Peptic ulcer therapeutics market is forecast to show low growth until 2018

London 9/07/2012 12:35 AM GMT (TransWorldNews)

GlobalData estimates that the global peptic ulcer therapeutics market was worth $892.4m in 2010, and is forecast to grow at a Compound Annual Growth Rate (CAGR) of 2% to $1,046.2m by 2018. Peptic ulcers develop due to two main factors: infection with Helicobacter pylori (H. pylori) and the long-term use of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). H. pylori infection accounts for almost 85% of all peptic ulcer cases. The peptic ulcer market is well served by Proton Pump Inhibitors (PPIs), which form the majority. PPIs include omeprazole, lansoprazole, pantoprazole, Nexium (esomeprazole) and Aciphex (rabeprazole); and histamine blockers such as ranitidine, nizatidine, famotidine and cimetidine. Omeprazole is currently the most widely prescribed drug for peptic ulcers across the seven major markets. It is available as a generic and an Over-The-Counter (OTC) drug, making it cost-effective. Between 2005 and 2010, the market grew at a CAGR of 2.8%, largely due to the lack of new drug launches and the entry of OTC versions of omeprazole and lansoprazole. The patent expiry of Prevacid (lansoprazole) in the US in 2009 did not impact the market significantly due to its small patient share within the US market.

Between 2010 and 2018, the global peptic ulcer market is expected to grow at a CAGR of 2%. During this period, Nexium (esomeprazole) and Aciphex (rabeprazole), both of which are PPIs, will lose their patent exclusivity. The patent for Nexium is set to expire in the US in 2015 and in Europe and Japan in 2014 and the patent for Aciphex will expire in the US in 2013. This is likely to be marginally compensated by the entry of new products. These new drugs include Vimovo, (naproxen/esomeprazole magnesium) launched in the US in 2010 and expected to enter the European markets in 2012; Axanum (aspirin/ esomeprazole), expected to be available in Europe by 2012; and PA32540 (aspirin/omeprazole) expected to be launched in the US by 2014 and in Europe by 2015. Vimovo, Axanum and PA32540, all are fixed-dose combinations containing an NSAID and a PPI. These drugs target NSAID-induced peptic ulcers. Therefore, their entry will positively impact the NSAID-induced peptic ulcer market.

Strong Presence of PPIs in the Peptic Ulcer Therapeutics Market

Peptic ulcer treatment relies on the use of PPIs and histamine blockers, although PPIs are most widely prescribed. PPI-based triple therapy (a combination of one PPI and two antibiotics) is the preferred approach for the treatment of H. pylori-induced peptic ulcers. PPIs are also used in the healing and risk reduction of NSAID-induced peptic ulcers. Although antihistamines have long been prescribed to treat ulcers, they are less effective than PPIs, of which omeprazole, lansoprazole, pantoprazole, Nexium and Aciphex are currently prescribed. Aciphex is under patent protection until 2013 and Nexium until 2014. Omeprazole, pantoprazole and lansoprazole are available in generic forms, and lansoprazole and omeprazole are also available in OTC form. Omeprazole's patent expired in 2002 but has maintained a strong market presence due to its high efficacy and low cost of treatment. Thus, generic PPIs currently form the majority of the peptic ulcer therapeutics market. After the patent expiry of Nexium and Aciphex, the entire market will be dominated by generic PPIs, leading to low growth.

The Peptic Ulcer Therapeutics Market has Low Unmet Need

Antihistamines have low efficacy and as such the treatment paradigm has shifted towards PPIs, as PPI-based triple therapy is highly effective in the eradication of H. pylori. Higher eradication rates have resulted in reduced incidence of peptic ulcer. They are also very effective in healing NSAID-induced peptic ulcers and their availability in generic and OTC forms renders unmet need low.

The current peptic ulcer market is very well served by the available therapies in terms of eradication of H. pylori, healing of ulcers and risk reduction of NSAID-induced ulcers. Thus, the market has low unmet need and offers limited opportunities for new pipeline molecules. The molecules that have novel disease-modifying mechanisms with better efficacy and safety would be able to further lower the unmet need.

Combination Drugs: A New Trend in the Peptic Ulcer Market

The prevalence of NSAID-induced ulcers is lower than that of H. pylori-induced ulcers but is increasing and as such a number of pharmaceutical companies are now developing combination medications to target NSAID-induced peptic ulcers. Pozen and AstraZeneca co-developed a fixed-dose combination of naproxen and esomeprazole, known as Vimovo, which was approved in the US in April 2010 and is expected to enter the European markets in 2012. Pozen is developing another drug, PA32540, which is a fixed-dose combination of aspirin and omeprazole, indicated for secondary prevention of cardiovascular disease in patients at risk of developing aspirin-associated gastric ulcers.

AstraZeneca's drug Axanum is a fixed-dose combination of Acetylsalicylic Acid (ASA) and esomeprazole. Axanum is indicated for the prevention of cardiovascular events in patients at risk of ASA-associated gastric or duodenal ulcers. Thus, by using this new approach, pharmaceutical companies are attempting to extend the product life cycle of their peptic ulcer drugs.

Weak Pipeline is Unlikely to Significantly Impact the Peptic Ulcer Market

Competition in the current peptic ulcer market is strong due to the many approved therapies for the treatment of peptic ulcer. GlobalData has found that the peptic ulcer pipeline consists of seven molecules in various Phases of development. Of these seven molecules, only Axanum, Nexium and PA32540 are in the late stage of development. Axanum and PA32540 are first-in-class molecules as they are fixed dose combinations containing one NSAID and one PPI. Axanum, developed by AstraZeneca, is filed for approval in Europe and is expected to enter the European market in 2012. PA32540, a Phase III molecule developed by Pozen, is expected to enter the US market by 2014. They are both targeted at the prevention of NSAID-induced ulcers, for which the prevalence is lower than that of H. pylori-induced ulcers. This suggests that Axanum and PA32540 have less chance of capturing a large share of the peptic ulcer market. The remaining molecules, Cobiprostone, SQ109, TAK438 and ARH-1029, are in the early stages of development and if approved, will intensify competition in the peptic ulcer market without significantly affecting the market size.

Report Scope

The report provides information on the key drivers and challenges of the Peptic Ulcer Therapeutics market. Its scope includes -
- Annualized seven key markets (US, France, Germany, Italy, Spain, UK and Japan) Peptic Ulcer Therapeutics market revenues data from 2005 to 2009, forecast for eight years to 2018.
- Pipeline analysis data providing a split across the different phases, mechanisms of action being developed and emerging trends by seven key markets. Pipeline candidates fall under major therapeutic classes.
- Analysis of the current and future competition in the seven key countries Peptic Ulcer Therapeutics market.
- Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide a qualitative analysis of its implications.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs and the implications for the Peptic Ulcer Therapeutics market.
- Analysis of key recent licensing and partnership agreements in Peptic Ulcer Therapeutics market

Click for Report details:Peptic Ulcer Therapeutics- Pipeline Assessment and Market Forecasts to 2018


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