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Redding, California - July 18, 2024

North America Molecular Diagnostics Market to be Worth $18.13 Billion by 2030

North America Molecular Diagnostics Market by Product (Reagents & Kits, Systems, Software), Test Type (Lab, PoC), Technology (PCR, ISH, INAAT, Sequencing, Microarray), Application (Infectious Diseases, Oncology, Neurological), End User - Forecast to 2030


Meticulous Research®, a leading global market research company, published a research report titled, ‘North America Molecular Diagnostics Market by Product (Reagents & Kits, Systems, Software), Test Type (Lab, PoC), Technology (PCR, ISH, INAAT, Sequencing, Microarray), Application (Infectious Diseases, Oncology, Neurological), End User—Forecast to 2030.’

According to this latest publication from Meticulous Research®, the North America molecular diagnostics market is expected to reach $18.13 billion by 2030 at a CAGR of 5.3% from 2024 to 2030. The growth of the North America molecular diagnostics market is driven by several factors, including the rising geriatric population, the increasing prevalence of communicable & non-communicable diseases, technological advancements in molecular diagnostics, and rising healthcare expenditures. However, unfavorable regulatory frameworks and the high costs of molecular diagnostic tests restrain the growth of this market.

Furthermore, increasing focus on companion diagnostics and the rising popularity of direct-to-consumer (DTC) genetic testing are expected to create growth opportunities for the players in this market. However, the shortage of skilled professionals is a major challenge for market growth. Additionally, the rising integration of artificial intelligence & machine learning is a prominent trend in the molecular diagnostics market.

Key Players

The key players operating in the North America molecular diagnostics market are Hologic, Inc. (U.S.), Danaher Corporation (U.S.), BioMérieux S.A. (France), Becton, Dickinson and Company (U.S.), Siemens Healthineers AG (Germany), DiaSorin S.p.A. (Italy), Abbott Laboratories (U.S.), Thermo Fisher Scientific Inc. (U.S.), Agilent Technologies, Inc. (U.S.), Illumina, Inc. (U.S.), F. Hoffmann-La Roche (Switzerland), QIAGEN N.V. (Netherlands), and Seegene, Inc. (South Korea).

North America Molecular Diagnostics Market: Future Outlook

The North America molecular diagnostics market is segmented by Product & Service (Kits & Reagents, Instruments, Software & Services), Test Type (Laboratory Tests and Point-of-Care Tests), Technology (Polymerase Chain Reaction (PCR), In Situ Hybridization (ISH), Isothermal Nucleic Acid Amplification Technology (INAAT), Microarrays, Mass Spectrometry, Sequencing, and Other Technologies), Application (Infectious Diseases {Hepatitis, HIV, Healthcare-Associated Infections (Hais), Chlamydia Trachomatis/Neisseria Gonorrhoeae (CT/NG), Human Papillomavirus (HPV), Tuberculosis, Influenza, COVID-19, and Other Infectious Diseases}, Oncology {Breast, Colorectal, Lung, Prostate, Lymphoma, Leukemia, Cervical, and Other Cancers}, Genetic Testing, Neurological Diseases, Cardiovascular Diseases, and Other Applications), End User (Hospitals & Clinics, Diagnostic Laboratories, Academic & Research Institutes, and Other End Users), and Country. The study also evaluates industry competitors and analyzes the market at the country level.

Among all the products & services studied in this report, in 2024, the kits & reagents segment is expected to account for the largest share of the market. The large market share of this segment is attributed to factors such as the ongoing development of tests for various infections, including HIV, malaria, and tuberculosis (TB), and the growing use of diagnostic platforms, which are likely to improve the existing diagnostics landscape in LMICs. The growing number of communicable and non-communicable cases and the awareness regarding the adoption of molecular diagnostics techniques for these cases have led to the development of diagnostic kits for various applications.

Among all the technologies studied in this report, the sequencing segment is expected to register the highest CAGR over the forecast period. Technological advancements in sequencing are driving the adoption of sequencing technologies, contributing to the market's growth. Sequencing technology offers several advantages over PCR and other technologies. For example, while qPCR can only detect known sequences, NGS does not require prior knowledge of sequence information due to its hypothesis-free approach. Furthermore, the continued innovation in sequencing technologies, such as the rising integration of nanopore technology into single-molecule sequencing (SMS), is fueling the growth of this segment.

Among all the test types studied in this report, in 2024, the laboratory tests segment is expected to account for the largest share of the market. The large market share of this segment is attributed to the numerous advantages associated with the laboratory testing approach for molecular diagnostics. It offers higher accuracy and reliability compared to point-of-care testing. Laboratory equipment and analyzers boast high sensitivity and specificity. Furthermore, unlike point-of-care testing, the laboratory testing approach can be applied to all tests.

Among all the applications studied in this report, the oncology segment is expected to register the highest CAGR during the forecast period. Molecular diagnostics is widely used for various cancer types, enabling reliable screening and guiding clinicians in making critical decisions for personalized cancer treatment. These benefits are anticipated to drive the growth of this segment during the forecast period.

Among all the end users studied in this report, in 2024, the hospitals & clinics segment is expected to account for the largest share of the market. Hospitals & clinics perform a wide range of tests to diagnose various medical conditions, including communicable and non-communicable diseases, to ensure proper clinical planning of treatment and prevention. Hospitals in urban and rural areas provide large populations with access to diagnosis. Also, during the COVID-19 pandemic, there was a significant increase in hospital admissions, which boosted the demand for diagnostic products.

Geographic Review

This research report comprehensively analyzes the major countries in North America (U.S. and Canada). In 2024, the U.S. is expected to account for the largest share of the North America molecular diagnostics market. In the U.S., the number of people aged 65 and above is increasing rapidly. The number of senior citizens is projected to increase from 56.0 million in 2020 to 94.7 million in 2060. Additionally, the number of people aged 85 and above is projected to nearly triple from 6.7 million in 2020 to 19.0 million by 2060. The aging population is vulnerable to various diseases and is more likely to go to the hospital for infectious diseases. In addition, the aging population is prone to Alzheimer’s disease and other types of dementia and is more likely to be hospitalized. Hence, the growing geriatric population will require frequent diagnostic testing, increasing the demand for molecular diagnostic products.

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Key questions answered in the report-

  • Which are the high-growth market segments in terms of product & service, test type, technology, application, end user, and geography?
  • What was the historical market for molecular diagnostics across North America?
  • What are the market forecasts and estimates for the period 2024–2030?
  • What are the major drivers, restraints, opportunities, and challenges in the North America molecular diagnostics market?
  • Who are the major players in the North America molecular diagnostics market?
  • What is the competitive landscape, and who are the market leaders in the North America molecular diagnostics market?

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