합성생물학 산업생태계 형성과 기술 거버넌스 연구

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연구보고서

합성생물학 산업생태계 형성과 기술 거버넌스 연구 Study on the Development of the Synthetic Biology Industry Ecosystem and Technology Governance

합성생물학 산업생태계 형성과 기술 거버넌스 연구 원문 다운로드 합성생물학 산업생태계 형성과 기술 거버넌스 연구 원문보기

보고서명
합성생물학 산업생태계 형성과 기술 거버넌스 연구
보고서명(영문)
Study on the Development of the Synthetic Biology Industry Ecosystem and Technology Governance

책임자 정일영
소속기관과학기술정책연구원
내부연구참여자이명화,유정민,이승윤,조원선,김소담,전수경,황정재
외부연구참여자
발행기관 과학기술정책연구원
ISBN978-89-6112-919-0
출판년도2023
페이지259
보고서유형 연구개발적립금보고서
연구유형 정책
표준분류 과학기술 > 과학기술일반
자료유형연구보고서
공공누리유형 4유형 (출처표시+상업적이용금지+변경금지)
주제어합성생물학,전략기술,바이오경제,바이오파운드리,기술거버넌스

조회수

조회수 반영까지 최대 10분 정도 소요될 수 있습니다.

828
다운로드

다운로드 수 반영까지 최대 10분 정도 소요될 수 있습니다.

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◎연구목적
○ 국가 경쟁력의 핵심이자 전략기술로 부상하는 합성생물학 진흥을 위해 주요국의 적극적인 투자 전략 및 생태계 강화 정책이 공격적으로 시행되나 국내의 경우 통합적 전략이 부족
○ 본 연구에서는 합성생물학의 성장과 발전을 위한 통합적 전략이 부족한 상황을 해결하고 한국 합성생물학 성장과 발전을 위해 원칙과 전략을 도출하여 제안하고자 함

◎주요내용
○ 합성생물학 기술의 혁신 특징에 부합하며 국내 산업적, 제도적, 조직적 여건을 고려했을 때, 가장 적합한 연구 진흥 및 산업생태계 형성 전략 분석
○ 합성생물학 기술의 위험관리 및 사회적 수용성을 고려한 기술거버넌스 프레임워크 분석 및 기술안보 관점에서 한국의 전략적 위치와 글로벌 협력 강화를 할 수 있는 방안 분석

◎정책대안
○ 합성생물학 성장과 발전을 위한 3대 원칙 : (제1원칙) 합성생물학의 새 지평을 위한 바이오경제 전략, (제2원칙) 합성생물학의 성장을 위해서는 양방향 전략의 동시 수행이 필수, (제3원칙) 대통령 수준의 리더십 체계와 혁신 특성에 적합한 제도 설계 필요
○ 합성생물학 성장과 발전을 위한 5대 전략 및 10대 과제
- 전략 1. 합성생물학 경쟁력 강화를 위한 기술 고도화 및 융합화(1-1. R&D의 양적 규모 및 투자 범위 확대, 1-2.인접기술(AI, 양자 등)과의 다학제 연구 촉진)
- 전략 2. 합성생물학 산업 생태계 형성을 위한 민간기업 지원 전략(2-1. 기업 지원을 위한 규제 샌드박스 신설 및 실증화 지원, 2-2. 글로벌 시장 연계 및 진출을 위한 기업 R&D 지원)
- 전략 3. 합성생물학의 스케일업을 가능하게 하는 바이오파운드리 구축(3-1. 공공 바이오파운드리 구축, 3-2. 바이오파운드리 기반 전략 및 타겟 전략 수립)
- 전략 4. 합성생물학의 사회적 수용성을 위한 기술거버넌스 수립과 연구 커뮤니티 확대(4-1. 데이터 기반 위험관리 및 차별화된 기술예측과 기술영향평가 추진, 4-2. 연구커뮤니티 확대)
- 전략 5. 합성생물학의 글로벌 협력 강화를 위한 국제협력체계 구축과 표준 선도 전략(5-1. 전략적 조력집단 형성과 전략적 자율성 확보, 5-2. 표준 선도를 위한 국가지원)

Summary

Study on the Development of the Synthetic Biology Industry Ecosystem and Technology Governance

ㆍProject Leader: Ilyoung Jung
ㆍParticipants: Myong Hwa Lee· Jungmin Ryu·Seung-yoon Lee·One-Sun Cho·Sodam Kim·Su-Gyeong Jeon ·Jeong-jae Lee

1. Background and Rationale for the Research
As synthetic biology has emerged as the core of the bioindustry and national competitiveness, major countries are aggressively implementing investment strategies and industrial ecosystem strengthening policies. In Korea, various synthetic biology promotion policies are being implemented, but there is a lack of an integrated policy roadmap, research community promotion policies, strategies for industrial ecosystem formation, and measures to enhance Korea's strategic position and social acceptance in terms of international politics. Therefore, this study aims to address the lack of an integrated strategy for the growth and development of synthetic biology and establish principles and strategies for the growth and development of synthetic biology in Korea.

