IngentaConnect Biologic Battlefields: Changes in the US Markets for Rheumatoid A...

Abstract:

Five million people globally have rheumatoid arthritis (RA), with 1.25 million suffering from moderate-to-severe symptoms. Biologic drugs are a second-line therapy prescribed to the 50% of these patients who fail disease-modifying antirheumatic drugs (DMARDs). Four biologics are licensed in the US for RA therapy; three targeting tumor necrosis factor (TNF) and one targeting interleukin-1 (IL-1) - proteins that play key roles in development of the inflammatory reaction characteristic of RA. Enbrel® (etanercept), a soluble TNF receptor, is the current market leader followed by Remicade® (infliximab), a chimeric monoclonal antibody (mAb) targeting TNF, Humira® (adalimumab), a fully human mAb targeting TNF, and Kineret™ (anakinra), a protein targeting interleukin-1 (IL-1) rather than TNF.

The anti-TNF biologics class is expected to continue steady growth within the RA market and Lehman Brothers analysts predict it will peak at sales of $US5 billion-$US6 billion per annum in the US. As evidence of therapeutic benefit in earlystage disease accumulates, it will become more difficult for physicians and payors to deny biologics to patients with moderate disease. Enbrel and Humira are clear market winners but Remicade will suffer if physicians accept erosion of efficacy data. From the pipeline, CDP-870 is the largest threat to the established brands. Rituxan®/MabThera® (rituximab) also has potential but other pipeline products pose no immediate threat.

Compared with RA, the market for biologics in psoriatic arthritis (PsA) is in its infancy. Lehman Brothers analysts estimate that it will reach $US2 billion-$US3 billion at its peak. Many of the same biologics from the RA market are also now targetting PsA. Enbrel opened up the PsA biologics market when it was launched in the US in early 2002 and both Humira and Remicade are in pivotal phase III trials. Two other biologics developed for psoriasis are also in phase II trials for PsA - Raptiva® (efalizumab) and Amevive® (alefacept). However, the PsA biologics market will not reach its growth potential until long-term clinical data are available in this indication. The market leaders are likely to be Enbrel and Humira; Amevive has cost and safety issues that make it unlikely to become a major player. Onercept - a biologic in phase II trials - has shown promising efficacy so far and could become a major brand. Further data on Raptiva are required.

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Biologic Battlefields: Changes in the US Markets for Rheumatoid Arthritis and Psoriatic Arthritis