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Molecular Diagnostics Market

Molecular Diagnostics Market Share, Size, Trends, Forecast: By Product & Service: Instruments, Reagents & Kits, Services & Software; By Test Location: Point-of-Care, Self-test or Over the Counter, Central Laboratories; By Technology; By Application; By End User; Regional Analysis; Patent Analysis; Supplier Landscape; 2024-2032

Molecular Diagnostics Market Outlook

The molecular diagnostics market size attained a value of USD 15.60 billion in 2023. The market is anticipated to grow at a CAGR of 11.4% during the forecast period of 2024-2032 to attain a value of USD 41.22 billion by 2032. The market growth is driven by the increased innovation in molecular diagnostic technologies and their widespread application across the globe.

 

Molecular Diagnostics Market Overview

Molecular diagnostics are used for the detection of genomic variants, diagnosis, and prognosis, facilitating detection, and monitoring patient response to treatment. The utilization of DNA and RNA is done to analyse and detect caution points indicating the potential emergence of a specific disease.

 

The rising prevalence of contagious diseases and growing cancer cases are the major factors driving the market growth for molecular diagnostics. As such cases increase in prevalence, healthcare providers are more focused on providing patients with better diagnostic and treatment solutions, which can propel the market demand for molecular diagnostics.

 

Increased funding provided through government initiatives, programs, or funding activities to new and established market players for research and development are expected to aid the proliferation of the market value. With the increased funding, market players will add significant innovation and development, making further contributions in the molecular diagnostics market share.

 

The rising geriatric population across the globe can enhance the development of the market as they are more susceptible to getting infected, leading to an increased number of cases. With the increased prevalence of diseases among the aging population, hospitals and healthcare institutes are expected to provide better diagnostic services, which can augment market growth.

 

Strategic Investments in Molecular Diagnostics

The market is expected to witness significant growth owing to the increasing funding activities by the key players. These investments are targeted toward bringing innovations and performing research and development activities to study and observe the efficacy of these innovations in the field of molecular diagnostics, propelling the molecular diagnostics market growth. For instance, in October 2023, Dutch-based Scope Biosciences, received nearly USD 552K led by SHIFT Invest’s Thematic Technology Transfer fund and OostNL to develop and commercialise agricultural diagnostics with CRISPR-Cas-based tech. This funding is expected to enable the Wageningen-based company’s innovative efforts to develop, launch, and commercialise agricultural tests with the use of the innovative scopeDx molecular diagnostic platform. The diagnosis and monitoring of diverse agricultural pathogens are expected to be simplified as these agricultural tests are targeted to simplify them through a specific on-site platform.

 

Continuous Innovation in the Market

The market has a huge gap of unmet needs for molecular testing at the point of need as remote towns and regions that are hard to reach do not have access to such diagnostic procedures. Key players in the market are expected to bring innovation to molecular diagnostics enabling the future growth of the market. For instance, Alveo Technologies is bringing a new perspective to the molecular diagnostics capabilities in its mission to enable earlier detection of pathogens at the point of need. The be.well™ platform may be small but it is exhibiting extreme power by responding to some of the most pressing demands of the healthcare industry. This technology has the potential to fill a crucial gap of unmet needs in molecular diagnostics and make an impact on the lives of people globally, especially in developing countries, bolstering the molecular diagnostics market demand.

 

Additionally, the market is further expected to experience continuous advancement and innovation to enhance the existing molecular diagnostic technologies such as nucleic acid detection in various diagnostic settings in the early detection of diseases. For instance, Changchun Liu, professor of Biomedical Engineering at UConn Health, has developed  a new method that improves existing diagnostic technology for a more rapid, sensitive, and deployable approach to molecular diagnostics. The research discovered new potential for simple and sensitive nucleic acid detection in various diagnostic settings, including early cancer diagnostics and infectious disease detection using new and improved clustered regularly interspaced short palindromic repeats (CRISPR) technology. CRISPR technology uses an enzyme that can be programmed to seek out a specific stretch of nucleic acid and grab onto it.

