Summary

KEY INSIGHTS
Pre-eclampsia is a common pregnancy-related complication, affecting 2–15% of pregnancies, and poses serious risks to both mother and fetus. This pregnancy complication usually develops after 20 weeks of gestation and is characterized by high blood pressure, proteinuria, and sometimes organ damage such as kidney impairment, liver dysfunction, or neurological symptoms.
Moreover, if left untreated or if it becomes severe, pre-eclampsia can result in life-threatening complications, including adverse fetal outcomes such as intrauterine growth restriction and preterm birth. Diagnosis and treatment of pre-eclampsia are crucial, involving various pre-eclampsia diagnostic tests to monitor the condition. Pre-eclampsia is further categorized into early-onset (before 34 weeks) and late-onset (at or after 34 weeks) based on when it occurs, indicating different underlying causes and potential complications.
MARKET INSIGHTS
Key growth enablers of the pre-eclampsia market:
• Advances in research and development
o Research and Development (R&D) initiatives play a vital role in enhancing the understanding, detection, and treatment of pre-eclampsia. Through dedicated resources and expertise, researchers explore the pre-eclampsia causes and mechanisms behind the condition. Extensive studies and clinical trials aim to discover biomarkers for early diagnosis, identify genetic factors that influence susceptibility, and develop innovative drug therapies. These efforts expand scientific knowledge of pre-eclampsia and support the development of targeted interventions to improve patient outcomes.
o R&D initiatives fuel the commercialization of new technologies and medical solutions to address pre-eclampsia. Pharmaceutical companies invest in developing emerging drugs and treatments from these efforts, creating a dynamic market centered on maternal health innovations. Collaboration between researchers, healthcare professionals, and industry stakeholders ensures that scientific advances are transformed into practical, marketable solutions.
o Collaboration among various stakeholders in R&D initiatives fosters a competitive market environment where advancements in pre-eclampsia research result in impactful products. These innovations provide both patients and healthcare providers with enhanced diagnostic tools and effective treatments, ultimately improving the quality of care for those affected by pre-eclampsia.
• Higher maternal age and associated health conditions
• Increasing prevalence of pre-eclampsia
Key growth restraining factors of the pre-eclampsia market:
• Elevated development costs
o The high costs of developing new pre-eclampsia diagnostic tests, therapeutic interventions, and preventive measures for pre-eclampsia pose significant challenges for stakeholders in the market. These financial barriers can be especially daunting for smaller companies or research institutions that may not have substantial financial resources.
o The research and development (R&D) process for innovative solutions in pre-eclampsia is resource-intensive and costly. It requires substantial financial investment to conduct comprehensive clinical trials, validate pre-eclampsia biomarkers, and ensure the safety and efficacy of new products. These steps are critical but can strain the budgets of the organizations involved.
• Lack of knowledge of the underlying root causes
• Healthcare access inequities
We are equipped to provide comprehensive data across all stages of development, including Pre-Clinical Stage and Mid-Stage.
Pre-Eclampsia | Disease Overview
• Introduction
• Pathophysiology of Pre-Eclampsia
o Stage 1
o Stage 2
o Limitations of the Placenta Model
• Systemic Manifestations of Pre-Eclampsia
o Central Nervous System (CNS)
 The brain utilizes approximately 20% of the body's oxygen and usually maintains stable cerebral blood flow (CBF) through autoregulation. However, brain injuries can impair this regulation, leading to either hypoperfusion, which can result in ischemic injury, or hyperperfusion, which may damage the blood-brain barrier (BBB) and cause edema. This disruption is commonly observed in pregnancy-related complications such as pre-eclampsia and eclampsia.
 In pre-eclampsia, cerebral perfusion pressure (CPP) is frequently elevated even when cerebral flow indices (CFI) remain normal, which can contribute to brain injury. Central nervous system (CNS) symptoms such as headaches, visual disturbances, altered consciousness, and seizures (preeclamptic encephalopathy) signal severe disease. Eclampsia, characterized by seizures, represents a severe form of pre-eclampsia with significant risks, though it often resolves without causing long-term neurological damage.
 Posterior reversible encephalopathy syndrome (PRES) and strokes are significant neurological complications associated with pre-eclampsia. PRES, associated with acute hypertension or endothelial dysfunction, generally resolves swiftly with treatment and has a more favorable prognosis in pregnant women. Although strokes are rare during pregnancy, they share risk factors with those in non-pregnant individuals and may indicate an increased long-term risk for cerebrovascular events.
o Cardiovascular Systems
o Liver
o Kidney
o Other Targets
• Diagnosis
o Pre-eclampsia is diagnosed by new-onset hypertension (≥140/90 mmHg) occurring after 20 weeks of pregnancy. Blood pressure should be measured twice, with a four-hour interval between readings, and home monitoring is encouraged for early detection, particularly for women at high risk.
o Proteinuria, a critical indicator of pre-eclampsia, is first screened with a dipstick test and then confirmed using the protein-to-creatinine or albumin-to-creatinine ratio from urine samples. This approach has replaced the outdated 24-hour urine collection method.
o Diagnosis is aided by testing for organ dysfunction through blood counts, liver enzymes, and creatinine levels, as well as evaluating angiogenic factors such as the PlGF and sFlt-1 ratio. Ultrasound assessments are used to assess uteroplacental function and monitor fetal well-being.
• Management of Pre-Eclampsia
o Antihypertensive Treatment
o Magnesium Sulfate
o Delivery and Termination of Pregnancy
COMPETITIVE INSIGHTS
Major players in the pre-eclampsia market:
• Dilafor AB
• Corion Biotech
• Comanche Biopharma
• Gmax Biopharm LLC
• MirZyme Therapeutics
• Vicore Pharma
• Paean Biotechnology
Comanche Biopharma, founded in 2020 and based in Concord, Massachusetts, is a biopharmaceutical company dedicated to developing an investigational siRNA therapy for preterm pre-eclampsia. Their approach focuses on creating molecules that reduce the production of sFlt1, a protein heavily involved in the disease's pathology. This strategy aims to address the underlying molecular mechanisms of pre-eclampsia by targeting and lowering sFlt1 levels.
The company's investigational therapy, CBP-4888, is currently undergoing Phase I clinical development. This innovative treatment specifically targets the placenta to decrease the production of soluble fms-like tyrosine kinase-1 (sFLT1) mRNA isoforms, which are linked to pre-eclampsia's development. By reducing sFLT1 levels, CBP-4888 seeks to alleviate the endothelial dysfunction and hypertension associated with pre-eclampsia, thereby improving outcomes for both mothers and their fetuses. This represents a novel approach in the pre-eclampsia therapeutics market, focusing on the disease's molecular mechanisms.
Frequently Asked Questions (FAQs):
1.) What causes pre-eclampsia?
A: The exact cause of pre-eclampsia is unknown, but it is believed to result from problems with the development of the placenta. Factors such as abnormal blood vessel development, immune system issues, genetic factors, and underlying health conditions may contribute to its development.
2.) Who is at risk of developing pre-eclampsia?
A: Risk factors for pre-eclampsia include having had pre-eclampsia in a previous pregnancy, chronic hypertension, kidney disease, diabetes, autoimmune disorders, being a first-time mother, carrying multiple pregnancies (such as twins or triplets), obesity, being over 35 or under 20 years old, and a family history of pre-eclampsia.
3.) Can pre-eclampsia affect future pregnancies?
A: Yes, women who have experienced pre-eclampsia are at a higher risk of developing the condition in future pregnancies. This risk is greater if pre-eclampsia occurs early in the pregnancy or is particularly severe. Women with a history of pre-eclampsia should notify their healthcare providers, who may then monitor them more closely in subsequent pregnancies.

