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Lupus Nephritis Market Analysis 2034 - Competitive Landscape, Clinical Trials, Market Share, Therapies, Patient Pool Forecasting, Companies | DelveInsight
Lupus Nephritis Market
Lupus Nephritis Market Summary
In Japan, the Lupus Nephritis market size was around USD 49 million in 2024, and it is anticipated to grow throughout the forecast period (2025-2034). Lupus Nephritis, a serious complication of Systemic Lupus Erythematosus (SLE), affects 40-60% of SLE patients, with 10-30% progressing to end-stage renal disease (ESRD) even with available treatments. While incidence peaked around 2020, prevalence continues to rise owing to improved survival, indicating a growing yet stabilizing patient base.
Class IV LN remains the most common and severe subtype, associated with high relapse and low remission rates, whereas Classes I and II are relatively mild, and Class V presents difficulties due to proteinuria and overlap with proliferative forms.
In 2024, approximately 385,000 diagnosed cases were reported across the 7MM, with Spain showing the highest prevalence among the EU4 and UK. Currently, BENLYSTA (belimumab) and LUPKYNIS (voclosporin) are the only FDA-approved treatments, while a strong pipeline-including ianalumab, FABHALTA, CAR-T therapy, GAZYVA, and SAPHNELO-is expected to broaden therapeutic options.
DelveInsight's report, "Lupus Nephritis Market Insights, Epidemiology, and Market Forecast - 2034", provides an extensive evaluation of Lupus Nephritis, detailing historical and forecasted epidemiology, treatment landscape, market dynamics, and size across the US, EU5 (Germany, Spain, Italy, France, and the UK), and Japan. It further explores market drivers, barriers, and unmet needs, offering insight into growth potential and opportunity areas.
Discover more about treatment approaches, pipeline therapies, and market expansion in the Lupus Nephritis Market Report 2034 by DelveInsight - https://www.delveinsight.com/report-store/lupus-nephritis-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Key Highlights of the Lupus Nephritis Market Report
• The Lupus Nephritis market is expected to register robust CAGR growth through 2034.
• Valued at USD 1.8 billion in 2024, the market is poised for growth owing to emerging therapies across the 7MM.
• The United States held over 80% of the total 7MM market share in 2023, followed by Japan and Spain.
• Leading companies operating in the space include Aurinia Pharmaceuticals, Roche, AstraZeneca, Boehringer Ingelheim, GSK, Novartis, Otsuka Pharmaceutical, MorphoSys, Vertice Pharma, Sun Pharma, Abbott, Johnson & Johnson, Bayer, Sanofi, Sumitomo Corporation, LEO Pharma, Cipla, Nimble Pharmaceuticals, and others.
• Prominent therapies expected to launch include BENLYSTA (belimumab), LUPKYNIS (voclosporin), Ianalumab (VAY736), SAPHNELO (anifrolumab), and GAZYVA/GAZYVARO (obinutuzumab).
• Recent regulatory updates:
o June 2025: The FDA approved a 200 mg/mL autoinjector of Benlysta (belimumab) for pediatric patients with active LN.
o March 2025: Roche's supplemental BLA for Gazyva/Gazyvaro was accepted, supported by positive Phase III REGENCY data, with an FDA decision expected by October 2025.
o February 2025: Allogene Therapeutics received FDA clearance for its IND for ALLO-329, a CAR-T therapy for autoimmune diseases including LN.
o November 2024: Adicet Bio dosed its first LN patient in a Phase I ADI-001 trial.
o November 2024: Kyverna Therapeutics shared new clinical data for KYV-101 in ongoing Phase I/II KYSA trials.
o October 2024: Kezar Life Sciences paused enrollment in its Phase II PALIZADE trial of zetomipzomib.
o June 2024: Nkarta initiated the Ntrust-I trial of NKX019, following FDA clearance of a second IND for autoimmune applications.
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 Overview
Lupus Nephritis (LN) is a serious renal manifestation of systemic lupus erythematosus (SLE) caused by autoimmune inflammation. It affects up to 60% of SLE patients, potentially progressing to ESRD if untreated.
