Preeclampsia Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Instruments, Consumables, Others), By End User (Hospitals, Specialty Clinics, Diagnostic Centers, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 849.03 Million
CAGR (2026-2031)	4.56%
Fastest Growing Segment	Consumables
Largest Market	North America
Market Size (2031)	USD 1109.47 Million

Market Overview

The Global Preeclampsia Diagnostics Market will grow from USD 849.03 Million in 2025 to USD 1109.47 Million by 2031 at a 4.56% CAGR. Preeclampsia diagnostics encompass medical devices and laboratory assays, including blood pressure monitors, proteinuria testing kits, and placental growth factor biomarkers, designed to detect hypertensive disorders during pregnancy. The market is primarily driven by the rising global incidence of maternal risk factors, such as obesity, chronic hypertension, and advanced maternal age, which necessitate rigorous prenatal monitoring. Furthermore, the integration of early risk assessment protocols into standard antenatal care and increasing government initiatives aimed at reducing maternal mortality rates serve as fundamental supports for industry growth, distinct from technological trends.

However, a significant challenge hindering market expansion is the lack of accessibility and the high cost of specific biomarker tests in low-resource settings where disease burden is often highest. This disparity limits the widespread adoption of effective screening tools necessary to mitigate severe outcomes. According to the Preeclampsia Foundation, in 2024, approximately 76,000 mothers and 500,000 babies lose their lives annually worldwide due to preeclampsia and related hypertensive disorders.

Key Market Drivers

Technological advancements in biomarker-based diagnostic assays serve as a critical market driver, transitioning care from reactive management to predictive risk stratification. The industry is witnessing a rapid shift toward assays that analyze angiogenic factors, such as the sFlt-1/PlGF ratio, offering superior predictive values over conventional blood pressure and proteinuria monitoring. According to Labcorp, May 2024, in the 'Labcorp Launches First Trimester Preeclampsia Screening Test' announcement, their newly introduced test method demonstrated a sensitivity of up to 90% for identifying early-onset risk, significantly outperforming traditional assessments. This diagnostic precision encourages widespread adoption in clinical workflows to facilitate timely interventions, directly influencing revenue growth for diagnostic manufacturers.

Simultaneously, the increasing incidence of hypertensive disorders in pregnancy expands the addressable market. This trend is closely linked to advanced maternal age and the rising prevalence of chronic conditions like obesity and diabetes among women of reproductive age. According to March of Dimes, November 2024, in the '2024 Report Card', the rate of pre-pregnancy hypertension increased by more than 10% nationally between 2022 and 2023, necessitating frequent diagnostic evaluation for a growing high-risk population. The disease's widespread reach is evident; according to Femtech Insider, May 2024, in the 'Labcorp Introduces New Screening Test for Preeclampsia Risk' article, approximately one in 25 pregnancies in the United States is currently affected by preeclampsia. This high prevalence underscores the urgent demand for accessible and accurate diagnostic solutions across healthcare systems.

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Key Market Challenges

The high cost and limited accessibility of specific biomarker tests in low-resource settings act as a primary constraint on the Global Preeclampsia Diagnostics Market. While the clinical need for rigorous prenatal monitoring is acute in developing regions, the financial and infrastructural limitations in these areas often preclude the procurement of specialized diagnostic devices and laboratory assays. This gap prevents market players from establishing a foothold in high-volume geographies, effectively limiting the total addressable market to predominantly high-income economies. Consequently, the discrepancy between disease prevalence and purchasing power slows the global adoption rate of these essential tools.

This economic barrier directly impacts industry revenue by leaving a vast portion of the global patient population unserved. The inability to penetrate these markets results in a significant loss of potential volume growth, as manufacturers cannot easily scale operations in regions where the clinical burden is highest. According to the World Health Organization, in 2024, it was reported that approximately 92% of all maternal deaths occurred in low- and lower-middle-income countries. This statistic demonstrates the profound imbalance in the market, where the regions with the highest implied need for diagnostics are the least able to access them, thereby stifling overall industry expansion.

Key Market Trends

The Integration of AI-Driven Predictive Analytics is fundamentally altering the market landscape by enabling non-invasive, high-accuracy screening methods that utilize complex physiological data. This trend moves beyond standard protein assays, leveraging machine learning algorithms to analyze novel inputs like retinal vascular changes for earlier disease detection. These digital tools improve screening scalability and offer superior predictive capabilities compared to traditional risk factor assessments, fostering the development of software-as-a-medical-device products. According to Medscape, March 2024, in the 'AI Identifies Retinal Biomarkers for Preeclampsia' article, a newly studied AI framework known as DVT-Net demonstrated an accuracy level of 0.813 for early prediction in the first and second trimesters, significantly enhancing the ability to identify at-risk patients before symptoms manifest.

