Herpes Simplex - Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• In 2023, approximately 232.85 million seroprevalent cases of Herpes Simplex existed in the 7MM, these cases are expected to decrease during the forecast period (2024-2034). The decline in seroprevalent cases of HSV is anticipated due to enhanced public health initiatives, widespread vaccination campaigns, improved antiviral treatments, and increased awareness about safe sexual practices. These measures collectively reduce transmission rates and contribute to a downward trend in HSV prevalence.
• In 2023, the market size of Herpes Simplex was highest in the US among the 7MM, accounting for approximately USD 1.59 billion which is further expected to increase by 2034.
• The total symptomatic cases of Herpes Simplex are categorized into the following groups: HSV 1 and HSV 2. In 2023, in the United States, a higher number of cases were observed in the HSV 1 compared to HSV 2, comprising approximately 14.52 million and 1.78 million cases respectively.
• The emerging drug PRITELIVIR is expected to launch in the US market by 2026, in the UK by 2027, and in Japan by 2027, which has the potential to reduce the disease burden of Herpes Simplex in the forecasted years.

This report delivers an in-depth understanding of the Herpes Simplex, historical and forecasted epidemiology as well as the Herpes Simplex market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Herpes Simplex market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Herpes Simplex market size from 2020 to 2034. The report also covers current Herpes Simplex treatment practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

Disease Understanding and Treatment Algorithm

Herpes Simplex Overview

Herpes viruses exhibit a distinctive structure comprising a core with a large double-stranded DNA genome, enclosed by an icosapentahedral capsid made of capsomeres. Surrounding the capsid is an amorphous protein shell called the integument, enveloped by a lipid bilayer containing a glycoprotein. Genital herpes, primarily caused by HSV-2 with occasional cases from HSV-1, is a prevalent sexually transmitted infection (STI). Both HSV-1 and HSV-2 spread through direct contact with lesions or secretions, affecting skin and mucous membranes by invading and reproducing within epithelial cells.

Herpes Simplex Diagnosis

Herpes simplex virus infection, caused by HSV-1 and HSV-2, is a widespread viral condition. Diagnosing herpes simplex can be complex due to varying clinical manifestations and symptoms that resemble other illnesses. Precision in diagnosis is essential for effectively treating and controlling transmission. Furthermore, additional tests such as microscopy and imaging, antigen detection, and direct immunofluorescence (DIF) tests may be conducted in specific cases to provide a comprehensive understanding of the condition.

The development of more advanced diagnostic tools represents a critical unmet need in the effective management of HSV infections. The limitations of the current diagnostic landscape, characterized by suboptimal sensitivity and specificity, particularly for the detection of asymptomatic or atypical HSV cases, pose significant challenges. This shortcoming in diagnostic capabilities impedes timely and accurate diagnosis, leading to delayed treatment initiation and increased risk of viral transmission within the population. The symptoms of HSV infections, such as fever, headache, and skin lesions, are not specific and can be confused with other conditions. This makes it difficult for clinicians to diagnose HSV based solely on clinical presentation. Moreover, the lack of sophisticated diagnostic assays hinders the ability to effectively monitor disease progression and guide targeted therapeutic interventions, compromising the overall clinical management of HSV.

In many parts of the world, particularly in developing countries, access to reliable HSV testing is limited due to resource constraints and weak healthcare infrastructure. This hinders early diagnosis and appropriate management. Addressing this unmet need through the innovation and implementation of more sensitive, specific, and accessible diagnostic tools would be transformative, enabling early detection, appropriate treatment, and the development of tailored prevention strategies. Improved diagnostic capabilities are essential to mitigate the substantial public health burden associated with this highly prevalent viral disease, which continues to pose significant challenges globally.

Herpes Simplex Treatment

The treatment of Herpes Simplex mostly involves oral antiviral agents which may occasionally cause gastrointestinal issues or headaches. The excellent safety profile and the ability to convert into active forms solely within virus-infected cells, enhancing tolerability and effectiveness are key attributes of oral therapies. In severe cases, antiviral therapies like acyclovir, valacyclovir, and famciclovir are utilized to target the complex interplay of hormonal influences and inhibit viral DNA synthesis by inhibiting viral DNA polymerase. Oral therapies are also useful in recurrent infections. Oral HSV-1 recurs when the virus reactivates from its latent state in the trigeminal ganglion. This reactivation results in symptomatic outbreaks known as cold sores appearing around the mouth. Recurrent mucosal HSV-1 infections typically present with milder symptoms and resolve more quickly compared to initial infections. Crucial supportive care, including client education, assessment, monitoring, and counseling, is essential for ensuring effective management and adherence to treatment regimens, thereby optimizing treatment outcomes.

Herpes Simplex Epidemiology

As the market is derived using a patient-based model, the Herpes Simplex epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by, Total Seroprevalent Cases of HSV, Total Symptomatic Cases of HSV, Total Diagnosed Cases of HSV, Gender-specific Diagnosed Cases of HSV, and Total Recurrent Cases of HSV in the 7MM covering, the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034.

• There were 13.03 million total diagnosed cases of HSV estimated to have occurred in the 7MM in 2023 of which approximately 4.94 million 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 study period.
• The categorization based on gender, showed that diagnosed prevalent cases in females were higher than that in males in the 7MM. The female diagnosed prevalent cases accounted for 55% of the total cases in the 7MM.
• There were 1.55 million 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 study 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 3.65 million cases as compared to HSV 1 with 1.82 million cases.

Herpes Simplex Drug Chapters

The drug chapter segment of the Herpes Simplex report encloses a detailed analysis of Herpes Simplex off-label drugs and late-stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Herpes Simplex clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

Marketed Drugs

SITAVIG (acyclovir): Bioalliance Pharma/Vectans Pharma

SITAVIG (acyclovir) is 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 significant 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. In April 2013, French pharmaceutical company BioAlliance Pharma obtained US FDA approval to market SITAVIG for treating recurrent cold sores.

