ループス腎炎 - 市場考察、疫学、市場予測（2034年）

主なハイライト

• ループス腎炎は臓器を脅かす重篤な全身性エリテマトーデス（SLE）の症状であり、SLE患者の40～60%に発症します。ループス腎炎の徴候には血尿（尿に血が混じる）やタンパク尿（尿にタンパクが混じる）があります。ループス腎炎は女性に多く、20～40歳の患者に発症します。
• ループス腎炎の最適な治療は、腎生検における形態学的所見の分類によって異なります。副腎皮質ステロイドと免疫抑制剤の併用がループス腎炎の治療の主流です。一般的な免疫抑制薬には、シクロホスファミド、ミコフェノール酸モフェチル、アザチオプリン、カルシニューリン阻害薬などがあります。
• 現在、ループス腎炎の治療薬としてFDAに承認されているのは2種類のみです。BENLYSTA（belimumab）は2020年12月に成人、2022年7月に5～17歳の活動性ループス腎炎の小児を対象に承認を取得し、点滴静注と皮下注射の両方の剤形があります。一方、2021年1月に承認されたLUPKYNIS（voclosporin）は、ループス腎炎に対する初の経口治療薬であり、ループスに関連した腎臓病患者にとっての重要なマイルストーンとなります。
• ループス腎炎に対する新たなパイプラインには、ianalumab（VAY736）、zetomipzomib（KZR-616）、GAZYVA/GAZYVARO（obinutuzumab）、SAPHNELO（anifrolumab）、iptacopan、ULTOMIRIS（ravulizumab）などを含む、後期段階と初期段階（フェーズ3、フェースII/III、フェーズII、フェーズI/II）にある複数の有力な治療薬があり、予測期間に市場に大きな変化をもたらす可能性があります。
• 2024年9月、Rocheはループス腎炎を対象としたGAZYVA/GAZYVARO（obinutuzumab）のフェーズ3 REGENCY試験の良好なトップライン結果を発表しました。データは米国FDAとEMAを含む保健機関と共有されます。
• AstraZenecaの2024年第2四半期企業プレゼンテーションによると、SAPHNELO（anifrolumab）のフェーズ3 IRIS試験で予測されるデータは2025年に発表される予定です。
• 主要7市場のループス腎炎の市場規模は、2023年に米国が80%を超える高いシェアを占め、日本、スペインがこれに続きます。
• 米国では、2023年のループス腎炎の症例数はクラスIVがもっとも多いです。
• 2023年のループス腎炎の有病者数は、日本が2番目に多いです。

ループス腎炎（LN）市場の見通し

rituximabは現在、ループス腎炎にもっともよく使用されているモノクローナル抗体（mAb）であり、ステロイドを温存する特性や難治性・再発例への有効性から支持されています。現在、FDAが承認しているループス腎炎の治療薬は、点滴静注またはSC注射のBENLYSTA（belimumab）と、唯一の経口治療薬で新規のカルシニューリン阻害薬であるLUPKYNIS（voclosporin）の2種類のみです。

Novartis、AstraZeneca、Roche、Kezar Life Sciencesなどの数社が、ループス腎炎の治療法を再構築する可能性のある新薬候補を開発しています。これらのアプローチには、B細胞枯渇剤（obinutuzumab）、抗B細胞活性化剤（ianalumab）、選択的免疫プロテアソーム阻害薬（zetomipzomib）、インターフェロンαβ受容体拮抗剤（anifrolumab）などが含まれます。さらに、近年の臨床例は、抗CD19 CAR-T細胞療法がLN治療に大きな影響を与える可能性を示しています。特にNovartisは、ループス腎炎に対する可能性のある選択肢として、抗CD19 CAR-T細胞療法であるYTB323（Rapcabtagene autoleucel）を研究しています。

一言で言えば、ループス腎炎を治療するために多くの可能性のある治療法が研究されているということです。予測期間（2024年～2034年）に市場に参入する上記の有力な候補についてコメントするのは時期尚早ですが、この市場の将来は明るいと考えられます。最終的には、これらの薬剤が今後数年間で情勢に大きな変化をもたらすと見られます。この治療領域は、世界の医療支出の改善により、今後数年間で大きくプラスに転じると予測されます。

当レポートでは、ループス腎炎の主要7市場（米国、ドイツ、スペイン、イタリア、フランス、英国、日本）について調査分析し、各地域の市場規模、現在の治療法、アンメットニーズ、新薬などの情報を提供しています。

