Molecular Diagnostics Market Size, Share, Growth Analysis, By Product & Service(Reagents & Kits, Instruments, Services & Software), By Test Type(Lab Tests, PoC Tests), By Sample Type(Blood, Serum, & Plasma, Urine), By Technology(Polymerase Chain Reaction, Isothermal Nucleic Acid Amplification Technology, DNA Sequencing & Next- Generation Sequencing, In Situ Hybridization), By Application(Infectious Disease Diagnostics (Hepatitis, HIV, CT/NG, HAI), By End User(Diagnostic Laboratories, Hospitals & Clinics, and Other End Users), By Region - Industry Forecast 2024-2031


Report ID: SQMIG35A2636 | Region: Global | Published Date: August, 2024
Pages: 157 |Tables: 61 |Figures: 75

Molecular Diagnostics Market Insights

Global Molecular Diagnostics Market size was valued at USD 14.00 billion in 2022 and is poised to grow from USD 15.60 billion in 2023 to USD 37.00 billion by 2031, growing at a CAGR of 11.4% during the forecast period (2024-2031).

Global molecular diagnostics market offers great potential for growth owing to the technological progress, development of new technologies, the growth of the number of cases of infectious diseases, and the utilization of individualized medicine. Molecular diagnostics includes detection and characterization of disease biomolecules ranging from genetic markers, proteins, and other analytes. This market is extensive, and it covers areas such as infectious diseases, oncology, genetic disorders, pharmacogenomics and many more.

Modern progress in molecular diagnosis led to the creation of new technologies: PCR, NGS, microarray in the recent years within the molecular diagnostics market. These innovations have thus resulted in increased sensitivity of tests and specificity of the diseases they diagnose, alongside increased multiplexing capabilities thus faster and accurate diagnosis of diseases. The molecular diagnostics market is growing significantly in the global market, especially with the increasing rates of infectious diseases like HIV, hepatitis, and respiratory infections. The molecular diagnostics market is currently undergoing significant growth in the worldwide market, particularly with the rising instances of infectious diseases including HIV, hepatitis, and respiratory infections. Besides, the global population is aging, and the prevalence of chronic diseases such as cancer and inherited disorders is growing, which necessitates effective molecular diagnostics tests for early identification and targeted therapeutic interventions.

Some of the major players in the global molecular diagnostics market are the Abbott Laboratories, F. Hoffmann-La Roche AG, Danaher Corporation, Qiagen N. V. and Thermo Fisher Scientific Inc. These companies are continually engaging in the strategies like mergers/net acquisitions, new products launches and strategic alliances to enhance their market position and offering portfolio.

US Molecular Diagnostics Market is poised to grow at a sustainable CAGR for the next forecast year.

Market Snapshot - 2024-2031

Global Market Size

USD 22.15 billion

Largest Segment

Lab tests

Fastest Growth

Lab tests

Growth Rate

5.2% CAGR

Global Molecular Diagnostics Market ($ Bn)
Country Share for North America Region (%)

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Molecular Diagnostics Market Segmental Analysis

The global molecular diagnostics market is segmented by Product & Service, Test Type, Sample Type, Technology, Application, End User, and region. Based on Product & Service, the market is segmented into reagents & kits, instruments, and services & software. Based on Test Type, the market is segmented into Lab Tests, and PoC Tests. Based on Sample Type, the market is segmented into Blood, Serum, & Plasma, Urine, and Others. Based on Technology, the market is segmented into Polymerase Chain Reaction, Isothermal Nucleic Acid Amplification Technology, DNA Sequencing & Next- Generation Sequencing, In Situ Hybridization, DNA Microarrays, and Others. Based on Application, the market is segmented into Infectious Disease Diagnostics, Oncology Testing, Genetic Testing, COVID-19, and Others. Based on Infectious Disease, the market is segmented into Hepatitis, HIV, CT/NG, HAI, HPV, Tuberculosis, Influenza, and Other Infectious Diseases. Based on Oncology Testing, the market is segmented into Breast Cancer, Colorectal Cancer, Lung Cancer, Prostate Cancer, and Other Cancers. Based on End User, the market is segmented into Diagnostic Laboratories, Hospitals & Clinics, and Other End Users. Based on region, the market is segmented into North America, Europe, Asia-Pacific, Middle East and Africa, and Latin America.

