Obefazimod

With the introduction of a subcutaneous formulation, ENTYVIO has expanded patient convenience and global accessibility. Continued growth is supported by rising IBD prevalence and ongoing geographic expansion. LAS VEGAS, April 15, 2025 /PRNewswire/ -- DelveInsight's " ENTYVIO Market Size, Forecast, and Market Insight Report" highlights the details around ENTYVIO, a gut-selective biologic developed by Takeda Pharmaceutical. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of ENTYVIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Takeda Pharmaceutical's ENTYVIO (vedolizumab) Overview Vedolizumab is a biologic medication approved for both intravenous (IV) and subcutaneous (SC) use, with regulatory approvals varying by region. The SC formulation is authorized for use in the United States, European Union, and over 50 other countries, while the IV formulation has received approval in more than 70 countries, including the US and the EU. Collectively, vedolizumab IV and SC have accumulated over one million patient-years of global exposure. Vedolizumab is a humanized monoclonal antibody that selectively targets the alpha4beta7 integrin, blocking its interaction with mucosal addressin cell adhesion molecule 1 (MAdCAM-1) — a protein primarily found on blood vessels and lymph nodes in the gastrointestinal tract. This integrin is present on certain white blood cells involved in the inflammatory processes of ulcerative colitis and Crohn's disease. By disrupting the binding between alpha4beta7 integrin and MAdCAM-1, vedolizumab may reduce the migration of these immune cells into the gut, thereby decreasing inflammation. ENTYVIO Dosage For adults with ulcerative colitis, the advised dosage of ENTYVIO is 300 mg given through intravenous infusion at weeks 0, 2, and 6, followed by maintenance infusions every 8 weeks. Treatment should be discontinued if no clinical improvement is observed by week 14. Learn more about ENTYVIO projected market size for Crohn's disease and ulcerative colitis @ ENTYVIO Market Potential Crohn's disease is a progressive type of inflammatory bowel disease (IBD) that results in chronic inflammation throughout the gastrointestinal tract, most commonly affecting the terminal ileum and colon. This inflammation can lead to complications such as strictures, fistulas, and ulcers. In 2024, there were 1.1 million diagnosed prevalent cases of Crohn's disease in the United States. Current treatment approaches primarily include biologics such as adalimumab (HUMIRA and its biosimilars), ustekinumab (STELARA), infliximab (REMICADE and biosimilars), along with systemic corticosteroids, immunosuppressants, 5-aminosalicylic acid (5-ASA), and other therapies. Among these, adalimumab held the largest market share in the 7MM in 2024, generating around USD 4 billion in revenue for Crohn's disease treatment. In 2024, the market size of Crohn's disease was highest in the US among the 7MM, accounting for approximately USD 8 billion, which is further expected to increase at a CAGR of 4.5%. The Crohn's disease market is projected to expand due to the introduction of novel therapies with improved efficacy and more convenient routes of administration, broader use of biologics in pediatric populations, growing commercial opportunities in biologic-treated patients, advancements in biomarker development for early diagnosis, and the overall rising prevalence of the disease. Discover more about the Crohn's disease market in detail @ Crohn's Disease Market Report Ulcerative colitis is one of the primary types of chronic inflammatory bowel disease (IBD) affecting the gastrointestinal tract. It is an idiopathic and long-standing inflammation of the colonic mucosa, typically presenting with symptoms like diarrhea, abdominal discomfort, and rectal bleeding. In 2023, there were an estimated 3.1 million diagnosed prevalent cases of ulcerative colitis across the 7MM, with numbers expected to rise over the forecast period. According to current US treatment guidelines, mild-to-moderate cases are initially managed with aminosalicylates or by using corticosteroids for induction followed by maintenance therapy with aminosalicylates. For patients with moderate-to-severe disease, maintenance treatment may involve immunosuppressants like azathioprine or 6-mercaptopurine after corticosteroid induction. Alternatively, biologics—particularly anti-TNF agents such as infliximab or adalimumab—can be used alone or alongside immunosuppressants to achieve and sustain remission and mucosal