Simultaneously, the Expansion of Remote and Home-Based Monitoring Solutions is extending diagnostic oversight beyond the hospital, particularly for high-risk postpartum management. This shift involves the deployment of connected blood pressure devices and telehealth platforms that facilitate continuous physiological tracking, ensuring timely intervention for hypertensive spikes that might otherwise go undetected. This approach is proving critical for reducing maternal morbidity rates associated with readmissions and ensuring continuity of care during the vulnerable postpartum period. According to The ObG Project, August 2024, in the 'How Does Remote BP Monitoring Program Impact Postpartum Care for Those with Hypertensive Disorders of Pregnancy?' article, enrollment in a remote hypertension management program was associated with a significantly lower six-week postpartum readmission rate, showing an adjusted risk ratio of 0.78 compared to usual care.

Segmental Insights

The consumables segment is currently the fastest-growing category within the global preeclampsia diagnostics market, driven primarily by the recurring need for reagents and kits for every individual test performed. This expansion is supported by the increasing adoption of biomarker-based screening protocols recommended by authorities such as the National Institute for Health and Care Excellence to improve maternal health monitoring. As laboratories and clinics experience higher testing volumes to identify hypertensive disorders early, the continuous procurement of these essential disposable products remains critical for maintaining routine diagnostic operations.

Regional Insights

North America maintains a dominant position in the global preeclampsia diagnostics market, driven by a well-established healthcare infrastructure and high public awareness regarding maternal health. The region’s leadership is reinforced by the presence of key industry players and favorable reimbursement policies that support accessible prenatal care. Additionally, robust regulatory frameworks, such as those overseen by the U.S. Food and Drug Administration (FDA), streamline the approval process for new diagnostic solutions and biomarkers. These elements, combined with a strong focus on early detection protocols, sustain North America's status as the primary revenue generator in this sector.

Recent Developments

• In February 2025, Roche announced that its Elecsys sFlt-1/PlGF ratio test received 510(k) clearance from the U.S. Food and Drug Administration. This prognostic tool is designed to stratify pregnant women hospitalized with hypertensive disorders into low- and high-risk categories for developing severe preeclampsia within two weeks. The test measures the ratio of soluble fms-like tyrosine kinase-1 to placental growth factor, providing objective data to aid clinicians in disease management. This clearance represents a significant advancement in identifying patients who require closer surveillance to prevent adverse maternal and fetal outcomes associated with this life-threatening condition.
• In September 2024, Trinity Biotech plc announced the acquisition of Metabolomic Diagnostics, a company specializing in biomarker-based diagnostic solutions for preeclampsia. The acquisition, valued at approximately $1.3 million in stock and cash, provided Trinity Biotech with access to the PrePsia technology, a test designed to predict preeclampsia risk as early as the 12th week of pregnancy. This test combines mass spectrometry with machine learning-powered bioinformatics to analyze specific metabolites. The company stated its intention to commercialize the test in the U.S. market through its reference laboratory to improve early detection capabilities and support better maternal health outcomes.
• In August 2024, ARUP Laboratories announced the launch of a new FDA-cleared test for assessing the risk of severe preeclampsia in pregnant women. The assay measures the ratio of two angiogenic biomarkers, soluble fms-like tyrosine kinase 1 (sFlt-1) and placental growth factor (PlGF), which are key indicators of placental function. This diagnostic tool is intended for use in women with singleton pregnancies between 23 and 35 weeks of gestation who are hospitalized for hypertensive disorders. The test aids clinicians in determining which patients are at imminent risk of progressing to severe preeclampsia, thereby facilitating timely medical decision-making.
• In May 2024, Labcorp launched a first-trimester screening test to assess the risk of developing preeclampsia before 34 weeks of pregnancy. This test, performed between 11 and 14 weeks of gestation, utilizes four biomarkers: placental growth factor, pregnancy-associated plasma protein-A, mean arterial pressure, and uterine artery pulsatility index. The company highlighted that this offering made it the only laboratory in the United States to provide preeclampsia risk screening across all three trimesters. The screening aims to identify high-risk patients early, enabling healthcare providers to implement preventative measures such as low-dose aspirin therapy to improve pregnancy outcomes.

Key Market Players

• Diabetomics Inc.
• DRG INSTRUMENTS GMBH
• F. Hoffmann-La Roche Ltd
• Afekta Technologies Ltd.
• MOMM Diagnostics GmbH
• PerkinElmer Inc.
• Sera Prognostics, Inc.
• Siemens Healthineers AG
• Thermo Fisher Scientific Inc.

By Product	By End User	By Region
Instruments Consumables Others	Hospitals Specialty Clinics Diagnostic Centers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Preeclampsia Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Preeclampsia Diagnostics Market, By Product:

• Instruments
• Consumables
• Others

• Preeclampsia Diagnostics Market, By End User:

• Hospitals
• Specialty Clinics
• Diagnostic Centers
• Others

• Preeclampsia Diagnostics Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE