Ulcerative Colitis Therapeutics - Pipeline Assessment and Market Forecasts to 2018

Sept. 9, 2011 - PRLog -- GlobalData estimates that the global ulcerative colitis market was valued at $1.4billion in 2010 and forecasts it to grow at a Compound Annual Growth Rate (CAGR) of 5.5% to reach $2.1billion by 2018. This growth forecast is primarily attributed to the currently approved drugs reaching their peak sales during the forecast period and secondarily due to the strong pipeline. The significant growth rate during the period 2005-2010 was due to the launch of Remicade (infliximab) and Apriso in 2006 and 2009 respectively. The current market is strong and is dominated by 5-ASA (5-aminosalicylates) and biologics
such as Remicade (infliximab). Resulting from the strong pipeline the market will see the probable launch of biologics such as Humira (adalimumab), Simponi (golimumab) currently in pre-registration and Phase III respectively, and corticosteroid such as Budesonide MMX now in Phase III of clinical development during the forecast period. Offsetting these growth factors and restricting the CAGR to a moderate level are the patent expiries of Asacol and Apriso in 2013 and 2018 respectively in the US and Europe. The other marketed drug, Lialda will also undergo patent expiry in June 2020.

GlobalData has found that the ulcerative colitis therapeutics market has low unmet need in the first line
therapeutic segment, which implies that the market is well served by the current products in terms of
efficacy and safety. However, unmet need exists for the second, third and fourth-line therapies, providing significant potential for new entrants in these segments. High adverse reactions are associated with the drugs used as second line treatment agents. Corticosteroids and Immunomodulators used as third line therapeutic agents are associated with serious side-effects on long-term use. In the fourth-line treatment segment, Remicade (infliximab) is the only biologic approved for ulcerative colitis. 50%-60% of patients on Remicade do not show any response or lose response over time to it. Therefore, high unmet need exists in this therapeutic segment for drugs with novel mechanisms of action which can offer sustained remission rates.

Thus, significant opportunities exist for new patient-friendly drugs that can offer superior efficacy and
safety profiles with low dosing schedules leading to better compliance rates.

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The ulcerative colitis developmental pipeline is strong, with 33 molecules in various phases of clinical development. There are 27 first-in-class molecules over all the phases of clinical development, along with two promising biologics, one in the pre-registration phase and one in Phase III. The fourth-line therapeutic segment of the ulcerative colitis therapeutics market which is currently dominated by Remicade willwitness stiff competition due to the launch of Humira and Simponi in the near future. Humira and Simponi have demonstrated superior results in terms of efficacy and safety as compared to Remicade. The penetration of other new drug molecules presently in the pipeline will offer a competitive edge to the currently marketed drugs due to their superior efficacy and safety profiles. Also, the currently marketed drugs, Asacol and Apriso, will lose their patent protection in 2013 and 2018 respectively leading to the introduction of generics which in turn will lead to price wars.


GlobalData, the industry analysis specialist, has released its new report, “Ulcerative Colitis Therapeutics - Pipeline Assessment and Market Forecasts to 2018”. The report is an essential source of information and analysis on the global ulcerative colitis therapeutics market. The report identifies the key trends shaping and driving the global ulcerative colitis 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 ulcerative colitis 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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