ループス腎炎治療の世界市場-2023年～2030年

概要

ループス腎炎は、全身性エリテマトーデスによって誘発される腎障害の一種です。ループスは自己免疫疾患であり、身体の免疫系が自分自身の細胞や臓器を攻撃する病気です。ループスによって誘発される腎臓の疾患は、長期にわたるとより脅威的になり、腎不全に直結する可能性があります。ループス腎炎の徴候は、泡のような尿と、体に過剰な水分があるときに起こる浮腫を包むかもしれません。高血圧になることもあります。

ループス腎炎を管理する主な目的は、慢性腎臓病（CKD）を回避することです。既存の治療法では、腎臓全体の反応を示すには不十分であり、腎臓の退縮、CKD、末期腎不全への移行を防ぐことはできません。米国ループス財団によると、米国では約150万人がループスに罹患しており、そのうち60％がループス腎炎を発症すると推定されています。

市場力学：市場促進要因と市場抑制要因

製品承認の増加

ループス腎炎を治療する医薬品の承認が増加していることは、予測期間中の世界市場の成長を後押しすると予想されます。例えば、2021年1月、Aurinia社は、ループス腎炎（全身性エリテマトーデスによって誘発される腎臓の炎症）の治療薬Lupkynis（ボクロスポリン）の最初のFDA承認を取得しました。

さらに2023年2月、GSK plcは全身性硬化症の治療薬として、B細胞阻害モノクローナル抗体であるベンリスタ（ベリムマブ）の希少疾病用医薬品指定（ODD）を米国食品医薬品局（FDA）から取得しました。ベンリスタ（ベリムマブ）は、全身性エリテマトーデス（SLE）やループス腎炎（LN）のような全身性自己免疫疾患患者において上昇する可溶性BLySに結合するBリンパ球刺激因子（BLyS）特異的阻害剤です。

さらに、ループス腎炎に対する意識の高まり、市場の発展、研究投資や活動の増加も、予測期間中の世界市場の成長を後押ししています。

厳しい規制当局

薬物治療を認可する規制当局の厳格さは、世界市場の成長を妨げると予想されます。さらに、高い薬剤開発コストと治療副作用も、予測期間中の世界市場成長の妨げになると予想されます。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
    • 製品承認の増加
  • 抑制要因
    • 厳しい規制当局
  • 機会
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• 価格分析
• 規制分析
• 償還分析
• 特許分析
• パイプライン分析
• PEST分析
• SWOT分析
• DMIオピニオン

第6章 COVID-19分析

第7章 治療法別

• 薬物治療
  • アカンプロサート
  • ペントキシフィリン
  • インフリキシマブ
  • 薬物治療
  • アカンプロサート
  • ペントキシフィリン
  • インフリキシマブ
  • ベンゾジアゼピン
  • コルチコステロイド
  • その他
• 幹細胞治療

第8章 投与経路別

• 注射剤
• 経口剤

第9章 流通チャネル別

• 病院薬局
• 小売薬局
• オンライン薬局
• その他

第10章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋
  • 中国
  • インド
  • 日本
  • オーストラリア
  • その他アジア太平洋
• 中東・アフリカ

第11章 競合情勢

• 競合シナリオ
• 市況/シェア分析
• M&A分析

第12章 企業プロファイル

• Aurinia Pharmaceuticals Inc.
  • 企業概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な動向
• AstraZeneca
• Novartis AG
• Beigene, Ltd.
• Glaxosmithkline Llc
• Equillium, Inc.
• Kymera Therapeutics, Inc.
• Remegen Co., Ltd.
• Immpact Bio Usa Inc.
• Gri Bio, Inc.

第13章 付録

Overview

Lupus nephritis is a kind of kidney disorder induced by systemic lupus erythematosus. Lupus is an autoimmune condition a disease in which the body's immune system attacks the body's own cells and organs. Kidney disorders induced by lupus may get more threatening over the period and direct to kidney failure. The signs of lupus nephritis may enclose foamy urine and edema that transpires when the body has excessive fluid, frequently in the legs, feet, or ankles, and sometimes in the hands or face. The patient may even develop high blood pressure.

The primary purpose of managing lupus nephritis is to circumvent chronic kidney disease (CKD). Existing therapy approaches remain inadequate in representations of total renal response, precluding regressions, CKD, and advancement to end-stage kidney disorder. According to the Lupus Foundation of America, roughly 1.5 million individuals in the United States suffer from lupus, and up to 60% of them are estimated to develop lupus nephritis.

Market Dynamics: Drivers & Restraints

Increasing Product Approvals

The increasing drug product approvals to treat lupus nephritis is expected to boost the global market growth during the forecast period. For instance, in January 2021, Aurinia grasped its first FDA authorization for Lupkynis (voclosporin) for the treatment of lupus nephritis, or kidney inflammation induced by systemic lupus erythematosus.

