Tumour Necrosis Factor Ligand Superfamily Member 15 Inhibitor Market Forecast

• TNFSF15 (TL1A), a key player in immune regulation and inflammation, modulates T-cell activation through its interaction with death receptor 3 (TNFRSF25). Targeting the TNFSF15 signaling pathway is emerging as a promising therapeutic strategy for inflammatory bowel diseases such as Crohn’s disease, ulcerative colitis and fibrosis linked to metabolic dysfunction-associated steatohepatitis (MASH).
• The lack of approved TNFSF15 inhibitors underscores a clear gap in the treatment landscape, creating a favorable environment for pipeline assets to establish first-mover advantage and capture unmet demand across multiple inflammatory and fibrotic conditions.
• The emerging pipeline of TNFSF15 inhibitors remains relatively non-competitive, providing early entrants such as RG6631 (RO7790121; RVT-3101) with a strategic opportunity to establish a strong foothold and potentially define the treatment paradigm.
• Currently, F. Hoffmann-La Roche and Chugai Pharmaceutical are engaged in the development and production of TNFSF15 inhibitor, which has the potential to significantly impact and enhance the TNFSF15 inhibitor market.
• In December 2022, Roivant Sciences and Pfizer established Telavant to develop and commercialize RVT-3101. Building on this, Roche entered into a definitive agreement in October 2023 to acquire Telavant from Roivant and Pfizer, securing full rights to RVT-3101. This acquisition enables Roche to take the lead in the development, manufacturing, and commercialization of the therapy across the US and Japan.

DelveInsight’s “Tumor Necrosis Factor Ligand Superfamily Member 15 (TNFSF15) Inhibitor – Target Population, Competitive Landscape, and Market Forecast – 2034” report delivers an in-depth understanding of the TNFSF15 Inhibitor, historical and projected epidemiological data, competitive landscape as well as the TNFSF15 Inhibitor market trends in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

The TNFSF15 Inhibitor market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM TNFSF15 inhibitor market size from 2020 to 2034. The report also covers current TNFSF15 Inhibitor treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

TNFSF15 Inhibitor Understanding and Treatment Algorithm

TNFSF15 Inhibitor Overview

Tumor necrosis factor ligand superfamily member 15 (TNFSF15), also known as VEGI (Vascular Endothelial Growth Inhibitor), TL1A, or TNLG1B, is a member of the TNF ligand superfamily involved in immune regulation and inflammation. It plays a critical role in maintaining vascular homeostasis and modulating inflammatory responses. TNFSF15 exerts its effects by binding to death receptor 3 (TNFRSF25), a process that promotes T-cell activation, proliferation, and the production of multiple cytokines. This TNFSF15-TNFRSF25 signaling axis is essential for sustaining effective T-cell-mediated immune responses, particularly in the context of autoimmune diseases.

TNFSF15 Inhibitor Clinical Relevance

TL1A, a member of the TNF ligand superfamily, plays a key role in negatively regulating epithelial cell proliferation and is found in both membrane-bound and soluble forms. Targeting the TL1A/death receptor 3 (TNFRSF25) signaling pathway has gained attention as a promising therapeutic strategy for inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis. Additionally, TNFSF15 inhibitors are being investigated for their potential in treating fibrosis associated with MASH. 

Further details related to country-based variations are provided in the report…

TNFSF15 Inhibitor Epidemiology

The TNFSF15 Inhibitor epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total cases in selected indications for TNFSF15 Inhibitor, total eligible patient pool in selected indications for TNFSF15 Inhibitor, and total treated cases in selected indications for TNFSF15 Inhibitor in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2020 to 2034. 

Ulcerative colitis

• In 2024, the total diagnosed prevalent cases of ulcerative colitis across the 7MM were estimated at more than 3 million and are expected to increase over the forecast period (2025–2034).
• The US accounted for the highest number of diagnosed prevalent cases in 2024, contributing nearly 47% of the total 7MM population.
• Germany and Japan each represented around 10% of the overall diagnosed prevalent ulcerative colitis population in the 7MM in 2024.

Crohn’s disease

• In 2024, the total number of diagnosed prevalent cases of Crohn’s disease in the US was estimated at approximately 1 million.
• The US accounted for the largest share of Crohn’s disease cases among the 7MM, representing around 54% of the total diagnosed prevalent population in 2024.
• In comparison, the EU4 and the UK collectively made up about 42% of the 7MM population share, while Japan accounted for approximately 4% in 2024.
• Among the EU4 and the UK, Germany had the highest number of diagnosed prevalent Crohn’s disease cases in 2024, with an estimated 300 thousand cases, followed by the UK with 230 thousand cases. Spain reported the lowest number, with around 95 thousand cases.

MASH

• In 2024, the diagnosed prevalent cases of MASH across the 7MM were estimated at approximately 8 million and are projected to increase by 2034.
• The US accounted for the largest share, with an estimated 5 million diagnosed prevalent cases of MASH in 2024.
• In 2024, EU4 and the UK collectively reported nearly 3 million diagnosed prevalent cases of MASH. Germany had the highest number within this group, with approximately 800 thousand cases, followed by Italy with around 650 thousand. In contrast, Spain recorded the lowest prevalence, with nearly 350 thousand cases.
• Japan accounted for nearly 700 thousand diagnosed prevalent cases of MASH in 2024. These cases are expected to change by 2034.