healing. The treatment landscape across the 7MM is categorized into commonly used drug classes, including conventional therapies, anti-TNF agents, anti-adhesion molecule therapies, JAK inhibitors, and others, reflecting some variations in prescribing practices. Looking ahead, the anticipated introduction of novel therapies, increased focus on early detection, enhanced use in secondary care, improved implementation strategies, and growing disease awareness are likely to contribute to more effective management of ulcerative colitis. As a result, the ulcerative colitis market will grow from USD 8.4 billion in 2023 at a significant CAGR by 2034. However, the high costs of new treatments and the financial burden of disease complications may pose challenges to widespread adoption. For a comprehensive view of the ulcerative colitis market, check out the Ulcerative Colitis Market Assessment 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. Landos Biopharma's Omilancor (BT-11) is in Phase II 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 Therapeutic, an α4β7 integrin inhibitor. Together, these developments illustrate a robust and diversified IBD pipeline. To know more about the number of competing drugs in development, visit @ ENTYVIO Market Positioning Compared to Other Drugs Key Milestones of ENTYVIO In April 2024, Takeda announced that the FDA has approved the subcutaneous (SC) formulation of ENTYVIO (vedolizumab) for maintenance treatment in adults with moderately to severely active Crohn's disease who have previously received induction therapy with the intravenous (IV) form of ENTYVIO. In September 2023, Takeda announced that the FDA has approved the SC formulation of ENTYVIO to be used as maintenance therapy in adults with moderately to severely active ulcerative colitis following induction treatment with the IV version of ENTYVIO. In September 2023, Takeda announced that the FDA has accepted for review its Biologics License Application (BLA) for the investigational subcutaneous formulation of ENTYVIO as a maintenance treatment for adults with moderately to severely active Crohn's disease, following induction therapy with the intravenous version of ENTYVIO. In April 2023, Takeda announced that the FDA has accepted for review its resubmitted Biologics License Application (BLA) for the investigational subcutaneous formulation of ENTYVIO as a maintenance treatment for adults with moderately to severely active ulcerative colitis following induction therapy with the intravenous version of ENTYVIO. In March 2023, Takeda announced that Japan's Ministry of Health, Labour, and Welfare has approved ENTYVIO Pens and prefilled syringes (108 mg for subcutaneous injection) for use as maintenance therapy in patients with moderate to severe ulcerative colitis. In May 2020, Takeda announced that the European Commission has approved the subcutaneous formulation of ENTYVIO, a gut-targeted biologic, for maintenance treatment in adults with moderately to severely active ulcerative colitis or Crohn's disease. In May 2019, Takeda announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved for an expanded indication of ENTYVIO, allowing its use in treating adult patients with moderately to severely active Crohn's disease. In May 2019, Takeda announced that the FDA has accepted for review the BLA for a SC formulation of vedolizumab, intended for maintenance treatment in adults with moderately to severely active ulcerative colitis. In November 2018, Takeda announced the launch of ENTYVIO in Japan for the treatment of patients with moderately to severely active ulcerative colitis. In June 2014, Takeda announced that ENTYVIO is now commercially available in the United States for treating adults with moderately to severely active ulcerative colitis or Crohn's disease. In May 2014, Takeda announced that the European Commission (EC) has granted Marketing authorization for ENTYVIO. It is the first and only biologic approved at the same time for treating adults with moderately to severely active ulcerative colitis and Crohn's disease who have not responded adequately to, lost response to, or were intolerant of conventional therapies or TNF-alpha inhibitors. In May 2014, Takeda announced that the FDA had granted simultaneous approval of ENTYVIO for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease. Discover how ENTYVIO is shaping the Crohn's disease and ulcerative colitis treatment landscape @ ENTYVIO Infusion ENTYVIO Market Dynamics ENTYVIO has established itself as a leading