Neurotrophic Keratitis Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• In 2023, the market size of Neurotrophic keratitis was highest in the US among the 7MM, accounting for approximately USD 743 million which is further expected to increase by 2034.
• In 2023, the prevalence of Neurotrophic keratitis was highest in the US among the 7MM, accounting for nearly 66 thousand cases which is further expected to increase by 2034.
• In the United States, in 2023, ~13 thousand males and ~19 thousand females were affected with Neurotrophic Keratopathy.
• The current market of neurotrophic keratopathy includes OXERVATE, lubricants, anti-inflammatory agents, antibiotics, and antiproteases, from artificial tears to serum/plasma droplets, all provide nonspecific relief that may be temporary, making up a market size of USD 763 million in the 7MM in 2023. The market size is expected to increase with the projected launch of emerging therapies during the forecast period (2024-2034).
• The market size of Neurotrophic Keratopathy in Japan was USD 1 million in 2023, which is expected to rise at a significant CAGR by 2034.

This 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) and 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.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Disease Understanding and Treatment Algorithm

Neurotrophic keratitis Overview

Neurotrophic keratitis, which is also known as Neurotrophic Keratopathy 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 the assessment, the estimated total diagnosed prevalent cases of Neurotrophic keratitis in the 7MM were nearly 65 thousand in 2023.
• The highest total diagnosed prevalent cases of Neurotrophic keratitis were accounted by the US in 2023 (33 thousand), which are expected to show a rise in the future.
• Among the European countries, the United Kingdom had the highest diagnosed prevalent cases of neurotrophic keratitis with ~8 thousand cases, followed by Germany, which had diagnosed prevalent population of ~6 thousand in 2023. On the other hand, Spain had the lowest prevalent population (3 thousand cases).
• Japan had nearly 5 thousand total diagnosed prevalent cases of Neurotrophic keratitis in 2023, accounting for approximately 8% in 7MM.
• Based on stage-specific segmentation, the people in Stage 3 were affected the most by Neurotrophic Keratitis in the US, accounting for approximately 14 thousand cases in 2023.
• The analysis indicates that among the EU4 and the UK, females were more affected than males, with approximately 16 thousand female cases and 11 thousand male cases in 2023.

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/rhNGF): Dompé Farmaceutici

OXERVATE is the first FDA-approved treatment for people with neurotrophic keratitis. The main ingredient of OXERVATE is cenegermin, a recombinant form of human nerve growth factor. OXERVATE is structurally identical to NGF which is naturally produced by human eyes. This recombinant form of human nerve growth factor 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 osmolarity of 280-320 mOsm/kg for topical ophthalmic use.

Emerging Drugs

RGN-259 (Timbetasin): ReGenTree/RegeneRx Biopharmaceuticals, Inc.

RGN-259 ophthalmic solution is formulated as thymosin beta 4 preservative-free eye drops for the treatment of both dry eye syndrome and Neurotrophic Keratitis. Tß4 is a synthetic copy of the naturally occurring 43-amino acid peptide that is found in all tissues and in all nucleated cells. In the eye, Tß4 promotes corneal epithelial cell migration, decreases both inflammation and apoptosis and accelerates both repair and regeneration.

REC 0559 (MT-8/Udonitrectag/REC 0/0559): Recordati Rare Diseases/MimeTech

REC 0559 is a low molecular weight, non-peptidic human NGF. The key component of REC 0559 is Udonitrectag, which mimics NGF to enhance their stability. Currently, this drug is undergoing global development by Recordati and has been licensed to MimeTech, an Italy-based company specializing in pharmaceutical applications for synthetic neurotrophin mimetics.

REC 0559 is formulated as eye drops designed to aid patients with neurotrophic keratitis. When administered, the medication is expected to help restore normal growth processes in the eye and mitigate damage to the cornea caused by the condition.

BRM424: BRIM Biotechnology Inc.

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.

It is currently being evaluated in Phase II clinical trials for treating Neurotrophic Keratitis.

Neurotrophic keratitis Market Outlook

Managing Neurotrophic Keratitis requires a multifaceted approach, primarily addressing the root cause and stabilizing the eye’s surface. Treatments vary by severity, from lubricants and anti-inflammatory agents to advanced interventions like eyelid closure, punctal plugs, and surgical procedures. Although effective, these can impair vision. Emerging biological treatments, including biopolymers, Coenzyme Q10, antisense oligonucleotides, and cenegermin, show promise in targeting neuropathology.

Stage I focuses on preventing epithelial deterioration using preservative-free lubricants and addressing related ocular surface disorders. Stage II aims to heal epithelial defects and prevent corneal ulcers, utilizing antibiotics and therapeutic contact lenses while cautiously using steroids. Stage III involves advanced surgical treatments for severe corneal damage and interstitial melts, employing collagenase inhibitors.

The Neurotrophic Keratitis market is poised for transformation with the anticipated introduction of therapies like RGN-259, OC-01, REC-0559, CSB-001, and BRM424. The approval of these therapies could significantly impact market dynamics, although their success rates remain uncertain.

