全球生物製剂安全测试市场规模（按测试类型、产品/服务、应用、地区、范围和预测）

生物製剂安全性测试的市场规模及预测

2024 年生物製剂安全测试市场规模价值为 42.6 亿美元，预计到 2031 年将达到 98 亿美元，2024 年至 2031 年的复合年增长率为 12.13%。生物製品安全测试对于确保疫苗、基因疗法和单株抗体等生物製品的安全性、纯度和有效性至关重要。我们进行各种测试，包括无菌测试、支原体鑑定测试和偶然药物测试，以确保生物製剂符合监管标准并可安全用于人类使用和临床试验。它们用于确保疫苗、基因疗法和单株抗体等生物製品的安全性、纯度和有效性。检测生产过程中可能产生的细菌、病毒、支原体和内毒素等污染物。此项测试确保生物製剂符合监管标准并且可供人类安全使用。

生物製剂安全性测试的未来将围绕确保基因疗法、细胞疗法和个人化医疗等尖端疗法的安全性和有效性。随着生物製剂变得越来越复杂，检测方法可能会发生变化，包括更灵敏、自动化和高通量的技术。预计监管机构将实施更严格的要求，增加对先进测试方法来检测污染物和杂质并确保产品的一致性的需求。

生物製剂安全测试的全球市场动态

主要市场推动因素：

对生物製剂和先进疗法的需求不断增加：

慢性病、癌症和自体免疫疾病的发生率不断上升，推动了对单株抗体、基因疗法和细胞疗法等生物製剂的需求。随着生物製剂变得越来越复杂和个人化，对严格的安全测试的需求也随之增加。生物製剂被认为对于治疗标准药物无法充分解决的疾病至关重要，其开发和商业化正在加速。

严格的法规要求和安全标准：

美国 FDA、欧洲药品管理局（EMA）和日本药品和医疗器材管理局（PMDA）等监管机构正在对生物製剂实施更严格的安全标准。公司必须遵守这些严格的监管框架，以确保生物製剂的安全性、品质和有效性，这需要在研究、製造和上市后进行广泛的安全测试。这包括筛选内毒素、病毒和蛋白质聚集体等污染物。

测试方法的技术进步：

高通量筛选、即时 PCR、先进色谱技术以及下一代定序等检测创新显着提高了生物安全检测的灵敏度和准确性。这些发展使得杂质检测能够更快、更一致，进而提高生物製剂的整体安全性。

主要问题

法规的复杂性与严格性：

生物製剂安全测试受到 FDA、EMA 和其他全球卫生当局等机构的严格且不断变化的监管标准的约束。这些法规要求对生物製剂进行广泛的测试，包括杂质、污染物和稳定性测试，这大大增加了产品开发的时间和成本。此外，不同地区没有统一的标准，增加了生产商和检测机构的工作复杂性。

成本高、测试时间长：

生物製剂安全性测试通常成本高且耗时。检测生物製剂中的污染物、毒素和其他安全问题需要复杂、高品质的设备、训练有素的人员和尖端技术。漫长的测试时间会增加营运成本，尤其是对于中小型企业而言。

测试新型生物製剂的复杂性：

基因疗法、单株抗体和细胞药物等新型生物製剂的出现为安全性评估带来了新的障碍。这些药物变得越来越复杂，并可能带来明显的安全风险，例如意外的免疫反应或基因异常。适用于传统生物製剂的测试程序可能不适用于这些新药，因此需要开发专门的测试。

主要趋势：

测试技术的进步：

最重要的主题之一是开发处理日益复杂的生物产品的测试技术。传统方法正在被更灵敏、更快速和更自动化的程序所补充，包括基于细胞的测试、PCR（聚合酶链反应）测试和下一代定序。这些技术能够更准确地检测生物製剂中的污染物、杂质和病原体，确保产品符合最高的安全性和有效性标准。

监理压力与合规性：

随着越来越多的生物製剂进入市场，美国FDA、EMA和WHO等监管机构正在加强安全标准。有关生物製剂的污染、效力和纯度的立法已经得到加强，并且要求製造商进行更严格的安全测试。这一趋势推动了对病毒清除和内毒素检测等专门检测服务的需求，以确保符合更严格的标准。

细胞与基因治疗的发展：

细胞和基因疗法的快速发展和商业化正在打开生物製剂安全测试市场。这些药物高度复杂，需要严格的安全测试技术来识别潜在问题，例如免疫原性、致瘤性和病毒污染。 CRISPR 等基因编辑技术的日益广泛使用需要进行专门的测试以确保这些疗法的安全性，这有助于推动市场扩张。

