Nonalcoholic Steatohepatitis - Drug Pipeline Analysis and Market Forecasts to 2016

26 May 2010 • by Natalie Aster

GlobalData, the industry analysis specialist’s new report, “Nonalcoholic Steatohepatitis (NASH) - Drug Pipeline Analysis and Market Forecasts to 2016” is an essential source of information and analysis on the global nonalcoholic steatohepatitis market. The report identifies the key trends shaping and driving the global nonalcoholic steatohepatitis market. The report also provides insight on the prevalent competitive landscape and the emerging players expected to bring significant shift in the market positioning of the existing market leaders. Most importantly, the report provides valuable insight on the pipeline products within the global nonalcoholic steatohepatitis 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.

The Nonalcoholic Steatohepatitis Market is Forecast to Show Marginal Growth between 2009 and 2016

GlobalData estimated that the Nonalcoholic Steatohepatitis (NASH) market was worth $1.8 billion in 2009. The major reason for the limited market revenues is that there is no approved drug for the treatment of NASH. NASH is an unrecognized cause of cryptogenic cirrhosis with emerging importance. It is a more aggressive form of NAFLD (Nonalcoholic Fatty Liver Disease), which often progresses to liver cirrhosis. The increased prevalence of diabetes, obesity and hyperlipidemia are considered to be important causes of NASH. Antioxidants, anti-diabetic medications, anti-obesity medications and antihyperlipidemics are some of the off-label products currently used by NASH patients. The modest growth forecast is primarily attributed to a weak pipeline landscape. Due to the fact that low diagnosis rates, low prescription rates and low treatment seeking rates continue to pose significant challenges for prospective market entrants, the market landscape in future is expected to remain static without any significant dynamism. Overall, between 2009 and 2016, the NASH market is expected to grow at a Compound Annual Growth Rate (CAGR) of only 8.4% to reach $3.1bn by 2016.

The Current Competition in the Nonalcoholic Steatohepatitis Market is Weak

GlobalData found that the current competition in the NASH market is weak. The market is devoid of any treatments being approved by the FDA (Food & Drug Administration) or the EMEA (European Medicines Agency) for the treatment of NASH. This is due to the poor understanding of the pathophysiology of the disease and also the niche symptoms the disease, which often means it goes unnoticed. The off-label usage of drugs like anti-diabetics, anti-hyperlipidemics, antioxidants, anti-obesity drugs in general is aimed at managing the conditions that contribute to NASH or make it worse. These include obesity, high cholesterol and diabetes. However, the most effective mode of treatment remains making life style changes and maintaining a modified diet with regular exercise.

Weak Pipeline Hindering the Future Growth of the Nonalcoholic Steatohepatitis Market

GlobalData identified that the pipeline in the NASH market is weak. Though research into the disease market is at a prominent level, there is a significant level of activity in Phase II. The late stage pipeline of NASH is very weak. Phase II has molecules like Raptor’s DR cysteamine (Delayed Release Cysteamine), Gilead Science’s GS-9450, Axcan Pharma’s HD-UDCA (High Dose Ursodesoxycholic Acid) , Eli Lilly’s Byetta and Enzo Biochem’s EGS21, which have shown promising results. There seems to be little possibility that these molecules will be approved for the treatment of NASH by 2016.

Huge Unmet Needs Exist in the Nonalcoholic Steatohepatitis Market

The NASH market poses huge unmet needs. This is due to lack of disease understanding, low diagnosis rates, low prescription rates and low treatment seeking rates. Thus, NASH continues to present opportunities for stronger pipeline candidates. However, if any company wants to capture the high unmet need posed by the existing market, it will need to overcome the prevailing product weaknesses and the adverse effects of the off-label products used in the treatment of NASH.