3 ms·
Depends on the type of insulin you want to make, but if you want to be at the cutting edge it would likely cost around a billion dollars. You have to avoid the
by pg_bot 4y ago
Depends on the type of insulin you want to make, but if you want to be at the cutting edge it would likely cost around a billion dollars.
You have to avoid the intellectual property minefield on the manufacturing side. The production of insulin and its delivery mechanisms are heavily patented and the big pharma companies will shut you down if you infringe on anything. If you want a reference for this happening you can google 'lusduna'.
Plus you have to make it through the FDA, which is its own can of worms. The 505(b)(2) is still not a cakewalk but at least it will give you 3-5 years of market exclusivity so you can recoup your costs. (Wait you can get market exclusivity for a biosimilar with an expired patent? That should sound insane to anyone not in healthcare.)
Then you have to actually manufacture and distribute your product. There are extremely high capital costs to get set up. For reference, Novo Nordisk's insulin manufacturing facility in North Carolina is 328,000 sqft and staffed by ~500 people 24/7. Just to get a comparable facility up and running you're talking about 400-500 million dollars in capital cost. Sanofi, Eli Lily, and Novo Nordisk have spent billions over the last decade upgrading and maintaining their facilities.
I would suspect it's about the hardest project you could tackle if you were a startup.
- idealmedtech 4y agoNo one in their right mind would build manufacturing from scratch. Contract manufacturers exist to do relatively cheap design work in exchange for access to their expensive-to-build (but cheap to use by comparison) manufacturing facilities. I can't speak to drug manufacturing, but I know from experience that when it comes to medical devices, you save almost 10x in up front fixed cost by outsourcing, like California is doing. You spend more per unit, but still profit, so you can build a healthy warchest while you accumulate experienced personnel to build out a more vertically integrated manufacturing process.
- pg_bot 4y agoWith regard to insulin 3 companies control 90% of worldwide production. I'm not aware of a third party manufacturer that can actually produce modern insulins at scale. Even if they existed, they still have to work around the issues previously stated. It is unlikely that you would be able to partner with the big players as they have no incentive to help a competitor and they are already running at full capacity. You probably don't have any other option than to build it yourself. Medical devices are frankly a lot simpler than making new drugs. (I know they are still exceptionally challenging)
- idealmedtech 4y agoThere are many many very difficult parts to novel drug developments, and I'm not saying they will have success finding something that doesn't infringe and also scales. What I'm saying is that the strategy of doing everything yourself with startup level funding and experience is not optimal, and you can save money and time by outsourcing at the beginning.