According to GlobalData’s Sales Analytics Database, Regeneron will maintain its leading position in the ophthalmology market in 2023, followed by Roche, Bayer and Novartis.
Regeneron’s solid position in the ophthalmology market is due to Eylea (aflibercept), its only marketed brand in this therapy area. It was FDA-approved in November 2011, and by the end of 2013 Eylea had already secured blockbuster status. Eylea’s sales trajectory is likely to continue unabated due to a broad indication including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy in DME, and macular edema following retinal vein occlusion. In addition, Eylea is currently being investigated in Phase III trials in diabetic retinopathy without DME, and in Phase II trials in combination with nesvacumab for wet AMD and DME, both of which are being co-developed with Bayer.
Regeneron has a longstanding history with Bayer, one that has proved fruitful over the years. In October 2006, Bayer and Regeneron signed a co-development and co-commercialization deal that allows Bayer to market and sell Eylea in ex-US markets, where, for countries other than Japan, the companies equally share the profits and losses from Eylea’s sales. Meanwhile, Regeneron retains exclusive rights to Eylea in the US market. As with Regeneron, Eylea is Bayer’s only ophthalmology brand on the market and in the pipeline. As such, Regeneron’s and Bayer’s presence in the ocular market will largely depend on Eylea’s potential to continue to steal market share from its rival, Roche/Novartis’s Lucentis (ranibizumab). Although Lucentis had a first-to-market advantage, its sales started to drop from 2015, indicating a trend that is set to continue as Eylea offers fewer eye injections at a slightly lower cost.
Unlike Regeneron and Bayer, however, Roche and Novartis have several ocular pipeline assets in development, which means that these companies will not rely on a single brand to keep their presence in the lucrative ophthalmology market. For example, Roche’s lampalizumab is expected to be the first drug for dry AMD, and as a result, to gain blockbuster status. Novartis’s ocular unit Alcon is developing brolucizumab for wet AMD and DME, which is also expected to reach blockbuster status in 2023. While GlobalData’s forecast indicates that these pipeline drugs will not be able to top Eylea’s peak sales of $5bn by 2023, beyond this date, Regeneron’s and Bayer’s leading position could be at stake.