日光角化症 - 市場考察、疫学、市場予測（2034年）

主なハイライト

• DelveInsightの分析によると、主要7市場の日光角化症の市場規模は、日焼けによるダメージを受けやすい老年人口や、皮膚の健康に対する意識の高まり、治療オプションの進歩などにより、予測期間にCAGRで約5%の大きな成長が見込まれます。
• さらに、VDA-1102、SR-T100 Gel、その他の革新的な外用治療薬のような新治療法の導入は、治療成績をさらに改善し、市場機会を拡大すると予測されます。
• 米国FDAが承認した日光角化症治療薬が利用可能であるにもかかわらず、特に皮膚反応に起因する患者アドヒアランスや一貫した使用に関する理解不足など、アンメットニーズが残っています。皮膚科医は、副作用の管理について議論する際に課題に直面し、最適な治療結果を得ることができません。また、副作用の少ないより効果的な治療や、未治療の日光角化症のリスクに対する認識の向上も求められています。
• 日光角化症治療の重大な市場障壁は、日光角化症という病態と皮膚がんへの進行の可能性に関する認識不足であり、これがしばしば診断と治療の遅れにつながっています。さらに、先進の治療に伴う高い治療費は、特に低所得層や医療資源が限られている地域の患者にとって、患者のアクセスを制限する可能性があります。
• G&E Herbal Biotechnology Bausch Health Companies、Athenex/Almirallなど、複数の主な日光角化症企業が、アンメットニーズの高さを考慮し、日光角化症市場の力学を変えていくと見られます。

日光角化症市場の見通し

日光角化症市場にはさまざまな治療オプションがあり、有病率の増加が市場の可能性を広げています。有病率の増加の要因としては、紫外線への度重なる曝露、高齢化、小児期の日光曝露、屋外で働く男性の割合の増加、赤道付近の緯度に居住する人口などが挙げられます。治療アプローチは、病変に対する治療と領域に対する治療に分類されます。病変に対する治療は個々の病巣を標的とするものであり、領域に対する治療は皮膚の広い範囲を治療するものです。

外用療法では、5-フルオロウラシルがもっとも広く使用されており、ALDARA（5%イミキモド）、ZYCLARA、SOLARAZEなどがこれに続きます。もう1つの申請済みの領域に対する治療法である光線力学的療法（PDT）も、日帰りPDTという新たな概念とともに、非侵襲的な治療アプローチであるため、成長中の治療領域ですが、PDTの市場シェアは他の治療法に比べて最低です。従来のPDTの有用性は十分に証明されていますが、コスト、時間のかかるプロトコル、そしてもっとも重要な光吸収時の痛みなど、複数の限界があります。全体として、日光角化症治療市場は、治療オプションの進歩やこの疾患のリスクに対する社会的認知の高まりに支えられ、堅調な拡大が見込まれています。

主な日光角化症治療薬企業は、Vidac Pharma、G&E Herbal Biotechnology、Sandoz Pharmaceuticalsなどで、臨床開発のさまざまな段階で主な候補薬を評価しています。彼らは、日光角化症を治療するための製品を研究することを目的としています。

当レポートでは、日光角化症の主要7市場（米国、ドイツ、スペイン、イタリア、フランス、英国、日本）について調査分析し、各地域の市場規模、現在の治療法、アンメットニーズ、新薬などの情報を提供しています。

目次

第1章 重要考察

第2章 レポートのイントロダクション

第3章 日光角化症市場の概要

• 日光角化症の市場シェアの分布（2020年）
• 日光角化症の市場シェアの分布（2034年）

第4章 日光角化症の疫学と市場の調査手法

第5章 エグゼクティブサマリー

第6章 重要な出来事

第7章 疾患の背景と概要

• 日光角化症のイントロダクション
• 臨床症状
• 病因
• 危険因子
• 病因
• 診断
• 治療と管理

第8章 ペイシェントジャーニー

第9章 疫学と患者人口

• 主な調査結果
• 前提条件と根拠：主要7市場
• 主要7市場の日光角化症の有病率
• 米国
• 欧州4ヶ国・英国
• 日本

第10章 上市済み薬品

• 主な競合
• ALDARA：Bausch Health Companies
• SOLARAZE：Sandoz Pharmaceuticals
• KLISYRI（tirbanibulin/KX01/KX2-391）：Athenex/Almirall

