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North America Molecular Diagnostics Market Size, Share & Trends Analysis Report By Product (Instruments, Reagents, Others), By Test Location, By Technology (PCR, ISH, INAAT, Sequencing), By Application, By Country, And Segment Forecasts, 2024 - 2030

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JHS 24.03.25

North America Molecular Diagnostics Market Growth & Trends:

The North America molecular diagnostics market size is expected to reach USD 7.23 billion by 2030, registering a CAGR of 4.2% from 2024 to 2030, according to a new report by Grand View Research, Inc. The introduction of technologically advanced products is expected to drive the market in North America. Advancements in molecular diagnostic technology enabled the early detection of numerous diseases and reduced the possibility of severe economic & social burdens. Molecular diagnostics enable early diagnosis of cancer, genetic disorders, and infectious diseases by using PCR, sequencing, & genetic technologies.

The rise in the prevalence of chronic & infectious diseases and genetic disorders, such as Alzheimer's disease, Turner syndrome, & Parkinson's disease, is expected to boost the market demand during the forecast period. According to the CDC, chronic diseases such as cancer & diabetes and chronic kidney & respiratory diseases are accountable for 7 in 10 deaths in the U.S. each year. Around 6 out of 10 adults are likely to suffer from a chronic disease in the U.S. In addition, the increasing incidence of diseases, such as influenza A & B, is projected to drive market growth. For instance, according to the CDC, in the flu season of 2021-2022, influenza was estimated to affect nine million people.

An increase in external funding to conduct clinical studies in molecular diagnostics is anticipated to fuel the market. Funding plays a significant role in the product development process. For instance, in April 2023, Promega Corporation announced to grant of USD 15,000 in 2023 in academic life sciences research using qPCR. Similarly, in June 2023, Accelerate Diagnostics, Inc. received USD 24 million to accelerate the development of Wave platform and novel rapid testing. Such initiatives are expected to encourage SMEs to be involved in the development of novel molecular diagnostic tests.

Key companies are making continuous efforts to launch new products in North America molecular diagnostics and gain a competitive edge by meeting the changing needs of buyers toward more advanced & efficient products. For instance, in November 2022, Cepheid, a Danaher subsidiary, launched Multiplex Vaginal Panel (MVP), a PCR test to detect various conditions, such as trichomoniasis, bacterial vaginosis, and vulvovaginal candidiasis.

Furthermore, increasing strategic partnerships among manufacturers and companies for developing novel therapeutics is anticipated to drive market growth. For instance, in February 2023, Thermo Fisher Scientific Inc.partnered with MyLab to procure RT-PCR kits for various infectious diseases, such as tuberculosis & HIV. Moreover, in January 2023, QIAGEN and Helix formed an exclusive alliance to enhance next-generation sequencing companion diagnostics in genetic disorders.

North America Molecular Diagnostics Market Report Highlights:

  • Based on the product, the reagents segment accounted for the largest revenue share of North America molecular diagnostics in 2023 owing to improved efficiency and cost-effectiveness
  • The central laboratories segment dominated the North America molecular diagnostics in 2023 owing to high market penetration and large procedure volumes
  • Based on technology, the PCR segment dominated the North America molecular diagnostics in 2023 and is the most preferred technology amongst doctors and patients for clinical diagnostics
  • The infectious disease segment led the application segment in 2023, attributable to North America's high incidence of infectious diseases
  • The U.S. dominated the regional market due to favorable reimbursement policies, the local presence of leading players, and the presence of well-established healthcare infrastructure

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation and Scope
    • 1.1.1. Segment Definitions
      • 1.1.1.1. Product segment
      • 1.1.1.2. Test Location segment
      • 1.1.1.3. Technology segment
      • 1.1.1.4. Application segment
  • 1.2. Regional Scope
  • 1.3. Estimates and Forecast Timeline
  • 1.4. Objectives
    • 1.4.1. Objective - 1
    • 1.4.2. Objective - 2
    • 1.4.3. Objective - 3
  • 1.5. Research Methodology
  • 1.6. Information Procurement
    • 1.6.1. Purchased Database
    • 1.6.2. GVR's Internal Database
    • 1.6.3. Secondary Sources
    • 1.6.4. Primary research
  • 1.7. Information or Data Analysis
    • 1.7.1. Data Analysis Models
  • 1.8. Market Formulation & Validation
  • 1.9. Model Details
    • 1.9.1. Commodity Flow Analysis
  • 1.10. List of Secondary Sources
  • 1.11. List of Abbreviations

