Residual DNA Testing Market Size is valued at US$ 0.25 Bn in 2024 and is predicted to reach US$ 0.54 Bn by the year 2034 at an 8.1% CAGR during the forecast period for 2025-2034.
Residual DNA testing is a quality control process used in biopharmaceuticals and vaccines to detect, measure, and ensure safe levels of host-cell DNA remaining after production, maintaining product safety, purity, and regulatory compliance standards. Rising biopharmaceutical R&D investments are a key driver for the residual DNA testing market, as stringent regulatory requirements mandate safety and purity validation in biologics and cell-based therapies. With the surge in monoclonal antibodies, vaccines, and gene therapies, companies are allocating higher budgets toward advanced quality control and analytical techniques.
Residual DNA testing ensures product safety, compliance, and reduced immunogenic risks, making it integral to biopharma workflows. As R&D pipelines expand globally, demand for sensitive, accurate, and regulatory-compliant DNA testing methods continues to strengthen, fueling market growth.
The residual DNA testing market is being strongly driven by the increasing number of biologics & biosimilar approvals worldwide. As regulatory agencies such as the FDA & EMA enforce stringent safety and quality standards, manufacturers of biologics and biosimilars are required to demonstrate that residual host cell DNA is within permissible limits.
With the growing demand for biologics in therapeutic areas like oncology, autoimmune disorders, and infectious diseases, and as biosimilar development for cost reduction is increasingly becoming a trend, the need for precise, sensitive, and validated residual DNA testing technology is more evident than ever before. This does not just ensure patient safety and regulatory compliance but also enables the speeding up of product commercialization.
Some of the Key Players in the Residual DNA Testing Market:
· Thermo Fisher Scientific Inc.
· Merck KGaA
· Eurofins Scientific
· Charles River Laboratories
· Bio-Rad Laboratories, Inc.
· QIAGEN
· Hoffmann-La Roche Ltd
· Maravai LifeSciences
· FUJIFILM Corporation
· SGS Société Générale de Surveillance SA.
· Jiangsu Hillgene Biopharma Co., Ltd
· Revvity
· Intertek Group plc
· WuXi AppTec
· Sartorius AG
· Lonza
The residual DNA testing market is segmented by offering, test type, technology, application, and end-user. By offering, the market is segmented into product {consumables, instruments & software}, and services. By test type, the market is segmented into final product release testing, bulk lot release testing, and raw material testing. The technology segment covers polymerase chain reaction, threshold assay, DNA probe hybridization, and other technologies. Whereas, the application segment categorized into monoclonal antibodies, cell & gene therapy, vaccines, and other applications. By end-user, the market is segmented into pharmaceutical & biotechnology companies, CROS & CDMOS, and academic & research institutes.
In 2024, stringent regulatory emphasis on product safety and purity in biopharmaceutical manufacturing drives the monoclonal antibodies segment and expands market growth. Since mAbs are produced using host cell lines, residual host cell DNA can pose risks of immunogenicity, oncogenicity, or infectious agent transmission. Regulatory bodies like the FDA and EMA require accurate quantitation and elimination of residual DNA to acceptable safety levels, driving the uptake of sophisticated testing technologies like qPCR, ddPCR, and next-generation sequencing. Increasing demand for therapeutic mAbs in cancer, autoimmune disorders, and infectious diseases further increases the demand for secure residual DNA testing solutions.
The residual DNA testing market is dominated by products due to the rising demand for biologics and biosimilars, where ensuring product safety and purity is critical. Stringent regulatory requirements by agencies like the FDA and EMA mandate residual DNA testing, pushing pharmaceutical companies and research laboratories to adopt advanced, sensitive, and high-throughput testing technologies. Universal products comprise PCR-based kits, qPCR equipment, nucleic acid purification systems, electrophoresis equipment, DNA-specific fluorescent dyes, and chromatography-based solutions. These products are extensively used in biologics production, vaccines, cell and gene therapies, and biosimilars for ensuring compliance with regulatory requirements.
North America dominates the market for residual DNA testing due to the region’s stringent regulatory frameworks and quality control standards set by authorities like the FDA and Health Canada. Biopharmaceutical firms are increasingly using residual DNA testing in order to guarantee the safety, purity, and potency of biologics, vaccines, and gene therapies.
The high emphasis in the region on cutting-edge healthcare infrastructure, increased demand for monoclonal antibodies, and accelerated growth in cell and gene therapy further fuel the need for testing. Increased investments in research and clinical trials in biotechnology also stimulate the use of sensitive analysis techniques. The increasing emphasis on patient safety as well as compliance with global regulatory guidelines significantly fuels market expansion.
Europe is following as a second-largest region in the market for residual DNA testing. This is due to the stringent regulatory guidelines laid down by organizations like the European Medicines Agency (EMA) and the European Pharmacopoeia, which have very strict safety protocols for the biologics, vaccines, and cell- or gene-based treatments. Greater usage of biopharmaceuticals, coupled with the progress in molecular biology methods like quantitative polymerase chain reaction (qPCR) and next-generation sequencing, is necessitating accurate and sensitive residual DNA detection. Additionally, rising investments in biosimilar development, expansion of pharmaceutical manufacturing, and emphasis on patient safety further propel market growth. Growing collaboration between biotech firms and contract research organizations also enhances adoption across Europe.