目录

第 1 章 全球生物製剂安全检测市场简介

市场概况
• 研究范围
• 先决条件

第 2 章执行摘要

第 3 章：经过验证的市场研究方法

• 资料探勘
• 验证
• 主要来源
• 资料来源列表

第 4 章全球生物製剂安全测试市场展望

• 概述
• 市场动态
  • 驱动程式
  • 阻碍因素
  • 机会
• 波特五力模型
• 价值链分析
• 监理框架

5. 全球生物製剂安全检测市场（依检测类型）

：

• 内毒素检测
• 无菌测试
• 细胞系认证和特性
• 生物课题测试
• 残留宿主污染物检测测试
• 杂质检测测试

6. 全球生物製剂安全测试市场（依产品及服务划分）

• 试剂盒和试剂
• 服务
• 设备

7. 全球生物製剂安全测试市场（按应用）

• 疫苗和治疗药物开发
• 血液及血液相关产品检测
• 细胞和基因治疗
• 组织与组织相关产品测试
• 干细胞研究

8. 全球生物製剂安全检测市场（按地区）

• 概述
• 北美洲
  • 美国
  • 加拿大
  • 墨西哥
• 欧洲
  • 德国
  • 英国
  • 法国
  • 其他欧洲国家
  亚太地区
  • 中国
  • 日本
  • 印度
  • 其他亚太地区
• 拉丁美洲
  • 巴西
  • 阿根廷
• 世界其他地区

第 9 章全球生物製剂安全测试市场的竞争格局

• 概述
• 公司市占率
• 供应商概况
• 主要发展策略

第十章 公司简介

• Charles River Laboratories International, Inc.
• Merck KGaA
• Lonza Group Ltd.
• SGS S.A.
• Thermo Fisher Scientific Inc.
• Wuxi Apptec
• Sartorius AG
• Cytovance Biologics, Inc.
• Pace Analytical Services Inc.
• Toxikon Corporation
• Eurofins Scientific Se
• Avance Biosciences Inc.
• Source Bioscience

第 11 章附录

• 相关报告

Biologics Safety Testing Market Size And Forecast

Biologics Safety Testing Market Size was valued at USD 4.26 Billion in 2024 and is projected to reach USD 9.8 Billion by 2031, growing at a CAGR of 12.13% from 2024 to 2031. Biologics safety testing is important for ensuring the safety, purity, and efficacy of biological products such as vaccinations, gene treatments, and monoclonal antibodies. To guarantee that biologics fulfill regulatory standards and are safe for human usage or clinical trials, various assays are used including sterility, mycoplasma identification, and adventitious agent testing. It is used to verify the safety, purity, and efficacy of biological products such as vaccines, gene treatments, and monoclonal antibodies. It entails detecting pollutants such as bacteria, viruses, mycoplasma, and endotoxins that may develop during production. This testing verifies that biologics adhere to regulatory criteria and are safe for human usage.

The future of biologics safety testing will center on guaranteeing the safety and efficacy of cutting-edge therapeutics such as gene therapies, cell-based treatments, and personalized pharmaceuticals. As biologics become more sophisticated, testing methods will change to include more sensitive, automated, and high-throughput technology. Regulatory bodies are projected to implement stricter requirements, increasing the need for advanced testing methods to detect pollutants, and impurities, and assure product uniformity.

Global Biologics Safety Testing Market Dynamics

The key market dynamics that are shaping the global biologics safety testing market include:

Key Market Drivers:

Increasing Demand for Biologics and Advanced Therapies:

The growing prevalence of chronic diseases, cancer, and autoimmune disorders is driving up demand for biologics such as monoclonal antibodies, gene therapies, and cell-based treatments. As biologics become more complicated and personalized, the necessity for rigorous safety testing has increased. Biologics are viewed as crucial in the treatment of disorders that standard pharmaceuticals cannot adequately address, increasing their development and commercialization.

Stringent Regulatory Requirements and Safety Standards:

Regulatory authorities such as the US FDA, the European Medicines Agency (EMA), and Japan's PMDA are enforcing stricter safety criteria for biologics. Companies must comply with these demanding regulatory frameworks to assure the safety, quality, and efficacy of biologics which necessitate extensive safety testing during the research, manufacturing, and post-marketing phases. This includes screening for pollutants such as endotoxins, viruses, and protein aggregation, among others.

