As Domestic Regulations And Market Supervision Become Increasingly Stringent, The Status Of API Is Continuously Elevated in The Pharmaceutical Industry.

May 06, 2026

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Since 2019, the pharmaceutical market has accelerated its regulatory standardization, while generic drug enterprises have entered a drastic reshuffling phase with a substantial rise in industrial concentration. This has created favorable development opportunities for the upstream API industry. Meanwhile, with the successive launch of policies including consistency evaluation, volume-based procurement and linked review and approval, the position of APIs in the pharmaceutical industrial chain has been continuously strengthened, and high-standard specialty APIs have become increasingly important for downstream pharmaceutical preparations.

 

1.In terms of new product expansion, domestic specialty API enterprises have accelerated the enrichment of product pipelines to enhance competitiveness in the global market.

 

2.Against the backdrop of volume-based procurement, specialty API enterprises have rapidly entered the downstream preparation market to realize the integration of API + preparation. Some API enterprises are also eligible to participate in the profit sharing of downstream pharmaceutical preparations.

 

3.A number of specialty API enterprises have gradually expanded their business into CMO/CDMO sectors.

 

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