Preeclampsia Diagnostics Market Size, Share & Industry Analysis, By Test Type (Blood Tests and Urine Analysis), By Product (Instruments and Consumables), By End-user (Hospitals, Specialty Clinics, Diagnostic Centers, and Others), and Regional Forecasts, 2024-2032

The global preeclampsia diagnostics market size was valued at USD 1.09 billion in 2023. The market is projected to grow from USD 1.11 billion in 2024 to USD 1.36 billion by 2032, exhibiting a CAGR of 2.6% during the forecast period. North America dominated the preeclampsia diagnostics market with a market share of 37.61% in 2023.

Preeclampsia, also known as toxemia, is a rapidly progressive disorder that is characterized by elevated blood pressure and excessive protein in the urine of pregnant women. It is one of the hypertensive disorders of pregnancy, which is responsible for accelerating the maternal & perinatal morbidity and mortality rate among women across the developed and emerging nations. If not diagnosed at an early stage, it could lead to preterm birth and other complications such as seizure or eclampsia, failure of organs, and death.

The preeclampsia diagnostics market growth is attributed to the rapid rise in the prevalence of this disease and the need to protect the life of the mother and the baby. Moreover, many players are focusing on strategic collaborations & partnerships to develop innovative blood tests to detect biomarkers indicating the disease, which is expected to propel the demand for a diagnosis during the forecast period.

• For instance, in June 2020, PerkinElmer Inc. announced the launch of the DELFIA Xpress sFlt-1 kit. The product enables short-term prediction of preeclampsia and aids in diagnosis in the second and third trimesters of pregnancy, together with the previously launched DELFIA Xpress PlGF 1-2-3 assay.

The coronavirus pandemic resulted in an unprecedented demand on healthcare system. A significant increase in preeclampsia diagnostics has been witnessed during these days, which is attributable to the rising number of pregnancies during the lockdown, delayed or canceled abortion cases due to the unavailability of midwives or healthcare facilities, and high risks associated with the incidence of this disease among pregnant women positive for COVID-19.

Moreover, there was an increased diagnostic dilemma associated with the existing COVID-19 cases and preeclampsia diagnostics due to the presence of proteinuria found in both conditions. Furthermore, positive government support in the form of amendments to guidelines to handle prenatal cases and manage this disease by ensuring the availability of the healthcare facilities increased the demand for toxemia screening in 2020.

The market players witnessed an increase in revenue generated during 2020. For instance, PerkinElmer Inc., a leader in the market, witnessed an increase of 31.2% in its revenue in 2020 to reach USD 3,782.8 million. The expansion of its customer base for diagnosis of toxemia is one of the reasons for the company's growth in revenue.  The market is projected to grow steadily over the forecast period of 2024-2032.

Preeclampsia Diagnostics Market Trends

Technological Advancements in Preeclampsia Diagnostics to Boost Market Growth

The increasing incidence of preeclampsia has created awareness regarding its diagnosis, and various government regulatory bodies are initiating programs under which they are approving various advanced tests.

• For instance, in 2019, the perinatal physician researchers from the Ohio State University, Wexner Medical Center, and Nationwide Children’s Hospital developed an affordable, non-invasive Congo Red Test (CRD). This urine test rapidly detects the disease at a point of care.

Furthermore, Congo Red Test (CRD) has been designed to measure misfolded proteins in the urine of pregnant women likely to develop toxemia. It is a fast test that generates results in just three minutes.

In addition, the usage of biomarkers, such as the placental (PIGF) and soluble fms-like tyrosine kinase-1 (SFLT-1), has gained attention in recent years as a reliable indicator for predicting the onset of preeclampsia.

Also, several researchers are conducting research initiatives for the diagnosis of preeclampsia with genomics. Similarly, artificial intelligence and machine learning models were utilized by many researchers for the detection of preeclampsia.  

• As per the data provided by the University College Dublin, in February 2024, the team of researchers from this university initiated research on preeclampsia diagnosis using technology from SAS.  


• For instance, as per the data provided by Genomics Clinical Research in September 2023, the scientists of Genomics Clinical Research have conducted a study to shed light on a potential diagnostic technique for preeclampsia using plasma cell-free RNA (cfRNA).

Such advent of technologically advanced products for the diagnosing of toxemia is driving the overall market growth.

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Preeclampsia Diagnostics Market Growth Factors

Increasing Women Population Suffering from Preeclampsia to Propel Novel Tests’ Demand

Preeclampsia, one of the hypertensive disorders of pregnancy, is responsible for increasing the maternal & perinatal morbidity and mortality rate among pregnant women across the globe. The disease is a serious multi-system complication of pregnancy, with prevalence increasing at a significant rate in developed countries.

• For instance, as per the World Health Organization (WHO) data, globally, the incidence of preeclampsia ranges between 2-10% out of the total pregnancies. This rate is higher in developing countries (1.8-16.7%) compared to developed countries (0.4%).


