Report Details

Global Systemic Lupus Erythematosus (SLE) Market (by Product Type, Route of Administration, End User, & Region): Insights & Forecast with Potential Impact of COVID-19 (2022-2026)

  • Published: 15th Sep 2023
  • Pages: 135
  • Format : Pdf

Market Insight:

Systemic Lupus Erythematosus (SLE) is a multi-systemic, incurable autoimmune disease that affects almost every organ and organ system in the human body. The immune system attacks the body's own tissues in this condition, causing significant inflammation and tissue damage in the organs implicated. Swollen joints, unexplained fever, chest discomfort, hair loss, mouth ulcers, enlarged lymph nodes, severe tiredness, and red rashes on the face are some of the most prevalent symptoms of SLE.

SLE is a highly undertreated condition with few viable therapy choices available worldwide. GSK's Benlysta (authorised by the US FDA in 2011 and China's NMPA in 2019), Astra Zeneca's Saphnelo (approved by the FDA in August 2021), and RemeGen's telitacicept (approved by China's NMPA in 2021) are the only biologic therapies approved in this indication globally. However, given enormous unmet medical need, the market would expand in the coming years. The global systemic lupus erythematosus market is expected to reach US$2.18 billion in 2023, progressing at a CAGR of 7.52% over the forecasted period. 

Segment Covered:

  • By Product Type: The market report has segmented the global systemic lupus erythematosus market into six segments in terms of product type: Biologics, NSAIDs, Antimalarial Drugs, Corticosteroids, Immunosuppressants and Others. The biologics segment lead the market with largest share. Demand for drugs with better efficacy and safety profile have increased among people. Biologics are safer than many other products, and can be used to treat women during pregnancy. The market is expected to grow at the highest CAGR, due to technological advancements in biologics.  
  • By Route of Administration: The report splits the global market into three segments on the basis of route of administration: Oral, Intravenous and Subcutaneous. The oral segment dominated the market by occupying maximum share of the market. Oral route of administration is convenient, safe and cost effective. Therefore, on most of the times, people prefer to use oral route of administration in SLE treatment. Subcutaneous segment is projected to grow at the highest CAGR over the forecast period.
  • By End User: According to report, the market has been segmented into three segments, based on end user: Hospitals, Drug Lab and Others. The hospital segment dominated the market with majority share. The hospital segment is expected to grow rapidly due to initiatives taken by several government around the world. Some hospitals are also providing free treatment to the SLE patients. Demand for drugs is increasing with increasing number od SLE patients and therefore drug lab segment would also grow in the coming years.

Geographic Coverage:

According to this report, the global systemic lupus erythematosus market is divided into five regions: North America, Europe, Asia Pacific, Latin America and Middle East & Africa. The countries covered in North America region include the US, Canada, and Mexico, while Europe includes UK, Germany, France, Spain, Italy and Rest of Europe.

North America dominated the market, by occupying largest share of the global market. Factors such as increasing prevalence of lupus and presence of prominent players have supported the growth of the systemic lupus erythematosus market in the region. On the other hand, the Asia Pacific network detection and response market is the emerging region in the global market, due to increasing adoption of cloud-based solutions by both large enterprises and SMEs in the region. 

Top Impacting Factors:

Growth Drivers

  • Increasing Healthcare Expenditure   
  • Increasing Female Population
  • Favorable Government Initiatives  
  • Rising Prevalence of SLE Disease   


  • Stringent Regulatory Environment  
  • High Cost of Drug Development   


  • Rising Clinical Trials 
  • Adoption of Stem Cell Therapy  
  • Rising Awareness Among People  

Driver: Increasing Healthcare Expenditure

As the economy advances, there comes a need for a proper healthcare infrastructure and subsequent technological advancement in the health sector. Investments in health care and research and development have made the development of medicines, treatments, and vaccinations easier and more effective. As a result of rising healthcare spending, the SLE market has become more advanced and accessible in recent years, and enhanced technology has paved the way for new drugs, therapies and antibodies, thus driving the growth of the market.

