DNA Diagnostics Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global DNA diagnostics market, valued at US$12.3 billion in 2023, is forecasted to grow at a robust CAGR of 9.7%, reaching US$13.3 billion in 2024 and an impressive US$21.2 billion by 2029. 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

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.

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