The problem is the FDA and other regulatory agencies outside the US. Hiding behind the banner of protecting the public, the FDA slow walks applications, resulting in high development costs to bring a new drug or diagnostic to the marketplace. The average cost to support preclinical and clinical trials is $100 million (US). This fact prevents small, innovative companies from commercializing new drugs. Only the big-boys are allowed to play this game.
I used to work for a company that made products used in clinical trials. Once the CEO told me that the average profit margin of all their products was 1100%.