Ophthalmic Drugs Market Report Size Analysis:

The Ophthalmic Drugs Market size was valued at USD 37.35 billion in 2023 and is expected to reach USD 62.74 billion by 2032, growing at a CAGR of 6.75% during 2024-2032.

Ophthalmic drugs are in high demand due to the rising prevalence of eye diseases, such as cataracts, glaucoma, and macular degeneration, coupled with advancements in drug delivery systems and increasing public awareness of eye health. Factors, including an aging population and changing lifestyles, are also contributing to the increased demand for these medications. 

• For instance, according to the American Academy of Ophthalmology, 16 million Americans are diagnosed with dry eye.

Recent developments, such as Miebo (perfluorohexyloctane ophthalmic solution) by Bausch & Lomb, are the first FDA-approved prescription medication for dry eye associated with Meibomian gland dysfunction, driving the global ophthalmic drugs market growth.

• In 2023, the ophthalmic drugs industry witnessed tremendous growth with a record 12 approvals made by the FDA. Apart from these approvals, some ophthalmic drug companies were also issued Complete Response Letters (CRLs) by the agency.

The U.S. ophthalmic drugs market valuation was USD 14.06 billion in 2023 and is expected to reach USD 23.11 billion by 2032, growing at a CAGR of 6.46% during 2024-2032.

The U.S. leads the North American ophthalmic drugs market because of its well-developed healthcare infrastructure, high healthcare expenditure, and high incidence of eye diseases. The pharmaceutical strength of the country, high investment in R&D, and presence of top ophthalmic drug companies also increase its market dominance. Moreover, the rising geriatric population and growing awareness of eye care add to the dominance of the U.S. in the market.

Ophthalmic Drugs Market Dynamics:

Drivers:

• Nanotechnology-based Ocular Drug Delivery Systems are Driving the Market Growth

The carriers deliver drugs to the site of action, enhance solubility and stability, prolong release, and reduce side effects. In the recent two decades, this technique has emerged as a potential system for bypassing ocular barriers and increasing the bioavailability of drugs. A few nanocarriers are approved by the FDA and are already commercially available for application in the clinical treatment of ocular disease.

For instance, according to MDPI, Ocular nanotechnology-based drug delivery is a focused technique for the precise delivery of therapeutic agents to the eye via nanoscale carriers or systems.

• Rising Prevalence of Eye Disorders to Propel Market Expansion

According to the WHO, more than 2.2 billion people have some degree of near or distance vision impairment globally. Importantly, at least 1 billion of these instances, nearly 50%, were preventable or remain to be treated. The main reasons for distance vision impairment or blindness in this group are cataract (94 million), refractive error (88.4 million), age-related macular degeneration (8 million), glaucoma (7.7 million), and diabetic retinopathy (3.9 million). Presbyopia is recognized as the primary cause of near vision blindness, which plagues about 826 million people globally.

There are also wide variations in regions; distance vision blindness has been estimated to be four times greater among low- and middle-income regions than in high-income areas. For near vision impairment, over 80% of the cases in western, eastern, and central sub-Saharan Africa go undiagnosed, while in high-income regions like North America, Australasia, Western Europe, and Asia-Pacific, it is below 10% only. Such variations, together with global population growth and the ever-growing elderly population, will tend to raise the risk of vision impairment over the next few years.

Restraints:

• Stringent Regulatory Approval Processes May Impede Ophthalmic Drugs Market Growth

In the U.S., medical device approval is regulated by the Food and Drug Administration (FDA), which itself has frequently been criticized over its regulatory processes, albeit for instances of delays and slower processing times when compared with other industrialized nations. In Japan, the Pharmaceutical and Medical Devices Agency (PMDA) regulates medical device approvals, utilizing evidentiary standards and processes that highly resemble those of the FDA.