目次

第1章 重要考察

第2章 レポートのイントロダクション

第3章 ループス腎炎市場の概要

• 主要7市場における市場シェアの分布（2020年）
• 主要7市場における市場シェアの分布（2034年）

第4章 ループス腎炎のエグゼクティブサマリー

第5章 重要な出来事

第6章 疫学と市場予測の調査手法

第7章 疾患の背景と概要

• イントロダクション
• 溶血性尿毒症症候群の種類
• ループス腎炎の危険因子と原因
• ループス腎炎の兆候と症状
• ループス腎炎の病態生理学
• 補体タンパク質の変異
• ループス腎炎の臨床症状
• ループス腎炎の診断と鑑別診断
  • ループス腎炎の診断アルゴリズム
  • 血液検査
  • 特異的検査
  • 遺伝子検査
  • 鑑別診断
  • 診断ガイドライン

第8章 ループス腎炎の現在の治療法

• ループス腎炎の治療アルゴリズム
  • 血漿交換
  • Eculizumab
  • Ravulizumab
  • 腎臓移植
  • 肝臓移植
• 治療ガイドライン
  • European Rare Kidney Disease Reference Networkの小児のループス腎炎の管理に関するガイドライン
  • 英国のループス腎炎の管理に関する診療ガイドライン
  • National Institute for Health and Research

第9章 ペイシェントジャーニー

第10章 疫学と患者人口

• 主な調査結果
• ループス腎炎の前提条件と根拠
• 主要7市場のループス腎炎の患者数
• 主要7市場のループス腎炎の診断数
• 米国
• 欧州4ヶ国・英国
• 日本

第11章 上市済みの治療法

• 上市済みの治療法の主な競合
• SOLIRIS（eculizumab）：Alexion Pharmaceuticals
  • 製品の説明
  • 規制のマイルストーン
  • その他の開発活動
  • 臨床開発
  • 安全性と有効性
• ULTOMIRIS（ravulizumab-cwvz）：Alexion Pharmaceuticals

第12章 新治療法

• 新治療法の主な競合
• Crovalimab（RG6107; SKY59）：Hoffmann-La Roche/Chugai
  • 製品の説明
  • 臨床開発
• Iptacopan（Lupus NephritisP023）：Novartis Pharmaceuticals

第13章 ループス腎炎：主要7市場の分析

• 主な調査結果
• 市場見通し
• コンジョイント分析
• 主な市場予測の前提条件
  • コストの想定とリベート
  • 価格動向
  • アナログの評価
  • 発売年と治療の普及
• 主要7市場のループス腎炎の総市場規模（2020年～2034年）
• 主要7市場のループス腎炎の市場規模：治療法別
• 米国の市場規模
  • 米国のループス腎炎の総市場規模
  • 米国のループス腎炎の市場規模：治療法別
• 欧州4ヶ国・英国の市場規模
  • 欧州4ヶ国・英国のループス腎炎の総市場規模
  • 欧州4ヶ国・英国のループス腎炎の市場規模：治療法別
• 日本の市場規模
  • 日本のループス腎炎の総市場規模
  • 日本のループス腎炎の市場規模：治療法別

第14章 アンメットニーズ

第15章 SWOT分析

第16章 KOLの見解

第17章 市場参入と償還

• 米国
• 欧州4ヶ国・英国
  • ドイツ
  • フランス
  • イタリア
  • スペイン
  • 英国
• 日本
• ループス腎炎における償還シナリオと主なHTAの決定
  • 患者アクセスプログラム
  • HTAの決定

