Hand, Foot, and Mouth Disease

Published Date : Nov 2023
Category : Infectious Diseases
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Hand, Foot, and Mouth Disease - A Contagious Skin Ailment

Hand, Foot, and Mouth disease (HFMD) is a mild, contagious viral infection that usually affects infants and children but can affect adults. The infection generally takes in the hands, feet, mouth, and sometimes, even the genitals and buttocks. The cause of foot and mouth disease is Coxsackievirus A type 16 in most cases, but different strains of coxsackieviruses and Enteroviruses can also cause infection. The coxsackievirus is a member of the Picornaviridae family, which contains non-enveloped single-stranded RNA viruses. In 2021, French surveillance found a speedy increase in HFMD cases, with more than 3400 cases.

Coxsackievirus A16 and enterovirus A71 are the serotypes generally associated with causative agents. Coxsackievirus A6 has recently developed as another cause of HFMD in the USA and worldwide. Coxsackievirus A10 is associated with severe disease. Coxsackievirus A4 to A7, A9, B1 to B3, and B5 have also been less commonly linked with HFMD.

HFMD starts with a low-grade fever, reduced appetite, and general malaise. The most common foot and mouth disease symptoms usually happen in hand foot and mouth disease in mouth or throat pain secondary to the enanthem. The vesicles are enclosed by a thin halo of erythema, ultimately rupturing, and forming superficial ulcers with a grey-yellow base and erythematous rim. The size of lesions is about 2 mm to 6 mm, are non-pruritic, and are generally not painful. They last around ten days, tend to rupture and result in painless and shallow ulcers that do not leave a mark. The exanthem contains the dorsum of the hand, feet, buttocks, legs, and arms. Oral lesions commonly involve buccal and tongue ulcers.

This virus is not restricted to any one place; it spreads across the globe. As children are more likely than adults to become infected with the virus, especially those under the age of seven, outbreaks can occur at daycares, summer camps, or even within families. According to extensive monitoring conducted in China, the majority of HFMD cases more than 90% occurred in children under the age of five. The death rate is around 0.03%, and the frequency of cases is higher in the late spring and early summer. According to Vietnamese research, there is a direct link between the occurrence of HFMD and rising ambient temperatures and humidity.

According to NCBI in 2021, French surveillance discovered a rapid increase in HFMD in adult cases, with almost 3400 cases. Although more than 90% of sequenced cases are related to Enterovirus, atypical instances were found to be associated with Coxsackievirus A6 and A16. In the US, coxsackievirus A6 continues to be the most common cause of HFMD.

DiseaseLandscape Insights assists the stakeholders by providing data related to the HFMD marketplace, and knowledgeable choices in healthcare equipment, therapies, and diagnostic techniques where various new technologies and innovations are impacting the disease market and driving higher expansion.

Diagnostic Analysis:

The diagnosis is often made clinically, but in severe cases, confirmatory laboratory testing employing reverse transcription PCR (RT-PCR) assays is available and carried out. Stool, throat or buccal swabs, and vesicle fluid are the preferred specimens for testing. RT-PCR assays are widely available for use in reference or commercial laboratories to identify enterovirus RNA.

Using light microscopy on biopsies or vesicle scrapings, feet hand mouth disease distinguished from herpes simplex and varicella-zoster viruses. Although serology is not sensitive enough to diagnose HFMD, levels of IgG are used to monitor the patient's recovery.

In consultation with state or local health departments in the US, the Centres for Disease Control and Prevention (CDC) Picornavirus Laboratory, part of the Division of Viral Diseases, regularly conducts qualitative pan-enterovirus molecular testing. Following this, the laboratory performs sequencing for enterovirus typing. Nasopharyngeal or oropharyngeal swabs, stool samples, rectal swabs, nasal wash or aspirate samples, cerebrospinal fluid, blood, and tissue biopsy or autopsy specimens are all tested by the CDC.

Diagnosis Market Players:


Key Players

Enterovirus 71(EV71) Real-Time RT-PCR


Life Technologies

Enterovirus Real-Time PCR Kit


HEV-C & EV-71 Real-time PCR Kit

CD Genomics

Coxsackievirus Diagnosis Kit

DaAn Gene


Lilif Diagnostics

Coxsackie A6/A10 Nucleic Acid Detection Kit

Rapid Microbiology


The market for the diagnosis of food hand-mouth disease is competitive. Market participants should use new technology to produce a variety of diagnostic products. The development of rapid, low-cost diagnostic tests is also crucial in the diagnosis of hand foot, and mouth disease. The development of single accurate diagnostic tests for HFMD is essential nowadays.

DiseaseLandscape Insights assists the industry leader in the use of new technologies for improving the existing diagnostic method and provides data on current market players and their product portfolios for more knowledge about market dynamics. By using the data from DLI, stakeholders choose the path of their business and implement strategies for the growth of the market.

Treatment Analysis:

HFMD is a mild clinical syndrome and resolves within 7 to 10 days. Treatment is primarily supportive. Pain and fever are managed with NSAIDs and Acetaminophen. During this period patient should remain well-hydrated. Additionally, a mixture of liquid Ibuprofen and liquid Diphenhydramine is used to gargle, which helps coat the ulcers and assist the pain. Steroids increase the risk of severe hand foot and mouth.

Over the past few decades, researchers have developed treatments to manage enterovirus 71-induced HFMD due to its severe neurological complications. Till date, no drug has been approved, but promising novel agents include molecular decoys, translation inhibitors, receptor antagonists, and replication inhibitors. The anti-picornaviral medication Pleconaril has demonstrated potential as a therapy for enterovirus 71. However, there are currently no licensed antivirals for the management of HFMD. Acyclovir has been demonstrated to have some clinical response in anecdotal accounts, although this has not been proven in large-scale research.

