Abstract

[Purpose/Significance] China’s biomanufacturing exerts a significant influence globally and is at a critical stage of industrial development driven by synthetic biology. Driven by the social demand under the “dual carbon” goal, biomanufacturing empowered by synthetic biology has shown strong vitality. [Methods/Procedures] Based on literature research and investigations and interviews conducted in long-term investment practices, this paper analyzes the impacts of biotechnologies on production modes in recent years, as well as the current status and trends of biomanufacturing in various fields. [Results/Conclusions] Biomanufacturing will continuously expand its boundaries, penetrate into all sectors of the national economy, and promote industrial transformation and upgrading. Novel quality proteins, functional sugars, natural products and other fields will become hotspots in future biomanufacturing. The biotechnological utilization of non-grain raw materials will become more diversified, forming a tiered development pattern in China, and the next five years will be a critical period for technological breakthroughs. Advanced biomanufacturing is still in the early stage of development, and R&D, industry and policies cannot yet meet the requirements of its rapid development. All sectors including industry, universities, research institutes and government should grasp the industrial characteristics, collaborate to smooth the innovation chain and industrial chain, and build a joint force to boost industrial progress.

Introduction

Biomanufacturing is a material production approach centered on biotechnology, and its related industries have undergone three generations of technological evolution. The first-generation industrial technology relies on fermentation using single natural microorganisms; the second-generation adopts microorganisms modified by genetic engineering and protein engineering for production; the third-generation refers to advanced biomanufacturing driven by synthetic biology. At present, the biomanufacturing industry features a coexistence pattern of the three generations of technologies, among which the third-generation technology has become a key area promoting a new round of global industrial revolution and transformation. China has made overall arrangements for biomanufacturing as a strategic priority for economic development and a new growth engine. In March 2025, biomanufacturing was officially proposed as a future industry in the Report on the Work of the Government. In October 2025, the CPC Central Committee’s Recommendations on Formulating the 15th Five-Year Plan for National Economic and Social Development put forward fostering, expanding and forward-looking deployment of biomanufacturing, and strengthening original innovation and research on core key technologies in the biomanufacturing sector. More than 20 provinces (autonomous regions and municipalities directly under the Central Government), including Beijing, Tianjin, Shanghai and Shenzhen, have successively issued supporting policies. With policy support, China’s biomanufacturing industry has developed rapidly, initially forming a full industrial chain layout. Bulk fermentation products enjoy a scale advantage, and synthetic biology has also demonstrated huge industrial potential.

1 Current Status of Industrial Development

The total scale of China’s biomanufacturing industry has reached 1.1 trillion yuan, and the output of biofermentation products accounts for more than 70% of the global total. Among them, the annual output value of each of the two sub-sectors, namely food and additives, and biopharmaceuticals, exceeds 400 billion yuan. In addition, sectors such as bio-based materials and chemicals are experiencing sustained growth.

At present, China’s biomanufacturing industry is still dominated by bulk biofermentation products, and industries such as amino acids, organic acids and vitamins rank among the top in the world. The growth of China’s biofermentation industry is slowing down, and the problem of overcapacity has emerged. Advanced biomanufacturing is setting off a wave of innovation in medicine and health, food, consumer goods, materials, energy and other fields, showing strong growth potential in addressing climate change, water shortage, food safety and other challenges. In the field of medicine and health, biopharmaceuticals have grown faster than traditional chemical drugs in recent years, with outstanding performance in innovative areas such as monoclonal antibodies, vaccines and gene therapy. In the field of new food, an increasing number of new food ingredients and additives developed through biotechnology have emerged, and the market scale of erythritol, coenzyme Q10, astaxanthin, polyunsaturated fatty acids, human milk oligosaccharides (HMOs), vanillin, psicose and other products has grown rapidly. In the consumer goods sector, the application and development of ergothioneine, hyaluronic acid, recombinant collagen and other products continue to expand boundaries. In the field of bio-based materials, emerging materials such as polylactic acid (PLA) and polyhydroxyalkanoates (PHAs) started late in China but grow rapidly. In 2024, China’s PLA production capacity accounted for 31% of the global total, and the existing PHAs production capacity accounted for 18% of the global total. In the field of bioenergy, China’s biodiesel industry mainly using waste kitchen oil as raw material occupies an important position globally, with an output of 3.03 million tons in 2024, making it one of the main sources of biodiesel for Europe. Meanwhile, China’s biodiesel technology has been upgraded, further extending the industrial chain to sustainable aviation fuel (SAF), and supplies to Hong Kong International Airport were launched in 2025. In addition, supported by circular economy policies, microbial pesticides, herbicides and microbial fertilizers for sustainable agriculture, as well as microbial applications in soil and wastewater treatment in the field of environmental governance, have become new growth points for the biomanufacturing industry.

