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Drug Shortages in the U.S. 2023
A closer look at volume and price dynamics
Nov 15, 2023
Report Summary
Drug shortages have recently received widespread news coverage for their impact on patient care and public health. The number of drug shortages in the U.S. is increasing as more shortages continue to be reported than resolved. Stakeholders have recommended various approaches to mitigate shortages, such as prioritizing essential medicines, stockpiling, and making changes to reimbursement or statutory rebates. Shortages appear to be driven by a variety of causes that need to be better understood, as they may impact which solutions will best address them.
In this report, shortages reported by the Food and Drug Administration are assessed in conjunction with sales and volume data of these medicines in the U.S. market. Characteristics of shortages, including product type, form, and the number of manufacturers are evaluated.
Market concentration is assessed for molecules with shortages based on current sales data. The causes and impacts of shortages across a range of therapy areas are analyzed and presented here.
Key findings:
- Over the past five-and-a-half years, an average of more than 25 new molecule shortages have occurred annually, with 160 in total added through June of 2023 and only 51 resolved.
- Resolved shortages have been more clustered in time without a steady pattern, with the largest number being resolved in the second and third year of the COVID-19 pandemic.
- For the currently active shortages affecting 132 molecules, 75% have been active for more than a year and 58% have been ongoing for more than two years.
- The concentration of market share among competitors is a key indicator of the potential resilience of the market to an unexpected driver of shortages and can be measured with the Herfindahl-Hirschman Index (HHI).
- Natural disasters, active or inactive ingredient supply issues, as well as disruptions to packaging materials such as vials can all contribute to manufacturing supply issues, and when those issues affect a significant share of a molecule, shortages may result.
- Another driver of disruptions has been regulatory oversight, where FDA inspections have triggered shutdowns of some sites and where those companies are leading suppliers of a medicine, the shortages are difficult for their peers to resolve.
- Shortages are more common in drugs with very low list prices, with 11% (70 of 631) of drugs priced less than $1.00 per extended unit in shortage, compared to 1.3% (3 of 238) of those priced more than $500 per unit.
- Low priced drugs (<$1) accounted for 56% of the 125 drugs in shortage with reported volume in this analysis.
- An extended unit is defined as a milliliter for some injections, and as a pill for oral solids. These variations notwithstanding, more than half of shortages are affecting drugs with very low list prices.
- As of June 2023, there are eight cancer medicines with active shortages while five other medicines have seen shortages over the last five years that have resolved.
- Oncology has seen a growing number of shortages since 2020, with four new molecule shortages between March and June 2023: cisplatin, methotrexate, capecitabine, and carboplatin.
- Although there are shortages having significant impacts across these molecules, the volume in shortage accounts for only 9% of the total oncology volume in June 2023, and overall oncology volume continues to grow, up 6% from June 2022.