Current BioIndustry Ecosystem in Korea

We conducted a comprehensive analysis of the bio-industry ecosystem in the Republic of Korea, encompassing industries, markets, technological advancements, policies, and regulations. Additionally, in recognition of the importance of public understanding and support for transitioning to a better industrial structure, we also conducted a survey on public perception of GMOs. Through these efforts, we aim to identify areas for improvement in the current industrial structure in South Korea and introduce the government's corresponding development strategies. Furthermore, we will present our team's recommendations for industrial advancement through synthetic biology.

S. Korea Bio-industry

• R&D investment scale & Technology level

(100 million ₩)	2017	2018	2019	2020	2021
State Investment	34,946	35,494	36,717	41,253	47,766
Private Investment	27,165	30,907	39,545	47,909	55,988
% Private	44%	47%	52%	54%	54%

National Research and Development Program Investigation and Analysis Report (Ministry of Science and ICT/KISTEP)

Private investment in the field of biotechnology has seen a sharp increase since the onset of the COVID-19 pandemic, surpassing government investment. As of 2021, out of the national R&D budget of 25.1 trillion won, the biotech budget accounted for 4.77 trillion won (19%), making it the second-highest in terms of proportion after the IT sector, which had 4.9 trillion won (19.5%).

(2020)	Comparison with a leader			Comparison with a leader
Technology domain	Level(%)	Gap year	Technology domain	Level(%)	Gap year
Identification of Disease Causes Using Genomic Information	70	3	Development of Biocompatible Materials	81	2.5
Gene Therapy	80	3	Disease Diagnosis Biochips	80	2.5
Stem Cell Function Regulation	70	4	Bio and Biomedical Engineering-based Artificial Organs	80	3
Utilization of Stem Cells	85	2	Analysis and Application of Systems Biology and Synthetic Biology	75	3
Personalized Drug Development	70	6	Identification and Treatment/Prevention of Brain-Neurological Disorders	75	2.5
Optimization of Intelligent drug delivery	85	2.5	Observation and Regulation of Brain Signals	70	4
Biomarkers	80	4	Development of Resistant and High-Functionality Varieties	80	5
Overcoming Infertility and Sterility	85	3	Useful Gene and Genetic Resource Development	80	4.3
Response to New and Variant Infectious Diseases	80	3	Control of Animal Diseases	80	4
Efficacy and Mechanisms of Traditional Korean Medicine	81	3	Creation of Food Value	80	3
Integration of Medical Imaging	67.5	4.3	Bio and Biomass Energy Conversion	78	4

2020 Technology Assessment -KISTEP

When comparing the technology assessment in 2020 to that of 2018, it was observed that the technological gap between leading nations has been steadily decreasing. However, it is now evaluated that a strategic transformation is needed for leading countries in technology rather than merely catching up. In fact, there has been a tendency for technology development to lag in leading sectors compared to the previous technology assessment. As another example, South Korea's ranking in SCIE paper publications in the field of biotechnology has remained in the top 10, and the number of U.S. patents registered has decreased from 5th place in 2019 to 6th place in 2021.

• Manpower statistics in Korean bio-industry




	bio-industry manpower in 2022
	Shortage Number of people	Shortage Percentage
Total	521	6.3
Office management	155	6.5
Research development	190	6.3
Tech / Production	170	6.8
Etc.	6	2

There are concerns about the quantitative and qualitative shortages in cultivating master's and doctoral-level talents in the bio-industry. According to the "Biotech and Health Talent Development Plan" released by the Korea Health Industry Development Institute, it is estimated that by 2027, an additional workforce of approximately 108,700 will be needed. However, during this period, the expected workforce entering the industry is only around 34,000, highlighting a significant gap.

Furthermore, according to the survey on the "Quantitative and Qualitative Mismatch of Human Resources in the Bio-pharmaceutical Field" conducted by the Chemical and Bio-industry Human Resources Development Committee, "failure to hire due to a lack of job competency" is identified as the most serious cause, accounting for 40.1% of the shortage of bio-industry personnel. This underscores the need to address issues such as a lack of competency in cutting-edge technologies like digital biotechnology and the disconnect between educational programs and industry demands.

