无菌测试市场规模：按产品类型、按应用、按地区、范围和预测

无菌测试的市场规模与预测

2024 年无菌测试市场规模价值 14.3 亿美元，预计到 2031 年将达到 33.6 亿美元，2024 年至 2031 年的复合年增长率为 12.40%。无菌测试是指用来确定药品、医疗器材和其他医疗相关物品中是否存在活体微生物的过程。此项测试对于确保产品在供人类使用之前的安全性和有效性至关重要。此外，无菌测试通常用于製药业、生物技术领域和医疗器材製造，以符合监管要求并维持产品品质。

无菌检测市场动态

影响无菌侦测市场的关键市场动态

主要市场驱动因子

增加製药和生技产量

全球製药和生物技术製造业的兴起，尤其是无菌製剂的兴起，是无菌测试产业发展的主要驱动力。根据国际製药商协会联合会（IFPMA）的报告，到2022年全球生物製药市场规模将达到1.5兆美元。对无菌生物製剂和疫苗的需求不断增加，推动了无菌测试的需求，以确保产品安全和法规遵循。

提高无菌药物核准的监管要求

对无菌药品生产和批准的严格监管要求促使公司利用无菌测试。美国食品药物管理局 (FDA) 要求新的无菌药品必须通过无菌测试，作为审批流程的一部分。 2021年，FDA批准了50种新型分子实体，其中许多需要进行大量的无菌测试，从而促进了市场的成长。

细胞和基因治疗的需求不断增加

细胞和基因疗法等先进药物的日益使用推动了无菌测试的需求。报告称，预计2022年全球将进行2,500多项细胞和基因治疗临床试验。这些治疗药物需要经过彻底的无菌测试才能满足品质和安全法规的要求，这对无菌测试市场的成长有重大贡献。

主要问题

无菌测试相关成本高：

与无菌测试设备、消耗品和熟练人力相关的成本被认为很高。这一因素可能会限制市场成长，尤其是在小型企业和新兴市场。

传统且耗时的方法：

传统的无菌测试方法通常很耗时，会延迟产品的发布。目前，人们正在透过开发快速无菌测试方法来应对这项课题，但采用这种方法仍然有限。

假阳性与伪阴性的风险：

无菌测试方法有时会产生假阳性或假阴性结果，对产品品质和安全有严重影响。克服这项课题对于提高无菌测试的可靠性至关重要。

主要趋势

采用快速微生物检测方法：

使用快速微生物学方法 (RMM) 进行无菌测试的趋势日益增长。与传统方法相比，这些方法的发展是为了提供更快的结果，同时保持或提高准确性。

无菌检测外包增加：

许多製药和生物技术公司将无菌测试外包给专门的合约测试组织。这一趋势是由对专业知识、先进技术和成本效益的需求所驱动。

自动化与机器人整合：

自动化和机器人技术越来越多地被融入无菌测试过程中。这些技术有助于减少人为错误，提高吞吐量并提高无菌测试程序的整体效率。

无菌测试市场的区域分析

北美

根据经过验证的市场研究，预计北美将在预测期内主导无菌测试市场。北美，尤其是美国，在生物製药和疫苗生产方面处于领先地位，推动了对无菌测试的需求，以确保产品安全。根据美国药品研究与製造商协会（PhRMA）统计，2021年美国生技公司将在研发上投入约1,023亿美元，占全球医药市场的40%以上。这种水准的生产和投资需要进行广泛的无菌测试以满足严格的监管标准。

美国食品药物管理局 (FDA) 对无菌药物和生物製剂实施严格的无菌测试指南。 2021 年，FDA 批准了 50 种新型分子实体，其中许多都需要在药物审批过程中进行无菌测试。北美严格的监管环境确保无菌测试仍然是药物开发的关键组成部分，从而极大地促进了该地区的市场成长。

此外，北美处于细胞和基因治疗发展的前沿，这需要进行密集的无菌测试以确保产品安全。据再生医学联盟称，截至 2021 年底，美国将有 92 种基因和细胞疗法进入后期临床试验。随着这些先进疗法获得批准并商业化，该地区对无菌测试的需求将持续上升，从而推动市场扩张。

欧洲

预计欧洲地区在预测期内将呈现最高的成长率。欧洲拥有蓬勃发展的製药和生物製药製造业，推动了对无菌测试的需求，以确保符合品质标准。根据欧洲製药工业协会联合会（EFPIA）的数据，2022年欧洲将占全球医药销售额的23.9%，重点是无菌药物、生物製剂和疫苗。如此强大的生产能力正在为整个地区带来对无菌测试的稳定需求。

