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1808107

残留 DNA 检测市场 - 全球及区域分析：按服务细分、检测类型、技术、应用、最终用户和国家/地区进行的分析和预测（2025 年至 2035 年）

Residual DNA Testing Market - A Global and Regional Analysis: Focus on Offering, Test Type, Technology, Application, End User, Country, and Region - Analysis and Forecast, 2025-2035

出版日期: 2025年09月10日 | 出版商:

BIS Research | 英文 120 Pages | 商品交期: 1-5个工作天内

价格

简介目录图表

残留 DNA 检测是一种用于检测和量化生物或药物过程后样本中可能残留的微量 DNA 的过程。

此类检测在生物技术、製药、法医学和环境科学等领域尤其重要。在生物製药领域，残留DNA检测可确保疫苗、基因治疗药物和生物製剂等产品不含可能影响其安全性和有效性的污染物。这种检测在生物製药製造过程中尤其重要，因为宿主细胞的DNA可能残留在最终产品中。 FDA和EMA等监管机构要求进行严格的残留DNA检测，以确保产品纯度和病患安全。

在法医学，残留DNA检测用于分析犯罪现场、物体表面和体液中残留的微量DNA，以协助刑事调查和识别。它也用于环境监测和农业领域，检测水、土壤和农产品中的遗传物质，有助于生物多样性调查、污染评估和基因改造作物（GMO）的检测。

残留DNA检测市场的主要成长要素之一是生物製药需求的不断增长。随着疫苗、基因疗法药物和单株抗体等生物製药产量的扩大，对严格的安全措施和品管的需求也日益增长。 FDA和EMA等监管机构要求对这些产品进行彻底的残留DNA检测，以确保其不含任何潜在的有害污染物。这确保了生物製药对人体的安全性，保护了患者的健康和治疗的有效性。人们对基因治疗和个人化医疗的日益关注，以及生物製药行业的快速扩张，极大地推动了残留DNA检测的需求。

此外，非何杰金氏淋巴瘤(NHL) 的发生率不断上升，尤其是在人口老化背景下，也推动了对先进治疗方案的需求。诊断技术的进步使更多患者能够在早期得到诊断，从而迅速扩大了残留 DNA 检测相关治疗的市场，并为製药公司开发和商业化创新疗法创造了机会。

然而，残留DNA检测市场面临许多挑战。其中最大的挑战之一是高成本。诸如次世代定序（NGS）和即时PCR等先进的DNA检测技术，其实施和维护成本高昂。这可能会限制它们的普及，尤其是在小型实验室和资源匮乏的地区。

样本劣化也是一大挑战。残留的DNA样本，尤其是在法医学和环境领域采集的样本，通常会劣化或残留量极低。如果DNA品质不够，就很难获得准确可靠的结果。

此外，还存在污染的风险：特别是在法医学应用中，通常从犯罪现场回收的 DNA 量很少，即使在样本采集、处理和分析过程中出现轻微污染，也会影响结果的可靠性，并导致假阳性或假阴性。

此外，基因资料的使用也存在伦理和隐私方面的担忧。在法医学和医疗环境中收集、储存和使用残留DNA，会引发资料安全、知情同意以及基因资讯滥用等问题。遵守隐私法规和应对伦理挑战仍然是市场参与企业面临的关键挑战。

此外，残留DNA检测通讯协定缺乏标准化，阻碍了此技术的广泛应用。由于缺乏普遍认可的指导方针和品质保证机制，不同实验室的结果可能会存在差异，从而影响检测的可靠性，并限制其在关键应用中的使用。

本报告调查了全球残留 DNA 检测市场，并总结了关键趋势、市场影响因素分析、法律制度、技术和专利分析、市场规模趋势和预测、各个细分市场、地区/主要国家的详细分析、竞争格局和主要企业的概况。

关键策略和发展
公司简介
- Thermo Fisher Scientific Inc.
- Charles River Laboratories
- F. Hoffmann-La Roche AG
- Merck KGaA
- Eurofins Scientific, Inc.
- Bio-Rad Laboratories, Inc.
- QIAGEN NV
- Fujifilm Corporation
- Revvity
- Sartorius AG
- Lonza
- WuXi AppTec
- Intertek Group PLC
- Hillgene Biopharma Co., Ltd.
- Maravai LifeSciences

