Preeclampsia Diagnostics - Market Insights, Competitive Landscape, and Market Forecast - 2032

Preeclampsia Diagnostics Market by Sample Type (Blood Test and Urine Test), Product Type (Reagents & Kits and Instruments), Mode of Testing (Laboratory-based Testing and Point-of-care Testing (POCT)), End-User (Hospitals, Specialty Clinics, Diagnostic Centers, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the rising cases of preeclampsia worldwide & associated risk factors and growing awareness among pregnant women and healthcare professionals
The preeclampsia diagnostics market is estimated to grow at a CAGR of 3.67% during the forecast period from 2025 to 2032. The growth of the preeclampsia diagnostics market is primarily driven by the increasing incidence of preeclampsia and its associated risk factors, along with rising awareness among pregnant women and healthcare professionals. Additionally, ongoing product development initiatives by key market players are expected to further contribute to the market’s expansion during the forecast period from 2025 to 2032.

Preeclampsia Diagnostics Market Dynamics:

The rising prevalence of preeclampsia globally is significantly boosting the overall market for preeclampsia diagnostics. According to the data provided by the World Health Organization (2024), preeclampsia affects 2-8% of pregnancies worldwide. As more women face this pregnancy-related complication, primarily marked by high blood pressure and signs of organ damage usually occurring after the 20th week of gestation, the need for early and accurate detection methods is steadily increasing.

Additionally, the UK Obstetric Surveillance System (UKOSS) study showed an incidence of preeclampsia of 9% in severely obese patients compared to 2% of nonobese controls. Also, according to the data provided by the Preeclampsia Foundation Organization (2024), hypertensive disorders of pregnancy (HDPs), which include conditions such as gestational hypertension, chronic hypertension, preeclampsia, and eclampsia, affected approximately 5-10% of all pregnancies worldwide.

Preeclampsia is a major and most severe form of HDP, often characterized by elevated blood pressure and signs of damage to organ systems, particularly the liver and kidneys. As HDPs continue to pose significant health risks, the adoption of advanced preeclampsia diagnostic technologies is expected to boost across the globe. Factors such as increasing maternal age, obesity, diabetes, hypertension, and multiple pregnancies are key contributors to the growing risk of developing preeclampsia. Therefore, the rising cases of preeclampsia across the globe are expected to boost the growth of the preeclampsia diagnostics market.

Increasing awareness among pregnant women is another key factor driving the growth of the preeclampsia diagnostics market. For example, in January 2025, in recognition of Maternal Health Awareness Day on January 23rd, the Preeclampsia Foundation, in collaboration with Patients & Purpose, launched the "GAP - SPIRIN" campaign. This evidence-based educational initiative promotes the use of low-dose aspirin to help prevent preeclampsia and address disparities in maternal health.

The campaign combines information on the unique challenges faced by Black expectant mothers with guidance on low-dose aspirin prophylaxis, equipping healthcare providers to better manage preeclampsia risk. Preeclampsia is a severe hypertensive condition that can pose life-threatening risks during pregnancy and the postpartum period. It is a central issue in the maternal health crisis, disproportionately affecting Black mothers, who are 60% more likely to develop the condition.

The development of innovative diagnostic tests by key market players is significantly contributing to market growth. A notable example is Mirvie, which in May 2022 announced it received U.S. FDA Breakthrough Device designation for its Mirvie Preeclampsia Test. This groundbreaking test is designed to assess a woman’s individualized risk of developing preeclampsia before symptoms arise. It is powered by the proprietary Mirvie RNA platform, which analyzes the unique biological signals of each pregnancy to predict the risk of unexpected complications enabling earlier and more personalized clinical intervention.

Despite these promising growth factors, the preeclampsia diagnostics market faces challenges. Limited awareness among patients and providers and limitations in the accuracy of preeclampsia diagnostic tests are significant constraints that could potentially hinder market growth during the forecast period.

Preeclampsia Diagnostics Market Segment Analysis:

Preeclampsia Diagnostics Market by Sample Type (Blood Test and Urine Test), Product Type (Reagents & Kits, and Instruments), Mode of Testing (Laboratory-based Testing and Point-of-care Testing (POCT)), End-User (Hospitals, Specialty Clinics, Diagnostic Centers, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the sample type segment of the preeclampsia diagnostics market, the blood test category held the largest revenue share in 2024. The growth of this category is attributed to the rising use of blood tests in preeclampsia diagnostics. These tests are playing a transformative role by enabling earlier, more accurate, and accessible detection of preeclampsia even before clinical symptoms manifest. Their ability to identify risk at an early stage allows for timely intervention, significantly improving maternal and fetal outcomes.

These tests provide precise risk stratification, helping clinicians predict which patients are more likely to develop severe preeclampsia. This capability supports the efficient use of hospital resources, minimizes unnecessary interventions, and enhances patient care. Moreover, blood-based diagnostics are highly scalable and easily integrated into routine prenatal care. As awareness of preeclampsia continues to grow, and as point-of-care testing becomes more accessible even in low-resource settings the demand for these tests is expected to increase.

A major advancement in this space is the development of biomarker-based blood tests, particularly those that measure levels of placental growth factor (PlGF) and soluble fms-like tyrosine kinase-1 (sFlt-1). These biomarkers allow healthcare providers to detect preeclampsia in its early or asymptomatic stages, offering a critical tool for proactive, personalized pregnancy management.

Recent innovations in molecular diagnostics and immunoassays have led to the development of advanced blood tests for preeclampsia. For instance, companies like Thermo Fisher Scientific, PerkinElmer, and Roche Diagnostics offer blood test-based platforms for preeclampsia detection. For instance, in May 2023, the U.S. FDA approved Thermo Scientific B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR novel blood-based biomarker test for the risk assessment and clinical management of preeclampsia.

