The cost to bring a medical diagnostic onto the market

At ZP we perform contract development and manufacturing of electrochemical biosensors, one of the questions we are regularly  asked is 'what does it cost to bring  medical diagnostic onto the market?'


In answering that questions we can use our industrial experience, which goes back over 20 years, and we can use the opinions and data from other world leaders in this field. In this article we draw upon comments from Professor Adam Heller and also from an excellent article on the Diaceutics website which can be found here.




Several years ago one of the principles at ZP spoke to Professor Adam Heller, a founder at Therasense; we asked asked Professor Heller what was the cost of bringing the Therasense glucose technology for diabetics to the market. Professor Heller have a very succinct reply:


1) $ 1 M to develop the technology to a point that it was robust enough to bring into manufacturing


2) $ 10 M to bring the product plus the quality system to a GMP level.


3) $ 100 M to win market share.


At the time of writing this document these number are 20 years old, but at ZP we still hold true to Professor Heller's comments and so if people are looking for a simple message on what it takes to develop an In-Vitro Diagnostic we suggest that the client needs three rounds of funding, starting at $ 1M, proceeding to $ 10 M and ultimately ending at $ 100 M.





For those who are looking for a higher resolution on  the activities and the costs behind Professor Heller's comments then we find an article from Diaceutics is excellent. The original article is here - click here.


In the adjacent table we have read and understood the information from Diaceutics and added our own take on their numbers.


You can see that Diaceutics gave a value in the range $20 M to $100 M which is inline with Professor Heller's comments.





At ZP we are always excited to work with clients who are ambitious and are driving to the market, and of course we want to support people on this road. We hope that these notes will help people in their buisness planning and their buisness models.


If you have questions regarding ZP's contract development and manufacturing services for IVD, please don't hesitate to contact us.    2020