生物制药产业化影响因素及作用机理研究
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摘要
生物产业是继信息产业之后又一个新兴的主导产业,人类社会进入了一个全新的生物经济时代。我国政府在2007年首次制订了生物产业的“十一五”规划,描绘了生物产业的宏伟蓝图。总体来看,我国生物产业还处于起步阶段。产业发展基础研究与发达国家差距在5年左右,而在产业化方面的差距却在15年以上。研究我国生物制药产业化实现的影响因素及其作用机理,从理论上指导企业采取合理的方式进行产业化,降低产业化成本,缩短产业化时间,同时对政府制订生物制药产业政策提供理论支撑,这对我国缩短与国外生物制药产业化差距,实现我国生物产业“十一五”规划目标具有重要意义。
本论文结合我国生物制药产业状况,从企业层面,以生物技术产业化路径为主线研究生物制药产业化实现路径的影响因素及其作用机理。本论文共分七章,第一章阐述选题背景与意义,提出拟研究的问题,简述研究内容与技术路线;第二章简述生物制药产业国内外发展现状,综述国内外关于生物制药产业化影响因素的研究进展;第三章设计影响因素量表,开展实证研究并分析实证结果:第四章综述集群创新网络国内外研究与发展现状,通过群组案例揭示集群创新网络对产业化的促进作用机理,分析利用机理促进产业化的途径;第五章综述资本因素国内外研究与发展现状,通过群组案例分析国家资助、风险投资、产业资本对产业化的促进作用机理,提出扩大产业化资本其它六种来源的建议;第六章综述内部协同创新因素的国内外研究现状,通过群组案例分析技术与市场、战略、组织、制度与文化协同对产业化的促进作用机理;第七章提出论文结论,展望未来研究的方向与内容。主要研究成果如下:
(1)通过实证研究,提出了影响我国生物制药产业化实现路径的因素:国家政策法规因素、外部集群创新网络、资本因素、内部协同创新因素、企业研发能力、经营团队、龙头企业引导、政府产业引导、生产装备与能力、销售网络与能力等。其中关键影响因素有四个:国家政策法规因素、外部集群创新网络因素、资本因素和内部协同创新因素。
通过对内部协同因素的实证分析得出:资源保证是生物制药企业协同创新需要考虑的因素,而技术与市场协同是生物制药产业化三阶段中最重要的协同因素。通过对资本因素的实证分析得出:在临床前研究阶段我国生物制药企业资金来源以自有资金、政府资助为主;在临床研究阶段,我国生物制药企业资金来源以自有资金、政府资助、风险投资为主;在产品上市阶段我国生物制药企业资金来源以产业资本、自有资金、风险投资为主。资金来源构成与国外有很大不同。
(2)运用群组案例分析,揭示了集群创新网络对生物制药产业化的作用机理:在临床前研究阶段,集群创新网络促进产业化的作用机理是知识溢出,企业与科研院所合作最为重要;在临床研究阶段,集群创新网络促进产业化的作用机理是集中专业化,企业与临床CRO合作最为重要:在上市与规模化销售阶段,集群创新网络促进产业化的作用机理是销售网络主导,企业与有销售网络的龙头企业合作最为重要。同时,通过研究发现科研院所的集中度与生物制药产业化不成完全正相关关系。
(3)运用群组案例剖析出资本对生物制药产业化的作用机理:①政府资助的促进作用机理是:资金+孵化效应。政府资助在生物制药临床前阶段和临床研究阶段具有显著促进作用。②风险资本的促进作用机理是:资金+运营能力增值效应。风险资本在生物制药产业化三阶段均具有显著促进作用,特别是在临床前研发阶段促进作用更显著。③产业资本的促进作用机理是:资金+网络输出效应。产业资本在药品上市与规模化销售阶段具有显著促进作用。
(4)在资源得到保证的前提下,通过案例归纳出技术与市场、战略、组织、流程和文化协同要素对生物制药产业化的作用机理:
①技术与市场、组织、战略、文化和制度等协同对生物制药企业产业化有重要促进作用,其中技术与市场是关键的协同因素。
②在临床前研发阶段,技术研发部门与营销部门主要是通过“信息对称”,共同促进产品技术创新决策;在临床试验阶段,技术研发部门与营销部门主要是通过“信息反馈”,丰富产品功能和完善使用方法;在上市与规模化阶段,技术研发部门与营销部门主要是通过“信息渗透”,为营销部门制定营销策略和医院销售提供依据,促进生物制药产业化进度。
③在生物制药产业化实现路径中技术与战略的协同是通过集中战略建立知识产权保护来实现的。不同研发实力的生物制药企业在产业化过程中可以选择不同的战略定位,如专业领域领先型、技术创新平台型和专业领域跟随型。但是,对于生物制药企业而言,无论采取那种集中战略的子战略,技术与战略协同的一个关键手段就是要保护好企业的自主知识产权。
④生物制药产业化过程是具有“项目”的特征,基于项目管理思想建立的项目组织形式促进生物制药产业化进程。
⑤积极进取的创新型文化是生物制药企业文化的主流;关键人员的激励制度是技术与制度协同的关键。
Bio-industry is another leading industry on the rise after information technology. We have entered into a brand new bio-economic era. Our government first framed the "11th Five Plan"of bio-industry in 2007, which depicted the grand road for our bio-industry. On the general view, our bio-industry is just taking the first step. Compared with developed countries, there's a 5-year gap in the fundamental research, and a 15-year gap in industrialization. Therefore, studying the influencing factors and mechanism of realizing the industrialization of our bio-pharmaceutical industry will provide a theoretical guidance for our enterprises to adopt proper means in realizing industrialization, so that enterprises can lower the cost and shorten the time needed. In the meantime, it will provide theoretical support to our government in formulating industrialization-related policies. In all, it is very meaningful in shortening our gap with foreign biopharmaceutical industry and realizing our bio-industry target stated in the "11th Five Plan".
