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Systemic Lupus Erythematosus market size increment is a direct consequence of expected entry of promising emerging therapies, increasing awareness of the disease, and recent advancements in research and development in the 7MM LAS VEGAS, June 14, 2022 /PRNewswire/ -- DelveInsight's Systemic Lupus Erythematosus Market Insights report proffers a detailed comprehension of the Systemic Lupus Erythematosus market size by treatment, epidemiology, emerging therapies, market share of the individual therapies, current and forecasted Systemic Lupus Erythematosus market size from 2018 to 2030 segmented into the 7MM (the USA, EU5 ( Germany, France, Italy, Spain and the UK), and Japan). Some of the salient features from the Systemic Lupus Erythematosus Market Report: DelveInsight analysts suggested that the Systemic Lupus Erythematosus market size in the 7MM was valued at USD 1,462 Million in 2020 and is expected to increase drastically owing to the launches of several potential emerging therapies during the study period (2018-2030). Key pharmaceutical Systemic Lupus Erythematosus companies such as GlaxoSmithKline, AstraZeneca, Sanofi, Eli Lilly and Company/Nektar Therapeutics, UCB Pharma, Hoffmann-La Roche, Biogen, ImmuPharma, Xencor, Bristol Myers Squibb, Alpine Immune Sciences, Johnson & Johnson (Janssen), Idorsia Pharmaceuticals, Resolve Therapeutics, Amgen, AbbVie, Novartis, Corestem, Horizon Therapeutics, Boston Pharmaceuticals, InnoCare Pharma, Landos Biopharma, Equillium, Merck Healthcare KGaA, Gilead sciences, I-Mab Biopharma/MorphoSys AG, Chipscreen Biosciences, and others are reported to bring a significant shift in the Systemic Lupus Erythematosus. The Systemic Lupus Erythematosus emerging therapies that are expected to launch in the forecast period include Dapirolizumab pegol, BIIB059, Obinutuzumab (Gazyva/Gazyvaro), IPP-201101 (Lupuzor), and others. As per DelveInsight analysis, the United States accounted for the largest Systemic Lupus Erythematosus market size that was valued at USD 1,181 million in 2020, in comparison to EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan. The current Systemic Lupus Erythematosus therapeutic landscape in the 7MM is driven by current treatment practices and the expected launch of emerging therapies. For further information on the market impact by therapies, download the Systemic Lupus Erythematosus sample @ Systemic Lupus Erythematosus Therapeutic Scenario Systemic Lupus Erythematosus Overview Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disease with multisystem involvement and is associated with significant morbidity and mortality. Genetic, immunological, endocrine, and environmental factors influence the loss of immunological tolerance against self-antigens leading to the formation of pathogenic autoantibodies that cause tissue damage through multiple mechanisms. The pathogenesis of Systemic Lupus Erythematosus is complex, and the understanding of SLE pathogenesis