Clostridium difficile infections are the most widely recognized cause of hospital acquired infectious diarrhea. There is a critical need for development of prevention vaccine for this disease. Clostridium difficile, is a gram-positive bacterium, which produces an anaerobic toxin that is transmitted through fecal-oral route. Clostridium difficile infection occurs during antibiotic treatment or can be caused due to healthcare associated infection with clinical manifestation ranging from asymptomatic infection to watery diarrhea or serious intestinal condition such as colitis and colonic perforation.
Growing C. difficile infections at healthcare facilities and antibiotic resistance to treatment drugs are propelling demand for development of prophylactic options to reduce the risk of infection in vulnerable patients. A 2013 bulletin published from the Centers for Disease Control and Prevention (CDC) outlined Clostridium difficile as urgent antibiotic-resistance threats in the U.S.
Clostridium Vaccine Market Drivers
Rising incidence and high prevalence of clostridium difficile infection is expected to boost growth of the market over the forecast period. Incidence of clostridium difficile infection has been witnessing an increase since the recent past, due to its infection recurrence and antibiotic resistance. According to Centers for Disease Control and Prevention (CDC), in 2015 around half a million people in the U.S. suffer from clostridium difficile infection in a year.
Moreover, according to National Center for Biotechnology Information (NCBI), an estimated 37,900 patients were suffering from clostridium difficile infection in Canada in 2012. A review and meta-analysis of studies published in National Center for Biotechnology Information (NCBI), 2016, conducted in China between 2010 and 2016, reported significant incidence of clostridium difficile infection in China.
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Currently, there is no alternative therapies apart from antibiotics available for the treatment of clostridium difficile infection and only option available is surgery (in severe cases), fecal microbiota transplant, and probiotics in case of recurrent clostridium difficile infection.
Moreover, key pharmaceutical players are engaged in conducting clinical trials for development of clostridium vaccine that can offer preventive measure in the clostridium difficile infection in near future.
For instance, in January 2017; Pfizer announced phase II study of investigational clostridium difficile vaccine candidate: PF-06425090; for the prevention of C. difficile infection. This randomized phase II study was conducted to examine the safety, tolerability, and immunogenicity of the vaccine in healthy adults 65 to 85 years of age. Pfizer initiated a phase III study in March 2017, with around 16,000 participants.
In July 2016, Valneva SE announced the successful completion of its phase II clinical study for its prophylactic vaccine candidate VLA84 targeting on primary prevention of C. difficile infection (CDI).
Clostridium Vaccine Market Regional Analysis
North America is expected to hold a dominant position in the global clostridium vaccine market and it is expected to account for largest market share over the forecast period, owing to increased prevalence of Clostridium difficile in the U.S. and growing awareness regarding the adoption of preventive measurement in Clostridium difficile infection in this region.
For instance, according to CDC, in 2011; healthcare-associated infections (HAIs) caused by C. difficile was estimated to cause around half a million infections in the U.S. and 29,000 died within 30 days of the initial diagnosis.
Clostridium Vaccine Market Restraint
Increased risk associated with the failure of vaccine candidate during the clinical trial studies and high cost associated with late stage testing is expected to slow down commercialization of clostridium vaccine and restrain the clostridium vaccine market growth over the forecast period.
For instance, in December 2017, Sanofi terminated its phase III C. difficile clinical trial studies, due to the results of an interim trial analysis, which stated low probability of success with its C. difficile candidate. Moreover, discontinuation of Sanofi’s C. difficile vaccine program is expected to offer great future opportunity for Pfizer and Valneva to offer its vaccine to patients after getting the satisfactory regulatory approval in the future.
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