Steady Sales for Monoclonal Antibodies in Rheumatoid Arthritis - Can Biologics Beat the Patent Cliff?

Wednesday 6 March 2013, Amsterdam

Since 2004, the market for mAbs in Rheumatoid Arthritis (RA) has experienced tremendous growth, and it is on the verge of entering a historically unprecedented scenario over the next six years, according to a new report by healthcare experts'.

Eight monoclonal antibodies (mAbs) are currently approved, half of which count among the top 10 best-selling drugs worldwide, collectively generating over $23 billion in sales in 2011. mAbs Remicade is also the bestselling pharmaceutical product across the entire industry. The upcoming patent cliff seems unlikely to knock these popular drugs off their position, in a market that is slow to embrace new products.

The first three mAbs to be approved to treat RA, Remicade, Humira and Enbrel, have consistently dominated RA drug sales since their market entry, despite the approval of arguably more effective mAb products since then. Analyst Dominic Trewartha states: “Physicians are likely to exercise great caution when prescribing biologics, in part due to their potentially serious side-effects. Rheumatologists in general are also quite conservative in their treatment patterns, which could explain why Remicade, Humira and Enbrel are doing so well, being the first mAbs approved for RA. In contrast, biosimilars are less likely to be prescribed. For this reason, the growth of the global market is expected to continue in spite of the impending patent expiry of three of the four top-selling RA mAbs in the US.”

He continues: “none of the potential market entrants appear to offer any significant improvements to existing medications, and thus will not dramatically affect the market size in the coming years, leaving Remicade, Humira and Enbrel to maintain their top-selling RA mAbs status”. The expense and difficulty associated with bringing biosimilars to the market is also expected to limit the number of biosimilars and their impact on drug pricing for RA mAbs, estimated to be as low as 10%.

The RA mAbs market in the US, Japan, Germany, France, the UK, Italy and Spain is expected to grow from US$11.5 billion in 2011 to US$15.7 billion by 2018.

Monoclonal Antibodies Market in Rheumatoid Arthritis to 2018 - Market Characterized by Large and Diversified Pipeline and Low Threat of Biosimilar Sales Erosion

This report covers the current therapy market for the treatment of RA across the top seven developed markets, including the US, Germany, France, the UK, Italy, Spain and Japan.