2022体外诊断科技创新发展报告

为总结国内外体外诊断领域的前沿技术进展和产业发展情况，推动体外诊断科技创新与成果转化，生物中心组织编制《2022体外诊断科技创新发展报告》。全书共分十章，从我国体外诊断技术发展进程、全球体外诊断战略规划与产业政策、体外诊断产品及其应用、体外诊断技术发展趋势、全球体外诊断文献计量学研究、 全球代表性产业园区及企业等角度进行全方位梳理，展示了体外诊断科技创新的重要进展与成果。

中国生物技术发展中心为国家科学技术部直属事业单位，主要职责是开展我国生物技术领域的战略研究和政策分析，参与国家科技规划的制定，承担科技计划项目的专业化管理，承担生物资源与生物安全管理的有关工作，推动成果转化和产业画，促进国际交流与合作。

目 录 第一章 体外诊断技术及产业发展历程 ····················································1 第一节 体外诊断发展简史 ·································································1 第二节 中国体外诊断产业发展回顾 ·····················································3 一、中国体外诊断产业初创期（1978—1990年） ·······························4 二、中国体外诊断产业成长期（1991—2000年） ·······························4 三、中国体外诊断产业快速增长和竞争加剧期（2001年至今） ·············5 第三节 中国体外诊断技术发展的历史进程 ············································8 一、新中国成立至20世纪70年代：医学检验原始萌芽时代 ·················9 二、20世纪80年代：体外诊断由半自动向全自动迈进 ······················10 三、20世纪90年代：体外诊断大发展的孕育时代 ·····························11 四、21世纪初叶前十年：体外诊断现代化发展时代 ···························11 五、21世纪第二个十年开始至今：体外诊断进入全新的里程碑 ···········12 第四节 创新与产业动态变化及演化关系 ·············································13 一、体外诊断产业链知识结构分布 ················································14 二、产业知识存量动态演化过程 ···················································15 三、技术创新与研发网络中协作关系变化 ·······································16 第二章 全球体外诊断战略规划与产业政策 ···········································20 第一节 中国体外诊断战略规划与产业政策 ··········································20 一、监管部门与行业组织 ····························································20 二、主要战略规划 ·····································································21 三、主要产业政策 ·····································································23 第二节 国外体外诊断战略规划与产业政策 ··········································27 一、主管部门 ···········································································27 二、主要行业法规及产业政策 ······················································28 第三章 体外诊断产品及其应用 ····························································33 第一节 体外诊断产品的分类 ····························································33 一、体外诊断产品的分类方法 ······················································33 二、体外诊断产品的七大类别 ······················································33 第二节 体外诊断产品的构成 ····························································35 一、体外诊断产品的系统组成 ······················································35 二、体外诊断产品的常见类型 ······················································36 第三节 体外诊断产品的应用 ····························································46 一、体外诊断产品的应用范围 ······················································46 二、体外诊断产品应用 ·······························································47 第四章 体外诊断技术发展趋势 ····························································55 第一节 体外诊断关键技术及发展趋势 ················································55 一、标记免疫类技术 ··································································55 二、测序扩增技术 ·····································································61 第二节 外诊断前沿技术 ·······························································68 一、循环肿瘤细胞和外泌体技术 ···················································68 二、谱学技术 ···········································································71 三、多组学技术 ········································································80 四、数字化技术 ········································································86 五、人工智能与智慧大数据 ·························································91 第五章 体外诊断产业链条 ··································································98 第一节 体外诊断试剂原材料及仪器元器件 ··········································98 一、体外诊断试剂原材料及仪器元器件概述 ····································98 二、国外体外诊断核心原材料与元器件发展现状 ······························99 三、国内体外诊断核心原材料与元器件发展现状 ·····························113 四、体外诊断原材料与元器件发展前景与展望 ································117 第二节 体外诊断生产制造与质量控制 ···············································119 一、体外诊断生产制造与质量控制的管理规范及现状 ·······················119 二、体外诊断设备生产制造与质量控制 ·········································128 三、体外诊断试剂生产制造与质量控制 ·········································131 第三节 体外诊断产品注册与备案 ·····················································144 一、体外诊断产品注册与备案的法规 ············································144 二、体外诊断产品评估与审批 ·····················································150 第四节 体外诊断市场渠道 ······························································176 一、体外诊断渠道现状 ······························································176 二、体外诊断渠道发展趋势 ························································180 第六章 体外诊断市场及其发展趋势 ····················································189 第一节 国内市场 ··········································································189 一、市场规模分析 ····································································189 二、产品注册情况 ····································································194 三、进出口贸易 ·······································································198 四、主要细分领域市场 ······························································202 五、市场营销分析 ····································································206 六、国内市场趋势 ····································································207 第二节 国际市场 ··········································································210 一、国际市场概况 ····································································210 二、主要细分领域市场 ······························································211 三、发达国家市场分析 ······························································215 四、新兴经济体市场分析 ···························································218 五、中国产品进入国际市场 ························································224 六、国际市场趋势 ····································································227 第七章 体外诊断监管机制 ·································································238 第一节 中国体外诊断监管 ·····························································238 一、体外诊断产品的管理类别 ·····················································238 二、产业及科技政策 ·································································239 三、监管政策 ··········································································241 四、发展趋势 ··········································································252 第二节 国外体外诊断监管 ······························································254 一、美国体外诊断监管 ······························································254 二、欧盟体外诊断监管 ······························································260 三、其他国家和地区体外诊断监管 ···············································264 第三节 WHO体外诊断监管 ····························································269 一、产品资格预审项目 ······························································269 二、实施协作注册程序 ······························································271 三、发布体外诊断试剂基本清单 ··················································271 四、组建体外诊断专家战略咨询小组（SAGE IVD） ························272 五、发布相关指南 ····································································272 第八章 全球体外诊断文献计量学研究 ·················································274 第一节 全球体外诊断论文分布 ························································274 一、体外诊断论文发表逐年分布情况 ············································274 二、体外诊断论文发表的国家分布情况 ·········································275 三、体外诊断论文发表的国际合作情况 ·········································276 四、体外诊断论文发表国家的学术影响力情况 ································278 五、体外诊断领域顶级机构的学术影响力情况 ································280 六、体外诊断研究的顶级机构合作情况 ·········································282 七、体外诊断论文排名前五十高被引论文情况 ································286 八、体外诊断论文资助机构情况 ··················································292 九、体外诊断领域论文资助机构的合作情况 ···································292 第二节 全球体外诊断专利分布 ···