The Systemic Lupus Erythematosus Market Size was estimated to be USD 1462 Million in 2020

The Systemic Lupus Erythematosus Market Size was estimated to be USD 1462 Million in 2020

The Systemic Lupus Erythematosus market report provides current treatment practices, emerging drugs, Systemic Lupus Erythematosus market share of the individual therapies, current and forecasted Systemic Lupus Erythematosus market Size from 2019 to 2032 segmented by seven major markets. The Report also covers current Systemic Lupus Erythematosus treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the Systemic Lupus Erythematosus market. Systemic Lupus Erythematosus market size increment is a direct consequence of expected entry of promising emerging therapies, increasing awareness of the disease, and recent advancements in research and development in the 7MM.

 

Key takeaways from the Systemic Lupus Erythematosus Market Research Report

  • The total Systemic Lupus Erythematosus market size is calculated by including the market size of both emerging and current therapies. The total market size in the 7MM for Systemic Lupus Erythematosus was estimated to be USD 1,462.5 million in 2020.
  • The total diagnosed prevalent population of Systemic Lupus Erythematosus in the 7MM ranges from 651,965 in 2020
  • Epidemiology assessed for Systemic Lupus Erythematosus showed that the US, in 2020, accounted for approximately 351,176 prevalent cases of Systemic Lupus Erythematosus.
  • Systemic Lupus Erythematosus Companies are working such as GlaxoSmithKline, AstraZeneca, Eli Lilly and Company, Biogen, UCB Pharma/Biogen, Immupharma, Hoffmann-La Roche, Xencor, Idorsia Pharmaceuticals, Bristol-Myers Squibb (Celgene), Resolve Therapeutics, Genentech (Roche), Pfizer, and others.
  • Systemic Lupus Erythematosus Pipeline therapies such as Anifrolumab, LY3471851, Baricitinib, Belimumab 10 mg/kg plus standard therapy, MEDI-546, and others.

 

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Systemic Lupus Erythematosus Overview

Systemic Lupus Erythematosus, referred to as SLE or lupus, is a chronic (long-term) disease that causes systemic inflammation which affects multiple organs. In addition to affecting the skin and joints, it can affect other organs in the body such as the kidneys, the tissue lining the lungs (pleura), heart (pericardium), and brain. Many patients experience fatigue, weight loss, and fever. Lupus flares vary from mild to serious. Most patients have times when the disease is active, followed by times when the disease is mostly quiet – referred to as a remission. Yet, there is much reason for hope.” The primary pathological findings in patients with SLE are those of inflammation, vasculitis, immune complex deposition, and vasculopathy. Lupus nephritis is a common and potentially disturbing sign of lupus. It is a leading cause of morbidity and mortality in patients with SLE. It leads to inflammation of small blood vessels which play an important role in filtering waste materials in the kidney.

 

Systemic Lupus Erythematosus Epidemiology Segmentation in the 7MM

  • Total Systemic Lupus Erythematosus Prevalent Population
  • Systemic Lupus Erythematosus Age-specific Prevalent Population
  • Systemic Lupus Erythematosus Gender-specific Prevalent Population
  • Systemic Lupus Erythematosus Severity-specific Prevalent Population

 

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Systemic Lupus Erythematosus Treatment Market

There are many treatments available to help particular symptoms. The disease involves a wide range of clinical features that encompasses vascular, immune and fibrotic manifestations along-with the involvement of many organs. Treatments of Systemic Lupus Erythematosus include NSAIDs and antimalarial agents, which are the first-line therapies for mild SLE. In addition, glucocorticoids and cytotoxic or immunosuppressive agents—such as azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine, and methotrexate —are used for SLE with organ involvement.

 

Systemic Lupus Erythematosus Market Outlook

Systemic Lupus Erythematosus involves a wide range of clinical features that encompasses vascular, immune, and fibrotic manifestations along with the involvement of many organs. Systemic Lupus Erythematosus treatment includes NSAIDs and antimalarial agents, which are the first-line therapies for mild Systemic Lupus Erythematosus. In addition, glucocorticoids and cytotoxic or immunosuppressive agents—such as azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine, and methotrexate —are used for Systemic Lupus Erythematosus treatment with organ involvement. The current Systemic Lupus Erythematosus market possesses two approved products, Benlysta (belimumab) and Saphnelo (anifrolumab-fnia).

