Preeclampsia Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Preeclampsia Diagnostics Market is projected to expand from USD 849.03 Million in 2025 to USD 1.10 billion by 2031, registering a compound annual growth rate of 4.56%. This sector comprises medical devices and laboratory assays - such as blood pressure monitors, proteinuria testing kits, and placental growth factor biomarkers - developed to identify hypertensive disorders during pregnancy. Growth is largely fueled by the increasing global incidence of maternal risk factors, including obesity, chronic hypertension, and advanced maternal age, which demand strict prenatal monitoring. Additionally, the incorporation of early risk assessment protocols into routine antenatal care and government-led initiatives to lower maternal mortality rates provide foundational support for market expansion, independent of specific technological trends.

However, market growth faces a substantial obstacle regarding the affordability and accessibility of specific biomarker tests in low-resource regions, where the burden of disease is frequently the heaviest. This inequality restricts the broad implementation of effective screening tools needed to prevent severe clinical outcomes. Data from the Preeclampsia Foundation in 2024 indicates that approximately 76,000 mothers and 500,000 infants die globally each year due to preeclampsia and associated hypertensive disorders, highlighting the critical nature of these diagnostic gaps.

Market Drivers

Technological progress in biomarker-based diagnostic assays acts as a pivotal market driver, shifting the standard of care from reactive management toward predictive risk stratification. The industry is rapidly adopting assays that evaluate angiogenic factors, such as the sFlt-1/PlGF ratio, which provide predictive accuracy superior to traditional blood pressure and proteinuria checks. For instance, Labcorp’s May 2024 announcement regarding their 'First Trimester Preeclampsia Screening Test' noted that the new method achieved a sensitivity of up to 90% in detecting early-onset risk, significantly outclassing conventional assessments. This level of diagnostic precision promotes broad uptake within clinical workflows to enable prompt interventions, thereby directly boosting revenue for diagnostic manufacturers.

Concurrently, the expanding addressable market is bolstered by the rising incidence of hypertensive disorders during pregnancy. This trend correlates closely with advanced maternal age and the increasing prevalence of chronic conditions, such as obesity and diabetes, among women of reproductive age. According to the March of Dimes '2024 Report Card' released in November 2024, the national rate of pre-pregnancy hypertension rose by over 10% between 2022 and 2023, requiring frequent diagnostic monitoring for an enlarging high-risk demographic. The extensive reach of the condition is highlighted by a May 2024 Femtech Insider article, 'Labcorp Introduces New Screening Test for Preeclampsia Risk,' which states that roughly one in 25 pregnancies in the United States is currently impacted by preeclampsia, underscoring the urgent need for accurate diagnostic solutions.

Market Challenges

The prohibitive cost and limited availability of specialized biomarker tests in low-resource environments represent a primary constraint on the Global Preeclampsia Diagnostics Market. Although the clinical necessity for strict prenatal monitoring is intense in developing regions, financial and infrastructural shortcomings often prevent the acquisition of advanced diagnostic devices and laboratory assays. This disparity precludes market participants from securing a presence in high-volume geographies, effectively confining the total addressable market to primarily high-income nations. As a result, the disconnect between disease prevalence and economic purchasing power retards the global adoption rate of these vital tools.

This economic hurdle directly affects industry revenue by leaving a substantial segment of the global patient population without access to care. The inability to penetrate these markets leads to a considerable loss in potential volume growth, as manufacturers are unable to scale operations in areas where the clinical burden is most severe. According to a 2024 report by the World Health Organization, approximately 92% of all maternal deaths took place in low- and lower-middle-income countries. This statistic illustrates a profound market imbalance, wherein the regions with the greatest implied need for diagnostics possess the least capacity to access them, thereby suppressing overall industry expansion.

Market Trends

The integration of AI-driven predictive analytics is fundamentally transforming the market landscape by facilitating non-invasive, highly accurate screening methods that process complex physiological data. This trend transcends standard protein assays by utilizing machine learning algorithms to examine novel inputs, such as retinal vascular changes, for earlier disease detection. These digital tools enhance the scalability of screening and provide predictive capabilities that exceed traditional risk factor assessments, encouraging the creation of software-as-a-medical-device products. As reported by Medscape in the March 2024 article 'AI Identifies Retinal Biomarkers for Preeclampsia,' a newly evaluated AI framework called DVT-Net achieved an accuracy level of 0.813 for early prediction during the first and second trimesters, significantly improving the identification of at-risk patients prior to symptom onset.

Simultaneously, the expansion of remote and home-based monitoring solutions is extending diagnostic supervision beyond hospital settings, specifically for high-risk postpartum management. This shift entails the use of connected blood pressure devices and telehealth platforms that enable continuous physiological tracking, ensuring timely responses to hypertensive spikes that might otherwise go unnoticed. This strategy is proving essential for lowering maternal morbidity rates linked to hospital readmissions and maintaining care continuity during the critical postpartum phase. According to an August 2024 article by The ObG Project titled 'How Does Remote BP Monitoring Program Impact Postpartum Care for Those with Hypertensive Disorders of Pregnancy?,' participation in a remote hypertension management program was linked to a significantly reduced six-week postpartum readmission rate, demonstrating an adjusted risk ratio of 0.78 compared to standard care.

Key Players Profiled in the Preeclampsia Diagnostics Market

• 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.

Report Scope

In this report, the Global Preeclampsia Diagnostics Market has been segmented into the following categories:

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
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Preeclampsia Diagnostics Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

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