Preterm Birth and PROM Testing Market to Reach USD 2,559.34 million by 2032, Growing at a CAGR of 8.43% says Credence Research

Market Outlook

The Preterm Birth and PROM Testing Market size was valued at USD 980.00 million in 2018, reached USD 1,344.49 million in 2024, and is anticipated to grow significantly to USD 2,559.34 million by 2032, at a compound annual growth rate (CAGR) of 8.43% during the forecast period. This robust growth reflects the increasing demand for effective diagnostic tools that aid in early detection and management of preterm labor and premature rupture of membranes (PROM), conditions that remain leading causes of neonatal morbidity and mortality worldwide.

Globally, preterm births account for nearly 15 million cases annually, with complications linked to these births being a major contributor to neonatal deaths. PROM and preterm labor present significant risks to maternal and infant health, necessitating advanced testing methods to ensure timely diagnosis and interventions. As a result, this market has become vital for healthcare systems aiming to reduce adverse pregnancy outcomes and improve neonatal survival rates.

The increasing emphasis on maternal health, combined with rising healthcare expenditure, growing awareness about preterm risks, and technological advancements in diagnostic testing, has accelerated market expansion. The development of biochemical marker-based testing, non-invasive procedures, and point-of-care diagnostic solutions have further enhanced clinical decision-making capabilities. With the growing collaboration between biotechnology firms and healthcare providers, the Preterm Birth and PROM Testing Market continues to gain relevance, driving both medical and economic impact globally.

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Market Drivers

Rising Global Preterm Birth Rates
The increasing prevalence of preterm births worldwide is a key driver fueling the growth of the Preterm Birth and PROM Testing Market. According to WHO estimates, more than one in ten babies is born prematurely each year, placing immense pressure on healthcare systems. This surge in cases necessitates reliable and rapid diagnostic testing methods to identify and manage risks effectively. Rising maternal age, lifestyle changes, and higher incidences of chronic diseases such as diabetes and hypertension are also contributing to the growing number of preterm deliveries. With neonatal complications being a major cause of infant mortality, the need for accurate and early diagnostic testing is stronger than ever. In both developed and developing regions, the burden of preterm births continues to create a substantial healthcare challenge. This scenario strengthens the role of diagnostic testing in providing solutions that can improve outcomes for both mothers and infants.

Advancements in Diagnostic Technologies
Technological innovations such as biomarker-based assays, immunoassays, and advanced ultrasound solutions are enhancing diagnostic accuracy. Recent progress in biochemical marker detection, including fetal fibronectin and interleukin-based assays, has enabled earlier detection and improved clinical outcomes. These innovations reduce uncertainty for healthcare providers and improve patient management strategies. Additionally, the introduction of AI-powered predictive tools is further refining the ability to identify at-risk pregnancies before complications arise. Portable ultrasound devices and rapid testing kits are making diagnostics more accessible, particularly in community health centers. The continuous pipeline of research and development ensures that healthcare professionals are equipped with more precise and less invasive tools. Collectively, these advancements not only improve diagnostic reliability but also encourage broader adoption across multiple healthcare environments.

Government and Institutional Support
Government initiatives promoting maternal and neonatal healthcare contribute significantly to market growth. For instance, funding for research, subsidies for diagnostic devices, and the implementation of maternal health programs across developed and emerging economies have accelerated the adoption of PROM and preterm testing solutions. These efforts align with broader goals of reducing maternal and infant mortality rates. In addition, global health organizations such as WHO and UNICEF are actively collaborating with governments to improve maternal care infrastructure. National health campaigns are increasing awareness among expecting mothers about the importance of early testing. Furthermore, favorable reimbursement frameworks in developed markets encourage hospitals and clinics to integrate advanced diagnostic solutions. This combined support from governments and institutions is a critical driver sustaining market momentum.

Growing Adoption of Point-of-Care Testing
Point-of-care diagnostic devices are gaining traction due to their rapid turnaround time and ease of use in clinical and hospital settings. The ability to provide accurate, on-site results helps clinicians make immediate decisions, thereby improving patient outcomes. This trend is particularly impactful in regions with limited access to advanced healthcare facilities, driving widespread adoption. In rural areas, where access to centralized laboratories is challenging, point-of-care solutions serve as a critical tool to bridge the healthcare gap. Portable kits designed for bedside use are also enabling physicians to deliver more personalized and timely care. The growing demand for convenient, user-friendly devices aligns well with global efforts to enhance maternal health outcomes. As healthcare systems emphasize efficiency, point-of-care diagnostics are expected to become a standard practice.

