North America Molecular Diagnostic Market Size, Share, and COVID-19 Impact Analysis, By Product (Instruments, Reagents, and Others), By Technology (Polymerase Chain Reaction (PCR), In Situ Hybridization, Isothermal Nucleic Acid Amplification Technology (INAAT), Chips and Microarrays, Mass spectroscopy, Sequencing, Transcription Mediated Amplification (TMA), and Others), By Application (Oncology, Pharmacogenomics, Infectious Diseases, Genetic Testing, Neurological Disease, Cardiovascular Disease, Microbiology, and Others), and North America, Molecular Diagnostic Market Insights, Industry Trend, Forecasts to 2035

North America Molecular Diagnostic Market Insights Forecasts to 2035

• The North America Molecular Diagnostic Market Size Was Estimated at USD 5.58 Billion in 2024
• The Market Size is Expected to Grow at a CAGR of Around 4.12% from 2025 to 2035
• The North America Molecular Diagnostic Market Size is Expected to Reach USD 8.70 Billion by 2035

According to a Research Report Published by Spherical Insights & Consulting, The North America Molecular Diagnostic Market Size is anticipated to Reach USD 8.70 Billion by 2035, Growing at a CAGR of 4.12% from 2025 to 2035. The growing desire for customized treatment, improved point-of-care technologies, more R&D investment, and growing applications in genetic testing, infectious illnesses, and oncology are all factors contributing to the growth of the North America molecular diagnostics market.    

Market Overview

The development, manufacture, and use of cutting-edge diagnostic technologies that examine biological markers at the molecular level, such as DNA, RNA, and proteins, are all included in the North America molecular diagnostics market. This market is essential for focused therapeutic interventions, personalized medicine, and early illness identification, especially in the fields of genetic disorders, infectious diseases, and oncology. It covers a broad spectrum of products used in labs, hospitals, and point-of-care settings, including reagents, equipment, and software.  

The North America molecular diagnostic market is primarily driven by increased external financing for research and development, a growing requirement for point-of-care facilities, and an increasing need for sophisticated molecular diagnostic techniques. The market is expected to grow as a result of the rising frequency of chronic and infectious disorders, including cancer, STIs, and genetic diseases. Growing usage of technologically advanced testing products at point-of-care facilities, including clinics, retail pharmacies, doctors' offices, and others, along with rising demand for patient-centric healthcare services, are also anticipated to propel the North America molecular diagnostic market.   

Report Coverage

This research report categorizes the market for North America molecular diagnostic market based on various segments and regions and forecasts revenue growth and analyzes trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the North America molecular diagnostic market. Recent market developments and competitive strategies such as expansion, product launch, development, partnership, merger, and acquisition have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segment of the North America molecular diagnostic market. 

Driving Factors

Increased use of molecular diagnostics for infectious diseases and the introduction of novel cancer diagnostic techniques are two major factors propelling the North America molecular diagnostic market. The market is also expected to be driven by increasing government funding to improve the development of innovative test kits. It is also anticipated that the growing use of molecular diagnostic tests in home-based health services will drive the North America molecular diagnostic market growth. Growing demand for precise and effective genetic testing options, an aging population, and technological developments are the main drivers of market expansion.   

Restraining Factors

The North America molecular diagnostic market is hampered by the high cost of sophisticated diagnostic technologies, complicated regulations, lax reimbursement guidelines, and data privacy issues, particularly for underprivileged populations and smaller healthcare providers.

Market Segmentation

The North America molecular diagnostic market share is classified into product, technology, and application.

• The reagents segment dominated the market in 2024 and is projected to grow at a substantial CAGR during the forecast period.  

The North America molecular diagnostic market is segmented by product into instruments, reagents, and others. Among these, the reagents segment dominated the market in 2024 and is projected to grow at a substantial CAGR during the forecast period. Reagents are expected to boost market expansion because they provide standardized outcomes, increased efficiency, and cost-effectiveness. Additionally, it is anticipated that the introduction and commercialization of new tests and reagents would accelerate market expansion.    

• The polymerase chain reaction segment held a largest share in 2024 and is expected to grow at a significant CAGR during the forecast period.

The North America molecular diagnostic market is segmented by technology into polymerase chain reaction (PCR), in situ hybridization, isothermal nucleic acid amplification technology (INAAT), chips and microarrays, mass spectroscopy, sequencing, transcription mediated amplification (TMA), and others. Among these, the polymerase chain reaction segment held a largest share in 2024 and is expected to grow at a significant CAGR during the forecast period. The market is expected to be driven by the growing adoption of high-throughput polymerase chain reaction (PCR) techniques for cancer diagnosis. Additionally, it is anticipated that the growing use of molecular assays for infectious illness detection will propel this market's expansion.  

• The infectious diseases segment held a largest share in 2024 and is expected to grow at a significant CAGR during the forecast period.

The North America molecular diagnostic market is segmented by application into oncology, pharmacogenomics, infectious diseases, genetic testing, neurological disease, cardiovascular disease, microbiology, and others. Among these, the infectious diseases segment held a largest share in 2024 and is expected to grow at a significant CAGR during the forecast period.  The increasing incidence of drug-resistant diseases in the infectious disease segment is creating opportunities for affordable diagnostics to increase their market share. Additionally, a rise in regional investments from governmental and non-governmental organizations is boosting accessibility and supporting the growing need for molecular diagnostics, which are used to identify different diseases.  

Competitive Analysis:

The report offers the appropriate analysis of the key organizations/companies involved within the North America Molecular Diagnostic market along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.

List of Key Companies

• Abbott
• Danaher
• Illumina, Inc.
• Hologic Inc.
• Agilent Technologies, Inc.
• Bio-Rad Laboratories, Inc.
• F. Hoffmann-La Roche, Ltd.
• Thermo Fisher Scientific Inc.
• Johnson & Johnson Services, Inc.
• Others

Recent Developments

• In May 2023, the Xpert NPM1 Mutation IVD test for Acute Myeloid Leukemia was certified CE by Cepheid. The test calculates the percentage ratio of mutant NPML1 to ABL1 endogenous control mRNA transcripts using an automated real-time reverse transcription polymerase chain reaction (RT-PCR). 

• In February 2023, A new digital PCR research tool called the Absolute Q AutoRun dPCR Suite, developed by Applied Biosystems and QuantStudio, was launched by Thermo Fisher Scientific, Inc. in February 2023. These PCRs are the only digital PCRs on the market that preserve consistency, flexibility, and usability while enabling lab automation and reducing administrative expenses.

Key Target Audience 

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting and Research Firm
• Venture capitalists
• Value-Added Resellers (VARs)

Market Segment

This study forecasts revenue at North America, regional, and country levels from 2020 to 2035. Spherical Insights has segmented the North America molecular diagnostic market based on the below-mentioned segments:

North America Molecular Diagnostic Market, By Product

• Instruments
• Reagents
• Others

North America Molecular Diagnostic Market, By technology

• Polymerase Chain Reaction (PCR)
• In Situ Hybridization
• Isothermal Nucleic Acid Amplification Technology (INAAT)
• Chips and Microarrays
• Mass spectroscopy
• Sequencing
• Transcription Mediated Amplification (TMA)
• Others

North America Molecular Diagnostic Market, By Application

• Oncology
• Pharmacogenomics
• Infectious Diseases
• Genetic Testing
• Neurological Disease
• Cardiovascular Disease
• Microbiology
• Others