Global Ophthalmology Drugs Market
Ophthalmology: Epidemiology and Causes
Visual impairment is a major global health issue, where the preventable causes are as high as 80% of the total global burden. The World Health Organization estimates that there are 285 million visually impaired people globally with approximately 90% of them residing in low and middle income countries. Out of the which, 39 million are blind and 246 million have moderate to severe vision impairment. 81% of people who are blind or have moderate or severe vision impairment are aged 50 years and above.
The major causes of visual impairment are uncorrected refractive errors (43%) and cataract (33%); the first cause of blindness is cataract (51%). Approximately 95 million people suffer from cataract, and a further 20 million suffer from diabetic retinopathy, glaucoma, macular degeneration, infective causes and childhood related conditions.
About 170 million people are visually impaired due to causes that have not yet been determined or from refractive errors. The prevalence of infectious eye diseases, such as trachoma and onchocerciasis, have reduced significantly over the last 25 years.
Ophthalmology Treatment Options
Drug discovery is an essential part of ophthalmic care, and biopharma companies are working towards more effective and safe treatments that appropriately target the site of disease and are acceptable to the patient. The proportion of the total visual impairment and blindness from diseases such as age-related macular degeneration (AMD), glaucoma and diabetes retinopathy (DR) is currently greater than that from infective causes such as trachoma and corneal opacities.
Most of the currently approved drugs for ophthalmological indications are comprised of small molecules or use conventional technologies, and have been focused on glaucoma, anti-inflammation, anti-infectives and allergies. However, a greater proportion of R&D dollars is now focused on gene therapies, monoclonal antibodies, DNA & RNA therapeutics, cell therapies and recombinant products targeting retinal disorders and orphan indications.
Despite the major breakthroughs in anti-VEGF therapies for wet AMD, diabetic macular oedema (DME) and retinal vein-occlusive (RVO) diseases, there is still a huge burden of both ‘untreatable’ and/ or ‘under-treated’ eye diseases where effective treatments are not yet available or are poorly tolerated. The advent of anti-VEGF drugs has revolutionized not only wet AMD but the treatment of a range of retinovascular diseases.
Before anti-VEGF therapy, the other major therapeutic options such as laser photocoagulation, surgical resection of choroidal neovascularization (CNV), and photodynamic therapy had limited efficacy, or could only be used only in selected cases and were sometimes associated with significant ocular morbidity.
Almost 55% of the current drug candidates are either at the research project or pre-clinical stage, and another 40% in the clinic for development. The large amount of drug candidates in earlier stages of the drug development continuum points to healthy innovation, and is indicative of the strong corporate and investor interest in the ophthalmology drug market.
Ophthalmology Drugs in the Market: (Lucentis, Avastin, and Eylea)
VEGF inhibitors are commonly used in wet AMD in order to stop vascularization and the coinciding leakage of blood and fluids that cause damage to the eye. Lucentis (ranibizumab; Roche/Novartis) is an antigen binding fragment developed specifically for the treatment of wet AMD. Lucentis is marketed by Genentech (a subsidiary of Roche) in North America and by Novartis in Japan and Europe.
The drug is also approved for diabetic macular edema, diabetic retinopathy, and macular edema following retinal vein occlusion. Off-label use of Roche’s anticancer Avastin accounts for 50% share of the market, with Lucentis and newly-launched Eylea dividing equally the rest.
The high price of Lucentis continues to cause it to lose market share to its full-length antibody counterpart, Avastin (bevacizumab; Roche/Chugai). Additionally, the introduction of Eylea (aflibercept; Regeneron/Bayer/Santen) into the market offered patients the possibility of a lower clinical burden and consequently further reduced Lucentis’s share of the market.
In the US, a single Lucentis injection costs $2,000, Eylea $1,850 and Avastin as little as $50. However, with Eylea having a once-every-2month dosing frequency, it has been taking share from once monthly Lucentis. In R&D, Novartis’ has a once every 3-month drug with RTH258, while Eylea has also been developed and filed as a 12-weekly dose. If approved they should make big inroads.
Unlike Avastin, Lucentis does not possess the fragment crystallizable (Fc) region of the antibody, significantly reducing its systemic half-life and minimizing the risk of an adverse immune response caused by the drug. Furthermore, when administered through intravitreal injection, the antigen binding fragment is theoretically better able to penetrate the retinal tissue than the full-length antibody due to its smaller size.
Retinal Disorders (AMD, DME, RVO)
Growth in retinal disorders is being driven by new innovative drugs that have been developed for the treatment of disorders such as AMD, DME and RVO. Increases in the addressable target population and innovative new products (Shire’s lifitegrast) are also driving the growth of the dry eye and anti-inflammatory/infective/allergy segments.