 

Strategic Collaborations between Key Players

The market for molecular diagnostics is one of the fastest-growing markets in the healthcare sector. The increasing awareness about the potential of early diagnosis and personalised medicine/treatments is collectively contributing to the molecular diagnostics market growth. For instance, in January 2023, Alveo even signed a Memorandum of Understanding (MOU) with the Barbados Investment and Development Corporation (Export Barbados (BIDC)) to co-develop its novel molecular sensing platform, while contributing to the growth of the life sciences industry in the Caribbean nation . Such collaborations are anticipated to expand the market reach while sharing the assets to co-develop novel solutions in the molecular diagnostics market.

 

Molecular Diagnostics Market Segmentation

Market Breakup by Product and Service

  • Instruments
  • Reagents and Kits
  • Services & Software

 

Market Breakup by Test Location

  • Point-of-Care
  • Self-test or Over the Counter
  • Central Laboratories

 

Market Breakup by Technology

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

 

Market Breakup by Application

  • Oncology
  • Breast Cancer
  • Colorectal Cancer
  • Lung Cancer
  • Prostate Cancer
  • Other Cancers
  • Pharmacogenomics
  • Infectious Diseases
  • Hepatitis
  • HIV
  • CT/NG
  • HAI
  • HPV
  • Tuberculosis
  • Influenza
  • Other Infectious Diseases
  • Genetic Testing
  • Neurological Diseases
  • Cardiovascular Diseases
  • Microbiology
  • Others

 

Market Breakup by End User

  • Diagnostic Laboratories
  • Hospitals and Clinics
  • Other End Users

 

Market Breakup by Region

  • United States
  • EU-4 and the United Kingdom
  • Germany
  • France
  • Italy
  • Spain
  • United Kingdom
  • Japan

 

Molecular Diagnostics Regional Analysis

Based on the geographic analysis of the market, the United States has been dominating the regional market. The increasing prevalence of infectious diseases and increasing preference for personalised medicine, coupled with increasing awareness among people, are some of the key factors likely to drive the molecular diagnostics market demand during the forecast period. The increasing research and development activities are also driving the market in the region. For instance, In July 2023, a group of researchers at Queensland University of Technology (QUT) developed a new approach for designing molecular ON-OFF switches based on proteins with widespread application in biotechnological, biomedical, and bioengineering.  The research team mentioned that this novel approach will enable them to develop diagnostic tests for the early detection of diseases that are designed and built faster and with more accuracy. This new approach with widespread applications is likely to assist scientists in performing better research and discovering new things to improve healthcare and environmental monitoring, contributing to market growth.

 

molecular diagnostics market by region

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Molecular Diagnostics Market: Competitor Landscape

In November 2023, Abbott received U.S. Food and Drug Administration (FDA) approval  for its molecular human papillomavirus or HPV screening solution. Alinity m diagnostic assays now include a powerful cancer screening tool for detecting high-risk HPV infections, a common infection.

 

The key features of the market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players.

 

The major companies in the market are as follows:

 

  • BioMérieux SA
  • BD
  • Bio-Rad Laboratories, Inc.
  • Abbott
  • Agilent Technologies, Inc.
  • Hologic Inc.
  • Danaher
  • DiaSorin
  • Illumina, Inc.
  • Johnson & Johnson Services, Inc.
  • Grifols, S.A.
  • QIAGEN N.V.
  • F. Hoffmann-La Roche, Ltd.
  • PerkinElmer, Inc.
  • Siemens Healthineers

 

Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.

