What is Herpes Labialis?

Herpes labialis also known as oral herpes or cold sores, is caused due to virus called herpes simplex type 1 (HSV-1). This infection can result in soaring of lips, gums, tongue, and inside the cheeks. Some of the symptoms of oral herpes are outburst of blisters around lips, that may cause inflammation, swollen lymph nodes, flu-like symptoms, and even headache.

According to the analysis by John Hopkins Medicine, around 50% to 80% people are expected to expose to oral herpes in the US. The National Institute of Health claims that about 9 in 10 adults have been exposed to the virus by the age of 50. According to the World Health Organization (WHO), around 3.7 Billion people are infected with oral herpes globally. This infection is highly contagious as it can easily spread by physical/intimate contact as well.

What are the drugs available for the oral herpes in the market?

Any of the drugs available in the market does not eliminate the HSV-1 virus from the body. Most of the drugs available in the market are antiviral in nature and can be taken in combination in the form of combination therapy. They are available in form of tablets, oral medication, ointment, and topical medication. Here are below are the common drug types:

  • Acyclovir

Acyclovir, an antiviral drug, is administered in the body to reduce the spread of infection and decrease the pain caused due to blisters around the lips and  the mouth. This drug is taken at even intervals to make it work effectively. This drug type is not only used to treat herpes labialis but also used to treat genital herpes, chickenpox, and shingles.
Brand name and manufacturer: Zovirax and Bausch Health Companies Inc.

Side effects (may happen): Upset stomach, dizziness, vomiting, pain in joints, and diarrhea, among others.

  • Valacyclovir

Valacyclovir is used to reduce the pain and itching near the infection area. Moreover, it prevents the formation of new blisters.  This drug type can decrease the probability of future episodes of outbreaks. Similar to the acyclovir drug type, it should be taken at regular interval.
Brand name and manufacturer: Valtrex and GlaxoSmithKline
Side effects (may happen): Kidney failure, depression, nausea, joint pain, fatigue, and vomiting, among others.

  • Penciclovir

Similar to above-mentioned drugs, it can reduce itching and pain. This drug type is mostly available in topical form and is the only FDA approved topical treatment option in the US, which acyclovir topical is not.
Brand name and manufacturer: Denavir and Renaissance Pharma
Side effects (may happen): headache, change in the sense of taste, numbness, and swollen mouth, among others.

  • Famciclovir

Famciclover is a prodrug form of Penciclovir, which means it has better bioavailability, used for the treatment of HSV-1 infection. It reduces outbreaks caused due to cold sores near mouth and also treats shingles. It is available in the form of tablet and generic drug.
Brand name and manufacturer: Famvir and Novartis
Side effects (may happen): Headache, stomach pain, sleepiness, gas, diarrhea, and dizziness, among others.

  • Docosanol

Docosanol is an antiviral drug, which is available as a topical cream, for the treatment of recurrent herpes labialis. It is a saturated aliphatic alcohol used to speed up the healing of cold sores. This topical cream blocks the virus from entering in healthy skin cells. Traditionally, it was used as thickener, emulsifier, and emollient in cosmetics and daily supplements. Docosanol is the over-the-counter (OTC) alternative to penciclovir.
Brand name and manufacturer: Abreva and GlaxoSmithKline
Side effects (may happen): Trouble in breathing and dizziness.

Herpes Labialis Market Analysis

As per the data published by GMR, the global herpes labialis market was valued at USD 925.4 Million in 2019 and is anticipated to expand at a CAGR of 4.6% during the forecast period, 2020-2027.

  • Drivers

    • Growing prevalence of oral herpes is propelling the growth of the market.
    • The increasing R&D activities to boost the development of novel therapeutics is expected to propel the market growth.
    • Increasing awareness about oral herpes is expected to encourage patients to visit doctor, fueling the sales of drugs.
  • Restraints

    • Stringent regulations regarding the approval of novel drugs can hinder the market growth.
    • Lack of awareness about oral herpes in low and middle-level countries can impede the growth of the market in the coming years.
  • Opportunities

    • Rising penetration of generic drugs is expected to create remunerative opportunities for new entrants in the global herpes market.

