Herpes Simplex Market Analysis, Epidemiology, and Forecast Through 2034

DelveInsight's comprehensive "Herpes Simplex Market Insights, Epidemiology, and Market Forecast - 2034" analysis delivers extensive understanding of Herpes Simplex, historical and projected epidemiology, alongside the Herpes Simplex market trends across the United States, EU4 nations (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

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Major Highlights from the Herpes Simplex Market Analysis

• During December 2025, AiCuris Anti-infective Cures AG launched a trial to assess the efficacy and safety in immunocompromised subjects diagnosed with acyclovir resistant or acyclovir susceptible mucocutaneous HSV infection, treated with pritelivir 100 mg once daily (following a loading dose of 400 mg as first dose to rapidly reach steady-state plasma concentration) or investigators choice, which can be either foscarnet 40 mg/kg every 8 hours or 60 mg/kg every 12 hours, or Cidofovir iv 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical applied 2 to 4 times daily, or Imiquimod 5% topical 3 times per week) (provided the drug is nationally approved).

• During December 2025, GlaxoSmithKline disclosed a Phase III, Randomized, Observer-blind, Placebo Controlled, Multicenter Clinical Trial to Assess Herpes Zoster Recurrence and the Reactogenicity, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine (HZ/su) When Administered Intramuscularly on a 0 and 2 Month Schedule to Adults ≥50 Years of Age With a Prior Episode of Herpes Zoster.

• There were 13,038 thousand total diagnosed cases of HSV estimated to have occurred in the 7MM in 2023 of which approximately 4,948 thousand of the accounted cases were estimated to be from the US alone and these cases are anticipated to decrease in the foreseeable future during the analysis period.

• The categorization based on gender, demonstrated that diagnosed prevalent cases in females were higher than that in males in the 7MM. The female diagnosed prevalent cases represented 55% of the total cases in the 7MM.

• There were 1,555 thousand total diagnosed cases of HSV estimated to have occurred in Japan in 2023 of which approximately 700 thousand and 856 thousand of the accounted cases were males and females respectively and these cases are anticipated to decrease in the foreseeable future during the analysis period.

• The total recurrent population of Herpes Simplex was further divided into HSV 1 and HSV 2 cases of total Herpes Simplex Virus. The recurrent cases of HSV 2 were highest in 2023 in the 7MM with nearly 3,651 thousand cases as compared to HSV 1 with 1,825 thousand cases.

• Leading Herpes Simplex pharmaceutical organizations include Teva Pharmaceutical Industries Ltd., Sanofi, Carlsbad Tech, Novartis AG, Emcure Pharmaceuticals Ltd., Fresenius Kabi AG, Viatris, Inc., Apotex Inc., Glenmark Pharmaceuticals Inc., GSK plc, among others.

• Notable Herpes Simplex investigational agents include Famciclovir, ASP2151, ASP2151, GSK208141, Zicam (Ionic zinc), Pritelivir, HDIT101, Valaciclovir, ME-609, among others.

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Herpes Simplex Epidemiology Classification in the 7MM

• Total Seroprevalence of Herpes Simplex in the 7MM

• Total Symptomatic Cases of Herpes Simplex in the 7MM

• Total Diagnosed Cases of Herpes Simplex in the 7MM

• Gender-specific Diagnosed Cases of Herpes Simplex in the 7MM

• Total Recurrent Cases of Herpes Simplex in the 7MM

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Herpes Simplex Commercialized Therapeutic Agents

SITAVIG (acyclovir): Bioalliance Pharma/Vectans Pharma

SITAVIG (acyclovir) represents an innovative therapy for herpes labialis (cold sores). It's a 50 mg Muco-Adhesive Buccal tablet applied under the lip, delivering acyclovir directly to the mouth where the virus replicates. This single-dose treatment marks a substantial advance in managing cold sores, offering targeted and effective delivery of acyclovir to the affected area. The recommended use of SITAVIG involves administering a single 50 mg buccal tablet placed gently in the upper gum (canine fossa) within one hour of prodromal symptoms and before visible signs of herpes labialis appear. Acyclovir, an antiviral drug effective against a-herpesviruses, inhibits DNA polymerases of HSV-1 and HSV-2. During April 2013, French pharmaceutical company BioAlliance Pharma obtained US FDA approval to market SITAVIG for treating recurrent cold sores.

AMENALIEF (amenamevir): Maruho Co., Ltd.

During 2023, Maruho Co., Ltd. obtained approval from Japan's Ministry of Health, Labor and Welfare to revise the indication and dosage of AMENALIEF Tab 200 mg for treating recurrent herpes simplex. AMENALIEF inhibits the helicase-primase complex, crucial for herpesvirus DNA replication, thereby suppressing viral activity. Maruho manufactures and markets the drug in Japan, recommending a 200 mg dosage. Early treatment involves taking 1,200 mg of the drug once after meals within 6 hours of initial symptoms.

