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

The residual DNA testing market 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. The expansion of this market is fueled by multiple factors, including the increasing frequency of approvals for biologics and biosimilars, as well as the implementation of rigorous regulatory frameworks governing the manufacture of biopharmaceutical products. Additionally, advancements in technologies related to residual DNA testing are anticipated to further bolster market growth throughout the forecast period.

By technology, the PCR segment accounted for the largest share of the residual DNA testing market in 2024.

By technology, the market is segmented into PCR, threshold Assays, DNA probe hybridization, and other technologies. In 2024, the Polymerase Chain Reaction (PCR) segment commanded the largest share of the market, reflecting its pivotal role in molecular diagnostics. This substantial market share can be primarily attributed to the high sensitivity and specificity offered by PCR, which enables the precise detection of even minute quantities of residual DNA. As a result, PCR effectively minimizes the risk of false positives, a critical factor in ensuring accurate test outcomes. Moreover, the versatility of the PCR technology plays a significant role in its widespread adoption. It can be easily adapted for various test types, making it applicable across a broad spectrum of biopharmaceutical applications. This adaptability, combined with its scalability, allows PCR to be employed in everything from small-scale research studies to large-scale clinical testing, catering to the evolving needs of the biopharmaceutical industry. With its exceptional performance characteristics and flexible applications, the PCR segment continues to be a cornerstone of advancements in molecular biology and diagnostics.

In 2024, by end user, the pharmaceutical & biotechnology companies segment accounted for the largest share of the residual DNA testing services market.

The residual DNA testing services market is categorized into two primary segments: pharmaceutical & biotechnology companies and academic & research institutes. As of 2024, the pharmaceutical & biotechnology companies segment holds the largest share of the market. This substantial growth can be attributed to the increasing emphasis on the development of biologics, which are innovative therapies aimed at treating a variety of diseases, including cancers, autoimmune disorders, and genetic conditions. As the industry evolves, pharmaceutical and biotechnology firms are required to adhere to stringent regulatory standards, which mandate the provision of comprehensive data concerning the entire manufacturing process. This includes the rigorous testing and validation of biological products to ensure their safety and efficacy. Consequently, the necessity for thorough quality inspections and regulatory approvals becomes paramount, driving the demand for residual DNA testing services. These services play a critical role in identifying and quantifying residual DNA left in biologics, ensuring that products meet safety guidelines and are free from contaminants that could pose risks to patients. Moreover, as companies invest in advanced biotechnological research and development, the demand for reliable and accurate testing methods continues to rise. This trend further augments the market for residual DNA testing services, highlighting its essential role in the pharmaceutical landscape. As the sector strives for innovation and compliance, the importance of these testing services will likely increase, underscoring their value in advancing medical science and patient safety.

In 2024, North America accounted for the largest share of the residual DNA testing market.

In 2024, North America emerged as the dominant force in the market, largely due to the strong presence of key industry leaders and a notable expansion in research initiatives aimed at innovating and developing biologics. This growth can be attributed to a significant increase in research and development investments within the life sciences sector, which, in turn, has escalated the demand for residual DNA testing products and services. Additionally, the region benefits from a concentration of numerous global entities, including pharmaceutical companies, biotech firms, and academic institutions, which collectively enhance its leadership position in the market. This collaborative environment fosters innovation and accelerates advancements in biologics, further solidifying North America's role as a pivotal hub for life sciences R&D.

The primary interviews conducted for this report can be categorized as follows:

• By Respondent: Tier 1-25%, Tier 2-35%, and Tier 3- 40%
• By Designation: CXOs and Directors- 30%, Managers- 45%, and Executives- 25%
• By Region: North America -35%, Europe - 25%, Asia Pacific -15%, Latin America -10%, Middle East- 10%, and Africa- 5%

List of companies profiled in the report:

• Thermo Fisher Scientific Inc. (US)
• Merck KGaA (Germany)
• Eurofins Scientific (Luxembourg)
• Charles River Laboratories (US)
• Bio-Rad Laboratories (US)
• QIAGEN (Germany)
• F. Hoffmann-La Roche Ltd (Switerland)
• Maravai LifeSciences (US)
• FUJIFILM Corporation (Japan)
• SGS Société Générale de Surveillance SA (Switzerland)
• Jiangsu Hillgene Biopharma Co.,Ltd (China)
• Revvity (US)
• Intertek Group plc (UK)
• WuXi AppTec (China)
• Sartorius AG (Germany)
• Lonza (Switzerland)

Research Coverage:

This research report categorizes residual DNA testing market by offering (products and services), technology (PCR, threshold assay, DNA probe hybridization, and other technologies), test type (final product release testing, bulk lot release testing, and final product release testing), application (monoclonal antibodies, cell & gene therapy, vaccines, and other applications), end user for products (pharmaceutical & biotechnology companies, CROs & CDMOs, and academic & research institutes), end user for services (pharmaceutical & biotechnology companies and academic & research institutes), and region (North America, Europe, the Asia Pacific, Latin America, the Middle East, and Africa).

The report offers an in-depth examination of the critical elements shaping the residual DNA testing market, including key drivers, constraints, challenges, and emerging opportunities. It presents a comprehensive analysis of leading industry players, detailing their business models, product and service offerings, strategic initiatives, new launches, acquisitions, and recent advancements pertinent to the residual DNA testing sector. Additionally, this report includes a competitive landscape assessment of emerging startups within the residual DNA testing ecosystem.

Key Benefits of Buying the Report:

The report will help market leaders/new entrants by providing the closest approximations of the revenue numbers for the residual DNA testing market and its subsegments. It will also help stakeholders better understand the competitive landscape and gain more insights to position their business and make suitable go-to-market strategies. This report will enable stakeholders to understand the market’s pulse and provide information on the key market drivers, restraints, challenges, trends, and opportunities.

The report provides insights on the following:

• Analysis of key drivers (Increase in biologics and biosimilars approvals, stringent regulatory compliance requirements, technological advancements in DNA quantification and detection, increasing cell culture contamination risks, rising investments in R&D spending), restraints (high cost of advanced testing techniques, lack of standardization across testing protocols), opportunities (application in novel modalities such as mRNA vaccines, cell therapies, and gene therapies, growth opportunities in emerging markets, integration with continuous and accelerated bioprocessing, rising outsourcing to CROs and CDMOs), and challenges (complexity in sample preparation and assay validation) are influencing the growth of the residual DNA testing market.
• Product Development/Innovation: Detailed insights on newly launched products of the residual DNA testing market.
• Market Development: Comprehensive information about lucrative markets – the report analyses the residual DNA testing market across varied regions.
• Market Diversification: Exhaustive information about new products and services, recent developments, and investments in the residual DNA testing market.
• Competitive Assessment: In-depth assessment of market shares, growth strategies, and product offerings of leading players, including Thermo Fisher Scientific Inc. (US), Merck KGaA (Germany), and Eurofins Scientific (Luxembourg), among others, offering products and services for the residual DNA testing market. Other companies in this market include TransGen Biotech Co., Ltd. (China), Vazyme International LLC (China), and EagleBio (US).