Market Challenges

High Cost of Advanced Testing Solutions
One of the major challenges facing the market is the high cost associated with advanced diagnostic technologies. Biochemical marker-based tests and immunoassays often remain inaccessible in resource-limited settings, restricting widespread adoption. The affordability gap between developed and developing nations continues to limit universal access to modern diagnostics. For healthcare providers in low-income regions, budget constraints hinder the purchase of advanced equipment. This cost barrier delays timely interventions, leading to poor maternal and infant outcomes. Without price reductions or targeted subsidies, many healthcare systems will continue relying on less effective, conventional methods.

Limited Awareness in Developing Regions
Despite technological advancements, awareness about preterm birth risks and PROM testing remains low in many developing regions. Lack of proper education among expecting mothers and insufficient healthcare outreach hampers timely diagnosis. In rural and underserved areas, women often depend on traditional practices rather than clinical advice. This situation is further compounded by cultural barriers that discourage regular prenatal checkups. Limited availability of awareness campaigns by governments and healthcare providers exacerbates the issue. Without effective education initiatives, the benefits of modern diagnostics cannot be fully realized.

Regulatory Barriers
Stringent regulatory requirements for the approval of diagnostic tests create hurdles for new entrants. Companies must undergo lengthy approval processes, delaying product availability and impacting competitive dynamics. These complex processes also demand significant financial investment, which small and mid-sized companies struggle to meet. Differing regulations across regions make it challenging for manufacturers to launch products globally. For instance, devices approved in one region may face lengthy reviews in another, slowing innovation. While regulations are necessary to ensure safety, overly strict frameworks limit faster adoption of critical diagnostic tools.

Competition from Traditional Testing Methods
Conventional diagnostic practices, such as pelvic exams and basic ultrasound, still dominate in many regions due to lower costs and wide availability. This reliance on traditional methods slows the adoption of more advanced and accurate testing technologies. Many physicians in low-resource settings continue to depend on familiar, cost-effective approaches. In addition, healthcare infrastructure limitations in rural areas make it difficult to adopt new testing devices. Resistance to change among healthcare professionals further contributes to slower transition rates. Unless clear evidence of clinical and economic benefits is demonstrated, traditional methods will continue to pose competition.

Market Opportunity

Expansion in Emerging Economies
Rapidly developing healthcare infrastructure in Asia Pacific and Latin America presents significant opportunities. Governments and private players are investing in maternal health programs, driving demand for PROM and preterm testing. Rising disposable incomes in these regions are allowing more families to access advanced healthcare solutions. Countries like India, China, and Brazil are witnessing large-scale public health investments that prioritize maternal care. The growing middle-class population is also creating demand for better diagnostic services. These dynamics position emerging economies as high-potential markets for sustained growth.

Integration of AI and Digital Health
The adoption of artificial intelligence and machine learning in diagnostic testing holds immense potential. AI-driven predictive models can identify at-risk pregnancies more efficiently, opening new avenues for innovation. Digital health platforms that integrate PROM and preterm test results with electronic health records enhance clinical decision-making. The ability to predict complications earlier improves treatment outcomes and reduces healthcare costs. As telemedicine adoption grows, AI-powered diagnostics will become more widely integrated into maternal healthcare. This technological synergy will redefine prenatal testing in the coming years.

Growth in Personalized Maternal Care
Personalized testing approaches tailored to individual risk profiles are gaining momentum. This shift is creating opportunities for specialized diagnostic solutions, enhancing maternal and neonatal care outcomes. By focusing on patient-specific factors, such as genetics and medical history, tests can provide more accurate risk assessments. The trend toward precision medicine is encouraging innovation in biomarker-based diagnostics. Expecting mothers are increasingly seeking personalized care to reduce risks and ensure safer pregnancies. This demand will continue to stimulate the growth of advanced maternal testing solutions.

Collaborations and Strategic Partnerships
Increasing collaboration between biotech firms, diagnostic companies, and healthcare institutions is fostering innovation. Strategic partnerships help expand market reach and enable the development of cost-effective solutions for wider adoption. Such collaborations also facilitate clinical trials and regulatory approvals, accelerating product availability. Large companies are increasingly acquiring startups to strengthen their diagnostic portfolios. Joint ventures further support knowledge sharing and technology transfer across regions. These alliances create a dynamic environment for sustainable market growth.

