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 $5.0 billion in 2021 to $11.1 billion in 2031, driven by the launch of longer-acting anti-vascular endothelial growth factor (VEGF) therapies among other pioneering pipeline therapies, forecasts GlobalData, a leading data and analytics company.

According to GlobalData, the growth will be supported by the US Food and Drug Administration (FDA) approval of Roche’s Vabysmo (faricimab) for DME in January 2022, coupled with the anticipated approval of other longer-acting anti-VEGF pipeline therapies, and the new mechanisms of action to the DME space, during the forecast period.

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

Sara Reci, MSc, Healthcare Analyst at GlobalData, comments: “Regeneron and Bayer’s Eylea (aflibercept) and Roche’s Lucentis (ranibizumab) have established the efficacy of anti-VEGF therapies for DME. However, the need for therapies which reduce the frequency of administration remains the utmost interest among the key opinion leaders (KOLs), who acknowledge the high treatment burden tied to the current gold standard DME therapy, Eylea, as a pressing issue among the DME patient population, many of whom are of working age.”

KOLs interviewed by GlobalData have recommended that on average, Eylea should be administered seven days a year and Lucentis should be administered nine days a year for DME patients.

The launch of Roche’s Vabysmo, however, is expected to reduce the frequency of administration to six treatment days per year on average, with data showing that the frequency may potentially be reduced to as little as twice per year following the loading phase—which comprises four injections, one administered every four weeks—depending on the visual acuity (VA) and optical coherence tomography (OCT) results.

Whilst promising, the need for therapies with other mechanisms of actions and routes of administration remains of paramount interest. As such, two therapies that are anticipated to reach the DME market during the forecast period will introduce new mechanisms of action in the space: APX-3330, which specifically targets apurinic/apyrimidinic endonuclease 1/redox effector factor-1 (APE1/Ref-1) protein, and THR-149, a plasma kallikrein inhibitor.

Reci explains: “This is of great benefit within the DME space, especially in the case of patients who have not experienced any benefit from currently marketed therapies and need alternatives.”

Furthermore, the market is currently saturated with therapies that employ an intravitreal route of administration, but two therapies are currently in the pipeline that employ alternative routes of administration: APX-3330 and dexamethasone acetate, the former of which employs an oral route of administration, and the latter of which is topical eye drops.

Reci continues: “As these therapies can be self-administered, this will greatly reduce treatment days, which is of paramount interest as most patients with DME are of working age.”

While the DME market is projected to grow strongly in the forecast period, potential barriers to this growth include loss of exclusivity within the forecast period. For example, Eylea (aflibercept) is set to lose market exclusivity in the US in 2023 and in the 5EU (France, Germany, Italy, Spain, and the UK) in 2022, leading to anticipated entry of biosimilars.

Reci concludes: “Ranibizumab biosimilars are also set to enter the DME market during the forecast period, which will undoubtedly compete with their parent drug, Lucentis. However, the launch of Vabysmo and other late-stage pipeline therapies with lower frequencies of administration, new mechanisms of action, and new routes of administration are undoubtedly a driving force for market growth in the DME space.”