OBJECTIVE： To investigate the development trend of traditional Chinese medicine （TCM） formula granules by SWOT analysis. METHODS： The development of TCM formula granules were summarized， and the strengths （S）， weaknesses （W）， opportunities （O） and threats （T） of TCM formula granules were expounded systematically. The development prospects of TCM formula granules were analyzed by SWOT analysis. RESULTS & CONCLUSIONS： In the development of foreign and domestic TCM formula granule study， there are some problems，such as lack of efficacy， high price， single production process， lack of uniform standards and weak foundation of research .Aiming at the existing problems， combined with SWOT analysis， the strategies are put forward as strengthening basic research， improving the technology and variety of products， uniforming standards， strengthening quality control and supervision， expanding the patient market and promoting clinical applications.