Preeclampsia Diagnostics Market Size, Share and Trends 2026 to 2035

Preeclampsia Diagnostics Market (By Test Type; Blood Pressure Monitoring, Biochemical Marker Assays, Placental Growth Factor (PlGF), Urine Protein Tests, Imaging-Based Diagnostics, Point-of-Care Testing, Others; By Technology Type: Immunoassays, ELISA, Molecular / PCR-based Assays, Biosensors, Ultrasound, Others; By Test Setting: Laboratory-based Testing, Home-based / Remote Monitoring; By Product & Services: Diagnostic Kits & Reagents, Testing Devices & Instruments, Laboratory Services, Data Analytics & Monitoring Platforms, Others; By End User: Hospitals & Maternity Clinics, Diagnostic Laboratories, Research & Academic Institutes;) - Global Industry Analysis, Size, Trends, Leading Companies, Regional Outlook, and Forecast 2026 to 2035

Last Updated : 22 Jun 2026  |  Report Code : 6983  |  Category : Healthcare   |  Format : PDF / PPT / Excel   |  Author : Rohan Patil   | Reviewed By : Aditi Shivarkar
Revenue, 2025
USD 1.29 Bn
Forecast Year, 2035
USD 1.75 Bn
CAGR, 2026 - 2035
3.10%
Report Coverage
Global

What is the Preeclampsia Diagnostics Market Size?

The global preeclampsia diagnostics market size accounted for USD 1.29 billion in 2025 and is predicted to increase from USD 1.33 billion in 2026 to approximately USD 1.75 billion by 2035, expanding at a CAGR of 3.10% from 2026 to 2035. The market is expanding due to rising awareness of maternal health, technological advancements in point-of-care testing, and increasing prenatal screening initiatives.

Preeclampsia Diagnostics Market Size 2026 to 2035

Market Highlights

  • North America led the preeclampsia diagnostics market with around 43% share in 2025.
  • Asia Pacific is expected to expand at the fastest CAGR in the market between 2026 and 2035.
  • By test type, the biochemical marker assays segment held approximately 40% share of the market in 2025.
  • By test type, the point-of-care testing segment is expected to grow at the fastest CAGR between 2026 and 2035.
  • By technology type, the immunoassays segment captured around 45% market share in 2025.
  • By technology type, the biosensors / point-of-care devices segment is expected to expand at a notable CAGR over the projected period.
  • By test setting, the laboratory-based testing segment captured approximately 50% market share in 2025.
  • By test setting, the home-based / remote monitoring segment is expected to expand at a notable CAGR over the projected period.
  • By product & services, the diagnostic kits & reagents segment held around 45% of market share in 2025.
  • By product & services, the data analytics & monitoring platforms segment is expected to expand at a notable CAGR over the projected period.
  • By end user, the hospitals & maternity clinics segment held approximately 50% of the market share in 2025.
  • By end user, the obstetrics & gynecology clinics segment is anticipated to grow at a fastest CAGR between 2026 and 2035.

What is the Preeclampsia Diagnostics Market?

The preeclampsia diagnostics market encompasses various diagnostic tools, assays, devices, and laboratory tests utilized to detect and monitor preeclampsia, a pregnancy-related hypertensive disorder that can lead to serious maternal and fetal complications. This market includes blood pressure monitoring, biochemical markers, urine protein tests, imaging-based diagnostics, and point-of-care testing. Preeclampsia is characterized by the onset of hypertension after 20 weeks of gestation, accompanied by signs of maternal organ or uteroplacental dysfunction or proteinuria. The growth of the preeclampsia diagnostics market is primarily driven by the increasing prevalence of this condition and the urgent need to protect the health of both mothers and their babies.

