well, I don't actually know, but my guess is there's not much money in it. If the market, in dollars, isn't big enough, competitors don't enter the field for 2 reasons: 1) Price competition against the originator destroys whatever value is left of a meager market and 2) getting approval from Regulatory Agencies all over the world is time consuming and expensive and if the market is small, well then I guess you have to be motivated by something other than profit , like helping sick people. But who would do THAT???? Oh , I forgot, Wave Systems was never in it for the money. They just wanted to help people (3 people, anyway).
So.... if you're the only company approved by FDA to sell in US, well, you go Full Shkreli.
I found this on Transparency Market Research site and it (plus the pill's original price) makes me think the $ market is not that big. Segmented market; North America dominates, because there's no price suppression in the US like there is in EU or 3rd world markets. Profitability is probably tough ex-US.
"The global pyrimethamine market has been segmented into brands and geography. On the basis of brand, the pyrimethamine treatment market has been segmented into two drugs that are presently marketed such as Daraprim and Fansidar. The Daraprim sub-segment held the largest share for the pyrimethamine treatment market. However, the Fansidar sub-segment is growing at a high rate due to affordable cost and availability.
Geographically, North America dominates the global pyrimethamine treatment market followed by Europe. The market domination was majorly due to the pricing structure of the pyrimethamine drug in the U.S. The High prevalence of toxoplasma in the region also acts as the driving factor for the growth of the pyrimethamine treatment in the North America. According to The Centers for Disease Control and Prevention (CDC), toxoplasmosis is one of the five neglected parasitic infections in the U.S. It is the second leading cause of death from foodborne illness in the country and more than 60 million people in the U.S. carry the toxoplasma parasite, and more than one million people in the U.S. are infected annually with the toxoplasma parasite, which is associated with high rates of morbidity and mortality. Asia-Pacific is also increasing constantly in the pyrimethamine drugs market mainly due to the high prevalence of protozoan disease such as malaria in India, China and other developing nations. Moreover, government initiatives and regulatory norms in these countries would fuel the market for pyrimethamine treatment market in the region during the forecast period. Latin America is also a growing market for pyrimethamine treatment due to developing healthcare expenditure and high prevalence rate of malaria and toxoplasma in the region. "
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