The DR / DME therapy market will grow moderately over the forecast period (6.6% annual growth through 2029); this growth will be due largely to:
The launch of five new therapeutic options for DME: Novartis’s brolucizumab; Roche’s ranibizumab port delivery system; Regeneron / Bayer’s high-dose aflibercept; Kodiak Sciences’ KSI-301, which are all VEGF inhibitors; and Roche’s faricimab, a VEGF / Ang-2 inhibitor.
The availability of approved therapies for DR without DME in the United States and EU5 (these treatments will contribute modest sales to the market).
Growth in the number of prevalent cases of severe NPDR, PDR, and DME in the G7.
As the trusted early-line agents in DME, VEGF inhibitors will dominate the market throughout the forecast period, and the IVT corticosteroid implants (i.e., Alimera Sciences’ Iluvien and AbbVie’s Ozurdex) will largely be reserved for later-line treatment in the markets in which they are available.
Uptake of Eylea will continue to grow in all major markets until the launch of emerging therapies in 2021, at the expense of Lucentis (Roche / Genentech / Novartis) and, to a lesser extent, off-label Avastin (Roche), driven by the positive results of the Protocol T trial and physicians’ positive experience with the product.
Commercially attractive opportunities remain in this market. They include the following:
DME therapies that provide superior efficacy to current VEGF inhibitors in improving vision.
DME therapies that are as effective and as safe as current VEGF inhibitors but have more-convenient delivery profiles.
Pharmacotherapies for the treatment of DR without DME.
The late-phase pipeline for DME is small; as of October 2020, only five agents are in active Phase III development for DME: brolucizumab, the ranibizumab port delivery system (Roche), high-dose aflibercept (Regeneron / Bayer), KSI-301 (Kodiak Sciences) and faricimab (Roche). Brolucizumab and the ranibizumab port delivery system are also in late-phase development for DR without DME.
The early- to mid-phase DR / DME pipeline is robust; these therapies are aimed at already validated targets, as well as new mechanisms of action. Various modes of administration are being evaluated, including IVT injections, oral therapies, and eye drops.