Artificial Intelligence: The Next Growth Catalyst in Preeclampsia Diagnostics

Artificial Intelligence (AI) is increasingly being applied in the preeclampsia diagnostics market, with predictive risk assessment emerging as a major area of focus. AI algorithms are being developed to analyze complex patient data, including blood biomarkers, maternal medical history, and placental imaging, to identify pregnancies at high risk for preeclampsia well before clinical symptoms manifest. For example, a 2024 study by the University of Oxford and King's College London demonstrated that an AI-based model could predict preeclampsia with high accuracy, showcasing its potential for early intervention. (Source: https://www.kcl.ac.uk)

Furthermore, nationally funded initiatives like the NIH's Human Placenta Project are exploring how machine learning can process molecular and imaging data to enable non-invasive diagnostic approaches. The broader integration of AI into prenatal care not only holds promise for maximizing early detection but also supports individualized monitoring and timely interventions, ultimately improving maternal and fetal health outcomes. This positions AI as a transformative tool in advancing the effectiveness and accessibility of preeclampsia diagnostics.

Artificial intelligence (AI) has the potential to surpass traditional methods for the early detection of preeclampsia. Machine learning techniques are well-suited for analyzing a large number of variables and identifying the most significant features. By harnessing the power of AI, researchers aim to develop innovative and accurate diagnostic tools for pregnant women at high risk for preeclampsia. For instance, a study conducted in 2024 by the University of Oxford and King's College London demonstrated that an AI-based model could predict preeclampsia with high accuracy, highlighting its potential for early intervention.

Preeclampsia Diagnostics Market Growth Factors

  • A rise in preeclampsia cases worldwide is expected to drive growth in the global preeclampsia diagnostics market, as this disorder accounts for 2% to 8% of pregnancy-related complications, resulting in over 50,000 maternal deaths and more than 500,000 fetal deaths each year. Early diagnosis and prompt management are crucial for preventing complications among mothers and newborns.
  • Increasing awareness among pregnant women is another vital factor fueling the growth of the preeclampsia diagnostics market. For example, in July 2025, the Provincial Council for Maternal and Child Health announced the release of a new patient resource focused on Preeclampsia Awareness and Prevention During Pregnancy.
  • Pharmaceutical companies and research institutions are actively conducting research and development efforts to create effective and less invasive solutions for preeclampsia, which can further contribute to market growth. Collaborations among pharmaceutical companies, academic institutions, and healthcare organizations are essential for advancing research and developing new solutions for this condition.
  • The introduction of innovative diagnostic tests by key market players significantly contributes to market expansion. For example, Monod Bio, with support from the Gates Foundation, is formulating a rapid point-of-care diagnostic test that delivers results in less than 15 minutes. Emerging diagnostic methods have shown that biomarkers such as soluble fms-like tyrosine kinase-1 (sFlt-1) and soluble endoglin (sEng) can effectively identify preeclampsia.

Preeclampsia Diagnostics Market Outlook

  • Market Growth Overview: The market is set for rapid growth between 2025 and 2034 due to the rising prevalence of preeclampsia. The WHO estimates that preeclampsia affects approximately 2-8% of pregnancies globally and is responsible for an estimated 46,000 maternal deaths annually, creating a strong market for early diagnostic solutions to identify preeclampsia and provide appropriate care. The rising integration of technologies to improve diagnostic accuracy and accessibility through biomarkers and AI-based screening platforms further support market growth.
  • Research & Development: Ongoing research is heavily focused on biomarker-based detection, particularly the sFlt-1/PlGF ratio, and molecular-level studies for improved risk stratification. This shift is supported by major funding bodies like the NIH and EU maternal health initiatives, enabling a transition from reactive diagnostics to predictive and preventative models aimed at reducing maternal and neonatal morbidity and mortality.
  • Industry Leaders: Key diagnostic companies are actively engaging with regulatory agencies to fast-track the clinical adoption of validated biomarkers, fostering greater trust in the medical community. Collaborative efforts between diagnostic developers, academic institutions, and healthcare organizations are accelerating product validation and commercialization, particularly for both developed and emerging healthcare markets.
  • Government and Policy Development: Global health organizations such as the WHO and CDC are advocating for standardized screening protocols and equitable access to preeclampsia diagnostics. Policy frameworks that incentivize R&D funding for maternal health and promote public-private partnerships are expected to drive procurement and implementation of testing solutions, especially in low- and middle-income countries.
  • Sustainability Trends: Sustainability trends involve worldwide health equity and accessibility, point-of-care testing, biomarker innovation for invasiveness, and telemedicine and remote monitoring.
  • Major Investors: Major investors in the market include The Vanguard Group, Inc., State Street Corporation, FMR LLC, Venture Capital and Investment Firms, Strategic Corporation, and Preeclampsia Foundation.
  • Startup Economy: The startup economy is focused on novel biomarkers and genetic testing, AI and machine learning for risk stratification, and home healthcare and tele-prenatal monitoring.

