Lupus Nephritis Market Size, Epidemiology, In-Market Drugs Sales, Pipeline Therapies, and Regional Outlook 2025-2035

Market Overview:

The lupus nephritis market reached a value of USD 2.4 Billion across the top 7 markets (US, EU4, UK, and Japan) in 2024. Looking forward, IMARC Group expects the top 7 major markets to reach USD 6.0 Billion by 2035, exhibiting a growth rate (CAGR) of 8.7% during 2025-2035.

The lupus nephritis market has been comprehensively analyzed in IMARC's new report titled "Lupus Nephritis Market Size, Epidemiology, In-Market Drugs Sales, Pipeline Therapies, and Regional Outlook 2025-2035". Lupus nephritis refers to a complication of systemic lupus erythematosus (SLE), an autoimmune disease affecting various parts of the body, including the kidneys. It occurs when the immune system accidentally attacks the kidneys, causing inflammation and tissue damage. The general symptoms of the ailment are fever, edema (mainly in the legs, feet, or ankles), joint and muscle pain, malar rash, foamy urine, etc. Some people may also experience fatigue, weight gain, and shortness of breath. In severe cases, these indications worsen over time and lead to kidney failure. The diagnosis of lupus nephritis depends on a review of the patient's symptoms and laboratory investigations. Blood and urine tests are performed to detect abnormalities in kidney function, such as protein and blood in the urine, as well as inflammation markers in the blood. The healthcare provider may also perform diagnostic procedures, including X-rays and kidney ultrasounds, to visualize the stage and extent of the disease. Additionally, a kidney biopsy, which involves taking a tiny piece of renal tissue for investigation under a microscope, is required to confirm a diagnosis and guide treatment.

The rising cases of autoimmune diseases, which cause inflammation and scarring of the kidney tissues, are primarily driving the lupus nephritis market. In addition to this, the increasing prevalence of various associated risk factors, including genetic predisposition, certain infections, exposure to toxins, etc., is also bolstering the market growth. Furthermore, the escalating utilization of immunosuppressive drugs, such as mycophenolate mofetil and azathioprine, to manage the underlying symptoms of the ailment is acting as another significant growth-inducing factor. Apart from this, the growing application of monoclonal antibodies, which are designed to treat an excess of interferon activation and reduce inflammation, is further creating a positive outlook for the market. Moreover, various government authorities are taking initiatives to enhance access to care for patients with lupus nephritis, including increasing funding for healthcare infrastructure and reimbursement rates for providers. This, in turn, is also propelling the market growth. Additionally, the emerging popularity of renin-angiotensin-aldosterone system (RAAS) blockers, such as angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), aldosterone antagonists, etc., which can reduce high blood pressure and preserve kidney function in patients, is expected to drive the lupus nephritis market in the coming years.

IMARC Group's new report provides an exhaustive analysis of the lupus nephritis market in the United States, EU4 (Germany, Spain, Italy, and France), United Kingdom, and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report, the United States has the largest patient pool for lupus nephritis and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario, unmet medical needs, etc., have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the lupus nephritis market in any manner.

Recent Developments:

• In September 2024, Aurinia Pharmaceuticals disclosed that the Japanese Ministry of Health, Labour, and Welfare had approved voclosporin, a second-generation calcineurin inhibitor, in combination with mycophenolate mofetil (MMF) to treat lupus nephritis.
• In March 2024, Lupus Therapeutics declared a collaboration with Artiva Biotherapeutics, Inc. on a phase 1 trial of the novel NK cell-based therapy AlloNK (also called AB-101), in combination with anti-CD20 antibodies for individuals with active lupus nephritis. AlloNK is a non-genetically modified, allogeneic, cryopreserved natural killer (NK) cell treatment candidate designed to improve the efficacy of targeted monoclonal antibodies in depleting dangerous B cells.
• In February 2024, Everest Medicines and Kezar Life Sciences, Inc. announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) granted Kezar's investigational new drug (IND) application for the Phase 2b PALIZADE trial of zetomipzomib in patients with lupus nephritis in China. Zetomipzomib is a new, first-in-class, selective immunoproteasome inhibitor with extensive therapeutic potential across numerous autoimmune disorders.
• In February 2024, Atara Biotherapeutics, Inc. announced that the company had recently submitted an Investigational New Drug (IND) application to the U.S. FDA for the use of ATA3219 as a monotherapy for the management of systemic lupus erythematosus with kidney involvement (lupus nephritis).
• In June 2023, Lupus Therapeutics announced the initiation of a collaboration to perform three Phase 3 clinical trials of ianalumab, an experimental treatment for lupus nephritis.

