DNA Diagnostics Market Size, Share & Trends by Product (Instruments, Reagents & Kits, Services & Software), Technology (PCR, Mass Spectroscopy, Microarrays), Application (Infectious Disease (Hepatitis, HIV, HPV), Oncology), Specimen (Blood, Urine) - Global Forecast to 2029
DNA Diagnostics Market Size, Share & Trends
The size of global DNA diagnostics market in terms of revenue was estimated to be worth $13.3 billion in 2024 and is poised to reach $21.2 billion by 2029, growing at a CAGR of 9.7% from 2024 to 2029. The comprehensive research encompasses an exhaustive examination of industry trends, meticulous pricing analysis, patent scrutiny, insights derived from conferences and webinars, identification of key stakeholders, and a nuanced understanding of market purchasing dynamics.
Growth in the market is primarily driven by the technological improvements in the DNA diagnostics industry and the growing need for personalized treatment and early disease diagnosis in developing nations. Also, the increased investments by healthcare-based companies are majorly contributing to growth of the market.
DNA Diagnostics Market Trends
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DNA Diagnostics Market Dynamics
DRIVER: Rising focus on R&D and increased funding by healthcare-based companies
Government initiatives, schemes, or funding activities that support and promote innovation and development provide growth opportunities in the market. These financial incentives and support systems enable companies/institutes to invest in R&D, infrastructure, and the production of advanced diagnostic technologies. By facilitating access to funds, manufacturers can push the boundaries of DNA diagnostics, leading to breakthrough innovations in disease detection, monitoring, and personalized medicine. For instance:
Some of the leading players operating in the market are investing significantly in research and development. For instance, in 2023, Abbott invested USD 2.74 billion, and F. Hoffmann-La Roche Ltd. invested USD 2.20 billion.
Restraint: Ethical and privacy concerns associated with DNA diagnosis
The development of each new genetic test brings significant challenges for medicine, public health, and social policy. These challenges include determining the appropriate circumstances for the test’s use, the methods for its implementation, and the applications of its results. After undergoing genetic testing, individuals have the right to privacy, which includes the ability to decide for themselves whether and with whom to share genetic information such as insurers, employers, educational institutions, employers, spouses and other family members, researchers, and social organizations.
A number of ethical concerns have emerged with respect to the privacy of the health data generated—for example, the possibility that giant software companies engaged in NGS data management may sell genome data. Another area of resistance is R&D on genetically modified organisms—an application of NGS. This is due to the possibility of environmental hazards arising from such experiments, risks to the food web, and issues concerning the prevalence of diseases and allergies, as well as contamination in animal test subjects. Such ethical issues serve to challenge the growth of DNA diagnostic applications.
Opportunity: Advancements in bioinformatics and artificial intelligence in DNA diagnostics
Advancements in bioinformatics and artificial intelligence (AI) have significantly impacted DNA diagnostics, leading to more efficient, accurate, and accessible testing methods. A major use of bioinformatics is the identification of genes in large DNA sequences. Prior to the advent of bioinformatics, the only methods available for locating genes along a chromosome were either isolating the DNA and studying it in a test tube (in vitro) or studying the gene’s behavior in the organism (in vivo). By utilizing a computer to analyze sequence data, bioinformatics enables experts to make educated estimates regarding the location of genes (in silico). A cancer patient’s prognosis is enhanced by early detection; however, early diagnosis may be challenging to accept. Technology has evolved with the use of DNA microarrays and proteomics studies for large-scale gene expression research, which has increased the use of bioinformatics tools.
However, AI and genetic engineering have opened new avenues for biotechnology and personalized medicine. Machine learning algorithms can analyze large-scale genetic sequence datasets, which can then be used to steer the development of more accurate and effective genome editing technologies by predicting probable off-target consequences. This is one way that AI helps predict and optimize genome editing methods like CRISPR-Cas9. These advancements are revolutionizing the landscape of DNA diagnostics, enabling more precise, timely, and personalized healthcare solutions.
