Hydrix recently undertook a market research initiative focusing on the in-vitro diagnostics/point-of-care (IVD/POC) market, engaging with key stakeholders in the US and EU. Our primary objective was to gain insights into market characteristics in the aftermath of the COVID-19 pandemic, identifying trends and learning of the challenges and opportunities that lay ahead. Below we share some of the key insights from the industry insiders.
The post-COVID-19 slowdown in funding and revenue:
After experiencing a massive inflow of funding and revenue during the peak of the pandemic, organizations are now facing a slowdown in these areas. Shifting priorities and changes to market dynamics have revealed an urgent need to find new opportunities, and new markets, for technologies developed over that period. This includes new test panels, or even seeking out ways to repurpose platform technologies.
There is a real sense of urgency to find revenue and new market opportunities soon.
“We know there is a market there, but people are very cautious because the whole market was overheated during COVID. Especially in the US, because they’ve put so much money into it. Many companies are going belly up right now. They received millions in funding but were unable to deliver. I can clearly see why people are getting more careful”.
Rise of At-Home Testing:
COVID-19 normalized at-home testing, generating excitement around the concept of “Point-of-Use” diagnostics. This shift has revealed new opportunities in the market and increased interest in developing innovative solutions for convenient and accessible testing at home.
Perception of Molecular POC:
The perception of molecular POC testing evolved during the pandemic. It is now seen as a valuable tool for rapid and accurate diagnostics and is driving an increased demand and interest in molecular POC technologies.
Digitization and Automation Opportunities:
There is growing curiosity and excitement about the potential impact of digitization and automation in the IVD/POC market. The concept of the “dark lab,” which refers to fully automated and digitized laboratories, presents opportunities for increased efficiency, accuracy, and streamlined workflows.
Regulatory Hurdles:
The implementation of the In Vitro Diagnostic Medical Device Regulation (IVDR) in the EU has made it more challenging to get devices approved. This regulatory landscape has added complexity to the process of bringing new IVD/POC products to market in the EU.
“Developing for the EU getting harder because of IVDR. It’s something we’ve prepared for and done a lot of work for, but we still see some cost and barriers that will make expanding in the European market a challenge”.
FDA ‘reluctance’:
The US FDA, often considered the “first customer” for new diagnostics tests, is still reluctant to approve at-home diagnostic tests. This cautious approach could be due to various factors, including concerns about test accuracy, reliability, and the potential misuse of at-home testing.
Time to market expectations:
Expectations are that development timeframes for new devices and tests can be shortened. However, developing both the assay and the instrument simultaneously is a difficult task. A stable instrument is required to create a reliable assay, and conversely, having a known assay helps in assessing the functionality of the instrument. Without a fixed assay or instrument, experimentation may yield unexpected results, making it challenging to determine whether the issue lies with the chemistry or the instrument. Resultant delays mean the market opportunity is missed.
In response to these industry insights, the Hydrix team has developed tailored packages of work to address some of your most immediate POC development challenges. We invite you to visit our AACC booth to experience how you can ‘drag and drop’ our offerings to meet your specific needs.
