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

Key Highlights:

• In the United States, over 42 million people are infected with HPV, including approximately 13 million new infections each year.
• More than 90% of condyloma (anogenital warts) cases are caused by low-risk HPV types 6 or 11, whereas around 10% of cases are associated with other strains of HPV.
• HPV infection is responsible for approximately 90% of anal cancer cases and nearly all cervical cancer cases in women, with HPV type 16 alone causing around 50% of these cancers.
• The prevalence of condyloma acuminata is highest among individuals aged 17-33 years, with incidence peaking in the 20-24-year age group.
• The current treatment options for condyloma are primarily centered upon removal of the warty growth rather than elimination of the underlying viral infection. Common treatments include topical therapeutic agents; physical removal of warts with cryotherapy, electrocautery cautery or lasers; or photodynamic therapy along with vaccines.
• The emerging pipeline for condyloma includes YCANTH (VP-102) (Verrica Pharmaceuticals) and others. However, there are no updates available for this therapy post November 2024.

DelveInsight's "Condyloma - Market Insight, Epidemiology and Market Forecast - 2034" report delivers an in-depth analysis of condyloma epidemiology, market, and clinical development in condyloma. In addition to this, the report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the condyloma market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

The condyloma market report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted condyloma market size from 2020 to 2034 in 7MM. The report also covers current condyloma 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

Condyloma Understanding and Treatment Algorithm

Condyloma Overview

Condyloma refers to a wart-like growth on the genitals or around the anus. It is caused by certain types of human papillomavirus (HPV), particularly types 6 and 11. It is a sexually transmitted infection that spreads through sexual or skin-to-skin contact with an infected person. Further, several factors such as having multiple sexual partners, early sexual activity, unprotected sex, weekend immunity, and existing sexually transmitted infections (STIs) can increase the risk of transmitting genital HPV. Additionally, in children it may also be transmitted through nonsexual ways, such as from an infected mother to her infant or through direct manual contact.

The common symptoms of condyloma include soft lumps in or around the anus; light brown, yellow, pink, or flesh-colored lumps that may cluster together; bleeding; itching or discomfort in the genital area; and increased vaginal discharge. While these growths are generally benign, some strains of HPV are linked to more serious conditions, including cervical cancer in women.

Condyloma Diagnosis

The diagnosis of condyloma is usually made by visual inspection but can be confirmed by biopsy, which is indicated if lesions are atypical (e.g., pigmented, indurated, and affixed to underlying tissue, bleeding, or ulcerated lesions). It may begin with a physical examination of all potentially affected mucocutaneous and anogenital areas (including a pelvic exam for women). Colposcopy is often used as a diagnostic tool, involving the application of a mild acetic acid solution to the genital area, which causes warts to temporarily turn white, making them easier to detect under a lighted magnifying instrument. In women, a Pap test may be performed to detect cervical cell abnormalities, and if abnormal results are found, an HPV test can identify high-risk viral strains. In certain cases, a cervical biopsy may be taken to check for precancerous or cancerous changes, with biopsy generally reserved for atypical or suspicious lesions.

Condyloma Treatment

The treatment of condyloma involves multiple approaches depending on the number, size, and location of lesions, as well as patient preferences. Topical medications such as imiquimod (ALDARA, ZYCLARA), podophyllin and podofilox (CONDYLOX), sinecatechins (VEREGEN), and systemic therapies like Alferon N are commonly used treatment options. For extensive, resistant, or recurrent lesions, procedure interventions including cryotherapy with liquid nitrogen, electrocautery, carbon dioxide laser ablation, and surgical excision can be used. In refractory cases, interferon therapy may be considered.

The primary aim of treatment includes the removal of visible lesions and alleviation of associated symptoms. However, it does not cure the underlying HPV infection, so warts may recur. Regular follow-up may be necessary to monitor and manage recurrences effectively. Patients are advised to avoid over-the-counter wart treatments meant for non-genital warts, as these are not suitable for the genital area.

Condyloma Epidemiology

The condyloma epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as incident cases of condyloma, gender-specific incident cases of condyloma, age-specific incident cases of condyloma, and anatomical location-specific incident cases of condylomain the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.

