Global Vernal Keratoconjunctivitis (VKC) Market Insights, Epidemiology and Forecast to 2030 - ResearchAndMarkets.com

The "Vernal Keratoconjunctivitis (VKC) - Market Insights, Epidemiology, and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.

This report delivers an in-depth understanding of the VKC, historical and forecasted epidemiology as well as the VKC market trends in the global pharmaceutical markets i.e., the United States, EU5 (Germany, France, Italy, Spain, and the UK), Japan, MEA (Saudi Arabia, Egypt), China, and Russia.

The market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted global VKC market size from 2017 to 2030.

The report also covers current VKC treatment practice, market drivers, market barriers, unmet medical needs, SWOT analysis to curate the best of the opportunities and assesses the underlying potential of the market.

Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Population of VKC, Diagnosed Prevalent Population of VKC, Gender-specific Diagnosed Prevalent Population of VKC, Type-specific Diagnosed Prevalent Population of VKC, Severity-specific Diagnosed Prevalent Population of VKC, and Age-specific Diagnosed Prevalent Population of VKC scenario of VKC in the global market from 2017 to 2030.

Key Findings

• The increasing population and rising prevalence of VKC generates a large patient population in the global market. In 2017, a total of 4,752,356 patients were affected by VKC in the global market.
• China contributes the largest share among EU-5, and Japan, with 2,248,706 cases in 2017.
• The total diagnosed prevalent population of VKC was 2,943,057 in the global market.

Drug Chapters

The drug chapter segment of the VKC report encloses the detailed analysis of VKC marketed drugs, early and mid-phase pipeline drugs. It also helps to understand the VKC clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details of each included drug and the latest news and press releases.

Marketed Drugs

Verkazia/Verkacia: Santen

Verkazia/Verkacia (0.1% cyclosporine), an immunomodulator that targets the underlying cause of the inflammation at the surface of the eye, controls the allergic response and inflammation. It is approved for the treatment of severe VKC in children from 4 years of age and adolescents.

Verkazia works differently to other licensed treatments, as it directly targets the underlying cause of the inflammation at the surface of the eye, controlling the allergic response and inflammation. It can be used over a sustained period which means that the use of steroids can be reduced. In clinical trials, Verkazia has been shown to significantly improve damage to the surface of the eye and reduce symptoms of severe VKC in children and adolescents (54% improvement vs. the control group given cationic emulsion. Verkazia was shown to improve the main symptoms of VKC: 68% improvement in light sensitivity; 58% in tearing; 72% in itching; and 67% in discharge.

Lodoxamide/Alomide: Novartis Pharmaceuticals/Alcon

Lodoxamide 0.1% (Alomide) is a mast cell stabilizer that is approximately 2,500 times more potent than cromolyn in the prevention of histamine release in several animal models. Lodoxamide is effective in reducing tryptase and histamine levels and the recruitment of inflammatory cells in the tear fluid after allergen challenge, as well as tear eosinophil cationic protein and leukotrienes (BLT and CysLT1) when compared to cromolyn. In early clinical trials lodoxamide (0.1%) was shown to deliver greater and earlier relief in patients with more chronic forms, such as VKC, including upper tarsal papilla, limbal signs (papilla, hyperemia, and Trantas' dots) and conjunctival discharge, and to improve epithelial defects seen in the chronic forms of conjunctivitis (VKC, GPC) than cromolyn. In patients with allergic conjunctivitis, it is approved for the treatment of VKC at a concentration of 0.1% four times daily. Lodoxamide may be used continuously for 3 months in children older than 2 years of age.

Talymus/Tacrolimus: Senju Pharmaceutical

Tacrolimus is a strong, nonsteroidal immune suppressant isolated from Streptomyces tsukubaensi. It binds to FK506-binding proteins in T-lymphocytes and inhibits calcineurin activity. Calcineurin inhibition suppresses dephosphorylation of the nuclear factor of activated T-cells and its transfer into the nucleus, which suppresses the formation of T-helper (Th) 1 (interleukin [IL]-2, interferon ) and Th2 cytokines (IL-4, IL-5). Tacrolimus also inhibits histamine release from mast cells, which is thought to alleviate allergic symptoms. Tacrolimus is up to 100 times more potent than cyclosporine.