Moreover, in February 2023, GSK plc obtained the US Food and Drug Administration (FDA) Orphan Drug Designation (ODD) to Benlysta (belimumab), a B-cell inhibiting monoclonal antibody, for the potential therapy of systemic sclerosis. Benlysta (belimumab) is a B-lymphocyte stimulator (BLyS) specific inhibitor that attaches to soluble BLyS, which is encountered to be raised in individuals with systemic autoimmune disorders like systemic lupus erythematosus (SLE) and lupus nephritis (LN).

Furthermore, the growing awareness about lupus nephritis, market developments, increase in research investments and activities are also driving the global market growth during the forecast period.

Stringent Regulatory Authorities

The stringent regulatory authorities authorizing the drug treatments are expected to hamper the global market growth. Furthermore, high drug development costs and treatment side effects are also expected to hamper the global market growth in the forecast period.

Segment Analysis

The global lupus nephritis treatment market is segmented based on treatment, route of administration, distribution channel and region.

Stem Cell Therapy Expected to Dominate Market

The increasing regulatory approvals for stem cell therapy are expected to boost the segment growth, dominating the global market in the forecast period. For instance, in June 2023, Kyverna Therapeutics ("Kyverna"), a cell therapy corporation with the mission of engineering a new class of therapies for severe autoimmune disorders, obtained the U.S. Food and Drug Administration (FDA) Fast Track designation for KYV-101 for the therapy of individuals with refractory lupus nephritis (LN). KYV-101 is a novel anti-CD19 chimeric antigen receptor T-cell (CAR T) therapy developed to deplete B cells, including autoreactive B cells, in autoimmune disorder patients

Moreover, in August 2023, Artiva Biotherapeutics, Inc., a clinical-stage corporation obtained the U.S. FDA Investigational New Drug (IND) designation for its AlloNK (also known as AB-101) a non-genetically-modified, cord blood-derived, allogeneic, cryopreserved NK cell therapy candidate, in mixture with rituximab for the treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis (LN).

Geographical Analysis

North America is Expected to Dominate the Global Market

Increasing clinical research activities in North America is expected to boost the regional market growth dominating the global market during the forecast period. For instance, in June 2023 Lupus Therapeutics formed a coalition to conduct three Phase 3 clinical trials testing an experimental therapeutic ianalumab for systemic lupus erythematosus and lupus nephritis.

Lupus Therapeutics, the clinical investigation affiliate of the Lupus Research Alliance, intends to assist Novartis Pharmaceuticals Corporation (Novartis) in conducting the trials via the Lupus Clinical Investigators Network (LuCIN) at leading academic centers throughout North America.

Moreover, in March 2023 AbbVie reported topline outcomes from a Phase 2 study of upadacitinib (RINVOQ, 30 mg) delivered independently or as combination therapy (ABBV-599) with a Bruton's Tyrosine Kinase inhibitor (elsubrutinib, 60 mg), once every day in patients with moderately to severely active systemic lupus erythematosus (SLE). AbbVie is extending its clinical schedule of upadacitinib in SLE to Phase 3.

COVID-19 Impact Analysis

During the COVID-19 pandemic, individuals with autoimmune rheumatic diseases (ARDs), including rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, lupus, and vasculitis, had learned risk factors that raised their chance of infections, intricacies from infection, and mortality from COVID-19 owing to compromised immune systems linked to their condition or the medications often prescribed to treat these conditions.

Market Segmentation

By Treatment

• Drug Treatment
  • Acamprosate
  • Pentoxifylline
  • Infliximab
  • Benzodiazepines
  • Corticosteroids
  • Others
• Stem Cell Therapy

By Route of Administration

• Injectable
• Oral

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies
• Others

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific
• Middle East and Africa

Key Developments

• In November 2022, Aurinia Pharmaceuticals Inc. obtained the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) Great Britain marketing authorization for LUPKYNIS (Voclosporin) for the treatment of adults with active lupus nephritis (LN), a severe intricacy of systemic lupus erythematosus (SLE).
• In August 2023, ImmPACT Bio USA, Inc., a clinical-stage corporation designing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies to treat cancer and autoimmune disorders, obtained the U.S. Food and Drug Administration (FDA) investigational new drug (IND) designation for IMPT-514, a bispecific CD19/CD20 CAR T therapy for the treatment of active, refractory systemic lupus erythematosus (SLE).
• In August 2023, GRI Bio, Inc., a biotechnology corporation offering an inventive pipeline of Natural Killer T ("NKT") cell modulators to treat inflammatory, fibrotic and autoimmune disorders, performed a presentation of preclinical data from its GRI-0803 development program at The Autoimmunity Conference hosted by FASEB held in July-August 2023 in Southbridge, MA.