Note: Indications are selected based on pipeline activity

TNFSF15 Inhibitor Drug Chapters

The drug chapter segment of the TNFSF15 inhibitor reports includes a detailed analysis of TNFSF15 inhibitor early-, mid-, and late-stage (Phase I, Phase II and Phase III) pipeline drugs. It also helps understand the TNFSF15 inhibitor’s clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug the latest news and press releases.

Emerging Drugs

RG6631 (RO7790121; RVT-3101): F. Hoffmann-La Roche/Chugai Pharmaceutical

RG6631 (RO7790121; RVT-3101), a monoclonal antibody developed by Roche, targets TL1A to inhibit the TH1 and TH17 inflammatory pathways. It is currently in Phase III clinical trials for Crohn’s disease and ulcerative colitis, with regulatory submissions for both indications expected after 2027. Additionally, RO7790121 is being evaluated in a Phase I trial for patients with advanced MASH liver fibrosis.

According to Roche’s pipeline, RG6631 is being developed in partnership with Chugai Pharmaceutical for the treatment of Crohn’s disease.

In December 2022, Roivant Sciences and Pfizer established Telavant to develop and commercialize RVT-3101. In October 2023, Roche entered into a definitive agreement to acquire Telavant from both companies, obtaining full rights to RVT-3101. This strategic acquisition allows Roche to lead the development, manufacturing, and commercialization of the therapy in the US and Japan.

Note: Detailed emerging therapies assessment will be provided in the final report.

Note: The emerging drug list is indicative, the full list will be given in the final report.

TNFSF15 Inhibitor Market Outlook 

The market potential for TNFSF15 inhibitors is gaining momentum, driven by their ability to address unmet needs in inflammatory and autoimmune conditions such as Crohn’s disease, ulcerative colitis, and MASH, particularly in patients who do not respond to existing therapies. Emerging data continues to emphasize TNFSF15’s unique role in immune regulation and vascular biology, positioning these inhibitors as differentiated from conventional TNF blockers. 

As pharmaceutical companies accelerate innovation and broaden clinical applications, competition in this space is expected to grow. With regulatory pathways becoming more streamlined and clinical evidence expanding, TNFSF15 inhibitors are well-placed to establish a distinct niche in the immunology landscape, supported by the advancement of precision medicine and the increasing demand for targeted biologic therapies.

TNFSF15 Inhibitor Uptake

This section focuses on the uptake rate of potential approved and emerging TNFSF15 inhibitor expected to be launched in the market during 2020–2034.

TNFSF15 Inhibitor Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II and Phase I. It also analyzes key players involved in developing targeted therapeutics. 

The presence of numerous drugs under different stages is expected to generate immense opportunity for TNFSF15 inhibitor market growth over the forecasted period.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for TNFSF15 inhibitor emerging therapies. 

KOL Views

To keep up with current and future market trends, we take Industry Experts’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on TNFSF15 inhibitor’s evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.

DelveInsight’s analysts connected with 25+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. 

Their opinion helps understand and validate current and emerging therapy treatment patterns or TNFSF15 Inhibitors market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Market Access and Reimbursement

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of TNFSF15 Inhibitor, explaining its mechanism, and therapies (current and emerging).
• Comprehensive insight into the competitive landscape, and forecasts, the future growth potential of treatment rate, drug uptake, and drug information have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current landscape.
• A detailed review of the TNFSF15 inhibitor market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis expert insights/KOL views, and treatment preferences that help shape and drive the 7MM TNFSF15 inhibitor market.

TNFSF15 Inhibitor Report Insights

• TNFSF15 Inhibitor Targeted Patient Pool
• TNFSF15 Inhibitor Therapeutic Approaches
• TNFSF15 Inhibitor Pipeline Analysis
• TNFSF15 Inhibitor Market Size and Trends
• Existing and Future Market Opportunity

TNFSF15 Inhibitor Report Key Strengths

• 10 Years Forecast
• The 7MM Coverage 
• Key Cross Competition 
• Drugs Uptake and Key Market Forecast Assumptions

TNFSF15 Inhibitor Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT)

Key Questions

• What is the projected TNFSF15 inhibitor total market size, the market size by therapies, market share (%) in 2034? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2034?
• Which is the most lucrative market for TNFSF15 inhibitor?
• What are the risks, burdens, and unmet needs of treatment with TNFSF15 inhibitor? What will be the growth opportunities across the 7MM for the patient population on TNFSF15 inhibitor?
• What are the key factors hampering the growth of the TNFSF15 inhibitor market?
• What are the indications for which recent novel therapies and technologies have been developed to overcome the limitations of existing treatments?
• What key designations have been granted to the therapies for TNFSF15 inhibitor?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?

Reasons to buy

• The report will help develop business strategies by understanding the latest trends and changing dynamics driving the TNFSF15 inhibitor market.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of indication-wise emerging therapies under the attribute analysis section to provide visibility around leading indications.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.