Market Scope

Report Coverage Details
Market Size in 2025 USD 1.29 Billion
Market Size in 2026 USD 1.33 Billion
Market Size by 2035 USD 1.75 Billion
Market Growth Rate from 2026 to 2035 CAGR of 3.10%
Dominating Region North America
Fastest Growing Region Asia Pacific
Base Year 2025
Forecast Period 2026 to 2035
Segments Covered Technology, Delivery System, Route of Administration, Target Disease, Target Tissue, End-User, and Region
Regions Covered North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa

Market Dynamics

Drivers

Rising Maternal Mortality Rates

The increase in global maternal mortality burden due to hypertensive disorders in pregnancy is emerging as a key driver of the preeclampsia diagnostics market. According to the WHO, preeclampsia affects 2%-8% of pregnancies, leading to approximately 46,000 maternal deaths and close to 500,000 fetal or newborn deaths each year. In Asia, Africa, and Latin America, preeclampsia accounts for as many as one-quarter of maternal deaths. (Source: https://www.who.int)

As a result, the global public health community, including policymakers, government agencies, and healthcare organizations, has begun prioritizing early screening and diagnostic advancements. The global growth in biomarker-based diagnostic tests, in addition to portable diagnostic kits and devices, is positively influencing early detection and pregnancy outcomes.

Restraint

Limited Biomarker Validation

A key inhibiting challenge for the preeclampsia diagnostics market is that the development of new biomarkers for early detection has received limited clinical validation. For example, sFlt-1/PlGF ratios and RNA-based signatures have demonstrated promising potential for early detection of risk; however, none have undergone extensive clinical trials across multiple ethnic groups. A 2024 portfolio study published on PubMed notes the regulatory challenges of inconsistent validation results when tested against various populations.

  • For instance, the Mirvie RNA test was first trialed to predict preterm preeclampsia with an accuracy rating of about 91% based on studies; however, it still awaits eventual validation beyond the original studies across a global community. The absence of standardization and population-wide datasets further contributes to a lack of confidence. (Source: https://www.mirvie.com)

Opportunity

Development of Point-of-Care Diagnostic Kits

Point-of-care (POC) diagnostic kits are changing the way preeclampsia is identified by providing rapid, affordable, and accessible diagnostic testing. These innovations can have a significant impact in low-resource settings, where traditional laboratory-based diagnostics are often lacking.

  • For example, in March 2024, the Lumella test utilizes the GlyFN biomarker to enable an easy-to-use clinical test that produces results in just 10 minutes with a single drop of blood, reporting a specificity of 92.8% and a sensitivity of 98.5%.
    (Source: https://www.aghealth.co.uk)
  • The Lepzi PLGF test is another cost-effective solution for detecting preeclampsia-related conditions, as it measures the PlGF biomarker directly from whole-blood samples, thereby contributing to diagnosis and prognosis.
  • (Source: https://unahealth.co.uk)

These types of solutions not only improve early detection but also assist healthcare practitioners in making timely decisions, both of which can lower maternal and neonatal morbidity and mortality in cases of preeclampsia.

Segment Insights

Test Type Insights

Which Test Type Segment Dominated the Preeclampsia Diagnostics Market in 2025?

The biochemical marker assays segment dominated the preeclampsia diagnostics market in 2025, primarily due to their high accuracy in early disease identification. Screening pregnant women with biochemical markers for preeclampsia can reduce unnecessary suffering and healthcare costs by facilitating early detection of those at increased risk, thus minimizing unnecessary hospitalizations.

