Development Of Biotechnology Industry Research Articles

RESEARCH ON WORLD TRENDS IN BIOTECHNOLOGY DEVELOPMENT

Purpose. The aim of the article is to study the practice and peculiarities of organization and development of biotechnology industries in the world, to identify common features of the economy of the industry enterprises, to determine the main trends of the world biotechnology market. Methodology of research. Theoretical and methodological principles of the article are based on the fundamental provisions of modern economic science. The following methods were used in the process of the research: theoretical generalization and scientific abstraction - when studying the basic concepts and categories of the study; method of system analysis - when forming the methodological base of the study; method of comparative analysis - when identifying regional and temporal patterns of development of biotechnology; tabular and graphical - for visual representation of the dynamics and structure of the analyzed indicators; generalization - to substantiate the conclusions. Findings. The features of economics and organization of biotechnology industries are considered, with an emphasis on the most exemplary international experience. The biotechnology is considered as a branch including many specific enterprises which have common features in the organization of the production and management process. Specific and common characteristics of biotechnology industries are highlighted with respect to the organization of management, the technologies used in management, attracting investment and the implementation of the whole range of business processes. Originality. Studies of the trends in the development of biotechnologies worldwide have been further developed. Future research will focus on the potential for biotechnology development in Ukraine. Practical value. Determination of global trends in biotechnology production can serve as prerequisites for the development of biotechnology in Ukraine. Key words: scientific and technological progress, biotechnology, biotechnology production, biotechnology companies, the world market for biotechnology.

PROBLEMS AND PROSPECTS OF THE WORLD BIOTECHNOLOGICAL MARKET DEVELOPMENT

Introduction. In recent decades, biotechnology industries have created the preconditions for the development of high-tech sectors in developed countries and provided opportunities for the transition to a model of sustainable development. According to experts, biotechnology in the coming decades will help improve human life, capable of becoming one of the fastest growing and most profitable sectors of the XXI century. The industry is high-tech, which determines the specifics of the innovation process and investment. The development of biotechnology is impossible without the coordinating and motivating role of the state, which will create a favorable environment for the development of biotechnology industries - an appropriate ecosystem, which will be an environment for effective interaction between all market participants. The formation of such an ecosystem depends on the formation of an effective institutional environment, the availability of resources and economic entities and the formation of effective interaction between participants through the creation of networks and the development of appropriate organizational forms.Purpose. The purpose of the article is to determine the features, problems and prospects of the global biotechnology market.Results. Features of geographical and commodity structure of the world biotechnological market are considered. It is determined that the conditions for the development of the biotechnology market are diversified sources of funding, but also relevant research and development resources, existing biotechnology companies capable of production, infrastructure that will promote the commercialization of finished products, intellectual property protection system. The factors of supply and demand are determined and it is substantiated that without purposeful state support the development of the biotechnology market is impossible.Originality. Factors of supply and demand in the biotechnological market are determined. Factors in demand for the biotechnology market in developed countries are high health care costs, high manufacturability of all industries, the desire to implement resource-saving and environmentally friendly technologies, the development of alternative energy. The main factors of supply in the biotechnology market are the availability of biotechnology companies with highly qualified specialists, the level of state support, the availability of basic technologies and the development of funding sources.Conclusion. The deep recession in the modern world economy and internal imbalances will lead to positive changes in the biotechnology industries, which will affect both product and geographical structure. The main drivers of growth will be developing countries as a result of stimulating policies to support biotechnology and cheaper resources. The dominant position in all markets will be occupied by developed countries as a result of significant investment in research and development, but large TNCs will increasingly take advantage of outsourcing, which will create additional opportunities for developing countries. The consolidation of key TNCs in biotechnology markets will be enhanced by their desire to integrate into their structure or to cooperate with research institutions and small innovative companies in various fields of biotechnology. Therefore, it is important for each country to develop its own mechanisms to intensify the development of biotechnology industries given the resource potential, production capacity and future markets.

