The American Gastroenterological Association (AGA) has recently released a major update to its clinical guideline for the pharmacological management of moderate-to-severe ulcerative colitis (UC). The new “living” guideline strongly recommends the early use of biologics and small-molecule therapies following 5-ASA failure, a significant departure from the traditional step-up approach. It marks a turning point in UC treatment strategy, with major implications for market access, prescribing behavior, and therapeutic competition, says GlobalData.
As the first “living” guideline for UC, the AGA will update recommendations semiannually, allowing rapid integration of new evidence and emerging therapies. For pharmaceutical companies, this creates both opportunity and urgency: drugs that demonstrate clear clinical benefit could gain swift recognition, while those without competitive differentiation may be deprioritised in treatment algorithms.
Sravani Meka, Senior Pharmaceutical Analyst at GlobalData, comments, “This guideline places clinical efficacy front and center. It gives clinicians the confidence to initiate treatment with the most effective advanced therapies early in the disease course, rather than cycling through older, less effective options.”
Ten agents were granted strong recommendations, including AbbVie’s upadacitinib and risankizumab, Pfizer’s etrasimod, J&J’s guselkumab, as well as legacy biologics like infliximab, vedolizumab, and ustekinumab. The guideline also supports biosimilars and the use of subcutaneous infliximab and vedolizumab for maintenance. Meanwhile, adalimumab was downgraded to a conditional recommendation due to lower comparative efficacy marking a significant shift for one of the most widely used therapies in the past decade.
GlobalData’s Ulcerative Colitis: Eight-Market Drug Forecast and Market Analysis (March 2023) report projected the UC market across the US, EU5, Japan, and Canada to grow from $7.3 billion in 2021 to $10 billion in 2031, driven by pipeline launches and expanded use of advanced therapies.
Meka explains, “These forecasts may need to be revised. The AGA’s new recommendations will likely accelerate uptake for newer therapies such as Rinvoq (upadacitinib), Skyrizi (risankizumab), Velsipity (etrasimod), and Tremfya (guselkumab), potentially reshaping commercial trajectories laid out in earlier forecasts.”
The guideline may also influence payer strategy, particularly in the US, where step therapy policies have long mandated TNF-failure before newer options are covered.
Meka concludes, “This is the clearest signal, yet that step therapy must evolve. With the AGA now endorsing multiple newer agents as high-efficacy first-line options, payers will face mounting pressure to align coverage decisions with evidence-based care.”