Angiofibroma - Market Insight, Epidemiology, and Market Forecast - 2034

Key Highlights:

• The rise in angiofibroma cases likely reflects better detection, greater awareness, and true shifts in underlying conditions like genetic syndromes and hormonal factors, highlighting the need for early diagnosis and tailored management.
• In the US, angiofibromas show a distinct age-specific pattern, with about 27.7% of cases occurring in individuals aged 0-17, 62% in those aged 18-45, and 10.3% in people 46 and older. This distribution highlights that angiofibromas most often develop during adolescence and early adulthood, emphasizing the need for timely diagnosis and intervention during these key stages of life.
• Nobelpharma's HYFTOR (sirolimus topical gel) is the first and only US FDA-approved therapy for angiofibromas, addressing a critical need for safe, targeted treatment of these benign tumors. Its approval highlights growing interest in precision therapies for rare dermatologic conditions, signaling a dynamic angiofibroma market with strong potential for innovation and improved patient outcomes.
• Despite the approval of HYFTOR, there remains a clear unmet need for emerging drugs in angiofibroma treatment that can offer deeper lesion clearance, prevent recurrence, and address more severe or refractory cases.
• In 2025, Quoin Pharmaceuticals plans to submit Investigational New Drug (IND) applications for at least two of these indications, with clinical development of QRX009 expected to begin in the first half of 2026, representing a meaningful step toward addressing significant treatment gaps for complex vascular and skin conditions.
• Novel targeted therapies and combination approaches are needed to expand options, enhance patient outcomes, and advance the management of this rare condition in the years ahead.

DelveInsight's comprehensive report titled "Angiofibromas - Market Insights, Epidemiology, and Market Forecast - 2034" offers a detailed analysis of angiofibromas. The report presents historical and projected epidemiological data covering total incident cases of angiofibromas, gender-specific incident cases of angiofibromas, age-specific incident cases of angiofibromas, and treated cases of angiofibromas. In addition to epidemiology, the market report encompasses various aspects related to the patient population. These aspects include the diagnosis process, prescription patterns, physician perspectives, market accessibility, treatment options, and prospective developments in the market across seven major markets: the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, spanning from 2020 to 2034.

The report analyzes the existing treatment practices and unmet medical requirements in angiofibromas. It evaluates the market potential and identifies potential business prospects for enhancing therapies or interventions. This valuable information enables stakeholders to make well-informed decisions regarding product development and strategic planning for the market.

Angiofibromas Overview

Angiofibromas are benign vascular tumors that typically develop on the skin, most commonly associated with genetic conditions like tuberous sclerosis complex. They are not caused by infection or inflammation but result from abnormal cell growth driven by genetic mutations affecting pathways such as mTOR. Angiofibromas can appear at any age but are most commonly seen in children and adolescents, often emerging during puberty when hormonal changes can trigger their growth.

The primary signs of angiofibromas are small, reddish or flesh-colored bumps that typically appear on the face, especially around the nose and cheeks. These growths are usually painless but can increase in size and number over time, leading to cosmetic concerns and potential disfigurement. In some cases, they may bleed easily with minor trauma. While angiofibromas themselves are benign, their presence can indicate an underlying genetic condition like tuberous sclerosis complex, which may be associated with other health issues requiring medical attention.

Angiofibromas Diagnosis and Treatment Algorithm

Diagnosing angiofibromas can be challenging because their appearance may overlap with other skin conditions. Clinicians typically rely on the characteristic presentation of small, firm, reddish or skin-colored bumps on the face, especially around the nose and cheeks, along with patient history and signs of underlying genetic conditions like tuberous sclerosis complex. A thorough skin examination, family history, and, when needed, a skin biopsy or genetic testing help confirm the diagnosis and guide appropriate management.

Treatment of angiofibromas focuses on reducing the size and number of lesions and preventing recurrence. The primary therapy is HYFTOR (topical sirolimus), which targets the underlying mTOR pathway to shrink existing growths and limit new ones. Other options include laser therapy or surgical removal for larger or bothersome lesions. Treatment choice depends on the severity and location of the angiofibromas, as well as any underlying conditions like tuberous sclerosis complex. Ongoing monitoring, patient education, and regular dermatologic follow-up are essential to manage recurrence, minimize scarring, and support long-term skin health.

Angiofibromas Epidemiology

The epidemiology section of the angiofibromas market report offers information on the patient populations, including historical and projected trends for each of the seven major markets. Examining key opinion leader views from physicians or clinical experts can assist in identifying the reasons behind historical and projected trends. The diagnosed patient pool, their trends, and the underlying assumptions are all included in this section of the report.

This section also presents the data with relevant tables and graphs, offering a clear and concise view of the incidence of angiofibromas. Additionally, the report discloses the assumptions made during the analysis, ensuring data interpretation and presentation transparency. This epidemiological data is valuable for understanding the disease burden and its impact on the patient population across various regions.

