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Ophthalmology MarketAn opportunity & Overview Ishan Shukla
Flow of the PresentationOphthalmology Market sizeMarket SegmentsPipeline of drugs in diabetic retinopathyGeneric to grow on back of patent expiriesTop 10 ophthalmic productsOpthalmic Product Range of Marck BiosciencesDossier In licensing Strategy
Current Market Size ,Trends and Vision 2022The size of the ophthalmic market reached USD14bn in 2008 (the US represents c40%).Ophthalmic Drugs Market Will Reach $18.7 Billion in 2012 (Including US/EU) From 2012 to 2022, the pharmaceutical industry will improve treatment of ocular disorders and increase revenues from those products.The world market for eye drugs will grow strongly from 2012 to 2022.It will be stimulated by increasing prevalence of eye disorders among aging populations worldwide.Sustained-release ocular implants, Gene therapy and RNA interference technology will influence R&D in ophthalmology, aswill neuroprotective agents for glaucoma.The main causes of visual impairment and sight loss in developed countries are retinal diseases. These include age-relatedmacular degeneration (AMD), diabetic macular oedema and macular oedema caused by retinal vein occlusion. Glaucoma isthe leading cause of irreversible blindness. It remains a large segment of the ophthalmic prescription drug market. Worldwide,there are many under-met treatment needs for eye disorders.Over coming years, there will be much research in ophthalmic, especially for sustained release implants and injectiontechnologies for retinal diseases.Sustained release formulations will offer marked potential for revenue growth.Diabetic macular oedema (DME) will also be important to the future of the ophthalmic drug market. The number of peopledeveloping Type II diabetes is rising, with many diabetics developing DME.In particular, anti-VEGF therapy will play an increasing role in the treatment of DME.
Ophthalmic Market segments Total Market is divided into following mentioned 5 Major Disease Conditions1. Glaucoma,2. Age related Macular Degeneration (AMD),3. Conjunctivitis,4. Dry eye conditions5. Cataracts.1. Glaucoma is the biggest market with sales over USD5bn in 2008 and a historical CAGR of over 10%. which is estimated to reach US$3.35 billion* by 2015.2. Conjunctivitis was next with sales of USD3bn.3. The AMD market is dominated by biologic Lucentis (ranibizumab).4. The dry eye market, though big at USD2bn, is dominated by many OTC brands and hence not directly relevant for all generics companies.
Generic to grow on back of patent expiriesthe expiry in the US of patents for big products like Xalatan and Patanol/Patadaywill drive growth for generics.Among the branded companies,1. Alcon is the global leader in eye care with sales of cUSD6.5bn in 2009.2. Novartis acquired Alcon from Nestle and recently completed 100% ownership. Novartis has ophthalmic assets through Ciba and Lucentis.3. Alcon’s key brands include Travatan,Patanol/Pataday, Vigamox, Tobradex and Azopt, and it also has a presence in other surgical/optical care segments. Indian companies have been practically nonexistent in this space. Wockhardt’s ANDA filing in olopatadine is the sole material para-IV challenge In our coverage universe, Sun Pharma generates a small amount of sales from generic Acular and generic Optivar, both for allergic conjunctivitis. Sun Pharma has shared its SMM technology(SWOLLEN MICELLE MICROEMULSION ), a platform for solubilizing lipophilic drugs like prostaglandins (latanoprost, travoprost,bimatoprost). In addition, Sun is also applying its proprietary GFR (Gel Free Reservoir ) technology to timolol and other products in development. Lupin is also aiming to launch a generic product in this space in the next two years.
Key Brands & Molecules
Pipeline of drugs in diabetic retinopathya large part of growth for branded companies will come from the lessresearched segment of diabetic retinopathy as there is no approved drug fortreating this condition.There are a number of drugs in the pipeline (see table below). Pipeline of drugs in diabetic retinopathy Sr. no. Compound Company Phase 1 Illuvien Alimera Sciences FDA filing; granted priority review status 2 Vitreosolve Vitreoretinal Technologies Phase III 3 Lucentis Genetech (Roche) Phase III 4 Ozurdex Allergan Phase III 5 Macugen Pfizer Phase II 6 Novadur Allergan Phase II 7 AL-39,324 Alcon Phase I/II
Top 10 Ophthalmic Products (March 2011)Sr. No Brand Molecule Indication Innovator Branded/Generic Patent Expiry Sales (USD Million) ANDA Filers 1 Xalantan Latanoprost Glaucoma Pfizer Branded 22/Mar/11 1737 Par Xalacom Pharmaceutical 2 Restasis Cyclosporine Opthalmic Solution Dry eye conditions Allergan Branded 523 3 Patanol Oloptadine Conjunctivitis Alcon Branded Dec/15 400 Wockhardt Pataday Sandoz Teva Apotex 4 Alphagan Brimonidine Glaucoma Allergan Branded Jan/22 315 Sandoz Alphagan -P Apotex Excela Hi-Tech 5 Lumigan Bimatoprost Glaucoma Allergan Branded Aug/14 250 Sandoz Teva Photomedex 6 Combigan Brimonidine +Timolol Glaucoma Allergan Branded Apr/22 100 Apotex Watson Hi-Tech Sandoz 7 Travatan Travoprost Glaucoma Allergan Branded 03/Aug/13 120 Teva Travatan -Z 8 Tobradex Tobramycin + Dexamethasone Conjunctivitis Alcon Branded 80 Opthalmic Suspension 9 Azopt Brinzolamide Opthalmic Solution Glaucoma Alcon Branded 91 10 Cosopt Dorzolamide Glaucoma Merck Generic 80 Apotex Trusopt Dorzolamide +Timolol Hi-Tech Alcon/Sandoz Teva