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市场调查报告书
商品编码
1390769

2023-2028 年按产品和服务、测试类型、应用和地区分類的生物安全测试市场报告

Biological Safety Testing Market Report by Product and Services, Test Type, Application, and Region 2023-2028
出版日期: | 出版商: IMARC | 英文 141 Pages | 商品交期: 2-3个工作天内

价格

抽象的

2022年全球生物安全检测市场规模达40亿美元。展望未来， IMARC Group预计到2028年市场规模将达到80亿美元，2022-2028年复合年增长率（CAGR）为12.25%。製药和生物技术行业的扩张、COVID-19 大流行的影响以及对监管合规性和安全标准的日益重视是推动市场的一些主要因素。

生物安全测试是评估与生物产品、物质或材料（包括药品、疫苗和医疗器材）相关的安全性和潜在风险的持续过程。该评估涵盖一系列活动，例如评估微生物、病毒或其他生物製剂污染的可能性，以及检查这些产品对人类、动物或环境的毒性和潜在不利影响。这是确保生物衍生产品符合监管标准并将对公众健康和安全造成的风险降至最低的关键方面。这种持续的测试过程涉及严格的分析和监控，以确保产品在整个生命週期的安全。

在製药和生物技术行业不断扩大以及对其产品进行严格安全评估的需求不断增加的推动下，全球生物安全检测行业正在经历强劲增长。随着这些行业不断创新和开发新药、疫苗和生物製剂，对全面的生物安全测试的需求不断增加，以确保产品的有效性和消费者的安全性，从而创造了积极的市场扩张前景。此外，COVID-19 大流行凸显了疫苗和治疗的重要性，进一步刺激了对生物安全检测服务的需求。此外，世界各地的监管机构越来越强调严格安全评估的必要性，这有助于市场的成长。此外，消费者对产品品质和安全性的认识不断增强，加上个人化医疗的新兴趋势以及基因和细胞疗法等先进疗法的发展，需要专门的安全测试方案，有助于市场扩张。

生物安全测试市场趋势/驱动因素：

扩大製药和生物技术领域

由于研发投资的增加，製药和生技产业正在不断扩张。这些部门在开发药物、生物製品和疫苗方面处于领先地位，以满足各种医疗保健需求，包括复杂疾病。因此，对严格安全评估的需求增加，生物安全测试对于确保病人安全至关重要。它涉及对病毒、微生物和内毒素等污染物的彻底评估，确保符合监管和安全标准。同时，疾病性质的不断演变和产品的不断创新对安全测试保持着很高的需求，包括对基因和细胞疗法等新兴疗法的专门评估，为市场的成长做出了重大贡献。

COVID-19 大流行的影响

COVID-19 大流行加速了疫苗和治疗方法的开发和部署，对该行业产生了重大影响。这强调了严格的安全测试的关键作用。除此之外，全球各国政府和监管机构加强了对这些产品的审查，导致对各种检测服务的需求激增，包括疫苗安全评估、病毒检测分析以及 COVID-19 诊断和治疗的品质控制措施。除此之外，疫情重塑了产业的焦点，凸显了面对未来健康危机做好准备的必要性，从而维持了市场的成长。

日益重视监理合规

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，使生物安全测试成为药物审批的一部分。製药和生物技术公司必须严格遵守不断发展的标准，以获得产品批准和市场准入，刺激对测试服务的需求，并加强合规生物安全测试的重要性。此外，日益复杂的监管要求，特别是基因和细胞疗法等先进疗法，凸显了对专门测试的需求。随着专门评估适应这些疗法的独特特征，确保其安全性和有效性并满足不断变化的监管要求，这可以维持市场成长。

生物安全检测产业细分：

IMARC Group提供了对市场报告各细分市场主要趋势的分析，以及 2023-2028 年全球、区域和国家层面的预测。我们的报告根据产品和服务、测试类型和应用程式对市场进行了分类。

按产品和服务细分：

试剂盒和试剂

仪器

服务

试剂盒和试剂占大部分市场份额

该报告根据产品和服务对市场进行了详细的细分和分析。这包括试剂盒和试剂、仪器和服务。根据该报告，试剂盒和试剂占据了最大的部分。

分散测试和即时护理 (POC) 诊断的日益增长的趋势推动了对用户友好型便携式测试套件的需求，这是推动生物安全测试需求的主要因素之一。这些套件使医疗保健专业人员能够快速有效地执行安全评估，特别是在资源有限的环境中。同时，包括基因组学、蛋白质组学和细胞培养在内的生命科学领域研发活动的扩大，需要持续供应用于各种应用的高品质检测试剂和试剂盒，从而刺激市场成长。此外，生物污染物可能带来重大风险的食品和饮料 (F&B) 行业越来越注重确保产品品质和安全，这增加了对微生物分析检测试剂盒和试剂的需求，从而有助于市场扩张。

