HPV Disease

Published Date : Sep 2023
Category : Infectious Diseases
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Comprehensive Analysis of the HPV Disease Landscape: Prevention, Diagnosis, and Treatment Approaches

Human Papillomavirus, or HPV, has become a big global health issue and is receiving more attention from healthcare payers. This widespread viral infection has led to several health problems, including several malignancies, with cervical cancer being a specific urgent concern. The high frequency of HPV infections and the significant burden of associated illnesses are the current challenges faced by healthcare payers.

HPV (Human Papillomavirus) Disease Overview

Human papillomavirus (HPV) is a group of related viruses and HPV is the most common Sexually Transmitted Disease (STD). There are more than 150 different HPV strains, and while the majority of infections with these strains normally go away on their own, there are more than 40 types of HPV that result in different cancers. HPV infection is a viral infection that commonly causes skin or mucous membrane growths and genital (warts). About 40 types of strains are spread through direct sexual contact with someone who has the virus. According to the study, HPV is the most common Sexually Transmitted Infection (STI) in the U.S. There are more than 13 million new HPV infections per year, and there are ~ 42.5 million Americans who are affected according to the Centre for Disease Control & Prevention (CDC).

There are two categories of sexually transmitted HPV –

  1. Low-risk HPV
  2. High-risk HPV

Some people develop different types of warts from certain low-risk HPV infections, but the other types (including the high-risk types) have symptoms. If a high-risk HPV infection lasts for many years and causes cell changes or mutations in genes it develops into cancer. Each year, ~47,199 new instances of cancer in areas of the body where HPV is frequently present are discovered in the United States. Furthermore, according to the CDC 37,300 tumours are caused by HPV.

Over 90% of cervical cancer cases are linked to HPV, with two strains (16 and 18) being responsible. This cervical alteration that could result in cancer is identified in women with screening testing.

Globally HPV infections are highly prevalent, and the epidemiology varies by region and HPV type. Prevalence varies by age, with the highest rates found in young adults. As a result, cervical cancer is a leading cause of cancer-related deaths among women in many parts of the world. The burden of HPV-related diseases is high worldwide. Low- and middle-income countries bear a significant burden of HPV-associated cancers due to limited access to vaccination and screening programs.

The battle against HPV-related diseases is still ongoing, with an emphasis on reducing the incidence of cervical cancer and other cancers caused by the virus through vaccination, early identification, and better access to medical care, especially in areas with high prevalence rates has become important.

The ability of industry participants to expand globally depends on developments in the fields of prevention, diagnosis, and treatment. As a result, it encourages the worldwide expansion of new services in the HPV disease market.

DiseaseLandscape Insights supports all healthcare stakeholders. By providing information on the HPV market, informed choices in medical technology, treatments, and diagnostic procedures, and information on how various new technological advancements are affecting the disease market and promoting higher expansion.

DiseaseLandscape Insights here assists in making informed judgments in the field of medical technology, medicines, and diagnostics, where different technologies and spectacular breakthroughs alter the landscape, resulting in increased growth.

"HPV Infection Testing and Methods: Market Player Analysis and Developments"

Diagnostic Analysis:

Every year as per WHO, about 12,000 women are diagnosed with cervical cancer and 4,000 women die from this HPV disease. The Food and Drug Administration (FDA) has approved several HPV tests that can identify up to 14 high-risk types.