2. Research Objectives and Methods
This study aims to address the absence of an integrated strategy for the growth and development of synthetic biology and to establish principles and strategies for the growth and development of synthetic biology in Korea.
The first research objective is to examine the field of synthetic biology in Korea broadly and integrally from the PEST (Politics, Economy, Society, Technology) perspective, and to suggest key principles for the growth and development of synthetic biology in Korea. The second research objective is to consider the innovation characteristics of synthetic biology technologies and fields and to derive and present strategies and specific tasks that can be utilized in practice to solve the problems captured in the PEST perspective. To this end, three specific research questions were addressed: (1) What are the most appropriate research promotion and industrial ecosystem formation strategies that are consistent with the innovation characteristics of synthetic biology technologies and take into account domestic industrial, institutional, and organizational conditions? (2) What is the technology governance framework that considers risk management and social acceptability of synthetic biology technologies? (3) What are the ways to strengthen Korea's strategic position and global cooperation from a technology security perspective?

[Figure1] Research question and research structure

The main research methods utilized in this study include literature analysis, statistical analysis, text mining, and in-depth interviews with experts. To analyze the technical features and R&D of synthetic biology, we utilized R&D data from KRIBB (Korea Research Institute of Bioscience and Biotechnology). To analyze the domestic and international synthetic biology industry ecosystem, we utilized global market trend analysis data, major company reports, and in-depth interviews with experts. The analysis of major policies, institutions, and organizations of synthetic biology at home and abroad is based on relevant policy documents of major countries. The analysis of international politics of synthetic biology is based on text mining and large language model (LLM) analysis of official documents of major countries from a constructivist perspective. The technical governance of synthetic biology was conducted based on literature analysis and in-depth interviews with experts.

3. Major findings

1) Analyzing Synthetic Biology R&D in Major Countries
This study analyzes the current status of synthetic biology R&D in Korea and abroad based on R&D data from KRIBB and provides implications for Korea's synthetic biology R&D. First, we derived the characteristics of synthetic biology R&D in major countries through country-level analysis and detailed technology-level analysis, and then diagnosed the current status of synthetic biology R&D through network analysis, and suggested implications for synthetic biology R&D from the Korean perspective. The results of the linkage centrality analysis suggest that Korea needs to expand its investment in synthetic biology R&D, and the results of the mediation centrality analysis suggest that Korea needs to expand its R&D performance in 'microbial-based chemical materials' and 'plant cell-based alternative foods'. Based on the characteristics of synthetic biology R&D in major countries, it is recommended to expand collaboration with the U.S. in order to expand R&D performance in 'microbial-based chemicals' and 'plant cell-based alternative foods', and to expand collaboration with institutions in the U.K. in academic research and with institutions in Germany and Japan in patent research. Lastly, we found that Korean researchers have excellent research publications in these two areas, and it is recommended to expand R&D in these two areas, which Korea should focus on.

2) Synthetic Biology Industry Ecosystem
As the technology of synthetic biology advances, a number of companies are emerging, and support and investment are expanding. A look at the synthetic biology industrial ecosystems of major countries shows that the world is emphasizing the development and commercialization of synthetic biology technologies. Despite this growing interest in synthetic biology, the actual start-up and commercialization of synthetic biology is often in its early stages. For example, mRNA vaccines were first introduced to the market during the COVID-19 pandemic, and there are not many other products that utilize synthetic biology, such as medicines and alternative meats, that are actually being sold in the market. In order to commercialize synthetic biology, there are challenges such as improving synthetic biology-related systems and consumer awareness, and it is necessary to identify and improve these factors to build a successful industrial ecosystem.
First of all, if we check the characteristics of synthetic biology startups, synthetic biology startups are mostly started in university laboratories. Due to the nature of synthetic biology as a new technology, startup ideas are often obtained through research in universities, and the construction of experimental facilities and equipment is essential to conduct research. Therefore, most synthetic biology startups are born as academic spin-out companies from university technology transfer offices (TTOs) (Nicolas et al., 2022). For example, Ginkgo Bioworks was founded in 2008 by five scientists from MIT, and the founder of Impossible Foods was a professor at Stanford University who started developing plant-based meat alternatives as a business to solve environmental problems.
In order to promote synthetic biology entrepreneurship, it is important to link research projects in laboratories to entrepreneurship. It is also necessary to support students and researchers interested in synthetic biology to easily access and utilize laboratory facilities and equipment, and since synthetic biology is a field that has developed through interaction and information sharing among researchers, it is important to activate networks among researchers. This can be accomplished through community activation programs such as iGEM. However, while it is important to foster promising synthetic biology companies, it is also important to ensure that startups and commercialization can take place under a clear business model, as risk management is now a very important part of the growth process.

