The Total Addressable Market (TAM) for Ophthalmic Drugs was valued at USD 32.9 billion in 2021. It is projected to reach USD 62.55 billion by 2030, growing at a CAGR of 7.4% during the forecast period (2022-2030). Anti-infectives in a product explicitly designed to be injected into or applied to the eye or eyes are known as ophthalmic anti-infectives. Anti-infectives for the eyes include eyedrops, gels, and ointments. Anti-infectives are medicines that either kill or stop the spread of an infectious pathogen. The demand is expected to increase due to rising research and development efforts to create and introduce novel ophthalmic medications and several strategic initiatives anticipated by the major players. Additionally, the market for ophthalmic medications is projected to rise due to unmet needs in ophthalmology.
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Strong Developmental Pipeline
The global market for ophthalmic pharmaceuticals is expected to expand profitably as more and more industry players emphasize R&D to develop cutting-edge treatments. To treat a variety of eye illnesses with novel medications and increase their market share, players are investing heavily in R&D. Due to the fast-rising prevalence of diseases, there is an increasing demand for novel cures and treatments. Since present treatments are known to only offer momentary symptomatic relief for various disorders, including dry eye and glaucoma, many people are working to create novel therapies. Additionally, COVID-19 has made it riskier for people to touch their faces frequently, a recognized transmission source. In order to address these issues, businesses are creating long-lasting, hands-free cures.
Patent Expiry of Blockbuster Drugs
One of the main problems in the pharmaceutical sector is the patent cliff, as giant pharmaceuticals often account for a sizable portion of firm closures. Several significant blockbuster medications have recently lost their patent exclusivity, and several more are anticipated to do the same in the upcoming years. For example, Patanol (Alcon) lost its patent in 2015, Travatan/Travatan Z (Allergan) in 2013, and Xalatan (Pfizer) in 2016. Additionally, in the following five to seven years, leading market players Allergan and Bausch & Lomb will no longer hold the market exclusivity for medications like Eylea, Lucentis, and Inveltys. Loss of patent protection is likely to have a detrimental effect on a company's profitability, prompting major pharmaceutical companies to think about alternative sources of income.
Advancements in Drug Delivery
Ophthalmic drugs have a considerable advantage over rivals thanks to their multiyear drug delivery mechanism. It was intended to release 190 mg of the medication over three years. Two more novel medication delivery techniques are implanted contact lenses and pharmaceuticals. In addition, reservoir implants release concentrated drugs gradually over six months. Although many therapeutic options are available for posterior ocular conditions such as DME, AMD, and uveitis, there are still no drug-delivery devices for anterior conditions like glaucoma.
One of the key drivers of this market is the emergence of gene treatments as a potent medication delivery method. In both in-vitro and in-vivo situations, gene therapy allows the manipulation of patient cells to create specific therapeutic entities with the aid of viral or non-viral vectors. Retinoblastoma, neurovascular retinal abnormalities, and inherited ophthalmic diseases like retinitis pigmentosa can all be diagnosed and treated with gene therapy. More research is still required to improve and broaden the use of gene therapy across ophthalmic diseases, which is expected to create opportunities for market growth over the forecast period.
The global ophthalmic drugs market is segmented by drug class, disease, route of administration, dosage form, and product type.
Based on drug class, the global ophthalmic drugs market is bifurcated into anti-allergy, anti-VEGF agents, anti-inflammatory, anti-glaucoma, and others.
The anti-VEGF segment is the highest contributor to the market and is expected to grow at a CAGR of 6.2% during the forecast period. Angiogenesis and edema are inhibited by anti-VEGF (Vascular Endothelial Growth Factor) medicines, a class of therapies. In ophthalmology, these medications help treat eye diseases that result in edema or the development of new blood vessels near the retina. Anti-VEGF medications were developed as a cutting-edge treatment to slow the progression of age-related macular degeneration (AMD). One of the top revenue producers in the ophthalmology market is Genentech's Lucentis (ranibizumab). The introduction of differentiation therapies, including Macugen (pegaptanib), Lucentis (ranibizumab), and Avastin (bevacizumab), has fueled market expansion because of their unique modes of action. These products help people avoid vision loss and eventually improve their vision with solid proof. The Cochrane Library statistics showed that injection of ranibizumab improved vision in about 3 out of 10 patients.
Steroids and non-steroids are the fundamental categories into which anti-inflammatory medications fall. Xibrom, Voltaren, Pollensa, Ocufen, Nevada, Ilevro, Bromsite, Bromday, Acuvail, Acular PF, Acular LS, and Acular are a few of the anti-inflammatory medications sold in the United States. Among the anti-inflammatory medications in Canada's stockpile are Ophtha, Voltaren, Vofenal, Ratio-Ketorolac, Indocid, and Apo-Ketorolac. Additionally, several businesses are conducting clinical trials to create novel anti-inflammatory medications for dry eye conditions, which will accelerate market expansion. For instance, OKYO Pharma Ltd. finished preclinical research on OK-113 and discovered that it has a strong anti-inflammatory effect in a mouse model of experimental dry eye syndrome. The preclinical efficacy results of OK-113 for dry eye conditions began in 2020.
