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市场调查报告书
商品编码
1832025

2025 年至 2033 年生物安全检测市场规模、份额、趋势及预测（按产品和服务、检测类型、应用和地区划分）

Biological Safety Testing Market Size, Share, Trends, and Forecast by Product and Services, Test Type, Application, and Region, 2025-2033
出版日期: | 出版商: IMARC | 英文 148 Pages | 商品交期: 2-3个工作天内

价格

2024年，全球生物安全检测市场规模为49.5亿美元。展望未来， IMARC Group估计，到2033年，市场规模将达到132.9亿美元，2025-2033年期间的复合年增长率为10.38%。目前，北美占据市场主导地位，2024年其市占率将超过38.8%。製药和生物技术领域的扩张、新冠疫情的影响以及对法规遵循和安全标准的日益重视，是生物安全检测市场份额成长的主要因素。

由于医疗保健需求的不断增长和慢性病的流行，对生物製药、疫苗和生物仿製药的需求不断增长，推动了生物安全检测市场的发展。严格的产品安全性和有效性监管准则，以及对生物技术研发不断增长的投资，进一步推动了市场的成长。细胞和基因疗法的进步以及合约研究组织 (CRO) 的扩张也推动了对可靠安全测试的需求。传染病和大流行病防范的增加加速了疫苗的生产，因此需要进行严格的安全测试。自动化系统和高通量筛选等测试技术的创新提高了测试效率，促进了市场的扩张。人们对产品品质的认识不断提高，进一步推动了全球生物安全检测市场的成长。

美国生物安全检测市场受慢性病和传染病发病率上升导致对生物製药、疫苗和先进疗法的需求不断增长的推动。 FDA 和其他机构制定的严格监管标准要求进行全面的安全检测，以确保产品品质和合规性。美国在采用创新检测技术方面也处于领先地位，包括自动化和高通量系统，从而提高了检测的准确性和效率。此外，知名製药公司的出现、对疫情防控的高度重视以及合约研究组织 (CRO) 的蓬勃发展，也代表了生物安全检测市场的一些关键趋势。例如，2024 年 10 月，在美国马里兰州罗克维尔，德国达姆施塔特默克集团旗下生命科学部门 MilliporeSigma 推出了价值 2.9 亿欧元的全新生物安全检测设施。对于传统和创新模式而言，生物安全检测和分析开发是药物开发和商业化的重要组成部分。全球对这些服务的需求正以两位数的速度成长。此次扩建是该公司历史上在合约测试方面最大的投资，它将能够在单一综合中心推动自动化和技术发展。

生物安全测试市场趋势：

不断扩大的製药和生物技术领域

由于研发投入的增加，製药和生物技术产业正在蓬勃发展。一份产业报告显示，2023年全球製药业的研发支出超过约3,000亿美元。这些产业主导着针对各种疾病（包括复杂疾病）的药物、生物製剂和疫苗的开发。因此，对全面安全评估的需求日益增加，而生物安全测试对于保障病人安全至关重要。它需要对细菌、病毒和内毒素等污染物进行全面评估，确保符合安全和法律要求。同时，疾病的演变和产品的持续创新使得对安全测试的需求持续旺盛，包括对基因和细胞疗法等新兴疗法的专门评估，这极大地促进了生物安全测试市场的需求。

COVID-19 疫情的影响

新冠疫情加速了疫苗和治疗方法的研发和部署，对疫苗产业产生了重大影响。例如，根据世界卫生组织 (WHO) 的数据，截至 2021 年，全球已接种超过 130 亿剂新冠疫苗。这凸显了严格的安全测试至关重要。此外，全球各国政府和监管机构加强了对这些产品的审查，导致对各种测试服务的需求激增，包括疫苗安全性评估、病毒检测以及新冠诊断和治疗的品质控制措施。此外，疫情改变了产业的重点，并强调了为即将到来的卫生紧急情况做好准备的必要性，从而保持了市场的成长。

