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Preterm Birth Diagnostic Test Kits Market Size & Share 2023 to 2032

Market Size by Product Type (Fetal Fibronectin Test Kits, Placental Alpha Micro-Globulin-1 Test Kits, Insulin Like Growth Factor Binding Protein-1 Test Kits), by Sample Type (Blood Sample, Urine Sample, Vaginal Discharge Sample), by End Use.

Report ID: GMI4044
   |
Published Date: May 2023
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Report Format: PDF

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Preterm Birth Diagnostic Test Kits Market Size

Preterm Birth Diagnostic Test Kits Market size was valued at over USD 419 million in 2022 and is anticipated to grow at a CAGR of over 7.4% between 2023 and 2032. Preterm birth diagnostic test kits are medical devices or tools used to assess the risk of preterm birth in pregnant women. These tests help healthcare providers identify women that are at elevated risk of delivering their babies before 37 weeks of gestation. Additionally, the high incidence of preterm births is accelerating market growth.

Preterm Birth Diagnostic Test Kits Market Key Takeaways

Market Size & Growth

  • 2022 Market Size: USD 420 Million
  • 2032 Forecast Market Size: USD 856 Million
  • CAGR (2023–2032): 7.4%

Key Market Drivers

  • Growing incidence of preterm births.
  • Increasing awareness of preterm births and their complications.
  • Surge in number of paediatric and neonatal intensive care units.
  • Rising development of new and improved diagnostic test kits.

Challenges

  • Lack of awareness regarding these kits.
  • High cost of kits.

Moreover, increasing awareness helps pregnant women, families, and healthcare providers recognize the signs and symptoms of preterm labor. Early recognition allows for prompt medical intervention, potentially preventing or managing preterm birth more effectively. Additionally, increased awareness can drive advocacy efforts aimed at improving healthcare policies, funding, and research focused on preterm birth prevention, treatment, and long-term outcomes. It helps foster collaboration among healthcare professionals, policymakers, and community organizations to address the challenges associated with preterm births, thereby augmenting preterm birth diagnostic test kits market growth. In addition, several market players are emphasizing on research and development activities for the development of novel preterm birth diagnostic test kits.

 

COVID-19 Impact

The COVID-19 epidemic had a moderately negative impact on the preterm birth diagnostic test kits market. The pandemic led to disruptions in healthcare systems globally, with resources and attention primarily focused on managing and responding to COVID-19. This resulted in reduced availability and access to routine preterm birth diagnostic testing. The focus of healthcare systems and researchers was largely on combating COVID-19, leading to a temporary shift in priorities away from other areas, including preterm birth diagnostics. Funding and resources were redirected towards pandemic-related efforts.
 

However, post pandemic to adapt to the challenges posed by the pandemic, healthcare providers have increasingly adopted telemedicine and remote testing options. Such innovations have helped bridge the gap in access to preterm birth diagnostic test kits. Therefore, COVID-19 pandemic hindered the preterm birth diagnostic test kits industry expansion.
 

Preterm Birth Diagnostic Test Kits Market

Preterm Birth Diagnostic Test Kits Market Trends

The rising incidence of preterm births, as well as the improved survival rates of premature infants, has contributed to the need for more neonatal ICUs. Preterm infants often require specialized care due to their unique medical needs and higher vulnerability to complications. Technological advancements in medical equipment, monitoring systems, and treatment modalities have allowed for more complex and specialized care in paediatric and neonatal ICUs. These advancements have driven the establishment of new units to provide the necessary infrastructure and resources. Additionally, paediatric, and neonatal ICUs increasingly prioritize family-centered care, recognizing the importance of involving parents and caregivers in the care of their child. This approach supports parental involvement, communication, and emotional support, creating a more inclusive and supportive environment for families. Thus, such initiatives will lead to high product demand in the near future.
 

Preterm Birth Diagnostic Test Kits Market Analysis

Preterm Birth Diagnostic Test Kits Market Size, By Product Type, 2021 - 2032 (USD Million)

Based on product type, the preterm birth diagnostic test kits market is segmented into fetal fibronectin test kits (fFN), placental alpha micro-globulin-1 test kits (PAMG-1), insulin like growth factor binding protein-1 test kits (IGFBP-1), and others. The fetal fibronectin test kits (fFN) segment held the largest revenue size over USD 197 million in 2022 and is estimated to witness significant growth more than USD 409 million by 2032. The fFN test demonstrates high sensitivity in detecting the presence of fetal fibronectin, a protein that acts as a biomarker for preterm birth. It can accurately identify women at higher risk of delivering prematurely. Furthermore, an increase in the availability of product type coupled with several other businesses working towards creating innovative technology will support the segment's revenue growth in the coming years.
 

