Vedolizumab (Entyvio) Market: Facing the Patent Cliff And Intensifying Competitive Landscape

Report Overview

Vedolizumab (Entyvio), developed by Takeda Pharmaceuticals, is a leading gut-selective α4β7 integrin antagonist used for treating inflammatory bowel diseases (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). Approved in over 70 countries, the drug is also under regulatory evaluation for expanded indications, including pediatric IBD and combination therapy approaches. With patents expiring in the U.S. by 2028 and Europe by 2027, the market is expected to face biosimilar competition, likely driving price adjustments and broader patient access. Despite this, Vedolizumab remains a preferred choice for moderate-to-severe IBD patients, supported by ongoing clinical trials exploring long-term efficacy, safety, and new treatment regimens. The drug’s market trajectory will be influenced by regulatory developments, the arrival of biosimilars, and real-world evidence, with Takeda strategically focusing on R&D, partnerships, and expansion in high-growth regions such as Asia Pacific and Latin America.

Key Report Deliverables

• A comprehensive analysis of the Vedolizumab (Entyvio) market landscape, covering global revenue performance, key growth drivers in the inflammatory bowel disease (IBD) sector, evolving treatment paradigms in ulcerative colitis (UC) and Crohn’s disease (CD), and the shifting competitive context within the gut-selective biologics segment.

• Forecasts evaluating post-patent market dynamics, including expected biosimilar entry timelines across major regions, and the projected impact on revenue growth, pricing pressures, and market access following patent expirations in the U.S. (2028) and Europe (2027).

• Identification of regulatory and market access barriers influencing biosimilar adoption, including approval complexities, interchangeability standards, pricing and reimbursement frameworks, and payer-driven formulary decisions in key geographies such as the U.S., Europe, and Asia Pacific.

• An in-depth competitive landscape overview, profiling direct competitors in the integrin antagonist and biologic IBD segments, emerging biosimilar developers, ongoing pipeline innovations, and the evolution of combination and step-up therapy strategies shaping the future of IBD management.

• Strategic implications for Takeda, including lifecycle management initiatives, biosimilar defense strategies, new formulation development (e.g., subcutaneous Vedolizumab), expansion into pediatric and new autoimmune indications, pricing optimization, and regional market expansion to maintain leadership in the global IBD therapeutics market amid intensifying biosimilar and biologic competition. 

Current Market Scenarios 

Vedolizumab (Entyvio), developed by Takeda Pharmaceuticals, currently enjoys strong market exclusivity across major global regions, with U.S. patents extending protection until 2028 and European patents until 2027. This exclusivity period continues to provide Takeda with a competitive edge and stable revenue stream in the inflammatory bowel disease (IBD) segment. However, as biosimilar development accelerates, the market is expected to undergo significant transformation, especially with multiple manufacturers already advancing late-stage biosimilar candidates. Regional differences in patent expirations, biosimilar entry timelines, and regulatory approval pathways will play a critical role in shaping pricing dynamics, market access, and competitive positioning across key markets. 

In Europe, where cost-containment policies and payer-driven decisions are prominent, biosimilar adoption is projected to occur rapidly post-patent expiry, likely exerting downward pressure on branded Vedolizumab pricing. In contrast, Asia Pacific markets-notably China, South Korea, and India are actively promoting biosimilar production and local manufacturing to enhance treatment affordability and expand access, potentially leading to an earlier shift toward biosimilars. Meanwhile, in markets such as Japan and the U.S., where clinical conservatism and complex interchangeability requirements prevail, biosimilar penetration may progress more gradually, allowing Takeda to retain premium market positioning in the near term. 

Despite the approaching patent cliff, demand for Vedolizumab remains strong, driven by its favorable safety profile, gut-selective mechanism, and long-term efficacy in treating ulcerative colitis (UC) and Crohn’s disease (CD). The drug continues to benefit from ongoing clinical trials exploring pediatric applications, subcutaneous formulations, and potential use in other autoimmune conditions. Takeda’s strategic emphasis on lifecycle management, indication expansion, and geographic diversification positions Vedolizumab to maintain its relevance and competitiveness even amid increasing biosimilar pressures. Moving forward, the IBD therapeutic landscape will be shaped by evolving biosimilar policies, pricing strategies, and innovation-driven differentiation, with Takeda expected to focus on sustaining market leadership through scientific advancement and targeted regional strategies.