日益重视监理合规性

全球监管机构正在加强对生物製药产品的监管，强调病人安全和产品品质。这些法规要求进行全面的安全评估，使生物安全性测试成为药品审批不可或缺的一部分。过去几年，基因和细胞疗法等先进疗法药物获得了越来越多的批准。例如，欧洲药品管理局先进疗法委员会在2024年5月的全体会议上通过了一份关于Durveqtix（fidanacogene elaparvovec）的积极意见草案，该药物用于治疗重度和中度血友病B。这反映了获批先进疗法药物（ATMP）数量持续增长的总体趋势。製药和生技企业必须严格遵守不断变化的标准才能获得产品审批和市场准入，这凸显了对检测服务的需求日益增长，生物安全性合规测试的重要性也因此凸显。此外，监管法规日益复杂，尤其对于基因和细胞疗法等复杂疗法而言，也凸显了专业检测的必要性。随着专家评估适应这些治疗方法的独特特点，确保其有效性和安全性，同时满足不断变化的监管要求，这保持了市场成长。

目录

第一章：前言

第二章：范围与方法

  • 研究目标
  • 利害关係人
  • 资料来源
    • 主要来源
    • 二手资料
  • 市场评估
    • 自下而上的方法
    • 自上而下的方法
  • 预测方法

第三章：执行摘要

第四章：简介

第五章：全球生物安全检测市场

  • 市场概况
  • 市场表现
  • COVID-19的影响
  • 市场预测

第六章：市场区隔：依产品与服务

  • 试剂盒和试剂
  • 仪器
  • 服务

第七章：市场区隔：依测试类型

  • 内毒素检测
  • 无菌测试
  • 细胞株鑑定和特性测试
  • 生物负载测试
  • 残留宿主污染物检测测试
  • 外来因子检测试验
  • 其他的

第 8 章：市场区隔：按应用

  • 疫苗研发
  • 血液製品检测
  • 细胞和基因治疗
  • 组织及组织相关产品检测
  • 干细胞研究

第九章：市场细分：依地区

  • 北美洲
    • 美国
    • 加拿大
  • 亚太
    • 中国
    • 日本
    • 印度
    • 韩国
    • 澳洲
    • 印尼
    • 其他的
  • 欧洲
    • 德国
    • 法国
    • 英国
    • 义大利
    • 西班牙
    • 俄罗斯
    • 其他的
  • 拉丁美洲
    • 巴西
    • 墨西哥
    • 其他的
  • 中东和非洲

第 10 章：SWOT 分析

第 11 章：价值链分析

第 12 章：波特五力分析

第十三章：价格分析

第 14 章：竞争格局

  • 市场结构
  • 关键参与者
  • 关键参与者简介
    • Avance Biosciences
    • Charles River Laboratories
    • Creative Biogene
    • Eurofins Scientific
    • Lonza Group AG
    • Maravai LifeSciences
    • Pace Analytical Services Inc.
    • Pacific BioLabs
    • Sartorius AG
    • SGS SA
    • ViruSure GmbH (Asahi Kasei Corporation)
    • WuXi Biologics
Product Code: SR112025A4634

The global biological safety testing market size was valued at USD 4.95 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 13.29 Billion by 2033, exhibiting a CAGR of 10.38% during 2025-2033. North America currently dominates the market, holding a significant market share of over 38.8% in 2024. The expansion of the pharmaceutical and biotechnology sectors, the impact of the COVID-19 pandemic, and the rising emphasis on regulatory compliance and safety standards are some of the major factors increasing the biological safety testing market share.

The increasing demand for biopharmaceuticals, vaccines, and biosimilars drives the biological safety testing market due to rising healthcare needs and chronic disease prevalence. Stringent regulatory guidelines for product safety and efficacy, and the growing investment in biotechnology research and development, further fuel market growth. Advancements in cell and gene therapies and the expansion of contract research organizations (CROs) have also boosted the demand for reliable safety testing. The rise in infectious diseases and pandemic preparedness has accelerated vaccine production, necessitating rigorous safety testing. Innovations in testing technologies, such as automated systems and high-throughput screening, enhance testing efficiency, contributing to the market's expansion. The increasing awareness about product quality further drives the biological safety testing market growth across the globe.

The biological safety testing market in the United States is driven by the growing demand for biopharmaceuticals, vaccines, and advanced therapies due to the rising prevalence of chronic and infectious diseases. Stringent regulatory standards from the FDA and other authorities necessitate comprehensive safety testing to ensure product quality and compliance. The U.S. is also a leader in adopting innovative testing technologies, including automation and high-throughput systems, enhancing testing accuracy and efficiency. Additionally, the presence of well-established pharmaceutical companies, a strong focus on pandemic preparedness, and the growth of contract research organizations (CROs) represent some of the key biological safety testing market trends. For instance, in October 2024, in Rockville, Maryland, USA, MilliporeSigma, the Life Science division of Merck KGaA, Darmstadt, Germany, unveiled a new biosafety testing facility worth €290 million. For conventional and innovative modalities, biosafety testing and analytical development are essential elements of medication development and commercialization. The demand for these services is increasing at a double-digit rate on a global scale. The company will be able to drive automation and technological development in a single integrated hub due to this expansion, which represents the largest investment in contract testing in its history.

