U.S. Actinic Keratosis Treatment Market Size, Share, Trends & Growth Report, 2033
The U.S. actinic keratosis treatment market size was valued at USD 2.94 billion in 2023 and is projected to surpass around USD 3.96 billion by 2033, registering a CAGR of 3.04% over the forecast period of 2024 to 2033.
The increasing prevalence of actinic keratosis, the increased risk of developing skin cancer, and the surge in the geriatric population of the country are the major driving growth factors. For instance, according to a report published in JAMA Dermatology, actinic keratosis affects around three of every 10 older Medicare recipients. Moreover, the presence of potential investigational candidates in the pipeline and the rising R&D efforts from pharmaceutical companies to develop novel treatment approaches for actinic keratosis are likely to contribute to market expansion over the forecast period.
According to the American Academy of Dermatology Association, more than 40 million Americans develop AK each year and the overall prevalence rate of AK in the U.S. is estimated to be about 26.5% in males and 10.2% in females. Factors such as severe baldness, the high tendency of sunburn, and skin wrinkling may increase the predisposition to AK in the male population. In addition, it is the most common pre-cancerous dermatological condition, around 5-10% of actinic keratosis can develop into Squamous cell carcinoma. Thus, the increasing prevalence of AK is anticipated to increase the treatment rate in the country.
Currently, treatment approaches such as home-based treatments with topical preparations, cryotherapy, and PDT are commonly employed to treat actinic keratosis. Moreover, several novel agents are under development phases to reduce adverse events, which is expected to increase the adoption rate of treatment of actinic keratosis. For instance, according to the NIH, some of the novel drugs being investigated for AK are resiquimod, betulinic acid, paclitaxel, potassium dobesilate, potassium hydroxide, and celecoxib. These therapeutic drugs are directed toward personalized treatment for patients having AK lesions as well as symptoms of cutaneous SCC.
In addition, the ongoing efforts to develop next-generation therapeutics for various dermatological disorders including AK, basal cell carcinoma, and atypical moles are expected to offer lucrative growth opportunities for the market. For instance, in October 2022, the Skin Cancer Foundation granted USD 125,000 to researchers to manage dermatological applications. This funding is mainly intended to promote innovation for the early detection and treatment of skin diseases such as AK.
Furthermore, higher rates of actinic keratosis treatment and increasing novel medicines usage in the country along with favorable initiatives from non-profit organizations to prevent actinic keratosis is a growth rendering factor for the market. For instance, in June 2021, the American Academy of Dermatology published new recommendations for the treatment of AK with its new GRADE approach. Moreover, according to Almirall’s presentation, the prescription of Klisyri in the U.S. AK topical market has increased by over 41,000 prescriptions since its launch.
However, most treatment options such as imiquimod, Solaraze, and Efudex have lost their patent exclusivities in the U.S., leading to the penetration of generics in the market. Genericization is expected to lower the revenue generation capacity of the market, thereby impeding market growth. Moreover, a stringent regulatory framework related to the safety and efficacy of drugs is further anticipated to reduce market growth over the forecast period. For instance, in October 2020, Leo Pharma’s Picato, a topical gel used to treat AK, was discontinued due to safety, efficacy, and quality reasons.
| Report Attribute | Details |
| Market Size in 2024 | USD 3.03 Billion |
| Market Size by 2033 | USD 3.96 Billion |
| Growth Rate From 2024 to 2033 | CAGR of 3.04% |
| Base Year | 2023 |
| Forecast Period | 2024 to 2033 |
| Segments Covered | Therapy, drug class, product, end-use |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Key Companies Profiled | Bausch Health Companies, Inc.; LEO Pharma A/S; Almirall, S.A; Biofrontera AG; GALDERMA; Sun Pharmaceutical Industries Ltd.; Novartis AG; Hill Dermaceuticals, Inc.; 3M; Viatris, Inc. |
The surgery segment held the largest share of 77.35% in 2023 and is anticipated to continue leading during the projected period. The higher demand for complete disease eradication and high penetration of cryotherapy procedures are fueling segment uptake. However, the topical/drugs segment held the second largest share owing to the increasing trend for home-based treatment, lesser possibility of adverse effects, higher preference by medical professionals for topical treatments, and ongoing regulatory approvals. For instance, in December 2020, the U.S. FDA approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis. Some of the common topical brands available for AK treatment are Carac, Efudex, Tolak, and Aldara among others.