• Similarly, according to the research published by NCBI in July 2021, the prevalence of preeclampsia in France was found to be 8.5% among pregnant women.

Growing adoption of a sedentary lifestyle leading to high incidences of the disease and increasing awareness among healthcare providers & pregnant women population are likely to surge the demand for early screening of this disease, which can elevate the growth of the market in the coming years.

Growing Focus on the Development of Innovative Preeclampsia Diagnostic Products to Drive Market

Early diagnosis of hypertensive disorders of pregnancy has always been a challenge. The rise in the incidence rate of preeclampsia and the growing demand for reducing the mortality rates of mothers and newborns increased the opportunity for market players to develop an innovative instrument for preeclampsia diagnostics.

The introduction of point-of-care tests for diagnosis of preeclampsia at an earlier stage can aid in avoiding unnecessary hospital admission, which can further reduce the cost burden associated with this disease. As the risk of preterm birth remains a major challenge in the disease, many key players are engaged in strategic partnerships and collaboration to introduce advanced diagnostic products in this market.

Furthermore, the advancements in biomarker tests, for the prediction of preeclampsia likely to drive the market during the forecast period.

• For instance, in July 2023, the U.S. FDA approved the first blood test developed by Thermo Fisher Scientific Inc. for the prediction of preeclampsia in pregnant women. This blood test is meant for women in their 23rd to 35th weeks of pregnancy.

RESTRAINING FACTORS

Less Awareness about Preeclampsia in Developing Regions to Hamper Market Growth

A single elevated increase in blood pressure does not effectively diagnose preeclampsia in pregnant women. Despite the growing prevalence of this disease, many pregnant women across the globe lack knowledge about the term preeclampsia and its complications.

Moreover, women who develop hypertension during pregnancy are unaware of this life‐threatening condition until late in their pregnancy, when symptoms of high blood pressure have already manifested. Detection of the disorder at this late stage typically leaves the mother with a few options.

This lack of awareness about the signs and symptoms of this disease that can worsen women’s health leads to increased infant death rates.

• For instance, according to the article published by the Preeclampsia Foundation in May 2020, around 50% of women with toxemia in California lack knowledge regarding the severity of the symptoms associated with the disease.

Such unavailability of preeclampsia diagnostics products, coupled with less awareness about the disease, could limit the adoption of these substitutes during the forecast period.

Preeclampsia Diagnostics Market Segmentation Analysis

By Test Type Analysis

Blood Tests to Hold Dominant Market Share Owing to Rising Adoption in Diagnostics Centers

Based on test type, the market is segmented into blood tests and urine analysis.

The blood tests segment is projected to expand at the highest growth rate during the forecast period. The increasing incidence of preeclampsia and the advantages of blood tests in effectively detecting the biomarkers are responsible for the market growth. Furthermore, many healthcare organizations are adopting blood tests for the detection of toxemia, which can further fuel the demand for more blood screening tests in the near future

• For instance, in March 2022, the National Institute for Health and Care Excellence (NICE) recommended four tests to detect preeclampsia such as DELFIA Xpress PLGF 1-2-3, Delfia Xpress sFlt-1/Xpress PLGF1-2-3 ratio, Elecsys immunoassay sFlt-1/PLGF ratio, and Triage PLGF Test in its guidance.

The urine analysis segment is expected to expand at a substantial CAGR during 2024-2032. The segmental growth is due to the preferred method of preliminary analysis of the disease, especially in emerging countries. Furthermore, various benefits associated with urine analysis, such as the accessible, convenient, and non-invasive nature, are likely to contribute to the segmental growth during the forecast period.

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By Product Analysis

Consumables to Hold Highest Share Due to Increasing Prevalence of Preeclampsia

Based on product, the market is segmented into instruments and consumables.

In 2023, the consumables segment held the largest market share and is expected to expand at the highest CAGR during the forecast period. The segmental growth is attributable to the rising number of pregnant women suffering from preeclampsia and the strong adoption of biomarkers diagnosis. Furthermore, increasing awareness of this disease and different detection methods is expected to surge the demand for consumables in the coming years.

• In May 2019, the International Federation of Gynecology and Obstetrics (FIGO) released new guidelines that provide recommendations for detecting biomarkers and assessing the risk due to preeclampsia. Such guidelines will promote more awareness among gynecologists about the reagents and kits available in the market, thereby spurring the segmental growth.

The instruments segment is expected to exhibit a strong CAGR during the upcoming years. The segmental growth is due to increasing hypertensive pregnancy disorders population who are more prone to toxemia. Moreover, the increasing need for urological disease diagnosis centers is expected to contribute to the segmental growth during the upcoming years.

By End-user Analysis

Diagnostic Centers to Continue Its Dominance Backed by Presence of Unique Instruments

Based on end-user, the market is categorized into hospitals, specialty clinics, diagnostic centers, and others.

In 2023, the hospitals segment held the second-largest market share and is expected to expand at a moderate CAGR during the forecast period. The segmental growth is attributed to rising number of in-hospital visits from patients suffering from toxemia. Moreover, increasing number of hospitals in developing regions with improved healthcare infrastructures and increased hospitalization rates are expected to drive segmental growth.

