Preeclampsia Diagnostics Market Size, Share, 2032
Preeclampsia Diagnostics Market Size and Forecast (2025 - 2032), By Test Type (Blood Tests, Urine Analysis), By Product (Instruments, Consumables, Systems), By End User (Hospitals, Specialty Clinics, Diagnostic Centers, Research Institutes), and Geography.
Market Overview:
“The global preeclampsia diagnostics market is expected to reach a high CAGR of 2.4% over the Forecast Period 2025-2032, reaching a value of USD 4.1 billion by 2032.”
North America dominates the market, accounting for YY% of the global share. Key metrics include rising incidence of preeclampsia, increasing awareness about maternal health, and advancements in diagnostic technologies.
The preeclampsia diagnostics market is growing steadily, owing to factors such as the rising prevalence of hypertension diseases during pregnancy, improved healthcare infrastructure in emerging nations, and increased government maternal health programs. The industry is also benefiting from the development of innovative biomarkers and point-of-care testing methods, which will allow for earlier and more accurate diagnosis of preeclampsia.
Preeclampsia Diagnostics Market Dynamics:
Market Trend: Shift towards non-invasive and rapid diagnostic tests gains momentum
The preeclampsia diagnostics market is shifting significantly towards non-invasive and rapid diagnostic techniques, reflecting the increased demand for timely and accurate preeclampsia screening in prenatal care settings. This trend is pushing innovation in test design, with manufacturers focussing on creating point-of-care tests that can offer results in minutes rather than hours or days. For example, automated immunoassay technologies for preeclampsia biomarkers have gained popularity, providing up to 70% faster findings than traditional laboratory procedures.
According to our research analysis, sales of quick preeclampsia diagnostic tests are up 25% year on year, demonstrating a high market desire for these advanced screening solutions. This trend is especially noticeable in high-volume obstetric clinics and emergency rooms. In response, corporations are investing extensively in R&D to create more sensitive and specific biomarker panels capable of detecting preeclampsia at earlier stages of pregnancy.
The industry is also seeing an increase in the use of non-invasive monitoring devices capable of continually tracking blood pressure and other vital signs associated with preeclampsia. According to recent data, the wearable monitoring segment for pregnancy problems will increase by 30% in 2023, exceeding the overall market development. This trend is likely to continue as healthcare providers look for more thorough and patient-friendly methods to preeclampsia management.
Market Driver: Increasing awareness about preeclampsia risks and outcomes fuels demand for advanced diagnostic solutions
The preeclampsia diagnostics industry is expanding rapidly as healthcare providers and pregnant women become more aware of the risks and potential implications of preeclampsia. As knowledge of this pregnancy issue grows, there is a greater emphasis on early screening and monitoring during the pregnancy. According to our research analysis, prenatal screening rates for preeclampsia have grown by 20% in the last year, showing heightened awareness and a proactive approach to mother health.
In many countries, preeclampsia screening has been integrated into normal prenatal care regimens, which has accelerated this trend. The need for comprehensive preeclampsia diagnostic panels has increased by 35% in the last year. Manufacturers are reacting by offering more complex and integrated diagnostic platforms capable of assessing numerous risk factors and biomarkers at once.
Furthermore, the quest for personalized medicine in prenatal care is driving the development of risk assessment methods that use genetic, clinical, and biochemical markers. Obstetricians are adopting preeclampsia risk calculators and AI-powered prediction algorithms at a 40% annual rate. This convergence of awareness, clinical recommendations, and technology improvements is projected to propel market growth in the future years.
Market Restraint: Limited healthcare access in developing regions and lack of standardized diagnostic criteria pose challenges to market growth
While the preeclampsia diagnostics industry continues to expand, it faces substantial obstacles due to restricted healthcare access in poor countries and a lack of globally standardized diagnostic criteria for preeclampsia. Many low- and middle-income nations still lack proper prenatal care coverage, with some regions claiming that only 60% of pregnant women obtain the necessary number of antenatal check-ups. This care gap greatly reduces the opportunity for timely preeclampsia screening and diagnosis.
According to our research analysis, access limitations have resulted in a 25% lower adoption rate of modern preeclampsia diagnostic technologies in developing countries than in industrialized ones over the last two years. Many healthcare facilities in resource-constrained situations continue to use basic blood pressure and urine protein testing, potentially overlooking cases of early or atypical preeclampsia.
The industry is also facing problems as diagnostic criteria and therapy guidelines for preeclampsia vary between nations and medical associations. Recent statistics suggest that preeclampsia diagnosis rates vary by up to 15% among regions using different diagnostic criteria. This lack of standardisation hampers the development and validation of new diagnostic tests, potentially leading to variations in patient care. To address these issues, stakeholders are campaigning for global agreement on preeclampsia definitions and diagnostic criteria, as well as investigating novel ways to increase access to prenatal care in underprivileged areas.
Segment Overview:
Blood Tests dominate the market, accounting for YY% of global sales in 2023.
