U.S. FDA Releases FY2025 Pharmaceutical Quality Report and Expands Inspections of Manufacturing Facilities in China and India
Trends in Global Pharmaceutical Manufacturing Hubs
The U.S. Food and Drug Administration (FDA)'s Office of Pharmaceutical Quality (OPQ) recently released its 'Report on the State of Pharmaceutical Quality for FY2025,' which indicates significant changes in the global landscape of pharmaceutical manufacturing facilities that distribute drugs within the United States. Among the 5,953 manufacturing facilities registered with the CDER (Center for Drug Evaluation and Research), those located in the continental United States still account for a majority (57%). However, the production base for newly approved drugs is rapidly shifting from the United States and Europe to India and China. This demonstrates that pharmaceutical companies are actively utilizing the contract development and manufacturing organization (CDMO) infrastructure in Asia to reduce production costs and maximize outsourcing. This diversification is increasing the complexity of global supply chains, leading regulatory authorities to invest more in quality control.
Enhanced Inspections and Monitoring of Overseas Manufacturing Facilities
In response to these supply chain risks, the FDA has significantly increased on-site inspections of overseas manufacturing facilities. The total number of pharmaceutical quality assurance inspections conducted during FY2025 was 1,248, a 28.4% increase compared to the 972 inspections conducted in FY2024. Notably, 74% of the non-face-to-face document requests under Section 704(a)(4) for pre-approval reviews were focused on companies in overseas locations such as India and China. This indicates the FDA's intention to prevent potential quality issues in drugs imported into the United States by combining proactive document reviews with rigorous on-site inspections, rather than relying solely on post-market corrective actions.
Rapid Growth of Biologics and Biosimilars
The report confirms a significant increase in the proportion of Biologics License Applications (BLAs) and biosimilars. The proportion of biologics (BLA) among all approved drugs has doubled, from 2.3% in FY2016 to 4.6% in FY2025, and the proportion of biosimilars has surged from 17% to 42%. This indicates that the market exclusivity of original biologics is expiring, and more affordable alternative drugs are becoming available. While this provides cost savings for patients, the complex manufacturing processes of biologics mean that even minor quality differences can cause adverse effects such as immunogenicity, requiring more stringent process validation.
Improving Manufacturing Quality Control and Building Market Trust
As a result, the strengthening of impurity monitoring for over-the-counter (OTC) drugs and the enhancement of facility assessment processes are leading to improved reliability in the pharmaceutical and biotechnology market. The FDA has strictly controlled the allowable limits for harmful residual solvents and impurities such as benzene and diethylene glycol (DEG), further strengthening consumer safety. These transparently disclosed quality indicators will eliminate less technologically advanced and poorly managed companies, and provide a more favorable market environment for leading pharmaceutical companies that demonstrate excellent cGMP capabilities.
The FDA's strengthened approach to overseas inspections, as revealed in this report (1,248 inspections in FY2025), may increase short-term regulatory costs and production delays for pharmaceutical companies that rely on contract manufacturing organizations (CMOs) in China and India. In particular, with the FDA focusing 74% of its non-face-to-face document requests (704(a)(4)) on overseas manufacturing facilities, proactive regulation is being implemented, making the diversification of global supply chains and the securing of local quality control (QC) expertise key priorities. In the medium to long term, with biosimilars accounting for 42% of approved BLAs, companies such as Samsung Biologics (208220) and Celltrion (068270), which have demonstrated excellent cGMP capabilities, are expected to benefit, and this market is projected to grow to approximately $74 billion by 2030. For pipelines that have completed Phase 3 clinical trials and are nearing final approval, ensuring commercial production quality is the top priority to prevent product approval delays and launch postponements due to facility assessment failures.
Source: FDA Drug Approvals (rss)