• The market size of Neurotrophic keratitis in the 7MM was ~USD 763 million in 2023, which is further anticipated to increase during the forecast period.
• The United States accounted for the highest market size of Neurotrophic keratitis approximately 97% of the total market size in 7MM in 2023, in comparison to the other major markets i.e., EU4 countries (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.
• Among the EU countries, France and Italy had the highest market size with nearly USD 5 million each in 2023, while Germany had the lowest market size for Neurotrophic keratitis with USD ~2 million in 2023.
• The market size for Neurotrophic keratitis in Japan was estimated to be about USD 1 million in 2023.
• With the expected launch of upcoming therapies, such as RGN-259, OC-01, REC-0559, CSB-001, and 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 launch in the market during 2020-2034. For example, RGN-259 in the US is expected to be launched by 2025 with a peak share of 40%. RGN-259 is anticipated to take 7 years to peak with a medium-fast uptake.

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.

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 the secondary research. Industry Experts were 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 KOL from Massachusetts Eye and Ear, Harvard Medical School, Boston, Massachusetts, US; Ospedale San Raffaele di Milano-IRCCS, Milan, Italy; Heinrich-Heine University Duesseldorf, Germany; Hôpital Bichat-Claude-Bernard, Paris, France; Department of Radiation Oncology, IRCCS San Matteo Polyclinic Foundation, Pavia, Italy; Nottingham University Hospitals, NHS Trust, Nottingham, England, UK and Yamaguchi University Graduate School of Medicine, Ube City, Yamaguchi, Japan; and others.

The analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, 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.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms 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.

Conjoint Analysis analyzes multiple approved and 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 acceptability, tolerability, and adverse events are majorly observed, and 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

The high cost of therapies for the treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, 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

• 11 years Forecast
• The 7MM Coverage
• Neurotrophic keratitis Epidemiology Segmentation
• Key Cross Competition
• Conjoint 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 Conjoint Analysis)

Key Questions

Market Insights

• What was the Neurotrophic keratitis market share (%) distribution in 2020 and how it would look like in 2034?
• What would be the Neurotrophic keratitis total market size as well as market size by therapies across the 7MM during the forecast period (2024-2034)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Neurotrophic keratitis market size during the forecast period (2024-2034)?
• At what CAGR, the Neurotrophic keratitis market is expected to grow at the 7MM level during the forecast period (2024-2034)?
• What would be the Neurotrophic keratitis market outlook across the 7MM during the forecast period (2024-2034)?
• What would be the Neurotrophic keratitis market growth till 2034 and what will be the resultant market size in the year 2034?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What is the disease risk, burden, and unmet needs of Neurotrophic keratitis?
• What is the historical Neurotrophic keratitis patient population in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
• What would be the forecasted patient population of Neurotrophic keratitis at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Neurotrophic keratitis?
• Out of the above-mentioned countries, which country would have the highest prevalent population of Neurotrophic keratitis during the forecast period (2024-2034)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2024-2034)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of Neurotrophic keratitis along with the approved therapy?
• What are the current treatment guidelines for the treatment of Neurotrophic keratitis in the US, Europe, And Japan?
• What are the Neurotrophic keratitis marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of Neurotrophic keratitis?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Neurotrophic keratitis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Neurotrophic keratitis therapies?
• What are the recent therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Neurotrophic keratitis and their status?
• What are the key designations that have been granted for the emerging therapies for Neurotrophic keratitis?
• What are the 7MM historical and forecasted market of Neurotrophic keratitis?

Reasons to Buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Neurotrophic 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 approved products 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 potential of current and emerging therapies under the conjoint analysis section to provide visibility around leading emerging drugs.
• 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 future.
• Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions

1. What is the forecast period covered in the report?

The Neurotrophic Keratitis Epidemiology and Market Insight report for the 7MM covers the forecast period from 2024 to 2034, providing a projection of market dynamics and trends during this timeframe.

2. Who are the key players in the Neurotrophic keratitis market?

The Neurotrophic keratitis market is quite robust. The major layers are ReGenTree/RegeneRx Biopharmaceuticals, Inc., Viatris, Recordati Rare Diseases/MimeTech, and others which are currently developing drugs for the treatment of Neurotrophic Keratitis.

3. How is the market size estimated in the forecast report?

The market size is estimated through data analysis, statistical modeling, and expert opinions. It may consider factors such as incident cases, treatment costs, revenue generated, and market trends.

4. What is the key driver of the Neurotrophic keratitis market?

The increase in diagnosed prevalent cases of Neurotrophic keratitis and the launch of emerging therapies are attributed to be the key drivers for increasing the Neurotrophic Keratitis market.

5. What is the expected impact of emerging therapies or advancements in Neurotrophic keratitis treatment on the market?

Introducing new therapies, advancements in diagnostic techniques, and innovations in treatment approaches can significantly impact the Neurotrophic keratitis treatment market. Market forecast reports may provide analysis and predictions regarding the potential impact of these developments.

6. Does the report provide insights into the competitive landscape of the market?

The market forecast report may include information on the competitive landscape, profiling key market players, their product offerings, partnerships, and strategies, and helping stakeholders understand the competitive dynamics of the Neurotrophic keratitis market.