Global Actinic Keratosis Treatment Market Size, Forecast, and Trend Highlights Over 2025-2037
Actinic Keratosis Treatment Market size was valued at USD 5.5 billion in 2024 and is projected to reach USD 10.1 billion by the end of 2037, rising at a CAGR of 6% during the forecast period, i.e., 2025-2037. In 2025, the industry size of actinic keratosis treatment is assessed at USD 5.8 billion.
According to the American Academy of Dermatology (AAD), the population of people suffering from actinic keratosis (AK) from across the U.S. and Europe was approximately 58.4 million in 2024. It also mentioned that around 50.1% of this epidemiology were aged above 60 and 90.2% of these cases were caused by prolonged UV exposure. Thus, the increasing prevalence of sun-damaged skin conditions and the rapidly aging population are further amplifying this epidemiology. Moreover, the impact of other risk factors, such as genetic disorders, climate change, organ transplantation, long-term outdoor working, and immunosuppression, are also contributing to this expansion in the consumer base for the market.
The payers’ pricing in the actinic keratosis treatment market varies due to changes in the supply chain, API production output, labor costs, transportation expenses, and regulatory compliance. For instance, from 2023 to 2024, the producer price index (PPI) for dermatological drugs in the U.S. witnessed a 4.4% year-over-year (YoY) rise due to heightened expenditure on API procurement and logistics. On the other hand, the consumer price index (CPI) for AK-related treatments was growing at an annual 4.0%, resulting from recent advances in therapeutics. Thus, to minimize this growth in financial barriers companies are focusing on cultivating localized or multiple raw material resources. In this regard, the FDA Drug Shortages Database reported that more than 65.4% of U.S.-based AK medicine manufacturers maintain dual API sourcing.
Actinic Keratosis Treatment Sector: Growth Drivers and Challenges
Growth Drivers
- Growing awareness about skin cancer prevention: An AHRQ study from 2022 demonstrated that early-stage treatment with AK drugs can reduce hospitalization by 22.4%, save USD 850.2 million over 2 years, and prevent squamous cell carcinoma progression. Thus, health authorities across mostly afflicted regions, such as North America and Europe, are prioritizing investments in the actinic keratosis treatment market. For instance, in 2024, a USD 538.3 million fund was allocated by Germany's public healthcare system to AK therapies. This expanded coverage for topical medications by 7.2% YoY. Furthermore, pioneers are applying strategized pricing structures to align with reimbursement criteria to secure maximum capital influx.
- Public and private support for innovations: Continuous participation and investments from pharma in extensive R&D are leveraging product efficacies and patient adherence in the market. In this regard, in 2024, the U.S. National Institutes of Health (NIH) rewarded the nationwide network of AK-associated dermatology research with a USD 350.4 million grant. Moreover, the substantial funding from both public and private organizations to accelerate clinical trials is also fueling growth in this sector. For instance, in 2023, the FDA gave clearance to the commercialization of tirbanibulin (Klisyri), which was intended to treat actinic keratosis within just 5 days while maintaining optimum adherence.
Historical Patient Growth & Its Impact on AK Treatment Market Expansion
The worldwide actinic keratosis treatment market experienced sustained growth due to increasing prevalence of AK, driven by the rapidly aging population and cumulative UV exposure. Between 2010-2020, developed markets such as the U.S., Germany, and Australia demonstrated robust growth in the patient pool due to having maximum fair-skin citizens, who are highly prone to skin cancer. Moreover, the collective contribution of these three landscapes accounted for 70.2% of the net revenue generation in this sector in 2024, reflecting a durable consumer base and underscoring ongoing evolution. Furthermore, the increased access to diagnostic systems and explorations in untapped and emerging markets, such as India and China, encompass greater possibilities for this field.
Historical Patient Growth Data (2010–2020)
|
Country |
2010 Patients (in million) |
2020 Patients (in million) |
CAGR |
Key Driver |
|
U.S. |
12.8 |
19.0 |
4.4% |
Medicare expansion, aging population |
|
Germany |
3.5 |
5.4 |
5.1% |
PHI coverage for cryotherapy |
|
France |
3.1 |
4.6 |
4.7% |
National sun-awareness programs |
|
Spain |
2.2 |
3.3 |
5.0% |
Dermatology clinic proliferation |
|
Australia |
1.5 |
2.8 |
7.9% |
UV radiation policy interventions |
|
Japan |
2.8 |
3.4 |
2.4% |
High out-of-pocket costs |
|
India |
1.1 |
2.0 |
8.1% |
Urbanization, rising diagnostics |
|
China |
1.8 |
4.2 |
10.3% |
Healthcare infrastructure growth |
Feasible Expansion Models Shaping the AK Treatment Market
Strategic alliance formation for cost-optimization is revolutionizing and leveraging accessibility in the Actinic Keratosis Treatment market across underpenetrated landscapes. This presents remarkable commercial and economic benefits. For instance, collaborations between local API manufacturers and generic drug producers have reduced treatment costs by 35.4%, leading to a 22% increment in patient adoption. On the other hand, the U.S. healthcare system saved USD 320.3 million from Medicare spending through utilizing value-based bulk procurement and payment models. These efforts are enhancing competency in both revenue generation and cost reduction. Furthermore, the ongoing R&D cohorts to integrate AI-powered triage and remote consultations are escalating the rate of adoption in this sector.
