生物安全检测产品和服务市场－全球产业规模、份额、趋势、机会和预测，按产品、应用、检测类型、地区和竞争格局划分，2020-2030年预测

2024年全球生物安全检测产品与服务市场规模为47.7亿美元，预计2030年将以9.32%的复合年增长率成长至81.4亿美元。该市场涵盖了对确保疫苗、基因疗法和生物製药等生物製品在其研发和生产生命週期中的纯度、效力和安全性至关重要的检测方法、试剂、仪器和合约检测服务。市场成长的主要驱动因素包括：先进疗法的日益复杂化、全球生物製药审批监管要求的日益严格，以及不断扩充的新型生物製剂和生物相似药研发管线。

主要市场驱动因素

主要市场挑战

主要市场趋势

目录

第一章：产品概述

第二章：研究方法

第三章：执行概要

第四章：顾客之声

第五章：全球生物安全检测产品与服务市场展望

• 市场规模及预测
  • 按价值
• 市占率及预测
  • 依产品分类（试剂与试剂盒、服务、仪器）
  • 依应用领域（疫苗及治疗药物、基因治疗、单株抗体、重组蛋白、血液及血液製品、组织及组织製品、干细胞）
  • 依检测类型（内毒素检测、无菌检测、细胞株鑑定及特性检测、生物负荷检测、外源性因子检测、残留宿主污染检测、其他）
  • 按地区
  • 按公司（2024 年）
• 市场地图

第六章：北美生物安全检测产品与服务市场展望

• 市场规模及预测
• 市占率及预测
• 北美洲：国家分析
  • 美国
  • 加拿大
  • 墨西哥

第七章：欧洲生物安全检测产品与服务市场展望

• 市场规模及预测
• 市占率及预测
• 欧洲：国家分析
  • 德国
  • 法国
  • 英国
  • 义大利
  • 西班牙

第八章：亚太地区生物安全检测产品与服务市场展望

• 市场规模及预测
• 市占率及预测
• 亚太地区：国家分析
  • 中国
  • 印度
  • 日本
  • 韩国
  • 澳洲

第九章：中东和非洲生物安全检测产品和服务市场展望

• 市场规模及预测
• 市占率及预测
• 中东和非洲：国家分析
  • 沙乌地阿拉伯
  • 阿联酋
  • 南非

第十章：南美洲生物安全检测产品与服务市场展望

• 市场规模及预测
• 市占率及预测
• 南美洲：国家分析
  • 巴西
  • 哥伦比亚
  • 阿根廷

第十一章：市场动态

• 司机
• 挑战

第十二章：市场趋势与发展

• 併购（如有）
• 产品发布（如有）
• 最新进展

第十三章：全球生物安全检测产品与服务市场：SWOT分析

第十四章：波特五力分析

• 产业竞争
• 新进入者的潜力
• 供应商议价能力
• 顾客的力量
• 替代产品的威胁

第十五章：竞争格局

• Charles River Laboratories International, Inc.
• BSL Bioservice Scientific Laboratories Munich GmbH
• Merck KGaA
• Samsung Biologics
• Sartorius AG
• Eurofins Scientific (Ireland) Limited
• SGS Societe Generale de Surveillance SA
• Thermo Fisher Scientific Inc.
• BIOMERIEUX SA
• Lonza Group Ltd.

第十六章：策略建议

第17章调查会社について・免责事项

The Global Biological Safety Testing Products and Services Market, valued at USD 4.77 Billion in 2024, is projected to experience a CAGR of 9.32% to reach USD 8.14 Billion by 2030. The Global Biological Safety Testing Products and Services Market encompasses assays, reagents, instruments, and contract testing services crucial for ensuring the purity, potency, and safety of biological products such as vaccines, gene therapies, and biopharmaceuticals throughout their development and manufacturing lifecycle. The market's growth is primarily driven by the increasing complexity of advanced therapeutic modalities, stringent global regulatory mandates for biopharmaceutical approval, and the expanding pipeline of new biologics and biosimilars.

