This Global Residual DNA Testing Market is analyzed in this report across component, test type, technology, application, end-user, and region, highlighting major trends and growth forecasts for each segment

Introduction

Residual DNA testing is a critical analytical method used to detect and quantify trace amounts of DNA that may remain in biopharmaceutical products manufactured using biological systems such as bacteria, yeast, or mammalian cells. This process plays a vital role in ensuring the safety and purity of biologics—including monoclonal antibodies, vaccines, cell and gene therapies, and biosimilars—by identifying and controlling host cell DNA contamination. As biologics manufacturing becomes more complex and regulatory scrutiny intensifies, residual DNA testing has become a key component of quality assurance protocols across the industry.

The global residual DNA testing market is experiencing steady growth and is projected to reach USD 1,310 million by 2030. This upward trajectory is being driven by the increasing production of biologics, rising regulatory emphasis on product safety, growing approvals of biosimilars, and expanding R&D in advanced therapies. Valued at approximately USD 640 million in 2024, the market is forecast to grow at a CAGR of 7.7% through the end of the decade.

Market Dynamics

The residual DNA testing market is evolving swiftly, shaped by scientific advancements, regulatory imperatives, and the increasing complexity of biologics manufacturing. Key growth drivers include the global expansion of biologics production, heightened regulatory expectations for product safety, and the widespread adoption of advanced analytical and purification technologies. As manufacturers innovate across monoclonal antibodies, vaccines, biosimilars, and cell and gene therapies, demand for precise, validated DNA quantification methods is intensifying.

Regulatory authorities have reinforced the importance of rigorous DNA testing. For example, the European Medicines Agency (EMA), in its 2023 draft guideline for mRNA vaccines, specifically mandated the control and quantification of residual host cell DNA—underscoring the need for standardized and highly sensitive testing protocols. In response, manufacturers are increasingly implementing PCR-based solutions, particularly quantitative PCR (qPCR) and digital PCR (dPCR), to meet compliance requirements, ensure batch consistency, and reduce contamination risk.

The market presents substantial growth opportunities through outsourcing trends and digital transformation. The increased reliance on contract research and manufacturing organizations (CROs and CDMOs), particularly in emerging markets, is creating demand for cost-effective and scalable testing platforms. Meanwhile, digital tools, lab automation, and AI-driven data analysis are streamlining quality control processes, enhancing test accuracy, and improving regulatory traceability.

Notably, the United States Pharmacopeia (USP) introduced genomic DNA reference standards in 2021 to support method validation, reinforcing the importance of consistency in residual DNA measurement. In response, biopharmaceutical companies are investing in integrated, real-time DNA quantification systems that support in-process control and continuous quality monitoring.

Key trends include the growing adoption of digital PCR for ultra-sensitive detection, development of ready-to-use test kits to reduce turnaround times, and global efforts to standardize protocols across manufacturing sites. As demand for biosimilars and personalized medicine continues to grow, residual DNA testing is being incorporated earlier in development pipelines—transforming it from a compliance tool into a strategic enabler of quality, efficiency, and innovation in biopharmaceutical production.

Segment Highlights and Performance Overview

By Components:

Consumables hold the largest share of the component segment, accounting for approximately 40% to 45% of the market. This dominance is driven by the continuous use of reagents, primers, enzymes, and DNA quantification kits in routine testing. Pre-validated kits are particularly favored in GMP and QC environments for their ease of use, regulatory compliance, and consistent performance. As biopharma companies seek efficiency and reliability in DNA testing workflows, demand for ready-to-use kits is expanding rapidly across both in-house and outsourced testing labs.

By Test Type:

Final product release testing represents the leading test type, with a market share of approximately 50%. Its primacy reflects its regulatory necessity—residual DNA quantification is mandatory for batch release of biologics. Pharmaceutical companies prioritize this testing to comply with FDA, EMA, and other global regulatory requirements, ensuring product safety before market distribution.

