North America Molecular Diagnostics Market

North America Molecular Diagnostics Market Size

The North America molecular diagnostics market size was valued at USD 11.4 billion in 2024. The market is projected to grow from USD 11.8 billion in 2025 to USD 17.2 billion by 2034, expanding at a CAGR of 4.2%, according to the latest report published by Global Market Insights Inc.

This steady growth is stimulated by various factors such as the rising prevalence of diseases, technological advancements in the molecular diagnostics market, the expansion of point of care testing and home-based testing across North America, and the increasing geriatric population base. Major companies in the industry include Abbott Laboratories, F. Hoffmann-La Roche, Danaher Corporation, Hologic, and Thermo Fisher Scientific.

The market increased from USD 9.7 billion in 2021 to USD 11.1 billion in 2023. The increasing burden of infectious diseases is a major catalyst for the growth of the molecular diagnostic market in the region, as pathogens evolve and spread more rapidly due to globalization and climate change, where traditional diagnostic methods often fall short in speedy diagnosis. Molecular diagnostics, which include techniques such as PCR and next-generation sequencing, offer rapid, sensitive, and timely detection.

For instance, according to the data from the Centers for Disease Control and Prevention (CDC), tuberculosis cases increased in the U.S., with 10,347 new TB cases reported in 2024, representing an 8% increase from the previous year. This upward trend underscores the need for technologically advanced molecular diagnostic tools such as the Xpert MTB/RIF test. This test not only detects the presence of Mycobacterium tuberculosis but also identifies drug resistance simultaneously from patient samples. Thus, the rising prevalence of diseases such as TB, along with emerging threats such as drug resistance, is increasing the adoption of molecular diagnostics, further accelerating the market growth in the region.

Moreover, the rapidly growing elderly population in North America is a major factor accelerating the demand for molecular diagnostics. Individuals aged 65 and older are more likely to suffer from infectious diseases, which require frequent testing. For instance, according to the Population Reference Bureau, the number of U.S. individuals aged 65 and older is expected to rise from 58 million in 2022 to 82 million by 2050, marking a 47% increase. Thus, as the elderly population expands, so does the need for reliable molecular diagnostics solutions, fostering market growth.

Molecular diagnostics refers to a diagnostic method that examines biological markers in the genome and proteome, including RNA, DNA, and proteins, to identify and monitor various diseases. This technique is widely utilized for diagnosing genetic disorders, infectious diseases, and cancer due to its high effectiveness and precision.  

North America Molecular Diagnostics Market Trends

• The growing demand for accessible and rapid healthcare solutions has led to a significant expansion of point-of-care molecular testing and home-based testing across North America. This shift is stimulated by the need for decentralized diagnostics to reduce the burden on healthcare facilities and help patients with timely health information.
  
• For instance, Abbott Laboratories' ID NOW platform perfectly aligns with this trend. The ID NOW platform is a compact, instrument-based system that uses isothermal nucleic acid amplification technology (NAAT) to deliver rapid molecular detection of infectious diseases. Designed for point-of-care settings, it provides accurate qualitative results within minutes, enabling healthcare professionals to make timely and informed clinical decisions.
  
• Thus, these advancements improve healthcare by enabling faster and more effective diagnosis and treatment. Innovations such as miniaturization, automation, and connectivity have made decentralized testing easier, affordable, and adaptable, which helps in driving the growth of the market.
  

North America Molecular Diagnostics Market Analysis

Learn more about the key segments shaping this market

Download Free PDF

The North America molecular diagnostics market was valued at USD 9.7 billion in 2021. The market size reached USD 11.1 billion in 2023, from USD 10.8 billion in 2022.

Based on the product type, the market is segmented into instruments, and reagents and kits. The reagents and kits segment led this market in 2024. This segment was valued at USD 8.2 billion in 2024 and is projected to reach USD 12.3 billion by 2034, growing at a CAGR of 4.1%. In comparison, the instruments segment was valued at USD 3.2 billion in 2024 and is projected to reach USD 4.9 billion by 2034, growing at a CAGR of 4.4%.

• This growth is stimulated by rising demand for accurate diagnostic solutions, spurred by the need for early disease detection and personalized treatments.
  
• The reagents and kits segment includes a wide range of products that are essential for conducting diagnostic tests, including biochemical reagents, probes, primers, and assay kits. Thus, these components are integral to various molecular diagnostic tests, which help in the detection and quantification of biomarkers associated with diseases or health conditions.
  
• Furthermore, they ensure precise and consistent test results, which reduces variability and minimizes the risk of diagnostic errors. Their standardized formulation supports maintaining high sensitivity and specificity, which is important for detecting diseases at an early stage, thereby demonstrating their crucial role in molecular diagnostic testing, fostering the segment's growth.
  