第11章 新薬

• 主な競合
• VDA-1102：Vidac Pharma
• SR-T100 Gel：G & E Herbal Biotechnology

第12章 日光角化症：市場の分析

• 主な調査結果
• 主な市場予測の前提条件
  • コストの想定とリベート
  • 価格動向
  • アナログの評価
  • 上市年と治療の普及
• 市場見通し
• コンジョイント分析
• 主要7市場の日光角化症の総市場規模
• 主要7市場の日光角化症の市場規模：治療法別
• 米国の日光角化症の市場規模
  • 米国の日光角化症の総市場規模
  • 米国の日光角化症の市場規模：治療法別
• 欧州4ヶ国・英国の日光角化症の市場規模
  • 欧州4ヶ国・英国の日光角化症の総市場規模
  • 欧州4ヶ国・英国の日光角化症の市場規模：治療法別
• 日本の日光角化症の市場規模
  • 日本の日光角化症の総市場規模
  • 日本の日光角化症の市場規模：治療法別

第13章 KOLの見解

第14章 SWOT分析

第15章 アンメットニーズ

第16章 市場参入と償還

• 米国
• 欧州4ヶ国・英国
  • ドイツ
  • フランス
  • イタリア
  • スペイン
  • 英国
• 日本

第17章 付録

第18章 DelveInsightのサービス内容

第19章 免責事項

第20章 DelveInsightについて

List of Tables

• Table 1: Summary of Actinic keratosis, Market, Epidemiology, and Key Events:
• Table 2: Clinical variants of Actinic Keratosis Criteria for Grading KIN:
• Table 3: Reclassification of Actinic Keratosis:
• Table 4: Clinical grading system (according to Olsen 1991):
• Table 5: Risk factors for the development of basal cell carcinomas (BCCs) and squamous cell carcinomas (SCCs)
• Table 6: Diagnostic Criteria for Actinic Keratosis
• Table 7: Total Prevalent Cases of Actinic Keratosis in the 7MM (2020-2034)
• Table 8: Total Prevalent Cases of Actinic Keratosis in the US (2020-2034)
• Table 9: Gender-specific Cases of Actinic Keratosis in the US (2020-2034)
• Table 10: Treated Cases of Actinic Keratosis in the US (2020-2034)
• Table 11: Total Prevalent Cases of Actinic Keratosis in EU4 and the UK (2020-2034)
• Table 12: Gender-specific Cases of Actinic Keratosis in EU4 and the UK (2020-2034)
• Table 13: Treated Cases of Actinic Keratosis in EU4 and the UK (2020-2034)
• Table 14: Total Prevalent Cases of Actinic Keratosis in Japan (2020-2034)
• Table 15: Gender-specific Cases of Actinic Keratosis in Japan (2020-2034)
• Table 16: Treated Cases of Actinic Keratosis in Japan (2020-2034)
• Table 17: Key Cross of Marketed Drugs
• Table 18: ALDARA, Clinical Trial Description, 2024
• Table 19: SOLARAZE, Clinical Trial Description, 2024
• Table 20: KLISYRI Clinical Trial Description, 2024
• Table 21: Comparison of Emerging Drugs
• Table 22: VDA-1102, Clinical Trial Description, 2024
• Table 23: SR-T100 Gel, Clinical Trial Description, 2024
• Table 24: Key Market Forecast Assumptions for VDA-1102
• Table 25: Key Market Forecast Assumptions for SR-T100 Gel
• Table 26: Total Market Size of Actinic Keratosis in the 7MM, in USD million (2020-2034)
• Table 27: Total Market Size of Actinic Keratosis by Therapies in the 7MM, in USD million (2020-2034)
• Table 28: Total Market Size of Actinic Keratosis in the US, in USD million (2020-2034)
• Table 29: Total Market Size of Actinic Keratosis by Therapies in the US, in USD million (2020-2034)
• Table 30: Total Market Size of Actinic Keratosis in EU4 and the UK, in USD million (2020-2034)
• Table 31: The Market Size of Actinic Keratosis by Therapies in EU4 and the UK, in USD million (2020-2034)
• Table 32: Total Market Size of Actinic Keratosis in Japan, in USD million (2020-2034)
• Table 33: The Market Size of Actinic Keratosis by Therapies in Japan, in USD million (2020-2034)

