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  • To Be Published : Nov 2023
  • Code : CMI1540
  • Pages : N/A
  • Formats :
      Excel and PDF
  • Industry : Pharmaceutical

Systemic Lupus Erythematosus (SLE) is chronic autoimmune disorder. It is characterized by excess production of the antibodies that attacks body’s own cells and vital organs. Various symptoms associated with the disease includes joint pain, swelling, rashes over face (butterfly rash) and other body area, severe fatigue, hair loss, anemia, and Raynaud’s phenomenon etc. SLE can also affect vital body organs such as heart, kidney, lungs, and behavioral changes. Exact causes of the disease is unknown, however, hereditary and environmental factors could be lead to SLE. There is no direct cure available for SLE, however, symptomatic treatment can be administered to lower or eliminate symptoms associated with disease. Major classes of drugs commonly used are antimalarial agents such as chlorquine and hydrochlorquine; topical steroid cream for rashes; NSAIDS for joint pain; and fever steroidal medication such as glucocorticoids through IV or oral route and immunosuppressive agents to lower immune response from the antibodies.

Market dynamics

Rise in incidence of SLE is one of major factors driving growth of the systemic lupus erythematosus treatment market. According to study published in the Expert Review of Clinical Immunology in 2017, the global incidence rate varied from about 0.3–23.7 per 100,000 person and the prevalence rates varied in the range from 6.5 to 178.0 per 100,000 people. Key companies are entering into collaborations for research and development in systemic lupus erythematosus, which is expected to support growth of the market. For instance, in 2015, a genomic mapping company, 23andMe, Inc. collaborated with Pfizer, Inc. to study and understand the genetics of lupus thereby, to develop treatment for it. In 2012, Alliance for Lupus Research and Pfizer’s Centers for Therapeutic Innovation collaborated to discover new therapies for patients living with systemic lupus erythematosus. Increasing approvals for products for the treatment of SLE is another factor expected to aid in growth of the market. For instance, GlaxoSmithKline, in July 2017, received U.S.FDA approval for the subcutaneous form of its biologic drug belimumab for treatment of systemic lupus erythematosus. Clinical guidelines to include biologics in the treatment of systemic lupus erythematosus would further aid in market growth. Multidisciplinary group consisting international experts in various branches such as internal medicine, rheumatology, nephrology, dermatology, pediatrics, and cardiology published recommendations in journal Autoimmune Review in 2017, for the use of biologics in patients with systemic lupus erythematosus, according to which biologic drugs such as abatacept, rituximab, or tocilizumab can be used after evaluating patient profile.

However, cost associated with the treatment of systemic lupus erythematosus is high, which makes the treatment unaffordable. Biological drugs are covered under Medi Claim, however, unfavorable reimbursement scenario for new drugs and biologics may limit adoption of these drugs, which is expected to adversely affect the market growth.

Regional dynamics

North America is expected to be the dominant market in the global SLE treatment market, over the forecast period. This is owing to relatively higher prevalence of SLE in this region as compared to other regions. According to study published in the Rheumatology Journal, in May 2017, incidence and prevalence of SLE in North America was 23.2 people per 1, 00,000 and 241 per 1, 00,000 people, respectively. High presence of market players in North America is also another factor for growth of the market in this region. Key players such as GlaxoSmithKline, F. Hoffmann-La Roche Ltd, Bristol-Myers Squibb in systemic lupus erythematosus market have high presence in this region.

Competitive landscape

Key players operating in the systemic lupus erythematosus treatment market are GlaxoSmithKline Plc (GSK), F. Hoffmann-La Roche Ltd, Anthera Pharmaceuticals Inc., Bristol-Myers Squibb, Eli Lilly, Pfizer Limited, Merck KGaA, Immupharma Plc, Sanofi, Lycera Corporation, Aurinia Pharmaceuticals Inc., Mylan N.V., and Sandoz International GmbH.

Companies in the market are engaged in developing novel therapy for treatment of systemic lupus erythematosus, which would also aid in market growth. Immupharma plc’s Lupozor completed phase 3 clinical trial in December 2017, which earlier was granted with fast track status by the US FDA. Atacicept from Merck Serono (German based Merck KGaA) completed phase 2 trial in February 2018. In March 2018, GlaxoSmithKline plc started phase 3 clinical trial by combining belimumab (Benlysta) with rituximab for treating patients with systemic lupus erythematosus which is expected to provide efficient treatment for SLE than single medicine.

Antimalarial is often used in mild SLE conditions, whereas, glucocorticoids and NSAIDS are commonly used in mild to moderate conditions. These are also preferred treatment in case of complications associated with SLE, where organs are damaging due to the disease. NSAIDS and immunosuppressive drugs segments hold a larger share in the market than other classes due to their proven efficacy in reducing symptoms and wider use in SLE conditions with organ complication. Biologics drugs segment are slowly gaining traction in the market with better outcomes and more patient compliance. Guidelines for use of biologic are also boosting confidence among physicians for adoption of biologics, as treatment for systemic lupus erythematosus.

Market Taxonomy

By Treatment Type

  • Antimalarial Drugs
    • Chlorquine
    • Hydrochlorquine
  • Non-Steroidal Anti-Inflammatory Drugs (NSAIDS)
  • Cytotoxic and Immunosuppressive Drugs
    • Cyclosporine
    • Cyclophosphamide
    • Methotrexate
    • Mycophenolate Mofetil
    • Tacrolimus
  • Biologics
    • B-Cell modulators
    • T-Cell modulators
    • Pro-inflammatory and cytokine inhibitors

By Route of Administration

  • Intravenous
  • Sub-cutaneous
  • Oral
  • Topical

By Distribution Channel

  • Retail Pharmacy
  • Online Pharmacy



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