Analysis by Product & Service 

Among the pivotal segments, reagents & kits emerge as the largest contributor, wielding considerable influence over molecular diagnostics market trends and revenue streams. These fundamental factors contribute to the basic framework of a molecular diagnostic process and are indispensable in identifying and characterizing nucleic acids, proteins, and other molecular markers or biomarkers of different diseases. Due to rapidly increasing incidence of infectious diseases, genetic disorders, cancer around the world, the requirement of reagents and kits are high because of the need of right diagnosis in right time. Additionally, the progress in the biotechnology field and the shift from one-size-fits-all therapies to more individualized treatment promotes this segment, increasing the applicability of molecular diagnostic solutions in various types of healthcare services.

The molecular diagnostics market has experienced significant growth, especially in the instruments category, and is expected to be the fastest growing over the forecast period. These complex equipment and technology comprise a range of devices for conducting molecular testing such as PCR machines, DNA sequencers, and mass spectrometers pirit among others. In molecular diagnostics laboratories, instruments are the front-line in terms of acting as enablers, providing the appropriate tools and capabilities to healthcare professionals to selectively amplify and analyze and interpreted genetic material with incredible accuracy and speed. The specific application of the molecular diagnostic instruments is further driven by the growing technological advancements and added commitments towards research which in turn have pressured the development of the molecular diagnostic instruments to achieve the higher throughput rates, automation as well as the multiplexing. In addition, point-of-care molecular diagnostic devices bring testing services to a wider population and decentralize testing further, which would help to increase the opportunities for the development of this segment in both developed and developing countries.

Analysis by Test Type 

The lab tests take the largest molecular diagnostics market share in the global market. These tests are usually a more complicated procedure and are usually performed in specialized laboratories. This gives better results, and most of such tests are done in large central laboratories. Lab tests have many diagnostic features including PCR and next generation sequencing. This can be explained by a variety of conditions, which include comparatively high accuracy and repeatability of the examinations, versatility in terms of the tested materials, and well-developed framework for the large-scale laboratory centers all around the world. Furthermore, the shift in the molecular diagnostic industry toward Tiered pricing and Personalized Medicine as well as the growing need for better diagnostic platforms have added to the prominence of Lab-based Molecular Diagnostics segment that is currently considered the biggest segment of the molecular diagnostic market.

On the other hand, the fastest growing segment in the global molecular diagnostics market is PoC tests. This paper has depicted that there are certain advantages of PoC tests as compared to laboratory-based diagnosis methods and these are; fast diagnostic time, availability, and point of care screening. Such tests are aimed at providing notorious results promptly, sometimes at the exact location of the patient care, thereby being instrumental in timely decision making. Growth is driven by increasing demand for faster diagnostic tools especially in cases where a prompt response is necessary or in instances where tests can be done away from central laboratories such as with PoC molecular diagnostics. Moreover, continuing improvements in miniaturization, automation of tests, and development of easy to use ‘point and click’ platforms have enhanced continued widespread use of PoC testing devices in various regions of the globe and across multiple healthcare environments. Thus, it is the PoC segment in the market that becomes primarily associated with innovation and growth in the field of molecular diagnostics and determining the trends of shifts in the paradigms of diagnostic tests in the future.

Global Molecular Diagnostics Market By Type

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Molecular Diagnostics Market Regional Insights

North America come up as the largest market and held a 39% share in 2023. This can be attributed to the increasing incidence of both infectious and chronic diseases; such trends make companies develop new molecular diagnostic tests to help drive the market further. For instance, in August 2023, QIAGEN recently got approval through the U. S FDA for Thera screen PDGFRA RGQ PCR kit; this helps physicians identify patients with gastrointestinal stromal tumor (GIST). In addition, in the year of January 2023, the FDA has granted EUA for the VIASURE Monkeypox Virus Real-Time PCR Reagents manufactured by BD and CerTest Biotec for identifying the Mpox virus. In addition, increased consumer awareness and health consciousness, high standards of living and specifically, well developed healthcare infrastructure can be said to be the factors that are driving this growth.