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Report Attribute |
Specifications |
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Market Size Value In 2024 |
USD 0.25 Bn |
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Revenue Forecast In 2034 |
USD 0.54 Bn |
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Growth Rate CAGR |
CAGR of 8.1% from 2025 to 2034 |
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Quantitative Units |
Representation of revenue in US$ Bn and CAGR from 2025 to 2034 |
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Historic Year |
2021 to 2024 |
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Forecast Year |
2025-2034 |
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Report Coverage |
The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
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Segments Covered |
By Offering, By Test Type, By Technology, By Application, By End-User and By Region |
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Regional Scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
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Country Scope |
U.S.; Canada; Germany; The UK; France; Italy; Spain; Rest of Europe; China; Japan; India; South Korea; Southeast Asia; Rest of Asia Pacific; Brazil; Argentina; Mexico; Rest of Latin America; GCC Countries; South Africa; Rest of the Middle East and Africa |
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Competitive Landscape |
Thermo Fisher Scientific Inc. (US), Merck KGaA (Germany), Eurofins Scientific (Luxembourg), Charles River Laboratories (US), Bio-Rad Laboratories, Inc. (US), QIAGEN (Germany), F. Hoffmann-La Roche Ltd (Switzerland), 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), and Lonza (Switzerland) |
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Customization Scope |
Free customization report with the procurement of the report, Modifications to the regional and segment scope. Geographic competitive landscape. |
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Pricing and Available Payment Methods |
Explore pricing alternatives that are customized to your particular study requirements. |
Chapter 1. Methodology and Scope
1.1. Research Methodology
1.2. Research Scope & Assumptions
Chapter 2. Executive Summary
Chapter 3. Global Residual DNA Testing Market Snapshot
Chapter 4. Global Residual DNA Testing Market Variables, Trends & Scope
4.1. Market Segmentation & Scope
4.2. Drivers
4.3. Challenges
4.4. Trends
4.5. Investment and Funding Analysis
4.6. Porter's Five Forces Analysis
4.7. Incremental Opportunity Analysis (US$ MN), 2025-2034
4.8. Competitive Landscape & Market Share Analysis, By Key Player (2024)
4.9. Use/impact of AI on Residual DNA Testing Market Industry Trends
4.10. Global Residual DNA Testing Market Penetration & Growth Prospect Mapping (US$ Mn), 2024-2034
Chapter 5. Residual DNA Testing Market Segmentation 1: By Offering, Estimates & Trend Analysis
5.1. Market Share by Offering, 2024 & 2034
5.2. Market Size Revenue (US$ Million) & Forecasts and Trend Analyses, 2021 to 2034 for the following Offering:
5.2.1. Products
5.2.2. Services
Chapter 6. Residual DNA Testing Market Segmentation 2: By End-User, Estimates & Trend Analysis
6.1. Market Share by End-User, 2024 & 2034
6.2. Market Size Revenue (US$ Million) & Forecasts and Trend Analyses, 2021 to 2034 for the following End-User:
6.2.1. Pharmaceutical & biotechnology companies
6.2.2. Cros & cdmos
6.2.3. Academic & research institutes
Chapter 7. Residual DNA Testing Market Segmentation 3: By Application, Estimates & Trend Analysis
7.1. Market Share by Application, 2024 & 2034
7.2. Market Size Revenue (US$ Million) & Forecasts and Trend Analyses, 2021 to 2034 for the following Application:
7.2.1. Monoclonal antibodies
7.2.2. Cell & gene therapy
7.2.3. Vaccines
7.2.4. Other applications
Chapter 8. Residual DNA Testing Market Segmentation 4: By Technology, Estimates & Trend Analysis
8.1. Market Share by Technology, 2024 & 2034
8.2. Market Size Revenue (US$ Million) & Forecasts and Trend Analyses, 2021 to 2034 for the following Technology:
8.2.1. Polymerase chain reaction
8.2.2. Threshold assays
8.2.3. Dna probe hybridization
8.2.4. Other technologies
Chapter 9. Residual DNA Testing Market Segmentation 5: By Test type, Estimates & Trend Analysis
9.1. Market Share by Test type, 2024 & 2034
9.2. Market Size Revenue (US$ Million) & Forecasts and Trend Analyses, 2021 to 2034 for the following Test type:
9.2.1. Final product release testing
9.2.2. Bulk lot release testing
9.2.3. Raw material testing
Chapter 10. Residual DNA Testing Market Segmentation 6: Regional Estimates & Trend Analysis
