Global Preterm Birth Diagnostic Test Kits Market Growth, Share, Size, Trends and Forecast (2025 - 2031)

• June 2022, Intercept Pharmaceuticals Inc., declared outcomes from two investigations planned to assess clinical results in patients with PBC on Ocaliva (obeticholic acid or OCA): COBALT, a Phase 3b/4 confirmatory clinical results investigation and HEROES-US, one of two HEROES real-world investigations.

• May 2022, Intercept Pharmaceuticals, Inc. declared that the earliest patient has been dosed in a Phase 2 investigation assessing a fixed-dose combination of obeticholic acid (OCA) and bezafibrate (BZF) for the treatment of patients with primary biliary cholangitis (PBC) who have not accomplished a sufficient biochemical response to ursodeoxycholic acid. The double-blind, randomized, active-controlled, parallel-group investigation will assess the decrease in alkaline phosphatase (ALP) over 12 weeks, succeeded by a long-term safety extension.

• May 2022, Intercept Pharmaceuticals, Inc. declared that it has entered into an agreement to market to Advanz Pharma, a pharmaceutical firm with a strategic focus on specialty and hospital pharmaceuticals in Europe, some foreign subsidiaries and rights concerning Intercept’s international operations, inclusive of a license to commercialize Ocaliva (obeticholic acid) external of the U.S.

• June 2022, Intercept Pharmaceuticals Inc., declared outcomes from two investigations planned to assess clinical results in patients with PBC on Ocaliva (obeticholic acid or OCA): COBALT, a Phase 3b/4 confirmatory clinical results investigation and HEROES-US, one of two HEROES real-world investigations.

• May 2022, Intercept Pharmaceuticals, Inc. declared that the earliest patient has been dosed in a Phase 2 investigation assessing a fixed-dose combination of obeticholic acid (OCA) and bezafibrate (BZF) for the treatment of patients with primary biliary cholangitis (PBC) who have not accomplished a sufficient biochemical response to ursodeoxycholic acid. The double-blind, randomized, active-controlled, parallel-group investigation will assess the decrease in alkaline phosphatase (ALP) over 12 weeks, succeeded by a long-term safety extension.

• May 2022, Intercept Pharmaceuticals, Inc. declared that it has entered into an agreement to market to Advanz Pharma, a pharmaceutical firm with a strategic focus on specialty and hospital pharmaceuticals in Europe, some foreign subsidiaries and rights concerning Intercept’s international operations, inclusive of a license to commercialize Ocaliva® (obeticholic acid) external of the U.S.

The Global Preterm Birth Diagnostic Test Kits Market is segmented by Product Type, with various test kits used to detect biomarkers associated with preterm birth. The most widely used products include fFN (fetal fibronectin) test kits, PAMG-1 (placental alpha-microglobulin-1) test kits, and IGFBP-1 (insulin-like growth factor-binding protein-1) test kits. The fFN test is among the most common and well-established methods for predicting preterm labor, as the presence of fetal fibronectin in vaginal discharge can indicate an increased risk of preterm birth. PAMG-1 and IGFBP-1 test kits are also important for identifying biomarkers in maternal fluids, providing additional diagnostic options for clinicians in assessing the likelihood of early delivery. Each product type serves a specific diagnostic purpose, catering to different clinical requirements for predicting and preventing preterm births.

The market is further segmented by Sample Type, which includes blood, urine, and vaginal discharge as primary samples for testing. Blood-based diagnostic kits are popular for detecting various biomarkers linked to preterm birth, offering accurate results and comprehensive data. Urine-based tests are non-invasive and easy to collect, often used in outpatient settings for routine screenings. Vaginal discharge samples are commonly used for detecting fetal fibronectin and other key markers that can predict premature labor, making them highly valuable for high-risk pregnancies. The choice of sample type depends on the specific clinical scenario, with blood and vaginal discharge tests being particularly prevalent in hospital settings, while urine tests are often used for less invasive, more frequent monitoring.

The market is segmented by End-Use, with the primary users of preterm birth diagnostic test kits being hospitals, clinics, and diagnostic laboratories. Hospitals are the largest segment, as they handle high-risk pregnancies and are equipped with the necessary facilities for administering these tests. Clinics, particularly those specializing in obstetrics and gynecology, also play a significant role in early detection and prevention of preterm births, offering routine screening services to pregnant women. Diagnostic laboratories are essential in processing samples and providing accurate results for various biomarkers associated with preterm birth. The demand from these end-users continues to grow, driven by the increasing focus on early detection and intervention for at-risk pregnancies. Other end-users include research institutions and public health organizations, contributing to the overall expansion of the market.

Global Preterm Birth Diagnostic Test Kits Segment Analysis

In this report, the Global Preterm Birth Diagnostic Test Kits Market has been segmented by Sample, Product Type, End-Use, and Geography.

