Cutaneous Squamous cell Carcinoma Market
- The Cutaneous Squamous Cell Carcinoma Market Size is anticipated to grow with a significant CAGR of study period (2020-2034).
- Cutaneous squamous cell carcinoma (cSCC) is a type of keratinocyte carcinoma that originates from the epidermal keratinocytes and can arise from actinic keratosis.
- The market is anticipated to witness a substantial positive shift owing to better uptake of existing drugs, the expected market launch of therapies, and raised awareness.
- The United States accounts for the largest market size of Cutaneous Squamous Cell Carcinoma (CSCC), in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
- Systemic treatment options used for advanced CSCC include immunotherapy with programmed death receptor-1 (PD-1) blocking antibodies, epidermal growth factor receptor (EGFR) inhibitors, chemotherapy, and electrochemotherapy. Currently, the anti-PD-1 agent LIBTAYO (cemiplimab) is the only approved systemic treatment for CSCC in Europe.
- KEYTRUDA and LIBTAYO are the two currently approved therapies for metastatic CSCC.
- In January 2024, Medison Pharma announced agreement with Regeneron Pharmaceuticals to commercialize LIBTAYO in select European markets and additional markets around the world.
- The major pharma players currently developing therapies for CSCC include Incyte Corporation (INCB99280), Sirnaomics (STP705), NeoImmuneTech (NT-I7), Checkpoint Therapeutics (cosibelimab), and others.
- In December 2023, Checkpoint received a complete response letter (CRL) from the FDA regarding the cosibelimab Biologics License Application (BLA). The CRL was issued solely due to inspection findings at Checkpoint’s third-party contract manufacturing organization. These issues are being resolved, and once addressed, Checkpoint plans to resubmit the BLA to seek marketing approval for cosibelimab.
DelveInsight's “Cutaneous Squamous Cell Carcinoma Market Insights, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of Cutaneous Squamous Cell Carcinoma (CSCC), historical and forecasted epidemiology as well as the Cutaneous Squamous Cell Carcinoma therapeutics market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
Cutaneous Squamous Cell Carcinoma (cSCC) market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM Cutaneous Squamous Cell Carcinoma (cSCC) market size from 2020 to 2034. The report also covers current Cutaneous Squamous Cell Carcinoma (cSCC) treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.
Geography Covered
- The United States
- EU4 (Germany, France, Italy, and Spain) and the United Kingdom
- Japan
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Study Period |
2020–2034 |
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Forecast Period |
2024–2034 |
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Geographies Covered |
US, EU4 (Germany, France, Italy, and Spain) the UK, and Japan |
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Cutaneous Squamous Cell Carcinoma (cSCC)Epidemiology |
Segmented by: Incident Cases of CSCC Age-specific Cases of CSCC Gender-specific Cases of CSCC Stage-specific Cases of CSCC Line-wise Treated Cases of CSCC |
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Cutaneous Squamous Cell Carcinoma (cSCC)key companies |
Merck Regeneron Pharmaceuticals |
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Cutaneous Squamous Cell Carcinoma (cSCC)key therapies/drug |
KEYTRUDA LIBTAYO |
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Cutaneous Squamous Cell Carcinoma (cSCC)Market |
Segmented by: · Region · Therapies |
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Analysis |
· KOL Views · SWOT Analysis · Reimbursement · Conjoint Analysis · Unmet needs |
Cutaneous Squamous Cell Carcinoma (cSCC) Understanding and Treatment Algorithm
Cutaneous Squamous Cell Carcinoma (cSCC) Overview, Country-Specific Treatment Guidelines and Diagnosis
Cutaneous squamous cell carcinoma (cSCC) is the second most common form of skin cancer and one of the most common cancers overall in the United States. It is a type of keratinocyte carcinoma that originates from the epidermal keratinocytes and can arise from actinic keratoses (premalignant lesions). The clinical presentation of cSCC typically includes a hard lump with a scaly surface or ulceration, often located in sun-exposed areas. Risk factors include ultraviolet radiation, actinic keratosis, tobacco smoking, lighter skin, arsenic exposure, radiotherapy, poor immune system function, and HPV infection.