Key Findings

• Based on secondary analysis, Juvenile Nasopharyngeal Angiofibroma (JNA)-a rare form of angiofibroma-accounts for approximately 0.05% to 0.5% of all head and neck tumors in the US. Its annual incidence is estimated to range between 1 in 5,000 and 1 in 60,000 individuals.
• In Spain, angiofibromas show a gender-specific pattern, with about 66.1% of cases occurring in males and 33.9% in females, underscoring that this benign tumor is more commonly seen in males in this population.
• In Japan, angiofibromas were identified in approximately 43% of individuals with a germline MEN1 gene mutation, including one asymptomatic gene carrier, highlighting their notable presence in this genetic context.

The epidemiology of angiofibromas is expected to change during the forecast period (2025-2034).

Angiofibromas Market Outlook

The angiofibromas therapeutics market is further expected to increase by the major drivers, such as the rising incident population, technological advancements, and upcoming therapies in the forecast period (2025-2034).

In March 2022, the US FDA approved HYFTOR for the treatment of facial angiofibromas, providing targeted topical option for this challenging benign tumor. With its novel mechanism and convenient application, HYFTOR is well-positioned to address an unmet need and capture a share of the emerging market for precision therapies in rare dermatologic conditions.

With ongoing research and continued dedication, the future holds hope for even more effective treatments and, ultimately, a cure for this challenging condition. According to DelveInsight, the angiofibromas market in the 7MM is expected to change significantly during the study period 2020-2034.

Angiofibromas Drug Chapters

Angiofibromas Marketed Drugs

HYFTOR: Nobelpharma

HYFTOR (sirolimus topical gel) 0.2%, developed by Nobelpharma, is the first and only clear topical medication approved by the US FDA to treat facial angiofibromas in adults and children 6 years of age and older.

Indicated for angiofibromas associated with TSC, HYFTO should be applied only to affected areas and without occlusion of application sites. In clinical trials, HYFTOR demonstrated significant improvement in the size and redness of facial angiofibromas at 12 weeks. It is contraindicated in patients with known hypersensitivity to sirolimus or any component of the gel.

Emerging Angioedema Drugs

The angiofibroma market continues to face significant gaps in care, with limited treatment options beyond HYFTOR. An important unmet need remains for emerging therapies that can provide deeper and more sustained lesion clearance, especially for patients with extensive or treatment-resistant growths. QRX009, currently in preclinical development, represents a promising step toward expanding targeted treatment choices and addressing this underserved area in the years ahead.

QRX009: Quoin Pharmaceuticals

QRX009 is a proprietary topical formulation of rapamycin (sirolimus) in development for rare and disfiguring conditions such as Microcystic Lymphatic Malformations (MLM), Venous Malformations, and Cutaneous Angiofibromas. These conditions can cause significant cosmetic and functional challenges, yet there are few or no FDA-approved topical treatments available. QRX009 is designed to improve local skin penetration and deliver rapamycin directly to the affected dermal layers, addressing the poor delivery seen with earlier formulations. By enhancing retention and absorption at the target site, QRX009 aims to offer a more effective option for these difficult-to-treat lesions.

Angiofibromas Market Segmentation

DelveInsight's 'Angiofibromas - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a detailed outlook of the current and future angiofibromas market, segmented within countries, by therapies, and by classes. Further, the market of each region is then segmented by each therapy to provide a detailed view of the current and future market share of all therapies.

Angiofibromas Market Size by Countries

The angiofibromas market size is assessed separately for various countries, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. In 2024, the United States held a significant share of the overall 7MM (Seven Major Markets) angiofibromas market, primarily attributed to the country's higher incidence of the condition and the elevated cost of the available treatments. This dominance is projected to persist, especially with the potential early introduction of new products.

Angiofibromas Drugs Uptake

This section focuses on the sales uptake of potential angiofibromas drugs that have recently been launched or are anticipated to be launched in the angiofibromas market between 2020 and 2034. It estimates the market penetration of angiofibromas drugs for a given country, examining their impact within and across classes and segments. It also touches upon the financial and regulatory decisions contributing to the probability of success (PoS) of the drugs in the angiofibromas market.

The emerging angiofibromas therapies are analyzed based on various attributes such as safety and efficacy in randomized clinical trials, order of entry and other market dynamics, and the unmet need they fulfill in the angiofibromas market.

Angiofibromas Market Access and Reimbursement

DelveInsight's 'Angiofibromas - Market Insights, Epidemiology, and Market Forecast - 2034' report provides a descriptive overview of the market access and reimbursement scenario of angiofibromas.

This section includes a detailed analysis of the country-wise healthcare system for each therapy, enlightening the market access, reimbursement policies, and health technology assessments.

KOL Views

To keep up with current angiofibromas market trends and fill gaps in secondary findings, we interview KOLs and SMEs' working in the angiofibromas domain. Their opinion helps understand and validate current and emerging therapies and treatment patterns or angiofibromas market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the angiofibromas unmet needs.