It is also expected that the Asia-Pacific region will have the fastest growing region rate during the forecast period because of better market access, joint market player efforts to encourage more of the diagnostic market, and the huge unmet demands in the Asia - Pacific region for diagnostic markets. For instance, in August 2023 CRISPRBits and MolBio Diagnostics Indians companies signed a strategic partnership to fast change the POC diagnostics to integrate the CRISPR system in both a POC test for pathogen and genetic markers’ identification. Additionally, the increase in Next-generation sequencing (NGS), the awareness of life-threatening diseases such as Cancer, Covid-19, Tuberculosis, STDs, the trend towards more personalised medicine, and the use of Artificial intelligence & Machine learning explains the regional market expansion.

Global Molecular Diagnostics Market By Geography
  • Largest
  • Fastest

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Molecular Diagnostics Market Dynamics

 

Molecular Diagnostics Market Drivers

Technological Advancements is Boosting the Molecular Diagnostics Market Growth

  • The PCR (Polymerase Chain Reaction), NGS (Next-Generation Sequencing), and microarray technologies have developed rapidly and evolved the entire molecular diagnostic technology, thus contributing to the enhanced market. Advancements in this diagnostic equipment have continued to develop better accuracy, sensitivity and speed thus contributing to market expansion. 

Increasing Prevalence of Infectious Diseases and Genetic Disorders

  • There is an increasing incidence of infective diseases, including HIV/Aids, Hepatitis B and C, Tuberculosis and growing occurrence of genetic disorders that has led to the need of molecular diagnostics. PCR and other molecular diagnostic work on pathogens allow accurate and sensitive diagnosis, permits timely management and treatment, and allows delivery of tailored or individualized care. 

Restraints 

High Cost of Molecular Diagnostic Tests

  • Even though molecular diagnostic tests are very accurate as well as effective, a lot of them can be very expensive to administer, and this makes the tests unaffordable in many parts of the developing world where the health care facilities have very tight budgets. The molecular testing equipment and the chemicals needed; skilled personnel required for molecular testing may be costly significantly putting a strain on the health facilities thereby restraining Molecular Diagnostics market growth. 

Regulatory Challenges and Reimbursement Issues

  • High regulatory bar that focuses on molecular diagnostic assays such as clinical trial validations and FDA approvals contributes to delays within the timeframe for new tests and augmented expenses. Thirdly, reimbursement policies are aligned differently depending on geographical regions, thus creating confusion as to whether reimbursement for molecular diagnostic tests will be available to the healthcare providers and manufacturers. This unequal bargaining balance can also result in this form of reimbursement hampering market development and advancement.

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Molecular Diagnostics Market Competitive Landscape

In the constantly shifting landscape of the molecular diagnostics market, companies are engaged in cut-throat competition and the process is characterized by innovations and strategies that can help the players gain a competitive edge over others. Some of the big players continue to dominate these markets through a broad portfolio of diagnostic services, mergers, and acquisitions, and broad sales and franchise networks. Also, the cooperation and collaboration between large-scaled companies and new entrant startups further intensify competition and innovation dynamics and the competition remained constant in bringing innovative technologies into the market thus maintaining a healthy market ecosystem with opportunities and threats simultaneously.

Molecular Diagnostics Market Top Player’s Company Profiles

  • F. Hoffmann-La Roche Ltd. (Switzerland) 
  • Hologic, Inc. (US) 
  • Abbott Laboratories (US) 
  • Illumina, Inc. (US) 
  • Thermo Fisher Scientific Inc. (US) 
  • bioMérieux (France) 
  • QIAGEN (Netherlands) 
  • Agilent Technologies Inc. (US) 
  • Becton Dickinson And Company (US) 
  • Grifols S.A. (Spain) 
  • Siemens AG (Siemens Healthineers) (Germany) 
  • Bio-Rad Laboratories, Inc. (US) 
  • Sysmex Corporation (Japan) 
  • Quidel Corporation (US) 
  • Biocartis (Belgium) 
  • DiaSorin (Italy) 
  • Myriad Genetics (US) 
  • Revvity (US) 
  • MDxHealth (Belgium) 
  • OncoCyte Corporation (US)

Molecular Diagnostics Market Outlooks

  • In May 2024, Bruker Corporation completed the acquisition of ELITechGroup for €870 million in cash excluding ELITech clinical chemistry business. A molecular diagnostics MDx, biomedical systems/specialty IVDs, Microbiology solutions and services provider ELITech posted near about EUR 150 million of FY 2023 revenues and over 80% by Consumable. The acquisition by Bruker is impressive since it brings changes and expansion to the company and situates it as an innovative infectious disease company in the IVD industry. Bruker’s MALDI Biotyper extended its portfolio in molecular diagnostics through the partnership with ELITech, which provides MDx platforms and niche MDx assays targeting niche markets.  