However, the photodynamic therapy segment is projected to register the fastest growth rate over the forecast period. Factors such as the high site specificity of PDT, less incidence of adverse effects, the high adoption rate for long-term treatments, and great efficiency in patients with multiple skin lesions are responsible for the lucrative growth rate of the segment. In addition, significant clinical studies to enhance outcomes from PDT are other factors contributing to segment growth. For instance, in November 2022, Biofrontera Inc. announced the initiation of a phase-3 clinical study to evaluate the safety of BF-RhodoLED-XL and Ameluz in the management of AK.
Based on topical/drugs segment, the nucleoside metabolic inhibitors dominated the market and is projected to hold a significant market share during the forecast period. The high growth rate of the segment is owing to the strong commercial performance of Fluroplex, Carac, and Efudex along with a higher demand for topical formulations to treat the initial stages of the condition. Moreover, the rising awareness regarding the diagnosis and treatment of disease has further fueled the segment’s growth.
The photoenhancers segment is anticipated to grow at the fastest rate throughout the forecast period. Factors including high efficacy, convenient handling, better skin rejuvenation, high healing rates, and lower recurrence rates of lesions are increasing the adoption of photoenhancers. In addition, the surge in demand for actinic keratosis treatment has also fueled segment uptake at a substantial rate. For instance, in 2021 an estimated 13.2 million actinic keratosis treatments were performed in the U.S.
Furthermore, several strategic initiatives undertaken by leading participants are another potential factor fueling segment growth. For instance, in March 2022, Biofrontera announced that the U.S. FDA added a patent for a novel RhodoLED XL lamp for performing PDT with its candidate Ameluz.
5-fluorouracil was the leading segment in 2023 having a 32.28% share of AK drugs in the country. Higher instances of reliable treatment and relatively lower chances of non-response to 5-FU are increasing the adoption of the drug for the treatment of actinic keratosis. In addition, the highest proven efficacy of up to 74% and significant therapeutic results are also expected to cater to the product demand. Moreover, owing to the high clearance rates it reduced the chance of developing squamous cell carcinoma.
The recent product approvals, strong commercial performance, satisfactory results in clinical trials, and fewer chances of remission are fueling the high growth rate of the tirbanibulin segment. Moreover, increasing awareness regarding the use of the product among the target population is further propelling the segment’s growth. For instance, in May 2022, Almirall partnered with Euromelanoma for raising awareness about skin conditions.
The hospitals segment captured the largest revenue share of 31% in 2023. Factors such as treatment accessibility, high penetration of surgery, and increasing photodynamic therapy procedures performed in hospitals are supporting the segment share. Moreover, the increase in the number of physician-assisted therapies like cryotherapy, PDT, and laser therapy in moderate to severe cases of actinic keratosis is expected to fuel the segment growth over the forecast period.
Whereas, the homecare segment is likely to be the fastest-growing segment during the coming years. The growth of the segment is attributed to the rising adoption of topical products, patient convenience factors, availability of OTC products, and the increasing launch of products for topical use. The homecare segment has witnessed an increased demand owing to the rising availability of topical products including imiquimod, 5-FU, diclofenac, and trainline among others.
Key players are adopting new product development, merger & acquisition, and partnership strategies to increase their market share. Market players such as Bausch Health Companies, Inc., LEO Pharma A/S, Almirall, S.A., Biofrontera AG, and others are actively involved in the development of therapeutics for actinic keratosis. For instance, in June 2020, Sun Pharmaceutical Industries Ltd. presented the results of its two specialty medicines ODOMZO and LEVULAN KERASTICK + BLU-U from its skincare portfolio. The data analysis provides insights for using BLU-U+ LEVULAN KERASTICK to treat moderate actinic keratosis. Some prominent players in the U.S. actinic keratosis treatment market include:
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. Actinic Keratosis Treatment market.