第九章调查方法

简介目录图表

Product Code: BHL3236SA

Global Residual DNA Testing Market, Analysis and Forecast: 2025-2035

Residual DNA Testing is a process used to detect and quantify trace amounts of DNA that may remain in a sample after a biological or pharmaceutical process. This type of testing is crucial in various fields, particularly in biotechnology, pharmaceuticals, forensics, and environmental sciences. In the context of biopharmaceuticals, residual DNA testing ensures that products, such as vaccines, gene therapies, and biologic drugs, are free from contaminants that could affect safety or efficacy. It is particularly important in the production of biologics, where host cell DNA could remain in the final product after the manufacturing process. Regulatory agencies like the FDA and EMA mandate strict testing for residual DNA to ensure product purity and patient safety.

In forensics, residual DNA testing is used to analyze minute traces of DNA left at crime scenes, on objects, or in bodily fluids, aiding in criminal investigations and identity verification. Environmental monitoring and agriculture also benefit from this type of testing, as it can detect genetic material from organisms in water, soil, or agricultural products, contributing to biodiversity studies, contamination assessments, and the detection of genetically modified organisms (GMOs).

One of the key drivers of the Residual DNA Testing market is the increasing demand for biopharmaceuticals. As the production of biologics, such as vaccines, gene therapies, and monoclonal antibodies, continues to rise, the need for stringent safety measures and quality control becomes essential. Regulatory agencies, like the FDA and EMA, require thorough testing for residual DNA in these products to ensure they are free from potentially harmful contaminants. This ensures that the biologics are safe for human use, which is crucial for patient health and the effectiveness of treatments. The growing focus on gene therapies, personalized medicine, and the rapid expansion of the biopharmaceutical industry is significantly driving the demand for residual DNA testing.

Furthermore, the increasing prevalence of non-Hodgkin lymphoma (NHL), especially in the aging population, is contributing to the rising demand for advanced treatment options. As more patients are diagnosed at earlier stages due to improved diagnostic tools, the Residual DNA Testing market for Residual DNA Testing therapies is expanding rapidly, creating opportunities for pharmaceutical companies to develop and commercialize innovative treatments.

Despite the growth of the Residual DNA Testing market, several challenges persist. One of the primary challenges is the high cost of testing. Advanced DNA testing technologies, such as next-generation sequencing (NGS) and real-time PCR, can be expensive to implement and maintain. This can limit the accessibility of residual DNA testing, particularly for smaller laboratories or in regions with limited resources.

Another significant challenge is sample degradation. Residual DNA samples, especially those collected from forensic or environmental settings, are often degraded or present in very small quantities. This can make it difficult to obtain accurate and reliable results, as the DNA may not be of sufficient quality for analysis.

Contamination is also a concern, particularly in forensic applications, where minute traces of DNA are often recovered from crime scenes. Even small amounts of contamination during sample collection, handling, or analysis can compromise the integrity of the results, leading to false positives or false negatives.

Additionally, there are ethical and privacy concerns surrounding the use of genetic data, especially in forensic and healthcare applications. The collection, storage, and use of residual DNA raises questions about data security, consent, and the potential misuse of genetic information. Ensuring compliance with privacy regulations and addressing these ethical issues remains a challenge for companies in the market.

Finally, the lack of standardization in residual DNA testing protocols can hinder the widespread adoption of these technologies. Without universally accepted guidelines and quality assurance measures, results may vary across laboratories, impacting the reliability of testing and limiting its use in critical applications.

The global Residual DNA Testing market is highly competitive, with several key players driving innovation and market growth. Leading companies such as Thermo Fisher Scientific Inc., Charles River Laboratories, F. Hoffmann-La Roche Ltd., Merck KGaA, Maravai LifeSciences, Eurofins Scientific, Bio-Rad Laboratories, Inc., QIAGEN, Fujifilm Corporation, and others are at the forefront, leveraging their technological expertise, strong R&D capabilities, and broad product portfolios to gain a significant market share.

These companies are focused on enhancing the accuracy, efficiency, and affordability of residual DNA testing through advanced technologies like next-generation sequencing (NGS) and real-time PCR. Additionally, many of these players are expanding their offerings by introducing specialized solutions tailored to the needs of the biopharmaceutical, forensic, and clinical diagnostics sectors. Strategic collaborations, mergers, and acquisitions are also common strategies among market leaders, helping them strengthen their positions and capitalize on new opportunities in the rapidly growing residual DNA testing market.

Residual DNA Testing Market Segmentation:

Segmentation 1: by Offering

Product
Services

Segmentation 2: by Test Type

Final Product Release Testing
Bulk Lot Release Testing
Raw Material Testing

Segmentation 3: by Technology

Polymerase Chain Reaction
Threshold Assays
DNA Probe Hybridization
Other Technologies

Segmentation 4: by Application

Monoclonal Antibodies
Cell & Gene Therapy
Vaccines
Other Applications

Segmentation 5: by End User

Pharmaceutical & Biotechnology Companies
CROS & CDMOS
Academic & Research Institutes

Segmentation 6: by Region

North America
Europe
Asia-Pacific
Rest-of-the-World

The global Residual DNA Testing market is experiencing several key emerging trends that are shaping its future. One of the most significant trends is the integration of advanced technologies, such as next-generation sequencing (NGS) and real-time PCR, which are enhancing the sensitivity, accuracy, and speed of DNA detection. Additionally, the rise of personalized medicine is driving the demand for precise genetic testing, as residual DNA testing becomes crucial in tailoring treatments based on individual genetic profiles.

The increasing use of forensic DNA testing is another key trend, with advancements in DNA analysis allowing for more accurate identification from trace or degraded samples, playing a critical role in criminal investigations and legal applications. Regulatory pressures, particularly in the biopharmaceutical industry, are also fuelling growth, as stricter guidelines require more rigorous DNA testing to ensure the safety of biologics and gene therapies.

Moreover, emerging markets, especially in Asia-Pacific and Latin America, are expanding their healthcare and biotechnology sectors, creating new opportunities for residual DNA testing solutions. The integration of artificial intelligence (AI) and machine learning (ML) is further driving innovation, automating data analysis and improving testing efficiency. Lastly, the growing interest in environmental and agricultural applications, such as detecting genetic material in water, soil, and food products, is broadening the scope of residual DNA testing beyond healthcare. These trends collectively indicate a rapidly evolving market with vast potential across various sectors.

Executive Summary

Scope and Definition

Market/Product Definition

Inclusion and Exclusion

Key Questions Answered

Analysis and Forecast Note

1. Global Residual DNA Testing Market: Industry Outlook

1.1 Introduction
1.2 Market Trends
1.3 Regulatory Framework
1.4 Epidemiology Analysis
1.5 Patent Analysis
1.6 Market Dynamics
- 1.6.1 Impact Analysis
- 1.6.2 Market Drivers
- 1.6.3 Market Challenges
- 1.6.4 Market Opportunities

