The North America companion diagnostics market is predicted to rise with a 13.41% CAGR during the forecasted years of 2022 to 2030, acquiring a revenue share of $6430.01 million by 2030.

NORTH AMERICA COMPANION DIAGNOSTICS MARKET FORECAST 2022-2030

North America Companion Diagnostics Market by Technology (in Situ Hybridization, Polymerase Chain Reaction, Immunohistochemistry, Next Generation Sequencing, Other Technologies) Market by Indication (Oncology, Neurology, Infectious Diseases, Other Indications) Market by End-user (Pharmaceutical and Biopharmaceutical Companies, Reference Laboratories, Other End-users) Market by Products & Services (Assay Kits and Reagents, Software & Services) by Geography

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The North America companion diagnostics market is predicted to rise with a 13.41% CAGR during the forecasted years of 2022 to 2030, acquiring a revenue share of $6430.01 million by 2030.

The market growth of the region is driven by the increasing prevalence of chronic diseases, the rise in the incidence of neurodegenerative conditions, including Alzheimer’s disease, intensifying health consciousness, as well as the rollout of healthcare plans by the government. However, the North America companion diagnostics market is likely to be negatively impacted by ethical, legal, and social issues associated with the protection of patients’ genetic information.

North America Companion Diagnostics Market

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The North America companion diagnostics market growth assessment comprises a detailed study of the United States and Canada. The growth of the companion diagnostics market in the United States is predominantly credited to the excellent network existing between manufacturers as well as service providers, compared to other nations. Moreover, the contribution of the United States Food and Drug Administration (FDA) has further aided the development of a flexible regulatory pathway, thereby resolving multiple queries linked to the co-development process. However, the rapid evolution of diagnostics technologies challenges the United States FDA in terms of continually redefining companion diagnostics’ regulatory ecosystem.

Likewise, factors such as unclear companion diagnostics regulatory pathways, limited healthcare policy, and market variability may hinder the demand and adoption of companion diagnostics in Canada. However, various private and public initiatives are set to enhance the country’s market growth. For example, the Alliance for Innovation in Molecular Diagnostics is establishing efforts toward refining the companion diagnostics innovation environment. Similarly, provincial HTA agencies, including INESSS and OHTAC, hospitals, and provincial ministries of health are also working towards promoting companion diagnostic applications through the provision of recommendations for reimbursement. As a result, these factors are expected to fuel the market growth in North America during the forecast years.

The North America companion diagnostics market is segmented into technology, indication, products & services, and end-user. The technology category constitutes in situ hybridization, polymerase chain reaction, immunohistochemistry, next generation sequencing, and other technologies. Upgrades in throughput, as well as analysis for in situ hybridization (ISH), will continue to ensure growth for competitive pressure and advanced training. Moreover, the in situ hybridization segment is anticipated to maintain a significant share, particularly in its core applications, while leveraging unique potential in niche avenues of companion diagnostics and histology diagnostics.

The notable share of the polymerase chain reaction segment is accredited to better results, ease of use, cost-effective solutions, and faster turnaround time. PCR-based companion diagnostics are set to capture a substantial share in neurology, in addition to new oncology applications like leukemia, ovarian cancer, and prostate cancer, owing to their effective detection of biomarkers.

Some of the distinguished companies operating in the North America companion diagnostics market are Danaher Corporation, Arup Laboratories, Abbott Technologies, etc.

Danaher Corporation, headquartered in the United States, is a manufacturer and developer of professional, industrial, medical, and commercial services and products. Its operations are focused on the development of applications for medical diagnostics, environmental and applied solutions, and life sciences.

The company’s major products entail microsystems for life sciences research, services and disinfection systems for environmental solutions, analytical instruments, reagents, software for medical diagnostics purposes, consumables, and instrumentation.

Report Synopsis

Report ScopeDetails
Market Forecast Years2022-2030
Base Year2021
Market Historical Years2018-2021
Forecast UnitsRevenue ($ Million)
Segments AnalyzedTechnology, Indication, Products & Services, End-User
Countries AnalyzedThe United States and Canada
Companies Analyzed

Abbott Laboratories, Almac Group, Arup Laboratories, Biocartis, Biomerieux SA, Danaher Corporation, GE Healthcare, Genomic Health, Illumina Inc, Qiagen NV, Agilent, Roche Diagnostics, Sysmex Corporation, Thermo Fisher Scientific Inc