Ophthalmic Drugs Market Segmentation Analysis:

By Class

In 2023, the Anti-VEGF agents segment held the dominant ophthalmic drugs market share of 32.15%. The agents operate by preventing the action of Vascular Endothelial Growth Factor (VEGF), a protein that causes the abnormal development of blood vessels. Anti-VEGF medications are commonly applied in the therapy of retinal diseases, such as age-related macular degeneration (AMD) and diabetic retinopathy, in which abnormal vascular growth and leakage lead to visual impairment. Through inhibition of VEGF binding to its receptors, these drugs effectively prevent the pathological angiogenesis and vascular permeability of these diseases.

Anti-glaucoma is anticipated to exhibit the fastest growth throughout the forecast period as anti-glaucoma medications are given either orally or topically, each mode having unique side effect profiles. Oral preparations are linked to systemic side effects, including depression, gastrointestinal upset, metabolic acidosis, metallic taste, and weakness, depending on the drug in question. On the other hand, topical preparations frequently result in local side effects, such as dry eyes, burning or stinging, tearing, and contact allergy.

By Disease

The retinal disorder segment dominated the market with a 36.11% share in 2023 because of changing lifestyle, aging, and the prevalence of chronic diseases. According to Ocular Therapeutix, it is estimated that about 401.6 million people worldwide are suffering from any type of retinal disease. Most of them can lead to loss of vision or serious visual impairment, disrupting visual acuity and seriously degrading the quality of life of a person. Of the many retinal diseases, age-related macular degeneration (AMD) and diabetic eye disease are the most common, together responsible for 42.4% of all retinal disease in the U.S. These diseases are the most common causes of vision loss and blindness and are assuming greater clinical significance with the aging world population and increasing incidence of diabetes.

Infection segments are anticipated to experience the fastest growth over the forecast period, as ophthalmic anti-infectives are medications specifically formulated for application or instillation into the eye to treat ocular infections. These products are available in various forms, including eye drops, gels, and ointments. Anti-infective agents work by either eliminating the infectious organism or inhibiting its ability to spread. They encompass a broad range of drug classes, such as antibiotics, antibacterials, antifungals, antivirals, and antiprotozoals.

By Route of Administration

The topical segment dominated the market with a 64.13% share in 2023. The segment’s dominance is attributed to the ability of topically applied ophthalmic medication to penetrate intraocular tissues along three major pathways, direct corneal, aqueous humor, and vitreous body penetration; conjunctival and scleral trans-scleral absorption, during which the medication penetrates the choroid and then gains access to the aqueous humor, vitreous, or retina; and systemic absorption, followed by transport to the retina via retinal blood vessels. Of these, the first two paths are the major vehicles that contribute to intraocular drug distribution following topical application.

The local ocular segment is expected to experience the fastest growth over the forecast period. Local ophthalmic drugs are medications administered directly to the eye, often in the form of eye drops or ointments, to treat various conditions, such as infections, inflammation, or glaucoma, further augmenting the segment’s expansion. These drugs target the anterior segment of the eye, including the cornea, conjunctiva, and iris. Some of the local ophthalmic drugs include antibiotics for infections, corticosteroids for inflammation, and glaucoma medications. 

By Dosage Form

In 2023, the eye drops segment led the ophthalmic drugs market with 68.46% total share. It is widely used, easy to administer, and its action sets in quickly to treat multiple eye diseases, including dry eye, glaucoma, infections, and allergies. The ease of delivery, cost-effectiveness, and non-invasive nature of eye drops make them the first choice among patients and physicians. Their capacity to provide drugs directly to the ocular surface provides high local concentrations of drugs with low systemic absorption, which minimizes side effects. In addition, the use of over-the-counter (OTC) eye drops is convenient, facilitating their universal adoption. The FDA has provided guidance on quality aspects of topical ophthalmic drug products, highlighting the need for sterility and good manufacturing practices for eye drops. This emphasis on quality and safety is a testament to the pivotal role that eye drops have in ophthalmic treatment.

The Eye Solutions & Suspensions segment is anticipated to exhibit the fastest growth over the forecast period because of its direct administration of therapeutic drugs to the action site, which lenables a greater localized concentration than is normally obtained by oral administration. Furthermore, topical administration serves to reduce the risk of systemic side effects since the drug acts mainly at the site of action and not in the circulation throughout the body.