Based on technology, the North America molecular diagnostics market is segmented into polymerase chain reaction (PCR), hybridization, sequencing, isothermal nucleic acid amplification technology (INAAT), microarrays, and other technologies. The polymerase chain reaction (PCR) segment accounted for the highest market share of 70.4% in 2024. In comparison, the hybridization segment, valued at USD 1.2 billion in 2024, is expected to grow to USD 1.7 billion by 2034, with a CAGR of 4%. 

• The polymerase chain reaction segment continues to lead the molecular diagnostic market due to its accuracy, speed, and versatility. PCR technology enables the detection of even small quantities of genetic material, making it an ideal choice for diagnosing infectious diseases, genetic disorders, and cancer.
  
• The rise of cartridge-based systems and multiplex panels allows simultaneous detection of multiple pathogens in a single test. These innovations have shortened the duration of testing and improved diagnostic efficiency, especially in emergency and outpatient settings, as healthcare systems prioritize rapid and reliable testing. PCR remains the main component of molecular diagnostics.
  
• For instance, Abbott’s Alinity m STI Assay, uses real-time PCR to detect four common sexually transmitted infections, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium, from a single sample.
  
• Thus, PCR continues to stimulate the molecular diagnostic market by offering precise and effective diagnostic results. Its widespread use across various disease areas, combined with ongoing technological improvements, ensures that PCR remains central to diagnostic innovation, further stimulating the market.
  

Based on application, the North America molecular diagnostics market is segmented into infectious disease diagnostics, genetic disease testing, oncology testing, and other applications. The infectious disease diagnostics segment is further bifurcated into COVID-19, flu, respiratory syncytial virus (RSV), tuberculosis, CT/NG, HIV, hepatitis C, hepatitis B, and other infectious disease diagnostics. The infectious disease diagnostics segment accounted for the highest market share of 71.8% in 2024.  

• The rise in infectious diseases is a major factor propelling the growth of the North America molecular diagnostics market. These diseases require fast, accurate, and sensitive testing methods to detect pathogens early and prevent their spread.
  
• Molecular diagnostics which is estimated to reach USD 40.4 billion by 2034. Particularly, PCR-based tests provide high precision and rapid testing, making them essential tools in managing infectious disease outbreaks and conducting routine screenings.
  
• For instance, in 2022, the U.S. saw a significant burden of hepatitis infections. According to the Centers for Disease Control and Prevention (CDC), in the U.S., approximately 4,848 acute hepatitis C cases were reported, corresponding to an estimated 67,400 infections. Additionally, 93,805 chronic hepatitis C cases were newly reported.
  
• In the same year, 2,126 acute hepatitis B cases were reported. These numbers underscore the need for reliable diagnostic tools to detect and monitor viral infections, particularly those that can remain asymptomatic for extended periods.
  
• Therefore, the growing prevalence of infectious diseases such as hepatitis B and C in the region is pushing healthcare systems to adopt advanced molecular diagnostics.
  
• Moreover, the demand for early detection, better disease management, and public health surveillance is stimulating market expansion and innovation in diagnostic technologies, further propelling the market growth.
  

Learn more about the key segments shaping this market

Download Free PDF

Based on end use, North America molecular diagnostics market is segmented into hospitals and clinics, diagnostic laboratories, and other end users. The hospitals and clinics segment was valued at USD 5.3 billion in 2024 and is projected to reach USD 7.9 billion by 2034.  

• Hospitals play a crucial role in the market due to their capacity to handle high patient volumes and complex testing needs. They are equipped with advanced laboratory infrastructure and skilled personnel, making them a valuable resource for conducting a wide range of molecular tests, from infectious disease screening to cancer diagnostics. Their ability to integrate molecular diagnostics into standard care and emergency settings ensures steady demand and usage.
  
• Moreover, hospitals benefit from having a centralized system that allows them to run a large volume of tests efficiently using advanced equipment and automated processes. This setup enables the delivery of fast and accurate results, which are essential for informed treatment decisions. Many hospitals also act as referral centers for specialized diagnostics, which contributes to their overall testing volume.
  
• Thus, the hospital segment continues to accelerate the molecular diagnostics market through enhanced IT infrastructure, testing capacity, and integration with advanced technologies, as healthcare systems prioritize early detection. Hospitals remain a crucial structure for diagnostic services, stimulating market growth.
  

Looking for region specific data?

Download Free PDF

The U.S. dominated the North America molecular diagnostics market, with the highest market share of 91.1% in 2024.

• The growing prevalence of infectious diseases in the U.S., such as COVID-19, influenza, TB, HIV, hepatitis B, and C, is one of the significant factors propelling the demand for technologically advanced molecular diagnostic instruments, kits, and reagents.
  
• For instance, according to data provided by the U.S. Department of Health and Human Services, in 2022, in the U.S., approximately 1.2 million people were living with HIV, and an estimated 31,800 people acquired HIV. These numbers underscore the ongoing need for reliable and accessible diagnostic testing solutions to facilitate early diagnosis and prevent the transmission of disease.
  