Based on the current situation of our country's biopharmaceutical industry and focusing on the realization route, this thesis studies the influencing factors and mechanisms of realizing biopharmaceutical industrialization from the enterprises' view. This thesis is composed of 7 chapters. In Chapter 1, the background and significance of choosing this subject is elaborated, the question to be studied is raised, and the content & technological methods is briefly described. In Chapter 2, the current situation of the both domestic and overseas biopharmaceutical industry is summarized; the research development of influencing factors on industrialization is also summed up. Chapter 3 designs the scales of influencing factors, carries out empirical study and analyzes the results. Chapter 4 sums up the current research and development situation of industry cluster innovation network in both domestic and overseas. Group cases are used to reveal the promotion mechanism of industry cluster innovation network on the industrialization. How to use this mechanism to promote industrialization is also analyzed. Chapter 5 introduces the current research and development situation of capital factor. Group cases are used to analyze the promotion mechanism of government grant, venture investment, industry capital on the industrialization. Suggestions on 6 sources to enlarge industrialization capital are also made. Chapter 6 summarizes the current research and development situation of internal synergetic innovation. Group cases are used to analyze the promotion mechanism of technology and market, strategy, organization, system and culture on the industrialization. In Chapter 7, the conclusion of this thesis and an outlook on the future research orientation & content are proposed. Major research achievements are as follows:
(1) Through case study, the following factors are found to have influence on the industrialization of our country's biopharmaceutical industry: laws and regulations, external cluster innovation network, capital, internal synergetic innovation, enterprises' R&D capability, operational team, guidance by leading companies, industry guidance from government, production facility and capability, sales network and capability. Among these factors, four of them are key influencing factors: laws and regulations, external cluster innovation network, capital and internal synergetic innovation.
Through case study on internal synergetic factors, this thesis finds out that: resources assurance needs to be considered for biopharmaceutical companies to achieve synergetic innovation, while technology and market synergism is the most important synergetic factor in all the 3 phases of industrialization. Through case study on capital factor, this thesis finds out that: in pre-clinical stage, capital sources are mainly enterprises' own fund and government grant; in clinical stage, mainly enterprises' own fund, government grant, and venture investment; in marketing stage, mainly industry capital, enterprises' own fund and venture investment. The constitution of capital sources is very different with that of overseas.