The diagnosis of cSCC typically involves a combination of clinical examination, histopathological evaluation, and imaging techniques. Dermoscopy and reflectance confocal microscopy can enhance diagnostic accuracy. The primary focus is on evaluating the tumor's histological subtype, tumor thickness, and perineal invasion to determine the likelihood of recurrence and metastasis. The European data on metastatic risk reveal a 2.1% cumulative incidence after a median follow-up of 15.2 months, with higher risk in males, older individuals, and certain anatomical locations.
Further details related to country-based variations in diagnosis are provided in the report
Cutaneous Squamous Cell Carcinoma (cSCC) Treatment
In general, surgical therapy remains the most effective treatment for cSCC. Nonsurgical therapies such as radiation therapy, cryosurgery, and photodynamic therapy may be selected for low-risk tumors or if surgery is contraindicated. For locally advanced and metastatic cSCC, immunotherapy with immune checkpoint inhibitors like cemiplimab and pembrolizumab has shown promising results. Early and complete treatment is crucial for managing advanced disease, and patients should have annual checks for recurrence or other new primary skin cancers.
Cutaneous Squamous Cell Carcinoma (cSCC) Epidemiology
The Cutaneous Squamous Cell Carcinoma epidemiology chapter in the report provides historical as well as forecasted in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2024 to 2034. The Cutaneous Squamous Cell Carcinoma (cSCC) epidemiology is segmented with detailed insights into Incident Cases, Age-specific Cases, Gender-specific Cases, Stage-specific Cases, Line-wise Treated Cases Cutaneous Squamous Cell Carcinoma (CSCC).
- • Men were more likely to have cSCCs arise on the head and neck, whereas women were more likely to have cSCCs develop on the lower extremity.
- • The highest Incident cases of cSCC occurred in the age groups ≥60 years.
- • cSCC incidence is higher in men than women.
Cutaneous Squamous Cell Carcinoma (cSCC) Drug Chapter
The drug chapter segment of the Cutaneous Squamous Cell Carcinoma (cSCC) report encloses a detailed analysis of Cutaneous Squamous Cell Carcinoma (cSCC) marketed drugs and late-stage (Phase III and Phase II) Cutaneous Squamous Cell Carcinoma pipeline drugs. It also deep dives into the Cutaneous Squamous Cell Carcinoma (cSCC) pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.
Marketed Drugs
KEYTRUDA: Merck
Merck’s KEYTRUDA (pembrolizumab) is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. In June 2020, the US FDA approved KEYTRUDA as monotherapy for the treatment of patients with recurrent or metastatic CSCC that is not curable by surgery or radiation. This approval was based on data from the Phase II KEYNOTE-629 trial.
In July 2021, the US FDA approved an expanded label for KEYTRUDA, as monotherapy for the treatment of patients with locally advanced CSCC that is not curable by surgery or radiation.
LIBTAYO: Regeneron Pharmaceuticals/ Medison Pharma
LIBTAYO (cemiplimab) is a type of drug called an immune checkpoint inhibitor (a type of immunotherapy). It is a monoclonal antibody that binds to the protein PD-1 on the surface of immune cells called T cells. It works by keeping cancer cells from suppressing the immune system. It is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. The US FDA granted the approval of LIBTAYO to Regeneron Pharmaceuticals in September 2018.
In January 2024, Medison Pharma announced agreement with Regeneron Pharmaceuticals to commercialize LIBTAYO in multiple countries. The company is planning to file sBLA for advanced CSCC next year.
Note: Detailed current therapies assessment will be provided in the full report of Cutaneous Squamous Cell Carcinoma (CSCC)
Emerging Drugs
Cosibelimab (CK-301): Checkpoint Therapeutics
Cosibelimab (CK-301) is an investigational fully-human monoclonal antibody that targets the PD-1/PD-L1 pathway to treat various cancers. It is being evaluated in a global, open-label, multicohort Phase I clinical trial in checkpoint therapy-naïve patients with selected recurrent or metastatic cancers, including locally advanced and metastatic cutaneous squamous cell carcinoma (cSCC).
