ENTYVIO Market

“ENTYVIO Market Size, Forecast, and Market Insight−2034” report provides comprehensive insights about ENTYVIO for Ulcerative Colitis and Crohn's Disease in the seven major markets. A detailed picture of the ENTYVIO in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 –2034 is provided in this report along with a detailed description of the ENTYVIO for Ulcerative Colitis. The ENTYVIO market report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the ENTYVIO market forecast analysis for Ulcerative Colitis and Crohn's Disease in the 7MM, SWOT, analysts’ views, comprehensive overview of market competitors, and brief about other emerging therapies in Ulcerative Colitis and Crohn's Disease.

ENTYVIO Drug Summary

ENTYVIO (vedolizumab) is a gut-selective biologic developed by Takeda Pharmaceutical and marketed under ENTYVIO. It is approved for the treatment of adult patients with moderately to severely active ulcerative colitis and Crohn’s disease (CD) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα)-antagonist. It is a humanized monoclonal antibody designed to specifically antagonize the alpha 4 beta 7 integrin, inhibiting the binding of alpha 4 beta 7 integrins to intestinal mucosal addressing cell adhesion molecule 1 (MAdCAM-1), but not Vascular Cell Adhesion Molecule 1 (VCAM-1). MAdCAM-1 is preferentially expressed in the gastrointestinal tract’s blood vessels and lymph nodes. The alpha 4 beta 7 integrin is expressed on a subset of circulating white blood cells, and these cells have been shown to mediate the inflammatory process in ulcerative colitis and Crohn’s disease. By inhibiting alpha 4 beta 7 integrin, vedolizumab may limit the ability of certain white blood cells to infiltrate gut tissues.

ENTYVIO Dosage 

The recommended dosage of ENTYVIO in adults with ulcerative colitis is 300 mg administered by intravenous infusion at 0, 2, and 6 weeks and then every 8 weeks after that. Therapy should be discontinued in patients who show no evidence of therapeutic benefit by Week 14. 

Emerging Competitors of ENTYVIO

Despite the presence of biosimilars, innovation in Crohn’s disease and ulcerative colitis treatment remains strong, with several emerging therapies exploring new inflammatory pathways to improve efficacy and long-term outcomes. RHB-104, a combination macrolide antibiotic, is in Phase III trials targeting potential mycobacterial involvement. VELSIPITY, an S1P receptor modulator, works by limiting lymphocyte migration and reducing inflammation. TREMFYA, which inhibits IL-23, is under evaluation for its immune-modulating effects, while ABBV-154, a TNF inhibitor conjugated with a steroid, aims to enhance TNF suppression.

Additional pipeline therapies include Merck’s TL1A inhibitor Tulisokibart (PRA023/MK-7240) in Phase III and Pfizer’s JAK3 inhibitor LITFULO in Phase II. Teva and Sanofi are also developing Duvakitug, a monoclonal antibody targeting TNFSF15. These investigational drugs represent significant progress for patients unresponsive to current treatments.

A range of other promising candidates are in development, each targeting unique pathways. NImmune’s Omilancor (BT-11) is in Phase II (for Crohn's disease) and in Phase III (for Ulcerative Colitis) and acts via LANCL2, while AVB-114 from Avobis Bio/Alimentiv is also in Phase II. Abivax S.A.’s Obefazimod (ABX464) is being studied for its ability to upregulate miR-124. Roche’s RVT-3101 (RG6631), an anti-TL1A antibody, is in Phase II trials, and Mesoblast’s RYONCIL (Remestemcel-L), a mesenchymal stem cell therapy, is progressing in Phase III, offering regenerative potential.

Other noteworthy agents in Phase II include Zasocitinib (TAK-279) from Takeda, a TYK2 inhibitor; AZD7798 from AstraZeneca, targeting CCR9; Sanofi’s Balinatunfib (SAR441566), which blocks TNFR1 signaling; AGMB-129 from Agomab Therapeutics, targeting ALK5/TGFβR1; MBF-118 by Medibiofarma, a PPARγ partial agonist; and MORF-057 by Eli Lilly and Morphic Therapeutics, an α4β7 integrin inhibitor. Together, these developments illustrate a robust and diversified IBD pipeline.

Scope of the ENTYVIO Market Report 

The report provides insights into:

• A comprehensive product overview including the ENTYVIO description, mechanism of action, dosage and administration, research and development activities in Ulcerative Colitis and Crohn's Disease.
• Elaborated details on ENTYVIO regulatory milestones and other development activities have been provided in this report.
• The report also highlights the ENTYVIO research and development activities in Ulcerative Colitis and Crohn's Disease across the United States, Europe, and Japan.
• The report also covers the patents information with expiry timeline around ENTYVIO.
• The report contains forecasted ENTYVIO sales for Ulcerative Colitis till 2032.
• Comprehensive coverage of the late-stage emerging therapies for Ulcerative Colitis.
• The report also features the SWOT analysis with analyst views for ENTYVIO in Ulcerative Colitis and Crohn's Disease.

ENTYVIO Methodology

The ENTYVIO market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

ENTYVIO Analytical Perspective by DelveInsight

• In-depth ENTYVIO Market Assessment

This ENTYVIO market report provides a detailed market assessment of ENTYVIO for Ulcerative Colitis and Crohn's Disease in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2025 to 2034.

• ENTYVIO Clinical Assessment

The report provides the ENTYVIO clinical trials information of ENTYVIO for Ulcerative Colitis and Crohn's Disease covering trial interventions, trial conditions, trial status, start and completion dates.

ENTYVIO Market Report Highlights  

• In the coming years, the market scenario for Ulcerative Colitis and Crohn's Disease is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.   
• The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence ENTYVIO dominance.
• Other emerging products for Ulcerative Colitis and Crohn's Disease are expected to give tough market competition to ENTYVIO and launch of late-stage emerging therapies in the near future will significantly impact the ENTYVIO market. 
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of ENTYVIO in Ulcerative Colitis and Crohn's Disease.
• Our in-depth analysis of the forecasted ENTYVIO sales data from 2025 to 2034 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the ENTYVIO in Ulcerative Colitis and Crohn's Disease. 

Key Questions

• What is the product type, route of administration and mechanism of action of ENTYVIO?
• What is the clinical trial status of the study related to ENTYVIO in Ulcerative Colitis and Crohn's Disease and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the ENTYVIO development?
• What are the key designations that have been granted to ENTYVIO for Ulcerative Colitis and Crohn's Disease?
• What is the forecasted market scenario of ENTYVIO for Ulcerative Colitis and Crohn's Disease?
• What are the forecasted ENTYVIO sales in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?  
• What are the other emerging products available and how are these giving competition to ENTYVIO for Ulcerative Colitis and Crohn's Disease?
• Which are the late-stage emerging therapies under development for the treatment of Ulcerative Colitis and Crohn's Disease?