개요
루푸스 신염은 전신성 홍반성 루푸스에 의해 유발되는 신장 질환의 일종입니다. 루푸스는 자가면역질환으로 신체의 면역체계가 자신의 세포와 장기를 공격하는 질환입니다. 루푸스에 의해 유발되는 신장 질환은 장기간 지속되면 더욱 위협적이며 신부전으로 이어질 수 있습니다. 루푸스 신염의 증상은 거품이 많은 소변과 몸에 과도한 수분이 있을 때 발생하는 부종으로 나타날 수 있습니다. 고혈압이 발생할 수도 있습니다.
루푸스 신염을 관리하는 주요 목적은 만성 신장 질환(CKD)을 피하는 것입니다. 기존 치료법은 신장 전체에 대한 반응을 보여주지 못하고 신장 퇴행, CKD, 말기 신부전으로의 전환을 예방할 수 없습니다. 미국 루푸스 재단에 따르면 미국에는 약 150만 명의 루푸스 환자가 있으며, 그 중 60%가 루푸스 신염을 앓고 있는 것으로 추정됩니다.
시장 역학: 시장 촉진요인과 시장 억제요인
제품 승인 증가
루푸스 신염을 치료하는 의약품의 승인 증가는 예측 기간 동안 세계 시장 성장을 촉진할 것으로 예상됩니다. 예를 들어, 2021년 1월 Aurinia는 루푸스 신염(전신성 홍반성 루푸스에 의해 유발되는 신장 염증) 치료제 Lupkynis(보크로스포린)의 첫 번째 FDA 승인을 획득했습니다.
또한 2023년 2월, GSK plc는 미국 식품의약국(FDA)으로부터 전신성 경화증 치료제인 B세포 억제 단일클론항체 벤리스타(성분명: 베링거인겔하임의 베링거인겔하임)에 대한 희귀의약품 지정(ODD)을 획득했습니다. 벤리스타(성분명: 베링거인겔하임)는 전신성 홍반성 루푸스(SLE), 루푸스 신염(LN)과 같은 전신성 자가면역질환 환자에서 상승하는 가용성 BLyS에 결합하는 B 림프구 자극인자(BLyS) 특이적 억제제입니다.
또한 루푸스 신염에 대한 인식 증가, 시장 발전, 연구 투자 및 활동 증가도 예측 기간 동안 세계 시장의 성장을 촉진하고 있습니다.
엄격한 규제당국
약물 치료를 승인하는 규제 당국의 엄격함은 세계 시장 성장을 저해할 것으로 예상됩니다. 또한, 높은 약물 개발 비용과 치료 부작용도 예측 기간 동안 세계 시장 성장에 걸림돌이 될 것으로 예상됩니다.
목차
제1장 조사 방법과 조사 범위
제2장 정의와 개요
제3장 주요 요약
제4장 시장 역학
제5장 산업 분석
- Porter's Five Forces 분석
- 공급망 분석
- 가격 분석
- 규제 분석
- 상환 분석
- 특허 분석
- 파이프라인 분석
- PEST 분석
- SWOT 분석
- DMI 오피니언
제6장 COVID-19 분석
제7장 치료법별
- 약물 치료
- 아캄프로세이트
- 펜톡시필린
- 인플릭시맙
- 약물 치료
- 아캄프로세이트
- 펜톡시필린
- 인플릭시맙
- 벤조디아제핀
- 코르티코스테로이드
- 기타
- 줄기세포 치료
제8장 투여 경로별
제9장 유통 채널별
제10장 지역별
- 북미
- 유럽
- 남미
- 아시아태평양
- 중동 및 아프리카
제11장 경쟁 상황
- 경쟁 시나리오
- 시장 상황/점유율 분석
- M&A 분석
제12장 기업 개요
- Aurinia Pharmaceuticals Inc.
- 기업 개요
- 제품 포트폴리오와 설명
- 재무 개요
- 주요 동향
- AstraZeneca
- Novartis AG
- Beigene, Ltd.
- Glaxosmithkline Llc
- Equillium, Inc.
- Kymera Therapeutics, Inc.
- Remegen Co., Ltd.
- Immpact Bio Usa Inc.
- Gri Bio, Inc.
제13장 부록
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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
By Distribution Channel
- Hospital Pharmacies
- Retail Pharmacies
- Online Pharmacies
- Others
By Region
- North America
- 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
