原发性膜性肾臟病（PMN）：市场展望、流行病学、竞争格局、市场预测报告（2025-2035年）

市场概览

• 2025年PMN治疗市场价值为6.22亿美元，预计2035年将达到31.8亿美元。这意味着在预测期内，复合年增长率将达到17.8%。
• 在市场早期阶段（2025-2027 年），ACE 抑制剂/ARB、皮质类固醇（泼尼松、Methylprednisolone）、免疫抑制剂（Cyclosporine、Tacrolimus、MMF）、利Rituximab和 IVIG 等传统治疗方法将占据主导地位。
• 到 2035 年，新型生物製药和标靶治疗预计将主导市场并占据大部分收入，从而极大改变治疗模式。

原发性膜肾臟病（PMN）概述

原发性膜性肾臟病（PMN）是一种特异性自体免疫肾丝球疾病，也是非糖尿病成人肾病变症候群的主要原因之一。临床上，它表现为大量蛋白尿（≥3.5 g/天）、週边水肿、低白蛋白血症、高血脂症以及血栓栓塞併发症（包括肾静脉血栓症）风险增加。

其病理生理特征是 IgG4 自体抗体和补体复合物（C5b-9 膜攻击复合物）沉积在肾小球基底膜上皮下，导致足细胞损伤和滤过屏障破坏。

现代多形核白血病 (PMN) 的分类是基于其分子机制。约 70-80% 的病例与抗 PLA2R（M 型磷脂酶 A2 受体）抗体相关，约 1-5% 的病例与抗 THSD7A 抗体相关。这种分子层面的认识显着改变了疾病管理，使得透过血清学检测进行非侵入性诊断成为可能，并可利用抗体滴度进行疾病后续观察和风险分层。

多形性嗜中性球性肾病变（PMN）主要影响成人，发生率在中老年人群最高。诊断主要透过血清学检测，必要时可进行切片检查。

治疗策略包括支持性治疗（血管紧张素转换酶抑制剂、血管紧张素受体阻断剂、他汀类药物、利尿剂）和免疫抑制疗法，包括糖皮质激素、Calcineurin抑制剂和单株抗体。特别是，Rituximab等B细胞清除疗法已成为现代治疗的核心，因为它们能够实现标靶免疫缓解。

儘管取得了进展，但 PMN 仍然是一种慢性复发性疾病，发展为慢性肾臟病(CKD) 和末期肾功能衰竭(ESRD) 的风险仍然存在，因此对新的标靶治疗的需求日益增长。

主要亮点

• 据估计，到 2025 年，美国患有 PMN 的人数为 86,410 人，预计到 2035 年将增加到 97,845 人，反映出疾病负担的稳定增加。
• 预计2025年新确诊患者人数为3,297人，2035年为3,546人，显示诊断率将逐渐上升。
• 2025 年，女性病例为 34,996 例，男性病例为 51,414 例，预计到 2035 年，这一差距将进一步扩大（女性病例为 39,627 例，男性病例为 58,218 例）。
• 患者平均年龄为 48 岁，疾病负担最重的人集中在 55 岁及以上年龄层。
• 这种疾病是慢性进行性，相当一部分患者需要长期接受免疫抑制治疗，因此对治疗的需求持续存在。

格式化和更新讯息

• 详细报告（PDF）
• 市场预测模型（基于微软Excel）
• 流行病学数据（MS Excel，互动式工具）
• 高阶主管洞察（PPT简报）
• 其他功能：定期更新、自订和顾问支援。
• 根据 Thelansis 的政策，我们确保所有最新更新在发布前都反映在报告内容和市场模型中。

主要问题

• 我们如何优化 G8 市场（美国、欧盟 5 国、日本、中国）的药物开发与生命週期管理策略？
• 从发病率、盛行率、人群组成以及接受药物治疗的患者人数来看，患者数量分别是多少？
• 未来十年市场收入和病患份额的预测是多少？
• 哪些因素对市场趋势影响最大？
• 受访专家对目前和新兴的治疗方法有何看法？
• 哪款在研发线产品最有前景？其上市潜力及未来市场定位如何？
• 主要未被满足的需求是什么？ KOL 对目标受众有何期望？
• 为确保药物核准并顺利进入市场，必须满足哪些关键的监管和支付方要求？