2. Global Residual DNA Testing Market (by Offering), ($Billion), 2024-2035

2.1 Product
- 2.1.1 Consumables
- 2.1.2 Instruments & Software
2.2 Services

3. Global Residual DNA Testing Market (by Test Type), ($Billion), 2024-2035

3.1 Final Product Release Testing
3.2 Bulk Lot Release Testing
3.3 Raw Material Testing

4. Global Residual DNA Testing Market (by Technology), ($Billion), 2024-2035

4.1 Polymerase Chain Reaction
4.2 Threshold Assays
4.3 DNA Probe Hybridization
4.4 Other Technologies

5. Global Residual DNA Testing Market (by Application), ($Billion), 2024-2035

5.1 Monoclonal Antibodies
5.2 Cell & Gene Therapy
5.3 Vaccines
5.4 Other Applications

6. Global Residual DNA Testing Market (by End User), ($Billion), 2024-2035

6.1 Pharmaceutical & Biotechnology Companies
6.2 CROS & CDMOS
6.3 Academic & Research Institutes

7. Global Residual DNA Testing Market (by Region), ($Billion), 2024-2035

7.1 North America
- 7.1.1 Key Findings
- 7.1.2 Market Dynamics
- 7.1.3 Market Sizing and Forecast
  - 7.1.3.1 North America Residual DNA Testing Market, by Country
    - 7.1.3.1.1 U.S.
    - 7.1.3.1.2 Canada
7.2 Europe
- 7.2.1 Key Findings
- 7.2.2 Market Dynamics
- 7.2.3 Market Sizing and Forecast
  - 7.2.3.1 Europe Residual DNA Testing Market, by Country
    - 7.2.3.1.1 Germany
    - 7.2.3.1.2 U.K.
    - 7.2.3.1.3 France
    - 7.2.3.1.4 Italy
    - 7.2.3.1.5 Spain
    - 7.2.3.1.6 Rest of the Europe
7.3 Asia Pacific
- 7.3.1 Key Findings
- 7.3.2 Market Dynamics
- 7.3.3 Market Sizing and Forecast
  - 7.3.3.1 Asia Pacific Residual DNA Testing Market, by Country
    - 7.3.3.1.1 China
    - 7.3.3.1.2 Japan
    - 7.3.3.1.3 India
    - 7.3.3.1.4 Australia
    - 7.3.3.1.5 Rest of Asia Pacific
7.4 Rest of the World
- 7.4.1 Key Findings
- 7.4.2 Market Dynamics
- 7.4.3 Market Sizing and Forecast

8. Global Residual DNA Testing Market: Competitive Landscape and Company Profiles

8.1 Key Strategies and Development
- 8.1.1 Mergers and Acquisitions
- 8.1.2 Synergistic Activities
- 8.1.3 Business Expansions and Funding
- 8.1.4 Product Launches and Approvals
- 8.1.5 Other Activities
8.2 Company Profiles
- 8.2.1 Thermo Fisher Scientific Inc.
  - 8.2.1.1 Overview
  - 8.2.1.2 Top Products / Product Portfolio
  - 8.2.1.3 Top Competitors
  - 8.2.1.4 Target Customers/End-Users
  - 8.2.1.5 Key Personnel
  - 8.2.1.6 Analyst View
- 8.2.2 Charles River Laboratories
  - 8.2.2.1 Overview
  - 8.2.2.2 Top Products / Product Portfolio
  - 8.2.2.3 Top Competitors
  - 8.2.2.4 Target Customers/End-Users
  - 8.2.2.5 Key Personnel
  - 8.2.2.6 Analyst View
- 8.2.3 F. Hoffmann-La Roche AG
  - 8.2.3.1 Overview
  - 8.2.3.2 Top Products / Product Portfolio
  - 8.2.3.3 Top Competitors
  - 8.2.3.4 Target Customers/End-Users
  - 8.2.3.5 Key Personnel
  - 8.2.3.6 Analyst View
- 8.2.4 Merck KGaA
  - 8.2.4.1 Overview
  - 8.2.4.2 Top Products / Product Portfolio
  - 8.2.4.3 Top Competitors
  - 8.2.4.4 Target Customers/End-Users
  - 8.2.4.5 Key Personnel
  - 8.2.4.6 Analyst View
- 8.2.5 Eurofins Scientific, Inc.
  - 8.2.5.1 Overview
  - 8.2.5.2 Top Products / Product Portfolio
  - 8.2.5.3 Top Competitors
  - 8.2.5.4 Target Customers/End-Users
  - 8.2.5.5 Key Personnel
  - 8.2.5.6 Analyst View
- 8.2.6 Bio-Rad Laboratories, Inc.
  - 8.2.6.1 Overview
  - 8.2.6.2 Top Products / Product Portfolio
  - 8.2.6.3 Top Competitors
  - 8.2.6.4 Target Customers/End-Users
  - 8.2.6.5 Key Personnel
  - 8.2.6.6 Analyst View
- 8.2.7 QIAGEN N.V.
  - 8.2.7.1 Overview
  - 8.2.7.2 Top Products / Product Portfolio
  - 8.2.7.3 Top Competitors
  - 8.2.7.4 Target Customers/End-Users
  - 8.2.7.5 Key Personnel
  - 8.2.7.6 Analyst View
- 8.2.8 Fujifilm Corporation
  - 8.2.8.1 Overview
  - 8.2.8.2 Top Products / Product Portfolio
  - 8.2.8.3 Top Competitors
  - 8.2.8.4 Target Customers/End-Users
  - 8.2.8.5 Key Personnel
  - 8.2.8.6 Analyst View
- 8.2.9 Revvity
  - 8.2.9.1 Overview
  - 8.2.9.2 Top Products / Product Portfolio
  - 8.2.9.3 Top Competitors
  - 8.2.9.4 Target Customers/End-Users
  - 8.2.9.5 Key Personnel
  - 8.2.9.6 Analyst View
- 8.2.10 Sartorius AG
  - 8.2.10.1 Overview
  - 8.2.10.2 Top Products / Product Portfolio
  - 8.2.10.3 Top Competitors
  - 8.2.10.4 Target Customers/End-Users
  - 8.2.10.5 Key Personnel
  - 8.2.10.6 Analyst View
- 8.2.11 Lonza
  - 8.2.11.1 Overview
  - 8.2.11.2 Top Products / Product Portfolio
  - 8.2.11.3 Top Competitors
  - 8.2.11.4 Target Customers/End-Users
  - 8.2.11.5 Key Personnel
  - 8.2.11.6 Analyst View
- 8.2.12 WuXi AppTec
  - 8.2.12.1 Overview
  - 8.2.12.2 Top Products / Product Portfolio
  - 8.2.12.3 Top Competitors
  - 8.2.12.4 Target Customers/End-Users
  - 8.2.12.5 Key Personnel
  - 8.2.12.6 Analyst View
- 8.2.13 Intertek Group PLC
  - 8.2.13.1 Overview
  - 8.2.13.2 Top Products / Product Portfolio
  - 8.2.13.3 Top Competitors
  - 8.2.13.4 Target Customers/End-Users
  - 8.2.13.5 Key Personnel
  - 8.2.13.6 Analyst View
- 8.2.14 Hillgene Biopharma Co., Ltd.
  - 8.2.14.1 Overview
  - 8.2.14.2 Top Products / Product Portfolio
  - 8.2.14.3 Top Competitors
  - 8.2.14.4 Target Customers/End-Users
  - 8.2.14.5 Key Personnel
  - 8.2.14.6 Analyst View
- 8.2.15 Maravai LifeSciences
  - 8.2.15.1 Overview
  - 8.2.15.2 Top Products / Product Portfolio
  - 8.2.15.3 Top Competitors
  - 8.2.15.4 Target Customers/End-Users
  - 8.2.15.5 Key Personnel
  - 8.2.15.6 Analyst View

