Neurotrophic Keratopathy Market

DelveInsight’s ‘Neurotrophic Keratopathy (NK)—Market Insights, Epidemiology, and Market Forecast–2030’ report deliver an in-depth understanding of the NK, historical and forecasted epidemiology as well as the NK market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

 

The NK market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM NK market size from 2018 to 2030. The Report also covers current NK treatment practice, market drivers, market barriers, SWOT analysis, reimbursement, and market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2018–2030

Neurotrophic Keratopathy (NK) Disease Understanding and Treatment Algorithm

Neurotrophic Keratopathy (NK) Overview

The eye in humans is one of the vital sensory organs that help in seeing around. The cornea is one of the exposed parts of the human eye that can be affected by different ophthalmic conditions if not taken proper care of it.

 

One such ophthalmic disorder affecting the cornea is Neurotrophic Keratopathy (NK), also called neurotrophic keratitis. It is a rare, degenerative ophthalmic disorder characterized by a reduction or absence of corneal sensitivity.

 

Corneal sensitivity is controlled by the trigeminal nerve (fifth cranial nerve). Corneal nerves also provide trophic (nutritive) support and play a key role in maintaining anatomical integrity and function of the cornea, particularly of epithelium. The cornea is one of the most richly innervated parts of the body. Corneal innervation provides sensations and is important in the maintenance of the structure and function of the cornea. Normal innervation helps regulate epithelial integrity, proliferation, and wound healing of the cornea.

 

Damage to trigeminal innervation is seen as the primary cause behind NK. It can be considered as the hallmark of the condition. Corneal nerves play an essential role in tear production and preservation of the normal metabolism and function of the ocular surface. Loss of sensitivity impairs corneal wound healing, leading to epithelial changes, including punctate epithelial keratopathy, persistent epithelial defects (PEDs), and corneal ulcer. A wide range of ocular and systemic conditions, including herpetic keratitis, ocular chemical burns, corneal surgery, diabetes, multiple sclerosis, and neurosurgical procedures, can cause NK by damaging trigeminal innervation.

 

As NK is associated with the impairment of the sensory innervation, patients do not commonly complain of ocular surface symptoms; this makes NK particularly challenging, as patients may seek medical advice months or years after the disease has started. However, blurred vision can sometimes be reported due to punctate keratopathy, irregular epithelium or epithelial defects, scarring, or edema.

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Neurotrophic Keratopathy (NK) Diagnosis

A diagnosis of neurotrophic keratitis is based on identifying characteristic symptoms, a detailed patient and family history, a thorough clinical evaluation, and a variety of specialized tests. A diagnosis should be suspected in individuals with unexplained signs of reduced corneal sensitivity and damage to the cornea.

 

Clinical history

Many ocular and systemic conditions may be associated with NK development, and the patient’s clinical history should be accurately investigated. Systemic diseases such as diabetes mellitus or systemic therapies (neuroleptic, antipsychotic, and antihistamine drugs) can cause impairment of trigeminal corneal innervation. Corneal surgery or traumas, topical anesthetic abuse, chronic topical drugs, chemical burns, or contact lens abuse can cause local injury to corneal sensory nerves. Additionally, conditions that may damage the fifth cranial nerve or its nuclei, such as neoplasms of the brain, neurosurgery, or vascular accident, should be considered. Finally, NK has been described in several congenital diseases, including familial dysautonomia, Goldenhar–Gorlin syndrome, Moebius syndrome, familial corneal hypoesthesia, and congenital insensitivity to pain with anhidrosis.

 

Ocular examination and ocular symptoms

NK patients rarely report symptoms of ocular surface discomfort. However, patients may complain of blurred vision due to PED, corneal stroma scarring, and/or swelling.

 

General examination

General examination assessing for cranial nerve involvement may aid the localization of trigeminal nerve damage. Seventh or eighth cranial nerve palsy may indicate trigeminal involvement from acoustic neuroma or from its surgical resection. Third, fourth, and sixth cranial nerve dysfunction may indicate an aneurysm or cavernous sinus that also damages the trigeminal nerve.

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Neurotrophic Keratopathy (NK) Treatment

NK treatment is directed toward the specific symptoms that are apparent in each individual. Treatment may require the coordinated efforts of a team of specialists. Pediatricians, surgeons, physicians who specialize in diagnosing and treating eye disorders (ophthalmologists), eye doctors who specialize in diagnosing and treating disorders of the cornea (corneal specialists), physicians who specialize in diagnosing and treating neurological disorders (neurologists), and other health care professionals may need to systematically and comprehensively plan treatment. Affected individuals should stop taking topical eye medications, especially those associated with the development of neurotrophic keratitis.

 

Treatments are typically used according to the NK stage/severity but are not mutually exclusive for one another.

 

In 2018, the US Food and Drug Administration (FDA) approved cenegermin (Oxervate) for the treatment of individuals with neurotrophic keratitis. Oxervate is a topical eye drop. In clinical studies, as many as 70% of affected individuals demonstrated complete corneal healing within 8 weeks.

