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  • Published On : Oct 2023
  • Code : CMI6403
  • Pages : 150
  • Formats :
      Excel and PDF
  • Industry : Medical Devices

The Preterm Birth and PROM Testing Market size is expected to reach US$ 3.85 billion by 2030, from US$ 1.69 billion in 2023, at a CAGR of 12.5% during the forecast period.

Preterm birth and PROM (premature rupture of membranes) testing involves various medical tests to check for the risk of preterm delivery in pregnant women. It helps in early diagnosis and timely clinical intervention to reduce preterm births and associated complications. The market is driven by the rising prevalence of preterm births, advancements in prenatal testing, and government initiatives to improve prenatal care.

The Preterm Birth and PROM Testing Market is segmented by test type, product, method, end-user, and region. By test type, the market is segmented into pelvic exam, ultrasound, uterine monitoring, biomarker testing, and others. The ultrasound segment accounted for the largest market share in 2023 owing to wide usage of ultrasound scans for detecting risks associated with preterm birth.

Preterm Birth And Prom Testing Market Regional Insights

  • North America is expected to be the largest market for Preterm Birth and PROM Testing Market during the forecast period, accounting for over 40% of the market share in 2023. The growth of the market in North America is attributed to the high prevalence of preterm births, presence of major players, and increasing adoption of innovative prenatal screening tests in the region.
  • The Europe market is expected to be the second-largest market for Preterm Birth and PROM Testing Market, accounting for over 32% of the market share in 2023. The growth of the market in Europe is attributed to the rising awareness about prenatal testing, government funding for prenatal screening programs and advancing healthcare infrastructure in the region.
  • The Asia Pacific market is expected to be the fastest-growing market for Preterm Birth and PROM Testing Market, with a CAGR of over 15% during the forecast period. The growth of the market in Asia Pacific is attributed to the large target population, improving healthcare expenditure, and growing investments by leading companies in the region.

Figure 1. Global Preterm Birth And Prom Testing Market Share (%), by Region, 2023


Preterm Birth and PROM Testing Market Drivers

  • Increasing prevalence of preterm births: The rising prevalence of preterm births is a major factor driving the growth of the preterm birth and PROM testing market. Globally, around 1 in 10 babies are born prematurely every year. Complications from preterm births are the leading cause of death among children under age 5. The increasing rate of preterm deliveries has led to greater demand for reliable diagnostic tests to screen and monitor high-risk pregnancies. Usage of prenatal testing tools helps in early detection of risks and timely clinical intervention to improve health outcomes.
  • Technological advancements in prenatal screening and diagnosis: Continuous advances in prenatal screening and diagnostic technologies such as ultrasound scans, biomarker tests, home-based pregnancy tests are contributing to the growth of the preterm birth and PROM testing market. Next-generation gene sequencing, cell-free DNA analysis, biochemical assays, and microfluidics allow detection of preterm birth risks with greater sensitivity and accuracy. Key companies are focused on developing innovative products integrated with advanced technologies to improve prenatal testing capabilities. This is expected to increase adoption of upgraded prenatal testing products and solutions.
  • Favorable government policies and reimbursement framework: Expanding government investments to improve prenatal care facilities and services are fostering the adoption of preterm birth and PROM testing globally. Government-led prenatal screening programs, favorable reimbursement policies, growing awareness initiatives, and funding for R&D in prenatal diagnostics are encouraging the development and commercialization of advanced preterm birth risk assessment products. This creates lucrative growth opportunities for market players.
  • Increasing demand for personalized medicine: The growing trend of personalized medicine is stimulating the preterm birth and PROM testing market growth. Prenatal screening tests allow risk stratification and enable physicians to design patient-centric management plans. Diagnosing and predicting preterm birth risks by assessment of genetic predisposition and physiological factors allows timely interventions customized to the specific health needs of expectant mothers. This is anticipated to propel the demand for personalized prenatal screening.

