Diphtheria Disease

Published Date : Feb 2024
Category : Infectious Diseases
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Comprehending the Battle Against Diphtheria: Raising the Market

The respiratory system is impacted by the highly contagious bacterial infection diphtheria, which is spread by the Corynebacterium diphtheriae. This illness is critically impairing breathing. Diphtheria is spread from person to person through close contact with the discharge from an infected person's eyes, nose, throat, or skin. Diphtheria in children under 5 and adults over 60 years old are particularly at risk of getting it. The key sign of diphtheria is the existence of a pseudo membrane.

The World Health Organization (WHO) estimates that 10,107 cases of diphtheria occurred worldwide in 2020.

By the EU case definition, there have been 281 confirmed cases of diphtheria since January 2022 as of August 11, 2023 (2022: 224 cases, 2023: 57 cases), and four deaths were tracked by the European Surveillance System (TESSy) in the EU/EEA. This contrasts with the average of 55 cases reported annually between 2017 and 2021.

As per data published by WHO Immunization the global incidence cases are (2022: 7,178 cases, 2021:10367 cases, 2020: 11962 cases)

The CDC forecasts that the case-fatality rate for diphtheria is between 5 and 10%. However, the death rate might reach ~20% for those under the age of five and more for those over 40.

For instance, on 13TH September 2023 as per data published by WHO between June 30, 2023, and August 31, 2023, Nigeria recorded an unusually high number of confirmed cases of diphtheria, with 5898 cases reported from 59 Local Government Areas (LGAs) in 11 states. Most of the instances were reported in Borno, Bauchi, Yobe, Kano, Katsina, and Kaduna. 4717 (56.5%) of the 8353 suspected cases were confirmed, whereas 22.2% were ruled out as not consistent with diphtheria. There was a small decrease in the case fatality ratio from 6.7% to 6.1%. With 2656 (56.3%) being female, the 4717 confirmed cases had an age range of 1-14 years, or 73.5%. Of the cases, just 22.8% had received all recommended vaccinations, while 59.4% had not.

Furthermore, twenty-eight million of the twenty-five million children who did not receive a single DTP dosage in 2021 are from low- and middle-income countries; the biggest numbers come from Ethiopia, the Philippines, Nigeria, India, and Indonesia.

Types of Diphtheria

 There are two fundamental types of diphtheria: cutaneous and classical respiratory.

Classical respiratory diphtheria, the most prevalent kind, damages the tonsils, larynx, nose, and throat (voice box). Depending on which bodily membranes are impacted, the symptoms differ. This illness is sometimes referred to as pharyngeal diphtheria or throat diphtheria.

Cutaneous diphtheria is the rarest kind of the disease; it is characterized by skin rashes, blisters, or sores that arise anywhere on the body. Cutaneous diphtheria is more prevalent in humid, tropical regions or densely populated areas where living conditions are poor.


The bacteria Corynebacterium diphtheriae is the cause of diphtheria. Usually, the bacteria grow on or close to the skin's or throat's surface. Diphtheria circulates through –

  • Airborne Droplet- People in proximity may breathe in C. diphtheriae when an infected individual sneezes or coughs and generates a mist of contaminated droplets. This is a simple way that transmit diphtheria, particularly in crowded areas.
  • Contaminated personal or household items- Diphtheria is occasionally contracted by handling an infected person's objects, such as hand towels or used tissues, which may be contaminated with the bacterium.

Bacteria that cause diphtheria also spread through contact with an infected wound.

Signs & Symptoms of Diphtheria Disease

Diphtheria might be mistaken for a sore throat in its early stages. The other early signs include enlarged neck glands and a low-grade fever.

A thick covering (or membrane) in the nose, throat, or airway might result from the toxin, or poison, that the bacteria produce. This distinguishes a diphtheria infection from other, more prevalent illnesses that also produce sore throats, such as strep throat. This covering, which is typically fuzzy grey or black, makes it difficult to swallow food and breathe.

