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Nico Rivelis's avatar

Hi Gad, this is not new. A very similar issue happened in 2017 when Maria hit Puerto Rico. https://www.baxter.com/perspectives/community-engagement/global-response-hurricane-maria

And previously with FDA warning letter to the Hospira manufacturing site the same year - a single warning letter to one of the suppliers can severely affect the whole supply chain.

This is unlikely to change as Health Systems and GPOs don't want to pay higher prices for increased reliability in supply and the IV fluid manufacturers are pressured to deliver earnings to Wall Street. There's no incentives for any party to reduce the risk.

Temporary importation from manufacturing sites across the world seems to be a reasonable approach to solve for these types of cataclysmic events. It seems that's the temporary solution being implemented. Although I agree that it would be ideal to have a better solution for this.

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Josh's avatar

I have personal experience in multiple adjacent businesses at one of the manufacturers you mention.

The fundamental challenge is that customers -- health systems and GPOs negotiating for them -- are completely unwilling to pay anything for increased reliability. This is a classic prisoner's dilemma in which neither major firm can afford to invest in capacity without losing share or suffering lower margins than its competitor.

As a result, prices are low. IV solutions produced so cleanly that they can be infused directly into veins sell for less per oz than bottled water at a convenience store.

The start-up costs to build a plant, both in terms of capital and regulatory requirements are not so onerous that they prevent market entry. In fact, I'd say that the regulatory barriers are immaterial to this analysis, especially as there are many firms that produce equivalent products (generic drugs in a bag) but not IV solutions or that produce IV solutions, but not at scale for the US market.

Because prices are low and aggressive price competition between Baxter and Braun would make the market unprofitable for both, both firms sell IV solutions as part of a bundle negotiated with GPOs. At a high level, the best price of something a hospital really wants (e.g. an expensive IV pump) is only achieved by committing to buy 80% or more of the IV solutions business from the same manufacturer. This scheme is what prevents market entry by making the prospect of gaining share unlikely for any new entrant. But the root cause is the lack of profitability in the category.

Two other barriers to increasing supply are significant, but secondary.

- The long-term trend for this market is slight reduction. I'm too far removed to have current data. But the general trend of treating more patients as outpatients in the hospital (versus multi-day inpatient stays) or outside of the hospital completely has put downward pressure on IV solutions demand, even though an aging population and increase in some conditions is a positive. As a result, no IV solution plant expansion is going to make the top 10 capex investments at any company.

- Bags of water are really heavy. At IV solutions prices, it's not profitable to manufacture these products OUS and ship to the US. This dynamic makes the business case for having multiple US plants easier to make, but low margins in this category and the lack of market growth make that argument moot.

Finally, lest we think this is specific to IV solutions, it's not. When patient deaths were linked to adulterated heparin many years ago, the root cause was Chinese "API" (the drug itself) suppliers who were making adulterated product to save money. Manufacturers explored the market for higher-priced products with increased controls over the supply chain, including US-manufacturing, but hospitals were similarly unwilling to pay a premium for those.

Absent government intervention, this is an unsolvable problem.

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