欧洲药品管理局（EMA）等欧洲监管机构对无菌测试实施了严格的指导方针，以确保药品的安全性和有效性。 2021年，EMA批准了92种新药，其中许多包括需要进行严格无菌测试的无菌生物製剂和疫苗。这些严格的监管要求正在推动欧洲在药品製造中采用无菌测试。

此外，欧洲在细胞和基因疗法等需要严格无菌测试的先进疗法的研究和开发方面处于领先地位。报告称，欧洲占全球细胞和基因治疗临床试验的23%。随着这些治疗方法通过临床试验并走向商业化，符合安全标准的无菌测试需求正在推动该地区的市场成长。

目录

第 1 章 全球无菌测试市场简介

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 章全球无菌测试市场展望

• 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

第 5 章全球无菌测试市场类型

• 概述
• 试剂盒和试剂
• 消耗品
• 生物医学设备
• 服务

第6章 全球无菌检测市场（依应用）

• 概述
• 製药公司
• 医院
• 病理学研究所
• 学术研究机构
• 其他

第 7 章 全球无菌测试市场（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
• 世界其他地区
  • 拉丁美洲
  • 中东和非洲

第 8 章全球无菌测试市场的竞争格局

• 概述
• 各公司的市场排名
• 主要发展策略

第9章 公司简介

• Danaher Corporation
• Pace Analytical Serv.
• Boston Analytical
• Toxicon Inc.
• Merck KGaA
• Thermo Fisher Scientific Inc.
• SGS SA
• Biomerieux SA
• Nelson Laboratories
• Charles River Laboratories International, Inc.

第 10 章附录

• 相关报告

Sterility Testing Market Size And Forecast

Sterility Testing Market size was valued at USD 1.43 Billion in 2024 and is projected to reach USD 3.36 Billion by 2031 , growing at a CAGR of 12.40% from 2024 to 2031. Sterility testing is defined as a process used to determine the presence or absence of viable microorganisms in pharmaceutical products, medical devices, and other healthcare-related items. This testing is crucial for ensuring the safety and efficacy of products before they are released for human use. Furthermore, sterility testing is commonly employed in the pharmaceutical industry, biotechnology sector, and medical device manufacturing to comply with regulatory requirements and maintain product quality.

Sterility Testing Market Dynamics

The key market dynamics that are shaping the sterility testing market include:

Key Market Drivers

Increasing Pharmaceutical and Biotechnology Production

: The global rise in pharmaceutical and biotechnology manufacturing, particularly for sterile drug products, is a significant driver of the sterility testing industry. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) reports that the worldwide biopharmaceutical business was worth $1.5 trillion in 2022. The rising demand for sterile biologics and vaccines has increased the requirement for sterility testing to ensure product safety and regulatory compliance.

Growing Number of Regulatory Requirements for Sterile Drug Approval

: Stringent regulatory requirements for the production and approval of sterile medications are driving firms to use sterility testing. The United States Food and Drug Administration (FDA) requires that any new sterile drug product pass sterility testing as part of the clearance procedure. In 2021, the FDA authorized 50 novel molecular entities, many of which required significant sterility testing, resulting in market growth.

Rising Demand for Cell and Gene Therapies

: The growing use of sophisticated medicines like cell and gene therapy has increased the necessity for sterility testing. According to a Report, more than 2,500 clinical studies for cell and gene therapies will be conducted worldwide in 2022. These therapies must go through thorough sterility testing to meet quality and safety regulations, which contributes significantly to the sterility testing market's growth.

Key Challenges

High Costs Associated with Sterility Testing:

The costs associated with sterility testing equipment, consumables, and skilled personnel are being considered high. This factor is potentially limiting market growth, especially among smaller companies and in developing regions.

Time-Consuming Nature of Traditional Methods:

Traditional sterility testing methods are often time-consuming, which delays product release. This challenge is being addressed through the development of rapid sterility testing methods, but their adoption is still limited.

Risk of False Positives and Negatives:

Sterility testing methods sometimes produce false positive or false negative results, which have significant implications for product quality and safety. Overcoming this challenge is being seen as crucial for improving the reliability of sterility testing.

Key Trends

Adoption of Rapid Microbial Methods:

There is a growing trend towards the adoption of rapid microbial methods (RMM) for sterility testing. These methods are being developed to provide faster results while maintaining or improving accuracy compared to traditional methods.

