艾昆纬-2023年美国药品短缺（英）-2023.11-32页_899kb

In 2023, the number of active drug shortages in the U.S. has shifted from being high-frequency to persisting longer, with 132 active molecules as of June 2023. Shortages disproportionately affect generic and injectable drugs, reinforcing the need for resilient supply chains. Economic pressures, including extremely low prices eroding profitability, and complex manufacturing processes further constrain capacity to resolve these issues.

Over the past five years, market concentration remains high even for multi-source generics, making it difficult for competitors to scale up production quickly. Key drivers of these shortages include regulatory inspections, market exits, and disruptions to the supply of active or inactive ingredients. Oncology shortages, particularly concerning platinum-based chemotherapeutics like carboplatin and cisplatin, are major concerns due to limited alternatives. Antibacterial shortages, exacerbated by the COVID-19 pandemic, contribute to antimicrobial resistance. Anesthetics face persistent supply challenges. The surge in demand for GLP-1 agonists has also led to shortages.

Key findings include:

• 84% of shortages are generic, 67% are injectable.
• Average prices for shortage drugs are lower than non-shortage drugs, hindering investment in new capacity.
• Shortages have persisted for over two years on average.
• Historical patterns show a decrease in the number of shortages but an increase in their duration.
• Oncology and antimicrobial chemotherapeutics remain vulnerable due to low prices and market concentration, while newer drugs like GLP-1 agonists face supply challenges due to rapidly increasing demand.