The Traditional Chinese Medicine (TCM) Market faces significant hurdles related to regulatory inconsistency. In 2025, nearly 40% of small-scale producers are restricted from international markets because their products do not meet the strict standardization requirements of the FDA or EMA. This fragmentation creates a "quality gap" where premium, certified brands command high prices, while unstandardized products struggle with consumer skepticism.

Economic factors, specifically herb-price volatility, are a major concern in late 2025. Climate change has impacted the yields of "authentic" medicinal materials in traditional sourcing regions like Shaanxi and Yunnan, leading to price spikes for rare ingredients. Manufacturers are forced to invest in greenhouse technologies and controlled-environment agriculture (CEA) to ensure a stable supply, which significantly increases the capital expenditure required for TCM production.

Furthermore, the "regulatory lag" for new TCM-based drugs remains a bottleneck. While modern medicine often requires placebo-controlled Phase III trials, the complex, multi-ingredient nature of TCM formulas makes these trials expensive and difficult to design. In 2025, many firms are pivoting toward "Herbal Functional Foods" and dietary supplements to bypass the lengthy drug approval process, though this limits their ability to make specific medicinal claims.

People Also Ask:

• What are the main regulatory barriers for TCM in the US and Europe?

• How does climate change affect the price of traditional herbs?

• Why is it difficult to conduct clinical trials on TCM formulas?