The global fungal keratitis treatment market size to grow to USD 1323 million in 2030 at a CAGR of 6% from the early market figures of USD 777 million in 2021. The fungal keratitis treatment market is driven by its rising incidence worldwide, the rising awareness of the potential dangers posed by fungal keratitis, and the advancements in its therapeutics. It is estimated that the incidence of fungal keratitis would exceed one million cases per year, with 8 to 11 percent of patients losing an eye. Fungal keratitis is an increasingly prevalent infection and for which the Aspergillus species are the most common causal agent for fungal keratitis.
Trauma, contact lens use, topical corticosteroid use, diabetes mellitus, and low socioeconomic status are risk factors for fungal keratitis. Undoubtedly, accidental ocular trauma is the most prevalent risk factor for fungal keratitis. The estimated prevalence rate of fungal keratitis is based on an infection of the cornea, which is frequently caused by improper care and cleaning of contact lenses or corneal injury. Increasing research activities to develop novel therapeutics and rising sales volume of ophthalmic drugs for fungal keratitis disorders are anticipated to be one of the major market drivers during the forecast period.
Government initiatives, such as awareness campaigns may also contribute to the growth of the fungal keratitis treatment market. In one of India's states, for example, the Government of Assam operates a "National Programme for Control of Blindness" to reduce the prevalence of blindness and its underlying diseases, such as fungal keratitis. It can aid in taking the necessary preventative measures. The provision of better health care facilities and the dissemination of information regarding the benefits of better and earlier diagnoses could serve as a motivating factor.
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Fungus-caused keratitis is an infection of the cornea, which is a transparent dome covering the colored portion of the eye. Some fungi known to commonly cause fungal infections are Fusarium, Aspergillus, and Candida species. This condition can cause eye pain, eye redness, vision blurring, light sensitivity, excessive tearing, and eye discharge. Untreated fungal keratitis is a rare condition that can lead to vision loss or blindness. Eye trauma, particularly involving plants (such as thorns or sticks), underlying eye disease, weakened immune system, and contact lens use, is all risk factors for developing fungal keratitis.
In addition, the increasing prevalence of fungal keratitis across the globe has a positive effect on the market expansion as a whole. According to research, there were 1,051,787 annual cases of fungal keratitis in the earlier days, with the highest rates in Asia and Africa. If it is assumed that all culture-negative cases are caused by fungi, the annual incidence would be 8 to 11%. The highest annual incidence of fungal keratitis and the highest ratio of fungi to bacteria as causes of microbial keratitis are observed in subtropical and tropical countries, primarily among male agricultural workers.
In addition, the prevalence of fungal keratitis is increasing as the number of people who wear contact lenses rises. The most prevalent predisposing risk factors for infection are contact lens use, associated poor hygiene, and exposure to water sources containing amoebas. Consequently, the increasing number of contact lens wearers exposed to the risk of fungal keratitis propels the market's expansion. Consequently, based on the aforementioned factors, it is evident that the burden of fungal keratitis is increasing, thereby contributing to the expansion of the studied market.
Multiple attempts are being made to develop and discover new antifungal treatments for fungal keratitis. In September 2018, for instance, the L.V. Prasad Eye Institute completed a Phase 2/Phase 3 study on Combination Treatment of 5% Natamycin and 1% Voriconazole for Fungal Keratitis using a Randomized Double-Masked Clinical Trial. Along with this, in the coming times, the research institute will likely initiate Phase IV trials. Thus, the positive results of such trials may lead to the development of a new treatment, which could stimulate market growth in the coming years.
The development of nanoparticle-based products is likely to facilitate market expansion. According to sources, researchers developed a nanoparticle-based drug delivery system that increases the drug residence time by anchoring the cornea, reduces inflammation, and releases the antifungal drug in a condition-responsive manner. Infected eyes exhibit significantly increased corneal retention, decreased inflammation, and resolution of infection.