3) Key policies, institutions, and organizations for synthetic biology
A review of policies in the U.S., U.K., China, Japan, and South Korea reveals that all countries view synthetic biology as a strategic technology that plays an important role in biotechnology innovation and industrial development, with biofoundries as a key tool and efforts to foster related technologies. Second, it is notable that countries have different perspectives on synthetic biology technology. With the exception of the United States and China, other countries aim to develop synthetic biology technologies and apply them to industrial development and social problem solving. However, the United States and China are not only applying synthetic biology to solve industrial and social problems, but also viewing synthetic biology from a national biosecurity perspective. Third, the United States, the United Kingdom, China, and Japan have relatively relaxed legal and institutional systems for synthetic biology technologies and products. In contrast, South Korea has a more rigid regulatory framework. Fourth, the United States, the United Kingdom, and Japan have strategies to foster community-based synthetic biology ecosystems. China and South Korea, on the other hand, have a weaker synthetic biology community base. The U.S. is a leader in synthetic biology, with government support accelerating R&D in synthetic biology when the community is active, and a virtuous cycle of institutional support enabling R&D to lead to entrepreneurship.

4) International Politics of Synthetic Biology
This study analyzed the process of securitization of synthetic biology, focusing on the United States and the United Kingdom. The analysis of the securitization process of synthetic biology shows that the United States is applying an expanded concept of security to secure synthetic biology, focusing on the global supply chain, while the United Kingdom is adopting a toned-down securitization strategy, avoiding over-securitization. This is due to differences in their perceptions of the main threats to synthetic biology and their domestic and international policy strategies. The United States tends to strongly securitize synthetic biology by linking it to maintaining supply chains, reflecting the impact of competition and potential rivalry with China. The UK, on the other hand, has made a strategic choice to avoid over-securitization and contribute to the formation of international standards and norms, given its relative lack of dominance in the synthetic biology market and the dominance of the US.
South Korea needs to strengthen its strategic autonomy to keep pace with the trend of securitization of advanced biotechnology, including synthetic biology. Based on its advantages in closely related technologies such as information and communication technology, robotics, and artificial intelligence, it is necessary to prepare a national strategy through a careful analysis of national threats and an accurate identification of domestic technological capabilities. To this end, it is necessary to review governance, institutions, and manpower conditions, which are functions of statecraft, and to utilize domestic strengths, such as the role of the CDMO market in the bio industry, to overcome the vulnerability of asymmetric interdependence in global supply chains. In this process, support systems should be strengthened to enable neighboring technologies to function as strategic enablers.

5) Synthetic Biology Technology Governance
In this study, we examined the issues of risk management, technology forecasting, and social acceptability from the perspective of technology governance to address potential risks and concerns that may accompany the development of synthetic biology and to ensure that it develops in a desirable direction. First, in terms of risk management, it is necessary to fully understand the risks created by synthetic biology and establish a governance system that can manage them well. Considering the different aspects from the existing risks due to the development of biotechnology, the existing LMO law may not be able to manage the risks sufficiently, and there are also issues of overlapping regulations. Therefore, in order to reduce regulatory uncertainty, risk management should provide a clear and solid direction, but the path to apply it should be flexible. Flexibility has been proposed in various frames, and the key is to ensure sufficient stakeholder participation and maintain an organic relationship with other factors such as education.
Next, in terms of technology foresight, given the uncertainty of synthetic biology, there is a need for in-depth analysis and prediction of how the technology will evolve, when and how much it will impact society, and the various spillover effects. We examined domestic and international cases of foresight, technology level assessment, and technology impact assessment as policy measures related to technology forecasting, and examined domestic status and issues. In the United States, horizon scanning for synthetic biology has already been conducted to identify issues that may affect global society in the short, medium, and long term. In Korea, future forecasts are regularly conducted under the name of the Science and Technology Forecast Survey, but there are limitations because it remains a technology-centered approach rather than fully considering the aspects of science and society. In the case of technology level assessment, improvements are needed to reflect clearer criteria and differences in detailed technologies in the qualitative assessment of experts. In the case of technology impact assessment, efforts are needed to recognize the various functions of technology impact assessment and to identify and utilize various methodologies for different purposes.
Social acceptance can be a key issue in technology governance when emerging technologies are perceived to carry risks, and as we have already seen in the case of genetically modified organisms, low social acceptance can have a significant impact on future technology development activities and related industry development. In Korea, institutional efforts to increase social acceptance of synthetic biology have not yet been active, while overseas countries have made efforts to increase social acceptance by operating various participation programs including civil society and the general public. Among them, the iGEM competition in the United States, which is still actively operating, is meaningful in that it can increase social acceptance by improving awareness and understanding of synthetic biology through extensive participation of students.

