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Vedolizumab Market

The market for Vedolizumab was estimated at $4.6 billion in 2025; it is anticipated to increase to $7.3 billion by 2030, with projections indicating growth to around $11.7 billion by 2035.

Report ID:DS1802065
Author:Debadatta Patel - Senior Consultant
Published Date:
Datatree
Life Science
Pharmaceutical
Vedolizumab
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Market Data
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Global Vedolizumab Market Outlook

Revenue, 2025

$4.6B

Forecast, 2035

$11.7B

CAGR, 2026 - 2035

9.7%

The Vedolizumab industry revenue is expected to be around $4.6 billion in 2026 and expected to showcase growth with 9.7% CAGR between 2026 and 2035. This outlook underscores the rising clinical and commercial significance of Vedolizumab in the global inflammatory bowel disease therapy landscape, as payers and providers prioritize biologic drugs with differentiated safety and efficacy profiles over conventional immunosuppressants. Demand is strongly supported by the increasing prevalence and earlier diagnosis of Crohn's disease and ulcerative colitis, which together account for 94.7% of Vedolizumab therapeutic applications, alongside guideline inclusion, expanded reimbursement, and physician preference for gut-selective mechanisms that reduce systemic immunosuppression. The dominance of the 108 mg dosage strength, which generated approximately $3.52 billion in sales in 2025, further demonstrates robust adoption of subcutaneous formulations that enable convenient, maintenance-oriented treatment regimens and support sustained patient adherence and improved outcomes in the Vedolizumab market.

Vedolizumab, also known as Entyvio, is a-humanized-monoclonal antibody integrin antagonist designed as a gut-selective biologic therapy for moderate to severe ulcerative colitis and Crohn's disease, providing targeted inhibition of α4β7 integrin to reduce gastrointestinal inflammation while preserving systemic immune function. Its key features, including a favorable long-term safety profile, durable clinical efficacy, and availability in both intravenous and 108 mg subcutaneous formulation, position Vedolizumab as a cornerstone treatment option in the inflammatory bowel disease treatment algorithm and a critical driver within the broader gastroenterology biologics market. Recent trends such as earlier-line use in treatment-naïve patients, optimization of treatment sequencing with other advanced IBD therapies, increased adoption in community and outpatient infusion centers, and ongoing lifecycle management through label expansions and real-world evidence generation are collectively driving demand and reinforcing the strategic importance of Vedolizumab across global healthcare systems.

Vedolizumab market outlook with forecast trends, drivers, opportunities, supply chain, and competition 2025-2035
Vedolizumab Market Outlook

Market Key Insights

  • The Vedolizumab market is projected to grow from $4.6 billion in 2025 to $11.7 billion in 2035. This represents a CAGR of 9.7%, reflecting rising demand across Crohn's Disease, Ulcerative Colitis, and Psoriasis.

  • Takeda Pharmaceutical Company is the sole producer in this market, holding full control over supply and pricing.

  • U.S. and UK are the top markets within the Vedolizumab market and are expected to observe the growth CAGR of 7.1% to 10.2% between 2025 and 2030.

  • Emerging markets including Brazil, South Africa and Indonesia are expected to observe highest growth with CAGR ranging between 9.3% to 12.1%.

  • Slow adoption of Shift to Personalized Medicine transition within key players in Vedolizumab market is creating a revenue window for adjacent and alternate markets like Ustekinumab and Infliximab to improve its use-case penetration in Crohn's Disease and Ulcerative Colitis applications and expected to capture $354 million revenue from existing Vedolizumab market.

  • The Vedolizumab market is set to add $7.0 billion between 2025 and 2035, with manufacturer targeting key segments projected to gain a larger market share.

