DNA Testing & Diagnostics Market Size, Share, Growth, and Industry Analysis, By Type (PCR-Based Diagnostics, ISH Diagnostics and NGS DNA Diagnosis), By Application (Hospital, Medical Research, Pharmacogenomics Diagnostic Testing), Regional Forecast To 2035

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DNA TESTING AND DIAGNOSTICS MARKET OVERVIEW

The global DNA testing & diagnostics market was valued at USD 17.31 billion in 2025 and is expected to grow to USD 19.32 billion in 2026, reaching USD 52.12 billion by 2035, with a projected CAGR of 11.6% during the forecast period.

DNA testing and diagnostics is a medical test that can find mutations in one’s proteins, chromosomes, or genes. These mutations can tell if one has a genetic condition or not. Additionally, DNA tests can determine your risk of inheriting a genetic disorder or developing a particular condition. The genetic diagnosis of susceptibility to inherited diseases and the determination of bloodlines are both aspects of DNA testing & diagnostics.

Market players have disclosed innovative techniques for developing new treatments with a focused strategies. Growing healthcare infrastructure, increasing global awareness of personalized and preventative medicine and diagnosis, treatments with high success rate, and rising investment by manufacturers are factors that will help to increase demand for DNA testing & diagnostics.

KEY FINDINGS

 COVID-19 IMPACT

 Pandemic Affected the Market Negatively

Due to the COVID-19 pandemic, a lockdown was imposed, preventing a variety of businesses and utilities from producing, processing, and importing and exporting. However, Pandemic had a negative impact on the growth of DNA testing & diagnostics market due to lack of genetic counsellors to look after patients and laboratories were not running as per government regulations. Risk of transmission through contact of testing devices negatively impacted the growth of market.

LATEST TRENDS

Awareness Regarding the Benefits of DNA testing & Diagnostics to drive Market Growth

Rising healthcare development, sophisticated infrastructure facilities, increase in the number of skilled doctors, awareness regarding benefits of DNA testing are expected to boost the growth of market during the forecast period. ColoClear by Circle (ColoClear), a cutting-edge, non-invasive at-home screening test for spotting colorectal cancer's early warning signals, was introduced in June 2022 by Prenetics Group Limited, a pioneer in genomic and diagnostic testing. A cancer test that examines a large number of tumor genes in a single tissue sample was introduced in Europe by the genome sequencing company Illumina in March 2022. This test has the potential to assist patients with uncommon disorders in locating appropriate treatment options. These recent developments are anticipated to drive market growth.

• According to the U.S. National Library of Medicine, over 26 million people globally have purchased direct-to-consumer genetic testing kits as of 2023.

• According to the U.S. Food & Drug Administration (FDA), the number of FDA-approved NGS tests increased from 14 in 2018 to 28 in 2023, highlighting rapid adoption in diagnostics.

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DNA TESTING AND DIAGNOSTICS MARKET SEGMENTATION

By Type Analysis

According to type, the market can be segmented into PCR-Based Diagnostics, ISH Diagnostics and NGS DNA Diagnosis.

By Application Analysis

Based on application, the market can be divided into Hospital, Medical Research, and Pharmacogenomics Diagnostic Testing.

DRIVING FACTORS

Increasing Prevalence Genetic Disease to Drive Market Demand

Healthcare expenses have been increasing over the years. A person's lifetime risk of developing various types of cancer can be determined with the assistance of genetic testing. There are genetic tests available to look for inherited variants and mutations in the DNA sequence that could cause cells to grow too much and cause cancer. Increase in the occurrence of different genetic diseases and rising consciousness among people regarding the benefits of DNA testing, developments in healthcare sector, and highly advanced devices are responsible to boost the DNA testing & diagnostics market growth.

• According to the Centers for Disease Control and Prevention (CDC), approximately 1 in 33 babies in the U.S. is born with a birth defect, fueling demand for genetic testing.

• As per the National Institutes of Health (NIH), more than 80% of physicians in the U.S. now consider genetic testing results for at least one therapeutic decision, reflecting growing integration into clinical practice.

