TFPA Discussion Paper

The Shadow Market

What happens to the demand a launch creates but cannot yet supply, and who pays when the gap stays open.

A considered, fully referenced look at the gap between approval and dependable access, why a slow launch can become a patient safety issue, and the uncomfortable idea that demand we cannot yet meet does not disappear. It goes looking.

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No form, no sign up. Every material figure referenced.

Cover of The Shadow Market discussion paper, click to download the PDF

What is inside

Two launches, not one: the one a maker plans, and the shadow launch it did not.
How long the access gap stays open, and why most of the delay is complexity, not pricing.
The scale of the problem, told straight, with substandard and falsified kept distinct.
Real falsified cases that reached regulated markets: Avastin, Ozempic, and Ibrance.
Three of the people who pay for the gap: the launch leader, the investor, and the patient.
A sharper question: the demand we create, measured against the access we actually deliver.

A few of the numbers

532 days

Median wait from approval to reimbursed availability in Europe (EFPIA W.A.I.T. 2025).

1 in 10

Medicines in low and middle income countries are substandard or falsified (WHO).

$30.5B

Spent each year on substandard and falsified medicines (WHO).

~96%

Of medicine selling websites NABP reviewed were not compliant with US law.

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