Genital Warts (Condyloma Acuminatum) - Market Insights, Epidemiology, and Market Forecast-2032

This ‘Genital Warts (Condyloma Acuminatum)-Market Insights, Epidemiology, and Market Forecast-2032' report deliver an in-depth understanding of the Genital Warts, historical and forecasted epidemiology as well as the Genital Warts market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), Japan, and China.

The Genital Warts market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM+China Genital Warts market size from 2019 to 2032. The Report also covers current Genital Warts treatment practice, market drivers, market barriers, SWOT analysis, reimbursement and market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan
• China

Study Period: 2019-2032

Genital Warts Disease Understanding and Treatment Algorithm

Human papillomavirus (HPV) is a small, nonenveloped, double-stranded DNA virus. Most of the HPV-related diseases and research are focused on HPV types within the alpha group. Individual types are further classified as high-risk (e.g., HPV16 and 18) and low-risk HPV (e.g., HPV6 and 11) based on oncogenic potential. E6 and E7 are the main oncoproteins, with E6 binding to p53.

Genital warts (also known as anogenital warts, condylomata acuminata, condylomas) are benign proliferative lesions caused by human papillomavirus (HPV) types 6 and 11, which are found in >95% of lesions. Genital warts (GWs) are transmitted by having sexual contact with someone who already has them and may be found on the outside of genitals. Some types, which cause cancer, result in the growth of lesions on a woman's cervix. It is possible to get genital warts, HPV infection, even if they are not visible. Besides, they look like flesh-colored bumps that have a cauliflower-like appearance, and are usually flat, papular, or pedunculated growths on the genital mucosa, occurring in clusters.

Genital Warts Diagnosis

Clinical diagnosis of GW is based on the appearance of warts, whereas histopathological diagnosis is not routinely indicated. Nucleic Acid Amplification Test for HPV DNA is also recommended. Accurate diagnosis is an essential first step in the treatment of GWs. Also, Pap test, HPV tests and newer technologies like Dermatoscopy are being used.

Genital Warts Treatment

The current options available for the treatment of GWs 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 or lasers; or photodynamic therapy along with vaccines. The criteria for warts treatment, developed by the American Academy of Dermatology include: the patient's desire for therapy, symptoms of pain, bleeding, itching or burning; (3) disabling or disfiguring lesions; (4) large numbers or large sizes of lesions; (5) the patient's desire to prevent the spread of warts to unblemished skin of self or others; and (6) an immunocompromised condition.

There are currently three approved vaccines for the prevention of HPV infection, Gardasil (recombinant HPV quadrivalent vaccine, Types 6, 11, 16, and 18; Merck), Gardasil (recombinant HPV nonavalent vaccine; Merck) and Cervarix (recombinant HPV bivalent vaccine, Types 16 and 18; GlaxoSmithKline). The vaccines are prepared from viral proteins but do not contain viral DNA. Therefore, neither vaccine can cause HPV infection. Both vaccines were designed for the prevention of HPV infection and did not treat existing HPV infection or disease. The therapeutic pipeline is active with many novel topical formulations like SB206, VP-102 and others in development.

Genital Warts Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Incident cases of Genital Warts, Gender-specific Incident Cases of Genital Warts, Age-specific Incident Cases of Genital Warts, and Anatomical Location of GWs in Incident Population in the 7MM+China covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), Japan, and China from 2019 to 2032.

Key Findings

• In the assessment done by the publisher, the estimated total incident cases of GWs in the 7MM+China were 1,392,836 in 2021.
• The highest incident cases of GWs were accounted by the US in 2021 (545,316 cases), which are expected to show a rise in the future.
• Among the European countries, Germany had the highest incident population of GWs with 77,210 cases, followed by France, which had incident population of 55,798 in 2021. On the other hand, Spain had the lowest incident population (42,588 cases).
• Japan had 38,043 incident cases for GWs in 2021, accounting for approximately 3% in 7MM+China.

Genital Warts Epidemiology

The epidemiology segment also provides the Genital Warts epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), Japan, and China.

Genital Warts Drug Chapters

The drug chapter segment of the Genital Warts report encloses the detailed analysis of Genital Warts marketed drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the Genital Warts clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug and the latest news and press releases.