is constantly evolving. A break in the tolerance in genetically susceptible individuals, on exposure to environmental factors, leads to the activation of autoimmunity. Systemic Lupus Erythematosus Epidemiology Segmentation As per the assessment of DelveInsight, the total diagnosed prevalent Systemic Lupus Erythematosus population in the 7MM was found to be 651,965 in 2020 which is expected to increase during the study period. As per DelveInsight's estimates, the United States accounted for 351,176 Systemic Lupus Erythematosus prevalent cases. The Systemic Lupus Erythematosus Market report offers epidemiological analysis for the study period 2018-2030 in the 7MM segmented into Total Diagnosed Prevalent Population of Systemic Lupus Erythematosus Gender-specific Diagnosed Prevalent Population of Systemic Lupus Erythematosus Age-specific Diagnosed Prevalent Population of Systemic Lupus Erythematosus Severity-specific Diagnosed Prevalent Population of Systemic Lupus Erythematosus Keen to learn how Systemic Lupus Erythematosus Epidemiological Trends are going to appear in 2030 for the 7 MM, Download @ Systemic Lupus Erythematosus Epidemiological Insights Systemic Lupus Erythematosus Market Outlook There is no complete cure for Systemic Lupus Erythematosus currently, but there are many treatments available to help particular symptoms. Systemic Lupus Erythematosus involves a wide range of clinical features that encompasses vascular, immune, and fibrotic manifestations along with the involvement of many organs. Systemic Lupus Erythematosus treatment includes NSAIDs and antimalarial agents, which are the first-line therapies for mild Systemic Lupus Erythematosus. In addition, glucocorticoids and cytotoxic or immunosuppressive agents—such as azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine, and methotrexate —are used for Systemic Lupus Erythematosus treatment with organ involvement. The current Systemic Lupus Erythematosus market possesses two approved products, Benlysta (belimumab) and Saphnelo (anifrolumab-fnia). The dynamics of the Systemic Lupus Erythematosus market is anticipated to change in the coming years owing to the improvement in the research and development activities for efficient treatment options to be available in the market. It includes several Systemic Lupus Erythematosus pipeline therapies such as Lupuzor (also known as IPP-201101), being developed by ImmuPharma, is a 21-mer linear peptide fragment analog. ImmuPharma has completed the Phase III clinical trial for the treatment of SLE. Lupuzor demonstrated a superior response rate over placebo (61.5% vs 47.3%). ImmuPharma and Avion Pharmaceuticals signed exclusive license and development agreement for Lupuzor to fund a new 'optimized' international Phase III trial which is expected to start by 2022. Avion Pharmaceuticals has the exclusive rights for the commercialization of Lupuzor in the US. ImmuPharma retains all the rights to commercialize Lupuzor outside the US. Apart from this, Biogen