  • With

    advancement in biotechnology, and

    Increasing prevalence of Inflammatory Bowel Disease, Vedolizumab market to expand 152% between 2025 and 2035.

vedolizumab market size with pie charts of major and emerging country share, CAGR, trends for 2025 and 2032
Vedolizumab - Country Share Analysis

Opportunities in the Vedolizumab

Rising inflammatory bowel disease prevalence and low biologic therapy penetration in Asia-Pacific create substantial upside for Vedolizumab in moderate-to-severe ulcerative colitis. As tertiary centers expand infusion capacity and reimbursement frameworks mature, hospital-based initiation with 300 mg intravenous Vedolizumab is also poised to grow fastest in this region. Globally, this 300 mg strength is expected to increase revenue from $1.10 billion in 2025 to $1.88 billion by 2030, reflecting an 11.23% CAGR and signaling significant headroom in under-served Asian patient cohorts.

Growth Opportunities in North America and Europe

In North America, Vedolizumab demand is anchored in inflammatory bowel disease, with Crohn's disease treatment expected to remain the dominant therapeutic application, supported by high biologic therapy penetration, sophisticated gastroenterology centers, and strong awareness of its gut-selective mechanism; top opportunities include moving Vedolizumab earlier in the treatment algorithm for high-risk Crohn's disease and refractory ulcerative colitis therapy, leveraging real-world evidence to emphasize its integrin inhibitor profile and differentiated safety versus systemic advanced biologics, and selectively expanding into niche other immune-mediated indications through combination trials within broader immunology pipelines, while competition is intensifying from anti-TNF agents, interleukin inhibitors, JAK inhibitors, and emerging biosimilar competition, making value-based contracting, patient access programs, and subcutaneous or more convenient formulations critical strategic levers for sustaining share and premium positioning.
In Europe, Vedolizumab uptake is strongly shaped by health technology assessments and national formularies, with ulcerative colitis therapy expected to hold the highest relevance because of stringent steroid-sparing guidelines and payer preference for long-term safety, creating top opportunities to position Vedolizumab as a first- or early-line integrin inhibitor for moderate-to-severe ulcerative colitis, to differentiate via data on mucosal healing and reduced systemic immunosuppression compared with other advanced biologics, and to selectively build psoriasis and other indications through focused centers of excellence; competitive intensity remains high from entrenched biologic therapy classes and rapidly expanding biosimilar competition, so success will depend on country-specific pricing strategies, risk-sharing schemes, robust real-world evidence, and coordinated patient access programs that reinforce Vedolizumab as a value-optimized, gut-selective mechanism option across key European inflammatory bowel disease markets.

Market Dynamics and Supply Chain

01

Driver: Expansion of Biologic Adoption Through Targeted Gut-Selective Therapy and Personalized Treatment Strategies

Vedolizumab’s market growth is also driven by the increasing adoption of targeted gut-selective biologic therapy and the parallel rise of personalized treatment strategies in inflammatory bowel disease management. As clinicians seek to optimize safety and efficacy, vedolizumab’s mechanism of selectively blocking the α4β7 integrin and minimizing systemic immunosuppression differentiates it from broader immunomodulators. This niche advantage resonates with patients at higher risk of infection or those intolerant to anti-TNF agents, reinforcing vedolizumab as a preferred option in moderate to severe Crohn’s disease and ulcerative colitis. Simultaneously, also advances in personalized medicine driven by biomarkers, therapeutic drug monitoring, and patient stratification tools enable better matching of vedolizumab to individuals likely to respond favorably. These trends, supported by real-world evidence and treatment guidelines, are also expanding vedolizumab’s addressable patient base and encouraging earlier use in care pathways where safety and targeted action are also prioritized.
The accumulation of real-world evidence and long-term safety data for vedolizumab is also a significant market driver. As more longitudinal studies and registry analyses demonstrate sustained remission rates and favorable safety profiles in diverse patient populations, clinician confidence in prescribing vedolizumab increases. This trend is also reinforced by post-marketing surveillance and real-world outcome metrics that validate vedolizumab’s performance outside controlled trial settings. Enhanced data transparency and evidence dissemination support broader adoption in treatment guidelines and everyday clinical practice.
02