10.1. Global Residual DNA Testing Market, Regional Snapshot 2024 & 2034
10.2. North America
10.2.1. North America Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
10.2.1.1. US
10.2.1.2. Canada
10.2.2. North America Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Offering, 2021-2034
10.2.3. North America Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034
10.2.4. North America Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
10.2.5. North America Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Component, 2021-2034
10.2.6. North America Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
10.2.7. North America Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Test type, 2021-2034
10.3. Europe
10.3.1. Europe Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
10.3.1.1. Germany
10.3.1.2. U.K.
10.3.1.3. France
10.3.1.4. Italy
10.3.1.5. Spain
10.3.1.6. Rest of Europe
10.3.2. Europe Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Offering, 2021-2034
10.3.3. Europe Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034
10.3.4. Europe Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
10.3.5. Europe Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
10.3.6. Europe Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Test type, 2021-2034
10.4. Asia Pacific
10.4.1. Asia Pacific Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
10.4.1.1. India
10.4.1.2. China
10.4.1.3. Japan
10.4.1.4. Australia
10.4.1.5. South Korea
10.4.1.6. Hong Kong
10.4.1.7. Southeast Asia
10.4.1.8. Rest of Asia Pacific
10.4.2. Asia Pacific Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Offering, 2021-2034
10.4.3. Asia Pacific Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034
10.4.4. Asia Pacific Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
10.4.5. Asia Pacific Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
10.4.6. Asia Pacific Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Test type, 2021-2034
10.5. Latin America
10.5.1. Latin America Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
10.5.1.1. Brazil
10.5.1.2. Mexico
10.5.1.3. Rest of Latin America
10.5.2. Latin America Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Offering, 2021-2034
10.5.3. Latin America Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034
10.5.4. Latin America Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
10.5.5. Latin America Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
10.5.6. Latin America Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Test type, 2021-2034
10.6. Middle East & Africa
10.6.1. Middle East & Africa Wind Turbine Rotor Blade Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
10.6.1.1. GCC Countries
10.6.1.2. Israel
10.6.1.3. South Africa
10.6.1.4. Rest of Middle East and Africa
10.6.2. Middle East & Africa Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Offering, 2021-2034
10.6.3. Middle East & Africa Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by End-User, 2021-2034
10.6.4. Middle East & Africa Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
10.6.5. Middle East & Africa Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
10.6.6. Middle East & Africa Residual DNA Testing Market Revenue (US$ Million) Estimates and Forecasts by Test type, 2021-2034
Chapter 11. Competitive Landscape
11.1. Major Mergers and Acquisitions/Strategic Alliances
11.2. Company Profiles
11.2.1. Thermo fisher scientific inc.
11.2.1.1. Business Overview
11.2.1.2. Key Product /Service Overview
11.2.1.3. Financial Performance
11.2.1.4. Geographical Presence
11.2.1.5. Recent Developments with Business Strategy
11.2.2. Charles river laboratories
11.2.3. F. Hoffmann-la roche ltd.
11.2.4. Maravai lifesciences
11.2.5. Eurofins Scientific
11.2.6. Bio-rad laboratories, inc.
11.2.7. Qiagen
11.2.8. Fujifilm corporation
11.2.9. Sgs société générale de surveillance sa.
11.2.10. Hillgene biopharma co., ltd.
11.2.11. Revvity
11.2.12. Intertek Group Plc
11.2.13. Sartorius Ag
11.2.14. Lonza
11.2.15. Wuxi Apptec
11.2.16. Other players
11.2.16.1. Transgen biotech co., ltd.
11.2.16.2. Eaglebio
11.2.16.3. Yeasen
11.2.16.4. Acrobiosystems
11.2.16.5. Creative Biogene
11.2.16.6. Minerva Biolabs Gmbh
11.2.16.7. Creative Proteomics
11.2.16.8. Avance Biosciences
11.2.16.9. Generi Biotech
Residual DNA Testing Market by Offering-
· Product {Consumables, and Instruments & Software}
· Services
Residual DNA Testing Market by Test Type -
· Final Product Release Testing
· Bulk Lot Release Testing
· Raw Material Testing
Residual DNA Testing Market by Technology-
· Polymerase Chain Reaction
· Threshold Assay
· DNA Probe Hybridization
· Other Technologies
Residual DNA Testing Market by Application-
· Monoclonal Antibodies
· Cell & Gene Therapy
· Vaccines
· Other Applications
Residual DNA Testing Market by End-User-
· Pharmaceutical & Biotechnology Companies
· CROS & CDMOS
· Academic & Research Institutes
Residual DNA Testing Market by Region-
North America-
· The US
· Canada
Europe-
· Germany
· The UK
· France
· Italy
· Spain
· Rest of Europe
Asia-Pacific-
· China
· Japan
· India
· South Korea
· Southeast Asia
· Rest of Asia Pacific
Latin America-
· Brazil
· Argentina
· Mexico
· Rest of Latin America
Middle East & Africa-
· GCC Countries
· South Africa
· Rest of the Middle East and Africa
InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.
Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.
Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.
Secondary research
The secondary research sources that are typically mentioned to include, but are not limited to:
The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista
Primary Research:
Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies
The contributors who typically take part in such a course include, but are not limited to:
Data Modeling and Analysis:
In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.
The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.
To know more about the research methodology used for this study, kindly contact us/click here.