Technological Advancements in Testing Methods:

Innovations in testing methods including high-throughput screening, real-time PCR, advanced chromatography, and next-generation sequencing have considerably improved the sensitivity and accuracy of biological safety testing. These developments allow for faster and more consistent detection of impurities which improves the overall safety of biologic goods.

Key Challenges:

Regulatory Complexity and Stringency:

Biologics safety testing is subject to stringent and ever-changing regulatory standards from agencies such as the FDA, EMA, and other worldwide health authorities. These rules require extensive testing of biologics including tests for impurities, pollutants, and stability which can greatly increase the time and cost of product development. Furthermore, the lack of harmonized standards across areas complicates operations for producers and testing facilities.

High Costs and Long Testing Timelines:

Biologics safety testing is often costly and time-consuming. Testing biologics for pollutants, toxins, and other safety problems necessitates complex and high-quality equipment, trained workers, and cutting-edge technology. The prolonged testing schedules add to high operational costs, especially for small and medium-sized businesses.

Complexity in Testing Novel Biologic Therapies:

The emergence of newer biologics such as gene therapies, monoclonal antibodies, and cell-based medicines has created new hurdles for safety assessment. These medicines are more sophisticated and may pose distinct safety risks such as unexpected immune reactions or genetic abnormalities. Testing procedures that were effective for traditional biologics may not apply to these novel medicines necessitating the development of specialized testing.

Key Trends:

Advancements in Testing Technologies:

One of the most important themes is the ongoing development of improved testing technology to address the growing complexity of biologics. Traditional approaches are being supplemented with more sensitive, quick, and automated procedures such as cell-based tests, PCR (Polymerase Chain Reaction) testing, and next-generation sequencing. These technologies allow for more accurate detection of pollutants, impurities, and pathogens in biologics guaranteeing that products satisfy the highest safety and efficacy criteria.

Regulatory Pressure and Compliance:

With an increasing number of biologics entering the market, regulatory authorities such as the US FDA, EMA, and WHO are strengthening safety standards. Stricter laws governing contamination, potency, and purity in biologics are prompting producers to implement more rigorous safety tests. This tendency has increased demand for specialized testing services such as viral clearance studies and endotoxin testing which ensure compliance with more stringent criteria.

Growth of Cell and Gene Therapies:

The fast development and commercialization of cell and gene therapies is driving the biologics safety testing market. These medicines are extremely complicated necessitating stringent safety testing techniques to identify possible concerns such as immunogenicity, tumorigenicity, and viral contamination. The increasing usage of gene editing techniques such as CRISPR, needs specialized testing to assure the safety of these therapeutics which fuels market expansion.

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Global Biologics Safety Testing Market Regional Analysis

Here is a more detailed regional analysis of the global biologics safety testing market:

North America:

North America dominates the biologics safety testing market due to its highly developed biopharmaceutical sector and superior healthcare infrastructure. The region is home to large pharmaceutical companies, research institutions, and contract research organizations (CROs) that are at the forefront of biologics development, increasing demand for extensive safety testing. The presence of strong regulatory organizations such as the United States Food and Drug Administration (FDA), maintains strict standards for biologics safety which encourages the use of cutting-edge testing technologies to meet compliance criteria.

Furthermore, North America's significant emphasis on research and development particularly in novel biologics such as gene and cell therapies strengthens its position. Significant expenditures in biotechnology, a high rate of clinical trials, and early acceptance of breakthrough technologies all help to drive the market forward. The region's leadership is also reinforced by government programs and financing aimed at encouraging biopharma innovation transforming North America into a global centre for biologics safety testing.

Asia-Pacific:

Asia Pacific is the fastest-growing region in the biologics safety testing market owing to the rapid growth of the biopharmaceutical industry in China, India, and South Korea. These countries are increasing their investments in biotechnology and pharmaceutical research owing to government assistance, rising healthcare demands, and the increased prevalence of chronic diseases. Furthermore, reduced manufacturing costs and trained labour make Asia Pacific a desirable hub for biologics production, increasing demand for safety testing to assure compliance with international quality standards.

Furthermore, as regulatory frameworks in the area tighten, particularly in China and India, businesses are focussing on enhancing biologics safety processes. This regulatory tightening is accompanied by increased collaborations between local and worldwide biopharmaceutical businesses accelerating the implementation of new safety testing technologies. The region's growing population, rising healthcare expenditure, and increased consumer awareness of biologic quality are all major drivers driving Asia Pacific's biologics safety testing market forward.