目标国家

• G8
  • 我们
  • EU5
    • 法国
    • 德国
    • 义大利
    • 西班牙
    • 英国
  • 日本
  • 中国

大公司

• Alexion Pharmaceuticals, Inc.
• Excyte Biopharma Ltd
• Climb Bio, Inc.
• Cerium Pharmaceuticals
• Vertex Pharmaceuticals Incorporated
• argenx
• BioRay Pharmaceutical Co., Ltd.
• Shanghai JMT-Bio Inc.
• Beijing Mabworks Biotech Co., Ltd.
• Biogen
• Guangdong Hengrui Pharmaceutical Co., Ltd
• BeOne Medicines
• Hoffmann-La Roche
• Everest Medicines（China）Co.,Ltd.
• Nkarta, Inc.
• Walden Biosciences
• Apellis Pharmaceuticals, Inc.
• Alpine Immune Sciences, Inc.
• Vera Therapeutics, Inc.
• Reistone Biopharma Company Limited

目录

第一章：主要调查结果及分析师说明

• 主要趋势：市场概况、SWOT分析、商业性利益与风险等。

第二章：疾病背景

• 疾病定义、分类、病因和病理生理学、药物标靶等。

第三章：流行病学

• 重点
• 发病率/盛行率
• 已确诊并接受药物治疗的患者人数
• 合併症
• 其他相关患者群

第四章 市场规模及预测

• 重点
• 市场驱动因素与限制因素
• 按药物类别分類的趋势
• 各国具体趋势

第五章 竞争情势

• 目前的治疗方法
  • 重点
  • 诊断和治疗过程/演算法
  • 主要治疗方法概述及KOL洞察
• 新兴治疗方法
  • 重点
  • 值得关注的后期新治疗方法－概述、市场上市预期及KOL洞察
  • 值得关注的早期管道

第六章：未满足的需求与TPP分析

• 主要未满足的需求以及透过新兴治疗方法实现的未来可能性
• TPP分析与KOL展望

第七章 监理与报销环境

第八章附录

Primary Membranous Nephropathy (PMN) Market Outlook

Thelansis's "Primary Membranous Nephropathy (PMN) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report - 2025 To 2035" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Primary Membranous Nephropathy treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Primary Membranous Nephropathy (PMN) Overview

Primary Membranous Nephropathy (PMN) is a specific, autoimmune-mediated glomerular disease and a leading cause of nephrotic syndrome in non-diabetic adults. Clinically, it presents with massive proteinuria (>3.5 g/day), peripheral edema, hypoalbuminemia, hyperlipidemia, and an increased risk of thromboembolic complications, including renal vein thrombosis.

The pathophysiology is characterized by subepithelial deposition of IgG4 autoantibodies and complement complexes (C5b-9 membrane attack complex) along the glomerular basement membrane, leading to podocyte injury and disruption of the filtration barrier.

Modern classification of PMN is based on its molecular drivers. Approximately 70-80% of cases are associated with anti-PLA2R (M-type phospholipase A2 receptor) antibodies, while ~1-5% are linked to THSD7A antibodies. This molecular understanding has significantly transformed disease management, enabling non-invasive diagnosis through serological testing and the use of antibody titers for disease monitoring and risk stratification.

PMN predominantly affects adults, with peak incidence in middle-aged and older populations. Diagnosis is supported by serology and, where required, kidney biopsy.

Treatment strategies include supportive therapy (ACE inhibitors, ARBs, statins, diuretics) and immunosuppressive regimens, including corticosteroids, calcineurin inhibitors, and monoclonal antibodies. Notably, B-cell depleting therapies such as rituximab have become central to modern management, enabling targeted immunological remission.

Despite advances, PMN remains a chronic, relapsing condition, with ongoing risk of progression to chronic kidney disease (CKD) or end-stage renal disease (ESRD), driving continued need for novel targeted therapies.

Key Highlights

• The diagnosed prevalent PMN population in the United States is estimated at 86,410 in 2025, increasing to 97,845 by 2035, reflecting steady disease burden growth.
• The incident diagnosed population grows from 3,297 cases in 2025 to 3,546 cases by 2035, indicating gradual increase in diagnosis rates.
• 34,996 female vs 51,414 male cases in 2025, widening further by 2035 (39,627 females vs 58,218 males).
• The average age of patients is 48 years, with the highest disease burden concentrated in ≥55 years age group.
• The disease is chronic and progressive, with a significant proportion of patients requiring long-term immunosuppressive therapy, contributing to sustained treatment demand.