(2) Through group case study, the mechanism of cluster innovation network on biopharmaceutical industrialization is revealed: in pre-clinical stage, it's intellectual overflow, so it is most important for enterprises to cooperate with scientific research institutes during this stage; in clinical stage, the mechanism is centralized professionalism, it is most important for enterprises to cooperate with clinical CRO during this stage; in marketing & large scale sales stage, the mechanism is sales network-oriented, it is most important for enterprises to cooperation leading companies with great sales network during this stage. In the meantime, it is found out that the concentration of scientific research institutes doesn't have fully positive relation with biopharmaceutical industrialization.
(3) Through group case study on the promotion mechanism of capital factor on biopharmaceutical industrialization, this article finds out that:①For government grant, its promotion mechanism is: capital + incubation effect. Government grant exerts notable promotion influence in both pre-clinical & clinical stages;②For venture investments, its promotion mechanism is: capital + appreciation effect of operation capability. Venture capital has evident promotion effect in all three stages of biopharmaceutical industrialization, especially in the pre-clinical R&D stages;③For industry capital, its promotion mechanism is:capital + network output effect. It has marked promotion effect in marketing & large scale sales stage.
(4) On the premises that resources are guaranteed, the synergism of technology with other factors (including market, strategy, organization, system and culture) has the following promotion mechanism, as concluded through case studies:
①The synergism of technology and other factors (including market, strategy, organization, system and culture) have important promotion mechanism on biopharmaceutical industrialization. Among them, the synergism of technology & market is the key synergetic factor.
②In pre-clinical R&D stage, R&D dept. and marketing dept. co-promote the innovation strategic decisions by "information symmetry" mechanism; in clinical trial stage, the two departments enrich the product functions and perfect the usage methods by "information feedback" mechanism; in marketing & large scale sales stage, the two departments cooperate via "information penetration" mechanism, to provide basis for marketing dept. to formulate marketing strategies.
③During the realization of industrialization, the synergism of technology and strategy is focus strategy with esteablishing intellectual protection system. Biopharmaceutical companies with different R&D capabilities can choose different strategic positioning, for example, leader in professional field, platform-based technology innovator, follower in professional field. All in all, the key method in technology & strategy synergism is protecting its intellectual property, no matter what strategy a biopharmaceutical company chooses.