The point-of-care testing segment is anticipated to grow at the fastest rate in the coming years, driven by the demand for quicker diagnostic results at the testing location. Point-of-care testing devices meet this need by providing rapid results within minutes, enabling clinical teams to implement timely interventions, make appropriate patient referrals, and optimize resource allocation. Technological advancements in biomarker discovery, immunoassay platforms, and microfluidic device design have led to increasingly sensitive and specific point-of-care tests.

Technology Type Insights

Why Did the Immunoassays Segment Lead the Preeclampsia Diagnostics Market in 2025?

The immunoassays segment led the market in 2025 with the largest share due to their widespread adoption, which is driven by their high sensitivity and specificity in detecting key preeclampsia biomarkers such as placental growth factor (PlGF) and soluble fms-like tyrosine kinase-1 (sFlt-1). These tests have transformed obstetric care by enabling rapid risk assessment and providing the ability to confidently rule out imminent disease.

The biosensors / point-of-care devices segment is expected to grow at the fastest CAGR in the upcoming period, primarily due to their portability, real-time monitoring capabilities, and ability to integrate with mobile health applications. This allows for fast detection in outpatient clinics and remote settings. The development of electrochemical, optical, mass, and other biosensor platforms has been crucial for translating biomarkers into practical, rapid, and precise detection systems. Additionally, point-of-care systems enable preeclampsia testing to be conducted directly in primary healthcare facilities or community settings without the need for complex laboratory infrastructure.

Test Setting Insights

Which Test Setting Dominated the Preeclampsia Diagnostics Market in 2025?

The laboratory-based testing segment dominated the preeclampsia diagnostics market in 2025, due to established central-lab ecosystems in hospitals and reference networks. Laboratory tests play an important role in diagnosing preeclampsia, particularly in finding biomarkers related to high blood pressure, liver, and kidney dysfunction. Laboratory-based testing also has a controlled and reproducible results environment, which is necessary with respect to early detection.

The home-based / remote monitoring segment is expected to grow at the fastest rate over the projection period due to the need to continuously monitor the maternal health parameters. This includes the use of connected blood pressure devices and telehealth platforms that enable continuous monitoring of physiological parameters. This ensures timely responses to hypertensive spikes that may otherwise go unnoticed. This strategy is proving vital in decreasing maternal morbidity rates linked to hospital readmissions and maintaining care continuity during the crucial postpartum phase.

Product & Services Insights

How Did the Diagnostics Kits & Reagents Segment Hold the Largest Share of the Market In 2025?

The diagnostics kits & reagents segment held the largest share of the market in 2025, as each test cycle requires fresh cartridges and antibody pairs. The growing emphasis on early detection and prevention of preeclampsia in pregnant women is likely to drive demand for consumables in diagnostic testing. Additionally, the increasing number of healthcare facilities and diagnostic laboratories focused on maternal health is expected to boost the use of these consumables.

The data analytics & monitoring platforms segment is anticipated to grow at the fastest rate in the coming years due to their ability to transform raw clinical and biological data into actionable insights. This enables early risk prediction and continuous monitoring of maternal health. Predictive analytics enhances accuracy in disease stratification, minimizes false positives, and supports tailored monitoring strategies that improve prenatal outcomes across various care settings.

End-User Insights

Which End-User Segment Dominated the Preeclampsia Diagnostics Market in 2025?

The hospitals & maternity clinics segment dominated the preeclampsia diagnostics market in 2025. This dominance is attributed to the presence of advanced diagnostic infrastructures, professional staff, and an increasing flow of patients seeking prenatal care. These facilities are also equipped to handle complicated and high-risk pregnancy cases that require extensive diagnostic assistance. Pregnant women are increasingly being treated in maternity clinics, which have specialized diagnostic equipment for regular prenatal monitoring and for early detection of complications like preeclampsia.

The obstetrics & gynecology segment is expected to grow at the fastest rate during the forecast period due to its central role in maternal healthcare and prenatal screening. Recommendations from the International Federation of Gynecology and Obstetrics (FIGO) have standardized the inclusion of biochemical markers for assessing preeclampsia risk. Obstetricians and gynecologists are often the first point of contact for pregnant women and are therefore directly responsible for initiating early diagnostic protocols.

