Lupus Nephritis Market to Advance at a CAGR of 8.5% During the Forecast Period (2025-2034) | DelveInsight

The total lupus nephritis market size is anticipated to experience growth during the forecast period due to the rising prevalence of lupus nephritis, increasing awareness and adoption of approved therapies beyond off-label corticosteroids, continued innovation in targeted therapies and next-generation therapies (dual APRIL/BAFF Antagonist, BAFF-R inhibitor, complement inhibitor, CAR-T cell therapies, etc.), and launch of promising emerging therapies, including GAZYVA (obinutuzumab), SAPHNELO (anifrolumab), and Ianalumab, among others.

LAS VEGAS, Oct. 6, 2025 /PRNewswire/ -- DelveInsight's Lupus Nephritis Market Insights report includes a comprehensive understanding of current treatment practices, lupus nephritis emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].

Lupus Nephritis Market Summary

• According to DelveInsight's analysis, the market size for lupus nephritis was found to be around USD 1.8 billion in the leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan] in 2024.
• The United States accounted for the largest lupus nephritis market size, approximately 85% of the total market size in the 7MM in 2024, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• The total number of diagnosed prevalent cases of lupus nephritis in the 7MM was approximately 385K in 2024, and this number is projected to increase by 2034.
• Lupus nephritis is a severe complication of Systemic Lupus Erythematosus (SLE), affecting 30–40% of patients, with 10–30% at risk of progressing to end-stage renal disease (ESRD) despite treatment.
• Leading lupus nephritis companies developing emerging therapies, such as Roche, Novartis, Alexion Pharmaceuticals, AstraZeneca, Cabaletta Bio, AbelZeta, and others, are developing new lupus nephritis treatment drugs that can be available in the lupus nephritis market in the coming years. 
• The promising lupus nephritis therapies in clinical trials include SAPHNELO (anifrolumab), Ianalumab (VAY736), GAZYVA/GAZYVARO (obinutuzumab), FABHALTA (iptacopan), Rapcabtagene autoleucel (YTB323), ULTOMIRIS (ravulizumab), Resecabtagene autoleucel (CABA-201), C-CAR168, and others.
• Roche's GAZYVA is expected to become the 3rd therapy to get regulatory nod for the treatment of Lupus Nephritis.

Discover the new lupus nephritis treatment @ Lupus Nephritis Treatment Market

Key Factors Driving the Growth of the Lupus Nephritis Market 

Rising Prevalence of Systemic Lupus Erythematosus and Lupus Nephritis

The increasing incidence of SLE, particularly in regions like the United States and Southern Europe, is contributing to a higher number of lupus nephritis cases. In the US, the lupus nephritis prevalent cases are expected to reach ~283K by 2034. This surge underscores the growing demand for effective treatments and diagnostics.

Advancements in Biologic and Targeted Lupus Nephritis Therapies

Innovations in biologic treatments, such as voclosporin (LUPKYNIS), belimumab (BENLYSTA), and anifrolumab (SAPHNELO), have revolutionized lupus nephritis management. These therapies offer targeted approaches that improve disease control and reduce reliance on traditional immunosuppressants. In addition to this, there is potential for CAR-T  cell therapy in Lupus nephritis, with early clinical trials showing promising, rapid, and prolonged remission in patients with otherwise severe, refractory cases. 

Increased Lupus Nephritis R&D Investments

Substantial investments in R&D by both public and private sectors are accelerating the discovery of novel therapies. The lupus nephritis clinical trial pipeline is experiencing momentum, with approximately 30 companies, including Roche, Novartis,Alexion Pharmaceuticals, AstraZeneca, Cabaletta Bio, AbelZeta, and others actively working on developing new treatments. This influx of resources enhances the therapeutic landscape and offers hope for improved patient care.

Growing Lupus Nephritis Awareness and Improved Diagnostics

Enhanced awareness among healthcare providers and patients has led to earlier and more accurate diagnoses of lupus nephritis. Advancements in diagnostic techniques, including the use of natural language processing to identify lupus nephritis phenotypes in electronic health records, are facilitating timely interventions and personalized treatment plans.

Lupus Nephritis Market Analysis

Currently, only two Food and Drug Administration (FDA)-approved therapies are available for lupus nephritis. Management typically follows two phases: induction to suppress acute inflammation and maintenance to sustain remission. However, real-world outcomes remain less than optimal. Treatment approaches vary, but mycophenolate mofetil (MMF) and cyclophosphamide remain the mainstay of induction therapy, while corticosteroids are often used to manage flares, though they provide limited long-term benefit when used alone. A trend is emerging toward more intensive regimens, especially for Class III/IV and V lupus nephritis, including triple therapy strategies such as glucocorticoids combined with MMF and BENLYSTA, MMF with a calcineurin inhibitor (CNI), or low-dose cyclophosphamide with BENLYSTA. For Class V disease, the preferred regimen often involves glucocorticoids, MMF, and a CNI. Increasingly, the treatment landscape is being shaped by BENLYSTA and LUPKYNIS, with a rapidly advancing pipeline.

BENLYSTA, a BLyS-specific inhibitor, represented a major milestone as the first biologic approved for both adults and children (ages 5–17) with lupus nephritis. LUPKYNIS, a next-generation CNI, distinguished itself as the first oral therapy specifically approved for active lupus nephritis. Compared to older agents like cyclosporine and tacrolimus, LUPKYNIS offers key advantages, including improved safety, consistent pharmacokinetics, and better long-term renal outcomes.

