Global Preterm Birth and PROM Testing Market By 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) By Application (PROM, Preterm Labor, Chorioamnionitis) By ENd-User (Hospitals, Disgnostic Laboratories, Others) Region and Companies – Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2024-2033

Report Overview

The Global Preterm Birth and PROM Testing Market size is expected to be worth around USD 3.1 Billion by 2033 from USD 1.4 Billion in 2023, growing at a CAGR of 8.4% during the forecast period from 2024 to 2033.

The preterm birth and PROM (Premature Rupture of Membranes) testing market focuses on diagnosing and treating early births and membrane ruptures. This market is growing due to increasing preterm birth rates and advancements in diagnostic technologies. As healthcare awareness rises, especially in emerging markets, demand for these tests is expected to grow.

The rising number of preterm births is a major driver of demand for preterm birth and PROM testing globally. According to the World Health Organization (WHO), approximately 15 million babies are born preterm each year. These tests are crucial for detecting the premature rupture of fetal membranes in pregnant women, enabling timely treatment to prevent preterm birth. Preterm birth is a leading cause of death among children under five years old, with rates ranging from 5% to 18% across 184 countries. This trend is expected to continue, driving further demand for testing.

Key factors driving the growth of the preterm birth and PROM testing market include the rising incidence of preterm births in both developed and emerging economies, better access to advanced neonatal and maternal care, and the launch of new point-of-care diagnostic products. Companies are focusing on research and development to enhance the accuracy and reliability of their testing devices, reducing error rates and improving patient outcomes. As a result, the preterm birth and PROM testing market is projected to witness substantial growth in the coming years.

Key Takeaways

• Market Size: Preterm Birth and PROM Testing Market size is expected to be worth around USD 3.1 Billion by 2033 from USD 1.4 Billion in 2023.
• Market Growth: The market growing at a CAGR of 8.4% during the forecast period from 2024 to 2033.
• Test Type Analysis: ultrasound testing leads the market, holding a 32.1% share due to its accuracy.
• Application Analysis: Preterm labor, occurring before 37 weeks of pregnancy, holds a significant 43.2% market share.
• End-Use Analysis: Hospitals leading the market at 62.7% share in 2023 due to their comprehensive care, advanced diagnostic tools.
• Regional Analysis: In 2023, North America led the Preterm Birth and PROM (Premature Rupture of Membranes) Testing Market with a 39.2% share.
• Technological Advancements: Advances in diagnostic technologies, including point-of-care devices, improve accuracy and accessibility in testing.
• Government Initiatives: Supportive government policies and healthcare programs aim to reduce preterm birth rates, further driving market expansion.
• R&D Investments: Companies invest in research and development to enhance the specificity and reliability of testing methods, reducing error rates.

Test Type Analysis

The Preterm Birth and PROM (Premature Rupture of Membranes) Testing Market includes various diagnostic methods that help detect preterm labor and membrane rupture early. Among these, ultrasound testing leads the market, holding a 32.1% share due to its accuracy in assessing fetal development and diagnosing preterm conditions.

Pelvic exams are another common method, used to physically assess changes in the cervix. In addition, biochemical markers, such as PAMG-1 and IGFBP tests, are critical for identifying membrane rupture. These markers offer precise detection of amniotic fluid, aiding in early diagnosis.

Fetal Fibronectin (fFN) testing is also significant, as it helps predict the risk of preterm birth. Uterine monitoring is another important technique used to detect contractions and assess labor progression.

Other diagnostic methods, like the Nitrazine test and Ferning test, are used for pH testing and microscopic examination of amniotic fluid. Pooling tests further assist in identifying amniotic fluid leakage.

Application Analysis

The Preterm Birth and PROM (Premature Rupture of Membranes) Testing Market is vital for early detection and management of preterm labor and related complications. Preterm labor, occurring before 37 weeks of pregnancy, holds a significant 43.2% market share. This dominance reflects the critical need for accurate testing to manage preterm birth risks effectively.

PROM, or premature rupture of membranes, is another major concern within this market. It involves the early breaking of the amniotic sac before labor begins, which can lead to serious complications, including infection and preterm birth. Accurate PROM testing is essential for prompt medical intervention, reducing risks for both the mother and baby.

Chorioamnionitis, an infection of the amniotic fluid and membranes, is often associated with PROM. This condition can lead to severe complications for both mother and fetus. Therefore, accurate testing for chorioamnionitis is crucial in this market, emphasizing the importance of early diagnosis and treatment.

End-User Analysis

The Preterm Birth and PROM (Premature Rupture of Membranes) Testing Market is driven by various end-users, with hospitals leading the market at 62.7% share. Hospitals dominate due to their comprehensive care, advanced diagnostic tools, and ability to provide immediate medical intervention. This highlights the essential role hospitals play in managing high-risk pregnancies and ensuring maternal and neonatal safety.

Diagnostic laboratories also play a significant role in the market. These laboratories offer specialized testing services that may not be available in all hospitals. Their advanced biochemical and molecular testing capabilities are crucial for precise diagnosis, supporting early detection and risk management in preterm birth and PROM cases.

Other end-users, including specialized clinics and home healthcare providers, contribute to the market, albeit on a smaller scale. These facilities provide testing options for patients who may not have easy access to hospitals or diagnostic labs, expanding the reach of these critical services.

