Frost & Sullivan officially releases the 'White Paper on the Development of Shanghai's Synthetic Biology and Biomanufacturing Industries (2025)’ (with full text available for download)

Synthetic biology, as a new frontier research paradigm, is committed to 'from 0 to 1' original innovation. Its goal is to design and reconstruct life systems, solve problems such as synthetic difficulties, low efficiency, energy consumption, and environmental pollution, and promote innovation at the scientific research level. Bio-manufacturing, as a new manufacturing paradigm, focuses on 'from 1 to 100' engineering implementation, aiming to transform new technologies such as synthetic biology into stable, efficient, and scalable industrial production processes. This leap requires breaking through engineering challenges such as process stability and cost control on the basis of scientific research innovation, and also depends on the integration and optimization of upstream and downstream supply chains to achieve large-scale production. Therefore, synthetic biology and bio-manufacturing constitute a complete innovation chain from basic research to industrial implementation.

Synthetic biology, through its engineering concept, can design and transform entirely new biological systems, directly responding to the needs of Bio-Make 4.0 for new products (artificial starches, renewable drugs), new methods (efficient, sustainable), and new goals (solving food-energy-water resource challenges). It collaborates with metabolic engineering, in vitro synthetic enzyme systems, and other technologies, breaking through the development limitations of the first three stages of bio-manufacturing that rely on natural biological systems. Therefore, with its disruptive innovation characteristics, it has become one of the core technologies at this stage.

Data source: Literature search, Frost & Sullivan analysis

The biomedical field is currently the largest application scenario, covering eight major sub-markets including new vaccines, cell and gene therapy, etc. Its core value lies in optimizing production processes. On one hand, it enhances the R&D and production efficiency of products such as new vaccines, bulk drugs, and excipients, and on the other hand, accelerates the discovery and preparation of natural products. At the same time, by systematically expanding the natural product library, it effectively alleviates the contradiction between resource acquisition and ecological protection. In the field of advanced materials, through process optimization and deep integration with cutting-edge technologies, it can not only achieve efficient material production but also precisely match the differentiated needs of high-end scenarios. In the consumer goods field, by means of process improvement and product formula optimization, it solves some raw material synthesis problems and helps with the R&D and product iteration and upgrading of precision nutrition. In the energy field, it focuses on the innovative R&D and large-scale mass production implementation of biofuels. In the environmental protection field, it can support the construction of advanced biosensing systems and the R&D of new biodegradable agents. In the agricultural field, through technical means such as transforming microbial metabolic pathways and designing synthetic high-yield gene clusters, it achieves the core goals of enhancing crop stress resistance, preventing and controlling plant diseases and pests, and reducing comprehensive production costs.

Therefore, 'synthetic biology' as a disruptive technology leading the transformation of the 'bio-manufacturing' industry, has three core strategic implications for the world: first, it reconstructs the logic of material production to aid sustainable development; second, it breaks through traditional industry boundaries to ensure supply chain security; third, it reshapes the global industrial landscape to seize the high ground for future development.

Data source: Public information and Frost & Sullivan analysis

The rapid development of the industry and the growth of enterprises in all links of the industrial chain are due to the industrial platforms established by various provinces, municipalities, and autonomous regions. This white paper sorts out the latest distribution of synthetic biology and biomanufacturing industries in mainland China according to three dimensions: industry organizations, research institutes, and industrial clusters, and analyzes in detail the advantages and models for each province in developing synthetic biology and biomanufacturing.

The first tier is centered around Jiangsu Province, Zhejiang Province, and Shanghai Municipality. Leveraging talent aggregation effects, local support policies, and a solid industrial foundation, it promotes regional resource circulation and innovation resource aggregation through deep collaboration among government, enterprises, and universities. It focuses on overcoming key challenges such as innovative technologies and scientific research transformation in the process of synthetic biology from laboratory to commercialization, forming a distinctive and complete industrial development pattern with each having its own characteristics. The second tier includes the Beijing-Tianjin-Hebei region and the Pearl River Delta region. Through coordinated development, fund support, and innovation platform construction, it constructs an industrial ecosystem linking research and market, promoting the large-scale development of the synthetic biology industry.

