As polypeptide drugs, represented by GLP-1, expand their applications across numerous chronic diseases—such as diabetes, weight management, chronic kidney disease, cardiovascular diseases, and osteoarthritis—their market potential is rapidly increasing. According to Sullivan data, measured by sales revenue, the global polypeptide drug market is expected to grow from USD 60.7 billion in 2018 to USD 261.2 billion by 2032. Moreover, 2014–2026 marks a peak period for patent expirations of major polypeptide drugs, which will lead to a wave of generics and accelerate pharmaceutical companies’ development of next-generation polypeptides. As old and new molecules compete in the same arena, reconstruction of synthetic processes and compliant capacity expansion will naturally propagate up the value chain, creating new opportunities for upstream companies controlling key R&D and production technologies, including intermediates and APIs.
Despite the broad market potential, few companies can rapidly invest in polypeptide R&D and large-scale production. This is because developing polypeptides into drugs is inherently challenging. On one hand, early-stage screening of polypeptides is labor-intensive and technically demanding: for a 14-amino-acid polypeptide, there are 10^18 possible compound combinations, and incorporating non-natural amino acids increases the number of combinations by several orders of magnitude. On the other hand, polypeptide drug development lacks well-established discovery pathways and target design methodologies. Although global libraries of polypeptide entities exist, their size and diversity are insufficient to meet the practical needs of innovative drug screening. Constructing physical libraries of long-chain polypeptides is particularly difficult, making targeted screening challenging.
The advent and integration of AI algorithms have addressed early discovery and design challenges in polypeptide drug development. By learning biomolecular features and simulating protein structure–function relationships, AI can overcome the limitations of traditional design methods, generating polypeptides with entirely novel structures and functions. Even structurally complex long-chain or cyclic peptides can have their prototypes “computed” in advance, bringing revolutionary changes to the field.
However, discovering new polypeptide molecules is only the first step. Once identified, these molecules must cross the “valley of death” of synthesis and large-scale production. The combination of technological innovation and AI increases the frequency of complex polypeptide discoveries. Yet complex structures introduce challenges in scale-up, such as increased condensation difficulty and higher levels of derivative impurities, where traditional chemical synthesis technologies no longer have advantages. Conventional production methods can only achieve 2,000–3,000 L scale, insufficient to meet the future ton-scale demand of the polypeptide industry.
Clearly, large-scale polypeptide production faces multiple challenges. In the current phase, where chemical polypeptide capacity is gradually being released, companies that can overcome the high technical barriers of complex polypeptide R&D and industrial-scale production will first occupy the next blue ocean of the polypeptide market. The polypeptide sector has entered an era where “internal capabilities” determine competitive advantage.
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Post-GLP-1 Era: Competing Through Innovation in Polypeptide Synthesis and Scale-Up
Currently, chemical synthesis remains the main method for polypeptide production. With the explosion of GLP-1 drugs, the industry has begun optimizing production processes, showing a trend of integrating chemical and biological synthesis. Industry experts note:
“Biological synthesis offers low production costs, strong targeted expression, and large-scale production capabilities. It is widely recognized as the future development trend in polypeptide synthesis.”
Chemical synthesis of polypeptides involves numerous steps, long production cycles, and generates large amounts of organic wastewater, resulting in high waste management costs and expensive production. Chemical synthesis also struggles with long and complex peptides. Furthermore, as chemical synthesis technology matures and equipment supply increases domestically, more companies have acquired chemical polypeptide production capabilities, intensifying market competition. For mature off-patent products, multiple API suppliers exist, leading to fierce competition in both raw materials and formulations. Competition among chemical synthesis companies is therefore mainly driven by scale, cost advantage, and market strategy, rather than technological breakthroughs. This mature, saturated chemical synthesis polypeptide sector no longer holds the same potential for capturing larger market value.
Traditional biological synthesis also faces industry challenges. Its strategies rely on limited technologies, suitable for only a few polypeptides with low yields, resulting in high production costs and inability to replace chemical synthesis effectively. Limitations include low target peptide ratio in fusion protein designs, amino acid composition, cyclization, and modifications that restrict general applicability. Engineering challenges for large-scale, cost-effective production, including cell factory construction and downstream process development, make traditional biological synthesis difficult.