• Current circumstance of bio-industrial market


In 2021, biotechnology production reached 48 trillion won, reflecting an average annual growth rate of 10% from 2017 to 2021. However, in terms of size compared to the global market, it accounted for only 1.9%, indicating a relatively small share. Furthermore, it's essential to diversify the industry, especially given that pharmaceuticals and medical devices dominate, making up approximately 80% of the sector. Additionally, there is a need to reduce the high dependency on foreign sources for raw pharmaceutical materials.

On the other hand, mid-sized pharmaceutical companies in South Korea have been diversifying their new drug development pipelines. Their global market share in the early-stage pipeline, which was 2% in 2015, increased significantly to 5.4% in 2020, marking a 2.7-fold growth. Furthermore, large corporations are increasingly entering the biotechnology sector. The approval of clinical trial plans has been on the rise, with 714 approvals in 2019, 799 in 2020, and 842 in 2021, indicating continuous growth in the field of bio-services, including contract manufacturing experiments and other related activities.

• Venture capital & Technology export


	Pharm	Diagnostic Devices	Agriculture	Food	Chemicals	Environment	Energy	Support Services	Other
Corporate	613	280	248	557	418	105	15	339	206
IPO	79	26	5	13	15	1	1	44	21
Time to IPO	9.1	10.3	10.6	13.4	7.6	7	4	10.7	10.9
Average Revenue	88.1	69.1	50.4	73.5	63.6	58.5	48.7	49.8	56
Net Profit/Sales(%)	-37.8	-5.5	-4.9	-0.1	-1.3	-15.1	16.0	-41.6	-22.1

In 2021, biotechnology production reached 48 trillion won, reflecting an average annual growth rate of 10% from 2017 to 2021. However, in terms of size compared to the global market, it accounted for only 1.9%, indicating a relatively small share. Furthermore, it's essential to diversify the industry, especially given that pharmaceuticals and medical devices dominate, making up approximately 80% of the sector. Additionally, there is a need to reduce the high dependency on foreign sources for raw pharmaceutical materials.

On the other hand, mid-sized pharmaceutical companies in South Korea have been diversifying their new drug development pipelines. Their global market share in the early-stage pipeline, which was 2% in 2015, increased significantly to 5.4% in 2020, marking a 2.7-fold growth. Furthermore, large corporations are increasingly entering the biotechnology sector. The approval of clinical trial plans has been on the rise, with 714 approvals in 2019, 799 in 2020, and 842 in 2021, indicating continuous growth in the field of bio-services, including contract manufacturing experiments and other related activities.



As of 2021, technology exports in the field of biotechnology (including life sciences, agriculture, forestry, fisheries, and healthcare) were at approximately 1.05 billion dollars. This marks an increase of more than double when compared to technology exports in 2017, which were at 400 million dollars.

Concerning these statistical data, a problem can be defined that even though the level of competition is sufficiently elaborated, It can be seen that the difficulty of survival for startups during the Death Valley period is very high, hindering the emergence of new companies. Therefore, for new companies to be derived, as well as financial and policy support, the government needs to support reproductivity and in silico estimation by public biological resources or data that can shorten the research and development period.

GM Circumstances in S.Korea

• Interview with a domestic GMO company
• Trends in Genetically Modified Organisms in Korea

We investigated whether Korea has commercialized using genetically modified organisms or imported or exported them from other countries, or whether we have voluntarily cultivated or raised organisms using genetically modified organisms and exported them to other countries.
Except for Korea and Japan, commercial cultivation is being carried out and exports are also actively carried out to other countries.[8] In the case of Japan, it was not commercially grown or exported unless there was demand.
In Korea, commercial cultivation or export is prohibited due to awareness and laws regarding LMOs.[8]

	Approval	Culture	Income	Export
Korea	Total 483 cases	doesn't exist	Total 165.2 ton	doesn't exist
U.S.	Total 170 cases	72.45 million ha cultivated	Total 1.56 million ton	Total 47.3 billion exports
Europe	MON810Bt Corn Approved	67,000 ha cultivated	61 million ton	doesn't exist
Argentina	Total 67 cases	26 million ha cultivated	some food imports	40% of total volume exported
Canada	Total 71 cases	11.28 million ha cultivated	some food imports	90% of canola is exported
Japan	Total 190 cases	doesn't exist	some food imports	doesn't exist
China	Total 60 cases	3.18 million ha	100 million ton	corn exports

figure 7. Number of cases of LMO import and export or cultivation and approval in each country
• International Trends in Genetically Modified Organisms