Key Market Segments

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

End-User

• Hospitals
• Disgnostic Laboratories
• Others

Driver

The primary driver of the Preterm Birth and PROM (Premature Rupture of Membranes) Testing Market is the increasing incidence of preterm births worldwide. As preterm birth rates continue to rise, the need for early detection and intervention becomes crucial for improving maternal and neonatal outcomes. Advancements in diagnostic technologies, such as ultrasound and molecular tests, further boost the market by providing more accurate and reliable testing options.

Government initiatives and healthcare programs focused on reducing preterm birth rates also contribute to market growth. Additionally, growing awareness among healthcare professionals and patients about the importance of timely testing supports market expansion.

Trend

A significant trend in the Preterm Birth and PROM Testing Market is the increasing use of non-invasive and point-of-care testing methods. Healthcare providers are favoring tests that offer quick and accurate results with minimal patient discomfort. The development of advanced biochemical markers and molecular diagnostics is gaining traction, enabling early detection of preterm labor and membrane rupture.

Another trend is the integration of artificial intelligence (AI) and machine learning in diagnostic tools, improving predictive accuracy. Additionally, the rise of telemedicine and remote monitoring enhances the management of high-risk pregnancies, especially in remote areas.

Restraint

The high cost of advanced diagnostic tests is a major restraint in the Preterm Birth and PROM Testing Market. Budget constraints in many healthcare systems, particularly in developing regions, limit access to these tests. Additionally, the lack of awareness and accessibility to advanced testing methods in low-resource areas hinders market growth.

Regulatory challenges and the need for extensive clinical validation before new tests can be widely adopted also slow down market expansion. Furthermore, concerns about the accuracy and reliability of some testing methods can create hesitancy among healthcare providers.

Opportunity

The Preterm Birth and PROM Testing Market presents significant growth opportunities, especially in emerging markets. As healthcare infrastructure improves in developing regions, the demand for advanced diagnostic tests is expected to rise. Companies can capitalize on this by expanding their presence in these markets and offering cost-effective testing solutions.

Another opportunity lies in developing innovative and affordable point-of-care testing devices for use in remote and underserved areas. Collaborations between key players and healthcare organizations to raise awareness and improve access to testing can also drive growth. Additionally, advancements in personalized medicine and predictive diagnostics offer new avenues for market expansion.

Regional Analysis

In 2023, North America led the Preterm Birth and PROM (Premature Rupture of Membranes) Testing Market with a 39.2% share. This dominance is due to the region’s advanced healthcare infrastructure and widespread access to diagnostic technologies. Increased awareness of preterm birth risks also plays a key role. High healthcare spending and ongoing research initiatives further strengthen North America’s position in the market.

The presence of key market players and supportive government policies contribute to this leadership. As preterm birth rates rise, the demand for accurate testing continues to grow, solidifying North America’s leading role in this global market.

Key Regions and Countries

• North America
  • The US
  • Canada
  • Mexico
• Western Europe
  • Germany
  • France
  • The UK
  • Spain
  • Italy
  • Portugal
  • Ireland
  • Austria
  • Switzerland
  • Benelux
  • Nordic
  • Rest of Western Europe
• Eastern Europe
  • Russia
  • Poland
  • The Czech Republic
  • Greece
  • Rest of Eastern Europe
• APAC
  • China
  • Japan
  • South Korea
  • India
  • Australia & New Zealand
  • Indonesia
  • Malaysia
  • Philippines
  • Singapore
  • Thailand
  • Vietnam
  • Rest of APAC
• Latin America
  • Brazil
  • Colombia
  • Chile
  • Argentina
  • Costa Rica
  • Rest of Latin America
• Middle East & Africa
  • Algeria
  • Egypt
  • Israel
  • Kuwait
  • Nigeria
  • Saudi Arabia
  • South Africa
  • Turkey
  • United Arab Emirates
  • Rest of MEA

Key Players Analysis

The Preterm Birth and PROM Testing Market is highly competitive, with key players focusing on innovation, advanced diagnostic technologies, and expanding their product portfolios. Companies are investing in research and development to introduce more accurate and rapid testing methods. Strategic partnerships, mergers, and acquisitions are common strategies to strengthen market positions.

Additionally, key players are expanding their global reach through collaborations and by entering emerging markets. Regulatory approvals and certifications are also crucial factors that players prioritize to maintain a competitive edge. Overall, the market’s growth is driven by technological advancements, strategic expansions, and the continuous development of new testing solutions.

Market Key Players

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

Recent Developments

• Qiagen N.V. (January 2024): Qiagen N.V. launched a new molecular diagnostic test specifically designed for the early detection of preterm birth risks. This test leverages advanced gene expression analysis to provide accurate predictions, helping healthcare professionals intervene early and reduce the risk of preterm delivery.
• Hologic, Inc. (March 2024): Hologic, Inc. introduced a new point-of-care diagnostic device for PROM testing, offering rapid and accurate results. The device, aimed at improving maternal-fetal outcomes, is designed for use in both hospital and clinical settings, enhancing access to essential diagnostic tools.
• Cooper Surgical Inc.(February 2024): Cooper Surgical Inc. acquired a leading biotechnology firm specializing in maternal-fetal health diagnostics. This acquisition strengthens Cooper Surgical’s portfolio in the preterm birth and PROM testing market, enabling the company to offer a broader range of innovative diagnostic solutions.
• Sera Prognostics (June 2024): Sera Prognostics unveiled a new predictive test for preterm birth, focusing on early risk assessment. This product launch marks a significant step forward in personalized maternal care, allowing for timely interventions and improved outcomes in high-risk pregnancies.

Report Scope