Market Overview

• The PMN treatment market is valued at $622M in 2025, projected to reach $3.18Bn by 2035, representing a robust CAGR of 17.8% over the forecast period.
• Early-stage market (2025-2027) is dominated by conventional therapies, including: ACE inhibitors / ARBs, Corticosteroids (prednisone, methylprednisolone), Immunosuppressants (cyclosporine, tacrolimus, MMF), Rituximab and IVIG
• By 2035, novel biologics and targeted therapies dominate the market, accounting for the majority of revenue share, significantly shifting the treatment paradigm.

Insights driven by robust research, including:

• In-depth interviews with leading KOLs and payers
• Physician surveys
• RWE analysis for claims and EHR datasets
• Secondary research (e.g., peer-reviewed journal articles, third-party research databases)

Deliverables format and updates*:

• Detailed Report (PDF)
• Market Forecast Model (MS Excel-based automated dashboard)
• Epidemiology (MS Excel; interactive tool)
• Executive Insights (PowerPoint presentation)
• Others: regular updates, customizations, consultant support
• As per Thelansis's policy, we ensure that we include all the recent updates before releasing the report content and market model.

Salient features of Market Forecast model:

• 10-year market forecast (2025-2035)
• Bottom-up patient-based market forecasts validated through the top-down sales methodology
• Covers clinically and commercially-relevant patient populations/ line of therapies
• Annualized drug-level sales and patient share projections
• Utilizes our proprietary Epilansis and Analog tool (e.g., drug uptake and erosion) datasets and conjoint analysis approach
• Detailed methodology/sources & assumptions
• Graphical and tabular outputs
• Users can customize the model based on requirements

Key business questions answered:

• How can drug development and lifecycle management strategies be optimized across G8 markets (US, EU5, Japan, and China)?
• How large is the patient population in terms of incidence, prevalence, segments, and those receiving drug treatments?
• What is the 10-year market outlook for sales and patient share?
• Which events will have the greatest impact on the market's trajectory?
• What insights do interviewed experts provide on current and emerging treatments?
• Which pipeline products show the most promise, and what is their potential for launch and future positioning?
• What are the key unmet needs and KOL expectations for target profiles?
• What key regulatory and payer requirements must be met to secure drug approval and favorable market access?

Countries Covered

• G8
  • United States
  • EU5
    • France
    • Germany
    • Italy
    • Spain
    • U.K.
  • Japan
  • China

Apart from the G8 Market, adding any additional country data to the dashboard/report will cost USD 1,750 per country

Companies Mentioned

• Alexion Pharmaceuticals, Inc.
• Excyte Biopharma Ltd
• Climb Bio, Inc.
• Cerium Pharmaceuticals
• Vertex Pharmaceuticals Incorporated
• argenx
• BioRay Pharmaceutical Co., Ltd.
• Shanghai JMT-Bio Inc.
• Beijing Mabworks Biotech Co., Ltd.
• Biogen
• Guangdong Hengrui Pharmaceutical Co., Ltd
• BeOne Medicines
• Hoffmann-La Roche
• Everest Medicines (China) Co.,Ltd.
• Nkarta, Inc.
• Walden Biosciences
• Apellis Pharmaceuticals, Inc.
• Alpine Immune Sciences, Inc.
• Vera Therapeutics, Inc.
• Reistone Biopharma Company Limited

Table of Contents

1. Key Findings and Analyst Commentary

• Key trends: market snapshots, SWOT analysis, commercial benefits and risks, etc.

2. Disease Context

• Disease definition, classification, etiology and pathophysiology, drug targets, etc.

3. Epidemiology

• Key takeaways
• Incidence / Prevalence
• Diagnosed and Drug-Treated populations
• Comorbidities
• Other relevant patient segments

4. Market Size and Forecast

• Key takeaways
• Market drivers and constraints
• Drug-class specific trends
• Country-specific trends

5. Competitive Landscape

• Current therapies
  • Key takeaways
  • Dx and Tx journey/algorithm
  • Key current therapies - profiles and KOL insights
• Emerging therapies
  • Key takeaways
  • Notable late-phase emerging therapies - profiles, launch expectations, KOL insights
  • Notable early-phase pipeline

6. Unmet Need and TPP Analysis

• Top unmet needs and future attainment by emerging therapies
• TPP analysis and KOL expectations

7. Regulatory and Reimbursement Environments (by country and payer insights)

8. Appendix (e.g., bibliography, methodology)