• Thus, as these infections continue to affect people, the U.S. healthcare systems are relying more on molecular testing to improve diagnosis and treatment. These tools help doctors identify infection quickly, guide appropriate therapies, and monitor disease progression.
  
• Therefore, the steady rise in infectious diseases such as HIV is stimulating the molecular diagnostic market to grow in the country.
  

Canada molecular diagnostics market was valued at USD 851.1 million and USD 953.7 million in 2021 and 2022, respectively. In 2024 the market size reached USD 1,018.5 million from USD 984.8 million in 2023.

• The growth of the market in the country is largely attributed to the well-established healthcare system with extensive access to diagnostic laboratories and large hospitals.
  
• Additionally, growing awareness among people towards timely diagnosis and treatment of chronic and infectious diseases is accelerating a shift in the market towards more timely and accurate healthcare solutions such as molecular diagnostic solutions.
  
• This trend is expected to continue, contributing to the growth of the market in Canada.
  

North America Molecular Diagnostics Market Share

• Leading companies such as Abbott Laboratories, F. Hoffmann-La Roche, Danaher Corporation, Hologic, and Thermo Fisher Scientific collectively command 51% of the molecular diagnostics market in North America. Their dominance is driven by extensive product portfolios, strategic partnerships, regulatory approvals, and continuous innovation.
  
• Meanwhile, new entrants are employing diverse strategies to gain traction in this competitive landscape. To stand out, they emphasize cutting-edge technologies such as PCR, next-generation sequencing, AI-powered analytics, and point-of-care solutions. Collaborations with hospitals, research institutions, and established diagnostics firms help them navigate high equipment costs and regulatory complexities.
  

North America Molecular Diagnostics Market Companies

Few of the prominent players operating in the North America molecular diagnostics industry include:

• Abbott Laboratories
• Agilent Technologies
• Becton, Dickinson, and Company
• Biocartis
• Biomerieux
• Bio-Rad Laboratories
• Danaher Corporation
• F. Hoffmann-La Roche
• Hologic
• Illumina
• Qiagen
• QuidelOrtho Corporation
• Siemens Healthineers
• Sysmex Corporation
• Thermo Fisher Scientific 
  
•  F. Hoffmann-La Roche 

F. Hoffmann-La Roche holds an 8% share of the North American molecular diagnostics market, supported by a strong regional presence and a well-integrated supply chain. Its extensive network of service centers and logistics partners ensures reliable delivery and accessibility of its molecular diagnostic solutions, including the widely used cobas Liat System.

• Siemens Healthineers

Siemens Healthineers is a key contributor to the molecular diagnostics sector. Its VERSANT kPCR molecular system facilitates high-throughput real-time PCR testing, making it especially valuable for diagnosing infectious diseases.

• Bio-Rad Laboratories

Bio-Rad Laboratories stands out in the molecular diagnostics field for its advanced PCR technologies and genomic analysis capabilities. Its flagship QX Continuum ddPCR System delivers accurate, high-throughput droplet digital PCR testing, supporting critical applications in oncology, infectious disease detection, and genetic research.

North America Molecular Diagnostics Industry News:

• In February 2025, Becton, Dickinson and Company (BD) announced that its board of directors had unanimously approved a plan for BD management to pursue the separation of its Biosciences and Diagnostic Solutions business. The goal of this move is to sharpen strategic focus, enable more targeted growth investments and capital allocation for both BD and the new standalone entity, and ultimately drive greater value for shareholders.
  
• In May 2022, Abbott received FDA approval for its Alinity m STI Assay, a molecular diagnostic test that identifies and distinguishes four common sexually transmitted infections, such as Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG). The test requires only one swab or urine sample, which can be collected by either a healthcare provider or the patient. It runs on Abbott’s high-throughput Alinity m system and uses advanced PCR technology for accurate detection. This launch broadened Abbott’s molecular diagnostics offerings and supported its revenue growth.
  

The North America molecular diagnostics market research report includes in-depth coverage of the industry with estimates and forecasts in terms of revenue in USD Million and from 2021 - 2034 for the following segments:

Click here to Buy Section of this Report

Market, By Product Type

• Instruments
• Reagents and kits

Market, By Technology

• Polymerase chain reaction (PCR)
• Hybridization
• Sequencing
• Isothermal nucleic acid amplification technology (INAAT)
• Microarrays
• Other technologies

Market, By Application

• Infectious disease diagnostics
  • COVID-19
  • Flu
  • Respiratory syncytial virus (RSV)
  • Tuberculosis
  • CT/NG
  • HIV
  • Hepatitis C
  • Hepatitis B
  • Other infectious disease diagnostics
• Genetic disease testing
• Oncology testing
• Other applications

Market, By End Use

• Hospitals and clinics
• Diagnostic laboratories
• Other end use

The above information is provided for the following countries:

• U.S.
• Canada