Chapter 2. Executive Summary

  • 2.1. Market Snapshot
  • 2.2. Product and Test Location Snapshot
  • 2.3. Technology and Application Snapshot
  • 2.4. Competitive Landscape Snapshot

Chapter 3. Market Variables, Trends, & Scope

  • 3.1. Market Lineage Outlook
    • 3.1.1. Parent Market Outlook
    • 3.1.2. Related/Ancillary Market Outlook
  • 3.2. Market Dynamics
    • 3.2.1. Market Driver Analysis
      • 3.2.1.1. Increase in geriatric population
      • 3.2.1.2. Introduction of technologically advanced products
      • 3.2.1.3. Increase in demand for point-of-care testing
      • 3.2.1.4. Growing prevalence of target diseases
      • 3.2.1.5. Increasing external funding for R&D
    • 3.2.2. Market Restraint Analysis
      • 3.2.2.1. Presence of ambiguous regulatory framework
      • 3.2.2.2. High prices of molecular diagnostics tests
  • 3.3. Industry Analysis Tools
    • 3.3.1. Porter's Five Forces Analysis
    • 3.3.2. PESTEL Analysis
    • 3.3.3. COVID-19 Impact Analysis

Chapter 4. North America Molecular Diagnostics Market: Product Business Analysis

  • 4.1. North America Molecular Diagnostics Market: Product Movement Analysis
  • 4.2. Instruments
    • 4.2.1. Instruments Market, 2018 - 2030 (USD Million)
  • 4.3. Reagents
    • 4.3.1. Reagents Market, 2018 - 2030 (USD Million)
  • 4.4. Others
    • 4.4.1. Others Market, 2018 - 2030 (USD Million)

Chapter 5. North America Molecular Diagnostics Market: Test Location Business Analysis

  • 5.1. North America Molecular Diagnostics Market: Test Location Movement Analysis
  • 5.2. Point-of-Care
    • 5.2.1. Point-of-Care Market, 2018 - 2030 (USD Million)
  • 5.3. Self-test or Over the Counter
    • 5.3.1. Self-test or Over the Counter Market, 2018 - 2030 (USD Million)
  • 5.4. Central Laboratories
    • 5.4.1. Central Laboratories Market, 2018 - 2030 (USD Million)

Chapter 6. North America Molecular Diagnostics Market: Technology Business Analysis