第18章 付録

第19章 DelveInsightのサービス内容

第20章 免責事項

第21章 DelveInsightについて

List of Tables

• Table 1: Summary of Lupus Nephritis Market, and Epidemiology (2023-2034)
• Table 2: EULAR/ERA-EDTA Recommendations for the Diagnosis of Lupus Nephritis
• Table 3: American College of Rheumatology Guidelines for Screening of Lupus Nephritis
• Table 4: KDIGO 2024 Clinical Practice Guidelines for the Diagnosis of Lupus Nephritis
• Table 5: Treatment of Lupus Nephritis
• Table 6: EULAR/ERA-EDTA Recommendations for the Management of Lupus Nephritis
• Table 7: American College of Rheumatology Guidelines for Treatment and Management of Lupus Nephritis
• Table 8: KDIGO 2024 Clinical Practice Guideline for the Management of Lupus Nephritis
• Table 9: Total Cases of Lupus Nephritis in 7MM (2020-2034)
• Table 10: Total Diagnosed Cases of Lupus Nephritis in 7MM (2020-2034)
• Table 11: Total Treated Cases of Lupus Nephritis in the 7MM (2020-2034)
• Table 12: Total Lupus Nephritis Diagnosed Cases in the US(2020-2034)
• Table 13: Total Diagnosed Cases of Lupus Nephritis in the US(2020-2034)
• Table 14: Age-specific Cases of Lupus Nephritis in the US (2020-2034)
• Table 15: Class-specific Cases of Lupus Nephritis in the US (2020-2034)
• Table 16: Total Treated Cases of Lupus Nephritis in the US (2020-2034)
• Table 17: Total Cases of Lupus Nephritis in EU4 and the UK (2020-2034)
• Table 18: Total Diagnosed Cases of Lupus Nephritis in EU4 and the UK (2020-2034)
• Table 19: Age-specific Cases of Lupus Nephritis in EU4 and the UK (2020-2034)
• Table 20: Class-specific Cases of Lupus Nephritis in EU4 and the UK (2020-2034)
• Table 21: Total Treated Cases of Lupus Nephritis in EU4 and the UK (2020-2034)
• Table 22: Total Lupus Nephritis Diagnosed Cases in the Japan (2020-2034)
• Table 23: Total Diagnosed Cases of Lupus Nephritis in the Japan (2020-2034)
• Table 24: Age-specific Cases of Lupus Nephritis in the Japan (2020-2034)
• Table 25: Class-specific Cases of Lupus Nephritis in the Japan (2020-2034)
• Table 26: Total Treated Cases of Lupus Nephritis in the Japan (2020-2034)
• Table 27: Key Cross
• Table 28: LUPKYNIS (voclosporin) Clinical Trial Description, 2024
• Table 29: Comparison of Emerging Drugs Under Development
• Table 30: SAPHNELO (anifrolumab), Clinical Trial Description, 2024
• Table 31: Ianalumab (VAY736) , Clinical Trial Description, 2024
• Table 32: Zetomipzomib, Clinical Trial Description, 2024
• Table 33: ULTOMIRIS, Clinical Trial Description, 2024
• Table 34: CABA-201, Clinical Trial Description, 2024
• Table 35: Obinutuzumab, Clinical Trial Description, 2024
• Table 36: Iptacopan, Clinical Trial Description, 2024
• Table 37: YTB323, Clinical Trial Description, 2024
• Table 38: Key Market Forecast Assumption of Lupus Nephritis in the US
• Table 39: Key Market Forecast Assumption of Lupus Nephritis in EU4 and the UK
• Table 40: Key Market Forecast Assumption of Lupus Nephritis in Japan
• Table 41: Total Market Size of Lupus Nephritis in the 7MM in USD million (2020-2034)
• Table 42: Market Size of Lupus Nephritis by Therapies in the 7MM in USD million (2020-2034)
• Table 43: Total Market Size of Lupus Nephritis in the United States in USD million (2020-2034)
• Table 44: Market Size of Lupus Nephritis by Therapies in the United States in USD million (2020-2034)
• Table 45: Total Market Size of Lupus Nephritis in EU4 and the UK in USD million (2020-2034)
• Table 46: Market Size of Lupus Nephritis by Therapies in EU4 and the UK in USD million (2020-2034)
• Table 47: Total Market Size of Lupus Nephritis in Japan in USD million (2020-2034)
• Table 48: Market Size of Lupus Nephritis by Therapies in Japan in USD million (2020-2034)
• Table 49: NICE Assessment for Lupus Nephritis Therapies
• Table 50: Medical service rendered (SMR)
• Table 51: Improvement in actual benefit (ASMR)