By Therapy
By Drug Class
By Product
By End-use
Chapter 1 Methodology and Scope
1.1 Market Segmentation and Scope
1.1.1 Segment scope
1.1.2 Regional scope
1.1.3 Estimates and forecast timeline
1.2 Research Methodology
1.3 Information Procurement
1.3.1 Purchased database:
1.3.2 nova one advisor internal database
1.3.3 Secondary sources
1.3.4 Primary research
1.3.5 Details of primary research
1.4 Information or Data Analysis
1.4.1 Data analysis models
1.5 Market Formulation & Validation
1.6 Model Details
1.6.1 Commodity Flow Analysis
1.6.1.1 Approach: Commodity Flow Approach
1.7 Research Assumptions
1.8 List of Secondary Sources
1.9 List of Abbreviations
1.10 Objectives
1.10.1 Objective 1
1.10.2 Objective 2
1.10.3 Objective 3
1.10.4 Objective 4
Chapter 2 Executive Summary
2.1 Market Outlook
2.2 Competitive Insights
Chapter 3 U.S. Actinic Keratosis Treatment Market Variables, Trends, & Scope
3.1 Market Lineage Outlook
3.1.1 Parent market
3.2 Market Dynamics
3.2.1 Market drivers analysis
3.2.1.1 Increasing disease prevalence
3.2.1.2 Preventive strategies
3.2.1.3 Easy availability of treatment
3.2.2 Market restraint analysis
3.2.2.1 Lack of consumer awareness
3.2.2.2 Generic penetration
3.3 Penetration & Growth Prospect Mapping
3.4 Influenza Vaccine: Market Analysis Tools
3.4.1 Industry analysis - Porter’s
3.4.2 PESTLE analysis
3.5 Regulatory Framework
3.6 Pricing Analysis
Chapter 4 U.S. Actinic Keratosis Treatment Market Segment Analysis, By Therapy, 2021 - 2033
4.1 Definition and Scope
4.2 Therapy Market Share Analysis, 2022 & 2030
4.3 Segment Dashboard
4.4 U.S. Actinic Keratosis Treatment Market, by Therapy, 2024 to 2033
4.5 Market Size & Forecasts and Trend Analyses, 2024 to 2033
4.5.1 Topical/Drugs
4.5.1.1 Topical/Drugs market estimates and forecast, 2021 - 2033
4.5.2 Surgery
4.5.2.1 Surgery market estimates and forecast, 2021 - 2033
4.5.2.2 Cryotherapy
4.5.2.2.1 Cryotherapy market estimates and forecast, 2021 - 2033
4.5.2.3 Others
4.5.2.3.1 Others market estimates and forecast, 2021 - 2033
4.5.3 Photodynamic Therapy
4.5.3.1 Photodynamic therapy market estimates and forecast, 2021 - 2033
Chapter 5 U.S. Actinic Keratosis Treatment Market Segment Analysis, By Product 2021 - 2033 (Volume, Number of Units Sold)
5.1 Definition and Scope
5.2 Product Market Share Analysis, 2022 & 2030
5.3 Segment Dashboard
5.4 U.S. Actinic Keratosis Treatment Market, by Product, 2024 to 2033
5.5 Market Size & Forecasts and Trend Analyses, 2024 to 2033
5.5.1 5-fluorouracil
5.5.1.1 5-fluorouracil market estimates and forecast, 2021 - 2033
5.5.1.2 Carac
5.5.1.2.1 Carac market estimates and forecast, 2021 - 2033
5.5.1.3 Fluoroplex
5.5.1.3.1 Fluoroplex market estimates and forecast, 2021 - 2033
5.5.1.4 Actikerall
5.5.1.4.1 Actikerall market estimates and forecast, 2021 - 2033
5.5.1.5 Tolak
5.5.1.5.1 Tolak market estimates and forecast, 2021 - 2033
5.5.1.6 Others
5.5.1.6.1 Others market estimates and forecast, 2021 - 2033
5.5.2 Diclofenac
5.5.2.1 Diclofenac market estimates and forecast, 2021 - 2033
5.5.2.2 Solaraze
5.5.2.2.1 Solaraze market estimates and forecast, 2021 - 2033
5.5.2.3 Voltaren
5.5.2.3.1 Voltaren market estimates and forecast, 2021 - 2033