 

Systemic Lupus Erythematosus Market Drugs

Benlysta: GlaxoSmithKline

Benlysta, developed by GlaxoSmithKline, is a human IgG1λ monoclonal antibody specific for B-lymphocyte stimulator (BLyS)-specific inhibitor specified for the treatment of patients aged 5 years and older with active, autoantibody-positive, SLE who are receiving standard therapy. It is provided as a lyophilized powder (120 mg or 400 mg) in a single-use vial for intravenous infusion and is also available as a subcutaneous formulation. The subcutaneous formulation was approved for use in the 2017 in US, EU5 and Japan. These Subcutaneous presentations enable patients to self-administer their medicine at home after initial supervision from their clinical team if considered appropriate.

Saphnelo: AstraZeneca

Saphnelo, developed by AstraZeneca, is a fully human monoclonal antibody that binds to subunit 1 of the Type I IFN receptor, deterring the activity of all Type I IFNs including IFN-α, IFN-β, and IFN-ω. In August 2021, US FDA approved Saphnelo (anifrolumab-fnia) to treat adult patients with moderate to severe SLE who are receiving standard therapy. In the second half of 2020, AstraZeneca received regulatory submission acceptances for the drug from the EMA and PDMA Japan for the treatment of adult patients with moderate-to-severe SLE. In 2015, the US FDA granted Anifrolumab Fast-Track designation for SLE.

 

Systemic Lupus Erythematosus Emerging Drugs

Olumiant (baricitinib): Eli Lilly

Eli Lilly is developing Olumiant (baricitinib) in collaboration with Incyte Corporation. It is an oral, small-molecule inhibitor of Janus kinase (JAK 1 and JAK 2). The drug has been approved by EMA for the treatment of moderate to severe rheumatoid arthritis and atopic dermatitis in adult patients with the brand name Olumiant. It is being evaluated in Phase III clinical trials for SLE. In December 2018, Eli Lilly and Incyte announced that the US FDA had granted Fast Track designation to Baricitinib, which is being studied for the treatment of SLE

Lupuzor: ImmuPharma

Lupuzor (also known as regiremod; IPP-201101), being developed by ImmuPharma, is a 21-mer linear peptide fragment analog. It has a novel mechanism of action aimed at modulating the body’s immune system so that it does not attack healthy cells and avoids causing adverse side effects. The unique mechanism of action involves modulating the activation of auto-reactive T-cells. This targeted approach marks a paradigm shift in treating autoimmune diseases. ImmuPharma has completed the Phase III clinical trial for the treatment of SLE. The therapeutic candidate has received the Fast Track designation and Special Protocol Assessment (SPA) by the FDA for SLE treatment.

BIIB059: Biogen

Biogen is developing, BIIB059, is an investigational humanized monoclonal antibody that specifically recognizes and binds to blood DC antigen 2 (BDCA2), a pDC-specific receptor that inhibits the production of IFN-I and other inflammatory mediators when ligated. BDCA2 is uniquely expressed on the surface of human pDCs (plasmacytoid dendritic cells). Biogen is conducting a Phase III clinical trial for the treatment of patients receiving Active SLE receiving background nonbiologic lupus standard of care.

Dapirolizumab pegol: UCB Pharma

Dapirolizumab pegol, developed by UCB Pharma and their partner Biogen. It is an investigational humanized anti-CD40L antibody fragment that acts by preventing the interaction between CD40L on T-cells with CD40 on antigen-presenting cells through interactions with its receptor-CD40. The drug failed to meet its primary endpoint in the Phase II trial. However, the company continued the development of dapirolizumab pegol. The product is currently being developed jointly by UCB and Biogen to treat SLE in a Phase III trial.

Gazyva/Gazyvaro (obinutuzumab): Hoffmann-La Roche

Hoffmann-La Roche is developing Gazyva/Gazyvaro (obinutuzumab), an engineered monoclonal antibody designed to attach to CD20, a protein expressed on certain B-cells but not on stem cells or plasma cells. Recently, in August 2021, the company initiated a Phase III trial (ALLEGORY) evaluating the efficacy and safety of obinutuzumab in participants with SLE. Additionally, in September 2019 FDA granted Breakthrough Therapy designation to the drug to treat lupus nephritis.