List of Figures

• Figure 1: Signs and Symptoms of Actinic Keratosis
• Figure 2: Clinical variants of Actinic Keratosis
• Figure 3: Causes of Actinic Keratosis
• Figure 4: Patient Journey of Actinic Keratosis
• Figure 5: Total Prevalent Cases of Actinic Keratosis in the 7MM (2020-2034)
• Figure 6: Total Prevalent Cases of Actinic Keratosis in the US (2020-2034)
• Figure 7: Gender-specific Cases of Actinic Keratosis in the US (2020-2034)
• Figure 8: Treated Cases of Actinic Keratosis in the US (2020-2034)
• Figure 9: Total Prevalent Cases of Actinic Keratosis in EU4 and the UK (2020-2034)
• Figure 10: Gender-specific Cases of Actinic Keratosis in EU4 and the UK (2020-2034)
• Figure 11: Treated Cases of Actinic Keratosis in EU4 and the UK (2020-2034)
• Figure 12: Total Prevalent Cases of Actinic Keratosis in Japan (2020-2034)
• Figure 13: Gender-specific Cases of Actinic Keratosis in Japan (2020-2034)
• Figure 14: Treated Cases of Actinic Keratosis in Japan (2020-2034)
• Figure 15: Total Market Size of Actinic Keratosis in the 7MM, in USD million (2020-2034)
• Figure 16: Total Market Size of Actinic Keratosis by Therapies in the 7MM, in USD million (2020-2034)
• Figure 17: Total Market Size of Actinic Keratosis in the US, in USD million (2020-2034)
• Figure 18: Total Market Size of Actinic Keratosis by Therapies in the US, in USD million (2020-2034)
• Figure 19: Total Market Size of Actinic Keratosis in EU4 and the UK, in USD million (2020-2034)
• Figure 20: The Market Size of Actinic Keratosis by Therapies in EU4 and the UK, in USD million (2020-2034)
• Figure 21: Total Market Size of Actinic Keratosis in Japan, in USD million (2020-2034)
• Figure 22: The Market Size of Actinic Keratosis by Therapies in Japan, in USD million (2020-2034)
• Figure 23: SWOT Analysis of Actinic Keratosis
• Figure 24: Unmet Needs of Actinic Keratosis
• Figure 25: Health Technology Assessment
• Figure 26: Reimbursement Process in Germany
• Figure 27: Reimbursement Process in France
• Figure 28: Reimbursement Process in Italy
• Figure 29: Reimbursement Process in Spain
• Figure 30: Reimbursement Process in the United Kingdom
• Figure 31: Reimbursement Process in Japan

Key Highlights:

• According to DelveInsight's analysis, the actinic keratosis market in the 7MM is expected to experience significant growth, with a projected CAGR of around 5% during the forecast period driven by the aging population vulnerable to sun damage, increased awareness of skin health, and advancements in treatment options.
• Moreover, the introduction of novel therapies like VDA-1102, SR-T100 Gel, and other innovative topical treatments is expected to further improve treatment outcomes and expand market opportunities.
• Despite the availability of the US FDA-approved treatments for actinic keratosis, unmet needs remain, particularly in patient adherence due to skin reactions and a lack of understanding about consistent use. Dermatologists face challenges in discussing side effect management, leading to suboptimal outcomes. There is also a need for more effective treatments with fewer side effects, and increased awareness of the risks of untreated actinic keratosis.
• A significant market barrier for actinic keratosis treatment is the lack of awareness regarding the condition and its potential progression to skin cancer, which often leads to delayed diagnosis and treatment. Additionally, high treatment costs associated with advanced therapies can restrict patient access, particularly for those in lower-income brackets or regions with limited healthcare resources.
• Given the high unmet needs several key Actinic Keratosis companies including G&E Herbal Biotechnology Bausch Health Companies, Athenex/ Almirall, among others will change the actinic keratosis market dynamics.

