The Residual DNA Testing Market plays a critical role in safeguarding the quality and safety of modern biologics, biosimilars, vaccines, and advanced therapeutic products. As biologic manufacturing becomes more complex and regulatory scrutiny intensifies, residual DNA testing has emerged as a mandatory quality control step to ensure that trace levels of host-cell DNA remain within acceptable safety limits.
The global residual DNA testing market is projected to reach USD 0.37 billion by 2030, growing from USD 0.28 billion in 2025, at a CAGR of 6.0% from 2025 to 2030. This steady growth is primarily driven by the rising number of biologics and biosimilar approvals, along with stringent regulatory compliance requirements imposed by global health authorities.
Market Overview: Growing Importance of DNA Safety Testing
Residual DNA testing is essential across biopharmaceutical manufacturing to detect and quantify host-cell DNA impurities that may remain after downstream processing. Regulatory agencies such as the FDA, EMA, and WHO mandate residual DNA testing to minimize immunogenicity and oncogenic risks associated with biologic products.
The residual DNA testing market by product & service includes consumables, instruments & software, and services. Among these, services are gaining strong traction as biopharmaceutical companies increasingly outsource complex testing to specialized laboratories and CROs/CDMOs to ensure regulatory compliance while optimizing costs and timelines.
Key Takeaways Highlighting Market Momentum
- North America accounted for 40.0% of global revenue in 2024, driven by a strong biologics pipeline and robust regulatory frameworks.
- By offering, the services segment is expected to register the highest CAGR of 6.9%, reflecting increased outsourcing trends.
- By test type, final product release testing is projected to grow at the fastest rate during the forecast period.
- By technology, polymerase chain reaction (PCR) continues to dominate due to its sensitivity and reliability.
- By application, the cell & gene therapy (CGT) segment is expected to witness the fastest growth.
- By end user, pharmaceutical & biotechnology companies held the largest share of 70.9% in 2024 and are expected to grow at the fastest rate through 2030.
These insights underline the market’s alignment with the rapid evolution of biologics and advanced therapeutic modalities.
Technology Outlook: PCR as the Gold Standard
The residual DNA testing market by technology is largely dominated by PCR-based methods, including quantitative PCR (qPCR) and digital PCR (dPCR). PCR remains the preferred choice due to its high sensitivity, specificity, and ability to detect low levels of residual DNA.
Advancements in digital PCR platforms are further enhancing accuracy, making them particularly valuable for applications such as cell and gene therapy, where ultra-low DNA detection is critical. The dominance of PCR underscores its role as a foundational technology in modern quality control workflows.
Test Type Analysis: Final Product Release Testing Gains Momentum
Based on test type, the market is segmented into raw material testing, in-process testing, bulk lot release testing, and final product release testing. Among these, final product release testing is expected to grow at the fastest rate from 2025 to 2030.
This growth is driven by regulatory requirements that emphasize end-product safety verification before market approval. As biologics and vaccines become more complex, manufacturers increasingly rely on robust final release testing to demonstrate compliance and ensure patient safety.
Driver: Increasing Number of Biologics and Biosimilar Approvals
A key growth driver for the residual DNA testing market is the global surge in biologics and biosimilar approvals. With biologics forming the backbone of treatments for cancer, autoimmune disorders, and rare diseases, regulatory agencies are enforcing stricter quality standards.
Residual DNA testing is now a non-negotiable component of biologics manufacturing. As approval pipelines expand, manufacturers are adopting advanced DNA testing solutions to meet regulatory expectations, fueling sustained demand across pharmaceutical, biotechnology, and contract testing sectors.
Restraint: High Costs of Advanced Testing Techniques
Despite strong growth drivers, the market faces challenges due to the high cost of advanced residual DNA testing techniques. Sophisticated instruments, specialized reagents, and the need for highly skilled personnel significantly increase operational costs.
These financial barriers particularly affect small and medium-sized enterprises, limiting widespread adoption and slowing market penetration. While regulatory pressures continue to rise, cost constraints remain a key restraint in the broader implementation of advanced testing solutions.
Opportunity: Expanding Applications in Novel Modalities
The residual DNA testing market presents significant opportunities through its expanding role in novel therapeutic modalities, including cell and gene therapies, RNA-based therapeutics, and personalized medicine.
These therapies often involve complex biological systems and heightened safety concerns, making reliable residual DNA testing indispensable. As investment in advanced therapies accelerates, demand for high-sensitivity DNA testing products and services is expected to grow substantially.
End User Insights: Pharma and Biotech Lead the Market
The residual DNA testing market by end user is segmented into pharmaceutical & biotechnology companies and CROs & CDMOs. Pharmaceutical and biotechnology companies dominate the market, driven by in-house quality control requirements and expanding biologics pipelines.
CROs and CDMOs are also experiencing growth as outsourcing becomes a strategic approach for managing costs, accessing specialized expertise, and accelerating time-to-market.
Regional Outlook: North America Maintains Market Leadership
North America remains the largest regional market, supported by advanced biomanufacturing infrastructure, high R&D spending, and stringent regulatory enforcement. The region’s leadership is further reinforced by the presence of major industry players and a strong focus on innovation.
Emerging markets in Asia Pacific and Latin America offer high-growth opportunities due to increasing biologics production, improving regulatory frameworks, and expanding healthcare investments.
Competitive Landscape and Recent Developments
The global residual DNA testing market is moderately consolidated, with key players such as Thermo Fisher Scientific Inc., Merck KGaA, and Maravai LifeSciences leading the market due to their extensive product portfolios and global reach.
Recent developments shaping the competitive landscape include:
- April 2025: Thermo Fisher Scientific announced a USD 2 billion investment in the US to strengthen innovation and manufacturing capabilities.
- February 2025: Bio-Rad acquired Stilla Technologies to enhance its digital PCR portfolio for residual DNA testing and CGT applications.
- September 2024: Eurofins Scientific acquired Infinity Laboratories, expanding its biopharma testing services in the US.
- September 2024: Qiagen launched 100 new digital PCR assays for its QIAcuity platform, improving low-abundance DNA detection.
Additionally, startups and SMEs such as Minerva Biolabs GmbH, TransGen Biotech Co., Ltd., and Creative Biogene are gaining traction by focusing on specialized niche applications.
Conclusion
The residual DNA testing market is positioned for steady growth, driven by expanding biologics pipelines, stringent regulatory mandates, and technological advancements in DNA detection. While high costs pose challenges, opportunities in cell and gene therapy, RNA therapeutics, and personalized medicine continue to broaden the market’s scope.
As pharmaceutical and biotechnology companies intensify their focus on safety, compliance, and product quality, residual DNA testing will remain a cornerstone of biopharmaceutical manufacturing—supporting innovation while protecting patient outcomes well into the next decade.