Key Market Drivers

The expanding pipeline of cell and gene therapies and stringent global regulatory requirements for biologics represent two pivotal drivers for the Global Biological Safety Testing Products and Services Market. The increasing proliferation of novel advanced therapeutic modalities, particularly cell and gene therapies, inherently demands extensive and specialized safety assessments throughout their development and manufacturing. These therapies involve complex biological constructs that necessitate rigorous testing to ensure product purity, potency, and freedom from adventitious agents. According to the Alliance for Regenerative Medicine's annual Cell & Gene State of the Industry Briefing, in January 2024, seven cell and gene therapies received FDA approval in the U. S. in 2023, with predictions for up to 17 approvals in the U.S. and EU in 2024.

Key Market Challenges

The substantial capital expenditure required for establishing and maintaining advanced testing infrastructure presents a significant impediment to the growth of the Global Biological Safety Testing Products and Services Market. This financial barrier limits the ability of new service providers to enter the market and hinders existing firms from expanding their capabilities or upgrading to the latest technologies. Developing and equipping laboratories with advanced assays, reagents, and instruments for complex biological product analysis demands considerable upfront investment, directly constraining the overall capacity available to meet increasing industry demand for safety assessments.

Key Market Trends

The Global Biological Safety Testing Products and Services Market is significantly shaped by advancements in rapid and high-throughput testing technologies. These innovations address the critical industry need for accelerated development timelines and increased efficiency in assessing biological product safety. The integration of advanced platforms, such as next-generation sequencing and automated systems, allows for faster detection of contaminants and more comprehensive characterization of complex biologics.

Key Market Players

• Charles River Laboratories International, Inc.
• BSL Bioservice Scientific Laboratories Munich GmbH
• Merck KGaA
• Samsung Biologics
• Sartorius AG
• Eurofins Scientific (Ireland) Limited
• SGS Societe Generale de Surveillance SA
• Thermo Fisher Scientific Inc.
• BIOMERIEUX SA
• Lonza Group Ltd.

Report Scope:

In this report, the Global Biological Safety Testing Products and Services Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Biological Safety Testing Products and Services Market, By Product:

• Reagents & Kits
• Services
• Instruments

Biological Safety Testing Products and Services Market, By Application:

• Vaccines & Therapeutics
• Gene Therapy
• Monoclonal Antibodies
• Recombinant Protein
• Blood & Blood-based Products
• Tissue & Tissue-based Products
• Stem Cells

Biological Safety Testing Products and Services Market, By Test Type:

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

Biological Safety Testing Products and Services Market, By Region:

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Biological Safety Testing Products and Services Market.

Available Customizations:

Global Biological Safety Testing Products and Services Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Biological Safety Testing Products and Services Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Product (Reagents & Kits, Services, Instruments)
  • 5.2.2. By Application (Vaccines & Therapeutics, Gene Therapy, Monoclonal Antibodies, Recombinant Protein, Blood & Blood-based Products, Tissue & Tissue-based Products, Stem Cells)
  • 5.2.3. By Test Type (Endotoxin Tests, Sterility Tests, Cell Line Authentication & Characterization Tests, Bioburden Tests, Adventitious Agent Detection Tests, Residual Host Contamination Detection Tests, Others)
  • 5.2.4. By Region
  • 5.2.5. By Company (2024)
• 5.3. Market Map

6. North America Biological Safety Testing Products and Services Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Product
  • 6.2.2. By Application
  • 6.2.3. By Test Type
  • 6.2.4. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Biological Safety Testing Products and Services Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Product
      • 6.3.1.2.2. By Application
      • 6.3.1.2.3. By Test Type
  • 6.3.2. Canada Biological Safety Testing Products and Services Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Product
      • 6.3.2.2.2. By Application
      • 6.3.2.2.3. By Test Type
  • 6.3.3. Mexico Biological Safety Testing Products and Services Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Product
      • 6.3.3.2.2. By Application
      • 6.3.3.2.3. By Test Type

