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

Key Highlights:

• DelveInsight research indicates that in 2024, there were approximately 140,000 prevalent cases of neurotrophic keratitis across the 7MM, which are expected to increase by 2034.
• In 2024, the prevalence of neurotrophic keratitis was highest in the US among the 7MM, accounting for nearly 67,000 cases which is further expected to increase by 2034.
• In Germany, prevalent cases of neurotrophic keratitis in 2024 were notably higher among females, at approximately 3,650 compared to approximately 2,400 among males. This gender disparity highlights a greater disease burden in females, with overall numbers expected to increase further by 2034.
• Several companies, including Dompe Farmaceutici and BRIM Biotechnology, are advancing novel therapeutic candidates for neurotrophic keratitis, reflecting a growing industry focus on developing targeted interventions to address the condition's underlying pathology and improve patient outcomes.
• The market size of neurotrophic keratitis in the US was nearly USD 850 million in 2024, which is expected to rise at a significant Compound Annual Growth Rate (CAGR) by 2034.

DelveInsight's "Neurotrophic keratitis - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of the neurotrophic keratitis, historical and forecasted epidemiology as well as the neurotrophic keratitis market trends in the United States, EU4 and the UK (Germany, France, Italy, Spain), the United Kingdom, and Japan.

The neurotrophic keratitis market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM neurotrophic keratitis market size from 2020 to 2034. The Report also covers current neurotrophic keratitis treatment practice, market drivers, market barriers, SWOT analysis, reimbursement and market access, and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Disease Understanding and Treatment Algorithm

Neurotrophic Keratitis Overview

Neurotrophic keratopathy, which is also known as neurotrophic keratitis or trigeminal neuropathic keratopathy, is a rare degenerative corneal disease characterized by symptoms like lack of or decreased corneal sensation, corneal epithelial breakdown and impaired healing that results in increased susceptibility of the corneal surface to injury and compromised healing. In severe cases, this can also lead to stromal melting, corneal ulceration, and even perforation.

Neurotrophic keratitis Diagnosis

Neurotrophic keratitis is diagnosed by careful investigation of any of the ocular and systemic conditions associated with the disease, along with quantitatively measuring the cornea's sensitivity. Neurotrophic keratitis has three different stages/severity levels: Stage I, II, and III. Timely diagnosis is very important for early-stage detection.

Neurotrophic keratitis Treatment

Treatment of neurotrophic keratitis is mainly targeted toward the apparent specific symptoms in the respective patients. Topical eye medications are advised to stop immediately. OXERVATE is the first medication that is approved by the US FDA for the treatment of neurotrophic keratitis patients. For the patients who have worsening neurotrophic keratitis, a surgical approach is adopted for the treatment. During the treatment process, amniotic membrane placement may be considered for patients with corneal ulcerations that are not healing over time or for patients with severely affected cornea.

For treating neurotrophic keratitis patients, it is important to prevent the progression of corneal damage. This can be achieved through early diagnosis, severity-based treatment, and continuous and careful monitoring of the patient's condition. Ocular surface conditions are important to timely monitor and treat on time. Other than pharmacological treatment options, therapeutic corneal or scleral contact lenses are also used to treat neurotrophic keratitis.

Neurotrophic Keratitis Epidemiology

As the market is derived using a patient-based model, the neurotrophic keratitis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by, total prevalent cases of neurotrophic keratitis, total diagnosed prevalent cases of neurotrophic keratitis, gender-specific diagnosed prevalent cases of neurotrophic keratitis, and severity-specific diagnosed prevalent cases of neurotrophic keratitis in the 7MM covering, the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034.

• In 2024, an estimated 60,300 people in EU4 and the UK had prevalent cases of neurotrophic keratitis, highlighting not only a significant regional disease burden but also the growing need for earlier diagnosis, improved treatment options, and targeted strategies to prevent long-term corneal damage.
• Among the EU4 and the UK, the UK had the highest diagnosed prevalent cases of neurotrophic keratitis with approximately 8,500 cases, followed by Germany, with approximately 6,000 cases in 2024. On the other hand, Spain had the lowest population with approximately 3,400 cases.
• In the US in 2024, diagnosed prevalent cases of neurotrophic keratitis showed a marked sex disparity, with females accounting for approximately 20,000 cases, significantly higher than the approximately 13,500 cases reported in males, highlighting a pronounced gender-related disease burden.
• In Japan, prevalent cases of neurotrophic keratitis were approximately 12,350 in 2024, with numbers expected to rise further by 2034, reflecting a growing disease burden.
• In 2024, in Japan, prevalent cases of neurotrophic keratitis were predominantly Stage 3 (corneal ulcers), with approximately 2,500 cases, compared to nearly 1,950 cases in Stage 2 (persistent epithelial defects) and 1,110 cases in Stage 1 (epithelial alterations). This distribution highlights the greater burden of advanced disease and underscores the need for timely intervention to prevent progression.

