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精准施策促进发展,医疗器械产业“量质双升”?

中国经济的稳定增长和居民健康意识的提升,公众对高质量医疗服务的需求日益增加,为中国医疗器械行业带来巨大的市场需求。目前,我国国产医疗器械行业发展稳中有增,国家统计局数据显示,2005~2022年,其市场规模由600亿元增至逾9000亿元,年增长率超全球平均水平。 罗兰贝格发布的《中国医疗器械行业发展现状与趋势》报告显示,2022年中国医疗器械市场规模达9582亿元(人民币),近7年复合增速约17.5%,已跃升为除美国外的全球第二大市场。同时,我国目前药械比水平仅为2.9,较低的人均器械支出及临床渗透率表明,中国医疗器械行业未来充满发展潜力。

7月24日,政策再加码。国家发展改革委、财政部发布《关于加力支持大规模设备更新和消费品以旧换新的若干措施》(以下简称《措施》),提出将统筹安排3000亿元左右超长期特别国债资金,加力支持大规模设备更新和消费品以旧换新。 国家发展改革委表示:“支持地方消费品以旧换新的1500亿元左右资金,以及支持设备更新的首批约500亿元资金,近日就会下达。同时,将组织新一批设备更新项目申报审核,计划在8月底前,将3000亿元左右资金全部下达。”

根据弗若斯特沙利文最新报告,2024年全球医疗器械市场规模达6230亿美元,中国增速更快,正以9417亿元人民币的规模成为亚洲增长最快的市场。 不过,中国医疗器械行业竞争激烈,据药智医械数据 - 生产企业数据库统计,当前中国医疗器械生产企业许可/备案证号达 45657 条,企业数量多但规模小,行业集中度低。 此外,医疗器械品类繁杂、产品同质化严重,加之市场需求增长以及医保控费、集采等政策推进,使得产品价格承压,倒逼行业挖掘新增长空间、加速创新产品研发 。

6月20日,国家药监局审议通过《关于优化全生命周期监管支持高端医疗器械创新发展的举措》,提出十条具体措施,支持高端医疗器械重大创新,促进更多新技术、新材料、新工艺和新方法应用于医疗健康领域。 作为大健康产业的重要组成部分,医疗器械行业当前正处于从低端制造向高附加值产品升级的关键转型期,高端化、智能化、国际化成为行业发展主线。

国家药品监督管理局官网消息,为落实《国务院办公厅关于全面深化药品医疗器械监管改革促进医药产业高质量发展的意见》相关工作部署,支持医疗器械产品出口贸易,规范药品监督管理部门出具医疗器械出口销售证明的服务性事项办理,国家药监局组织起草了《医疗器械出口销售证明管理规定(修订草案征求意见稿)》,现向社会公开征求意见。

数智脑健康基地展区前,脑血管介入手术机器人展品吸引了众人的目光。据展品生产方北京万思医疗器械有限公司负责人史文宝介绍,传统的神经介入脑血管造影术为了避免辐射,需要参与手术的医护人员身着沉重的铅衣、铅围脖等。而该手术机器人问世之后,医护人员只需要坐在置于手术间外的操作台旁,通过操作手柄控制手术间内的机械臂即可完成手术,实现了“零”辐射手术的实施,解决了长久以来血管介入医生辐射损伤的临床痛点。“此次大会上,丰台区针对脑科学与高端医疗器械领域两大重点项目的首发,对于我们创新医疗器械的成果孵化具有很强的吸引力,可以帮助我们从源头上解决产品的临床需求,实现‘从临床到临床’的产业链闭环。”史文宝说。

医疗器械正是上述以旧换新方案的重要内容。在实施设备更新行动部分,以旧换新方案指出,加强优质高效医疗卫生服务体系建设,推进医疗卫生机构装备和信息化设施迭代升级,鼓励具备条件的医疗机构加快医学影像、放射治疗、远程诊疗、手术机器人等医疗装备更新改造。推动医疗机构病房改造提升,补齐病房环境与设施短板。

苏州和武汉是唯二在所有环节都进入排名前十的非一线城市。苏州一方面积极承接了来自一线城市研发的溢出效应,同时也在纳米材料、医疗机器人等垂直领域充分深耕,完成了从承接配套到细分领域龙头的转型。 武汉则是依托在生物领域的技术和创新优势,结合本身的制造底蕴,吸引了迈瑞生物、联影医疗等龙头企业的落户。

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