2020年由于新冠肺炎疫情的影响,体外诊断行业市场规模实现了超过15%的增长,带动体外诊断试剂核心原材料市场规模超过100亿元,较2019年增长30%以上,预计2021年体外诊断试剂原材料市场增长率在20%以上。中国体外诊断试剂原材料企业在各个细分领域市场占有率持续提升,但80%以上体外诊断试剂原材料产品仍为海外品牌,在未来3~5年进口替代仍将是体外诊断试剂原材料市场发展的主要趋势。2020年至今,科技部、国务院、证监会均出台相关政策,为体外诊断关键原材料行业发展提供了指导性意见;先后有5家体外诊断试剂原材料企业提交IPO申请,计划募集资金59。33亿元。中国体外诊断试剂原材料行业虽已进入高速发展期,但也受到一些限制性因素影响。体外诊断试剂原材料企业需要在行业内部协同、政产学研用金合作、海外市场开拓等方面寻找突破口。
<<Due to the impact of Coronavirus epidemic in 2020,the market size of the in vitro diagnostic(IVD)industry has achieved a growth of more than 15% in total,which driving the market size of the core raw materials of IVD reagents to exceed ¥10 billion,an increase of more than 30% compared with 2019. It is estimated that the growth of the raw materials of IVD reagents will be more than 20% in 2021. IVD reagents raw material enterprises in various segments of the market share continues to increase,whereas more than 80% of the products are provided by overseas brands,from which the next 3-5 years import substitution is still the main trend. The Ministry of Science and Technology,State Council China and Securities Regulatory Commission has issued relevant policies to provide guidance for the development of key raw materials industry for in vitro diagnosis. Five IVD reagents raw materials companies submitted an IPO application successively,planning to raise a total of ¥5.933 billion. China’s IVD reagent raw materials industry enters high-speed development,but there are also some restrictions. The enterprises need collaborative breakthrough from intra-industry collaboration and cooperation with government,industry,university,research and funds also in overseas market development.
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