Several potential vaccinations against enteroviruses hand, foot, and mouth have been developed. Now, China is responsible for the development of strain-specific inactivated whole-virus aluminum adjuvant vaccines that are authorized for general use.

There are several options available to firms in the HFMD treatment sector. To enhance patient health and increase company profitability, the market players focus on creating a range of reasonably priced therapeutic goods and repurposing current pharmaceuticals utilizing new technology.

Market participants use DiseaseLandscape Insights' market research and consulting services to investigate and prosper in the scabies therapy industry. Through comprehensive research on new goods, technologies, and treatment choices, we help our customers stay competitive and robust. DLI services provide crucial assistance in planning, conducting, and evaluating clinical trials for the development of novel drugs.

Treatment Market Players:


Key Players


Johnson & Johnson


Glaxo SmithKline Pharmaceuticals Ltd.

Dolo 650

Micro labs






Clinical Trial Assessment:

The government's growing focus on comparative effectiveness research highlights the significance of clinical trials for evidence-based medicine and healthcare reform. One of the main objectives of health care reform is accomplished with the aid of clinical data, which enables market participants to correctly compare medical therapy.

The table below lists the study names of the ongoing clinical trials along with the stages at which they are being carried out.

Phase 1

Phase 2

Phase 3

Phase 4

A Randomized, Open, Phase I/II to Evaluate the Inactivated EV 71 Vaccine Safety in Healthy Adults Followed by Safety and Immunogenicity Administered in 2 Consecutive Doses, 1 Month Apart Among Child Aged 6 to 71 Months.

A Randomized, Open, Phase I/II to Evaluate the Inactivated EV 71 Vaccine Safety in Healthy Adults Followed by Safety and Immunogenicity Administered in 2 Consecutive Doses, 1 Month Apart Among Child Aged 6 to 71 Months.

A Phase III Clinical Trial with Randomized, Double-blinded, Controlled Design as Well as Bridging Design to Evaluate the Safety and Immunogenicity of EV71 Vaccine in Children Aged 36-71 Months

An Open, Observational Study to Evaluate the Immunity Persistence of an Inactivated Enterovirus 71 Vaccine (Vero Cell) in Subjects Aged 6 to 71 Months

A Randomized, Double-blind, Placebo-controlled, Phase 1 Clinical Trial to Investigate the Safety and Immunogenicity of High-dose IN-B001 After Administration in Healthy Subjects

A Randomized, Placebo-controlled, Double-blind Trial of Intravenous Magnesium Sulfate for the Management of Severe Hand, Foot Mouth Disease with Autonomic Nervous System Dysregulation in Vietnamese Children.

Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine: A Double-blind, Randomized and Controlled Trial

A Randomized, Controlled Clinical Trial to Evaluate the Safety and Immunogenicity of Concomitant Administration of EV71 Vaccine with Measles, Mumps, and Rubella Combined Live Attenuated Vaccine/ Encephalitis Live Attenuated Vaccine

A Randomized, Double-blind, Placebo-controlled, Phase 1 Clinical Trial to Investigate the Safety and Immunogenicity of CJ-40010 After Administration in Healthy Subjects

Inactivated Bivalent Enterovirus Vaccine Phase I/II Clinical Trial: Open-Label Observation in Healthy Adults and Children, and Randomized, Double-Blind, Controlled Clinical Trial in Children

A Multicentered, Double - Blind, Randomized, and Placebo - Controlled Clinical Trial with Inactivated Enterovirus Type 71 (EV71) Vaccines

An Opened,Randomized and Controlled Trial to Evaluate the Immunity and Safety of Sequential Vaccination of Two Different Commercial EV71 Inactived Vaccines in Healthy Infants Aged 6-35 Months

A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study to Evaluate the Tolerance and Pharmacokinetics of Suramin Sodium in Healthy Chinese Adults

Sucralfate to Improve Oral Intake in Children with Infectious Oral Ulcers: A Randomized, Double-blind, Placebo-Controlled Trial

A Multiple-center Randomized Double-blind Placebo-controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of an Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children Aged 6-35 Months

Three Batches Consistency, Immunity Duration and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China

Phase I, Double Blind, Randomized, Placebo-controlled, Dose Escalation Study to Assess the Safety and Immunogenicity of a Prophylactic Vaccine Against Enterovirus Infection in Healthy Adults

A Phase II Clinical Trial for Inactivated Enterovirus Type 71 Vaccine (Human Diploid Cell, KMB-17 Cell) in Chinese Infants

A Randomized, Open Label Study Comparing the Efficacy of Topical Corticosteroids or Bepantol in the Prophylaxis of Hand-foot Syndrome in Patients Receiving Oral Xeloda for Treatment of Metastatic Breast Cancer or Colorectal Cancer.

Phase Ⅳ Clinical Trial, to Evaluate the Efficacy of the Enterovirus 71 (EV71) Inactivated Vaccine and Its Correlation with EV71 Antibody Level



DiseaseLandscape Insights (DLI) assists producers in developing and implementing practical strategies to halt and manage Hand, foot, and mouth disease outbreaks. In addition, there is a rising need for clinical evaluations, diagnostic instruments, and hand, foot, and mouth disease therapy due to rising awareness and anticipated outbreaks.

Our experts offer critical knowledge and expertise to major participants in the manufacturing of medicinal commodities. Market players more readily plan and carry out clinical trials for new medications and medicines, patient recruiting tactics, and regulatory compliance with the use of DiseaseLandscape Insights.

Additionally, DLI provides business players with extensive information on international rules and regulations, market trends, and competitors in the field. DLI assists all market participants in forging a stronger foothold in the healthcare sector.

Vishal SawantBusiness Development

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