Neurotrophic Keratitis Drug Chapters

The drug chapter segment of the neurotrophic keratitis report encloses a detailed analysis of neurotrophic keratitis off-label drugs and late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the neurotrophic keratitis clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed Drugs

OXERVATE (Cenegermin-bkbj): Dompe Farmaceutici

OXERVATE is the first FDA-approved treatment for people with neurotrophic keratitis. The main ingredient of OXERVATE is cenegermin, a structurally identical recombinant form of human Nerve Growth Factor (NGF). This recombinant form of human NGF is produced in E. coli. Cenegermin-bkbj contains 118 amino acids and has a relative molecular mass of 13,266 Da. OXERVATE (cenegermin-bkbj) is a clear, colorless sterile solution with a pH of 7.0-7.4 and osmolality of 280-320 mOsm/kg for topical ophthalmic use.

• In July 2020, Dompe Farmaceutici partnered with Tanner Pharma Group, making them the exclusive distributor of OXERVATE (cenegermin) in select countries.
• In March 2019, Dompe Farmaceutici announced that the NORD had awarded them the 2019 Industry Innovation Award for OXERVATE.
• In August 2018, the US FDA approved OXERVATE (cenegermin) for the treatment of neurotrophic keratitis, a rare corneal disorder affecting the clear front layer of the eye.
• In May 2017, the EMA granted a positive opinion recommending OXERVATE for marketing authorization to treat moderate to severe neurotrophic keratitis.

Emerging Drugs

BRM424: BRIM Biotechnology

BRM 424 is a regenerative peptide that has neurotrophic properties, and its mechanism of action is based on its ability to stimulate limbal stem cell regeneration. Preclinical studies demonstrate that BRM424 stimulates the proliferation and differentiation of corneal limbal stem cells to effectively regenerate healthy limbus after extensive limbal layer removal and to speed up the cornea repair process. This direct activation of limbal stem cells can lead to fast and effective corneal healing.

• In December 2022, the US FDA granted an Orphan Drug Designation (ODD) for BRM424 in the treatment of neurotrophic keratitis.
• In April 2023, Brim Biotechnology submitted an Investigational New Drug (IND) application for BRM424 for Phase II trial for the treatment of neurotrophic keratitis.
• In September 2023, BRIM Biotechnology raised approximately USD 45.8 million by issuing 22,500 shares at NTD 65 (USD 2.03) each, with full payment received four days early. The funds will advance pipeline development, including the Phase III trial of BRM421 for dry eye disease and Phase II enrollment of BRM424 for neurotrophic keratitis.

Neurotrophic Keratitis Market Outlook

Managing neurotrophic keratitis requires a comprehensive approach focused on treating the underlying cause and maintaining corneal integrity. Therapeutic strategies vary by severity, ranging from lubricants and anti-inflammatory agents to advanced interventions such as eyelid closure, punctal plugs, and surgical procedures, which, while effective, may temporarily affect vision. Emerging biological therapies, including cenegermin, biopolymers, Coenzyme Q10, and antisense oligonucleotides, offer promising potential to directly address corneal neuropathy and improve long-term outcomes.

Stage I focuses on preventing epithelial damage through preservative-free lubricants and managing associated ocular surface disorders. Stage II targets the healing of persistent epithelial defects and the prevention of corneal ulcers, using antibiotics, therapeutic contact lenses, and careful steroid administration. Stage III addresses severe corneal damage and interstitial melts with advanced surgical interventions and, when appropriate, the use of collagenase inhibitors.

The neurotrophic keratitis market is poised for transformation with the anticipated introduction of the emerging therapy BRM424. Its approval could significantly influence market dynamics, although the ultimate success of the therapy remains uncertain.

• The market size of neurotrophic keratitis in the 7MM was ~USD 870 million in 2024, which is further anticipated to increase during the forecast period.
• The United States accounted for the highest market size of neurotrophic keratitis approximately 98% of the total market size in 7MM in 2024, in comparison to the other major markets i.e., EU4 countries (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.
• In 2024, France accounted for the largest share of EU4 and the UK market for neurotrophic keratitis, representing nearly 30%, whereas Germany registered the smallest market share at about 10% during the same period.
• With the expected launch of upcoming therapies, such as BRM424, among others, the total market size of neurotrophic keratitis is expected to show change in the upcoming years.

Neurotrophic keratitis Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during study period 2020-2034.

Neurotrophic Keratitis Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for neurotrophic keratitis emerging therapies.

Neurotrophic Keratitis KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on neurotrophic keratitis evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and others.

