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狼瘡性腎炎藥物市場 - 全球及區域 - 分析與預測（2025-2035）
市場調查報告書
商品編碼
1789841

狼瘡性腎炎藥物市場 - 全球及區域 - 分析與預測（2025-2035）

Lupus Nephritis Drugs Market - A Global and Regional Analysis: Analysis and Forecast, 2025-2035
出版日期: | 出版商: BIS Research | 英文 100 Pages | 商品交期: 1-5個工作天內

價格

狼瘡性腎炎是全身性紅斑性狼瘡（SLE）的嚴重且常見的併發症，SLE 是一種人體免疫系統攻擊組織的自體免疫疾病。

在狼瘡性腎炎中，免疫系統會攻擊腎臟，引起發炎和結構性損傷，尤其是腎小球（腎臟的過濾器官）。這會損害腎功能，如果不及時治療，可能會發展為末期腎功能衰竭（ESRD）。根據切片檢查的組織學觀察，狼瘡性腎炎可分為六種疾病類型（I-VI 類）。 III 類（局部）、IV 類（瀰漫性）和 V 類（膜性）是臨床上最重要的類型，因為它們與活動性發炎和慢性腎臟損傷的風險有關。

狼瘡性腎炎盛行率的上升是推動市場成長的主要因素之一。狼瘡性腎炎影響約60%的全身性紅斑性狼瘡（SLE）患者，主要影響育齡女性和某些族裔群體，例如非裔美國人、亞裔和西班牙裔，病情較為嚴重。隨著人們對狼瘡性腎炎嚴重後果的認知不斷提高，診斷和早期療育也不斷提高，推動了對有效治療的需求。

歷史上，治療依賴副作用顯著的免疫抑制劑。然而，2020年Benlysta（belimumab）和2021年Lupkynis（voclosporin）的核准，標誌著治療轉向基於機制的標靶治療，其療效和安全性均更佳。這些生物製藥和新型小分子藥物拓展治療選擇，改善患者預後，並推動市場成長。例如，GlaxoSmithKline開發的Belimumab在一項3期臨床試驗（BLISS-LN）中顯示出顯著改善腎臟反應，因此獲得了FDA核准並迅速應用於臨床實踐。

儘管取得了這些進展，仍有相當一部分狼瘡性腎炎患者對現有治療方法反應不足或不耐受。這種尚未滿足的需求推動了針對B細胞、補體途徑和干擾素訊號傳導的下一代生物製藥的研究和開發。

然而，疾病的複雜性和患者群體的異質性限制著市場的成長。狼瘡性腎炎的臨床表現和嚴重程度各不相同，使診斷和治療的標準化變得複雜。這種異質性挑戰藥物研發人員，他們需要設計出廣泛且個人化的治療方法。此外，生物製藥的高成本限制了藥物的可近性，尤其是在新興市場。較長的治療週期進一步影響了經濟性和依從性。此外，在罕見且異質性的狼瘡性腎炎患者群體中進行大規模臨床試驗需要耗費大量資源和時間，這會延遲藥物的核准和上市，並阻礙市場的成長。

開發生物製藥與免疫抑制劑或新型藥物的聯合治療，以提高臨床療效並減少副作用，為狼瘡性腎炎治療帶來了巨大的市場機會。基於生物標記的患者分層應用日益廣泛，使得治療方案更加精準、個人化，進而改善治療效果。Voclosporin與Mycophenolate Mofetil和皮質類固醇的聯合使用就是一個很好的例子，該方案已顯示出良好的腎臟反應率，凸顯了多重藥物組合方案的商業性潛力。此外，全身性紅斑性狼瘡（SLE）和狼瘡的盛行率不斷上升，加上醫療基礎設施的進步，為區域擴張帶來了巨大的潛力。同時，包括複雜的生物標記和先進的成像技術在內的診斷技術的創新，促進早期診斷和更有效的疾病監測。這些發展不僅改善了患者管理，還間接刺激了對狼瘡性腎炎治療的需求，並推動市場持續成長。

狼瘡性腎炎治療市場競爭激烈，主要生物製藥公司佔據主導地位，它們既提供成熟的免疫抑制劑，也提供創新的標靶治療。GlaxoSmithKline憑藉Benlysta（通用名：Belimumab）確立了強勢地位，這是首個核准用於狼瘡性腎炎的生物製藥，並擁有豐富的臨床資料和強勁的全球市場行銷支持。此外，新興生技公司正透過干擾素抑制和補體調節等創新機制，推動針對難治性和高風險患者的候選藥物研發管線。

本報告研究了全球狼瘡性腎炎治療市場，提供了市場概述以及區域趨勢和參與市場的公司概況。

目錄

執行摘要

第1章 全球狼瘡性腎炎藥物市場：產業展望

  • 市場概覽
  • 狼瘡性腎炎區域流行病學分析
  • 監管狀況
  • 主要趨勢
  • 臨床試驗分析
  • 市場動態
    • 影響分析
    • 市場促進因素
    • 市場限制
    • 市場機會

