North America Molecular Diagnostics Research Report 2026: An $11.6 Billion Market By 2035, Driven By Innovations In Point-Of-Care Testing, The Integration Of AI, And Companion Diagnostics

(MENAFN- GlobeNewsWire - Nasdaq) Opportunities in the North America molecular diagnostics market include rising demand due to increased chronic and infectious diseases, advances in point-of-care testing, and next-generation sequencing. Personalized medicine and supportive government initiatives further drive growth, especially in the U.S.

Dublin, Feb. 12, 2026 (GLOBE NEWSWIRE) -- The "North America Molecular Diagnostics Market, till 2035: Distribution by Test Type, Type of Offering, Type of Sample, Type of Technology, Therapeutic Area, End User and Geographical Regions - Industry Trends and Forecast 2026-2035" report has been added to ResearchAndMarkets's offering.
The North America molecular diagnostics market is estimated to grow from USD 6.5 billion in the current year to USD 11.6 billion by 2035 at a CAGR of 5.6% during the forecast period, 2026-2035.
Molecular diagnostic tests are designed to identify specific sequences in human genomic samples, including DNA or RNA, to diagnose a specific disease. Additionally, these tests seek to detect single nucleotide polymorphisms, deletions, rearrangements, and insertions within the genetic sequences.
The World Health Organization (WHO) states that there are more than 40,000 in vitro diagnostic products presently in the market. This extensive range of products emphasizes the essential importance of diagnostics in healthcare. It is important to note that more than 70% of healthcare decisions rely on laboratory test results, since they offer critical information that aids in diagnoses, directs treatment options, tracks disease progression, and evaluates responses to therapy. This highlights the crucial importance of laboratory specialists and diagnostic testing in providing precise, prompt, and efficient patient care.
Molecular diagnostic tests are essential for identifying different diseases, tracking healthcare reactions, and forecasting healthcare results. The growth of the North America molecular diagnostics market is largely propelled by the growing incidence of chronic and infectious illnesses, a higher adoption rate of personalized medicine, and innovations in technology, such as point-of-care testing and next-generation sequencing.

Considering the advantages provided by these diagnostic solutions for delivering quick results and enhancing patient outcomes, the North America molecular diagnostics market is expected to expand at a robust CAGR throughout the projected period.
Growth Drivers: Strategic Enablers of Market Expansion
The North America molecular diagnostics market is driven by several important factors, including the increasing incidence of chronic and infectious diseases, such as cancer, heart diseases, and diabetes, which require rapid and precise testing techniques including PCR and next-generation sequencing.

Innovations in technology, such as point-of-care testing, the integration of AI, and companion diagnostics, along with rising healthcare spending and an older population, further boost demand, especially in the US where millions of laboratory tests are conducted every year. Government initiatives aimed at early detection, personalized medicine, and pandemic preparedness also contribute to significant market growth.
Market Challenges: Critical Barriers Impeding Progress
The North America molecular diagnostics market encounters several challenges, including the high expenses associated with advanced diagnostic instruments, reagents, and tests, which hinder adoption particularly in smaller laboratories or underserved areas. Further, regulatory challenges are considerable, characterized by complex and rigorous approval procedures that delay market entry and escalate development costs.

Furthermore, a lack of skilled laboratory professionals trained in molecular methodologies and bioinformatics also limits test precision. Additionally, concerns over data privacy related to the handling of genetic information and challenges with integrating electronic health records impede the scalability and comprehensive implementation of molecular diagnostic solutions in healthcare systems.
Polymerase Chain Reaction (PCR): Leading Market Segment
Currently, polymerase chain reaction (PCR) segment captures more than 40% of the overall market share, owing to its accuracy, speed, and widespread application in diagnosing infectious diseases, genetic disorders, and cancer. However, the next generation sequencing segment is likely to grow at a higher CAGR of 7.3% during the forecast period, which is most likely to be driven by its ability to provide comprehensive genomic information and advanced personalized medicine.
Blood, Serum and Plasma: Dominating Market Segment
In terms of sample, the North America molecular diagnostics market is segmented across blood, serum and plasma. Currently, majority (~80%) of the market share is held by blood, serum and plasma. This can be attributed to the fact that blood, serum, and plasma are routinely collected in clinical settings, making them convenient for large-scale testing and continuous monitoring. Further, the urine segment is likely to grow at a higher CAGR (7.1%) during the forecast period.