Increasing Outsourcing of Sterility Testing:

Many pharmaceutical and biotechnology companies are outsourcing their sterility testing to specialized contract testing laboratories. This trend is being driven by the need for expertise, advanced technologies, and cost efficiencies.

Integration of Automation and Robotics:

Automation and robotics are increasingly being integrated into sterility testing processes. These technologies are helping to reduce human error, increase throughput, and improve the overall efficiency of sterility testing procedures.

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Sterility Testing Market Regional Analysis

The regional analysis of the sterility testing market is provided below:

North America

According to Verified Market Research, North America is estimated to dominate the sterility testing market over the forecast period. North America, particularly the U.S., is a leader in biopharmaceutical and vaccine production, driving the demand for sterility testing to ensure product safety. According to the Pharmaceutical Research and Manufacturers of America (PhRMA), U.S. biopharmaceutical companies spent nearly $102.3 billion on research and development in 2021, accounting for over 40% of the global pharmaceutical market. This significant production and investment necessitate extensive sterility testing to meet stringent regulatory standards.

The U.S. Food and Drug Administration (FDA) enforces rigorous sterility testing guidelines for sterile pharmaceuticals and biologics. In 2021, the FDA approved 50 new molecular entities, many of which required sterility testing as part of the drug approval process. The strict regulatory landscape in North America ensures that sterility testing is a crucial component of pharmaceutical development, significantly boosting market growth in the region.

Furthermore, North America is at the forefront of cell and gene therapy development, which requires intensive sterility testing to ensure product safety. According to the Alliance for Regenerative Medicine, 92 gene and cell therapies were in late-stage clinical trials in the U.S. by the end of 2021. As these advanced therapies gain approval and commercialization, the demand for sterility testing in the region continues to rise, driving market expansion.

Europe

The Europe region is expected to exhibit the highest growth rate during the forecast period. Europe is home to thriving pharmaceutical and biopharmaceutical manufacturing sectors, driving the demand for sterility testing to ensure compliance with quality standards. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), Europe accounted for 23.9% of global pharmaceutical sales in 2022, with a focus on sterile drug products, biologics, and vaccines. This strong production capacity creates a consistent demand for sterility testing across the region.

European regulatory agencies, such as the European Medicines Agency (EMA), enforce strict guidelines for sterility testing to ensure the safety and efficacy of pharmaceuticals. In 2021, the EMA approved 92 new medicines, many of which included sterile biologics and vaccines that require rigorous sterility testing. These stringent regulatory requirements are driving the adoption of sterility testing across pharmaceutical manufacturing in Europe.

Furthermore, Europe is a leader in the research and development of advanced therapies such as cell and gene therapy, which necessitate thorough sterility testing. According to a Report, Europe accounted for 23% of global clinical trials for cell and gene therapies. As these therapies move through clinical trials and into commercialization, the demand for sterility testing to meet safety standards is driving market growth in the region.

Sterility Testing Market: Segmentation Analysis

The Global Sterility Testing Market is being segmented based on Product, Test Type, Application, and Geography.

Sterility Testing Market, By Product

• Kits & Reagents
• Instruments
• Services

Based on Product, the market is segmented into Kits & Reagents, Instruments, and Services. The kits & reagents segment is estimated to dominate the market over the forecast period. This dominance is attributed to the frequent and recurring use of these products in sterility testing procedures. The increasing demand for ready-to-use sterility testing kits and the growing emphasis on quality control in the pharmaceutical and biotechnology industries are further driving the growth of this segment.

Sterility Testing Market, By Test Type

• Membrane Filtration
• Direct Inoculation
• Others

Based on Test Type, the market is segmented into Membrane Filtration, Direct Inoculation, and Others. The membrane filtration segment is projected to hold the largest market share during the forecast period. This method is preferred due to its high sensitivity and ability to test large sample volumes. It is particularly suited for testing water-soluble products, which is contributing to its widespread adoption in the pharmaceutical industry.

Sterility Testing Market, By Application

• Pharmaceutical & Biological Manufacturing
• Medical Devices Manufacturing
• Others

Based on Application, the market is segmented into Pharmaceutical & Biological Manufacturing, Medical Devices Manufacturing, and Others. The pharmaceutical & biological manufacturing segment is estimated to dominate the market. This dominance is being attributed to the stringent regulatory requirements for ensuring the sterility of pharmaceutical and biological products, the increasing production of biologics and biosimilars, and the growing focus on quality assurance in drug manufacturing.