Genital Warts Marketed Drugs

Imiquimod: Medicis Pharmaceuticals

Imiquimod (Zyclara/Aldara) is an immune response modifier. It is a prescription medicine used to treat actinic keratosis (a condition caused by extensive sun exposure) on the face and scalp of adults who are over 18 years of age. It is also used to treat genital warts that appear on the outside of the body in adults and children who are at least 12 years old. This medicine is not a cure for genital warts.

Imiquimod, under brand Aldara cream (5%) was approved by FDA in 1997 for the treatment of external genital warts and perianal warts for patients 12 years or older. The drug was manufactured by 3M pharmaceuticals. In 2004, the drug was also approved for biopsy-confirmed, primary superficial basal cell carcinoma. Additionally, the drug was also licensed for Actinic Keratosis by FDA.

European Medicine Agency (EMA) on September 18, 1998, approved the medical use of Imiquimod (5%) whereas it was further accepted by Pharmaceuticals and Medicals Devices Agency of Japan (PMDA) on August 31, 2007.

Veregen (Polyphenon E): Aresus Pharma

Veregen, first drug in its class for the local treatment of genital warts, is based on a defined extract of green tea leaves produced in a complex and specifically developed process. Veregen was the first and is one of the few innovative herbal medicines which were approved by the US Food and Drug Administration (FDA).

Veregen (sinecatechins) ointment, 15% is a botanical drug product for topical use. The drug substance in Veregen is sinecatechins, which is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis, and is a mixture of catechins and other green tea components. Catechins constitute 85-95% (by weight) of the total drug substance which includes more than 55% of Epigallocatechin gallate (EGCg), other catechin derivatives such as Epicatechin (EC), Epigallocatechin (EGC), Epicatechin gallate (ECg), and some additional minor catechin derivatives, i.e., Gallocatechin gallate (GCg), Gallocatechin (GC), Catechin gallate (Cg), and Catechin (C). In addition to the known catechin components, it also contains gallic acid, caffeine, and theobromine which together constitute about 2.5% of the drug substance. The remaining amount of the drug substance contains undefined botanical constituents derived from green tea leaves (MediGene, 2008).

Genital Warts Emerging Drugs

VP-102: Verrica Pharmaceuticals

VP-102 is a proprietary drug-device combination of 0.7% w/v cantharidin delivered via a single-use precision applicator. The active ingredient, cantharidin, is a naturally occurring vesicant that causes the degradation of desmosomal plaques. It is topical, applied directly to the lesions, and designed to be convenient for both patients and practitioners. Verrica is also advancing its lead product, VP-102, a proprietary topical therapy, in many common skin indications, including molluscum contagiosum and verruca vulgaris (common warts) (Verrica Pharmaceuticals, 2022).

Ranpirnase (RanTop): Tamir Biotechnology

Orgenesis completed its pre-Investigational New Drug (“IND”) consultation with the US FDA regarding the development of RanTop® (Ranpirnase topical gel) for the treatment of anogenital warts. The company is on track to start Phase II trials in this indication after completing the FDA pre-IND requests. Two Phase I/IIa trials were previously completed for the treatment of AGW caused by human papillomavirus. In both these trials, Ranpirnase 0.1% gel was applied twice daily to the affected areas for up to 8 weeks. The results demonstrated the product's tolerability and signs of preliminary clinical efficacy (Orgenesis Inc., 2021).

Genital Warts Market Outlook

The current therapeutic options available for the treatment of GW are largely centered upon removal of the warts. There is little evidence to suggest that existing treatments are effective in the long-term eradication of genital warts or that they play any significant role in reducing the relapse rate of disease. 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. The 's market forecast focus on the market revenue generated by pharmacological therapies (including all the currently used chemical therapies) prescribed for the management of genital warts and doesn't comprise the revenue generated by devices &/or surgical procedures (such as Cryotherapy, Electrosurgery, Scissor excision or laser removal of warts) or prophylaxis measures (Gradasil or Cervarix). The market is subdivided bases of mode of treatment that is either Topical or Systemic treatment.

Along with the topical therapies, there are a variety of treatment options for genital warts. No data shows the superiority of one treatment over another. Moreover, few data are available from direct head-to-head comparisons of treatments. It would be beneficial to carry out a high quality study to compare directly the preferred treatment options to make better informed decisions. According to an article by Hoy et al. (2009), it is estimated that treatment regimens involving patient-applied therapies include almost 40% of individuals, and slightly more than one-half of these individuals are treated with physician-applied therapies.