7. Europe Biological Safety Testing Products and Services Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Product
  • 7.2.2. By Application
  • 7.2.3. By Test Type
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Biological Safety Testing Products and Services Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Product
      • 7.3.1.2.2. By Application
      • 7.3.1.2.3. By Test Type
  • 7.3.2. France Biological Safety Testing Products and Services Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Product
      • 7.3.2.2.2. By Application
      • 7.3.2.2.3. By Test Type
  • 7.3.3. United Kingdom Biological Safety Testing Products and Services Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Product
      • 7.3.3.2.2. By Application
      • 7.3.3.2.3. By Test Type
  • 7.3.4. Italy Biological Safety Testing Products and Services Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Product
      • 7.3.4.2.2. By Application
      • 7.3.4.2.3. By Test Type
  • 7.3.5. Spain Biological Safety Testing Products and Services Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Product
      • 7.3.5.2.2. By Application
      • 7.3.5.2.3. By Test Type

8. Asia Pacific Biological Safety Testing Products and Services Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Product
  • 8.2.2. By Application
  • 8.2.3. By Test Type
  • 8.2.4. By Country
• 8.3. Asia Pacific: Country Analysis
  • 8.3.1. China Biological Safety Testing Products and Services Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Product
      • 8.3.1.2.2. By Application
      • 8.3.1.2.3. By Test Type
  • 8.3.2. India Biological Safety Testing Products and Services Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Product
      • 8.3.2.2.2. By Application
      • 8.3.2.2.3. By Test Type
  • 8.3.3. Japan Biological Safety Testing Products and Services Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Product
      • 8.3.3.2.2. By Application
      • 8.3.3.2.3. By Test Type
  • 8.3.4. South Korea Biological Safety Testing Products and Services Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Product
      • 8.3.4.2.2. By Application
      • 8.3.4.2.3. By Test Type
  • 8.3.5. Australia Biological Safety Testing Products and Services Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Product
      • 8.3.5.2.2. By Application
      • 8.3.5.2.3. By Test Type

9. Middle East & Africa Biological Safety Testing Products and Services Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Product
  • 9.2.2. By Application
  • 9.2.3. By Test Type
  • 9.2.4. By Country
• 9.3. Middle East & Africa: Country Analysis
  • 9.3.1. Saudi Arabia Biological Safety Testing Products and Services Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Product
      • 9.3.1.2.2. By Application
      • 9.3.1.2.3. By Test Type
  • 9.3.2. UAE Biological Safety Testing Products and Services Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Product
      • 9.3.2.2.2. By Application
      • 9.3.2.2.3. By Test Type
  • 9.3.3. South Africa Biological Safety Testing Products and Services Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Product
      • 9.3.3.2.2. By Application
      • 9.3.3.2.3. By Test Type

10. South America Biological Safety Testing Products and Services Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Product
  • 10.2.2. By Application
  • 10.2.3. By Test Type
  • 10.2.4. By Country
• 10.3. South America: Country Analysis
  • 10.3.1. Brazil Biological Safety Testing Products and Services Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Product
      • 10.3.1.2.2. By Application
      • 10.3.1.2.3. By Test Type
  • 10.3.2. Colombia Biological Safety Testing Products and Services Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Product
      • 10.3.2.2.2. By Application
      • 10.3.2.2.3. By Test Type
  • 10.3.3. Argentina Biological Safety Testing Products and Services Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Product
      • 10.3.3.2.2. By Application
      • 10.3.3.2.3. By Test Type

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Global Biological Safety Testing Products and Services Market: SWOT Analysis

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Products

15. Competitive Landscape

• 15.1. Charles River Laboratories International, Inc.
  • 15.1.1. Business Overview
  • 15.1.2. Products & Services
  • 15.1.3. Recent Developments
  • 15.1.4. Key Personnel
  • 15.1.5. SWOT Analysis
• 15.2. BSL Bioservice Scientific Laboratories Munich GmbH
• 15.3. Merck KGaA
• 15.4. Samsung Biologics
• 15.5. Sartorius AG
• 15.6. Eurofins Scientific (Ireland) Limited
• 15.7. SGS Societe Generale de Surveillance SA
• 15.8. Thermo Fisher Scientific Inc.
• 15.9. BIOMERIEUX SA
• 15.10. Lonza Group Ltd.

16. Strategic Recommendations

17. About Us & Disclaimer