Preterm Birth And PROM Testing Market Size, Share & Trends Analysis Report By Test Type (Pelvic Exam, Ultrasound, Biochemical Markers, Uterine Monitoring), By Application (PROM, Preterm Labor), By Region- Global Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2024-2033

The global preterm birth and PROM testing market size was exhibited at USD 1.32 billion in 2023 and is projected to hit around USD 2.98 billion by 2033, growing at a CAGR of 8.5% during the forecast period of 2024 to 2033.

Key Takeaways:

• In 2023, the ultrasound segment held 31.61% of the global preterm birth and PROM testing market.
• The preterm labor segment held 44.0% of market share in 2023 and is anticipated to have a similar trend in the forecasted period.
• North America captured the largest revenue share of 40.0% of preterm birth and PROM testing market in 2023.

Preterm Birth And PROM Testing Market: Overview

The Preterm Birth and Premature Rupture of Membranes (PROM) Testing Market is a critical component of maternal and neonatal healthcare, addressing the challenges associated with preterm births and the risk of premature rupture of membranes. This comprehensive overview aims to shed light on the key aspects, trends, and advancements within this dynamic market.

Preterm Birth And PROM Testing Market Growth

The growth of the Preterm Birth and Premature Rupture of Membranes (PROM) Testing Market is underpinned by several key factors. Firstly, increasing awareness and understanding of the serious health implications associated with preterm births drive the demand for advanced diagnostic solutions. Technological advancements in diagnostic techniques, including innovative imaging and biochemical methods, contribute significantly to the market's growth, enhancing the accuracy and early detection of preterm labor and PROM. Furthermore, a rising global prevalence of preterm births, particularly in high-risk regions, propels the demand for reliable testing options. Collaborative efforts between healthcare organizations, research institutions, and industry players also play a pivotal role in driving research and development initiatives, fostering the introduction of cutting-edge technologies to the market. As regulatory frameworks evolve to ensure the safety and efficacy of testing products, the market is poised for sustained growth, presenting both challenges and opportunities for stakeholders in the field of maternal and neonatal healthcare.

Preterm Birth And PROM Testing Market Report Scope

Market Dynamics

Market size and growth:

The Preterm Birth and Premature Rupture of Membranes (PROM) Testing Market exhibit dynamic and robust market dynamics, with a notable focus on market size and growth trends. The increasing prevalence of preterm births globally, coupled with a growing awareness of the associated health risks, propels the demand for effective diagnostic solutions. The market is witnessing a substantial rise in investments in research and development, leading to the introduction of innovative testing methodologies and technologies. Key players in the market are strategically focusing on mergers, acquisitions, and partnerships to expand their product portfolios and geographical presence. Additionally, the market is influenced by evolving healthcare infrastructures, reimbursement policies, and regulatory frameworks, all of which contribute to shaping the landscape of preterm birth and PROM testing.

• Technological Advancements:

Technological advancements play a pivotal role in shaping the dynamics of the Preterm Birth and PROM Testing Market. Ongoing innovations in diagnostic techniques, such as advanced imaging modalities and sophisticated biochemical markers, enhance the accuracy and efficiency of early detection for preterm labor and PROM. The integration of artificial intelligence (AI) and machine learning algorithms further refines diagnostic capabilities, providing healthcare professionals with valuable insights. Moreover, continuous research and development efforts are fostering the introduction of novel testing solutions, addressing the evolving needs of maternal and neonatal healthcare. As technological breakthroughs continue to drive progress, market stakeholders are poised to capitalize on these advancements, ensuring a dynamic and competitive landscape in the realm of preterm birth and PROM testing.

Market Restraint

• Regulatory Challenges:

The Preterm Birth and Premature Rupture of Membranes (PROM) Testing Market faces significant restraint due to regulatory challenges. Stringent regulatory requirements and varying approval processes across different regions can hinder the timely introduction of new diagnostic products to the market. Compliance with regulatory standards is crucial for ensuring the safety and efficacy of testing solutions, but the complexity of navigating diverse regulatory landscapes poses a barrier for manufacturers. Achieving regulatory approval involves substantial investments of time and resources, delaying the availability of advanced diagnostic technologies and potentially limiting the market's growth potential.

• Cost Constraints:

Cost constraints represent a notable restraint in the preterm Birth and PROM testing markets. The development and deployment of sophisticated diagnostic technologies often involve high research and production costs. These expenses may be passed on to end-users, creating challenges in accessibility, especially in resource-limited healthcare settings. Additionally, reimbursement policies and coverage limitations can impact the affordability of these tests for patients. As a result, the adoption of advanced preterm birth and PROM testing solutions may be impeded, particularly in regions where healthcare budgets are constrained. Addressing cost-related challenges becomes crucial for market stakeholders to ensure widespread access to innovative testing options and foster market growth.

Market Opportunity

• Global Healthcare Initiatives and Awareness Programs:

A significant opportunity within the Preterm Birth and Premature Rupture of Membranes (PROM) Testing Market lies in global healthcare initiatives and awareness programs. Increasing efforts by governments, non-profit organizations, and healthcare agencies to raise awareness about the importance of early detection and management of preterm births create a favorable environment for market growth. Collaborative campaigns and educational initiatives can drive the demand for advanced testing solutions, encouraging expectant mothers to undergo routine screenings. Strategic partnerships between market players and public health entities can capitalize on these opportunities to promote comprehensive prenatal care, ultimately expanding the market reach and addressing the global burden of preterm births.