④The biopharmaceutical industrialization process has the feature of a "project". Organization forms based on project management thought will expediate the industrialization process.
⑤Innovative culture with positive enterprising spirit will be the main stream culture of biopharmaceutical enterprises. And the motivational system for key innovation personnel is especially important for the technology and system synergism.
本论文结合我国生物制药产业状况,从企业层面,以生物技术产业化路径为主线研究生物制药产业化实现路径的影响因素及其作用机理。本论文共分七章,第一章阐述选题背景与意义,提出拟研究的问题,简述研究内容与技术路线;第二章简述生物制药产业国内外发展现状,综述国内外关于生物制药产业化影响因素的研究进展;第三章设计影响因素量表,开展实证研究并分析实证结果:第四章综述集群创新网络国内外研究与发展现状,通过群组案例揭示集群创新网络对产业化的促进作用机理,分析利用机理促进产业化的途径;第五章综述资本因素国内外研究与发展现状,通过群组案例分析国家资助、风险投资、产业资本对产业化的促进作用机理,提出扩大产业化资本其它六种来源的建议;第六章综述内部协同创新因素的国内外研究现状,通过群组案例分析技术与市场、战略、组织、制度与文化协同对产业化的促进作用机理;第七章提出论文结论,展望未来研究的方向与内容。主要研究成果如下:
(1)通过实证研究,提出了影响我国生物制药产业化实现路径的因素:国家政策法规因素、外部集群创新网络、资本因素、内部协同创新因素、企业研发能力、经营团队、龙头企业引导、政府产业引导、生产装备与能力、销售网络与能力等。其中关键影响因素有四个:国家政策法规因素、外部集群创新网络因素、资本因素和内部协同创新因素。
通过对内部协同因素的实证分析得出:资源保证是生物制药企业协同创新需要考虑的因素,而技术与市场协同是生物制药产业化三阶段中最重要的协同因素。通过对资本因素的实证分析得出:在临床前研究阶段我国生物制药企业资金来源以自有资金、政府资助为主;在临床研究阶段,我国生物制药企业资金来源以自有资金、政府资助、风险投资为主;在产品上市阶段我国生物制药企业资金来源以产业资本、自有资金、风险投资为主。资金来源构成与国外有很大不同。
(2)运用群组案例分析,揭示了集群创新网络对生物制药产业化的作用机理:在临床前研究阶段,集群创新网络促进产业化的作用机理是知识溢出,企业与科研院所合作最为重要;在临床研究阶段,集群创新网络促进产业化的作用机理是集中专业化,企业与临床CRO合作最为重要:在上市与规模化销售阶段,集群创新网络促进产业化的作用机理是销售网络主导,企业与有销售网络的龙头企业合作最为重要。同时,通过研究发现科研院所的集中度与生物制药产业化不成完全正相关关系。
(3)运用群组案例剖析出资本对生物制药产业化的作用机理:①政府资助的促进作用机理是:资金+孵化效应。政府资助在生物制药临床前阶段和临床研究阶段具有显著促进作用。②风险资本的促进作用机理是:资金+运营能力增值效应。风险资本在生物制药产业化三阶段均具有显著促进作用,特别是在临床前研发阶段促进作用更显著。③产业资本的促进作用机理是:资金+网络输出效应。产业资本在药品上市与规模化销售阶段具有显著促进作用。
(4)在资源得到保证的前提下,通过案例归纳出技术与市场、战略、组织、流程和文化协同要素对生物制药产业化的作用机理:
①技术与市场、组织、战略、文化和制度等协同对生物制药企业产业化有重要促进作用,其中技术与市场是关键的协同因素。
②在临床前研发阶段,技术研发部门与营销部门主要是通过“信息对称”,共同促进产品技术创新决策;在临床试验阶段,技术研发部门与营销部门主要是通过“信息反馈”,丰富产品功能和完善使用方法;在上市与规模化阶段,技术研发部门与营销部门主要是通过“信息渗透”,为营销部门制定营销策略和医院销售提供依据,促进生物制药产业化进度。
③在生物制药产业化实现路径中技术与战略的协同是通过集中战略建立知识产权保护来实现的。不同研发实力的生物制药企业在产业化过程中可以选择不同的战略定位,如专业领域领先型、技术创新平台型和专业领域跟随型。但是,对于生物制药企业而言,无论采取那种集中战略的子战略,技术与战略协同的一个关键手段就是要保护好企业的自主知识产权。
④生物制药产业化过程是具有“项目”的特征,基于项目管理思想建立的项目组织形式促进生物制药产业化进程。
⑤积极进取的创新型文化是生物制药企业文化的主流;关键人员的激励制度是技术与制度协同的关键。
Bio-industry is another leading industry on the rise after information technology. We have entered into a brand new bio-economic era. Our government first framed the "11th Five Plan"of bio-industry in 2007, which depicted the grand road for our bio-industry. On the general view, our bio-industry is just taking the first step. Compared with developed countries, there's a 5-year gap in the fundamental research, and a 15-year gap in industrialization. Therefore, studying the influencing factors and mechanism of realizing the industrialization of our bio-pharmaceutical industry will provide a theoretical guidance for our enterprises to adopt proper means in realizing industrialization, so that enterprises can lower the cost and shorten the time needed. In the meantime, it will provide theoretical support to our government in formulating industrialization-related policies. In all, it is very meaningful in shortening our gap with foreign biopharmaceutical industry and realizing our bio-industry target stated in the "11th Five Plan".
