The Companion Diagnostics Market has become a cornerstone of the personalized medicine era, enabling healthcare providers to tailor treatments to individual patient profiles. Companion diagnostics are medical devices, often in the form of in-vitro tests, that provide essential information for the safe and effective use of a corresponding drug or biological product. Their role in cancer care, particularly in identifying genetic mutations such as EGFR, ALK, and HER2, has significantly transformed treatment strategies. With precision medicine becoming a priority, pharmaceutical companies are collaborating closely with diagnostic firms to develop integrated drug–diagnostic solutions. Regulatory bodies such as the FDA and EMA are also encouraging co-development strategies.

Market growth is driven by advancements in molecular diagnostics, increased adoption of targeted therapies, and rising demand for early disease detection. Challenges remain, including high costs, regulatory complexities, and the need for widespread reimbursement policies. Nevertheless, the future points towards broader application in infectious diseases, cardiovascular disorders, and autoimmune conditions.