Pharmaceutical excipients play a crucial role in the key quality indicators of pharmaceutical preparations. High-quality pharmaceutical excipients can not only enhance the stability of active pharmaceutical ingredients (APIs) and extend the shelf life of drugs but also better regulate the dissolution or release behavior of APIs in vitro and in vivo. Therefore, the selection of excipients is of great importance. In practical R&D and production, the same pharmaceutical excipient can be used for different administration routes and dosage forms, and serve different purposes. There are 66 categories of pharmaceutical excipients based on their functions in preparations, and they can also be classified by source, chemical structure, application, dosage form, and administration route.
- Global Market: The global pharmaceutical excipients market was valued at USD 87.3 billion in 2020 and is projected to reach USD 128.9 billion by 2027, with a compound annual growth rate (CAGR) of 5.57% from 2021 to 2027.
- Chinese Market: China’s pharmaceutical excipients market is growing rapidly. It is expected to increase from USD 12.8 billion in 2020 to USD 21.0 billion by 2027, at a CAGR of 8.00% during the period 2021–2027.
However, in 2017, the scale of China’s pharmaceutical excipients market accounted for only 3–5% of the total output value of pharmaceutical preparations, while that of foreign pharmaceutical excipients accounted for 10–20% of the total output value of pharmaceutical preparations in their respective regions. This indicates that there is still a significant gap between China’s pharmaceutical excipients market and foreign markets. Nevertheless, China’s market is currently developing rapidly and has broad prospects for the future.
- Product Composition: Domestic pharmaceutical excipients in China are mainly traditional, large-volume varieties, while imported excipients are mostly new-type, complex, and high-end ones. Currently, more and more enterprises are switching from imported pharmaceutical excipients to domestic ones of equivalent quality, which has raised requirements for the quality control and cost management of domestic excipients.
- Standardization Gaps: The varieties of domestic pharmaceutical excipients in China are numerous and diverse, and the pharmacopoeial standards for pharmaceutical excipients need to be improved. As of December 2019, among the 459 registered pharmaceutical excipient varieties (some products with different names but the same substance were merged), only 62% had pharmacopoeial standards in four regions (China, the United States, Europe, and Japan), and only 45% had standards in the Chinese Pharmacopoeia (ChP). In terms of the number of pharmaceutical excipient varieties covered by pharmacopoeias, there is still a considerable gap between the ChP and the United States Pharmacopeia (USP).
However, progress has been made: the 2020 edition of the ChP added 65 new pharmaceutical excipient varieties compared with the previous version. Additionally, the types of commonly used functional indicators studied and established for pharmaceutical excipients (classified by application) were adjusted from 12 categories in the 2015 edition to 19 categories in the 2020 edition.
With the development of China’s pharmaceutical industry, the domestic pharmaceutical excipients market will maintain rapid growth in the future, driven by the following factors:
- Correlation with the Pharmaceutical Preparation Industry: The growth of the pharmaceutical excipients industry has a strong positive correlation with that of the pharmaceutical preparation industry. The steady growth of the pharmaceutical preparation industry will drive the natural growth of the pharmaceutical excipients industry.
- Policy Promotion: With the advancement of policies such as "associated review and approval" and "consistency evaluation," pharmaceutical enterprises will pay more attention to high-quality and highly stable pharmaceutical excipients—and high quality usually corresponds to higher prices.
- Development of Novel Formulation Technologies: The promotion and development of novel pharmaceutical formulation technologies in China, such as sustained-release, immediate-release, controlled-release, transdermal absorption, mucosal drug delivery, and targeted drug delivery, will promote the structural adjustment of China’s pharmaceutical excipients industry. New-type pharmaceutical excipients with high added value will gradually increase in number.
