The U.S. preeclampsia diagnostics market size was estimated at USD 60 million in 2025 and is projected to be worth around USD 78.32 million by 2035, growing at a CAGR of 2.7% from 2026 to 2035. The traditional diagnostics pattern are revolutionizing into the advance one with the arrival of convincing diagnostic tools. This has strengthened the accuracy needed for measuring placental biomarkers. The utilization of uterine artery Doppler is adding value to the risk screening.

U.S. Preeclampsia Diagnostics Market Statical Scope

The emergency diagnostic is promoting the role of advanced diagnostic tools in such cases with the trend of precision in healthcare. The growing stress of depression or anxiety conditions demands this precise diagnostic process to avoid any risk to patients. The painless tools and POC are a popular trend arrived back in this market as well due to the interconnected potency of the tools to heal the preeclampsia condition, mainly for pregnant women. The biomarker-based tests are another market trend that has enhanced diagnostic management with more precision in the results.

The non-invasive biomarker assays have taken all the limelight in the preeclampsia condition prediction by highlighting the commendable performance of multiplex and genetic assays in the market. The FDA is a legal strength of the market, as the FDA has allowed new diagnostic tools to enter the healthcare space.

U.S. Preeclampsia Diagnostics Market Share, By Test Type, 2025 (%)

• Blood Tests – The blood tests segment acquired 59% of the share as the leaders are showing interest in the blood test category and driving some advocacy for this solution. For instance, 2 years back, the FDA signalled LabCorp's blood test as a promising idea for evaluating risk in extreme preeclampsia and prognosis. The help of AI-fuelled analytics is contributing technically to the market.
• Urine Analysis – The urine analysis segment held 41% of the share with the hype of the supportive processes like UPCR, which ensures convenience and quickness. While the CRD test is also an investigator of misfolded protein aggregates, spotting a remarkable solution for preterm or extreme preeclampsia. The urinary podocyturia acts as a tool to count the volume of podocytes.

U.S. Preeclampsia Diagnostics Market Share, By Product, 2025 (%)

• Consumables – The consumables segment acquired 62% of the share with the growing manufacturing of test strips, specialized kits and reagents. The popular adoption rate of biomarkers is driving demand for biomarker-related diagnostic kits. The traffic in labs and hospitals makes space for disposable kits and reagents in the mass volume.
• Instruments – The instruments segment covered 38% of the share due to the rising adoption of dedicated portable devices and automated analysers, exposing the strength of the segment in the market. The sustainable diagnostic platforms are driving the need for eco-friendly instruments supporting innovation in the market.

U.S. Preeclampsia Diagnostics Market Share, By End-user, 2025 (%)

• Hospitals – Hospitals segment acquired 49% of the share due to modern changes in the common blood tests tradition in the healthcare. The urine sample traffic at the hospital labs is highlighting the busy profit in the segmental market. The massive consumables and diagnostic kits used in hospitals are boosting the foundation of the market in this popular setting.
• Specialty Clinics - The specialty clinics segment held 24% of the share due to the confidence of the FDA in the market. The famous leaders receiving FDA clearance for their new tests are justifying the sincerity and capability of the segment towards this market. The funding for innovations doubles the power of clinics' recognition.
• Diagnostic Centers – The diagnostic centers segment covered 19% of the share due to its tech-driven approaches, encouraging the blood-based biomarker assays with more perfect forecasting of preeclampsia conditions. The supporters of these centers are pillars for the segment's excellence.

Competitive Landscape

The popular market leaders such as Siemens Healthineers, Roche Diagnostics, Thermko Fisher Scientific, Sera Prognostics, Diabetomics, Inc. and PerkinElmer (Revvity) are attracting massive revenue to the healthcare sector with the dedication and interest towards the advanced approaches. Revvity's aim is on diagnostic solutions and maternal health screening that eventually secures profit in prenatal screening. Roche service of Elecsys Preeclampsia immunoassay is expanding the market with full power in the vast regional healthcare sector. The contribution of Sera highlights its popular alliance with the Newborn Foundation, named ‘Every Mother, Every Baby Project'.

Segments Covered in the Report

By Test Type

• Blood Tests
• Urine Analysis

By Product

• Consumables
• Instruments

By End-user

• Hospitals
• Specialty Clinics
• Diagnostic Centers
• Others