Data source: Public information, Frost & Sullivan analysis

Currently, climate change has become a major challenge shared by the global community, fundamentally due to the massive emissions of greenhouse gases and the high dependence on fossil fuels. Against this backdrop, synthetic biology provides a new technological pathway for energy production, demonstrating significant advantages and enormous application potential. Unlike the traditional fossil path, which highly relies on geological carbon reservoirs, has limited energy conversion efficiency, and is emission-intensive, synthetic biology is committed to using biological systems to achieve renewable, low-carbon, or even negative carbon energy production. For example, through microbial carbon sequestration to synthesize biofuels, using synthetic metabolic pathways to convert carbon dioxide or waste biomass into hydrogen energy, methane, or high-value energy molecules. This pathway essentially shifts energy production from the 'exploitation-burning' linear model to a 'cycle-fixation' green model.

In recent years, the investment logic of the global synthetic biology industry has undergone profound adjustments. The investment scale significantly declined in 2022-2023, closely related to the capital market fluctuations triggered by global epidemics. This reflects the increasing emphasis on risk control among investors, leading to more cautious capital flows. As a result, the overall number of transactions in the market decreased, but the average transaction amount increased.

Looking at the total investment in synthetic biology-related industries globally in 2024 and their focus areas, healthcare and biopharmaceuticals accounted for the largest proportion of investments. Areas such as gene therapy, cell therapy, and AI drug development have attracted a significant amount of capital. Investments in the chemical and materials sector have rebounded significantly, reflecting the main investment direction in synthetic biology globally in 2024, which indicates an increasing demand for gene synthesis and efficient chemicals. Investment in the energy and environment sector has grown significantly, especially in the biofuel field, suggesting that energy transformation and sustainable development are becoming hotspots for investment.

Looking globally, the US synthetic biology and biomanufacturing industries started early and are the most mature, continuously leading global technological innovation and industrialization processes. Currently, the regulatory system for synthetic biology and biomanufacturing in the US is centered around 'end products as the core, incorporated into the existing legal framework,' relying on an existing institutional and cross-departmental collaborative regulatory model to construct a relatively clear regulatory path. However, there are still significant shortcomings: first, the problem of fragmented regulation is prominent, with overlapping departmental responsibilities and inconsistent enforcement standards, leading to uncertainties in corporate compliance and market access; second, there are regulatory gaps in frontier areas, lacking targeted policy guidance for emerging technologies such as AI design and cell-free platforms; third, regulatory updates lag behind technological iterations, not only restricting the efficiency of innovation implementation but also increasing additional compliance costs for companies. It can be seen that although the US regulatory system covers major application areas and has clear divisions of labor, it still needs further optimization and improvement in dealing with cross-border products and frontier technological innovations.

As one of the pioneering markets in synthetic biology globally, the UK has established a complete innovation ecosystem consisting of academia, startups, growing companies, and multinational giants. After Brexit, relying on an independent regulatory environment and flexible policy design, its industrial development is accelerating from 'research leadership' to 'industrialization leadership'. However, faced with limited local market size, the continuous impact of Brexit's aftermath on scientific research cooperation and market access, coupled with the need to strengthen policy and financial support, the industrial development still faces multiple practical challenges.

Focusing on the Chinese market, China's industrial regulatory system is still dominated by existing product categories and pathways, characterized by 'relying on the existing legal framework with decentralized management by multiple departments.' Regulatory authorities have been conducting research on synthetic biology science regulation but have not yet issued or revised regulatory documents specific to synthetic biology due to new features. Currently, many novel and uniquely functional synthetic biological raw materials lack clear criteria for determination and access paths, leading companies to often choose overseas registration first, increasing commercial costs. This regulatory situation brings uncertainty but also harbors opportunities for transformation. In areas with clear categorization such as biomedicine, a clear and increasingly efficient approval process supports the orderly development of the industry; however, for new products in ambiguous territories, with the gradual rise of the domestic industrial ecosystem and strong cultivation by local governments, it is urgent to adjust existing regulations according to actual conditions, or innovate and break through to formulate new regulations, quickly establishing a comprehensive, scientifically classified, efficient, transparent, and clearly anticipated regulatory scientific framework that is conducive to the development of synthetic biology and bio-manufacturing industries.

