Residual DNA Testing Global Market Forecast to 2030 | Novel Modalities, Emerging Markets Growth, Continuous Processing Integration, and Rising CRO/CDMO Outsourcing

The residual DNA testing market is set to grow from USD 0.28 billion in 2025 to USD 0.37 billion by 2030, with a 6.0% CAGR. Key factors driving this growth include increasing biologics and biosimilars approvals and stringent regulatory frameworks. PCR technology holds the largest market share due to its high precision. The pharmaceutical and biotechnology sector dominates the demand for testing services. North America leads the market, fueled by robust R&D investments. Major players include Thermo Fisher, Merck KGaA , and Eurofins. The report provides detailed analysis on market trends, challenges, and growth opportunities.

Dublin, Aug. 05, 2025 (GLOBE NEWSWIRE) -- The "Residual DNA Testing Market by Product & Service, Technology, Test Type, Application, End User - Global Forecast to 2030" has been added to ResearchAndMarkets.com's offering.

The residual DNA testing market is anticipated to expand significantly, reaching USD 0.37 billion by 2030 from USD 0.28 billion in 2025, at a CAGR of 6.0%.

The report offers insights into the key drivers shaping the market, including the increasing number of biologics approvals, rising regulatory compliance requirements, and growing R&D investments. It features detailed analyses of product development and innovation, market expansion, diversification strategies, and competitive positioning. Additionally, the report presents a comprehensive regional market analysis, helping stakeholders identify lucrative growth opportunities across various geographies.

This growth is driven by the increasing approvals of biologics and biosimilars, alongside stringent regulations for biopharmaceutical manufacturing. Technological advancements in residual DNA testing are expected to further accelerate market growth during the forecast period.

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

The market is segmented into PCR, threshold assays, DNA probe hybridization, and other technologies. PCR held the largest market share in 2024 due to its high sensitivity and specificity, ensuring precise detection of residual DNA and minimizing the risk of false positives. Its versatility for various tests and its scalability for diverse biopharmaceutical applications enhance its widespread adoption. PCR remains a cornerstone in molecular diagnostics.

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

The market is divided into pharmaceutical & biotechnology companies and academic & research institutes. As of 2024, the former dominates, driven by the focus on biologics development. These companies must meet stringent regulations requiring comprehensive manufacturing process data, which boosts the demand for residual DNA testing services to ensure safety and regulatory compliance. This trend amplifies the need for reliable testing methods, underscoring the significance of residual DNA testing in advancing medical science.

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

North America led the market in 2024, attributed to a robust presence of industry leaders and expansion in biologics R&D. Increased investments in the life sciences sector have elevated demand for residual DNA testing products and services. The region's concentration of global entities, including pharmaceutical and biotech firms, supports its market leadership and fosters innovation in biologics.

The report provides insights on the following:

• Key drivers include increasing biologics approvals, regulatory compliance requirements, and R&D investments.
• Analysis of product development/innovation, market development, diversification, and competitive assessment.
• Comprehensive market analysis by region, providing stakeholders with lucrative avenues for growth.

Key Attributes:

Market Dynamics

Drivers

• Increasing Number of Biologics and Biosimilar Approvals
• Stringent Regulatory Compliance Requirements
• Technological Advancements in DNA Quantification and Detection
• Increasing Risk of Cell Culture Contamination
• Rising Biopharmaceutical R&D Investments

Challenges

• High Costs of Advanced Testing Techniques
• Lack of Standardization Across Testing Protocols

Opportunities

• Rising Number of Applications in Novel Modalities
• High Growth Opportunities in Emerging Markets
• Integration With Continuous and Accelerated Bioprocessing
• Rising Outsourcing to CROs and CDMOs

Industry Trends

• Complexity in Sample Preparation and Assay Validation

Company Profiles

• Thermo Fisher Scientific .
• Charles River Laboratories
• F. Hoffmann-La Roche Ltd.
• Merck KGaA Kgaa
• Maravai Lifesciences
• Eurofins Scientific
• Bio-Rad Laboratories , Inc.
• Qiagen
• Fujifilm Corporation
• SGS Limited Societe Generale De Surveillance Sa.
• Hillgene Biopharma Co., Ltd.
• Revvity
• Intertek Group PLC
• Sartorius Ag
• Lonza
• Wuxi Apptec
• Transgen Biotech Co., Ltd.
• EagleBio
• Yeasen
• Acrobiosystems
• Creative Biogene
• Minerva Biolabs GmbH
• Creative Proteomics
• Avance Biosciences
• Generi Biotech

For more information about this report visit https://www.researchandmarkets.com/r/p0mp3q

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• Residual DNA Testing Market

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