In March 2023, Checkpoint announced FDA acceptance of the cosibelimab BLA for treating cSCC patients ineligible for surgery or radiation, with a PDUFA goal date of January 2024. However, in December 2023, a complete response letter was issued by the FDA, citing inspection findings at the third-party manufacturing site as the reason for delay.
INCB99280: Incyte Corporation
INCB099280 is a novel targeted therapy that is being developed to treat advanced cSCC, which is an aggressive form of skin cancer.
Incyte Corporation is conducting a Phase II clinical trial (NCT05888844) to assess the safety, tolerability, and initial efficacy of INCB099280 in advanced cutaneous squamous cell carcinoma (cSCC). The study comprises two parts: Part 1 involves random assignment of participants with metastatic or locally advanced cSCC to three different dose levels of INCB099280 to determine the optimal dose. Part 2 will expand on the chosen dose from Part 1, evaluating clinical response rates, response duration, and safety in a larger group of patients with metastatic or locally advanced cSCC.
Note: Detailed emerging therapies assessment will be provided in the final report.
|
Therapy Name |
Company Name |
ROA |
MOA |
Phases |
Any Special Status |
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cosibelimab (CK-301) |
Checkpoint Therapeutics |
IV |
PD-L1 inhibitor |
I |
N/A |
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Incyte Corporation |
Oral |
PD-L1 inhibitor |
II |
N/A |
Cutaneous Squamous Cell Carcinoma (cSCC) Market Outlook
Key players, such as Incyte Corporation, NeoImmuneTech, Checkpoint Therapeutics, Merck, Sirnaomics, and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Cutaneous Squamous Cell Carcinoma (cSCC).
- • Currently, the anti-PD-1 agent cemiplimab is the only approved systemic treatment for cSCC in Europe.
- • Immunotherapies, such as pembrolizumab, are associated with higher treatment costs than chemotherapy.
- • Ongoing research and advancements in the understanding of cSCC may lead to the development of new treatment options and targeted therapies would eventually impact market revenue positively.
Cutaneous Squamous Cell Carcinoma (cSCC) Recent Developments
- In October 2025, the FDA approved cemiplimab-rwlc (Libtayo, Regeneron) for adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence following surgery and radiation.
- In August 2025, Regeneron Pharmaceuticals highlighted its PD-1 inhibitor Libtayo as the standard of care for advanced cutaneous squamous cell carcinoma (CSCC), with ongoing research in melanoma and multiple myeloma.
- In June 2025, Medicus Pharma submitted a product development plan to the FDA under Investigational New Animal Drug (INAD) for its dissolvable doxorubicin microneedle array (D-MNA) to treat external squamous cell carcinoma (SCC) in horses, following its December 2024 MUMS designation.
- In May 2025, Incyte (Nasdaq: INCY) announced FDA approval of Zynyz® (retifanlimab-dlwr) for the treatment of squamous cell carcinoma of the anal canal (SCAC). The approval includes its use in combination with chemotherapy for first-line treatment of inoperable locally recurrent or metastatic SCAC, and as a monotherapy for patients with disease progression or intolerance to platinum-based chemotherapy.
- In December 2024, Checkpoint Therapeutics, Inc. announced that the FDA approved UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation. UNLOXCYT is the first and only PD-L1 blocking antibody approved for this indication.
Cutaneous Squamous Cell Carcinoma Drugs Uptake
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2024–2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.
Further detailed analysis of emerging therapies drug uptake in the report…
Cutaneous Squamous Cell Carcinoma Pipeline Development Activities
The Cutaneous Squamous Cell Carcinoma pipeline report provides insights into Cutaneous Squamous Cell Carcinoma clinical trials within Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.