Prospects of the biotechnology industry development in Poland

Background: The dominant sector of the biotechnology industry in Poland and worldwide is the medical biotechnology sector, therefore, along with its development (creation of new technologies), there was a need to formulate appropriate legal acts regulating the activity of various enterprises on the biotechnology market as well as initiatives and institutions financing this development. The aim of the study was to assess the current state and direction of development of the biotechnology industry in Poland against the global sector. Methods: The conducted research was based on the analysis of statistical data of the Central Statistical Office (CSO) covering the time horizon 2011 - 2017. Results: The analysis of CSO reports indicated that the biotechnology market in Poland is constantly developing and highly expansive. In the years 2011-2017, the number of biotechnological enterprises in the country increased from 91 to 188 and the number of employees in the sector in this period increased from 1972 in 2011 to 3321 in 2017. However, the Polish biotechnology sector, compared to the sector of Western European countries, is a young market, which is only just moving towards the maturity phase (product/branch life cycle). Conclusion: Both in Poland and worldwide, the dominant sector of the biotechnology industry is medical biotechnology. A characteristic feature of this sector is its high innovativeness, which combines business with research and development activities, and it employs a relatively large number of highly qualified people and educated professionals. With the expansion of the market and the development of new technologies, the need has arisen to formulate appropriate legal acts regulating the activity of various companies on the market, which directly affect the pace and direction of development of this industry globally.

THE IMPACT OF THE UKRAINE'S GREEN DEAL CONCEPT AND THE COVID-19 PANDEMIC ON THE TRAJECTORY OF UKRAINE'S INNOVATIVE DEVELOPMENT

The article examines the impact of Ukraine's Green Deal concept and the COVID-19 pandemic on the country's innovation development trajectory. The authors study the thematic focus of scientific publications in the context of the impact of the pandemic on global socio-economic and managerial processes. As a result, 9 clusters connected by thematic proximity were identified. It is identified that the new challenges require profound changes in the organization of the health care system, which will lead to large-scale investments in disease prevention infrastructure and the accelerated digital transformation of health care delivery. Telemedicine services, knowledge and technology transfer in health care practice, industrial and system design, development of bio- and nanotechnology are defined as innovative development trajectories. At the same time, the authors noted that the process of developing and implementing innovations is constrained by the problems of imports and a shortage of personnel for entrepreneurship due to supply chain disruptions and self-isolation policies. Besides, the uncertainty of the pace of pandemic development and its impact on the economy of states complicates the development of longterm macroeconomic policy. Socio-economic development planning should include sectoral transformation programs, and adequate financial incentives for the development of innovative entrepreneurship, the creation of reliable and sustainable business models. The article identifies the key areas of innovative development such as programs for sustainable economic restructuring, achieving the goals of Ukraine's Green Deal and the development of biotechnology industry and telemedicine.

Indonesia’s Patent Policy on the Protection of Genetic Resources related Traditional Knowledge; Is it a Synergy to Fulfill the TRIPs agreement and CBD Compliance?

This research analyses the compatibility of Indonesian Patent Act with the Trade related Aspect of Intellectual Property Rights (TRIPs) Agreement and the Convention on Biological Diversity (CBD) dealing with Genetic Resources Related to Traditional Knowledge (GRTK). The focus this analyses on whether the new Indonesian Patent Act provides a clear policy on the protection of GRTKF and the development of the biotechnology in Indonesia, particularly on the patentability of genetic resources related inventions, including genes patent. This research found that the new Indonesian Patent Act on GRTK is not only to synergise between the TRIPs Agreement obligation and the CBD compliance, but also adopted patent policies derived from other developed countries particularly in examining the patentability thresholds and exceptions from patentability. Even, in the context of patentability of living organisms, Indonesia adopts a very liberal approach compared to most industrialised countries. This research advises that Indonesian patent policy on GRTK should take into account the richness of this country on biodiversity and the level of biotechnology industry development.

Biotechnology clusters needs innovative minds and critical mass

The development of biotechnology industry is strongly based on the interaction with research laboratories and universities. The process of creating new companies and bringing new products to the market depend on how the actors are prepared and aware about the innovation process. Successful movements towards acceleration startups have overcome two major difficulties: Dissemination of the innovation virus in the academy and get enough critical mass of brain and resources. How long does it take to change the order of magnitude of the production of a new material from milligrams to tons? A PhD student probably has speculated about the final use of the new biomaterial introduced subcutaneously in some (un)fortunate mice. It is important to make researchers aware that one does not need to leave the comfort zone and face risks in a jungle to think big and find a noble application for their pet biomaterial. It is known that creative energy may be used beyond the Petri's dishes, bioreactors, scientific papers and patent applications. The ideas, like stem cells, may differentiate in whatever product the scientist mind would imagine. To play the game of innovation, scientists must learn new rules and new metrics. To be successful in this race, one must work hard and have a strategy. Probably, the podium will not be achieved in the first race but the sweat drops will evaporate from the road as quickly as the entrepreneur is getting better. He/she will evolve. So as patents and papers will evolve to business plan, in vitro/in vivo test will evolve to clinical trials or to medical prescriptions and inventions will transform into innovations. In order to survive in the 21st Century environment, the new species of entrepreneur with PhD degree, Homo innovatus, will populate biotechnology startups. In more evolved ecosystems, ideas and knowledge are translated into innovation. The process becomes easier when there is a minimum of critical mass of people and companies. The combination of quality, diversity and large number of ideas makes huge difference in a cluster. The main challenge is how to concentrate bright people in one place. There are a number of strategies to make it happen. The process of attracting talents to a region is to provide infrastructure for good life quality, i.e., high quality elementary and secondary schools for the children, nice hospitals, variety of cultural and touristic attractions. It is also necessary to create a flow of bright people into the place. The best way of achieving this is to have a number of universities that provide high quality workforce for the companies. The reputation of good salaries, good place to raise the family, good cultural activities help immensely to create and strengthen the brand of the cluster. Other than traditional metrics, the impact of cluster on the local and regional economic development and quality of life will be decisive on the success of attraction of talents and investments to a city or region.