Age-related Macular Degeneration
Age-related Macular Degeneration is a slowly-progressive degeneration of the retina, and is the major cause of blindness in the elderly. The disease is characterized by unwanted blood vessel growth (neovascularisation). Although approximately 90% of AMD patients possess the dry (atrophic) form of the disease, a minority will develop the wet (exudative) form of AMD, which progresses quickly and causes debilitating damage to the eye.
Treatment entails use of monoclonal antibodies such as Avastin, Lucentis and Eylea that bind and inhibit VEGF which prevent further vascularisation. These are given by direct injections into the eye, the best drug is going to be a) the one you can afford, and b) the one with the lowest frequency of injection.
AMD is thought to have genetic and environmental causes; however, age remains the most attributable risk factor for the disease. Furthermore, the cause of progression from dry AMD to wet AMD is still being investigated. Late-stage pipeline candidate Fovista (pegpleranib; Ophthotech/Novartis) has the potential to improve outcomes for patients and alter the competitive landscape of the wet AMD market upon launch.
In 2016, there were 93.2 million prevalent cases of glaucoma in adults aged 40 years and older worldwide, and forecasts that number to increase to 110.7 million prevalent cases by 2025. There has been a lack of innovation in the glaucoma market for a long period of time, with no new drugs approved in the US for almost 20 years.
Current pharmaceutical treatments for glaucoma include generic versions of prostaglandin analogues (PGA), beta blockers, alpha-andrenergic agonists and carbonic anhydrase inhibitors, with PGAs being the most widely prescribed drug class for glaucoma, and Lantonoprost being the most prescribed PGA in the US. Zioptan and Neptazane are the only marketed drugs for glaucoma administered via the intraocular/subretinal/subconjunctival and oral routes, respectively, with the remainder being topical formulations.
The number of classes of new drugs in development such as Aerie Pharmaceutical’s Rho kinase inhibitors or Inotek Pharmaceutical’s adenosine mimetics, which are expected to offer attractive new treatment options for patients.
Global Ophthalmology Drugs Market: Overview and Growth Drivers
The global market for ophthalmic drugs estimated to reach $50.8 billion by 2027, with the largest increase in the retinal disorders market, followed by the glaucoma segment and dry eye syndrome market, respectively. The global market is projected to grow at a CAGR of 5.8% over the forecast period.
The ophthalmology market is dominated by ocular angiogenesis-modifying compounds, accounting for majority of share in the total ophthalmology drugs market, followed by miotics and antiglaucoma preparations, and products for dry eye, respectively.
The strong growth in ophthalmology drug sales is resulting directly from substantial increases in the number of people suffering from age related ophthalmic conditions in the developed nations. At the same time, the developing countries are further driving the market due to increased expenditures in all areas of healthcare including vision impairment and eye diseases.
Given the growth in the ophthalmology market, the R&D effort is being carried out by large global ophthalmology players as well as many new start-up companies, and should provide a healthy environment for collaborations and partnerships.
The global ophthalmology drugs market is expected to become increasingly crowded with many drug companies inevitably having candidates that address the same target disease.
Major competitors operating in the global ophthalmic drugs market and profiled in this report include Aerie Pharmaceuticals, Inc., Allergan plc, Bausch Health Companies Inc. (Valeant Pharmaceuticals International, Inc.), Bayer AG, Novartis AG, Pfizer, Inc., Renegeron Pharmaceuticals, Inc., Roche Holding AG (F. Hoffmann-La Roche AG/ Genentech), Santen Pharmaceuticals Company Ltd., and Takeda Pharmaceutical Company Ltd. (Shire plc).
- Ocular Antineovascularization Products
- Miotics and Antiglaucoma Preparations
- Dry Eye Products
- Ocular Anti-Allergics, Decongestants and Antiseptics
- Ophthalmological Corticosteroids
- Ophthalmological Anti-Infectives
- Ophthalmological Anti-Inflammatory and Anti-Ineffective Combinations
- Other Products
- Disease (Condition)
- Allergy / Inflammation / Infections
- Dry Eye Syndrome (DES)
- Retinal Disorders (AMD, DME, RVO)
- Dispense Type
- North America (U.S., Canada)
- Europe (U.K., Germany, France, Italy, Spain, Rest of EU)
- Asia Pacific (Japan, China, India, Rest of APAC)
- Latin America (Brazil, Mexico, Rest of LA)
- Rest of the World (Middle East & Africa)
- Company Profiles
- Aerie Pharmaceuticals, Inc.
- Allergan plc
- Bausch Health Companies Inc. (Valeant Pharmaceuticals International, Inc.)
- Bayer AG
- Novartis AG
- Pfizer, Inc.
- Renegeron Pharmaceuticals, Inc.
- Roche Holding AG (F. Hoffmann-La Roche AG/ Genentech)
- Santen Pharmaceuticals Company Ltd.
- Takeda Pharmaceutical Company Ltd. (Shire plc)
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