第2章 全球狼瘡性腎炎治療市場（依地區，百萬美元，2023-2035）

  • 北美洲
  • 歐洲
  • 亞太地區

第3章 全球狼瘡性腎炎藥物市場：競爭格局與公司概況

  • 競爭格局
    • 各公司主要策略及發展
  • 公司簡介
    • AstraZeneca
    • Novartis Pharmaceuticals Corporation
    • F. Hoffmann-La Roche Ltd
    • GlaxoSmithKline plc
    • Kyverna Therapeutics
    • Lyell Immunopharma（ImmPACT Bio）
    • Otsuka Pharmaceutical Co., Ltd.
    • Aurinia Pharmaceuticals Inc.
    • LiveKidney

第4章 調查方法

Product Code: BHL3169SA

Global Lupus Nephritis Drugs Market, Analysis and Forecast: 2025-2035

Lupus Nephritis is a serious and common complication of systemic lupus erythematosus (SLE), an autoimmune disease in which the body's immune system attacks its tissues. In lupus nephritis, the immune system targets the kidneys, causing inflammation and structural damage, particularly in the glomeruli, the filtering units of the kidneys. This leads to impaired kidney function and, if untreated, can progress to end-stage renal disease (ESRD). Lupus nephritis is classified into six types (Class I to VI) based on histological findings from kidney biopsy, with Class III (focal), Class IV (diffuse), and Class V (membranous) forms being the most clinically significant due to their association with active inflammation and risk of chronic kidney damage.

The increasing prevalence of lupus nephritis is one of the major factors driving the market growth. Lupus nephritis affects approximately 60% of patients with systemic lupus erythematosus (SLE), predominantly impacting women of reproductive age and certain ethnic groups such as African Americans, Asians, and Hispanics, who experience more severe disease. Growing awareness of lupus nephritis' serious consequences has led to increased diagnosis rates and early intervention, driving demand for effective therapeutics.

Historically, treatment relied on broad-spectrum immunosuppressants with significant side effects. However, the approval of Benlysta (belimumab) in 2020 and Lupkynis (voclosporin) in 2021 marks a transformative shift toward targeted, mechanism-based therapies with better efficacy and safety profiles. These biologics and novel small molecules have expanded treatment options and improved patient outcomes, encouraging market growth. For instance, Belimumab, developed by GlaxoSmithKline, showed significant renal response improvements in Phase 3 trials (BLISS-LN study), leading to its FDA approval and rapid adoption in clinical practice.

Despite advances, a substantial subset of lupus nephritis patients exhibits inadequate response or intolerance to existing therapies. This unmet need drives ongoing R&D investments into next-generation biologics targeting B cells, complement pathways, and interferon signaling.

However, the complexity of the disease and the heterogeneous patient population are restraining the market growth. Lupus nephritis presents varied clinical manifestations and disease severity, complicating diagnosis and treatment standardization. This heterogeneity challenges drug developers to design broad-acting yet personalized therapies. Also, biologics and novel therapies carry high costs, limiting access, especially in emerging markets. Long-term treatment duration further impacts affordability and adherence. Moreover, conducting large-scale clinical trials in rare and heterogeneous lupus nephritis populations is resource-intensive and slow, delaying drug approvals and market entry, thereby hampering market growth.

Significant market opportunities in lupus nephritis are emerging from the development of combination therapies that pair biologics with immunosuppressants or novel agents, aiming to enhance clinical efficacy while reducing adverse effects. The increasing utilization of biomarker-driven patient stratification is enabling more precise and personalized treatment protocols, thereby improving therapeutic outcomes. A pertinent example is the use of voclosporin in combination with mycophenolate mofetil and corticosteroids, which has demonstrated superior renal response rates, underscoring the commercial potential of multi-agent regimens. Furthermore, the growing prevalence of systemic lupus erythematosus (SLE) and lupus, alongside advancements in healthcare infrastructure, presents substantial avenues for geographic expansion. Concurrently, innovations in diagnostic technologies, including refined biomarkers and advanced imaging techniques, are facilitating earlier diagnosis and more effective disease monitoring. These developments not only improve patient management but also indirectly stimulate demand for lupus nephritis therapeutics, positioning the market for sustained growth.

The lupus nephritis drug market is highly competitive, dominated by leading biopharmaceutical companies offering both established immunosuppressants and innovative targeted therapies. GlaxoSmithKline holds a strong position with Benlysta (belimumab), the first FDA-approved biologic specifically for lupus nephritis, supported by extensive clinical data and robust global marketing. Additionally, emerging biotech firms are advancing pipeline candidates targeting refractory and high-risk patients through innovative mechanisms like interferon inhibition and complement modulation.