Key Highlights:

• Lupus nephritis affects over 40% of patients with systemic lupus erythematous.
• Approximately 3 out of 10,000 people have lupus nephritis.
• Lupus nephritis frequently arises early in the illness course, usually within the first 6 to 36 months, and may be present at the first diagnosis.
• Asians had a higher incidence of lupus nephritis (55%), followed by Africans (51%) and Hispanics (43%), compared to Caucasians (14%).
• Patients with lupus nephritis had a death rate of more than 50% after 20 years, and of those who survived, 40% had end-stage renal disease.

Drugs:

Lupkynis (Voclosporin) works through a dual mechanism in lupus nephritis: it suppresses the immune system by inhibiting T-cell activation, and it stabilizes kidney podocytes to reduce protein in the urine. It achieves this by inhibiting calcineurin, a protein involved in T-cell activation and podocyte function. Specifically, it blocks the production of IL-2 and other cytokines, reducing inflammation and T-cell mediated immune responses. It also stabilizes podocytes, which are specialized cells in the kidney that help filter the blood, preventing protein from leaking into the urine.

CFZ533 is a fully human, Fc-silent (non-depleting) monoclonal antibody targeting CD40, a critical co-stimulatory receptor on B cells and antigen-presenting cells. By blocking the CD40-CD40L interaction, it suppresses T-cell-dependent B-cell activation and germinal center formation, thereby reducing autoantibody production and inflammatory responses, without depleting B cells, offering a precise immunomodulatory strategy for lupus nephritis.

Itolizumab is a monoclonal antibody that works by targeting the CD6-ALCAM signaling pathway in immune cells. It specifically downregulates effector T cells, which are a type of immune cell that can contribute to inflammation in autoimmune diseases like lupus nephritis, while preserving regulatory T cells, which help maintain immune balance. This action reduces the proliferation and activity of these harmful T cells, leading to a decrease in the production of pro-inflammatory cytokines (like IFN-γ, TNF-α, IL-6, and IL-17) and potentially reducing the infiltration of these cells into inflamed tissues like the kidneys.

Zanubrutinib is under clinical development by BeiGene. It is designed to be taken orally in the form of hard gelatin capsules. The drug is used to treat adult patients with lupus nephritis.

Time Period of the Study

• Base Year: 2024
• Historical Period: 2019-2024
• Market Forecast: 2025-2035

Countries Covered

• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan

Analysis Covered Across Each Country

• Historical, current, and future epidemiology scenario
• Historical, current, and future performance of the lupus nephritis market
• Historical, current, and future performance of various therapeutic categories in the market
• Sales of various drugs across the lupus nephritis market
• Reimbursement scenario in the market
• In-market and pipeline drugs

Competitive Landscape:

This report also provides a detailed analysis of the current lupus nephritis marketed drugs and late-stage pipeline drugs.

In-Market Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance

Late-Stage Pipeline Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report.

Key Questions Answered in this Report:

Market Insights

• How has the lupus nephritis market performed so far and how will it perform in the coming years?
• What are the markets shares of various therapeutic segments in 2024 and how are they expected to perform till 2035?
• What was the country-wise size of the lupus nephritis across the seven major markets in 2024 and what will it look like in 2035?
• What is the growth rate of the lupus nephritis across the seven major markets and what will be the expected growth over the next ten years?
• What are the key unmet needs in the market?

Epidemiology Insights

• What is the number of prevalent cases (2019-2035) of lupus nephritis across the seven major markets?
• What is the number of prevalent cases (2019-2035) of lupus nephritis by age across the seven major markets?
• What is the number of prevalent cases (2019-2035) of lupus nephritis by gender across the seven major markets?
• What is the number of prevalent cases (2019-2035) of lupus nephritis by type across the seven major markets?
• How many patients are diagnosed (2019-2035) with lupus nephritis across the seven major markets?
• What is the size of the lupus nephritis patient pool (2019-2024) across the seven major markets?
• What would be the forecasted patient pool (2025-2035) across the seven major markets?
• What are the key factors driving the epidemiological trend lupus nephritis of?
• What will be the growth rate of patients across the seven major markets?

Lupus Nephritis: Current Treatment Scenario, Marketed Drugs and Emerging Therapies

• What are the current marketed drugs and what are their market performance?
• What are the key pipeline drugs and how are they expected to perform in the coming years?
• How safe are the current marketed drugs and what are their efficacies?
• How safe are the late-stage pipeline drugs and what are their efficacies?
• What are the current treatment guidelines for lupus nephritis drugs across the seven major markets?
• Who are the key companies in the market and what are their market shares?
• What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the lupus nephritis market?
• What are the key regulatory events related to the lupus nephritis market?
• What is the structure of clinical trial landscape by status related to the lupus nephritis market?
• What is the structure of clinical trial landscape by phase related to the lupus nephritis market?
• What is the structure of clinical trial landscape by route of administration related to the lupus nephritis market?