In emerging scenario, companies such as Verrica Pharmaceuticals, Tamir Biotechnology and Novan Inc. are conducting late phase clinical trials for topical treatment of genital warts.

Key Findings

• The therapeutic market of Genital Warts in the 7MM+China was USD 983 million in 2021.
• The United States accounts for the highest market size of Genital Warts approximately 66% of the total market size in 7MM+China in 2021, in comparison to the other major markets i.e., EU5 countries (the United Kingdom, Germany, Italy, France, and Spain), Japan, and China.
• Among the EU5 countries, Germany had the highest market size with USD 53 million in 2021, while Spain had the lowest market size of Genital Warts with USD 29 million in 2021.
• The market size for Genital Warts in Japan was estimated to be USD 18 Million in 2021, which accounts for 2% of the total 7MM+China market.
• With the expected launch of upcoming therapies, such as VP-102, SB-207, and RanTop, and others the total market of Genital Warts is expected to show a decent change in upcoming years.

The United States Market Outlook

This section provides the total Genital Warts market size and; market size by therapies in the United States.

EU-5 Market Outlook

The total Genital Warts market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total Genital Warts market size and market size by therapies in Japan are provided.

China Market Outlook

The total Genital Warts market size and market size by therapies in China are provided.

Genital Warts Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the Genital Warts market or expected to get launched in the market during the study period 2019-2032. The analysis covers Genital Warts market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Genital Warts Development Activities

The report provides insights into different therapeutic candidates in phase II, and phase III stages. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for Genital Warts emerging therapies.

Reimbursement Scenario in Genital Warts

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

The publisher performs competitive and market Intelligence analysis of the Genital Warts market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of Genital Warts, explaining its signs and symptoms, causes, classification, and currently available therapies.
• Comprehensive insight has been provided into the Genital Warts epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Genital Warts is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the Genital Warts market; historical and forecasted is included in the report, covering the 7MM+China drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM+China Genital Warts market.

Report Highlights

• The robust pipeline with novel MOA and oral ROA and increasing incidence will positively drive the Genital Warts market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Genital Warts R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition and underlying cause.
• Major players are involved in developing therapies for Genital Warts. The launch of emerging therapies will significantly impact the Genital Warts market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Genital Warts Report Insights

• Patient Population
• Therapeutic Approaches
• Genital Warts Pipeline Analysis
• Genital Warts Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Genital Warts Report Key Strengths

• 11-Years Forecast
• 7MM+China Coverage
• Genital Warts Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Genital Warts Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• SWOT analysis

Key Questions Answered

Market Insights:

• What was the Genital Warts market share (%) distribution in 2019 and how it would look like in 2032?
• What would be the Genital Warts total market size as well as market size by therapies across the 7MM+China during the forecast period (2022-2032)?
• What are the key findings pertaining to the market across the 7MM+China and which country will have the largest Genital Warts market size during the forecast period (2022-2032)?
• At what CAGR, the Genital Warts market is expected to grow at the 7MM+China level during the forecast period (2022-2032)?
• What would be the Genital Warts market outlook across the 7MM+China during the forecast period (2022-2032)?
• What would be the Genital Warts market growth till 2032 and what will be the resultant market size in the year 2032?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What is the disease risk, burden, and unmet needs of Genital Warts?
• What is the historical Genital Warts patient population in the United States, EU5 (Germany, France, Italy, Spain, and the UK), Japan, and China?
• What would be the forecasted patient population of Genital Warts at the 7MM+China level?
• What will be the growth opportunities across the 7MM+China with respect to the patient population pertaining to Genital Warts?
• Out of the above-mentioned countries, which country would have the highest incident population of Genital Warts during the forecast period (2022-2032)?
• At what CAGR the population is expected to grow across the 7MM+China during the forecast period (2022-2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Genital Warts along with the approved therapy?
• What are the current treatment guidelines for the treatment of Genital Warts in the US, Europe, Japan and China?
• What are the Genital Warts marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of Genital Warts?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Genital Warts?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Genital Warts therapies?
• What are the recent therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Genital Warts and their status?
• What are the key designations that have been granted for the emerging therapies for Genital Warts?
• What are the 7MM+China historical and forecasted market of Genital Warts?

Reasons to Buy

• The report will help in developing business strategies by understanding trends shaping and driving the Genital Warts.
• To understand the future market competition in the Genital Warts market and an Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Genital Warts in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), Japan, and China.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the Genital Warts market.
• To understand the future market competition in the Genital Warts market.