The diagnosis of HPV (Human Papillomavirus) infection and related diseases typically involves a combination of clinical assessment, laboratory tests, and sometimes imaging. Here are the primary diagnostic methods and tests used for HPV-related diseases-

  1. Physical Assessment:

    Healthcare providers perform a visual inspection of the genital and anal areas to identify any visible warts or lesions caused by HPV. For women, a colposcopy is performed to closely examine the cervix, vagina, or vulva. During a colposcopy, a special instrument with a light and magnifying lens is used to identify abnormal areas.
  2. Pap Smear (Cervical Cytology):

    A Pap smear is a common test for detecting precancerous abnormalities in the cervix and cervical cancer. Cervical cells must be sampled to look for abnormalities brought on by high-risk HPV strains. Results from an abnormal Pap smear trigger more testing or a colposcopy. An anal Pap test is used to check HPV-related abnormalities in the anal canal, much like a cervical Pap test. It is frequently advised for people who are at a higher risk of developing anal cancer in men.
  3. HPV Genotyping:

    HPV genotyping distinguishes between different HPV types, particularly high-risk types that are associated with a higher risk of cervical cancer. It helps in identifying the specific type of HPV infection.
  4. Biopsy:

    A biopsy involves removing a small sample of tissue from an abnormal region, such as a rare cervical lesion seen during colposcopy, an anal or vaginal wart, or both. To determine whether a tissue sample is malignant or precancerous, it is inspected under a microscope.
  5. Imaging Studies:

    In advanced cases of HPV-related cancers, imaging studies such as CT scans, MRI scans, or PET scans are used to assess the extent of the disease and plan treatment.

The following table lists the names of the market payers who are redefining healthcare with their forefront diagnostic innovations:

                                                     Diagnostic Market Players for HPV Infection

HPV Testing Types

HPV Genotyping Tests

Imaging Tools (CT scan and MRI)

HPV Assay

Roche Diagnostics

Abbott Laboratories

General Electric (GE) Healthcare




Siemens Healthineers



Greiner Bio-One

Philips Healthcare

Cepheid (a Danaher company):



Hitachi Healthcare

BD (Becton, Dickinson, and Company)



                                                                    Diagnostic Market Products

HPV Testing Types

HPV Genotyping Tests

HPV Assay

Imaging Tools (CT scan and MRI)

Cobas HPV Test

Digene HPV Genotyping PS Test

Aptima HPV Assay


Digene Hybrid Capture 2 (HC2) HPV Test

RealTime High-Risk HPV Assay

BD Onclarity HPV Assay


Abbott RealTime High-Risk HPV Test


Xpert HPV Assay

ngenia MRI Systems

Anyplex II HPV28 Detection



Aquilion CT Scanners




Echelon Oval MRI Systems


"From Diagnosis to Cure: Understand the Latest Trends and Alternatives in HPV Disease Treatments with DLI "

Treatment Analysis:

The treatment for HPV (Human Papillomavirus) disease also varies depending on the type of HPV infection, the specific condition it causes, and its severity.

Many HPV infections, especially low-risk types, are cured on their own without the need for medical intervention. Healthcare providers recommend regular monitoring to see if the infection clears naturally. Here are different treatment types for HPV disease.

  1. Topical Treatments for Warts:

For visible warts caused by low-risk HPV types, healthcare providers prescribe topical treatments. Common options include -

  • Podophyllotoxin:

    A topical solution or gel that is applied directly to the warts.
  • Imiquimod:

    A topical cream that stimulates the immune system to fight the virus.
  • Trichloroacetic Acid (TCA) or Bichloroacetic Acid (BCA):

    Chemical solutions that are applied to warts to destroy them.
  1. Cryotherapy (Freezing):

    Liquid nitrogen is used to freeze and destroy warts. This is a common treatment for genital warts.
  2. Electrocautery or Laser Therapy:

    Healthcare providers use electric currents or lasers to remove warts, particularly for larger or stubborn warts.
  3. Intralesional Immunotherapy:

    For recurrent or difficult-to-treat warts, an immunotherapy called intralesional injection of antigens or interferon is used to stimulate the body's immune response to the virus.

For instance, in 2023, most of the pipeline drugs approved by the FDA in the HPV vaccine landscape were injected by injections.