Global Preterm Birth Diagnostic Test Kits Market Share, By Sample Type, 2022

Preterm birth diagnostic test kits market is bifurcated based on the sample type including blood sample, urine sample, and vaginal discharge sample. The blood sample segment dominated the market and is anticipated to grow over USD 347 million by 2032. Blood-based tests have demonstrated high diagnostic accuracy in identifying biomarkers and indicators associated with preterm birth. These tests can measure specific proteins, hormones, or genetic markers present in the maternal blood that may be indicative of an increased risk of preterm birth. Thus, the aforementioned factors will drive the segmental growth.
 

The industry is segmented by end-use into hospitals, diagnostic centers, clinics, and others. Diagnostic centers segment dominated the global preterm birth diagnostic test kits market accounting for more than 43% market share in 2022 and is estimated to witness significant revenue over USD 370 million by 2032. The diagnostic centers segment is anticipated to hold high growth potential during the analysis period. Factors such as surging laboratory tests and rising preference towards diagnostics laboratories due to presence of advanced technologies and cost-effective treatment will fuel market growth. Additionally, these centers provide early and accurate disease diagnosis and patient management, thus, anticipated to augment the segmental growth in upcoming years.
 

U.S. Preterm Birth Diagnostic Test Kits Market Size, 2020 -2032 (USD Million)

U.S. preterm birth diagnostic test kits industry accounted for more than USD 158 million in 2022 and will grow momentously more than USD 344 million by 2032. The affordability of preterm birth diagnostic test kits among the target population base and ongoing technological developments are primarily responsible for the growth of the regional preterm birth diagnostic test kits industry. Further, the region's high healthcare spending on health care management and rising disposable income will propel the expansion of the North America preterm birth diagnostic test kits market. Also, the substantial presence of well-established market participants and the favourable regulatory environment result in a number of product approvals and launches, particularly in the U.S. hence, the potential for market expansion will stimulate over the coming years.
 

Preterm Birth Diagnostic Test Kits Market Share

Some of the notable key industry players operating in the preterm birth diagnostic test kits industry include:

  • Abbott
  • Creative Diagnostics
  • Clinical Innovations
  • Hologic
  • IQ Products
  • Qiagen
  • Medixbiochemica
  • Biosynex
  • CooperSurgical Inc
  • Sera Progonstics
  • Stryker Corporation
     

 These market participants are implementing various growth strategies such as collaborations, partnerships, acquisitions & mergers, and new product development and launches to strengthen product type offerings as well as gain a competitive edge over others.
 

Preterm Birth Diagnostic Test Kits Market News: 

  • In June 2021, Medix Biochemica declared the launch of ‘MedixMDx’, a new molecular diagnostic reagents division offering a vast range of products and services. Such initiatives are anticipated to bolster market growth.
     

Preterm birth diagnostic test kits market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2018 to 2032 for the following segments:

By Product Type

  • Fetal fibronectin test kits (fFN)
  •  Placental alpha micro-globulin-1 test kits (PAMG-1)
  • Insulin like growth factor binding protein-1 test kits (IGFBP-1)
  • Others

By Sample Type

  • Blood sample
  • Urine sample
  • Vaginal discharge sample

By End-use

  • Hospitals
  • Diagnostic centers
  • Clinics
  • Others

The above information is provided for the following regions and countries:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • France
    • UK
    • Spain
    • Italy
    • Russia
    • Poland
    • Switzerland
    • Norway
    • Finland
    • Sweden
    • Denmark
    • The Netherlands
  • Asia Pacific
    • Japan
    • China
    • India
    • Australia
    • South Korea
    • Taiwan
    • Indonesia
    • Vietnam
  • Latin America
    • Brazil
    • Mexico
    • Argentina
    • Colombia
    • Chile
  • Middle East & Africa
    • Saudi Arabia
    • South Africa
    • UAE
    • Israel

 

Authors:  Monali Tayade, Jignesh Rawal

Research methodology, data sources & validation process

This report draws on a structured research process built around direct industry conversations, proprietary modelling, and rigorous cross-validation and not just desk research.

