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-01-引言：靶向治疗的黄金时代自身免疫性疾病（如银屑病、类风湿关节炎、系统性红斑狼疮等）以免疫系统失调为特征，全球患者群体庞大且治疗需求迫切。在过去的25年里，通过调节细胞因子信号来靶向免疫系统一直是自身免疫性疾病治疗创新的基石，例如英夫利昔单抗和阿达木单抗等肿瘤坏死因子（TNF）抑制剂的成功，它们已成为多种适应症的标准治疗方法。随着白细胞介素（IL）抑制剂以及参与细胞因子受体下游信号传导的激酶抑制剂（如Janus酪氨酸激酶）的成功，人们对细胞因子调节的兴趣进一步扩大。近年来IL-13、IL-31、IL-36和TYK2等新靶点的崛起，标志着行业进入精准化与多样化的新阶段。2022年全球TOP100畅销药合计实现了4868亿美元的销售收入，自免疾病领域已经是仅次于肿瘤的第二大药物市场。跻身TOP100榜单的自免产品共18款，总金额达861.7亿美元。如今，自免领域已成为重磅炸弹的密集诞生地，也成为各大制药巨头业绩贡献的主要来源。-02-一、靶点全景扫描：2024年Top 15靶点与竞争格局 根据2024年最新数据，自身免疫疾病领域进入II/III期或已上市的药物靶点中，TNF超家族成员、IL家族及下游激酶（JAK/TYK2）仍是核心方向，但新兴靶点的崛起正在重塑行业版图。自2020年以来，已经推出了四种治疗自身免疫性疾病的first-in-class药物，其中三种针对皮肤病适应症中的上皮屏障功能障碍和炎症（IL-13、IL-31和IL-36抑制剂）。第四种也是在皮肤病学中，是酪氨酸激酶2（TYK2）抑制剂，它调节细胞因子如IL-12和IL-23下游的信号传导。在分析的92个治疗靶点中，正在研究的自身免疫性疾病药物数量从2020年的131种增加到2024年的193种。最显著的进展发生在靶向TNF超家族成员而非TNFα的药物上：虽然CD40/CD40配体轴是2020年III期的唯一靶点，但靶点包括OX40、TNF样配体1A（TL1A）、核因子κβ受体激活剂（RANK）、B淋巴细胞刺激剂（BLyS）和B细胞活化因子（BAFF）的药物在2024年均进入III期试验。白细胞介素靶向药物的创新包括药理学的选择性增强（如IL-17A/F抑制剂）、活性延长（如GSK的长效IL-5抑制剂depemokimab）和创新技术（如礼来的口服小分子靶向IL-17）。First-in-class的药物包括靶向IL-4、IL-33和IL-18。靶向IL-1受体相关激酶4（IRAK4）引起了人们广泛的兴趣，因为它有可能用单一药物抑制整个IL-1家族（IL-1、IL-18、IL-33和IL-36；涉及银屑病和哮喘）和toll样受体。靶向胸腺基质淋巴细胞生成素（TSLP）也引起了人们的关注，因为它解决了2型炎症的上游驱动因素（IL-5、IL-4和IL-13）。在免疫级联的下游，参与银屑病和克罗恩病的IL-12和IL-23途径的TYK2抑制剂正在积极推进，因为与JAK抑制剂相比，它们避免了对造血系统的影响。联合策略，如共同靶向IL-17和TNF或双激酶抑制剂（JAK1、2或3与TYK2、SYK或TEC），正在进一步扩大治疗选择。-03-二、跨疾病影响：从皮肤病到系统性疾病的全线突破自2020年以来，皮肤病学取得了最大的进步，推出了几种新型药物。其中包括两种IL-13抑制剂tralokinumab（Adtralza；LEO Pharma）和lebrikizumab（Ebglyss；Lilly）用于治疗中度至重度特应性皮炎；IL-17A/F选择性抑制剂bimekizumab（Bimzelx；UCB）用于治疗斑块状银屑病，IL-31抑制剂nemolizumab（Nemluvio；Galderma）用于治疗结节性痒疹，IL-36抑制剂spesolimab（Spevigo；Boehringer Ingelheim）用于治疗泛发性脓疱性银屑病。还推出了用于银屑病的选择性TYK2抑制剂（Sotyktu；百时美施贵宝）和第一种用于脱发的JAK3/TEC抑制剂（Litfulo；辉瑞）。  JAK抑制剂继续扩大其治疗范围，特别是在风湿病适应症中，如强直性脊柱炎和类风湿性关节炎。随着选择性JAK1抑制剂的使用越来越多，以及针对嗜酸性食管炎的IL-4/IL-13靶向疗法的引入，胃肠道疾病也出现了创新。呼吸系统疾病的进展包括推出首个针对TSLP的药物tezepelumab（Tezspire；阿斯利康/安进）用于治疗严重哮喘，以及首次批准用于治疗慢性阻塞性肺疾病（COPD）的生物制剂dupilumab（Dupixent；赛诺菲）。创新治疗的最大竞争是针对2型炎症性疾病，如特应性皮炎、慢性痒疹、慢性荨麻疹、哮喘和伴有鼻息肉的慢性鼻窦炎。IL-5、效应细胞因子（IL-4、IL-13）、警报素细胞因子（TSLP、IL-25、IL-33）、IgE、IL-31、BTK和JAK是关键靶点。