The diabetic macular edema (DME) market in the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan) is set to grow from $5.4 billion in 2021 to $9.6 billion in 2031, driven by the launch of longer-acting anti-vascular endothelial growth factor (VEGF) therapies to treat patients with DME, an increase in the number of people with DME, and drugs with new mechanisms of action, new routes of administration, or both, forecasts GlobalData, a leading data and analytics company.

GlobalData’s latest report, “Diabetic Macular Edema: Seven-Market Drug Forecast and Market Analysis – Update,” reveals that anti-VEGF therapies will remain the dominant treatment modality for DME during the forecast period. This theme is observed both in currently marketed products and late-stage pipeline products for DME, with companies focusing on reducing the treatment burden associated with these therapies.

Sara Reci, MSc, Senior Pharma Analyst at GlobalData, comments: “In interviews with GlobalData, key opinion leaders (KOLs) emphasized that some of the greatest unmet needs in the DME space included the need for drugs with better efficacy and safety, longer-acting therapies, other mechanisms of action.”

Looking ahead, some of the current late-stage pipeline products for DME 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.

Furthermore, the need for therapies with other mechanisms of actions remains of paramount interest. As such, three therapies are anticipated to reach the DME market during the forecast period and introduce new mechanisms of action into the DME space: APX-3330, which 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.

Simultaneously, therapies with longer treatment intervals are a dominant trend in the DME pipeline. GlobalData forecasts that the highly anticipated high-dose Eylea will capture a significant share of the DME market upon its launch due to its potential to extend treatment intervals, as shown in clinical trials.Kodiak Sciences’s KSI-301 also aims to provide longer treatment intervalss.

Reci concludes: “While the DME 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 UK) in 2025, leading to the anticipated entry of biosimilars; ranibizumab biosimilars have already entered the DME market. Nonetheless, the launch of high-dose Eylea and late-stage pipeline therapies with new mechanisms of action, longer treatment intervals, and improved efficacies will undoubtedly be a driving force for market growth in the DME space.”