• Condylomata acuminata, also known as external genital warts, are extremely common, with between 500,000 to one million new cases diagnosed each year in the United States alone.
• In the United States, about 80% of condyloma cases are reported among individuals aged 17 ̶ 33, with the highest incidence in the 20 ̶ 24 age group.
• Both men and women are susceptible to condyloma acuminata, with overt disease reported more often in men, while overall infection tends to be more prevalent in women.

Condyloma Drug Chapters

The drug chapter segment of condyloma report encloses a detailed analysis of condyloma-marketed drugs and emerging pipeline drugs. It also deep dives into condyloma's pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Marketed Drugs

VEREGEN: MediGene

VEREGEN, a topical treatment for external genital warts, contains a concentrate of catechins with a complex, defined composition extracted from green tea leaves. MediGene acquired the basic rights to the active ingredient in VEREGEN from Epitome Pharmaceuticals and was solely responsible for the drug's successful preclinical and clinical development, as well as the approval process. It was first approved by the US FDA in October 2006 for the treatment of external genital warts. In Europe, it received its initial approval in Germany in 2009, which then served as the reference for the mutual recognition procedure (MRP) in other European countries. By early 2015, marketing authorization had been secured in multiple markets, including the UK and Italy, along with several other European regions.

Emerging Drugs

YCANTH (VP-102): Verrica Pharmaceuticals

YCANTH (VP-102) is a proprietary drug-device combination that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration. In November 2024, the company announced the results from its Phase II trial of VP-102, demonstrating that VP-102 significantly outperforms standard treatments for condyloma. As per the company's pipeline, there are currently no plans to initiate a Phase III trial.

Condyloma Market Outlook

The current therapeutic approaches for the treatment of condyloma are primarily focused on the removal of visible lesions or warts. However, there is limited evidence to support the long-term efficacy of existing treatments in eradicating the condition or significantly reducing recurrence rates. Further, a wide range of therapies are presently in use, which are highly variable and can differ dramatically with respect to cost, side-effect profiles, dosing schedules, duration of treatment, and overall effectiveness. Currently, the treatment of condyloma includes topical treatment (such as ALDARA, ZYCLARA (imiquimod), CONDYLOX (podofilox or podophyllin)), and VEREGEN (sinecatechins), and systemic treatment (such as Alferon N). The dynamics of condyloma market is anticipated to change in the coming years owing to the rising awareness of the disease, and the development of vaccines across the world. The major key players involved in the development for the treatment of condyloma are YCANTH (VP-102) by Verrica Pharmaceuticals, and others.

Condyloma Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025-2034, which depends on the competitive landscape, safety, and efficacy data, along with the 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.

Condyloma Pipeline Development Activities

The report provides insights into different therapeutic candidates in the marketed and emerging stages. It also analyses key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for condyloma therapies.

KOL Views

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, including Medical/scientific writers, Professors, and others.

DelveInsight's analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as University Medical Center Hamburg-Eppendorf, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or condyloma market trends.

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.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

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.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and a payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present.

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 Report:

• The report covers a segment of key events, an executive summary, a descriptive overview of condyloma, 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 the diagnosis rate, and 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 condyloma 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 and conjoint analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM condyloma market.

Condyloma Report Insights

• Patient Population
• Therapeutic Approaches
• Condyloma Pipeline Analysis
• Condyloma Market Size and Trends
• Existing and Future Market Opportunity

Condyloma Report Key Strengths

• Ten-Year Forecast
• 7MM Coverage
• Condyloma Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Condyloma Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint)

FAQs:

• What was the condyloma 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 for this growth?
• At what CAGR, condyloma market is expected to grow at the 7MM level during the study period (2020-2034)?
• How is Japan's condyloma competitive landscape evolving?
• What are the disease risks, burdens, and unmet needs of condyloma?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to condyloma?
• What is the historical and forecasted condyloma patient pool in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• What factors are affecting the increase in the diagnosis of symptomatic cases?
• What are the current options for the treatment of condyloma? What are the current treatment guidelines for the treatment of condyloma in the US and Europe?
• How many companies are developing therapies for the treatment of condyloma?
• Which key designations have been granted for the emerging therapies for condyloma?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies? Focus on reimbursement policies.

Reasons to Buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics and driving factor for condyloma market.
• Insights on patient share/disease burden, 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 upcoming players in the market will help devise strategies to help get ahead of competitors.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand KOLs' 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.