Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, driven primarily by the launch and uptake of Human Genome Sciences/GlaxoSmithKline's Benlysta, the systemic lupus erythematosus (SLE) drug market will quadruple from about $400 million in 2009 to more than $1.6 billion in 2019 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.
The Pharmacor 2010 findings from the topic entitled Systemic Lupus Erythematosus reveal that the majority of sales in 2009 were generated by the off-label use of two branded agents -- market leader Roche/Galenica's CellCept and the biologic, rituximab (Biogen Idec/Roche/Chugai/Zenyaku Kogyo's Rituxan, Roche's MabThera). In 2019, drugs from the B-cell modulator drug class such as rituximab and Benlysta will account for approximately three-quarters of the overall market.
"Rituximab will emerge as the market leader in 2019, with the premium-priced biologic, Benlysta, as a close second," said Decision Resources Analyst Dancella Fernandes, Ph.D. "Rituximab's uptake will be driven by its use for SLE manifestations that are refractory to current treatments. Despite the drug's failed clinical trials for both SLE and lupus nephritis, rituximab's off-label uptake in the indication highlights the challenges associated with drug development, the high unmet need in this indication and the unusual dynamics of the SLE market."
The Pharmacor 2010 findings also reveal that the difficulties in drug development for SLE serve as the most significant market constraint for the indication. As more than 50 years have passed since a drug for SLE has received regulatory approval, the lack of available therapies for the indication is of great concern to physicians and drug developers alike.
"Although off-label use of several therapies has continued -- despite the failure of these drugs in clinical trials -- agents receiving regulatory approval would likely face fewer barriers to use than off-label agents," Dr. Fernandes said. "The use of therapies off-label is characterized by reimbursement issues, the lack of evidence-based guidance on use and the restriction of unapproved agents to last-line use and to severe disease segments. These factors often result in restricted and suboptimal utilization of these agents."
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