Introduction:
Last Updated 28 July 2010The rheumatoid arthritis (RA) therapy market has matured to
the point that TNF-α inhibitors are firmly established as first-line
biological agents. Novel entrants to the market—the interleukin-6 (IL-6)
inhibitor tocilizumab (Roche/Chugai’s Actemra/RoActemra), the selective
costimulation modulator abatacept (Bristol-Myers Squibb’s Orencia), and the
B-cell-targeted therapy rituximab (Biogen Idec/Roche/Chugai/Zenyaku Kogyo’s
Rituxan, Roche’s MabThera)—underscore the dominance of the TNF-α
inhibitors because these new agents are reserved for patients who fail to
achieve an adequate response to TNF-α inhibitor therapy. For emerging
agents, the remaining opportunity is limited and the barrier to entry is high
in the absence of clear advantages and improvements over marketed therapies.
Questions Answered in This Report:
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The most recent novel drug
approved for RA is the IL-6 inhibitor tocilizumab in Japan in 2008, in Europe
in 2009, and in the United States in 2010. However, its Phase III clinical
trials and reports of cardiovascular-related deaths in tocilizumab-treated RA
patients in Japan have raised questions about its safety. In addition, the FDA
issued a complete response letter requesting animal studies and a risk
evaluation and mitigation strategy (REMS).
How concerned are experts
interviewed about tocilizumab’s safety profile and do they view it as a
deterrent to use? Will it prevent the agent from overtaking abatacept and
rituximab? Which line of therapy will tocilizumab occupy?
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Two later-stage novel oral agents in development for RA have
the potential to challenge the TNF-α inhibitors and thereby constrain the
biologics market: AstraZeneca’s (formerly Rigel Pharmaceutical’s) Syk
inhibitor, fostamatinib disodium (R-788), and Pfizer’s Jak-3 inhibitor,
tasocitinib (CP-690550).
What do rheumatologists interviewed expect in terms
of these drugs’ efficacy and safety? What is the market potential of an oral
agent for RA?
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Apart from the recently launched tocilizumab and the novel oral
agents in the pipeline for RA, the majority of late-stage or recently launched
agents are members of marketed drug classes: the TNF-α inhibitors,
B-cell-targeted therapies, and IL-1 inhibitors.
Will these agents achieve
the same level of success as their respective predecessors? Will the patient
share of their predecessors significantly decline following launch of these new
agents?Scope:
Markets covered: United States, France, Germany, Italy,
Spain, United Kingdom, Japan.
Primary research: 27 country-specific interviews with
expert rheumatologists.
Epidemiology: The number of total, diagnosed, and drug-treated
prevalent cases of RA; the number of total prevalent cases of RA by severity.
Emerging therapies: Phase II: 12 drugs; Phase III: 3
drugs
Market forecast features: We forecast population sizes
and drug sales for conventional and biological disease-modifying antirheumatic
drugs from 2009 through 2019.