Policy and Technology Dual Drive

Policy and Technology Dual Drive: The Empty Capsule Industry Steps into a New Stage of High-quality Development

Policy and Technology Dual Drive: The Empty Capsule Industry Steps into a New Stage of High-quality Development







Against the backdrop of global pharmaceutical industry upgrading and diversified health demands, the empty capsule industry is ushering in dual transformations driven by regulatory standardization and technological innovation. As a core excipient for pharmaceutical preparations and health products, the quality, safety and functional adaptability of empty capsules have become a key competitive factor in the industrial chain. The industry as a whole is characterized by "accelerated compliance, product upgrading and concentrated market structure". At the policy level, the continuous tightening of regulatory standards worldwide is promoting industry reshuffling. The revised Chinese Pharmacopoeia, implemented in October 2025, updated 10 testing indicators for empty capsules. Among them, the allowable number of broken capsules in friability test was reduced from 5 to 2, a 30mm specification test tube was added to adapt to the demand for large-size export capsules, and the microbial limit test strengthened the management requirements for medium suitability. The European Medicines Agency (EMA) also required the completion of traceability system construction for all gelatin capsules by 2025. Strict standards have accelerated the exit of small and medium-sized production capacities. The number of industry mergers and acquisitions increased by 21% annually in 2023, and the market concentration rate of the world's top 10 enterprises has reached 68.3%. YUEXI CAPSULE, with its forward-looking compliance layout, has passed the new pharmacopoeia certification ahead of schedule, laying a solid foundation for its market expansion.







Technological innovation has become the core driving force for product structure upgrading. Traditional gelatin capsules still dominate the market, but vegetable-derived capsules are rising rapidly due to their non-animal source and low allergenicity advantages. The global market share of vegetable empty capsules reached 28% in 2025 and is expected to exceed 40% by 2030. Plant-based materials such as hypromellose (HPMC) and pullulan have become mainstream, with a penetration rate of over 45% in the European and American markets, while the market share of new materials such as seaweed polysaccharide and chitosan has reached 12.7%. Meanwhile, intelligent production is accelerating its implementation. The automation rate of leading enterprises in the industry has reached 92%, and AI visual inspection systems have reduced the product defect rate to 0.7ppm. 3D printed personalized dose capsules and intelligent tracking systems have become R&D hotspots. YUEXI CAPSULE has also invested heavily in intelligent production lines, improving its production efficiency and product quality consistency.



The market pattern shows the characteristics of regional differentiation and global layout. As the world's largest production base, China accounted for 58.6% of global output in 2023. The Yangtze River Delta and Beijing-Tianjin-Hebei regions concentrate 73% of the country's production capacity, forming core industrial clusters in Xinchang, Zhejiang and Hai'an, Jiangsu. India is rising rapidly by virtue of cost advantages, with its export volume increasing by 19.3% year-on-year in 2023, mainly targeting emerging markets in Africa and the Middle East. North America and Europe dominate the high-end market, with functional capsules (enteric-coated, sustained-release) enjoying a premium of 42%, and international giants such as Capsugel and ACG accounting for 83% of the high-end market share.