DelveInsight's "Actinic Keratosis Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of actinic keratosis, historical and forecasted epidemiology, as well as the actinic keratosis market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Actinic Keratosis market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM actinic keratosis market size from 2020 to 2034. The report also covers actinic keratosis treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Actinic Keratosis Treatment Market

Actinic keratosis overview

Actinic keratosis is a common precancerous skin condition characterized by rough, scaly patches that develop on sun-damaged skin, primarily due to chronic exposure to ultraviolet (UV) radiation. Typically seen in older individuals with lighter skin types, actinic keratosis lesions often appear on areas frequently exposed to sunlight, such as the face, neck, and hands. While these lesions are not cancerous, they are considered potential precursors to squamous cell carcinoma, with a small percentage progressing to invasive cancer if left untreated.

Actinic keratosis diagnosis

The diagnosis of actinic keratosis primarily relies on clinical evaluation, where healthcare providers examine the skin for characteristic rough, scaly patches that often develop in sun-exposed areas. A dermatoscope may be used to enhance visualization of the lesions, and in cases where there is suspicion of malignant transformation, a skin biopsy may be performed to confirm the diagnosis and rule out squamous cell carcinoma. The lesions can be classified based on their thickness, with grades ranging from slightly palpable to very thick and hyperkeratotic. Early diagnosis is crucial, as untreated actinic keratosis can progress to skin cancer, making regular skin examinations important, especially for individuals at higher risk due to factors such as fair skin, age, and significant sun exposure.

Actinic keratosis treatment

Treatment for actinic keratosis involves various modalities aimed at removing or destroying the abnormal skin lesions to prevent progression to squamous cell carcinoma. Common options include cryosurgery, where liquid nitrogen is applied to freeze the lesions, and topical therapies such as 5-fluorouracil (5-FU), imiquimod, and diclofenac, which are creams that promote the immune response or induce cell death in the affected areas. Several US FDA-approved topical medications that target the abnormal skin cells associated with this condition. These include 5-fluorouracil (5-FU), which inhibits cell proliferation; imiquimod, an immune response modifier; diclofenac, a nonsteroidal anti-inflammatory drug; ingenol mebutate, which induces cell death; and tirbanibulin, a microtubule inhibitor that promotes lesion clearance. Additionally, photodynamic therapy (PDT) using topical delta-aminolevulinic acid is also approved for treating actinic keratosis. These treatments can be used alone or in combination, depending on the number and severity of lesions, and are generally well tolerated, although they may cause local irritation and discomfort during the treatment course.

As the Actinic Keratosis market is derived using a patient-based model, the actinic keratosis epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total prevalent cases of actinic keratosis, gender-specific cases of actinic keratosis, and treated cases of actinic keratosis in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• According to estimates in the US, the prevalence of actinic keratosis is significant, with estimates indicating more males affects as compared to females. This reflects a higher incidence in men, likely due to greater sun exposure from outdoor activities. Overall, the condition is particularly common among older adults, with prevalence rates increasing with age.
• As per multisource data from Germany, the prevalence of actinic keratosis was reported to range between 2.0% and 7.4%.
• According to Dhariwal et al. (2020), in the UK, the prevalence of actinic keratosis is estimated to be around 19-24% among individuals over the age of 60 with observations suggesting a higher prevalence in men (3.9%) than in women (1.5%).

Actinic Keratosis Drug Chapters

Marketed Actinic Keratosis Drugs

ALDARA (imiquimod): Bausch Health Companies

ALDARA (imiquimod), an immune response modifier, was approved by the US FDA in March 2004 for treating clinically typical, non-hyperkeratotic, non-hypertrophic Actinic Keratosis on the face or scalp. The 5% cream formulation contains 50 mg of imiquimod per gram in an off-white, oil-in-water vanishing cream base. The base includes ingredients such as isostearic acid, cetyl alcohol, stearyl alcohol, white petrolatum, polysorbate 60, sorbitan monostearate, glycerin, xanthan gum, purified water, benzyl alcohol, methylparaben, and propyl paraben.

In September 2010, Perrigo Company announced that US FDA approved Perrigo to manufacture and market imiquimod 5%. Perrigo will vertically integrate this product with their own API. This product is a generic equivalent to Graceway Pharmaceutical's ALDARA 5%. While in November 2011, Mochida Pharmaceutical announced that Beselna Cream (5% imiquimod) received approval in Japan for the additional indication of actinic keratosis.

