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.
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.
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.
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:
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 Aministration: The report includes bifurcation of the market into three segments on the basis of route of aministration: 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.
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).
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
Table of Contents
1. Executive Summary
2. Introduction
3. Global Market Analysis
4. Regional Market Analysis
5. Impact of COVID-19
6. Market Dynamics
7. Competitive Landscape
8. Company Profiles
List of Figures
List of Tables
Executive Summary
The report titled “Global Systemic Lupus Erythematosus Market: Analysis By Product Type, By Route of Administration, By End User, By Region Size and Trends with Impact of COVID-19 and forecast up to 2026”, provides an in-depth analysis of the systemic lupus erythematosus market by value, by product type, route of administration, by end user, by region, etc. The report provides a regional analysis of the systemic lupus erythematosus market, including the following regions: North America (The US, Canada and Mexico), Europe (UK, Germany, France, Spain, Italy and Rest of Europe), Asia Pacific, Middle East & Africa and Latin America. The report also provides an analysis of the COVID-19 impact on the global systemic lupus erythematosus market.
Scope of the Report:
The report titled “Global Systemic Lupus Erythematosus Market: Analysis By Product Type, By Route of Administration, By End User, By Region Size and Trends with Impact of COVID-19 and forecast up to 2026”, includes:- An in-depth analysis of the global systemic lupus erythematosus market by product type, by route of administration, by end user, by region, etc.
- The regional analysis of the systemic lupus erythematosus market, including the following regions: North America (The US, Mexico and Canada), Europe (UK, Germany, France, Spain, Italy and Rest of Europe), Asia Pacific, Middle East & Africa
- Latin America
- Comprehensive information about emerging markets. This report analyses the market for various segments across geographies.
- Provides an analysis of the COVID-19 impact on the global systemic lupus erythematosus market.
- Assesses the key opportunities in the market and outlines the factors that are and would be driving the growth of the industry. Growth of the overall systemic lupus erythematosus market has also been forecasted for the period 2022-2026, taking into consideration the previous growth patterns, the growth drivers, and the current and future trends.
- Evaluation of the potential role of systemic lupus erythematosus to improve the market status.
- Identification of new technological developments, R&D activities, and product launches occuring in the systemic lupus erythematosus market.
- In-depth profiling of the key players, including the assessment of the business overview, market strategies, regional and business segments of the leading players in the market.
- The recent developments, mergers and acquisitions related to mentioned key players are provided in the market report.
- The in-depth analysis provides an insight into the market, underlining the growth rate and opportunities offered in the business.
Companies Mentioned
- AbbVie, Inc.
- Amgen Inc.
- Astra Zeneca PLC
- Biotest AG
- Boston Pharmaceuticals
- GlaxoSmithKline plc
- Hoffman-LA-Roche ltd
- Merck & Co., Inc.
- Novartis Ag
- Pfizer, Inc
- RemeGen Co., Ltd.
- Sanofi
- UCB SA
- Xencor, Inc.
Methodology
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