Herpes Genitalis Market

Key Highlights

• The Herpes Genitalis market is projected to grow consistently throughout the forecast period (2023–2032) due to increased immunosuppression and chronic conditions, lack of awareness and education, and inadequate testing and diagnosis.
• Analysts from DelveInsight have observed a significant surge in the incidence of Herpes Genitalis in recent times. Breakthrough discoveries and advancements in scientific knowledge are expected to drive market growth along with the introduction of new therapeutic approaches.
• To propel the growth of the Herpes Genitalis market in the coming years, several companies, such as United BioPharma, Heidelberg ImmunoTherapeutic, Moderna Inc., and others, are currently engaged in the development of drugs in early to mid-phase clinical trials. With the anticipated approval of these innovative therapies within the forecast period (2023–2032), the therapeutic market for Herpes Genitalis is expected to experience a substantial increase, exhibiting a significant compound annual growth rate (CAGR). 

DelveInsight’s report titled “Herpes Genitalis – Market Insights, Epidemiology, and Market Forecast – 2032” comprehensively analyzes Herpes Genitalis. The report includes a detailed examination of the historical and projected epidemiology data that includes Total Incident Cases of Herpes Genitalis, Etiology-Specific Incident Cases of Herpes Genitalis, Gender-specific Incident Cases of Herpes Genitalis, Treatable Cases of Herpes Genitalis. The Herpes Genitalis market report offers an in-depth understanding of the various aspects related to the patient population, including diagnosis, prescription patterns, physician perspectives, market access, treatment, and future market developments for the seven major markets, including the United States, EU4 (Germany, France, Italy, and Spain) and the UK, and Japan from 2019 to 2032.

In order to gauge the market’s overall potential and identify business opportunities, the report discusses current Herpes Genitalis treatment practices and algorithms as well as unmet medical needs.

Herpes Genitalis Overview

Genital Herpes is the most common ulcerative sexually transmitted infection in developed countries. It is caused by human herpesviruses 1 (HSV-1) or 2 (HSV-2), two of the eight types of herpesviruses that infect humans. Most cases of primary genital Herpes do not cause noticeable symptoms; many people infected with HSV-2 do not know they have genital Herpes. Primary genital lesions develop 4–7 days after contact. The vesicles usually erode to form ulcers that may coalesce. Lesions may occur in different locations such as on the prepuce, glans penis, and penile shaft in men; on the labia, clitoris, perineum, vagina, and cervix in women; around the anus and in the rectum in men or women who engage in receptive rectal intercourse.

Herpes Genitalis Diagnosis and Treatment Algorithm 

The diagnosis of Genital Herpes is frequently made through clinical observation of characteristic lesions, which typically manifest as clusters of vesicles or ulcers on an erythematous base. Such lesions are uncommon in other types of genital ulcers, except those caused by HSV. However, these lesions may not be present in all patients, and therefore, testing for HSV is necessary to confirm the diagnosis when it is unclear. Typically, testing involves obtaining a fluid sample from the base of a vesicle or a newly ulcerated lesion. It should be noted that the absence of HSV in culture, particularly in patients without active lesions, does not necessarily exclude HSV infection, as viral shedding is intermittent. 

Additionally, culture has limited sensitivity, and PCR is increasingly used due to its higher sensitivity. Direct immunofluorescence with fluorescein-labeled monoclonal antibodies may also be available, although it is specific but not sensitive. Serologic tests can accurately detect HSV-1 and HSV-2 antibodies, which typically develop within the first few weeks after infection and persist thereafter. Therefore, if Genital Herpes is suspected to be a recent acquisition, tests may need to be repeated to allow sufficient time for seroconversion.

There is no medication to cure the infection due to the herpes virus. Management aims to ease symptoms, reduce the frequency of recurrences, and reduce transmission. Salt baths, ice packs for the affected area, and pain-relieving medication such as paracetamol can improve symptoms. The most commonly employed treatment is antiviral medication, such as acyclovir, famciclovir, and valaciclovir, which can mitigate the severity of an outbreak if taken promptly (ideally upon the onset of symptoms). It should be noted that topical antivirals, typically utilized for cold sores on the lips or face, are inappropriate for application to the genital region.

Herpes Genitalis Epidemiology

The Herpes Genitalis epidemiology section provides insights into the historical and current Herpes Genitalis patient pool and forecasted trends for seven individual major countries. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool, its trends, and assumptions undertaken.

The epidemiology section of the Herpes Genitalis 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.

