The market for prescription ophthalmological therapeutics will experience considerable and consistent growth throughout the next 10 years as demographic changes and lifestyle factors drive the need for developing safe and effective therapies for eye disorders.
Although the overall ophthalmological market—projected to be about $19 billion for all pharmaceutical, consumer, and surgical products that come into direct contact with the eyes—amounts to just a niche, it is a niche that appears poised to outperform the general drug market.
For the entire U.S. ophthalmological prescription drug market, a compound annual growth rate of 15% is projected for the 2007–2010 period, with the compound annual growth rate flattening to 10% or less during the following 5–10 years (Figure).
The ophthalmology market is primarily driven by age- and lifestyle-related diseases including age-related macular degeneration and glaucoma, which affects only 1 in 200 people under age 50. Diabetic retinopathy is linked to type 2 diabetes and as type 2 diabetes spreads among the under-50 population, the incidence of diabetic retinopathy will increase.
An estimated 20.7 million people in the U.S. are affected by dry eye syndrome at any given time, which makes dry eye one of the most common reasons for an ophthalmologist’s appointment. A number of over-the-counter products are available for dry eye, but only one prescription therapy is FDA-approved for increasing tear production in moderate and severe chronic dry eye. Restasis (cyclosporin 0.05% ophthalmic solution) from Allergan was licensed from Novartis and is copromoted with Inspire Pharmaceuticals in the U.S. Allergan reported Restasis net sales at $270.2 million in 2006. Not surprisingly, dry eye is a highly active area for drug development (Table).
R&D in the opthalmology field is conducted largely out of the big pharma realm. In fact, the most significant characteristic of the ophthalmic drug scene is its dichotomy. Not considering Bausch & Lomb, which is primarily an ophthalmic device and surgery company, there are only two medium-sized companies, Alcon and Senju, that are almost exclusively focused in this field. A third, Allergan, has ophthalmological drugs as a crucial part of its business. Almost all ophthalmological drug research is carried out by small companies, frequently in close partnership with academia.
According to published figures, the number of people with impaired vision, including blindness, living in the U.S. will at least double over the next three decades. About 119 million Americans are older than 40, which is the age at which serious eye diseases typically become a problem. Some 35 million are already affected by the four most prevalent: age-related macular degeneration, diabetic retinopathy, glaucoma, and cataracts, although cataract treatment is confined to surgery rather than therapeutics.
With the leading edge of the baby-boomer generation approaching 60, the number of eye disease sufferers in the U.S. is expected to top 50 million or more over the next 15 years.