  1. Surgical Removal:

    In some cases, particularly for larger or more complex warts, surgical procedures such as excision or laser ablation are required. For instance, Cryoalfa manufactures cryosurgical devices for various dermatological applications, including the treatment of warts.
  2. Antiviral Medications:

    For certain HPV-related conditions, such as recurrent respiratory papillomatosis or HPV-associated cancers, antiviral medications like cidofovir are used to inhibit viral replication. Antiviral medications are not typically used to treat common skin or genital warts.

Treatment for conditions caused by HPV, such as Cervical Dysplasia or HPV-related cancers, includes procedures like Loop Electrosurgical Excision Procedure (LEEP), Cryotherapy, or surgery to remove abnormal cells or tumors.

  1. Vaccination:

    HPV vaccines, such as Gardasil and Cervarix, are available to prevent certain HPV infections. They are most effective when administered before HPV exposure. Vaccination is recommended for adolescents and young adults to prevent HPV-related cancers and diseases.

In cases of HPV-related cancers or pre-cancerous conditions, regular monitoring and follow-up with healthcare providers are essential to track the progression of the disease and determine the need for further treatment.

It is important to consult with a healthcare provider to determine the most appropriate treatment for specific HPV- side effects. Additionally, prevention through HPV vaccination and safe sexual practices, such as condom use, significantly reduce the risk of HPV infection and related diseases.

The worldwide HPV disease market is highly competitive since it is a common sexually transmitted disease and owes a prominent market player with a global presence. 

The market leaders in the table below are building the landscape and pushing innovation to achieve better health lives for patients suffering.

                                                          Market Players for HPV Treatment

Topical Treatments for Warts

Cryotherapy (Freezing)

Intralesional Immunotherapy

Vaccinations & Anti-Viral Medications

GlaxoSmithKline (GSK)

 CryoPen, Inc

Merck & Co., Inc

Merck & Co., Inc

Taro Pharmaceuticals

Wartner Cryotherapy

TOLMAR Pharmaceuticals, Inc.

GlaxoSmithKline (GSK)

Valeant Pharmaceuticals (now Bausch Health Companies Inc.)

Cryoalfa by Cryoalfa S.r.l

Verrica Pharmaceuticals Inc.


Medimetriks Pharmaceuticals

OraSure Technologies


Shanghai Bovax Biotechnology Co Ltd

Perrigo Pharmaceuticals

Dr. Scholl's







Dr. Reddy's Laboratories





                                                                Products for HPV Treatment

Topical Treatments for Warts

Cryotherapy (Freezing)

Intralesional Immunotherapy

Vaccinations & Anti -Viral Medications

Zyclara (Imiquimod)


Zyclara (imiquimod) Cream


Aldara (Imiquimod)


Imiquimod Cream


Efudex (5-Fluorouracil)



Gardasil 9

Veregen (Sinecatechins)




Condylox (Podofilox)









DiseaseLandscape Insights assists the market participant in changing and expanding the treatment domain of HPV disease to improve patient retention, explore advancements in the field of therapy, and reach novel heights.

With our extensive study and service offerings, DLI allows market participants to stay one step ahead in the competition in the diagnostic and treatment market to give cutting-edge competitiveness.

 "Understand the Evolving Market Dynamics of HPV Disease: Patterns, Players, and Innovations with DLI”

Market Trends Analysis:

The global market trend analysis for HPV (Human Papillomavirus) disease indicates a growing focus of market players on prevention and management strategies. That is because of the increasing recognition of the virus in various cancers and the need for comprehensive healthcare solutions.

One of the most significant trends in the global HPV disease market is the widespread adoption of HPV vaccination programs. Many countries are expanding their vaccination efforts, targeting adolescents and young adults to prevent HPV infections to significantly reduce the burden of HPV-related diseases, particularly cervical cancer.

Another notable trend is the emphasis on improved screening and early detection methods for HPV-related diseases. Advances in HPV DNA testing and visual inspection techniques are facilitating earlier diagnosis of Cervical Dysplasia and other conditions.