Market Dynamics 

Growing Demand for Gut-Selective Biologics

The rising global prevalence of inflammatory bowel diseases (IBD)-notably ulcerative colitis (UC) and Crohn’s disease (CD)-has fueled strong demand for gut-selective biologics such as Vedolizumab (Entyvio). Owing to its targeted α4β7 integrin inhibition, Vedolizumab offers superior gut-specific efficacy with a favorable safety profile, making it a preferred treatment option for patients unresponsive to conventional or systemic biologics. The drug’s expanding clinical utility across pediatric IBD, combination therapies, and maintenance regimens continues to strengthen its market position. Supported by robust real-world evidence, high physician confidence, and broad geographic adoption, Vedolizumab has established itself as a cornerstone therapy in IBD management. The growing global awareness of biologic-driven disease control and ongoing label expansions will further sustain demand across both developed and emerging markets.

Pricing and Market Erosion Post-Patent

With patent expirations approaching in the U.S. (2028) and Europe (2027), the Vedolizumab market is expected to experience heightened biosimilar competition and downward pricing pressures. As biosimilars enter key markets, payers in Europe, India, and Asia Pacific will increasingly favor cost-effective alternatives, accelerating the transition toward lower-priced biologics. While physician familiarity with the originator brand and interchangeability regulations may initially slow biosimilar adoption, affordability-driven healthcare systems are likely to embrace biosimilars faster than mature markets. Consequently, Takeda’s market share could face gradual erosion as regional pricing policies, reimbursement shifts, and biosimilar approvals reshape the competitive landscape. However, early biosimilar entrants will need to demonstrate comparable safety, efficacy, and real-world outcomes to gain meaningful traction against the established Vedolizumab brand.

Opportunities in Lifecycle Management and Regional Divergence

Takeda is proactively addressing the patent cliff through lifecycle management strategies, including subcutaneous (SC) formulation launches, expanded indications, and combination therapy research aimed at enhancing convenience and therapeutic outcomes. Ongoing clinical programs exploring pediatric use, early-stage IBD, and new autoimmune indications could provide additional growth pathways post-patent expiry. The impact of biosimilar competition will vary regionally: in the U.S., Japan, and Western Europe, stringent regulatory pathways and physician loyalty may delay biosimilar uptake, sustaining branded Vedolizumab’s presence; conversely, emerging markets such as China, India, and Latin America are likely to witness faster biosimilar adoption driven by affordability initiatives and government-backed access programs. To maintain leadership, Takeda is expected to emphasize innovation, strategic partnerships, and regional pricing optimization, ensuring Vedolizumab remains a dominant force in the evolving global IBD therapeutics market.

The Pressure of Pricing and Market Erosion Post-Patent 

As Vedolizumab (Entyvio) approaches patent expirations in Europe by 2027 and the U.S. by 2028, the market is expected to face intensifying biosimilar competition, driving pricing pressures and potential market share erosion for Takeda Pharmaceuticals. While biosimilars will gain faster traction in cost-sensitive regions such as China, India, and Latin America due to government incentives and affordability initiatives, adoption in mature markets like the U.S., Europe, and Japan may progress more gradually amid regulatory complexities, interchangeability concerns, and physician loyalty to the originator brand. Over time, payer-driven pricing policies and value-based procurement systems are expected to accelerate biosimilar uptake globally, reshaping market access and competitive dynamics within the inflammatory bowel disease (IBD) space. Despite these challenges, Vedolizumab’s strong safety profile, proven long-term efficacy, and ongoing clinical innovations, including subcutaneous formulations and expanded indications, will help Takeda mitigate the impact of biosimilar entry. To sustain leadership in the gut-selective biologics segment, the company is focusing on lifecycle management, R&D-driven differentiation, and patient-centric strategies to preserve its competitive edge in a rapidly evolving therapeutic landscape.