5.5.2.4 Pennsaid
5.5.2.4.1 Pennsaid market estimates and forecast, 2021 - 2033
5.5.2.5 Others
5.5.2.5.1 Others market estimates and forecast, 2021 - 2033
5.5.3 Imiquimod
5.5.3.1 Imiquimod market estimates and forecast, 2021 - 2033
5.5.3.2 Aldara
5.5.3.2.1 Aldara market estimates and forecast, 2021 - 2033
5.5.3.3 Zyclara
5.5.3.3.1 Zyclara market estimates and forecast, 2021 - 2033
5.5.3.4 Others
5.5.3.4.1 Others market estimates and forecast, 2021 - 2033
5.5.4 Tirbanibulin
5.5.4.1 Tirbanibulin market estimates and forecast, 2021 - 2033
5.5.5 Capecitabine
5.5.5.1 Capecitabine market estimates and forecast, 2021 - 2033
5.5.5.2 Xeloda
5.5.5.2.1 Xeloda market estimates and forecast, 2021 - 2033
5.5.5.3 Others
5.5.5.3.1 Others market estimates and forecast, 2021 - 2033
5.5.6 Aminolevulinic acid
5.5.6.1 Aminolevulinic acid market estimates and forecast, 2021 - 2033
5.5.6.2 Ameluz
5.5.6.2.1 Ameluz market estimates and forecast, 2021 - 2033
5.5.6.3 Levulan
5.5.6.3.1 Levulan market estimates and forecast, 2021 - 2033
5.5.7 Porfimer sodium
5.5.7.1 Porfimer sodium market estimates and forecast, 2021 - 2033
5.5.8 Others
5.5.8.1 Others market estimates and forecast, 2021 - 2033
5.5.8.2 Gemzar
5.5.8.2.1 Gemzar market estimates and forecast, 2021 - 2033
5.5.8.3 Clolar
5.5.8.3.1 Clolar market estimates and forecast, 2021 - 2033
5.5.8.4 Vidaza
5.5.8.4.1 Vidaza market estimates and forecast, 2021 - 2033
5.5.8.5 Metvix
5.5.8.5.1 Metvix market estimates and forecast, 2021 - 2033
5.5.8.6 Others
5.5.8.6.1 Others market estimates and forecast, 2021 - 2033
Chapter 6 U.S. Actinic Keratosis Treatment Market Segment Analysis, By Drug Class, 2021 - 2033
6.1 Definition and Scope
6.2 Drug Class Market Share Analysis, 2022 & 2030
6.3 Segment Dashboard
6.4 U.S. Actinic Keratosis Treatment Market, by Drug Class, 2024 to 2033
6.5 Market Size & Forecasts and Trend Analyses, 2024 to 2033
6.5.1 Nucleoside metabolic inhibitors
6.5.1.1 Nucleoside metabolic inhibitors market estimates and forecast, 2021 - 2033
6.5.2 Nonsteroidal anti-inflammatory drugs
6.5.2.1 Nonsteroidal anti-inflammatory drugs market estimates and forecast, 2021 - 2033
6.5.3 Immune response modifiers
6.5.3.1 Immune response modifiers market estimates and forecast, 2021 - 2033
6.5.4 Photoenhancers
6.5.4.1 Photoenhancers market estimates and forecast, 2021 - 2033
6.5.5 Others
6.5.5.1 Others market estimates and forecast, 2021 - 2033
Chapter 7 U.S. Actinic Keratosis Treatment Market Segment Analysis, By End-use, 2021 - 2033
7.1 Definition and Scope
7.2 End-use Market Share Analysis, 2022 & 2030
7.3 Segment Dashboard
7.4 U.S. Actinic Keratosis Treatment Market, by End-use, 2024 to 2033
7.5 Market Size & Forecasts and Trend Analyses, 2024 to 2033
7.5.1 Hospitals
7.5.1.1 Hospitals market estimates and forecast, 2021 - 2033
7.5.2 Private clinics
7.5.2.1 Private clinics market estimates and forecast, 2021 - 2033
7.5.3 Homecare
7.5.3.1 Homecare market estimates and forecast, 2021 - 2033
7.5.4 Others
7.5.5.1 Others market estimates and forecast, 2021 - 2033
Chapter 8 U.S. Actinic Keratosis Treatment Market Segment Analysis, By Region, 2021 - 2033
