The Future of Diagnostics

For diagnostics, the postpandemic future is bright Technological advances, innovative platforms, and decentralized test options are driving exciting developments and optimism across the diagnostics industry. While the industry was put front and center during the COVID-19 pandemic, diagnostics have always played a critical role in treating illnesses and managing health. The ability to gain a fast, accurate understanding of a person’s disease status helps to drive effective treatment in a timely manner and improve patient outcomes. With new, more targeted and personalized therapies coming to the market quickly, and changing the way we treat complex conditions, it’s increasingly important that diagnostics developers and manufacturers keep pace. Technological advancements, along with recent industry shifts and learnings, are setting the stage for exciting changes in diagnostics and clinical care. To gain an understanding of where the diagnostics industry is at this pivotal time ― and where it’s going in the next 5 years — we surveyed a sample of people from the diagnostics industry. The objectives of this study were to: •Gain an understanding of which external factors will have the most significant positive and negative impacts on the industry in the next 5 years •Uncover and understand the challenges facing diagnostics customers, currently and in the next 5 years •Learn what solutions and technologies diagnostics customers are seeking •Find out how anticipated changes in key areas are likely to affect patients •Identify growth areas for diagnostics development Who we spoke to for our diagnostics research From March through April of 2023, we surveyed 175 members of the diagnostics industry, gathering information and insight on the current state of the diagnostics across three key regions: 41% of respondents came from the European Union (EU); 40% from the United States and Canada (USCAN); the remaining 19% were from the Asia Pacific region (APAC). This sample size and the respondent characteristics were selected to represent the broader, global diagnostics landscape. Our industry representatives included a mix of senior and junior employees across various roles, company sizes, and diagnostic application areas (Fig 1). The majority of those surveyed worked for mid- to large-sized biotech or biopharma companies (43%), followed by molecular diagnostics organizations (19%) and start-up biotechs (16%). Nearly a quarter of respondents were senior scientists. Most of those surveyed were working on the development or manufacturing of diagnostic kits (57%), with the rest involved in later stages of the process, closer to the patient, doing clinical diagnostics work (43%). When asked the area of research where they spent over 50% of their time, most responded with molecular diagnostics (58%) ― where an assay’s target is a nucleic acid ― with the remainder working with immunodiagnostics that center around the identification and quantitation of proteins. 6 CY34331-14Jul23-EBOptimism for the diagnostics industry is strong Overall, the members of the diagnostics community who participated in our survey are feeling optimistic. When asked to rate their confidence about the industry’s future on a five-point scale, more than half of those surveyed responded with the most optimistic outlook possible. Only 13% feel entirely pessimistic about the future of diagnostics, with all other responses falling somewhere in between (Fig 2). With talent being an important driver of biopharma growth and resilience, checking in on how the diagnostics workforce is feeling about the future can help shed light on the industry’s health and trajectory. Reassuringly, there was a similarly positive distribution when people were asked if they felt inspired about their future careers in diagnostics. This result is good news for companies looking to grow their diagnostics business, as finding and retaining trained, knowledgeable employees is a known challenge in biopharma. Fig 1. A breakdown of organizations and roles that are represented within our survey sample. Fig 2. A measure of diagnostics customers’ optimism about the industry and their careers, as well as expectations of challenges to come. CY34331-14Jul23-EB 7 How customers spend their time on diagnostic activities Our research participants focus on a wide range of clinical and across diagnostics applications. Based on survey results, there isn’t expected to be a drastic change in how time is spent within the industry over the next 3 to 5 years (Fig 3). There’s expected to be a slight move away from infectious disease diagnostics, perhaps related to COVID-19 work slowing down. The anticipated increase in genetic testing can, in part, be explained by an increased focus on genetic biomarkers and companion diagnostics associated with novel therapeutics. A projected rise in time spent on home-based diagnostics aligns with a recent overall shift toward telehealth and more at-home services, catalyzed by the pandemic. 5 constructive changes from COVID-19 The COVID-19 pandemic has shaped the diagnostics industry in many ways over the past 3 years and will continue to influence its trajectory into the future. Respondents to our survey see many of the lessons learned from the pandemic as good ones. Below is a summary of five positive changes members of the diagnostics community identified as coming from COVID-19: 1. Access to telemedicine and remote healthcare Because of COVID-19, the ability to deliver and receive care via telephone, video, and online chat gained traction. With patients staying home, payers began reimbursing for virtual consultations and remote monitoring. Diagnostics, being an integral part of the care process, is now being called upon to develop test platforms to support a more home-based care model. In addition to providing exciting new test options for the industry to pursue, this shift also offers