BURLINGTON, Mass.--()--Decision Resources, one of the world’s leading research and advisory firms for pharmaceutical and healthcare issues, finds that the TNF-alpha inhibitors infliximab (Janssen Biotech/Merck/Mitsubishi Tanabe’s Remicade) and adalimumab (Abbott/Eisai’s Humira) dominated the Crohn’s disease (CD) market in 2011, capturing more than three-quarters of market share in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. Although sales of Remicade and Humira will peak at $3.7 billion in 2016, sales will begin to decline in 2017 due in part to the increasing uptake of biosimilar versions of these TNF-alpha inhibitors. Sales of biosimilar infliximab and adalimumab will account for 27 percent of combined infliximab and adalimumab molecule sales in 2021.
“However, no current therapy is completely effective in maintaining remission and significant opportunity remains for more-effective emerging therapies in the maintenance space. In particular, new agents hold the potential to fulfill some of the unmet need for effective and safe therapies for the TNF-refractory CD patient population.”
The Pharmacor advisory service entitled Crohn’s Disease also finds that the 2008 U.S. launches of Biogen Idec/Elan’s Tysabri and UCB’s Cimzia continue to have a relatively minor impact on the CD market. Through 2021, Cimzia will be considered primarily after Remicade and/or Humira, and Tysabri will continue to be relegated to last-line biological therapy.
Launch of emerging biologics, the cell adhesion molecule (CAM) inhibitor vedolizumab (Takeda Pharmaceuticals) and the interleukin (IL)-12/IL-23 inhibitor ustekinumab (Janssen Biotech/Janssen Cilag’s Stelara), in 2013 and 2016, respectively, will contribute to CD market growth. In particular, Stelara’s estimated high price will drive notable sales to achieve 10 percent of major-market sales in 2021. Decision Resources anticipates that both agents will be primarily reserved for the TNF-refractory population, with vedolizumab achieving slightly greater uptake due to its earlier entry to the market and its potentially lower price. In addition to these biologics, the oral chemokine receptor vercirnon (GlaxoSmithKline/ChemoCentryx’s Traficet-EN), which is expected to launch in 2016, could be an alternative to biological therapy and secure a position earlier in the treatment algorithm; however in the absence of robust data, this agent is expected to experience only moderate uptake.
The findings also reveal sales of maintenance therapies for CD greatly exceeded sales of acute therapies in 2011.
“We expect that the forecasted growth of the CD market will be attributable largely to increased sales of maintenance therapies and that sales of acute therapies—while rising—will contribute less to market growth during the study period,” said Decision Resources Analyst Kathrina Quinn, Ph.D. “However, no current therapy is completely effective in maintaining remission and significant opportunity remains for more-effective emerging therapies in the maintenance space. In particular, new agents hold the potential to fulfill some of the unmet need for effective and safe therapies for the TNF-refractory CD patient population.”
The overall CD market will increase from approximately $3.8 billion in 2011 to $5.6 billion in 2021. This moderate growth reflects shifting competitive dynamics as market growth from emerging agents vedolizumab, Stelara, and vercirnon outpaces the decline in sales of older, established agents, which will face increasing generics erosion and declining use.
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