2020年全球系统性硬皮病治疗市场价值15.2亿美元,预计在预测期内复合年增长率为4.1%。导致系统性硬皮病治疗的关键因素包括系统性硬皮病的科学文献的迅速转变、针对症状性疾病的非标签药物以及一线疗法的创新。靶向生物制剂和联合疗法的发展也补充了系统性硬皮病治疗行业的增长。
然而,缺乏有效的结果,独特的药物velopment challenges, and recent failures in clinical trials to prove real-world evidence support curtailing the systemic scleroderma treatment industry growth. For instance, in September 2020, Corbus Pharmaceuticals, pipeline product, Lenabasum, failed to show positive results in phase III trials, despite promising phase II trials.
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Growth Drivers
Systemic scleroderma treatment industry players are focusing on a novel drug candidate at a rapid pace, varying in the mode of action and molecular entities. In the recent past, for instance, in September 2020, the U.S. based Kadmon Holdings, Inc. approved of orphan drug designation by the U.S. FDA for the potential drug candidate belumosudil (KD025). The drug was intended to treat systemic sclerosis. KD025 is a Rho-associated coiled kinase 2, addressing both immune and fibrotic mechanisms, currently being into phase II trials.
新的批准和强大的药物管道预计将推动系统性硬皮病治疗行业的增长。例如,2019年9月,美国食品和药物管理局(USFDA)批准了勃林格英格海姆国际公司(Boehringer Ingelheim International)的Ofev(nintedanib)药物,用于治疗伴有间质性肺病(SSc ILD)的系统性硬化症患者,随后于2020年4月获得欧洲医疗机构(European Medical Agency)的批准。此外,基于尼罗替尼和齐利他司他的新疗法有望很快推出,使市场竞争更加激烈。
系统性硬皮病治疗行业主要根据药物类别和地区进行细分:
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Based upon the drug class, the global market for systemic scleroderma treatment is categorized into immunosuppressors, phosphodiesterase-5-inhibitors-PHA, endothelin receptor antagonists, prostacyclin analogs, calcium channel blockers, and others. In 2020, the immunosuppressors market segment of the systemic scleroderma treatment industry accounted for the largest share in the global market for systemic scleroderma treatment and is projected to remain dominant. This high market share is due to the availability of immune suppressants as a gold standard among all the treatments. Most of the drug candidates are based on such drug class, as it offers better patient outcomes.
系统性硬皮病治疗市场的PDE-5抑制剂细分市场预计将在研究期间占据相当大的市场份额。市场参与者正专注于非标产品扩张,以扩大其客户群。例如,在2020年6月,辉瑞公司宣布完成其候选药物Revatio的三期试验,以治疗婴儿肺动脉高压。由于这种发展,ERA有望继续作为品牌疗法来治疗多环芳烃的高发病率。
从地理上看,全球系统性硬皮病治疗市场分为北美、欧洲、亚太地区、拉丁美洲和中东及非洲(MEA)。北美地区是收入贡献最大的地区,其次是欧洲和亚太地区。2020年,北美系统性硬皮病治疗市场占全球市场的40%以上。
The regional factors responsible for the market growth include high penetration of biologics, favorable reimbursement scenario, and recent innovations in the immune suppressants-based drug pipeline. In the U.S. alone there are around 20 to 21 annual cases of the diseases per million adults and approximately 276 cases of the concerned cases per millions of the total population in the market. The condition also has direct economic costs of around USD 17,365 to USD 18,396 per individual. The steady increase in the burden of disease is expected to spur the market of systemic scleroderma treatment.
欧洲的系统性硬皮病治疗市场估计将跟随北美,主要是由于广泛使用非专利药和非标签药物的条件。在英国,由于生物制剂的引入和对小分子的研究,预计市场将在市场研究期间出现广泛增长。
For instance, Actelion Pharmaceuticals Ltd., announced the approval for its drug, Uptravi, for the treatment of PAH. In developing nations of Asia Pacific, the use of generics and OTC drugs is going to be a mainstay in the treatment method. The increasing access to biosimilar and immune suppressants is likely to spur regions' systemic scleroderma treatment industry growth.
系统性硬皮病治疗行业的主要市场参与者包括罗氏有限公司、联合疗法公司、勃林格英格尔海姆国际股份有限公司、强生服务公司、葛兰素史克公司、辉瑞公司、礼来公司、拜耳公司、迈兰N.V.和特瓦制药工业有限公司。必威体育app手机版官网必威开户注册