We may have a global market but do we really consider options outside of USA and EU when developing our Therapeutic Product Commercialization strategy?
The USA, EU/UK are large markets with clear regulatory requirements, so they are often first targets for therapeutic product commercialization, either for medicines or medical devices.
A New Perspective
But what if… you could launch in another country sooner and begin a (smaller) revenue stream earlier?
How would that boost your share price, cashflow, team morale and investor confidence when partnering or licensing?
Commercialization planning needs to be a whole of world exercise, including all relevant key elements such as the stage of your CMC development program, early clinical trial results and likelihood of reimbursement in the target markets.
Going single-mindedly for a traditional market with the highest $ returns as the first target may not be the best option overall, particularly if you have an early exit strategy.
Countries such as Australia have a well recognised and highly respected regulatory agency in the Therapeutic Goods Administration (TGA). The TGA is also involved in multiple work sharing and mutual recognition arrangements that may facilitate your next approval in a larger market.
An early approval will also help to validate your development program.