艾昆纬-美国药品短缺和ANDA批准的趋势（英）-2025_19页_2mb

Analysis Summary of Drug Shortages and ANDA Approvals in the U.S.

Overview

• The U.S. healthcare system faces persistent drug shortages, particularly for generic medications and sterile injectables. As of June 2024, there are 102 active shortages, with over half lasting more than two years.
• Shortages are most prevalent in pain management and oncology, with injectables comprising the majority of cases. Generic drugs account for 84% of shortages, highlighting impacts on affordable healthcare access.
• Drug shortages stem from supply-side issues (e.g., manufacturing difficulties, supply chain fragility) and demand-side factors (e.g., pricing pressures, market dynamics discouraging new entries).

Key Trends in ANDA Approvals and Launches

• Between 2013 and Q1 2024, 37% of approved generics had not launched, and it can take over four years for 70% of generics to reach the market.
• Average launch delays are long, with many approved generics remaining unlaunched for years. For instance, 200 generics with approved ANDAs were unlaunched two years post-approval.
• Injectables are disproportionately affected, with 75% of shortages involving unlaunched generics in this form.
• Smaller generic companies (those with global sales under $500 million) are more active in launching approved generics, accounting for over half of all generic approvals since 2013.

Causes and Challenges

• Economic barriers, such as high production costs for complex products like injectables and low profit margins due to pricing models, discourage manufacturers from entering or sustaining the market.
• Supply chain vulnerabilities exacerbate shortages by reducing resilience to disruptions.
• Demand-side factors, including hoarding during medical surges, and the difficulty in launching approved generics timely, contribute to prolonged shortages.
• Company size influences launch behavior, with smaller firms showing higher launch rates, possibly due to greater incentive to address shortages quickly.

Impact and Recommendations

• Addressing shortages requires enhancing incentives, streamlining manufacturing processes, and strengthening supply chain resilience to ensure timely availability of approved generics.
• Policy interventions may be needed to balance pricing, reduce economic disincentives, and encourage market participation.
• Further research is warranted to understand barriers to launch and improve responses to shortages.

Conclusions

• Drug shortages persist due to multifaceted challenges, including production complexities, economic pressures, and supply chain issues.
• Trends in delayed launches underscore the need for systemic changes to improve drug availability and patient access.
• Action from policymakers and manufacturers is essential to mitigate shortages and support generic drug development.