Global Preterm Birth Diagnostic Test Kits Market, Segmentation by Sample

The Global Preterm Birth Diagnostic Test Kits Market has been segmented by Sample into Blood, Urine , and Vaginal discharge.

The Global Preterm Birth Diagnostic Test Kits Market is segmented based on the sample type used for testing, which includes blood, urine, and vaginal discharge. Each of these sample types offers distinct advantages and has its specific role in the early detection of preterm birth risk. Blood samples are commonly used for tests that measure biomarkers associated with preterm birth, such as inflammatory markers or certain proteins that can indicate the likelihood of premature labor. Blood-based diagnostic kits are particularly valued for their accuracy and ability to provide comprehensive insights into a pregnant woman’s health, especially in cases where there are complications or high-risk pregnancies.

Urine samples are another key segment in the preterm birth diagnostic test market. Urine-based diagnostic tests are non-invasive, easy to collect, and can provide valuable information regarding maternal health. These tests often focus on detecting urinary biomarkers that may indicate an increased risk of preterm birth, such as elevated levels of certain proteins or metabolites. Urine-based diagnostic kits are generally more accessible for routine screenings and are often used in outpatient settings or during regular prenatal visits, offering a simple and convenient way to monitor at-risk pregnancies.

Vaginal discharge samples are used in diagnostic kits that detect changes or markers in the cervicovaginal environment, which can be indicative of preterm birth risk. These tests often focus on the presence of certain infections or biomarkers, such as fetal fibronectin, which can predict the likelihood of premature labor. Vaginal discharge-based diagnostic kits are valuable because they offer a targeted approach to detecting infections or physiological changes in the cervix that could lead to preterm birth. These kits are commonly used in hospital settings, especially for high-risk pregnancies, to provide early detection and allow for timely intervention to prevent preterm delivery.

Global Preterm Birth Diagnostic Test Kits Market, Segmentation by Product Type

The Global Preterm Birth Diagnostic Test Kits Market has been segmented by Product Type into fFN Test Kits, PAMG-1 Test Kits, IGFBP 1 Test Kits, and Others.

fFN Test Kits, PAMG-1 Test Kits, IGFBP-1 Test Kits, and Others. fFN (fetal fibronectin) Test Kits are widely used due to their ability to predict the likelihood of preterm birth by detecting fetal fibronectin, a biomarker present when the fetal membrane is disrupted. PAMG-1 (Placental Alpha Microglobulin-1) Test Kits are another significant segment, offering high sensitivity and specificity for diagnosing preterm rupture of membranes, a common precursor to preterm birth. IGFBP-1 (Insulin-like Growth Factor Binding Protein-1) Test Kits are employed for similar diagnostic purposes, detecting protein levels associated with premature membrane rupture.

The 'Others' category encompasses various emerging diagnostic technologies and assays that contribute to the early detection and management of preterm birth risks. These can include novel biomarker tests and integrated screening tools that combine multiple indicators for more comprehensive assessments. This segmentation highlights the diverse range of diagnostic options available to healthcare providers, facilitating tailored approaches to preterm birth prevention and management. As the market continues to innovate, the development and adoption of these specialized test kits are expected to play a crucial role in reducing the global incidence of preterm births.

Global Preterm Birth Diagnostic Test Kits Market, Segmentation by End-Use

The Global Preterm Birth Diagnostic Test Kits Market has been segmented by End-Use into Hospitals, Clinics, Diagnostic Laboratories, and Others

Hospitals are the primary end-users, leveraging these diagnostic kits for routine screening and monitoring of pregnant individuals, particularly those at high risk for preterm birth. Hospitals are equipped with comprehensive diagnostic facilities, enabling the effective use of various test kits, such as fFN, PAMG-1, and IGFBP-1, to assess and manage preterm birth risks efficiently.

Clinics and Diagnostic Laboratories also represent significant segments within the market. Clinics, often the first point of contact for expecting mothers, utilize these kits for early detection and referral for specialized care when necessary. Diagnostic Laboratories play a crucial role in providing detailed and accurate test results, supporting healthcare providers in making informed decisions. The 'Others' category includes point-of-care settings and home healthcare, reflecting the growing trend towards accessible and rapid diagnostic solutions. This segmentation underscores the widespread application of preterm birth diagnostic test kits across various healthcare settings, ensuring early intervention and better management of preterm birth risks.

Global Preterm Birth Diagnostic Test Kits Market, Segmentation by Geography

In this report, the Global Preterm Birth Diagnostic Test Kits Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East and Africa and Latin America.