按测试类型划分：

内毒素测试

无菌测试

细胞株验证和表征测试

生物负载测试

残留宿主污染物检测测试

外来因子检测测试

其他的

内毒素检测市占率最大

报告中还提供了基于测试类型的详细市场区隔和分析。这包括内毒素、无菌、细胞株认证和表征、生物负载、残留宿主和污染物检测、外来因子检测测试等。报告称，内毒素检测占据最大的市场份额。

对内毒素检测的需求不断增长，主要是由于确保医疗器材和药品的安全性和有效性的迫切需要推动的，这正在加强全球生物安全检测市场。内毒素是存在于革兰氏阴性细菌细胞壁中的有毒物质，进入人体后会导致严重的健康併发症。医疗设备（包括植入物和药物输送系统）的复杂性和多样性日益增加，需要对内毒素进行严格的测试，以减轻对患者的潜在风险。此外，对基因疗法和单株抗体等个人化医疗和生物製药的日益关注，需要进行细緻的内毒素检测，以确保这些先进疗法的纯度和安全性，从而增强市场。除此之外，世界各地的监管机构要求遵守严格的内毒素限值，增强了药品製造和医疗保健环境中对准确可靠的内毒素检测的需求，从而促进了市场成长。

按应用划分：

疫苗开发

血液製品检测

细胞和基因治疗

组织和组织相关产品测试

干细胞研究

疫苗研发主导市场

该报告根据应用程式提供了详细的市场细分和分析。这包括疫苗开发、血液产品测试、细胞和基因治疗、组织和组织相关产品测试以及干细胞研究。报告称，疫苗开发是最大的部分。

疫苗开发中对生物安全测试的需求主要是由全球对安全有效疫苗的迫切需求所推动的。随着世界面临各种传染病和病毒爆发，包括 COVID-19 大流行，疫苗开发受到前所未有的关注。监管机构要求进行全面的安全评估，以确保疫苗不仅有效，而且不含有害污染物。生物安全测试在此过程中发挥着至关重要的作用，包括评估候选疫苗的潜在病毒和微生物污染物，确保不含内毒素，并评估其供人类使用的整体安全性。此外，新型疫苗技术（例如基于mRNA的疫苗）的出现需要专门的安全性评估，导致对生物安全检测服务的需求不断增长。对疫苗安全性的高度重视凸显了此类测试在维护全球范围内的公共卫生方面所发挥的关键作用。

按地区划分：

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

北美占据明显主导地位，占据最大的生物安全检测市场份额

市场研究报告还对所有主要区域市场进行了全面分析，其中包括北美（美国和加拿大）；亚太地区（中国、日本、印度、韩国、澳洲、印尼等）；欧洲（德国、法国、英国、义大利、西班牙、俄罗斯等）；拉丁美洲（巴西、墨西哥等）；以及中东和非洲。报告称，北美占据最大的市场份额。

北美拥有强大的製药和生物技术产业，非常重视研究和开发。新药、生物製剂和医疗器材的不断创新和推出需要严格的安全性评估，从而推动了对生物安全检测服务的需求。除此之外，该地区积极主动的监管环境，受到 FDA 和其他监管机构制定的严格标准的监管，要求进行全面的安全评估，进一步推动市场成长。此外，为应对新冠肺炎（COVID-19）大流行等公共卫生威胁而进行的持续努力，增加了对疫苗开发和测试的需求，特别是在北美，许多製药公司和研究机构积极参与疫苗研究和生产。这些因素，加上该地区先进的医疗基础设施以及对产品品质和安全意识的不断提高，继续推动北美生物安全检测市场的扩张。

竞争格局：

全球生物安全检测市场的特点是主要参与者之间竞争激烈，该行业在确保药品、生物製品和医疗器材的安全和品质方面发挥关键作用。这一领域的知名公司采取各种策略来维持其市场地位，例如合併、收购和合作，以扩大其服务组合和地理范围。此外，投资研发以引入创新测试技术和方法是常见策略，使公司能够走在行业趋势的最前沿。对个人化医疗和先进疗法（例如基因和细胞疗法）的日益关注，为专门从事专业安全测试服务的公司提供了成长机会。总体而言，全球生物安全侦测市场的竞争格局以成熟参与者的动态交互作用为特征。

