Preeclampsia - Market Insight, Epidemiology, and Market Forecast - 2034

Preeclampsia is a complex pregnancy disorder characterized by new-onset hypertension and proteinuria after 20 weeks of gestation. It is believed to stem from placental dysfunction, leading to systemic endothelial activation and inflammatory responses that affect maternal circulation. Preeclampsia is more prevalent in first-time mothers, women with a family history of the condition, and those with preexisting health issues such as hypertension or diabetes.

• Diagnosis of preeclampsia is based on routine prenatal screenings measuring blood pressure and urine protein, confirmed with readings of =140/90 mmHg and proteinuria =300 mg in a 24-h urine collection.
• In May 2023, Thermo Fisher Scientific received FDA clearance for two assays that assess preeclampsia risk by measuring PIGF and sFlt-1 levels. These assays, the first to receive the breakthrough designation, run in 30 min on the BRAHMS KRYPTOR analyzer and can help evaluate the risk of developing severe preeclampsia in hospitalized pregnant individuals within the next 2 weeks.
• The differential diagnosis of preeclampsia includes antiphospholipid antibody syndrome, thrombotic microangiopathies, lupus nephritis, epilepsy or seizure disorder, chronic renal disease, chronic liver disease, gestational hypertension, chronic hypertension, and others.
• According to the publisher's estimates, the total diagnosed incidence cases of preeclampsia in the 7MM were found to be ~334,000 in 2024.
• In the 7MM, the US accounts for the highest incidence cases of preeclampsia in 2024 with ~218,000 cases.
• There is no approved therapies for preeclampsia, delivery is the only cure and management majorly relies on antihypertensive agents, anticonvulsants, and corticosteroids.
• In 2024, the total market size of preeclampsia in the 7MM is ~USD 80 million and expected to grow in the forecasted period.
• In 7MM, the US accounted for highest market revenue with ~USD 70 million in 2024.
• Currently emerging space for preeclampsia is not so active, only few companies are developing and they are also in preclinical stage. Recently Comanche biopharma’s CBP-4888 has become active with Fast Track Designation (FTD) for preeclampsia.

Report Summary

• The report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
• Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of late-stage (Phase II and Phase I) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
• The report also encompasses a comprehensive analysis of the Preeclampsia market, providing an in-depth examination of its historical and projected market size (2020-2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
• The report includes qualitative insights that provide an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM Preeclampsia market.

Market

A few key players are leading the treatment landscape of Preeclampsia, such as Comanche biopharma, and others. The details of the country-wise and therapy-wise market size have been provided below.

• In the total market size of Preeclampsia in the 7MM, the United States accounted for the highest market share, i.e. approximately USD 70 million in 2024.
• In 2024, Germany and France generated the highest revenue among the EU4 and the UK, reaching nearly USD 4 million.
• There is no approved therapies for preeclampsia, delivery is the only cure and management majorly relies on antihypertensive agents, anticonvulsants, and corticosteroids.
• Antihypertensive therapy remains the cornerstone of preeclampsia management. In 2024, antihypertensive agents accounted for ~USD 50 million of the US market valuation.

Preeclampsia Drug Chapters

The section dedicated to drugs in the Preeclampsia report provides an in-depth evaluation of pipeline drugs related to Preeclampsia. The drug chapters section provides valuable information on various aspects related to clinical trials of Preeclampsia, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases on drugs targeting Preeclampsia.

Preeclampsia Market Outlook

Currently, there are no effective pharmacological treatments or preventive strategies for preeclampsia. Available therapies primarily focus on controlling hypertension, a secondary consequence of placental dysfunction, rather than addressing the underlying pathophysiology. The optimal management strategy hinges on gestational age and disease severity, balancing maternal safety with fetal viability. As delivery remains the only definitive cure, clinicians must carefully time interventions to minimize risks while ensuring fetal maturation.

Aspirin is the most widely used preventive measure, with evidence suggesting that early initiation before 16 weeks of gestation may mitigate the risk of preeclampsia. However, its efficacy is significantly diminished when started later, underscoring the importance of early risk stratification and intervention.