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Table of Contents

TABLE OF CONTENTS
1. INTRODUCTION TO THE REPORT
2. PRE-ECLAMPSIA: SUMMARY
3. OVERVIEW
3.1. INTRODUCTION
3.2. PATHOPHYSIOLOGY OF PRE-ECLAMPSIA
3.2.1. STAGE 1
3.2.2. STAGE 2
3.2.3. LIMITATIONS OF THE PLACENTA MODEL
3.3. SYSTEMIC MANIFESTATIONS OF PRE-ECLAMPSIA
3.3.1. CENTRAL NERVOUS SYSTEM (CNS)
3.3.2. CARDIOVASCULAR SYSTEMS
3.3.3. LIVER
3.3.4. KIDNEY
3.3.5. OTHER TARGETS
3.4. DIAGNOSIS
3.5. MANAGEMENT OF PRE-ECLAMPSIA
3.5.1. ANTIHYPERTENSIVE TREATMENT
3.5.2. MAGNESIUM SULFATE
3.5.3. DELIVERY AND TERMINATION OF PREGNANCY
4. MARKET DYNAMICS
4.1. KEY DRIVERS
4.1.1. ADVANCES IN RESEARCH AND DEVELOPMENT
4.1.2. HIGHER MATERNAL AGE AND ASSOCIATED HEALTH CONDITIONS
4.1.3. INCREASING PREVALENCE OF PRE-ECLAMPSIA
4.2. KEY RESTRAINTS
4.2.1. ELEVATED DEVELOPMENT COSTS
4.2.2. LACK OF KNOWLEDGE OF THE UNDERLYING ROOT CAUSES
4.2.3. HEALTHCARE ACCESS INEQUITIES
5. PIPELINE THERAPEUTICS
5.1. PIPELINE SCENARIO
6. EARLY-STAGE PRODUCTS (PHASE I)
6.1. COMPARATIVE ANALYSIS
6.2. CBP-4888: COMANCHE BIOPHARMA
6.2.1. PRODUCT DESCRIPTION
6.2.2. RESEARCH AND DEVELOPMENT
6.2.3. PRODUCT AND DEVELOPMENTAL ACTIVITIES
7. UNMET NEEDS