U.S. Actinic Keratosis Treatment Market Rises with Focus on Skin Health

The U.S. actinic keratosis (AK) treatment market was valued at USD 2.32 billion in 2022 and is projected to reach USD 2.94 billion by 2030, expanding at a CAGR of 3.03% from 2024 to 2030. Market growth is driven by the increasing prevalence of actinic keratosis, heightened risk of progression to skin cancer, and the expanding geriatric population in the country. According to JAMA Dermatology, approximately three in every ten older Medicare recipients are affected by AK. Additionally, the market is benefiting from a growing pipeline of investigational candidates and intensified R&D efforts from pharmaceutical companies to develop advanced treatment options.

Data from the American Academy of Dermatology Association highlights that more than 40 million Americans develop AK annually. The condition's prevalence in the U.S. stands at approximately 26.5% among males and 10.2% among females. Contributing risk factors include extensive baldness, a high tendency to sunburn, and skin wrinkling, especially among men. Furthermore, as AK is recognized as the most common pre-cancerous skin condition—where 5% to 10% of cases may progress to squamous cell carcinoma—treatment demand is projected to increase.

Current treatments include home-based topical therapies, cryotherapy, and photodynamic therapy (PDT). Several innovative agents are undergoing clinical development aimed at minimizing adverse effects and improving treatment outcomes. The NIH has identified promising compounds such as resiquimod, betulinic acid, paclitaxel, potassium dobesilate, potassium hydroxide, and celecoxib, which are being explored for their efficacy in treating AK and related skin conditions like cutaneous squamous cell carcinoma.

Further advancements in dermatological therapeutics, including treatments for AK, basal cell carcinoma, and atypical moles, are opening up substantial growth avenues. In October 2022, the Skin Cancer Foundation allocated USD 125,000 in funding to foster innovations in early detection and treatment of skin diseases, including AK.

Supportive efforts from non-profit organizations, along with increased usage of novel medications, are also positively impacting the market. For example, in June 2021, the American Academy of Dermatology introduced updated AK treatment recommendations under its GRADE approach. Additionally, Klisyri, a topical treatment from Almirall, has recorded over 41,000 prescriptions since its U.S. launch, indicating strong market uptake.

Nevertheless, challenges remain. The expiration of patent protection for major drugs like imiquimod, Solaraze, and Efudex has led to an influx of generics, reducing revenue potential. Furthermore, regulatory scrutiny surrounding drug safety and efficacy may hamper market expansion. An example includes Leo Pharma’s discontinuation of Picato in October 2020 due to concerns related to its safety, efficacy, and quality.

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Key Market Trends & Insights

• Therapy-based: The surgery segment dominated with a 76.55% share in 2022 and is expected to maintain its lead.
• Topical/Drugs segment: Nucleoside metabolic inhibitors held the largest share and are expected to continue leading.
• Product-based: 5-fluorouracil was the top-selling product in 2022, accounting for 31.28% of the drug segment.
• End-use-based: Hospitals were the largest end-users, holding a 30.4% revenue share in 2022.

Market Size & Forecast

• 2022 Market Size: USD 2.32 billion
• 2030 Projected Market Size: USD 2.94 billion
• CAGR (2023–2030): 3.03%

Key Companies & Market Share Insights

Leading players are focused on product innovation, partnerships, and strategic acquisitions to enhance their market presence. Notable participants include Bausch Health Companies, Inc., LEO Pharma A/S, Almirall, S.A., Biofrontera AG, GALDERMA, Sun Pharmaceutical Industries Ltd., Novartis AG, Hill Dermaceuticals, Inc., 3M, and Viatris, Inc. For instance, in June 2020, Sun Pharmaceutical Industries showcased results for ODOMZO and LEVULAN KERASTICK + BLU-U, highlighting their efficacy in managing moderate AK.

Browse Horizon Databook for U.S. Actinic Keratosis Treatment Market Size & Outlook

Conclusion

The U.S. actinic keratosis treatment market is poised for steady growth, supported by rising prevalence rates, robust R&D pipelines, and expanding geriatric demographics. Despite challenges such as generic competition and regulatory hurdles, advancements in targeted therapies and increased awareness about early detection and prevention are expected to sustain market momentum. Strategic initiatives by both public organizations and private players will continue to play a vital role in shaping the future of AK treatment in the country.