The global systemic lupus erythematosus market size was estimated at USD 1.87 billion in 2017. It is anticipated to register a CAGR of 7.0% over the forecast period. 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 2017 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 2017. 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 2017, 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.
The leading players of the market include GlaxoSmithKline, Roche, Pfizer, Novartis, Bayer, and Sanofi. Among key strategies, GlaxoSmithKline in collaboration with Roche is conducting clinical trials with Benlysta and rituximab to determine their combined efficacy in treating severe symptoms of SLE. Furthermore, Novartis developed a biosimilar rituximab at a low cost, which is used as an off label drug to fuel the adoption of biological therapies in developing regions.
Key strategic efforts among manufacturers center on development of biologics with higher efficacy. New players including ImmuPharma, Aurinia Pharmaceuticals, and Astra Zeneca are anticipated to come up with promising therapies, including Lupuzor, Voclosporin, and anifrolumab, respectively, in the near future.
Base year for estimation
Actual estimates/Historical data
2014 - 2016
2018 - 2025
Revenue in USD Million & CAGR from 2018 to 2025
North America, Europe, Asia Pacific, LATAM, and MEA
U.S., Canada, U.K., Germany, France, Italy, Spain, Greece, Sweden, Norway, Poland, Japan, China, Hong Kong, Taiwan, South Korea, New Zealand, Australia, India, Malaysia, Singapore, Brazil, Mexico, Argentina, South Africa, Saudi Arabia, Turkey, Kuwait, and Israel
Revenue, company share, competitive landscape, growth factors, trends
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This report forecasts revenue growth at global, regional & country levels and provides an analysis of the industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global systemic lupus erythematosus market report based on drug classes, route of administration, and region:
Drug Classes Outlook (Revenue, USD Million, 2014 - 2025)
Route of Administration Outlook (Revenue, USD Million,2014 - 2025)
Regional Outlook (Revenue, USD Million, 2014 - 2025)
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