Written by Bill Finger, Managing Director, Kineticos

The market for point of care diagnostics is growing. MarketsandMarkets recently released a report stating that the global point of care market is expected to hit $27.5 billion by 2018, with a CAGR of 9.3%. Companies of all sizes are working to find their niche in the market. Whether it is a small start up with a unique technology, or a large diagnostic company looking to acquire new technologies to fit in their portfolio of products, they are all focused on the next big idea. Let me point out a few recent examples of companies working in the space along with some challenges they face.

Recently, Achira Labs announced the launch of a new platform for thyroid testing. This new technology, which is competing with existing platforms where testing currently being performed in a central lab, offers a faster turnaround time at a lower cost. While thyroid testing is routine in many areas, there is now an opportunity to bring this testing to developing countries that otherwise may not have access.

Chembio Diagnostics, Inc. also showed their commitment to the point of care space when they announced a collaboration with Bio-Manguinhos, a unit of the Oswaldo Cruz Foundation (Fiocruz), to develop a point of care diagnostic for Zika virus. Their goal is to add Zika virus testing to a panel with other rare diseases, such as Dengue and Chikungunya. Ultimately, they want to develop a rapid and cost effective diagnostic that can be available worldwide.

While a growing and evolving market presents plenty of opportunities, they are typically accompanied by challenges. For example, understanding the existing practices a technology is going up against in the lab, especially around FDA approved tests, is critical. Some of these practices are considered gold standard testing regimens, and introducing a new way of doing things is not always welcomed, or approved. Other areas to consider when developing a go-to-market strategy are customer-buying preferences and the reimbursement landscape, both of which can vary greatly across geographies and target markets.

Operational factors should also be accounted for when developing a new point of care device. These factors include who will collect the sample and perform the testing, where the instrument and consumables will be kept, how the data will be sent to the physician, and who will maintain the instrument. Operational challenges typically do not earn much, if any, attention in the planning phases, but they should not be taken lightly.

Lets face it- everyone thinks that their technology is the latest and greatest. The truth is none of that matters if the knowledge base is lacking and/or the approach to the market is not carefully thought through.   Doing the market research throughout development will not guarantee success, but it will help guide the optimal path to market acceptance.


Bill Finger, Managing Director of Kineticos’ Diagnostics Practice, brings 20 years of diagnostics and laboratory experience to the team.  His team is focused on helping   diagnostic companies maximize their commercial potential at the corporate and product levels while ensuring companies operate in an efficient manner.

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