The global Systemic Lupus Erythematosus market size was valued at US$ 3.87 billion in 2020 and is anticipated to grow at a CAGR of 10.0% during forecast period 2021 to 2030.
The market is estimated to gain traction with arrival of key pipeline agents, which promise higher efficacy than existent therapies, in the offing.
Biologics for autoimmune conditions improve treatment to a large extent and are increasingly gaining physicians’ confidence. Benlysta, the first biologic in the past five decades, was approved by the FDA and EMA in 2011. However, in countries such as the U.K., it was first rejected on grounds of unfavorable cost-benefit analysis and later launched in the year 2016, but with price concessions. Low to moderate efficacy of Benlysta towards patients diagnosed with severe systemic lupus erythematosus (SLE), including Lupus Nephritis, is a major limitation deterring market adoption. Hence, GSK is undertaking clinical trials to determine the combined efficacy of Benlysta and rituximab, in order to boost the adoption of its therapies in the market.
Some of the key pipeline biologics that are undergoing phase III clinical trials are expected to enter the market during 2018-2021. Eligibility for biologics in the market is defined by the European League against Rheumatism (EULAR) that sets guidelines for reimbursement of therapies.
As per these guidelines, physicians are to prescribe biologics only after two or more non-biologic immunosuppressant fail to improve disease activity in a patient. Based on these guidelines, several countries have formulated their reimbursement policies, which vary widely. Demand for Benlysta in developed regions is greater due to better healthcare infrastructure and coverage availability, whereas in developing regions, high cost and lack of government-funded coverage impede access to biologics.
Immunosuppressants held the leading revenue share in the market in 2020 and was valued at USD 1.01 billion. The growth of the segment can be attributed to the worldwide adoption of methotrexate, which is available at low cost. Biologics was positioned after the segment owing to slow penetration of Benlysta.
Nevertheless, biologics are poised to witness the highest CAGR of 12.0% during the forecast period. Introduction of new biologics with improved efficacy is likely to support the growth of the overall market. Benlysta, the first on-label biologic for SLE treatment, has gained physician confidence for mild to moderate SLE. However, its efficacy and safety are still under observation for the severe form. In addition, other biologic agents such as rituximab are used as off label treatment for systemic lupus erythematosus, which, unlike corticosteroids and immunosuppressants, do not carry the risk of side effects.
The oral segment represented more than half of the overall value in the SLE market in 2020. The segment was followed by intravenous, which accounted for just over 35.0% in the same year. The oral segment comprises small molecule drugs that are easily administered and remain the mainstream treatment for SLE.
The subcutaneous segment is progressing at a CAGR of 10.4% during the forecast period. Recent approval of subcutaneous formulation of Benlysta and rituximab in several countries such as the U.S. and several European countries is one of the primary growth stimulants for the segment. This formulation type enables patients to self-administer these therapies, which raise prospects for this segment.
North America dominated the market in 2020, with the U.S. at the forefront. The region is projected to retain its position through 2025, progressing at a CAGR of 8.1% during the forecast period. Higher prevalence of SLE coupled with coverage for specialty drugs and better healthcare infrastructure is contributing to the growth of the regional market.
Europe was the second-largest regional market in 2017, which stood at a valuation of USD 397.6 million. This can be attributed to the fact that the five major European Union countries (U.K., Germany, Spain, Italy, and France) were the first to approve Benlysta as an add-on therapy for the treatment of active SLE. In addition, due to better coverage policies, there is a higher adoption of belimumab since it is available in both formulations.
APAC, LATAM, and MEA trail behind, with low prominence in the market. Low revenue generation in these regions can be attributed to multiple factors, including low rheumatologist to population ratio, which prevents treatment and diagnosis at an early stage. Moreover, despite availability of belimumab in these regions, the therapy is not accessible to patients due to its price and unfavorable reimbursement scenario. In low-income economies, majority of the patients seek the public care system, which typically does not provide good medical facilities.
GlaxoSmithKline, Roche, Pfizer, Novartis, Bayer, and Sanofi. Among key strategies, GlaxoSmithKline
Drug Classes Outlook
Route of Administration Outlook
The Systemic Lupus Erythematosus market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.
The report provides size (in terms of volume and value) of Systemic Lupus Erythematosus market for the base year 2020 and the forecast between 2021 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.
This report focuses on the global Systemic Lupus Erythematosus market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Systemic Lupus Erythematosus market development in United States, Europe and China.
It is pertinent to consider that in a volatile global economy, we haven’t just conducted Systemic Lupus Erythematosus market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.
In terms of production side, this report researches the Systemic Lupus Erythematosus capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.
In terms of consumption side, this report focuses on the consumption of Systemic Lupus Erythematosus by regions (countries) and application.
Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Systemic Lupus Erythematosus market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.
With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Systemic Lupus Erythematosus market companies.
Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Systemic Lupus Erythematosus market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.
The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.
Overall, this is an in-depth research report specifically for the Systemic Lupus Erythematosus industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.
The Systemic Lupus Erythematosus market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Systemic Lupus Erythematosus market.
Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Systemic Lupus Erythematosus market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.
Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Systemic Lupus Erythematosus market. These factors have benefited the growth of the global market for Systemic Lupus Erythematosus. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.
New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Systemic Lupus Erythematosus. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).
In this study, the years considered to estimate the market size of Systemic Lupus Erythematosus are as follows:
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- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.
This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.
Market Size Estimation
Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).
The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.
Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.
All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.
Market Breakdown and Data Triangulation
After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.
Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.
In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.
The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.
The study objectives of this report are: