微生物附着量测试市场：按产品类型、按应用、按最终用户、按地区

2024年微生物附着量测试市场规模为14亿美元，预计2024年至2031年复合年增长率为9.2%，到2031年达到25.9亿美元。

图 1. 2024 年微生物附着量测试市场占有率(%)，依地区划分

微生物附着量测试是指对产品、原料、表面等上存在的微生物进行检测和定量。微生物附着量测试可确保生产中使用的材料和设备符合适当的卫生标准，从而帮助监控药品和保健产品的品质。它对于维持无菌及防止无菌设备、设备及成品污染有重要作用。由于严格的医疗设备测试法规、契约製造组织的渗透率不断提高以及药品製造外包的增加，微生物附着量测试市场正在不断扩大。由于医疗设备和药品与患者直接接触，因此保持无菌条件并防止微生物生长非常重要。微生物附着量测试提供了一种品管措施，用于检验灭菌过程并检测製造或运输过程中可能引入的污染物。这些测试结果将有助于确定适当的保质期并调查该产品批次的任何未来问题。

市场动态：

全球微生物附着量测试市场受到製药和医疗设备製造中微生物附着量测试严格监管要求的推动。监管机构，例如食品药物管理局(FDA) 和欧洲药品管理局 (EMA)。 FDA 和欧洲药品管理局 EMA 等监管机构要求在各个阶段进行微生物附着量测试，以确保非无菌产品的安全性和有效性。製药和医疗设备业的成长也推动了微生物附着量测试的需求。然而，与微生物附着量测试设备和服务相关的高成本限制了该市场的成长。快速自动化微生物附着量测试解决方案的出现提供了一个利润丰厚的机会，因为它可以更快地获得结果和更高的通量。在製造过程中采用连续监测系统进行微生物附着量测试为未来几年提供了更多机会。

本研究的主要特点

• 本报告详细分析了全球微生物附着量测试市场，并提供了以2023年为基准年的预测期（2024-2031）的市场规模和年复合成长率（CAGR%）。
• 它还揭示了各个细分市场的潜在商机，并为该市场说明了一系列有吸引力的投资提案。
• 它还提供了有关市场驱动因素、限制因素、机会、新产品发布和核准、市场趋势、区域前景、主要企业采取的竞争策略等的重要见解。
• 它根据公司亮点、产品系列、主要亮点、财务表现和策略等参数，介绍了全球微生物附着量测试市场的主要企业。
• 该报告的见解使行销人员和经营团队负责人就未来的产品发布、类型升级、市场扩张和行销策略做出明智的决策。
• 本研究报告针对该产业的各个相关人员，如投资者、供应商、产品製造商、经销商、新进业者和财务分析师。

第一章 研究目的与前提

• 研究目标
• 先决条件
• 简称

第二章 市场概况

• 报告说明
• 市场定义和范围
• 执行摘要
• Coherent Opportunity Map（COM）

第三章市场动态、法规及趋势分析

• 市场动态
• 影响分析
• 主要亮点
• 监管场景
• 产品发布/核准
• PEST分析
• 波特的分析
• 併购场景

第四章 冠状病毒（COVID-19）大流行对微生物附着量测试市场的影响

• 新型冠状病毒感染疾病（COVID-19）的流行病学
• 供需面分析
• 影响微生物附着量测试市场

第 5 章微生物附着量测试市场（按产品），2019-2031

• 消耗品，2019-2031
• 设备，2019-2031

第六章微生物附着量测试市场，依测试类型，2019-2031

• 有氧运动测试，2019-2031
• 厌氧计数测试，2019-2031
• 真菌/霉菌计数测试，2019-2031
• 孢子计数测试，2019-2031

第 7 章微生物附着量测试市场，依应用分类，2019-2031

• 原料测试，2019-2031
• 医疗设备测试，2019-2031
• 进程内材料测试，2019-2031
• 灭菌检验测试，2019-2031
• 设备清洗检验，2019-2031

第 8 章微生物附着量测试市场，依最终用途，2019-2031

• 製药和生物技术公司，2019-2031
• 医疗设备製造商，2019-2031
• 契约製造组织，2019-2031
• 食品、饮料和农产品製造商，2019-2031
• 微生物检测实验室，2019-2031