Main challenges in developing biotechnology industry in Malaysia: perspectives from the innovative biotechnology firms

Background Innovative biotechnology firms play major roles in the development of biotechnology industry because of their product innovations. Since 2005, the Malaysian government has increased support towards the biotechnology sector to drive this industry forward. The aim of this paper was to identify the challenges in developing biotechnology industry from the prospective of private biotechnology firms in Malaysia.

Current status and considerations on biosimilar in China

Since the WHO “Guidelines on Evaluation of Similar Biotherapeutic Products (SBPs)” was published in April 2010[1], twenty two Countries and regions including EU and FDA have established their guidelines or guideline drafts on evaluation of biosimilar. In terms of the technical features, WHO guidelines are consistent with that of EU[2-4], head-to-head comparison exercise between SBP and reference biotherapeutic product (RBP) are required. In the prerequisite of quality similarity, the unnecessary or repeated non-clinical and/or clinical data might be reduced. Furthermore, extrapolation to other indications of the RBP may be possible. As for the FDA draft, requirements of interchangeability and substitution of SBP with RBP were introduced [5,6]. Guidelines of other developing countries generally used the WHO guidelines and the FDA guidance draft as blueprints to set up the technical requirements. These regulations and guidelines have far-reaching significance for each country’s biotechnology industry development and the availability and affordability of public medicine use. Up to now, there are not yet specified regulations for SBPs in China. Based on “The Provisions for Drug Registration (SFDA Order 28)” [7], Part I “Biological Products for Therapeutic Use” of the appendix 3 includes fifteen categories, three of them (7, 10 and 15) are related to SBPs. With respect to the technical requirements, there are no essential differences between China and WHO guidelines. However, our current regulations pay more attention to the requirements for the new drug approval. Consequently, some candidate SBPs products which might be suitable for abbreviated licensure pathway still need to experience the complete non-clinical and clinical studies. In addition, extrapolating to other indications is not allowed in our current regulations. Among the research projects of the Twelfth Five-Year Plan significant new drugs creation special, me too biothreapeutics are still the major part of the projects of biotechnology medicines. Therefore, accelerating the process of establishing our SBPs guidelines has great benefit for achieving the goal of ensuring the availability and affordability of public medicine and improving the development of our country’s biotechnology industry. Recently, our department has initiated the process of surveying the need to draft a specified SBP guideline. As some suggestions, due to very hard to obtain and very high costing of RBP would surely increase the difficulties of developing and evaluation of SBPs, how to define the requirement of RBP should be elaborately considered during the process of establishing our guidelines. Besides, special attention should be focused on how to perform the comparability exercise with RBP in the non-clinical and/or clinical study during the development of SBPs of therapeutic monoclonal antibodies. We believe that a SBPs guideline which considering both the actual situation of development of biomedicine in China and the general WHO framework would be established in the near future.

Functions and Inter-Relationships of Operating Agencies in Policy Implementation from a Viable System Perspective

Existence of supporting entities and their cohesive operations are important elements in industry development policy undertaken in emerging economies, which are characterized by heavy government interventions and involved many agencies and institutions. One of the models that emphasizes on cohesiveness as a precondition for viability is the viable system model (VSM). In this study, we adopt the VSM in combination with theories of innovation and innovation system as our conceptual framework to describe and explain the functions and relational structure that exist among agencies/institutions and that of the agencies with their environment elements within one policy level system implementation. We select a biotechnology industry development policy for our analysis, the implementation of which has been designated as a strategic vehicle to support the economic development goals of an emerging economy. The findings, which generate a model of the policy-level system implementation, explain the operating agencies’ functions and their inter-relationships. The emergent model provides policy makers and implementers recommendations for improvements, as well as offers future researchers potential for comparison between existing performance of a policy implementation against its expected performance targets. The study concludes that the biotechnology industry development is an effort by the Malaysian government to institutionalize biotechnology businesses and industry. The perspective of systems thinking, in combination with theories of institutionalization, innovation and innovation system, provide important foundations in explaining technology-based industry development. All these findings highlight that the knowledge gain in explaining and interpreting the problem in focus is worthwhile, although the use of VSM as a research tool demands considerable efforts.