As the infection worsens, a person may have trouble breathing or swallowing, complain of double vision, speak slurred, or exhibit shock symptoms, such as pale, chilly skin, a fast heartbeat, sweating, and an uneasy demeanor are some of the examples of diphtheria disease symptoms.

Diagnostic Analysis

The efficacy of the diphtheria diagnosis disease market depends on the availability of quick laboratory tests, creative diagnostic approaches, better testing procedures, and more financing and awareness. Public health campaigns, international immunization programs, and regulatory laws are some of the factors affecting the industry. The availability of diagnostic tools, the state of the healthcare system, and the market's ability to successfully integrate into current systems for the prompt and accurate identification of diphtheria cases are all critical to its success.

Laboratory Examinations:

Cultures: To determine whether Corynebacterium diphtheriae is present, a specimen or throat swab is obtained and cultured.

Gram Staining: Under a microscope, Gram staining reveals some basic details about the kind of bacteria that exist.

Serological Examinations:

Antibodies against the diphtheria toxin: Blood tests are performed to determine the number of antibodies against the toxin.

Elek test - Elek test is used to determine whether C. diphtheriae strains produce toxins, which confirms the diagnosis of diphtheria.

However, for identifying diphtheria toxin (DT) in toxigenic corynebacteria, the Elek test is considered the gold standard. The procedure is called immunodiffusion or in vitro immunoprecipitation. The test's foundation is the double diffusion of antitoxin and diphtheria toxin in an agar medium.

Immunochromatographic strip (ICS) test - The diphtheria toxin is quickly detected with the immunochromatographic strip (ICS) test. The assay detects fragment A of the diphtheria toxin molecule using a horse polyclonal antibody and colloidal gold-labeled monoclonal antibodies.

Polymerase chain reaction (PCR) and matrix-assisted laser desorption/ionization-time of flight mass spectrometry (MALDI-TOF) Molecular methods like PCR are utilized to identify Corynebacterium diphtheriae genetic material, resulting in a prompt and precise diagnosis.

Top Players of Diagnostic Kits

The global Diphtheria diagnostic market is highly competitive and owing to the number of large market players with a global presence below in the given table there is a list of top manufacturers of diagnostic testing of Diphtheria globally.

                                                                            Diagnostic Kits

Market Players


Thermo Fisher Scientific

Pierce™, ELISA MAX™

Bio-Rad Laboratories

BioPlex®, ELISA Ready-SET-Go!

BD Biosciences


R&D Systems

Quantikine® ELISA


SimpleStep ELISA®

Merck (Sigma-Aldrich)






Invitrogen (Thermo Fisher Scientific)




Enzo Life Sciences

ADI Quantikine®





Bio Vision


Cloud-Clone Corp

Cloud-Clone Corp ELISA Kits


DiseaseLandscape Insights supports industry leaders in the creation of diverse diagnostic kits. Furthermore, the use of state-of-the-art technology to improve present diagnostic processes and the dissemination of data on current market players and their products to comprehend market dynamics.

Treatment Analysis

"Treatment Examination Advancement: Encouraging Better Health"

The treatment for diphtheria entails a multimodal strategy to control complications, eradicate the infection, and neutralize the toxin. It is imperative to administer antibiotics and antitoxins as early as possible, in addition to supportive treatment and isolation protocols. Essential elements include vaccination and post-exposure treatment; public health initiatives include diphtheria immunization coverage and contact tracing. Complications require ongoing observation and action, highlighting the significance of an all-encompassing and prompt treatment plan for better patient outcomes.

For instance, Azithromycin is suggested by the World Health Organization (WHO), Médecins Sans Frontiers (MSF), and the UKHSA for the prevention and treatment of diphtheria.

Antibiotics - Antibiotics, like Erythromycin and Penicillin, assist in killing germs in the body to treat illnesses. The duration of a diphtheria patient's infectious period is reduced by antibiotics.