Sterility Testing Market, By Geography

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

Based on Geography, the sterility testing market is classified into North America, Europe, Asia Pacific, and the Rest of the World. North America is estimated to dominate the market during the forecast period. This dominance is attributed to the presence of a well-established pharmaceutical and biotechnology industry, stringent regulatory standards, and high adoption of advanced sterility testing technologies in the region.

Key Players

• The "Sterility 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, Merck KGaA, Thermo Fisher Scientific, bioMerieux SA, SGS SA, Sartorius AG, WuXi AppTec, Becton, Dickinson and Company, Nelson Laboratories, LLC, and Eurofins Scientific.

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.

• Sterility Testing Market Recent Developments
• In December 2023, Charles River Laboratories announced the expansion of its sterility testing capabilities in Europe with the opening of a new facility in Ireland, aimed at meeting the growing demand for these services in the region.
• In October 2023, Merck KGaA launched a new rapid sterility testing kit that promises to deliver results in half the time of traditional methods, addressing the industry's need for faster product release.
• In August 2023, Thermo Fisher Scientific introduced an automated sterility testing system that integrates robotics and advanced analytics, aimed at improving efficiency and reducing human error in sterility testing procedures.

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL STERILITY 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 STERILITY 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

5 GLOBAL STERILITY TESTING MARKET, BY TYPE

• 5.1 Overview
• 5.2 Kits & Reagents
• 5.3 Consumables
• 5.4 Biomedical Instruments
• 5.5 Services.

6 GLOBAL STERILITY TESTING MARKET, BY APPLICATION

• 6.1 Overview
• 6.2 Pharmaceutical Companies
• 6.3 Hospitals
• 6.4 Pathological Laboratories
• 6.5 Academic Laboratories
• 6.6 Others

7 GLOBAL STERILITY TESTING MARKET, BY GEOGRAPHY

• 7.1 Overview
• 7.2 North America
  • 7.2.1 U.S.
  • 7.2.2 Canada
  • 7.2.3 Mexico
• 7.3 Europe
  • 7.3.1 Germany
  • 7.3.2 U.K.
  • 7.3.3 France
  • 7.3.4 Rest of Europe
• 7.4 Asia Pacific
  • 7.4.1 China
  • 7.4.2 Japan
  • 7.4.3 India
  • 7.4.4 Rest of Asia Pacific
• 7.5 Rest of the World
  • 7.5.1 Latin America
  • 7.5.2 Middle East and Africa

8 GLOBAL STERILITY TESTING MARKET COMPETITIVE LANDSCAPE

• 8.1 Overview
• 8.2 Company Market Ranking
• 8.3 Key Development Strategies

9 COMPANY PROFILES

• 9.1 Danaher Corporation
  • 9.1.1 Overview
  • 9.1.2 Financial Performance
  • 9.1.3 Product Outlook
  • 9.1.4 Key Developments
• 9.2 Pace Analytical Serv.
  • 9.2.1 Overview
  • 9.2.2 Financial Performance
  • 9.2.3 Product Outlook
  • 9.2.4 Key Developments
• 9.3 Boston Analytical
  • 9.3.1 Overview
  • 9.3.2 Financial Performance
  • 9.3.3 Product Outlook
  • 9.3.4 Key Developments
• 9.4 Toxicon Inc.
  • 9.4.1 Overview
  • 9.4.2 Financial Performance
  • 9.4.3 Product Outlook
  • 9.4.4 Key Developments
• 9.5 Merck KGaA
  • 9.5.1 Overview
  • 9.5.2 Financial Performance
  • 9.5.3 Product Outlook
  • 9.5.4 Key Developments
• 9.6 Thermo Fisher Scientific Inc.
  • 9.6.1 Overview
  • 9.6.2 Financial Performance
  • 9.6.3 Product Outlook
  • 9.6.4 Key Development
• 9.7 SGS SA
  • 9.7.1 Overview
  • 9.7.2 Financial Performance
  • 9.7.3 Product Outlook
  • 9.7.4 Key Developments
• 9.8 Biomerieux SA
  • 9.8.1 Overview
  • 9.8.2 Financial Performance
  • 9.8.3 Product Outlook
  • 9.8.4 Key Developments
• 9.9 Nelson Laboratories
  • 9.9.1 Overview
  • 9.9.2 Financial Performance
  • 9.9.3 Product Outlook
  • 9.9.4 Key Development
• 9.10 Charles River Laboratories International, Inc.
  • 9.10.1 Overview
  • 9.10.2 Financial Performance
  • 9.10.3 Product Outlook
  • 9.10.4 Key Development

10 Appendix

• 10.1.1 Related Reports