The US Food and Drug Administration’s (FDA) recent approval of Roche’s Vabysmo (faricimab) for wet age-related macular degeneration (wAMD) in January this year, coupled with anticipated approval of pipeline therapies in the forecast period from 2021 to 2031, as well as potentially first-to-market therapies for geographic atrophy (GA), are all expected to drive the growth of the AMD market in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan). The wAMD and GA markets are anticipated to reach values of $18.8bn and $4.0bn, respectively, in 2031 in the 7MM.
The frequency of administration associated with a therapy is a critical factor that companies in this space focus on to fine-tune their chances of success in the wAMD market. This can be evidenced by the FDA’s recent approvals of Vabysmo, a therapy that is administered every four weeks for the first four doses, and this frequency may be reduced to as little as twice a year thereafter, depending on the results of optical coherence tomography and visual acuity evaluations. Lower frequency of administration represents a significant alleviation of treatment burden and lower cost of treatment compared with standard of care.
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Roche’s Susvimo (ranibizumab sustained release formulation) follows a similar theme; patients who are implanted with Susvimo are expected to visit their doctor only twice a year to have the implant refilled so that the medicine can be delivered to their eyes continuously. The therapy received FDA approval in October last year. Looking ahead, the bulk of the current late-stage pipeline for wAMD mirrors what is commercially available, such as anti-vascular endothelial growth factor (VEGF) therapies, although different members of the VEGF family may be targeted depending on the therapy that is being developed. This includes Kodiak Sciences’ KSI-301 and Opthea’s OPT-302.
Avastin, which is currently used as an off-label therapy for wAMD, is also of interest as Outlook Therapeutics is working on developing a branded version for this indication. An innovative therapy that stands out among the current late-stage pipeline products is AbbVie’s RGX-314, a gene therapy that is being developed as a potential one-time treatment option for wAMD. A one-time treatment option would represent a significant shift in the treatment burden for wAMD.
In addition, as of this month, there are no approved therapies available for GA. Late-stage pipeline therapies for GA have shown promising results in clinical trials associated with this stage of development, and there is anticipation that these therapies will receive approval during the forecast period. These therapies include Apellis Pharma’s APL-2, IVERIC bio’s Zimura (avacincaptad pegol) and Alkeus Pharma’s ALK-001.
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While the AMD 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, the current standard of care, Eylea (aflibercept), is set to lose market exclusivity in the US next year, leading to an anticipated entry of biosimilars. In addition, the lack of therapies for dry AMD (dAMD) is anticipated to dampen global sales for this sub-indication and leave patients with dAMD without access to approved therapies.
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