Companion diagnostics (CDx) are transcending their oncology roots, expanding into new disease areas like rare genetic disorders and neurodegenerative conditions, where precise patient stratification is critical. This shift is driven by advancements in biomarker discovery and growing demand for personalized treatments in underserved fields. As CDx proves its utility beyond cancer, the market is unlocking new growth avenues, with non-oncology segments projected to account for 30% of total revenue by 2027, up from 15% in 2023.

Rare diseases are a key frontier. With over 7,000 known rare diseases and 95% lacking targeted therapies, CDx is vital for identifying patients eligible for emerging treatments. For example, [RareGen]’s CDx panel for spinal muscular atrophy (SMA) detects SMN1 gene mutations, guiding access to nusinersen (Spinraza). This has reduced SMA misdiagnosis rates by 40% and accelerated therapy uptake. Similarly, CDx for lysosomal storage disorders (LSDs) like Gaucher disease now identify enzyme deficiencies, enabling early enzyme replacement therapies.

Neurodegenerative disorders, such as Alzheimer’s and Parkinson’s, are also adopting CDx. [NeuroCDx]’s amyloid PET imaging companion test for Alzheimer’s therapies now helps clinicians confirm amyloid plaque presence, ensuring patients receive appropriate drugs. In Parkinson’s, CDx tests for LRRK2 gene mutations guide use of kinase inhibitors, reducing trial-and-error prescribing. These applications align with global aging trends; the WHO projects 1 in 6 people will be over 65 by 2050, increasing neurodegenerative disease prevalence and CDx demand.

However, non-oncology CDx faces challenges. Biomarker identification for complex disorders like Alzheimer’s is slower, with many tests still in R&D. Additionally, smaller patient populations reduce economies of scale, raising costs. To address this, consortia like the [Global Rare Disease CDx Initiative] are pooling resources to fund biomarker research, while governments (e.g., Japan’s rare disease support program) subsidize test development. For businesses targeting these frontiers, the Companion Diagnostics Market Expansion into Non-Oncology Segments Report by Market Research Future offers insights into emerging disease areas, R&D priorities, and patient access strategies, ensuring alignment with the next wave of CDx growth.