The prognosis for diagnostic services

Rapid and efficient disease identification is a pressing issue for the healthcare sector. Earlier diagnosis of infectious diseases can reduce transmission, improve patient quality of life and reduce some of the burden on healthcare services – a phenomenon that was observed on a global scale during the COVID-19 pandemic. The diagnostics sector is also contending with rising cases of chronic diseases, an ageing population and staff shortages in healthcare. This increased demand for diagnostic services predates the pandemic. Factors such a rise in hospital attendance and more direct requests for tests from GPs were already driving demand in the UK.¹ This heightened pressure means that six week waits for diagnostics in pathology have risen by 17% per year since 2010.²

Laboratories globally are also contending with other pressures. The surging demand for their services during the pandemic absorbed higher volumes of supply, leading to ongoing shortages.^3-7 In the EU, the In Vitro Diagnostics Regulation, which came into force in May 2022, entails much stricter requirements for 85%-90% of IVDs.⁸ To allow manufacturers breathing room to achieve compliance, the regulation is being rolled out progressively based on device classification. Higher risk devices have a shorter timeframe to comply, while the final deadline for lower risk devices falls in May 2027.⁹ The ability of manufacturers in the EU to meet the new requirements in time will impact laboratory supply, since non-compliant devices may have to be temporarily or permanently withdrawn. One estimate is that at least 22% of IVD tests on the market today will be discontinued.¹⁰

Additionally, staff shortages which are common to wider health services are affecting diagnostics. A census by the Royal College of Pathologists in the UK found that that only 3% of histopathology departments in the National Health Service have enough staff to meet clinical demand,¹¹ while the Royal College of Radiologists (RCR) reported in 2016 that nearly 97% of the UK’s radiology departments were unable to meet diagnostic reporting requirements.¹² In the US, the level of training required for phlebotomists is proving an obstacle to meeting surging demand for blood collection, expected to increase by double-digit percentages over the next few years.¹³