 

Other therapies that are used to treat NK include frequent lubrication and the application of artificial tears in order to keep the cornea wet and clean. This treatment is recommended for all stages of neurotrophic keratitis. Topical antibiotic eye drops are used to treat a bacterial infection or for preventive (prophylactic) treatment of infection.

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Neurotrophic Keratopathy (NK) Epidemiology  

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Cases of Neurotrophic Keratopathy, Total Diagnosed Prevalent Cases of Neurotrophic Keratopathy, Gender-specific Diagnosed Prevalent Cases of Neurotrophic Keratopathy, and Stage-specific Diagnosed Prevalent Cases of Neurotrophic Keratopathy scenario in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2018 to 2030.

 

Key Findings

• In 2020, the total prevalent cases of Neurotrophic Keratopathy (NK) were found out to be 136,945 in the 7MM, these cases are expected to grow during the study period 2018–2030.
• The highest number, 65,000 cases of NK were prevalent in the US in 2020 and the least number, 7,965 cases of NK were prevalent in 2020, in Spain.
• The estimates suggest the highest diagnosed prevalent cases of NK was found in the United States with 49,999 cases in 2020.
• As per DelveInsight’s analysis, a higher percentage of diagnosed prevalence was observed for females than males among all the 7MM countries.
• Among the EU-5 countries, the United Kingdom had the highest diagnosed prevalence of NK with 12,826 cases, followed by Germany (9,193 cases) and France (7,777 cases). On the other hand, Spain had the lowest diagnosed prevalent population of 5,718 cases in 2020.
• Japan had 8,343 diagnosed prevalent cases of NK in 2020. Which is estimated to plummet down by 2030.

Country-Wise Neurotrophic Keratopathy (NK) Epidemiology

The epidemiology segment also provides the NK epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

Neurotrophic Keratopathy (NK) Drug Chapters

Neurotrophic Keratopathy (NK) Marketed Drugs

 

Oxervate (Cenegermin-bkbj/rhNGF): Dompé Farmaceutici

Cenegermin-bkbj is a human-made form of a substance made by the body. It is used by the body to help maintain and produce more nerve cells in the eyes. This medication may help prevent decreased vision or loss of vision caused by neurotrophic keratitis. Oxervate was granted Priority Review designation as well as Orphan Drug designation.

 

Oxervate ophthalmic solution contains cenegermin-bkbj, a recombinant form of human nerve growth factor produced in Escherichia coli. Cenegermin-bkbj contains 118 amino acids and has a relative molecular mass of 13,266 Daltons and the following molecular formula: C583H908N166O173S8. Oxervate (cenegermin-bkbj) is a clear, colorless sterile solution with a pH of 7.0–7.4 and osmolarity 280–320 mOsm/kg for topical ophthalmic use.

Products detail in the report…

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NK Emerging Drugs

 

RGN-259 (Tβ4): ReGenTree

RGN-259 is a Thymosin beta 4 (Tβ4)-based sterile and preservative-free eye drop, is used as a novel treatment for dry eye and neurotrophic keratitis (NK). The drug works to promote cell migration in a way that helps tissue regeneration. It also reduces cell death and inflammation of the cornea (Amino acids are the building blocks of proteins.)

 

In December 2013, the company received orphan drug status from the US FDA for RGN-259 for the treatment of NK. Through the US joint venture, the company initiated Phase III clinical trials in September 2015 in patients with dry eye syndrome and Neurotrophic Keratopathy. Preclinical studies have shown that Tβ4 promotes cell migration, increases cell-cell and cell-matrix contacts through increased laminin-5 production, and reduces both apoptosis and inflammation in the cornea. 

 

RGN-259 is the subject of two Phase III clinical trials in the US for patients with dry eye syndrome and Neurotrophic Keratopathy. Due to slow patient recruitment, the trial was closed after 18 of 46 patients completed treatment. According to clinicaltrials.gov the status of the study is terminated due to a business decision. In addition to dry eye, the company is planning to conduct a Phase III study (SEER-2) for Neurotrophic Keratopathy (NK).

 

OC-01(varenicline/Chantix): Oyster Point Pharma

OC-01 (varenicline) nasal spray is a highly selective cholinergic agonist being developed as a multidose preservative-free nasal spray to treat the signs and symptoms of dry eye disease and Neurotrophic Keratopathy. The parasympathetic nervous system, the “rest and digest” system of the body, controls tear film homeostasis partially via the trigeminal nerve, which is accessible within the nose. Administered as a preservative-free, aqueous nasal spray, in pre-clinical and clinical studies, OC-01 (varenicline) nasal spray was shown to have a novel mechanism of action with activation of the trigeminal parasympathetic pathway in the nasal cavity to activate natural tear film production. The human tear film is a complex mixture of more than 1,500 different proteins, including growth factors and antibodies, as well as numerous classes of lipids and mucins. This complex tear film is responsible for forming the primary refracting surface of the eye, as well as protecting and moisturizing the cornea.

