China's pharmaceutical excipient industry looks forward to higher-quality development.

May 27 — Pharmaceutical excipients play crucial roles such as serving as excipients, acting as carriers, enhancing drug stability, improving solubility, aiding dissolution, and enabling controlled-release formulations. They are vital ingredients that can significantly influence the quality, safety, and efficacy of pharmaceutical preparations. In the current policy environment, which encourages the development of advanced dosage forms and promotes green practices in both active pharmaceutical ingredients and excipients, it has become imperative to foster high-quality growth in China's pharmaceutical excipient industry. The increasingly critical foundational role of excipients is becoming more evident. Based on their functions and applications, excipients can be categorized into four main types: For injectable formulations, excipients include antioxidants, solubilizers, and isotonicity regulators; for oral solid dosage forms, they encompass lubricants, fillers, binders, and diluents; for oral liquid preparations, excipients such as dispersants, stabilizers, and suspending agents are commonly used; and for topical medications, excipients like anti-adhesives, flavoring agents, and propellants are essential components. In China, the development of pharmaceutical formulations

May 27 — Pharmaceutical excipients play crucial roles such as serving as excipients, acting as carriers, enhancing drug stability, improving solubility, aiding dissolution, and enabling controlled-release formulations. They are essential components that can significantly impact the quality, safety, and efficacy of pharmaceutical preparations. Amidst the current policy landscape—where high-end formulations are encouraged and green development is promoted for both APIs and excipients—it has become imperative to foster the high-quality advancement of pharmaceutical excipients in China.

　　The critical and foundational role is becoming increasingly prominent.

　　Pharmaceutical excipients can be classified into four main categories based on their functions and applications. Excipients for injectables include antioxidants, solubilizers, and isotonicity regulators; those for oral solid dosage forms consist of lubricants, fillers, binders, and diluents; excipients for oral liquid formulations encompass dispersants, stabilizers, and suspending agents; and for topical medications, they include anti-adhesive agents, flavoring agents, and propellants.

　　In China, there has traditionally been a mindset of prioritizing active pharmaceutical ingredients (APIs) over excipients in the development of pharmaceutical formulations. While the country has rapidly expanded its API industry on a large scale, the importance attached to the excipient sector remains relatively insufficient. China's excipient industry also started much later compared to other regions. Currently, excipients account for only 3% to 5% of the total value of pharmaceutical preparations produced in China, with the market size reaching approximately 119.3 billion yuan in 2017. In contrast, internationally, excipients typically make up 10% to 20% of the overall pharmaceutical formulation market value. By 2023, the global excipient market is projected to reach US$85.3 billion. This highlights the vast potential for growth in China's excipient market.

　　Currently, amid the growing emphasis on fostering pharmaceutical innovation and development, drug formulations are evolving toward greater efficiency, rapid onset of action, prolonged efficacy, reduced dosages, and minimized side effects. Emerging trends include oral fast-release and sustained/controlled-release systems, as well as innovative injectable delivery platforms such as liposomes, lipid microspheres, and nanocarriers. Additionally, transdermal and mucosal delivery systems, along with dosage forms tailored for pediatric populations and other special groups, are gaining traction. Meanwhile, cutting-edge formulation technologies—such as these new drug delivery systems—are becoming increasingly critical, while novel pharmaceutical excipients play a decisive role in the development and production of high-end drug products.

　　The implementation of bioequivalence evaluations for generic drugs has also spurred the transformation and upgrading of the pharmaceutical excipient industry. These evaluations mandate that generic drugs must match the quality and therapeutic efficacy of their originator counterparts. Pharmaceutical excipients play a crucial role in ensuring that drugs are selectively delivered to specific tissue sites according to a defined mechanism, while simultaneously controlling the rate of drug release—factors that directly influence both the in vitro dissolution profiles and the in vivo bioequivalence of the medication. As the process of bioequivalence evaluation gains momentum, it prompts pharmaceutical manufacturers to raise their quality standards for excipients, shifting their focus from cost minimization to achieving high quality and enhanced stability. Consequently, companies are now placing greater emphasis on whether excipient production adheres to regulatory standards, maintains consistent quality, and meets all relevant performance criteria when selecting excipients. As a result, excipients used in reference-listed formulations have become the preferred choice for generic drugmakers. With the growing sales volume of products that have successfully passed bioequivalence assessments—and with the increasing number of drugs undergoing such evaluations—this trend will accelerate the pharmaceutical excipient industry’s transition from low-end, bulk-oriented excipients toward more sophisticated, high-value-added, and specialized products.