Additionally, efforts to address global health disparities related to HPV are gaining momentum. Organizations like Gavi, the Vaccine Alliance, and the World Health Organization (WHO) are working to increase access to HPV vaccines and screening programs in low- and middle-income countries, where the burden of HPV-related cancers is particularly high, especially in South Africa.

However, research and development efforts taken by Becton Dickinson (BD) have been involved in the development of HPV testing technologies, which includes the BD Onclarity™ HPV Assay, which is designed for high-throughput labs. The company has made strategic investments to expand its presence in the HPV testing market and is focusing on risk management and designed to treat HPV infections.

 The global market trend analysis for HPV disease reveals a concerted effort by healthcare companies to fight the virus associated with health risks through vaccination, improved screening, and equitable access to healthcare services. These trends show the importance of proactive measures to reduce the prevalence and impact of HPV-related diseases on a global scale.

Our Team at DLI provides comprehensive assistance in planning, carrying out, and assessing market demands and curves for the development of revolutionary new medications by providing strategic approaches to overcome gaps in the market. We are a committed partner to market players in the healthcare industry who aim for better health outcomes.

 "The Conflict for Dominance: Strategic Trends in the HPV Disease Market"

Competitive Analysis-

The market for HPV disease is highly competitive; this is mostly due to the realization of significant development prospects and the necessity of implementing efficient market penetration methods in the diagnostic and treatment market.

Several healthcare companies are actively involved in the development of HPV-related products, treatments, and vaccines. Here are some notable developments and deals up to that point:

Merck & Co., Inc. (MSD) and GSK Collaboration:

In December 2020, Merck, and GlaxoSmithKline (GSK) announced a collaboration to research and develop a combination of GSK's investigational immunotherapy and Merck's HPV vaccine, Gardasil 9. The goal was to evaluate the potential of this combination in the prevention and treatment of HPV-related cancers.

Companies like Merck, GSK, Pfizer, and many more pharma firms are actively working on expanding access to HPV vaccines in low- and middle-income countries through initiatives and partnerships with organizations.

Several other companies and research institutions are developing advanced HPV testing technologies and point-of-care devices for more accessible and efficient cervical cancer screening. Along with that various organizations and healthcare companies are forming partnerships to support global efforts to eliminate cervical cancer.

Governments worldwide continued to allocate funding and resources to support HPV vaccination programs, cervical cancer screening, and research initiatives to alter the landscape, resulting in increased growth.

As these companies enter the HPV disease market, they contribute to a competitive landscape that encourages advancements in prevention, diagnosis, and treatment. They introduce new technologies, therapies, and strategies that enhance the overall management of HPV-related conditions, ultimately benefiting patients and public health efforts.

DiseaseLandscape Insights helps the industry player by providing intense knowledge about all the existing market players, their innovations, and strategies by studying the gaps in treatment flow. Our regulatory expertise helps market players focus on collaborations globally and helps in selecting the correct marketplace to grow exponentially.

The Analysis of the Impact of Regulatory Bodies and Organizations on the Management of HPV Disease

Regulatory Framework Analysis :

As per DLI Analysis, here are some Regulatory frameworks and announcements related to the treatment and diagnosis of HPV (Human Papillomavirus) diseases.

Many countries have established guidelines as per (the FDA) and (EMA) for HPV vaccination, especially targeting adolescents and young adults. However, Regulatory agencies in various countries periodically update guidelines for cervical cancer screening and HPV testing. These guidelines aim to improve early detection and reduce the burden of cervical cancer in women.

For example, the U.S. Preventive Services Task Force (USPSTF) updated its cervical cancer screening recommendations, including the use of HPV testing alongside Pap smears (cotesting) for certain age groups.

Along with that Regulatory agencies have also approved various HPV tests for diagnostic purposes. These tests have helped to identify high-risk HPV types and assess the risk of cervical cancer.