Innovating Beyond the Patent - Unlocking Future Growth Paths

As Vedolizumab (Entyvio) faces upcoming biosimilar competition following patent expirations in Europe (2027) and the U.S. (2028), significant opportunities remain to drive future growth in the IBD biologics market. Next-generation innovations, including subcutaneous formulations, optimized dosing regimens, and enhanced delivery methods, can improve patient convenience and adherence, broadening the therapy’s adoption. Ongoing research into combination therapies with other biologics or immunomodulators provides further differentiation, reinforcing Vedolizumab’s role in multi-modal IBD management. Takeda’s innovation strategy, centered on novel formulations, expanded indications, and pediatric applications, will be critical in sustaining clinical relevance amid intensifying biosimilar pressures. Additionally, the growth of affordable biosimilar options opens avenues for enhanced market access in emerging economies, where cost-effective therapies are increasingly prioritized. As healthcare infrastructure strengthens in regions such as Asia Pacific, Latin America, and the Middle East, demand for both branded Vedolizumab and lower-cost alternatives is expected to rise, enabling broader patient access and reinforcing Takeda’s strategic leadership in the global IBD treatment landscape.

Shaping the Future - Biosimilars, Patient-Centric Models, and Regional Shifts

The movement toward patient-centric IBD treatments is accelerating, emphasizing convenience, adherence, and improved quality of life. Innovations such as subcutaneous formulations, optimized dosing regimens, and combination therapies will enable more personalized treatment approaches, reinforcing the clinical relevance of Vedolizumab (Entyvio) even as biosimilars enter the market. The growing adoption of value-based healthcare is expected to drive faster biosimilar uptake in price-sensitive regions, reshaping the competitive dynamics between branded Vedolizumab and lower-cost alternatives. Regional variations will remain a key factor: in mature markets such as the U.S., Europe, and Japan, regulatory hurdles and conservative clinical adoption may slow biosimilar penetration, whereas emerging markets like China, India, and Latin America are likely to witness rapid uptake fueled by affordability pressures, government initiatives, and streamlined regulatory pathways. These regional differences will create distinct competitive landscapes, requiring Takeda to tailor strategies to maintain market leadership and expand patient access globally. 

Overview of Alternative Therapeutics 

Vedolizumab (Entyvio) is facing increasing competition from other IBD-targeted biologics and emerging therapies, including ustekinumab, infliximab biosimilars, adalimumab biosimilars, and next-generation integrin or cytokine-targeting agents. These competitors are broadening their indications, treatment regimens, and geographic presence to capture larger shares of the global inflammatory bowel disease (IBD) market. In parallel, innovations such as combination therapies, targeted biologics, and novel immunomodulators are reshaping the therapeutic landscape, intensifying competitive pressures in ulcerative colitis (UC) and Crohn’s disease (CD) management.

A growing wave of Vedolizumab biosimilars is progressing through global regulatory and clinical pathways, with market entry expected following patent expirations in Europe (2027) and the U.S. (2028). The success of these biosimilars will depend on demonstrating clinical comparability, securing regulatory approvals, offering cost advantages, and implementing strategic pricing approaches to gain traction in price-sensitive markets, where payers and healthcare systems strongly influence treatment decisions.

Overall, the evolving competitive landscape emphasizes the need for Takeda Pharmaceuticals to leverage innovation, lifecycle management, and strategic collaborations to maintain leadership in the gut-selective biologics segment. As biosimilars and alternative therapeutics reshape the IBD treatment market, Takeda must focus on differentiating Vedolizumab through novel formulations, expanded indications, and patient-centric strategies to sustain its market position and ensure continued relevance in a rapidly changing therapeutic environment.

Competitive Landscape

The competitive landscape for Vedolizumab (Entyvio) is rapidly evolving as emerging biosimilars and next-generation IBD-targeted biologics intensify competition in the treatment of ulcerative colitis (UC) and Crohn’s disease (CD). Takeda Pharmaceuticals, the primary developer of Vedolizumab, continues to leverage its strong market position through an extensive label portfolio, expanded indications, and proactive lifecycle management strategies, including subcutaneous formulations and optimized dosing regimens. Competitors such as ustekinumab, infliximab biosimilars, adalimumab biosimilars, and other emerging integrin- or cytokine-targeting agents are broadening their indications and geographic reach, creating a more competitive environment in the IBD therapeutics market. 