  • 6.1. North America Molecular Diagnostics Market: Technology Movement Analysis
  • 6.2. PCR
    • 6.2.1. PCR Market, 2018 - 2030 (USD Million)
      • 6.2.1.1. PCR, by Type
      • 6.2.1.1.1. PCR, by Type Market, 2018 - 2030 (USD Million)
      • 6.2.1.1.1.1. Multiplex PCR
      • 6.2.1.1.1.1.1. Multiplex PCR Market, 2018 - 2030 (USD Million)
      • 6.2.1.1.1.2. Other PCR
      • 6.2.1.1.1.2.1. Other PCR Market, 2018 - 2030 (USD Million)
      • 6.2.1.2. PCR, by Procedure
      • 6.2.1.2.1. PCR, by Procedure Market, 2018 - 2030 (USD Million)
      • 6.2.1.2.1.1. Nucleic Acid Extraction
      • 6.2.1.2.1.1.1. Nucleic Acid Extraction Market, 2018 - 2030 (USD Million)
      • 6.2.1.2.1.2. Others
      • 6.2.1.2.1.2.1. Others Market, 2018 - 2030 (USD Million)
      • 6.2.1.3. PCR, by Product
      • 6.2.1.3.1. PCR, by Product Market, 2018 - 2030 (USD Million)
      • 6.2.1.3.1.1. Instruments
      • 6.2.1.3.1.1.1. Instruments Market, 2018 - 2030 (USD Million)
      • 6.2.1.3.1.2. Reagents
      • 6.2.1.3.1.2.1. Reagents Market, 2018 - 2030 (USD Million)
      • 6.2.1.3.1.3. Others
      • 6.2.1.3.1.3.1. Others Market, 2018 - 2030 (USD Million)
  • 6.3. In Situ Hybridization (ISH)
    • 6.3.1. In Situ Hybridization (ISH) Market, 2018 - 2030 (USD Million)
    • 6.3.2. Instruments
      • 6.3.2.1. Instruments Market, 2018 - 2030 (USD Million)
    • 6.3.3. Reagents
      • 6.3.3.1. Reagents Market, 2018 - 2030 (USD Million)
    • 6.3.4. Others Market, 2018 - 2030 (USD Million)
      • 6.3.4.1. Others Market, 2018 - 2030 (USD Million)
  • 6.4. Isothermal Nucleic Acid Amplification Technology (INAAT)
    • 6.4.1. Isothermal Nucleic Acid Amplification Technology (INAAT) Market, 2018 - 2030 (USD Million)
    • 6.4.2. Instruments
      • 6.4.2.1. Instruments Market, 2018 - 2030 (USD Million)
    • 6.4.3. Reagents
      • 6.4.3.1. Reagents Market, 2018 - 2030 (USD Million)
    • 6.4.4. Others Market, 2018 - 2030 (USD Million)
      • 6.4.4.1. Others Market, 2018 - 2030 (USD Million)
  • 6.5. Chips and Microarrays
    • 6.5.1. Chips and Microarrays Market, 2018 - 2030 (USD Million)
    • 6.5.2. Instruments
      • 6.5.2.1. Instruments Market, 2018 - 2030 (USD Million)
    • 6.5.3. Reagents
      • 6.5.3.1. Reagents Market, 2018 - 2030 (USD Million)
    • 6.5.4. Others Market, 2018 - 2030 (USD Million)
      • 6.5.4.1. Others Market, 2018 - 2030 (USD Million)
  • 6.6. Mass Spectroscopy
    • 6.6.1. Mass Spectroscopy Market, 2018 - 2030 (USD Million)
    • 6.6.2. Instruments
      • 6.6.2.1. Instruments Market, 2018 - 2030 (USD Million)
    • 6.6.3. Reagents
      • 6.6.3.1. Reagents Market, 2018 - 2030 (USD Million)
    • 6.6.4. Others Market, 2018 - 2030 (USD Million)
      • 6.6.4.1. Others Market, 2018 - 2030 (USD Million)
  • 6.7. Sequencing
    • 6.7.1. Sequencing Market, 2018 - 2030 (USD Million)
    • 6.7.2. Instruments
      • 6.7.2.1. Instruments Market, 2018 - 2030 (USD Million)
    • 6.7.3. Reagents
      • 6.7.3.1. Reagents Market, 2018 - 2030 (USD Million)
    • 6.7.4. Others Market, 2018 - 2030 (USD Million)
      • 6.7.4.1. Others Market, 2018 - 2030 (USD Million)
  • 6.8. Transcription Mediated Amplification (TMA)
    • 6.8.1. Transcription Mediated Amplification (TMA) Market, 2018 - 2030 (USD Million)
    • 6.8.2. Instruments
      • 6.8.2.1. Instruments Market, 2018 - 2030 (USD Million)
    • 6.8.3. Reagents
      • 6.8.3.1. Reagents Market, 2018 - 2030 (USD Million)
    • 6.8.4. Others Market, 2018 - 2030 (USD Million)
      • 6.8.4.1. Others Market, 2018 - 2030 (USD Million)
  • 6.9. Others
    • 6.9.1. Others Market, 2018 - 2030 (USD Million)
    • 6.9.2. Instruments
      • 6.9.2.1. Instruments Market, 2018 - 2030 (USD Million)
    • 6.9.3. Reagents
      • 6.9.3.1. Reagents Market, 2018 - 2030 (USD Million)
    • 6.9.4. Others Market, 2018 - 2030 (USD Million)
      • 6.9.4.1. Others Market, 2018 - 2030 (USD Million)

Chapter 7. North America Molecular Diagnostics Market: Application Business Analysis