Biological Safety Testing Market Trends:

Expanding Pharmaceutical and Biotechnology Sectors

The pharmaceutical and biotechnology industries are expanding due to increased investments in research and development. According to an industrial report, in 2023, global R&D spending in the pharmaceutical sector exceeded approximately USD 300 billion. The development of medications, biologics, and vaccines for a range of medical conditions, including complicated illnesses, is dominated by these sectors. As a result, there is a greater need for thorough safety evaluations, and biological safety testing is essential to guaranteeing patient safety. It entails comprehensive assessments for pollutants including bacteria, viruses, and endotoxins, ensuring adherence to safety and legal requirements. Concurrently, the evolving nature of diseases and the continuous innovation in products maintain a high demand for safety testing, including specialized assessments for emerging therapies including gene and cell therapies, contributing significantly to the biological safety testing market demand.

Impact of the COVID-19 Pandemic

The COVID-19 pandemic has significantly impacted the industry by accelerating the development and deployment of vaccines and treatments. For instance, according to the World Health Organization (WHO), more than 13 billion COVID-19 vaccine doses were administered globally by 2021. This has emphasized the crucial role of rigorous safety testing. In addition to this, governments and regulatory authorities globally have intensified their scrutiny of these products, leading to a surge in demand for various testing services, including vaccine safety assessments, virus detection assays, and quality control measures for COVID-19 diagnostics and treatments. In addition, the pandemic has changed the industry's emphasis by emphasizing the necessity of readiness for upcoming health emergencies, which has maintained market expansion.

Rising Emphasis on Regulatory Compliance

Global regulatory bodies are tightening oversight of biopharmaceutical products, emphasizing patient safety and product quality. These regulations mandate comprehensive safety evaluations, making biological safety testing integral to drug approvals. Advanced therapy medicinal products, such as gene and cell therapies, have been receiving more approvals over the past few years. For example, the Committee for Advanced Therapies of the European Medicines Agency adopted a positive draft opinion for Durveqtix (fidanacogene elaparvovec) during its plenary meeting in May 2024 for the treatment of severe and moderately severe haemophilia B. This is part of a general trend where the number of approved ATMPs is constantly on the rise. The need for testing services is increased and the significance of biological safety testing in compliance is emphasized by the strict adherence to changing standards that pharmaceutical and biotech businesses must follow to obtain product approval and market access. Additionally, the necessity for specialist testing is highlighted by the growing complexity of regulatory regulations, particularly for sophisticated therapeutics like gene and cell therapies. As specialist evaluations adjust to the distinct features of these treatments, guaranteeing their efficacy and safety while satisfying changing regulatory requirements, this maintains market growth.

Biological Safety Testing Industry Segmentation:

Analysis by Product and Services:

  • Kits and Reagents
  • Instruments
  • Services

Kits and reagents leads the market with around 41.3% of market share in 2024. The increasing trend towards decentralized testing and point-of-care (POC) diagnostics driving the need for user-friendly and portable testing kits represents one of the prime factors fueling the demand for biological safety testing. These kits enable healthcare professionals to perform safety assessments quickly and efficiently, especially in resource-limited settings. In confluence with this, the expansion of research and development activities in the life sciences, including genomics, proteomics, and cell culture, necessitates a continuous supply of high-quality testing reagents and kits for various applications, spurring market growth. Furthermore, the growing focus on ensuring product quality and safety in the food and beverage (F&B) industry, where biological contaminants can pose significant risks, is boosting demand for testing kits and reagents for microbiological analysis, aiding market expansion.

