Enbrel, Humira to dominate TNF-alpha market

By Steve Mitchell

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An analyst firm predicts that Amgen/Wyeth/Takeda's Enbrel and Abbott Laboratories/Eisai's Humira will dominate the market of tumor necrosis alpha inhibitors for the next ten years.

"Enbrel and Humira are going to continue to grow," Cynthia Mundy, an analyst with Decision Resources in Waltham, Mass., and author of a new report, told United Press International.

TNF-alpha inhibitors are used to treat a variety of auto-immune diseases, including psoriasis, Crohn's disease, and rheumatoid arthritis. Decision Resources estimates the market for TNF-alpha inhibitors in the United States, Western Europe and Japan will grow from $7.1 billion this year to almost $12 billion in 2014.

Mundy's reasoning for the predicted success of Enbrel and Humira is that both drugs will continue to get approvals for and be increasingly used for new indications. In addition, they have the advantage over other drugs in this market of being self-administered agents that provide ease of use.

"Basically, these are drugs that are really treating indications that are underserved ... and they're fairly convenient," Mundy said.

Another agent, Remicade, which is marketed in the United States by Centocor and elsewhere by Schering-Plough, will do well over the next decade but "its going to be little bit flatter" than Enbrel and Humira, Mundy said. One reason for this is that Remicade has to be administered by a physician, making it less convenient, she said.

Other drugs that could make a showing in this field include UCB's certolizumab pegol, which is in late phase clinical development but is expected to launch for Crohn's disease and rheumatoid arthritis in late 2006 or 2007, and Centocor/Schering-Plough's golimumab, which is in phase 2 trials.

However, these drugs are likely to run into the same problems that other new entries will face in this field, Mundy said. They will need to offer characteristics that distinguish them from the approved agents used to treat these diseases and they lack the long-term efficacy and safety data of Enbrel and Humira.

The long-term data is "a big issue for all the specialists that treat these chronic disease, because these drugs are used for long-term chronic administration," Mundy said.

Looking several years ahead, Mundy thinks novel cytokine inhibiting agents, such as interleukin-12 inhibitors, could also have an impact on this market. Drugs in this class are "on the horizon as the next wave of biologics for this set of immune disorders," she said.

Mundy added that it's too early to know if these agents will offer sufficient efficacy to allow them to compete head-to-head with the TNF-alpha inhibitors, but she noted that all the companies with TNF-alpha inhibitors also have other cytokine inhibitors in development.

"They're definitely agents to watch," she said.

Matthew Murray, senior biotechnology analyst with Rodman and Renshaw in New York City, agreed that Enbrel and Humira will dominate the field for the foreseeable future.

"Enbrel's primary competition going forward will be from Abbot's Humira, not Johnson and Johnson's Remicade," Murray told UPI.

One issue that previously hindered Enbrel was manufacturing limitations, but Amgen has now resolved that and expanded its production capacity, Murray said. This should enable Enbrel to capture more of the market, but the drug will have to overcome the fact that it requires more frequent dosing than Humira, he noted.

"Now that Amgen has addressed the manufacturing issues that limited Enbrel's market share competitiveness against Remicade in the past, I think its challenge going forward will be to use the larger amount of clinical data available for Enbrel to counter-balance Humira's advantage on dosing frequency," he said.