Based on disease, the global market is bifurcated into dry eye, allergies, glaucoma, infection, retinal disorders, uveitis, and others.
The retinal disorders segment owns the highest market share and is expected to grow at a CAGR of 6.2% during the forecast period. Diabetic retinopathy, Age-related Macular Degeneration (AMD), and retinitis pigmentosa are the three most prevalent retinal diseases. Other retinal diseases include X-linked retinoschisis, inherited retinal dystrophies, choroideremia, Leber's Hereditary Optic Neuropathy, and Best Vitelliform Macular Dystrophy (BVMD). The market has been driven by the increasing prevalence of retinal illnesses worldwide and the demand for effective and economical treatment options. For instance, according to the National Eye Institute, there will be around 10 and 14 million cases of diabetic retinopathy in America by the years 2030 and 2050, respectively. Lucentis, Eylea, and Avastin are the three most used medications for retinal diseases. In addition, Platelet-Derived Growth Factor (PDGF) therapy is predicted to usher in a new era in treating retinal diseases.
Ocular infection medications reduce the duration of the illness, stop the infection from spreading, or do both. One of the most common illnesses of the eye is bacterial conjunctivitis. According to a WebMD LLC article from 2019, 6 million Americans suffer from conjunctivitis each year, which accounts for 1% of all visits to primary care offices. Additionally, 30% of conjunctivitis patients have bacterial conjunctivitis, and antibiotics are used to treat them in 80% of cases. Broad-spectrum antibiotics are frequently used as the first line of treatment for conjunctivitis. Compared to their oral equivalents, topical antibiotics are recommended because they transfer the medicine immediately to the illness site, boosting the antibacterial action.
Based on the route of administration, the global ophthalmic drugs market is bifurcated into topical, local ocular, and systemic.
The topical segment is the highest contributor to the market and is expected to grow at a CAGR of 6.4% during the forecast period. The most common dosage forms for topical medications include ointments, liquids, and suspensions. The principal route for topical absorption through the cornea has significant anatomical obstacles. According to estimates, the primary driver of this market is the availability of various medications administered by topical route of administration. For instance, the market currently offers OTC ocular decongestants such as phenylephrine, tetrahydrozoline, oxymetazoline, and naphazoline. It is often recommended to apply oxymetazoline topically to reduce allergic conjunctivitis symptoms like tearing, burning, and itching. Other topical ophthalmic medications used as antibiotics include besifloxacin, ciprofloxacin, moxifloxacin, tobramycin, and trimethoprim.
The maximum peak of medication concentration can be reached by using the intraocular delivery channel since it makes it easier for pharmaceuticals to enter the blood-retinal barrier directly. The posterior segment tissues of the eye, such as the cone-containing fovea or macula, have the highest intraocular bioavailability. However, because it involves drug penetration in the eye, this is the most intrusive mode of delivery and is therefore not without risks associated with injections. These include endophthalmitis, cataracts, retinal hemorrhage, elevated IOP, floaters, temporary blurriness of vision, retinal tears, retinal detachment, and vitreous hemorrhage. The most common delivery methods are subconjunctival, intravitreal, retrobulbar, and intracameral.
Based on dosage form, the global market is bifurcated into gels, eye solutions and suspensions, capsules and tablets, eye drops, and ointments.
The eye drops segment owns the highest market share and is expected to grow at a CAGR of 6.31% during the forecast period. The most popular medicine delivery method for treating ocular illnesses like glaucoma, corneal ulcers, and acute allergies is eye drops. When compared to other dose types, eye drops are fairly affordable. Besivance (besifloxacin hydrochloride—suspension/drops; ophthalmic), azithromycin, besifloxacin, timolol eye drops, etc., are a few types of eye drops. Leading manufacturers of ophthalmic eye drops include Alcon and Bausch & Lomb. Due to expanding usage and incidence of various eye-related ailments, which increased the need for ophthalmic medications, the eye drops segment led the market in 2021. For instance, Santen Pharmaceutical Co Ltd. introduced Ikervis, an eye drop, in July 2015 to treat adult patients with dry eye illnesses with severe keratitis. Additionally, it is predicted that the market will grow throughout the projected period due to solid products in the pipeline.
Eyelids or the edge of the eye are immediately treated with ophthalmic gels. Viscous liquids called gels are used to treat cataracts, chronic inflammation, and uveitis. Hydrophilic and stimuli-responsive polymer-based aqueous gel formulations remain the leading investment in this industry. Pharmaceutical medications can be included in gels to produce the desired therapeutic impact and bioactivity at the targeted eye locations. Hydrogels, premade gels, and in situ gelling technologies are recent advancements in ophthalmic gels. It is anticipated that the development of molecularly imprinted gels, stimuli-sensitive gels, 3D-printed hydrogels, and nanogels will further accelerate the growth of this market over the forecast period.