List of Figures

• Figure 1: Understanding of Lupus Nephritis
• Figure 2: Types of Lupus
• Figure 3: Risk Factors of lupus nephritis
• Figure 4: Classification of Lupus Nephritis (lupus nephritis)
• Figure 5: Pathophysiology of Lupus Nephritis
• Figure 6: Risk Factors of Lupus Nephritis
• Figure 7: Diagnosis of Lupus Nephritis
• Figure 8: Diagnosis of Lupus Nephritis
• Figure 9: Diagnosis of Lupus Nephritis
• Figure 10: Treatment of Lupus Nephritis
• Figure 11: Total Cases of Lupus Nephritis in 7MM (2020-2034)
• Figure 12: Total Diagnosed Cases of Lupus Nephritis in 7MM (2020-2034)
• Figure 13: Total Treated Cases of Lupus Nephritis in 7MM (2020-2034)
• Figure 14: Total Lupus Nephritis Cases in the US (2020-2034)
• Figure 15: Total Diagnosed Cases of Lupus Nephritis in the US (2020-2034)
• Figure 16: Age-specific Cases of Lupus Nephritis in the US (2020-2034)
• Figure 17: Class-specific Cases of Lupus Nephritis in the US (2020-2034)
• Figure 18: Total Treated Cases of Lupus Nephritis in the US (2020-2034)
• Figure 19: Total Cases of Lupus Nephritis in EU4 and the UK (2020-2034)
• Figure 20: Total Diagnosed Cases of Lupus Nephritis in EU4 and the UK (2020-2034)
• Figure 21: Age-specific Cases of Lupus Nephritis in EU4 and the UK (2020-2034)
• Figure 22: Class-specific Cases of Lupus Nephritis in EU4 and the UK (2020-2034)
• Figure 23: Total Treated Cases of Lupus Nephritis in EU4 and the UK (2020-2034)
• Figure 24: Total Lupus Nephritis Cases in the Japan (2020-2034)
• Figure 25: Total Diagnosed Cases of Lupus Nephritis in the Japan (2020-2034)
• Figure 26: Age-specific Cases of Lupus Nephritis in the Japan (2020-2034)
• Figure 27: Class-specific Cases of Lupus Nephritis in the Japan (2020-2034)
• Figure 28: Total Treated Cases of Lupus Nephritis in the Japan (2020-2034)
• Figure 29: Total Market Size of Lupus Nephritis in the 7MM (2020-2034)
• Figure 30: Market Size of Lupus Nephritis by Therapies in the 7MM (2020-2034)
• Figure 31: Total Market Size of Lupus Nephritis in the US (2020-2034)
• Figure 32: Market Size of Lupus Nephritis by Therapies in the United States (2020-2034)
• Figure 33: Total Market Size of Lupus Nephritis in EU4 and the UK (2020-2034)
• Figure 34: Market Size of Lupus Nephritis by Therapies in EU4 and the UK (2020-2034)
• Figure 35: Market Size of Lupus Nephritis by Therapies in EU4 and the UK (2020-2034)
• Figure 36: Total Market Size of Lupus Nephritis in Japan (2020-2034)
• Figure 37: Total Market Size of Lupus Nephritis in Japan (2020-2034)
• Figure 38: Market Size of Lupus Nephritis by Therapies in Japan (2020-2034)
• Figure 39: Market Size of Lupus Nephritis by Therapies in Japan (2020-2034)
• Figure 40: Health Technology Assessment
• Figure 41: Reimbursement Process in Germany
• Figure 42: Reimbursement Process in France
• Figure 43: Reimbursement Process in Italy
• Figure 44: Reimbursement Process in Spain
• Figure 45: Reimbursement Process in the United Kingdom
• Figure 46: Reimbursement Process in Japan

Key Highlights:

• Lupus nephritis is a severe, organ-threatening manifestation of systemic lupus erythematosus (SLE), developed in 40-60% of patients with SLE. Signs of lupus nephritis include hematuria (blood in the urine) and proteinuria (protein in the urine). Lupus nephritis is more common in women and occurs in patients aged 20-40.
• The optimal treatment of lupus nephritis varies with the classification of the morphological findings in kidney biopsy. Corticosteroids combined with immunosuppressants have been the mainstay of treating lupus nephritis. Common immunosuppressive medications include cyclophosphamide, mycophenolate mofetil, azathioprine, and calcineurin inhibitors.
• Currently, only two FDA-approved medications for the treatment of lupus nephritis exist. BENLYSTA (belimumab) received approval in December 2020 for adults and in July 2022 for children aged 5-17 with active lupus nephritis, available in both IV infusion and subcutaneous injection forms. Whereas, LUPKYNIS (voclosporin) got approved in January 2021, marking the first oral treatment for lupus nephritis and representing a significant milestone for people living with lupus-related kidney disease.
• The emerging pipeline for lupus nephritis includes several potential drugs in late and early stages (Phase III, II/III, II, and I/II) that include ianalumab (VAY736), zetomipzomib (KZR-616), GAZYVA/GAZYVARO (obinutuzumab), SAPHNELO (anifrolumab), iptacopan, ULTOMIRIS (ravulizumab), and others, which can bring about significant change in the market during the forecast period.
• In September 2024, Roche announced positive topline results from the Phase III REGENCY study of GAZYVA/GAZYVARO (obinutuzumab) in lupus nephritis. Data is being shared with health authorities, including the US FDA and the EMA.
• As per AstraZeneca's 2024 second-quarter corporate presentation, the data anticipated for the Phase III IRIS trial of SAPHNELO (anifrolumab) is to be announced > in 2025.
• In the total market size of Lupus Nephritis in the 7MM, the United States accounted for the highest market share that is more than 80% in 2023, followed by Japan and the Spain.
• In the United States, Class IV accounts for the highest number of cases of Lupus Nephritis in 2023.
• Japan accounts for the second-highest number of prevalent cases of Lupus Nephritis in 2023.