Analysis by Test Type:

  • Endotoxin Tests
  • Sterility Tests
  • Cell Line Authentication and Characterization Tests
  • Bioburden Tests
  • Residual Host Contaminant Detection Tests
  • Adventitious Agent Detection Tests
  • Others

Endotoxin tests leads the market with around 24.9% of market share in 2024. The rising demand for endotoxin tests primarily propelled by the critical need to ensure the safety and efficacy of medical devices and pharmaceutical products is strengthening the global biological safety testing market. Endotoxins, toxic substances present in the cell walls of Gram-negative bacteria, can lead to severe health complications when introduced into the human body. The increasing complexity and diversity of medical devices, including implants and drug delivery systems, necessitate stringent testing for endotoxins to mitigate potential patient risk. Furthermore, the rising focus on personalized medicine and biopharmaceuticals, such as gene therapies and monoclonal antibodies, requires meticulous endotoxin testing to guarantee the purity and safety of these advanced therapies, strengthening the market. Besides this, regulatory agencies worldwide mandate compliance with strict endotoxin limits, reinforcing the demand for accurate and reliable endotoxin tests in pharmaceutical manufacturing and healthcare settings, thereby bolstering the market growth.

Analysis by Application:

  • Vaccine Development
  • Blood Products Testing
  • Cellular and Gene Therapy
  • Tissue and Tissue-related Products Testing
  • Stem Cell Research

Vaccine development leads the market with around 28.7% of market share in 2024. The demand for biological safety testing in vaccine development is primarily propelled by the urgent global need for safe and effective vaccines. As the world faces various infectious diseases and viral outbreaks, including the COVID-19 pandemic, there is an unprecedented focus on vaccine development. Regulatory authorities require comprehensive safety assessments to ensure that vaccines are not only effective but also free from harmful contaminants. Biological safety testing plays a critical role in this process, involving the evaluation of vaccine candidates for potential viral and microbial contaminants, ensuring the absence of endotoxins, and assessing their overall safety for human use. Moreover, the emergence of novel vaccine technologies, such as mRNA-based vaccines, necessitates specialized safety evaluations, contributing to the growing demand for biological safety testing services. This heightened emphasis on vaccine safety underscores the crucial role played by such testing in safeguarding public health on a global scale.

Regional Analysis

  • North America
    • United States
    • Canada
  • Europe
    • Germany
    • France
    • United Kingdom
    • Italy
    • Spain
    • Russia
    • Others
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Indonesia
    • Others
  • Latin America
    • Brazil
    • Mexico
    • Others
  • Middle East and Africa

In 2024, North America accounted for the largest market share of over 38.8%. North America boasts a robust pharmaceutical and biotechnology industry, with a strong emphasis on research and development. The constant innovation and introduction of new drugs, biologics, and medical devices necessitate rigorous safety evaluations, driving the demand for biological safety testing services. In addition to this, the region's proactive regulatory environment, governed by stringent standards set by the FDA and other regulatory bodies, mandates comprehensive safety assessments, further propelling market growth. Moreover, the ongoing efforts to combat public health threats, such as the COVID-19 pandemic, have heightened the demand for vaccine development and testing, particularly in North America, where numerous pharmaceutical companies and research institutions are actively involved in vaccine research and production. These factors, combined with the region's advanced healthcare infrastructure and the increasing awareness of product quality and safety, continue to fuel the expansion of the North America biological safety testing market.

Key Regional Takeaways:

United States Biological Safety Testing Market Analysis

In 2024, the United States accounted for the largest market share of over 88.60% in North America. There are increased growth aspects related to U.S. biological safety testing with an increase in the development of pharmaceuticals, the rise of treatments based on biologics. In 2023 alone, the FDA approved 25 biologics under 55 newly approved drugs; 12 monoclonal antibodies (mAbs) and 5 of those were either an enzyme or protein. According to an industrial report, as of January 2024, there were 20,465 clinical trials accepting patients in the United States that clinically signified the growing need for biologics safety testing. There are major vendors of companies such as Charles River Laboratories and WuXi AppTec, which are interested in bringing testing technologies forward. The high urge for advanced safety testing of gene therapies and vaccines further amplified the market growth. The increasing focus on in-vitro testing and automation is also augmenting enhanced market efficiency. Improvements in technology are enhancing testing accuracy and reducing the turnaround time, while higher standards of safety regulatory requirements continue to drive innovation that positions the United States as the key player globally in the field of biological safety testing.

