGR) 6.27% (2024 - 2035)
REPORT COVERAGE Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR 2024
Market Forecast Period 2025 - 2035
Historical Data 2019 - 2024
Market Forecast Units USD Billion
Key Companies Profiled Market analysis in progress
Segments Covered Market segmentation analysis in progress
Key Market Opportunities Advancements in non-invasive testing technologies enhance early detection in the Preterm Birth and PROM Testing Market.
Key Market Dynamics Rising demand for accurate preterm birth and premature rupture of membranes testing drives innovation and competitive dynamics.
Countries Covered North America, Europe, APAC, South America, MEA

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FAQs

What is the projected market valuation for the Preterm Birth and PROM Testing Market in 2035?

The projected market valuation for the Preterm Birth and PROM Testing Market in 2035 is expected to reach 4.49 USD Billion.

What was the overall market valuation for the Preterm Birth and PROM Testing Market in 2024?

The overall market valuation for the Preterm Birth and PROM Testing Market was 2.3 USD Billion in 2024.

What is the expected CAGR for the Preterm Birth and PROM Testing Market during the forecast period 2025 - 2035?

The expected CAGR for the Preterm Birth and PROM Testing Market during the forecast period 2025 - 2035 is 6.27%.

Which test type segment is projected to have the highest valuation by 2035?

The Biochemical Marker Test segment is projected to have the highest valuation, expected to range from 0.6 to 1.2 USD Billion.

How do hospitals compare to clinics in terms of market valuation for the Preterm Birth and PROM Testing Market?

Hospitals are anticipated to dominate the market with a valuation ranging from 0.92 to 1.78 USD Billion, compared to clinics at 0.46 to 0.89 USD Billion.

Which key players are leading the Preterm Birth and PROM Testing Market?

Key players in the market include Hologic, Thermo Fisher Scientific, Roche, and Abbott Laboratories, among others.

What is the expected valuation range for the Amniotic Fluid Test segment by 2035?

The Amniotic Fluid Test segment is expected to have a valuation range from 0.5 to 0.95 USD Billion by 2035.

What distribution channel is projected to show significant growth in the Preterm Birth and PROM Testing Market?

The Direct Sales distribution channel is projected to show significant growth, with a valuation range from 0.69 to 1.36 USD Billion.

What indication segment is expected to have the highest market valuation by 2035?

The Preterm Birth indication segment is expected to have the highest market valuation, projected to range from 0.92 to 1.8 USD Billion.

How does the market valuation for the Premature Rupture of Membranes compare to that of Gestational Diabetes?

The market valuation for Premature Rupture of Membranes is projected to range from 0.69 to 1.35 USD Billion, which is higher than the 0.46 to 0.9 USD Billion range for Gestational Diabetes.

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