 

Key Highlights of the Report

REPORT FEATURES DETAILS
Base Year 2023
Historical Period 2017-2023
Forecast Period 2024-2032
Scope of the Report

Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:

  • Product & Service
  • Test Location
  • Technology
  • Application
  • End User
  • Region
Breakup by Product & Service
  • Instruments
  • Reagents and Kits
  • Services & Software
Breakup by Test Location
  • Point-of-Care
  • Self-test or Over the Counter
  • Central Laboratories
Breakup by Technology
  • Polymerase Chain Reaction (PCR)
  • In Situ Hybridisation
  • Isothermal Nucleic Acid Amplification Technology (INAAT)
  • Chips and Microarrays
  • Mass Spectrometry
  • Sequencing
  • Transcription Mediated Amplification
  • Others
Breakup by Application
  • Oncology
  • Pharmagenomics
  • Infectious Diseases
  • Genetic Testing
  • Neurological Diseases
  • Cardiovascular Diseases
  • Microbiology
  • Others
Breakup by End User
  • Diagnostic Laboratories
  • Hospitals & Clinics
  • Other End Users
Breakup by Region
  • United States
  • EU-4 and the United Kingdom
  • Japan
Market Dynamics
  • Market Drivers and Constraints
  • SWOT Analysis
  • Porter’s Five Forces Model 
  • Key Demand Indicators
  • Key Price Indicators
  • Industry Events, Initiatives, and Trends 
  • Value Chain Analysis
Competitive Landscape
  • Market Structure
  • Company Profiles
    • Financial Analysis
    • Product Portfolio
    • Demographic Reach and Achievements
    • Mergers and Acquisitions
    • Certifications
Companies Covered
  • BioMérieux SA 
  • BD
  • Bio-Rad Laboratories, Inc.
  • Abbott 
  • Agilent Technologies, Inc.
  • Hologic Inc.
  • Danaher
  • DiaSorin
  • Illumina, Inc.
  • Johnson & Johnson Services, Inc.
  • Grifols, S.A.
  • QIAGEN N.V.
  • F. Hoffmann-La Roche, Ltd.
  • PerkinElmer, Inc.
  • Siemens Healthineers

 

*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.

1    Preface
    1.1    Objectives of the Study
    1.2    Key Assumptions 
    1.3    Report Coverage – Key Segmentation and Scope  
    1.4    Research Methodology
2    Executive Summary
3    Molecular Diagnostics Overview 

    3.1    Guidelines and Stages
    3.2    Pathophysiology
    3.3    Screening and Diagnosis
    3.4    Treatment Pathway 
4    Patient Profile
    4.1    Patient Profile Overview
    4.2    Patient Psychology and Emotional Impact Factors
    4.3    Risk Assessment and Treatment Success Rate
5    Oncological Disorder Epidemiology Analysis – 7MM
    5.1    7MM Epidemiology Scenario Overview (2017-2032)
    5.2    United States Oncological Disorder Epidemiology Forecast (2017-2032)
    5.3    EU-4 and United Kingdom Oncological Disorder Epidemiology Forecast (2017-2032)
        5.3.1    Germany Oncological Disorder Epidemiology Forecast (2017-2032)
        5.3.2    France Oncological Disorder Epidemiology Forecast (2017-2032)
        5.3.3    Italy Oncological Disorder Epidemiology Forecast (2017-2032)
        5.3.4    Spain Oncological Disorder Epidemiology Forecast (2017-2032)
        5.3.5    United Kingdom Oncological Disorder Epidemiology Forecast (2017-2032)
    5.4    Japan Oncological Disorder Epidemiology Forecast (2017-2032)
6    Molecular Diagnostics Market Overview – 7MM
    6.1    Molecular Diagnostics Market Historical Value (2017-2023) 
    6.2    Molecular Diagnostics Market Forecast Value (2024-2032)
7    Molecular Diagnostics Market Landscape – 7MM
    7.1     Molecular Diagnostics Developers Landscape
        7.1.1    Analysis by Year of Establishment
        7.1.2    Analysis by Company Size
        7.1.3    Analysis by Region
    7.2     Molecular Diagnostics Product Landscape
        7.2.1    Analysis by Product & Service
        7.2.2    Analysis by Test Location
        7.2.3    Analysis by Test Type
        7.2.4    Analysis by Technology
        7.2.5    Analysis by Application
        7.2.6    Analysis by End User
8    Oncological Disorder Challenges and Unmet Needs
    8.1    Treatment Pathway Challenges
    8.2    Compliance and Drop-Out Analysis
    8.3    Awareness and Prevention Gaps
9    Cost of Treatment
10    Molecular Diagnostics Market Dynamics