市场研究报告对竞争格局进行了全面分析。也提供了所有主要公司的详细资料。市场上的一些主要参与者包括：

先锋生物科学公司

查尔斯河实验室

创意百基因

欧陆科技

龙沙集团公司

马拉威生命科学公司

佩斯分析服务公司

太平洋生物实验室

赛多利斯公司

通标公司

ViruSure GmbH（旭化成株式会社）

药明生物

（请注意，这只是关键参与者的部分列表，报告中提供了完整列表。）

最近的发展：

2022 年 5 月，Charles River Laboratories 与一家药物发现技术公司合作开发 Logica，这是一款专门为促进新疗法开发而设计的人工智慧 (AI) 工具。

2022 年 5 月，Avance Biosciences 宣布新收购的 26,000 平方英尺实验室空间竣工。此次扩张将使 Avance 能够为其生物製药和 CDMO 客户提供更广泛的蛋白质和细胞检测服务。新设施将专注于蛋白质分析服务，包括 ELISA 测定、蛋白质表征和免疫测定。

2023 年 9 月，Pace (R) Analytical Services 宣布了一种新的 PFAS 测试方法，可以更快、更低成本地提供可靠的结果。此方法符合 ASTM D8421/EPA 8327 标准，使用同位素稀释和 LC/MS/MS 分析水样本和固体样品中多达 44 种 PFAS 化合物。该方法具有诸如更快地提供结果、减少样本量和可靠的定量等优点。

本报告回答的关键问题：

  • 全球生物安全检测市场迄今表现如何，未来几年将如何表现？
  • 全球生物安全检测市场的驱动因素、限制因素和机会是什么？
  • 每个驱动因素、限制因素和机会对全球生物安全检测市场有何影响？
  • 主要区域市场有哪些？
  • 哪些国家代表了最具吸引力的生物安全检测市场？
  • 基于产品和服务的市场区隔是什么？
  • 生物安全检测市场最具吸引力的产品和服务是什么？
  • 根据测试类型，市场的细分是什么？
  • 生物安全检测市场上最具吸引力的检测类型是什么？
  • 基于应用程式的市场区隔是什么？
  • 生物安全检测市场最有吸引力的应用是什么？
  • 全球生物安全检测市场的竞争格局如何？
  • 全球生物安全检测市场的主要参与者/公司有哪些？

本报告回答的关键问题：

  • 全球生物安全检测市场迄今表现如何，未来几年将如何表现？
  • 全球生物安全检测市场的驱动因素、限制因素和机会是什么？
  • 每个驱动因素、限制因素和机会对全球生物安全检测市场有何影响？
  • 主要区域市场有哪些？
  • 哪些国家代表了最具吸引力的生物安全检测市场？
  • 基于产品和服务的市场区隔是什么？
  • 生物安全检测市场最具吸引力的产品和服务是什么？
  • 根据测试类型，市场的细分是什么？
  • 生物安全检测市场上最具吸引力的检测类型是什么？
  • 基于应用程式的市场区隔是什么？
  • 生物安全检测市场最有吸引力的应用是什么？
  • 全球生物安全检测市场的竞争格局如何？
  • 全球生物安全检测市场的主要参与者/公司有哪些？

目录

第一章：前言

第 2 章：范围与方法

  • 研究目的
  • 利害关係人
  • 资料来源
    • 主要资源
    • 二手资料
  • 市场预测
    • 自下而上的方法
    • 自上而下的方法
  • 预测方法

第 3 章：执行摘要

第 4 章：简介

  • 概述
  • 主要行业趋势

第 5 章：全球生物安全检测市场

  • 市场概况
  • 市场业绩
  • COVID-19 的影响
  • 市场预测

第 6 章：按产品和服务分類的市场细分

  • 试剂盒和试剂
    • 市场走向
    • 市场预测
  • 仪器
    • 市场走向
    • 市场预测
  • 服务
    • 市场走向
    • 市场预测