4. Conclusion and Policy Recommendations
Based on the analysis, we propose 3 principles, 5 strategies, and 10 challenges for the growth and development of synthetic biology in Korea.
The first principle for growth is that to promote the field of synthetic biology, it is paradoxically necessary to step outside of its technology and domain and discuss it within a larger framework. Moving away from the specific technology of "bio" and toward a "bioeconomy" involves multiple government ministries and provides momentum for the development of synthetic biology. The second principle is that the growth of synthetic biology requires the simultaneous implementation of interactive strategies. A balance must be struck between top-down, strategic government initiatives and bottom-up, ecosystem-building research and industry efforts. The third principle requires a presidential-level leadership structure and an institutional design appropriate to the nature of the innovation. In addition, a flexible institutional design that reflects the nature of the innovation will ensure the sustainability of the development of synthetic biology.

[Figure ] Three Principles for the Growth and Development of Synthetic Biology

In order to realize the three principles of synthetic biology, detailed strategies are needed, and this study proposes five strategies. First, technological advancement and convergence are necessary to strengthen Korea's competitiveness in synthetic biology. In particular, the technological advancement of Korean synthetic biology requires an increase in the quantitative scale and scope of investment in R&D. In addition, since synthetic biology generates a large amount of data through biofoundries, it is necessary to promote multidisciplinary research with neighboring technologies, such as artificial intelligence (AI) and quantum technology, from the beginning of technology development.
Second, we need to establish a strategy to support private companies to form a synthetic biology industrial ecosystem. Consider designating regulatory sandboxes where companies can design products using synthetic biology and produce commercial prototypes. This would support demonstration and increase the likelihood of synthetic biology products entering domestic and global markets.
Third, establishing a biofoundry for enabling the scale-up of synthetic biology is a crucial element, requiring the formulation of an operational strategy. To ensure the biofoundry, serving as a core infrastructure, functions effectively within the ecosystem, it is imperative to develop both a foundational and targeted strategy. The foundational strategy involves identifying core technologies through the segmentation of value chain stages and formulating an operational strategy by assessing domestic competitiveness.
Fourth, policy efforts are needed to establish technology governance and expand the research community for social acceptance of synthetic biology. To increase the social acceptability of synthetic biology, differentiated risk management, technology forecasting, and technology impact assessment are needed. In addition, support for expanding the synthetic biology research community to foster the next generation is essential.
Finally, it is necessary to establish an international cooperation system to strengthen global cooperation in synthetic biology and to establish a strategy for leading standards. In order to establish an international cooperation system for synthetic biology, a way to secure strategic autonomy based on domestic technological competitiveness should be explored by forming strategic supporting groups. In addition, national support for standards and consortium projects with industry are needed. Standards can accelerate knowledge transfer and promote innovation, and countries or companies that lead standards have a better chance of preempting the market. Therefore, the government should actively support the research community and industry to preempt synthetic biology standards that have not yet been finalized.

[Figure 3] Policy Recommendations

｜목 차｜

국문 요약 i

영문 요약 I

제1장 서론 1
제1절 연구의 배경 및 필요성 1
제2절 연구 목적 2
제3절 연구 방법 4

제2장 합성생물학의 기술적 특징과 R&D 분석 5
제1절 합성생물학의 기술적 특징 5
1. 합성생물학 개요 5
2. 합성생물학의 기술적 특징 5
제2절 국내외 합성생물학 R&D 프로젝트 현황 13
1. 미국 13
2. 영국 17
3. 중국 20
4. 일본 24
5. 한국 30
제3절 국내외 합성생물학 R&D 분석 38
1. 국가별 합성생물학 R&D 현황 분석 39
2. 국가별 합성생물학 세부기술 R&D 현황 분석 48
4. 글로벌 합성생물학 R&D 생태계 속 한국의 현황 66
5. 한국의 합성생물학 R&D에 대한 시사점 75
제4절 소결 및 시사점 78
제3장 국내외 합성생물학 산업생태계 80
제1절 합성생물학 산업의 특징 및 시장 전망 80
1. 합성생물학 산업의 특징 80
2. 글로벌 합성생물학 시장 현황 및 전망 84
제2절 합성생물학 주요 기업 및 제품 88
1. 합성생물학 주요 기업 88
2. 합성생물학 벤처투자 및 창업 현황 93
3. 합성생물학 주요 제품 96
제3절 주요국의 산업생태계 98
1. 미국의 합성생물학 산업생태계 98
2. 유럽의 합성생물학 산업생태계 99
3. 아시아(중국, 일본, 한국) 합성생물학 산업생태계 100
제4절 소결 및 시사점 103