Regional Insights

What is the U.S. Preeclampsia Diagnostics Market Size?

The U.S. preeclampsia diagnostics market size is evaluated at USD 427.12 million in 2025 and is projected to be worth around USD 593.08 million by 2035, growing at a CAGR of 3.34% from 2026 to 2035.

U.S. Preeclampsia Diagnostics Market Size 2026 to 2035

Why Did North America Lead the Preeclampsia Diagnostics Market in 2025?

North America led the preeclampsia diagnostics market by capturing a 43% share in 2025, driven by its advanced healthcare infrastructure, heightened awareness, and substantial research and development funding. In the United States, robust public-private partnerships and a proactive regulatory environment are fostering diagnostic innovation. For instance, in February 2024, the Foundation for the National Institutes of Health (FNIH) launched a public-private initiative to develop tools that can identify women at high risk for early-onset preeclampsia.

U.S. Preeclampsia Diagnostics Market Trends

The U.S. maintains its leadership through significant investments in maternal health research, a strong focus on personalized medicine, and the early adoption of cutting-edge diagnostics. A key milestone is the January 2024 launch of the PERA test by Mayo Clinic Laboratories, offering 94% sensitivity in detecting preeclampsia. Backed by regulatory initiatives that support rapid diagnostic innovation, these factors collectively reinforce the United States' dominant role in shaping the regional and global market landscape.
(Source: https://news.mayocliniclabs.com)

Preeclampsia Diagnostics Market Share, By Region, 2025 (%)

Why is Asia Pacific Considered the Fastest-Growing Region in the Preeclampsia Diagnostics Market?

Asia Pacific is emerging as the fastest-growing market for preeclampsia diagnostics, driven by improved access to healthcare services, rising awareness of maternal health, and increasing investment in diagnostic infrastructure. Countries such as India and China are witnessing significant upgrades in healthcare systems, alongside the adoption of advanced diagnostic technologies. Factors like rapid urbanization, a growing middle-class population, and expansion of maternal care services are further fueling demand for timely and efficient preeclampsia diagnostics.

India Preeclampsia Diagnostics Market Trends

In India, specifically, the market is expanding rapidly due to a large underserved pregnant population and increasing emphasis on early detection and monitoring of high-risk pregnancies. A notable development is the launch of Amazon India's diagnostics service in May 2025, which offers at-home testing solutions with fast sample collection and digital reporting. These innovations are making diagnostics more accessible and timely, particularly in rural and semi-urban regions, thereby contributing to improved maternal outcomes and further market growth. (Source: https://www.aboutamazon.in)

How is the Opportunistic Rise of Europe in the Preeclampsia Diagnostics Market?

Europe is expected to grow at a significant rate in the coming years, driven by the rising awareness about maternal health risks. The rising incidence of preeclampsia aggravated by lifestyle and demographic factors, such as advanced maternal age and obesity, is driving demand for better diagnostic solutions. The growing prevalence of angiogenic biomarker tests aligns with the urgent need for clinical interventions that facilitate quick diagnosis and timely management of conditions. The EU-funded PEDPOC project has successfully supported MOMM Diagnostics, a Swiss-based firm, in conducting a commercial feasibility study for an innovative test designed to offer swift early diagnosis and ongoing monitoring of pre-eclampsia.

Germany Preeclampsia Diagnostics Market Trends

The market in Germany is evolving in response to the implementation of the Digital Healthcare Act, which permits physicians to prescribe approved digital health applications that are connected to diagnostic testing. Hospitals are progressively integrating laboratory biomarkers with digital monitoring tools, thereby enhancing the continuous observation of pregnant women at elevated risk and improving both early intervention strategies and clinical decision-making accuracy.

What Drives the Middle East & Africa Preeclampsia Diagnostics Market?

The Middle East & Africa (MEA) region displays significant growth potential, albeit with a relatively low current market value. Governments in nations such as Saudi Arabia, the United Arab Emirates, and South Africa are dedicating resources to enhance maternal health infrastructure and prenatal care programs. Urban centers are swiftly adopting advanced preeclampsia diagnostic platforms and guideline-based treatment protocols, while rural and low-income regions continue to depend on fragmented care and limited access to essential medications.

