| dc.description.abstract | Companion Diagnostics (CDx) are mandatory biomarker based assays used to stratify patients for the safe and effective use of a specific corresponding medicinal product. In the last twenty years the number of medicinal products developed with a CDx increased and so has their role in targeted healthcare. In May 2022 new regulations on the market approval of CDx in the European Union become fully applicable. Important change with the current regulatory situation is that CDx are no longer considered as low-risk assay and can enter the market by self-certification of the manufacturer, but are classified as high risk assays and require conformity assessment by a notified body. Consequently, manufacturers must provide evidence of clinical by conducting clinical studies and set-up a comprehensive quality management system and post-marketing surveillance programme. In this thesis, the potential consequences of these new regulations on CDx development has been reviewed by interviewing manufacturers involved in CDx development and reviewing opinion articles from interest organizations. Additionally, by analysing the influence of other factors, such as patents, market size and competition, presence of a scientific base, resource availability, potential partnerships, reimbursement and adoption by healthcare professionals, an overview was provided on the influence of these factors on CDx development and its innovation activities with the aim to manage CDx development and to contribute to targeted healthcare.
It is expected that with the introduction of these new regulations the innovation activities in small diagnostic companies and health institutions will be hampered. However, CDx development will remain interesting for large diagnostic companies and pharmaceutical companies. The major drivers in this respect lie within the possibility for the diagnostic companies to acquire a potential monopoly position and the pharmaceutical company having the ability to compete in markets with many competing products present. Future CDx development and its expansion to other disease areas greatly depends on research conducted on disease pathology and involved biomarkers. Nevertheless, the concept CDx rely on, i.e. measuring a limited amount of biomarkers for the prescription of a specific medicinal product, is not considered to be future proof. Healthcare institutions are expected to perceive increasing difficulties in organizing healthcare when more CDx enter the market and patients need to be tested multiple times before prescribing an effective medicinal product. Future prospects, therefore, lie within the assembly of relevant biomarkers in one single assay comparing potential medicinal products. | |
