Global Systemic Lupus Erythematosus Market 2022-2026: Hoffmann-LA-Roche Ltd, Pfizer, Inc, Abbvie, Inc, Novartis AG, AstraZeneca Plc, GlaxoSmithKline Plc, Merck & Co., Inc, UCB SA, RemeGen Co., Ltd, Amgen Inc.

In 2021, the global systemic lupus erythematosus market was valued at US$1.89 billion. The market is projected to reach US$2.71 billion by 2026. Systemic Lupus Erythematosus (SLE) is a multi-systemic, incurable autoimmune disease with symptoms affecting nearly every organ and organ system in the human body. In this disease, the immune system targets the body's own tissues, resulting in extensive inflammation and tissue destruction in the organs involved. Some of the most common symptoms of SLE are swollen joints, unexplained fever, chest pain, hair loss, mouth ulcers, swollen lymph nodes, excessive exhaustion, and red rashes on the face.

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SLE is a very undertreated disease with limited effective therapeutic options globally. The only available biologic therapy approved in this indication globally are GSK's Benlysta (approved by US FDA 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). However, with significant unmet medical need, the market would grow in the years to come. The systemic lupus erythematosus market is expected to grow at a CAGR of 7.49% over the forecasted years 2022-2026.

Market Segmentation Analysis:

By Product Type: The report identifies six segments on the basis of Product Type: Biologics, NSAIDs, Antimalarial Drugs, Corticosteroids, Immunosuppressants and Others. In 2021, the biologics segment lead the market accounted for 33.7% share of the market. 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. For instance, gene-based and cellular biologics are frequently at the forefront of biomedical research and may be utilized to treat a number of medical problems for which no other treatments exist.

By Route of Administration: The report includes bifurcation of the market into three segments on the basis of route of administration: Oral, Intravenous and Subcutaneous. The oral segment dominated the market by occupying almost half of the share of the market in 2021. 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 of 8.62% over the forecast period. Subcutaneous is a good route of administration especially in skin infections.

By End User: The report includes bifurcation of the market into three segments on the basis end user: Hospitals, Drug Lab and Others. The hospital segment dominated the market with 46.7% share of the market in 2021. 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. Drug labs are commonly used for research and development of new drugs. Demand for drugs is increasing with increasing number od SLE patients and therefore drug lab segment would also grow in the coming years.

By Region: In the report, the global systemic lupus erythematosus market is divided into five regions: North America, Europe, Asia Pacific, Latin America and Middle East & Africa. North America dominated the market in 2021, by occupying around 44.4% 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. North America systemic lupus erythematosus market provides lucrative opportunities in the coming years. Economic stability, government initiatives and presence of various market players in the region gives a resilient opportunity for Systemic Lupus Erythematosus market.

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Market Dynamics:

Growth Drivers: The market has been growing over the past few years, due to factors such as increasing healthcare expenditure, increasing female population, rapid urbanization, favorable Government initiatives, rising prevalence of SLE disease, etc. Several initiatives are taken by various organizations and government to aware people about SLE. With government support, various research institutes are providing drugs and therapies to the SLE patients. Several new drugs are under trial which are funded by government. The Centers for Disease Control and Prevention (CDC) in the US is regularly releasing SLE disease statistics and warning citizens about the severe consequences of the disease, especially in women population.

Challenges: However, the market has been confronted with some challenges specifically, stringent regulatory environment, high cost of drug development, etc. Stringent regulatory environment is one of the major challenges to the systemic lupus erythematosus market. 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. The strict regulations would restrain the growth of the market.

Trends: The market is projected to grow at a fast pace during the forecast period, due to various latest trends such as rising clinical trials, adoption of stem cell therapy, rising awareness among people, etc. For the treatment of Lupus, stem cell therapy may be one of the most promising new dimensions of medicine, especially for those who do not respond well to more traditional kinds of treatment. Adoption of Stem cell therapy is increasing because this is a new and advance technique to treat lupus and that would boost the SLE market growth.

Impact Analysis of COVID-19 and Way Forward:

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.

Competitive Landscape:

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).

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The key players of the global systemic lupus erythematosus market are:

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

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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