In the post-GLP-1 era, the number of complex polypeptides is rapidly increasing, but traditional synthesis technologies cannot meet all needs. Demand for GLP-1 and next-generation GLP-1 products will soon require ton-scale production, yet many polypeptide APIs still lack mature production processes, with multiple steps needing exploration and verification. Production scale-up remains a bottleneck.
To address complex polypeptide synthesis challenges, some companies are turning to synthetic biology. Despite China’s later start in synthetic biology, it has huge potential in polypeptide applications. XiuShi Biotech, founded in 2020 by experts with over 10 years of synthetic biology experience, anticipated these needs and has become a domestic leader in large-scale biological synthesis of complex short peptides. The company has developed proprietary innovative biosynthesis technology and an integrated platform combining AI, genetic engineering, enzymology, fermentation, protein engineering, and chemical engineering, enabling high-efficiency, low-cost, scalable polypeptide biosynthesis.
Polypeptide Production Technology Comparison
XiuShi Biotech’s innovative biosynthesis technology has been applied to over ten polypeptide products. Through a core platform of diverse protein building blocks, gene elements, peptide chain modifications, and non-natural amino acid incorporation, XiuShi has overcome challenges in synthesizing short peptides and complex cyclic peptides. By combining chemical and biological modifications, it solves issues like multiple disulfide bond cyclization, non-natural amino acid modification, and fatty acid side-chain attachment.
Products using XiuShi’s innovative biosynthesis technology cost only 10–20% of chemical synthesis, while production efficiency is over five times higher and fermentation scale requirements smaller than traditional biological synthesis.
XiuShi continues to enhance its platform using AI for rapid process iteration. Leveraging its protein and enzyme libraries, the company has built neural network models to shorten R&D cycles and improve biosynthesis quality. This allows cost- and quality-optimized process solutions for emerging multi-target polypeptide drugs, increasing R&D efficiency and competitive advantage.
In the era of “technology iteration + demand explosion + capacity reconstruction,” only companies continuously enhancing their capabilities can meet the changing needs of polypeptide industry clients. XiuShi Biotech has established a strong technological moat in the domestic polypeptide biosynthesis field.
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“Capacity + Ecosystem” Synergy: From Self-Build to Shared Value
Breaking through synthesis technology is only the first step. Efficient scale-up is key to gaining industry partners’ trust and long-term competitiveness. Over five years, XiuShi Biotech has built a full-chain system from lab R&D to GMP-compliant production.
XiuShi operates a 5,000㎡ AI-powered R&D center and a 13,000㎡ intelligent polypeptide production base, capable of flexible production from gram-scale research samples to ton-scale commercial products. This supports small-batch clinical samples and large-scale commercial supply. The facility is China’s first GMP-compliant, fully synthetic biology-based polypeptide production line.
By providing one-stop empowerment to industry partners, XiuShi is reshaping the polypeptide ecosystem. The company supports clients with high technical and quality demands, such as AI drug discovery and cell therapy firms, to develop and commercialize complex polypeptides.
Wu Yinsong, XiuShi’s founder and chairman, emphasizes:
“Client commercialization is not just scaling the molecule—it’s about future cost accessibility. We solve both technical and scale challenges, delivering products with superior cost, speed, and quality.”
Co-founder and GM Yin Haixing notes:
“Clients often say that after collaborating with us, they see polypeptide molecules they never considered before.”
XiuShi’s platform and production lines have earned industry recognition and capital support. On November 21, the company announced nearly RMB 100 million in Series A funding from new and existing investors, including Huatai Zijin, Shicui Capital, and others. Previous rounds included Chuangjing Capital and Jinyumao.
With dual recognition from industry partners and investors, XiuShi is rapidly expanding globally. Its polypeptide API R&D is advancing in multiple overseas jurisdictions, with 80% of commercial orders from abroad. The intelligent polypeptide production base is also undergoing audits by overseas clients.
Wu Yinsong explains:
“Our rapid growth comes from innovation and ecosystem-building. We often act as a co-developer (‘甲方’) with clients, collaboratively solving polypeptide industry challenges. Only with an open, cooperative approach can we provide know-how that is otherwise invisible to the industry.”
As the industry shifts from scale-driven value to technology innovation and ecosystem construction, XiuShi aims to deepen collaboration with global pharmaceutical companies, helping the polypeptide sector overcome technical bottlenecks and integrate R&D, production, and commercialization, unlocking scalable, sustainable, and regulatory-compliant value across the industry chain.
