Overview

This Market Spotlight report covers the Glaucoma market, comprising key marketed and pipeline drugs, clinical trials, upcoming and regulatory events, probability of success, patent information, recent events and analyst opinion, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts

Key Takeaways

• Datamonitor Healthcare estimates that in 2017, there were 95.5 million prevalent cases of glaucoma in adults aged 40 years and older worldwide, and forecasts that number to increase to 113.4 million prevalent cases by 2026.
• Africa is estimated to have the highest disease prevalence (4.79%), while Europe and Oceania have the lowest prevalence (2.93% and 2.97%, respectively).
• The majority of approved drugs in the glaucoma space target beta adrenergic receptors or the prostaglandin F receptor. Zioptan and Neptazane (generic) are the only marketed drugs for glaucoma administered via the intraocular/subretinal/subconjunctival, and oral routes, respectively, with the remainder being topical formulations.
• The majority of industry-sponsored drugs in active clinical development for glaucoma are in Phase II, with only one drug in the NDA/BLA phase.
• While a small number of mid-to-late-stage drugs in the glaucoma space are exploring new targets, the established target prostaglandin F receptor continues to lead clinical development. The largest number of drugs in mid-to-late-stage development for glaucoma are administered via the intraocular/subretinal/subconjunctival route.
• High-impact upcoming events for drugs in the glaucoma space comprise expected CHMP supplemental filing results for Ganfort, topline Phase II trial results for Nyxol, and an expected PDUFA date for Bimatoprost Sustained Release.
• The overall likelihood of approval of a Phase I glaucoma/ocular hypertension (ophthalmology) asset is 4%, and the average probability a drug advances from Phase III is 61.5%. Drugs, on average, take 9.3 years from Phase I to approval, compared to 8.9 years in the overall ophthalmology space.
• There have been 25 licensing and asset acquisition deals involving glaucoma drugs during 2014–19. The largest deal was in 2014, when Merck & Co sold Asian rights for five of its glaucoma drugs to Santen for $600m.
• The distribution of clinical trials across Phase I–IV indicates that the majority of trials for glaucoma have been in the late phases of development, with 59% of trials in Phase III–IV, and 41% in Phase I–II.
• The US has a substantial lead in the number of glaucoma clinical trials globally. Germany leads the major EU markets, while Japan has the top spot in Asia.
• Clinical trial activity in the glaucoma space is dominated by completed trials. Novartis has the highest number of completed clinical trials for glaucoma, with 157 trials.
• Novartis leads industry sponsors with by far the highest overall number of clinical trials for glaucoma, followed by Allergan.