Revenue Feasibility Models (2020–2024)
|
Region |
Strategy |
Revenue Impact |
|
India |
Local API partnerships |
+12.3% revenue (2022–2024) |
|
U.S. |
Medicare-combo therapies |
USD 320.5 million cost savings |
|
Germany |
Cryo-device leasing programs |
+9.1% adoption (2023) |
|
Japan |
Biosimilar subsidies |
40.2% cost reduction |
Challenge
- Disparities in financial and commercial aspects: The high cost of dermatology procedures is a major hurdle in the actinic keratosis treatment market. Shortage of adequate reimbursement policies and out-of-pocket expenses often limits access to advanced therapeutics. For instance, in 2024, over 30.1% of the patients undergoing related therapies in the U.S. discontinued due to excessive financial exhaustion, as per the ADD report. Furthermore, the stringent criteria for maintaining regulatory compliance may also delay product launches and raise the overall pricing, creating hesitance among both new market entrants and consumers in investing. However, the recent developments in this sector are introducing more cost-effective solutions to mitigate this barrier.
Actinic Keratosis Treatment Market: Key Insights
| Report Attribute | Details |
|---|---|
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
6% |
|
Base Year Market Size (2024) |
USD 5.5 billion |
|
Forecast Year Market Size (2037) |
USD 10.1 billion |
|
Regional Scope |
|
Actinic Keratosis Treatment Segmentation
Treatment Type (Topical, Cryotherapy, Photodynamic Therapy)
Based on treatment type, the topical segment is expected to dominate the actinic keratosis treatment market with a share of 38.4% throughout the assessed timeline. The clinically proven efficacy of this subtype in preventing worsened conditions of AK, such as skin cancer, while maintaining its cost-effectiveness is making this segment a priority for consumers and pharma producers. For instance, a study demonstrated that Fluorouracil is capable of targeting and combating precancerous cells with a remarkable range of complete AK clearance, lying between 60.2% and 90.4%. Moreover, the efficiency of this type of therapy in fighting against multiple AK lesions has influenced dedicated organizations to expand their reimbursement coverage, improving accessibility and increasing adoption in this segment.
End user (Hospitals, Dermatology Clinics, Retail Pharmacies)
In terms of end user, the dermatology clinics segment is poised to hold the largest share of 45.3% in the actinic keratosis treatment market by 2037. With the presence of specially trained professionals and dedicated infrastructure, these clinical settings have become the first point-of-care establishments for personalized dermatology services. Additionally, the perfect alignment of their regular practices with universal protocols and government initiatives are inspiring more patients to invest in this segment. In this regard, the American Academy of Family Physicians (AAFP) revealed that the demand for AK treatment from these service providers increased by 25.2% due to the widespread awareness about the importance of early diagnosis and management of this condition in preventing squamous cell carcinoma (SCC) progression.
Our in-depth analysis of the global market includes the following segments:
|
Treatment Type |
|
|
End user |
|
Vishnu Nair
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Actinic Keratosis Treatment Industry - Regional Synopsis
North America Market Analysis
The North America actinic keratosis treatment market is anticipated to garner the highest share of 42.4% in the global landscape over the analyzed period. The region’s captivity on the majority proportion of the worldwide patient pool and robust healthcare system are fueling its dominance over others. For instance, in 2025 the population of citizens with AK surpassed 50.1 million and 3.7 million in the U.S. and Canada, respectively. Particularly, in the sunbelt states, including Arizona, Florida, and California, the residents are more prone to developing this ailment due to heavy UV exposure and rapid aging. Thus, the governing authorities across these demanding marketplaces are implementing favorable policies and initiatives to attract both domestic and foreign pioneers to invest in this field.
The undisputed leadership of the U.S. in the market is primarily fueled by the rising prevalence and mortality of SCC and Federal investments. This country contributes to more than 90.1% of the regional revenue generation in this field, which can be testified by the nationwide annual conduction of AK-associated procedures to be 5.5 million. Thus, to make advanced treatments, such as cryotherapy and photodynamic therapy, more accessible to these patients, the Medicare coverage for this category expanded up to 1.3 billion in 2023. Moreover, the efforts for maintaining an undisrupted supply chain to back these emerging segments, where the annual imports of cryotherapy systems in the U.S. reached 420.2 million, is fueling growth in this sector.