While looking into trends in the use of genetically modified organisms in Korea, we learned that Korea imports from other countries but does not cultivate or export them for commercial purposes.
To find out, we investigated trends in the use of genetically modified organisms in overseas countries.
The United States, Canada, Argentina, Japan, and China all grow GM foods, and Japan does not make or export GM crops for commercial purposes.[8]



Research includes GM corn with pest resistance and anti-oxidizing properties, GM microorganisms, and pharmaceutical production.
Although the number of GM crops tested has decreased since the beginning, various GM crops are still tested.
Commercially, the USDA APHIS (United States Animal and Plant Health Inspection Service) approved 170 GM crops, and the FDA (Food and Drug Administration) approved GM salmon and GM pigs for food or medical use (organ transplant using GM pigs).
The United States grows GM crops such as corn, soybeans, cotton, canola, and alfalfa, with total exports worth $14 billion.



In Canada, research is being conducted on canola and corn, and recently, research on barley borage, camelina, poplar, soybeans, sataum, and white mustard.
For commerce, plants and foods with new characteristics are approved. The Food Inspection Agency approved 12 cases for environmental release, 14 cases for feed, and the Ministry of Health approved 14 cases for food safety.
Canada is experimentally cultivating canola, soybeans, corn, and sugar beets, and exports them to the United States, China, Japan, and the EU.



Argentina is the only country that has received approval for cultivation of GM wheat, and is currently conducting research on wheat, soybeans, and corn using the sunflower-derived HB4 gene introduced into wheat.
As of September 2022, 67 have been approved for commercial import, and GM corn is being exported to over 50 countries.



Although test cultivation is taking place in the EU, it is difficult to commercialize GM crops in a short period of time.
GM crops approved in the EU include MON810 Bt corn, and cotton, soybeans, rapeseed, sugarcane, and microorganisms have also been approved. MON810 Bt corn is grown in Spain and Portugal.

(Unit: 1000ha)	Total : 2018	Total : 2019	Total : 2020	Total : 2021	Total : 2022
GM soybeans	2105	1861	1642	1718	1720
GM sugar beet	19	17	17	18	18
GM corn	1303	1346	1280	1276	1317
GM crops sown area	12198	11367	10928	11577	11281
GM canola	8771	8143	7990	8565	8226
total	24396	22734	21857	23154	22562

figure7-2. This table shows the GM food test cultivation area in Europe by year.



Japan is actively conducting GM research with the introduction of gene scissors, but is not pursuing commercialization. As of December 2022, the total number of approvals for importing GM crops is 198.
Except for GM roses and GM Phalaenopsis orchids, Japan imports other crops and does not export any crops.



China is conducting research and development with securing food security as its top priority.
As of December 2022, there are a total of 60 GM crops. China grows corn but imports some.

• LMO Legal system

LMO law and system (Korean vs U.S.)

We compared LMO-related systems in the United States, which actually test-cultivate and export for commercial purposes, to understand why LMOs or GMOs cannot be commercially produced or exported due to negative perceptions or laws and must rely only on imports.
The United States' LMO law is handled only by each ministry, and the approval process is also simple.[8] However, in the case of Korea, the approval process is carried out through the central government and then to each ministry, so many problems arise due to the central government's insufficient response and the process is also complicated.[8] In order to solve these problems, the process must first proceed with each expert or each ministry, rather than with the central government.

Comparison	US	Korea
State	The size of GMO test cultivation in the United States is approximately 72.45 million hectares, making it the largest grower of GM crops in the world.	Korea is amending and amending laws with the goal of preventing harm to the human body and the environment caused by genetically modified organisms, improving people's lives, and promoting international cooperation by establishing and implementing an effective safety management plan.
Problem	The United States approved GM rapeseed with plant resistance for commercial use and conducted tests to use it in North Dakota, but an incident occurred in which a large amount of it was leaked into the North Dakota environment.	The zucchini pumpkin incident occurred on April 14, 2023, as documents related to LMO and GMO were passed through the central administrative agency and then delivered.
Laws	Each U.S. department, USDA, FDA, and EPA, has guidelines and laws, and they are implemented based on these laws.	Korea's LMO or GMO-related laws are implemented based on the Act on Transnational Movement of Genetically Modified Organisms, etc. A fine will be imposed if this law is violated.
System	This is a system in which documents are submitted to each ministry in charge of the use of a specific LMO or GMO and approval is obtained after going through a separate approval process with that ministry.	When documents related to GMO or LMO import or export are submitted, they are first submitted to the central administrative agency and the contents are then delivered to each expert and ministry.