Report Summary

• The report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
• Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of late-stage (Phase III and Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
• The report also encompasses a comprehensive analysis of the LN market, providing an in-depth examination of its historical and projected market size (2020-2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
• The report includes qualitative insights that provide an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM LN market.

Market

Various key players are leading the treatment landscape of Lupus Nephritis, such as Aurinia Pharmaceuticals, GlaxoSmithKline, Novartis, AstraZeneca, and Roche. The details of the country-wise and therapy-wise market size have been provided below.

• In the total market size of Lupus Nephritis in the 7MM, the United States accounted for the highest market share, i.e. more than 80% in 2023, followed by Japan and the Spain.
• Among EU4 and the UK, Spain accounted for more than 30% of the market size in 2023.
• The United States accounted for approximately USD 1,500 million in 2023.
• Among the emerging therapies, GAZYVA/GAZYVARO (obinutuzumab) and SAPHNELO (anifrolumab) appear to be the drugs that can potentially transform the LN market.
• By 2034, among the emerging therapies, the highest revenue is expected to be generated by SAPHNELO (anifrolumab), i.e., more than USD 300 million in the United States.

Lupus Nephritis (LN) Drug Chapters

The section dedicated to drugs in the Lupus Nephritis report provides an in-depth evaluation of late-stage pipeline drugs (Phase III and Phase II) related to Lupus Nephritis. The drug chapters section provides valuable information on various aspects related to clinical trials of Lupus Nephritis, 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 Lupus Nephritis.

Marketed Therapies

LUPKYNIS (voclosporin): Aurinia Pharmaceuticals/Otsuka Pharmaceutical

LUPKYNIS is a novel, structurally modified Calcineurin Inhibitor (CNI) with a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The drug has improved near and long-term outcomes in Lupus Nephritis when combined with a background immunosuppressive therapy regimen for treating adult patients with active Lupus Nephritis. In January 2021, Aurinia Pharmaceuticals received US FDA approval for LUPKYNIS to treat adult lupus nephritis patients in combination with immunosuppressive therapy. In September 2022, the European Commission approved LUPKYNIS for active Class III, IV, or V Lupus Nephritis, and in September 2024, Japan's Ministry of Health approved it for Lupus Nephritis treatment alongside mycophenolate mofetil.

BENLYSTA (belimumab): GlaxoSmithKline

BENLYSTA is an intravenous and subcutaneously administered, fully-humanized monoclonal antibody that binds and inactivates B-lymphocyte stimulator (a cytokine expressed by B-cell lineage cells that activate B-cells and stimulate their proliferation and differentiation), inhibiting B-lymphocyte proliferation and differentiation. It is the first and only biologic approved for both the chronic autoimmune disease Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN), the kidney inflammation caused by lupus. In December 2020, the US FDA approved BENLYSTA for adult lupus nephritis, followed by pediatric approval in July 2022. In May 2021, the European Commission approved BENLYSTA for adult Lupus Nephritis, and Japan approved it for adult Lupus Nephritis the same year.