Commercially, LUPKYNIS has shown strong momentum. Net product sales of LUPKYNIS rose 36% in 2024 to USD 216.2 million, up from USD 158.5 million in 2023. Aurinia reports that more than 2,300 patients in the US are currently receiving the therapy, while international uptake is expanding through its partnership with Otsuka in Europe and Japan.

Lupus Nephritis Competitive Landscape

The lupus nephritis pipeline comprises several drugs in mid- and late-stage development, which are expected to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including SAPHNELO (anifrolumab), Ianalumab (VAY736), GAZYVA/GAZYVARO (obinutuzumab), FABHALTA (iptacopan), Rapcabtagene autoleucel (YTB323), ULTOMIRIS (ravulizumab), Resecabtagene autoleucel (CABA-201), C-CAR168, and others. 

GAZYVA/GAZYVARO (obinutuzumab) is an engineered monoclonal antibody, administered intravenously, that targets the CD20 protein expressed on lymphoma and leukemia cells. Unlike traditional CD20 antibodies, it binds specifically to Type 2 CD20, resulting in stronger antibody-dependent cytotoxicity and more potent direct cytotoxic activity. Once attached to CD20, obinutuzumab induces B-cell lysis by engaging immune effector cells, activating intracellular death signaling pathways, and/or triggering the complement cascade. The drug is marketed as GAZYVARO in Europe and is currently undergoing evaluation in two Phase III clinical trials.

In March 2025, the FDA accepted a supplemental Biologics License Application (sBLA) for Roche's GAZYVA/GAZYVARO for the treatment of lupus nephritis, supported by data from the Phase III REGENCY trial, which also underpins an European Medicines Agency (EMA) submission. An FDA decision is expected by October 2025.

Ianalumab, developed by Novartis, is a fully human HuCAL antibody targeting BAFF-R, administered subcutaneously. It is designed as an anti-BAFF receptor monoclonal antibody that mediates direct antibody-dependent cellular cytotoxicity (ADCC) to deplete B cells. The therapy is being studied for autoimmune hepatitis, idiopathic pulmonary fibrosis, SLE, and lupus nephritis, with Phase III clinical trials ongoing. Novartis is planning to submit regulatory filings around 2028.

The anticipated launch of these emerging therapies are poised to transform the lupus nephritis market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the lupus nephritis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

Discover more about the class 5 lupus nephritis treatment @ Managing Lupus Nephritis 

Recent Developments in the Lupus Nephritis Market

• In June 2025, Novartis announced new rese-cel safety and efficacy data in patients with myositis, lupus, and scleroderma.
• In May 2025, C-CAR168 received an RMAT (Regenerative Medicine Advanced Therapy designation) designation for the treatment of refractory SLE, including lupus nephritis.
• In May 2025, AbelZeta presented new data on C-CAR168 for the treatment of autoimmune diseases at the LUPUS 2025 conference.

What is Lupus Nephritis?

Lupus nephritis is a serious complication of SLE, an autoimmune disorder characterized by chronic inflammation and multi-organ damage, with the kidneys being the most frequently affected. Key clinical indicators include hematuria and proteinuria. The condition predominantly affects women between the ages of 20 and 40. Based on pathology, lupus nephritis is classified into six categories (I–VI), with Classes III (focal proliferative, ~30%), IV (diffuse proliferative, ~40%), and V (membranous, ~20%) being the most common and consistently reported worldwide. Monitoring renal function in SLE patients is vital, as timely detection and management of kidney involvement significantly improve long-term outcomes. Typically, lupus nephritis develops within 3–5 years after SLE diagnosis and considerably heightens the risk of End-Stage Renal Disease (ESRD).

Lupus Nephritis Epidemiology Segmentation

The lupus nephritis epidemiology section provides insights into the historical and current lupus nephritis patient pool and forecasted trends for the leading markets [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders.

The lupus nephritis treatment market report proffers epidemiological analysis for the study period 2020–2034 in the leading markets [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan], segmented into:

• Total Diagnosed Prevalent Cases of Lupus Nephritis
• Diagnosed Prevalent Cases of Lupus Nephritis by Class
• Age-specific Diagnosed Prevalent Cases of Lupus Nephritis
• Total Treated Cases of Lupus Nephritis (First Line, and Relapsed/ Refractory)

Scope of the Lupus Nephritis  Market Report

• Therapeutic Assessment: Lupus Nephritis current marketed and emerging therapies
• Lupus Nephritis Market Dynamics: Key Market Forecast Assumptions of Emerging Lupus Nephritis Drugs and Market Outlook
• Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
• Unmet Needs, KOL's views, Analyst's views, Lupus Nephritis Market Access and Reimbursement

Download the report to understand lupus nephritis epidemiology trends @ Lupus Nephritis Market Size 

Table of Contents

Related Reports

Lupus Nephritis Clinical Trial Analysis

Lupus Nephritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Hoffmann-La Roche, Qilu Pharmaceutical, Vera Therapeutics, Kyverna Therapeutics, Cabaletta Bio, Takeda, Nkarta Therapeutics, Annexon, Century Therapeutics, Lepton Pharmaceuticals, Transcenta Holding, Inflection Biosciences, among others.

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IgA Nephropathy Market 

IgA Nephropathy Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key IgAN companies including Novartis, F. Hoffmann-La Roche, Ionis Pharmaceuticals, AstraZeneca (Alexion Pharmaceuticals), Vertex Pharmaceuticals, Otsuka Pharmaceutical, Biogen, Arrowhead Pharmaceuticals, NovelMed, Q32 Bio, Walden Biosciences, Takeda Pharmaceutical, Vera Therapeutics, among others.

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