SOLARAZE (diclofenac topical gel): Sandoz Pharmaceuticals

SOLARAZE 3% Gel is indicated for the topical treatment of actinic keratosis contains the active ingredient, diclofenac sodium, in a clear, transparent, colorless to slightly yellow gel base. Diclofenac sodium is a white to slightly yellow crystalline powder. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water, slightly soluble in acetone, and partially insoluble in ether. It a widely used non-steroidal anti-inflammatory drug (NSAID) has a high affinity for cyclooxygenase-2 (COX-2), an enzyme that appears to play an important role in the development of AK. The hyaluronic acid component is an inert delivery system that intensifies the therapeutic effect of diclofenac by minimizing its systemic absorption and ensuring it locates to the target site within the epidermis.

In 2001, SOLARAZE was launched by Bioglan in five European countries including (France, UK, Germany, Italy and Sweden). While In 2013, Sandoz launched an authorized generic version of a topical drug for treating actinic keratosis.

KLISYRI (tirbanibulin/KX01/ KX2-391): Athenex/ Almirall

KLISYRI (tirbanibulin/KX01/ KX2-391) is a novel, small molecule topical first-in-class microtubule inhibitor indicated for the topical treatment of actinic keratosis of the face or scalp. The drug acts as a dual Src/pre-tubulin inhibitor. It also increases p53 levels during unchecked proliferation and hence addresses the dysregulation of p53 in actinic keratosis. The drug has excellent skin penetration when formulated as a topical ointment. In December 2017, Almirall and Athenex announce strategic partnership for developing KX2-391 in the US and Europe for the treatment of actinic keratosis. The US FDA approved KLISYRI in December 2020 and was launched in the US in February 2021.

Emerging Actinic Keratosis Drugs

VDA-1102: Vidac Pharma

VDA-1102 ointment is a first in a new class drug that selectively targets malignant cutaneous cells with minimal effects on the surrounding healthy skin. VDA-1102 is an anti-neoplastic agent that utilizes a novel mechanism of action involving selective modulation of VDAC/HK2, a molecular system that is unique to glycolysis and mitochondrial function in cancer cells. This mechanism of action selectively triggers apoptosis in cancer cells with minimal effects on surrounding normal cells.

Currently, the drug candidate is being investigated for a second part of Phase IIb stage for the treatment of actinic keratosis with 9 months to topline data readout. Furthermore, the interim results from 50% of subjects in January 2024 showed favorable results compared to the standard of care, which has a lower complete response rate and a much longer median response time.

SR-T100 Gel: G&E Herbal Biotechnology

SR-T100 Gel, which contains solamargine derived from the Solanum undatum plant, is being evaluated for its effectiveness in treating actinic keratosis, common warts and genital warts. SR-T100 gel contains high amounts of the steroidal alkaloid glycoside solamargine. Solamargine is able to upregulate expression of tumor necrosis factor receptors 1 (TNFR1) and 6 (TNFRSF6 or Fas), and their signaling adaptors TNFR1-associated death domain, and Fas-associated death domain. In addition, this agent is able to upregulate expression of apoptosis promoter Bax, and suppress the expression of the anti-apoptotic proteins Bcl-xL and Bcl-2. Altogether, this induces apoptosis in tumor cells and may lead to an inhibition of tumor cell proliferation.

As per the company's pipeline the drug candidate is being investigated in a Phase II and Phase III trial for actinic keratosis in Taiwan, and the US respectively.

Drug Class Insights

Treatment for actinic keratosis encompasses several drug classes, each targeting the condition through different mechanisms. Topical therapies are predominant, including nucleoside metabolic inhibitors like 5-fluorouracil, which disrupt cell division in abnormal keratinocytes, and immune response modifiers such as imiquimod, which enhance the local immune response to eliminate affected cells. Nonsteroidal anti-inflammatory drugs (NSAIDs), like diclofenac, are also utilized to reduce inflammation and promote healing. Additionally, microtubule inhibitors like tirbanibulin have emerged as effective treatments, offering a novel approach to managing actinic keratosis lesions. The diversity of these drug classes reflects the ongoing evolution in the management of actinic keratosis, providing healthcare providers with multiple options tailored to individual patient needs and preferences.