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    1. RESEARCH SCOPE & METHODOLOGY
      • STUDY OBJECTIVES
      • SCOPE OF STUDY
      • METHODOLOGY
      • ASSUMPTIONS & LIMITATIONS
    2. EXECUTIVE SUMMARY
      • MARKET SIZE & ESTIMATES
      • MARKET OVERVIEW
    3. MARKET DYNAMICS
      • KEY DRIVERS
        • GROWING NUMBER OF CANCER CASES AND MORTALITIES
        • INCREASING POPULARITY OF PRECISION MEDICINES
        • RISING NUMBER OF ADVERSE DRUG REACTION CASES
      • KEY RESTRAINTS
        • COUNTRY-SPECIFIC REIMBURSEMENT ISSUES
        • FREQUENT CASES OF LEAKAGE IN COMPANION DIAGNOSTICS FOR ONCOLOGY
    1. KEY ANALYTICS
      • IMPACT OF COVID-19 ON COMPANION DIAGNOSTICS MARKET
      • KEY MARKET TRENDS
      • PORTER’S FIVE FORCES ANALYSIS
        • BUYERS POWER
        • SUPPLIERS POWER
        • SUBSTITUTION
        • NEW ENTRANTS
        • INDUSTRY RIVALRY
      • OPPORTUNITY MATRIX
      • VENDOR LANDSCAPE
      • VALUE CHAIN ANALYSIS
      • KEY BUYING CRITERIA
      • REGULATORY FRAMEWORK
    2. MARKET BY TECHNOLOGY
      • IN SITU HYBRIDIZATION
      • POLYMERASE CHAIN REACTION
      • IMMUNOHISTOCHEMISTRY
      • NEXT GENERATION SEQUENCING
      • OTHER TECHNOLOGIES
    3. MARKET BY INDICATION
      • ONCOLOGY
      • NEUROLOGY
      • INFECTIOUS DISEASES
      • OTHER INDICATIONS
    4. MARKET BY END-USER
      • PHARMACEUTICAL AND BIOPHARMACEUTICAL COMPANIES
      • REFERENCE LABORATORIES
      • OTHER END-USERS
    5. MARKET BY PRODUCTS & SERVICES
      • ASSAY KITS AND REAGENTS
      • SOFTWARE & SERVICES
    6. GEOGRAPHICAL ANALYSIS
      • NORTH AMERICA
        • MARKET SIZE & ESTIMATES
        • KEY GROWTH ENABLERS
        • KEY CHALLENGES
        • KEY PLAYERS
        • COUNTRY ANALYSIS
          • UNITED STATES
          • CANADA
    1. COMPETITIVE LANDSCAPE
      • KEY STRATEGIC DEVELOPMENTS
        • MERGERS & ACQUISITIONS
        • PRODUCT LAUNCHES & DEVELOPMENTS
        • PARTNERSHIPS & AGREEMENTS
      • COMPANY PROFILES
        • ABBOTT LABORATORIES
        • AGILENT
        • ALAMC GROUP
        • ARUP LABORATORIES
        • BIOCARTIS
        • BIOMERIEUX SA
        • DANAHER CORPORATION
        • GE HEALTHCARE
        • GENOMIC HEALTH
        • ILLUMINA INC
        • MYRIAD GENETICS INC
        • QIAGEN NV
        • ROCHE DIAGNOSTICS
        • SYSMEX CORPORATION
        • THERMO FISHER SCIENTIFIC INC

    LIST OF TABLES

    TABLE 1: MARKET SNAPSHOT – COMPANION DIAGNOSTICS

    TABLE 2: NEW CASES OF CANCER PATIENTS IN 2020

    TABLE 3: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY TECHNOLOGY, HISTORICAL YEARS, 2018-2021 (IN $ MILLION)

    TABLE 4: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY TECHNOLOGY, FORECAST YEARS, 2022-2030 (IN $ MILLION)

    TABLE 5: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY INDICATION, HISTORICAL YEARS, 2018-2021 (IN $ MILLION)

    TABLE 6: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY INDICATION FORECAST YEARS, 2022-2030 (IN $ MILLION)

    TABLE 7: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY END-USER, HISTORICAL YEARS, 2018-2021 (IN $ MILLION)

    TABLE 8: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY END-USER, FORECAST YEARS, 2022-2030 (IN $ MILLION)

    TABLE 9: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY PRODUCTS & SERVICES, HISTORICAL YEARS, 2018-2021 (IN $ MILLION)

    TABLE 10: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY PRODUCTS & SERVICES, FORECAST YEARS, 2022-2030 (IN $ MILLION)

    TABLE 11: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY COUNTRY, HISTORICAL YEARS, 2018-2021 (IN $ MILLION)