Tacrolimus ointment is used widely for the treatment of atopic dermatitis. Topical tacrolimus (0.02-0.1%) has also been used to treat giant papillary conjunctivitis, AKC, and VKC, with good results. Furthermore, a tacrolimus 0.1% ophthalmic suspension has been used for the treatment of AKC and VKC with only 4 weeks of follow-up. Tacrolimus, 0.1% ointment, is a safe and effective treatment for VKC refractory to standard treatment and is used as a substitute for steroid treatments used to controlled disease activity.

Emerging Drugs

Antolimab (AK002): Allakos

Antolimab (AK002), is an investigational therapeutic antibody that targets siglec-8, an inhibitory receptor found on the surface of mast cells and eosinophils. By targeting siglec-8, antolimab offers the potential to treat a broad range of serious, complex inflammatory diseases.

Allakos has conducted an open-label Phase Ib clinical trial in patients with three forms of severe allergic conjunctivitis (atopic keratoconjunctivitis, VKC, and perennial allergic conjunctivitis refractory to topical treatments). After treatment with antolimab in the Phase Ib study, there was a reduction of patient-reported ocular symptoms and the physician assessed signs and symptoms. Patients also reported improvements in the severity of comorbid atopic dermatitis, asthma, and rhinitis symptoms.

Bertilimumab/iCo-008: iCo Therapeutics

Bertilimumab (also known as iCo-008 or CAT-213) is a human immunoglobulin monoclonal antibody targeting eotaxin-1, a member of the chemokine family of proteins that act as messenger molecules between the cells of the immune system. Bertilimumab has shown a good safety profile and has shown evidence of efficacy in a severe allergy indication.

More recently, bertilimumab has been investigated in two Phase II trials. The first trial targeted patients with a skin condition called bullous pemphigoid and revealed good safety and efficacy results. A Phase II clinical trial for patients with VKC and/or atopic keratoconjunctivitis (involving cornea and conjunctiva) is in preparation.

Nomacopan: Akari Therapeutics

Nomacopan, which is a second-generation complement inhibitor, acts on complement component-C5, preventing the release of C5a and formation of C5b-9 (also known as the membrane attack complex, or MAC), and independently also inhibits leukotriene B4, or LTB4, activity, both elements that are co-located as part of the immune/inflammatory response. It is a small recombinant protein (16,740 Da) derived from a protein originally discovered in the saliva of the Ornithodoros moubata tick, where it modulates the host immune system to allow the parasite to feed without alerting the host to its presence or provoking an immune response.

Additionally, Nomacopan's biophysical properties allow it to be potentially used in a variety of formulations, including subcutaneous, intravenous, topical or inhaled routes of administration. Currently, Akari Therapeutics is investigating the molecule in phase I/II clinical trial in patients with atopic keratoconjunctivitis (including VKC, Sjgren's syndrome, and mucous membrane pemphigoid).

Market Outlook

Treatment of VKC requires multiple approaches that include conservative measures and pharmacologic treatment. Patients and parents should be made aware of the prolonged duration of disease, its chronic evolution, and possible complications. Treatment should be based on the duration and frequency of symptoms and the severity of corneal involvement.

Currently available topical drugs for allergic conjunctivitis belong to several pharmacologic classes, such as vasoconstrictors, antihistamines, mast cell stabilizers, dual-acting' agents (with antihistaminic and mast cell stabilizing properties), non-steroidal anti-inflammatory agents, corticosteroids, and immunosuppressive drugs.

Mast cell stabilizers are the first-line drugs for VKC. Several studies have demonstrated the efficacy of 2% and 4% sodium cromoglicate (DSCG, cromolyn), nedocromil sodium 2%, lodoxamide tromethamine 0.1%, and spaglumic acid 4%.

