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生技設備

生物安全檢測市場規模、佔有率及成長分析（按產品類型、檢測類型、應用和地區分類）－2026-2033年產業預測

市場調查報告書

商品編碼

1901883

生物安全檢測市場規模、佔有率及成長分析（按產品類型、檢測類型、應用和地區分類）－2026-2033年產業預測

Biological Safety Testing Market Size, Share, and Growth Analysis, By Product (Reagents & Kits, Services), By Test Type (Endotoxin Tests, Sterility Tests), By Application, By Region - Industry Forecast 2026-2033

出版日期: 2025年12月16日 | 出版商:

SkyQuest | 英文 157 Pages | 商品交期: 3-5個工作天內

價格

簡介目錄

全球生物安全檢測市場規模預計在 2024 年達到 58.1 億美元，從 2025 年的 64.9 億美元成長到 2033 年的 157.3 億美元，在預測期（2026-2033 年）內複合年成長率為 11.7%。

由於製藥和生物技術行業研發活動的活性化以及醫療保健領域對品管意識的提高，全球生物安全檢測市場預計將顯著成長。該市場涵蓋生物製品（包括疫苗和細胞療法）上市前安全性和有效性的評估。嚴格的監管標準要求進行嚴謹的安全測試，以降低不利事件的風險。此外，對核酸擴增和定序等創新檢測方法的需求不斷成長，提高了檢測潛在污染物的敏感度和特異性，從而提升了患者安全。體外檢測技術（例如基於細胞的檢測和免疫檢測）的日益普及也推動了市場擴張，這些技術能夠提供更快的檢測結果，減少動物試驗，並提高成本效益。

全球生物安全檢測市場促進因素

由於體外檢測方法（包括細胞檢測和免疫檢測）日益受到青睞，全球生物安全檢測市場正經歷顯著成長。這些創新技術相比傳統的動物實驗具有許多優勢，例如更快的檢測速度、更少的動物實驗依賴以及更高的成本效益。隨著越來越多的機構認知到這些現代方法的優勢，體外檢測方法的普及速度正在加快，其應用率也隨之提高。這種轉變不僅符合倫理考量，也促進了整體市場擴張，並凸顯了生物安全檢測領域的變革趨勢。

限制全球生物安全檢測市場的因素

全球生物安全檢測市場的成長可能受到合格檢測技術人員短缺的限制。這些調查方法的複雜性要求專業人員具備生物樣本管理、準確解讀結果以及遵守監管要求等方面的專業知識。缺乏此類訓練有素的人員可能會阻礙市場擴張，因為企業可能難以吸引具備必要專業知識的人才來維持高標準並在行業內進行創新。因此，熟練專業人員的短缺可能會對市場發展速度和服務提升產生重大影響。

全球生物安全檢測市場趨勢

全球生物安全檢測市場呈現顯著成長趨勢，這主要得益於醫療保健產業對病人安全的日益重視。隨著對高品質生物製藥需求的不斷成長，包括醫療服務提供者、監管機構和生產商在內的相關人員相關方正優先考慮嚴格的安全通訊協定，以降低受污染或不合格產品帶來的風險。對潛在不利事件的日益關注，強化了全面生物安全檢測的必要性，促使各機構投資於先進的調查方法和技術，從而推動市場成長。因此，市場正朝著加強品管措施、確保各種醫療環境中的病人安全和健康的方向發展。

北美洲
- 美國
- 加拿大
歐洲
- 德國
- 西班牙
- 法國
- 英國
- 義大利
- 其他歐洲地區
亞太地區
- 中國
- 印度
- 日本
- 韓國
- 亞太其他地區
拉丁美洲
- 巴西
- 其他拉丁美洲地區
中東和非洲
- 海灣合作理事會國家
- 南非
- 其他中東和非洲地區

