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.
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.
Causes
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 –
Bacteria that cause diphtheria also spread through contact with an infected wound.
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.
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.
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 |
Products |
Thermo Fisher Scientific |
Pierce™, ELISA MAX™ |
Bio-Rad Laboratories |
BioPlex®, ELISA Ready-SET-Go! |
BD Biosciences |
BD OptEIA™ |
R&D Systems |
Quantikine® ELISA |
Abcam |
SimpleStep ELISA® |
Merck (Sigma-Aldrich) |
MILLIPLEX®, EZ-Set™ |
PerkinElmer |
AlphaLISA® |
BioLegend |
LEGEND MAX™ |
Invitrogen (Thermo Fisher Scientific) |
eBioscience™ |
RayBiotech |
RayBio® |
Enzo Life Sciences |
ADI Quantikine® |
Cusabio |
CUSABIO ELISA Kit |
MyBioSource |
MBS ELISA Kits |
Bio Vision |
QuickDetect™ |
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.
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 |
|||
Market Players |
Antibiotics Drugs |
Antitoxin |
|
Pfizer Inc. |
Penicillin G |
Diphtheria Antitoxin (Injection) |
|
GlaxoSmithKline (GSK) |
Erythromycin |
Erythromycin |
|
Merck & Co., Inc. |
Clarithromycin |
Penicillin |
|
Novartis Pharmaceuticals |
Azithromycin |
Macrolides |
|
Sanofi |
Rifampin |
Diphtheria CRM197 Protein |
|
Johnson & Johnson |
Ciprofloxacin |
Diphtheria Toxoid |
|
AstraZeneca |
Levofloxacin |
Diphtheria Antitoxin (CDC) |
|
Roche |
Clindamycin |
Diphtheria Antitoxin (Injection) |
|
Abbott Laboratories |
Doxycycline |
|
|
Bristol Myers Squibb |
Tetracycline |
|
|
Panacea Biotec |
Gentamicin |
|
|
Cipla |
Vancomycin |
|
|
Bio Farma |
Linezolid |
|
|
PT Sanbe Farma |
Trimethoprim-sulfamethoxazole (TMP-SMX) |
|
|
Teva Pharmaceutical Industries |
|
|
|
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.
The above flowchart shows a general description of antibiotics' mode of action.
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.
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.
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.
PHASE 1 (Human Pharmacology) |
PHASE 3 (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.
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