DelveInsight’s “Systemic Lupus Erythematosus Treatment Market Insights, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of Systemic Lupus Erythematosus, historical and forecasted epidemiology as well as the Systemic Lupus Erythematosus market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

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Key Takeaways from the Systemic Lupus Erythematosus Market Report

• In June 2025, UCB Biopharma SRL announced a study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.
• In June 2025, Novartis Pharmaceuticals conducted a study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).
• In June 2025, AstraZeneca conducted a study to evaluate the efficacy and safety of a subcutaneous treatment regimen of anifrolumab versus placebo in participants with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE) while receiving standard of care (SOC) treatment. Participants must be taking either 1 or any combination of the following: oral glucocorticoids, antimalarial, and/or immunosuppressants. The study will be performed in adult participants of 18 to 70 years of age.
• In June 2025, Merck Sharp & Dohme LLC organized a study is to evaluate the efficacy and safety of MK-6194 in adult participants with Systemic Lupus Erythematosus. The primary hypothesis is that at least 1 of the MK-6194 arms is superior to placebo in the primary endpoint of percentage of participants with systemic lupus erythematosus responder index (SRI-4) response at Week 28.
• In June 2025, AbbVie organized a study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed.
• Between EU4 and the UK, Spain accounted for the highest number of Systemic Lupus Erythematosus Diagnosed Prevalent Cases followed by the UK and Germany.
• The age group most affected by the systemic lupus erythematosus prevalence is 40-59 years. In 2023, among 7MM, approximately 40% of cases belonged to the 40-59 years age group.
• In 2023, approximately 50% of cases were found to be moderate cases in Spain.
• The leading Systemic Lupus Erythematosus Companies such as Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie and others.
• Promising Systemic Lupus Erythematosus Pipeline Therapies such as Obexelimab, Telitacicept, DS-7011a, Belimumab (GSK1550188), Sirolimus, Ianalumab, ALPN-101, BMS-986165, JMKX000189, BMS-986165 and others.

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Systemic Lupus Erythematosus Epidemiology Segmentation in the 7MM

• Total Diagnosed Prevalent Cases
• Total Diagnosed Prevalent Cases by Gender
• Total Diagnosed Prevalent Cases by Age
• Severity-Based Diagnosed Prevalent Cases
• Total Treated Cases

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Systemic Lupus Erythematosus Marketed Drugs

• BENLYSTA (belimumab): GlaxoSmithKline

BENLYSTA (belimumab), a B-lymphocyte stimulator (BLyS) specific inhibitor, is a fully human monoclonal antibody that binds to soluble BLyS, which is found to be increased in patients with systemic autoimmune diseases like SLE and lupus nephritis (LN). ABy bding BLyS, BENLYSTA inhibits the prolonged survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. BENLYSTA does not bind B cells directly. The US FDA first approved BENLYSTA for the treatment of active systemic lupus erythematosus; it is the first and only approved biologic for both SLE and LN in more than 50 years, including for the pediatric population. It was first approved by the US FDA in 2011.

• SAPHNELO (anifrolumab): AstraZeneca

SAPHNELO (anifrolumab) is a first in class, fully human monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor, blocking the activity of type I IFN. Type I IFNs, such as IFN-alpha, IFN-beta and IFN-kappa, are cytokines involved in regulating the inflammatory pathways implicated in SLE. The majority of adults with SLE have increased type I IFN signaling, which is associated with increased disease activity and severity. SAPHNELO is approved to treat systemic lupus erythematosus in more than 60 countries worldwide including the US, EU and Japan, with reviews ongoing in other countries.