Ocular drugs with antihistaminic activity may offer therapeutic advantages to patients with allergic conjunctivitis, including VKC, by inhibiting proinflammatory cytokine secretion from conjunctival epithelial cells. The first-generation antihistamines pheniramine and antazoline have a long safety record. The newer antihistamines such as levocabastine hydrochloride 0.5% and emedastine difumarate 0.05% have a longer duration of action (4-6 h) and are better tolerated than their predecessors.

A meta-analysis of randomized clinical trials in VKC showed a large number of studies evaluated the efficacy of common anti-allergic eye drops (levocabastine, lodoxamide, mipragoside, N-acetyl aspartyl glutamic acid, nedocromil sodium, DCG). Among these, lodoxamide appeared to be the most effective.

Papilock mini and Verkazia both produced by Santen (Osaka, Japan) are specifically indicated for the treatment of VKC.

Generally, NSAIDs employed in ocular allergy treatment inhibit both cyclooxygenase (COX)-1 and COX-2 enzymes. Also, Ketorolac, diclofenac and pranoprofen may be valid alternatives to steroids, since they have a proven effect on itching, intercellular adhesion molecule-1 expression, and tear tryptase levels. Indomethacin 1%, ketorolac 0.5%, and diclofenac 0.1% have shown effectiveness in the treatment of VKC.

Aspirin 0.5-1 g/day has been shown as a steroid-sparing factor in the treatment of VKC; however, it should be used with caution because of the well-known possible side effects.

In severe cases, systemic treatment with T-lymphocyte signals transduction inhibitors such as Cyclosporine A or tacrolimus may ameliorate both the dermatologic and ocular manifestations in critical patients who are refractory to conventional treatment.

Omalizumab, an anti-IgE recombinant, humanized, non-anaphylactogenic antibody, directed against the receptor-binding domain of IgE, may be used in VKC patients with high levels of total serum IgE. Calcineurin inhibitors are off-label treatments in the European Union.

As discussed, the current treatment for VKC depends solely on the use of antihistamines, mast cell inhibitors, and several other classes. But till now the treatment is only supportive and is not that effective. But due to the advancement of technology and a better understanding of the disease, several companies are trying to modify the treatment of VKC.

Key Findings

• The market size of VKC in the global market was USD 307.89 million in 2017.
• According to the estimates, the highest market size of VKC is found in China followed by Japan, and Russia.
• Among the MENA regions, the highest market share is contributed by Egypt, followed by Saudi Arabia.
• The upcoming therapy AK002 is anticipated to reach the market by 2023 (in Europe).

Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the VKC market or expected to get launched in the market during the study period 2017-2030. The analysis covers VKC 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.

Pipeline & Development Activities

The report provides insights into different therapeutic candidates in phase I, and phase II stage. It also analyzes key players involved in developing targeted therapeutics. The report covers the detailed information of collaborations, acquisition, and merger, licensing and patent details for VKC emerging therapies.

Reimbursement Scenario

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

The report performs competitive and market Intelligence analysis of the VKC 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 VKC, explaining its causes, signs and symptoms, risk factors, pathophysiology, histopathology, and currently available therapies.
• Comprehensive insight has been provided into the VKC epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for VKC is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the VKC market; historical and forecasted is included in the report, covering the global drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the global VKC market.

Report Highlights

• The increasing prevalence of the disease along with promising emerging pipeline therapies will positively drive the VKC market.
• The companies and academics are working to assess challenges and seek opportunities that could influence VKC R&D.
• Major players are involved in developing therapies for VKC. Launch of emerging therapies will significantly impact the VKC market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase II and phase I), 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.

Companies Mentioned

• Akari Therapeutics
• Allakos
• iCo Therapeutics
• Santen
• Senju Pharmaceutical
• Novartis Pharmaceuticals/Alcon

For more information about this drug pipelines report visit https://www.researchandmarkets.com/r/v9u8v4

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