Actinic keratosis Market Outlook

The actinic keratosis market offers a range of treatment options, with the growing prevalence of the condition broadening the market's potential. Factors contributing to the increased prevalence include cumulative exposure to ultraviolet radiation, advancing age, childhood sun exposure, a higher proportion of men working outdoors, and populations residing in latitudes near the equator. Treatment approaches are categorized into lesion-directed and field-directed therapies. Lesion-directed therapies focus on targeting individual lesions, while field-directed therapies are used to treat a broader area of the skin.

Among topical therapies, 5-fluorouracil is the most widely used treatment, followed by ALDARA (5% imiquimod), ZYCLARA, SOLARAZE, and others. The other filed-directed therapy option, i.e., Photo Dynamic Therapy (PDT), is also a growing segment of therapy due to its non-invasive approach of treatment along with the emerging concept of daylight PDT; however, PDT accounts for the lowest market share as compared to other therapies. Although the utility of conventional PDT is well proven, it has several limitations that include cost, time-intensive protocols, and most significantly, pain during light absorption. Overall, the actinic keratosis treatment market is poised for robust expansion, supported by advancements in therapeutic options and heightened public awareness of the condition's risks.

Key Actinic Keratosis companies are Vidac Pharma, G&E Herbal Biotechnology, Sandoz Pharmaceuticals and others are evaluating their lead candidates in different stages of clinical development. They aim to investigate their products to treat actinic keratosis.

Actinic Keratosis Drugs Uptake

This section focuses on the uptake rate of potential Actinic Keratosis drugs expected to be launched in the market during 2020-2034. For example VDA-1102, a proprietary small molecule designed to modulate the HK2 enzyme, plays a role in cellular metabolism by preventing its blockade of the VDAC channel in mitochondria and may be particularly effective for advanced actinic keratosis lesions, providing a promising alternative to existing treatments that often have limited efficacy or undesirable side effects.

Actinic Keratosis Pipeline Development Activities

The Actinic Keratosis market report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key Actinic Keratosis companies involved in developing targeted therapeutics.

Pipeline development activities

The Actinic Keratosis market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for actinic keratosis.

KOL Views

To keep up with current Actinic Keratosis market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on Actinic Keratosis evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the University of Colorado Anschutz Medical Campus, Harvard Medical School, University of Buckingham Medical School UK, University Medical Center Hamburg-Eppendorf, Hamburg, Germany, Kobe University School of Medicine, Japan, among others, were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Actinic Keratosis market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Physician's View

There are several challenges in treating actinic keratosis, including dealing with diagnostic uncertainty, as actinic keratosis can sometimes resemble other skin conditions. To increase diagnostic certainty, some physicians use dermatoscope, while others rely on skin biopsies when the diagnosis is unclear or the lesions are atypical. Another challenge is managing extensive or difficult-to-treat lesions, particularly on the face and scalp. Physicians may need to refer patients to dermatologists for more advanced treatments in these cases. Additionally, there are patient misconceptions about actinic keratosis and its treatment.

"As per the KOLs from the US, the most effective way to prevent actinic keratosis is by protecting the skin from UV exposure. This includes using broad-spectrum sunscreen, wearing protective clothing, and avoiding tanning beds."

"As per the KOLs from the UK, treatments like imiquimod, fluorouracil, and diclofenac gels or creams are commonly used to target and destroy abnormal cells in actinic keratosis patients."

"As per the KOLs from Japan, actinic keratosis lesions typically appear as small, rough, and dry patches or plaques on the skin. They can be flesh-colored, pink, red, or brown."

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 emerging Actinic Keratosis 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.

To analyze the effectiveness of these therapies, have calculated their attributed analysis by giving them scores based on their ability to improve atrial and ventricular dimension/function and ability to regulate heart rate.

Further, the therapies' safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. 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.

Actinic Keratosis Market Access and Reimbursement

Increasing healthcare spending and supportive reimbursement policies facilitate patient access to various therapies, including topical treatments like 5-fluorouracil, imiquimod, and tirbanibulin. The growing prevalence of actinic keratosis has led to heightened awareness among healthcare providers and patients, further driving demand for effective treatments. However, challenges remain, such as the need for ongoing education about the importance of treatment adherence and the potential for generic competition following the expiration of patents for some established therapies, which may impact revenue generation in the market. Overall, the combination of favorable policies and an expanding range of treatment options positions the actinic keratosis market for continued growth.