競爭資訊

前五大公司對比
主要企業的市場定位（2025 年）
主要市場參與者所採取的策略
近期市場趨勢
公司市佔率分析（2025 年）
主要企業公司簡介
- 公司詳情
- 產品系列分析
- 依業務板塊進行公司股票分析
- 2023-2025年營收年比比較

主要企業簡介

bioMerieux SA（France）
Charles River Laboratories International, Inc.（United States）
Eurofins Scientific SE（Luxembourg）
Lonza Group Ltd.（Switzerland）
Merck KGaA（Germany）
Samsung Biologics（South Korea）
Sartorius AG（Germany）
SGS Societe Generale de Surveillance SA（Switzerland）
Thermo Fisher Scientific Inc.（United States）
Avance Biosciences（United States）
Promega Corporation（United States）
Toxikon Corporation（United States）
WuXi AppTec（China）
Pace Analytical Services LLC（United States）
Nelson Laboratories, LLC（United States）
BioReliance Corporation（United States）
Microbac Laboratories, Inc.（United States）
Intertek Group plc（United Kingdom）
Covance Inc.（United States）

結論與建議

簡介目錄

Product Code: SQMIG35J2092

Global Biological Safety Testing Market size was valued at USD 5.81 Billion in 2024 and is poised to grow from USD 6.49 Billion in 2025 to USD 15.73 Billion by 2033, growing at a CAGR of 11.7% during the forecast period (2026-2033).

The global biological safety testing market is poised for substantial growth, driven by escalating research and development efforts within the pharmaceutical and biotechnology industries, along with a heightened awareness of quality control in healthcare. This market encompasses the assessment of biological products, including vaccines and cell-based therapies, to ensure their safety and efficacy prior to commercialization. Stringent regulatory standards necessitate rigorous safety testing to mitigate risks of adverse events. Additionally, the rising demand for innovative testing methods, such as nucleic acid amplification and sequencing, enhances detection sensitivity and specificity of potential contaminants, thereby fostering patient safety. The increasing preference for in vitro testing techniques like cell-based assays and immunoassays is also fueling market expansion, offering faster results, reduced animal testing, and greater cost effectiveness.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Biological Safety Testing market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Biological Safety Testing Market Segments Analysis

Global Biological Safety Testing Market is segmented by Product, Test Type, Application and region. Based on Product, the market is segmented into Reagents & Kits, Services and Instruments. Based on Test Type, the market is segmented into Endotoxin Tests, Sterility Tests, Cell Line Authentication & Characterization Tests, Bioburden Tests, Adventitious Agent Detection Tests, Residual Host Contamination Detection Tests and Others. Based on Application, the market is segmented into Vaccines & Therapeutics, Blood & Blood-based Products, Gene Therapy, Tissue & Tissue-based Products, Stem Cell and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Biological Safety Testing Market

The Global Biological Safety Testing market is experiencing a significant boost from the rising preference for in vitro testing methods, including cell-based assays and immunoassays. These innovative techniques present numerous benefits compared to conventional animal testing, such as delivering faster results, minimizing the reliance on animal subjects, and enhancing cost-effectiveness. As more organizations recognize the advantages of these modern approaches, the transition towards in vitro methods is accelerating, leading to increased adoption rates. This shift not only contributes to ethical considerations in testing but also supports the overall expansion of the market, highlighting a transformative trend within the biological safety testing landscape.

Restraints in the Global Biological Safety Testing Market

The growth of the Global Biological Safety Testing market may be hindered by a shortage of qualified professionals skilled in testing techniques. The advanced nature of these methodologies necessitates individuals who possess specialized knowledge in managing biological samples, accurately interpreting results, and adhering to regulatory requirements. The scarcity of such trained personnel can create obstacles for the market's expansion, as organizations may struggle to find the expertise needed to maintain high standards and innovate within the sector. Consequently, this lack of skilled professionals could significantly impact the pace at which the market develops and enhances its service offerings.

