The synthetic biology production technology of L-Arginine

Currently, microbial fermentation dominates the synthetic biology production technology of L-arginine, with continuous upgrades in strain modification and process optimization. Meanwhile, emerging technologies such as enzyme-catalyzed synthesis and electrochemical synthesis are being gradually explored. Leveraging technological advantages and strong downstream demand, this technology boasts broad industrialization prospects but also faces certain technical and market challenges. A detailed analysis is as follows:

I. Mainstream Synthetic Biology Production Technologies

Microbial Fermentation

As the core technology for the industrialization of L-arginine synthetic biology, this method uses Corynebacterium glutamicum, Escherichia coli, and other strains as model organisms, with metabolic pathways optimized through genetic engineering. For example, the Corynebacterium glutamicum engineering strain ARG-2025 developed by Cargill achieves a yield exceeding 120 g/L and a conversion rate of over 85% using glucose as the substrate, while reducing wastewater COD by 60%. Leading domestic enterprises have achieved a glucose conversion rate of over 65% through this technology, with the comprehensive energy consumption per ton of product decreasing by approximately 22% compared to 2018. The production process involves strain mutagenesis and screening, followed by submerged liquid fermentation to obtain L-arginine-containing fermentation broth, and final extraction and purification to yield the finished product. Giants such as Ajinomoto (Japan) and Meihua Biotech (China) adopt this process for large-scale production.

Enzyme-Catalyzed Hydrolysis Technology

Serving as a supplementary technical route in synthetic biology, it focuses on resource recycling. For instance, Novozymes’ collagenase Collagenase-ARG25 can extract L-arginine from leather waste, increasing the extraction rate from the traditional 55% to 92%. It has also obtained EU "circular economy" certification, addressing waste disposal issues, reducing raw material costs, and aligning with green production concepts.

Emerging Auxiliary Synthesis Technologies

Some enterprises are exploring innovative routes such as electrochemical synthesis. For example, BASF’s ammonia-carbon dioxide coupling method produces L-arginine in an electrolytic system, reducing carbon emissions by 50% compared to traditional fermentation. Additionally, in the research field, CRISPR-Cas12 gene editing technology is used to further optimize the arginine synthesis pathway of strains, targeting a yield breakthrough of 150 g/L and reserving space for subsequent technical upgrades.

II. Industrialization Prospects

Favorable Factors

Strong Market Demand Drives Capacity Expansion

Continuous growth in demand from downstream sectors such as pharmaceuticals, functional foods, and feed. In 2023, China’s annual output of L-arginine API was approximately 18,000 tons, with 65% used for export. It is expected that by 2030, China’s market size will exceed 3.5 billion yuan, maintaining a compound annual growth rate of 9%-11%. Globally, the market size is projected to approach 1.8 billion US dollars in 2025 and surpass 2.5 billion US dollars by 2030. The huge demand provides support for the industrialization of synthetic biology technology. As the world’s largest producer, China’s capacity reached 98,000 tons in 2023, accounting for 53% of the global total, and leading enterprises are continuing to expand production to further consolidate their capacity advantages.

Policy and Cost Advantages Lay the Foundation for Development

Policies such as the 14th Five-Year Plan for Bioeconomy Development list the amino acid industry as a key supported sector, providing institutional guarantees for the industrialization of synthetic biology technology. Meanwhile, synthetic biology technology continues to reduce production costs—for example, after strain modification, the L-arginine yield per unit of fermentation broth exceeds 120 g/L, driving a cost reduction of approximately 40%. From 2023 to 2025, its average price remained stable in the range of 28-35 yuan per kilogram. With further technological optimization, costs will continue to decrease, improving the cost-effectiveness of industrialization.

Technological Iteration Opens Up High-End Market Space

Synthetic biology technology enables product upgrades toward high purity. Pharmaceutical-grade L-arginine requires a purity of ≥99.0%, and domestic enterprises are narrowing the gap with Europe and the United States through technological breakthroughs. In 2023, the global market size of pharmaceutical-grade L-arginine reached 480 million US dollars, with an expected CAGR of 6.2% from 2024 to 2030. High-value-added pharmaceutical-grade products will become an important growth driver for industrialization.

Existing Challenges

Coexistence of Technical and Competitive Pressures

The high-end market is still dominated by European, American, Japanese, and South Korean enterprises, which possess high technical barriers in high-purity pharmaceutical-grade products. Some domestic high-end products still rely on imports. Meanwhile, non-natural amino acid analogs developed by companies such as Zymergen achieve 90% functional equivalence with a 35% cost reduction, potentially posing a substitution threat to the L-arginine market. Additionally, the EU will impose a carbon tax of 60 euros per ton on fermented arginine starting from 2026, forcing enterprises to upgrade low-carbon technologies and increasing short-term industrialization costs.

Structural Risks in the Industry

Currently, the industry’s supply and demand are generally balanced but structurally tight. While the utilization rate of some low-end production capacity remains at 75%-85%, high-end capacity is insufficient. Furthermore, price fluctuations of raw materials such as glucose and liquid ammonia, coupled with stricter environmental regulations, may affect the stable advancement of synthetic biology industrialization. Enterprises need to address these issues through technological innovation and supply chain management.