Emerging Therapies

SAPHNELO (anifrolumab): AstraZeneca

SAPHNELO, being developed by AstraZeneca, is an intravenously administered, fully human monoclonal antibody that binds to subunit 1 of the Type I IFN receptor, blocking the activity of Type I IFN. Anifrolumab induces rapid internalization of IFNAR1 from the surface of monocytes, thereby reducing heterodimerization with IFNAR2 and the setting up of the IFN signaling complex. By antagonizing the binding of the different IFNs to the IFNAR1 receptor, anifrolumab blocks STAT1 phosphorylation and IFN-stimulated Response Element (ISRE) activity. SAPHNELO is already approved for the treatment of adult patients with moderate to severe SLE. Currently, the company is evaluating the drug in the Phase III IRIS trial to treat adult subjects with active proliferative Lupus Nephritis.

GAZYVA/GAZYVARO (obinutuzumab): Roche

GAZYVA/GAZYVARO (obinutuzumab) injection, for intravenous use, is an engineered monoclonal antibody that targets a protein called CD20 on the surface of the lymphoma and leukemia cells. It binds to type II CD20 antibodies. This allows obinutuzumab to have a much higher induction of antibody-dependent cytotoxicity and a higher direct cytotoxic effect than the classic CD20 antibodies. Upon binding to CD20, it mediates B-cell lysis through the engagement of immune effector cells by directly activating intracellular death signaling pathways and/or activation of the complement cascade. GAZYVA is marketed as GAZYVARO in Europe. Currently, the drug is being evaluated in two Phase III trials for the treatment of Lupus Nephritis. In September 2019, the US FDA granted Breakthrough Therapy Designation (BTD) to GAZYVA for adults with lupus nephritis.

Lupus Nephritis (LN) Market Outlook

Rituximab is currently the most commonly used monoclonal antibody (mAb) for lupus nephritis, favored for its steroid-sparing properties and effectiveness in refractory or relapsing cases. Currently, only two FDA-approved treatments for lupus nephritis exist BENLYSTA (belimumab), available as an IV infusion or SC injection, and LUPKYNIS (voclosporin), the only oral treatment and a novel calcineurin inhibitor.

Several companies, including Novartis, AstraZeneca, Roche, and Kezar Life Sciences, are developing new drug candidates that could reshape the lupus nephritis treatment landscape. These approaches include B-cell depletion (obinutuzumab), anti-B-cell activation (ianalumab), selective immune-proteasome inhibitors (zetomipzomib), and interferon-alpha-beta receptor antagonists (anifrolumab). Additionally, recent clinical cases suggest that anti-CD19 CAR-T cell therapies could significantly impact LN treatment. Novartis, in particular, is investigating YTB323 (Rapcabtagene autoleucel), an anti-CD19 CAR-T cell therapy, as a potential option for lupus nephritis.

In a nutshell, many potential therapies are being investigated to manage lupus nephritis. Even though it is too soon to comment on the above-mentioned promising candidate to enter the market during the forecast period (2024-2034), it is safe to assume that the future of this market is bright. Eventually, these drugs will create a significant difference in the landscape of LN in the coming years. The treatment space is expected to experience a significant positive shift in the coming years owing to the improvement in healthcare spending worldwide.

Lupus Nephritis (LN) Disease Understanding and Treatment

Lupus Nephritis (LN) Overview

Lupus nephritis is a common manifestation of Systemic lupus erythematosus and is primarily caused by a Type 3 hypersensitivity reaction that leads to immune complex formation. Anti-double-stranded DNA (anti-dsDNA) antibodies bind to DNA, creating immune complexes that deposit in the kidney, triggering inflammation and activating the complement pathway. This results in an influx of neutrophils and inflammatory cells. While lupus nephritis is autoimmune, genetic factors may predispose certain Systemic lupus erythematosus patients to its development. Lupus nephritis can cause various symptoms, including blood (hematuria) and protein (proteinuria) in the urine, often leading to pink or foamy urine. Other signs include edema, weight gain due to fluid retention, and high blood pressure. Kidney issues may occur alongside lupus symptoms like joint and muscle pain, unexplained fever, and a red "butterfly" rash across the nose and cheeks.

Lupus Nephritis (LN) Diagnosis

Lupus nephritis is diagnosed using urine and blood tests along with a kidney biopsy. Blood tests check kidney function by measuring creatinine, which rises as kidney disease worsens. A 24-hour urine collection measures protein levels to assess kidney filtering ability. Urine tests look for blood and protein, indicating kidney damage. A kidney biopsy, guided by imaging, involves examining a small tissue sample to confirm lupus nephritis and assess disease progression.

