세계의 분자진단 시장 평가 : 제품 및 서비스별, 검사 유형별, 샘플 유형별, 기술별, 용도별, 최종 사용자별, 지역별, 기회, 예측(2017-2031년)

Global molecular diagnostics market is projected to witness a CAGR of 10.07% during the forecast period 2024-2031, growing from USD 14.31 billion in 2023 to USD 30.83 billion in 2031.

Molecular diagnostics help patients and healthcare professionals make educated decisions about their treatment, which leads to positive results, by offering vital information. Molecular diagnostics techniques have shown to be useful in clinical settings since they allow sensitive and quick detection methods, which makes it easier to monitor a variety of infectious disorders, including cancer and other chronic illnesses. The market for molecular diagnostics is expected to rise due to the growing illness, rising numbers of pathogens and even rising geriatric population, which is more prone to disease and hence needs continuous diagnosis. Numerous medical diseases have been effectively identified by the widespread use of molecular diagnostics, including genetic testing, microbiology, STDs, oncology, blood screening, virology, tissue type, and prenatal diagnosis. Using the study of DNA, RNA, or proteins, laboratory-based molecular diagnostics are vital instruments used for the detection of human diseases. Molecular diagnostic kits and reagents are tailored according to the desired use and contain probes that are unique to certain bacterial, viral, or parasitic sequences. The market for molecular diagnostics is expected to rise due to the growing use of biomarker-specific testing kits, which are essential before starting any kind of medication or treatment. The USFDA, for instance, granted 510(k) clearance for Hologic, Inc.'s Panther Fusion SARS-CoV-2/Flu A/B/RSV assay in May 2023. This assay distinguishes between the four most prevalent respiratory viruses by molecular diagnostic testing.

Market Growth Due to Rising Prevalence of Chronic Ailments

The market for molecular diagnostics is expanding significantly due to the increased incidence of chronic illnesses. Aging populations, changing lifestyles, and environmental factors are all contributing to the rise in chronic diseases such as cancer, diabetes, and cardiovascular ailments. For these illnesses to be managed and treated effectively, sophisticated diagnostic methods are required. In this setting, molecular diagnostics, which use advanced technology to analyze genetic, genomic, and proteomic data, are essential. Through the identification of particular biomarkers and genetic alterations linked to chronic disorders, they facilitate the timely and accurate detection of diseases. Customizing therapy regimens according to each patient's unique molecular profile increases treatment effectiveness and boosts patient outcomes. For instance, by detecting mutations unique to a tumor, molecular diagnostics might assist in determining the best cancer treatments by minimizing the need for trial-and-error when choosing medications. These diagnostics make it easier to continue tracking how the disease progresses and how the body responds to treatment, which enables prompt therapeutic modifications.

The need for molecular diagnostics that offer comprehensive and individualized insights into disease causes and patient health is growing as the prevalence of chronic diseases keeps rising. The pattern promotes ongoing development and innovation in the molecular diagnostics industry, aiding in the improved treatment of long-term medical disorders. For instance, the International Diabetes Federation reported in 2023 that there has been a notable global increase in prevalence of Type 2 diabetes. According to the federation's research, 537 million adults worldwide had diabetes in 2023, i.e., a significant increase over the previous year. Ageing populations, an increase in obesity rates, and sedentary lifestyles are blamed for the trend. The increasing number of people with Type 2 diabetes highlights the critical need for better preventative measures and medical therapies to control and lessen the effects of this long-term illness.

