BURLINGTON, Mass., Oct. 30, 2013 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the systemic lupus erythematosus (SLE) market will grow dramatically over the next decade from approximately $900 million in 2012 to $4 billion in 2022 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.
The Pharmacor advisory service entitled Systemic Lupus Erythematosus finds that Benlysta, the first approved biologic for the disease, will be the primary driver of market growth throughout the forecast period with sales in 2022 of $1.1 billion. However, physician perceptions of Benlysta's modest efficacy, slow onset to action and restrictive label—which does not include patients with severe, active renal and central nervous system disease—leave opportunity for emerging agents with better efficacy profiles and acceptable safety to gain market share. In the B-cell modulator class alone, the anticipated entry of UCB's epratuzumab, Eli Lilly's tabalumab and Anthera Pharmaceuticals' blisibimod will drive sales of $1.1 billion by 2022, accounting for almost 30 percent of total SLE sales. Though concerns regarding safety will initially limit their uptake, as physicians gain experience towards the end of our forecast period, these new agents may see use ahead of Benlysta. As a class, the B-cell modulators will account for 65 percent of total market sales in 2022.
The report also finds that the uptake of Bristol-Myers Squibb's Orencia for the treatment of lupus nephritis, beginning in 2018, will be a significant driver of SLE market growth. Orencia's patient share in 2022 will be modest; however, the anticipated high price of the 30 mg/kg dose being tested in Phase III trials will drive its sales to account for approximately 19 percent of total SLE sales in 2022.
"Benlysta has received a lukewarm reception to the SLE market owing primarily to physician perceptions of its modest efficacy, slow onset to action and inability to be used in the high unmet need population of patients with severe, life-threatening organ involvement," said Decision Resources Analyst Laura Croal, Ph.D. "Owing to its high price in a largely generic market, Benlysta will lead market sales in 2022 on the strengths of its excellent safety profile, demonstrated efficacy in pivotal trials and first-to-market advantage. However, the drug will be vulnerable to emerging agents with acceptable safety profiles that demonstrate improvements in these key perceived weaknesses."
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