Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory disorder of unknown origin with no known cure. The disease causes pain, swelling, stiffness and restricts the motion of multiple joints. Additionally, RA generally affects the joints symmetrically (so when the joints of one hand are affected it is likely that the joints of the other hand will also be affected). At least 1.3 million Americans are affected by the disorder, which is almost three times more prevalent in women than men. One to three percent of women will develop RA during her lifetime. The prevalence of disease increases with advanced age, with the peak onset of disease occurring between the fourth and sixth decades of life. RA can be extraordinarily debilitating and carries with it an unacceptable degree of compromised quality of life, morbidity, and mortality.

The current treatment guidelines for RA include a combination of therapies: non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids (also known as glucocorticoids), disease-modifying anti-rheumatic drugs (DMARDs) and biologic DMARDs. The goal of treatment is to have early and intensive treatment using a combination of agents which allows for rheumatologists to control disease symptoms and hamper the progression of disease and associated joint damage. The treatment paradigm has shifted to incorporate biologic agents in earlier stage disease, including the widespread use of the anti-TNF-alpha antibodies.

Compounds in clinical development will further alter the treatment of disease by increasing efficacy, decreasing toxicity and offering the option of oral dosing. Oral dosing is a significant change, as the current standard of care biologic DMARDs are dosed subcutaneously or intravenously. The oral kinase inhibitors will be the first next generation compounds to be added to the RA disease armamentarium. These compounds are designed to act against novel targets, which are key components of the inflammatory cascade. Of the kinase inhibitors, we expect Tasocitinib to enter the market first and to eventually eclipse the anti-TNF-alpha compounds as a front-line treatment option.

Domestic sales of biologic DMARDs for the treatment of RA have been growing at a double digit rate (CAGR) since their introduction approximately 10 years ago. A more aggressive treatment paradigm for early stage patients and newer, more patient-friendly formulations of current treatments will likely continue to cultivate the market over the next several years. Beginning in three to five years, we speculate that the introduction of several more efficacious agents – particularly oral medications to be used either before or after anti-TNF-alpha inhibitor treatment – will provide a long-term stimulus for overall sales.

For the full report, please download the PDF version at the top of this page. For a copy of our revenue models in Excel, you can download the models from the RA indication page.

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