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2022体外诊断科技创新发展报告9787518995806

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作者编者:中国生物技术发展中心|责编:李晴

出版社科技文献

ISBN9787518995806

出版时间2022-10

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定价228元

货号31596601

上书时间2024-07-30

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目录
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 ···

内容摘要
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。

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