The age-related macular degeneration (AMD) market in the seven major markets (7MM) is set to grow from $7.8 billion in 2024 to $20.5 billion in 2034, driven by the entry of therapies with longer durations, new mechanisms of action, the availability of therapies for geographic atrophy (GA), and the launch of the first therapy for early AMD, which will increase treatment options available for patients with this sub-indication, forecasts GlobalData, a leading intelligence and productivity platform.
GlobalData’s latest report, “Age-Related Macular Degeneration: Seven-Market Drug Forecast and Market Analysis,” reveals that the market’s growth will be supported by the anticipated launch of 26 novel pipeline agents, coupled with the growing AMD population throughout the forecast period.
Sara Reci, MSc, Managing Pharma Analyst at GlobalData, comments: “While AMD does not lead to complete blindness, the loss of central vision can negatively impact patients’ quality of life as everyday tasks becomes increasingly challenging. In interviews with GlobalData, key opinion leaders (KOLs) emphasized that the greatest unmet needs in the AMD space include the need for longer-acting therapies, treatment for GA, the prevention of fibrosis, and reducing the burden on patients and the healthcare system.”
Looking ahead, some of the current late-stage pipeline products for wet AMD (wAMD) emulate what is currently on the market, employing the VEGF mechanism of action. This includes AbbVie and REGENXBIO’s RGX-314 (surabgene lomparvovec), Adverum Biotechnologies’ ADVM-022 (ixoberogene soroparvovec), and 4DMT’s 4D-150, among others.
Therapies that are anticipated to reach the AMD market during the forecast will introduce new mechanisms of action in the wAMD space, including EyePoint Pharmaceuticals’ Duravyu (vorolanib), and Ocular Therapeutix’s Axpaxli (axitinib SR), both which are TKIs; Ashvattha Therapeutics’ D-4517, which is a platelet-derived growth factor receptor (PDGFR) inhibitor and VEGF inhibitor; and Merck’s MK-3000, which is a wingless-related integration site (wnt) agonist therapy, among others.
The late-stage pipeline for GA comprises 12 therapies across the 7MM. These include Annexon’s ANX-007, which is a complement C1q subcomponent inhibitor; Ocugen’s OCU-410, which is a nuclear receptor ROR alpha activator; and Lineage Cell Therapeutics’ OpRegen, which is a cell therapy comprising allogenic RPE stem cells, among others.
Reci adds: “While there are already two therapies on the market for GA in the US, and one conditionally approved therapy for GA in Japan, the late-stage pipeline is of great benefit for patients in the EU, where there are no approved therapy options for GA.”
As for early AMD, Novartis’ Fabhalta, a complement factor B inhibitor already marketed for IgA nephropathy (Berger’s disease), membranoproliferative glomerulonephritis type II (dense deposit disease or C3 glomerulopathy), or paroxysmal nocturnal hemoglobinuria, is set to launch across the 7MM within the forecast period.
Furthermore, the market is currently saturated with therapies that employ the intravitreal route of administration. Nonetheless, there are some therapies currently in the pipeline for both wAMD and GA that employ alternative routes of administration. For wAMD, options include Ashvattha Therapeutics’ D-4517, which employs a subcutaneous route of administration, whereas for GA, options include Belite Bio’s LBS-008 and Alkeus Pharmaceuticals’ ALK-001, both of which are administered orally, as well as Regeneron’s Veopoz and cemdisiran, both of which are administered subcutaneously.
Simultaneously, therapies with longer treatment intervals are a dominant trend in the AMD pipeline. GlobalData forecasts that high-dose Bayer and Regeneron’s Eylea (aflibercept 8mg) will ensure that Eylea retains a large market share within the wAMD space throughout the forecast period, due to its potential shown in extending treatment intervals in clinical trials. Nonetheless, it will directly compete with Roche and Genentech’s Vabysmo (faricimab).
Other examples of therapies that aim to provide longer treatment intervals include Adverum Biotechnologies’ ADVM-022, AbbVie and REGENXBIO’s RGX-314, 4DMT’s 4D-150, EyePoint Pharmaceuticals’ Duravyu, and Ocular Therapeutix’s axitinib SR, among others. As for GA, therapies that aim to provide longer treatment intervals include Ocugen’s OCU-410, Roche’s OpRegen, and Luxa Biotechnology’s RPESCRPE-4W, among others.
Reci continues: “All in all, these late-stage pipeline candidates are of great benefit within the AMD space, especially in the cases of patients who do not respond well to existing treatment options for wAMD, patients in markets in which there are currently no available treatments for GA, and for early AMD patients, for whom there are no approved therapies across the 7MM.”
While the AMD market is projected to grow in the forecast period across the 7MM, it may face some challenges. Throughout the forecast period, therapies are expected to lose market exclusivity, leading to the anticipated entry of biosimilars.
Reci concludes: “Nonetheless, the launch of 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 AMD space.”
7MM-the US, France, Germany, Italy, Spain, the UK, and Japan