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This chapter explores the many reasons why Big Pharma
hasn’t embraced edible biologics: the regulatory friction,
the IP disruption, the loss of manufacturing monopolies,
and the existential threat to their current business model.

What you’ll see is not failure to innovate.
It’s a refusal to.

Because when disruption threatens to make medicine
cheaper, more accessible, and more durable—but less
profitable—the greatest risk isn’t technical.

It’s institutional.

6.1 – A Threat Hiding in Plain Sight

For over two decades, Big Pharma has carefully
constructed an empire around complex biologic therapies—
monoclonal antibodies, fusion proteins, and enzyme
replacements manufactured in sterile, centralized facilities.
These therapies are potent, high-margin, and deeply
entrenched in the global healthcare economy. But beneath
the surface, a quiet revolution has begun—one that could
unravel that model from the roots.

Edible biologics don’t just offer an alternative
manufacturing method. They rewrite the rules. They
sidestep the need for bioreactors, cold-chain logistics, and
sterile injection infrastructure. They transform the drug into
the delivery vehicle. And for a pharmaceutical industry
built on tightly controlled distribution and proprietary
delivery platforms, that is nothing short of existential.

Edible biologics pose a threat on four major fronts:

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