Challenges Faced by Peptide Drugs

While peptide drugs are ushering in broad development opportunities driven by technological innovation and market demand, they also face multiple challenges in the process of industrialization, market competition, and global layout. These challenges involve market competition, production capacity, technology, compliance, raw materials and patents, which restrict the high-quality development of the industry and pose a severe test to the comprehensive strength of enterprises.

1. Intensified Track Involution and Shrinking Profit Margins Due to Price Wars

As the main force in the peptide drug track, GLP-1 has officially entered the era of stock competition in 2026. The price war between Novo Nordisk and Eli Lilly has become increasingly fierce, and the launch of small-molecule GLP-1 drugs has further intensified market competition. Domestically, more than 10 enterprises have flocked to deploy GLP-1 generics and improved new drugs, with more than 20 research projects highly overlapping in targets. Enterprises are competing for the first batch of approval documents, and products lacking differentiated design will fall into low-price scuffles after listing, leading to a significant compression of profit margins. In addition, the price of semaglutide API has dropped sharply, and the profit space of enterprises relying on generic peptide products has been further squeezed.

2. Prominent Overcapacity and the Risk of Elimination for Small and Medium-Sized Enterprises

At present, the planned production capacity of GLP-1 peptide API in China reaches 33-40 tons, while the global demand for core varieties is only about 50 tons by 2030, and the global peptide API production capacity will be fully saturated in 2026. Many domestic enterprises have adopted the strategy of "building production capacity first and then obtaining approval documents", which has further exacerbated the contradiction of overcapacity. Small and medium-sized CDMOs that lack cost control capabilities and only rely on general solid-phase synthesis capacity have an operating rate of less than 60%. It is expected that the industry elimination rate will reach 30%-40% from 2026 to 2028, and only enterprises with large-scale production capacity and efficient process technology can survive in the fierce competition.

3. Dual Increase in Technical and Compliance Thresholds, Escalating R&D and Operation Pressure

The technical competition of peptide drugs has shifted from "production capacity quantity" to "technical depth". Long-chain peptides, complex modified peptides, and new delivery technologies have become core barriers, and enterprises with R&D investment accounting for less than 8% are difficult to keep up with the pace of iteration. At the same time, global supervision is continuously tightening. The requirements for cGMP compliance, impurity control, and supply chain traceability are constantly strengthened. A domestic pharmaceutical enterprise was once warned by the FDA because it failed to conduct process verification on semaglutide API and test incoming production materials, and its products were included in the import warning list, which affected its overseas market layout. Enterprises that fail to pass international certifications will be excluded from the mainstream supply chain, and medical insurance collection will further force enterprises to reduce costs and offer concessions.

4. Restrictions from Core Raw Materials and Patent Barriers

High-end amino acids for peptide synthesis have long relied on imports, and the localization rate of some special modified amino acids is less than 30%. Price fluctuations directly affect production costs and the stability of the industrial chain. Multinational pharmaceutical companies have built a broad "patent moat" through comprehensive patent layout in drug molecules, synthesis processes, and preparation technologies. For example, Novo Nordisk has applied for 53 patents related to GLP-1, and even if the core compound patent expires, generic enterprises may still be blocked by supporting patents such as crystal forms and preparation methods, which is known as the "patent evergreen" strategy in the industry. Domestic enterprises are prone to patent infringement risks in the R&D of improved new drugs, while the R&D of original targets faces the dilemma of long cycle and large investment. The patent challenge between domestic enterprises and Novo Nordisk over semaglutide has lasted for four and a half years, and finally ended with the patent being maintained valid, which also reflects the difficulty of breaking through patent barriers.