2024 and early 2025 was a time of transition for the diagnostics industry, marked by regulatory shifts, technological advances and select investment rebounds. Many hurdles and uncertainties remain, particularly when it comes to reimbursement, the clinical utility and adoption of AI (or lack thereof), and regulation.

However, we believe that the sector’s growth opportunities are promising. Clinically, liquid biopsy adoption continues to grow quickly in oncology and is ready to expand in neurology and autoimmune disease. Technologically, sequencing continues to expand, especially single-cell genomics and proteomics. Diagnostics are playing an increasingly central role in clinical genomic medicine, health care at home and AI-driven clinical decision-making. For the seventh time in eight years, more than one-third of new drug approvals included biomarkers to guide drug usage in their labels.

A complex mix of forces will define whether and how the industry is able to grow in the next phase. It will all depend on how quickly stakeholders can capitalize on new testing technology opportunities, integrate into therapeutic development and leverage AI’s growing clinical effectiveness.

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If you would be interested in learning more about the report findings and what it means for the future of diagnostics, please don't hesitate to contact us at info@illuminaventures.com