Navigating a regulatory pathway to open a premium market

A European industrial biotech company was preparing to scale its technology in the United States, but the economics of the existing business model did not hold up in the US market. Through market development and work with technical specialists, I surfaced a secondary application of the technology that could create a much higher-value output for a certified premium market.

The initiative did not sit naturally within any single function. Capturing the opportunity meant keeping decisions inside the company aligned with regulators, investors and commercial counterparties outside it. My role was to hold the whole path together.

Accessing the market required certification through a process that had never been applied to an output like this. The technical review was demanding, and the certification decision sat inside a politically contested debate over what the category should include.

The case was made around the category rather than as an exception for one company, and the facility inspection was completed during the pandemic. The result was a first-of-its-kind certification, opening access to the premium market.

But market access did not yet make the projects financeable.

Project investors needed predictable revenue under long-term contracts, but the premium market did not normally operate that way. Once the certification established the product’s value, counterparties were willing to change their usual commercial model to secure access. The result was competitive bidding for a long-term agreement.

The product went from a secondary application of the technology to a central pillar of the company’s global business model, materially changing the economics of future deployments.