Cutaneous Squamous Cell Carcinoma Development Activities
The Cutaneous Squamous Cell Carcinoma clinical trials analysis report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Cutaneous Squamous Cell Carcinoma (cSCC) emerging therapies.
KOL Views on Cutaneous Squamous Cell Carcinoma Market Report
To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts were contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility.
DelveInsight’s analysts connected with 40+ KOLs to gather insights; however, interviews were conducted with 25+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging treatment patterns of Cutaneous Squamous Cell Carcinoma (CSCC). This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Cutaneous Squamous Cell Carcinoma Report Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.
Conjoint Analysis analyzes multiple approved and emerging 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.
Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and 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 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.
Cutaneous Squamous Cell Carcinoma Market Access and Reimbursement
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, 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 Cutaneous Squamous Cell Carcinoma Market Report
- The report covers a segment of key events, an executive summary, descriptive overview of Cutaneous Squamous Cell Carcinoma (CSCC), explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
- Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along with country specific treatment guidelines.
- Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
- A detailed review of the Cutaneous Squamous Cell Carcinoma (cSCC) 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 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 in shaping and driving the 7MM Cutaneous Squamous Cell Carcinoma (cSCC) market.
Cutaneous Squamous Cell Carcinoma Market Report Insights
- Cutaneous Squamous Cell Carcinoma Patient Population
- Cutaneous Squamous Cell Carcinoma Therapeutic Approaches
- Cutaneous Squamous Cell Carcinoma (cSCC) Pipeline Analysis
- Cutaneous Squamous Cell Carcinoma (cSCC) Market Size and Trends
- Existing and future Market Opportunity
Cutaneous Squamous Cell Carcinoma Market Report Key Strengths
- Eleven Years Forecast
- 7MM Coverage
- Cutaneous Squamous Cell Carcinoma (cSCC) Epidemiology Segmentation
- Inclusion of Country specific treatment guidelines
- KOL’s feedback on approved and emerging therapies
- Key Cross Competition
- Conjoint analysis
- Cutaneous Squamous Cell Carcinoma Drugs Uptake
- Key Cutaneous Squamous Cell Carcinoma Market Forecast Assumptions
Cutaneous Squamous Cell Carcinoma Market Report Assessment
- Current Cutaneous Squamous Cell Carcinoma Treatment Practices
- Cutaneous Squamous Cell Carcinoma Unmet Needs
- Cutaneous Squamous Cell Carcinoma Pipeline Product Profiles
- Cutaneous Squamous Cell Carcinoma Market Attractiveness
- Qualitative Analysis (SWOT and Conjoint Analysis)
- Cutaneous Squamous Cell Carcinoma Market Drivers
- Cutaneous Squamous Cell Carcinoma Market Barriers
FAQs
- What is the growth rate of the 7MM Cutaneous Squamous Cell Carcinoma (cSCC) treatment market?
- What was the Cutaneous Squamous Cell Carcinoma (cSCC) total market size, the market size by therapies, market share (%) distribution in 2020, and what would it look like in 2034? What are the contributing factors/key catalysts for this growth?
- Is there any unexplored patient setting that can open the window for growth in the future?
- What are the pricing variations among different geographies for approved and off-label therapies?
- How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends? Although multiple expert guidelines recommend testing for targetable mutations before therapy initiation, why do barriers to testing remain high?
- What are the current and emerging options for the treatment of Cutaneous Squamous Cell Carcinoma (cSCC)?
- How many companies are developing therapies for the treatment of Cutaneous Squamous Cell Carcinoma (cSCC)?
- What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
- Patient/physician acceptability in terms of preferred treatment options as per real-world scenarios?
- What are the country-specific accessibility issues of expensive, recently approved therapies?
Reasons to buy Cutaneous Squamous Cell Carcinoma Market Forecast Report
- The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Cutaneous Squamous Cell Carcinoma (cSCC) 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 market opportunities in varying geographies and the growth potential over the coming years.
- Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
- Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
- Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, 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 players can strengthen their development and launch strategy.