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the Harvard Medical School, US; University of Minnesota, US; Heinrich-Heine University Duesseldorf, Germany; Hopital Bichat-Claude-Bernard, France; Ospedale San Raffaele di Milano-IRCCS, Italy; University of Valencia, Spain; Nottingham University Hospitals, UK; Yamaguchi University Graduate School of Medicine, Japan; and Chiba University, Japan; among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or neurotrophic keratitis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

KOLs in the US, "Highlight a critical gap in neurotrophic keratitis care, noting that despite increasing prevalence, timely diagnosis remains challenging due to subtle early symptoms and overlap with other ocular surface disorders. This delay often results in patients progressing to advanced disease stages, increasing the risk of corneal ulcers, vision impairment, and long-term complications."

According to the UK KOLs, "Current treatment options for neurotrophic keratitis remain largely supportive, with limited therapies addressing the underlying corneal nerve damage. This gap emphasizes the urgent need for innovative, disease-modifying interventions that can halt progression, promote corneal healing, and ultimately preserve long-term vision."

According to Japanese KOLs, "The rising burden of neurotrophic keratitis, particularly among aging populations, highlights that existing therapies do not sufficiently address the condition's varied manifestations. They also note that the lack of standardized treatment guidelines further complicates management in routine clinical practice."

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Attribute Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in neurotrophic keratitis of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Attribute Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Neurotrophic keratitis is a complex and potentially sight-threatening condition characterized by corneal nerve damage, leading to impaired healing, persistent epithelial defects, and, in severe cases, corneal ulcers or vision loss. Despite advances in understanding its pathophysiology, effective therapies that directly target the underlying neuropathy remain limited, and emerging regenerative treatments, while promising, often involve substantial costs.

These financial barriers can restrict patient access to sight-preserving interventions, resulting in delayed care and worse long-term outcomes. Implementing a comprehensive reimbursement program is therefore critical, not only to reduce the direct economic burden on patients but also to promote early diagnosis and sustained adherence to therapy. Such programs can help ensure equitable access across diverse patient populations, allowing innovations in treatment to translate into real-world benefits.

Moreover, improving access through reimbursement can reduce broader societal and healthcare system costs associated with vision impairment, disability, and disease progression. In essence, reimbursement initiatives play a pivotal role in bridging the gap between advanced clinical therapies and meaningful improvements in patient quality of life, ultimately supporting better health outcomes and more sustainable healthcare delivery for those affected by neurotrophic keratitis.

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, neurotrophic keratitis making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug neurotrophic keratitis, etc.

Scope of the Report:

• The report covers a segment of key events, an executive summary, descriptive overview of neurotrophic keratitis, explaining its causes, signs and symptoms, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the neurotrophic keratitis market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the approach is included in the report covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM neurotrophic keratitis market.

Neurotrophic Keratitis Report Insights

• Patient Population
• Therapeutic Approaches
• Neurotrophic Keratitis Pipeline Analysis
• Neurotrophic Keratitis Market Size and Trends
• Existing and Future Market Opportunity

Neurotrophic Keratitis Report Key Strengths

• 10 years Forecast
• The 7MM Coverage
• Neurotrophic Keratitis Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Drugs Uptake and Key Market Forecast Assumptions

Neurotrophic Keratitis Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Attribute Analysis)

Key Questions:

Market Insights

• What was the total market size of neurotrophic keratitis, the market size of neurotrophic keratitis by therapies, and market share (%) distribution in 2024, and what would it look like by 2034? What are the contributing factors for this growth?
• How will OXERVATE affect the treatment paradigm of neurotrophic keratitis?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and marketed therapies?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of neurotrophic keratitis? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to neurotrophic keratitis?
• What is the historical and forecasted neurotrophic keratitis patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Out of the countries mentioned above, which country would have the highest prevalence cases of neurotrophic keratitis population during the forecast period (2025-2034)?
• What factors are contributing to the growth of neurotrophic keratitis cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of neurotrophic keratitis? What are the current clinical and treatment guidelines for treating neurotrophic keratitis?
• How many companies are developing therapies for the treatment of neurotrophic keratitis?
• How many emerging therapies are in the mid-stage and late stage of development for treating neurotrophic keratitis?
• What are the recent novel therapies, targets, neurotrophic keratitis of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in neurotrophic keratitis of preferred treatment options as per real-world scenarios?
• What is the 7MM historical and forecasted market of neurotrophic keratitis?

Reasons to Buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the neurotrophic keratitis market.
• Insights on patient burden/prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• The distribution of historical and current patient share is based on real-world prescription data in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying upcoming solid players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis, ranking of class-wise potential current, and emerging therapies under the attribute analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies for neurotrophic keratitis, barriers to accessibility of approved therapy, and patient assistance neurotrophic keratitis.
• To understand key opinion leaders' perspectives 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.