  • Challenge: Stringent Regulatory Environment 

Traditionally, all vaccinations, medical gadgets, and helpful medications developed to treat certain diseases have undergone extensive testing in clinical trials to ensure their safety and feasibility in treating the disease. These trials are very time consuming and rules and regulations associated with it are very stringent. Due to this reason, research organizations or pharmaceutical companies have to experience slow progress towards regulatory approvals. Because of the uncertainty in the trials only a few pharmaceutical companies are able to enter the market since they can bear the loss. Therefore, it is difficult for small and medium drug manufacturers to enter into the market. Apart from that recruitment, enrollment and retention of patients for trial is an another challenge to the drug manufacturer. Since, without a standard number of participants any kind of drug trial can not be approved.

  • Trend: Rising Awareness Among People

Autoimmune disease like systemic lupus erythematosus (SLE) is rare therefore a few people know about its severity and treatments. But, now people are more aware about this disease than before due to several awareness campaigns. Every year, events are held to educate the public about lupus and how it affects individuals. Furthermore, fundraising aids research initiatives as well as families whose lives have been affected by the disease. These events raise awareness of the physical, emotional, and financial consequences of lupus. People fighting the disease will receive better support, resources, and advocacy as their awareness grows. Therefore, rising awareness among the people through this type of events by various organizations would drive the market growth in the coming years.

The COVID-19 Analysis:   

In the early phases of the pandemic, the world was put under lockdown to stop the virus from spreading, suspending the majority of commercial operations. The lockdown had a huge influence on industries that are considered the backbone of the world economy, such as manufacturing, aviation, tourism, and so on, causing the global economy to enter a recession. The healthcare businesses encountered a number of challenges during the early stages of the pandemic. The availability of doctors, health workers as well as the supply of medical devices, diagnostics, and treatments, were all affected. Regular identification and treatment of other diseases were missed in the first half of 2020, because entire healthcare sector was focused on preventing, detecting and treating COVID-19.

On the contrary, as the lockdowns were gradually released near the second half of 2020, there was an increase in the number of patients seeking treatment for autoimmune diseases. Healthcare sector restored to normal as rate of transmission was reduced. Treatment for autoimmune diseases began at a better pace. As a result, COVID-19 had a short-term detrimental impact on the systemic lupus erythematosus market. 

Analysis of Key Players: 

The global market for systemic lupus erythematosus is fragmented. Most of the approved therapies for SLE are small molecule immunosuppressive agents such as azathioprine (first approved by the FDA in 1968), mycophenolate mofetil (first approved by the FDA in 1995) and methotrexate (first approved by the FDA in 1953), all of which are now off-patent and being marketed by multiple pharmaceutical companies in generic forms.

Beyond these small molecule drugs, there are currently two biologic drugs approved for the treatment of SLE globally: GSK’s belimumab (approved by the FDA in 2011 and NMPA in 2019) and RemeGen’s Telitacicept (approved by the NMPA in 2021 and not approved yet in the US). Beyond these two approved products, there are two innovative biologics for the treatment of SLE in phase III development in the US (along with eighteen other molecules in Phase I/II) and no Phase III pipeline assets in China (but five assets in Phase I/II). The key players of the global systemic lupus erythematosus market are:

  • Novartis AG
  • Hoffmann-LA-Roche Ltd.
  • Pfizer, Inc.
  • AstraZeneca Plc
  • GlaxoSmithKline Plc
  • Merck & Co., Inc.
  • Abbvie, Inc
  • Biotest AG
  • Sanofi
  • Boston Pharmaceuticals
  • UCB SA
  • RemeGen Co., Ltd.
  • Amgen Inc.
  • Xencor, Inc.

Hoffmann-LA-Roche Ltd., Pfizer, Inc., Abbvie, Inc. are some of the major drug manufacturer and have a dominance around the world. However, company like AstraZeneca Plc has a strong presence in the vaccine development and manufacturing as well. GlaxoSmithKline plc. is also a significant participant in the market with segments like pharmaceuticals, consumer healthcare, vaccine, etc.

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