Global Preterm Birth Diagnostic Test Kits Market Share (%), by Geographical Region, 2024

North America, Europe, Asia Pacific, Middle East and Africa, and Latin America. This geographic segmentation allows for a detailed analysis of regional market trends, healthcare infrastructure, and the prevalence of preterm births. North America and Europe are expected to dominate the market due to advanced healthcare systems, high awareness, and significant R&D investments. In these regions, the demand for preterm birth diagnostic test kits is driven by a strong focus on early diagnosis and preventive healthcare measures.

In contrast, the Asia Pacific, Middle East and Africa, and Latin America regions are anticipated to experience substantial growth due to increasing healthcare expenditure, improving healthcare infrastructure, and rising awareness about preterm birth complications. The Asia Pacific region, in particular, is projected to witness rapid market expansion due to the large population base and growing incidence of preterm births. These regions are also benefitting from international aid and government initiatives aimed at reducing neonatal mortality rates, further driving the demand for preterm birth diagnostic test kits.

This report provides an in depth analysis of various factors that impact the dynamics of Global Preterm Birth Diagnostic Test Kits Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers :

• Rising awareness of preterm birth complications
• Technological advancements

• Government initiatives - Government initiatives are playing a crucial role in driving the growth of the Global Preterm Birth Diagnostic Test Kits Market. Various governments worldwide are increasingly recognizing the importance of early detection and prevention of preterm births, which are a leading cause of neonatal morbidity and mortality. As a result, many countries are implementing national programs and policies aimed at improving maternal and neonatal health. These initiatives include funding for research and development of advanced diagnostic test kits, public awareness campaigns about the risks associated with preterm births, and the establishment of guidelines for routine screening during pregnancy. For instance, the U.S. government has been actively supporting research through the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) to develop and improve diagnostic technologies for preterm birth.

  Additionally, collaborations between governments, healthcare providers, and private companies are further bolstering the market. Public-private partnerships are facilitating the development and distribution of innovative diagnostic solutions, ensuring wider access to these critical tools. Governments are also investing in healthcare infrastructure and training programs to enhance the capabilities of healthcare professionals in early diagnosis and management of preterm birth risks. These concerted efforts are expected to significantly reduce the incidence of preterm births and improve outcomes for mothers and infants, thereby driving the demand for preterm birth diagnostic test kits. The growing emphasis on maternal and child health, supported by robust government initiatives, is poised to accelerate market growth over the coming years.

Restraints :

• High cost of tests
• Limited reimbursement coverage

• Accuracy limitations - The Global Preterm Birth Diagnostic Test Kits Market faces significant challenges due to accuracy limitations. Diagnostic tests for predicting preterm birth, such as fetal fibronectin tests and cervical length measurements, often have variable sensitivity and specificity. This variability can result in false positives or false negatives, leading to either unnecessary interventions or missed opportunities for timely intervention. For instance, a false positive result may cause undue stress for the expectant mother and lead to unnecessary medical procedures, while a false negative could result in a lack of necessary medical attention, potentially compromising the health of both the mother and the baby.

  These accuracy limitations are a major concern in the clinical adoption of preterm birth diagnostic test kits. Healthcare providers require reliable and accurate diagnostic tools to make informed decisions regarding the management and treatment of pregnancies at risk of preterm birth. The inconsistency in test results can undermine the confidence of healthcare professionals in these diagnostic kits, thereby affecting their widespread use. Despite advancements in technology, improving the accuracy and reliability of preterm birth diagnostic tests remains a critical focus for researchers and manufacturers in this market.

Opportunities :

• Development of non-invasive tests
• Technological innovations

• Increased awareness and education - The Global Preterm Birth Diagnostic Test Kits Market is experiencing growth due to increased awareness and education about preterm births. Public health campaigns and educational initiatives by healthcare organizations and governments have significantly raised awareness about the risks and complications associated with preterm births. This heightened awareness has led to a greater demand for diagnostic test kits that can help in early detection and management of preterm births, enabling timely interventions and better outcomes for both mothers and infants.

  Furthermore, advancements in medical technology and increased access to healthcare information have empowered expectant mothers and healthcare providers to proactively monitor and manage pregnancies. Educational programs aimed at both healthcare professionals and the general public emphasize the importance of early diagnosis and regular prenatal care, driving the adoption of preterm birth diagnostic test kits. As awareness continues to grow, supported by ongoing educational efforts, the market for these diagnostic tools is expected to expand, improving the overall standard of prenatal care and reducing the incidence of preterm births.

Key players in Global Preterm Birth Diagnostic Test Kits Market include

• Abbott
• Biosynex
• Clinical Innovations, LLC
• CooperSurgical Inc
• Creative Diagnostics
• Hologic, Inc
• IQ Products
• Medixbiochemica
• Qiagen
• Sera Prognostics

In this report, the profile of each market player provides following information:

• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis