Clostridium difficile, a Gram-positive, spore-forming, toxin-producing, non-invasive, anaerobic bacterium, is the causative organism of C. difficile infection (CDI), which is commonly associated with colitis, as well as C. difficile-associated diarrhea (CDAD). CDI onset begins with colonization of the intestinal tract with C. difficile through community-acquired or healthcare-associated means. C. difficile has been identified as a major cause of antibiotic-associated pseudomembranous colitis and diarrhea, with the earliest cases largely attributed to clindamycin. As penicillins and cephalosporins became more widely used throughout the years, their administration also became associated with an increased risk of developing CDAD. Since 2000, CDIs have become more frequent, more severe, more difficult to treat using existing therapies, and more likely to recur than previously described. These realities, along with increasing threat of antibiotic resistance, underscore the importance of developing CDI-specific therapies and bringing them to market.
For the purposes of this report, GlobalData defines the global CDI market to include sales of therapeutic and prophylactic agents aimed at treatment and prevention of CDI and CDAD in patients 18 years and older across the 7MM, which is comprised of the US, 5EU (France, Germany, Italy, Spain, and the UK), and Japan. GlobalData anticipates a major driver of market growth to be the steady increase in uptake of novel CDI-specific antibiotics once they are approved, but the arrival of non-antibiotic products to the market, such as rationally designed microbiologics and vaccines, are poised to make the biggest clinical impact if approved.
Key Questions Answered
– Based on interviews with key opinion leaders (KOLs), GlobalData has identified the major unmet needs in the CDI marketplace. Will the leading therapeutic and prophylactic pipeline agents fulfil these unmet needs during the forecast period (2014-2024)?
– What research and development (R&D) strategies will companies leverage to compete in the future CDI marketplace?
– What adjunctive therapies to standard of care (SOC) antibiotics are poised to make a major clinical and commercial impact?
– What clinical and commercial factors are likely to influence CDI product uptake in the US and 5EU (France, Germany, Italy, Spain, and the UK) and Japan (7MM)?
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– GlobalData projects CDI therapeutics and prophylactics market in the 7MM to grow from approximately $356m in 2014 to a little over $1.5bn in 2024, at a compound annual growth rate (CAGR) of 15.8%. This growth will be driven by the increased uptake of novel adjunctive therapies to SOC antibiotics, increased use of Mercks first-to-market antibiotic Dificid, and the arrival of ACAM-CDIFF, the worlds first prophylactic vaccine developed by Sanofi Pasteur to prevent primary infections.
– KOLs interviewed by GlobalData were split on the ability of a prophylactic vaccine developer to demonstrate statistically significant prevention of primary infections in a pivotal Phase III study, specifically citing difficulties reliably anticipating CDI transmission in the patient population. Expert consensus was that non-antibiotic approaches, specifically rationally designed microbiologic therapies, have the potential to shift the treatment paradigm for intractable recurrent infections, although antibiotics should remain the main treatment options through 2024.
– GlobalData anticipates that firms will continue to invest in CDI-specific antibiotics development throughout the forecast period, but product differentiation will remain a difficult task due to the high clinical cure rates with current cost-effective generic antibacterials and the superior sustained cure rate exhibited with Mercks Dificid.
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