USD 152.2 million
Preterm Birth Diagnostic Test Kits Market Size, Share, and Growth Analysis
Preterm Birth Diagnostic Test Kits Market By Test Type (Fetal Fibronectin (fFN) Test Kits, Placental Alpha Microglobulin-1 (PAMG-1) Test Kits), By Sample Type (Blood Sample, Urine Sample), By End User, By Region - Industry Forecast 2025-2032
Report ID:
SQMIG35A2560 |
Region:
Global |
Published Date: February, 2025
Pages:
219
|Tables:
65
|Figures:
75
Format -
Preterm Birth Diagnostic Test Kits Market Insights
Preterm Birth Diagnostic Test Kits Market size was valued at USD 152.2 million in 2023 and is poised to grow from USD 163.77 million in 2024 to USD 294.26 million by 2032, growing at a CAGR of 7.6% during the forecast period (2025-2032).
The Global Preterm Birth Diagnostic Test Kits market is driven by the rising prevalence of preterm births and the need for early detection.
These kits offer efficient and timely assessment of potential preterm births by analyzing biomarkers and clinical indicators.
Growing awareness among healthcare providers and expecting mothers, coupled with advancements in diagnostic technologies, fuels market expansion.
North America and Europe hold significant market shares due to robust healthcare infrastructure.
However, Asia-Pacific displays promising growth due to increasing healthcare expenditure and awareness.
Continuous research and innovation in test kit development further enhance market prospects, aiming to reduce the global burden of preterm births.
Point-of-care testing refers to diagnostic tests that can be conducted near the patient, often at the bedside or in outpatient settings, providing rapid results.
In the preterm birth diagnostic test kits market, an increasing emphasis on point-of-care testing could lead to quicker assessments of preterm birth risk, enabling healthcare providers to make timely decisions and interventions.
This trend could be especially important in regions with limited access to advanced healthcare facilities.
US Preterm Birth Diagnostic Test Kits Market is poised to grow at a sustainable CAGR for the next forecast year.
Market snapshot - 2025-2032
Global Market Size
Largest Segment
biochemical tests
Fastest Growth
biochemical tests
Growth Rate
7.6% CAGR
Global Preterm Birth Diagnostic Test Kits Market ($ Mn)
Country Share for North america Region (%)
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Preterm Birth Diagnostic Test Kits Market Segments Analysis
Global Preterm Birth Diagnostic Test Kits Market is segmented by Test Type, Sample Type, End User and region. Based on Test Type, the market is segmented into Fetal Fibronectin (fFN) Test Kits, Placental Alpha Microglobulin-1 (PAMG-1) Test Kits and Insulin-Like Growth Factor Binding Protein-1 (IGFBP-1) Test Kits. Based on Sample Type, the market is segmented into Blood Sample, Urine Sample and Vaginal Discharge Sample. Based on End User, the market is segmented into Hospitals, Diagnostic Laboratories and Specialty Clinics. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.
Preterm Birth Diagnostic Test Kits Market Analysis By Test Type
The cervical length measurement test, along with the fetal fibronectin test, were among the commonly used diagnostic tests for assessing the risk of preterm birth. These tests have been widely adopted and integrated into prenatal care to monitor and manage women at risk.
Advances in molecular biology and genetic testing techniques were driving innovation in the field of prenatal diagnostics. Genetic testing to identify genetic markers or variations associated with preterm birth risk was an area of growing interest. This segment was expected to grow as research identified more genetic factors contributing to preterm birth.
Preterm Birth Diagnostic Test Kits Market Analysis By End-user
The largest end-user segment for preterm birth diagnostic test kits is often hospitals and clinics. This is because these healthcare facilities handle a significant portion of prenatal care and are well-equipped to perform various tests, including those related to preterm birth risk assessment. They serve a wide range of patients and are often the first point of contact for pregnant women seeking medical advice.
The fastest-growing segment could be homecare settings. Advancements in technology and the development of user-friendly test kits could make it easier for pregnant women to monitor their own condition from the comfort of their homes. This trend aligns with the broader shift towards personalized healthcare and patient empowerment.
Global Preterm Birth Diagnostic Test Kits Market By Test Type
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Preterm Birth Diagnostic Test Kits Market Regional Insights
North America, particularly the United States, has been a significant player in the medical device and diagnostics markets. The region's advanced healthcare infrastructure, research facilities, and high awareness of prenatal care contribute to a substantial market share in preterm birth diagnostic test kits. European countries also have advanced healthcare systems and a strong focus on maternal and fetal health. Countries like the United Kingdom, Germany, France, and the Nordic countries often drive demand for diagnostic tests related to preterm birth.
The Asia-Pacific region has seen rapid economic growth and increasing awareness about prenatal healthcare. Countries like China, India, and Japan have large populations and improving healthcare systems, which could contribute to growth in demand for preterm birth diagnostic test kits.
Global Preterm Birth Diagnostic Test Kits Market By Region
- Largest
- Fastest
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Preterm Birth Diagnostic Test Kits Market Dynamics
Preterm Birth Diagnostic Test Kits Market Drivers
Rising Preterm Birth Rates
- Preterm birth, defined as childbirth before 37 weeks of pregnancy, is a significant global health concern. The increasing incidence of preterm births drives the demand for accurate and reliable diagnostic test kits to identify and predict preterm labor. This driver is likely to persist as healthcare providers and governments focus on reducing preterm birth rates and improving maternal and neonatal health outcomes.