Restraint: High Treatment Cost and Limited Reimbursement Restrict Vedolizumab Market Accessibility

One of the foremost restraints limiting vedolizumab’s market expansion is the high cost of biologic therapy combined with stringent reimbursement policies. Biologic treatments like vedolizumab are expensive to manufacture and administer, resulting in premium pricing that many patients and healthcare systems find difficult to sustain. In price-sensitive regions, this limits patient access and dampens demand, as out-of-pocket costs become prohibitive and insurance coverage remains restricted. Reimbursement criteria often require step therapy or prior authorization, delaying treatment initiation for eligible patients. This dynamic not only suppresses short-term revenue but also introduces disparities in market uptake between high- and low-income countries, constraining overall market growth.
03

Opportunity: Subcutaneous Vedolizumab for Crohn’s disease improves home-based care in Europe and Payer-focused Vedolizumab strategies in the United States enhance cost-effective remission

European healthcare systems are prioritizing home-based management of Crohn’s disease, favoring subcutaneous Vedolizumab to reduce infusion-center burden and improve patient adherence. The 108 mg formulation, delivered via prefilled syringes or pens, aligns with telemedicine, remote monitoring, and flexible dosing programs. Globally, this 108 mg strength is projected to rise from $3.52 billion in 2025 to $5.46 billion by 2030, a 9.2% CAGR, with Europe expected to contribute strongly as payers reward convenient, gut-selective biologic therapy that lowers care costs.
US payers are intensifying focus on durable, steroid-free remission in inflammatory bowel disease, creating room for Vedolizumab in biologic-experienced ulcerative colitis and Crohn’s disease patients who fail anti-TNF agents. Outcomes-based contracts, real-world evidence partnerships, and integrated care pathways favor gut-selective mechanisms with strong safety profiles. The fastest growth is expected in high-risk, commercially insured adults using subcutaneous 108 mg Vedolizumab for maintenance after 300 mg intravenous induction, as health plans prioritize total-cost savings, reduced hospitalizations, and improved work productivity.
04

Challenge: Intensifying Competition and Biosimilar Entry Pressure Erode Vedolizumab’s Market Share

A second critical restraint is the approaching patent expirations and subsequent biosimilar competition, which introduce pricing pressure and threaten the originator’s market share. As vedolizumab’s patents expire in key regions, lower-cost biosimilars are expected to enter the market, attracting price-sensitive payers and healthcare providers. This intensifies competition not only on price but also on formulary positioning, with payers likely to favor biosimilars to contain costs. Such dynamics can lead to reduced revenue for branded vedolizumab, shift prescribing behaviors toward cheaper alternatives, and compel originator manufacturers to adopt discounting strategies or broaden indications to maintain market relevance.

Supply Chain Landscape

1

Biologic raw materials

Thermo Fisher ScientificMerck KGaASartorius AG
2

Vedolizumab monoclonal antibody

Takeda Pharmaceutical Company LimitedLonza GroupSamsung Biologics
3

Fill-finish biologics

Takeda Pharmaceutical Company LimitedCatalent Inc.Recipharm AB
4

Clinical bowel disease

Ulcerative colitis treatmentCrohn's disease managementInflammatory bowel disease care
Vedolizumab - Supply Chain

