Acanthamoeba Keratitis - Market Insights, Epidemiology, and Market Forecast - 2034

Key Highlights:

• The Acanthamoeba keratitis market is anticipated to sustain a steady Compound Annual Growth Rate (CAGR) during the forecast period (2024-2034). This growth in market revenue is primarily propelled by increasing incidence of contact lens use, advancements in diagnostic techniques, and aging population.
• The Acanthamoeba keratitis cases are increasing due to several factors such as increased contact lens use, poor hygiene practices, exposure to contaminated water, and growing awareness of the infection among patients and healthcare providers, among others.
• SIFI's AKANTIOR is the only approved treatment for Acanthamoeba keratitis, filling a critical gap in care. Its approval underscores the urgent need for awareness and research in this challenging infection.
• The absence of emerging drugs in the pipeline for Acanthamoeba keratitis presents a critical gap in treatment options, limiting effective management of this rare but severe condition and underscoring the need for innovative therapeutic development.
• Pharmaceutical companies have been hesitant to develop treatments for Acanthamoeba keratitis due to its rarity and limited market potential. The resilient cystic form of the amoeba further complicates drug development, resulting in minimal incentives for investment in effective therapies.

DelveInsight's comprehensive report titled "Acanthamoeba Keratitis - Market Insights, Epidemiology, and Market Forecast - 2034" offers a detailed analysis of Acanthamoeba keratitis. The report presents historical and projected epidemiological data covering total number of contact lens users, total incident cases of Acanthamoeba keratitis, genotype-specific cases of Acanthamoeba keratitis, and total treated cases of Acanthamoeba keratitis. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.

The report analyzes the existing treatment practices and unmet medical requirements in Acanthamoeba keratitis. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.

Acanthamoeba Keratitis Overview

Acanthamoeba keratitis is a rare but serious corneal infection primarily affecting contact lens wearers, though it can also occur in individuals who experience corneal trauma without lens use. This infection is caused by the Acanthamoeba genus, a ubiquitous unicellular protozoan parasite found in diverse environments, including soil, water, and air. Acanthamoeba keratitis poses a significant threat to vision, as it can lead to severe corneal ulceration, loss of visual acuity, and potentially blindness if not diagnosed and treated promptly.

The disease is associated with various genotypes of Acanthamoeba, with genotype T4 being the most commonly implicated. Symptoms of Acanthamoeba keratitis typically include redness and inflammation of the eye, photophobia (sensitivity to light), blurred vision, and ocular pain. These symptoms can progress rapidly, emphasizing the need for early detection and intervention to prevent complications. As awareness of Acanthamoeba keratitis grows, understanding its risk factors, clinical presentation, and management strategies remains crucial for preserving visual health in at-risk populations.

Acanthamoeba Keratitis Diagnosis and Treatment Algorithm

Acanthamoeba keratitis presents significant diagnostic challenges, often being misdiagnosed due to its clinical resemblance to other keratitis forms, such as herpetic and bacterial keratitis. Early and accurate diagnosis is imperative for effective management, utilizing several diagnostic modalities. Corneal scrape or biopsy can provide direct evidence of the organism, while polymerase chain reaction (PCR) techniques enhance sensitivity and specificity in identifying Acanthamoeba DNA. Impression cytology and in vivo confocal microscopy serve as valuable adjuncts, allowing for real-time visualization of the corneal epithelium and detection of the parasite.

The treatment landscape for Acanthamoeba keratitis primarily revolves around the use of topical anti-amoebic agents, which are often employed in combination to enhance efficacy against both the trophozoite and cyst forms of the pathogen. The standard treatment regimen necessitates aggressive topical therapy, typically involving medications such as chlorhexidine and voriconazole, tailored to the severity of the infection. In advanced cases, where corneal damage is extensive, corneal transplantation may become necessary to restore vision. Thus, preventing Acanthamoeba keratitis through avoidance of risk factors, coupled with prompt diagnosis and treatment, remains pivotal in mitigating the impact of this sight-threatening infection.

SIFI's AKANTIOR (polihexanide) emerges as the only approved therapy specifically for Acanthamoeba keratitis, addressing a critical unmet need in the treatment of this rare condition. Its approval not only positions SIFI as a leader in the market but also sets a potential new standard of care, paving the way for further global expansion and the introduction of additional therapeutic options.

Acanthamoeba Keratitis Epidemiology

The epidemiology section of the Acanthamoeba keratitis market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the data with relevant tables and graphs, offering a clear and concise view of the incidence of Acanthamoeba keratitis. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

Key Findings

According to the United States Centers for Disease Control and Prevention (CDC), it was estimated that around 85% of Acanthamoeba keratitis cases occur in contact lens users in the US.

In the US, 95% of the patients were contact lens wearers, of whom 74% wore soft contact lenses. The number of cases increased from 2009 to 2015. This resulted in an estimated incidence of one in 21,000 for soft contact lens wearers in 2015.

