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1808107

殘留DNA檢測市場 - 全球及區域分析：按服務區分、檢測類型、技術、應用、最終用戶和國家的分析和預測（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個工作天內

價格

簡介目錄圖表

殘留DNA檢測是一種用於檢測和量化生物或藥物過程後樣本中可能殘留的微量DNA的過程。

此類檢測在生物技術、製藥、法醫學和環境科學等領域尤其重要。在生物製藥領域，殘留DNA檢測可確保疫苗、基因治療藥物和生物製劑等產品不含可能影響其安全性和有效性的污染物。這種檢測在生物製藥製造過程中尤其重要，因為宿主細胞的DNA可能殘留在最終產品中。 FDA和EMA等監管機構要求進行嚴格的殘留DNA檢測，以確保產品純度和病患安全。

在法醫學，殘留DNA檢測用於分析犯罪現場、物體表面和體液中殘留的微量DNA，以協助刑事調查和識別。它也用於環境監測和農業領域，檢測水、土壤和農產品中的遺傳物質，有助於生物多樣性調查、污染評估和基因改造作物（GMO）的檢測。

殘留DNA檢測市場的主要成長要素之一是生物製藥需求的不斷成長。隨著疫苗、基因療法藥物和單株抗體等生物製藥產量的擴大，對嚴格的安全措施和品管的需求也日益成長。 FDA和EMA等監管機構要求對這些產品進行徹底的殘留DNA檢測，以確保其不含任何潛在的有害污染物。這確保了生物製藥對人體的安全性，保護了患者的健康和治療的有效性。人們對基因治療和個人化醫療的日益關注，以及生物製藥行業的快速擴張，大幅推動了殘留DNA檢測的需求。

此外，非何傑金氏淋巴瘤（NHL）的發生率不斷上升，尤其是在人口老化背景下，也推動了對先進治療方案的需求。診斷技術的進步使更多患者能夠在早期得到診斷，迅速擴大了殘留DNA檢測相關治療的市場，並為製藥公司開發和商業化創新療法創造了機會。

然而，殘留DNA檢測市場面臨許多挑戰。其中最大的挑戰之一是高成本。諸如次世代定序（NGS）和即時PCR等先進的DNA檢測技術，其實施和維護成本高昂。這可能會限制它們的普及，尤其是在小型實驗室和資源匱乏的地區。

樣本劣化也是一大挑戰。殘留的DNA樣本，尤其是在法醫學和環境領域採集的樣本，通常會劣化或殘留量極低。如果DNA品質不夠，就很難獲得準確可靠的結果。

此外，還存在污染的風險：特別是在法醫學應用中，通常從犯罪現場回收的DNA 量很少，即使在樣本採集、處理和分析過程中出現輕微污染，也會影響結果的可靠性，並導致假陽性或假陰性。

此外，基因資料的使用也存在倫理和隱私方面的擔憂。在法醫學和醫療環境中收集、儲存和使用殘留DNA，會引發資料安全、知情同意以及基因資訊濫用等問題。遵守隱私法規和應對倫理挑戰仍然是市場參與企業面臨的關鍵挑戰。

此外，殘留DNA檢測通訊協定缺乏標準化，阻礙了此技術的廣泛應用。由於缺乏普遍認可的指導方針和品質保證機制，不同實驗室的結果可能會存在差異，影響檢測的可靠性，並限制其在關鍵應用中的使用。

本報告調查了全球殘留DNA檢測市場，並總結了關鍵趨勢、市場影響因素分析、法律制度、技術和專利分析、市場規模趨勢和預測、各個細分市場、地區/主要國家的詳細分析、競爭格局和主要企業的概況。

關鍵策略和發展
公司簡介
- 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9章調查方法

簡介目錄圖表

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

簡介目錄圖表

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