Table of Contents

Executive Summary

Scope and Definition

Market/Product Definition

Key Questions Answered

Analysis and Forecast Note

1. Global Lupus Nephritis Drugs Market: Industry Outlook

  • 1.1 Market Overview
  • 1.2 Epidemiological Analysis of Lupus Nephritis, By Region
  • 1.3 Regulatory Landscape
  • 1.4 Key Trends
  • 1.5 Clinical Trial Analysis
  • 1.6 Market Dynamics
    • 1.6.1 Impact Analysis
    • 1.6.2 Market Drivers
    • 1.6.3 Market Restraint
    • 1.6.4 Market Opportunities

2. Global Lupus Nephritis Drugs Market, by Region, $Million, 2023-2035

  • 2.1 North America
    • 2.1.1 Market Dynamics
    • 2.1.2 Market Size and Forecast
      • 2.1.2.1 North America Lupus Nephritis Drugs Market, by Country
        • 2.1.2.1.1 U.S.
  • 2.2 Europe
    • 2.2.1 Market Dynamics
    • 2.2.2 Market Size and Forecast
      • 2.2.2.1 Europe Lupus Nephritis Drugs Market, by Country
        • 2.2.2.1.1 Germany
        • 2.2.2.1.2 U.K.
        • 2.2.2.1.3 France
        • 2.2.2.1.4 Italy
        • 2.2.2.1.5 Spain
  • 2.3 Asia-Pacific
    • 2.3.1 Market Dynamics
    • 2.3.2 Market Size and Forecast
      • 2.3.2.1 Asia-Pacific Lupus Nephritis Drugs Market, by Country
        • 2.3.2.1.1 Japan

3. Global Lupus Nephritis Drugs Market: Competitive Landscape and Company Profiles

  • 3.1 Competitive Landscape
    • 3.1.1 Key Strategies and Developments by Company
      • 3.1.1.1 Funding Activities
      • 3.1.1.2 Mergers and Acquisitions
      • 3.1.1.3 Regulatory Approvals
      • 3.1.1.4 Partnerships, Collaborations and Business Expansions
  • 3.2 Company Profiles
    • 3.2.1 AstraZeneca
      • 3.2.1.1 Overview
      • 3.2.1.2 Product Portfolio
      • 3.2.1.3 Target Customers
      • 3.2.1.4 Key Personnel
      • 3.2.1.5 Analyst View
    • 3.2.2 Novartis Pharmaceuticals Corporation
      • 3.2.2.1 Overview
      • 3.2.2.2 Product Portfolio
      • 3.2.2.3 Target Customers
      • 3.2.2.4 Key Personnel
      • 3.2.2.5 Analyst View
    • 3.2.3 F. Hoffmann-La Roche Ltd
      • 3.2.3.1 Overview
      • 3.2.3.2 Product Portfolio
      • 3.2.3.3 Target Customers
      • 3.2.3.4 Key Personnel
      • 3.2.3.5 Analyst View
    • 3.2.4 GlaxoSmithKline plc
      • 3.2.4.1 Overview
      • 3.2.4.2 Product Portfolio
      • 3.2.4.3 Target Customers
      • 3.2.4.4 Key Personnel
      • 3.2.4.5 Analyst View
    • 3.2.5 Kyverna Therapeutics
      • 3.2.5.1 Overview
      • 3.2.5.2 Product Portfolio
      • 3.2.5.3 Target Customers
      • 3.2.5.4 Key Personnel
      • 3.2.5.5 Analyst View
    • 3.2.6 Lyell Immunopharma (ImmPACT Bio)
      • 3.2.6.1 Overview
      • 3.2.6.2 Product Portfolio
      • 3.2.6.3 Target Customers
      • 3.2.6.4 Key Personnel
      • 3.2.6.5 Analyst View
    • 3.2.7 Otsuka Pharmaceutical Co., Ltd.
      • 3.2.7.1 Overview
      • 3.2.7.2 Product Portfolio
      • 3.2.7.3 Target Customers
      • 3.2.7.4 Key Personnel
      • 3.2.7.5 Analyst View
    • 3.2.8 Aurinia Pharmaceuticals Inc.
      • 3.2.8.1 Overview
      • 3.2.8.2 Product Portfolio
      • 3.2.8.3 Target Customers
      • 3.2.8.4 Key Personnel
      • 3.2.8.5 Analyst View
    • 3.2.9 LiveKidney
      • 3.2.9.1 Overview
      • 3.2.9.2 Product Portfolio
      • 3.2.9.3 Target Customers
      • 3.2.9.4 Key Personnel
      • 3.2.9.5 Analyst View

4. Research Methodology

List of Figures

Figure Global Lupus Nephritis Drugs Market, Market Overview

  • Figure: Global Lupus Nephritis Drugs Market Key Trends, Impact Analysis, 2023-2035
  • Figure: Global Lupus Nephritis Drugs Market, Competitive Landscape, January 2022-Julyy 2025

List of Tables

  • Table: Global Lupus Nephritis Drugs Market, Regulatory Scenario
  • Table: Global Lupus Nephritis Drugs Market Dynamics, Impact Analysis