Systemic lupus erythematosus (SLE) is a systemic inflammatory autoimmune disease that can affect any organ or tissue and is the prototypic autoimmune disease. As a multisystem disorder, SLE is heterogeneous in nature-no two cases of lupus are alike-and can affect multiple major organ systems in the body, one of its most severe manifestations includes renal (kidney) involvement, known as lupus nephritis (LN). The etiology of SLE and LN remains incompletely understood, but genetic and environmental factors have been shown to play pivotal roles in the development of the disease.
To date, the cornerstone of lupus therapy still relies on generic steroids and unspecific immunosuppressive agents; both of which are associated with severe adverse events (SAEs) and contribute significantly to the morbidity and mortality in lupus. The much anticipated approval of Benlysta (belimumab) in 2011 had only a small impact on the treatment paradigm, and off-label Rituxan/MabThera (rituximab) remains the market leader in terms of sales. R&D efforts in lupus are high, however late-stage clinical failure remains a major barrier to market entry. The anticipated release of six new pipeline agents for SLE and LN will have the potential to revolutionize the lupus treatment. GlobalData expects the global SLE and LN market-which, for the purposes of this report, comprises the seven major pharmaceutical markets (7MM; US, France, Germany, Italy, Spain, UK, Japan)-to expand during the next decade at an astonishing CAGR of 10.6%, reaching total sales of $3.2 billion by 2025.
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Key Questions Answered
– Based on interviews with key opinion leaders (KOLs), GlobalData has identified key unmet needs in the SLE and LN marketplace.
– What will be the effect of recent and upcoming biologics on the SLE and LN treatment landscape?
– How will the upcoming first-in-class and me-too pipeline agents be received in the different markets?
– What research and development (R&D) strategies will companies leverage to compete in the future SLE and LN marketplace?
– Which patient population(s) are most likely to be targeted by newly introduced pipeline agents?
– GlobalData has calculated that the global SLE and LN market generated about $1.2 billion in sales in 2015. This global market is expected to grow by an astonishingly strong compound annual growth rate (CAGR) of 10.6% from 2015-2025, reaching annual sales of $3.2 billion by the end of the forecast period. The majority of this growth will occur in the US, driven by an increased diagnosed disease prevalence of SLE and LN and the launch of three new first-in-class pipeline drugs (anifrolumab, Orencia [abatacept], and Lupuzor) and three improved therapeutic options (atacicept, blisibimod, and voclosporin). The SLE and LN market in the US is expected to grow at a CAGR of 10.4%, reaching sales of $2.8 billion by 2025. GlobalData estimates that sales in the 5EU to grow at a CAGR of 14.1% during the next 10 years, reaching $312.4m by 2025, while Japan will experience the lowest growth with a CAGR of 9.8%.
– KOLs interviewed by GlobalData repeatedly identified the need for efficacious drugs as the most important clinical unmet need, with reducing lupus morbidity and mortality and the development of sensitive and reliable biomarkers for diagnosis and disease management as key areas of need as well.
– GlobalData anticipates that opportunities will center on the development of safer and more efficacious drugs to treat the various disease manifestations in lupus.
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– Overview of SLE and LN, including epidemiology, etiology, pathophysiology, as well current routine SLE and LN recommendations of all 7MM covered.
– Top-line SLE and LN market revenue from 2015-2025. Recent acquisitions, approvals and governmental recommendations are included in the forecast model.
– Key topics covered include strategic competitor assessment, market characterization, unmet needs, R&D strategies, and clinical trial design for the SLE and LN market.
– Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and analysis of late-stage pipeline products. An interactive clinical and commercial analyzer tool is available.
– Analysis of the current and future market competition in the global SLE and LN marketplace. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Reasons to buy
The report will enable you to –
– Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
– Develop business strategies by understanding the trends shaping and driving the global SLE and LN market.
– Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the SLE and LN market in the future.
– Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
– Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
– Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
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