Challenge: Introduction of alternative technologies for disease detection and diagnosis
The introduction of alternative technologies can be challenging for the growth of the market. A majority of diagnostic tests can be divided into serological, antigen tests, and polymerase chain reaction (PCR). PCR tests directly detect an antigen’s presence rather than the presence of the body’s immune response or antibodies. PCR tests can be very labor-intensive, with several stages at which errors may occur between sampling and analysis. It can take a few days to a week or longer to get results with PCR. Antibody tests also detects the number of antibodies produced by the immune system. Antigens and antibodies are considerably more stable than RNA, making them less susceptible to destruction during transport and storage, thereby reducing the chance of false-negative results.
Also, antigens and antibodies are more uniformly available in sputum and blood samples, improving testing accuracy. PCR tests are more useful for confirming an infection, whereas antigen tests usually diagnose an active virus infection faster than DNA tests.
Thus, the introduction of alternative technologies may be challenging to the growth of the market.
DNA Diagnostics Market Ecosystem
By offering, the reagents & kits segment of the DNA diagnostics industry is projected to register the highest CAGR in the forecasted period.
Based on offering, the DNA diagnostics market is segmented into reagents & kits, instruments, and services & software. DNA diagnostic test volume is steadily rising due to rising disease prevalence and the demand for prompt, accurate diagnosis. In order to accommodate this increase in test numbers, reagents and & kits are essential, assuring a continuous demand for this segment.
By application, the oncology testing segment of the DNA diagnostics industry is projected to register the highest CAGR in the forecasted period.
Based on application, the DNA diagnostics market is segmented into infectious disease diagnostics, oncology testing, prenatal, pre-implantation, myogenic disorders, and other applications. Oncology testing segment is expected to register the highest CAGR during the forecasted period. Growth in the oncology testing segment can be attributed to the rising prevalence of cancer and the increasing focus on personalized medicine.
By technology, sequencing technology segment of the DNA diagnostics industry is projected to register the highest CAGR in the forecasted period.
Based on technology, the DNA diagnostics market is segmented into polymerase chain reaction (PCR), microarrays, in situ hybridization, sequencing technology, mass spectroscopy, and other technologies. Sequencing technology segment is projected to register the highest CAGR in the market during the forecasted period. This can be attributed to factors such as the rising prevalence of infectious diseases, the emergence of newer pathogens, and the cost benefits of sequencing technologies.
Blood, serum and plasma specimens has the largest market share of the DNA diagnostics industry in 2023 and is projected to have highest CAGR during the forecast period, by specimen
Based on specimens, the DNA diagnostics market is segmented into blood, serum, and plasma, urine, and other specimens. Blood, serum and plasma specimens has the largest market share of market in 2023 and is projected to have highest CAGR during the forecast period. High share is attributes since blood is the most often obtained sample for DNA diagnostic methods and is preferred for general health screening since it offers information on a range of medical issues, including infectious diseases, cancer, genetic disorders, and other diseases.
Diagnostics laboratories has the largest market share of the DNA diagnostics industry in 2023 and is projected to have highest CAGR during the forecast period, by end user
Based on end users, the DNA diagnostics market is segmented into hospitals and clinics, diagnostic laboratories, and other end users. Diagnostics laboratories has the largest market share in 2023 and is projected to have highest CAGR during the forecast period. In an effort to save expenses and technical difficulties associated with laboratory management, hospitals are increasingly outsourcing diagnostic testing to diagnostic laboratories. This approach has been embraced by numerous hospitals and clinics, propelling growth in this industry.
In 2023, North America accounted for the largest share of the DNA diagnostics industry, followed by Europe, by region
The global DNA diagnostics market is segmented into six major regions namely, North America, Europe, the Asia Pacific, Middle East & Africa, Latin America, and the GCC Countries. North America accounted for the largest share of the market in 2023. The growth of the North American market is mainly driven by increased healthcare expenditure, and technologically advanced healthcare infrastructure. Also, increasing cases of chronic and infectious diseases are contributing to the market growth in this region.
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The major players in this market are Illumina, Inc. (US), Danaher Corporation (US), F. Hoffmann-La Roche Ltd. (Switzerland), BIOMÉRIEUX (France), Hologic, Inc. (US), QIAGEN (Germany), Thermo Fisher Scientific Inc. (US), Abbott Laboratories (US), Siemens Healthineers AG (Germany), Myriad Genetics, Inc. (US), and Revvity Inc. (US). These players’ market leadership is due to their comprehensive product portfolios and expansive global footprint. These dominant market players have several advantages, including strong research and development budgets, strong marketing and distribution networks, and well-established brand recognition.