Market Trends of the Global Biological Safety Testing Market

The Global Biological Safety Testing market is witnessing a significant trend driven by an increased emphasis on patient safety within the healthcare sector. As the demand for high-quality biological products grows, stakeholders-including healthcare providers, regulatory bodies, and manufacturers-are prioritizing stringent safety protocols to mitigate risks associated with contaminated or substandard products. This heightened awareness of potential adverse events reinforces the necessity for thorough biological safety testing, thereby propelling market growth as organizations invest in advanced testing methodologies and technologies. Consequently, the market is evolving to enhance quality control measures, ensuring the safety and well-being of patients across various healthcare settings.

Introduction

Objectives of the Study
Scope of the Report
Definitions

Research Methodology

Information Procurement
Secondary & Primary Data Methods
Market Size Estimation
Market Assumptions & Limitations

Executive Summary

Global Market Outlook
Supply & Demand Trend Analysis
Segmental Opportunity Analysis

Market Dynamics & Outlook

Market Overview
Market Size
Market Dynamics
- Drivers & Opportunities
- Restraints & Challenges
Porters Analysis
- Competitive rivalry
- Threat of substitute
- Bargaining power of buyers
- Threat of new entrants
- Bargaining power of suppliers

Key Market Insights

Key Success Factors
Degree of Competition
Top Investment Pockets
Market Ecosystem
Market Attractiveness Index, 2025
PESTEL Analysis
Macro-Economic Indicators
Value Chain Analysis
Pricing Analysis
Regulatory Landscape
Case Studies
Technological Advancement

Global Biological Safety Testing Market Size by Product & CAGR (2026-2033)

Market Overview
Reagents & Kits
Services
Instruments

Global Biological Safety Testing Market Size by Test Type & CAGR (2026-2033)

Market Overview
Endotoxin Tests
Sterility Tests
Cell Line Authentication & Characterization Tests
Bioburden Tests
Adventitious Agent Detection Tests
Residual Host Contamination Detection Tests
Others

Global Biological Safety Testing Market Size by Application & CAGR (2026-2033)

Market Overview
Vaccines & Therapeutics
- Vaccines
- Monoclonal Antibodies
- Recombinant Protein
Blood & Blood-based Products
Gene Therapy
Tissue & Tissue-based Products
Stem Cell
Others

Global Biological Safety Testing Market Size & CAGR (2026-2033)

North America (Product, Test Type, Application)
- US
- Canada
Europe (Product, Test Type, Application)
- Germany
- Spain
- France
- UK
- Italy
- Rest of Europe
Asia Pacific (Product, Test Type, Application)
- China
- India
- Japan
- South Korea
- Rest of Asia-Pacific
Latin America (Product, Test Type, Application)
- Brazil
- Rest of Latin America
Middle East & Africa (Product, Test Type, Application)
- GCC Countries
- South Africa
- Rest of Middle East & Africa

Competitive Intelligence

Top 5 Player Comparison
Market Positioning of Key Players, 2025
Strategies Adopted by Key Market Players
Recent Developments in the Market
Company Market Share Analysis, 2025
Company Profiles of All Key Players
- Company Details
- Product Portfolio Analysis
- Company's Segmental Share Analysis
- Revenue Y-O-Y Comparison (2023-2025)

Key Company Profiles

bioMerieux S.A. (France)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Charles River Laboratories International, Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Eurofins Scientific SE (Luxembourg)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Lonza Group Ltd. (Switzerland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Merck KGaA (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Samsung Biologics (South Korea)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Sartorius AG (Germany)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
SGS Societe Generale de Surveillance SA (Switzerland)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Thermo Fisher Scientific Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Avance Biosciences (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Promega Corporation (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Toxikon Corporation (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
WuXi AppTec (China)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Pace Analytical Services LLC (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Nelson Laboratories, LLC (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
BioReliance Corporation (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Microbac Laboratories, Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Intertek Group plc (United Kingdom)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments
Covance Inc. (United States)
- Company Overview
- Business Segment Overview
- Financial Updates
- Key Developments