AMENALIEF (amenamevir): Maruho Co., Ltd.

In 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.

Emerging Drugs

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

PRITELIVIR is 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. 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.

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 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 with genital herpes. Phase I/II data for GSK-3943104 is anticipated in 2024.

Herpes Simplex Market Outlook

Herpes simplex is 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.

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.

Keeping in mind, the current strategies which are insufficient to manage the disease burden there is an urgent need for development of novel therapy. The market awaits the launch of the potential entities PRITELIVIR, and others that would be a helpful in the reduction of affected population accomplishing a critical global public health need, if proved to be efficacious.

• The total market size of Herpes Simplex in the 7MM is approximately USD 3.15 billion in 2023 and is projected to increase during the forecast period (2024-2034).
• The market size in the 7MM will increase at a significant CAGR due to increasing awareness of the disease and launch of the emerging drugs.
• Among EU4, the Germany accounted for the maximum market size of USD 320 million followed by the UK of USD 282 million in 2023 while Spain occupied the bottom of the ladder in the same year with USD 173 million.
• In 2023, Japan accounted for a market of USD 349 million, accounting for 11% of the total 7MM herpes simplex market.

Herpes Simplex Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to launch in the market during 2020-2034. For example, PRITELIVIR in the EU4 and the UK is expected to be launched by 2027 with a peak shared of 2%. PRITELIVIR is anticipated to take 8 years to peak with a slow-medium uptake.

Herpes Simplex Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, Phase I/II, and Phase I stage. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

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

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate the secondary research. Industry Experts were contacted for insights on Herpes Simplex evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from Dartmouth Institute for Health Policy and Clinical Practice, USA; American Social Health Association, USA; Institute for Medical Virology, Germany; University of Genova, Italy; Kyushu University, Fukuoka, Japan, and others.

The analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or Herpes Simplex market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

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.

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 route of administration, order of entry and designation, 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

The high cost of therapies for the treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved 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, descriptive overview of Herpes Simplex, explaining its causes, signs and symptoms, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Herpes Simplex market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the 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 analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Herpes Simplex market.

Herpes Simplex Report Insights

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

Herpes Simplex Report Key Strengths

• 11 years Forecast
• The 7MM Coverage
• Herpes Simplex Epidemiology Segmentation
• Key Cross Competition
• Conjoint Analysis
• Drugs Uptake and Key Market Forecast Assumptions

Herpes Simplex Report Assessment

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

Key Questions

Market Insights

• What was the Herpes Simplex total market size, the market size by therapies, and market share (%) distribution in 2020, and how it would all look in 2034? What are the contributing factors for this growth?
• Will the coverage of drug depend on their efficacy in Herpes Simplex?
• What will be the impact on the market with the launch of emerging drug?
• Which is going to be the largest contributor to the market in 2034?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risk, burdens, and unmet needs of Herpes Simplex? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Herpes Simplex?
• What is the historical and forecasted Herpes Simplex patient pool in the United States, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan?
• Why do patients develop persistent Herpes Simplex symptoms? Why is the current year diagnosis rate not high?
• Which type of severity is the largest contributor in patients affected with Herpes Simplex?
• What factors are affecting the decrease in the diagnosis of Herpes Simplex?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of Herpes Simplex? What are the current treatment guidelines for the treatment of Herpes Simplex in the US and Europe?
• How many companies are developing therapies for the treatment of Herpes Simplex?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of Herpes Simplex?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the key designations that have been granted for the emerging therapies for Herpes Simplex?
• What will be the impact on the market after the expected patent expiry of the emerging drug?
• What is the cost burden of off-label therapies on patients?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of recommended therapies? Focus on reimbursement policies.
• What are the 7MM historical and forecasted market of Herpes Simplex?

Reasons to Buy

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Herpes Simplex Market.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• To understand the existing market opportunity 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.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Detailed analysis and potential of current and emerging therapies under the conjoint analysis section to provide visibility around leading emerging drugs.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of off-label expensive therapies, and patient assistance programs.
• To understand the perspective of Key Opinion Leaders around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in future.
• Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy.

Frequently Asked Questions

1. What is the forecast period covered in the report?

The Herpes Simplex Epidemiology and Market Insight report for the 7MM covers the forecast period from 2024 to 2034, providing a projection of market dynamics and trends during this timeframe.

2. Who are the key players in the Herpes Simplex market?

The Herpes Simplex market is quite robust. The major layers are GSK, AiCuris Anti-infective Cures AG, United BioPharma, Inc., Innovative Molecules, Assembly Biosciences, and others which are currently developing drugs for the treatment of Herpes Simplex.

3. How is the market size estimated in the forecast report?

The market size is estimated through data analysis, statistical modeling, and expert opinions. It may consider factors such as incident cases, treatment costs, revenue generated, and market trends.

4. What is the key driver of the Herpes Simplex market?

The increase in demand for effective antiviral treatments that can manage and alleviate symptoms associated with HSV infections and the launch of emerging therapies are attributed to be the key drivers for increasing Herpes Simplex market.

5. What is the expected impact of emerging therapies or advancements in Herpes Simplex treatment on the market?

Introducing new therapies, advancements in diagnostic techniques, and innovations in treatment approaches can significantly impact the Herpes Simplex treatment market. Market forecast reports may provide analysis and predictions regarding the potential impact of these developments.

6. Does the report provide insights into the competitive landscape of the market?

The market forecast report may include information on the competitive landscape, profiling key market players, their product offerings, partnerships, and strategies, and helping stakeholders understand the competitive dynamics of the Herpes Simplex market.