第 9 章 2019-2031 年微生物附着量测试市场（按地区）

• 按地区
• 北美洲
• 美国
• 加拿大
• 欧洲
• 英国
• 德文
• 义大利
• 法国
• 西班牙
• 俄罗斯
• 欧洲其他地区
• 亚太地区
• 中国
• 印度
• 日本
• 澳洲
• 韩国
• ASEAN
• 其他亚太地区
• 中东/非洲
• GCC
• 以色列
• 其他中东地区
• 拉丁美洲
• 巴西
• 墨西哥
• 阿根廷

第十章公司简介-微生物附着量测试市场

• Charles River Laboratories International, Inc.
  • 公司简介
  • 产品/服务组合
  • 财务绩效
  • 最新动态/最新讯息
  • 策略概览
• SGS SA
• Merck KGaA
• Becton
• Dickinson and Company
• Wuxi Apptec
• North American Science Associates Inc.
• Nelson Laboratories, LLC
• Biomerieux SA
• Thermo Fisher Scientific
• Pacific Biolabs

第十一章 参考文献与调查方法

• 参考
• 调查方法

The bioburden testing Market size is valued at US$ 1.40 Bn in 2024 and is expected to reach US$ 2.59 Bn by 2031, growing at a compound annual growth rate (CAGR) of 9.2% from 2024 to 2031.

Figure 1. Bioburden Testing Market Share (%), by Region, 2024

Bioburden testing refers to the detection and quantification of microorganisms present in or on a product, raw material, or surface. Bioburden testing helps monitor the quality of pharmaceutical and healthcare products by ensuring materials and equipment used in production meet appropriate hygienic standards. It plays a key role in maintaining sterility and preventing contamination of sterile devices, equipment, and finished products. The bioburden testing market is growing due to stringent regulations mandating testing of medical devices, rising penetration of contract manufacturing organizations, and increasing outsourcing of pharmaceutical manufacturing. As medical devices and pharmaceuticals are intended to interact directly with patients, maintaining sterility and preventing microbial growth are critical. Bioburden testing provides quality control measures to validate sterilization processes and detect any contaminants that may have been introduced during manufacturing or shipping. The results of these tests help determine appropriate shelf life and assist in investigations should any issues arise with a product batch in the future.

Market Dynamics:

The global bioburden testing market is driven by stringent regulatory mandates for the testing of bioburden in pharmaceutical and medical device manufacturing. Regulatory agencies like the Food and Drug Administration. FDA and European Medicines Agency EMA require bioburden testing at various stages to ensure the safety and efficacy of non-sterile products. The growth in pharmaceutical and medical device industries has also fueled the demand for bioburden testing. However, the high costs associated with bioburden testing equipment and services limit the growth of this market. The emergence of rapid automated bioburden testing solutions presents lucrative opportunities, as they enable faster results and higher throughput. The adoption of continuous monitoring systems for bioburden testing during manufacturing further offers opportunities in the coming years.

Key features of the study:

• This report provides in-depth analysis of the global bioburden testing market, and provides market size (US$ Billion) and compound annual growth rate (CAGR%) for the forecast period (2024-2031), considering 2023 as the base year
• It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
• This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players
• It profiles key players in the global bioburden testing market based on the following parameters - company highlights, products portfolio, key highlights, financial performance, and strategies
• Key companies covered as a part of this study include Charles River Laboratories, Merck KGaA, SGS, WuXi AppTec, and Becton, Dickinson and Company ,North American Science Associates Inc. , Nelson Laboratories LLC , Biomerieux SA ,Thermo Fisher ScientifiC and Pacific Biolabs.
• Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
• The global bioburden testing market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts.

Detailed Segmentation:

• Bioburden Testing Market ,By Product
  • Consumables
  • Culture Media
  • Reagents and Kits
  • Instruments
  • Automated Microbial Identification Systems
  • PCR Instruments
• Bioburden Testing Market,By Test Type
  • Aerobic Count Testing
  • Anaerobic Count Testing
  • Fungi/Mold Count Testing
  • Spore Count Testing
• Bioburden Testing Market, By Application
  • Raw Material Testing
  • Medical Device Testing
  • In-Process Material Testing
  • Sterilization Validation Testing
  • Equipment Cleaning Validation
• Bioburden Testing Market, By End Use
  • Pharmaceutical & Biotechnology Companies
  • Medical Device Manufacturers
  • Contract Manufacturing Organizations
  • Manufacturers of Food & Beverage and Agricultural Products
  • Microbial Testing Laboratories
• Bioburden Testing Market, By Region
  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East and Africa
• Top Companies in the Bioburden Testing Market.
  • Charles River Laboratories International Inc.
  • SGS SA
  • Merck KGaA
  • Becton
  • Dickinson and Company
  • Wuxi Apptec
  • North American Science Associates Inc.
  • Nelson Laboratories LLC
  • Biomerieux SA,
  • Thermo Fisher Scientific
  • Pacific Biolabs.

