Estimate the time and expense of qualifying a competent entrant. Count existing licensees as competitors, and distinguish a capped market from one in which every qualified applicant can enter.
How companies won with Licenses & approvals
From the win chains in Strategy Canon case studies: what the winner did, and what its rival did at the same step.
vs. Foundation Medicine · 2015–21
Guardant Health
Evidence, coverage and approval make blood testing routine
What it did
80 peer-reviewed publications and 29 outcomes studies, all NCCN centers, Medicare coverage for lung cancer (2018)
Foundation Medicine
FoundationOne Liquid CDx approved Aug 26, 2020, nineteen days later, with broader companion indications (NSCLC EGFR, prostate BRCA)
Catch-up barrier: regulatory record and validated library
What it did
375+ label claims in place of clinical studies (2024)
Simulations Plus
GastroPlus and PK-Sim matched Simcyp's average predictive performance in a comparative study and outperformed it on poorly absorbed drugs, yet held about 3% of FDA PBPK filings
Is authorization scarce or merely costly? How many credible competitors can qualify, and does the permission cover the actual market served?
Who names it
Author
What they call it / where it appears
Neumann
A Taxonomy of Moats — Licenses & approvals
Note. The diagnostic and scenario are Strategy Canon’s analytical application. Test the firm’s benefit and exclusion mechanism separately; this category alone does not establish Power.