    10.1    Market Drivers and Constraints
    10.2    SWOT Analysis
    10.3    Porter’s Five Forces Model
    10.4    Key Demand Indicators 
    10.5    Key Price Indicators
    10.6    Industry Events, Initiatives, and Trends  
    10.7    Value Chain Analysis
11    Molecular Diagnostics Market Segmentation – 7MM
    11.1     Molecular Diagnostics Market by Product & Service
        11.1.1    Market Overview
        11.1.2    Instruments
        11.1.3    Reagents & Kits
        11.1.4    Services & Software
    11.2    Molecular Diagnostics Market by Test Location
        11.2.1    Market Overview
        11.2.2    Point-of-Care
        11.2.3    Self-test or Over the Counter
        11.2.4    Central Laboratories
    11.3    Molecular Diagnostics Market by Technology
        11.3.1    Market Overview
        11.3.2    Polymerase Chain Reaction (PCR) 
        11.3.3    In Situ Hybridisation
        11.3.4    Isothermal Nucleic Acid Amplification Technology (INAAT)
        11.3.5    Chips and Microarrays
        11.3.6    Mass Spectrometry
        11.3.7    Sequencing
        11.3.8    Transcription Mediated Amplification
        11.3.9    Others
    11.4    Molecular Diagnostics Market by Application
        11.4.1    Market Overview
        11.4.2    Oncology
            11.4.2.1    Breast Cancer
            11.4.2.2    Colorectal Cancer
            11.4.2.3    Lung Cancer
            11.4.2.4    Prostate Cancer
            11.4.2.5    Other Cancers
        11.4.3    Pharmagenomics
        11.4.4    Infectious Diseases
            11.4.4.1    Hepatitis
            11.4.4.2    HIV
            11.4.4.3    CT/NG
            11.4.4.4    HAI
            11.4.4.5    HPV
            11.4.4.6    Tuberculosis
            11.4.4.7    Influenza
            11.4.4.8    Other Infectious Diseases
        11.4.5    Genetic Testing
        11.4.6    Neurological Diseases
        11.4.7    Cardiovascular Diseases
        11.4.8    Microbiology
        11.4.9    Others
    11.5    Molecular Diagnostics Market by End User
        11.5.1    Market Overview
        11.5.2    Diagnostic Laboratories
        11.5.3    Hospitals & Clinics
        11.5.4    Other End Users
    11.6    Molecular Diagnostics Market by Region
        11.6.1    Market Overview
        11.6.2    United States
        11.6.3    EU-4 and the United Kingdom
            11.6.3.1    Germany
            11.6.3.2    France
            11.6.3.3    Italy
            11.6.3.4    Spain
            11.6.3.5    United Kingdom
        11.6.4    Japan
12    United States Molecular Diagnostics Market
    12.1    Molecular Diagnostics Market Historical Value (2017-2023) 
    12.2    Molecular Diagnostics Market Forecast Value (2024-2032)
        12.2.1    Molecular Diagnostics Market by Product & Service
        12.2.2    Molecular Diagnostics Market by Technology
13    EU-4 and United Kingdom Molecular Diagnostics Market
    13.1    Molecular Diagnostics Market Historical Value (2017-2023) 
    13.2    Molecular Diagnostics Market Forecast Value (2024-2032)
    13.3    Germany Molecular Diagnostics Market Overview
        13.3.1    Molecular Diagnostics Market by Product & Service
        13.3.2    Molecular Diagnostics Market by Technology
    13.4    France Molecular Diagnostics Market Overview
        13.4.1    Molecular Diagnostics Market by Product & Service
        13.4.2    Molecular Diagnostics Market by Technology
    13.5    Italy Molecular Diagnostics Market Overview
        13.5.1    Molecular Diagnostics Market by Product & Service
        13.5.2    Molecular Diagnostics Market by Technology
    13.6    Spain Molecular Diagnostics Market Overview
        13.6.1    Molecular Diagnostics Market by Product & Service
        13.6.2    Molecular Diagnostics Market by Technology
    13.7    United Kingdom Molecular Diagnostics Market Overview
        13.7.1    Molecular Diagnostics Market by Product & Service
        13.7.2    Molecular Diagnostics Market by Technology
14    Japan Molecular Diagnostics Market
    14.1    Molecular Diagnostics Market Historical Value (2017-2023) 
    14.2    Molecular Diagnostics Market Forecast Value (2024-2032)
        14.2.1    Molecular Diagnostics Market by Product & Service
        14.2.2    Molecular Diagnostics Market by Technology
15    Patent Analysis
    15.1    Analysis by Type of Patent
    15.2    Analysis by Publication year
    15.3    Analysis by Issuing Authority
    15.4    Analysis by Patent Age
    15.5    Analysis by CPC Analysis
    15.6    Analysis by Patent Valuation 
    15.7    Analysis by Key Players
16    Grants Analysis
    16.1    Analysis by year
    16.2    Analysis by Amount Awarded
    16.3    Analysis by Issuing Authority