  • In February 2024, Eurofins Scientific completed the purchase deal of Diatherix Laboratories, Inc. for about US$50 million with an earn out provision for specific kinds of revenue and profitability at the end of the purchase amount. This deal is expected to be closed in 30 days (about 4 and a half weeks) and will post Eurofins’ decisive step on the way to strengthening its positions in the sphere of specialty clinical diagnostics. Based in Huntsville, Alabama, Diatherix focuses has a specialized molecular diagnostics company employing the TEM-PCR™ testing of infectious diseases, providing accurate information quickly. 

  • In April 2024, Bosch Healthcare and Randox disclosed, they will be working jointly to develop the Vivalytic analysis platform with $159 million (€150 million). With this partnership, the parties intend to create brand-new tests for the Bosch point of care molecular diagnostic device that has a record-fast PCR test turnaround. Attention will be paid to the development of a fast sepsis diagnostics approach. As part of a strategic collaboration, both companies will work together to expand joint research and development and sales and marketing projects. Point of care molecular diagnostics is a promising market where Bosch is targeting to position as a market leader. The chairman of Bosch, Stefan Hartung said, “With technologies developed in house and finest production line in our company we aim at establishing long term cooperation with partners in diagnostics sector".

Molecular Diagnostics Key Market Trends

  • Shift towards Point-of-Care Testing: There is a growing trend towards point-of-care molecular testing, driven by the need for rapid diagnosis and treatment monitoring in various healthcare settings, including clinics, emergency rooms, and ambulances. Miniaturized and portable molecular diagnostic devices are being developed to enable real-time testing outside traditional laboratory settings, enhancing patient care and healthcare efficiency.
     
  • Integration of Artificial Intelligence (AI) and Big Data Analytics: The integration of AI and big data analytics in molecular diagnostics is revolutionizing data interpretation, enabling more accurate and personalized diagnosis and treatment strategies. Machine learning algorithms can analyze vast amounts of genomic data to identify disease patterns, predict treatment responses, and optimize therapeutic outcomes. This trend is expected to accelerate the adoption of molecular diagnostics in precision medicine and improve patient outcomes.

Molecular Diagnostics Market SkyQuest Analysis

SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyzes the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research. 

According to our analysis, global molecular diagnostics market is rising at a rapid rate and this is due to several factors these include technological developments, the rise in the incidences of diseases, and the rising trend in the consumer desire for customized treatment. Some of the factors that are driving growth in this market include the rising adoption of companion diagnostics, advancements in DNA sequencing technologies, and expanding applications in oncology, infectious diseases, and genetic testing. Furthermore, there is a rising regulated environment and decentralized testing, empowering point-of-care in the market and with the Patient Outcomes. Also, partnerships and alliances between major stakeholders, acquisitions, and strong emphasis on research and development are other factors that are fostering the market growth even further. Nevertheless, factors like a higher cost connected to molecular diagnostic procedures and a regulatory framework in emerging economies may act as a restraint in the growth of the market to a certain extent. In conclusion, due to the focus on diagnosing diseases at an early stage and targeted interventions (precision medicine), the global molecular diagnostics market is expected to continuously expand.