Influence of government R&D support and inter-firm collaborations on innovation in Korean biotechnology SMEs

Although the development of biotechnology industry has been a national agenda, particularly in developing countries, few studies address factors that influence innovation performance in countries with unfavorable environments for biotechnology development. This paper examines the effects of inter-firm collaborations as well as the direct and indirect effects of government R&D support on innovation outputs. It is predicated on the national innovation system approach and the resource-based view. Data from 2005 through 2007 were obtained from a survey of small- and medium-sized enterprises (SMEs) in biotechnology in South Korea. Findings show that upstream partnerships were significantly associated with the innovation output of biotechnology SMEs, and international linkages were much stronger than domestic connections. The government support through project funding directly and indirectly affects firms' innovation by stimulating internal R&D and domestic upstream and downstream collaborations. The study findings imply the importance of governmental R&D funding and networking with foreign universities and research institutions as well as downstream partners. These Korea specific findings seem particularly relevant for countries where private investment firms are not well developed and knowledge bases and markets lag behind leading nations.

A Comparison of Biotechnology Industry in Japan and Other Developed Countries

Biotechnology has become a “global industry” with many countries trying to promote it as the next new industry. However, the state and development of biotechnology industry clearly differed even among the developed countries. This paper compares and discusses the recent state of biotechnology industry in Japan with the United States, the United Kingdom and Germany. As the second biggest biotechnology market in the world, Japan trailed behind its counterparts in the United States and Europe in the race to develop a robust biotechnology industry. This paper suggests that the current venture capital system in Japan presents a major impediment to the development of biotechnology industry in Japan.

Resource-based and institution-based approaches to biotechnology industry development in Malaysia

In this study, we use both resource-based and institution-based theories to examine potential sources of competitive advantage in the relatively new and rapidly growing biotechnology sector. We then use those theories as the basis for a multimethod study to assess the priorities, capabilities, and competitiveness of the emerging biotechnology industry in Malaysia. Multifunctional experts from a biotechnology industry organization in Malaysia identified the use of biotechnology for agriculture and biofuels as key country priorities, with access to funding and talent cited as key capabilities required for successful sector development. The gap between capabilities required and strategic priorities provides a “to do” list for industry development, with government institutions playing a central role in accelerating technology development and providing the capital flows necessary to bridge this gap. Implications include the need for public–private sector collaboration to enable biotech firms to efficiently obtain international investment and alliances to ensure sustainability, as well as to develop bold and creative approaches for developing and recruiting talent both at home and abroad.

Tracking progress: Two approaches to biotechnology development – Cases from Central Europe

A number of emerging economies increasingly expend resources to improve national innovative capabilities and create knowledge economies through the development of biotechnology industries. Standard measures and ways of tracking biotechnology industry progress, such as those used by the OECD, were designed for developed economies. In this paper we review critically a recent report funded by the European Union which also assesses biotechnology industry development in the new member states of Central Europe. Going beyond the report we identify additional characteristics important for an evaluation of nascent biotechnology industries and apply them to Hungary and Poland. Our analysis reveals that the two countries are pursuing different approaches to biotechnology industry development with Hungary following a relatively well-funded national strategy of launching a biotechnology sector specialised in innovative drug discovery whereas Poland has adopted a more hands-off approach. Developing appropriate measures and tools to monitor the potential and progress of an emerging biotechnology industry can help avoid expensive and wasteful policy failures and also provide investors with more reliable information on which to base their decisions. However, those measures should take into account the differing policy objectives and national strategies pursued by different countries.

The determinants of biotechnology innovative capability: the dynamics of knowledge and marketplace

Developing the biotechnology industry relies on advances in scientific knowledge and its commercial exploitation. Recent efforts to develop biotechnology businesses yielded mixed results, due to the gulf between science and business sensibilities. Turning good science into commercially valuable biotechnology products requires specialised skills, knowledge, effective communication, and imagination. Scientific motives and convictions clash with less precise and risky research commercialisation imperatives. Marketplace realities are driven by a number of human, cultural, and political factors that fall within the domain of business of biotechnology. This paper explores the organisational dynamics of developing medical biotechnology businesses and argues that the successful development of biotechnology industry requires effective organisational structures and the coevolution of two types of knowledge systems – scientific and innovative- for continuous growth of biotechnology firms.

