Actinic Keratosis - Market Insight, Epidemiology, and Market Forecast - 2034

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.