　　Meanwhile, the nation's emphasis on the pharmaceutical excipient industry has been steadily increasing. In 2012, the State Council issued the "Bio-Industry Development Plan," which clearly highlighted the critical, foundational role of pharmaceutical excipients in drug development. Then, in 2016, the Ministry of Industry and Information Technology released the "Guidelines for the Development Plan of the Pharmaceutical Industry," underscoring the need to support the development and application of innovative pharmaceutical excipients. At the same time, the regulatory framework governing the pharmaceutical excipient industry has become increasingly standardized. For instance, the 2015 edition of the Chinese Pharmacopoeia marked a significant milestone by separately compiling general rules and excipient-related content into distinct volumes, while also introducing the "Guiding Principles for Research on Functional Indicators of Pharmaceutical Excipients"—a move that has further propelled the industry toward more rigorous and systematic development. In 2016, China's national drug regulatory authority issued the "Announcement on Matters Related to the Joint Review and Approval of Drug Packaging Materials, Pharmaceutical Excipients, and Drugs," shifting the approval process for excipients from an independent review to being evaluated concurrently with drug registration applications. This pivotal change signaled a transition in excipient management—from the era of individual approval documents to a more streamlined, document-based system—aligning China's regulatory practices with international standards for pharmaceutical excipient management.

　　Development Faces Four Major Challenges

　　China's pharmaceutical excipient market has vast potential for growth, yet it still faces four major challenges.

　　First, the international-standard system still requires optimization. The Chinese Pharmacopoeia serves as the legally mandated technical standard that China’s pharmaceutical excipient research and development, as well as production, must follow. It is a crucial technical benchmark for the standardized and normalized development of China’s pharmaceutical excipient industry. Currently, China has over 540 types of pharmaceutical excipients in use, while the number of excipient standards included in the Chinese Pharmacopoeia has increased from 132 in the 2010 edition to 270 in the 2015 edition. In contrast, the United States and Europe currently utilize approximately 1,500 and 3,000 types of pharmaceutical excipients, respectively, with their pharmacopoeias listing around 750 and 1,500 excipient standards—significantly higher than China’s figures in both quantity and standardization. Moreover, many innovative pharmaceutical excipients are already widely adopted abroad, yet they remain unavailable for production in China. Therefore, there remains substantial room for expansion in both the variety and specification range of China’s pharmaceutical excipient standards.

　　Second, achieving import substitution requires a multi-faceted approach. While China can largely meet domestic demand for bulk pharmaceutical excipients, there remains a gap in quality standards compared to international levels. In contrast, complex and innovative pharmaceutical excipients still rely heavily on imports. Currently, there are 144 types of foreign pharmaceutical excipients registered in China, with microcrystalline cellulose and lactose being the most commonly registered varieties. Germany and the United States are currently the largest suppliers of imported pharmaceutical excipients to China, followed by Japan. For the development of advanced drug formulations, the availability of pharmaceutical excipients has become a major pain point for Chinese pharmaceutical companies. In recent years, China has begun to ramp up production of cutting-edge pharmaceutical excipients, establishing new facilities such as the Tianjin New Pharmaceutical Excipient Base and the Zhuhai Gel Industrialization Base. However, overall, the number of newly developed excipient varieties remains limited, and their specifications and dosage forms still fall far short of meeting the demands for creating novel formulations and enhancing the quality of pharmaceutical preparations. Therefore, strategically investing in the research and development of innovative excipients is crucial for driving the growth and advancement of China's pharmaceutical excipient industry.