figure 8. This table compares the differences in GMO laws and systems between the United States and Korea.
• GMO Awareness

GMO Awareness and Attitudes (Korean)

A survey was conducted in September 2023, targeting 182 Korean individuals for the purpose of recognizing Local Market Opportunities (LMO) within the country. The sample was divided based on their major fields of study as follows: 39 from the humanities and social sciences, 40 from the natural sciences, 86 from engineering, 14 from fine arts and physical education, and 3 from other disciplines. Among these, 17 individuals were found to be in professions related to the life sciences.

figure 9-1. When conducting a survey, the occupation and major of the person surveyed

figure 9-2. Survey on LMO perceptions

Regarding awareness of LMO, 26% of respondents answered that they do not know, 45% responded that they have some knowledge and 29% responded that they are knowledgeable about LMO.

Among the associated keywords related to genetically modified organisms (GMOs), 78 individuals (43%) responded with "food" as the most frequent term. Following that, "GMO" and "LMO" were mentioned by 37 individuals (20%), while 22 individuals (12%) expressed negative perceptions. Additionally, 22 individuals (12%) mentioned "innovative technology," 14 individuals (8%) mentioned "genetically modified animals," 2 individuals (1%) provided other opinions, and 7 individuals (4%) responded with "no opinion"

figure 9-3. Survey of LMO Thoughts

figure 9-4. Survey of LMO Importance

In addition, the results of a survey on the necessity of LMO revealed that 114 individuals (63%) responded affirmatively, 8 individuals (4%) responded negatively, and 60 individuals (33%) expressed uncertainty. This suggests that there is a prevailing perception of the necessity of GMOs, but it is also evident that there is a lack of awareness and understanding about LMO.

Among the 129 respondents who indicated that LMO are necessary, 93 individuals (72%) mentioned White Biotechnology as the area where LMO are most needed, while 23 individuals (18%) mentioned Red Biotechnology, and 13 individuals (10%) mentioned Green Biotechnology. This indicates that the response favoring the necessity of White Biotechnology is predominant at 72%. As a result, when it comes to essential fields of use for LMOs, White Biotechnology received the highest proportion of responses. However, in areas associated with genetically modified organisms, Green Biotechnology received the highest percentage of responses.

figure 9-5. Survey of Essential bio fields

figure 9-6.Survey of LMO concerns

In the survey on concerns, 65% of the 182 respondents expressed safety as their primary concern, accounting for 118 individuals. Following that, 29 individuals (16%) indicated concerns about the potential for dual use (Dual Use), and 23 individuals (13%) mentioned worries about mutations.Among those who cited safety as a concern, 31% had awareness of LMOs, while among those concerned about dual use, 38% were aware of LMOs.

GMO Awareness and Attitudes (Korean vs U.S.)

Our HP team investigated the extent of awareness of LMOs in Korea and the awareness in the United States, where LMOs are open and a lot of research is being conducted, and what the differences were.
When comparing American and Korean perceptions of GMOs, Korean and American citizens generally have a negative perception of GMOs due to safety and environmental concerns[9][12][13]. However, both the United States and Korea view the need for GMOs positively for reasons such as solving food problems, contributing to society, and profit.[9][12][13]

Comparison	US	Korea
Recognization	Only 12% said they had seen about GMOs, and 45% said they had heard of them a little or at all.	The number of people who are aware of LMO is decreasing as 2022 approaches.
Understanding	"In terms of their level of knowledge, 55% said they knew very little, 22% said they did not know at all, and the remaining 23% said they knew a little or well."	Most people know a little bit, and only 1% know it in detail.
Attitude	American life science students are positive about GMO foods (63%), but 51% of American citizens are negative about GMOs.	In Korea, GMO foods are viewed negatively in terms of food safety, and although they do not appear to be a major environmental problem, there is general concern about food problems using LMOs.
Necessity	A total of 136 U.S. citizens think positively about food supply and cheap GMO food, and a total of 110 people think it will cause side effects or environmental problems.	Korean people view GMO foods positively because they can contribute to society and solve food problems.

figure 10. Differences in perception between the United States and Korea