Rheumatoid Arthritis

Pharmacor -- June 2008

  Introduction:

The market for rheumatoid arthritis (RA) drugs is dominated by tumor necrosis factor-alpha (TNF-alpha) inhibitors; these agents have achieved considerable clinical and commercial success as first-line biological agents since their launch in the late 1990s. The advent of agents to treat RA patients who respond inadequately to TNF-alpha inhibitors will expand treatment into later-line, niche market segments and create strong growth in the RA market.

  Questions Answered in This Report:

Six new drugs will launch during our forecast period; the majority will be biological agents and will include agents with novel mechanisms of action, such as the interleukin-6 inhibitor tocilizumab. Which of these agents will be most successful? In what lines of treatment and in which patient populations will they be used?

Two TNF-alpha inhibitors will launch during our forecast period. These drugs offer greater dosing convenience with efficacy and safety comparable to that of the currently marketed TNF-alpha inhibitors. Can these new TNF-alpha inhibitors challenge the current market leaders, etanercept and adalimumab?

Agents that are approved for use as first-line biological treatments are often relegated to second- or third-line treatment because of reimbursement and treatment guidelines. How do these guidelines shape the RA market? Which agents benefit and which agents are at a disadvantage because of these guidelines?

  Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 38 country-specific interviews with rheumatologists.

Epidemiology: Prevalence of rheumatoid arthritis; diagnosed prevalence by severity.

Emerging therapies: Phase II: 12 drugs; Phase III: 2 drugs; preregistration: 3 drugs; registered: 1 drug.

Market forecast features: Using a patient-based model, we forecast RA sales of small-molecule drugs and biological disease-modifying anti-rheumatic drugs (DMARDs) from 2007 to 2017.

Alternative market scenarios: A biosimilar infliximab emerges that is similar to the original molecule (minimal humanization of the molecule) and inferior to golimumab in safety.