8.1 Definition & Scope
8.2 Regional Market Share Analysis, 2022 & 2030
8.3 Regional Market Dashboard
8.4 Regional Market Snapshot
8.5 SWOT Analysis
8.6 Market Size, & Forecasts, Revenue and Trend Analysis, 2022 to 2030
8.6.1 U.S.
8.6.1.1 U.S. actinic keratosis treatment market estimates and forecasts, 2021 - 2033
8.6.1.2 U.S.
8.6.1.2.1 Key Country Dynamics
8.6.1.2.2 Competitive Scenario
8.6.1.2.3 Regulatory Framework
8.6.1.2.4 Reimbursement Scenario
Chapter 9 U.S. Actinic Keratosis Treatment Market - Competitive Analysis
9.1 Recent Developments & Impact Analysis, by Key Market Participants
9.1.1 Ansoff matrix
9.1.2 Heat map analysis
9.1.3 Major Deals and Strategic Alliances Analysis
9.1.3.1 Joint Ventures
9.1.3.2 Licensing Agreements
9.1.3.3 Product Launches
9.1.3.1 Conferences and Campaigns
9.2 Company Categorization
9.2.1 Innovators
9.2.2 Market Leaders
9.3 Vendor Landscape
9.3.1 List of key distributors and channel partners
9.3.2 Key customers
9.4 Public Companies
9.4.1 Competitive Dashboard Analysis
9.4.1.1 Market Differentiators
9.5 Private Companies
9.5.1 List of key emerging companies
9.6 Company Profiles
9.6.1 Bausch Health Companies, Inc
9.6.1.1 Company overview
9.6.1.2 Financial performance
9.6.1.3 Product benchmarking
9.6.1.4 Strategic Initiatives
9.6.2 LEO Pharma A/S
9.6.2.1 Company overview
9.6.2.2 Financial performance
9.6.2.3 Product benchmarking
9.6.2.4 Strategic Initiatives
9.6.3 Almirall, S.A
9.6.3.1 Company overview
9.6.3.2 Financial performance
9.6.3.3 Product benchmarking
9.6.3.4 Strategic Initiatives
9.6.4 Biofrontera AG
9.6.4.1 Company overview
9.6.4.2 Financial performance
9.6.4.3 Product benchmarking
9.6.4.4 Strategic Initiatives
9.6.5 GALDERMA
9.6.5.1 Company overview
9.6.5.2 Financial performance
9.6.5.3 Product benchmarking
9.6.5.4 Strategic Initiatives
9.6.6 Sun Pharmaceutical Industries Ltd
9.6.6.1 Company overview
9.6.6.2 Financial performance
9.6.6.3 Product benchmarking
9.6.6.4 Strategic Initiatives
9.6.7 Novartis AG
9.6.7.1 Company overview
9.6.7.2 Financial performance
9.6.7.3 Product benchmarking
9.6.7.4 Strategic initiatives
9.6.8 Hill Dermaceuticals, Inc
9.6.8.1 Company overview
9.6.8.2 Financial performance
9.6.8.3 Product benchmarking
9.6.8.4 Strategic initiatives
9.6.9 Viatris Inc.
9.6.9.1 Company overview
9.6.9.2 Financial performance
9.6.9.3 Product benchmarking
9.6.9.4 Strategic initiatives
9.6.10 3M
9.6.10.1 Company overview
9.6.10.2 Financial performance
9.6.10.3 Product benchmarking
9.6.10.4 Strategic initiatives
Cross-segment Market Size and Analysis for
Mentioned Segments
Additional Company Profiles (Upto 5 With No Cost)
Additional Countries (Apart From Mentioned Countries)
Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers