The worldwide ophthalmology drugs market was roughly valued at USD 11 billion in 2015 and estimated to reach USD 16 billion by 2020. The strength and attractive view of the market is supported by (1) Favorable macro trends, (2) Scientific innovation, and (3) increasing interest and focus on ophthalmology.
The aging global population especially people over 65 will grow from 630 million today to 1.2 billion in 2030. The aging population in developed countries represents a strong market opportunity for ophthalmic drugs. Moreover, the rapid growth of middle class in emerging markets and rising global prevalence of diabetes and the resulting complication such as diabetic retinopathy and diabetic macular edema (DME) are few key macro trends that should drive the future growth of the market.
There are still many large unmet clinical needs in the ophthalmology drugs market and new scientific innovation will spur market growth. The key therapeutic segments with large unmet needs include retinal diseases Wet and dry AMD, diabetic retinopathy & diabetic edema, glaucoma, and dry eye (keratoconjunctivitis sicca).
The view of rising innovation in ophthalmology is supported by continued uptick and increased R&D spend and breakthrough collaborations. For example, Alcon spends roughly USD 1 billion annually on ophthalmology R&D. Alcon entered into an agreement with Google for “smart lens” technology for all ocular medical uses in presbyopia and glucose monitoring for patients with diabetes who are prone to macular degeneration and retinopathy.
Increasing Interest and Focus on Ophthalmology
The M&A landscape is rife with activities in ophthalmology drugs space. This is evidenced by transformational deals such as Novartis/Alcon, Valeant/Bausch & Lomb, and Actavis/Allergan. Consolidation is expected to continue as smaller players look to expand and replenish their pipelines with disruptive technologies to stay competitive.
Market View & Outlook
The key players in the ophthalmology space are Regeneron, Allergan (now part of Actavis), Novartis, Roche & Pfizer. Shire entered the market in 2016 with a new product launch in dry eye.
Glaucoma category that has experienced generics incursion will be offset by continued growth from new treatment modalities for age-related macular degeneration (AMD) and other retina disorders such as Diabetic Macular Edema (DME) and Retinal Vein Occlusions (RVO).
In glaucoma, Pfizer’s Xalatan, Allergan’s Lumigan and Novartis/Alcon’s Travatan are expected to dominate through 2018. However, market share of Pfizer’s Xalatan franchise has declined meaningfully due to the launch of generics of Xalatan in March 2011. The current development focus in glaucoma is on new mechanisms of action (MOA) and long-acting, more convenient schedule aimed at improving compliance, which is normally very poor in this patient population. Valeant’s Vesneo (approval expected late 2016), Aerie Pharmaceutical’s Rhopressa (Phase III), and Inotek’s trabodenoson (Phase III) are among the promising late-stage candidates with new mechanism of actions for the treatment of glaucoma.
Roche & Novartis’s Lucentis was the leading brand of Vascular Endothelial Growth Factor (VEGF) therapy for many years in retinal diseases. However, Regeneron’s Eylea launched in late 2011 took the majority brand share in wet AMD and more recently, in Diabetic Macular Edema (DME). Eylea is providing strong competition to Lucentis by virtue of a less frequent injection schedule.
Platelet Derived Growth Factor (PDGF) therapy are expected to be the next frontier for retinal disorders. Ophthotech’s Fovista, a PDGF therapy demonstrated clinically meaningful vision gains in a Phase II study when used in conjunction with VEGF therapy. A Phase III study is currently ongoing with data expected by the end of this year. Regeneron, Novartis, and Allergan are reported to be evaluating combination therapies for the treatment of retinal disorders.
Dry AMD represents a strong commercial opportunity as currently there are no approved treatments. Roche’s Phase II data for lampalizumab generated some interesting positive results. Phase III trials have been initiated with data likely in 2018. Additionally, Acucela and its partner Otsuka’s ACU-4429 is in a Phase III study, which could release by mid-2016. Ophthotech’s Zimura started a Phase II study in early 2015.
Dry eye represents an emerging area and innovation seems to pick up amid low regulatory hurdles. In July 2016, Shire received approval of Xiidra (lifitegrast), the first dry eye drug to be approved in over a decade. Allergan’s Restasis so far has been the leader in the dry eye market with sales exceeding USD 1 billion in 2015. From a clinical development standpoint, a number of dry eye drugs are making their way through clinical development including Ocular Theraputics’ Dextenza (sustained release dexamethasone intracanalicular depot) and Mimetogen’s tavilermide (novel small molecule TrkA agonist) which was licensed by Allergan in 2015.
Looking forward, Allergan, driven by the dominance of its glaucoma franchise and Restasisis expected to lose leading share of the ophthalmology category by 2020 to Regeneron’s Eylea franchise for retinal diseases. By 2020, Novartis and Roche are estimated to cede share as Lucentis sales continue to decline. Interestingly, Shire is a new entrant and could be a category leader in the space driven by Xiidra (lifitegrast) launch in dry eye in July 2016.