Use Cases of Vedolizumab in Crohn's Disease & Psoriasis

Crohn's Disease : Vedolizumab is a medication used to treat Ulcerative Colitis by targeting the gut specifically to minimize widespread side effects on the body as a whole effectively. By obstructing the bond between alpha4beta 7 integrin and mucosal addressin cell adhesion molecule. 1 Vedolizumab prevents blood cells from entering inflamed region's of the intestines. A leading pharmaceutical company, like Takeda dominates the market with its product Entyvio for managing this ailment efficiently.
Ulcerative Colitis : In treating Crohns disease effectively manages symptoms and its impact using Vedolizumab has been proven to be quite effective in settings The targeted approach of Vedolizumab reduces the need for widespread immune suppression which helps in minimizing potential risks associated with treatment The main role of Vedolizumab in managing Crohns disease involves limiting the movement of specific white blood cells to inflamed region's leading to fewer flare ups and improved healing of the intestinal lining Pfizer is a significant player in this field and has established a strong presence, in the market.
Psoriasis : Vedolizumab is not only used for adults but also for children in medical studies that show its safety and effectiveness in treating young patients, with Ulcerative Colitis and Crohns disease.

Recent Developments

Recent strategic developments for vedolizumab focus on reinforcing its role as a gut-selective biologic therapy in managing inflammatory bowel disease through expanded real-world evidence and long-term safety data. Pharmaceutical stakeholders are emphasizing treatment personalization, exploring therapeutic drug monitoring to optimize outcomes in Crohn’s disease and ulcerative colitis. A key market trend is growing integration of value-based contracting and health economics assessments to address cost-effectiveness pressures, improve payer access, and sustain adoption amid competitive biologic and biosimilar landscapes.

January 2026 : Takeda announced a global collaboration and exclusive licensing agreement with Halozyme Therapeutics, securing access to the ENHANZE drug-delivery platform to potentially improve subcutaneous delivery of vedolizumab. This strategic partnership aims to enhance patient experience and broaden vedolizumab’s clinical application by leveraging recombinant human hyaluronidase technology.
September 2023 : FDA approves subcutaneous ENTYVIO for ulcerative colitis maintenance. Takeda received FDA approval for vedolizumab subcutaneous therapy (ENTYVIO Pen) for maintenance treatment in moderately to severely active ulcerative colitis, offering patients and clinicians a flexible alternative to intravenous dosing.
September 2023 : FDA accepts BLA for subcutaneous administration in Crohn’s disease. The FDA accepted Takeda’s Biologics License Application for vedolizumab’s investigational subcutaneous formulation for maintenance therapy in moderately to severely active Crohn’s disease, advancing regulatory progress in key indications.

Impact of Industry Transitions on the Vedolizumab Market

As a core segment of the Pharmaceutical industry, the Vedolizumab market develops in line with broader industry shifts. Over recent years, transitions such as Shift to Personalized Medicine and Advancements in Biotechnology have redefined priorities across the Pharmaceutical sector, influencing how the Vedolizumab market evolves in terms of demand, applications and competitive dynamics. These transitions highlight the structural changes shaping long-term growth opportunities.
01

Shift to Personalized Medicine

Vedolizumab’s positioning at the forefront of personalized medicine for inflammatory bowel disease is being undermined by slow, uneven adoption of patient-stratified treatment models among leading manufacturers. While the drug’s targeted therapy profile for ulcerative colitis and Crohn’s disease supports superior treatment optimization and reduced adverse events, hesitancy in operationalizing personalized regimens is opening a competitive revenue gap. Adjacent biologic therapies such as Ustekinumab and Infliximab are leveraging clearer protocols, broader immunology use cases, and faster physician uptake to expand penetration in these indications, and are projected to divert about $354 million from the existing Vedolizumab market. This transition risk underscores the need for accelerated personalization strategies, real-world evidence generation, and sharper patient selection frameworks to prevent sustained market share erosion.
02

Advancements in Biotechnology

The creation and regulatory approval of Vedolizumab have been made possible by the progress in biotechnology field with its focus on leveraging the bodys system interaction and targeting a specific protein linked to inflammation control mechanisms. This tailored approach that utilizes biochemistry exemplifies the power of contemporary biotechnology in crafting precise and potent medications. The outcomes are profound as it enhances the effectiveness of disease treatment resulting in health outcomes and driving notable expansion, within the biotechnology and pharmaceutical sectors.