The incidence of Acanthamoeba keratitis was found to be approximately 1-2 new cases per million contact lens wearers annually in the US; approximately 17% of the US adult population wears contact lenses.

In a systemic review, it was found that the ratio of eyes with Acanthamoeba keratitis in relationship to the entire population in Italy, was estimated at 2.34 eyes per million people.

A prospective survey conducted in the UK reported an overall incidence of 2.35 cases per million. Contact lens wearers accounted for 87%, in whom the Acanthamoeba keratitis incidence was 26.94 per million.

It was found that in Europe, the UK has the highest incidence of Acanthamoeba keratitis, and its growth is associated with the increase in the use of contact lenses since the 1990's. Thus, Acanthamoeba keratitis remains a significant concern for contact lens wearers accounting for approximately 87% incidence.

According to various studies which estimated the genotype of Acanthamoeba species in Acanthamoeba keratitis, the isolates were predominantly genotype T4 with nearly 80%, while the genotype T3 accounted for nearly 13%.

Acanthamoeba Keratitis Market Outlook

The treatment of Acanthamoeba keratitis is challenging due to the cyst form's resilience, requiring a multifaceted approach. Current regimens typically include topical cationic antiseptics, such as polyhexamethylene biguanide (0.02%) or chlorhexidine (0.02%), often combined with diamidines like propamidine (0.1%) or hexamidine (0.1%). Treatment duration ranges from six months to a year, with pain management through topical cycloplegic solutions and oral non-steroidal medications.

Evolving treatment strategies have shown success with various combinations of antibiotics, antivirals, antifungals, and antiparasitic drugs, although many topical therapies are not available in the US. Therapeutic regimens may include diamidines, biguanides, and antibiotics like neomycin-polymyxin B-gramicidin, which eliminate bacteria serving as a food source for Acanthamoeba. Antifungals such as voriconazole and miconazole may also be used.

Close monitoring is essential, often requiring daily follow-ups until clinical improvement is observed. Given the potential for recurrence and the cysts' resistance to treatment, tapering therapy should be gradual. The use of corticosteroids is controversial due to the risk of impairing the immune response. Surgical interventions, including penetrating keratoplasty, may be necessary for corneal perforation or significant scarring, but if active infection persists, medical therapy must resume. No single chemotherapeutic agent has proven universally effective against Acanthamoeba keratitis, reflecting the diverse virulence traits of Acanthamoeba isolates.

With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the Acanthamoeba Keratitis market in the 7MM is expected to change significantly during the study period 2020-2034.

Acanthamoeba Keratitis Drug Chapters

Marketed Acanthamoeba Keratitis Drugs

AKANTIOR (polihexanide): SIFI SpA/Avanzanite Bioscience

AKANTIOR (polihexanide) is the first and only approved treatment for Acanthamoeba keratitis, targeting both the trophozoites and cysts of the Acanthamoeba protozoan. Formulated as 0.08% eye drops, it is available as a monotherapy in single-dose containers. This represents a significant advancement over current treatments, which rely on various unlicensed and non-standardized alternatives, often requiring combination therapy. AKANTIOR has received Orphan Drug Designation from both the European Medicines Agency (EMA) and the US FDA. Recently, the European Commission approved AKANTIOR for the treatment of Acanthamoeba keratitis in Europe. SIFI has partnered with Avanzanite Bioscience to exclusively commercialize and distribute AKANTIOR in 26 countries across the European Economic Area.

In August 2024, the European Commission approved AKANTIOR for the treatment of Acanthamoeba keratitis.

In September 2024, SIFI received a Notice of Allowance from the European Patent Office (EPO). Another patent, already granted in Italy and EurAsian countries, provides intellectual property protection until 2040.

Acanthamoeba Keratitis Market Segmentation

DelveInsight's 'Acanthamoeba Keratitis - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a detailed outlook of the current and future Acanthamoeba keratitis market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.

Acanthamoeba Keratitis Market Size by Countries

The Acanthamoeba keratitis market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan. In 2023, the United States held a significant share of the overall 7MM (Seven Major Markets) Acanthamoeba keratitis market, primarily attributed to the country's higher incidence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.

Acanthamoeba keratitis Market Size by Therapies

Acanthamoeba keratitis Market Size by Therapies is categorized into current and emerging markets for the study period 2020-2034.

Acanthamoeba Keratitis Drugs Uptake

This section focuses on the sales uptake of potential Acanthamoeba keratitis drugs that have recently been launched or are anticipated to be launched in the Acanthamoeba keratitis market between 2020 and 2034. It estimates the market penetration of Acanthamoeba keratitis drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the Acanthamoeba keratitis market.

The emerging Acanthamoeba keratitis therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the Acanthamoeba keratitis market.

