North America Companion Diagnostics Devices Market Size

North America Companion Diagnostics Devices Market Analysis

The North American companion diagnostics devices market is expected to witness a CAGR of 18.5% over the forecast period.

COVID-19 has impacted the growth of the companion diagnostics devices market. For instance, according to an article published by Systematic Reviews in Pharmacy, in May 2022, serological antibody tests were used as SARS-CoV-2 vaccination companion diagnostics to enhance COVID-19 immunization schedules. In addition, as per the same source, SARS-CoV-2 vaccination companion diagnostics offered several advantages, including long-lasting, dependable immune protection through monitoring with a particular test combination and, consequently, medical security against COVID-19. This has increased the demand for companion diagnostics during the pandemic. Moreover, the emerging new or treatment-resistant variants has increased the demand for alternative therapies and rapid companion diagnostics for combatting acute infections as well as to understand the short- and long-term impact of variants on health. Thus, the studied market has witness significant growth and is expected to grow over the forecast period.

Factors such as the increasing demand and awareness for personalized medicines and targeted therapy, increasing cases of adverse drug reactions, and technological advancements in the devices are expected to boost market growth over the forecast period.

The growing company's focus on adopting various key strategies such as collaboration, partnerships, and others to improve access to personalized medicines as well as increasing awareness regarding targeted therapies among the population is expected to increase the adoption of companion diagnostic tests. This in turn is anticipated to fuel market growth. For instance, in May 2021, Hoffmann-La Roche Limited, Canada, signed a joint initiative with BC Cancer and the Canadian Personalized Healthcare Innovation Network (CPHIN) to co-create a real-world evidence (RWE) framework in British Columbia. The PREDiCT initiative generates and assesses RWE, which can be used to shape new sustainable reimbursement pathways for personalized cancer treatments.

Furthermore, a surge in research and development of targeted therapies is also expected to increase the demand for companion diagnostics tests and devices, hence contributing to the market growth. For instance, in May 2021, the United States FDA approved Rybrevant (amivantamab) as a targeted therapy for treating adult patients with non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

Moreover, the growing company activities in developing technologically advanced products, and increasing new product launches and approvals are also expected to bolster the market growth in the region over the forecast period. For instance, in July 2021, Labcorp launched therascreen KRAS PCR Mutation Analysis, a companion diagnostic to identify patients with non-small cell lung cancer (NSCLC) who are eligible for therapy with LUMAKRAS (sotorasib). Similarly, in May 2021, QIAGEN N.V. launched an expanded scope of companion diagnostic (CDx) claims for the therascreen KRAS RGQ PCR Kit after the United States as a companion diagnostic to aid in the identification of non-small cell lung cancer (NSCLC) patients that may be eligible for treatment with LUMAKRAST approval.

Therefore, owing to the aforementioned factors, the studied market is anticipated to grow over the forecast period. However, the high cost of drug development and associated clinical trials are likely to impede the growth of the companion diagnostics devices market over the forecast period.