The diagnostics industry is vast and rapidly expanding, with an estimated 3.3 billion in vitro diagnostic (IVD) tests performed annually in the US (The Role of Lab-Developed Tests in the In Vitro Diagnostics Market, Pew Report, 2021). However, it is also a fast-evolving sector with growing uncertainties, particularly due to recent FDA rulings that have further complicated development timelines for new tests.
To better understand the current landscape, CRA experts conducted the CRA Diagnostics Industry Pulse (CDIP) survey earlier this year, gathering insights from a wide range of clients. Participants ranged from employees from some of the world’s largest laboratory and point-of-care test-makers to startups with fewer than 50 employees. These respondents, primarily working in marketing, customer insights, and market access, are predominantly focused on oncology diagnostics, including cancer detection and screening. Other areas of focus included cardiometabolic diseases and women’s health. The survey results highlight key challenges diagnostics companies face in today’s competitive and uncertain market.