The Actinic Keratosis market report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, 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 Actinic keratosis Market Report

• The Actinic Keratosis market report covers a segment of key events, an executive summary, and a descriptive overview of actinic keratosis explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• 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 actinic keratosis market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The Actinic Keratosis market 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 actinic keratosis market.

Actinic keratosis Market report insights

• Actinic Keratosis Patient Population
• Actinic Keratosis Therapeutic Approaches
• Actinic Keratosis Pipeline Analysis
• Actinic Keratosis Market Size
• Actinic Keratosis Market Trends
• Existing and Future Actinic Keratosis Market Opportunity

Actinic keratosis Market report key strengths

• 11 years Forecast
• The 7MM Coverage
• Actinic Keratosis Epidemiology Segmentation
• Key Cross Competition
• Attribute analysis
• Actinic Keratosis Drugs Uptake
• Key Actinic Keratosis Market Forecast Assumptions

Actinic keratosis Market Report assessment

• Current Treatment Practices
• Actinic Keratosis Unmet Needs
• Actinic Keratosis Pipeline Product Profiles
• Actinic Keratosis Market Attractiveness
• Qualitative Analysis (SWOT and Attribute Analysis)

Key Questions:

Actinic Keratosis Market Insights

• What was the total Actinic Keratosis market size, the market size of actinic keratosis by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• How will VDA-1102 affect the treatment paradigm of actinic keratosis?
• How will ALDARA compete with the upcoming Actinic Keratosis therapies?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and marketed therapies?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Actinic Keratosis Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of actinic keratosis? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to actinic keratosis?
• What is the historical and forecasted actinic keratosis patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• Out of the countries mentioned above, which country would have the highest prevalent actinic keratosis population during the forecast period (2024-2034)?
• What factors are contributing to the growth of actinic keratosis cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of actinic keratosis? What are the current clinical and treatment guidelines for treating actinic keratosis?
• How many Actinic Keratosis companies are developing therapies for the treatment of actinic keratosis?
• How many emerging Actinic Keratosis therapies are in the mid-stage and late stage of development for treating actinic keratosis?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the accessibility issues of approved therapy in the US?
• What is the 7MM historical and forecasted actinic keratosis market?

Reasons to Buy:

• The Actinic Keratosis market report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the actinic keratosis market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing Actinic Keratosis market opportunities in varying geographies and the growth potential over the coming years.
• The distribution of historical and current Actinic Keratosis patient share is based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying upcoming solid players in the Actinic Keratosis market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging Actinic Keratosis therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies for actinic keratosis, barriers to accessibility of approved therapy, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming Actinic Keratosis companies can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Actinic Keratosis Market Overview at a Glance

• 3.1. Market Share (%) Distribution of Actinic Keratosis in 2020
• 3.2. Market Share (%) Distribution of Actinic Keratosis in 2034

4. Methodology of Actinic Keratosis Epidemiology and Market

5. Executive Summary

6. Key Events

7. Disease Background and Overview

• 7.1. Introduction to Actinic Keratosis
• 7.2. Clinical Manifestations
• 7.3. Etiology
• 7.4. Risk Factors
• 7.5. Pathogenesis
• 7.6. Diagnosis
  • 7.6.1. Genetic Basis of Actinic Keratosis
• 7.7. Treatment and Management
  • 7.7.1. Lesion-Directed Therapies: First line treatment
  • 7.7.2. Field-Directed Therapies: Topical Therapies
  • 7.7.3. Photodynamic therapy
  • 7.7.4. Guidelines
    • 7.7.4.1. British Association Of Dermatologists Guidelines For The Care Of Patients With Actinic Keratosis 2017
    • 7.7.4.2. Evidence And Consensus Based (S3) Guidelines For The Treatment Of Actinic Keratosis
  • 7.7.5. Treatment Algorithm