　　Third, the technological barriers and R&D investments remain to be overcome. The production of novel pharmaceutical excipients demands advanced technical expertise. Transforming raw chemical products into high-quality excipients is a sophisticated refining process. Currently, domestic chemical companies often lack mature technology for producing pharmaceutical excipients, while specialized excipient manufacturers tend to underinvest in research and development—and their quality management systems are relatively outdated. Moreover, quality control for many large-molecule excipients still relies primarily on basic physicochemical tests, with insufficient focus on assessing and verifying critical functional attributes. Meanwhile, complex and cutting-edge pharmaceutical excipients are predominantly manufactured by internationally established, technologically advanced chemical giants such as DowDuPont, BASF, Wacker Chemie, Ashland, Arkema, and Evonik. As a result, China’s journey toward breakthroughs in pharmaceutical excipient technology remains long and challenging.

　　Fourth, the closed-loop integration of the upstream and downstream industrial chains remains to be established. Currently, China's pharmaceutical excipient industry exhibits a "two-tiered" structure. Constrained by limited capital and technology, most domestically produced pharmaceutical excipients are positioned in the low-end market, featuring simple manufacturing processes and low technical requirements, leading to intense competition among these products. Meanwhile, there is an insufficient supply of innovative and complex excipients that demand advanced technologies, higher quality standards, and more sophisticated production processes. China has approximately 470 pharmaceutical excipient manufacturers, primarily concentrated in the Bohai Rim, Yangtze River Delta, and Pearl River Delta regions. Shandong, Jiangsu, Guangdong, and Hebei have emerged as key provinces hosting a high concentration of excipient-producing enterprises. Many companies specializing in excipient production have historically transitioned from food additive or chemical industries, often operating on a small scale, offering a limited product range, and lacking standardized practices. At present, several sizable pharmaceutical excipient manufacturers in China include Hunan Erkang Pharmaceutical, Shanhe Pharmaceutical Excipients, Huangshan Capsule, and Hongri Pharmaceutical. However, these four companies collectively hold less than 5% of the market share within the pharmaceutical excipient industry. Overall, the domestic pharmaceutical excipient industry suffers from weak connectivity across its upstream and downstream value chains, and a cohesive industrial ecosystem linking chemical companies, excipient producers, and pharmaceutical firms—or even direct links between chemical and pharmaceutical enterprises—has yet to take shape.

　　Future development direction is becoming clear.

　　The author believes that, with continuous advancements in formulation R&D innovation and increasingly stringent quality standards, novel pharmaceutical excipients will become the primary focus for China's future development in this field. Specifically, this includes developing entirely new excipients, conducting secondary development of existing excipients into new specifications, and creating pre-mixed excipients. Among these approaches, the research and development of entirely new excipients and those with novel specifications typically involve long cycles, high risks, substantial investments, and relatively low returns. In contrast, pre-mixed excipients—formed by precisely blending multiple individual excipients according to a specific formula and production process—are used as a unified component in formulations. They offer unique advantages such as a tailored formulation composition, combined functionality, and significant time and cost savings. Therefore, developing pre-mixed excipients represents the optimal pathway for advancing the research and application of innovative pharmaceutical excipients.

　　As the institutional and standard systems continue to mature, the industry is gradually becoming more professional and scalable. Looking ahead, China's pharmaceutical excipient sector will steadily enter a mature phase. In terms of quantity, there remains significant room for growth in both the variety and specification models of excipients used in the country. On the quality front, the ongoing evaluation of generic drug quality and efficacy consistency will drive increased imports of pharmaceutical excipients, while also promoting greater standardization within the domestic market, thereby accelerating the industry's transformation and upgrading. Meanwhile, driven by innovation in new formulation development, it has become imperative to accelerate the alignment of China's pharmaceutical excipient industry with international standards.