Shigella is a gram-negative pathogenic enterobacteria that causes severe diarrhea and dysentery in humans. Symptoms associated with Shigella infection includes fever, stomach pain, tenesmus, watery diarrhea, vomiting, dehydration, and convulsions. Various strains of Shigella are encompassed, such as S. dysenteriae, S. flexneri, S. sonnei and S. boydii. Each species of Shigella has different serotypes classified on the basis of the structure of O-antigens repeats that are the polysaccharides moiety of the lipopolysaccharide, a virulence factor consist of toxic lipid. According to the Centers for Disease Control and Prevention (CDC), in 2013, the average annual incidence of shigellosis in the U.S. was around 5 cases per 100,000 individuals. Bacillary dysentery with brutal epidemics are caused by S. dysenteriae by the production of shiga toxins whereas, the endemic form of disease is caused by the S. flexneri and S. sonnei. The bacillary dysentery is accompanied with fever, rectal inflammation, and abdominal cramps.
According to World Health Organization (WHO), nearly one million people die from Shigella infection annually. Moreover, the high incidence rate is seen among children less than five years age, travelers, and military personnel from industrialized economies. Shigella species have been identified from centuries and it represents a major threat to public health, due to non-availability of licensed vaccine and thus affecting overall Shigella vaccines market.
Developing vaccine against Shigella infections is difficult, due to the diversity of Shigella species and their serotypes. Shigella genome is continuously modified by deletion and acquisition of genes mediated by the mobile genetic elements, such as plasmids, insertion sequences, and integrons. These modifications are the major foundation for the generation of novel antibiotic resistant strains and it also leads to the formation of novel Shigella serotype variants. Centers for Disease Control and Prevention (CDC) in April 2017, warned the physicians and public health officials in the U.S. by stating that the recent strains of Shigella bacteria shows the reduced susceptibility to ciprofloxacin, which is one of the main antibiotics recommended by WHO for the treatment of shigellosis.
Joint ventures and collaborations of major players to develop and commercializes the vaccine are expected to propel the Shigella vaccines market in near future
Joint ventures and partnership of the players to develop and commercialize Shigella vaccine is expected to provide momentum to the Shigella vaccines market. For instance, in October 2019, The European Vaccine Initiative (EVI) and Hilleman Laboratories, announced partnership for the development of new shigella vaccine. Moreover, the EVI has received grant of US$ 9.5 Mn from the European and Developing Countries Clinical Trials Partnership (EDCTP) which aims in developing safe and effective shigella vaccine.
Also, in March 2017, Hilleman Laboratories, a non-profit organization established with joint venture partnership between Merck & Co., and Wellcome Trust has entered into an agreement with National Institute of Cholera and Enteric Disease (NICED) for the development and commercialization of vaccines against Shigella by 2024. Besides, in June 2016, Immuron- an Australian biopharmaceutical company entered into an agreement to produce Shigella vaccine with the U.S Army’s biomedical research lab-Walter Reed Army Institute of Research (WRAIR).
Prokarium and Probiomed in January 2017, collaborated to manufacture orally-administrated vaccine to prevent diarrhea. The new vaccine is expected to be manufactured as a part of two-year collaboration having thermostable capabilities for a longer period. The new vaccine is expected to be delivered to the people living in the remote areas. Thermostable vaccine, which is manufactured approximately one third of the price of the conventional injectable vaccines helps to facilities the growth of Shigella vaccines market.
The new research trial drives the Shigella vaccines market
The University Of Maryland School Of Medicine (UM SOM) in August 2017 received US$ 2.47 Million grant from the National Institute of Allergy and Infectious Diseases (NIAID) to develop vaccine against Shigella and Enterotoxigenic Escherichia coli (ETEC) for the treatment of diarrheal disease. The researchers in the UM SOM’s Center for Vaccine Development (CVD) have developed Shigella-ETEC prototype vaccine, which has been tested in animals successfully. Moreover, the latest funding helps to translate prototype to a human vaccine for Phase 1 clinical trials. Similarly, in September 2019, EveliQure Biotechnologies received grant of US$ 9,470,750 from Horizon2020 the European Union´s Research and Innovation programme, that supports the study of ShigETEC vaccine developed by EveliQure Biotechnologies
Moreover, in September 2019, LimmaTech Biologics AG and GlaxoSmithKline plc., collaboratively initiated Phase I/II clinical trial of 4-valent candidate vaccine in Kenya to prevent diarrheal disease cause due to Shigella in the developing economies.
Key players in the shigella vaccines market:
Some of the key players operating in the shigella vaccines market includes MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd., Novartis (Novartis Vaccines Institute for Global Health), and GlaxoSmithKline plc.