Bowel disorders require safe, effective therapies

Despite availability of many therapies indicated for bowel disorders, there is still an unmet need and heterogeneity among these patients, necessitating availability of a wide variety of therapeutics.  Awareness of potential new products, their key benefits, and where they may fit into the treatment paradigm will be important when making decisions impacting patients and physicians, according to new analysis. 

“Analysis of the Expanding U.S. Market for Gastrointestinal Disorders Prescription Pharmaceuticals” research from Frost & Sullivan looked at the US markets for prescription pharmaceuticals for inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS). The US market for IBD and IBS drugs was approximately $4.2 billion, with the majority in both revenue and volume attributed to sales of IBD drugs. The IBS (moderate to severe patients) market is a much larger patient pool, approximately 10 times the size of the IBD patient population, yet remains largely untapped, according to the analysis.

“This is a highly active market with a pipeline bursting with potential new therapies.  The sheer size of the addressable patient population is driving market growth,” Frost & Sullivan Life Sciences Senior Industry Analyst Debbie Toscano, told Formulary.

IBD (Crohn's disease and ulcerative colitis) is a serious progressive inflammatory disease, for which the main unmet need is more effective therapies with better outcomes with regard to slowing disease progression and maintaining remission, according to the analysis.  Poor adherence to medication is also a significant issue, due to poor tolerability or pill burden of standard therapies.

“Tumor necrosis inhibitors [TNFs] are very effective and are the gold-standard therapy for moderate to severe patients who need more effective therapy beyond standard of care drugs such as aminosalicylates [ie, mesalamine] or corticosteroids.” “However, several novel therapies in development have the potential for superior efficacy compared to currently available products, such as Takeda Pharmaceuticals’ vedolizumab, a novel biological, being developed for ulcerative colitis” Toscano said.  This drug is a gut-targeted agent similar in mechanism to Tysabri (natalizumab), a highly effective drug for multiple sclerosis.  It is noteworthy that, although some therapies are effective for both Crohn’s disease and ulcerative colitis, many emerging therapies with more specific targets will likely only be efficacious in 1 or the other.

TNF inhibitor therapy will likely be initiated sooner in the treatment paradigm as the evidence of the benefits of early initiation of aggressive therapy and physician experience with this class continues to accumulate, according to Toscano.  “Although introduction of this drug class has vastly improved outcomes for many patients, overall there has been no significant impact on the number of patients who eventually require surgery,” she said.

IBS is a less serious condition, although has important quality-of-life issues and a great deal of unmet need as there are only 3 drugs currently available indicated for treatment of IBS.  “Unlike treatment of IBD, which centers on targeting the underlying inflammatory cause, treatments for IBS largely focus on symptom management since the underlying cause of IBS is still incompletely understood,” Toscano said. “Safety issues and lack of sufficient efficacy have led to many failures.”

In addition, Toscano said that IBD and IBS were once thought to be 2 distinct disorders, but the lines between them are becoming blurred as new findings are pointing to pathological similarities between the 2.  “This could lead to increasing off-label use of many IBD therapies for IBS, and eventual label expansion,” she said.

“Be on the lookout for therapies that can demonstrate improved patient compliance, as this is a major barrier to optimal outcomes in the real world,” Toscano advised.  “Many available treatments are not so patient-friendly, due to high pill burden, side effects, or injectable administration.  Drugs only work when patients take them.”

Frost & Sullivan, based in Mountain View, Calif., is a global growth consulting company that also provides market research to a wide range of industries, among other offerings.