Addressing the global shortage of TICE BCG
A new facility will support a phased ramp-up, with the goal of tripling our manufacturing capacity, which we anticipate will help better meet the needs of physicians and patients over time
September 21, 2026
Since 2012, Merck has been the sole U.S. manufacturer and primary global supplier of TICE® BCG (BCG LIVE for intravesical use; “TICE BCG”). Increasing global demand for TICE BCG has exceeded our manufacturing capabilities. In our commitment to the reliable and sustainable production of TICE BCG, in 2021, we announced our decision to build a new manufacturing facility to fulfill all needed demand — investing more than $650 million.
This investment reaffirms Merck’s longstanding commitment to producing this medicine, and all our medicines, for patients who need them. Once operational, the facility will support a phased ramp-up, with the goal of tripling our TICE BCG manufacturing capacity, which we anticipate will help better meet the needs of physicians and patients over time.
Update on manufacturing for TICE BCG
We previously communicated that, barring unforeseen circumstances, our new plant was on track to open by the end of 2026. Since then, we’ve encountered a series of delays due to mechanical interdependencies at our new facility. While work is underway to address these issues, the cumulative impact is substantial and will unfortunately further delay the opening of the facility.
We’re working with urgency to address the current challenges and advance the project while taking the necessary steps to reduce the risk of further delays. We’ll provide an update on the expected timing of our new facility’s opening in the first quarter of 2027. Until the new facility is complete, we’ll continue to use a system to proportionally allocate TICE BCG to minimize disruption to patient care as much as possible.
If patients have questions regarding TICE BCG, they should speak with their physicians. Additional information related to the shortage, current allocation practices and our efforts to increase supply, including construction of a new manufacturing site, is below.
What caused the TICE BCG shortages and backorders?
Since 2012, Merck has been the sole U.S. manufacturer and primary global supplier of TICE BCG. While we have made efforts to maximize production of TICE BCG, increasing global demand has outpaced our current maximum manufacturing capabilities. The manufacturing of this product is highly complex. Each batch takes more than three months to make, 30 days of which are spent waiting for the growth of a bacteria used to make the medicine. Merck continues to do everything we can to complete this new manufacturing project as expediently as possible.
Prior to 2012, additional manufacturers supplied the U.S. market with TICE BCG, with Merck providing 30-40% of the U.S. supply. As other manufacturers exited the U.S. market in 2012, Merck increased production of TICE BCG to the full extent allowed by our current manufacturing capacity, which effectively doubled our supply of TICE BCG to the U.S. market.
How does the TICE BCG allocation process work?
To minimize disruption to patient care as much as possible until the new facility is complete, we’ll continue to use a system to proportionally allocate TICE BCG based on historical demand or in accordance with existing contractual obligations.
Merck allocates available supply of TICE BCG to wholesalers and distributors based on their historical purchasing patterns or in accordance with existing contractual obligations. In turn, wholesalers and distributors allocate their inventory of TICE BCG to their healthcare professional customers based on available supply and the historical purchasing patterns of those customers. Merck does not directly determine the amount of supply to individual hospitals, hospital pharmacies or medical practices.
Where can I find more information about the availability of TICE BCG?
Patients:
Patients should reach out to their physician, as they are in the best position to answer questions about the availability of the medicine in their practice and can inquire about the quantity and timing of product availability with their supplier.
Healthcare professionals:
Healthcare professionals with questions regarding allocation should contact their wholesaler or distributor.