8. Patient Journey

9. Epidemiology and Patient Population

• 9.1. Key Findings
• 9.2. Assumptions and Rationale: The 7MM
  • 9.2.1. Total Prevalent Cases of Actinic Keratosis
  • 9.2.2. Gender-specific Cases of Actinic Keratosis
  • 9.2.3. Treated Cases of Actinic Keratosis
• 9.3. Total Prevalent Cases of Actinic Keratosis in the 7MM
• 9.4. The US
  • 9.4.1. Total Prevalent Cases of Actinic Keratosis
  • 9.4.2. Gender-specific Cases of Actinic Keratosis
  • 9.4.3. Treated Cases of Actinic Keratosis
• 9.5. EU4 and the UK
  • 9.5.1. Total Prevalent Cases of Actinic Keratosis
  • 9.5.2. Gender-specific Cases of Actinic Keratosis
  • 9.5.3. Treated Cases of Actinic Keratosis
• 9.6. Japan
  • 9.6.1. Total Prevalent Cases of Actinic Keratosis
  • 9.6.2. Gender-specific Cases of Actinic Keratosis
  • 9.6.3. Treated Cases of Actinic Keratosis

10. Marketed Drugs

• 10.1. Key Cross Competition
• 10.2. ALDARA: Bausch Health Companies
  • 10.2.1. Product Description
  • 10.2.2. Product Profile
  • 10.2.3. Regulatory Milestones
  • 10.2.4. Other Development Activities
  • 10.2.5. Clinical Trial Information
  • 10.2.6. Safety and Efficacy
• 10.3. SOLARAZE: Sandoz Pharmaceuticals
  • 10.3.1. Product Description
  • 10.3.2. Product Profile
  • 10.3.3. Regulatory Milestones
  • 10.3.4. Other Development Activities
  • 10.3.5. Clinical Trial Information
  • 10.3.6. Safety and Efficacy
• 10.4. KLISYRI (tirbanibulin/KX01/ KX2-391): Athenex/ Almirall
  • 10.4.1. Product Description
  • 10.4.2. Product Profile
  • 10.4.3. Regulatory Milestones
  • 10.4.4. Other Development Activities
  • 10.4.5. Clinical Trial Information
  • 10.4.6. Safety and Efficacy

11. Emerging Drugs

• 11.1. Key Cross Competition
• 11.2. VDA-1102: Vidac Pharma.
  • 11.2.1. Drug Description
  • 11.2.2. Drug Profile
  • 11.2.3. Other Development Activities
  • 11.2.4. Clinical Trial Information
  • 11.2.5. Safety and Efficacy
  • 11.2.6. Analysts' Views
• 11.3. SR-T100 Gel: G & E Herbal Biotechnology
  • 11.3.1. Drug Description
  • 11.3.2. Drug Profile
  • 11.3.3. Other Development Activities
  • 11.3.4. Clinical Trial Information
  • 11.3.5. Safety and Efficacy
  • 11.3.6. Analysts' Views

12. Actinic Keratosis: Market Analysis

• 12.1. Key Findings
• 12.2. Key Market Forecast Assumptions
  • 12.2.1. Cost Assumptions and Rebates
  • 12.2.2. Pricing Trends
  • 12.2.3. Analogue Assessment
  • 12.2.4. Launch Year and Therapy Uptake
• 12.3. Market Outlook
• 12.4. Conjoint Analysis
• 12.5. Total Market Size of Actinic Keratosis in the 7MM
• 12.6. Total Market Size of Actinic Keratosis by Therapies in the 7MM
• 12.7. Market Size of Actinic Keratosis in the US
  • 12.7.1. Total Market Size of Actinic Keratosis in the US
  • 12.7.2. The Market Size of Actinic Keratosis by Therapies in the US
• 12.8. Market Size of Actinic Keratosis in EU4 and the UK
  • 12.8.1. Total Market Size of Actinic Keratosis in the EU4 and the UK
  • 12.8.2. The Market Size of Actinic Keratosis by Therapies in EU4 and the UK
• 12.9. Market Size of Actinic Keratosis in Japan
  • 12.9.1. Total Market Size of Actinic Keratosis in Japan
  • 12.9.2. The Market Size of Actinic Keratosis by Therapies in Japan

13. Key Opinion Leaders' Views

14. SWOT Analysis

15. Unmet Needs

16. Market Access and Reimbursement

• 16.1. The United States
  • 16.1.1. Center for Medicare & Medicaid Services (CMS)
• 16.2. EU4 and the UK
  • 16.2.1. Germany
  • 16.2.2. France
  • 16.2.3. Italy
  • 16.2.4. Spain
  • 16.2.5. The United Kingdom
• 16.3. Japan
  • 16.3.1. MHLW

17. Appendix

• 17.1. Bibliography
• 17.2. Acronyms and Abbreviations
• 17.3. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight