Actinic Keratosis Market Size in the 7MM is projected to grow at a significant CAGR by 2034, estimates DelveInsight

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

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Key Takeaways from the Actinic Keratosis Market Report

* In October 2025, Case Comprehensive Cancer Center announced a clinical trial is to see if shorter Photodynamic Therapy (PDT) treatment times will still be effective at treating actinic keratoses (AK) while reducing or eliminating the pain that patients sometimes experience during conventional PDT treatment.
* 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%).
* The leading Actinic Keratosis Companies such as VidacPharma, DFB Soria, G&E Herbal Biotechnology, Promius Pharma, Sol-Gel Technologies, PROVECTUS BIOPHARMACEUTICALS, Coegin Pharma, Jupiter Wellness, MedC Biopharma CorporationGlaukos Corporation, Ivantis Inc., Allergan, Ellex, Alcon, BVI, Johnson and Johnson Services, Inc., Microsurgical technology, Molteno Ophthalmic Ltd. ,New World Medical , Santen Pharmaceutical, Sight Scientific, Topcon Corporation, Merck & Co., Inc., Carl Zeiss AG, Alimera Sciences, Annexin Pharmaceuticals, Amgen Inc., Cangene Corporation, BD and Bosch Healthcare Solutions GmbH and others.
* Promising Actinic Keratosis Therapies such as AVX001, VDA-1102 , Fluorouracil, Imiquimod 3.75% Cream, Tirbanibulin 2.5 mg ointment, KX01 ointment 1%, Tretinoin 0,05% cream, Bimiralisib, Solcera, LAS41005, LAS106521 and others.

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Actinic Keratosis Epidemiology Segmentation in the 7MM

* Total Actinic Keratosis Prevalent Cases
* Actinic Keratosis Gender-specific Cases
* Actinic Keratosis Treated Cases

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Actinic Keratosis Marketed 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.

* 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.

* 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.

Actinic Keratosis Emerging 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.

Actinic Keratosis Drugs Market 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.

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Actinic Keratosis Therapies and Companies

* Almirall S.A.: Tirbanibulin 2.5 mg ointment
* PharmaEssentia: KX01 ointment 1%
* Vidac Pharma: 10% VDA-1102
* TORQUR: Bimiralisib
* Infectopharm Arzneimittel GmbH: Solcera

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.

Scope of the Actinic Keratosis Market Report

- Study Period: 2020-2034

- Coverage: 7MM

- Actinic Keratosis Companies- VidacPharma, DFB Soria, G&E Herbal Biotechnology, Promius Pharma, Sol-Gel Technologies, PROVECTUS BIOPHARMACEUTICALS, Coegin Pharma, Jupiter Wellness, MedC Biopharma CorporationGlaukos Corporation, Ivantis Inc., Allergan, Ellex, Alcon, BVI, Johnson and Johnson Services, Inc., Microsurgical technology, Molteno Ophthalmic Ltd. ,New World Medical , Santen Pharmaceutical, Sight Scientific, Topcon Corporation, Merck & Co., Inc., Carl Zeiss AG, Alimera Sciences, Annexin Pharmaceuticals, Amgen Inc., Cangene Corporation, BD and Bosch Healthcare Solutions GmbH and others.

- Actinic Keratosis Therapies- AVX001, VDA-1102 , Fluorouracil, Imiquimod 3.75% Cream, Tirbanibulin 2.5 mg ointment, KX01 ointment 1%, Tretinoin 0,05% cream, Bimiralisib, Solcera, LAS41005, LAS106521 and others.

- Actinic Keratosis Therapeutic Assessment: Actinic Keratosis current marketed and Actinic Keratosis emerging therapies

- Actinic Keratosis Market Dynamics: Actinic Keratosis market drivers and Actinic Keratosis market barriers

- Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies

- Actinic Keratosis Unmet Needs, KOL's views, Analyst's views, Actinic Keratosis Market Access and Reimbursement

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Table of Contents

1. Actinic Keratosis Market Report Introduction

2. Executive Summary for Actinic Keratosis

3. SWOT analysis of Actinic Keratosis

4. Actinic Keratosis Patient Share Overview at a Glance

5. Actinic Keratosis Market Overview at a Glance

6. Actinic Keratosis Disease Background and Overview

7. Actinic Keratosis Epidemiology and Patient Population

8. Country-Specific Patient Population of Actinic Keratosis

9. Actinic Keratosis Current Treatment and Medical Practices

10. Actinic Keratosis Unmet Needs

11. Actinic Keratosis Emerging Therapies

12. Actinic Keratosis Market Outlook

13. Country-Wise Actinic Keratosis Market Analysis

14. Actinic Keratosis Market Access and Reimbursement of Therapies

15. Actinic Keratosis Market Drivers

16. Actinic Keratosis Market Barriers

17. Actinic Keratosis Appendix

18. Actinic Keratosis Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About Us

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