The COVID-19 diagnostics market in North America has experienced unprecedented growth since the pandemic’s onset, with testing playing a critical role in containment efforts. The rapid development of diagnostic tests, especially in the United States, helped track the virus’s spread and informed public health decisions.

By March 2021, the USA had conducted approximately 390 million tests, underscoring the scale of demand for diagnostics. The market includes multiple types of tests, from PCR (polymerase chain reaction) tests, which remain the gold standard, to rapid antigen tests and antibody tests. These tests serve diverse needs, from immediate detection in symptomatic individuals to widespread screening in asymptomatic populations.

2. Key Market Drivers and Trends

2.1 Increasing Testing for Variants

The emergence of new variants like Omicron and its sub-variants (e.g., XBB.1.5 and EG.5, also called Eris) has necessitated ongoing diagnostic efforts. As these variants have shown increased transmissibility and the ability to partially evade immunity, testing has remained critical to monitor outbreaks and inform public health strategies.

• Many diagnostic companies are updating their tests to ensure they can detect these variants. For instance, multiplex tests capable of identifying different strains at once are becoming a focal point in market growth.
• Laboratories and healthcare providers are using genomic surveillance to track variants, integrating this data into diagnostics to stay ahead of the virus’s evolution.

2.2 Growth of At-Home Testing

A major trend in the post-pandemic period is the shift toward at-home testing kits, driven by demand for convenience and safety. Companies such as Abbott Laboratories and Lucira Health pioneered at-home COVID-19 tests, allowing people to self-administer tests and get results within minutes.

• These tests are becoming more sophisticated, offering telehealth integration, where users can connect with healthcare providers directly through mobile apps for guidance on their results.
• With FDA approval for at-home tests, this trend is expected to persist, especially as COVID-19 becomes more endemic, and routine testing becomes part of people’s healthcare habits.

2.3 Expansion of PCR Testing

While rapid tests are popular, PCR tests have maintained their dominance due to their high sensitivity and accuracy. PCR testing can detect the virus at lower levels, making it suitable for detecting asymptomatic carriers and diagnosing early-stage infections.

• Recent advancements have made PCR tests more cost-effective and time-efficient. Companies like Thermo Fisher Scientific and Cepheid are focusing on faster turnaround times, bringing the standard 24-48 hour window down to as little as 1 hour.
• Point-of-care PCR tests are another innovation that’s helping to decentralize testing, allowing for rapid testing in locations such as airports, schools, and offices.

3. Key Players in the Market

3.1 Abbott Laboratories

Abbott has been instrumental in developing some of the most accessible COVID-19 diagnostic tools. Its BinaxNOW™ rapid antigen tests have been widely used for at-home testing and by government agencies. Abbott’s ID NOW™ platform, a portable molecular testing device, has also seen large-scale deployment in healthcare settings.

• Recent Developments: Abbott recently expanded its capacity for producing both PCR and rapid tests, positioning itself as a leading provider of diagnostic solutions in North America. The company has also invested in global supply chains, ensuring resilience against shortages in test components.

3.2 Thermo Fisher Scientific

Thermo Fisher, a key player in PCR testing, has been leading efforts in high-throughput testing solutions for laboratories. The company’s TaqPath™ COVID-19 Combo Kit became one of the most widely used PCR tests during the pandemic.

• Recent Developments: Thermo Fisher has expanded its diagnostic capabilities by acquiring smaller diagnostic companies and integrating automated testing systems into laboratories. The firm’s focus on liquid handling robots and automated workflows has increased testing efficiency.

3.3 Becton, Dickinson and Company

Becton Dickinson (BD) is known for its rapid testing solutions, including the Veritor™ System, a highly efficient antigen testing platform. BD has also been at the forefront of multiplex diagnostics, where tests can detect not just COVID-19, but also influenza and RSV (Respiratory Syncytial Virus).

• Recent Developments: The company’s multiplex testing kits are gaining traction as healthcare providers seek to streamline testing for multiple respiratory illnesses simultaneously, a critical development as flu and COVID-19 seasons overlap.

3.4 Co-Diagnostics, Inc.

Co-Diagnostics has focused on developing molecular diagnostic tests with high sensitivity. The company’s CoPrimer™ technology provides high specificity for detecting COVID-19, reducing the chances of false positives/negatives.

• Recent Developments: The company continues to innovate, working on at-home molecular diagnostics that combine the accuracy of PCR with the convenience of rapid antigen testing.

4. Recent Developments in the Market

4.1 Mergers and Acquisitions

Mergers and acquisitions have accelerated in the diagnostics market as companies seek to enhance their technological capabilities and broaden their product portfolios. For example, Thermo Fisher’s acquisition of Mesa Biotech brought rapid PCR technology under its umbrella, increasing the company’s presence in point-of-care diagnostics.

• Impact: These mergers allow companies to scale up production, integrate new technologies, and expand into new markets like telemedicine diagnostics and home testing.

4.2 Technological Advancements

The market is seeing an infusion of AI and machine learning in diagnostics, which promises to improve the accuracy and speed of testing. AI-powered diagnostics can analyze vast datasets to identify infection trends, predict outbreaks, and optimize the use of diagnostic resources.

• AI in PCR Testing: Companies are using AI to automate the testing process, from sample collection to result analysis, reducing human error and increasing throughput.

4.3 Regulatory Approvals

Regulatory agencies like the FDA and Health Canada have fast-tracked the approval process for COVID-19 tests, particularly those incorporating new technologies or aimed at new variants. This expedited approval has allowed companies to rapidly bring innovative tests to market, ensuring that healthcare providers have access to the most up-to-date diagnostic tools.

• Trend: Post-pandemic, the regulatory landscape is expected to continue supporting the rapid development of diagnostic tests, as these tools are likely to become a permanent fixture in healthcare systems.

5. The Future of COVID-19 Diagnostics

5.1 Innovations in Multiplex Testing

Multiplex testing is rapidly gaining attention as a next-generation diagnostic tool, particularly in regions where flu season coincides with COVID-19 spikes. Tests that can simultaneously screen for multiple pathogens (e.g., flu, RSV, and COVID-19) are becoming essential in healthcare settings.

• Future Outlook: As multiplex testing becomes more widespread, the industry could see a decline in single-pathogen tests, making diagnostics more cost-effective and efficient.

5.2 Long-Term Monitoring

Long COVID, characterized by symptoms persisting for months after infection, is a growing concern. Diagnostic tools are evolving to monitor long-term health effects, using more integrated testing approaches to track health data over time. Companies are beginning to explore ways to combine wearables and telehealth platforms with diagnostic testing, offering a more holistic view of patient health post-infection.