    16.4    Analysis by Grant Application
    16.5    Analysis by Funding Institute
    16.6    Analysis by NIH Departments
    16.7    Analysis by Recipient Organization 
17    Clinical Trials Analysis
    17.1     Analysis by Trial Registration Year
    17.2    Analysis by Trial Status
    17.3    Analysis by Trial Phase
    17.4    Analysis by Therapeutic Area
    17.5    Analysis by Geography
18    Funding and Investment Analysis
    18.1    Analysis by Funding Instances
    18.2    Analysis by Type of Funding
    18.3    Analysis by Funding Amount
    18.4    Analysis by Leading Players
    18.5    Analysis by Leading Investors
    18.6    Analysis by Geography
19    Partnership and Collaborations Analysis
    19.1    Analysis by Partnership Instances
    19.2    Analysis by Type of Partnership
    19.3    Analysis by Leading Players
    19.4    Analysis by Geography
20    Supplier Landscape
    20.1    BioMérieux SA 
        20.1.1    Financial Analysis
        20.1.2    Product Portfolio
        20.1.3    Demographic Reach and Achievements
        20.1.4    Mergers and Acquisition
        20.1.5    Certifications
    20.2    BD
        20.2.1    Financial Analysis
        20.2.2    Product Portfolio
        20.2.3    Demographic Reach and Achievements
        20.2.4    Mergers and Acquisition
        20.2.5    Certifications
    20.3    Bio-Rad Laboratories, Inc.
        20.3.1    Financial Analysis
        20.3.2    Product Portfolio
        20.3.3    Demographic Reach and Achievements
        20.3.4    Mergers and Acquisition
        20.3.5    Certifications
    20.4    Abbott 
        20.4.1    Financial Analysis
        20.4.2    Product Portfolio
        20.4.3    Demographic Reach and Achievements
        20.4.4    Mergers and Acquisition
        20.4.5    Certifications
    20.5    Agilent Technologies, Inc.
        20.5.1    Financial Analysis
        20.5.2    Product Portfolio
        20.5.3    Demographic Reach and Achievements
        20.5.4    Mergers and Acquisition
        20.5.5    Certifications
    20.6    Hologic Inc.
        20.6.1    Financial Analysis
        20.6.2    Product Portfolio
        20.6.3    Demographic Reach and Achievements
        20.6.4    Mergers and Acquisition
        20.6.5    Certifications
    20.7    Danaher
        20.7.1    Financial Analysis
        20.7.2    Product Portfolio
        20.7.3    Demographic Reach and Achievements
        20.7.4    Mergers and Acquisition
        20.7.5    Certifications
    20.8    DiaSorin
        20.8.1    Financial Analysis
        20.8.2    Product Portfolio
        20.8.3    Demographic Reach and Achievements
        20.8.4    Mergers and Acquisition
        20.8.5    Certifications
    20.9    Illumina, Inc.
        20.9.1    Financial Analysis
        20.9.2    Product Portfolio
        20.9.3    Demographic Reach and Achievements
        20.9.4    Mergers and Acquisition
        20.9.5    Certifications
    20.10    Johnson & Johnson Services, Inc.
        20.10.1    Financial Analysis
        20.10.2    Product Portfolio
        20.10.3    Demographic Reach and Achievements
        20.10.4    Mergers and Acquisition
        20.10.5    Certifications
    20.11    Grifols, S.A.
        20.11.1    Financial Analysis
        20.11.2    Product Portfolio
        20.11.3    Demographic Reach and Achievements
        20.11.4    Mergers and Acquisition
        20.11.5    Certifications
    20.12    QIAGEN N.V.
        20.12.1    Financial Analysis
        20.12.2    Product Portfolio
        20.12.3    Demographic Reach and Achievements
        20.12.4    Mergers and Acquisition
        20.12.5    Certifications
    20.13    F. Hoffmann-La Roche, Ltd.
        20.13.1    Financial Analysis
        20.13.2    Product Portfolio
        20.13.3    Demographic Reach and Achievements
        20.13.4    Mergers and Acquisition
        20.13.5    Certifications
    20.14    PerkinElmer, Inc.
        20.14.1    Financial Analysis
        20.14.2    Product Portfolio
        20.14.3    Demographic Reach and Achievements
        20.14.4    Mergers and Acquisition
        20.14.5    Certifications
    20.15    Siemens Healthineers
        20.15.1    Financial Analysis
        20.15.2    Product Portfolio
        20.15.3    Demographic Reach and Achievements
        20.15.4    Mergers and Acquisition
        20.15.5    Certifications
21    Molecular Diagnostics Market - Distribution Model (Additional Insight)
    21.1    Overview 
    21.2    Potential Distributors 
    21.3    Key Parameters for Distribution Partner Assessment 
22    Key Opinion Leaders (KOL) Insights (Additional Insight)
23    Company Competitiveness Analysis (Additional Insight)