Based on product type, the global ophthalmic drugs market is bifurcated into prescription and OTC.
The prescription segment is the highest contributor to the market and is expected to grow at a CAGR of 6.2% during the forecast period. Prescription medications are recommended for treating ocular diseases brought on by germs and viruses, DES, glaucoma, retinal problems, and in some circumstances, following cataract surgery and surgical inflammations. Lotemax gel/ointment, Zylet, Durezol, Bepreve (bepotastine besilate ophthalmic solution), and prescription artificial tears are a few of the medications offered in this market. Antihistamine Bepreve is used to treat allergic conjunctivitis. Some pharmaceutical medicines have lubricating and moisturizing ingredients that temporarily increase tear production. Prescription drugs are chosen over over-the-counter ones because they are thought to be the most effective in treating ocular conditions.
The over-the-counter (OTC) drug category is anticipated to grow at the fastest rate over the forecast period due to the increasing prevalence of generic pharmaceuticals on the market and the fact that effective drugs no longer enjoy patent exclusivity. These medications are affordable for a sizable patient population in low and middle-income nations due to their comparatively low price. OTC eye medications feature anti-infective, anti-inflammatory, and antibiotic effects. They can be purchased commercially in various dosage forms, such as gels, emulsions, capsules, ointments, and ocular drops. Alaway (Bausch & Lomb, Inc.), Zaditor (Alcon, Inc.), Otrivine-Antistin (Novartis Consumer Health), Brolene (Sanofi), Golden Eye Ointment (Sigma Pharmaceuticals), GelTears (Bausch & Lomb), and Viscotears are some of the OTC medicines that are most frequently prescribed.
The global ophthalmic drugs market is bifurcated into four regions, namely North America, Europe, Asia-Pacific, and LAMEA.
North America Dominates the Global Market
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North America is the most significant global ophthalmic drugs market shareholder and is expected to grow at a CAGR of 6.7% during the forecast period. Increased eye illness prevalence and growing public knowledge of eye ailments are factors in the region's growth. Additionally, it is projected that increased research and development by significant firms will support regional prosperity. Notable players like Bausch and Lomb, Pfizer Inc., and Alcon are present. For instance, Harrow Health Inc. declared in June 2022 that MAXITROL and IOPIDINE 1% would be sold commercially in the United States. The Prescription Drug User Fee Act's new FDA guidelines offer a structured method for weighing the risks and advantages of these ophthalmic medicines in clinical studies.
Asia-Pacific is expected to grow at a CAGR of 5.65% over the forecast period. The availability of a sizable patient pool, high illness prevalence, and the rise of local businesses are all credited with expanding the Asia-Pacific region. The Asia-Pacific region has the largest patient population but the lowest treatment rate, which is expected to drive market growth. Additionally, several market participants' strategic actions are anticipated to foster regional expansion. For instance, Otsuka Pharmaceutical Co., Ltd. and Senju Pharmaceutical Co., Ltd. announced the release of AILAMIDE in June 2020 as a combined ophthalmic solution for the treatment of glaucoma and ocular hypertension.
Europe is expected to grow significantly over the forecast period. Key international companies with regional operations, such as QIAGEN N.V. and Abcam, are anticipated to hasten European market expansion. It is projected that rising consumer awareness will fuel market expansion. The European Medicines Agency also conducted an E.U. Regulatory Workshop to exchange knowledge and learn about new and upcoming pharmacological treatments for eye illnesses. Additionally, it is projected that increasing drug approval and launch will increase drug supply and patient access, supporting market expansion. For instance, Roclanda (netarsudil & latanoprost ophthalmic solution), developed by Aerie Pharmaceuticals, Inc. and approved by the European Commission, is meant to lower intraocular pressure in people with open-angle glaucoma.
Growth in the Latin American region's market is predicted to be fueled by rising healthcare costs and government measures to upgrade the region's healthcare infrastructure. The UCLA Center for World Health, PAHO, and Lions Club International Foundation are just a few organizations working to raise life expectancy and enhance healthcare quality. In addition, Cataract & Refractive Surgery Today (CRST) is a resourceful industry-surgeon link that allows companies to market to and advertise to cataract and refractive doctors. Additionally, the market expansion is anticipated to be fueled by rising government investment, the presence of qualified healthcare professionals, and a rising multinational primary player focus in this region.
The global ophthalmic drugs market’s major key players are Alcon, Novartis Ag, Johnson & Johnson Services, Inc., Bausch Health, Merck & Co., Inc., Regeneron Pharmaceuticals, Inc., Coherus Biosciences, Inc., Allergan, Bayer Ag, and Pfizer Inc.