APAC Market Statistics
Asia Pacific is predicted to register the highest CAGR in the global actinic keratosis treatment market by the end of 2037. The region’s accelerated pace of progress is stimulated by the growing adoption of technologically advanced diagnostic tools and awareness about SCC prevention. In this regard, the 2023 NIH report projected the annual regionwide surge in AK diagnosis to be 9.2% by 2030, mostly driven by the rapid aging and excessive sunlight afflictions among citizens. For instance, in 2023, extreme solar radiation caused AK in over 40.1% of the adults aged 40 and over in Australia, as per the Australian Institute of Health and Welfare (AIHW). As a respond, the government in this country commenced a national skin cancer screening program, SunSmart Initiative, promoting the benefits of investing in this sector.
India is emerging as the world’s biggest supplier of essential ingredients and components used during the production in the actinic keratosis treatment market. For instance, India supplies AK drug APIs for more than 30.3% demand in the U.S., according to the U.S. International Trade Commission. Additionally, government-initiated campaigns are spreading knowledge about the available diagnosis and treatment options for AK, propelling wide adoption in this sector across the nation. Their interest on improving public access to most effective curatives can also be testified by the country’s yearly medical expenditure of USD 2.0 billion on AK therapies, backing the treatment of over 2.6 million afflicted residents. Further, the nation is focusing on eliminating the reliance on foreign forces for finished product manufacturing in this field.
Companies Dominating the Actinic Keratosis Treatment Landscape
With the continuous efforts from key players to leverage their potential in delivering the highest quality care and cure, the market is fostering a healthy competency. For instance, LEO Pharma, in collaboration with Almirall, is focusing on the expansion of their existing AK pipeline, including Klisyri for forearms, to grab new revenue opportunities with a wider field of application and consumer base. Simultaneously, the alliance of Sun Pharma and Cipla concentrated on developing value-based generics to reduce the gap in affordability for price-sensitive marketplaces, such as India. On the other hand, in 2024, Biofrontera partnered with Pfizer to invest up to USD 200.2 million to develop innovative hybrid therapies, combining photodynamic therapy and immunotherapy.
This cohort of world’s top 20 innovators and pioneers include:
|
Company Name |
Country |
Market Share (2024) (in %) |
Industry Focus & Notable Products |
|
LEO Pharma |
Denmark |
18.8 |
Topical therapies (Klisyri), cryotherapy solutions |
|
Almirall |
Spain |
12.6 |
Field-directed treatments (KX-01), photodynamic therapy (PDT) |
|
Galderma |
Switzerland |
11.0 |
Fluorouracil creams (Efudex), laser-based AK treatments |
|
Sun Pharmaceutical Industries |
India |
9.2 |
Generic AK drugs (5-FU, imiquimod), cost-effective solutions |
|
Bausch Health |
Canada |
7.5 |
Combination therapies (5-FU + salicylic acid), dermatology-focused R&D |
|
Pfizer |
USA |
xx |
Ingenol mebutate (Picato), immunomodulators |
|
Novartis |
Switzerland |
xx |
Topical retinoids, emerging AK biologics |
|
Mylan (Viatris) |
USA |
xx |
Generic AK treatments, tele-dermatology partnerships |
|
Perrigo Company |
Ireland |
xx |
OTC AK therapies, store-brand dermatology products |
|
Taro Pharmaceutical |
Israel |
xx |
Low-cost topical generics, emerging markets focus |
|
Cipla |
India |
xx |
Affordable AK creams, API manufacturing |
|
Mayne Pharma |
Australia |
xx |
Specialty generics, cryotherapy devices |
|
Hisamitsu Pharmaceutical |
Japan |
xx |
Transdermal AK patches (Tegafur), targeted drug delivery |
|
Maruho Co. |
Japan |
xx |
Japan-focused AK treatments (Tirbanibulin) |
|
Biofrontera |
Germany |
xx |
PDT systems (Ameluz), light therapy devices |
|
Medimetriks Pharmaceuticals |
USA |
xx |
Topical AK formulations (Solage), niche dermatology products |
|
Hikma Pharmaceuticals |
UK |
xx |
Generic AK drugs, MENA market expansion |
|
LG Chem Life Sciences |
South Korea |
xx |
Novel AK biologics, Asia-Pacific distribution |
|
Pharmaderm |
USA |
xx |
Hospital-supplied AK treatments, compounding solutions |
|
Duopharma Biotech |
Malaysia |
xx |
Regional AK generics, ASEAN market penetration |
Recent Developments
- In June 2024, Almirall attained the supplemental New Drug Application clearance from the FDA for the expanded use of its AK drug, Klisyri, for larger treatment areas (up to 100 cm²). This microtubule inhibitor ointment is available in a 350 mg package size and is a 5-day topical field treatment for actinic keratosis (AK) of the face or scalp.
- In the 3rd quarter of 2024, Biofrontera filed for the increased 30% ALA HCl dosage, enhancing the efficacy of its photodynamic therapy (PDT) portfolio, treating actinic keratosis. This strategic move was intended to redefine PDT standards and solidifying the company’s leadership in the light-based therapies segment.
- Report ID: 1527
- Published Date: May 23, 2025
- Report Format: PDF, PPT
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