Our 6-step research process

  1. 1. Research design & analyst oversight

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    Our approach integrates extensive primary research through direct engagement with industry participants and experts, complemented by comprehensive secondary research from verified global sources. We apply quantified impact analysis to deliver dependable forecasts, while maintaining complete traceability from original data sources to final insights.

  2. 2. Primary research

    Primary research forms the backbone of our methodology, contributing nearly 80% to overall insights. It involves direct engagement with industry participants to ensure accuracy and depth in analysis. Our structured interview program covers regional and global markets, with inputs from C-suite executives, directors, and subject matter experts. These interactions provide strategic, operational, and technical perspectives, enabling well-rounded insights and reliable market forecasts.

  3. 3. Data mining & market analysis

    Data mining is a key part of our research process, contributing nearly 20% to the overall methodology. It involves analysing market structure, identifying industry trends, and assessing macroeconomic factors through revenue share analysis of major players. Relevant data is collected from both paid and unpaid sources to build a reliable database. This information is then integrated to support primary research and market sizing, with validation from key stakeholders such as distributors, manufacturers, and associations.

  4. 4. Market sizing

    Our market sizing is built on a bottom-up approach, starting with company revenue data gathered directly through primary interviews, alongside production volume figures from manufacturers and installation or deployment statistics. These inputs are then pieced together across regional markets to arrive at a global estimate that stays grounded in actual industry activity.

  5. 5. Forecast model & key assumptions

    Every forecast includes explicit documentation of:

    • ✓ Key growth drivers and their assumed impact

    • ✓ Restraining factors and mitigation scenarios

    • ✓ Regulatory assumptions and policy change risk

    • ✓ Technology adoption curve parameter

    • ✓ Macroeconomic assumptions (GDP growth, inflation, currency)

    • ✓ Competitive dynamics and market entry/exit expectations

  6. 6. Validation & quality assurance

    The final stages involve human validation, where domain experts manually review filtered data to identify nuances and contextual errors that automated systems might miss. This expert review adds a critical layer of quality assurance, ensuring data aligns with research objectives and domain-specific standards.

    Our triple-layer validation process ensures maximum data reliability:

    • ✓ Statistical Validation

    • ✓ Expert Validation

    • ✓ Market Reality Check

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  • Regulatory filings

    Government procurement records and policy documents

  • Academic research

    University studies and specialist institution reports

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  • GMI archive

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  • Trade data

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Parameters studied & evaluated

Every data point in this report is validated through primary interviews, true bottom-up modelling, and rigorous cross-checks. Read about our research process →

Frequently Asked Question(FAQ) :
How big is global preterm birth diagnostic test kits industry?
Global market size for preterm birth diagnostic test kits was valued at over USD 419 million in 2022 and is projected to reach more than USD 856 million by 2032, owing to high incidence of preterm births, along with increasing awareness about early detection of fetal anomalies.
Why is fetal fibronectin test kits (fFN) segment gaining traction in preterm birth diagnostic test kits market?
Fetal fibronectin test kits (fFN) segment held the largest revenue size over USD 197 million in 2022 and will grow significantly through 2032, on account of high sensitivity of the test in detecting the presence of fetal fibronectin, a protein that acts as a biomarker for preterm birth.
What is the size of the U.S. preterm birth diagnostic test kits industry?
U.S. market for preterm birth diagnostic test kits accounted for more than USD 158 million in 2022 and will gather more than USD 344 million by 2032. The affordability of preterm birth diagnostic test kits and ongoing technological developments are primarily responsible for the regional market growth.
Who are the main contenders in preterm birth diagnostic test kits business?
Abbott, Creative Diagnostics, Clinical Innovations, Hologic, IQ Products, Qiagen, Medixbiochemica, Biosynex, CooperSurgical Inc, Sera Progonstics, and Stryker Corporation among others.
Preterm Birth Diagnostic Test Kits Market Scope
  • Preterm Birth Diagnostic Test Kits Market Size

  • Preterm Birth Diagnostic Test Kits Market Trends

  • Preterm Birth Diagnostic Test Kits Market Analysis

  • Preterm Birth Diagnostic Test Kits Market Share

Authors:  Monali Tayade, Jignesh Rawal
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Premium Report Details:

Base Year: 2022

Companies Profiled: 11

Tables & Figures: 277

Countries Covered: 32

Pages: 200

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