Press release
Lupus nephritis Market Size was USD 1.8 billion in 2024, estimates DelveInsight
Lupus nephritis Market
A robust late-stage pipeline, featuring candidates such as Novartis' ianalumab, FABHALTA, and CAR-T-based therapies, along with biologics like GAZYVA and SAPHNELO, is anticipated to broaden the therapeutic landscape and fuel market expansion through 2034.
Lupus nephritis (LN) represents a serious renal manifestation of systemic lupus erythematosus (SLE), affecting nearly 40-60% of lupus patients, with 10-30% eventually developing end-stage renal disease (ESRD) despite ongoing treatment. Although disease incidence reached its peak around 2020 and has shown a gradual decline since, overall prevalence continues to rise due to improved patient survival, indicating a stabilizing yet persistent disease burden.
Among Lupus nephritis subtypes, Class IV lupus nephritis remains the most prevalent and clinically severe form, characterized by high relapse rates and suboptimal remission outcomes. Classes I and II are generally less aggressive, while Class V is associated with significant proteinuria and overlapping pathological features. In 2024, the diagnosed LN population across the 7MM was estimated at nearly 385,000 cases, a figure projected to increase by 2034, with Spain contributing the highest patient share among EU4+UK countries.
DelveInsight's "Lupus Nephritis Market Insights, Epidemiology, and Market Forecast - 2034" delivers a detailed assessment of the lupus nephritis landscape across the United States, EU5, and Japan. The report integrates historical data and future projections on epidemiology, current standards of care, pipeline innovations, market size, and therapy-wise revenue contribution spanning 2020-2034. It further evaluates treatment pathways, growth catalysts, market constraints, unmet clinical needs, and emerging opportunities shaping the future of the lupus nephritis market.
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Key Highlights from the Lupus Nephritis Market Report
• DelveInsight projects the lupus nephritis market to grow at a healthy CAGR through 2034.
• The total market size across the 7MM was estimated at around USD 1.12 billion in 2022 and is expected to rise steadily during the 2023-2034 forecast period.
• In 2023, the United States dominated the 7MM market, accounting for over 80% of total revenues, followed by Japan and Spain.
• Major companies active in the lupus nephritis space include Aurinia Pharmaceuticals, Roche, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Novartis, Otsuka Pharmaceutical, MorphoSys, Vertice Pharma, Sun Pharmaceutical, Abbott, Johnson & Johnson, Bayer, Sanofi, Cipla, LEO Pharma, Nimble Pharmaceuticals, and others.
• Prominent therapies expected to shape the future market include BENLYSTA (belimumab), LUPKYNIS (voclosporin), ianalumab (VAY736), SAPHNELO (anifrolumab), and GAZYVA/GAZYVARO (obinutuzumab).
Recent Developments in Lupus Nephritis (2024-2025)
• June 2025: Fate Therapeutics presented updated clinical data from the first five patients treated with FT819 for moderate-to-severe SLE at the EULAR 2025 Congress in Barcelona.
• March 2025: Roche announced FDA acceptance of its supplemental BLA for Gazyva/Gazyvaro in lupus nephritis, supported by positive Phase III REGENCY trial outcomes, with a regulatory decision expected by October 2025.
• February 2025: Phase III data demonstrated superior renal outcomes when obinutuzumab was combined with standard therapy versus standard care alone.
• February 2025: Kezar Life Sciences shared a safety update from the PALIZADE Phase IIb trial of zetomipzomib in active lupus nephritis during a virtual KOL event.
• February 2025: The FDA cleared Allogene Therapeutics' IND for ALLO-329, an allogeneic CAR-T therapy, enabling Phase I evaluation across autoimmune indications including LN.
• November 2024: Adicet Bio dosed the first lupus nephritis patient in its Phase I trial of ADI-001.
• June 2024: Nkarta initiated the Ntrust-I clinical trial for NKX019 in lupus nephritis following FDA IND clearance.
Learn more about Lupus Nephritis treatment algorithms in different geographies, and patient journeys. Contact to receive a sample @ Lupus Nephritis Treatment Market - https://www.delveinsight.com/sample-request/lupus-nephritis-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Lupus Nephritis Disease Overview
Lupus nephritis is a serious kidney complication of systemic lupus erythematosus, arising from immune-mediated inflammation of renal glomeruli. The condition significantly contributes to lupus-related morbidity and may progress to chronic kidney disease or ESRD if not adequately managed.
Clinical manifestations include proteinuria, hematuria, edema, hypertension, and declining renal function. Diagnosis relies on renal biopsy for histological classification, supported by laboratory tests such as urinalysis, blood markers, and eGFR monitoring.
Lupus Nephritis Treatment Landscape
Management strategies aim to control inflammation, protect kidney function, and prevent disease flares. Standard therapy includes corticosteroids, mycophenolate mofetil, or cyclophosphamide, while biologics such as belimumab and rituximab are used in refractory cases. Supportive care with ACE inhibitors or ARBs remains essential for proteinuria control.
Early diagnosis and timely intervention play a critical role in improving long-term renal outcomes.