Report Metric Details
Market size value in 2022 USD 14.00 billion
Market size value in 2031 USD 37.00 billion
Growth Rate 11.4%
Base year 2023
Forecast period 2024-2031
Forecast Unit (Value) USD Billion
Segments covered
  • Product & Service
    • Reagents & Kits, Instruments, Services & Software
  • Test Type
    • Lab Tests, PoC Tests
  • Sample Type
    • Blood, Serum, & Plasma, Urine, and Others
  • Technology
    • Polymerase Chain Reaction, Isothermal Nucleic Acid Amplification Technology, DNA Sequencing & Next- Generation Sequencing, In Situ Hybridization, DNA Microarrays, and Others
  • Application
    • Infectious Disease Diagnostics (Hepatitis, HIV, CT/NG, HAI, HPV, Tuberculosis, Influenza, And Other Infectious Diseases), Oncology Testing (Breast Cancer, Colorectal Cancer, Lung Cancer, Prostate Cancer, and Other Cancers), Genetic Testing, Covid-19, and Others
  • End User
    • Diagnostic Laboratories, Hospitals & Clinics, and Other End Users
Regions covered North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA)
Companies covered
  • F. Hoffmann-La Roche Ltd. (Switzerland) 
  • Hologic, Inc. (US) 
  • Abbott Laboratories (US) 
  • Illumina, Inc. (US) 
  • Thermo Fisher Scientific Inc. (US) 
  • bioMérieux (France) 
  • QIAGEN (Netherlands) 
  • Agilent Technologies Inc. (US) 
  • Becton Dickinson And Company (US) 
  • Grifols S.A. (Spain) 
  • Siemens AG (Siemens Healthineers) (Germany) 
  • Bio-Rad Laboratories, Inc. (US) 
  • Sysmex Corporation (Japan) 
  • Quidel Corporation (US) 
  • Biocartis (Belgium) 
  • DiaSorin (Italy) 
  • Myriad Genetics (US) 
  • Revvity (US) 
  • MDxHealth (Belgium) 
  • OncoCyte Corporation (US)

Molecular Diagnostics Market Outlooks

  • In May 2024, Bruker Corporation completed the acquisition of ELITechGroup for €870 million in cash excluding ELITech clinical chemistry business. A molecular diagnostics MDx, biomedical systems/specialty IVDs, Microbiology solutions and services provider ELITech posted near about EUR 150 million of FY 2023 revenues and over 80% by Consumable. The acquisition by Bruker is impressive since it brings changes and expansion to the company and situates it as an innovative infectious disease company in the IVD industry. Bruker’s MALDI Biotyper extended its portfolio in molecular diagnostics through the partnership with ELITech, which provides MDx platforms and niche MDx assays targeting niche markets.  

  • In February 2024, Eurofins Scientific completed the purchase deal of Diatherix Laboratories, Inc. for about US$50 million with an earn out provision for specific kinds of revenue and profitability at the end of the purchase amount. This deal is expected to be closed in 30 days (about 4 and a half weeks) and will post Eurofins’ decisive step on the way to strengthening its positions in the sphere of specialty clinical diagnostics. Based in Huntsville, Alabama, Diatherix focuses has a specialized molecular diagnostics company employing the TEM-PCR™ testing of infectious diseases, providing accurate information quickly. 

  • In April 2024, Bosch Healthcare and Randox disclosed, they will be working jointly to develop the Vivalytic analysis platform with $159 million (€150 million). With this partnership, the parties intend to create brand-new tests for the Bosch point of care molecular diagnostic device that has a record-fast PCR test turnaround. Attention will be paid to the development of a fast sepsis diagnostics approach. As part of a strategic collaboration, both companies will work together to expand joint research and development and sales and marketing projects. Point of care molecular diagnostics is a promising market where Bosch is targeting to position as a market leader. The chairman of Bosch, Stefan Hartung said, “With technologies developed in house and finest production line in our company we aim at establishing long term cooperation with partners in diagnostics sector".

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Table Of Content

Executive Summary

Market overview

  • Exhibit: Executive Summary – Chart on Market Overview
  • Exhibit: Executive Summary – Data Table on Market Overview
  • Exhibit: Executive Summary – Chart on Molecular Diagnostics Market Characteristics
  • Exhibit: Executive Summary – Chart on Market by Geography
  • Exhibit: Executive Summary – Chart on Market Segmentation
  • Exhibit: Executive Summary – Chart on Incremental Growth
  • Exhibit: Executive Summary – Data Table on Incremental Growth
  • Exhibit: Executive Summary – Chart on Vendor Market Positioning

Parent Market Analysis

Market overview

Market size

  • Market Dynamics
    • Exhibit: Impact analysis of DROC, 2021
      • Drivers
      • Opportunities
      • Restraints
      • Challenges
  • SWOT Analysis