Technological Developments Fuel Market Growth

Technological developments have a major role in propelling the molecular diagnostics market's expansion. The area has seen a revolutionary change due to the advancement of high-throughput sequencing, real-time PCR, and next-generation sequencing (NGS) technologies, which offer enhanced precision, speed, and comprehensive diagnostic capabilities. These technologies make it possible to analyze genetic material with previously unheard-of precision, which helps with disease early detection and individualized therapy. High-throughput sequencing makes it possible to analyze multiple genetic variants which improves the efficiency of identifying mutations linked to disease. To diagnose infections and genetic abnormalities, real-time PCR improves the sensitivity and specificity of detecting particular genetic sequences. Deep genetic data insights are provided by NGS, which helps with focused therapy development and the identification of new biomarkers. Moreover, developments in data analytics and bioinformatics have enhanced the ability to comprehend intricate molecular data, enabling the extraction of useful insights from sizable datasets. Molecular diagnostics benefits from the integration of artificial intelligence (AI) and machine learning, which improves predictive analytics facilitates early diagnosis and personalized medication. The market for molecular diagnostics is growing due to these technical advancements since they provide more advanced instruments for accurate and effective illness detection and treatment. For instance, F. Hoffmann-La Roche Ltd. introduced the LightCycler PRO System in November 2023 to improve the usefulness of molecular PCR testing for applications such as in vitro diagnostics and translational research.

Instruments to Dominate the Global Molecular Diagnostics Market Share

Due to the high cost of equipment and the requirement for regular replacement or updates, the instruments category holds the highest revenue share of the market based on products and services. The rising incidence of chronic illnesses including cancer, genetic abnormalities, and infectious diseases, which need more sophisticated diagnostic techniques, expected to drive the demand for molecular diagnostic tools. This expansion can be linked to the growing need for personalized medicine and companion diagnostics, which need specifically designed instruments for particular uses. New and affordable diagnostic assays are anticipated to drive growth in the reagent and kit market. As more people are using electronic health record (EHR) and laboratory information management system (LIMS) systems, the software market is predicted to grow significantly over the course of the forecast period. More accurate and efficient patient diagnosis and treatment are expected to be made possible by the integration of molecular diagnostic software with electronic medical records.

Furthermore, it is anticipated that the advancement of machine learning and artificial intelligence (AI) technologies would support the growth of molecular diagnostic software by enabling the automated analysis of big datasets. For instance, Thermo Fisher Scientific, Inc. announced the release of a new digital PCR research tool called QuantStudio, Applied Biosystems, Absolute Q AutoRun dPCR (digital polymerase chain reaction) Suite in February 2023. Additionally, in May 2023, Sansure Biotech Inc. showcased its extensive line of IVD devices at EuroMedLab Rome 2023, which included the iconic III portable molecular workstations.

North America Dominates the Global Molecular Diagnostics Market Share

With the highest market share, North America led the largest proportion of the market. This is ascribed to the increasing prevalence of both infectious and chronic illnesses, which in turn motivates businesses to launch cutting-edge molecular diagnostic tests and propel market expansion. The growth is due to the robust healthcare infrastructure present in the region. Highly advanced diagnostic centers and laboratories in the region aid scientific development and growth, leading to a highly competitive market. For instance, QIAGEN N.V.'s therascreen PDGFRA RGQ PCR kit was approved by the USFDA in August 2023. This tool helps doctors detect individuals who have gastrointestinal stromal tumors (GIST). Additionally, the VIASURE Monkeypox viral Real-Time PCR Reagents, created by Becton, Dickinson and Company and CerTest Biotec, S.L. for Mpox viral identification, was authorized by the USFDA in January 2023. Furthermore, a strong healthcare system, excellent living standards, and consumer knowledge of early diagnosis serve as important growth-promoting factors.

Future Market Scenario (2024 - 2031F)

The main factors contributing to the anticipated growth of the molecular diagnostics market are the rising numbers of pathogens, the increasing prevalence of diseases, and, thus, the rising requirement to conduct diagnostic tests. However, the growing need to have precision medicine to maintain a healthy population is going to fuel market growth in the future. Players in this market are expanding at an unparalleled rate, introducing cost-effective and efficient technologies. Policies by welfare bodies and the government are greatly fueling the market expansion. For instance, the USFDA gave the COVID-19 and Flu Home Test, the first and only Emergency Use Authorization (EUA) for OTC usage at home and other non-laboratory locations.

Key Players Landscape and Outlook

Several companies are expanding their businesses by planning and adopting new strategies. They are complying with new strategic initiatives regarding the launch of newly developed molecular diagnostics to help researchers and strengthen their presence in the market. New product launches, agreements based on contracts, acquisitions and mergers, investments, and partnerships are a few ways through which they are trying to achieve the same.

For example, in October 2023, QIAGEN N.V. and Myriad Genetics, Inc. collaborated to create companion diagnostic tests for cancer based on PCR, dPCR, and NGS technology.