Preterm Birth and PROM Testing Market Opportunities

  • Significant untapped potential in emerging economies: Developing nations across Asia Pacific, Latin America, and Africa represent untapped markets with huge growth potential for preterm birth and PROM testing products owing to the high birth rate and rising healthcare expenditure in these regions. Improving reimbursement scenarios, penetration of cutting-edge technologies, and growing health awareness are anticipated to promote adoption of innovative prenatal diagnostic tools and services. Players can focus on collaborations, partnerships, and geographical expansion to tap into these high-growth markets.
  • Integration of AI and big data analytics: Incorporation of emerging technologies like AI, machine learning, and big data analytics in prenatal testing products for intelligent risk assessment and predictive insights represents a significant opportunity for market growth. Platforms combining advanced algorithms, fetal medicine expertise, and patient data analysis will allow accurate quantification of preterm birth risks and support proactive clinical management. Key players can leverage these technologies to develop smarter, personalized prenatal screening solutions.
  • Development of direct-to-consumer testing models: Expanding adoption of at-home pregnancy testing and emergence of direct-to-consumer prenatal screening options is creating lucrative avenues for preterm birth and PROM testing products. Key players can focus on over-the-counter and home-based solutions designed for in-home sample collection and virtual result consultation. User-friendly self-testing kits that enable remote risk assessment and monitoring of high-risk pregnancies hold immense potential for growth.
  • Strategic collaborations and acquisitions: The preterm birth and PROM testing space is witnessing rising collaborations, partnerships, and M&As among leading diagnostics companies, research institutions, and technology firms. Strategic deals focused on expanding product portfolios, entering new markets, technology integration can significantly elevate companies’ market standing and commercialization capabilities. Collaborative models for large-scale clinical studies and product development also support growth.

Preterm Birth And Prom Testing Market Report Coverage

Report Coverage Details
Base Year: 2022 Market Size in 2023: US$ 1.69 Bn
Historical Data for: 2018 to 2021 Forecast Period: 2023 - 2030
Forecast Period 2023 to 2030 CAGR: 12.5% 2030 Value Projection: US$ 3.85 Bn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East & Africa:  GCC Countries, Israel,  South Africa, North Africa, and Central Africa and Rest of Middle East
Segments covered:
  • By Test Type: Pelvic exam, Ultrasound, Uterine monitoring, Biomarker testing, Others
  • By Product: PROM test kits, pH test kits, Ferning test kits, Ultrasound devices, Fetal fibronectin test kits, Others
  • By Method: Nitrazine test, Ferning test, Pooling, Ultrasound, Biomarker assays, Others
  • By End-User: Hospitals, Diagnostics laboratories, Outpatient clinics, Research centers, Others
Companies covered:

Abbott Laboratories, Biosynex, Qiagen Sciences LLC, Clinical Innovations LLC, Sera Prognostics, The Cooper Companies Inc., Medixbiochemica, Hologic Inc., IQ Products, NX Prenatal Inc., Promega Corporation, Medical Predictive Technologies Inc., Biosynex, Clinical Innovations LLC, NX Prenatal Inc., Medixbiochemica, Qiagen Sciences LLC, Sera Prognostics Inc., Insight Pharmaceuticals LLC, Creative Diagnostics

Growth Drivers:
  • Rising prevalence of preterm births
  • Advancements in prenatal testing
  • Increased risk of preterm birth
  • Government support for prenatal care
Restraints & Challenges:
  • High cost of prenatal testing products
  • Stringent regulatory requirements
  • Limited awareness among patients
  • Shortage of trained professionals

Preterm Birth and PROM Testing Market Trends

  • Shift toward point-of-care and self-testing models: Point-of-care and home-based diagnostic testing platforms are gaining prominence in the preterm birth and PROM testing market owing to their simplicity, convenience, and rapid results. Handheld devices and self-testing kits enabling quick risk assessment and timely intervention at the convenience of home are witnessing high adoption. Market players are increasingly focusing on developing patient-centric solutions for decentralized testing. The POC and self-testing trend is expected to continue gaining momentum during the forecast period.
  • Use of multiple biomarkers for risk prediction: Advances in omics and systems biology approaches are enabling the discovery of novel biomarkers associated with preterm birth risks. The market is gradually moving away from single biomarker-based tests toward multiplex biomarker panels and molecular signatures for accurate prediction of preterm birth likelihood. Next-generation tools analyzing combinations of biomarkers, demographic information, and clinical data will likely become the future of prenatal risk screening.
  • Influx of new products with superior accuracy: Key diagnostics companies are investing significantly in R&D initiatives to introduce innovative products integrated with cutting-edge technologies to enhance accuracy and reliability of preterm birth risk assessment. New product launches focused on early screening, predictive capabilities, and greater sensitivity, such as premature birth indicators, advanced NIPT assays, wearable uterine activity monitors, hold immense commercialization potential. The influx of novel prenatal testing solutions is expected to intensify during the coming years.
  • Growing industry focus on expanding prenatal test portfolio: Leading diagnostics manufacturers are focused on diversifying their offerings of reproductive and prenatal genetic screening tests including carrier screening, NIPT, and newborn testing. Strategic developments through collaborations, partnerships, and acquisitions concentrated on adding new testing capabilities to leverage cross-selling opportunities. The ability to provide a comprehensive panel of prenatal assessments for complete pregnancy care is becoming an important competitive edge. This trend is likely to shape market dynamics during the forecast period.

