Age-Related Macular Degeneration: Global Drug Forecast and Market Analysis to 2028

Summary

Age-related macular degeneration (AMD) is an eye condition that is characterized by the gradual deterioration of the macula, which is the oval-shaped area of the retina that is responsible for central vision. AMD is the most common cause of significant irreversible vision loss among the elderly. Classified by disease severity, AMD can be divided into three distinct stages. These are the early, intermediate, and late types of AMD. Out of the late forms, there are two further subtypes: dry (dAMD) and wet (wAMD). Dry AMD is evidenced by atrophy of the cells lining the retina, the accumulation of debris and the death of photoreceptors near the center of the fundus.

Wet AMD is characterized by the growth of abnormal blood vessels that disrupt and misalign the layers of the retina, leading to sight loss. Another form late AMD is geographic atrophy (GA), a slowly progressing subtype characterized by cell death and extensive damage to the retinal pigment epithelium which is a layer of cells attached to blood vessels in the choroid.

There is no way to reverse the sight loss caused by AMD although the progression of the disease can be slowed through treatment with intravitreal anti-angiogenic drugs. Commonly used therapy options in the 9MM are Bayer/Regeneron’s Eylea (aflibercept), Roche/Genentech’s Lucentis (ranibizumab) and Roche’s anti-neoplastic agent Avastin (bevacizumab), which is used as an off-label therapy for retinal diseases. These drugs inhibit vascular endothelial growth factor (VEGF) which is a protein that promotes the growth of new blood vessels, which leak contents onto the macula in the pathophysiology of wet AMD. There are no approved therapies for neither GA nor dAMD.

Geographic atrophy, dry AMD and wet AMD are treated as separate indications in this forecast model although it is possible to have dry AMD in one eye and wet AMD in the second eye. Although severe side effects from anti-VEGF drugs are rare, it is possible for patients to develop ocular inflammation and increased intraocular pressure as well as a temporary worsening of sight loss in the immediate aftermath of an intravitreal injection. Unmet needs include the desire to reduce the frequency of administration of intravitreal therapies, the need to identify and monitor at earlier stages of disease and to develop therapies for dry AMD and GA.

GlobalData estimates that drug sales for AMD in 2018 were approximately $8.6B across the nine major markets (US, France, Germany, Italy, Spain, UK, Japan, China, and Australia). Over the 10-year forecast period, the market is expected to grow to $18.4B at a CAGR of 7.9%. This growth will be driven by the launch of 11 late-stage pipeline products. The two highest selling drugs are expected to be MacuCLEAR’s therapy for dry AMD, MC-1101, and Roche/Chugai’s faricimab, a monoclonal antibody for wet AMD.

Key Highlights

– The AMD market is expected to grow at a CAGR of 7.9% from 2018 to 2028, reaching a global value of $18.4 billion.
– Anti-VEGFs dominate the AMD marketplace, although the frequency of administration of intravitreal injections is burdensome for wet AMD patients. Other unmet needs include the fact that there are no treatments available for dry AMD or GA, lack of early diagnosis, and the fact that there is no way to reverse the sight loss caused by untreated AMD.
– KOLs were satisfied by the anti-angiogenic mechanism of action as a way to control wet AMD, although the invasive route of administration of anti-VEGF therapies is uncomfortable for many patients.
– Clinical trial data is limited for MacuCLEAR’s MC-1101 (dry AMD) and Alkeus Pharma’s ALK-001 (GA), although this is unlikely to be a significant obstacle in generating sales because of the lack of approved therapies for these indications.
– Dobecure, a Spanish biopharmaceutical company are developing ethamsylate, which is a fibroblast inhibitor. This product is being developed to treat both dry and wet AMD. This is the only pipeline product being developed for both late forms of AMD and is expected to launch in the 5EU markets. The product is marketed for hematological conditions and is genericized, limiting sales in comparison to biologics such as fusion proteins and monoclonal antibodies.
– Despite the warning from the American Society of Retina Specialists that Novartis’ Beovu (brolucizumab) was linked to retinal vasculitis in a subset of wet AMD patients, the drug is still expected to become a top-selling marketed product by the end of the forecast period because of its high annual cost of therapy and classification as a longer-acting anti-VEGF therapy.
– Allergan’s abicipar pegol is also a longer-acting anti-VEGF therapy, administered five times a year, as is Roche/Genentech’s faricimab, injected four times a year. Faricimab is expected to launch in all of the 9MM, contributing to its position as the top-selling late-stage pipeline product for wet AMD.
– Apellis Pharma’s first-in-class immunosuppressive therapy APL-2 is expected to generate higher sales than Alkeus Pharma’s GA therapy, ALK-001. This is because complement inhibition is a mechanism of action that has shown efficacy in clinical trials exploring the potential for immunosuppressive techniques to treat geographic atrophy. Furthermore, APL-2, will launch in the US, 5EU, and Australian markets whereas ALK-001 will only launch in the US market during the forecast window.
– Chengdu Kanghong’s Langmu (conbercept) will also become a top-selling marketed product and benefit from a significant increase in sales. This is partially because the drug is more likely to be selected in China for its less expensive annual cost of therapy compared to Eylea and Lucentis. The large Chinese patient population will be a key driver of sales and the drug is also in the pipeline in the US market, expected to launch in 2023. Another low-cost anti-VEGF, which is Roche/Genentech’s Avastin, is widely available across the 9MM. Sales of Avastin will increase in sales at the beginning of the forecast window before the launch of longer-acting anti-angiogenic therapies.
– The sales of Eylea, Lucentis, and Avastin will decline in all of the 9MM due to the emergence of longer-acting therapies and the entry of biosimilars which will erode sales of their branded counterparts.
– A sustained release version of ranibizumab being developed by Roche is expected to become a top-selling drug because the product, administered in the form of an ocular implant is changed after several months and may be selected as a more convenient option for patients in the US and 5EU markets, where the drug is expected to launch in 2021 and 2022, respectively.

Key Questions Answered in This Report

– What were the main drugs used to manage wet AMD in 2018?
– When will the late stage pipeline products launch in each of the 9MM?
– What effect will each of the late-stage pipeline agents have on drug sales in the 9MM?
– Which unmet needs will remain unaddressed in the forecast period?
– What opportunities remain for drug developers?

Scope

– Overview of AMD, including the epidemiology, etiology, pathophysiology, symptoms, diagnosis, and the management of wet AMD.
– Annualized AMD therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in patient segments including dry AMD, GA, and wet AMD in a dynamic market forecast from 2018 to 2028.
– Topics covered include a competitive assessment of key players in the market, characterization of marketed and pipeline drugs, an examination of unmet needs, and clinical trials in the 9MM.
– Pipeline analysis: Provides a comprehensive analysis of pipeline products including their mechanism of action, route of administration, the patient population(s) for which the product is being developed, and performance of each drug candidate in clinical trials. Candidates in Phase III have been profiled and innovative therapeutic approaches in the early-stage pipeline are also discussed within the report.
– Analysis of the current and future market competition in the global AMD market, with a particular focus on the new drugs being developed for dry AMD and geographic atrophy.
– The report provides an insightful review of industry drivers, barriers and challenges across the 9MM. Each industry trend in relation to AMD is independently researched to provide an extensive qualitative review of its implications.

Reasons to Buy

The report will enable you to –
– Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.
– Develop business strategies by understanding the trends shaping and driving the global AMD pharmacotherapy market.
– Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global AMD market in the future.
– Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing the performance of various competitors.
– Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
– Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.