Acanthamoeba Keratitis Market Access and Reimbursement

DelveInsight's 'Acanthamoeba Keratitis - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of Acanthamoeba keratitis.

This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.

KOL Views

To keep up with current Acanthamoeba keratitis market trends and fill gaps in secondary findings, we interview KOLs and SMEs' working in the Acanthamoeba keratitis domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or Acanthamoeba keratitis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the Acanthamoeba keratitis unmet needs.

Acanthamoeba keratitis: KOL Insights

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as Northwestern University Feinberg School of Medicine in the US, Universita di Roma "Tor Vergata," Rome, Italy, University of Catania in Italy, and Moorfields Eye Hospital NHS Foundation Trust, London, United Kingdom, among others.

"Many contact lens wearers do not follow proper lens care guidelines, such as using tap water to clean lenses or cases, which can introduce Acanthamoeba. However, as the number of contact lens users grows, the pool of individuals at risk for Acanthamoeba keratitis also expands."

"Photodynamic therapy and corneal cross-linking are emerging as alternative treatment options for therapy-resistant Acanthamoeba keratitis cases. However, their effectiveness requires further investigation."

"The diagnostic criteria for Acanthamoeba keratitis, include persistent deficits in social interaction, communication, and restricted, repetitive patterns of behavior. The onset of Acanthamoeba keratitis typically occurs in early childhood, with symptoms becoming more evident as social demands increase. There is a need for a comprehensive evaluation by qualified professionals, such as developmental pediatric psychologists, child neurologists, and child and adolescent psychiatrists, to accurately diagnose Acanthamoeba keratitis and rule out other disorders."

Competitive Intelligence Analysis

We conduct a Competitive and Market Intelligence analysis of the Acanthamoeba keratitis Market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

Acanthamoeba keratitis Pipeline Development Activities

The report offers an analysis of therapeutic candidates in Phase II and III stages and examines companies involved in developing targeted therapeutics for Acanthamoeba keratitis. It provides valuable insights into the advancements and progress of potential treatments in clinical development for this condition.

Pipeline Development Activities

The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging Acanthamoeba keratitis therapies.

Acanthamoeba Keratitis Report Insights

• Acanthamoeba Keratitis Patient Population
• Therapeutic Approaches
• Acanthamoeba Keratitis Pipeline Analysis
• Acanthamoeba Keratitis Market Size and Trends
• Acanthamoeba Keratitis Market Opportunities
• Impact of Upcoming Therapies

Acanthamoeba Keratitis Report Key Strengths

• 11 Years Forecast
• The 7MM Coverage
• Acanthamoeba Keratitis Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Acanthamoeba Keratitis Market
• Acanthamoeba Keratitis Drugs Uptake

Acanthamoeba Keratitis Report Assessment

• Acanthamoeba Keratitis Current Treatment Practices
• Unmet Needs
• Acanthamoeba Keratitis Pipeline Product Profiles
• Acanthamoeba Keratitis Market Attractiveness

Key Questions:

• How common is Acanthamoeba keratitis?
• What are the key findings of Acanthamoeba keratitis epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020-2034)?
• What are the currently available treatments for Acanthamoeba keratitis?
• What are the disease risk, burden, and unmet needs of Acanthamoeba keratitis?
• At what CAGR is the Acanthamoeba keratitis market and its epidemiology is expected to grow in the 7MM during the forecast period (2024-2034)?
• How would the unmet needs impact the Acanthamoeba keratitis market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of Acanthamoeba keratitis in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the UK, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2024-2034)?
• How many companies are currently developing therapies for the treatment of Acanthamoeba keratitis?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Acanthamoeba keratitis Market.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years
• To understand the existing market opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of current treatment in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions:

1. What are the treatment goals for Acanthamoeba keratitis?

The treatment goals for Acanthamoeba keratitis are to eliminate the infection, manage inflammation, prevent corneal damage, alleviate pain, restore vision, and minimize recurrence through sustained medical therapy and close monitoring.

2. What are the challenges in managing Acanthamoeba keratitis?

Managing Acanthamoeba keratitis is challenging due to the pathogen's cyst resilience, delayed diagnosis, treatment resistance, prolonged therapy duration, recurrence risk, and the limited availability of effective therapeutic agents.

3. What are the key factors driving the growth of the Acanthamoeba keratitis market?

Key factors driving the Acanthamoeba keratitis market growth include rising contact lens use, improved diagnostic techniques, increased awareness, advancements in therapeutics, and the development of targeted treatments like AKANTIOR.

4. How will the Acanthamoeba keratitis Market and Epidemiology Forecast Report benefit the clients?

The report will provide comprehensive insights into the current Acanthamoeba keratitis market landscape, emerging therapies, competitive dynamics, regulatory requirements, and market access considerations, enabling informed decision-making, strategic planning, and optimization of business strategies to capitalize on market opportunities and drive growth.