Key Findings

• According to the study conducted by Spicknall et al. (2018), in the US, there were an estimated 572,000 (Q1 = 479,000, Q3 = 673,000) incident genital herpes infections among 18–49-year-olds. Women accounted for two-thirds of infections. Incidence was highest among 18–24-year-olds with an estimated 242,000 (Q1 = 210,000, Q3 = 274,000) infections. Sensitivity analyses indicated that HSV-1 could be responsible for tens of thousands of additional incident genital herpes infections, depending on the percentage of HSV-1 infections that are genital.
• As per the Centers for Disease Control and Prevention studies, two types of HSV have been identified as causing genital Herpes: HSV-1 and HSV-2. HSV-2 causes most cases of recurrent Genital Herpes. Genital HSV-2 infection is more common in women (approximately one out of five women 14–49 years of age) than in men (about one out of nine men 14–49 years of age).
• According to the study conducted by James et al. (2016), 23.9 million (95% UI: 21.0 million–29.5 million) people 15–49 years of age became infected with HSV type 2 in 2016, an incidence of 0.6% (95% UI: 0.6–0.8;) of these, 14.7 million (95% UI: 12.4 million–18.1 million) were women, and 9.2 million (95% UI: 7.4 million–13.6 million) were men.
• According to the recent World Health Organization Report 2020, it was found that about half a billion people worldwide are living with Genital Herpes.
• A study by Ribes et al. (2001) found that in men, 23.3% of culture-positive Genital Herpes was caused by HSV-1 over the 6-year study period (yearly range, 11.1–31.8%). In women, 31.7% of Genital Herpes was caused by HSV-1, with a yearly range of 24.3–44.8%.

Get detailed insights into the historical as well as forecasted epidemiology in the 7MM, at: Herpes Genitalis Epidemiology Forecast

Herpes Genitalis Market Outlook

The therapeutic market for Herpes Genitalis primarily relies on using antiviral medications. Regrettably, there exists no definitive cure for this condition. Nevertheless, the regular administration of antiviral drugs has been shown to effectively prevent or abbreviate outbreaks while decreasing the likelihood of transmission to others. Acyclovir, valacyclovir, and famciclovir are the standard first-line drugs for managing Herpes Genitalis.

The medical management of patients afflicted with Herpes Genitalis is frequently deemed inadequate. However, implementing existing diagnostic, therapeutic, and preventative measures, coupled with proficient patient counseling, can greatly enhance the efficacy of treatment. Despite this, the current antiviral treatment and prophylaxis options exhibit certain limitations, particularly in managing recurrent outbreaks. The advent of novel drug categories and the development of effective vaccines and therapies are anticipated to ameliorate the situation in the future substantially.

According to DelveInsight, the Herpes Genitalis market in the 7MM is expected to significantly change during the study period (2019–2032).

Herpes Genitalis Drug Chapters 

Marketed Herpes Genitalis Drugs

The therapeutic market for Herpes Genitalis is replete with generic products of various approved drugs such as ZOVIRAX and FAMVIR. Consequently, the entry of emerging therapies into the market is expected to face challenges due to the lower cost advantage enjoyed by generics. Nevertheless, the introduction of innovative drug categories and the advancement of efficacious vaccines and therapies are expected to improve the situation in the future significantly.

Note: Detailed marketed therapies assessment will be provided in the final report.

Emerging Herpes Genitalis Drugs

The Herpes Genitalis market dynamics are expected to change, primarily due to increased healthcare spending worldwide. Herpes Genitalis Market players such as United BioPharma, Heidelberg ImmunoTherapeutic, Moderna Inc., and others are actively involved in developing Herpes Genitalis treatments. 

UB 621: United BioPharma

UB-621 is a fully human monoclonal antibody for human herpes simplex virus (HSV) infection. Unlike other traditional small molecule anti-herpes virus drugs, UB-621 blocks the binding of the virus to receptors on the surface of host cells by specifically binding to the viral envelope glycoprotein D, preventing the virus from entering the host cells. It also interrupts HSV virus transmission between cells. Since UB-621 acts on foreign pathogens, it will not affect the normal immune function of the human body. UB-621 subcutaneous injection has completed Phase I clinical study (NCT02346760), showing good safety, tolerability, and a half-life of up to 25 days. Currently, United BioPharma is conducting Phase II clinical trials of UB-621 for adult patients with frequent recurrences of Genital Herpes.

HDIT 101: Heidelberg ImmunoTherapeutic

HDIT101, being developed by Heidelberg ImmunoTherapeutics GmbH, is a first-in-class humanized monoclonal antibody recognizing a conserved epitope in glycoprotein B, a target present on the surface of herpes simplex virus 1 (HSV-1) and HSV-2 particles as well as on virus-infected cells. The drug is currently in the Phase II stage of development for treating Herpes Genitalis.

mRNA-1608: Moderna Inc

Moderna Inc.’s herpes simplex virus (HSV) vaccine candidate (mRNA-1608) is a Messenger RNA (mRNA) vaccine targeted against HSV-2 disease. On February 18, 2022, Moderna Inc. stated that it expects an HSV-2 vaccine could provide cross-protection against HSV-1. With mRNA-1608, Moderna aims to induce a strong antibody response with neutralizing and effector functionality combined with cell-mediated immunity. Moderna is developing mRNA-1608 to reduce the burden of HSV lesions based on mRNA technology that offers potential advantages in efficacy, speed of development, and production scalability and reliability, which may position the company as a leader in preparing for and responding to infectious disease threats that place millions of people at risk worldwide.