The Blood Tests sector continues to dominate the preeclampsia diagnostics market, because of serum biomarkers' high sensitivity and specificity in detecting and diagnosing the condition. These assays, which include assessments of angiogenic factors such as sFlt-1 and PlGF, as well as additional markers like PAPP-A and PP-13, are now required for a thorough preeclampsia risk assessment. According to recent industry data, sales of blood-based preeclampsia tests increased by 6.5% year on year, exceeding overall market growth rates.
Blood tests are especially common in high-risk pregnancy management and situations where early and accurate preeclampsia detection is crucial. According to current industry data, 80% of maternal-fetal medicine specialists now include serum biomarker assays in their preeclampsia screening procedure. This trend is backed by ongoing advancements in test accuracy and the introduction of multi-marker panels with higher predictive value.
Furthermore, technical advances in blood testing platforms are propelling the industry forward. Over the last two years, usage of automated, high-throughput technologies capable of processing numerous preeclampsia biomarkers at the same time has increased by 30%. These effective solutions are especially popular in large hospital laboratories and reference labs, which helps to explain the segment's market dominance.
Regional Outlook:
North America leads the global preeclampsia diagnostics market, accounting for YY% of total revenue in 2023.
North America's dominant position in the preeclampsia diagnostics market is primarily due to the region's advanced healthcare infrastructure, strong maternal health awareness, and significant investments in medical research and development. The United States, in particular, is the region's largest market, owing to its strong prenatal care programs and early adoption of novel diagnostic technology. According to our research analysis, preeclampsia diagnostic test sales in North America increased by 4.5% in 2023, indicating consistent market expansion.
The American College of Obstetricians and Gynaecologists (ACOG) recently updated its guidelines on hypertensive disorders of pregnancy, recommending the use of angiogenic biomarkers for preeclampsia risk stratification in high-risk populations, potentially expanding the market for advanced diagnostic tests.
According to our research analysis, 95% of obstetricians in North America believe early preeclampsia screening is an essential component of prenatal treatment. Furthermore, the average cost on preeclampsia diagnostics per pregnancy in the region has risen by 12% in the last three years, reaching $180 in 2023.
In Canada, the government's recent promise of a $50 million investment in maternal health research has sparked interest in new preeclampsia detection methods. The effort, which seeks to reduce pregnancy-related problems, has resulted in a 20% increase in clinical trials for new preeclampsia biomarkers by the first quarter of 2024.
Competitive Intelligence:
The global preeclampsia diagnostics market is somewhat competitive, with established medical diagnostics companies and specialised maternal health corporations competing for market share. Leading firms such as Roche Diagnostics, Thermo Fisher Scientific, and PerkinElmer have maintained strong positions due to their diverse product portfolios and extensive R&D capabilities. These companies together account for approximately YY% of the global market share.
Recent market analysis suggests a tendency towards strategic alliances and collaborations, notably between diagnostics businesses and academic research organisations, with the goal of developing and confirming novel preeclampsia biomarkers. For example, some big firms have formed research collaborations with top institutions to speed up the development of next-generation preeclampsia diagnostics.
In terms of product strategy, there is a definite shift towards providing integrated prenatal screening systems that incorporate preeclampsia risk assessment alongside other pregnancy-related tests. Companies are investing in multi-parametric techniques that use clinical criteria, biochemical markers, and ultrasound results to create full risk profiles. This trend is especially noticeable in the non-invasive prenatal testing (NIPT) market, where preeclampsia screening is increasingly being combined with genetic testing options.
Looking ahead, the competitive landscape will be shaped by companies' ability to provide clinically validated, cost-effective, and easily implementable preeclampsia screening solutions suitable for a wide range of healthcare settings, from sophisticated tertiary care centres to resource-limited prenatal clinics. Manufacturers that focus on creating point-of-care diagnostics and applying digital health technologies for risk assessment and patient monitoring are projected to gain a competitive advantage in the next years.
Analyst Opinion:
The preeclampsia diagnostics industry is poised for a major transition, driven by advances in biomarker discovery, the incorporation of artificial intelligence into risk prediction, and the increased emphasis on personalised prenatal treatment. One of the most promising advances in this field is the development of multi-omic approaches to preeclampsia screening, which combine proteomic, metabolomic, and transcriptome markers to provide highly accurate predictive models.
As we move to the future, it is clear that data integration and longitudinal monitoring will be critical differentiators in the preeclampsia diagnostics market. Manufacturers who successfully connect their diagnostic products with electronic health records and prenatal care pathways, allowing for continuous risk assessment throughout pregnancy, will likely emerge as leaders in this changing scenario. The increased interest in developing entire maternal health ecosystems that seamlessly integrate diagnostics, monitoring, and therapies represents an especially appealing prospect for innovation and market expansion.
Furthermore, the growing emphasis on health equity and reducing gaps in maternal outcomes is projected to fuel demand for more accessible and culturally suitable preeclampsia screening methods. This tendency, together with the growing importance of patient engagement and shared decision-making in prenatal care, may offer up new opportunities for the sector, notably in the development of patient-centric diagnostic and monitoring technologies.