By Technology:

Quantitative PCR (qPCR) accounts for the largest share in the technology segment, representing around 70% of the market. qPCR remains the method of choice due to its established accuracy, scalability, and regulatory acceptance in GMP-compliant facilities. While digital PCR (dPCR) is gaining ground for its enhanced precision, qPCR continues to dominate routine residual DNA testing workflows across biomanufacturing.

By Application:

Monoclonal antibodies (mAbs) are the largest application segment, contributing approximately 45% to 50% of total market value. As mAbs lead global biologic development pipelines, the need for robust residual DNA testing in their production processes remains strong. These therapies require consistent monitoring to meet strict quality and purity standards, reinforcing the role of DNA quantification as a critical control measure.

By End Users:

Pharmaceutical and biotechnology companies dominate the end-user segment, holding 60% to 65% of the market. These organizations are primary developers and producers of biologics, necessitating high-volume and in-house testing for regulatory compliance. Their commitment to quality control, regulatory readiness, and production scale make them the largest consumers of residual DNA testing technologies.

Geographical Analysis

The global residual DNA testing market is examined across key regions, including North America, Europe, Asia-Pacific, South & Central America, and the Middle East & Africa.

North America leads the global residual DNA testing market, accounting for approximately 40% of total revenue. This leadership is supported by the region’s advanced biopharmaceutical infrastructure, strict regulatory oversight from agencies such as the FDA, and high production volumes of monoclonal antibodies and vaccines. The strong presence of key market players and robust GMP implementation further reinforce North America’s dominant position.

Asia-Pacific is expected to register the highest compound annual growth rate (CAGR), estimated between 7% and 9%. This acceleration is fueled by expanding biomanufacturing capacity, growing R&D investments, and increasing adoption of PCR-based testing technologies across major markets including China, India, South Korea, and Japan. The region’s rising focus on biosimilars and contract manufacturing also contributes to surging demand for residual DNA testing services.

Competition Landscape

The global residual DNA testing market is characterized by a competitive mix of biopharmaceutical manufacturers, contract development and manufacturing organizations (CDMOs), and specialized analytical service providers. Key players are focusing on innovation in detection technologies, alignment with evolving regulatory standards, and strategic partnerships to strengthen their market presence and support the safety and quality assurance needs of modern biologics production.

Leading companies profiled in this report include:

Thermo Fisher Scientific, Merck KGaA, Bio-Rad Laboratories, QIAGEN N.V., Roche Diagnostics, Eurofins Scientific, Charles River Laboratories, WuXi AppTec, SGS SA, Sartorius AG, Agilent Technologies, and Eppendorf.

Key Developments

• May 22, 2024 – Merck KGaA announced the acquisition of Mirus Bio LLC for USD 617 million to expand its capabilities in viral vector manufacturing. This acquisition strengthens Merck’s residual DNA removal and detection workflows, aligning with rising regulatory expectations for impurity testing in biologics and enhancing its market competitiveness in advanced therapeutics manufacturing.
• June 2024 – Thermo Fisher Scientific introduced the KingFisher PlasmidPro Maxi Processor, the first fully automated system for maxi-scale plasmid DNA purification. By automating the full purification process, this innovation significantly reduces manual error and contamination risk, enhancing consistency in biologics manufacturing and supporting more efficient residual DNA control

Segmentations:

By Components:

• Consumables
  • Kits
  • Assays
  • Others
• Instruments
• Software

By Test Type:

• Raw
• Final
• Bulk Lot Release Testing

By Technology:

• Quantitative Polymerase Chain Reaction (qPCR)
• Digital Polymerase Chain Reaction (dPCR)

By Application:

• mAb
• CGT
• Vaccine

By End-Users:

• Pharma & Biotech Companies
• Contract Research Organizations(CRO) & Contract Development and Manufacturing Organizations (CDMO)

Companies:

• Thermo Fisher Scientific
• Merck KGaA 
• Bio-Rad Laboratories
• QIAGEN N.V.
• Roche Diagnostics
• Eurofins Scientific
• Charles River Laboratories
• WuXi AppTec
• SGS SA
• Sartorius AG
• Agilent Technologies
• Eppendorf