The North America companion diagnostics market is predicted to rise with a 13.41% CAGR during the forecasted years of 2022 to 2030, acquiring a revenue share of $6430.01 million by 2030.

The market growth of the region is driven by the increasing prevalence of chronic diseases, the rise in the incidence of neurodegenerative conditions, including Alzheimer’s disease, intensifying health consciousness, as well as the rollout of healthcare plans by the government. However, the North America companion diagnostics market is likely to be negatively impacted by ethical, legal, and social issues associated with the protection of patients’ genetic information.

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The North America companion diagnostics market growth assessment comprises a detailed study of the United States and Canada. The growth of the companion diagnostics market in the United States is predominantly credited to the excellent network existing between manufacturers as well as service providers, compared to other nations. Moreover, the contribution of the United States Food and Drug Administration (FDA) has further aided the development of a flexible regulatory pathway, thereby resolving multiple queries linked to the co-development process. However, the rapid evolution of diagnostics technologies challenges the United States FDA in terms of continually redefining companion diagnostics’ regulatory ecosystem.

Likewise, factors such as unclear companion diagnostics regulatory pathways, limited healthcare policy, and market variability may hinder the demand and adoption of companion diagnostics in Canada. However, various private and public initiatives are set to enhance the country’s market growth. For example, the Alliance for Innovation in Molecular Diagnostics is establishing efforts toward refining the companion diagnostics innovation environment. Similarly, provincial HTA agencies, including INESSS and OHTAC, hospitals, and provincial ministries of health are also working towards promoting companion diagnostic applications through the provision of recommendations for reimbursement. As a result, these factors are expected to fuel the market growth in North America during the forecast years.

The North America companion diagnostics market is segmented into technology, indication, products & services, and end-user. The technology category constitutes in situ hybridization, polymerase chain reaction, immunohistochemistry, next generation sequencing, and other technologies. Upgrades in throughput, as well as analysis for in situ hybridization (ISH), will continue to ensure growth for competitive pressure and advanced training. Moreover, the in situ hybridization segment is anticipated to maintain a significant share, particularly in its core applications, while leveraging unique potential in niche avenues of companion diagnostics and histology diagnostics.

The notable share of the polymerase chain reaction segment is accredited to better results, ease of use, cost-effective solutions, and faster turnaround time. PCR-based companion diagnostics are set to capture a substantial share in neurology, in addition to new oncology applications like leukemia, ovarian cancer, and prostate cancer, owing to their effective detection of biomarkers.

Some of the distinguished companies operating in the North America companion diagnostics market are Danaher Corporation, Arup Laboratories, Abbott Technologies, etc.

Danaher Corporation, headquartered in the United States, is a manufacturer and developer of professional, industrial, medical, and commercial services and products. Its operations are focused on the development of applications for medical diagnostics, environmental and applied solutions, and life sciences.

The company’s major products entail microsystems for life sciences research, services and disinfection systems for environmental solutions, analytical instruments, reagents, software for medical diagnostics purposes, consumables, and instrumentation.

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