Healthcare technological developments will boost market expansion

The healthcare sector has expanded and medical facilities have developed in ways that make it possible to produce testing and diagnostic tools of high quality and at a reasonable cost. In order to gain market share, the major players in the business are also developing fresh concepts and innovations. In order to draw customers, they are presenting a variety of new products. This is anticipated to fuel market expansion.

RESTRAINING FACTORS

High Cost of R&D to Restrict Market Demand

It is anticipated that the high cost of research and development (R&D) associated with the development and application of alternative methods will limit industry expansion to some extent. Additionally, it is anticipated that unclear reimbursement structures and stringent government regulations regarding DNA prototyping will impede the entry of new market players. These factors are responsible to hinder the growth of market.

• According to the World Health Organization (WHO), advanced genomic tests can cost between $500 to $5,000 per test, limiting access in low- and middle-income regions.

• According to the U.S. Department of Health and Human Services, over 40% of patients express concerns about sharing their genetic data due to potential misuse.

DNA TESTING AND DIAGNOSTICS MARKET REGIONAL INSIGHTS

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Increase in the Use of DNA diagnostics in North America to Expand Market Size

As a result of growing use of DNA diagnostics and the incidence of many chronic and infectious disorders and rapid technological advancements in North America, it is considered to be the most dominating region in DNA testing & diagnostics market share. The main element anticipated to contribute to the industry growth is the introduction of new products by key players, improved healthcare infrastructure, strong government initiatives.

KEY INDUSTRY PLAYERS

Key Players Implementing Innovative Strategies to Influence Market Development

Prominent market players are making collaborative efforts by partnering with other companies to stay ahead of the competition. Many companies are also investing in new product launches to expand their product portfolio. The top key players in the market are GE Healthcare, 454 Life Sciences, Abbott Laboratories, Beckman Coulter, Bio-Rad Laboratories, Thermo Fisher Scientific, Illumina, Cephide, Hologic and others. Mergers and acquisitions are also among the key strategies used by players to expand their product portfolios. In addition, the strategies to develop new technologies, capital investment in R&D, improve product quality, acquisitions, mergers, and compete for the market competition help them to perpetuate their position and value in the market. Besides, collaboration with other companies & extensive possession over market shares by the key players stimulates the market demand.

• GE Healthcare: Operates over 50 genomic research collaborations globally, focusing on diagnostic equipment.

• 454 Life Sciences: Developed one of the first commercial next-generation sequencing platforms, processing up to 1 million DNA fragments per run.

List of Top DNA Testing and Diagnostics Companies

• GE Healthcare
• 454 Life Sciences
• Abbott Laboratories
• Beckman Coulter
• Bio-Rad Laboratories
• Thermo Fisher Scientific
• Illumina
• Cephide
• Hologic
• Transgenomic
• Siemens Healthcare
• Roche Diagnostics
• Qiagen
• Affymetrix
• Agilent Technologies

REPORT COVERAGE

This report examines an understanding of the DNA testing & diagnostics market’s size, share, growth rate, segmentation by type, application, key players, and previous and current market scenarios. The report also collects the market’s precise data and forecasts by market experts. Also, it describes the study of this industry’s financial performance, investments, growth, innovation marks, and new product launches by the top companies and offers deep insights into the current market structure, competitive analysis based on key players, key driving forces, and restraints that affect the demand for growth, opportunities, and risks.

Furthermore, the post-COVID-19 pandemic’s effects on international market restrictions and a deep understanding of how the industry will recover, and strategies are also stated in the report. The competitive landscape has also been examined in detail to provide clarification of the competitive landscape.

This report also discloses the research based on methodologies that define price trend analysis of target companies, collection of data, statistics, target competitors, import-export, information, and previous years’ records based on market sales. Moreover, all the significant factors which influence the market such as small or medium business industry, macro-economic indicators, value chain analysis, and demand-side dynamics, with all the major business players have been explained in detail. This analysis is subject to modification if the key players and feasible analysis of market dynamics change.