Preterm Birth and PROM Testing Market Restraints

  • High costs of prenatal diagnostic tests: Despite favorable reimbursement policies, the high costs of advanced prenatal screening solutions such as NIPT and genetic testing is a key factor limiting adoption of these tests in low and middle-income countries. Additionally, out-of-pocket expenditure remains high in developing regions with inadequate insurance coverage and accessibility constraints. This impedes market growth to some extent. Players are increasingly developing cost-effective rapid diagnostic kits and expanding access programs to address affordability challenges.
  • Shortage of trained professionals in developing regions: The shortage of trained medical professionals specializing in prenatal care in rural areas and low-resource settings of emerging countries negatively impacts adoption of innovative preterm birth testing tools and technologies. Lack of knowledge regarding best practices in prenatal screening and diagnosis also contributes to hesitation among physicians against using new products without proper training. Players are conducting awareness programs and workshops focused on prenatal testing to help overcome this barrier.
  • Low sensitivity of traditional diagnostic methods: Traditional diagnostic approaches for preterm birth risk screening such as ultrasound monitoring, pelvic exams exhibit low sensitivity and accuracy in predicting preterm delivery. This limits their reliability for timely and proactive interventions during pregnancy. However, advances in omics, biomarker discovery, and AI-based risk quantification are helping enhance the capabilities of modern prenatal screening solutions. This trend will help address limitations of conventional diagnostic techniques in the coming years.

Recent Developments

New product launches

  • In March 2022, Clinical Innovations launched the ROM Plus PROM Test, a rapid diagnostic test to detect premature rupture of membranes in pregnant women. This helped expand its product portfolio of preterm birth and PROM detection tools.
  • In January 2021, Biosynex received FDA clearance and CE marking for its Amnioquick Duo Quick test to detect premature rupture of membranes during pregnancy. This strengthened company's position in point-of-care prenatal testing solutions.
  • In June 2020, NX Prenatal announced the launch of its rapid LABORchestra test to predict premature births by analyzing biomarkers in pregnant women. This advanced the company's innovative product pipeline for preterm birth testing.

Acquisition and partnerships

  • In September 2022, Promega acquired Cellular Research to accelerate innovation in cell analysis tools including for prenatal and reproductive testing. This strengthened Promega's capabilities in life sciences tools.
  • In June 2021, PerkinElmer acquired Immunodiagnostic Systems Holdings PLC to expand its first-trimester screening assays and prenatal test offerings. This helped PerkinElmer expand its prenatal and newborn screening solutions.
  • In March 2020, Yourgene Health partnered with Illumina to develop NIPT and carrier screening capabilities on Illumina's verifi prenatal test platform. This partnership helped Yourgene enhance its NIPT product offerings.

Figure 2. Global Preterm Birth And Prom Testing Market Share (%), by Product, 2023


Top companies in Preterm Birth And Prom Testing Market

  • Abbott Laboratories
  • Biosynex
  • Qiagen Sciences LLC
  • Clinical Innovations, LLC
  • Sera Prognostics
  • The Cooper Companies, Inc.
  • Medixbiochemica
  • Hologic, Inc.
  • IQ Products
  • NX Prenatal, Inc.
  • Promega Corporation
  • Medical predictive Technologies Inc.
  • Biosynex
  • Clinical Innovations, LLC
  • NX Prenatal, Inc.
  • Medixbiochemica
  • Qiagen Sciences LLC
  • Sera Prognostics Inc.
  • Insight Pharmaceuticals LLC
  • Creative Diagnostics

*Definition The Preterm Birth and PROM Testing Market refers to the industry and domain of diagnostic tests and tools used to detect the risk of preterm birth and premature rupture of membranes (PROM) in pregnant women. It includes various prenatal screening and diagnostic products such as pelvic exams, ultrasound devices, biomarker testing kits, pH test kits, fetal fibronectin tests, ferning test tools, and PROM detection kits. The preterm birth and PROM testing solutions facilitate early clinical intervention, planning, and management of preterm delivery risks to improve maternal and fetal health outcomes. The market is driven by rising preterm births, advancements in prenatal diagnostics, and increasing demand for personalized prenatal screening.

Frequently Asked Questions

Lack of awareness, high costs, limited access to healthcare facilities, and stringent regulatory frameworks are key factors hampering the growth of the Preterm Birth and Prom Testing Market.

The major factors driving the Market growth include rising incidences of preterm births, advancements in testing technologies, growing awareness and concern for maternal and fetal health, and increasing healthcare expenditure.

The biomarker testing segment is the leading component in the Market owing to its accuracy and reliability in predicting preterm birth risks.

The major players operating in the preterm birth and PROM testing market are Abbott Laboratories, Qiagen Sciences LLC, Clinical Innovations LLC, Hologic Inc., Sera Prognostics, Cooper Companies, NX Prenatal, Biosynex, Medixbiochemica, Promega Corporation among others.

North America is expected to continue dominating the Market during the forecast period.

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