  • 7.1. North America Molecular Diagnostics Market: Application Movement Analysis
  • 7.2. Oncology
    • 7.2.1. Oncology Market, 2018 - 2030 (USD Million)
    • 7.2.2. Breast Cancer
      • 7.2.2.1. Breast Cancer Market, 2018 - 2030 (USD Million)
    • 7.2.3. Prostate Cancer
      • 7.2.3.1. Prostate Cancer Market, 2018 - 2030 (USD Million)
    • 7.2.4. Colorectal Cancer Market, 2018 - 2030 (USD Million)
      • 7.2.4.1. Colorectal Cancer Market, 2018 - 2030 (USD Million)
    • 7.2.5. Cervical Cancer
      • 7.2.5.1. Cervical Cancer Market, 2018 - 2030 (USD Million)
    • 7.2.6. Kidney Cancer
      • 7.2.6.1. Kidney Cancer Market, 2018 - 2030 (USD Million)
    • 7.2.7. Liver Cancer Market, 2018 - 2030 (USD Million)
      • 7.2.7.1. Liver Cancer Market, 2018 - 2030 (USD Million)
    • 7.2.8. Blood Cancer
      • 7.2.8.1. Blood Cancer Market, 2018 - 2030 (USD Million)
    • 7.2.9. Lung Cancer
      • 7.2.9.1. Lung Cancer Market, 2018 - 2030 (USD Million)
    • 7.2.10. Other Cancer Market, 2018 - 2030 (USD Million)
      • 7.2.10.1. Other Cancer Market, 2018 - 2030 (USD Million)
  • 7.3. Pharmacogenomics
    • 7.3.1. Pharmacogenomics Market, 2018 - 2030 (USD Million)
  • 7.4. Infectious Diseases
    • 7.4.1. Infectious Diseases Market, 2018 - 2030 (USD Million)
    • 7.4.2. Methicillin-resistant Staphylococcus Aureus (MRSA)
      • 7.4.2.1. Methicillin-resistant Staphylococcus Aureus (MRSA) Market, 2018 - 2030 (USD Million)
    • 7.4.3. Clostridium Difficile
      • 7.4.3.1. Clostridium Difficile Market, 2018 - 2030 (USD Million)
    • 7.4.4. Vancomycin-resistant Enterococci (VRE)
      • 7.4.4.1. Vancomycin-resistant Enterococci (VRE) Market, 2018 - 2030 (USD Million) Instruments
    • 7.4.5. Carbapenem-resistant Bacteria
      • 7.4.5.1. Carbapenem-resistant Bacteria Market, 2018 - 2030 (USD Million)
    • 7.4.6. Flu
      • 7.4.6.1. Flu Market, 2018 - 2030 (USD Million)
    • 7.4.7. Candida Market, 2018 - 2030 (USD Million)
      • 7.4.7.1. Candida Market, 2018 - 2030 (USD Million)
    • 7.4.8. Tuberculosis and Drug-resistant TBA
      • 7.4.8.1. Tuberculosis and Drug-resistant TBA Market, 2018 - 2030 (USD Million)
    • 7.4.9. Meningitis
      • 7.4.9.1. Meningitis Market, 2018 - 2030 (USD Million)
    • 7.4.10. Gastrointestinal Panel Testing
      • 7.4.10.1. Gastrointestinal Panel Testing Market, 2018 - 2030 (USD Million)
    • 7.4.11. Chlamydia
      • 7.4.11.1. Chlamydia Market, 2018 - 2030 (USD Million)
    • 7.4.12. Gonorrhea
      • 7.4.12.1. Gonorrhea Market, 2018 - 2030 (USD Million)
    • 7.4.13. HIV
      • 7.4.13.1. HIV Market, 2018 - 2030 (USD Million)
    • 7.4.14. Hepatitis C
      • 7.4.14.1. Hepatitis C Market, 2018 - 2030 (USD Million)
    • 7.4.15. Hepatitis B
      • 7.4.15.1. Hepatitis B Market, 2018 - 2030 (USD Million)
    • 7.4.16. Others Infectious Diseases
      • 7.4.16.1. Other Infectious Diseases Market, 2018 - 2030 (USD Million)
  • 7.5. Genetic Testing
    • 7.5.1. Genetic Testing Market, 2018 - 2030 (USD Million)
    • 7.5.2. Newborn Screening
      • 7.5.2.1. Newborn Screening Market, 2018 - 2030 (USD Million)
    • 7.5.3. Predictive and Presymptomatic Testing
      • 7.5.3.1. Predictive and Presymptomatic Market, 2018 - 2030 (USD Million)
    • 7.5.4. Other Genetic Testing Market, 2018 - 2030 (USD Million) Instruments
      • 7.5.4.1. Other Genetic Testing Market, 2018 - 2030 (USD Million)
  • 7.6. Neurological Disease
    • 7.6.1. Neurological Disease Market, 2018 - 2030 (USD Million)
  • 7.7. Cardiovascular Disease
    • 7.7.1. Cardiovascular Disease Market, 2018 - 2030 (USD Million)
  • 7.8. Microbiology
    • 7.8.1. Microbiology Market, 2018 - 2030 (USD Million)
  • 7.9. Others
    • 7.9.1. Others Market, 2018 - 2030 (USD Million)