On the biosimilar front, Vedolizumab biosimilars are progressing through regulatory and clinical pathways, with market entry expected following patent expirations in Europe (2027) and the U.S. (2028). In emerging markets such as China, India, and Latin America, local developers and government-backed initiatives are facilitating faster market access, increasing competitive pressures and driving biosimilar adoption. Additionally, next-generation therapies, including novel integrin-targeted biologics and combination therapies, represent longer-term competition due to their potential for improved efficacy and differentiated mechanisms of action.

To maintain market leadership, Takeda is focusing on lifecycle extensions, strategic collaborations, and patient-centric initiatives, while competitors emphasize pipeline diversification and digital health integration. The rise of biosimilars and next-generation IBD therapies is expected to drive pricing pressures, enhance treatment accessibility, and redefine the IBD treatment landscape. Ultimately, the ability to innovate, differentiate, and deliver patient-focused solutions will be critical for Takeda and other market players to maintain resilience and leadership in the rapidly evolving gut-selective biologics segment. 

North America Vedolizumab Market

North America remains the largest market for Vedolizumab (Entyvio), with the U.S. driving the majority of sales due to its advanced healthcare infrastructure and high demand for biologic therapies in IBD management. Vedolizumab’s patent protection in the U.S. is set to expire in 2028, creating a window for biosimilar entry. Post-patent, the market is likely to experience pricing pressures, as payers prioritize cost-effective alternatives. In Canada, where exclusivity is expected to end around 2027-2028, similar dynamics will emerge, with biosimilars entering earlier, intensifying competition. While regulatory and clinical adoption hurdles may delay immediate biosimilar uptake, pricing erosion is anticipated once biosimilars gain market confidence. 

Europe Vedolizumab Market

Europe represents a significant market for Vedolizumab, with Germany, France, and the U.K. as key contributors. Patent protections are expected to remain in most major markets until 2027, after which biosimilars and generics are likely to gain approval. Europe’s cost-conscious healthcare systems will encourage a rapid transition to lower-cost alternatives, with tender-based procurement and competitive pricing reshaping market dynamics. Regulatory delays may slow initial uptake, but once approved, biosimilars are expected to capture market share rapidly, significantly impacting originator pricing and overall treatment access. 

Asia Pacific Vedolizumab Market

The Asia Pacific region presents substantial growth potential for Vedolizumab, particularly in China, India, and Japan, where IBD awareness and biologic adoption are increasing. In China, early biosimilar launches are expected due to local patent challenges and government support for domestic therapies, driving competition. India will see rapid biosimilar adoption driven by affordability, while Japan, despite high demand for advanced biologics, may experience slower biosimilar penetration due to stringent regulatory frameworks. Overall, Asia Pacific offers strong growth opportunities, but strategic navigation of regulatory timelines and local competition is essential. 

Latin America Vedolizumab Market

In Latin America, the rising prevalence of IBD is fueling demand for Vedolizumab, with Brazil, Mexico, and Argentina as key markets. Affordability is a primary concern, and the introduction of biosimilars post-patent expiration is expected to reduce costs and expand access to biologic therapies. Regulatory agencies in Brazil and Mexico are expected to facilitate faster approvals, accelerating biosimilar adoption. However, logistical challenges and healthcare infrastructure limitations in certain areas will require innovative pricing and distribution strategies to ensure broad market access. 

Middle East and Africa Vedolizumab Market

The Middle East and Africa (MEA) market is still emerging, with Saudi Arabia, UAE, and South Africa as key contributors, where awareness of IBD and access to biologic therapies are increasing. High treatment costs remain a significant barrier, making the introduction of biosimilars essential for expanding accessibility. Regulatory pathways vary across countries, with more efficient approvals in the UAE and Saudi Arabia, while other nations may face delays. As healthcare infrastructure improves and patient access expands, MEA is expected to witness long-term growth, with biosimilars playing a pivotal role in increasing access to Vedolizumab. 

