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生物医药产业发展规律与政策研究

A Study of the Rule and Policy of Biopharmaceutical Industry Development

【作者】 王健聪

【导师】 黎苑楚;

【作者基本信息】 华中师范大学 , 情报学, 2011, 博士

【副题名】基于产业经济的视角

【摘要】 生物医药产业正成为继信息产业之后又一个令全世界瞩目和心动的高成长性产业。作为复杂的产业系统,生物医药产业有其自身的产业特征、发展规律和内在发展机制,传统产业发展所遵循的基本规律已不能完全解释生物医药产业的增长与发展。研究生物医药产业的发展规律和政策,对于我国充分发挥后发优势,实现生物医药产业跨越式发展具有重要的现实意义。本论文基于产业经济的视角,研究分析生物医药产业的内涵和特征、生物医药产业的价值链结构、生物医药产业内部企业之间的相互作用、生物医药产业的国际化布局和聚集式发展、生物医药技术创新以及生物医药产业政策。全文共分七章。第一章为绪论,分析本文的研究背景和意义、国内外研究现状以及研究方案和创新点。第二章根据“产业”的经济学特性,提出了广义的生物医药产业框架——包括核心层、支撑层和关联层——和狭义的生物医药产业范围——直接从事研究、开发、制造和销售人用药品的各种生产性企业和组织的集合,并将本文研究对象限定在狭义范围内。从技术关联的角度分析化学药、生物药和传统药子产业的地位;从生产活动阶段的角度分析医药研发业和医药制造业等子产业的地位;从产品特征角度分析处方药和非处方药子产业的地位。指出生物医药产业具有技术性与社会性高度结合、技术性与制度性密切依存、现代技术与自然资源紧密联系等三大基本特征。第三章至第六章分别从产业结构、产业组织、产业布局、产业技术四个方面研究分析了生物医药产业发展的基本规律。第三章是关于生物医药产业的价值结构分析。这部分基于产业价值链理论,提出生物医药产业价值链模型,指出在生物医药产业价值链中,包含着四个环节的药品生产过程——药物发现、临床前/临床试验、药物制造和药物销售,五种类型的产业参与主体——跨国公司和大型制药企业、小型制药企业、各种研发机构、独立研发公司和专业外包组织,三种主要的产业价值关系——技术转移关系、战略联盟关系和外包关系;生物医药产业价值链具有链化周期长、垂直一体化特色明显、遵循“微笑曲线”的特征,并将其与信息产业价值链进行比较,提出二者在研发和制造环节的主要区别。第四章是关于生物医药产业的组织分析。这部分主要从企业集中度、产品集中度、创新要素集中度、小型企业作用等方面分析阐述了生物医药产业市场结构寡头垄断与中小企业共生并存的基本特征,并从生物医药产业的产品高度差别化、自然垄断性、规模经济等方面对其市场结构进行了经济学分析;从产业市场行为的内容入手,总结了生物医药产业的价格行为和广告行为,揭示了制药企业的价格决定模式、价格歧视行为以及药品广告的特征和功能:探析了跨国公司和大型制药企业、小型制药企业以及独立研发公司各自的发展路径。第五章是关于生物医药产业的布局分析。这部分指出当代生物医药产业的国际布局实际上是以美国、欧洲和日本等少数发达国家为主导的产业内水平分工体系,发展中国家零散分布于产业价值链边缘,通过某些价值链低端环节有限的参与全球垂直专业化分工;产业高度集聚发展是发达国家生物医药产业的重要特征之一,生物医药产业聚集区往往具有雄厚的学术力量和产业力量、企业之间的社会网络联系密切、拥有丰富的医疗和临床资源并且资金网络高度密集;生物医药产业集群的培育模式主要包括孵化器模式和科技园区模式。第六章是关于生物医药产业的技术创新。这部分概述生物医药技术创新的界定、分类和主要制约因素,分析医药技术创新的重要价值——促进人类社会进步、支撑产业经济增长、引领产业结构走向、改变产业价值分配以及创造极高的产业壁垒;总结医药技术创新的基本特征——高成本性、成果评价反馈滞后、政府作用显著、路径依赖较弱、综合系统性强;并探讨当今世界生物医药技术创新的趋势。第七章对促进生物医药产业发展的产业政策进行深入分析。在探索生物医药产业政策内涵和特征的基础上,重点分析生物医药产业结构政策、产业组织政策、产业布局政策和产业技术政策的内涵、内容,总结美国、日本、印度等国家生物医药产业发展的政策选择和经验,并分别就我国生物医药产业的产业结构政策、产业组织政策、产业布局政策与产业技术政策等提出建议。

