The diabetic macular oedema (DMO) market is expected to grow at a compound annual growth rate (CAGR) of 6.0% over the course of the forecast period, reaching $9.6 billion across the seven major markets (7MM) (US, France, Germany, Italy, Spain, UK, and Japan) according to GlobalData’s recent Diabetic Macular Edema: Seven-Market Drug Forecast and Market Analysis – Update report. The major driving factors of this growth include the launch of longer-acting anti-vascular endothelial growth factor (VEGF) therapies to treat patients with DMO, an increase in the number of people with DMO, and drugs with new mechanisms of action, new routes of administration, or both.
DMO is a condition where blood vessels leak into the central macula, causing it to swell due to the accumulation of excess fluid, and resulting in impaired vision or even blindness. In interviews with GlobalData, key opinion leaders (KOLs) emphasised that the greatest unmet needs in the DMO space included the need for drugs with better efficacy and safety, less invasive formulations, longer-acting therapies, other mechanisms of action, and earlier diagnosis of patients. Currently, marketed first-line therapies focus on the VEGF mechanism of action.
Looking ahead, some of the current late-stage pipeline products for DMO emulate what is currently on the market, employing the VEGF mechanism of action. This includes Kodiak Sciences’s KSI-301 (tarcocimab tedromer) and Roche’s Susvimo (ranibizumab sustained release formulation), the latter of which was formerly on the market for wet age-related macular degeneration (AMD) and was praised for its significantly reduced frequency of administration of two days per year. However, Susvimo was voluntarily recalled by Genentech and Roche following concerns over suspected leakage of the implant. Three therapies that are anticipated to reach the DMO market during the forecast period will introduce new mechanisms of action into the DMO space: APX-3330, which specifically targets apurinic/apyrimidinic endonuclease 1/redox effector factor-1 (APE1/Ref-1) protein; THR-149, a plasma kallikrein inhibitor; and UBX1325, a Bcl 2 inhibitor. This will greatly benefit the DMO space, especially in the case of patients who have not experienced any improvement from currently marketed therapies and are in need of therapies with alternative mechanisms of action. Furthermore, the market is currently saturated with therapies that employ the intravitreal route of administration, but two therapies are currently in the pipeline that employ alternative routes of administration: APX-3330, which employs an oral route of administration; and dexamethasone acetate, which employs a topical route of administration. As these therapies can be self-administered, this will greatly reduce treatment days, which is of paramount interest as most patients with DMO are of working age.
Simultaneously, therapies with longer treatment intervals are a dominant trend in the DMO pipeline. GlobalData forecasts that the highly anticipated high-dose Eylea (aflibercept 8mg) will capture a significant share of the DMO market upon its launch due to its potential to extend treatment intervals, as shown in clinical trials. Another therapy that aims to provide a longer treatment interval is Kodiak Sciences’s KSI-301.
While the DMO market is projected to grow during the forecast period across the 7MM, it may face some challenges. Throughout the forecast period, Eylea (aflibercept) is set to lose market exclusivity in the US in 2023 and in the five major European markets (5EU) (France, Germany, Italy, Spain, and the UK) in 2025, leading to the anticipated entry of biosimilars. Ranibizumab biosimilars are also set to enter the DMO market during the forecast period, which will undoubtedly compete with their parent drug, Lucentis. Nonetheless, the launch of high-dose Eylea and late-stage pipeline therapies with new mechanisms of action, routes of administration, longer treatment intervals, and improved efficacies will undoubtedly be a driving force for market growth in the DMO space.