Analyst Perspective

The Vedolizumab (Entyvio) market is approaching a pivotal juncture as key patents near expiration, with U.S. patents set to expire in 2028 and European patents by 2027. Dominated by Takeda Pharmaceuticals, the market is expected to face intensified competition from biosimilars and next-generation IBD biologics, which are likely to drive price reductions and market share shifts. Emerging competitors such as ustekinumab, infliximab biosimilars, adalimumab biosimilars, and novel integrin- or cytokine-targeted therapies, along with combination regimens, are expected to heighten competitive pressures, particularly in price-sensitive regions including Europe, Asia, and Latin America. 

Despite these challenges, demand for Vedolizumab remains robust, supported by its proven efficacy in treating moderate-to-severe ulcerative colitis (UC) and Crohn’s disease (CD), favorable safety profile, and growing clinical adoption across patient populations. The drug’s relevance is further reinforced by ongoing clinical trials exploring pediatric indications, subcutaneous formulations, and expanded treatment regimens, ensuring it remains central to IBD management guidelines. 

To sustain competitiveness, Takeda is focusing on lifecycle innovation, generating real-world evidence, and developing novel formulations to maintain a clinical edge. Patient-centric strategies, including access programs, flexible dosing options, and combination therapies, will be critical to retaining market leadership. Strategic initiatives such as regional expansion, biosimilar management, and collaborations with healthcare providers will help navigate the evolving post-patent landscape, ensuring Vedolizumab maintains its position as a leading gut-selective biologic in the global IBD treatment market. 

Case Study (Recent Engagement): Keytruda Patent-Cliff & Price- Erosion Impact Model

PROJECT OBJECTIVE 

To evaluate the potential revenue, price, and patient access implications of Keytruda’s 2028 patent cliff, incorporating biosimilar entry dynamics, country-specific adoption curves, and Merck’s lifecycle defense strategies (remarkably the subcutaneous formulation). The goal was to provide the client with a transparent, scenario-based model to anticipate outcomes and inform strategy 

GVR SOLUTION 

• Built a bottom-up commodity-flow and analogue-based model, anchored on Merck’s $29.5B Keytruda sales in 2024.

• Integrated jurisdictional LOE timelines (EU mid-2028, U.S. 2028-2029 pending litigation outcomes).

• Modeled biosimilar adoption S-curves calibrated to oncology antibody analogues (EU faster via tenders, U.S. slower via contracting).

• Applied price-erosion benchmarks (EU -15-30% Yr-1, deepening to -45-60% by Yr-3; U.S. -10-25% net decline over same horizon).

• Layered lifecycle defenses (SC uptake assumptions of 25-40% of innovator units, combo refresh, contracting) to quantify buffers.

• Delivered outputs as a dynamic Excel scenario tool and a management-ready PPT deck with revenue bridges, sensitivity tornadoes, and SC migration visuals. 

IMPACT FOR CLIENT

• Enabled the client to quantify downside vs. defense-optimized revenue trajectories:

  • Base case: 30-40% global revenue decline by Year-3 post-LOE.

  • Downside: 45-55% decline in tender-heavy markets.

  • Defense-optimized: Contained erosion to ~-20-25% with strong SC adoption.

• Gave the client a clear view of which markets drive early erosion (EU) and where strategic contracting or SC migration can preserve share (U.S.).

• Equipped decision-makers with a playbook of watch-points (tender concentration, litigation outcomes, SC IP coverage, combo pipeline) to guide commercial strategy.

• Provided a transparent methodology that could be presented to boards/investors with evidence-backed assumptions 

WHY THIS MATTERS

• Keytruda is the world’s best-selling cancer drug, representing nearly one-third of Merck’s revenue.

• Patent expiry will reshape both Merck’s earnings profile and global oncology access dynamics.

• Payers and governments stand to benefit from biosimilar entry through lower costs, but manufacturers need to manage cliff risk while capturing upside from lifecycle innovations.

• Understanding how quickly revenues erode and how patient access expands post-biosimilar is critical for:

  • Biopharma companies (strategic planning, pipeline prioritization).

  • Investors (valuing Merck’s cash flows beyond 2028).

  • Payers and policymakers (budgeting for oncology drug spend).

A robust patent cliff model helps clients navigate the dual challenge of price erosion and patient expansion, ensuring strategies are grounded in real-world benchmarks.