By Product Type

The prescription drug segment led the ophthalmic drug market with a 75.10% total share in 2023, owing to its critical position in the management of serious and vision-risking eye diseases, including glaucoma, age-related macular degeneration, and diabetic retinopathy. Such diseases necessitate specialized drugs available only through a physician's prescription to guarantee correct diagnosis, dosage, and monitoring. Governmental agencies, such as the U.S. FDA, and organizations, including the American Academy of Ophthalmology, highlight the importance of prescription-based medications for proper treatment. Their safety, clinical efficacy, and need in the management of chronic ocular conditions make prescription medication the best and most common option in ophthalmologic practice.

OTC drugs are expected to witness the fastest growth over the forecast period as the over-the-counter (OTC) medications are readily available as they can be bought without a prescription from a health expert. Such medications are obtainable at supermarkets, pharmacies, and convenience stores, making them readily available for patients to gain easy access to the medications.

By Drug Type

The branded drug segment dominated the ophthalmic drugs market with an 85.12% share in 2023. As per the U.S. Food and Drug Administration, these drugs undergo rigorous testing to ensure quality, safety, and efficacy, providing physicians and patients with more assurance in their usage (FDA – Ophthalmic Drugs). Also, the American Academy of Ophthalmology (AAO) emphasizes the vital function of branded medicines in bringing innovative solutions to treat and prevent vision impairment among high-risk groups (AAO – Eye Health). Branded products also commonly use new drug delivery technologies, making patients more compliant and therapy successful, hence underpinning their stronghold on ophthalmic drugs.

Ophthalmic Drugs Market Regional Analysis:

North America dominated the ophthalmic drugs market with a 48.07% share in 2023 owing to its advanced healthcare infrastructure, huge healthcare spending, and well-developed pharmaceutical industry.

The U.S. specifically holds the largest market share, owing to its established presence of leading ophthalmic drug manufacturers, ongoing innovation, and extensive R&D efforts. Besides, the widespread occurrence of eye ailments such as age-related macular degeneration, diabetic retinopathy, and glaucoma, along with increased awareness about eye care, leads to market leadership in the region. Availability of top-class healthcare providers, specialist clinics, and high insurance coverage also enhances the prevalence of ophthalmic medications in the nation.

Asia Pacific is anticipated to exhibit the fastest growth with 7.41% CAGR over the forecast period in the ophthalmic drugs market. The region is witnessing a swift growth in the aging population, which results in an increased prevalence of age-related eye diseases. Additionally, the enhanced healthcare infrastructure, growing access to sophisticated treatments, and improving awareness regarding eye health are fueling the demand for ophthalmic medications. Economies, such as China and India, with their huge population and growing middle class, are also fueling this growth by embracing innovative eye care practices and investing in healthcare infrastructure.

Ophthalmic Drugs Market Key Players:

AbbVie, Alcon Vision, Bausch Health Companies, Bayer, Coherus BioSciences, F. Hoffmann-La Roche, Novartis, Pfizer, Regeneron Pharmaceuticals, Sun Pharmaceutical Industries, Teva Pharmaceutical Industries, and other players.

Recent Developments in the Ophthalmic Drugs Market:

• March 2024 – Roche Pharma India brought Vabysmo to the Indian market, a cost-effective therapy for neovascular age-related macular degeneration and diabetic macular edema. Roche is collaborating with the government and insurance companies to increase access for patients. Worldwide, Vabysmo has achieved robust sales and provides long-lasting benefits against retinal vision loss.

• June 30, 2023 – Novartis will divest its 'front of eye' ophthalmology assets to Bausch + Lomb for up to USD 2.5 billion. The transaction entails Xiidra, SAF312 (libvatrep), the AcuStream delivery device, and OJL332.

• May 2023 – The U.S. FDA approved MIEBO (perfluorohexyloctane ophthalmic solution), which was created by Bausch + Lomb and Novaliq GmbH, as the first and sole treatment for dry eye disease that specifically addresses tear evaporation.