Europe Biological Safety Testing Market Analysis

The biological safety testing market is also growing in Europe due to strong regulatory framework and increased demands for safe pharmaceutical and biologic products. A recent industrial report suggests that revenue in the European pharmaceutical industry already surpassed EUR 300 billion (USD 309 billion) in 2022, which creates high demand for solutions in terms of safety testing. Germany and Switzerland happen to be strong market contributors while the pharmaceutical leaders Roche and Bayer are always concerned about their biologic safety. In more detail, especially, regulatory institutions such as EMA have upgraded testing standards due to which more quality biologic testing services flourished. Growth in the demand for clinical research, gene therapy, and also the increasing significance of biosimilars fuels the market demand. Additionally, the emerging concept of personalized medicine, coupled with precision testing, is further changing the playing field for regional safety testing service providers. Efficiency in testing has been improved with the increasing utilization of automation and AI technology.

Asia Pacific Biological Safety Testing Market Analysis

Asia Pacific's market for biological safety testing is fast growing due to increased investments in biotechnology as well as increasing pharmaceutical manufacturing. According to industrial reports, China's pharmaceutical market reached a value of USD 160 billion in 2023, which also led to greater demand for biologics. Rising population with above the age bracket population makes investment by the nation, in region attractive to multinationals for example Labcorp and Bio-merieux extending the presence based on rising spending in R and D. Advanced technologies like high-throughput testing and next-generation sequencing have been adopted by the biotech sector in the region, leading to a more sophisticated safety testing environment. In addition, strong manufacturing capabilities in the region along with cost-effective testing solutions have made it an important player in the global biological safety testing arena.

Latin America Biological Safety Testing Market Analysis

The biological safety testing market in Latin America is also on the rise, that is driven by growing pharmaceutical production and a deepening focus on compliance with international standards for safety. Brazil leads this boom, and the growing demand for biologic safety testing services can be tracked in response to the country's further increasing biologics production capability. Argentina and Mexico are also contributing to the growth through investments in upgrading their pharmaceutical manufacturing capabilities. According to an industry report, as of April 2024, Brazil boasts the highest number of clinical trials in the region with approximately 10,000 studies. Mexico ranks next with about 5,000 studies. Thus, this signifies a heavy reliance on clinical research and biologic safety. Testing requirements have become even more rigorous on the part of Brazil's regulatory body, ANVISA. This is leading to increased demands for high-tech safety testing to meet the new international standards set. Moreover, the investment by local manufacturers in testing services and infrastructure enhancement to meet the increasing demands is directly contributing to the expanding market and makes the region increasingly significant in the global biological safety testing market.

Middle East and Africa Biological Safety Testing Market Analysis

In the Middle East and Africa, the biological safety testing market is burgeoning, driven by increased healthcare investment and pharmaceutical production in many countries. Saudi Arabia's defense spending, which includes allocations for medical and pharmaceutical safety, fuels the growth of the market. The pharmaceutical market in the UAE remains in growth mode, and biological safety testing is fast becoming a key area of focus. South Africa is emerging as one of the key biomanufacturing hubs. There is a huge growth in domestic biologic production. There are 4,593 clinical trials in the Middle East and 861 in Africa as of 2022 according to the WHO International Clinical Trial Registry Platform, where there is increased demand for clinical research and biologic safety. Demand for biological safety testing services will be raised due to increases in healthcare facilities and clinical trials in the region. Testing service will grow annually at 10% over the next five years. This trend is further supported by the efforts of local governments to improve healthcare standards and infrastructure.

Competitive Landscape:

The fierce competition among major companies in the global biological safety testing market is a result of the sector's vital role in guaranteeing the quality and safety of pharmaceuticals, biologics, and medical devices. Prominent companies in this landscape engage in various strategies to maintain their market positions, such as mergers, acquisitions, and collaborations to expand their service portfolios and geographic reach. Furthermore, companies can also remain ahead of industry trends by investing in research and development to adopt cutting-edge testing technologies and procedures. The increasing focus on personalized medicine and advanced therapies, such as gene and cell therapies, presents growth opportunities for firms specializing in specialized safety testing services. Overall, the competitive landscape of the global biological safety testing market is marked by a dynamic interplay of established players.

The market research report has provided a comprehensive analysis of the competitive landscape. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

  • Avance Biosciences
  • Charles River Laboratories
  • Creative Biogene
  • Eurofins Scientific
  • Lonza Group AG
  • Maravai LifeSciences
  • Pace Analytical Services Inc.
  • Pacific BioLabs
  • Sartorius AG
  • SGS SA
  • ViruSure GmbH (Asahi Kasei Corporation)
  • WuXi Biologics

Key Questions Answered in This Report

  • 1.How big is the biological safety testing market?
  • 2.What is the future outlook of biological safety testing market?
  • 3.What are the key factors driving the biological safety testing market?
  • 4.Which region accounts for the largest biological safety testing market share?
  • 5.Which are the leading companies in the global biological safety testing market?

