Information About the BCG Shortage

Since 2012, when Merck unexpectedly became the sole manufacturer of TICE BCG in many countries around the world, increasing global demand has outpaced our current maximum manufacturing capabilities. While the company has many years of experience producing TICE BCG, this medicine has a lengthy and inherently complex manufacturing process.

Between 2012 and 2019, Merck increased production of TICE BCG by more than 200%. Merck’s maximum capacity at our current facility for global supply is between 600,000 to 870,000 vials of TICE BCG annually. Merck has been producing TICE BCG to the full extent of manufacturing capacity over the past several years. In recognition of the medical need for this product, Merck continues to operate at maximum production capacity.

In October 2020, Merck announced it will construct a new manufacturing facility to significantly expand its production capacity of TICE BCG. In that original announcement, we stated that construction of the new manufacturing facility may take approximately 5 to 6 years. Construction is well underway, and we believe that, barring any unforeseen circumstances, including pandemic-related supply chain and other issues, the new facility is on track to the previously announced timeline and will be completed in late 2025 to late 2026, which includes time for all necessary regulatory approvals.

When construction is complete, and following regulatory reviews and approvals, supplies of TICE BCG will gradually increase over time. Once this new facility is fully operational, we expect to triple our current manufacturing capacity of TICE BCG. We anticipate that this will meet the needs of physicians and their patients for the foreseeable future. The investment in this new manufacturing facility reaffirms Merck’s longstanding commitment to producing this medicine for patients.

September 2023

Read Merck’s letter about meeting BCG demand sent to BCAN’s Board of Directors.

January 2021

Last year, BCAN and its partners shared a message regarding the global shortage of Merck’s TICE BCG due to an increasing global demand for the product.

Merck, the sole manufacturer globally since 2012, approved plans to construct a new manufacturing facility to significantly expand production capacity for TICE® BCG (BCG Live For Intravesical Use), a medicine for the treatment of certain forms of bladder cancer. While this commitment is an important step in making sure that an adequate supply of TICE BCG is available, completing the construction of a manufacturing facility may take approximately 5 to 6 years. Read the message from Merck here.

The American Urological Association (AUA), American Association of Clinical Urologists (AACU), Bladder Cancer Advocacy Network (BCAN), Society of Urologic Oncology (SUO), the Large Urology Group Practice Association (LUGPA) and the Urology Care Foundation (UCF) remain extremely concerned about this ongoing shortage and its effects on the care of bladder cancer patients.

Read the full joint statement here.