2014年10月16日讯 /生物谷BIOON/ --哮喘（asthma）是一种常见的慢性炎症性呼吸道疾病，主要特征是多变和复发的症状、可逆性气流阻塞、和支气管痉挛，常见症状表现为喘息、咳嗽、胸腔紧迫、胸闷和气短。
哮喘是一个全球性的健康问题，估计有3亿人受本病困扰。在过去30年间，发达国家的患病率一直在增高，目前似乎已趋于稳定；发展中国家的患病率仍处于上升阶段。在我国，随着空气污染加重、过敏原的增多，哮喘发病率明显上升，特别是在3-10岁儿童中明显多发。
根据全球领先的制药与医疗保健顾问公司Decision Resources日前发布的一份新报告，美国、日本、欧洲5国（法国、德国、意大利、西班牙、英国）全球7大主要医药市场，哮喘市场2013年市值151亿美元，在未来10年（2013-2023），该市场将保持稳定并小幅增长，2023年市值将达到161亿美元。
——重磅产品到期，创新药物驱动市场恢复：当前，哮喘市场的领导产品包括：葛兰素史克的Advair/Seretide/Adoair，阿斯利康的Symbicort，默沙东/Kyorin的Singulair（顺尔宁），这些药物因专利悬崖，正遭受仿制药的侵蚀。在以后的几年，创新药物的快速市场接纳将驱动哮喘市场的恢复。这些新药包括：每日一次的LABA/ICS复方产品（如葛兰素史克/Theravance的Breo/Relvar）；长效毒蕈碱受体拮抗剂（LAMA），如勃林格殷格翰/辉瑞的思力华（Spiriva），该药是首个批准用于哮喘治疗的LAMA；以及5个新颖抗细胞因子药物，包括葛兰素史克的Bosatria、梯瓦的Cinquil、阿斯利康/协和发酵麒麟的benralizumab、罗氏/中外制药的lebrikizumab、阿斯利康的tralokinumab。
——重症哮喘群体中存在新市场潜力：未来10年，预期上市的抗细胞因子药物，将部分满足重度、难治性哮喘群体中存在的巨大医疗需求，目前，该类哮喘群体中可用的药物仅为系统性类固醇类药物，以及上市的唯一一种生物药物——罗氏/诺华的索雷尔（Xolair，奥马珠单抗）。在2015-2019年期间，5种新的生物制剂的上市，将推动哮喘市场生物类药品销售翻一番，从2013年的12亿美元，增长至2023年的24亿美元。
——思力华（Spiriva）未来销售大幅增长：思力华（Spiriva）是慢性阻塞性肺病（COPD）市场中的重磅长效毒蕈碱受体拮抗剂（LAMA），该药于2014年9月在欧盟赢得一个新适应症，用于哮喘的治疗，该药预计将于2015年获美国和日本批准用于治疗哮喘。尽管Spiriva已被标签外治疗哮喘，尤其是重度哮喘患者，但这些新的监管批准，预计将刺激Spiriva在哮喘临床治疗中的应用，届时Spiriva的销售额将大幅增长，该药在哮喘市场中的年增长率预计将达到8.8%。
——未来10年哮喘市场格局发生变化：一方面，新类创新药物的上市，将解决亚群重症哮喘患者的巨大医疗需求，将有助于推动哮喘市场的增长。另一方面，相对廉价的仿制药、生物仿制药将扩大更多患者群体对传统哮喘药物的获取。然而，总体而言，这最终将限制全球哮喘市场的增长潜力。
——生物标志物驱动哮喘个性化治疗：专门针对高嗜酸性粒细胞重症哮喘群体的首个抗白介素-5（IL-5）制剂的上市，将不仅意味着解决当前药物难治性重症哮喘群体远未满足的医疗需求，同时也标志着在异质哮喘群体中生物标志物驱动的更个性化医疗的新时代。这些昂贵生物疗法的市场接纳，包括抗IL-5和抗IL-3制剂，将部分依赖于使用相应的生物标志物检测的有效性和应用性以及这类检测的报销。
英文原文：The Asthma Market Is Forecast to Remain Stable over the Next Decade, Despite Generic Erosion of Market Leading Asthma Therapies
Emerging Anticytokines, Are Expected to Drive the Market Growth and Open a New Era of Personalized Medicine in Asthma, According to Findings from Decision Resources Group
Burlington, Mass. – Decision Resources Group finds that the market for asthma will remain stable, increasing slightly from $15.1 billion in 2013 to $16.1 billion in 2023 in the United States, France, Germany, Italy, Spain, the United Kingdom, and Japan. As the current market leaders, which includes GlaxoSmithKline’s Advair/Seretide/Adoair, AstraZeneca’s Symbicort, and Merck/Kyorin’s Singulair undergo generic erosion, asthma sales in later years will be driven by uptake of novel therapies. These novel therapies include the once-daily long-acting beta2 agonist (LABA)/inhaled corticosteroid (ICS) combination GlaxoSmithKline/Theravance’s Breo/Relvar, Boehringer Ingelheim/Pfizer’s Spiriva (the first LAMA approved for the treatment of asthma), and five novel anticytokine agents—GlaxoSmithKline’s Bosatria, Teva’s Cinquil, AstraZeneca/Kyowa Hakko Kirin’s benralizumab, Roche/Chugai’s lebrikizumab, and AstraZeneca’s tralokinumab.
Other key findings from the Pharmacor report entitled Asthma:
New market potential in underserved asthma population: Emerging anticytokines that are predicted to launch during the next decade will serve part of the unmet need in the severe, refractory asthma population, which is currently served by only systemic steroids and the one currently available biologic Roche/Novartis’s Xolair. The launch of five novel biologics between 2015 and 2019 are forecast to almost double sales of biologics over the forecast period from just over $1.2 billion in 2013 to approximately $2.4 billion in 2023.
LAMA, a new class of drugs for asthma: Spiriva, a blockbuster long-acting muscarinic antagonist (LAMA) in COPD, won an additional license for asthma in the European market in September 2014 and is projected to be approved for this indication in both the U.S. and Japan in 2015. Even though the drug is already used off-label for asthma, particularly in more severe patients, these new regulatory approvals in asthma are expected to spur the drug’s usage, and sales are expected to increase substantially at an 8.8 percent annual growth rate in this market.
Comments from Decision Resources Group Analyst Eun-Jin Yang, Ph.D.:
“Over the course of the next decade, the landscape of the asthma market will undergo a number of changes. On one hand, the market will experience a rise of new classes of innovative drugs that target small subpopulations of severe asthma patients, which will contribute to sales. On the other, the modestly cheaper branded-generic, generic, and biosimilar versions of current market leaders will expand the accessibility of conventional asthma therapies to a greater number of asthma patients. However, this will ultimately constrain the sales potential of the overall asthma market.”
“Launch of the first anti-interleukin-5 agent specifically targeting severe asthma patients with high levels of eosinophils will mean not only addressing the unmet needs of severe asthma patients who are refractory to available asthma therapies but also mark the beginning of a new era of more personalized medicine in the heterogeneous asthma patient population with a biomarker-driven therapeutic approach. Uptake of these expensive biological therapies, including anti-IL-5 and anti-IL-13 agents, will partly rely on the validity and ease of use of their corresponding biomarker tests and the reimbursement of such tests.”