KEY MARKET INSIGHTS

  • Technology Analysis
    • (Exhibit: Data Table: Name of technology and details)
  • Pricing Analysis
    • (Exhibit: Data Table: Name of technology and pricing details)
  • Supply Chain Analysis
    • (Exhibit: Detailed Supply Chain Presentation)
  • Value Chain Analysis
    • (Exhibit: Detailed Value Chain Presentation)
  • Ecosystem Of the Market
    • Exhibit: Parent Market Ecosystem Market Analysis
    • Exhibit: Market Characteristics of Parent Market
  • IP Analysis
    • (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
  • Trade Analysis
    • (Exhibit: Data Table: Import and Export data details)
  • Startup Analysis
    • (Exhibit: Data Table: Emerging startups details)
  • Raw Material Analysis
    • (Exhibit: Data Table: Mapping of key raw materials)
  • Innovation Matrix
    • (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
  • Pipeline product Analysis
    • (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
  • Macroeconomic Indicators

COVID IMPACT

  • Introduction
  • Impact On Economy—scenario Assessment
    • Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
  • Revised Market Size
    • Exhibit: Data Table on Molecular Diagnostics Market size and forecast 2021-2027 ($ million)
  • Impact Of COVID On Key Segments
    • Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
  • COVID Strategies By Company
    • Exhibit: Analysis on key strategies adopted by companies

MARKET DYNAMICS & OUTLOOK

  • Market Dynamics
    • Exhibit: Impact analysis of DROC, 2021
      • Drivers
      • Opportunities
      • Restraints
      • Challenges
  • Regulatory Landscape
    • Exhibit: Data Table on regulation from different region
  • SWOT Analysis
  • Porters Analysis
    • Competitive rivalry
      • Exhibit: Competitive rivalry Impact of key factors, 2021
    • Threat of substitute products
      • Exhibit: Threat of Substitute Products Impact of key factors, 2021
    • Bargaining power of buyers
      • Exhibit: buyers bargaining power Impact of key factors, 2021
    • Threat of new entrants
      • Exhibit: Threat of new entrants Impact of key factors, 2021
    • Bargaining power of suppliers
      • Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
  • Skyquest special insights on future disruptions
    • Political Impact
    • Economic impact
    • Social Impact
    • Technical Impact
    • Environmental Impact
    • Legal Impact

Market Size by Region

  • Chart on Market share by geography 2021-2027 (%)
  • Data Table on Market share by geography 2021-2027(%)
  • North America
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • USA
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Canada
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Europe
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • Germany
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Spain
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • France
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • UK
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of Europe
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Asia Pacific
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • China
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • India
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Japan
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • South Korea
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of Asia Pacific
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Latin America
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • Brazil
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of South America
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
  • Middle East & Africa (MEA)
    • Chart on Market share by country 2021-2027 (%)
    • Data Table on Market share by country 2021-2027(%)
    • GCC Countries
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • South Africa
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)
    • Rest of MEA
      • Exhibit: Chart on Market share 2021-2027 (%)
      • Exhibit: Market size and forecast 2021-2027 ($ million)

KEY COMPANY PROFILES

  • Competitive Landscape
    • Total number of companies covered
      • Exhibit: companies covered in the report, 2021
    • Top companies market positioning
      • Exhibit: company positioning matrix, 2021
    • Top companies market Share
      • Exhibit: Pie chart analysis on company market share, 2021(%)

Methodology

For the Molecular Diagnostics Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:

1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.

2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Molecular Diagnostics Market.

3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.

4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.

Analyst Support

Customization Options

With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Molecular Diagnostics Market:

Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.

Regional Analysis: Further analysis of the Molecular Diagnostics Market for additional countries.

Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.

Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.

Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.

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Global Molecular Diagnostics Market size was valued at USD 14.00 billion in 2022 and is poised to grow from USD 15.60 billion in 2023 to USD 37.00 billion by 2031, growing at a CAGR of 11.4% during the forecast period (2024-2031).

