Residual DNA Testing Market

The report "Residual DNA Testing Market by Product & Service (Consumable, Instrument & Software), Technology (PCR), Test Type (Raw, Final, Bulk Lot Release Testing), Application (mAb, CGT, Vaccine), End User (Pharma & Biotech, CRO & CDMO) - Global Forecast to 2030", is projected to reach USD 0.37 billion by 2030 from USD 0.28 billion in 2025, at a CAGR of 6.0% during the forecast period.

Browse 453 market data Tables and 62 Figures spread through 356 Pages and in-depth TOC on "Residual DNA Testing Market by Product & Service (Consumable, Instrument & Software), Technology (PCR), Test Type (Raw, Final, Bulk Lot Release Testing), Application (mAb, CGT, Vaccine), End User (Pharma & Biotech, CRO & CDMO) - Global Forecast to 2030"
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The residual DNA testing market is currently witnessing substantial expansion, largely attributed to the increasing regulatory approvals for biologics and biosimilars. The rigorous standards imposed by regulatory bodies are fueling the demand for residual DNA assays, which are vital for ensuring product safety and efficacy. Additionally, emerging markets are presenting new avenues for growth, driven by escalating R&D investments in these regions, thereby enhancing the landscape for market participants.

By test type, the final product release testing segment accounted for the largest market share in 2024.

By test type, the residual DNA testing market is categorized into raw material testing, bulk lot release testing, and final product release testing. In 2024, the final product release testing segment accounted for the largest share of the market. Process optimization and batch release assurance are critical components for biopharmaceutical manufacturers during the final stages of product release testing. Implementing residual DNA testing methods and services at this juncture plays a crucial role in refining purification processes aimed at effectively eliminating residual DNA from the end product. Furthermore, conducting residual DNA assays not only verifies the integrity of the purification processes but also ensures that production batches comply with stringent regulatory standards.

In 2024, the pharmaceutical & biotechnology companies were the fastest-growing end-user segment of the residual DNA testing products market.

By end user (product), the residual DNA testing products market includes pharmaceutical & biotechnology companies, CROs & CDMOs, and academic & research institutes. In 2024, the pharmaceutical & biotechnology companies segment accounted for the largest share of the market. The expansion of the pharmaceutical and biotechnology segment can be largely attributed to heightened investments in advanced therapeutic modalities and the development of biologics. Moreover, there is a notable trend towards the outsourcing of clinical and laboratory testing services by these companies. Regulatory requirements are also significantly propelling the growth of the residual DNA testing market within the pharmaceutical and biotechnology sectors, as compliance with stringent regulations becomes essential for product efficacy and safety.

By region, North America accounted for the largest share of the market in 2024.

In 2024, North America dominated the residual DNA testing market, largely due to the presence of established product manufacturers and service providers in this niche. The US has emerged as a key player within this region, driven by the increasing demand for residual DNA testing solutions stemming from the burgeoning biopharmaceutical sector. This demand is further enhanced by strategic partnerships between regulatory bodies and national organizations focused on biologics R&D. A notable example of such collaboration is between the American Type Culture Collection (ATCC) and the US Pharmacopeia (USP). Together, they have developed genomic DNA Analytical Reference Materials (ARMs), which are critical for the measurement of residual DNA in biopharmaceutical products derived from host cells. Comprehensive application notes outlining testing protocols to assess the quality and applicability of these ARMs are available, providing valuable guidance for their implementation in quality control processes.

Some of the leading players in the market include Thermo Fisher Scientific Inc. (US), Merck KGaA (Germany), Eurofins Scientific (Luxembourg), Charles River Laboratories (US), QIAGEN (Germany), FUJIFILM Corporation (Japan), Maravai LifeSciences (US), and Bio-Rad Laboratories (US).

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