PUBLISHER: GlobalData | PRODUCT CODE: 1265387
PUBLISHER: GlobalData | PRODUCT CODE: 1265387
Inflammatory bowel disease (IBD) refers to two chronic autoimmune diseases that cause intestinal inflammation: Crohn's disease (CD) and Ulcerative Colitis (UC). In Ulcerative Colitis (UC), chronic inflammation affects the colon (also known as the large intestine). Initially, Ulcerative Colitis (UC) usually manifests in the terminal part of the colon, the rectum, and is termed ulcerative proctitis. It can extend to the entire left part of the colon (left-sided proctitis) or the entire colon (pancolitis).
The etiology of Ulcerative Colitis (UC) is classified as idiopathic, although there are numerous theories regarding possible causes. The following hypotheses and factors have been proposed to explain the source of the continuous inflammation of the colon seen in Ulcerative Colitis (UC) patients. For the analysis in this report, patients are segmented by severity: mild to moderate, moderate to severe, and severe to fulminant.
GlobalData estimates by 2031 Ulcerative Colitis (UC) drug sales to grow at a compound annual growth rate (CAGR) of 2.8%, which will be driven by the approvals and launches of nine pipeline therapies and biosimilars.
The current Ulcerative Colitis (UC) market is overcrowded with cheap generic drugs for mild to moderate disease, expensive biologics such as anti-tumor necrosis factors (TNFs) and anti-integrins, and biosimilars for severe disease that are used as short- or long-term alternatives to surgical options. The R&D within this space consists of 11 late-stage pipeline drugs with five oral formulations, more convenient dosing frequencies, novel mechanisms of action (MOAs), and improved safety profiles and drug availability. However, the pipeline products will be challenged by the increasing emergence of biosimilars, since the major brands will experience patent cliffs throughout the forecast period.
There are still high levels of unmet clinical need in the Ulcerative Colitis (UC) market, especially relating to the lack of safe and efficacious treatment alternatives. Additionally, key opinion leaders (KOLs) interviewed by GlobalData indicated the need for biomarkers to predict responsiveness to therapy and prognosis, the lack of highly efficacious treatment alternatives, the low availability of treatments for patients with comorbidities, as well as the standardization of patient-reported outcomes (PROs).
Major drivers of growth in the Ulcerative Colitis (UC) market over the forecast period include:
An increase in prevalence rates in four of the eight major markets and an increase in diagnosed
prevalent cases in seven markets.
The approval and launch of 11 pipeline products into the market during the forecast period, some of which are directed towards significant unmet needs
The high treatment rates across the 8MM
The high unmet need for safe efficacious therapies.
The major barriers of growth in the Ulcerative Colitis (UC) market during the forecast period include:
The high prices of biologic agents, which will prevent physicians from prescribing them to all
severe patients.
The crowded market dynamics, including the already established biologics market, which will
make the uptake of pipeline drugs more difficult.
Patent expiries of key biologics, which will decrease sales due to the launch of biosimilars and
subsequent brand erosion, as well as adding to the overall competitiveness of the market for
newcomers.