Additionally, Oxford Nanopore and bioMerieux SA established a strategic alliance in April 2023 to use nanopore technology to provide innovative cures for infectious diseases.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. Global Molecular Diagnostics Market Outlook, 2017-2031F

• 4.1. Market Size Analysis & Forecast
  • 4.1.1. By Value
  • 4.1.2. By Volume
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Product and Service
    • 4.2.1.1. Reagents and Kits
    • 4.2.1.2. Instruments
    • 4.2.1.3. Services and Software
  • 4.2.2. By Test Type
    • 4.2.2.1. Lab Tests
    • 4.2.2.2. POC Tests
  • 4.2.3. By Sample Type
    • 4.2.3.1. Blood, Serum, and Plasma
    • 4.2.3.2. Urine
    • 4.2.3.3. Others
  • 4.2.4. By Technology
    • 4.2.4.1. Polymerase Chain Reaction (PCR)
    • 4.2.4.2. Isothermal Nucleic Acid Amplification Technology
    • 4.2.4.3. In-situ Hybridization
    • 4.2.4.4. DNA Sequencing
    • 4.2.4.5. Microarray
    • 4.2.4.6. Others
  • 4.2.5. By Application
    • 4.2.5.1. Infectious Diseases Tests
    • 4.2.5.2. Oncology Tests
    • 4.2.5.3. Genetic Tests
    • 4.2.5.4. Others
  • 4.2.6. By End-user
    • 4.2.6.1. Hospitals and Clinics
    • 4.2.6.2. Diagnostic Laboratories
    • 4.2.6.3. Others
  • 4.2.7. By Region
    • 4.2.7.1. North America
    • 4.2.7.2. Europe
    • 4.2.7.3. Asia-Pacific
    • 4.2.7.4. South America
    • 4.2.7.5. Middle East and Africa
  • 4.2.8. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2023)
• 4.3. Market Map Analysis, 2023
  • 4.3.1. By Product and Service
  • 4.3.2. By Test Type
  • 4.3.3. By Sample Type
  • 4.3.4. By Technology
  • 4.3.5. By Application
  • 4.3.6. By End-user
  • 4.3.7. By Region

5. North America Molecular Diagnostics Market Outlook, 2017-2031F*

• 5.1. Market Size Analysis & Forecast
  • 5.1.1. By Value
  • 5.1.2. By Volume
• 5.2. Market Share Analysis & Forecast
  • 5.2.1. By Product and Service
    • 5.2.1.1. Reagents and Kits
    • 5.2.1.2. Instruments
    • 5.2.1.3. Services and Software
  • 5.2.2. By Test Type
    • 5.2.2.1. Lab Tests
    • 5.2.2.2. POC Tests
  • 5.2.3. By Sample Type
    • 5.2.3.1. Blood, Serum, and Plasma
    • 5.2.3.2. Urine
    • 5.2.3.3. Others
  • 5.2.4. By Technology
    • 5.2.4.1. Polymerase Chain Reaction (PCR)
    • 5.2.4.2. Isothermal Nucleic Acid Amplification Technology
    • 5.2.4.3. In-situ Hybridization
    • 5.2.4.4. DNA Sequencing
    • 5.2.4.5. Microarray
    • 5.2.4.6. Others
  • 5.2.5. By Application
    • 5.2.5.1. Infectious Diseases Tests
    • 5.2.5.2. Oncology Tests
    • 5.2.5.3. Genetic Tests
    • 5.2.5.4. Others
  • 5.2.6. By End-user
    • 5.2.6.1. Hospitals and Clinics
    • 5.2.6.2. Diagnostic Laboratories
    • 5.2.6.3. Others
  • 5.2.7. By Country Share
    • 5.2.7.1. United States
    • 5.2.7.2. Canada
    • 5.2.7.3. Mexico
• 5.3. Country Market Assessment
  • 5.3.1. United States Molecular Diagnostics Market Outlook, 2017-2031F*
    • 5.3.1.1. Market Size Analysis & Forecast
      • 5.3.1.1.1. By Value
      • 5.3.1.1.2. By Volume
    • 5.3.1.2. Market Share Analysis & Forecast
      • 5.3.1.2.1. By Product and Service
        • 5.3.1.2.1.1. Reagents and Kits
        • 5.3.1.2.1.2. Instruments
        • 5.3.1.2.1.3. Services and Software
      • 5.3.1.2.2. By Test Type
        • 5.3.1.2.2.1. Lab Tests
        • 5.3.1.2.2.2. POC Tests
      • 5.3.1.2.3. By Sample Type
        • 5.3.1.2.3.1. Blood, Serum, and Plasma
        • 5.3.1.2.3.2. Urine
        • 5.3.1.2.3.3. Others
      • 5.3.1.2.4. By Technology
        • 5.3.1.2.4.1. Polymerase Chain Reaction (PCR)
        • 5.3.1.2.4.2. Isothermal Nucleic Acid Amplification Technology
        • 5.3.1.2.4.3. In-situ Hybridization
        • 5.3.1.2.4.4. DNA Sequencing
        • 5.3.1.2.4.5. Microarray
        • 5.3.1.2.4.6. Others
      • 5.3.1.2.5. By Application
        • 5.3.1.2.5.1. Infectious Diseases Tests
        • 5.3.1.2.5.2. Oncology Tests
        • 5.3.1.2.5.3. Genetic Tests
        • 5.3.1.2.5.4. Others
      • 5.3.1.2.6. By End-user
        • 5.3.1.2.6.1. Hospitals and Clinics
        • 5.3.1.2.6.2. Diagnostic Laboratories
        • 5.3.1.2.6.3. Others
  • 5.3.2. Canada
  • 5.3.3. Mexico