The diagnosis centers segment is expected to expand at the highest CAGR during the forecast period. The segmental growth is attributable to rising footfalls of the pregnant population suffering from preeclampsia in diagnosis centers. Moreover, diagnosis centers focus on providing advanced screening for early-onset and late-onset preeclampsia during pregnancy, which is expected to drive the segmental growth.

REGIONAL INSIGHTS

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North America dominated the market with a revenue of USD 0.41 billion in 2023 and is expected to continue dominating the market during the upcoming years. The high adoption of technologically advanced products, rising awareness among the healthcare providers and patients about the severity of the disease, and significant healthcare spending contribute to the market growth in this region. Moreover, increasing launch of technologically advanced preeclampsia diagnostics solutions is likely to drive market growth.

Europe accounted for the significant share of the preeclampsia diagnostics market in 2023 and may expand substantially during the forecast period. The growth is attributable to a large patient pool suffering from hypertensive disorders in pregnancy. Moreover, increasing approvals for hypertensive disorders in pregnancy diagnosis by government healthcare organizations may foster market growth in Europe.

In Asia Pacific, the presence of an ever-increasing population, growing awareness about the disease, high pregnancy rate, and the growing usage of fertility treatments. The highest CAGR of the region is attributable to the increasing number of pregnant women.

Latin America and the Middle East & Africa are expected to expand at a comparatively lower CAGR during the forecast period. The growth is attributable to rising healthcare expenses and the increasing incidence of toxemia

List of Key Companies in Preeclampsia Diagnostics Market

Strong Product Offerings by Key Players to Propel Preeclampsia Diagnostics Industry Growth

F. Hoffmann-La Roche Ltd., PerkinElmer Inc., and DRG INSTRUMENTS GMBH are the leading players in the market with a strong brand presence combined with a wide range of product offerings. These players are likely to continue their dominance in the preeclampsia diagnostics area and generate significant revenue in the forthcoming years. The companies are focusing on investments in research and development activities to launch cost-effective and highly advanced diagnostic kits to detect the disease rapidly. Moreover, a strong focus on strategic collaborations with other players & various research organizations to develop effective tests for toxemia is likely to support the expansion of their footprints in the market.

Other players engaged in the manufacturing and distribution of the preeclampsia diagnostics kits in the market include Thermo Fisher Scientific Inc., Diabetomics, Inc., Metabolomic Diagnostics Ltd., Sera Prognostics, Siemens Healthineers AG, and Bayer AG. These players are constantly focusing on strategic developments such as new product launches, improvements in the distribution network, and partnerships with other companies.

LIST OF KEY COMPANIES PROFILED:

• F. Hoffmann-La Roche Ltd (Switzerland)


• PerkinElmer Inc. (U.S.)


• DRG INSTRUMENTS GMBH (Germany)


• Thermo Fisher Scientific Inc. (U.S.)


• Diabetomics, Inc. (U.S.)


• Metabolomic Diagnostics Ltd. (Ireland)


• Sera Prognostics (U.S.)


• Siemens Healthineers AG (Germany)


• Bayer AG (Germany)

KEY INDUSTRY DEVELOPMENTS:

• January 2024 - LabCorp introduced a new, U.S. FDA-cleared blood test for the prognosis and risk assessment of severe preeclampsia in pregnant women.


• July 2021 - LifeCell Diagnostics launched a comprehensive preeclampsia screening in India. The advanced screening detects biomarker, sFLT-1 (soluble FMS-like tyrosine kinase-1), which enables the prediction of the disease and helps in accurate diagnosis even in the third trimester.


• July 2019- Predictive Laboratories, Inc. announced a research collaboration with Preeclampsia Foundation. This collaboration aims to develop a personalized test for the early detection of risk in women with the disease.


• June 2019- NHS England approved two blood test products, Elecsys sFlt-1 and PlGF immunoassays of F. Hoffmann-La Roche Ltd., under the ‘Innovation and Technology Payment’ program.


• February 2019- Diabetomics, Inc. launched Lumella, the first rapid, point-of-care test for preeclampsia assessment in India. The Lumella accurately estimates the protein biomarker, Glycosylated Fibronectin (GlyFN), present in pregnant women with preeclampsia.


• October 2018- PerkinElmer Inc. announced a collaboration with the Fetal Medicine Foundation (FMF), a non-profit organization dedicated to improving women's and newborn babies' healthcare.

REPORT COVERAGE

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The research report provides detailed information regarding various insights into the market. Some of them are market dynamics, growth drivers, restraints, competitive landscape, regional analysis, and challenges. It further offers an analytical depiction of the market trends and estimations to illustrate the forthcoming investment pockets. Furthermore, the overall analysis by product, test type, and end-user is included in the report. The market is quantitatively analyzed from 2019 to 2032 to provide market values. The information gathered in the report has been taken from several primary and secondary sources.

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