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市場調查報告書
商品編碼
2017487

原發性膜性腎臟病（PMN）：市場展望、流行病學、競爭格局、市場預測報告（2025-2035年）

Primary Membranous Nephropathy (PMN) - Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report - 2025 To 2035
出版日期: | 出版商: Thelansis Knowledge Partners | 英文 152 Pages | 商品交期: 2-3個工作天內

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簡介目錄

市場概覽

  • 2025年PMN治療市場價值為6.22億美元，預計2035年將達到31.8億美元。這意味著在預測期內，複合年成長率將達到17.8%。
  • 在市場早期階段（2025-2027 年），ACE 抑制劑/ARB、皮質類固醇（潑尼松、Methylprednisolone）、免疫抑制劑（Cyclosporine、Tacrolimus、MMF）、利Rituximab和 IVIG 等傳統治療方法將佔據主導地位。
  • 到 2035 年，新型生物製藥和標靶治療預計將主導市場並佔據大部分收入，從而極大改變治療模式。

原發性膜腎臟病（PMN）概述

原發性膜性腎臟病（PMN）是一種特異性自體免疫腎絲球疾病，也是非糖尿病成人腎病變症候群的主要原因之一。臨床上，它表現為大量蛋白尿（≥3.5 g/天）、周邊水腫、低白蛋白血症、高血脂症以及血栓栓塞併發症（包括腎靜脈血栓症）風險增加。

其病理生理特徵是 IgG4 自體抗體和補體複合物（C5b-9 膜攻擊複合物）沉積在腎小球基底膜上皮下，導致足細胞損傷和濾過屏障破壞。

現代多形核白血病 (PMN) 的分類是基於其分子機制。約 70-80% 的病例與抗 PLA2R（M 型磷脂酶 A2 受體）抗體相關，約 1-5% 的病例與抗 THSD7A 抗體相關。這種分子層面的認知顯著改變了疾病管理，使得透過血清學檢測進行非侵入性診斷成為可能，並可利用抗體滴度進行疾病後續觀察和風險分層。

多形性嗜中性球性腎病變（PMN）主要影響成人，發生率在中老年人群最高。診斷主要透過血清學檢測，必要時可進行切片檢查。

治療策略包括支持性治療（血管緊張素轉換酶抑制劑、血管緊張素受體阻斷劑、他汀類藥物、利尿劑）和免疫抑制療法，包括糖皮質激素、Calcineurin抑制劑和單株抗體。特別是，Rituximab等B細胞清除療法已成為現代治療的核心，因為它們能夠實現標靶免疫緩解。

儘管取得了進展，但 PMN 仍然是一種慢性複發性疾病，發展為慢性腎臟病(CKD) 和末期腎功能衰竭(ESRD) 的風險仍然存在，因此對新的標靶治療的需求日益成長。

主要亮點

  • 據估計，到 2025 年，美國患有 PMN 的人數為 86,410 人，預計到 2035 年將增加到 97,845 人，反映出疾病負擔的穩定增加。
  • 預計2025年新確診患者人數為3,297人，2035年為3,546人，顯示診斷率將逐漸上升。
  • 2025 年，女性病例為 34,996 例，男性病例為 51,414 例，預計到 2035 年，這一差距將進一步擴大（女性病例為 39,627 例，男性病例為 58,218 例）。
  • 患者平均年齡為 48 歲，疾病負擔最重的人集中在 55 歲及以上年齡層。
  • 這種疾病是慢性進行性，相當一部分患者需要長期接受免疫抑制治療，因此對治療的需求持續存在。

格式化和更新訊息

  • 詳細報告（PDF）
  • 市場預測模型（基於微軟Excel）
  • 流行病學數據（MS Excel，互動式工具）
  • 高階主管洞察（PPT簡報）
  • 其他功能：定期更新、自訂和顧問支援。
  • 根據 Thelansis 的政策，我們確保所有最新更新在發布前都反映在報告內容和市場模型中。

主要問題

  • 我們如何最佳化 G8 市場（美國、歐盟 5 國、日本、中國）的藥物開發與生命週期管理策略？
  • 從發病率、盛行率、人群組成以及接受藥物治療的患者人數來看，患者數量分別是多少？
  • 未來十年市場收入和病患佔有率的預測是多少？
  • 哪些因素對市場趨勢影響最大？
  • 受訪專家對目前和新興的治療方法有何看法？
  • 哪款在研發線產品最有前景？其上市潛力及未來市場定位如何？
  • 主要未被滿足的需求是什麼？ KOL 對目標受眾有何期望？
  • 為確保藥物核准並順利進入市場，必須滿足哪些關鍵的監管和支付方要求？

目標國家

  • G8
    • 美國
    • EU5
      • 法國
      • 德國
      • 義大利
      • 西班牙
      • 英國
    • 日本
    • 中國

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

目錄

第1章：主要調查結果及分析師說明

  • 主要趨勢：市場概況、SWOT分析、商業性利益與風險等。

第2章：疾病背景

  • 疾病定義、分類、病因和病理生理學、藥物標靶等。

第3章：流行病學

  • 重點
  • 發病率/盛行率
  • 已確診並接受藥物治療的患者人數
  • 合併症
  • 其他相關患者群

第4章 市場規模及預測

  • 重點
  • 市場促進因素與限制因素
  • 按藥物類別分類的趨勢
  • 各國具體趨勢

第5章 競爭情勢

  • 目前的治療方法
    • 重點
    • 診斷和治療過程/演算法
    • 主要治療方法概述及KOL洞察
  • 新興治療方法
    • 重點
    • 值得關注的後期新治療方法－概述、市場上市預期及KOL洞察
    • 值得關注的早期管道

第6章：未滿足的需求與TPP分析

  • 主要未滿足的需求以及透過新興治療方法實現的未來可能性
  • TPP分析與KOL展望

第7章 監理與報銷環境

第8章附錄

簡介目錄

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)