Scope of the DNA Diagnostics Industry
|
Report Metric |
Details |
|
Market Revenue in 2024 |
$13.3 billion |
|
Projected Revenue by 2029 |
$21.2 billion |
|
Revenue Rate |
Poised to Grow at a CAGR of 9.7% |
|
Market Driver |
Rising focus on R&D and increased funding by healthcare-based companies |
|
Market Opportunity |
Advancements in bioinformatics and artificial intelligence in DNA diagnostics |
This research report categorizes the DNA diagnostics market to forecast revenue and analyze trends in each of the following submarkets:
By Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
- GCC Countries
By Offering
- Reagents & kits
- Instruments
- Services & software
By Technology
- Polymerase chain reaction (PCR)
- Microarrays
- In situ hybridization
- Sequencing
- Mass spectroscopy
- Other technologies
By Specimen
- Blood, Serum, and Plasma
- Urine
- Other Specimens
By Application
- Infectious disease diagnostics
- Oncology testing
- Myogenic disorders
- Prenatal
- Preimplantation
- Other applications
By End User
- Diagnostic laboratories
- Hospitals & clinics
- Other end users
Recent Developments of DNA Diagnostics Industry:
- In March 2024, F. Hoffmann-La Roche Ltd. (Switzerland) launched cobas Malaria test. The cobas Malaria test received approval from the US Food and Drug Administration (FDA) for use on the cobas 6800/8800 systems.
- In November 2023, Illumina Inc. (US) launched an assay, TruSight Oncology 500 ctDNA v2. This assay enables noninvasive comprehensive genomic profiling (CGP) of circulating tumor DNA (ctDNA) from blood when tissue testing is not available or to complement tissue-based testing.
- In December 2023, F. Hoffmann-La Roche Ltd. (Switzerland) partnered with Global Fund (Switzerland) to support low- and middle-income countries in strengthening critical diagnostics infrastructure.
Frequently Asked Questions (FAQ):
What are the recent trends driving the DNA diagnostics market?
The recent trends include the increasing prevalence of chronic, infectious, and genetic diseases, rising fous on R&D and increased funding by healthcare-baaased companies, technological advancements in DNA diagnostics, and growing demand for early disease diagnosis and personalized medicine in developing countries.
What is the global market for global DNA diagnostics?
The global DNA diagnostics market is projected to reach USD 21.2 billion by 2029 from USD 13.3 billion in 2024, at a CAGR of 9.7% during the forecast period. .
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To determine the current size of the DNA diagnostics market, this study engaged in four main activities. A comprehensive study was conducted using secondary research methods to gather data about the market, its parent market, and its peer markets. The next stage involved conducting primary research to confirm these conclusions, assumptions, and sizing with industry experts throughout the value chain. A combination of top-down and bottom-up methods was used to assess the overall market size. The market sizes of segments and subsegments were then estimated using data triangulation techniques and market breakdown.
The four steps involved in estimating the market size are
Collecting Secondary Data
Within the secondary data collection process, a range of secondary sources were reviewed so as to identify and gather data for this study, including regulatory bodies, databases (like D&B Hoovers, Bloomberg Business, and Factiva), white papers, certified publications, articles by well-known authors, annual reports, press releases, and investor presentations of companies.
Collecting Primary Data
During the primary research phase, a comprehensive approach was adopted, involving interviews with a diverse array of sources from both the supply and demand sides. These interviews aimed to gather qualitative and quantitative data essential for compiling this report. Primary sources primarily comprised industry experts spanning core and related sectors, as well as favored suppliers, manufacturers, distributors, service providers, technology innovators, and entities associated with all facets of this industry's value chain. In-depth interviews were meticulously conducted with a range of primary respondents, including key industry stakeholders, subject-matter authorities, C-level executives representing pivotal market players, and industry advisors. The objective was to obtain and authenticate critical qualitative and quantitative insights and to evaluate future potentialities comprehensively.