Antitoxin - To counteract the body's circulating diphtheria toxin, horse serum makes diphtheria antitoxin.

The following table lists the top players in the market who are altering the industry and fostering innovation to achieve better health results, along with the names of the drugs they are offering to treat diphtheria.

Treatment Market Players and Products

                                                                 Treatment Market Players and Products

Market Players

Antibiotics Drugs


Pfizer Inc.

Penicillin G

Diphtheria Antitoxin (Injection)

GlaxoSmithKline (GSK)



Merck & Co., Inc.



Novartis Pharmaceuticals





Diphtheria CRM197 Protein

Johnson & Johnson


Diphtheria Toxoid



Diphtheria Antitoxin (CDC)



Diphtheria Antitoxin (Injection)

Abbott Laboratories



Bristol Myers Squibb



Panacea Biotec






Bio Farma



PT Sanbe Farma

Trimethoprim-sulfamethoxazole (TMP-SMX)


Teva Pharmaceutical Industries





Vaccination for Diphtheria

Safeguarding the Future: The Crucial Function of the Diphtheria Vaccine

In many countries, the normal childhood immunization program includes the diphtheria vaccination as a critical component. To protect against numerous diseases, the diphtheria vaccination is frequently combined with other immunizations. The diphtheria-prevention-containing combination vaccination is commonly known as the DTaP or DTP vaccine.

DTaP Vaccine - DTaP is an acronym for acellular pertussis, tetanus, and diphtheria. This vaccination offers protection against pertussis (whooping cough), tetanus, and diphtheria. The Bordetella pertussis bacterium's purified components are used in the pertussis vaccine, which is known as its "acellular" component.

Tdap Vaccine - Tdap is administered as a booster shot to adults and adolescents and is comparable to DTaP. Moreover, it offers a defence against pertussis, tetanus, and diphtheria.

Td Vaccine - Another booster shot that protects against diphtheria and tetanus is called Td. It doesn't offer protection against pertussis, in contrast to Tdap.

Moreover, pregnant women worldwide have received tetanus and diphtheria toxoids and tetanus toxoid vaccines to prevent neonatal tetanus, with no proven harm to the mother or fetus.

The mechanism of action of antibiotics provides a better understanding of one of the Diphtheria treatment therapies.

Mechanism of Action of Antibiotics for the Treatment of Diphtheria


The above flowchart shows a general description of antibiotics' mode of action.

Market Trends Analysis

"Remain Ahead in the Industry by Comprehending the Diphtheria Market Drifts"

Worldwide initiatives to fight the illness and its extensive incorporation into childhood vaccination regimens impact the market for diphtheria vaccines. The need for these vaccinations is being driven by government programs, research, technology developments, and growing awareness of the value of vaccination. Global health issues, such as the COVID-19 pandemic, highlight the significance of vaccinations and have an impact on vaccine distribution and development patterns. The market dynamics around diphtheria prevention are also influenced by the engagement of pharmaceutical corporations, industry collaborations, and mergers. Consult the latest industry assessments, market reports, and updates from pertinent health organizations for up-to-date information.

  • On October 05, 2023, Pfizer Highlights Advances in the Prevention and Treatment of Specific Respiratory Illnesses and Other Infectious Diseases at IDWeek 2023 with New Data.

Competitive Analysis

  • To satisfy the growing need for early detection and improve their competitive position, leading companies in the international market have been focusing on new product launches and expanding their testing capabilities. In addition to that they are adopting organic and inorganic strategies for growth and expansion which majorly include drug discovery regulatory approval and inorganic strategies such as acquisition partnership and majorly focusing on collaboration in order to improve and grow their product portfolio.
  • On 3rd January 2024, Remix and Roche announced a partnership and license agreement for the development of small molecule therapeutics that use Remix's REMaster drug discovery platform to modulate RNA processing. Remix Therapeutics (Remix) is a clinical-stage biotechnology company that is working on small molecule therapies to modulate RNA processing and target the underlying causes of disease.
  • On 16th August 2022, Affinivax, Inc. (Affinivax), a clinical-stage biopharmaceutical company with its headquarters in Cambridge, Massachusetts, was acquired by GSK plc. The most advanced of this new class of vaccines, called next-generation pneumococcal vaccines, was developed by Affinivax.

