The “Keratoconus – Market Insight, Epidemiology and Market Forecast -2030” drug pipelines has been added to ResearchAndMarkets.com’s offering.
This ‘Keratoconus (KC) – Market Insights, Epidemiology and Market Forecast- 2030’ report delivers an in-depth understanding of the Keratoconus (KC), historical and forecasted epidemiology as well as the Keratoconus (KC) market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
Keratoconus (KC) Market Outlook
According to the Cornea Research Foundation of America, Keratoconus (KCN) is a disease characterized by thinning and protrusion of the cornea, resulting in an irregular, conical shape. Irregular astigmatism occurs as the KC progresses, and results in blurred vision, which can be impossible to correct with spectacles. Usually, keratoconus occurs in both eyes, and involves the central cornea with the apex of the cone just below the visual axis. Approximately 50-200 of every 100,000 people are afflicted with KC. In the US, a study found a prevalence of 54.5 per 100,000 people.
The current treatment option includes the use of cornea cross-linking, intrastromal corneal ring segments, and other combined treatments, which provide the corneal clinicians a variety of treatment options for the visual rehabilitation of KC patients. In the mildest form of keratoconus, eyeglasses or soft contact lenses are preferred. But as the disease progresses and the cornea thins and becomes increasingly more irregular in shape, glasses and regular soft contact lens designs no longer provide adequate vision correction. The treatment of progressive KC includes corneal collagen cross-linking or CXL, custom soft contact lenses, gas permeable contact lenses, “Piggy backing”, contact lenses, Hybrid contact lenses, Scleral and semi-scleral lenses, Prosthetic lenses, Topography-guided conductive keratoplasty (CK), and corneal transplant.
In addition to these therapies, the US FDA has approved Avedro’s Photrexa and Photrexa Viscous photoenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of patients with progressive KC and post-LASIK ectasia. Although the EMA does not approve this therapy; however, it was used in Europe way before its FDA approval in April 2016 as a CE marked product.
Cross-linking is approved by the FDA for halting the progression of KC. Once the condition progresses, FDA has approved Intacs or a cornea transplant as more advanced treatment options. Crosslinking utilizes riboflavin drops (Vitamin B2) and ultraviolet light, which interact with the corneal tissue to create “cross-links” between corneal proteins. This strengthens the cornea, which is weak in keratoconus, to decrease KC progression.
In addition to standard riboflavin formulations comparable to the US FDA-approved ophthalmic solutions, a variety of modified riboflavin formulations are in use in regions outside the United States and are regulated under the CE Mark in the European Union. These formulations have not been evaluated by the US FDA and are not approved for sale in the United States. These formulations include the Avedro’s family of CE marked riboflavin (VibeX Xtra, VibeX Rapid, ParaCel, MedioCROSS TE, MedioCROSS M, MedioCROSS D, and MedioCROSS H), Lightmed’s Collagex riboflavin (vitamin B2) family of products which includes- Collagex – Isotonic, Collagex – Hypotonic, Collagex – Trans-Epithelial (TE), Collagex – Rapid, and Collagex – Plus and Sooft Italia’s Ricrolin.
Other than these CE marked products that are being marketed in Europe, Peschke Riboflavin is also available in the European market. These solutions are also available in different formulations, namely Peschke TE, Peschke M, Peschke D, Peschke H, and Peschke L.. These Peschke Riboflavin solution formulations are used in conjunction with the PXL Platinum 330 system.
The current pipeline holds a major unmet need for the novel and potential emerging therapy. The emerging emerging-market holds IVMED-80, which is under development by iVeena Delivery Systems to treat KC without the need for adjunctive laser treatment or surgical intervention. The drug is in phase I/II clinical-developmental trial.
- The market size of KC in the seven major markets was estimated to be USD 2,456 million in 2017.
- The United States accounted for the largest market size of KC in comparison to EU5 (the United Kingdom, Germany, France, Italy, and Spain) and Japan.
- In 2017, among the EU5 countries, Germany had the largest market size with USD 280 million, while Spain had the smallest market size of KC with USD 135 million.
- The Japan KC market accounted for USD 299 million in 2017.