    TABLE 12: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY COUNTRY, FORECAST YEARS, 2022-2030 (IN $ MILLION)

    TABLE 13: LEADING PLAYERS OPERATING IN NORTH AMERICA COMPANION DIAGNOSTICS MARKET

    TABLE 14: LIST OF MERGERS & ACQUISITIONS

    TABLE 15: LIST OF PRODUCT LAUNCHES & DEVELOPMENTS

    TABLE 16: LIST OF PARTNERSHIPS & AGREEMENTS          

    LIST OF FIGURES

    FIGURE 1: CDX LEAKAGE

    FIGURE 2: KEY MARKET TRENDS

    FIGURE 3: PORTER’S FIVE FORCES ANALYSIS

    FIGURE 4: OPPORTUNITY MATRIX

    FIGURE 5: VENDOR LANDSCAPE

    FIGURE 6: VALUE CHAIN ANALYSIS

    FIGURE 7: FDA GUIDELINES FOR CDX APPROVAL

    FIGURE 8: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, GROWTH POTENTIAL, BY TECHNOLOGY, IN 2021

    FIGURE 9: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY IN SITU HYBRIDIZATION, 2022-2030 (IN $ MILLION)

    FIGURE 10: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY POLYMERASE CHAIN REACTION, 2022-2030 (IN $ MILLION)

    FIGURE 11: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY IMMUNOHISTOCHEMISTRY, 2022-2030 (IN $ MILLION)

    FIGURE 12: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY NEXT GENERATION SEQUENCING, 2022-2030 (IN $ MILLION)

    FIGURE 13: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY OTHER TECHNOLOGIES, 2022-2030 (IN $ MILLION)

    FIGURE 14: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, GROWTH POTENTIAL, BY INDICATION, IN 2021

    FIGURE 15: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY ONCOLOGY, 2022-2030 (IN $ MILLION)

    FIGURE 16: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY NEUROLOGY, 2022-2030 (IN $ MILLION)

    FIGURE 17: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY INFECTIOUS DISEASES, 2022-2030 (IN $ MILLION)

    FIGURE 18: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY OTHER INDICATIONS, 2022-2030 (IN $ MILLION)

    FIGURE 19: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, GROWTH POTENTIAL, BY END-USER, IN 2021

    FIGURE 20: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY PHARMACEUTICAL AND BIOPHARMACEUTICAL COMPANIES, 2022-2030 (IN $ MILLION)

    FIGURE 21: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY REFERENCE LABORATORIES, 2022-2030 (IN $ MILLION)

    FIGURE 22: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY OTHER END-USERS, 2022-2030 (IN $ MILLION)

    FIGURE 23: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, GROWTH POTENTIAL, BY PRODUCTS & SERVICES, IN 2021

    FIGURE 24: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY ASSAY KITS AND REAGENTS, 2022-2030 (IN $ MILLION)

    FIGURE 25: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, BY SOFTWARE & SERVICES, 2022-2030 (IN $ MILLION)

    FIGURE 26: NORTH AMERICA COMPANION DIAGNOSTICS MARKET, COUNTRY OUTLOOK, 2021 & 2030 (IN %)

    FIGURE 27: UNITED STATES COMPANION DIAGNOSTICS MARKET, 2022-2030 (IN $ MILLION)

    FIGURE 28: CANADA COMPANION DIAGNOSTICS MARKET, 2022-2030 (IN $ MILLION)       

    1. GEOGRAPHICAL ANALYSIS
      • NORTH AMERICA
        • MARKET SIZE & ESTIMATES
        • KEY GROWTH ENABLERS
        • KEY CHALLENGES
        • KEY PLAYERS
        • COUNTRY ANALYSIS
          • UNITED STATES
          • CANADA
    1. MARKET BY TECHNOLOGY
      • IN SITU HYBRIDIZATION
      • POLYMERASE CHAIN REACTION
      • IMMUNOHISTOCHEMISTRY
      • NEXT GENERATION SEQUENCING
      • OTHER TECHNOLOGIES
    2. MARKET BY INDICATION
      • ONCOLOGY
      • NEUROLOGY
      • INFECTIOUS DISEASES
      • OTHER INDICATIONS
    3. MARKET BY END-USER
      • PHARMACEUTICAL AND BIOPHARMACEUTICAL COMPANIES
      • REFERENCE LABORATORIES
      • OTHER END-USERS
    4. MARKET BY PRODUCTS & SERVICES
      • ASSAY KITS AND REAGENTS
      • SOFTWARE & SERVICES

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