Lessons from the Trend of Biotechnology Industry in the World

The biotechnology industry consists of organizations that solve problems or make useful products by use of biological processes. There are crucial problems awaiting solutions which activate biotechnology research and encourage the biotechnology industry in Japan.This paper has two aims. The first is to assess trends in the American and European biotechnology industries and biotechnology clusters from the published data and literatures. The second is deriving prerequisites for creating biotechnology clusters in Japan from analyzing these trends.Definite trends in the overseas biotechnology industry show that the biotechnology industry constructs a collaborative network. This collaborative network forms as research institutes, manufacturers, providers of funding, management, and legal services, and administrative agencies join in promoting the development of biotechnology industry in specific areas. In general, the biotechnology industry grows through developing biotechnology clusters.We derive two prerequisites for creating biotechnology clusters. The first is the requisite of classification. The roles of institutions (universities, research institutes, firms, funding institutions, patent attorneys, etc.) must be classified. The second is the requisite of cooperation. If the various institutions achieve closer cooperation with each other, it can promote reciprocation of valuable information.

Commercialisation of biotechnology in newly industrialised economies

Biotechnology, the surging wave of economic development in the world, prompted Newly Industrialised Economies (NIEs) in Asia to emulate developed countries in biotechnology development. The stakes are however high and the uncertainty about return on investment has provoked a careful assessment of national scientific and technological strengths. With a focus on Hong Kong, Singapore, and Taiwan, this paper reviews the current market conditions and key factors that may advantage the development of biotechnology industry in the NIEs. It is argued that co-evolution of scientific and technology capabilities are essential, and the NIEs will have to leverage their comparative advantages in technological capabilities and should focus on core competencies in the already locally established biotechnology areas.

The Development of Biotechnology Industry in Taiwan

The article is about the development of biotechnology industry in Taiwan. It is an overview of the progress of the research and development in the biomedical sector in Taiwan.

The contrasting roles of government in the development of biotechnology industry in the US and Germany

During the last 30 years, biotechnology development has charted different paths in the US and in Germany. Even though in Germany federal support programs started very early to target biotechnology, the innovative performance of this sector has been lagging behind that of the US, where the federal support was less direct. This article compares the two national science and technology (S&T) policies and analyzes the political, economic and social factors that determined the different paths. The paper concludes that an indirect S&T policy that tries to spread the factors, thereby enabling a preferable “economic ecology” for biotech development, is more successful than an interventionist policy. Political action, however, is limited and can only enhance science and technology development if the policies mesh with the social and economic dispositions.

Japanese biotechnology industry development

Clyde V. Prestowitz, Jr., Counselor to the Secretary of Commerce for Japan, provides an overview of the competition the US biotechnology industry faces internationally. He examines the competition posed by Great Britain and Western Europe, but notes that the most important competition to the US industry is from Japan. Dr. Prestowitz describes the efforts of the Japanese Government, through its Ministry of Industry and Trade, in cooperation with industry, to target biotechnology for industrial development. He also reviews Japanese barriers that limit access to Japanese markets by US and other foreign biotechnology companies. He summarizes bilateral discussions between the US and Japan to reduce barriers and to eliminate unfair trade practices. These efforts are critical, he concludes, for the leadership of the US biotechnology industry is at stake.

Tracking progress: Two approaches to biotechnology development – Cases from Central Europe

A number of emerging economies increasingly expend resources to improve national innovative capabilities and create knowledge economies through the development of biotechnology industries. Standard measures and ways of tracking biotechnology industry progress, such as those used by the OECD, were designed for developed economies. In this paper we review critically a recent report funded by the European Union which also assesses biotechnology industry development in the new member states of Central Europe. Going beyond the report we identify additional characteristics important for an evaluation of nascent biotechnology industries and apply them to Hungary and Poland. Our analysis reveals that the two countries are pursuing different approaches to biotechnology industry development with Hungary following a relatively well-funded national strategy of launching a biotechnology sector specialised in innovative drug discovery whereas Poland has adopted a more hands-off approach. Developing appropriate measures and tools to monitor the potential and progress of an emerging biotechnology industry can help avoid expensive and wasteful policy failures and also provide investors with more reliable information on which to base their decisions. However, those measures should take into account the differing policy objectives and national strategies pursued by different countries.