第 7 章：按测试类型分類的市场

  • 内毒素测试
    • 市场走向
    • 市场预测
  • 无菌测试
    • 市场走向
    • 市场预测
  • 细胞株验证和表征测试
    • 市场走向
    • 市场预测
  • 生物负载测试
    • 市场走向
    • 市场预测
  • 残留宿主污染物检测测试
    • 市场走向
    • 市场预测
  • 外来因子检测测试
    • 市场走向
    • 市场预测
  • 其他的
    • 市场走向
    • 市场预测

第 8 章：按应用分類的市场区隔

  • 疫苗开发
    • 市场走向
    • 市场预测
  • 血液製品检测
    • 市场走向
    • 市场预测
  • 细胞和基因治疗
    • 市场走向
    • 市场预测
  • 组织和组织相关产品测试
    • 市场走向
    • 市场预测
  • 干细胞研究
    • 市场走向
    • 市场预测

第 9 章：按地区分類的市场区隔

  • 北美洲
    • 美国
      • 市场走向
      • 市场预测
    • 加拿大
      • 市场走向
      • 市场预测
  • 亚太
    • 中国
      • 市场走向
      • 市场预测
    • 日本
      • 市场走向
      • 市场预测
    • 印度
      • 市场走向
      • 市场预测
    • 韩国
      • 市场走向
      • 市场预测
    • 澳洲
      • 市场走向
      • 市场预测
    • 印尼
      • 市场走向
      • 市场预测
    • 其他的
      • 市场走向
      • 市场预测
  • 欧洲
    • 德国
      • 市场走向
      • 市场预测
    • 法国
      • 市场走向
      • 市场预测
    • 英国
      • 市场走向
      • 市场预测
    • 义大利
      • 市场走向
      • 市场预测
    • 西班牙
      • 市场走向
      • 市场预测
    • 俄罗斯
      • 市场走向
      • 市场预测
    • 其他的
      • 市场走向
      • 市场预测
  • 拉丁美洲
    • 巴西
      • 市场走向
      • 市场预测
    • 墨西哥
      • 市场走向
      • 市场预测
    • 其他的
      • 市场走向
      • 市场预测
  • 中东和非洲
    • 市场走向
    • 按国家/地区分類的市场细分
    • 市场预测

第 10 章：SWOT 分析

  • 概述
  • 优势
  • 弱点
  • 机会
  • 威胁

第 11 章：价值链分析

第 12 章：波特五力分析

  • 概述
  • 买家的议价能力
  • 供应商的议价能力
  • 竞争程度
  • 新进入者的威胁
  • 替代品的威胁

第 13 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: SR112023A4634

Abstract

The global biological safety testing market size reached US$ 4.0 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 8.0 Billion by 2028, exhibiting a growth rate (CAGR) of 12.25% during 2022-2028. 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 propelling the market.

Biological safety testing is the ongoing process of evaluating the safety and potential risks associated with biological products, substances, or materials, including pharmaceuticals, vaccines, and medical devices. This assessment encompasses a range of activities, such as assessing the potential for contamination by microorganisms, viruses, or other biological agents, as well as examining the toxicity and potential adverse effects of these products on humans, animals, or the environment. It is a critical aspect of ensuring that biologically derived products meet regulatory standards and pose minimal risks to public health and safety. This continuous testing process involves rigorous analysis and monitoring to guarantee product safety throughout its lifecycle.

The global biological safety testing industry is experiencing robust growth driven by the expanding pharmaceutical and biotechnology sectors and the increasing the demand for stringent safety assessments for their products. As these industries continue to innovate and develop new drugs, vaccines, and biologics, the need for comprehensive biological safety testing has intensified to ensure product efficacy and safety for consumers, creating a positive outlook for market expansion. Additionally, the COVID-19 pandemic has accentuated the importance of vaccines and therapeutic treatments, further fueling the demand for biological safety testing services. Moreover, regulatory bodies worldwide are increasingly emphasizing the need for rigorous safety evaluations, which is contributing to the market's growth. Furthermore, the growing awareness of product quality and safety among consumers combined with the emerging trend toward personalized medicine and the development of advanced therapies, such as gene and cell therapies, necessitates specialized safety testing protocols, thereby aiding in market expansion.

Biological Safety Testing Market Trends/Drivers:

Expanding pharmaceutical and biotechnology sectors

The pharmaceutical and biotechnology industries are expanding due to increased investments in research and development. These sectors lead in developing drugs, biologics, and vaccines for various healthcare needs, including complex diseases. Consequently, the demand for stringent safety assessments has risen, with biological safety testing being vital in ensuring patient safety. It involves thorough evaluations for contaminants such as viruses, microbes, and endotoxins, guaranteeing compliance with regulatory and safety standards. 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 market's growth.