2 Industrial Hotspots and Development Trends

2.1 Biotechnology Supports Rapid Iteration of Biomanufacturing

Biotechnology has driven a sharp decline in R&D costs, becoming a key driving force for the development of the biomanufacturing industry. The rapid progress of underlying technologies such as gene synthesis and gene editing is the main factor enabling synthetic biology to promote the rapid iteration of biomanufacturing. Gene editing technology has expanded from gene deletion or silencing to single nucleotide substitution, multi-site editing, large-fragment DNA editing, site-specific gene insertion, precise genome rearrangement and other functions. A variety of gene editing tools derived from the CRISPR/Cas system, as well as the development of auxiliary tools for design and analysis, have greatly helped improve strain R&D efficiency. In terms of gene synthesis technology, automated DNA synthesis and assembly platforms have emerged globally. For example, the primer synthesis cost of GenScript’s high-throughput platform can be as low as 0.01 yuan per base pair. Enterprises such as MGI Tech and Zhonghe Gene are also at the international leading level. Through the integration and optimization of the above technologies, China has greatly improved the efficiency of strain development. The Biofoundry platform of the Tianjin Institute of Industrial Biotechnology, Chinese Academy of Sciences, can achieve a strain construction throughput of 3,000 strains per month for commonly used industrial chassis such as Escherichia coli and Corynebacterium glutamicum. In the future, industrial strain development will cover more chassis strains and develop toward higher throughput.

2.2 The R&D Paradigm of Synthetic Biology Is Becoming Mature

Synthetic biology adopts a core R&D paradigm of “Design-Build-Test-Learn” (DBTL cycle). Engineered strains created through synthetic biology can significantly enhance biomanufacturing capabilities. Early synthetic biological systems relied on repeated manual trial and error, which was slow, inefficient and limited to simple microorganisms. The limited design capacity of synthetic biological systems severely restricted the development of synthetic biology. At present, the in-depth integration of artificial intelligence (AI), big data and other technologies into the DBTL cycle, combined with the extensive application of high-throughput equipment, has formed a new paradigm for the design of biological components and gene circuits, significantly improving R&D efficiency and accuracy. The model of guiding the design and assembly of new components based on massive high-quality standardized data and the learning and prediction of AI models such as AlphaFold, combined with wet laboratory verification, has become increasingly popular and is a hotspot in the development of modern synthetic biotechnology. The Shenzhen Institute of Agricultural Genomics, Chinese Academy of Agricultural Sciences, assisted in the product and enzyme molecular structure design and expression regulatory network analysis through AI, helping to realize the heterologous biosynthesis of baccatin III, a raw material for paclitaxel. MolecularMind proposed an AI enzyme design method “SENZ”, achieving breakthroughs in highly challenging industrial problems and realizing the design of complex enzyme molecules with low-sample and zero-sample data.

2.3 Biomanufacturing Will Promote the Transformation and Upgrading of More Manufacturing Industries

Biomanufacturing is integrating into various fields of manufacturing, forming numerous industrial hotspots and becoming a core driving force for economic transformation and development. Among them, the advantages of the biological method in protein and chiral molecule synthesis will highlight the development of novel quality proteins, sugars, natural products and other fields.

Novel quality proteins refer to protein products with new or alternative functions created through synthetic biology, with a long-term market potential of up to trillions of yuan. China has an increasing number of microbial protein products, including Clostridium autoethanogenum protein, yeast protein, fusarium protein, microalgae protein and others. Microbial proteins are expected to be produced on a large scale through biological fermentation to meet the protein demand of the feed and food industries, reducing the current dependence on planting and breeding industries. In the future, they can replace bulk protein raw materials such as fish meal and soybean meal, alleviating or even completely solving the major problem of protein resource shortage in China. Whey protein, lactoferrin, human-derived collagen, human serum albumin, sweet protein and other products obtained through precise fermentation of cell factories can replace traditional counterparts in food nutrition, cosmetics, medical treatment and other fields, with broad prospects. Spider silk protein and mussel protein have superior mechanical properties and are expected to become new materials for special fields. In addition, peptides and enzyme preparations designed with new functions through synthetic biology will also be applied in various fields.