is developing, BIIB059, is an investigational humanized monoclonal antibody that specifically recognizes and binds to blood DC antigen 2 (BDCA2), a pDC-specific receptor that inhibits the production of IFN-I and other inflammatory mediators when ligated. Biogen is conducting Phase III clinical trials for the treatment of patients receiving Active SLE receiving background nonbiologic lupus standard of care. In addition, Dapirolizumab pegol is being developed by UCB Pharma in partnership with Biogen. It is an investigational humanized anti-CD40L antibody fragment that acts by preventing the interaction between CD40L on T-cells with CD40 on antigen-presenting cells through interactions with its receptor-CD40. The drug failed to meet its primary endpoint in the Phase II trial. However, the company continued the development of dapirolizumab pegol. The product is currently being developed jointly by UCB and Biogen to treat SLE in a Phase III trial. The topline results are expected in the first-half of 2024. Discover more about therapy set to grab substantial Systemic Lupus Erythematosus share @ Systemic Lupus Erythematosus Market Landscape Systemic Lupus Erythematosus Pipeline Therapies and Key Companies Itolizumab: Equillium/Biocon Limited ICP-022: InnoCare Pharma BOS161721: Boston Pharmaceuticals NKTR-358: Nektar Therapeutics/Eli Lilly ABBV-599: AbbVie Deucravacitinib: Bristol Myers Squibb BIIB059: Biogen Gazyva/Gazyvaro (Obinutuzumab): Hoffman-La-Roche Lupuzor: ImmuPharma SAR441344: Sanofi To know about more pipeline therapies covered in the report, visit @ Systemic Lupus Erythematosus Pipeline Analysis, Clinical Trials, and Emerging Therapies Systemic Lupus Erythematosus Market Dynamics The expected launch of potential SLE therapies is the main factor responsible for an increase in the Systemic Lupus Erythematosus market size in the coming years, assisted by an increase in the diagnosed Systemic Lupus Erythematosus prevalent population. Also, owing to the positive outcomes of the several products during the developmental stage by many key players, and improvement in the research and development activities for efficient treatment options to be made available in the market will directly boost the Systemic Lupus Erythematosus market. The increased awareness of the disease is also considered an aspect driving the Systemic Lupus Erythematosus market growth. On the other hand, factors such as a high annual cost and the hit and trial approach of researchers serve as setbacks for the Systemic Lupus Erythematosus market growth. The high failure rate of emerging drugs makes entering the SLE market challenging for the pharmaceutical key players. Also, several obstacles experienced in the Systemic Lupus Erythematosus pipeline, undiagnosed and unreported cases might also play as obstructions in the Systemic Lupus Erythematosus market in the future. Know which therapy is expected to score the touchdown first @ Systemic Lupus Erythematosus Market Landscape and Forecast Scope of