Systemic Lupus Erythematosus Emerging Drugs

• Cenerimod: Idorsia Pharmaceuticals/Viatris

Cenerimod is a highly selective sphingosine-1-phosphate receptor 1 (S1P1) receptor modulator, given as an oral once-daily tablet. While the cause of SLE is not fully known, T and B-lymphocytes are considered the key immune cells playing a role in the development of SLE. T and B-lymphocytes have a cell surface receptor called S1P1. These receptors enable T and B-lymphocytes to detect the signaling molecule S1P – sphingosine 1 phosphate – which is responsible for lymphocyte trafficking from the lymph nodes to the circulation. By binding to S1P1 receptors, a receptor modulator can trigger the internalization of those receptors. This effectively blinds T and B lymphocytes to the S1P gradient, thereby holding them in the lymph nodes and reducing autoreactive T and B cells in the circulation and, consequently, also in the tissues. In December 2017, the US FDA designated the investigation of cenerimod for the treatment of SLE as a fast-track development program. Currently it is in Phase III of its clinical development.

• Litifilimab: Biogen

Litifilimab is a humanized IgG1 monoclonal antibody (mAb) targeting BDCA2 and is being investigated for the potential treatment of SLE and cutaneous lupus erythematosus (CLE). BDCA2 is a receptor that is predominantly expressed on a subset of human immune cells called Plasmacytoid Dendritic Cells (pDCs). The binding of litifilimab to BDCA2 has been shown to reduce the production of pro-inflammatory molecules by pDCs, including type-I interferon (IFN-I) as well as other cytokines and chemokines. Currently it is in Phase III of its clinical development.

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Systemic Lupus Erythematosus Treatment Market

Systemic lupus erythematosus is a chronic autoimmune disease that can affect many parts of the body. Lupus occurs when the immune system, which normally helps protect the body from infection and disease, attacks its own tissues. This attack causes inflammation, and in some cases permanent tissue damage, which can be widespread – affecting the skin, joints, heart, lung, kidneys, circulating blood cells, and brain. The systemic lupus erythematosus diagnosis is based on a combination of clinical findings and laboratory evidence. Familiarity with the diagnostic criteria helps clinicians to recognize systemic lupus erythematosus and to subclassify this complex disease based on the pattern of target-organ manifestations. The ACR/EULAR classification requires an antinuclear antibody (ANA) titer of at least 1:80 on HEp-2 cells or an equivalent positive test at least once. If that is present, 22 “additive weighted” classification criteria are considered, comprising seven clinical domains (constitutional, hematologic, neuropsychiatric, mucocutaneous, serosal, musculoskeletal, renal) and three immunologic domains (antiphospholipid antibodies, complement proteins, SLE-specific antibodies). Each criterion is assigned points, ranging from 2 to 10. Patients with at least one clinical criterion and 10 or more points are classified as having systemic lupus erythematosus.

Scope of the Systemic Lupus Erythematosus Market Report

• Coverage- 7MM
• Study Period- 2020-2034
• Systemic Lupus Erythematosus Companies- Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie and others.
• Systemic Lupus Erythematosus Pipeline Therapies- Obexelimab, Telitacicept, DS-7011a, Belimumab (GSK1550188), Sirolimus, Ianalumab, ALPN-101, BMS-986165, JMKX000189, BMS-986165 and others.
• Systemic Lupus Erythematosus Therapeutic Assessment: Systemic Lupus Erythematosus current marketed and emerging therapies
• Systemic Lupus Erythematosus Market Dynamics: Systemic Lupus Erythematosus market drivers and Systemic Lupus Erythematosus market barriers
• Systemic Lupus Erythematosus Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
• Systemic Lupus Erythematosus Unmet Needs, KOL’s views, Analyst’s views, Systemic Lupus Erythematosus Market Access and Reimbursement

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Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Systemic Lupus Erythematosus

4. Epidemiology and Market Forecast Methodology

5. SLE Market Overview at a Glance

6. Systemic Lupus Erythematosus Market Disease Background and Overview

7. Systemic Lupus Erythematosus Epidemiology and Patient Population

8. Systemic Lupus Erythematosus Marketed Therapies

9. Systemic Lupus Erythematosus Emerging Therapies

10. Systemic Lupus Erythematosus (SLE): The 7MM Analysis

11. Systemic Lupus Erythematosus Unmet Needs

12. Systemic Lupus Erythematosus SWOT Analysis

13. Systemic Lupus Erythematosus KOL Views

14. Systemic Lupus Erythematosus Market Access and Reimbursement

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