Therefore, based on the case analysis of benchmark markets in the United States and the United Kingdom, the development experiences and insights that China can adopt in the future are as follows:

1. Carefully choose the commercialization path to avoid low-end competition in high-tech industries:

The core lesson from Amyris' bankruptcy restructuring is that even with top-notch technology, if the initial product is chosen as bulk chemicals or raw materials, it will face fierce cost competition with the mature petrochemical industry and is highly susceptible to difficulties due to massive investments in large-scale production and market price fluctuations. Future layouts should solidly conduct competitive market research, fully consider rapid technological iteration, prioritize the establishment of moats in areas with high profit margins and strong technological barriers, and then gradually expand scale.

2. The core of supervision lies in certainty, not in simply pursuing speed:

The GRAS notification system of the US FDA is an extremely efficient and predictable pathway. Companies clearly define the data they need to prepare and the declaration principles they must follow from the beginning of their research and development. The certainty of this regulation far promotes industrial development more than a regulatory system that is inconsistent and subject to frequent changes in standards. Establishing and improving a biosimilar product review system that conforms to national conditions and is in line with international standards can stimulate long-term innovation vitality more than any single subsidy policy.

3. The industry has broken through industrialization bottlenecks, with pilot testing and scale-up being key to industrial transformation:

The U.S. government has the ability to accurately identify and solve core bottlenecks in promoting industrial development. When it perceives that laboratory results are difficult to mass-produce, the Department of Defense takes the lead in establishing BioMADE, a public-private partnership platform focused on pilot-scale production and large-scale manufacturing. The UK has also built open sharing platforms through the Catapult network and FBRH model to accelerate the transformation of research results. Therefore, the Chinese government and industry associations can take the lead in establishing open sharing validation bases and supply chain alliances to help startups overcome commercialization challenges.

Shanghai is one of the earliest regions in China to develop synthetic biology, establishing the country's first "Synthetic Biology Key Laboratory" (Chinese Academy of Sciences) and the first Synthetic Biology Innovation Alliance (led by Shanghai Jiao Tong University). It also gave birth to the first listed company in the field of synthetic biology (Kaisai Biotech). As an industrial originator, Shanghai has numerous platforms and core research institutions related to the synthetic biology industry, accumulating a profound first-mover advantage and leading the innovation direction of the national synthetic biology industry. This originator status endows Shanghai with unparalleled callability and attractiveness in setting industry standards, leading technological routes, and gathering top talents. The strong originative ability is integrated with the industrialization strength of the Yangtze River Delta to form a powerful "magnetic field," continuously attracting global innovation resources to gather and accelerating their transformation into mature industries.

Shanghai's development of synthetic biology and biomanufacturing industries possesses global connectivity due to its geographical location (linking domestic and international dual circulations), collaborative leadership in regional areas (driving industrial linkage in the Yangtze River Delta), and pioneering advantages in industrial locations (as an innovation leader at the forefront of synthetic biology). This is a composite strategic advantage that integrates a strategic gateway, industrial hub, and innovation source.

These dimensions empower each other, enabling Shanghai to possess both the advantages of being a gateway connecting to global resources and exploring international markets, as well as the convenience of integrating regional forces and deepening industrial collaboration. Moreover, it holds the power to lead industry innovation and gather high-end elements, creating an excellent development environment for the soaring of synthetic biology and biomanufacturing industries that is 'multi-dimensional, three-dimensional, and internally and externally linked'. This not only gives Shanghai the capability to represent the country in global biotechnology competition but also promises to become a world-class industrial cluster leading the future era of the bioeconomy.

Data source: Public information, Frost & Sullivan analysis