Global Biologics Safety Testing Market: Segmentation Analysis

The Global Biologics Safety Testing Market is segmented based on Test Type, Application, Products & Services, and Geography.

Biologics Safety Testing Market, By Test Type

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

Based on Test Type, the Global Biologics Safety Testing Market is bifurcated into Endotoxin Tests, Sterility Tests, Cell Line Authentication and Characterization Tests, Bioburden Tests, Residual Host Contaminant Detection Tests, Adventitious Agent Detection Tests. The endotoxin test is the most dominant in the biologic safety testing market due to its critical role in detecting harmful bacterial endotoxins in biological products which can cause severe immune reactions in patients. Given the strict regulatory requirements for ensuring product safety in industries like pharmaceuticals and biotechnology, endotoxin testing is a mandatory step.

Biologics Safety Testing Market, By Application

• Vaccine & Therapeutics Development
• Blood and Blood-Related Product Testing
• Cellular and Gene Therapy
• Tissue and Tissue-Related Product Testing
• Stem Cell Research

Based on Application, the Global Biologics Safety Testing Market is bifurcated into Vaccine and Therapeutics Development, Blood and Blood-Related Product Testing, Cellular and Gene Therapy, Tissue And Tissue-Related Product Testing, and Stem Cell Research. Vaccine and therapeutics development is the most dominant segment in the biologics safety testing market due to the global focus on developing vaccines for infectious diseases like COVID-19 and ongoing efforts for therapeutic innovations. The increasing demand for vaccines and biologics to combat emerging health threats has driven the need for stringent safety testing to ensure product efficacy and patient safety. Regulatory agencies emphasize rigorous testing protocols for vaccines making this segment a key driver in the biologics safety testing market.

Biologics Safety Testing Market, By Products & Services

• Instruments
• Services
• Kits & Reagents

Based on Products and Services, the Global Biologics Safety Testing Market is bifurcated into Instruments, Services, Kits and Reagents. Kits & reagents are the most dominant segment in the biologics safety testing market due to their essential role in a wide range of testing applications, including contamination detection, endotoxin testing, and sterility checks. These consumables are used regularly in laboratories, driving continuous demand. Unlike instruments which are typically a one-time investment, kits and reagents need to be replenished frequently, making them a recurring expense. Their crucial role in ensuring biologics' safety and compliance with regulatory standards further boosts their dominance.

Biologics Safety Testing Market, By Geography

• North America
• Europe
• Asia Pacific
• Rest of the world

Based on Geography, the Global Biologics Safety Testing Market is classified into North America, Europe, Asia Pacific, and the Rest of the world. North America is the most dominant region in the biologics safety testing market due to its advanced biotechnology sector, strong pharmaceutical industry presence, and well-established regulatory frameworks. The region is home to major biologics manufacturers and extensive research and development activities. Additionally, stringent FDA guidelines and high investment in cutting-edge technologies drive the demand for comprehensive safety testing.

Key Players

• The "Global Biologics Safety Testing Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are
• Charles River Laboratories International, Inc., Merck KGaA, Lonza Group Ltd., SGS S.A., Thermo Fisher Scientific Inc., Wuxi Apptec, Sartorius AG, Cytovance Biologics, Inc., Pace Analytical Services Inc., Toxikon Corporation, Eurofins Scientific Se, Avance Biosciences Inc., Source Bioscience.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

• Biologics Safety Testing Market Recent Developments:
• In January 2023, Charles River Laboratories, Inc. purchased SAMDI Tech, Inc., a high-throughput screening (HTS) solutions provider. This acquisition seeks to improve drug discovery procedures by utilizing SAMDI Tech's technologies to speed up the identification of prospective medication candidates.
• In September 2022, Thermo Fisher Scientific, Inc. will debut the Thermo Scientific 1500 Series Biological Safety Cabinet (BSC) designed to satisfy the needs of a variety of laboratories. This revolutionary device protects from biological dangers and contaminations.