제4장 국내외 합성생물학 주요 정책, 제도 및 조직 106
제1절 주요국 합성생물학 관련 정책 106
1. 미국 106
2. 영국 109
3. 중국 110
4. 일본 114
5. 한국 119
제2절 주요국 합성생물학 관련 법·제도 현황 123
1. 미국 123
2. 영국 125
3. 중국 127
4. 일본 130
5. 한국 133
제3절 주요국 합성생물학 조직 및 커뮤니티 139
1. 미국 139
2. 유럽 143
3. 중국 150
4. 일본 153
5. 한국 154
제4절 소결 및 시사점 158

제5장 합성생물학의 국제정치 163
제1절 서론 163
제2절 합성생물학의 발전과 국제질서 변화: 협력에서 경쟁으로 164
1. 합성생물학의 발전 164
2. 국제질서의 변화: 미·중전략경쟁의 심화와 코로나 팬데믹 165
제3절 합성생물학의 안보화: 왜 그리고 어떻게 안보화 되는가? 169
1. 안보화 이론 169
2. 합성생물학의 위협요인: 비대칭 상호의존 구조와 네트워크 외부효과 170
3. 분석자료와 방법 174
제4절 주요국의 안보화 과정 분석 177
1. 미국의 합성생물학 안보화 과정과 결과 177
2. 영국의 합성생물학 안보화 과정과 결과 182
제5절 소결 187

제6장 합성생물학 기술 거버넌스 189
제1절 개요 189
제2절 위험 관리 190
1. 필요성 190
2. 신기술에 적용 가능한 유연한 법체계 192
제3절 기술예측 198
1. 필요성 198
2. 관련 정책수단들 199
제4절 사회적 수용성 210
1. 필요성 210
2. 국내 현황 211
3. 관련 사례들 215
제5절 소결 220

제7장 합성생물학 성장과 발전을 위한 3대 원칙, 5대 전략 및 10대 과제 222
제1절 합성생물학 성장과 발전을 위한 3대 원칙 222
1. 합성생물학의 새 지평을 위한 바이오경제 전략 222
2. 합성생물학의 성장을 위해서는 양방향 전략의 동시 수행이 필수 224
3. 대통령 수준의 리더십 체계와 혁신 특성에 적합한 제도 설계 필요 225
제2절 합성생물학 경쟁력 강화를 위한 기술 고도화 및 융합화 227
1. 합성생물학 R&D의 양적 규모 및 투자 범위 확대 227
2. 합성생물학 발전을 위한 인접기술과의 다학제 연구 촉진 228
제3절 합성생물학 산업 생태계 형성을 위한 민간기업 지원 전략 230
1. 합성생물학 기업 지원을 위한 규제 샌드박스 신설 및 실증화 지원 230
2. 글로벌 시장 연계 및 진출을 위한 기업 R&D 지원 232
제4절 합성생물학의 스케일업을 가능하게 하는 바이오파운드리 구축 233
1. 연구 및 산업의 스케일업 지원을 위한 공공 바이오파운드리 구축 233
2. 바이오파운드리의 성공을 위한 기반 전략 및 타겟 전략 수립 235
제5절 합성생물학의 사회적 수용성을 위한 기술거버넌스 수립과 연구 커뮤니티 확대 237
1. 데이터 기반 위험관리 및 차별화된 기술예측과 기술영향평가 추진 237
2. 후속 세대 양성을 위한 합성생물학 연구커뮤니티 확대 238
제6절 합성생물학의 글로벌 협력 강화를 위한 국제협력체계 구축과 표준 선도 전략 240
1. 국제협력체계 구축을 위한 전략적 조력집단 형성과 전략적 자율성 확보 240
2. 표준 선도를 위한 국가지원 및 산업계와의 컨소시엄 프로젝트 241

참고문헌 243

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합성생물학 산업생태계 형성과 기술 거버넌스 연구

Study on the Development of the Synthetic Biology Industry Ecosystem and Technology Governance

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