Companion Diagnostics Development Services Market : Distribution By Type of Service Offered, Analytical Technique Used, Therapeutic Areas and Key Geographies : Industry Trends and Global Forecasts, 2022-2035

Reportlinker.com announces the release of the report “Companion Diagnostics Development Services Market: Distribution by Type of Service Offered, Analytical Technique Used, Therapeutic Areas and Key Geographies: Industry Trends and Global Forecasts, 2022-2035” –

These therapies are tailored to target specific disease-related molecular signatures and require appropriate companion diagnostics (CDx) in order to make physicians aware of patients’ unique genetic profiles, enabling them to make informed treatment-related decisions. These tests are most often developed parallel to an investigational drug in order to identify the latter’s safety and efficacy and measure its therapeutic effect on the target. With the approval of trastuzumab and HercepTest™ (an IHC-based companion diagnostic assay designed for the determination of HER2 overexpression) by the USFDA in 1998, several novels targeted cancer drugs guided by a diagnostic assay, have progressed into clinical stages or are approved for commercial use. In fact, since 2020, a total of 44 companion diagnostics have been approved by the USFDA. Further, a study of nearly 200 unique pharmacological interventions evaluated across more than 670 clinical trials, suggests that the likelihood of a lead compound passing through various phases of clinical development and eventually getting approved is only 11%. The use of disease-specific biomarker information to recruit patients not only increases the success rates of the studies but also reduces the trial costs by nearly 60%.

Given the various benefits, the healthcare industry is gradually shifting from the conventional, one-drug-for-all, paradigm to using tailored pharmacological interventions, which is expected to increase the need for companion diagnostics as well. However, given the complexities involved in the co-development of a drug and the affiliated companion diagnostic test, drug developers have demonstrated the preference to outsource the diagnostics development operations. In fact, around 80% of the companies are known to rely on third-party service providers for companion diagnostics development, primarily owing to the lack of in-house expertise for the development of these tests. As a result, many companies have made heavy investments in order to install robust tools and technologies, such as polymerase chain reaction (PCR), immunohistochemistry (IHC), in situ hybridization (ISH), next-generation sequencing (NGS), and offer end-to-end services to sponsor companies engaged in this domain. In addition to conventional analytical techniques, several innovators have made the latest upgrades in their portfolio by installing novel solutions, including digital PCR (dPCR) and digital immunoassay, in order to cater to the evolving needs of their customers. Given the growing demand for personalized therapies and ongoing innovations in technologies, we are led to believe that the opportunity for companion diagnostic developers/service providers is likely to witness sustained growth over the coming years.