biologic therapy in the treatment of moderate to severe ulcerative colitis and Crohn's disease. As a gut-selective integrin antagonist, ENTYVIO offers a differentiated mechanism of action compared to anti-TNF therapies, which contributes to its positioning as a safer long-term option, particularly for patients at risk of systemic immunosuppression. Its favorable safety profile and efficacy in inducing and maintaining remission have led to its widespread adoption, particularly among patients who have failed previous therapies. The biologics market for inflammatory bowel disease is highly competitive, with key players including HUMIRA, REMICADE, STELARA, and newer entrants like SKYRIZI and RINVOQ. ENTYVIO has managed to capture significant market share by appealing to both gastroenterologists and patients seeking gut-targeted treatment. Its intravenous formulation, though initially a barrier, has been partially offset by the 2019 launch of the subcutaneous version in global markets, enhancing patient convenience and adherence. However, uptake in the US for the SC version has been slower due to regulatory timelines and physician inertia. Biosimilar competition is also a factor shaping ENTYVIO's future market dynamics. While biosimilars of anti-TNFs are gaining traction, ENTYVIO currently remains insulated due to patent protections, with biosimilar entry expected post-2026. This provides Takeda a limited window to maximize revenue, expand its patient base, and reinforce brand loyalty. Strategic moves such as expanding indications, enhancing real-world evidence, and increasing global access will be crucial to maintaining its competitive edge. Moreover, the shift in payer dynamics and healthcare cost containment efforts are increasingly influencing biologic prescribing behavior. Takeda must continue to demonstrate value through outcome-based contracts and cost-effectiveness data. As newer agents with novel mechanisms enter the market, maintaining differentiation and proving long-term value will be central to ENTYVIO's sustained success. Dive deeper to get more insight into ENTYVIO's strengths & weaknesses relative to competitors @ ENTYVIO Market Drug Report Table of Contents Related Reports Crohn's Disease Market Crohn's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Crohn's disease companies including Novo Nordisk, Eli Lilly and Company, MedImmune, Boehringer Ingelheim, Raziel Therapeutics, Altimmune, Saniona, YSOPIA Bioscience, Innovent Biologics, Glaceum, Shionogi, Aardvark Therapeutics, NuSirt Biopharma, Novartis, CSPC Baike (Shandong) Biopharmaceutical, Jiangsu HengRui Medicine, Carmot Therapeutics, Pfizer, Sciwind Biosciences, Empros Pharma, among others. Crohn's Disease Pipeline Crohn's Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Crohn's disease companies, including Janssen, RedHill Biopharma, Amgen, Pfizer, Prometheus Biosciences, AgomAb Therapeutics, Hoffmann-La Roche, Gilead Sciences, Eli Lilly and Company, Celgene, AstraZeneca, Mesoblast, Alfasigma, Tiziana Life Sciences, Abivax, Arena Pharmaceuticals, Cytocom, HAV Vaccines Ltd, Enzo Biochem Inc., Stero Biotechs, Reistone Biopharma Company Limited, Qu Biologics, Pfizer, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals, Soligenix, Immunic, Pfizer, Atlantic Healthcare, 4D Pharma, Landos Biopharma, Janssen, Roche, Eisai, Bristol-Myers Squibb, Iltoo Pharma, Suzhou Connect Biopharmaceuticals, Theravance Biopharma, TaiwanJ Pharmaceuticals, Celularity, Cerecor, GlaxoSmithKline, KangStem Biotech, Immunic, Alpha Cancer Technologies, Koutif Therapeutics, Tract Therapeutics, Trio medicines, ChemoCentryx, Algernon Pharmaceuticals, Neuclone, JHL Biotech, Innovative Pharmacological Research (IPHAR) Co Ltd, Innovation Pharmaceuticals, Exeliom Biosciences SAS, AbbVie, Finch Therapeutics, Akeso Biopharma, Draconis Pharma, MakScientific, Engitix, Origo Biopharma, Navidea Biopharmaceuticals, Orchard Therapeutics, Xbrane, Thetis Pharmaceuticals, Temisis Therapeutics, Synedgen, Synlogic, Morphic Therapeutic, Metacrine, Curacle, Commence Bio Inc, Cloud Pharmaceuticals, Chong Kun Dang Pharmaceutical Corp, Avobis Bio LLC, Avexegen Therapeutics, Assembly Biosciences, Aibios Co Ltd, Aclaris Therapeutics, Athos Therapeutics, Denali Therapeutics, Educell doo, among others. Ulcerative Colitis Market Ulcerative Colitis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key Ulcerative Colitis companies, including Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, Celgene, among others. Ulcerative Colitis Pipeline Ulcerative Colitis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Ulcerative Colitis companies, including Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, Celgene, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . 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iStock, z_wei Biopharma doubles down on immunology and inflammation as companies target new pathways and seek to improve on current options in inflammatory bowel disease, atopic dermatitis, myasthenia gravis and more. One of biopharma’s hottest therapeutic areas, immunology and inflammation has seen an uptick in M&A activity in recent years, with big names like Sanofi and Gilead dropping billions of dollars to expand their I&I pipelines. At the same time, the space is seeing an influx of new companies, including Bambusa Therapeutics , which launched Friday with $90 million in series A funds. Momentum in this space was sparked at the turn of the century by the arrival of therapeutic antibodies. After winning FDA approval in 2002, Abbvie’s Humira—the first tumor necrosis factor (TNF) inhibitor—became one of the best-selling drugs of all time, generating over $200 billion in lifetime sales to patients with rheumatoid arthritis, psoriasis, ulcerative colitis, Crohn’s disease and more. Over 20 years later, with Humira and other key medicines having lost their exclusivity and research providing a better understanding of the biology underlying the field, it’s time for the next wave of I&I. Indeed, novel targets and modalities are attracting an influx of investment into the I&I space, said Thomas Smith, a senior research analyst covering immunology at Leerink Partners. “We’re seeing antibodies that are going after targets that have not been targeted before, small molecules that were previously thought to be undruggable,” he told BioSpace . “We’re seeing the emergence of cell therapies.” And there’s room for them all. The second largest therapeutic area by value in 2023, the immunology market is projected to be worth more than $257 billion by 2032. “[I&I] has large end markets of highly prevalent diseases that, despite having multiple treatment options, still have persistent, high medical need,” Smith said. M&A Expected to Continue in 2025 The I&I space has made headlines recently for a spate of high-pro In April 2024, Vertex struck the biggest deal in biopharma last year with its $ 4.9 billion buy of Alpine Immune Sciences. Then in June, Eli Lilly dropped $3.2 billion to acquire Morphic Holding. These deals followed Merck’s eyepopping $10.8 billion pick-up of Prometheus Biosciences a year earlier. While many big pharma companies already have their own immunology platforms, “innovation does not happen in isolation,” Shaju Backer, global head of immunology at Sanofi, told BioSpace in an email. This is why his company also complements its in-house R&D with a myriad of strategic partnerships and acquisitions. In 2021, Sanofi acquired Kymab for $1.4 billion to add an anti-OX40 ligand to its pipeline, hoping to address the underlying disease pathologies of inflammatory diseases like atopic dermatitis without depleting T cells. More recently, Gilead struck a deal last month with LEO Pharma worth up to $1.7 billion for its preclinical STAT6 program. Smith expects more of the same in the near future. “We have a lot of reason for thinking this is going to continue to be the case in 2025,” he said. Pursuit of Novel Targets TNF blockers like Humira cast a wide net, pulling in some ten indications. Yet patients and practitioners have seen the effects of Humira and other anti-TNF therapies wear off relatively quickly because ancillary pathways take over, according to Backer, making it necessary to target other pathways for disease management and, hopefully, remission. One of these, the TL1A pathway, plays a key role in driving inflammation and fibrosis in various autoimmune diseases, making its inhibition a promising strategy for multiple indications, including inflammatory bowel disease (IBD). Merck’s Prometheus buy brought in a potentially best-in-class TL1A inhibitor in late-stage studies for ulcerative colitis and Crohn’s disease. And Sanofi is co-developing a TL1A-targeting antibody, duvakitug, with Teva Pharmaceuticals. Another target generating a lot of interest is the signal transducer and activator of transcription 6 (STAT6) transcription factor, which is a key regulator of Th2-driven immune response. Indication potential is wide-ranging for STAT6-targeted oral drugs, which could offer an