The global DNA diagnostics market size was valued at USD 10.61 billion in 2024 and is projected to reach USD 14.14 billion by 2030, expanding at a CAGR of 8.7% from 2025 to 2030. This growth is largely fueled by continuous advancements in genomic technologies, the rising prevalence of genetic disorders, and the growing adoption of personalized medicine across healthcare systems worldwide. Innovative technologies such as next-generation sequencing (NGS) and CRISPR-based diagnostics have significantly enhanced diagnostic accuracy, improved efficiency, and expanded the scope of DNA-based testing. The increasing awareness of the importance of early disease detection is further driving demand, with DNA diagnostics becoming increasingly important in fields such as oncology, infectious disease testing, and prenatal screening. In particular, the growing use of DNA diagnostics for early cancer detection and precision treatment planning is creating new opportunities for market expansion.

The DNA diagnostics industry is characterized by a high level of innovation and strong R&D activity, with companies consistently developing novel diagnostic solutions. For instance, in April 2024, Bio-Rad Laboratories launched a digital PCR assay for detecting breast cancer mutations in clinical research, showcasing how technology is enabling earlier and more precise disease identification. At the same time, regulation plays a crucial role in shaping the industry, as agencies such as the U.S. FDA and the European Medicines Agency (EMA) impose strict requirements to ensure safety, accuracy, and clinical reliability of DNA-based diagnostic tests. A notable example includes Abbott’s Alinity m HR HPV assay, which received FDA approval in November 2023 for identifying high-risk HPV genotypes associated with cervical cancer and other malignancies. While regulatory oversight safeguards patient safety and quality, it can also create barriers such as delayed product launches, higher development costs, and complex compliance requirements, presenting challenges for smaller companies trying to compete in this highly dynamic market.

Key Market Trends & Insights:

• Regional Insights: North America dominated the global DNA diagnostics market in 2024, accounting for a 42.72% revenue share, supported by advanced healthcare infrastructure, widespread adoption of genetic testing, and the presence of key market players.
• Technology Insights: PCR-based diagnostics held the largest market share at 49.40% in 2024, as PCR remains a widely used and trusted method for detecting genetic variations. However, the NGS DNA diagnostics segment is expected to grow at the fastest CAGR of 13.9% during the forecast period, driven by its ability to provide deeper genetic insights and support personalized medicine applications.
• Application Insights: The cancer genetics testing segment led the market in 2024 with a 29.80% share, reflecting the increasing demand for oncology-focused DNA diagnostics in early cancer detection and precision treatment planning. Meanwhile, the newborn genetic screening segment is projected to witness substantial growth through 2030 due to its critical role in the early detection and management of genetic disorders.

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Market Size & Forecast:

• 2024 Market Size: USD 10.61 Billion
• 2030 Projected Market Size: USD 14.14 Billion
• CAGR (2025-2030): 8.7%
• North America: Largest market in 2024

Key Players

The following are the leading companies in the DNA diagnostics market. These companies collectively hold the largest market share and dictate industry trends.

• Abbott Laboratories
• Hoffmann-La Roche Ltd.
• QIAGEN
• Bio-Rad Laboratories, Inc.
• Thermo Fisher Scientific, Inc.
• Illumina, Inc.
• Hologic, Inc.
• Agilent Technologies Inc.
• Siemens Healthineers AG
• Danaher Corporation

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Conclusion:

The global DNA diagnostics market is set to experience steady growth, supported by technological breakthroughs in NGS, PCR, and CRISPR-based tools that are enhancing accuracy and efficiency. The rising prevalence of genetic disorders, cancer, and infectious diseases is accelerating demand for reliable and rapid diagnostic solutions. While North America currently dominates the market, emerging economies in Asia Pacific are expected to drive future expansion due to increasing healthcare investments and growing awareness of genetic testing. Regulatory oversight ensures safety and quality but also creates hurdles for smaller companies, making innovation and compliance critical for success. Expanding applications in oncology, prenatal testing, and newborn genetic screening highlight the market’s pivotal role in shaping the future of personalized medicine. Overall, the industry is well-positioned to evolve into a cornerstone of modern healthcare, enabling earlier disease detection and more effective patient outcomes.