Angiofibromas: KOL Insights

DelveInsight's analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. These KOLs were from organizations, institutes, and hospitals, such as Boston Children's Hospital, US; Saarland University Medical Center, Germany; La Timone University Hospital Center, France; University of Brescia, Italy; United Hospitals of Bergamo, Italy; and Shinshu University, Japan, among others.

"Diagnosing angiofibromas remains challenging as it relies on recognizing typical skin lesions and patient history, often supported by biopsy or genetic testing. With no single definitive test, careful clinical judgment is essential to confirm the diagnosis and rule out similar skin conditions."

"Initial management of angiofibromas focuses on reducing lesion size and preventing new growth with topical therapies. For larger or resistant lesions, laser treatment or surgical removal may be necessary. Since recurrence is common, regular monitoring and maintenance care are essential. New therapies in development aim to achieve deeper and longer-lasting results."

"A key unmet need in the management of angiofibromas is the development of more targeted therapies that can achieve deeper lesion clearance and prevent recurrence with minimal side effects. Despite advances in topical and procedural treatments, gaps remain for patients with extensive, resistant, or syndromic angiofibromas, underscoring the need for novel approaches and more personalized treatment strategies."

Competitive Intelligence Analysis

We conduct a Competitive and Market Intelligence analysis of the angiofibromas market, utilizing various Competitive Intelligence tools such as SWOT analysis and Market entry strategies. The inclusion of these analyses is contingent upon data availability, ensuring a comprehensive and well-informed assessment of the market landscape and competitive dynamics.

Angiofibromas Pipeline Development Activities

The report offers an analysis of therapeutic candidates in early phases of development and examines companies working on targeted treatments for angiofibromas. It provides valuable insights into the progress and innovation driving potential new options for managing this challenging condition.

Pipeline Development Activities

The report covers information on collaborations, acquisition and merger, licensing, patent details, and other information for emerging angiofibromas therapies.

Angiofibromas Report Insights

• Angiofibromas Patient Population
• Therapeutic Approaches
• Angiofibromas Pipeline Analysis
• Angiofibromas Market Size and Trends
• Angiofibromas Market Opportunities
• Impact of Upcoming Therapies

Angiofibromas Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage
• Angiofibromas Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Angiofibromas Market
• Angiofibromas Drugs Uptake

Angiofibromas Report Assessment

• Angiofibromas Current Treatment Practices
• Unmet Needs
• Angiofibromas Pipeline Product Profiles
• Angiofibromas Market Attractiveness

Key Questions:

• How common is angiofibromas?
• What are the key findings of angiofibromas epidemiology across the 7MM, and which country will have the highest number of patients during the study period (2020-2034)?
• What are the currently available treatments for angiofibromas?
• What are the disease risk, burden, and unmet needs of angiofibromas?
• At what CAGR is the angiofibromas market and its epidemiology is expected to grow in the 7MM during the forecast period (2025-2034)?
• How would the unmet needs impact the angiofibromas market dynamics and subsequently influence the analysis of the related trends?
• What would be the forecasted patient pool of angiofibromas in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Among EU4 and the UK, which country will have the highest number of patients during the forecast period (2025-2034)?
• How many companies are currently developing therapies for the treatment of angiofibromas?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the angiofibromas Market.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity 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 current treatment in the US, EU4 (Germany, France, Italy, and Spain), the UK, and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting 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 off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders 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.

Frequently Asked Questions:

1. What are the treatment goals for angiofibromas?

The main treatment goals for angiofibromas are to reduce the size and number of lesions, prevent new growths, and minimize cosmetic and functional impact. Management also aims to maintain clear skin over time, address any discomfort or bleeding, and prevent recurrence through ongoing monitoring and maintenance therapy. Early detection and individualized care are crucial for achieving the best long-term outcomes.

2. What are the challenges in managing angiofibromas?

The main challenges in managing angiofibromas include achieving complete and sustained lesion clearance, as recurrence is common even after treatment. Some lesions may be extensive, resistant to standard therapies, or located in cosmetically sensitive areas, making treatment more complex. Limited targeted options and the need for long-term monitoring add to the burden, while balancing effectiveness with minimal side effects remains an ongoing challenge for patients and clinicians.

3. What are the key factors driving the growth of the angiofibromas market?

The angiofibroma market is driven by increasing diagnosis rates, growing awareness among clinicians and patients, advances in targeted treatment approaches, and the development of next-generation topical and precision therapies by innovative companies. Together, these factors are expanding demand for more effective, long-lasting solutions and supporting sustained market growth.

4. How will the Angiofibromas Market and Epidemiology Forecast Report benefit the clients?

The angiofibromas market and epidemiology forecast report will benefit clients by providing comprehensive insights into market trends, treatment options, patient populations, and future growth opportunities, helping them make informed strategic decisions and identify potential areas for investment or expansion.