the Systemic Lupus Erythematosus Market Report Study Period: 2018-30 Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan] Key Systemic Lupus Erythematosus Companies: GlaxoSmithKline, AstraZeneca, Sanofi, Eli Lilly and Company/Nektar Therapeutics, UCB Pharma, Hoffmann-La Roche, Biogen, ImmuPharma, Xencor, Bristol Myers Squibb, Alpine Immune Sciences, Johnson & Johnson (Janssen), Idorsia Pharmaceuticals, Resolve Therapeutics, Amgen, AbbVie, Novartis, Corestem, Horizon Therapeutics, Boston Pharmaceuticals, InnoCare Pharma, Landos Biopharma, Equillium, Merck Healthcare KGaA, Gilead sciences, I-Mab Biopharma/MorphoSys AG, Chipscreen Biosciences, and many others. Key Systemic Lupus Erythematosus Pipeline Therapies: Dapirolizumab pegol, Itolizumab, ICP-022, NKTR-358, ABBV-599, Deucravacitinib, BIIB059, Gazyva/Gazyvaro, Lupuzor, and several others. Systemic Lupus Erythematosus Therapeutic Assessment: Systemic Lupus Erythematosus current marketed and emerging therapies Systemic Lupus Erythematosus Dynamics: Systemic Lupus Erythematosus drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs KOL's views Analyst's views Systemic Lupus Erythematosus Access and Reimbursement Request for a Webex demo of the report @ Systemic Lupus Erythematosus Therapeutics Market Table of Contents Get in touch with our Business executive @ Systemic Lupus Erythematosus Regulatory and Patent Analysis Related Reports Cutaneous Lupus Erythematosus Market DelveInsight's "Cutaneous Lupus Erythematosus - Market Insights, Epidemiology, and Market Forecast-2032" report delivers an in-depth understanding of the Cutaneous Lupus Erythematosus, historical and forecasted epidemiology, market drivers, market barriers and key companies included like Centessa Pharmaceuticals, Bristol-Myers Squibb, Merck, Biogen, Sanofi, Zylo Therapeutics, Galapagos, Gilead Sciences, Viela Bio, Rigel Pharmaceuticals, and others. 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摘要系统性红斑狼疮发病机制复杂，药物研发难度大，目前市场治疗药物主要分为批准用药和超说明书用药；当前，系统性红斑狼疮治疗药物作用机制包括非甾体抗炎药、皮质激素类、抗疟药、细胞毒性药物、细胞因子调节剂、B细胞和T细胞靶向治疗、免疫调节剂等；针对SLE并发症狼疮性肾炎、冠心病等治疗药物也在同步开发中。本文简介系统性红斑狼疮治疗药物及在研药物的作用机制。 系统性红斑狼疮（Systemic lupus erythematosus，SLE），通常被称为狼疮，是一种慢性多系统结缔组织疾病，引起自体免疫耐受损伤，SLE症状一般是高度异质的，发病机制较为复杂，涉及遗传、表观遗传及环境等多因素的相互作用。事实上，根据已报道的临床表现和疾病严重程度，狼疮很可能并非单一疾病，而是涉及多个疾病的多种遗传途径。SLE属全球患病疾病，约90%发生于女性，好发于育龄期女性。我国SLE的患病率估计为0.03％，近年来，随着对轻度SLE形式的认识不断提高，全球报告SLE病例持续增加。 已获批治疗药物 SLE表现形式多样，目前尚无治愈方法，仅能达到病情缓解，治疗原则为积极控制狼疮活动、改善和阻止脏器损害，基于个体年龄、性别、症状及生活方式等进行个性化治疗是最佳方案，市场上使用的药物治疗多以控制症状、预防耀斑、减少器官损伤为主。市场上用于SLE治疗药物主要分为批准用药和超说明书用药。其中，抗疟药羟氯喹用于治疗SLE皮肤表现已超过了60年时间，二线抗疟药氯喹用于辅助，静脉注射甲基强的松龙用于短时间内治疗危象，小剂量强的松用于治疗活动性疾病表现。免疫抑制剂（硫唑嘌呤、霉酚酸酯和环孢素）用于治疗肾炎和其他重要器官受累。生物制剂Belimumab是继羟氯喹获批后的50多年里唯一一款获批的新药，用于治疗活动性SLE；2021年，国内荣昌生物自主研发的1类新药Telitacicept（泰它西普）获NMPA批准。SLE超说明书用药包括激素类、非甾体抗炎药，细胞毒性和免疫抑制剂及生物制剂，如利妥昔单抗也是SLE临床上常用药（表1）。 表1：市场上用于治疗系统性红斑狼疮的药物 SLE发病机制复杂，药物研发难度大。当前，SLE治疗药物作用机制包括非甾体抗炎药、皮质激素类、抗疟药、细胞毒性药物、细胞因子调节剂、B细胞和T细胞靶向治疗、免疫调节剂等；针对SLE并发症狼疮性肾炎、冠心病等治疗药物也在同步开发中。 作用机制研究进展 1 非甾体抗炎药 阿司匹林等非甾体抗炎药（NSAIDs）经常用于减轻狼疮的炎症以及发烧等体质症状，一般在开始治疗的几天内就可以缓解症状，且对于轻度患者来说，NSAIDs可能是唯一用药。