Lupus Nephritis (LN) Treatment

Treatment for lupus nephritis depends on its classification. Classes 1 and 2 generally require only monitoring, while Classes 3 and 4 need immunosuppressive and steroid therapy. In Class 6, where most glomeruli are scarred, renal replacement therapy may be necessary. Treatment is divided into two phases: induction and maintenance. The induction phase aims to achieve a renal response using immunosuppressive and anti-inflammatory medications. Once this response is achieved, maintenance therapy, involving both immunosuppressive and non-immunosuppressive agents, is used over a prolonged period to sustain kidney function.

Lupus Nephritis (LN) Epidemiology

The Lupus Nephritis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total prevalent cases, diagnosed cases, total treated cases, age-specific cases, and class-specific cases of Lupus Nephritis in the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.

• Among the 7MM, the United States accounted for the highest number of cases of LN in 2023, nearly 211,300 cases. These cases are anticipated to increase by 2034.
• In the United States, the Adolescents and adult population accounted for ~90% of total cases of LN in 2023.
• Among EU4 and the UK, Spain accounted for the highest number of prevalent cases in 2023, while France accounted for the least.

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 Lupus Nephritis, 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 15 KOLs across the 7MM. We contacted institutions such as the University of Munich, the University of Tokyo, the European Dialysis and Transplant Association, the American Society of Nephrology, etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the Lupus Nephritis 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.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in trials for Lupus Nephritis, one of the most important primary endpoints was achieving hemolysis control, LDH normalization, etc. Based on these, the overall efficacy is evaluated.

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.

Lupus Nephritis (LN) Report Insights

• Patient Population
• Therapeutic Approaches
• Lupus Nephritis Market Size and Trends
• Existing Market Opportunity

Lupus Nephritis (LN) Report Key Strengths

• Eleven-year Forecast
• The 7MM Coverage
• Lupus Nephritis Epidemiology Segmentation
• Key Cross Competition

Lupus Nephritis (LN) Report Assessment

• Current Treatment Practices
• Reimbursements
• Market Attractiveness
• Qualitative Analysis (SWOT, Conjoint Analysis, Unmet needs)

Key Questions:

• Would there be any changes observed in the current treatment approach?
• Will there be any improvements in Lupus Nephritis management recommendations?
• Would research and development advances pave the way for future tests and therapies for Lupus Nephritis?
• Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of Lupus Nephritis?
• What kind of uptake will the new therapies witness in the coming years in Lupus Nephritis patients?

Table of Contents

1. Key Insights

2. Report Introduction

3. Lupus Nephritis Market Overview at a Glance

• 3.1. Market Share Distribution (%) in the 7MM in 2020
• 3.2. Market Share Distribution (%) in the 7MM in 2034

4. Executive Summary of Lupus Nephritis

5. Key Events

6. Epidemiology and Market Forecast Methodology

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Types of Hemolytic Uremic Syndrome
• 7.3. Risk Factors and Causes of Lupus Nephritis
• 7.4. Signs and Symptoms of LUPUS NEPHRITIS
• 7.5. Pathophysiology of LUPUS NEPHRITIS
• 7.6. Complement Protein Mutations
• 7.7. Clinical Manifestations of Lupus Nephritis
• 7.8. Diagnosis and Differential Diagnosis of Lupus Nephritis
  • 7.8.1. Diagnostic Algorithm of Lupus Nephritis
  • 7.8.2. Blood Tests
  • 7.8.3. Specific Testing
  • 7.8.4. Genetic Testing
  • 7.8.5. Differential Diagnosis
  • 7.8.6. Diagnostic Guidelines

8. Current Treatment Practices of Lupus Nephritis

• 8.1. Treatment Algorithm of Lupus Nephritis
  • 8.1.1. Plasma Exchange
  • 8.1.2. Eculizumab
  • 8.1.3. Ravulizumab
  • 8.1.4. Kidney Transplant
  • 8.1.5. Liver Transplantation
• 8.2. Treatment Guidelines
  • 8.2.1. The European Rare Kidney Disease Reference Network Guidelines for the Management of Lupus Nephritis in Children
  • 8.2.2. Clinical Practice Guidelines for the Management of Lupus Nephritis in the United Kingdom
  • 8.2.3. National Institute for Health and Research

