BURLINGTON, Mass., Oct. 10, 2013 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the rheumatoid arthritis drug market will experience moderate growth over the next decade as sales increase from $12.3 billion in 2012 to $15.8 billion in 2022 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.
The Pharmacor advisory service entitled Rheumatoid Arthritis finds that TNF-alpha inhibitors continue to dominate as first-line biological agents, accounting for 73 percent of major-market sales in 2012, because rheumatologists are relatively satisfied with the TNF-alpha inhibitors' efficacy and place great importance on positive long-term safety and physician familiarity. However, as the number of effective alternative biologics and oral kinase inhibitors increases, and following the entry of biosimilars of several agents in the TNF-alpha inhibitor class starting in 2015, TNF-alpha inhibitors' market share will fall to 53 percent in 2022.
The findings also reveal that oral agents have the potential to alter the RA treatment algorithm, after demonstration of efficacy comparable to TNF-alpha inhibitors and establishing acceptable long-term safety profiles. Pfizer/Takeda's Jak inhibitor Xeljanz will likely be used after the TNF-alpha inhibitors initially, competing with Bristol-Myers Squibb/Ono Pharmaceutical's Orencia, rituximab (Biogen Idec/Roche/Chugai/Zenyaku Kogyo's Rituxan, Roche's MabThera) and Roche/Chugai's Actemra/RoActemra, until it has built up an acceptable postmarketing safety profile, most likely after two to three years on the market. After this point, and assuming physicians are convinced that it has meaningful efficacy in slowing or inhibiting structural damage, Xeljanz will increasingly divert a minority of patients from TNF-alpha inhibitor therapy. Xeljanz's launch in Europe will be delayed to 2016-2017 following the CHMP's negative opinion on Xeljanz's marketing authorization application, but the agent will likely eventually receive approval. Several other Jak inhibitors are also in development for RA, including Eli Lilly/Incyte's baricitinib and Vertex's VX-509.
"Jak inhibitors, led by Xeljanz, will be the major contributors to growth of the RA market from 2012 to 2022, accounting for two-thirds of market growth during this period," said Decision Resources Principal Business Insights Analyst Bingnan Kang, Ph.D. "Initial use of Xeljanz is primarily in patients who have failed one or more biological therapies; however, we expect earlier line use of Xeljanz—in particular in the United States and Japan—in the second half of our forecast period, owing to its mix of efficacy profile and convenience and the expected accumulation of postmarketing safety data and increase in physician familiarity."
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