With the improvement of living standards in China, the demand for healthy sugars is gradually growing. A new generation of representative healthy sugars such as human milk oligosaccharides, psicose and tagatose are becoming market hotspots. Among natural products produced by fermentation instead of extraction, various chiral compounds such as steviol glycosides, γ-aminobutyric acid, L-malic acid and lycopene will greatly meet the rapidly growing market demand in nutrition and health, healthcare and other sectors.

2.4 Tiered Development of Biomanufacturing in Non-Grain Raw Material Utilization

The industrialization of non-grain raw material utilization in the energy sector continues to advance, including biodiesel production from waste kitchen oil, biogas production from anaerobic fermentation of kitchen waste and livestock manure, and ethanol production from corn stover and industrial tail gas. Important progress has been made in three-component separation technology, and the graded utilization technology of agricultural straw has taken initial shape. Technologies such as protein production through fermentation using methane and methanol as substrates are undergoing industrial trials. A series of technologies are being actively explored, including microalgae conversion using carbon dioxide as a carbon source, or the synthesis of intermediates such as methanol and acetic acid, followed by the production of sugars and starch through microbial or enzymatic utilization. The next five years will be a critical period for biotechnological breakthroughs in non-grain raw material utilization.

3 Challenges Faced by the Industry

In the process of moving toward the high end of the global value chain, China’s biomanufacturing industry still faces many bottlenecks and challenges. At the policy level, the special supporting policies for China’s biomanufacturing industry need to be refined and strengthened. The biomanufacturing industry involves multiple regulatory authorities, making it difficult to systematically coordinate policy formulation, and the regulatory system needs to adapt to the rapid development of the industry. At the R&D level, research on core strains/enzymes and applied R&D are both weak, and some core links face “bottleneck” problems. China lacks many disruptive and original “from 0 to 1” achievements in the biotechnology field, and is highly dependent on imports or foreign patent licenses for high-end industrial enzyme preparations and core industrial strains. Applied research targeting end products has not received sufficient attention from research institutions. The localization rate of core equipment and special consumables is relatively low. At the industrial level, the conversion rate of scientific and technological achievements from laboratory to mass production is low. The “industry-university-research-application” coordination mechanism is not smooth, and the software and hardware capabilities for industrial transformation are insufficient. Technological innovation enterprises in biomanufacturing lack medium- and long-term capital support in the key stage of industrialization, and a large number of scientific research achievements struggle to cross the “valley of death”.

4 Discussion and Conclusion

Biotechnology is at a critical stage of industrial migration, and there are still problems in technology, industry, policies and other aspects that require joint efforts from all parties. The author holds that China’s biomanufacturing industry should strengthen empowerment in the following aspects:

(1) Achieve independent control of core technologies. The national major science and technology program for biomanufacturing will provide long-term and stable support for basic research, cutting-edge research and interdisciplinary research. The “Biomanufacturing Foundation Strengthening Project” will be implemented to jointly tackle key “bottleneck” technologies, equipment and raw and auxiliary materials, and promote the integrated innovation of cutting-edge and disruptive technologies in the field of biomanufacturing.

(2) Build a smooth “industry-university-research-application” innovation chain. Policies will support and guide researchers to carry out market-oriented basic research and applied research, support the construction of infrastructure such as pilot platforms, and optimize the market access and approval of products. Funding will meet the demand of start-ups for medium- and long-term venture capital, and a sound technology transfer and achievement transformation service system will be established in supporting facilities.

(3) Enhance the resilience of the industrial chain and supply chain. Implement projects to strengthen and supplement the industrial chain, and focus on domestic substitution. Establish a reserve mechanism for key materials and technologies to cope with potential supply chain disruption risks. Strengthen the substantive role of industrial alliances, and build an industry-level data sharing and collaboration platform.