KEY QUESTIONS ANSWERED IN THIS REPORT

• How many molecular diagnostic service providers are currently engaged in this market?
• Which are the leading companies in this market?
• Which country dominates the North America molecular diagnostics market?
• What are the key trends observed in the North America molecular diagnostics market?
• What factors are likely to influence the evolution of this market?
• What are the primary challenges faced by molecular diagnostic service providers in North America?
• What is the current and future North America molecular diagnostics market size?
• What is the CAGR of North America molecular diagnostics market?
• How is the current and future market opportunity likely to be distributed across key market segments?

MARKET LANDSCAPE

• North America Molecular Diagnostics Market: Overall Market Landscape
• Analysis by Year of Establishment
• Analysis by Company Size
• Analysis by Location of Headquarters
• Analysis by Ownership Structure
• Analysis by Type of Technology
• Analysis by Diagnostic Applications
• Analysis by Type of Technology and Diagnostic Applications

COMPANY COMPETITIVENESS ANALYSIS

• Assumptions and Key Parameters
• Methodology
• Molecular Diagnostic Solution Providers in North America: Company Competitiveness Analysis
• Small Molecular Diagnostic Solution Providers (Peer Group I)
• Mid-sized Molecular Diagnostic Solution Providers (Peer Group II)
• Large Molecular Diagnostic Solution Providers (Peer Group III)
• Capability Benchmarking of top Molecular Diagnostic Solution Providers

PARTNERSHIPS AND COLLABORATIONS

• Partnership Models
• Molecular Diagnostic Solution Providers: Partnerships and Collaborations
• Analysis by Year of Partnership
• Analysis by Type of Partnership
• Most Active Players: Analysis by Number of Partnerships
• Analysis by Geography
• Intercontinental and Intracontinental Agreements
• Local and International Agreements

COMPANY PROFILES

• 10x Genomics
• Abbott
• Accelerate Diagnostics
• ACON Laboratories
• Admera Health
• Agilent Technologies
• Analiza
• Azenta
• BD
• BioIVT
• Bio-Rad
• Boster Biological Technology
• Bruker
• Caris Life Scienes
• Cepheid
• Charles River Laboratories
• Chembio Diagnostics
• Creative Bioarray
• Creative Biolabs
• Danaher
• DECODE HEALTH
• Epitope Diagnostics
• Exact Sciences
• Freenome
• Hologic
• iCubate
• IDgenomics
• Illumina
• Inflammatix
• Interpace Biosciences
• Invivoscribe
• Ipsum Diagnostics
• Lab Genomic
• Lifetime Sciences
• Lucence Health
• Mammoth Biosciences
• mdxhealth
• Meso Scale Diagnostics
• MicroGenDX
• MiraDX
• Myriad Genetics
• Nanopath
• Nanostring
• NeoGenomics Laboratories
• Oasis Diagnostics
• Pangea Laboratory
• PerkinElmer
• Pro-Lab Diagnostics
• QuidelOrtho
• Qvella
• Ranomics
• RNA Diagnostics
• Roche
• Thermo Fisher Scientific
• VedaBio

NORTH AMERICA MOLECULAR DIAGNOSTICS MARKET: KEY SEGMENTS

Test Type

• Laboratory
• Point-of-Care Testing

Type of Offering

• Reagents
• Instruments
• Services

Type of Sample

• Blood, Serum and Plasma
• Urine
• Others

Type of Technology

• PCR
• In situ Hybridization
• Isothermal Nucleic Acid Amplification Technology
• Next Generation Sequencing
• Microarrays
• Mass Spectrometry
• Others

Therapeutic Area

• Cardiovascular Diseases
• Genetic Diseases
• Others

End Users

• Hospitals
• Laboratories
• Others

Geographical Regions

• North America
• US
• Canada

COMPLEMENTARY BENEFITS

• Complimentary Excel Data Packs for all Analytical Modules in the Report
• 15% Free Content Customization
• Detailed Report Walkthrough Session with the Research Team
• Free Updated report if the report is 6-12 months old or older

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