【Abstract】 Biopharmaceutical industry is becoming another high-growing industry after information industry. As a complex industrial system, biopharmaceutical industry develops with its own industrial characteristics, fundamental routine and internal mechanism. This paper analyses the rule and policy of the biopharmaceutical industry development from the perspective of industrial economy. The whole paper is divided into seven chapters.ChapterⅠis an introduction of the background, status, programs and innovations of this research.In ChapterⅡ, the author proposes the generalized framework of biopharmaceutical industry-including the core layer, the support layer and the associated layer, and the narrow scope of biopharmaceutical industry -the productive enterprises and organizations which are directly engaged in researching, developing, manufacturing and selling the medicines for human use. The author also analyses the status of different sub-industries, and notes that the biopharmaceutical industry is not only closely related to high-technology, but also directly bound up with sociality, institutional, and natural resources.From ChapterⅢtoⅥ, fundamental rules of biopharmaceutical industry development are analyzed and elaborated from the point of view of industrial structure, industrial organization, industrial layout and technology innovation.In the industrial value structure analysis of biopharmaceutical industry in ChapterⅢ, the author proposes biopharmaceutical industry value chain model. It includes four links -drug discovery, preclinical / clinical trials, drug manufacturing and drug sales; five types of participants multinational companies and large pharmaceutical companies, small pharmaceutical companies, R & D institutions, independent research and development companies and professional outsourcing organizations; and three types of relationship-technology transfer, strategic alliances and outsourcing relationships. The biopharmaceutical industry value chain has its own features. Firstly, it takes a very long time from the first link to the last; secondly, it is featured by vertical integration; thirdly, it follows the law of "smiling curve". Compared with the information industry value chain, there are some differences in R & D and manufacturing links of biopharmaceutical industry value chain.In the organizational analysis of biopharmaceutical industry in ChapterⅣ, the author prompts and analyzed the basic features of biopharmaceutical industry market from the point of view of enterprise centralization, product concentration, innovative resources concentration, and the role of small enterprises. Furthermore,the market structure of biopharmaceutical industry is given an economic analysis with respect of product differentiation, natural monopoly, and economies of scale. As for the market behavior, the author illuminates the price behavior and advertising behavior of biopharmaceutical enterprises, and reveals the price model, price discrimination behavior, and the characteristics and functions of drug advertising. Finally, the development paths of multinational companies and large pharmaceutical companies, small pharmaceutical companies, and independent R & D companies are showed.ChapterⅤis about the layout of biopharmaceutical industry. In the contemporary biopharmaceutical industry layout, the international level division of labor that is dominated by developed countries as the United States, Europe and Japan is the main forms of international division of labor. Developing countries scattered distribute on the edge of the biopharmaceutical industry value chain, and limitedly participate in the international vertical division of labor through some low-end links of the value chain. Industry cluster is an important layout characteristic of the biopharmaceutical industry development in developed countries. The cluster of biopharmaceutical industry tend to have four characteristics:strong academic power and industrial strength, close contact of social networking among enterprises, rich medical and clinical resources, and intensive capital-network. At last, the author puts forward two approaches to cultivate the biopharmaceutical industry clusters-Technology Park model and Incubator model.In the research to industrial innovation in ChapterⅥ, the author outlines the definition, the classification, and the major constraints of biopharmaceutical technology innovation. The important value of technological innovation are elaborated, such as improving human social, promoting industrial progress, leading the industrial structure adjustment, changing the value distribution, and creating high industry barriers. The author summarizes some essential features of biopharmaceutical technology innovation- high cost, delayed feedback of the research results, significant role of government, weaken path-dependence, and stronger systematic. Finally, the author explores the contemporary trend of biopharmaceutical technology innovation.In ChapterⅦ, the policy of the biopharmaceutical industry is deeply analyzed. After concluding the necessity and features of the policy, the author focuses on the concept and the content of it from the perspective of industrial structure, industrial organization, industrial layout, and industrial innovation. The different choices of policy content are showed with example elaboration of biopharmaceutical industry development in the United States, Japan, and India. Furthermore, the fundamental experience of policy choice in these typical countries is summarized. Finally, the author proposes the industrial policy for biopharmaceutical industry in China from the perspectives of industrial structure, industrial organization, industrial layout, and industrial innovation.

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