All segments will be provided for all regions and countries covered

6. Europe Molecular Diagnostics Market Outlook, 2017-2031F

• 6.1. Germany
• 6.2. France
• 6.3. Italy
• 6.4. United Kingdom
• 6.5. Russia
• 6.6. Netherlands
• 6.7. Spain
• 6.8. Poland

7. Asia-Pacific Molecular Diagnostics Market Outlook, 2017-2031F

• 7.1. India
• 7.2. China
• 7.3. Japan
• 7.4. Australia
• 7.5. Vietnam
• 7.6. South Korea
• 7.7. Indonesia
• 7.8. Philippines

8. South America Molecular Diagnostics Market Outlook, 2017-2031F

• 8.1. Brazil
• 8.2. Argentina

9. Middle East and Africa Molecular Diagnostics Market Outlook, 2017-2031F

• 9.1. Saudi Arabia
• 9.2. UAE
• 9.3. South Africa
• 9.4. Israel

10. Demand Supply Analysis

11. Import and Export Analysis

12. Value Chain Analysis

13. Porter's Five Forces Analysis

14. PESTLE Analysis

15. Pricing Analysis

16. Market Dynamics

• 16.1. Market Drivers
• 16.2. Market Challenges

17. Market Trends and Developments

18. Regulatory Framework and Innovation

• 18.1. Clinical Trials
• 18.2. Regulatory Approvals

19. Patent Landscape

20. Case Studies

21. Competitive Landscape

• 21.1. Competition Matrix of Top 5 Market Leaders
• 21.2. SWOT Analysis for Top 5 Players
• 21.3. Key Players Landscape for Top 10 Market Players
  • 21.3.1. Danaher Corporation
    • 21.3.1.1. Company Details
    • 21.3.1.2. Key Management Personnel
    • 21.3.1.3. Products and Services
    • 21.3.1.4. Financials (As Reported)
    • 21.3.1.5. Key Market Focus and Geographical Presence
    • 21.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisition
  • 21.3.2. F. Hoffmann-La Roche Ltd
  • 21.3.3. Hologic, Inc.
  • 21.3.4. Thermo Fisher Scientific Inc.
  • 21.3.5. Abbott Laboratories
  • 21.3.6. bioMerieux SA
  • 21.3.7. Illumina, Inc.
  • 21.3.8. QIAGEN N.V.
  • 21.3.9. Myriad Genetics, Inc.
  • 21.3.10. Siemens Healthineers

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

22. Strategic Recommendations

23. About Us and Disclaimer