Saudi Arabia Preeclampsia Diagnostics Market Trends

The preeclampsia diagnostics market in Saudi Arabia is rapidly growing, bolstered by national healthcare initiatives, the adoption of state-of-the-art diagnostic solutions in hospitals, and heightened patient awareness regarding prenatal care and early screening. Health system reforms, under Saudi Arabia's Vision 2030, have led to the establishment of regional health clusters aimed at improving care quality and reducing the burden on hospitals.

Latin America Preeclampsia Diagnostics Market Trends

Latin America preeclampsia diagnostics market is experiencing steady growth, driven by increased healthcare expenditure, the expansion of hospital networks, and growing awareness of maternal health issues. Countries such as Brazil and Argentina are investing in prenatal care programs alongside improvements in diagnostic testing infrastructure. Both public and private healthcare entities are increasingly incorporating advanced screening techniques, including blood-based biomarker tests and urinalysis, to enhance early detection rates.

Brazil Preeclampsia Diagnostics Market Trends

Brazil preeclampsia diagnostics market is experiencing rapid growth. Preeclampsia and eclampsia remain significant contributors to maternal morbidity and mortality in Brazil, exacerbated by persistent racial and regional disparities. Efforts are being directed toward reducing maternal and fetal morbidity and mortality, a central focus for governments and healthcare organizations across the region.

Value Chain Analysis of the Preeclampsia Diagnostics Market

  • Research and Development (R&D): This phase involves the identification of biomarkers, the development of diagnostic kits, and the validation of diagnostic test accuracy through clinical trials and partnerships among biotechnological innovation and clinical healthcare institutions.
  • Raw Material and Component Sourcing: Suppliers coordinate the provision of essential materials, including but not limited to reagents, antibodies, biosensors, and diagnostic kits. Intermediaries require vendors to provide assurance of high purity and acknowledged physician-grade quality for reliability and long-term diagnostic performance.
  • Manufacturing and Production: Diagnostics device manufacturers or laboratories generally produce test kits, point-of-care systems, and consumables in accordance with stringent regulatory guidelines to enable rationalized practices throughout the supply chain, ensuring mass-consistent reliability, sterility of performance, and size consistency across batches.
  • Distribution of Platforms in Healthcare Settings: Comprehensive third-party manufacturers have multiple distributors, wholesalers, providers, and healthcare supply chains to expedite the delivery of diagnostic product availability to hospitals, clinics, and labs to stay current on treatment intervention options; however, the delivery almost always requires a cold-chain process for the maintenance of the living biosensor or components like reagents.
  • End User/Service Delivery: Hospitals, diagnostic centers, and maternity-level clinics utilize these tests or living notebooks for early detection and monitoring of pre-eclampsia (e.g., with pregnancy screening for pre-eclampsia) to determine timely treatment approaches and improve maternal-fetal outcomes.

Competitive Landscape

The market is characterized by intense competition among established entities and emerging firms. Strategic partnerships, mergers and acquisitions, and product innovation are pivotal strategies employed by market participants. Anticipated growth in the sector is attributed to the rising incidence of preeclampsia, increasing research and development initiatives focused on preeclampsia biomarkers, heightened demand for advanced diagnostic tests, and proactive organic and inorganic growth strategies pursued by industry players.

Furthermore, medical technology companies are advancing diagnostic devices that offer fast and accurate testing for preeclampsia, thereby equipping healthcare providers with essential tools to improve patient care. As the global preeclampsia diagnostics market continues to progress, the development of enhanced screening methods, more effective treatments, and preventive strategies will be critical to improving outcomes for both mothers and infants.