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. 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. Apart from this, the pandemic has reshaped the industry's focus, highlighting the need for preparedness in the face of future health crises, thereby sustaining the growth of the market.

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. Pharmaceutical and biotech companies must rigorously adhere to evolving standards to gain product approval and market access, fueling demand for testing services and reinforcing the importance of biological safety testing in compliance. Furthermore, increasingly complex regulatory requirements, especially for advanced therapies like gene and cell therapies, highlight the need for specialized testing. This sustains market growth as specialized assessments adapt to the unique characteristics of these therapies, ensuring their safety and efficacy and meeting evolving regulatory demands.

Biological Safety Testing Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the market report, along with forecasts at the global, regional and country levels from 2023-2028. Our report has categorized the market based on product and services, test type and application.

Breakup by Product and Services:

Kits and Reagents

Instruments

Services

Kits and reagents account for the majority of the market share

The report has provided a detailed breakup and analysis of the market based on the product and services. This includes kits and reagents, instruments, and services. According to the report, kits and reagents represented the largest segment.

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, thereby aiding in market expansion.

Breakup 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 hold the largest share in the market

A detailed breakup and analysis of the market based on the test type have also been provided in the report. This includes endotoxin, sterility, cell line authentication and characterization, bioburden, residual host and contaminant detection, adventitious agent detection tests, and others. According to the report, endotoxin tests accounted for the largest market share.

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, which are 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 risks to patients. 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.

Breakup by Application:

Vaccine Development

Blood Products Testing

Cellular and Gene Therapy

Tissue and Tissue-related Products Testing

Stem Cell Research

Vaccine development dominates the market

The report has provided a detailed breakup and analysis of the market based on the application. This includes vaccine development, blood product testing, cellular and gene therapy, tissue and tissue-related product testing, and stem cell research. According to the report, vaccine development represented the largest segment.

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.

Breakup by Region:

North America

United States

Canada

Asia-Pacific

China

Japan

India

South Korea

Australia

Indonesia

Others

Europe

Germany

France

United Kingdom

Italy

Spain

Russia

Others

Latin America

Brazil

Mexico

Others

Middle East and Africa

North America exhibits a clear dominance, accounting for the largest biological safety testing market share

The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.

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.

Competitive Landscape:

The global biological safety testing market is characterized by intense competition among key players, driven by the industry's critical role in ensuring the safety and quality 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, investments in research and development to introduce innovative testing technologies and methodologies are common strategies, allowing companies to stay at the forefront of industry trends. 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

(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)

Recent Developments:

In May 2022, Charles River Laboratories collaborated with a drug discovery technology firm on Logica which is an artificial intelligence (AI) tool specially designed to boost the development of new treatments.

In May 2022, Avance Biosciences announced the completion of their newly acquired 26,000 square feet of laboratory space. This expansion will allow Avance to offer a wider range of protein and cell-based assay services to their biopharma and CDMO clients. The new facilities will focus on protein analysis services, including ELISA assays, protein characterization, and immunoassays.

In September 2023, Pace® Analytical Services announced a new PFAS test method that provides reliable results faster and at a lower cost. The method, ASTM D8421/EPA 8327, uses isotope dilution and LC/MS/MS to analyze for up to 44 PFAS compounds in aqueous and solid samples. This method offers advantages such as faster delivery of results, reduced sample size, and reliable quantification.

Key Questions Answered in This Report:

  • How has the global biological safety testing market performed so far, and how will it perform in the coming years?
  • What are the drivers, restraints, and opportunities in the global biological safety testing market?
  • What is the impact of each driver, restraint, and opportunity on the global biological safety testing market?
  • What are the key regional markets?
  • Which countries represent the most attractive biological safety testing market?
  • What is the breakup of the market based on the product and services?
  • Which is the most attractive product and services in the biological safety testing market?
  • What is the breakup of the market based on the test type?
  • Which is the most attractive test type in the biological safety testing market?
  • What is the breakup of the market based on the application?
  • Which is the most attractive application in the biological safety testing market?
  • What is the competitive structure of the global biological safety testing market?
  • Who are the key players/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 US$), 2017-2022
  • Figure 3: Global: Biological Safety Testing Market Forecast: Sales Value (in Billion US$), 2023-2028
  • Figure 4: Global: Biological Safety Testing Market: Breakup by Product and Services (in %), 2022
  • Figure 5: Global: Biological Safety Testing Market: Breakup by Test Type (in %), 2022
  • Figure 6: Global: Biological Safety Testing Market: Breakup by Application (in %), 2022
  • Figure 7: Global: Biological Safety Testing Market: Breakup by Region (in %), 2022
  • Figure 8: Global: Biological Safety Testing (Kits and Reagents) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 9: Global: Biological Safety Testing (Kits and Reagents) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 10: Global: Biological Safety Testing (Instruments) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 11: Global: Biological Safety Testing (Instruments) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 12: Global: Biological Safety Testing (Services) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 13: Global: Biological Safety Testing (Services) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 14: Global: Biological Safety Testing (Endotoxin Tests) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 15: Global: Biological Safety Testing (Endotoxin Tests) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 16: Global: Biological Safety Testing (Sterility Tests) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 17: Global: Biological Safety Testing (Sterility Tests) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 18: Global: Biological Safety Testing (Cell Line Authentication and Characterization Tests) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 19: Global: Biological Safety Testing (Cell Line Authentication and Characterization Tests) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 20: Global: Biological Safety Testing (Bioburden Tests) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 21: Global: Biological Safety Testing (Bioburden Tests) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 22: Global: Biological Safety Testing (Residual Host Contaminant Detection Tests) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 23: Global: Biological Safety Testing (Residual Host Contaminant Detection Tests) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 24: Global: Biological Safety Testing (Adventitious Agent Detection Tests) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 25: Global: Biological Safety Testing (Adventitious Agent Detection Tests) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 26: Global: Biological Safety Testing (Other Test Types) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 27: Global: Biological Safety Testing (Other Test Types) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 28: Global: Biological Safety Testing (Vaccine Development) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 29: Global: Biological Safety Testing (Vaccine Development) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 30: Global: Biological Safety Testing (Blood Products Testing) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 31: Global: Biological Safety Testing (Blood Products Testing) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 32: Global: Biological Safety Testing (Cellular and Gene Therapy) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 33: Global: Biological Safety Testing (Cellular and Gene Therapy) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 34: Global: Biological Safety Testing (Tissue and Tissue-related Products Testing) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 35: Global: Biological Safety Testing (Tissue and Tissue-related Products Testing) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 36: Global: Biological Safety Testing (Stem Cell Research) Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 37: Global: Biological Safety Testing (Stem Cell Research) Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 38: North America: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 39: North America: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 40: United States: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 41: United States: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 42: Canada: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 43: Canada: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 44: Asia-Pacific: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 45: Asia-Pacific: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 46: China: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 47: China: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 48: Japan: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 49: Japan: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 50: India: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 51: India: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 52: South Korea: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 53: South Korea: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 54: Australia: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 55: Australia: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 56: Indonesia: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 57: Indonesia: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 58: Others: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 59: Others: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 60: Europe: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 61: Europe: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 62: Germany: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 63: Germany: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 64: France: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 65: France: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 66: United Kingdom: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 67: United Kingdom: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 68: Italy: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 69: Italy: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 70: Spain: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 71: Spain: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 72: Russia: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 73: Russia: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 74: Others: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 75: Others: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 76: Latin America: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 77: Latin America: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 78: Brazil: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 79: Brazil: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 80: Mexico: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 81: Mexico: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 82: Others: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 83: Others: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • Figure 84: Middle East and Africa: Biological Safety Testing Market: Sales Value (in Million US$), 2017 & 2022
  • Figure 85: Middle East and Africa: Biological Safety Testing Market: Breakup by Country (in %), 2022
  • Figure 86: Middle East and Africa: Biological Safety Testing Market Forecast: Sales Value (in Million US$), 2023-2028
  • 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, 2022 and 2028
  • Table 2: Global: Biological Safety Testing Market Forecast: Breakup by Product and Services (in Million US$), 2023-2028
  • Table 3: Global: Biological Safety Testing Market Forecast: Breakup by Test Type (in Million US$), 2023-2028
  • Table 4: Global: Biological Safety Testing Market Forecast: Breakup by Application (in Million US$), 2023-2028
  • Table 5: Global: Biological Safety Testing Market Forecast: Breakup by Region (in Million US$), 2023-2028
  • Table 6: Global: Biological Safety Testing Market: Competitive Structure
  • Table 7: Global: Biological Safety Testing Market: Key Players