    23.1    Very Small Companies
    23.2    Small Companies
    23.3    Mid-Sized Companies
    23.4    Large Companies
    23.5    Very Large Companies
24    Payment Methods (Additional Insight)
    24.1    Government Funded
    24.2    Private Insurance
    24.3    Out-of-Pocket


*Additional insights provided are customisable as per client requirements.

Key Questions Answered in the Report

The market attained a value of about USD 15.60 billion in 2023, driven by increasing focus on bringing innovation to the field of molecular diagnostics.

The market is anticipated to grow at a CAGR of 11.4% during the forecast period of 2024-2032, likely to reach a market value of USD 41.22 billion by 2032.

The prevalence of contagious diseases, increasing number of cancer cases, research and development activities, funding activities, and government initiatives are some major factors driving the market growth.

The market is further expected to be influenced by trends such as the continuous technological advancements in the market.

The 7 major markets include the United States, EU-4, and the United Kingdom (Germany, France, Italy, Spain, United Kingdom), and Japan.

Products and services available in the market are instruments, reagents, kits, services, and software.

Test locations include point-of-care, self-test or over-the-counter, and central laboratories.

Technologies used in the market are polymerase chain reaction (PCR), in situ hybridization, isothermal nucleic acid amplification technology (INAAT), chips and microarrays, mass spectrometry, sequencing, and transcription-mediated amplification, among others.

Molecular diagnostics find wide applications in oncology, pharmacogenomics, infectious diseases, genetic testing, neurological diseases, cardiovascular diseases, and microbiology, among others.

End users in the market include diagnostic laboratories, hospitals, and clinics, among other end users.

Key players involved in the market are BioMérieux SA, BD, Bio-Rad Laboratories, Inc., Abbott, Agilent Technologies, Inc., Hologic Inc., Danaher, DiaSorin, Illumina, Inc., Johnson & Johnson Services, Inc., Grifols, S.A., QIAGEN N.V., F. Hoffmann-La Roche, Ltd., PerkinElmer, Inc., and Siemens Healthineers.

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