Common symptoms include proteinuria, hematuria, edema, fatigue, and hypertension, though some early-stage patients may remain asymptomatic.
Diagnosis relies on urinalysis, blood tests, kidney function tests, and renal biopsy for subtype classification.
Treatment typically involves immunosuppressants such as corticosteroids, cyclophosphamide, and mycophenolate mofetil, along with FDA-approved agents-BENLYSTA and LUPKYNIS. New therapies aim to reduce relapse rates and enhance long-term outcomes.
Lupus Nephritis Market Overview
The 7MM Lupus Nephritis market was worth USD 1.8 billion in 2024, with the US leading, followed by Spain (highest in EU4 + UK) and Japan (~USD 49 million). Emerging therapies are expected to meet unmet needs and fuel growth through 2034.
Currently, BENLYSTA and LUPKYNIS are the only FDA-approved drugs, used in induction and maintenance phases. Conventional regimens involve MMF and cyclophosphamide, supported by corticosteroids. Combination therapies-such as MMF + CNI or low-dose cyclophosphamide + BENLYSTA-are gaining prominence, especially for Class III/IV/V LN.
The treatment ecosystem is rapidly evolving with major contributions from Novartis, Roche, and AstraZeneca, focused on next-generation therapies to improve patient outcomes.
Dive into comprehensive Lupus Nephritis epidemiology across the 7MM, analyze total and age-specific cases, class-wise prevalence, and treatment patterns. Explore now @ Lupus Nephritis Prevalence - https://www.delveinsight.com/report-store/lupus-nephritis-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Lupus Nephritis Epidemiology
In 2024, the US recorded about 218,000 diagnosed cases, representing ~60% of total 7MM cases. The EU4 and UK together had ~130,000 cases, with Spain having the highest and France the lowest prevalence.
Epidemiological projections show a steady rise in LN diagnoses across these regions, owing to better disease recognition and improved survival.
Lupus Nephritis Epidemiology Segmentation includes:
• Total diagnosed prevalent cases
• Age-specific distribution
• Class-wise prevalence
• Total treated cases
Lupus Nephritis Emerging Drugs
Ianalumab (VAY736) - Novartis:
A fully human monoclonal antibody targeting the BAFF receptor (BAFF-R), administered subcutaneously. It is in Phase III trials, with regulatory submission anticipated by 2028.
GAZYVA/GAZYVARO (obinutuzumab) - Roche:
An IV monoclonal antibody targeting CD20 with enhanced cytotoxicity. Supported by positive Phase III REGENCY data, it's under FDA and EMA review, with US approval expected by October 2025.
Uncover Lupus Nephritis market trends, emerging therapies, and opportunities across major global markets @ Lupus Nephritis Drugs Market - https://www.delveinsight.com/sample-request/lupus-nephritis-market?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Lupus Nephritis Market Dynamics
Lupus Nephritis Market Drivers:
• Increasing prevalence of SLE and LN globally
• Advances in FDA-approved and pipeline therapies
• Persistent unmet medical needs in severe subtypes
• Growing diagnostic awareness and treatment adoption
Lupus Nephritis Market Barriers:
• High therapy costs limiting accessibility
• Disease heterogeneity complicating treatment standardization
• Regulatory complexities delaying drug launches
• Adverse effects of prolonged immunosuppressive therapy
Therapeutic Assessment & Key Companies
Major players include Aurinia Pharmaceuticals, Roche, AstraZeneca, Boehringer Ingelheim, GSK, Novartis, Otsuka, MorphoSys, Vertice Pharma, Sun Pharma, Abbott, J&J, Bayer, Sanofi, Sumitomo, LEO Pharma, Cipla, and Nimble Pharmaceuticals.
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
Key Insights from the Report
1. Lupus Nephritis patient population
2. Market size and emerging trends
3. Competitive landscape and pipeline
4. Key drivers, restraints, and opportunities
5. Treatment practices and algorithms
6. Impact of emerging therapies on the market
About DelveInsight
DelveInsight is a trusted life science market research and consulting firm, specializing in syndicated market reports and customized solutions for the global healthcare sector.
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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