A breakdown of the primary respondents is provided below:
Breakdown of Primary Participants:
Note 1: Others include sales, marketing, and product managers.
Note 2: Tiers of companies are defined based on their total revenue. As of 2023, Tier 1 = >USD 5 billion, Tier 2 = USD 500 million to USD 5 billion, and Tier 3 = <USD 500 million.
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|
COMPANY NAME |
DESIGNATION |
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Roche Diagnostics Ltd. |
Area Sales Manager |
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Danaher Corporation |
General Manger |
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Thermo Fisher Scientific Inc. |
Consultant |
Market Size Estimation
All major product providers offering various products and services were identified at the global/regional level. Revenue mapping was done for the major players and was extrapolated to arrive at the global market value of each type of segment. The market value of the DNA diagnostics market was also split into various segments and subsegments at the region and country level based on:
- Offering mapping of various manufacturers for each type in the DNA diagnostics market at the regional and country-level
- Relative adoption pattern of each DNA diagnostics market among key application segments at the regional and/or country-level
- Detailed primary research to gather qualitative and quantitative information related to segments and subsegments at the regional and/or country level.
- Detailed secondary research to gauge the prevailing market trends at the regional and/or country level
Global DNA Diagnostics Market Size: Bottom Up Approach
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Global DNA Diagnostics Market Size: Top-Down Approach
Data Triangulation
After arriving at the overall market size applying the process mentioned above, the total market was split into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments, data triangulation and market breakdown procedures were employed, wherever applicable. The data was triangulated by studying various factors and trends from both the demand and supply sides.
Market Definition
DNA diagnostic tests detect and analyze variations in the sequence, structure, or expression of deoxyribonucleic acid (DNA) to diagnose diseases or medical conditions. This includes identifying indications caused by specific pathogens or determining genetic carrier status.
DNA diagnostic techniques can detect numerous diseases, such as cancer, viral diseases, and myogenic disorders. They are also employed in prenatal diagnostics and clinical diagnostic confirmation.
Key Stakeholders
- Manufacturers and Distributors of DNA Diagnostic Instruments and Assays
- In Vitro Diagnostic (IVD) Companies
- Hospital Laboratories
- Diagnostic Laboratories
- Diagnostics Suppliers
- Blood Banks
- Home Health Agencies
- Market Research and Consulting Firms
- Government Associations
- Venture Capitalists and Investors
Report Objectives
- To define, describe, segment, and forecast the DNA diagnostics market by offering, technology, specimen, application, end user, and region
- To provide detailed information regarding the major factors influencing the market growth (such as drivers, restraints, opportunities, and challenges)
- To assess the DNA diagnostics market with respect to Porter’s five forces, regulatory landscape, the value chain, the supply chain, ecosystem analysis, patent protection, pricing assessment, key stakeholders, and buying criteria
- To analyze the micromarkets1 with respect to individual growth trends, prospects, and contributions to the overall DNA diagnostics market
- To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players
- To forecast the size of the market segments with respect to six regions, namely, North America, Europe, Asia Pacific, Latin America, the Middle East & Africa, and GCC Countries
- To profile the key players and comprehensively analyze their product portfolios, market positions, and core competencies2
- To track and analyze company developments such as product launches & approvals, acquisitions, collaborations, expansions, and other developments
- To benchmark players within the market using the proprietary Company Evaluation Matrix framework, which analyzes market players on various parameters within the broad categories of business and product excellence
Available Customizations
With the given market data, MarketsandMarkets offers customizations to meet the company’s needs. The following customization options are available for the report:
Geographic Analysis:
Further breakdown of the DNA diagnostics market into specific countries/regions in Europe, Asia Pacific, Latin America, Middle East & Africa, and GCC Countries.
Company Information:
Detailed analysis and profiling of additional market players (up to Five), inclusive of:
- Business Overview
- Financial Information
- Product Portfolio
- Developments (last three years)
Note: Some companies are privately owned, and their revenues are unavailable in the public domain. Hence, revenues for privately owned companies will not be included in their profile. In addition, company developments that are not reported in the public domain will not be included.
Growth opportunities and latent adjacency in DNA Diagnostics Market