生物技术

Synthetic Biology Reshaping the Healthcare Industry: At the Forefront of Biotech Innovation in 2025

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As of November 2025, the synthetic biology market is experiencing unprecedented growth, redefining the boundaries of the traditional biotech industry. The global synthetic biology market size is projected to grow from $35 billion in 2024 to $85 billion by 2030, with an average annual growth rate of 15.8%, significantly outpacing the traditional pharmaceutical industry growth rate of 6-8%. In particular, South Korea has announced a total investment of 2.5 trillion won in the synthetic biology sector by 2027, alongside the government’s K-Bio Belt project, aiming to secure global competitiveness in this field. Ginkgo Bioworks, headquartered in Cambridge, Massachusetts, recorded a market capitalization of $4.5 billion as of the third quarter of 2025, leading the industry alongside Zymergen (now acquired by Ginkgo) in Emeryville, California, creating a new industrial category of ‘biological manufacturing.’

Synthetic Biology Reshaping the Healthcare Industry: At the Forefront of Biotech Innovation in 2025
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The core of synthetic biology is the technology of designing and editing the DNA of living organisms as if it were computer code to produce desired compounds or proteins. Unlike traditional chemical synthesis or natural product extraction methods, microorganisms or yeast can be used as ‘living factories’ to produce a wide range of products from pharmaceutical raw materials to biofuels and food additives. Novozymes, headquartered in Copenhagen, Denmark (now merged into Novonesis), has been producing industrial enzymes for 30 years, but reports that the development speed has increased more than tenfold with the recent combination of CRISPR-Cas9 technology and AI-based protein design technology. While traditional new drug development takes an average of 10-15 years, the development of biopharmaceuticals using synthetic biology is shortened to 3-5 years, attracting industry attention.

One of the most notable areas in the market is personalized medicine. Genentech, headquartered in South San Francisco, California (a subsidiary of Swiss Roche), announced an additional investment of $1.5 billion in the first half of 2025 for the development of synthetic biology-based CAR-T cell therapies. This treatment involves extracting a patient’s immune cells, editing the genes, and reinjecting them into the body, achieving a treatment success rate of 70-80% compared to existing cancer drugs. South Korea’s Celltrion (headquartered in Songdo, Incheon) also announced that it would begin full-scale development of biosimilars using a synthetic biology platform from the fourth quarter of 2024, expecting to reduce development costs by 40% compared to existing methods. Notably, the South Korean government has decided to operate a separate approval review track for synthetic biology-based therapeutics from the second half of 2025, making it the third in the world after the US FDA and European EMA.

The Rise of Industrial Biomanufacturing and Competitive Landscape

The most mature field in the commercial application of synthetic biology is industrial biomanufacturing. Archer Daniels Midland (ADM), headquartered in Chicago, Illinois, began mass production of bio-plastic raw materials using microorganisms designed through synthetic biology from early 2025. The PLA (Polylactic Acid) produced through this process can reduce carbon emissions by 65% compared to conventional petrochemical-based plastics and save $200 per ton in production costs. DSM-Firmenich, headquartered in Delft, Netherlands, holds a 35% global market share in vitamin production using synthetic biology, with approximately 30% of its 2024 annual revenue of €12.5 billion coming from synthetic biology-related products.

In terms of the competitive landscape, while US and European companies lead in technology development, Asian companies show strengths in commercialization and mass production. BGI Genomics, headquartered in Beijing, China, announced an investment of 5 billion yuan (approximately $700 million) in a dedicated synthetic biology manufacturing facility in the first half of 2025, marking the largest single investment in the industry. Japan’s Ajinomoto (headquartered in Tokyo) applied synthetic biology to amino acid production, improving productivity threefold compared to existing methods, and recorded a 28% market share in the global industrial amino acid market as of 2024. In South Korea, CJ CheilJedang (headquartered in Seoul) possesses synthetic biology-based amino acid production technology, maintaining the world’s second-largest market share, particularly in lysine and tryptophan.

Analyzing investment trends, venture capital investment in synthetic biology startups has surged in 2025. Andreessen Horowitz in San Francisco, California, has raised $750 million through the ‘a16z bio fund III,’ with plans to invest 60% by the second half of 2025. A particularly notable field is ‘bio computing,’ which utilizes DNA as a data storage medium. Microsoft, headquartered in Seattle, Washington, has invested $200 million in developing DNA data storage technology, aiming for commercialization by 2030. Once commercialized, this technology could store exabyte-scale data in a sugar cube-sized DNA, potentially reducing the energy consumption of existing data centers by over 90%.

Regulatory Environment and Ethical Considerations

With the rapid advancement of synthetic biology, establishing a regulatory framework has emerged as a critical issue. The US FDA released new guidelines for synthetic biology products in September 2025, particularly strengthening safety evaluation standards for products using genetically modified microorganisms (GMOs). The European Union is taking a more stringent approach, mandating environmental impact assessments for synthetic biology products under new biosafety regulations implemented in July 2025. This has extended the approval process for entering the European market by an average of 18 months, leading some companies to delay or abandon European market entry.

On the ethical front, societal concerns about ‘life creation’ technology persist. Particularly controversial are attempts to control wild mosquito populations using ‘drive’ technology. Oxitec, headquartered in Oxford, UK, is conducting experiments releasing genetically modified mosquitoes into the wild to reduce malaria-carrying mosquito populations, facing strong opposition from environmental groups. A pilot program conducted in Brazil in October 2025 showed an 85% reduction in mosquito populations in the target area, but the long-term ecological impact remains unclear. Reflecting these concerns, the World Health Organization (WHO) announced plans to establish global guidelines for synthetic biology technology by the end of 2025.

The industry is also working to build trust through self-regulation. The Broad Institute in Cambridge, Massachusetts, established a ‘Synthetic Biology Ethics Committee’ in early 2025, setting ethical guidelines for research processes. Additionally, the ‘SynBio Industrial Consortium,’ involving major industry companies, agreed to apply common safety standards to member companies from the second half of 2025. These efforts are analyzed as strategic approaches to gaining the trust of consumers and regulatory authorities. Notably, the South Korean government plans to introduce a ‘safety certification system’ for synthetic biology products from December 2025, offering tax benefits and government procurement priority for certified products.

Summarizing market prospects, synthetic biology is entering a full-fledged commercialization stage from 2025, transitioning from the research and development phase. Goldman Sachs recently projected that the synthetic biology market could grow to $3 trillion by 2030, matching the current total biotech market size. With rapid expansion in healthcare, chemical, agriculture, and energy sectors, fundamental changes in existing industrial structures are anticipated. Investors are also paying attention to these changes, with the scale of synthetic biology-related IPOs in the first half of 2025 increasing by 340% year-on-year to $8.5 billion. However, the complexity of the technology, regulatory uncertainties, and ethical controversies continue to pose risk factors, necessitating a cautious approach from a long-term perspective.

Disclaimer: This analysis is based on publicly available information and industry trends and should not be used as a basis for investment decisions. Investments related to synthetic biology should be made cautiously, considering high technological risks and potential regulatory changes.

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