In the current situation, Regulatory efforts mostly focus on ensuring the availability and accessibility of HPV tests, especially in regions with limited healthcare resources. Since vaccine safety is a crucial part of regulatory bodies many regulatory agencies constantly monitor the safety of HPV vaccines. They investigate and address reported adverse events and provide guidance to healthcare providers and the public.

Regulatory approval processes for therapeutic vaccines and treatments for HPV-related diseases are ongoing. The approval and availability of such therapies vary by region and depend on clinical trial outcomes. International organizations such as the World Health Organization (WHO) play a role in establishing global strategies for HPV prevention, including vaccination and screening programs.

DiseaseLandscape Insights simplifies the regulatory criteria for stakeholders from several nations for HPV Disease. DLI delivers the right findings regarding risk assessment, monitoring, and regulatory framework.  With DLI services organizations and market participants are able to manage and react to HPV infections and protect the safety of affected people.

Clinical Assessment -

The important role of clinical trials in the practice of evidence-based medicine and health care reform is highlighted by the government's increasing concentration on comparing the effectiveness of studies.

One of the main goals of rebuilding healthcare is achieved by the market participants accurately examining medical therapy with the use of clinical data.

The table below includes the study names of the ongoing clinical trials as well as the stages at which they are taking place.

Phase 1

Phase 2

Phase 3

Phase 4

A Randomized, Double-Blind, controlled (Positive and Placebo) Phase I Clinical Trial to Estimate the Safety and Immunogenicity of the SCT1000 in Healthy Women Aged 18 to 45 Years

The Effects of Probiotics Against Reducing Abundance of Human Papilloma Virus (HPV) in Women

Nine-valent HPV Vaccine to Prevent Persistent Oral HPV Infection in Men Living With HIV

Concomitant HPV Vaccination and HPV Screening for Rapid Elimination of HPV Infection and Cervical Cancer in Sweden

A Phase I/II Study of Adjuvant PRGN-2012 in Adult Patients with Recurrent Respiratory Papillomatosis

A Phase II Double-Blind, Placebo-controlled, Randomized Trial of Artesunate Vaginal Inserts for the Treatment of Patients with Cervical Intraepithelial Neoplasia (CIN2/3)

The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa"

An Open-Label Clinical Trial Evaluating the Immunogenicity of the 9vHPV Vaccination Regimen Over 6 Months Among Women Aged 16 to 45 Years Old, An Exploratory Immunogenicity Study

A Phase I/II Trial of T Cell Receptor Gene Therapy Targeting HPV-16 E7 for HPV-Associated Cancers

A Phase I/II Study of Adjuvant PRGN-2012 in Adult Patients with Recurrent Respiratory Papillomatosis

A Multicentre Randomized, Blinded, Placebo-controlled Phase III Clinical Trial Evaluating the Protective Efficacy, Safety, and Immunogenicity of an 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years

Randomized, Placebo-controlled, Double-blind Study to Evaluate 2LPAPI® Efficacy on the Clearance of Genital HR-HPV Infections.

Evaluate the Safety and Immunogenicity of the 9-valent Human Papillomavirus Recombinant Vaccine (Hansenula polymorpha) in Chinese Male Aged 9-45 Years: A Randomized, Blinded and Placebo-Controlled Phase I Study

A Phase II Double-Blind, Placebo-controlled, Randomized Trial of Artesunate Suppositories for the Treatment of HIV-negative Patients with Anal High-grade Squamous Intraepithelial Lesions (Anal HSIL)

The Effects of Probiotics Against Reducing Abundance of Human Papillomavirus (HPV) in Women

Comparison of the Immune Response After Administration of 2 vs. 3 Doses of the FDA-approved 9-Valent HPV Vaccine Among Women 27-45 Years of Age

Therapeutic Intralesional Nonavalent HPV Vaccine for Genital Condylomata in Adults: An Open-Label Pilot Study

A Phase I/II Trial of T Cell Receptor Gene Therapy Targeting HPV-16 E7 for HPV-Associated Cancers