Key Players Operating in the Preeclampsia Diagnostics Market and Their Offering

Tier Companies in Tier Approx % Cumulative Share Commentary
Tier I - Market Leaders (~45 55%) Thermo Fisher Scientific; F. Hoffmann La Roche Ltd.; PerkinElmer Inc. ~?50% These firms dominate via strong biomarker assay platforms (especially sFlt 1/PlGF), large global lab networks, regulatory approvals, and broad product portfolios.
Tier II - Established Players (~20 30%) Siemens Healthineers; Abbott Laboratories; Bayer AG; QuidelOrtho Corporation ~?25% These contribute significantly via diagnostics instruments, rapid/point of care platforms, complementary assays, and expanding reach into emerging markets.
Tier III - Emerging / Niche Players (~15 20%) DRG Instruments GmbH; Diabetomics, Inc.; Metabolomic Diagnostics Ltd.; Sera Prognostics ~?15% These smaller or more specialized companies often focus on risk score tools, early detection/prognostic assays, or regional deployment.

Top Companies in the Preeclampsia Diagnostics Market & Their Offerings:

  • F. Hoffmann-La Roche Ltd. (Roche): Roche contributes significantly to the preeclampsia diagnostics market through its development and commercialization of diagnostic tests, notably those using the sFlt-1/PlGF ratio (soluble fms-like tyrosine kinase-1/placental growth factor) biomarkers.
  • PerkinElmer Inc. (now part of Bio-Techne): PerkinElmer has a notable presence through its diagnostic product portfolio, which includes screening and detection kits for various pregnancy-related conditions, including preeclampsia.
  • Abbott Laboratories: Abbott offers a wide range of diagnostic solutions and testing equipment used in hospital and clinical settings to monitor the general health parameters relevant to preeclampsia.
  • Bayer AG: Bayer contributes through its pharmaceutical and consumer health divisions, offering treatments for conditions that might arise from preeclampsia, such as blood pressure management medications.
  • QuidelOrtho Corporation: QuidelOrtho is a major diagnostics company that provides a wide range of in vitro diagnostic solutions and clinical laboratory products used in hospitals and clinics.
  • Diabetomics, Inc. (now Miraca Holdings): This company previously focused on developing non-invasive diagnostic tests, including an early screening platform for preeclampsia based on specific biomarkers.
  • Metabolomic Diagnostics Ltd. (now part of PerkinElmer): The company developed a preeclampsia screening test based on a specific panel of metabolomic biomarkers identified in early pregnancy blood samples.
  • Sera Prognostics: Sera Prognostics is a leader in using predictive biomarker technologies for maternal and premature birth health risks, including tests related to preeclampsia.

Recent Developments

  • In May 2026, the South African Medical Research Council (SAMRC) announced the establishment of a new Extramural Research Unit (EMU) dedicated to preeclampsia at Stellenbosch University's Faculty of Medicine and Health Sciences. This initiative represents a significant advancement in addressing one of the leading causes of maternal and neonatal mortality globally.
  • In April 2025, Mirvie announced its new, straightforward RNA-based blood test can identify distinct molecular signatures to predict preeclampsia risk months in advance, with results ranging from high to low.
    (Source: https://www.preeclampsia.org)
  • In January 2024, Labcorp introduced a blood test (B·R·A·H·M·S sFlt-1/PlGF KRYPTOR) that has received FDA clearance to determine whether a pregnant woman is at risk of progressing to severe preeclampsia.
    (Source: https://ir.labcorp.com)
  • On April 30, 2025, IIT-Madras and its collaborators shared a portable fiber-optic biosensor test that can identify a key protein biomarker in just 30 minutes, enabling the detection of early preeclampsia risk during pregnancy.
    (Source: https://www.business-standard.com)

Expert Analysis

The preeclampsia diagnostics market is poised for robust expansion driven by escalating prevalence of hypertensive disorders during pregnancy and heightened clinical emphasis on early detection to mitigate maternal-fetal morbidity and mortality. The evolving diagnostic landscape, underpinned by advancements in biomarker-based assays, particularly the sFlt-1/PlGF ratio, integrated with innovative point-of-care and home-based testing platforms, is catalyzing market penetration across both developed and emerging geographies. Substantial influxes of public and private funding, coupled with regulatory incentives and collaborative frameworks among biotech firms, research institutions, and healthcare providers, are accelerating translational research and commercial scalability of predictive diagnostics.