alternative to existing injectable biologics. Gilead’s recent deal with LEO Pharma is one example. While the specific indication has not yet been announced, Flavius Martin, executive vice president of research at Gilead, told BioSpace in an email that the program is “advancing rapidly” toward clinical testing. Elsewhere, Sanofi extended its collaboration with Nurix Therapeutics last year to include a targeted protein degrader of STAT6. These are but a few of the many targets now being explored in the I&I space. Others run the gamut from Sanofi’s T cell receptor–targeting amlitelimab for atopic dermatitis, with a 52-week data readout expected in March, to the microRNA-targeting obefazimod from Paris-based biotech Abivax, which is awaiting a Q3 2025 Phase III readout in ulcerative colitis. Finally, the “unbridled success” of cell therapies in hematological malignancies is now driving efforts to bring cell therapy to the I&I space, particularly for autoimmune disease , Smith said. Companies like Kyverna are developing CAR T cell therapies to deliver complete B cell depletion that could help reset a patient’s immune system to eliminate the need for chronic treatment. Kyverna is targeting a 2026 filing for its lead therapy KYV-101 in stiff person syndrome, with myasthenia gravis and lupus nephritis to follow. Meanwhile, Arcellx is taking its cell therapy pipeline from multiple myeloma into autoimmune disease. Last fall, the FDA cleared the company’s Investigational New Drug (IND) application to begin a Phase I trial of its CAR T anito-cell in generalized myasthenia gravis. If successful, Smith said the biggest challenges to cell therapies for autoimmune indications would be logistics, scalability, reimbursement and identifying the right patients for treatment. The beauty of the I&I space is that one molecule can have many different applications, Jorge Santos da Silva, CEO of Moonlake Therapeutics, which is developing treatments for inflammatory indications including hidradenitis suppurativa, told BioSpace . “In I&I, you can have these molecules that just walk across a whole lot of therapeutic areas,” a feature he said makes it ripe for investment by biopharma. Smith agreed. “The end markets for I&I relative to targeted oncology are much broader,” he told BioSpace . “There’s a lot of white space.” 5 I&I Diseases Poised for Disruption in 2025 Thomas Smith, a senior research analyst covering immunology at Leerink Partners, highlighted five indications within the I&I space that he believes could see substantive movement this year. Editor’s note: Lists of approved products and products in development are not comprehensive. Metabolic Dysfunction-Associated Steatohepatitis (MASH) The most severe form of nonalcoholic fatty liver disease, MASH affects 5% to 7% of the global population. Approved Products : Madrigal’s Rezdiffra In Development : Akero Therapeutics’ efruxifermin (Phase III) Boehringer Ingelheim’s survodutide (Phase III) Novo Nordisk’s semaglutide (Phase III) Eli Lilly’s tirzepatide (Phase II) Inflammatory Bowel Disease Inflammatory bowel disease (IBD)—including ulcerative colitis (UC) and Crohn’s disease (CD)—affects between 2.4 and 3.1 million people in the U.S. Approved Products : Eli Lilly’s Omvoh Johnson & Johnson’s Remicade AbbVie’s Humira In Development : Abivax’s obefazimod for UC (Phase III) Sanofi and Teva’s duvakitug for UC (Phase II) Equillium and Biocon’s Itolizumab for UC (Phase II) Myasthenia Gravis A chronic autoimmune disorder causing weakness in the voluntary muscles, myasthenia gravis afflicts up to 60,000 people in the U.S. Approved Products : Argenx’s Vyvgart AstraZeneca’s Ultomiris UCB’s Rystiggo In Development : Johnson & Johnson’s nipocalimab (under review) Cabaletta Bio and Kyverna Therapeutics’ CABA-201 (Phase I/II) COUR Pharmaceuticals’ CNP-106 (Phase II) Atopic Dermatitis Atopic dermatitis—a chronic skin condition that causes the skin to become red, itchy and inflamed—affects more than 7% of people in the U.S. Approved Products: Sanofi and Regeneron’s Dupixent Eli Lilly’s Ebglyss Galderma’s Nemluvio In Development : Sanofi’s amlitelimab (Phase III) Kymera Therapeutics and Sanofi’s IRAK4 (Phase II) Apogee Therapeutics’ APG777 (Phase II) Hidradenitis Suppurativa Another chronic, inflammatory skin condition, hidradenitis suppurativa afflicts 1% to 4% of the global population. Approved Products : AbbVie’s Humira Novartis’ Cosentyx UCB’s Bimzelx In Development : Moonlake Therapeutics’ sonelokimab (Phase III) Incyte’s povorcitinib (Phase III)