Competitive Landscape

The major global players in the market include: Aurinia Pharmaceuticals Inc., AstraZeneca, Novartis Ag, Beigene, Ltd., Glaxosmithkline Llc, Equillium, Inc., Kymera Therapeutics, Inc., Remegen Co., Ltd., And Immpact Bio Usa Inc. among others.

Why Purchase the Report?

• To visualize the global lupus nephritis treatment market segmentation based on treatment, route of administration, distribution channel and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of lupus nephritis treatment market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global lupus nephritis treatment market report would provide approximately 61 tables, 56 figures and 186 pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Treatment
• 3.2. Snippet by Route of Administration
• 3.3. Snippet by Distribution Channel
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Increasing Product Approvals
  • 4.1.2. Restraints
    • 4.1.2.1. Stringent Regulatory Authorities
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis
• 5.5. Reimbursement Analysis
• 5.6. Patent Analysis
• 5.7. Pipeline Analysis
• 5.8. PEST Analysis
• 5.9. SWOT Analysis
• 5.10. DMI Opinion

6. COVID-19 Analysis

• 6.1. Analysis of COVID-19
  • 6.1.1. Scenario Before COVID
  • 6.1.2. Scenario During COVID
  • 6.1.3. Scenario Post COVID
• 6.2. Pricing Dynamics Amid COVID-19
• 6.3. Demand-Supply Spectrum
• 6.4. Government Initiatives Related to the Market During Pandemic
• 6.5. Manufacturers Strategic Initiatives
• 6.6. Conclusion

7. By Treatment

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 7.1.2. Market Attractiveness Index, By Treatment
• 7.2. Drug Treatment*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.2.3. Acamprosate
  • 7.2.4. Pentoxifylline
  • 7.2.5. Infliximab
  • 7.2.6. Drug Treatment
  • 7.2.7. Acamprosate
  • 7.2.8. Pentoxifylline
  • 7.2.9. Infliximab
  • 7.2.10. Benzodiazepines
  • 7.2.11. Corticosteroids
  • 7.2.12. Others
• 7.3. Stem Cell Therapy

8. By Route of Administration

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 8.1.2. Market Attractiveness Index, By Route of Administration
• 8.2. Injectable*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Oral

9. By Distribution Channel

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 9.1.2. Market Attractiveness Index, By Distribution Channel
• 9.2. Hospital Pharmacies*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Retail Pharmacies
• 9.4. Online Pharmacies
• 9.5. Others

10. By Region

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 10.1.2. Market Attractiveness Index, By Region
• 10.2. North America
  • 10.2.1. Introduction
  • 10.2.2. Key Region-Specific Dynamics
  • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.2.6.1. U.S.
    • 10.2.6.2. Canada
    • 10.2.6.3. Mexico
• 10.3. Europe
  • 10.3.1. Introduction
  • 10.3.2. Key Region-Specific Dynamics
  • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.3.6.1. Germany
    • 10.3.6.2. UK
    • 10.3.6.3. France
    • 10.3.6.4. Italy
    • 10.3.6.5. Spain
    • 10.3.6.6. Rest of Europe
• 10.4. South America
  • 10.4.1. Introduction
  • 10.4.2. Key Region-Specific Dynamics
  • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.4.6.1. Brazil
    • 10.4.6.2. Argentina
    • 10.4.6.3. Rest of South America
• 10.5. Asia-Pacific
  • 10.5.1. Introduction
  • 10.5.2. Key Region-Specific Dynamics
  • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.5.6.1. China
    • 10.5.6.2. India
    • 10.5.6.3. Japan
    • 10.5.6.4. Australia
    • 10.5.6.5. Rest of Asia-Pacific
• 10.6. Middle East and Africa
  • 10.6.1. Introduction
  • 10.6.2. Key Region-Specific Dynamics
  • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Treatment
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
  • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel

11. Competitive Landscape

• 11.1. Competitive Scenario
• 11.2. Market Positioning/Share Analysis
• 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

• 12.1. Aurinia Pharmaceuticals Inc.*
  • 12.1.1. Company Overview
  • 12.1.2. Product Portfolio and Description
  • 12.1.3. Financial Overview
  • 12.1.4. Key Developments
• 12.2. AstraZeneca
• 12.3. Novartis AG
• 12.4. Beigene, Ltd.
• 12.5. Glaxosmithkline Llc
• 12.6. Equillium, Inc.
• 12.7. Kymera Therapeutics, Inc.
• 12.8. Remegen Co., Ltd.
• 12.9. Immpact Bio Usa Inc.
• 12.10. Gri Bio, Inc.

LIST NOT EXHAUSTIVE

13. Appendix

• 13.1. About Us and Services
• 13.2. Contact Us