Regulatory Framework for Diphtheria

The regulatory framework for diphtheria is a setup put in place by government health organizations to prevent, track, and manage the illness. It gives vaccination laws priority and engages regulatory agencies such as the FDA and EMA in the licensing and approval of vaccines. Public health initiatives relate to surveillance systems that track the disease's incidence and prevalence. International cooperation guarantees a worldwide approach to control and is frequently spearheaded by institutions such as the World Health Organization. Initiatives for research and development are also included in regulatory frameworks.

  • On 4th December 2023, Gavi-eligible nations can apply to switch to the hexavalent vaccine, a six-in-one shot that combines the pentavalent vaccine (diphtheria, tetanus, whole-cell pertussis [DTwP], hepatitis B, and Haemophilus influenzae type b) with inactivated polio vaccine (IPV). This is in addition to introducing DTP-containing vaccine boosters.
  • To execute the Global Immunization Agenda 2030 (IA2030), WHO and UNICEF have collaborated with Gavi, the Vaccine Alliance, and other partners.
  • April 27, 2023, the U.S. Food and Drug Administration (FDA) approved PREVNAR 20®, also known as the 20-valent Pneumococcal Conjugate Vaccine, according to a press release from Pfizer Inc. The vaccine is intended to prevent invasive pneumococcal disease (IPD) in infants and children aged six weeks to 17 years, as well as otitis media in infants aged six weeks to 5 years, which is caused by the vaccine's original seven serotypes.

Clinical Assessment

The DiseaseLandscape Insights consulting firm provides valuable support in future market trends on the development of new pharmaceutical products. This support helps to streamline the planning and execution of clinical trials of novel medications and treatments, implement effective patient recruitment strategies, ensure regulatory compliance, and increase the likelihood of successful trial outcomes.

The below table gives information about some currently ongoing clinical trials, including their study titles and respective stages.


(Human Pharmacology)


(Therapeutic Confirmatory Trial)

To Evaluate Safety and Preliminary Immunogenicity of the Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine in Children Aged 2 Months to 6 Years: A Randomized, Blinded, Active-controlled Phase I Clinical Trial

Single Blind, Randomized, Comparative, Multicentre Clinical Trial of the Immunogenicity and Safety of Booster Immunization with Bivalent Vaccine Against Tetanus and Diphtheria CLODIVAC (IBSS Biomed S.A.) and Td-Impfstoff Mérieux (Sanofi Pasteur) in Healthy Adults.

A Randomized, Blinded, Controlled Phase I Clinical Trial for Preliminary Evaluation of the Safety and Immunogenicity of Adsorbed Cell-free DPT Vaccine (for People Aged 6 Years and Above)

A Randomized, Blinded, Positive Vaccine-controlled Phase III Clinical Trial to Evaluate the Safety and Immunogenicity of DTcP in Infants and Children at 2 and 3 Months of Age


DiseaseLandscape Insights (DLI) helps companies build and run effective strategies to prevent and control diphtheria. Furthermore, as awareness and anticipated epidemics grow, there is a growing demand for diagnostic tools, clinical evaluations, and novel therapeutics.

Major players involved in the production of medicinal items benefit from the information and experience provided by DiseaseLandscape Insights. The assistance provided by DLI facilitates patient recruitment strategies, regulatory compliance, and the planning and execution of clinical trials for novel medications and pharmaceuticals.

This ultimately motivates the leaders to conduct qualitative research, investigate manufacturing companies, and find out about raw material sources. All industry participants gain a stronger foothold in Diphtheria and keep one step ahead with the help of DiseaseLandscape Insights.

Vishal SawantBusiness Development

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