North America Molecular Diagnostics Market Key Takeaways:
· The reagents segment accounted for largest revenue share of 62.70% in 2024 and is anticipated to grow at a fastest CAGR over the forecast period.
· Moreover, instruments segment also accounted for a significant share in 2024.
· Central laboratories segment accounted for largest revenue share of 75.32% of the market in 2024.
· Self-test or over-the-counter segment is expected to grow at a significant CAGR during forecast period.
· Polymerase chain reaction (PCR) segment held a high revenue share of 46.12% of the market in 2024.
· Sequencing technology is anticipated to grow with a significant CAGR over the forecasted years.
· Infectious disease segment accounted for largest revenue share of 54.0% of the market in 2024.
· Oncology segment is anticipated to grow at fastest CAGR during projected timeframe.
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North America molecular diagnostics market deals with identifying a disease by studying molecules such as RNA, DNA, and proteins in a fluid or tissue. These molecular diagnostics services are used as a strategy to diagnose, analyze, and research certain molecules with the help of technologies in the laboratory. The market growth is attributed to factors such as increasing R&D activities, rising government and private collaborations, and increasing strategic initiatives by major market players. In addition, the increasing prevalence of infectious and chronic diseases is also a major factor driving the market growth during the forecast period.
One of the major opportunities driving the growth of the North America molecular diagnostics market. The increasing focus on companion diagnostics. Companion molecular diagnostics measure the levels of specific mutations, genes, and proteins to reveal effective and specific therapies for an individual’s condition. Companion diagnostics are a form of precision, stratified, and personalized medicine that individualizes a patient’s treatment. In addition, molecular microbiology provides technologies that can identify and detect microorganisms rapidly, further enhancing market growth.
Artificial intelligence can play an important role in improving molecular diagnostics. AI-generated technologies can be used to enhance clinically actionable and relevant information in a way that is reproducible, accurate, and quantitative. In addition, AI-generated technologies may increase standardization that provide operator-independent actions and efficient automation. Furthermore, by analyzing large amounts of molecular data, AI can improve diagnostic accuracy and reduce errors, which is further expected to revolutionize the growth of the molecular diagnostic market in north America.
Market Trends
· Increasing partnerships and collaborations: The increasing strategic partnerships and collaborations between healthcare providers and diagnostic companies are reshaping the north America molecular diagnostics market.
· Growing funding in molecular diagnostics: The government funding, schemes, and initiatives to promote and support development and innovation have increased, as a result, the molecular diagnostics segment is growing rapidly in north America.
· Increasing demand for therapies and testing: The adoption of analyzer software for molecular diagnostics is increasing rapidly and awareness among consumers about faster diagnostics is rising in the region.
North America Molecular Diagnostics Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2025 |
USD 6.10 billion |
|
Revenue forecast in 2034 |
USD 8.91 billion |
|
Growth rate |
CAGR of 4.3% from 2025 to 2034 |
|
Base year for estimation |
2024 |
|
Historical data |
2018 - 2024 |
|
Forecast period |
2025 - 2034 |
|
Report updated |
February 2025 |
|
Quantitative units |
Revenue in USD million and CAGR from 2025 to 2034 |
|
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Segments covered |
Product, Test location, Technology, Application, Country |
|
Regional scope |
North America |
|
Country scope |
U.S.; Canada |
|
Key companies profiled |
BD; Bio-Rad Laboratories, Inc.; Abbott; Agilent Technologies, Inc.; Danaher; Hologic Inc. (Gen Probe); Illumina, Inc.; Johnson & Johnson Services, Inc.; Thermo Fisher Scientific Inc.; F. Hoffmann-La Roche, Ltd. |
|
Customization scope |
Free report customization (equivalent to up to 8 analyst’s working days) with purchase. Addition or alteration to country, regional, and segment scope |
Segment Insights
By Product Insights
The reagents segment accounted for the largest revenue share of 62.70% in 2024 and is anticipated to grow at a fastest CAGR over the forecast period. The growth in the market is attributed to the increasing introduction and commercialization of new reagents and tests. Reagents improved cost-effectiveness and efficiency and offered standardized results.
The instruments segment is expected to grow the fastest during the forecast period. The segment growth in the market is attributed to excellent support services, user-friendly software, and robust machine structure. Market players are engaged in expanding their product portfolios and launching novel instruments for molecular diagnostics.
By Test Location Insights
Central laboratories segment accounted for the largest revenue share of 75.32% of the market in 2024. The segment growth in the region is attributed to the increasing favorable government initiatives to provide various services, like reimbursement for diagnostic tests and rising high market penetration and volumes. Various reference laboratories, academic institutions, and hospitals that service various healthcare facilities are frequently connected to central laboratories. These laboratories have advanced technology and equipment to process various samples effectively.
The self-test or over-the-counter segment is expected to grow fastest during the forecast period. The segment growth in the market is driven by the increasingly intensified focus of regulatory bodies on self-test molecular diagnostics and over the counter to reduce the burden on laboratories. In addition, self-testing assays are culture-independent and minimally dependent on refrigeration, electricity, and cost-effectiveness.
By Technology Insights
The Polymerase chain reaction (PCR) segment held a high revenue share of 46.12% of the market in 2024. The growth in the region is driven by the increasing adoption of molecular assays for the diagnosis of infectious diseases and the rising use of high-throughput polymerase chain reaction techniques for the detection of cancer. The advent of polymerase chain reaction technology led to technological advances that continue to shape modern like forensic identification from tiny bits of DNA, diagnostic testing for diseases, new medical drugs, and more.