Note: Detailed emerging therapies assessment will be provided in the final report.

Herpes Genitalis Market Segmentation

DelveInsight’s ‘Herpes Genitalis Market Insights, Epidemiology, and Market Forecast – 2032’ report provides a detailed outlook of the current and future Herpes Genitalis 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.

Herpes Genitalis Market Size by Countries

The total Herpes Genitalis market size is analyzed for individual countries (the United States Market, EU4 [Germany, France, Italy, and Spain] and the UK market, and Japan). The United States accounted for a larger portion of the 7MM market for Herpes Genitalis in 2022 due to the high prevalence of the condition and higher cost of treatments. This dominance is predicted to continue with the potential early entry of new products.

Country-wise Market Size Distribution of Herpes Genitalis

Herpes Genitalis Market Size by Therapies

The Herpes Genitalis market encompasses antiviral therapies aimed at managing and treating this lifelong condition characterized by frequent symptomatic recurrences. There is no cure for Herpes, so treatment goals are to reduce the number of outbreaks and lessen symptoms when one has an outbreak.

Major companies, such as United BioPharma, Heidelberg ImmunoTherapeutic, and Moderna Inc., are some of the key players involved in developing new therapies for managing Herpes Genitalis. As research and development efforts continue, it is expected that the market size for Herpes Genitalis therapies will expand further, driven by advancements in treatment options, increased awareness, and growing demand for innovative approaches to address the needs of individuals living with Herpes Genitalis.

Note: Detailed market segment assessment will be provided in the final report.

Explore more about the emerging therapies and key companies working in the therapeutic domain, at: Herpes Genitalis Pipeline Insight

Herpes Genitalis Drugs Uptake

This section focuses on the sales uptake of potential Herpes Genitalis drugs that have recently launched or are anticipated to be launched in the Herpes Genitalis market between 2019 and 2032. It estimates the market penetration of Herpes Genitalis 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 Herpes Genitalis market.

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

Note: Detailed assessment of drug uptake and attribute analysis will be provided in the full report on Herpes Genitalis.

Herpes Genitalis Market Access and Reimbursement

DelveInsight’s ‘Herpes Genitalis – Market Insights, Epidemiology, and Market Forecast – 2032’ report provides a descriptive overview of the market access and reimbursement scenario of Herpes Genitalis.

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

Herpes Genitalis: 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 the Department of Pediatrics, Microbiology, and Medicine, University of Alabama at Birmingham Children’s Hospital, Birmingham, USA; Institut für Virologie und Antivirale Therapie, Konsiliarlabor für HSV und VZV, Universitätsklinikum Jena, Jena, Germany, and others.

“Despite the advances in managing HSV infections with nucleoside analogs, improved therapeutics with alternative mechanisms of actions and enhanced bioavailability are required.”

“There exists no definitive cure for herpes; hence, the primary objectives of treatment are to mitigate the frequency of outbreaks and alleviate symptoms during an outbreak.”

Note: Detailed assessment of KOL Views will be provided in the full report of Herpes Genitalis.

Competitive Intelligence Analysis

We perform Competitive and Market Intelligence analysis of the Herpes Genitalis Market using various Competitive Intelligence tools, including SWOT analysis, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Herpes Genitalis Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase II and Phase III stages. It also analyzes Herpes Genitalis Companies involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, patent details, and other information for emerging Herpes Genitalis therapies.

Herpes Genitalis Report Insights

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

 Herpes Genitalis Report Key Strengths

• Ten Years Forecast
• The 7MM Coverage
• Herpes Genitalis Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Herpes Genitalis Market
• Herpes Genitalis Drugs Uptake

 Herpes Genitalis Report Assessment

• Herpes Genitalis Current Treatment Practices
• Unmet Needs
• Herpes Genitalis Pipeline Product Profiles
• Herpes Genitalis Market Attractiveness

Key Questions

• At what CAGR is the Herpes Genitalis market, and is epidemiology expected to grow in the 7MM during the forecast period (2023–2032)?
• What are the key findings of the market across the 7MM, and what country will have the largest Herpes Genitalis market size during the forecast period (2023–2032)?
• Are there any barriers or challenges hindering the growth of the Herpes Genitalis market (2023–2032)?
• What strategies are pharmaceutical companies adopting to capture a larger share of the Herpes Genitalis market (2023–2032)?