These research advancements have resulted in numerous breakthrough innovations of highly effective drugs against various fungal keratitis diseases, which has led the majority of investors to favor investing in R&D and has contributed to market expansion. As a result, the market is likely to expand at a faster rate in the coming years as a result of the aforementioned factors.
In 2018, pharmaceuticals such as Vfend (Voriconazole) lost their patent protection which is why it is anticipated that the studied market will experience a slowdown. AmBisome remained protected in the United States by two patents (US5874104, US5965156) until 2016 and in Canada by one patent (CA1339008) until 2014. Numerous pharmaceutical companies in India and elsewhere are currently developing generic versions of AmBisome. These patent expirations will allow generics and low-cost competitors to enter the market, resulting in a loss of revenue for market leaders.
Widespread use of antifungal medications for the treatment of this condition is accompanied by the occurrence of side effects. These side effects are typically mild and short-lived. Redness of the eye, severe pain, and soreness of the eye, the sensation of having something in the eye, tearing, pus or other discharge, blurred vision, sensitivity to light, and swelling of the eyelids are potential side effects of fungal keratitis treatment. Typically, these adverse effects are mild and short-lived. In addition, these medications are generally well-tolerated and safe, with only the possibility of local side effects.
Additionally, it has been discovered that the use of counterfeit medications for the treatment of fungal keratitis results in a variety of adverse effects for the patient. Consequently, all of these adverse effects caused by antifungal keratitis medications and the loss of patent protection for blockbuster drugs have acted as a restraint on market growth.
The global fungal keratitis treatment market share is segmented on the basis of route of administration and distribution channel.
With respect to the route of administration, it is further segmented as an oral, injection, and topical. The topical segmentation is the most dominant one, with a market share of USD 376 million in 2021 and expected to reach USD 651 million by 2030 at a CAGR of 6%. Topical antifungals, either commercially available or compounded from a systemic preparation into eye drops, are the most frequently prescribed medications for the treatment of fungal keratitis.
The only topical antifungal medication approved for the treatment of fungal keratitis is natamycin. However, inadequate ocular penetration is the primary market constraint. On the other hand, due to the approval of new topical formulations for fungal keratitis, the topical route of administration is anticipated to experience substantial growth over the forecast period. The oral route of administration is the second most utilized one, which has a market value of USD 226 million in 2021 and reaching at USD 376 million by 2030 at a CAGR of 6%. Oral treatment is conventional and the most reliable route of drug administration, with effective systemic and local effects. In addition, both the physician and the patient favor this route of drug administration.
Consequently, it is anticipated that all of these factors will boost the market for oral fungal keratitis drugs over the forecast period. The third and the least market value generator in this segment is the injection route, which has a market share of USD 124 million in 2021 and is expected to grow to USD 205 million by 2030 at a CAGR of 6%.
When segmented by the distribution channel, the said market is segmented into hospitals and drug stores, where the drug stores contribute the major share of the market, valued at USD 393 million in 2021 and anticipated to grow to USD 659 million by 2030 at a CAGR of 6%. Independent pharmacies with a state license to dispense medications to the general public at retail prices are referred to as drug stores. The medications are also redirected to hospital pharmacies, government pharmacies, and charitable organizations.
People rely on retail pharmacies as one-stop shops to purchase antifungals and other medications. The hospital segment accounts for a market value of USD 212 million in 2021 and is expected to grow to USD 351 million by 2030 at a CAGR of 6%.
The global fungal keratitis treatment market is primarily divided into three regions, North America, Europe, and Asia.
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Which, North America has a dominance in the global market with the market valued at USD 274 million in 2021 and is expected to reach USD 440 million in 2030 at a CAGR of 5%. The Asia-pacific region is the second dominant region that accounts for a market value of USD 198 million in 2021 and reaching at USD 367 million by 2030 at a CAGR of 7%. Among these three regions, the least contributing region is Europe, which accounts for USD 187 million in 2021 and is expected to grow to USD 300 million in 2030 at a CAGR of 5%.