Table of Contents

1 Preface

2 Scope and Methodology

  • 2.1 Objectives of the Study
  • 2.2 Stakeholders
  • 2.3 Data Sources
    • 2.3.1 Primary Sources
    • 2.3.2 Secondary Sources
  • 2.4 Market Estimation
    • 2.4.1 Bottom-Up Approach
    • 2.4.2 Top-Down Approach
  • 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

  • 4.1 Overview
  • 4.2 Key Industry Trends

5 Global Biological Safety Testing Market

  • 5.1 Market Overview
  • 5.2 Market Performance
  • 5.3 Impact of COVID-19
  • 5.4 Market Forecast

6 Market Breakup by Product and Services

  • 6.1 Kits and Reagents
    • 6.1.1 Market Trends
    • 6.1.2 Market Forecast
  • 6.2 Instruments
    • 6.2.1 Market Trends
    • 6.2.2 Market Forecast
  • 6.3 Services
    • 6.3.1 Market Trends
    • 6.3.2 Market Forecast

7 Market Breakup by Test Type

  • 7.1 Endotoxin Tests
    • 7.1.1 Market Trends
    • 7.1.2 Market Forecast
  • 7.2 Sterility Tests
    • 7.2.1 Market Trends
    • 7.2.2 Market Forecast
  • 7.3 Cell Line Authentication and Characterization Tests
    • 7.3.1 Market Trends
    • 7.3.2 Market Forecast
  • 7.4 Bioburden Tests
    • 7.4.1 Market Trends
    • 7.4.2 Market Forecast
  • 7.5 Residual Host Contaminant Detection Tests
    • 7.5.1 Market Trends
    • 7.5.2 Market Forecast
  • 7.6 Adventitious Agent Detection Tests
    • 7.6.1 Market Trends
    • 7.6.2 Market Forecast
  • 7.7 Others
    • 7.7.1 Market Trends
    • 7.7.2 Market Forecast

8 Market Breakup by Application

  • 8.1 Vaccine Development
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 Blood Products Testing
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast
  • 8.3 Cellular and Gene Therapy
    • 8.3.1 Market Trends
    • 8.3.2 Market Forecast
  • 8.4 Tissue and Tissue-related Products Testing
    • 8.4.1 Market Trends
    • 8.4.2 Market Forecast
  • 8.5 Stem Cell Research
    • 8.5.1 Market Trends
    • 8.5.2 Market Forecast

9 Market Breakup by Region

  • 9.1 North America
    • 9.1.1 United States
      • 9.1.1.1 Market Trends
      • 9.1.1.2 Market Forecast
    • 9.1.2 Canada
      • 9.1.2.1 Market Trends
      • 9.1.2.2 Market Forecast
  • 9.2 Asia-Pacific
    • 9.2.1 China
      • 9.2.1.1 Market Trends
      • 9.2.1.2 Market Forecast
    • 9.2.2 Japan
      • 9.2.2.1 Market Trends
      • 9.2.2.2 Market Forecast
    • 9.2.3 India
      • 9.2.3.1 Market Trends
      • 9.2.3.2 Market Forecast
    • 9.2.4 South Korea
      • 9.2.4.1 Market Trends
      • 9.2.4.2 Market Forecast
    • 9.2.5 Australia
      • 9.2.5.1 Market Trends
      • 9.2.5.2 Market Forecast
    • 9.2.6 Indonesia
      • 9.2.6.1 Market Trends
      • 9.2.6.2 Market Forecast
    • 9.2.7 Others
      • 9.2.7.1 Market Trends
      • 9.2.7.2 Market Forecast
  • 9.3 Europe
    • 9.3.1 Germany
      • 9.3.1.1 Market Trends
      • 9.3.1.2 Market Forecast
    • 9.3.2 France
      • 9.3.2.1 Market Trends
      • 9.3.2.2 Market Forecast
    • 9.3.3 United Kingdom
      • 9.3.3.1 Market Trends
      • 9.3.3.2 Market Forecast
    • 9.3.4 Italy
      • 9.3.4.1 Market Trends
      • 9.3.4.2 Market Forecast
    • 9.3.5 Spain
      • 9.3.5.1 Market Trends
      • 9.3.5.2 Market Forecast
    • 9.3.6 Russia
      • 9.3.6.1 Market Trends
      • 9.3.6.2 Market Forecast
    • 9.3.7 Others
      • 9.3.7.1 Market Trends
      • 9.3.7.2 Market Forecast
  • 9.4 Latin America
    • 9.4.1 Brazil
      • 9.4.1.1 Market Trends
      • 9.4.1.2 Market Forecast
    • 9.4.2 Mexico
      • 9.4.2.1 Market Trends
      • 9.4.2.2 Market Forecast
    • 9.4.3 Others
      • 9.4.3.1 Market Trends
      • 9.4.3.2 Market Forecast
  • 9.5 Middle East and Africa
    • 9.5.1 Market Trends
    • 9.5.2 Market Breakup by Country
    • 9.5.3 Market Forecast

