Moderate Growth in the Crohn’s Disease Drug Market Will Mask Dramatic Changes as Sales of Newer and Emerging Agents Will Outpace the Decline in Sales of Older, Established Agents

Starting in 2014, Emerging Biologics for Crohn’s Disease Will Compete for Patient Share in the TNF-alpha Inhibitor-Refractory Patient Population, According to Findings from Decision Resources

BURLINGTON, Mass.--(BUSINESS WIRE)--Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that, from 2010 to 2020, the Crohn’s disease drug market will experience modest annual growth of approximately 3 percent in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. However, this moderate growth rate will mask dramatic changes as sales of newer and emerging biological agents will outpace the decline in sales of older, established agents, which will face increasing generic erosion and declining use.

“Thought leaders are cautiously optimistic about the prospects for the emerging biologics”

The Pharmacor advisory service entitled Crohn’s Disease, which will be published by the end of the month, finds that two tumor necrosis factor-alpha (TNF-alpha) inhibitors, Janssen Biotech/Merck/Mitsubishi Tanabe’s Remicade and Abbott/Eisai’s Humira, dominated the market in 2010, capturing more than three-quarters of market share. Sales of Remicade and Humira are forecasted to peak at $3.3 billion in 2015, owing to increasing physician familiarity with these agents and continuing emergence of favorable postmarketing clinical trial data. However, sales will be tempered starting in 2016 following the entry of biosimilar TNF-alpha inhibitors to the Crohn’s disease market.

The 2008 U.S. launches of Biogen Idec/Elan’s cell adhesion molecule (CAM) inhibitor Tysabri and the TNF-alpha inhibitor UCB/Otsuka’s Cimzia had a minor impact on the Crohn’s disease market. Cimzia will primarily be considered after Remicade and/or Humira, and Tysabri will continue to be relegated to last-line biological therapy through 2020. The findings also reveal that sales of maintenance therapies for Crohn’s disease greatly exceeded sales of acute therapies in 2010.

Several therapies with different mechanisms of action are expected to launch for Crohn’s disease beginning in 2014, including Millennium Pharmaceuticals’ CAM inhibitor vedolizumab, Janssen Biotech/Janssen Cilag’s interleukin (IL)-12/IL-23 inhibitor Stelara and GlaxoSmithKline/ChemoCentryx’s chemokine receptor antagonist GSK-1605786 (formerly Traficet-EN or CCX-282B). These agents hold the potential to viably fulfill some of the unmet need for effective and safe therapies for the TNF-alpha-refractory CD patient population. However, none of these agents will likely rival the efficacy or market share of the TNF-alpha inhibitors.

“Thought leaders are cautiously optimistic about the prospects for the emerging biologics,” said Decision Resources Analyst Bingnan Kang, Ph.D. “Any emerging biological therapy with a novel mechanism of action will be positioned after TNF-alpha inhibitors until it accumulates adequate safety data.”

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