North America Molecular Diagnostics Market size exceeded USD 10.52 billion in 2021 and is anticipated to expand at a CAGR of 2% from 2022 to 2028.

Early detection is adopted as a proven strategy for the effective treatment of chronic and infectious diseases. In North American countries, genetic testing and the diagnosis of syphilis, HIV, and other sexually transmitted diseases have increased considerably. This factor, alongside the growing awareness of early disease diagnosis, will escalate the requirement for molecular diagnostics.

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Some of the major applications using molecular diagnostics include drug regimen selection, therapeutic monitoring, and patient stratification. Likewise, research and development programs and deployment of automation technologies are emerging as prominent trends favoring the industry outlook.

Over the years, developments in nucleic acid amplification and single pathogen detection methods to offer accurate and faster results have been witnessed. However, the introduction of stringent regulations may create a hindrance to the regional industry expansion.

Impact of COVID-19 on the North America Molecular Diagnostics Industry Dynamics

In the wake of the COVID-19 pandemic, the need for reagents and kits for effective diagnostic testing has surged considerably. To address this burgeoning demand, in August 2021, the DoD (Department of Defense) awarded a contract worth $0.6 million to QIAGEN Beverly, Inc. to boost the manufacturing capacity of enzymatic reagents and kits for use in COVID-19 molecular diagnostic tests. This expansion effort was intended to allow the company to increase the production of reagent kits by over 7,000 per month in its Massachusetts, facility by February 2022 end.

North America Market, By Product

The instruments segment accounted for USD 2,840 million revenue in 2021, attributed to rapid technological advancements and the widespread usage of molecular diagnostics in microfluidic devices as an effective approach for pathogen detection.

North America Market, By End-use

The diagnostic laboratories segment will witness substantial growth through 2028, led by the mounting investment in lab expansion projects in countries including the U.S. For example, in April 2022, Mayo Clinic announced an investment in a major laboratory expansion project in Rochester to support patient care service delivery.

North America Market, By Application

The infectious disease testing segment will gain remarkable momentum during the forecast timeline, credited to the escalating number of elderly people who are at high risk of chronic infections. North America also witnesses a high prevalence of tuberculosis. These factors, along with the favorable reimbursement scenario, will boost the popularity of molecular diagnostics across the region.

North America Market, By Country

Canada molecular diagnostics market revenue will increase exponentially till 2028, driven by the escalating geriatric population and the high burden of chronic diseases such as diabetes. According to the 2021 census data, the number of people aged over 85 years and above increased by 12% since 2016, which is more than twice the overall increase in the Canadian population at 5.2%.

Competitive Industry Landscape

Major players involved in the North America market include Roche Diagnostics, Johnson & Johnson, Danaher, Cephied, BioRad Laboratories, Biomerieux, Becton Dickinson, Analytik Jena, Alere, Agilent (Dako), and Abbott Molecular. These companies are emphasizing new product launches, mergers, acquisitions, and other strategies to increase their customer base and expand their footprint in the market.