导读——
1、缘起:政策面推动国产创新。在“十四五” 规划指导下,国产器械创新审批上市加速,同时国产神经介入器械随着疗法成熟逐步获批上市。高值耗材国家带量采购趋于常态化,神经介入区域性集采在浙江、河北陆续落地,预计未来国产市占率有较大提升空间。2021年有2家神经介入公司先后上市,1家已递交招股书待上市。
2、神经介入行业:创新器械“蓝海市场”。脑卒中具有高发病率、高致残率、高死亡率的特点,中国2019年有1480万脑卒中患者,神经介入手术约12万台,2020年受疫情影响依然达到16万台。2019年中国神经介入市场约57.9亿元,外资市占率超过90%。国产创新产品主要有取栓支架和弹簧圈,种类逐渐丰富。受益于疗法渗透率提高与国产创新加速,国产神经介入市场将迅速扩大,我们预测2030年中国神经介入市场规模将超300亿元,2020-2030CAGR为23.2%。归创通桥、心玮医疗、微创脑科学等国产公司产品迅速获批上市,在临床学术推广、销售渠道等方面具有先发优势。
3、他山之石:MNC创新之路的启示。国际领先神经介入公司主要有平台型企业如美敦力、史赛克、强生,通过跨赛道并购建立全面的产品线;“专精特”类公司如Penumbra依赖拳头产品抽吸导管成为细分领域龙头,通过丰富的产品组合和不断的技术迭代保持优势,股价一路上涨,市值约85亿美元。随着器械和影像设备技术进步、从业人员培训体系逐渐完善,术式和治疗方法不断升级,神经介入治疗快速发展。2018年全球神经介入市场规模已达22.6亿美元。急性缺血性脑卒中(AIS)是脑卒中主要病因,占比接近70% ,从静脉溶栓治疗、静脉溶栓配合机械取栓治疗再发展到单纯机械取栓疗法,机械取栓器械普及率快速提升。美敦力取栓器械已完成三代五款产品的技术迭代。出血性脑卒中治疗术式持续突破,自传统开颅手术、药物治疗、弹簧圈栓塞治疗发展到血流导向治疗。
4、中国神经介入市场:渗透率提升、进口替代为未来十年主旋律。中国卒中治疗渗透率中为1.7%,相较于美国的11.8%,有较大提升空间。中国神经介入手术集中在头部医院,基层卒中治疗水平差距大,随着卒中中心建设、临床基础设施改善,神经介入手术量将持续增加。2011年起弹簧圈、微导管、远端通路导管相继获批,开启国产神经介入产品时代,2020-2021年取栓支架、血流导向装置获批,2021年超过22款神经介入产品密集获批上市。国产企业不断更新迭代,临床数据优异,部分产品临床设计独特,效果甚至优于进口产品。预计未来三年将有大批神经介入产品完成技术创新和产品上市。未来十年,渗透率提升和进口替代将成为中国神经介入市场的主旋律。
5、未来展望:神经介入手术机器人市场将扩张。近年国际巨头纷纷完成手术机器人布局,国内形成2家国产+2家进口的市场格局。未来外科手术辅助机器人与血管介入机器人渗透率有望提升。当前国外Prosurgics、Medtech、Renishaw等公司成功研发神经外科手术机器人,国内柏惠维康、华科精准和华志微创有5款神经外科手术机器人。神经介入公司心玮医疗已有布局,平台型公司微创医疗拥有扎实广阔的研发能力与技术平台,多品类铺设产品线,有较强先发优势。国产企业还处于发展初期,借助产学研结合优势有望赶超。
注:
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