Biotech market entry barrier.

While listening to experts on viral clearance on seminar series for Biotech manufacturers, I realized that the price on market entry costs is going up. As science improves our view of surrounding world it visualizes more and more threats, what on markets like one in the US results in more and more regulations and requirements from FDA as ultimate consumer protector. As such, FDA updates the product testing and manufacturing regulations every year. This results in piling up of the costs on every drug that must be FDA approved before approved for market. Of course there is limit what companies are willing to pay in development phase and are eager to cash after approval, therefore so much criticism of drug prices from public. Inadvertently public safety increases drug prices.   

Just as example: current price for characterization of the production  cell line used to make recombinant proteins is between $55000 - $100000. Actual FDA new drug application can cost up to $250000.