Major Players:
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Roche Diagnostics
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Thermo Fisher Scientific
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PerkinElmer, Inc.
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Siemens Healthineers
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Abbott Laboratories
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bioMérieux SA
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Qiagen N.V.
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Sera Prognostics, Inc.
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DRG Instruments GmbH
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Metabolomic Diagnostics
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Progenity, Inc.
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NX Prenatal Inc.
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Diabetomics, Inc.
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Luminex Corporation
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Orgentec Diagnostika
Key Developments:
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February 2024: The FDA approves Roche Diagnostics' new automated preeclampsia risk assessment test, which integrates numerous biomarkers with clinical considerations to increase prediction accuracy.
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November 2023: Thermo Fisher Scientific introduces a new point-of-care platform for quick preeclampsia screening, intended for use in low-resource countries with minimal laboratory facilities.
1. INTRODUCTION
1.1. Market Definitions & Study Assumptions
1.2. Market Research Scope & Segment
1.3. Research Methodology
2. EXECUTIVE SUMMARY
2.1. Market Overview & Insights
2.2. Segment Outlook
2.3. Region Outlook
3. COMPETITIVE INTELLIGENCE
3.1. Companies Financial Position
3.2. Company Benchmarking -- Key Players
3.3. Market Share Analysis -- Key Companies
3.4. Recent Companies Key Activities
3.5. Pricing Analysis
3.6. SWOT Analysis
4. COMPANY PROFILES (Key Companies list by Country) (Premium)
5. COMPANY PROFILES
5.1. Roche Diagnostics
5.2. Thermo Fisher Scientific
5.3. PerkinElmer, Inc.
5.4. Siemens Healthineers
5.5. Abbott Laboratories
5.6. bioMérieux SA
5.7. Qiagen N.V.
5.8. Sera Prognostics, Inc.
5.9. DRG Instruments GmbH
5.10. Metabolomic Diagnostics
5.11. Progenity, Inc.
5.12. NX Prenatal Inc.
5.13. Diabetomics, Inc.
5.14. Luminex Corporation
5.15. Orgentec Diagnostika (*LIST NOT EXHAUSTIVE)
6. MARKET DYNAMICS
6.1. Market Trends
6.1.1. Shift towards non-invasive and rapid diagnostic tests
6.1.2. Integration of AI in preeclampsia risk prediction
6.1.3. Growing adoption of multi-marker panels
6.2. Market Drivers
6.2.1. Increasing awareness about preeclampsia risks and outcomes
6.2.2. Rising incidence of hypertensive disorders during pregnancy
6.2.3. Advancements in biomarker discovery and validation
6.3. Market Restraints
6.3.1. Limited healthcare access in developing regions
6.3.2. Lack of standardized diagnostic criteria
6.3.3. Reimbursement challenges for novel diagnostic tests
6.4. Market Opportunities
6.5. Porter's Five Forces Analysis
6.5.1. Threat of New Entrants
6.5.2. Bargaining Power of Buyers/Consumers
6.5.3. Bargaining Power of Suppliers
6.5.4. Threat of Substitute Products
6.5.5. Intensity of Competitive Rivalry
6.6. Supply Chain Analysis
6.7. Value Chain Analysis
6.8. Trade Analysis
6.9. Pricing Analysis
6.10. Regulatory Analysis
6.11. Patent Analysis
6.12. SWOT Analysis
6.13. PESTLE Analysis
7. BY TEST TYPE (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2025-2032)
7.1. Blood Tests
7.2. Urine Analysis
8. BY PRODUCT (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2025-2032)
8.1. Instruments
8.2. Consumables
8.3. Systems
9. BY END USER (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2025-2032)
9.1. Hospitals
9.2. Specialty Clinics
9.3. Diagnostic Centers
9.4. Research Institutes
10. REGION (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2025-2032)
10.1. North America
10.1.1. United States
10.1.2. Canada
10.1.3. Mexico
10.2. South America
10.2.1. Brazil
10.2.2. Argentina
10.2.3. Rest of South America
10.3. Europe
10.3.1. Germany
10.3.2. United Kingdom
10.3.3. France
10.3.4. Italy
10.3.5. Spain
10.3.6. Russia
10.3.7. Rest of Europe
10.4. Asia-Pacific
10.4.1. China
10.4.2. Japan
10.4.3. India
10.4.4. Australia
10.4.5. South Korea
10.4.6. Rest of Asia-Pacific
10.5. Middle-East
10.5.1. UAE
10.5.2. Saudi Arabia
10.5.3. Turkey
10.5.4. Rest of Middle East
10.6. Africa
10.6.1. South Africa
10.6.2. Egypt
10.6.3. Rest of Africa
*NOTE: All the regions mentioned in the scope will be provided with (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2025-2032)
By Test Type:
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Blood Tests
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Urine Analysis
By Product:
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Instruments
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Consumables
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Systems
By End User:
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Hospitals
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Specialty Clinics
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Diagnostic Centers
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Research Institutes
By Region:
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North America
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Europe
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Asia-Pacific
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Latin America
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Middle East & Africa
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