Thus, all these factors are fueling the adoption of blood tests, thereby acting as a strong catalyst in the growth of the blood-based preeclampsia test, thereby driving the overall expansion of the preeclampsia diagnostics market.

North America is expected to dominate the overall Preeclampsia Diagnostics Market:

North America is projected to account for the largest share of the preeclampsia diagnostics market in 2024. This dominance can be attributed to several key factors, including the rising cases of preeclampsia, increased awareness among patients and healthcare providers, strong healthcare infrastructure, and widespread access to advanced diagnostic tools. Additionally, support from government initiatives and ongoing innovations by key players are further driving market expansion through the forecast period from 2025 to 2032.

According to the recent data provided by the Centre for Disease Control and Prevention (2022), preeclampsia is estimated to occur in 5 to 7 percent of all pregnancies in the US. Additionally, as per the same source, in the United States, the rate of preeclampsia in Black women is 60 percent higher than in White women.

Given the serious health risks it poses to both mother and baby, including preterm birth, placental abruption, and even maternal or fetal death, healthcare providers are placing increased emphasis on early screening and continuous monitoring thereby boosting the overall market of preeclampsia diagnostics across the region.

Moreover, growing product development activities among the key market players are likely to propel the revenue shares for the preeclampsia in the region. For example, In January 2024, Labcorp, a global leader in innovative and comprehensive laboratory services, announced the launch and availability of a new FDA-cleared blood test designed for the risk assessment and clinical management of severe preeclampsia, a potentially life-threatening blood pressure disorder that can occur during pregnancy and the postpartum period.

Preeclampsia Diagnostics Market Key Players:

Some of the key market players operating in the Preeclampsia Diagnostics Market include F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific Inc., Labcorp, PerkinElmer, ARUP Laboratories, Siemens Healthineers AG, QuidelOrtho Corporation, Revvity, Randox Laboratories, CERCA Biotech, and others.

Recent Developmental Activities in the Preeclampsia Diagnostics Market:

• In February 2025, Roche announced that its Elecsys® sFlt-1/PlGF ratio test for preeclampsia received 510(k) clearance from the U.S. FDA. The test was intended to stratify hospitalized pregnant women with hypertensive disorders into low- and high-risk groups for developing severe preeclampsia within two weeks. This enabled better prediction, earlier interventions, and reduced adverse outcomes.
• In May 2024, Labcorp launched its first-trimester preeclampsia screening test, designed to be performed between 11 and 14 weeks of gestation to assess the risk of developing preeclampsia before 34 weeks. It was the only test of its kind available in the U.S. and applied to all pregnant individuals, including those with low- to average-risk or first-time pregnancies.

Key Takeaways from the Preeclampsia Diagnostics Market Report Study

• Market size analysis for current preeclampsia diagnostics market size (2024), and market forecast for 8 years (2025 to 2032)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
• Key companies dominating the preeclampsia diagnostics market
• Various opportunities available for the other competitors in the preeclampsia diagnostics market space
• What are the top-performing segments in 2024? How these segments will perform in 2032?
• Which are the top-performing regions and countries in the current preeclampsia diagnostics market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for preeclampsia diagnostics market growth in the coming future?

Target Audience Who Can be benefited from this Preeclampsia Diagnostics Market Report Study

• Preeclampsia diagnostics product providers
• Research organizations and consulting companies
• Preeclampsia diagnostics-related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing in preeclampsia diagnostics
• Various end-users who want to know more about the preeclampsia diagnostics market and the latest technological developments in the preeclampsia diagnostics market 

Frequently Asked Questions for the Preeclampsia Diagnostics Market:

1. What are Preeclampsia Diagnostics?

• Preeclampsia diagnostics refers to the methods and tools used to detect preeclampsia, a pregnancy complication characterized by high blood pressure and signs of damage to other organs, often the liver and kidneys. Diagnostics typically involve blood pressure monitoring, urine protein tests, and biomarker-based blood tests (e.g., sFlt-1/PlGF ratio) to assess the risk, presence, or severity of the condition.

2. What is the market for Preeclampsia Diagnostics Market?

• The preeclampsia diagnostics market is estimated to grow at a CAGR of 3.67% during the forecast period from 2025 to 2032.

3. What are the drivers for the global Preeclampsia Diagnostics Market?

• The growth of the preeclampsia diagnostics market is primarily driven by the increasing incidence of preeclampsia and its associated risk factors, along with rising awareness among pregnant women and healthcare professionals. Additionally, ongoing product development initiatives by key market players are expected to further contribute to the market’s expansion during the forecast period from 2025 to 2032.

4. Who are the key players operating in the global Preeclampsia Diagnostics Market?

• Some of the key market players operating in the preeclampsia diagnostics market include F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific Inc., Labcorp, PerkinElmer, ARUP Laboratories, Siemens Healthineers AG, QuidelOrtho Corporation, Revvity, Randox Laboratories, CERCA Biotech, and others.

5. Which region has the highest share in the global Preeclampsia Diagnostics Market?

• North America is expected to dominate the overall preeclampsia diagnostics market during the forecast period, 2025 to 2032. This dominance can be attributed to several key factors, including the rising cases of preeclampsia, increased awareness among patients and healthcare providers, strong healthcare infrastructure, and widespread access to advanced diagnostic tools. Additionally, support from government initiatives and ongoing innovations by key players are further driving market expansion through the forecast period from 2025 to 2032.

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