10 SWOT Analysis

  • 10.1 Overview
  • 10.2 Strengths
  • 10.3 Weaknesses
  • 10.4 Opportunities
  • 10.5 Threats

11 Value Chain Analysis

12 Porters Five Forces Analysis

  • 12.1 Overview
  • 12.2 Bargaining Power of Buyers
  • 12.3 Bargaining Power of Suppliers
  • 12.4 Degree of Competition
  • 12.5 Threat of New Entrants
  • 12.6 Threat of Substitutes

13 Price Analysis

14 Competitive Landscape

  • 14.1 Market Structure
  • 14.2 Key Players
  • 14.3 Profiles of Key Players
    • 14.3.1 Avance Biosciences
      • 14.3.1.1 Company Overview
      • 14.3.1.2 Product Portfolio
      • 14.3.1.3 SWOT Analysis
    • 14.3.2 Charles River Laboratories
      • 14.3.2.1 Company Overview
      • 14.3.2.2 Product Portfolio
      • 14.3.2.3 SWOT Analysis
    • 14.3.3 Creative Biogene
      • 14.3.3.1 Company Overview
      • 14.3.3.2 Product Portfolio
      • 14.3.3.3 SWOT Analysis
    • 14.3.4 Eurofins Scientific
      • 14.3.4.1 Company Overview
      • 14.3.4.2 Product Portfolio
      • 14.3.4.3 SWOT Analysis
    • 14.3.5 Lonza Group AG
      • 14.3.5.1 Company Overview
      • 14.3.5.2 Product Portfolio
      • 14.3.5.3 SWOT Analysis
    • 14.3.6 Maravai LifeSciences
      • 14.3.6.1 Company Overview
      • 14.3.6.2 Product Portfolio
      • 14.3.6.3 SWOT Analysis
    • 14.3.7 Pace Analytical Services Inc.
      • 14.3.7.1 Company Overview
      • 14.3.7.2 Product Portfolio
      • 14.3.7.3 SWOT Analysis
    • 14.3.8 Pacific BioLabs
      • 14.3.8.1 Company Overview
      • 14.3.8.2 Product Portfolio
      • 14.3.8.3 SWOT Analysis
    • 14.3.9 Sartorius AG
      • 14.3.9.1 Company Overview
      • 14.3.9.2 Product Portfolio
      • 14.3.9.3 SWOT Analysis
    • 14.3.10 SGS SA
      • 14.3.10.1 Company Overview
      • 14.3.10.2 Product Portfolio
      • 14.3.10.3 SWOT Analysis
    • 14.3.11 ViruSure GmbH (Asahi Kasei Corporation)
      • 14.3.11.1 Company Overview
      • 14.3.11.2 Product Portfolio
      • 14.3.11.3 SWOT Analysis
    • 14.3.12 WuXi Biologics
      • 14.3.12.1 Company Overview
      • 14.3.12.2 Product Portfolio
      • 14.3.12.3 SWOT Analysis