Cenerimod: Idorsia Pharmaceuticals

Cenerimod, developed by Idorsia Pharmaceuticals, is an oral, selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, which potentially offers a novel approach for SLE. S1P1 modulator binds to the S1P1 receptor on the surface of T and B lymphocytes. In December 2018, the company initiated a Phase II (CARE) multiple-dose efficacy and safety study with cenerimod for the treatment of adult patients with moderately to severely active autoantibody-positive SLE. In December 2017, the US Food and Drug Administration (FDA) had granted cenerimod Fast Track designation for the SLE treatment. The results for the CARE Phase IIb study are expected in Q4 2021.

 

Systemic Lupus Erythematosus Market Dynamics

The dynamics of the Systemic Lupus Erythematosus market is anticipated to change in the coming years owing to the improvement in the research and development activities for efficient treatment options to be available in the market. It includes several Systemic Lupus Erythematosus pipeline therapies such as Lupuzor (also known as IPP-201101), being developed by ImmuPharma, is a 21-mer linear peptide fragment analog. ImmuPharma has completed the Phase III clinical trial for the treatment of SLE. Lupuzor demonstrated a superior response rate over placebo (61.5% vs 47.3%). ImmuPharma and Avion Pharmaceuticals signed exclusive license and development agreement for Lupuzor to fund a new ‘optimized’ international Phase III trial which is expected to start by 2022. Avion Pharmaceuticals has the exclusive rights for the commercialization of Lupuzor in the US. ImmuPharma retains all the rights to commercialize Lupuzor outside the US. Apart from this, Biogen is developing, BIIB059, is an investigational humanized monoclonal antibody that specifically recognizes and binds to blood DC antigen 2 (BDCA2), a pDC-specific receptor that inhibits the production of IFN-I and other inflammatory mediators when ligated. Biogen is conducting  Phase III clinical trials for the treatment of patients receiving Active SLE receiving background nonbiologic lupus standard of care.

 

Discover more about therapy set to grab substantial Systemic Lupus Erythematosus share @ Systemic Lupus Erythematosus Market Landscape

 

Scope of the Systemic Lupus Erythematosus Market Report

  • Coverage- 7MM
  • Study Period- 2019-2032
  • Forecast Period- 2022-2032
  • Systemic Lupus Erythematosus Companies- GlaxoSmithKline, AstraZeneca, Eli Lilly and Company, Biogen, UCB Pharma/Biogen, Immupharma, Hoffmann-La Roche, Xencor, Idorsia Pharmaceuticals, Bristol-Myers Squibb (Celgene), Resolve Therapeutics, Genentech (Roche), Pfizer, and others.
  • Systemic Lupus Erythematosus Pipeline therapies such as Anifrolumab, LY3471851, Baricitinib, Belimumab 10 mg/kg plus standard therapy, MEDI-546, and others.

 

Table of Content

1. Key Insights

2. Executive Summary of Systemic Lupus Erythematosus

3. Competitive Intelligence Analysis for Systemic Lupus Erythematosus

4. Systemic Lupus Erythematosus: Market Overview at a Glance

5. Systemic Lupus Erythematosus: Disease Background and Overview

6. Patient Journey

7. Systemic Lupus Erythematosus Epidemiology and Patient Population

8. Systemic Lupus Erythematosus Treatment Algorithm, Current Treatment, and Medical Practices

9. Systemic Lupus Erythematosus Unmet Needs

10. Key Endpoints of Systemic Lupus Erythematosus Treatment

11. Systemic Lupus Erythematosus Marketed Products

12. Systemic Lupus Erythematosus Emerging Therapies

13. Systemic Lupus Erythematosus: Seven Major Market Analysis

14. Attribute analysis

15. 7MM: Systemic Lupus Erythematosus Market Outlook

16. Access and Reimbursement Overview of Systemic Lupus Erythematosus

17. KOL Views

18. Systemic Lupus Erythematosus Market Drivers

19. Systemic Lupus Erythematosus Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

23. About DelveInsight

 

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