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Residual DNA Testing to Hit $370M by 2030 -- The Silent Guardian of Biologics Safety | MarketsandMarkets™

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MarketsandMarkets

01 Jul, 2025, 14:30 GMT

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DELRAY BEACH, Fla., July 1, 2025 /PRNewswire/ -- 

What's driving this $370 million transformation?

The global residual DNA testing market, valued at US$0.27 billion in 2024, stood at US$0.28 billion in 2025 and is projected to advance at a resilient CAGR of 6.0% from 2025 to 2030, culminating in a forecasted valuation of US$0.37 billion by the end of the period. Behind this steady surge lies a critical mission—ensuring biologics are safe, compliant, and globally trusted. With biosimilar and biologic approvals accelerating, and regulatory oversight tightening across FDA, EMA, and ICH, residual DNA testing has become non-negotiable for biopharma leaders.

Download PDF Brochure: https://www.marketsandmarkets.com/pdfdownloadNew.asp?id=89689614

Why is residual DNA testing a non-negotiable in biomanufacturing?

The shift from small molecules to monoclonal antibodies, gene therapies, and vaccines has made biologics the backbone of modern medicine. With that evolution comes a heightened risk of contamination and compliance failure. Residual host cell DNA must be measured with high precision and consistency—this testing isn't just regulatory—it's a guarantee of clinical safety and product integrity.

What problem does this technology solve?

Residual DNA testing eliminates a multi-million-dollar compliance and quality risk. Whether you're manufacturing biosimilars or cutting-edge cell therapies, undetected host cell DNA could derail product safety, delay regulatory approvals, or damage brand trust. This testing ensures batch reliability, boosts regulatory confidence, and enables fast-track market access.

Where's the next big growth wave?

Emerging markets like India, China, Brazil, and Japan are rapidly scaling their biopharma capabilities. A case in point: Sun Pharma's acquisition of Concert Pharmaceuticals in 2023 signalled deeper commitments to immunotherapy and innovation. These regions are investing in precision testing and validation tools, making them ripe for residual DNA tech adoption as they chase global compliance standards.

Request Sample Pages : https://www.marketsandmarkets.com/requestsampleNew.asp?id=89689614

Who's dominating this high-stakes market?

  • Thermo Fisher Scientific leads the pack with a powerhouse portfolio of PCR platforms and DNA quantification kits, bolstered by its Advanced Therapies Collaboration Center (ATxCC) in California.
  • Merck KGaA, Maravai LifeSciences, Bio-Rad, Eurofins Scientific, and QIAGEN are doubling down through product launches, regional expansions, and strategic acquisitions.

Together, the top 5 players command 43–45% of the market—but room remains for disruptors.

What's slowing adoption—and how do we fix it?

Despite the growth, standardization remains the Achilles' heel. Differing protocols for DNA extraction, assay validation, and quantification are stalling global harmonization. Companies must invest in platform standardization, cross-site validation, and training frameworks to ensure regulatory alignment and scalable operations. In a global market, consistency is currency.

The real questions C-suites should ask today:

  • Are we future proofing our biologics pipeline with robust DNA testing protocols?
  • How do we bridge regulatory gaps between our global sites?
  • What are our KPIs for assay accuracy, reproducibility, and compliance readiness?
  • Which testing partners or platforms will de-risk our path to market?

Final Thought: In Biologics, Clean Isn't Enough—It Must Be Proven.

In a biologics-led future, residual DNA testing is the new quality currency. It secures regulatory approvals, mitigates safety risks, and drives brand equity. Leaders who invest early in scalable, standardized DNA testing frameworks will define the next wave of biopharma growth.

Residual DNA testing isn't an expense—it's a trust accelerator.

For more information, Inquire Now!

Related Reports:

In Situ Hybridization Market

DNA Diagnostics Market

Human Identification Market

Gene Expression Analysis Market

Epigenetics Market  

Get access to the latest updates on Top Companies in Residual DNA Testing and Residual DNA Testing Market Size

About MarketsandMarkets™:

MarketsandMarkets™ has been recognized as one of America's Best Management Consulting Firms by Forbes, as per their recent report.

MarketsandMarkets™ is a blue ocean alternative in growth consulting and program management, leveraging a man-machine offering to drive supernormal growth for progressive organizations in the B2B space. With the widest lens on emerging technologies, we are proficient in co-creating supernormal growth for clients across the globe.

Today, 80% of Fortune 2000 companies rely on MarketsandMarkets, and 90 of the top 100 companies in each sector trust us to accelerate their revenue growth. With a global clientele of over 13,000 organizations, we help businesses thrive in a disruptive ecosystem.

The B2B economy is witnessing the emergence of $25 trillion in new revenue streams that are replacing existing ones within this decade. We work with clients on growth programs, helping them monetize this $25 trillion opportunity through our service lines – TAM Expansion, Go-to-Market (GTM) Strategy to Execution, Market Share Gain, Account Enablement, and Thought Leadership Marketing.

Built on the 'GIVE Growth' principle, we collaborate with several Forbes Global 2000 B2B companies to keep them future-ready. Our insights and strategies are powered by industry experts, cutting-edge AI, and our Market Intelligence Cloud, KnowledgeStore™, which integrates research and provides ecosystem-wide visibility into revenue shifts.

To find out more, visit www.MarketsandMarkets™.com or follow us on Twitter , LinkedIn and Facebook .

Contact:
Mr. Rohan Salgarkar
MarketsandMarkets™ INC.
1615 South Congress Ave.
Suite 103, Delray Beach, FL 33445
USA: +1-888-600-6441
Email: sales@marketsandmarkets.com
Visit Our Website: https://www.marketsandmarkets.com/

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