In the constantly shifting landscape of the molecular diagnostics market, companies are engaged in cut-throat competition and the process is characterized by innovations and strategies that can help the players gain a competitive edge over others. Some of the big players continue to dominate these markets through a broad portfolio of diagnostic services, mergers, and acquisitions, and broad sales and franchise networks. Also, the cooperation and collaboration between large-scaled companies and new entrant startups further intensify competition and innovation dynamics and the competition remained constant in bringing innovative technologies into the market thus maintaining a healthy market ecosystem with opportunities and threats simultaneously. 'F. Hoffmann-La Roche Ltd. (Switzerland) ', 'Hologic, Inc. (US) ', 'Abbott Laboratories (US) ', 'Illumina, Inc. (US) ', 'Thermo Fisher Scientific Inc. (US) ', 'bioMérieux (France) ', 'QIAGEN (Netherlands) ', 'Agilent Technologies Inc. (US) ', 'Becton Dickinson And Company (US) ', 'Grifols S.A. (Spain) ', 'Siemens AG (Siemens Healthineers) (Germany) ', 'Bio-Rad Laboratories, Inc. (US) ', 'Sysmex Corporation (Japan) ', 'Quidel Corporation (US) ', 'Biocartis (Belgium) ', 'DiaSorin (Italy) ', 'Myriad Genetics (US) ', 'Revvity (US) ', 'MDxHealth (Belgium) ', 'OncoCyte Corporation (US)', ' In May 2024, Bruker Corporation completed the acquisition of ELITechGroup for €870 million in cash excluding ELITech clinical chemistry business. A molecular diagnostics MDx, biomedical systems/specialty IVDs, Microbiology solutions and services provider ELITech posted near about EUR 150 million of FY 2023 revenues and over 80% by Consumable. The acquisition by Bruker is impressive since it brings changes and expansion to the company and situates it as an innovative infectious disease company in the IVD industry. Bruker’s MALDI Biotyper extended its portfolio in molecular diagnostics through the partnership with ELITech, which provides MDx platforms and niche MDx assays targeting niche markets.   ', ' In February 2024, Eurofins Scientific completed the purchase deal of Diatherix Laboratories, Inc. for about US$50 million with an earn out provision for specific kinds of revenue and profitability at the end of the purchase amount. This deal is expected to be closed in 30 days (about 4 and a half weeks) and will post Eurofins’ decisive step on the way to strengthening its positions in the sphere of specialty clinical diagnostics. Based in Huntsville, Alabama, Diatherix focuses has a specialized molecular diagnostics company employing the TEM-PCR™ testing of infectious diseases, providing accurate information quickly.  ', ' In April 2024, Bosch Healthcare and Randox disclosed, they will be working jointly to develop the Vivalytic analysis platform with $159 million (€150 million). With this partnership, the parties intend to create brand-new tests for the Bosch point of care molecular diagnostic device that has a record-fast PCR test turnaround. Attention will be paid to the development of a fast sepsis diagnostics approach. As part of a strategic collaboration, both companies will work together to expand joint research and development and sales and marketing projects. Point of care molecular diagnostics is a promising market where Bosch is targeting to position as a market leader. The chairman of Bosch, Stefan Hartung said, “With technologies developed in house and finest production line in our company we aim at establishing long term cooperation with partners in diagnostics sector". '

The PCR (Polymerase Chain Reaction), NGS (Next-Generation Sequencing), and microarray technologies have developed rapidly and evolved the entire molecular diagnostic technology, thus contributing to the enhanced market. Advancements in this diagnostic equipment have continued to develop better accuracy, sensitivity and speed thus contributing to market expansion. 

Shift towards Point-of-Care Testing: There is a growing trend towards point-of-care molecular testing, driven by the need for rapid diagnosis and treatment monitoring in various healthcare settings, including clinics, emergency rooms, and ambulances. Miniaturized and portable molecular diagnostic devices are being developed to enable real-time testing outside traditional laboratory settings, enhancing patient care and healthcare efficiency. 

North America come up as the largest market and held a 39% share in 2023. This can be attributed to the increasing incidence of both infectious and chronic diseases; such trends make companies develop new molecular diagnostic tests to help drive the market further. For instance, in August 2023, QIAGEN recently got approval through the U. S FDA for Thera screen PDGFRA RGQ PCR kit; this helps physicians identify patients with gastrointestinal stromal tumor (GIST). In addition, in the year of January 2023, the FDA has granted EUA for the VIASURE Monkeypox Virus Real-Time PCR Reagents manufactured by BD and CerTest Biotec for identifying the Mpox virus. In addition, increased consumer awareness and health consciousness, high standards of living and specifically, well developed healthcare infrastructure can be said to be the factors that are driving this growth.

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Molecular Diagnostics Market

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