Lupus Nephritis Market & Epidemiology Insights
The report analyzes lupus nephritis epidemiology across the 7MM from 2020-2034, segmented by age, class, prevalence, and treatment status. In 2024, the US accounted for nearly 60% of diagnosed cases, followed by the EU4+UK and Japan. Class IV LN remained the most prevalent subtype across regions.
Explore more about Lupus Nephritis Epidemiology @ Lupus Nephritis Patient Pool Forecasting and Market Dynamics - https://www.delveinsight.com/report-store/lupus-nephritis-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Lupus Nephritis Pipeline Development & Key Therapies
• GAZYVA/GAZYVARO (Roche): A next-generation anti-CD20 monoclonal antibody undergoing Phase III evaluation, with regulatory review underway.
• Ianalumab (Novartis): A BAFF-R-targeting antibody in Phase III development, with potential regulatory filing expected by 2028.
Lupus Nephritis Report Key Takeaways
• Patient population trends
• Market size and growth patterns
• Competitive dynamics
• Drivers, barriers, and unmet needs
• Emerging therapies and pipeline outlook
Lupus Nephritis Pipeline Development Activities and Drugs Uptake
GAZYVA/GAZYVARO (obinutuzumab) - Roche
Obinutuzumab is a Type II CD20-targeting monoclonal antibody with stronger cytotoxic activity than traditional CD20 antibodies, driving B-cell lysis via immune effector mechanisms. Marketed as GAZYVARO in Europe, it is under evaluation in two Phase III trials. In March 2025, the FDA accepted a supplemental BLA for lupus nephritis, with a decision expected by October 2025; EMA review is also underway using Phase III REGENCY data.
Ianalumab (VAY736) - Novartis
Ianalumab is a fully human, subcutaneous BAFF-R antibody designed for ADCC-mediated B-cell depletion. It is in Phase III development for autoimmune conditions, including lupus nephritis, with a regulatory submission targeted for 2028.
Lupus Nephritis Pipeline Development Activities
The Lupus Nephritis report provides insights into different therapeutic candidates in Phase II, and Phase III stages. It also analyses Lupus Nephritis key players involved in developing targeted therapeutics.
Request for a sample report to understand more about the Lupus Nephritis pipeline development activities @ Lupus Nephritis Drugs Market - https://www.delveinsight.com/sample-request/lupus-nephritis-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Lupus Nephritis Therapeutics Assessment
Major key companies are working proactively in the Lupus Nephritis Therapeutics market to develop novel therapies which will drive the Lupus Nephritis treatment markets in the upcoming years are Aurinia Pharmaceuticals (NASDAQ: AUPH), Roche (SWX: ROG), AstraZeneca (LSE: AZN), Boehringer Ingelheim, GlaxoSmithKline (LSE: GSK), Novartis (SWX: NOVN), Otsuka Pharmaceutical (TYO: 4578), MorphoSys (ETR: MOR), Vertice Pharma (Privately Held), Pharmaceutical Associates Inc. (Privately Held), Sun Pharmaceutical (NSE: SUNPHARMA), Abbott (NYSE: ABT), Johnson & Johnson Private Limited (NYSE: JNJ), Bayer (ETR: BAYN), Sanofi (EPA: SAN), Sumitomo Corporation (TYO: 8053), LEO Pharma A/S (Privately Held), Cipla (NSE: CIPLA), and Nimble Pharmaceuticals, and others.
Learn more about the emerging Lupus Nephritis therapies & key companies @ Lupus Nephritis Clinical Trials and Advancements - https://www.delveinsight.com/sample-request/lupus-nephritis-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Lupus Nephritis Report Key Insights
1. Lupus Nephritis Patient Population
2. Lupus Nephritis Market Size and Trends
3. Key Cross Competition in the Lupus Nephritis Market
4. Lupus Nephritis Market Dynamics (Key Drivers and Barriers)
5. Lupus Nephritis Market Opportunities
6. Lupus Nephritis Therapeutic Approaches
7. Lupus Nephritis Pipeline Analysis
8. Lupus Nephritis Current Treatment Practices/Algorithm
9. Impact of Emerging Therapies on the Lupus Nephritis Market
Table of Contents
1. Key Insights
2. Executive Summary
3. Lupus Nephritis Competitive Intelligence Analysis
4. Lupus Nephritis Market Overview at a Glance
5. Lupus Nephritis Disease Background and Overview
6. Lupus Nephritis Patient Journey
7. Lupus Nephritis Epidemiology and Patient Population
8. Lupus Nephritis Treatment Algorithm, Current Treatment, and Medical Practices
9. Lupus Nephritis Unmet Needs
10. Key Endpoints of Lupus Nephritis Treatment
11. Lupus Nephritis Marketed Products
12. Lupus Nephritis Emerging Therapies
13. Lupus Nephritis Seven Major Market Analysis
14. Attribute Analysis
15. Lupus Nephritis Market Outlook (7 major markets)
16. Lupus Nephritis Access and Reimbursement Overview
17. KOL Views on the Lupus Nephritis Market
18. Lupus Nephritis Market Drivers
19. Lupus Nephritis Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer
Contact Us:
Ankit Nigam
Manager Marketing
info@delveinsight.com
+14699457679
About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.
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