-04-三、未来展望：精准医疗与多维度创新自身免疫管线预计在未来几年将提供几种first-in-calss的疗法。在皮肤病学领域，安进的罗卡替尼和赛诺菲的氨利替尼是针对OX40/OX40L T细胞活化轴的新型药物，有望解决IL-4和IL-13产生的关键上游调节因子。预计慢性阻塞性肺病也将受益于一种新的治疗类别，有两种针对IL-33的竞争性候选药物：itepekimab（赛诺菲）和双重IL-33/IL-1受体样1（ST2）抑制剂tozorakimab（阿斯利康）。此外，CD40/CD40L轴可能会为系统性疾病引入新的治疗替代方案，包括用于干燥综合征的dazodalibep（安进）和用于系统性红斑狼疮的dapirolizumab（Biogen/UCB）。克罗恩病和溃疡性结肠炎可能受益于一种新的药物类别，该药物类别有三种针对TL1A的候选药物：默克公司的tulisokibart和罗氏/Roivant的RVT-3101目前处于III期，赛诺菲/Teva的duvakitug正在进入III期。 制药行业必须应对治疗策略中药物定位的复杂挑战，包括临床研究中治疗比较物的选择、联合疗法和生物标志物驱动的患者细分。药物之间的区别将取决于作用机制和创新的药物设计，例如提高靶点选择性和耐受性，口服小分子和注射细胞因子抑制剂之间治疗方案的便利性，特别是在考虑长效与短效药物制剂的情况下。目前，对于率先上市的药物（针对TL1A、OX40、TSLP、IL-33和TYK2等靶点）、first-in-class的创新（如对IL-17、IL-23和JAK抑制剂的选择性增强）和多适应症机会（如针对2型炎症性疾病中的IL-4/13和IL-5抑制剂）的竞争加剧。这些进展预示着治疗自身免疫性疾病的新时代的到来。-05-四、自身免疫疾病的全球和中国市场经统计，全球自身免疫疾病治疗药物处于稳定增长的趋势。弗若斯特沙利文数据显示，全球自身免疫疾病药物市场预计将由2021年的1,277亿美元，增长至2030年的1760亿美元，复合年增长率为3.6%。2021年，自身免疫疾病生物制剂市场规模为891亿美元，预计到2030年将增至1421亿美元，分别占2021年及2030年全球自身免疫疾病药物市场的69.8%及80.8%。来源：弗若斯特沙利文报告鉴于中国庞大的患者群体及自身免疫疾病创新疗法的进步，中国自身免疫疾病药物市场有望快速增长，由2017年的17亿美元增长至2021年的30亿美元，复合年增长率为15.2%，估计2030年将达到231亿美元，2021年至2030年复合年增长率为25.5%。估计生物药在中国自身免疫疾病中的份额将由2021年的32.9%增加至2030年的71.8%。来源：弗若斯特沙利文报告虽然中国的自免市场在快速增长，但潜力仍未完全发掘。一方面是由于中国自免药物市场仍以传统小分子为主导，而进口自免新药已进入中国，但众多的自免患者由于分布在经济欠发达地区，支付能力仍有限。另一方面，则由于自免疾病作为慢性病并不致死，导致患者认知程度不高，因此，该领域许多疾病的诊断和治疗率一直很低。不过，随着治疗手段的升级，疗效更好的生物制剂逐渐将被医生和患者所接受。而中国创新药的崛起也将凭借价格优势覆盖更广泛的患者群体。此外，银屑病、特应性皮炎、系统性红斑狼疮等自免疾病主要影响年轻群体，这类新生代人群更注重个人生活品质的提高，对身体、形象的受损容忍度低，因此有更强的支付意愿。多种有利因素将促进中国自免市场规模的快速增长。-06-结语自身免疫疾病的药物研发正经历从“广谱抗炎”到“精准调控”的范式转变。未来十年，随着疾病特异性机制解析、多组学技术及新型递送系统的突破，我们将见证更多创新靶点被攻克，患者将迎来更安全、长效且个体化的治疗方案。中国凭借庞大的患者基数、快速发展的生物医药产业和政策支持，正在重塑全球市场格局。随着IL-17抑制剂、JAK抑制剂等药物的普及，更多人将实现"疾病控制"到"临床治愈"的跨越。期待中国创新力量在自身免疫治疗领域继续书写传奇。参考文献：1.The multifunctional protein HMGB1: 50 years of discovery. Nat Rev Immunol. 2023 Jun 15.2. Trends in the drug target landscape for autoimmune diseases. Nat Rev Drug Discov.2025 Apr 3公众号内回复“ADC”或扫描下方图片中的二维码免费下载《抗体偶联药物：从基础到临床》的PDF格式电子书！公众号已建立“小药说药专业交流群”微信行业交流群以及读者交流群，扫描下方小编二维码加入，入行业群请主动告知姓名、工作单位和职务。

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. 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