A Randomized, Placebo-Controlled Trial of HPV Vaccination to Reduce Cervical High-Grade Squamous Intraepithelial Lesions Among HIV-Infected Women Participating in an HPV Test-and-Treat Program (COVENANT)

Acceptance and Completion Rate of Free HPV Vaccination Among Underserved Adult Patients (Age 18-45)


A Phase II Study of Bevacizumab in Adults with Recurrent Respiratory Papillomatosis (RRP)

Evaluating the Immunogenicity and Safety of Quadrivalent Human Papillomavirus Recombinant Vaccine (Type 6, 11, 16, 18) in Healthy Chinese Female Subjects Aged 9 to 26 Years: A Phase 3, Open-label, Non-randomized Clinical Trial

Interventional Study on Efficacy of Lactobacillus Crispatus M247 in Patients Affected by HPV Low-grade Preneoplastic Cervical Lesions and Evaluation of Vaginal Microbiota Changes Before and After Oral Supplementation


          Phase 2a Multicenter, Randomized, Double-Blinded, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Topical Nitric Oxide Releasing Solution for The Treatment Of Human Papillomavirus Verrucae Plantaris

Evaluating the Immunogenicity and Safety of 9-valent Human Papillomavirus (Type6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine in Chinese Females Aged 9 to 45 Years: A Phase 3, Open-label, Non-randomised Clinical Trial

Evaluación de la Eficacia de la combinación de GLIZIGEN® solución Oral 1/día y Gel Vaginal 1/Noche Durante 2 Meses en Pacientes Con Neoplasia Intraepitelial Cervical de Grado 1 (LSIL/CIN-1) Causada Por el Virus Del Papiloma Humano de Alto Riesgo (VPH-AR).


Candida Antigen and Bivalent HPV Vaccine in the Treatment of Multiple Warts: Monotherapy Versus Combined Therapy

Efficacy of the Nonavalent HPV Vaccine in the Treatment of Difficult-to-treat Palmo-plantar Warts

Prospective Observational Immunogenicity Trial of Gardasil-9 HPV Vaccine in People Living with Adequately Managed HIV


A Phase II Clinical Study of KNP2002 Ointment in Patients with Common Warts (OM202JA)

A Multicenter, Randomized, Blind, and Positive-Controlled Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity, and Safety of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula polymorpha) in Chinese Female Subjects Aged 20-45 Years

Clinical and Dermoscopic Study of Intralesional Injection of Acyclovir Versus Candida Antigen in Treatment of Plantar Warts


Protocol 250-1951-201: A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled Study of the Safety and Efficacy of VDMN-21 in Subjects with Verruca Vulgaris

A Study of Reduced Dosing of the Nonavalent HPV Vaccine in Women Living With HIV

Study to Evaluate the Efficacy of 2LVERU® JUNIOR and 2LVERU® on the Treatment of Warts.



DiseaseLandscape Insights (DLI) Consultancy is well-positioned to play a crucial role in assisting market participants in HPV disease to successfully manage the difficulties in the diagnosis and treatment market. We aim to provide excellent service to the healthcare payers in understanding market opportunities by supporting them with diverse strategies that help them grow globally.

DiseaseLandscape Insights assists industry players in developing and implementing viable treatment plans for managing HPV infection. Furthermore, there is an increasing need for diagnostic tools, and clinical evaluations, to detect and cure HPV infection and prevent cancer and HPV infections.

We provide the necessary information and regulatory expertise to key players who are involved in the process. Support from DiseaseLandscape Insights and experience in regulatory norms make it easy for market participants to organize and carry out clinical trials for innovative medicines and pharmaceuticals, patient recruiting tactics, and regulatory compliance.

Additionally, our detailed gap analysis services provide stakeholders with crucial information about areas that require development. We aim to promote innovation, improve patient outcomes, and contribute to the global fight to eradicate HPV-related health concerns by establishing a collaborative environment and providing specialized services.

Vishal SawantBusiness Development

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