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL BIOLOGICS SAFETY TESTING MARKET

• 1.1 Overview of the Market
• 1.2 Scope of Report
• 1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

• 3.1 Data Mining
• 3.2 Validation
• 3.3 Primary Interviews
• 3.4 List of Data Sources

4 GLOBAL BIOLOGICS SAFETY TESTING MARKET OUTLOOK

• 4.1 Overview
• 4.2 Market Dynamics
  • 4.2.1 Drivers
  • 4.2.2 Restraints
  • 4.2.3 Opportunities
• 4.3 Porters Five Force Model
• 4.4 Value Chain Analysis
• 4.5 Regulatory Framework

5 GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY TEST TYPE

:

• 5.1 Endotoxin Tests
• 5.2 Sterility Tests
• 5.3 Cell Line Authentication and Characterization Tests
• 5.4 Bioburden Tests
• 5.5 Residual Host Contaminant Detection Tests
• 5.6 Adventitious Agent Detection Tests

6 GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY PRODUCTS AND SERVICES:

• 6.1 Kits & Reagents
• 6.2 Services
• 6.3 Instruments

7 GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY APPLICATION:

• 7.1 Vaccine & Therapeutics Development
• 7.2 Blood and Blood-Related Products Testing
• 7.3 Cellular and Gene Therapy
• 7.4 Tissue and Tissue-Related Products Testing
• 7.5 Stem Cell Research

8 GLOBAL BIOLOGICS SAFETY TESTING MARKET, BY GEOGRAPHY

• 8.1 Overview
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
  • 8.2.3 Mexico
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 U.K.
  • 8.3.3 France
  • 8.3.4 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 Japan
  • 8.4.3 India
  • 8.4.4 Rest of Asia Pacific
• 8.5 Latin America
  • 8.5.1 Brazil
  • 8.5.2 Argentina
• 8.6 Rest of the World

9 GLOBAL BIOLOGICS SAFETY TESTING MARKET COMPETITIVE LANDSCAPE

• 9.1 Overview
• 9.2 Company Market Share
• 9.3 Vendor Landscape
• 9.4 Key Development Strategies

10 COMPANY PROFILES

• 10.1 Charles River Laboratories International, Inc.
  • 10.1.1 Overview
  • 10.1.2 Financial Performance
  • 10.1.3 Product Outlook
  • 10.1.4 Key Developments
• 10.2 Merck KGaA
  • 10.2.1 Overview
  • 10.2.2 Financial Performance
  • 10.2.3 Product Outlook
  • 10.2.4 Key Developments
• 10.3 Lonza Group Ltd.
  • 10.3.1 Overview
  • 10.3.2 Financial Performance
  • 10.3.3 Product Outlook
  • 10.3.4 Key Developments
• 10.4 SGS S.A.
  • 10.4.1 Overview
  • 10.4.2 Financial Performance
  • 10.4.3 Product Outlook
  • 10.4.4 Key Developments
• 10.5 Thermo Fisher Scientific Inc.
  • 10.5.1 Overview
  • 10.5.2 Financial Performance
  • 10.5.3 Product Outlook
  • 10.5.4 Key Developments
• 10.6 Wuxi Apptec
  • 10.6.1 Overview
  • 10.6.2 Financial Performance
  • 10.6.3 Product Outlook
  • 10.6.4 Key Developments
• 10.7 Sartorius AG
  • 10.7.1 Overview
  • 10.7.2 Financial Performance
  • 10.7.3 Product Outlook
  • 10.7.4 Key Developments
• 10.8 Cytovance Biologics, Inc.
  • 10.8.1 Overview
  • 10.8.2 Financial Performance
  • 10.8.3 Product Outlook
  • 10.8.4 Key Developments
• 10.9 Pace Analytical Services Inc.
  • 10.9.1 Overview
  • 10.9.2 Financial Performance
  • 10.9.3 Product Outlook
  • 10.9.4 Key Developments
• 10.10 Toxikon Corporation
  • 10.10.1 Overview
  • 10.10.2 Financial Performance
  • 10.10.3 Product Outlook
  • 10.10.4 Key Developments
• 10.11 Eurofins Scientific Se
  • 10.11.1 Overview
  • 10.11.2 Financial Performance
  • 10.11.3 Product Outlook
  • 10.11.4 Key Developments
• 10.12 Avance Biosciences Inc.
  • 10.12.1 Overview
  • 10.12.2 Financial Performance
  • 10.12.3 Product Outlook
  • 10.12.4 Key Developments
• 10.13 Source Bioscience
  • 10.13.1 Overview
  • 10.13.2 Financial Performance
  • 10.13.3 Product Outlook
  • 10.13.4 Key Developments

11 Appendix

• 11.1 Related Reports