Sequencing technology is expected to grow fastest during the forecast period. The growth in the region is driven by various factors such as increasing strategic alliances and collaboration among major market players, declining costs and sizes of DNA sequencers, rising R&D activities for novel medications, and rising number of genome profiling activities.
· For instance, in October 2024, Illumina, Inc. a global leader in array-based and DNA sequencing technologies launched its MiSeq™ i100 Series of sequencing systems, delivering unparalleled benchtop simplicity and speed to advance next-generation sequencing (NGS) for labs.
By Application Insights
The infectious disease segment accounted for largest revenue share of 54.0% of the market in 2024. The segment growth in the region is attributed to the increasing demand for molecular diagnostics used in the identification of various pathogens, increasing growth in investments from both governmental and non-governmental bodies, and increasing prevalence of drug-resistant infections. In addition, by introducing technologically advanced and innovative products, companies are receiving approvals to enhance their market presence, further driving segment growth.
The oncology segment is expected to grow the fastest during the forecast period. The increasing prevalence of cancer, rising development of user-friendly methods of molecular analysis, and increasing strategic partnerships and collaborations are expected to drive the segment growth in the north America molecular diagnostics market.
· For instance, in August 2024, Gencurix, Inc. and Hitachi High-Tech Corporation entered a strategic partnership in the field of oncology molecular diagnostics. The Partnership aims to develop a testing service for cancer molecular diagnostics by manufacturing in vitro diagnostic products and digital technology and combining Hitachi High-Tech's core expertise in R&D.
By Country Insights
The U.S. is dominated the North America molecular diagnostics market in 2024. The market growth in the country is attributed to the increasing awareness programs, prevalence of cancer, increasing reimbursement & regulatory landscape to adapt to fast-paced research progress, increasing prevalence of chronic and infectious diseases, and increasing adoption of molecular diagnostics.
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· Point-of-Care Molecular Diagnostics Market - https://www.precedenceresearch.com/point-of-care-molecular-diagnostics-market
· Molecular Diagnostics Market - https://www.precedenceresearch.com/molecular-diagnostics-market
· U.S. Oncology Molecular Diagnostics Market - https://www.precedenceresearch.com/us-oncology-molecular-diagnostics-market
· Infectious Disease Molecular Diagnostics Market - https://www.precedenceresearch.com/infectious-disease-molecular-diagnostics-market
Some of the prominent players in the North America molecular diagnostics market include:
· BD
· Abbott
· Agilent Technologies, Inc.
· Danaher
· Hologic Inc. (Gen Probe)
· Johnson & Johnson Services, Inc.
· Thermo Fisher Scientific Inc.
Recent Developments
· In June 2024, Molecular diagnostics company Genetic Signatures Ltd. Launched its Easyscreen gastrointestinal parasite detection kit in the U.S.
· In September 2024, Roche announced the launch of the cobas® Respiratory flex test, the first to use Roche’s novel and proprietary TAGS technology. This new technology enables up to 15 targets to be detected simultaneously in a single patient sample on the high throughput molecular diagnostic analyzers Cobas 5800, 6800, and 8800.
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2034. For this study, Nova one advisor, Inc. has segmented the North America molecular diagnostics market
By Product
· Instruments
· Reagents
· Others
By Test Location
· Point-of-Care
· Self-test or Over the Counter
· Central Laboratories
By Technology
o Polymerase Chain Reaction (PCR)
o PCR, by Type
o Multiplex PCR
o Other PCR
o PCR, by Procedure
o Nucleic Acid Extraction
o Others
o PCR, by Product
o Instruments
o Reagents
o Others
· In Situ Hybridization
o Instruments
o Reagents
o Others
· Isothermal Nucleic Acid Amplification Technology (INAAT)
o Instruments
o Reagents
o Others
· Chips and Microarrays
o Instruments
o Reagents
o Others
· Mass spectroscopy
o Instruments
o Reagents
o Others
· Sequencing
o Instruments
o Reagents
o Others
· Transcription Mediated Amplification (TMA)
o Instruments
o Reagents
o Others
· Others
o Instruments
o Reagents
o Others
By Application
· Oncology
o Breast Cancer
o Prostate Cancer
o Colorectal Cancer
o Cervical Cancer
o Kidney Cancer
o Liver Cancer
o Blood Cancer
o Lung Cancer
o Other Cancer
· Pharmacogenomics
· Infectious Diseases
o Methicillin-resistant Staphylococcus Aureus (MRSA)
o Clostridium Difficile
o Vancomycin-resistant Enterococci (VRE)
o Carbapenem-resistant Bacteria
o Flu
o Respiratory Syncytial Virus (RSV)
o Candida
o Tuberculosis and Drug-resistant TBA
o Meningitis
o Gastrointestinal Panel Testing
o Chlamydia
o Gonorrhea
o HIV
o Hepatitis C
o Hepatitis B
o Other Infectious Disease
· Genetic Testing
o Newborn Screening
o Predictive and Presymptomatic Testing
o Other Genetic Testing
· Neurological Disease
· Cardiovascular Disease
· Microbiology
· Others
By Regional
· North America
o U.S.
o Canada
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