• Integration of Point-of-Care Testing (POCT) Solutions:

The integration of Point-of-Care Testing (POCT) solutions presents a promising opportunity in the Preterm Birth and PROM Testing Market. The demand for rapid and on-the-spot diagnostic solutions is growing, especially in settings with limited access to sophisticated laboratory infrastructure. POCT technologies enable timely and convenient testing, providing healthcare professionals with real-time results at the bedside. Market players investing in the development of portable and user-friendly POCT devices for preterm birth and PROM testing can tap into unmet needs, particularly in resource-constrained regions. The adoption of POCT solutions aligns with the trend towards decentralized healthcare, opening avenues for market expansion and improved accessibility to testing services.

Market Challenges

• Limited Awareness and Education:

A prominent challenge in the Preterm Birth and Premature Rupture of Membranes (PROM) Testing Market is the limited awareness and education surrounding the risks and consequences of preterm births. In many regions, expectant mothers may not be fully informed about the importance of early detection and testing for preterm labor and PROM. This lack of awareness can lead to delayed or inadequate prenatal care, hindering the effectiveness of testing initiatives. Market stakeholders face the challenge of developing and implementing comprehensive awareness campaigns to educate both healthcare providers and the general population, thereby fostering a proactive approach towards preterm birth prevention and timely testing.

• Economic Disparities and Access to Testing:

Economic disparities pose a significant challenge in the Preterm Birth and PROM Testing Market, affecting access to testing services. In regions with limited healthcare infrastructure and resources, affordability becomes a critical barrier for expectant mothers seeking preterm birth and PROM testing. High testing costs, coupled with inadequate insurance coverage, can result in unequal access to advanced diagnostic solutions. Addressing economic disparities requires innovative pricing models, strategic collaborations, and advocacy for improved healthcare policies to ensure that all pregnant individuals, regardless of their financial situation, have equal access to essential testing services. Overcoming economic challenges is pivotal for the widespread adoption of testing solutions and the reduction of preterm birth-related complications globally.

Segments Insights:

Test Type Insights

In 2023, the ultrasound segment held 31.61% of the global preterm birth and PROM testing market. Ultrasound imaging is one of the traditional methods of testing premature labor, however, researchers are integrating the traditional method with advanced Artificial Intelligence (AI) to offer the optimal solution. For instance, in March 2023, Ultrasound AI Inc. announced receiving its first patent for software, Preterm AI. The product combines ultrasounds and AI to predict premature birth.

The PAMG-1 immunoassay segment is estimated to register highest CAGR during the forecast period. Placental Alpha Microglobulin 1 (PAMG-1) is a protein biomarker for PROM testing. The protein is present in amniotic fluid during pregnancy. When the amniotic sac surrounding the baby is intact, the concentration of PAMG-1 in vaginal fluid is very low (0.05–0.2 ng/mL). High levels of PAMG-1 (2,000–25,000 ng/mL) in vaginal discharge indicate membrane rupture. In April 2018, Qiagen’s PartoSure (cervicovaginal PAMG-1 test kit) received FDA approval for evaluating the risk of premature birth in expecting mothers with symptoms of preterm labor.

Application Insights

The preterm labor segment held 44.0% of market share in 2023 and is anticipated to have a similar trend in the forecasted period with the highest CAGR. As per the Lancet article published in September 2021, China is the second highest region with preterm births. It is estimated that from 2012 to 2018, there has been an average increase of 1.3% per year in preterm rate. While 29.5% of preterm births are accounted for spontaneous preterm labor, and 27.8% for preterm premature rupture of the fetal membranes.

The Premature Rupture of Membranes (PROM) application segment is estimated to register considerable CAGR during the forecast period. As per data published in NCBI in June 2021, the PROM condition occurs in 8% to 10% of pregnancies worldwide. For accurate and timely management of PROM, it is important to emphasize efficient diagnosis. Some of the traditional diagnosis methods involve a vaginal examination, speculum examination, and fern tests, among others. However, the lower efficiency and correctness of these physical examinations lead to biomarker testing.

Regional Insights

North America captured the largest revenue share of 40.0% of preterm birth and PROM testing market in 2023 due to changes in lifestyle factors such as excessive alcohol consumption & sedentary lifestyles and the high prevalence of preterm births in the region. Several awareness campaigns and initiatives being undertaken by nonprofit organizations in the region are expected to address challenges faced by premature babies and their families.

Asia Pacific is expected to expand at a fastest CAGR over the foreseeable future owing to the presence of a large population in India and China. Moreover, the rising number of preterm births in developing countries of the region is significantly creating a potential market in these regions, thereby leading to high market growth. Rapid technological advancements and increase in the number of awareness campaigns & nonprofit organizations supporting preterm infants and their families are some of the vital factors positively impacting the market. China is considered among the top five countries with highest preterm births, and preterm birth is one of the major causes of neonatal death in India. The WHO reported 3.5 million premature births, and among these, around 300,000 babies die due to associated complications.

Some of the prominent players in the Preterm birth and PROM testing markets include:

Qiagen N.V.

Hologic, Inc.

Cooper Surgical Inc.

Abbott

Medixbiochemica

Sera Prognostics

Clinical Innovations, LLC

Biosynex

NX Prenatal, Inc.

IQ Products

Segments Covered in the Report

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, Nova one advisor, Inc. has segmented the global preterm birth and PROM testing market.

Test Type

• Pelvic exam
• Ultrasound
• Biochemical Markers

• • Interleukin (IL)-6
  • C-Reactive Protein (CRP)
  • IL-1, IL-2, IL-8, TNF-a
  • Corticotropin-Releasing Hormone (CRH)
  • Alpha-fetoprotein (AFP)

• Uterine Monitoring
• Nitazine Test
• Ferning Test
• Pooling
• PAMG-1 Immunoassay
• IGFBP Test
• Fetal Fibronectin (fFN)
• Others

Application

• PROM
• Preterm Labor
• Chorioamnionitis

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)