Chapter 8. North America Molecular Diagnostics Market: Country Business Analysis

  • 8.1. North America
    • 8.1.1. North America Molecular Diagnostics Market, 2018 - 2030 (USD Million)
    • 8.1.2. U.S.
      • 8.1.2.1. Key Country Dynamics
      • 8.1.2.2. Target Disease Prevalence
      • 8.1.2.3. Competitive Scenario
      • 8.1.2.4. Regulatory Framework
      • 8.1.2.5. U.S. Molecular Diagnostics Market, 2018 - 2030 (USD Million)
    • 8.1.3. Canada
      • 8.1.3.1. Key Country Dynamics
      • 8.1.3.2. Target Disease Prevalence
      • 8.1.3.3. Competitive Scenario
      • 8.1.3.4. Regulatory Framework
      • 8.1.3.5. Canada Molecular Diagnostics Market, 2018 - 2030 (USD Million)

Chapter 9. North America Molecular Diagnostics Market: Competitive Landscape

  • 8.1. Participant Categorization
    • 9.1.1. BD
      • 9.1.1.1. Overview
      • 9.1.1.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 9.1.1.3. Product Benchmarking
      • 9.1.1.4. Strategic Initiatives
    • 9.1.2. Bio-Rad Laboratories, Inc.
      • 9.1.2.1. Overview
      • 9.1.2.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 9.1.2.3. Product Benchmarking
      • 9.1.2.4. Strategic Initiatives
    • 9.1.3. Abbott
      • 9.1.3.1. Overview
      • 9.1.3.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 9.1.3.3. Product Benchmarking
      • 9.1.3.4. Strategic Initiatives
    • 9.1.4. Agilent Technologies, Inc.
      • 9.1.4.1. Overview
      • 9.1.4.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 9.1.4.3. Product Benchmarking
      • 9.1.4.4. Strategic Initiatives
    • 9.1.5. Danaher
      • 9.1.5.1. Overview
      • 9.1.5.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 9.1.5.3. Product Benchmarking
      • 9.1.5.4. Strategic Initiatives
    • 9.1.6. Hologic Inc. (Gen Probe)
      • 9.1.6.1. Overview
      • 9.1.6.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 9.1.6.3. Product Benchmarking
      • 9.1.6.4. Strategic Initiatives
    • 9.1.7. Illumina, Inc.
      • 9.1.7.1. Overview
      • 9.1.7.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 9.1.7.3. Product Benchmarking
      • 9.1.7.4. Strategic Initiatives
    • 9.1.8. Johnson & Johnson Services, Inc.
      • 9.1.8.1. Overview
      • 9.1.8.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 9.1.8.3. Product Benchmarking
      • 9.1.8.4. Strategic Initiatives
    • 9.1.9. Thermo Fisher Scientific Inc.
      • 9.1.9.1. Overview
      • 9.1.9.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 9.1.9.3. Product Benchmarking
      • 9.1.9.4. Strategic Initiatives
    • 9.1.10. F. Hoffmann-La Roche, Ltd.
      • 9.1.10.1. Overview
      • 9.1.10.2. Financial Performance (Net Revenue/Sales/EBITDA/Gross Profit)
      • 9.1.10.3. Product Benchmarking
      • 9.1.10.4. Strategic Initiatives
  • 9.2. Participant's Overview
  • 9.3. Financial Performance
  • 9.4. Product Benchmarking
  • 9.5. Company Market Share Analysis, 2023
  • 9.6. Strategy Mapping
    • 9.6.1. Expansion
    • 9.6.2. Acquisition
    • 9.6.3. Product/Service Launch
    • 9.6.4. Others

Chapter 10. Analyst View

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