Irritable Bowel Syndrome

Pharmacor -- February 2007

  Introduction:

Although a highly prevalent condition, irritable bowel syndrome (IBS) is marked by low diagnosis rates within the major pharmaceutical markets. Many patients self-medicate with OTC products, and many of the prescription drugs available to treat patients who are diagnosed offer suboptimal efficacy and side-effect profiles. Considerable commercial potential is available to companies that can develop and promote safe, effective therapies for this undertapped market. Approval of even a few of the many investigative therapeutic approaches will permit a near tripling of major-market IBS sales during our ten-year forecast period.

  Questions Answered in This Report:

Concerns regarding the safety, trial result reproducibility in clinical practice, and the cost-benefit concerns of 5-HT receptor modulators have stymied the attempts of a handful of developers to gain IBS marketing approval for their agents. Will new 5-HT receptor modulators overcome these hurdles and prove themselves superior to current 5-HT receptor modulators in the major pharmaceutical markets during our forecast period?

Several novel drug classes, including chloride-channel modulators, neurokinin receptor antagonists, and opioid receptor modulators, are in late-phase investigation for IBS in the major markets. What novel therapies for treating IBS are likely to have an impact on the market through 2015?

IBS is an indication rife with unmet needs, one of the most important being the need for effective treatments for IBS-related abdominal pain. Will any of the novel therapies under investigation supersede antispasmodics and antidepressants as the therapies of choice for IBS pain management during the next decade?

Early iterations of the Rome diagnostic criteria for functional GI disorders (including IBS) have been criticized for their inability to be easily applied in clinical practice. What role do thought leaders believe the recently launched Rome III criteria for IBS will have in practice, and will they facilitate increases in diagnosis?

  Scope:

Markets: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 31 country-specific interviews with key opinion leaders and one PCP.

Epidemiology: Prevalence, diagnosed patients, and drug-treated patients.

Emerging therapies: Phase II: 12 drugs; Phase III: 3 drugs; preregistration: 2 drugs. Coverage of 7 select preclinical and Phase I products.

Market forecast features: Incorporating pharmacological treatment of constipation-predominant IBS, diarrhea-predominant IBS, and alternating or mixed IBS, we forecast drug sales for IBS through 2015.

Alternative market scenarios: (1) If no 5-HT receptor modulators are launched in Europe and (2) if Astellas’s 5-HT₃ receptor antagonist ramosetron is not launched.