此外，环氧合酶2型（COX-2）抑制剂具有许多与NSAIDs相同的抗炎和镇痛作用，且胃肠道副作用较低，尽管尚未获批，但显示类似或优于NSAIDs的效果。 2皮质激素类 局部使用皮质激素类（软膏、凝胶等）可用于治疗狼疮皮疹和耀斑，对于严重的狼疮症状如肾病（肾炎）、癫痫、贫血和血小板减少症等可大剂量使用。泼尼松、氢化可的松、甲基泼尼松和地塞米松是治疗SLE最常用的皮质激素类，但这类药物的副作用较大，不适用于长期使用，所以仅限于严重患者使用。 3抗疟药 羟氯喹等抗疟药物可广泛用于各种狼疮症状的治疗，包括狼疮性关节炎、皮疹和口腔溃疡等，且羟氯喹可安全用于妊娠期SLE女性患者，但其在治疗严重SLE方面并不有效。最新研究表明，抗疟药物能够抑制Toll样受体介导的先天免疫反应激活，鉴于良好的疗效和安全性，推荐大多数SLE患者使用羟氯喹。4细胞毒性药物对于使用皮质激素类不能得到充分控制的病人，可选择细胞毒性或免疫抑制药物治疗狼疮性肾炎和神经系统性严重狼疮。常用的细胞毒性剂是硫唑嘌呤、环磷酰胺、甲氨蝶呤和环孢素，由于毒性已知，接受细胞毒性药物治疗的患者需密切监测。一直以来，环磷酰胺被认为是治疗主要器官受累SLE的“金标准“，但由于其非特异性抑制炎症免疫反应，因此副作用较多。研究人员继续寻找特异性强且副作用小的新一代化合物，最新研究的一类霉酚酸酯具有类似或更好的疗效且毒性更小，可能取代环磷酰胺的地位。5 细胞因子调节剂 细胞因子调节剂作为炎症性疾病的治疗策略显示了前所未有的成功，研究人员也尝试在SLE中使用，但迄今为止结果不太乐观。靶向细胞因子治疗SLE处于火热开发中，是未来SLE治疗的储备力量，已有一些处于临床研究后期和监管阶段：靶向I型干扰素受体1单抗Anifrolumab于2020年已提交审批。BAFF拮抗剂Blisibimod、靶向CD40L抗体片段Dapirolizumab-pegol均处于治疗SLE临床Ⅲ期研究中（表2）。表2：细胞因子调节剂用于SLE在研药物6B细胞和T细胞靶向治疗传统观点认为，SLE是由于过度活跃的免疫系统对外来刺激的反应过于激进，导致产生抗核抗体的B细胞和抗体反应增强的T细胞处于过度兴奋状态。由于无法自行关闭，患者过度活跃的免疫系统除了异物外开始攻击自身。B细胞耐受性的丧失在SLE的发生和维持中起着关键的病理作用，靶向B细胞的产生、相互作用和功能性治疗被认为是一种有前途的新策略（表3）。表3：B细胞和T细胞靶向治疗SLE在研药物B细胞激活因子（BAFF）又称TNFSF13B（肿瘤坏死因子配体超家族成员13B）或BLyS（B淋巴细胞刺激因子），是一种天然存在的蛋白质，属于肿瘤坏死因子（TNF）配体和受体超家族，是B淋巴细胞发育成成熟血浆B细胞所必需。研究表明，BAFF蛋白的组成型过量表达会导致小鼠出现狼疮样综合征，从而推测BAFF可能参与狼疮等自身免疫性疾病的发病机制。另据全基因组关联研究表明，编码BAFF的基因TNFSF13B中的一个变体参与了SLE的发病机制，进一步证实了该靶点的有效性。Belimumab是一种特异性识别和抑制BAFF生物活性的人源性单克隆抗体，临床前研究和临床结果表明，Belimumab能显著降低循环B细胞水平。2011年3月，Belimumab获得首次在美国获批准，用于治疗接受标准治疗的活动性、自身抗体阳性的SLE的成年患者。2019年，Belimumab获批使用范围扩大到5岁及以上的儿童。泰它西普是一种同时靶向B淋巴细胞刺激因子（BLyS）和增殖诱导配体（APRIL）这两类重要细胞信号分子的新型重组融合蛋白。通过阻止BLyS和APRIL与B细胞表面表达的BAFF-R、BCMA及TACI受体结合，泰它西普可以抑制BLyS及APRIL信号传导，并抑制成熟B细胞和浆细胞的发育和存活。目前，BLyS和APRIL已成为自身免疫治疗的重要靶点，不过针对该信号通路的大部分临床阶段候选药物旨在中和两者中的一种。IL-17是一种T细胞源性细胞因子，参与T-helper 17亚群产生的不同自身免疫性疾病的致病机制。研究表明，SLE患者的IL-17辅助性T细胞水平升高，将IL-17与SLE中的B细胞联系起来，因为IL-17可以与BLyS协同作用来影响SLE的B细胞功能。因此，IL-17也被认为是SLE治疗潜在靶标。7免疫调节剂 Forigerimod是一种从核内小核糖核蛋白U1-70K中提取并在Ser140位磷酸化的21位线性肽，虽然其作用机制尚未完全阐明，但在MRL/lpr狼疮易感小鼠模型和SLE患者外周血单个核细胞的研究表明，Forigerimod具有耐受性和免疫调节作用，从而抑制T细胞与MHC呈现的自身肽的反应。临床Ⅱb期双盲或安慰剂对照研究显示其可以显著降低SLE疾病活动性且耐受性良好。8SLE并发症的治疗SLE具有严重甚至危及生命的并发症（肾炎、中枢神经系统受累、心脏/肺受累等），需要特定领域或潜在疾病领域的专业治疗。肾炎的治疗狼疮性肾炎是SLE发病和死亡的主要原因，当病人失去免疫耐受并形成自身抗体沉积在肾脏时，就会发展为肾炎。国际肾脏病学会（ISV）认定的Ⅰ或Ⅱ肾炎患者通常不需要治疗，严重的患者则需要药物干预，以防止进展为慢性肾功能衰竭。治疗方案包括皮质激素类、环磷酰胺和硫唑嘌呤等。免疫抑制剂他克莫司于2007年在日本被批准用于治疗狼疮性肾炎。另一种上市的免疫抑制剂，肌苷5'-单磷酸脱氢酶抑制剂霉酚酸酯，是狼疮性肾炎治疗的又一重大进展。该药于2006年在马来西亚被批准用于治疗狼疮性肾炎，这是全球首次批准的适应症疗法。截止目前，已有3款治疗狼疮性肾炎药物获批上市（表4）。表4：狼疮性肾炎上市治疗药物当前研究也发现了一些机制和介质被确定为治疗干预的靶标，开发了一系列候选药物，其中也包括SLE治疗药物Belimumab和在研药物Anifrolumab等（表5）。表5：狼疮性肾炎在研药物冠心病的治疗动脉粥样硬化和由此导致的冠状动脉疾病（CAD）是系统性红斑狼疮的常见并发症，发病率为6%~54%，冠心病在年轻狼疮患者中尤其普遍。预防性心脏病，包括危险因素的评估和早期治疗，应成为所有SLE患者护理的基本要素。研究表明，长期高剂量皮质激素类治疗被认为有助于病理学改变，低剂量的皮质激素类可能会起到保护作用。他汀类药物除了降低低密度脂蛋白胆固醇外，还具有抗炎和免疫调节作用，已被建议在这类患者中使用，并且已经进行了一些临床前和临床研究，用于预防和治疗SLE患者的动脉粥样硬化性疾病。研究表明，给易患狼疮的NZB/wf1小鼠注射阿托伐他汀可通过抑制免疫反应延缓疾病进展。然而，长期使用他汀类药物治疗与药物诱导的SLE和其他自身免疫性疾病可能相关，因此应谨慎使用。9干细胞移植 近年来，造血干细胞移植（HSCT）在治疗严重自身免疫性疾病方面取得了显著进展。与通常只靶向一种细胞类型或可溶性细胞因子的生物药不同，HSCT作用于所有免疫效应细胞（B和T淋巴细胞、单核细胞、自然杀伤细胞和树突状细胞）。然而，尽管这种治疗方法具有潜在的治疗效果，但风险性较大，仅限于某些患者。 参考资料： Clarivate Analytics Integrity数据库及其它网络公开资源。