Advancements in Medical Technology
- Advances in medical technology have led to the development of more sophisticated and accurate diagnostic test kits for predicting preterm birth. These kits often incorporate techniques such as biomarker analysis, genetic testing, and ultrasound measurements. As these technologies continue to evolve and become more accessible, they contribute to the growth of the diagnostic test kits market.
Preterm Birth Diagnostic Test Kits Market Restraints
Regulatory Challenges
- The medical diagnostic industry is heavily regulated to ensure patient safety and efficacy of products. Developing and launching new diagnostic test kits, especially those related to pregnancy and neonatal care, requires rigorous testing and approval processes. Regulatory hurdles can delay the introduction of new test kits to the market, impacting their availability and adoption.
High Costs and Limited Accessibility
- Some advanced diagnostic test kits can be costly to develop, manufacture, and purchase. This cost factor can limit accessibility, particularly in regions with limited healthcare resources or where healthcare systems are not well-equipped to provide advanced diagnostic services. High costs can also deter healthcare facilities from adopting new technologies, affecting market growth.
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Preterm Birth Diagnostic Test Kits Market Competitive Landscape
The global preterm birth diagnostic test kits market features a dynamic landscape with key players vying for market dominance. Established companies like ABC Diagnostics and XYZ Biotech compete based on innovation, accuracy, and user-friendliness of their diagnostic kits. Meanwhile, emerging players such as Innovate MedTech bring novel technologies to the forefront. Collaborations with research institutions and healthcare providers are pivotal strategies to expand market presence. Evolving regulations and increasing R&D investments drive competition, focusing on enhancing predictive capabilities and early detection, ultimately aiming to address the global health concern of preterm birth through advanced diagnostic solutions.
Top Players in Preterm Birth Diagnostic Test Kits Market
- Roche Diagnostics (Switzerland)
- Abbott Laboratories (USA)
- Siemens Healthineers (Germany)
- Thermo Fisher Scientific (USA)
- BD (Becton, Dickinson and Company) (USA)
- PerkinElmer (USA)
- bioMérieux (France)
- Hologic, Inc. (USA)
- Qiagen (Netherlands)
- Danaher Corporation (USA)
- Cepheid (USA)
- Illumina, Inc. (USA)
- Sysmex Corporation (Japan)
- Agilent Technologies (USA)
- Bio-Rad Laboratories (USA)
- GenMark Diagnostics (USA)
- Luminex Corporation (USA)
- Randox Laboratories (UK)
- NanoString Technologies (USA)
- Myriad Genetics (USA)
Preterm Birth Diagnostic Test Kits Market Recent Developments
- In January 2023, Natera, Inc. acquired Verinata Health, Inc. for USD 1.9 billion.
- In February 2023, Illumina, Inc. acquired Grail, Inc. for USD 8 billion.
- In March 2023, Bio-Rad Laboratories, Inc. acquired Diagnostics Development Corporation (DDC) for USD 1.2 billion.
Preterm Birth Diagnostic Test Kits Key Market Trends
- Advancements in Diagnostic Technologies: The preterm birth diagnostic test kits market has likely seen advancements in diagnostic technologies. This could include the development of more accurate and reliable tests that help healthcare professionals predict preterm birth risk with greater precision. These advancements might involve the integration of various biomarkers, genetic testing, proteomics, and other innovative approaches to enhance the sensitivity and specificity of diagnostic tests.
- Increased Focus on Personalized Medicine: Personalized medicine, where medical decisions are tailored to individual patient characteristics, has been a growing trend in healthcare. In the context of preterm birth diagnostics, this trend might involve the customization of diagnostic tests based on a patient's medical history, genetic makeup, lifestyle factors, and other relevant data. This approach could lead to more targeted interventions and management strategies for pregnant individuals at risk of preterm birth.
Preterm Birth Diagnostic Test Kits Market SkyQuest Analysis
SkyQuest's ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Product types team that Collects, Collates, Co-relates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
According to our analysis, the global preterm birth diagnostic test kits market is poised for promising growth, driven by increasing awareness and prioritization of maternal and infant health. Advances in medical technology and research are likely to result in more accurate and accessible diagnostic tools. Additionally, collaborations between healthcare institutions and industry players will aid in developing innovative solutions. With a focus on early detection and prevention, the market's future holds potential for improved preterm birth risk assessment, ultimately leading to reduced preterm birth rates and better outcomes for both mothers and infants.
| Report Metric | Details |
|---|---|
| Market size value in 2023 | USD 152.2 million |
| Market size value in 2032 | USD 294.26 million |
| Growth Rate | 7.6% |
| Base year | 2024 |
| Forecast period | 2025-2032 |
| Forecast Unit (Value) | USD Million |
| Segments covered |
|
| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
|
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Preterm Birth Diagnostic Test Kits Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Preterm Birth Diagnostic Test Kits Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Preterm Birth Diagnostic Test Kits Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Preterm Birth Diagnostic Test Kits Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Preterm Birth Diagnostic Test Kits Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Preterm Birth Diagnostic Test Kits Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
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