Key Topics Covered:
1 Key Insights
2 Keratoconus (KC) Market Overview at a Glance
2.1 Market Share (%) Distribution of Keratoconus (KC) in 2017
2.2 Market Share (%) Distribution of Keratoconus (KC) in 2030
3 Executive Summary of Keratoconus (KC)
4 Disease Background and Overview: Keratoconus (KC)
4.2 Types of KC
4.2.1 Shape-based differentiation
4.2.2 Severity- based differentiation
4.2.3 Index-based differentiation
4.4 Signs and Symptoms
4.6.2 Basement membrane
4.6.3 Nerve fibers
4.6.4 Bowman’s layer
4.7.1 Eye refraction
4.7.2 Slit-lamp examination
4.7.4 Corneal Topography
4.7.5 Corneal Tomography
4.7.6 Keratoconus indices
4.7.7 The Belin Ambrosio Enhanced Ectasia Display (BAD)
4.7.8 Holladay 6 map display
4.7.9 Corneal pachymetry
4.7.10 Automated detection program for subclinical KC
4.7.11 Corneal biomechanics
4.8 Differential Diagnosis
5 Epidemiology and Patient Population
5.1 Key Findings
5.2 Total Diagnosed Prevalent Population of Keratoconus in the 7MM
6 Country-wise Epidemiology of Keratoconus
6.1 United States
6.1.1 Assumptions and Rationale
6.1.2 Total Diagnosed Prevalent Population of Keratoconus in the United States
6.1.3 Severity-specific Distribution of Keratoconus in the United States
6.1.4 Age-specific Distribution of Keratoconus in the United States
6.2 EU5 Countries
6.7 United Kingdom
7.1 Spectacles and Contact Lenses in Keratoconus
7.2 Intrastromal Corneal Ring Segments (ICRS)
7.3 Keratoplasty: Penetrating Keratoplasty (PK) – Deep Anterior Lamellar Keratoplasty (DALK)
7.4 Corneal Cross-Linking (CXL)
7.4.1 Corneal cross-linking Plus
7.4.2 Accelerated Cross-Linking
7.5 Future of Keratoconus Treatment
7.5.1 Pulse CXL
7.5.2 Epi-on Cross-Linking
7.5.3 CXL Using Topography-Guided UV-A Energy Emission
7.5.4 Bowman Layer Transplantation
8 Photochemical corneal collagen cross linkage using riboflavin and ultraviolet A for keratoconus and keratectasia
8.2 Indications and current treatments
8.3 The Procedures
8.4.1 Epithelium off CXL
8.4.2 Epithelium off CXL in combination with other interventions (CXL plus)
8.4.3 Epithelium-on (transepithelial) CXL with or without additional interventions (CXL plus)
9 Treatment Algorithm
10 Recognized Establishments
11 Unmet Needs
12 Marketed and Emerging Therapies
12.1 Key Cross Competition
12.2 Photrexa Viscous and Photrexa: Glaukos/Avedro
12.2.1 Drug Description
12.2.2 Regulatory Milestones
12.2.3 Other Development Activities
12.2.4 Safety and Efficacy
12.2.5 Product Profile
12.3 CE Marked Riboflavin Formulations: Avedro/ Glaukos Corporation
12.4 Ricrolin: Sooft Italia
12.5 Collagex Riboflavin: Lightmed_OptiMed
12.6 Peschke Riboflavin Solutions: Peschke Meditrade GmbH
13 Emerging Drug
13.1 IVMED-80: iVeena Delivery Systems
13.1.1 Drug Description
13.1.2 Other Development Activities
13.1.3 Clinical Development
13.1.4 Safety and Efficacy
13.1.5 Product Profile
14 Keratoconus (KC): Seven Major Market Analysis
14.1 Key Findings
14.2 Market Size of Keratoconus (KC) in the 7MM
15 7MM Market Outlook
16 United States Market Size
17 Market Access and Reimbursement
18 Market Drivers
19 Market Barriers
20 SWOT Analysis
For more information about this drug pipelines report visit https://www.researchandmarkets.com/r/hlvukf
Laura Wood, Senior Press Manager
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