The BCG shortage is not expected to meaningfully improve until late 2026 at the earliest. Merck, the sole manufacturer of TICE BCG in the United States and many other countries, is building a new production facility that it expects to be fully operational by late 2026, pending regulatory inspection and approval. Once running, that plant will triple current manufacturing capacity, which the company says should meet global demand. Until then, supply will remain constrained and subject to allocation.
Why the Shortage Has Lasted So Long
The BCG shortage has been ongoing since at least 2013, when the other major supplier (producing the Connaught strain) experienced plant shutdowns tied to potential batch contamination and eventually exited the market. That left Merck as the only source of intravesical BCG in the U.S. and much of the world. The FDA formally listed TICE BCG as a shortage product in January 2019, and the listing remains active today with no estimated recovery date.
BCG is a live bacterial product, which makes it far harder to manufacture than a typical drug. Production batches take months and are vulnerable to contamination. Meanwhile, demand has steadily climbed. Bladder cancer diagnoses continue to rise, and more patients with high-grade tumors are receiving BCG as the standard of care. Merck has increased output from its existing facility, but production simply cannot keep pace with global need using the current infrastructure.
What the New Merck Facility Changes
Merck announced plans in 2021 to build a dedicated BCG manufacturing plant, investing more than $650 million in the project. The company expects the facility to be fully operational by late 2026, after construction, inspection, and regulatory approval are complete. Once it is running, Merck’s total manufacturing capacity will triple.
That tripling won’t happen overnight. Merck has said supply will “gradually increase over time” after the plant opens, as production ramps up and individual countries complete their own regulatory reviews. So even in the best-case scenario, patients and clinics may not see a fully normal supply chain until sometime in 2027 or later. Any construction delays, regulatory complications, or contamination issues at the new facility could push the timeline further.
How the Shortage Affects Patients Right Now
When supply runs short, Merck places TICE BCG under allocation, meaning hospitals and clinics receive limited quantities rather than ordering freely. In practice, this forces urologists to make difficult choices about who gets treatment and how much they receive. Some patients have their maintenance therapy reduced or skipped entirely, while induction courses for newly diagnosed patients are prioritized.
The consequences are real. A study of a previous BCG shortage (2013 to 2016, when the Connaught strain disappeared) found that the 24-month recurrence rate for bladder cancer patients nearly tripled, jumping from 16% to 47%. The rate of patients ultimately needing full bladder removal was five times higher during the shortage period. These numbers came from a single institution, but they illustrate how directly BCG access affects outcomes.
Alternatives During the Shortage
With BCG in limited supply, oncologists have turned to combination chemotherapy delivered directly into the bladder. The most studied alternative pairs two drugs, gemcitabine and docetaxel, given weekly for six weeks, similar to the BCG schedule.
A study of 312 high-risk bladder cancer patients published in JAMA Network Open found that this combination actually outperformed BCG on several measures. At one year, 85% of patients on the combination were free of high-grade recurrence, compared to 71% of BCG patients. At two years, the gap narrowed but persisted: 81% versus 69%. Patients also tolerated the combination better and were less likely to stop treatment early due to side effects. These results have made gemcitabine and docetaxel a widely accepted first-line option when BCG is unavailable, not just a compromise.
Researchers are also testing whether a different BCG strain could expand supply. A large phase III trial (known as S1602) is comparing the Tokyo-172 strain against TICE BCG in patients who have never received BCG before. An earlier trial of 129 patients found similar recurrence-free survival between strains, which provided the rationale for the larger study. If Tokyo-172 proves equivalent, approving a second strain could reduce dependence on a single manufacturer, though this would take additional years of regulatory review.
What to Do If Your Treatment Is Affected
If you have non-muscle-invasive bladder cancer and your urologist tells you BCG is unavailable or delayed, the gemcitabine and docetaxel combination is the most evidence-backed alternative. It is not a lesser option. Ask your care team whether it makes sense for your specific risk level.
For patients currently receiving BCG maintenance therapy, your urologist may reduce the number of doses per cycle or extend the interval between treatments. This is a common rationing strategy during the shortage. Staying in close follow-up with regular cystoscopy (the procedure where a camera checks the inside of your bladder) is especially important when treatment schedules are modified, so any recurrence is caught early.
The realistic outlook: supply will remain tight through at least 2026, with gradual improvement possible in 2027 as the new facility ramps up. Planning your treatment around current availability, rather than waiting for the shortage to resolve, gives you the best chance of staying ahead of the disease.