List of Figures

  • Figure 1: Global: Biological Safety Testing Market: Major Drivers and Challenges
  • Figure 2: Global: Biological Safety Testing Market: Sales Value (in Billion USD), 2019-2024
  • Figure 3: Global: Biological Safety Testing Market Forecast: Sales Value (in Billion USD), 2025-2033
  • Figure 4: Global: Biological Safety Testing Market: Breakup by Product and Services (in %), 2024
  • Figure 5: Global: Biological Safety Testing Market: Breakup by Test Type (in %), 2024
  • Figure 6: Global: Biological Safety Testing Market: Breakup by Application (in %), 2024
  • Figure 7: Global: Biological Safety Testing Market: Breakup by Region (in %), 2024
  • Figure 8: Global: Biological Safety Testing (Kits and Reagents) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 9: Global: Biological Safety Testing (Kits and Reagents) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 10: Global: Biological Safety Testing (Instruments) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 11: Global: Biological Safety Testing (Instruments) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 12: Global: Biological Safety Testing (Services) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 13: Global: Biological Safety Testing (Services) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 14: Global: Biological Safety Testing (Endotoxin Tests) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 15: Global: Biological Safety Testing (Endotoxin Tests) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 16: Global: Biological Safety Testing (Sterility Tests) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 17: Global: Biological Safety Testing (Sterility Tests) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 18: Global: Biological Safety Testing (Cell Line Authentication and Characterization Tests) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 19: Global: Biological Safety Testing (Cell Line Authentication and Characterization Tests) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 20: Global: Biological Safety Testing (Bioburden Tests) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 21: Global: Biological Safety Testing (Bioburden Tests) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 22: Global: Biological Safety Testing (Residual Host Contaminant Detection Tests) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 23: Global: Biological Safety Testing (Residual Host Contaminant Detection Tests) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 24: Global: Biological Safety Testing (Adventitious Agent Detection Tests) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 25: Global: Biological Safety Testing (Adventitious Agent Detection Tests) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 26: Global: Biological Safety Testing (Other Test Types) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 27: Global: Biological Safety Testing (Other Test Types) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 28: Global: Biological Safety Testing (Vaccine Development) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 29: Global: Biological Safety Testing (Vaccine Development) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 30: Global: Biological Safety Testing (Blood Products Testing) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 31: Global: Biological Safety Testing (Blood Products Testing) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 32: Global: Biological Safety Testing (Cellular and Gene Therapy) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 33: Global: Biological Safety Testing (Cellular and Gene Therapy) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 34: Global: Biological Safety Testing (Tissue and Tissue-related Products Testing) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 35: Global: Biological Safety Testing (Tissue and Tissue-related Products Testing) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 36: Global: Biological Safety Testing (Stem Cell Research) Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 37: Global: Biological Safety Testing (Stem Cell Research) Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 38: North America: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 39: North America: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 40: United States: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 41: United States: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 42: Canada: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 43: Canada: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 44: Asia-Pacific: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 45: Asia-Pacific: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 46: China: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 47: China: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 48: Japan: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 49: Japan: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 50: India: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 51: India: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 52: South Korea: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 53: South Korea: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 54: Australia: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 55: Australia: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 56: Indonesia: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 57: Indonesia: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 58: Others: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 59: Others: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 60: Europe: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 61: Europe: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 62: Germany: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 63: Germany: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 64: France: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 65: France: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 66: United Kingdom: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 67: United Kingdom: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 68: Italy: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 69: Italy: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 70: Spain: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 71: Spain: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 72: Russia: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 73: Russia: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 74: Others: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 75: Others: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 76: Latin America: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 77: Latin America: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 78: Brazil: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 79: Brazil: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 80: Mexico: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 81: Mexico: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 82: Others: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 83: Others: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 84: Middle East and Africa: Biological Safety Testing Market: Sales Value (in Million USD), 2019 & 2024
  • Figure 85: Middle East and Africa: Biological Safety Testing Market: Breakup by Country (in %), 2024
  • Figure 86: Middle East and Africa: Biological Safety Testing Market Forecast: Sales Value (in Million USD), 2025-2033
  • Figure 87: Global: Biological Safety Testing Industry: SWOT Analysis
  • Figure 88: Global: Biological Safety Testing Industry: Value Chain Analysis
  • Figure 89: Global: Biological Safety Testing Industry: Porter's Five Forces Analysis

List of Tables

  • Table 1: Global: Biological Safety Testing Market: Key Industry Highlights, 2024 and 2033
  • Table 2: Global: Biological Safety Testing Market Forecast: Breakup by Product and Services (in Million USD), 2025-2033
  • Table 3: Global: Biological Safety Testing Market Forecast: Breakup by Test Type (in Million USD), 2025-2033
  • Table 4: Global: Biological Safety Testing Market Forecast: Breakup by Application (in Million USD), 2025-2033
  • Table 5: Global: Biological Safety Testing Market Forecast: Breakup by Region (in Million USD), 2025-2033
  • Table 6: Global: Biological Safety Testing Market: Competitive Structure
  • Table 7: Global: Biological Safety Testing Market: Key Players