Neurotrophic Keratitis (NK) | Primary Research (KOL's Insight) | Market Intelligence | Epidemiology & Market Forecast-2034

The Neurotrophic Keratitis (NK) market is hugely contributed by the first and only approved therapy Oxervate/cenegermin and supportive treatments like preservative-free artificial tears, ointments and more. By 2034, the uptake of novel emerging therapies will serve as a major breakpoint to get a drastic change in the Neurotrophic Keratitis (NK) therapeutics market. The sales of the emerging therapies for the treatment Neurotrophic Keratitis (NK) in the study countries (United States, France, Germany, Italy, Spain, United Kingdom, and Japan) will experience high growth over the 2020-2034 study period, with 11% CAGR.

"One of the major obstacles in treating neurotrophic keratitis is once there is damage to the corneal nerves, there is impairment of those vital functions, which creates a significant disruption to the ocular surface. Most of these treatments are supportive and only stabilize the surface."

Neurotrophic keratitis, also known as neurotrophic keratopathy, is a degenerative disease characterized by decreased corneal sensitivity and poor corneal healing. This disorder leaves the cornea susceptible to injury and decreases reflex tearing. Epithelial breakdown can lead to ulceration, infection, melting, and perforation secondary to poor healing.

Patients with neurotrophic keratitis have damage to the trigeminal nerve. This results in reduced or lack of sensation in the cornea, and reduced production of the substances that play a vital role in repairing damage and ensuring survival of cornea cells.

Neurotrophic keratitis (NK) can be challenging to diagnose, but it is crucial to identify it early to prevent disease progression. The primary goals of treatment for NK are to preserve epithelial integrity, promote epithelial healing, and prevent the progression of corneal damage. Early diagnosis, severity-based treatment, and frequent monitoring are crucial for achieving these goals. The treatment of NK is often sequential in nature, starting with less invasive pharmacological options such as lubricant eye drops for eye lubrication, topical antibiotics to prevent super-infections, and eye drops or gels to promote healing and preserve epithelial integrity. In refractory cases or those with advanced disease at diagnosis, more invasive, non-pharmacological treatment alternatives may be required. These can include therapeutic contact lenses, amniotic membrane transplantation (AMT), tarsorrhaphy (permanent or temporary), or conjunctival flap.

Mellalta's Neurotrophic Keratitis (NK) Report- Market Summary

Market Size 2034: $2.4 billion

CAGR%: 11%

Key Market Players: RegeneRx Biopharmaceuticals/ReGenTree/HLB Therapeutics; BRIM Biotechnology; Recordati; Claris Biotherapeutics; Neuroptika

Forecast Period: 2020-2034

Countries Covered: US, France, Germany, Italy, Spain, UK, China, and Japan.

Current SOC: Nerve Growth Factor; Preservative free antibiotics; Artificial eye drops; Ointments; Surgical Interventions

Future SOC: NGF; HGF; Regenerative therapies

Key Unmet Need: Lack of restorative treatments for neurotrophic keratitis and early diagnosis; Variability in Clinical Practice

Key Insights: Approval of Cenegermin /Oxervate (Dompe) changed the treatment landscape by targeting underlying pathology with upto 72% patient achieving complete corneal healing at 8 weeks.

Provider-Patient (PPP) Perspective: Cost-effectiveness of treatment; Better Diagnostic Identification; Access to appropriate treatments and improved options

Mellalta's Neurotrophic Keratitis (NK) Report - Epidemiology

The total prevalent cases of Neurotrophic Keratitis (NK) in the G7 countries are anticipated to increase by a significant number of cases by 2034 for the study period (2020-2034). As per estimates, the United States will present with the highest prevalence of Neurotrophic Keratitis (NK) cases in 2034. Among the EU5, Germany had the highest Neurotrophic Keratitis (NK) cases, followed by France, Italy, Spain, and UK. Japan is reported to have the highest number of treated cases after the United States, Germany, France, and Italy.

Mellalta's Neurotrophic Keratitis (NK) Report - Current Market Size & Forecast Trends

The Neurotrophic Keratitis (NK) therapeutics market is expected to experience high growth throughout our study period (i.e., 2020 to 2034) with a CAGR of 11%. The United States captured the highest market share as compared to the European 5 countries and Japan.

The current standard of care is limited to therapies such as Artificial Tears, Autologous Serum Drops (SED), Corneal Neurotization/PK, and Amniotic Membrane Transplantation (AMT). Initial interventions advocate the cessation of corneal-sensitivity-reducing therapies, favoring instead preservative-free artificial tears and lubricant ointments. While the efficacy of topical corticosteroids in NK is debated due to potential adverse effects, emerging heparin sulfate biomimetic matrix regenerating agents offer promising prospects, demonstrating remarkable corneal healing and antiviral properties. The focus shifts to averting corneal ulcer development and promoting epithelial repair in NK Stage 2 and reduce corneal stromal scarring and prevent possible perforations in NK Stage 3.

Cenegermin, containing recombinant human nerve growth factor (rhNGF), marks a breakthrough, becoming the first FDA-approved drug for NK treatment in 2018. Clinical trials reveal its efficacy in promoting corneal healing, with patients exhibiting significant improvement compared to vehicle-treated counterparts. Moreover, its favorable safety profile underscores its potential as a cornerstone therapy. Apart from promoting corneal epithelial wound healing, cenegermin 20 µg/ml shows significant improvement in corneal sensitivity and in visual acuity with minor side effects. Moreover, findings suggest that cenegermin 20 µg/ml is also effective in pediatric patients.

In the 2024-2034 forecast period, there will be tremendous growth and shift in therapeutic market with the launch of novel emerging therapies like Timbetasin/RGN-259 (RegeneRx Biopharmaceuticals/ReGenTree/HLB Therapeutics), BRM424 (BRIM Biotechnology), REC 0/0559 (Recordati), CSB-001 (Claris Biotherapeutics), and NRO-1 (Neuroptika). The emerging therapies will likely compete with and replace existing treatments, reflecting a dynamic shift towards more advanced therapeutic options in the Neurotrophic Keratitis space and more.

Questions Answered

What is the size of clinically and commercially relevant drug-treatable Neurotrophic Keratitis (NK) populations, and how will drug-treatment rates change over time?

Potential challenges and opportunities in implementing approved therapy for Neurotrophic Keratitis (NK).

What are the most promising agents in the pipeline, and how will they shape the future of this therapy market?

What key drivers and constraints will affect the Neurotrophic Keratitis (NK) therapy market over the forecast period?

Report Highlights

Neurotrophic Keratitis (NK) - Current Market Trends

Neurotrophic Keratitis (NK) - Current & Forecasted Cases across the G7 Countries

Neurotrophic Keratitis (NK) - Market Opportunities and Sales Potential for Agents

Neurotrophic Keratitis (NK) - Patient-based Market Forecast to 2034

Neurotrophic Keratitis (NK) - Untapped Business Opportunities

Neurotrophic Keratitis (NK) - Product Positioning Vis-a-vis Competitors' Products

Neurotrophic Keratitis (NK) - KOLs Insight