Preeclampsia Disease Understanding and Treatment

Preeclampsia Overview

Hypertensive disorders of pregnancy constitute a leading cause of maternal and perinatal mortality worldwide. Preeclampsia, with or without severe features, is a disorder of pregnancy associated with new-onset hypertension, usually with accompanying proteinuria, which occurs most often after 20 weeks of gestation and frequently near term. This disease represents a spectrum of hypertensive disease in pregnancy, beginning with gestational hypertension and progressing to develop severe features, ultimately leading to its more severe manifestations, such as eclampsia and HELLP (hemolysis, elevated liver enzymes, low platelet count) syndrome. Early diagnosis and prompt management are essential to preventing both maternal and neonatal complications through symptomatic management and delivery planning.

Preeclampsia Diagnosis

Preeclampsia is diagnosed based on the presence of hypertension (systolic BP = 140 mmHg or diastolic BP = 90 mmHg) after 20 weeks of gestation, along with proteinuria (= 300 mg/24 hours or a protein-to-creatinine ratio = 0.3). In the absence of proteinuria, it can still be diagnosed if there are signs of organ dysfunction, such as renal impairment (creatinine > 1.1 mg/dL), elevated liver enzymes, neurological symptoms (e.g., headache, visual disturbances), or thrombocytopenia. Severe preeclampsia is characterized by significantly elevated BP (= 160/110 mmHg), marked proteinuria, or complications like pulmonary edema and organ damage.

Preeclampsia Treatment

To manage high blood pressure, medications like labetalol, nifedipine, or methyldopa may be prescribed. Labetalol is specifically licensed for pregnant women, while the others are used off-label when the benefits outweigh the risks. In severe cases, anticonvulsant medicine may be given to prevent or treat fits. Delivery is typically recommended around the 37th to 38th week, either through induced labor or cesarean section, to minimize complications. If the condition worsens before 37 weeks, earlier delivery may be necessary. Premature birth may pose additional risks for the baby. After delivery, preeclampsia generally improves, but complications can develop in the days following birth. Blood pressure will continue to be monitored, and additional medication may be prescribed if necessary. The baby may require monitoring in a neonatal intensive care unit if born prematurely. Postpartum, the patient will have follow-up appointments to check blood pressure and assess whether ongoing treatment is needed.

Preeclampsia Epidemiology

The Preeclampsia epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Incidence Cases, Total Diagnosed Incidence Cases, Age-specific Cases, Sub-type specific Cases, Severity specific Cases, Treated Cases of Preeclampsia in the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• The US accounted for ~220,000 diagnosed incidence cases of Preeclampsia in 2024.
• Among the age-specific cases, 25-29 yrs comprised ~66,000 cases, whereas 30-34 yrs comprised ~63,000 cases of preeclampsia in the US in 2024.
• Among EU4 and the UK, Germany had the highest diagnosed incidence population of preeclampsia with ~26,000 cases, followed by the France, which had ~25,000 cases in 2024.
• In 2024, the US reported the highest number of late-onset cases and early-onset, with ~260,000 and ~30,000 cases, respectively.

KOL Views

To stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.

We have reached out to industry experts to gather insights on various aspects of Preeclampsia, including the evolving treatment landscape, patients’ reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.

Analysts connected with more than 10 KOLs across the 7MM. We contacted institutions such as the National Institute of Child Health and Human Development, St. Joseph's Health Care, University of Milan, Nagoya City University, etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the Preeclampsia market, which will assist our clients in analyzing the overall epidemiology and market scenario.

Qualitative Analysis

We perform Qualitative and Market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Preeclampsia Report Insights

• Patient Population
• Therapeutic Approaches
• Preeclampsia Market Size and Trends
• Existing Market Opportunity

Preeclampsia Report Key Strengths

• Ten-year Forecast
• The 7MM Coverage
• Preeclampsia Epidemiology Segmentation
• Key Cross Competition

Preeclampsia Report Assessment

• Current Treatment Practices
• Reimbursements
• Market Attractiveness
• Qualitative Analysis (SWOT, Conjoint Analysis, Unmet needs)

Key Questions

• Would there be any changes observed in the current treatment approach?
• Will there be any improvements in Preeclampsia management recommendations?
• Would research and development advances pave the way for future tests and therapies for Preeclampsia?
• Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of Preeclampsia?
• What kind of uptake will the new therapies witness in the coming years in Preeclampsia patients?