Clinical diagnostics have always been at the intersection of medicine and technology. With rapid technological innovation and shifting global healthcare market dynamics, I anticipate several trends in 2025 will shape the laboratory medicine industry. Here are nine that could have a major impact:
- Rapid Evolution of Large Language Models and Artificial Intelligence (AI) The rapidly growing volume of health data, increasing power of computing, and expansion of talented bioinformaticians and computer scientists are generating unprecedented advancements in AI, particularly with large language models. These will continue to evolve at a previously unimaginable pace. With more than 70% of the quantitative data in the electronic health record generated by the clinical laboratory, this growth will undoubtedly impact how clinical testing results are interpreted and assimilated into healthcare.
- Significant Strides in Digital Pathology Digital pathology is poised to make significant strides in 2025 as adoption of the technology expands amid declining costs of scanning and data storage. This data will become a powerful driver of biomarker discovery crucial for developing new diagnostics and therapeutic solutions and creating more personalized treatment plans. Most importantly, digitization will enable new workflows to hopefully alleviate workforce constraints and improve speed and accuracy.
- Increased Interest in Proteomics, Metabolomics, and Mass Spectrometry Mass spectrometry is a methodology for measuring the mass-to-charge ratio of both large and small molecules. As mass spectrometry technology becomes more accessible and extends beyond specialized labs, it will increasingly be used to assess both large molecules like proteins and small molecules like drugs and metabolites. Combined with increased computing power, mass spectrometry will fuel clinical proteomics, the large-scale study of proteins, and clinical metabolomics, the simultaneous analysis of numerous metabolites and metabolic pathways. As these methods become clinically actionable, they will propel advances in diagnosis and disease management.
- Continued Regulatory Uncertainty The regulatory environment will remain uncertain as the diagnostics industry prepares to implement the changes outlined in the FDA's final rule on regulating laboratory-developed tests as medical devices. With a new federal administration in place, changes are anticipated. Still, major resolutions may not materialize immediately, and the option of a legislative solution to laboratory-developed test oversight may be revisited.
- Data and Personalized Medicine Influence Acquisition Landscape It remains uncertain if investors will view clinical diagnostics as an area of interest in 2025. However, the number of diagnostic companies focused on single or limited applications and the increasing need for access to data and portfolio diversification make continued mergers and acquisitions likely in the diagnostic industry in 2025. The growing importance of data may also influence which companies show interest in laboratory acquisitions as insurers, pharmaceutical firms, and other organizations seek to establish direct data pipelines.
- Public-Private Partnerships for Disease Management The trend toward public-private partnerships for monitoring and preparing for emerging infectious diseases is likely to persist in 2025. Meanwhile, the massive investments in distributed diagnostics that some anticipated for addressing infectious outbreaks seem unlikely this year.
- Ambulatory Care Fuels Point-of-Need Testing The pandemic spurred the adoption of at-home testing, but its expansion remains limited to tests with easily obtainable samples. More growth is expected in point-of-need testing, particularly in ambulatory care settings, where quick, on-the-spot answers are crucial.
- Ongoing Exploration of Diagnostic Solutions for Telemedicine While telemedicine has surged in recent years, integrating diagnostics into this ecosystem remains a challenge. Most successes in diagnostics have come from advancements in remote monitoring and wearable diagnostic devices, like smartwatches and outpatient cardiac monitors. Yet, the widespread adoption of biometric signals for clinical diagnostics has not been seen, and the absence of a convenient, FDA-approved self-blood collection device continues to be a hurdle for performing many diagnostics at home.
- Retail Companies Continue to Trial Health Services Retail companies are likely to continue pushing consumerism in healthcare, leveraging their deep customer insights. Despite some high-profile failures, the appeal of convenient, immediate results remains strong. Retailers will likely keep experimenting with healthcare models, including diagnostic solutions that offer quick answers to consumers.
In the year ahead, the healthcare and diagnostics fields will witness significant advancements, driving personalized medicine, emphasizing the importance of data, and exploring increased easy access to diagnostic testing as part of more consumer-centered healthcare delivery. It is important that healthcare and laboratory leaders monitor these trends and other changes throughout the year to ensure they evolve and remain successful in this dynamic landscape.