9. Patient Journey

10. Epidemiology and Patient Population

• 10.1. Key Findings
• 10.2. Assumptions and Rationale for Lupus Nephritis
• 10.3. Prevalent Cases of Lupus Nephritis in the 7MM
• 10.4. Diagnosed Cases of Lupus Nephritis in the 7MM
• 10.5. The United States
  • 10.5.1. Prevalent Cases of Lupus Nephritis in the United States
  • 10.5.2. Diagnosed Cases of Lupus Nephritis in the United States
  • 10.5.3. Age group-specific Cases of Lupus Nephritis in the United States
  • 10.5.4. Treated Cases of Lupus Nephritis in the United States
• 10.6. EU4 and the UK
  • 10.6.1. Prevalent Cases of Lupus Nephritis in EU4 and the UK
  • 10.6.2. Diagnosed Cases of Lupus Nephritis in EU4 and the UK
  • 10.6.3. Age group-specific Cases of Lupus Nephritis in EU4 and the UK
  • 10.6.4. Treated Cases of Lupus Nephritis in EU4 and the UK
• 10.7. Japan
  • 10.7.1. Prevalent Cases of Lupus Nephritis in Japan
  • 10.7.2. Diagnosed Cases of Lupus Nephritis in Japan
  • 10.7.3. Age group-specific Cases of Lupus Nephritis in Japan
  • 10.7.4. Treated Cases of Lupus Nephritis in Japan

11. Marketed Therapies

• 11.1. Key Cross of Marketed Therapies
• 11.2. SOLIRIS (eculizumab): Alexion Pharmaceuticals
  • 11.2.1. Product Description
  • 11.2.2. Regulatory Milestones
  • 11.2.3. Other Developmental Activity
  • 11.2.4. Clinical Development
  • 11.2.5. Safety and Efficacy
• 11.3. ULTOMIRIS (ravulizumab-cwvz): Alexion Pharmaceuticals
  • 11.3.1. Product Description
  • 11.3.2. Regulatory Milestones
  • 11.3.3. Other Developmental Activity
  • 11.3.4. Clinical Development
  • 11.3.5. Safety and Efficacy

12. Emerging Therapies

• 12.1. Key Cross of Emerging Therapies
• 12.2. Crovalimab (RG6107; SKY59): Hoffmann-La Roche/Chugai Pharmaceutical
  • 12.2.1. Product Description
  • 12.2.2. Clinical Development
• 12.3. Iptacopan (Lupus NephritisP023): Novartis Pharmaceuticals
  • 12.3.1. Product Description
  • 12.3.2. Clinical Development

13. Lupus Nephritis: Seven Major Market Analysis

• 13.1. Key Findings
• 13.2. Market Outlook
• 13.3. Conjoint Analysis
• 13.4. Key Market Forecast Assumptions
  • 13.4.1. Cost Assumptions and Rebate
  • 13.4.2. Pricing Trends
  • 13.4.3. Analogue assessment
  • 13.4.4. Launch Year and Therapy Uptake
• 13.5. Total Market Size of Lupus Nephritis in the 7MM in USD million (2020 - 2034)
• 13.6. Market Size of Lupus Nephritis by Therapies in the 7MM
• 13.7. United States Market Size
  • 13.7.1. Total Market Size of Lupus Nephritis in the United States
  • 13.7.2. Market Size of Lupus Nephritis by Therapies in the United States
• 13.8. EU4 and the UK Market Size
  • 13.8.1. Total Market Size of Lupus Nephritis in EU4 and the UK
  • 13.8.2. Market Size of Lupus Nephritis by Therapies in EU4 and the UK
• 13.9. Japan Market Size
  • 13.9.1. Total Market Size of Lupus Nephritis in Japan
  • 13.9.2. Market Size of Lupus Nephritis by Therapies in Japan

14. Unmet Needs

15. SWOT Analysis

16. KOL Views

17. Market Access and Reimbursement

• 17.1. United States
  • 17.1.1. Centre for Medicare and Medicaid Services (CMS)
• 17.2. EU4 and the UK
  • 17.2.1. Germany
  • 17.2.2. France
  • 17.2.3. Italy
  • 17.2.4. Spain
  • 17.2.5. United Kingdom
• 17.3. Japan
  • 17.3.1. MHLW
• 17.4. Reimbursement Scenario and Key HTA Decisions in Lupus Nephritis
  • 17.4.1. Patient Access Programs
  • 17.4.2. HTA Decisions

18. Appendix

• 18.1. Acronyms and Abbreviations
• 18.2. Bibliography
• 18.3. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight