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狼疮性肾炎药物市场 - 全球及区域 - 分析与预测（2025-2035）
市场调查报告书
商品编码
1789841

狼疮性肾炎药物市场 - 全球及区域 - 分析与预测（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个工作天内

价格

狼疮性肾炎是全身性红斑性狼疮(SLE) 的严重且常见的併发症，SLE 是一种人体免疫系统攻击组织的自体免疫疾病。

在狼疮性肾炎中，免疫系统会攻击肾臟，引起发炎和结构性损伤，尤其是肾小球（肾臟的过滤器官）。这会损害肾功能，如果不及时治疗，可能会发展为末期肾功能衰竭(ESRD)。根据切片检查的组织学观察，狼疮性肾炎可分为六种疾病类型（I-VI 类）。 III 类（局部）、IV 类（瀰漫性）和 V 类（膜性）是临床上最重要的类型，因为它们与活动性发炎和慢性肾臟损伤的风险有关。

狼疮性肾炎盛行率的上升是推动市场成长的主要因素之一。狼疮性肾炎影响约60%的全身性红斑性狼疮(SLE) 患者，主要影响育龄女性和某些族裔群体，例如非裔美国人、亚裔和西班牙裔，病情较为严重。随着人们对狼疮性肾炎严重后果的认识不断提高，诊断和早期疗育也不断提高，从而推动了对有效治疗的需求。

历史上，治疗依赖副作用显着的免疫抑制剂。然而，2020年Benlysta（Benlysta，贝利尤单抗）和2021年Lupkinis（voclosporin）的核准，标誌着治疗转向基于机制的标靶治疗，其疗效和安全性均更佳。这些生物製药和新型小分子药物正在拓展治疗选择，改善患者预后，并推动市场成长。例如，葛兰素史克开发的贝利尤单抗在一项3期临床试验（BLISS-LN）中显示出显着改善肾臟反应，因此获得了FDA核准并迅速应用于临床实践。

儘管取得了这些进展，仍有相当一部分狼疮性肾炎患者对现有治疗方法反应不足或不耐受。这种尚未满足的需求推动了针对B细胞、补体途径和干扰素讯号传导的下一代生物製药的研究和开发。

然而，疾病的复杂性和患者群体的异质性限制着市场的成长。狼疮性肾炎的临床表现和严重程度各不相同，使诊断和治疗的标准化变得复杂。这种异质性挑战药物研发人员，他们需要设计出广泛且个人化的治疗方法。此外，生物製药的高成本限制了药物的可近性，尤其是在新兴市场。较长的治疗週期进一步影响了经济性和依从性。此外，在罕见且异质性的狼疮性肾炎患者群体中进行大规模临床试验需要耗费大量资源和时间，这会延迟药物的核准和上市，并阻碍市场的成长。

开发生物製药与免疫抑制剂或新型药物的联合治疗，以提高临床疗效并减少副作用，为狼疮性肾炎治疗带来了巨大的市场机会。基于生物标记的患者分层应用日益广泛，使得治疗方案更加精准、个人化，进而改善治疗效果。沃氯孢素与Mycophenolate Mofetil和皮质类固醇的联合使用就是一个很好的例子，该方案已显示出良好的肾臟反应率，凸显了多重药物组合方案的商业性潜力。此外，全身性红斑性狼疮(SLE) 和狼疮的盛行率不断上升，加上医疗基础设施的进步，为区域扩张带来了巨大的潜力。同时，包括复杂的生物标记和先进的成像技术在内的诊断技术的创新，正在促进早期诊断和更有效的疾病监测。这些发展不仅改善了患者管理，还间接刺激了对狼疮性肾炎治疗的需求，并推动市场持续成长。

狼疮性肾炎治疗市场竞争激烈，主要生物製药公司占据主导地位，它们既提供成熟的免疫抑制剂，也提供创新的标靶治疗。葛兰素史克凭藉Benlysta（通用名：贝利尤单抗）确立了强势地位，这是首个核准用于狼疮性肾炎的生物製药，并拥有丰富的临床数据和强劲的全球市场营销支持。此外，新兴生技公司正透过干扰素抑制和补体调节等创新机制，推动针对难治性和高风险患者的候选药物研发管线。

本报告研究了全球狼疮性肾炎治疗市场，提供了市场概述以及区域趋势和参与市场的公司概况。

目录

执行摘要

第一章全球狼疮性肾炎药物市场：产业展望

  • 市场概览
  • 狼疮性肾炎区域流行病学分析
  • 监管状况
  • 主要趋势
  • 临床试验分析
  • 市场动态
    • 影响分析
    • 市场驱动因素
    • 市场限制
    • 市场机会

2. 全球狼疮性肾炎治疗市场（按地区，百万美元，2023-2035）

  • 北美洲
  • 欧洲
  • 亚太地区

3. 全球狼疮性肾炎药物市场：竞争格局与公司概况

  • 竞争格局
    • 各公司主要策略及发展
  • 公司简介
    • 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

第四章调查方法

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