Drugs Segment Overview

Based on the drug types, the market is segmented into acyclovir, valacyclovir, penciclovir, docosanol, famciclovir, and others. The acyclovir segment accounted for a large share of the market, in 2019, in terms of revenue. This is due to the fact that its effectivity has inculcated trust among patients, which has increased the sales of this drug type in the market. On the other hand, the valacyclovir segment is anticipated to exhibit a high CAGR owing to its better effectiveness and immediate effect on the HVS-1 infection. Additionally, its limited dosage to treat the infection is propelling its demand across the globe.

What type of dosage form is popular in the market?

On the basis of dosage forms, the global herpes labialis market is categorized as ointments/gels/lip balms/creams, medicines, and injections. The medicines segment accounted for a significant market share in 2019, in terms of revenue. This is due to the fact that medicines showcase high success rate of recovery than ointments or creams. Furthermore, the increasing doctor prescription for medicines is spurring the growth of this market segment. The former segment is anticipated to grow at a robust rate owing to its easy availability and its increasing prescription with medications to relieve the pain and improve the rate of recovery.

Which is the most preferred route of administration?

In terms of route of administration, the market is divided into topical, oral, and parenteral. The oral segment is expected to constitute massive share during the forecast period. This route of drug administration is much easier as compared to other types. On the other hand, the topical are prescribed with oral medications, which, in turn, is expected to drive the growth of the topical segment.

Regional Landscape

Based on the regions, the market is segregated into North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. North America held a significant market position in 2019, in terms of revenue. Increasing demand for medicines and creams owing to the rising prevalence of oral herpes in countries such as the US and Canada is driving the growth of the market in region. The presence of prominent manufacturers in this region and growing investment in the development of novel therapeutics are further positively impacting the market growth.

The market in Asia Pacific is anticipated to grow at a robust rate during the forecast period. Increasing government initiatives to increase the awareness about the infection is driving the growth of the market in the region. Additionally, the rise in the government spending on the healthcare sector in the emerging economies such as India and China is expected to stimulate the growth of Asia Pacific market. The rapid growth of pharmaceutical industry owing to the increasing number of contract manufacturing organizations (CROs) and rising number of FDI policies in the same is speculated to spur the growth in the region during the forecast period.

Impact of COVID-19 Pandemic

The COVID-19 pandemic had disrupted the manufacturing space and increased the burden on the healthcare sector. However, the market is anticipated to reach the pre-COVID level soon. Industry players are relying on local contract research organizations (CROs) and CMOs to pace up the pre-clinical trials and manufacturing of the drugs respectively.

Developments by Major Companies of the Herpes Labialis Market

  • Pfizer Inc.

The multi-national pharmaceutical company introduced Valaciclovir for the treatment of HSV infection, shingles, herpes labialis, and genital herpes for patients above 12 years old.  The drug stops the multiplication of the virus and shortens the duration of pain caused due to cold sores outbreak.

  • Mylan N.V.

Mylan N.V., the Netherland-based company, launched acyclovir (Zovirax) ointment, a nucleoside analogue antiviral, for the management of HSV infections.
In November 2019, Pfizer and Mylan announced a joint-venture for the company called Viatris to provide high-quality medicines to the patients.

  • Teva Pharmaceuticals

The Israel-based company, majorly specializes in generic drugs, introduced the generic version of acyclovir drug, which has strength of 200mg/5 ml.

  • Novartis AG

Novartis partnered with TAP Pharmaceuticals Inc. to market its Famvir, an oral antiviral prescription. The company has been engaging in partnerships with industry players to develop drugs and market the same across the globe.
Other industry players of herpes labialis market include Apotex Inc, Hikma Pharmaceuticals PLC, Bausch Health (Valeant Pharmaceuticals), Asahi Kasei Corporation, Onxeo, VECTANS PHARMA, ALLERGAN, Abbott, Sun Pharmaceutical Industries Ltd, and GlaxoSmithKline plc.

Bottom Line

The global herpes labialis market is anticipated to witness an increasing demand for generic drugs due to the cost-effective nature of the drugs. On the other hand, the development of novel drugs and increase in the number of research grants from private and government organizations are expected to drive the market growth during the forecast period.