Emerging opportunities reside in the confluence of AI-driven predictive analytics, multi-omics biomarker discovery, and digital health integration, enabling personalized risk stratification and real-time monitoring. Moreover, expanding healthcare infrastructure and increasing maternal health awareness in Asia Pacific and Latin America signal high-growth trajectories, supported by governmental policy reforms and investment in maternal care innovation. Despite challenges related to heterogeneity in clinical presentation and variability in biomarker specificity, ongoing R&D initiatives targeting multiplexed assay development and standardized screening protocols are expected to consolidate diagnostic accuracy and market adoption.

In summary, the preeclampsia diagnostics market is entering a transformative phase characterized by technological convergence, regulatory facilitation, and expanding global demand, rendering it an attractive domain for stakeholders aiming to capitalize on unmet clinical needs through innovative, scalable, and accessible diagnostic solutions.

Segments Covered in the Report

By Test Type

  • Blood Pressure Monitoring
  • Biochemical Marker Assays
  • Placental Growth Factor (PlGF)
    • sFlt-1 / sEng Ratio
    • Others
  • Urine Protein Tests
  • Imaging-Based Diagnostics (Ultrasound / Doppler)
  • Point-of-Care Testing
  • Others

By Technology Type

  • Immunoassays
  • ELISA / Chemiluminescence-based
  • Molecular / PCR-based Assays
  • Biosensors / Point-of-Care Devices
  • Ultrasound / Imaging-based
  • Others

By Test Setting

  • Laboratory-based Testing
  • Point-of-Care / Bedside Testing
  • Home-based / Remote Monitoring

By Product & Services

  • Diagnostic Kits & Reagents
  • Testing Devices & Instruments
  • Laboratory Services
  • Data Analytics & Monitoring Platforms
  • Others

By End User (no sub-segments)

  • Hospitals & Maternity Clinics
  • Diagnostic Laboratories
  • Obstetrics & Gynecology Clinics
  • Research & Academic Institutes

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and Africa

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Frequently Asked Questions

Answer : The preeclampsia diagnostics market size is expected to increase from USD 1.29 billion in 2025 to USD 1.75 billion by 2035.

Answer : The preeclampsia diagnostics market is expected to grow at a compound annual growth rate (CAGR) of around 3.10% from 2026 to 2035.

Answer : The major players in the preeclampsia diagnostics market include Diabetomics, DRG Instruments GmbH, Metabolomic Diagnostics Ltd, QuidelOrtho Corporation, Abbott Laboratories, Bayer AG, Siemens Healthineers, Thermo Fisher Scientific, F. Hoffmann La Roche Ltd, and PerkinElmer Inc.

Answer : The driving factors of the preeclampsia diagnostics market are the rising awareness of maternal health, technological advancements in point-of-care testing, and increasing prenatal screening initiatives.

Answer : North America region will lead the global preeclampsia diagnostics market during the forecast period 2026 to 2035.

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Meet the Team

Rohan Patil

Rohan Patil

Author

Rohan Patil is a leading analyst at Precedence Research, contributing to shaping the future of healthcare market insights with his deep industry expertise and forward-thinking approach. Holding a B.Sc. in Biotechnology and an MBA in Marketing, Rohan combines scientific understanding with strategic business acumen to provide comprehensive, actionable market intelligence. With over five years of experience in the market research industry, he has developed a strong track record of analyzing healthcare trends, regulatory developments, and competitive landscapes, helping clients identify growth opportunities and make informed strategic decisions.

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Aditi Shivarkar

Aditi Shivarkar LinkedIn

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Aditi brings more than 14 years of experience to Precedence Research, serving as the driving force behind the accuracy, clarity, and relevance of all research content. She reviews every piece of data and insight to ensure it meets the highest quality standards, supporting clients in making informed decisions. Her expertise spans healthcare, ICT, automotive, and diverse cross-industry domains, allowing her to provide nuanced perspectives on complex market trends. Aditi’s commitment to precision and analytical rigor makes her an indispensable leader in the research process.

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