Clostridium difficile Infection (CDI) Therapeutics – Pipeline Assessment

Feb. 10, 2012 - PRLog -- GlobalData’s analysis shows that the Clostridium difficile (C. diffiicle) infection (CDI) therapeutics market grew at a compound annual growth rate (CAGR) of 4.1% from $256.9m in 2006 to reach $314.2m in 2011. The CDI therapeutics market is set to show marginal growth in the forecast period at a CAGR of 6.0%, from $314.2m in 2011 to $500.9m in 2019. The significant growth in the market can be attributed to the entry of new antibiotics with better safety and efficacy than the existing antibiotics to which patients have developed resistance, and the rising elderly population.

Dificid (fidaxomicin) received approval from the US Food and Drug Administration (FDA) in May 2011. In
December 2011 fidaxomicin received approval from the European Medicines Agency (EMEA) for the treatment of adults with CDI with the brand name of Dificlir. This drug has better efficacy and safety profiles for the treatment of CDI in recurring case of infection where as metronidazole and oral vancomycin is ineffective to manage the CDI. Apart from this, Merck’s Phase III molecule MK-3415A, a monoclonal antibody, is expected to be launch in 2016. Additionally, the significant morbidity, mortality and cost aligned with drug-resistant CDI will allow the future players in the CDI therapeutics market to justify the relative premium pricing of the antibiotics in the market.

GlobalData’s analysis suggests that the metronidazole and oral vancomycin do not serve the need of the CDI therapeutic market. The current CDI therapeutics market is weak due to a lack of effective treatment options. Metronidazole, oral vancomycin and the recently launched Dificid in the US are the only available treatment options in the CDI therapeutics market. In the UK and Europe, Dificlir expected to be launch in mid 2012. Metronidazole has been recommended (off label) as a first line of treatment in the CDI. Oral vancomycin is the only approved drug for the treatment of CDI. Currently, Optimer‘s Dificid has received approval for Clostridium difficile Associated Diarrhea (CDAD) in May 2011in the US. Although, metronidazole is used off lable it is still the mainstay of treatment for the first episodes of CDAD. After clinical failure of metronidazole only vancomycin is available to manage the CDAD.

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The CDI therapeutics pipeline consists of 20 products in different stages of clinical development. The Phase III stage of clinical development consists of one molecule, Phase II consists of six molecules, and Phase I consists of two molecules. The molecules in the pipeline can be categorized on the basis of their mechanism of action as 15 first-in-class molecules, and one me-too candidate. The mechanism of action is unknown for the rest of the four molecules.

Merck’s MK-3415A, a monoclonal antibody, is perceived to be most promising molecules which is currently in Phase III of clinical trials for CDI. MK 3415A is a combination of MK 066 and MK 1388. MK 066 is a fully human monoclonal antibody that targets Toxin A, a Clostridium difficile-produced toxin. MK 1388 is another monoclonal antibody that targets Toxin B. Additionally the molecule also shows better safety and efficacy profiles and compliance in dosing, and is expected to be a preferred agent to treat recurrent cases of CDI. Apart from these, in Phase II, Sanofi’s C. diffiicle toxoid Vaccine (ACAM-CDIFF) is being investigated in patients with first episodes of CDI who are receiving standard antibiotics treatment.

GlobalData, the industry analysis specialist, has released its new report, “Clostridium difficile Infection (CDI) Therapeutics - Pipeline Assessment and Market Forecasts to 2019”. The report is an essential source of information and analysis on the global Clostridium difficile (CDI) Therapeutics market. The report identifies the key trends shaping and driving the global Clostridium difficile (CDI) Therapeutics market. The report also provides insights on the prevalent competitive landscape and the emerging players expected to significantly alter the market positioning of the current market leaders. Most importantly, the report provides valuable insights on the pipeline products within the global Clostridium difficile (CDI) Therapeutics sector. This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData’s team of industry experts.

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