Herpes Simplex Investigational Therapeutic Agents

PRITELIVIR (AIC-316): AiCuris Anti-infective Cures AG

PRITELIVIR represents an innovative therapy targeting HSV replication, currently undergoing Phase III trials for treating acyclovir-resistant mucocutaneous HSV infections in immunocompromised patients. HSV causes recurrent labial and genital herpes in healthy individuals but severe symptoms like disseminated disease and encephalitis in immunocompromised patients, often resistant to existing drugs. As of April 2025, pritelivir has not yet received FDA approval. It is currently in a pivotal Phase 3 clinical trial for managing acyclovir-resistant herpes simplex virus (HSV) infections in immunocompromised patients. PRITELIVIR, a thiazolylamide compound, is effective against both HSV-1 and HSV-2, demonstrating efficacy against resistant strains in clinical trials. Its promising results earned it FDA Breakthrough Therapy Designation. The cost of Pritelivir represents a key consideration in the Herpes Simplex treatment landscape, with pricing anticipated to reflect its novel mechanism and clinical efficacy in resistant HSV cases.

GSK3943104: GlaxoSmithKline

GSK-3943104, developed by GlaxoSmithKline (GSK), combines HSV antigens with an adjuvant to boost immune responses in HSV-infected individuals. It's currently undergoing Phase I/II trials to assess safety, immune response, efficacy, and reactogenicity in both healthy subjects and those diagnosed with recurrent genital herpes. Successful outcomes could enhance management of symptomatic outbreaks, reduce viral shedding, and alleviate emotional burdens, potentially improving quality of life for individuals diagnosed with genital herpes. Phase I/II data for GSK-3943104 is anticipated in 2024.

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Herpes Simplex Pharmaceutical Organizations

Teva Pharmaceutical Industries Ltd., Sanofi, Carlsbad Tech, Novartis AG, Emcure Pharmaceuticals Ltd., Fresenius Kabi AG, Viatris, Inc., Apotex Inc., Glenmark Pharmaceuticals Inc., GSK plc, among others.

Herpes Simplex Market Perspective

Herpes simplex represents a prevalent infection characterized by painful blisters or ulcers, primarily spread through skin-to-skin contact. It presents in two forms: HSV-1, often causing mouth or oral sores known as fever blisters or cold sores, and HSV-2, which typically results in genital sores. Both types can affect various body parts. Many infected individuals show no or mild symptoms, with recurrent outbreaks managed by symptomatic treatments that do not cure the infection. Living with oral or genital herpes can be emotionally challenging, with genital herpes also carrying social stigma and impacting intimate relationships. However, over time, most individuals adjust to living with the condition.

Herpes Simplex Treatment Market

The treatment approach for herpes simplex involves several mechanisms, including nucleoside analogs that target viral DNA polymerase to halt DNA replication, non-nucleoside/nucleotide inhibitors that also block herpes DNA polymerase, helicase/primase inhibitors, and binding and entry inhibitors that disrupt virus-host cell interactions. Despite no cure being available, antiviral medications like acyclovir, famciclovir, and valacyclovir are commonly prescribed to accelerate healing during initial outbreaks or recurrent episodes of herpes. While these medications can reduce symptom severity and duration, they do not eradicate the infection. Starting treatment within 48 hours of symptom onset is crucial for effectively managing recurrent outbreaks, particularly for individuals experiencing frequent or painful episodes or seeking to minimize transmission risk.

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Coverage of the Herpes Simplex Market Analysis

• Coverage: 7MM

• Analysis Period: 2020-2034

• Herpes Simplex Pharmaceutical Organizations: Teva Pharmaceutical Industries Ltd., Sanofi, Carlsbad Tech, Novartis AG, Emcure Pharmaceuticals Ltd., Fresenius Kabi AG, Viatris, Inc., Apotex Inc., Glenmark Pharmaceuticals Inc., GSK plc, among others.

• Herpes Simplex Therapeutic Agents: Famciclovir, ASP2151, ASP2151, GSK208141, Zicam (Ionic zinc), Pritelivir, HDIT101, Valaciclovir, ME-609, among others.

• Herpes Simplex Competitive Intelligence Evaluation: SWOT analysis and Market entry methodologies

• Herpes Simplex Unmet Requirements, KOL perspectives, Analyst perspectives, Herpes Simplex Market Access and Reimbursement

Report Structure

1. Key Insights

2. Herpes Simplex Market Analysis Introduction

3. Herpes Simplex Market Overview at a Glance

4. Herpes Simplex Epidemiology and Market Methodology

5. Herpes Simplex Executive Summary

6. Key Events

7. Herpes Simplex Background and Overview

8. Herpes Simplex Epidemiology and Patient Population

9. Herpes Simplex Patient Journey

10. Herpes Simplex Marketed drugs

11. Herpes Simplex Emerging Drugs

12. Key Cross Competition

13. Herpes Simplex Unmet Needs

14. Herpes Simplex SWOT Analysis

15. Key Opinion Leaders' Views

16. Reimbursement and Market Access

17. Appendix

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

About DelveInsight

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