 

Once OC-01 (varenicline) is bound to a nAChR, it stabilizes the open state of the ion channel, allowing an influx of cations such as Ca and Na ions, thus creating an action potential. This action potential ultimately activates the glands and cells of the LFU to produce natural tear film. Once OC-01 (varenicline) nasal spray is delivered, it takes approximately 10–15 s before tear film is produced. The receptors can be in the activated state for many minutes to hours after stimulation (a process termed smoldering activation).

 

The company has identified several additional indications, including some outside of ophthalmology, where this approach could provide a meaningful therapeutic benefit to patients. Oyster Point Pharma has initiated a Phase II OLYMPIA study for NK treatment.

Products detail in the report…

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Neurotrophic Keratopathy (NK) Market Outlook

Neurotrophic Keratopathy is a degenerative disease of the corneal epithelium caused by impaired corneal innervation. Decreased corneal sensitivity or complete corneal anesthesia is characteristic of the disease and is responsible for developing epithelial keratopathy, ulceration and perforation. Many eye and systemic disorders can cause Neurotrophic Keratopathy, but there is one common injury. It is a lesion of the trigeminal nerve (cranial nerve V) or its branches.

 

Patients with Neurotrophic Keratopathy should undergo a complete medical and surgical history, medication review, and eye examination. Clinical diagnosis can be made without problems, but treating Neurotrophic Keratopathy can be challenging.

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Key Findings

• The market size of NK in the seven major markets is expected to increase from USD 220 million in 2020 during the study period (2018–2030).
• The United States accounts for the highest market size of NK, compared to the other major markets, i.e., EU5 countries (the United Kingdom, Germany, Italy, France, and Spain), and Japan.
• Among the EU5 countries, Germany had the highest market size with USD 21.2 million in 2020, while the United Kingdom had the lowest market size of NK with USD 5 million in 2020.
• Of the emerging therapies RGN-259, OC-01, REC 0559 and CSB-001 are expected to enter the treatment market, during the forecast period.
• The expected launch of potential therapies shall increase the market size in the coming years, assisted by an increase in the prevalent population of NK during the forecast period (2021–2030).

 

The United States Market Outlook

This section provides the total NK market size and; market size by therapies in the United States.

 

EU-5 Market Outlook

The total NK market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

 

Japan Market Outlook

The total NK market size and market size by therapies in Japan are provided.

Neurotrophic Keratopathy (NK) Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the NK market or expected to get launched in the market during the study period 2018–2030. The analysis covers the NK market uptake by drugs; patient uptake by therapies; and sales of each drug.  

 

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Neurotrophic Keratopathy (NK) Development Activities

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

 

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for NK emerging therapies.

Reimbursement Scenario in Neurotrophic Keratopathy (NK)

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

We perform competitive and market Intelligence analysis of the NK market by using various competitive intelligence tools that include–SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability. 

Scope of the Report

• The report covers the descriptive overview of NK, explaining its causes, symptoms, pathophysiology, genetic basis, and currently available therapies.
• Comprehensive insight has been provided into the NK epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for NK is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the NK market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM NK market.

Report Highlights

• The robust pipeline with novel MOA and oral ROA, increasing incidence, effectiveness of drugs as both mono and combination therapy will positively drive the NK market.
• The companies and academics are working to assess challenges and seek opportunities that could influence NK R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for NK. The launch of emerging therapies will significantly impact the NK market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

NK Report Insights

• Patient Population
• Therapeutic Approaches
• NK Pipeline Analysis
• NK Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

NK Report Key Strengths

• 10 Years Forecast
• 7MM Coverage
• NK Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

NK Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• SWOT analysis

Key Questions

Market Insights:

• What was the NK market share (%) distribution in 2018 and how it would look like in 2030?
• What would be the NK total market size as well as market size by therapies across the 7MM during the forecast period (2021–2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest NK market size during the forecast period (2021–2030)?
• At what CAGR, the NK market is expected to grow at the 7MM level during the forecast period (2021–2030)?
• What would be the NK market outlook across the 7MM during the forecast period (2021–2030)?
• What would be the NK market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

 

Epidemiology Insights:

• What are the disease risk, burdens, and unmet needs of NK?
• What is the historical NK patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
• What would be the forecasted patient pool of NK at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to NK?
• Out of the above-mentioned countries, which country would have the highest incident population of NK during the forecast period (2021–2030)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2021–2030)?

 

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of NK along with the approved therapy?
• What are the current treatment guidelines for the treatment of NK in the US and Europe?
• What are the NK 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 NK?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of NK?
• What are the key collaborations (Industry–Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the NK therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for NK and their status?
• What are the key designations that have been granted for the emerging therapies for NK?
• What are the 7MM historical and forecasted market of NK?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving NK.
• To understand the future market competition in the NK market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for NK in the US, Europe (Germany, Spain, Italy, France, and 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.
• Organize sales and marketing efforts by identifying the best opportunities for the NK market.
• To understand the future market competition in the NK market.