Based on the current situation of our country's biopharmaceutical industry and focusing on the realization route, this thesis studies the influencing factors and mechanisms of realizing biopharmaceutical industrialization from the enterprises' view. This thesis is composed of 7 chapters. In Chapter 1, the background and significance of choosing this subject is elaborated, the question to be studied is raised, and the content & technological methods is briefly described. In Chapter 2, the current situation of the both domestic and overseas biopharmaceutical industry is summarized; the research development of influencing factors on industrialization is also summed up. Chapter 3 designs the scales of influencing factors, carries out empirical study and analyzes the results. Chapter 4 sums up the current research and development situation of industry cluster innovation network in both domestic and overseas. Group cases are used to reveal the promotion mechanism of industry cluster innovation network on the industrialization. How to use this mechanism to promote industrialization is also analyzed. Chapter 5 introduces the current research and development situation of capital factor. Group cases are used to analyze the promotion mechanism of government grant, venture investment, industry capital on the industrialization. Suggestions on 6 sources to enlarge industrialization capital are also made. Chapter 6 summarizes the current research and development situation of internal synergetic innovation. Group cases are used to analyze the promotion mechanism of technology and market, strategy, organization, system and culture on the industrialization. In Chapter 7, the conclusion of this thesis and an outlook on the future research orientation & content are proposed. Major research achievements are as follows:
(1) Through case study, the following factors are found to have influence on the industrialization of our country's biopharmaceutical industry: laws and regulations, external cluster innovation network, capital, internal synergetic innovation, enterprises' R&D capability, operational team, guidance by leading companies, industry guidance from government, production facility and capability, sales network and capability. Among these factors, four of them are key influencing factors: laws and regulations, external cluster innovation network, capital and internal synergetic innovation.
Through case study on internal synergetic factors, this thesis finds out that: resources assurance needs to be considered for biopharmaceutical companies to achieve synergetic innovation, while technology and market synergism is the most important synergetic factor in all the 3 phases of industrialization. Through case study on capital factor, this thesis finds out that: in pre-clinical stage, capital sources are mainly enterprises' own fund and government grant; in clinical stage, mainly enterprises' own fund, government grant, and venture investment; in marketing stage, mainly industry capital, enterprises' own fund and venture investment. The constitution of capital sources is very different with that of overseas.
(2) Through group case study, the mechanism of cluster innovation network on biopharmaceutical industrialization is revealed: in pre-clinical stage, it's intellectual overflow, so it is most important for enterprises to cooperate with scientific research institutes during this stage; in clinical stage, the mechanism is centralized professionalism, it is most important for enterprises to cooperate with clinical CRO during this stage; in marketing & large scale sales stage, the mechanism is sales network-oriented, it is most important for enterprises to cooperation leading companies with great sales network during this stage. In the meantime, it is found out that the concentration of scientific research institutes doesn't have fully positive relation with biopharmaceutical industrialization.
(3) Through group case study on the promotion mechanism of capital factor on biopharmaceutical industrialization, this article finds out that:①For government grant, its promotion mechanism is: capital + incubation effect. Government grant exerts notable promotion influence in both pre-clinical & clinical stages;②For venture investments, its promotion mechanism is: capital + appreciation effect of operation capability. Venture capital has evident promotion effect in all three stages of biopharmaceutical industrialization, especially in the pre-clinical R&D stages;③For industry capital, its promotion mechanism is:capital + network output effect. It has marked promotion effect in marketing & large scale sales stage.
(4) On the premises that resources are guaranteed, the synergism of technology with other factors (including market, strategy, organization, system and culture) has the following promotion mechanism, as concluded through case studies:
①The synergism of technology and other factors (including market, strategy, organization, system and culture) have important promotion mechanism on biopharmaceutical industrialization. Among them, the synergism of technology & market is the key synergetic factor.
②In pre-clinical R&D stage, R&D dept. and marketing dept. co-promote the innovation strategic decisions by "information symmetry" mechanism; in clinical trial stage, the two departments enrich the product functions and perfect the usage methods by "information feedback" mechanism; in marketing & large scale sales stage, the two departments cooperate via "information penetration" mechanism, to provide basis for marketing dept. to formulate marketing strategies.
③During the realization of industrialization, the synergism of technology and strategy is focus strategy with esteablishing intellectual protection system. Biopharmaceutical companies with different R&D capabilities can choose different strategic positioning, for example, leader in professional field, platform-based technology innovator, follower in professional field. All in all, the key method in technology & strategy synergism is protecting its intellectual property, no matter what strategy a biopharmaceutical company chooses.
④The biopharmaceutical industrialization process has the feature of a "project". Organization forms based on project management thought will expediate the industrialization process.
⑤Innovative culture with positive enterprising spirit will be the main stream culture of biopharmaceutical enterprises. And the motivational system for key innovation personnel is especially important for the technology and system synergism.
引文
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