Page 24 - Binder2

year. When these drugs lose effectiveness prematurely, the
return on investment collapses.

And yet, the costs keep climbing:

• Dose intensification adds thousands in monthly
expenses.
• Diagnostic workups to determine failure are often
non-definitive.
• Switching to a new biologic resets the billing
clock—without resetting the immune system’s
memory.

The U.S. spends tens of billions annually on biologics,
and estimates suggest that 10% to 30% of that spend may
be wasted due to immunogenic rejection. These are not
theoretical losses—they’re real dollars poured into drugs
that no longer deliver results.

Pharma Has Its Own Dilemma

Pharmaceutical companies are not blind to this.
Tolerization introduces both regulatory and commercial
risk. A drug that fails prematurely is harder to defend in
value-based pricing models. It weakens real-world data. It
invites scrutiny.

Yet paradoxically, the industry’s current model can tolerate
a surprising amount of… tolerization. Why? Because churn
can be profitable:

• Patients cycle from one biologic to another, often
within the same manufacturer’s portfolio.

22