9. Research Methodology

简介目录图表

List of Figures

Figure: Global Residual DNA Testing Market (by Offering), $Billion, 2024 and 2035
Figure: Global Residual DNA Testing Market (by Test Type), $Billion, 2024 and 2035
Figure: Global Residual DNA Testing Market (by Technology), $Billion, 2024 and 2035
Figure: Global Residual DNA Testing Market (by Application), $Billion, 2024 and 2035
Figure: Global Residual DNA Testing Market (by End User), $Billion, 2024 and 2035
Figure: Global Residual DNA Testing Market (by Region), $Billion, 2024 and 2035
Figure: Global Residual DNA Testing Market Key Trends, Analysis

List of Tables

Table: Global Residual DNA Testing Market Dynamics, Impact Analysis
Table: Global Residual DNA Testing Market (by Region), $Billion, 2024-2035

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License/价格

残留 DNA 检测市场 - 全球及区域分析：按服务细分、检测类型、技术、应用、最终用户和国家/地区进行的分析和预测（2025 年至 2035 年）

Residual DNA Testing Market - A Global and Regional Analysis: Focus on Offering, Test Type, Technology, Application, End User, Country, and Region - Analysis and Forecast, 2025-2035

目录

执行摘要

第一章全球残留 DNA 检测市场：产业展望

第二章：全球残留 DNA 检测市场（按服务细分）

3. 全球残留 DNA 检测市场（依检测类型）

4. 全球残留 DNA 检测市场（依技术）

5. 全球残留DNA检测市场（依应用）

6. 全球残留 DNA 检测市场（以最终用户划分）

7. 全球残留 DNA 检测市场（按地区）

8. 全球残留 DNA 检测市场：竞争格局与公司概况