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시장보고서
상품코드
1652665
자간전증 시장 - 시장 인사이트, 역학, 시장 예측(-2034년)Preeclampsia - Market Insight, Epidemiology, and Market Forecast - 2034 |
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자간전증은 임신 20주 이후에 새롭게 발생하는 고혈압과 단백뇨를 특징으로 하는 복잡한 임신 질환입니다. 태반의 기능 장애로 인해 전신 내피의 활성화와 염증 반응을 일으켜 모체의 순환에 영향을 미치는 것으로 알려져 있습니다. 자간전증은 초산부, 가족력이 있는 여성, 고혈압이나 당뇨병 등의 기왕증이 있는 여성에게 많이 발생합니다.
임신성 고혈압성 신증의 진단은 혈압과 요단백을 측정하는 정기적인 산전 검사에 근거하며, 24시간 채뇨에서 140/90mmHg, 단백뇨 300mg으로 확진합니다.
2023년 5월, Thermo Fisher Scientific은 PIGF와 sFlt-1 수치를 측정하여 임신성 고혈압성 신증의 위험을 평가하는 두 가지 분석법을 FDA로부터 승인받았습니다. 주 이내에 중증 임신성 고혈압성 신증 발병 위험을 평가할 수 있습니다.
임신성 고혈압 신증의 감별 진단에는 항인지질 항체 증후군, 혈전성 미세 혈관 질환, 루푸스 신염, 간질 또는 발작 질환, 만성 신장 질환, 만성 간 질환, 임신성 고혈압 증후군, 만성 고혈압 등이 포함됩니다.
주요 7개국에서 2024년 임신성 고혈압성 신증으로 진단받은 환자 수는 334,000명이며, 2024년 주요 7개국에서 임신성 고혈압성 신증의 총 시장 규모는 8,000만 달러로 평가되었고, 예측 기간 동안 성장할 것으로 예상됩니다. 주요 7개국 중 미국이 2024년 7,000만 달러로 가장 높은 시장 매출을 기록할 것으로 예상됩니다.
현재, 임신성 고혈압 신증은 신흥 영역으로 개발 중인 기업이 많지 않고, 전임상 단계에 머물러 있습니다. 최근 Comanche biopharma의 CBP-4888이 자간전증에 대한 패스트트랙 지정(FTD)을 받아 활성화되고 있습니다.
본 보고서는 주요 7개국 임신성 고혈압 신증 시장에 대해 조사했으며, 시장 개요와 함께 역학, 환자 동향, 새로운 치료법, 2034년까지 시장 규모 예측, 의료 미충족 수요 등에 대해 조사하여 전해드립니다.
Report Summary
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.
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.
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.
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.
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.
Our team of analysts at Delveinsight 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.