Market Segmentation

Based on Type
• Pelvic Exam
• Ultrasound
• Biochemical Markers
• Interleukin (IL)-6
• C-Reactive Protein (CRP)
• IL-1, IL-2, IL-8, TNF-α
• Corticotropin-Releasing Hormone (CRH)
• Alpha-Fetoprotein (AFP)
• Uterine Monitoring
• Nitazine Test
• Ferning Test
• Pooling Request Sample
• PAMG-1 Immunoassay
• IGFBP Test
• Fetal Fibronectin (fFN)
• Others

Based on Application
• PROM (Premature Rupture of Membranes)
• Preterm Labor
• Chorioamnionitis

Based on Region

• North America
o U.S.
o Canada
o Mexico

• Europe
o UK
o France
o Germany
o Italy
o Spain
o Russia
o Belgium
o Netherlands
o Austria
o Sweden
o Poland
o Denmark
o Switzerland
o Rest of Europe

• Asia Pacific
o China
o Japan
o South Korea
o India
o Thailand
o Indonesia
o Vietnam
o Malaysia
o Philippines
o Taiwan
o Rest of Asia Pacific

• Latin America
o Brazil
o Argentina
o Peru
o Chile
o Colombia
o Rest of Latin America

• Middle East & Africa
o GCC Countries
o South Africa
o Rest of the Middle East and Africa

Regional Analysis

North America
North America leads the market due to advanced healthcare infrastructure, strong government support for maternal care, and the presence of key diagnostic players. The U.S. accounts for the largest share, driven by high testing adoption and technological innovation. Strong insurance coverage and reimbursement policies further boost testing uptake. Rising awareness among expecting mothers also contributes to market expansion. The region continues to set benchmarks in research and development for maternal diagnostics.

Europe
Europe follows closely, with countries like Germany, France, and the UK investing heavily in maternal health programs. Supportive healthcare policies and insurance coverage further boost the adoption of PROM and preterm testing. The European Union's emphasis on maternal and child health has created a favorable environment for diagnostics. Growing collaborations between public health institutions and private companies are enhancing accessibility. Rising birth rates in some nations also sustain demand for maternal testing solutions.

Asia Pacific
The Asia Pacific region is expected to witness the fastest growth, driven by rising awareness, expanding healthcare infrastructure, and government-led initiatives in India and China. Increasing birth rates also create high demand for maternal diagnostics. Countries like Japan and South Korea are investing in advanced healthcare technologies, accelerating adoption. Government subsidies in countries such as India are making testing more affordable. This dynamic environment positions Asia Pacific as a critical growth hub for the market.

Latin America
Latin America presents emerging opportunities, with Brazil and Argentina leading adoption. However, limited access in rural areas remains a challenge, creating room for point-of-care solutions to gain traction. Investments in maternal health initiatives are gradually improving access to testing. Governments are focusing on reducing neonatal mortality, which encourages the use of advanced diagnostics. Partnerships with international organizations are also helping to strengthen regional healthcare systems. These combined factors make Latin America a growing but uneven market.

Middle East & Africa
In the Middle East & Africa, adoption is gradually increasing, particularly in GCC countries and South Africa. Investments in healthcare modernization and maternal health awareness campaigns are propelling growth, though challenges in rural access persist. Government-driven initiatives are targeting maternal mortality reduction, creating demand for PROM and preterm testing. Private healthcare expansion in the Middle East is also playing a significant role. Although barriers remain in underdeveloped regions, steady progress is evident. This positions the region as an evolving market with long-term potential.

Top Companies

• Qiagen N.V.
• Hologic, Inc.
• Cooper Surgical Inc.
• Abbott
• Medixbiochemica
• Sera Prognostics
• Clinical Innovations, LLC
• Biosynex
• NX Prenatal, Inc.
• IQ Products

Recent Developments

• In March 2024, Hologic, Inc. launched a point-of-care diagnostic device for PROM testing, designed to provide rapid and accurate results in both hospitals and clinics.

• In June 2024, Sera Prognostics introduced a predictive test for preterm birth, enabling early risk assessment and personalized maternal care.

• In February 2024, Cooper Surgical Inc. acquired a biotechnology company specializing in maternal-fetal health diagnostics, strengthening its prenatal testing portfolio.

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