Table of Content:

1. Research Objectives and Assumptions

• Research Objectives
• Assumptions
• Abbreviations

2. Market Overview

• Report Description
• Market Definition and Scope
• Executive Summary
  • Bioburden Testing Market, By Product
  • Bioburden Testing Market, By Test Type
  • Bioburden Testing Market, By Application
  • Bioburden Testing Market, By End Use
  • Bioburden Testing Market, By Region
• Coherent Opportunity Map (COM)

3. Market Dynamics, Regulations, and Trends Analysis

• Market Dynamics
  • Drivers
  • Restraints
  • Oppertunities
• Impact Analysis
• Key Highlights
• Regulatory Scenario
• Product Launches/Approvals
• PEST Analysis
• PORTER's Analysis
• Merger and Acquisition Scenario

4. Bioburden Testing Market Impact of Coronavirus (COVID-19) Pandemic

• COVID-19 Epidemiology
• Supply Side and Demand Side Analysis
• Impact Bioburden Testing Market

5. Bioburden Testing Market, By Product, 2019 - 2031 ( US$ Billion)

• Introduction
  • Market Size and Forecast, 2019 - 2031, ( US$ Billion)
  • Y-o-Y Growth Analysis, 2019 - 2031
  • Segment Trends
• Consumables, 2019 - 2031( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2019 - 2031, ( US$ Billion)
• Instruments, 2019 - 2031( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2019 - 2031, ( US$ Billion)

6. Bioburden Testing Market, By Test Type, 2019 - 2031 ( US$ Billion)

• Introduction
  • Market Size and Forecast, 2019 - 2031, ( US$ Billion)
  • Y-o-Y Growth Analysis, 2019 - 2031
  • Segment Trends
• Aerobic Count Testing 2019 - 2031( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2019 - 2031, ( US$ Billion)
• Anaerobic Count Testing Count Testing 2019 - 2031( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2019 - 2031, ( US$ Billion)
• Fungi/Mold Count Testing Count Testing Count Testing 2019 - 2031( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2019 - 2031, ( US$ Billion)
• Spore Count Testing Count Testing Count Testing 2019 - 2031( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2019 - 2031, ( US$ Billion)

7. Bioburden Testing Market, By Application, 2019 - 2031 ( US$ Billion)

• Introduction
  • Market Size and Forecast, 2019 - 2031, ( US$ Billion)
  • Y-o-Y Growth Analysis, 2019 - 2031
  • Segment Trends
• Raw Material Testing , 2019 - 2031( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2019 - 2031, ( US$ Billion)
• Medical Device Testing, 2019 - 2031( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2019 - 2031, ( US$ Billion)
• In-process Material Testing , 2019 - 2031( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2019 - 2031, ( US$ Billion)
• Sterilization Validation Testing, 2019 - 2031( US$ Billion)
  • Introduction
  • Market Size and Forecas and Y-o-Y Growth t, 2019 - 2031, ( US$ Billion)
• Equipment Cleaning Validation, 2019 - 2031( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2019 - 2031, ( US$ Billion)

8. Bioburden Testing Market, By End Use, 2019 - 2031 ( US$ Billion)

• Introduction
  • Market Size and Forecast, 2019 - 2031, ( US$ Billion)
  • Y-o-Y Growth Analysis, 2019 - 2031
  • Segment Trends
• Pharmaceutical & Biotechnology Companies , 2019 - 2031( US$ Billion)
  • Introduction
  • Market Size and Forecast, 2019 - 2031, ( US$ Billion)
• Medical Device Manufacturers , 2019 - 2031( US$ Billion)
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth 2019 - 2031, ( US$ Billion)
• Contract Manufacturing Organizations , 2019 - 2031( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2019 - 2031, ( US$ Billion)
• Manufacturers Of Food & Beverage And Agricultural Products , 2019 - 2031( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2019 - 2031, ( US$ Billion)
• Microbial Testing Laboratories, 2019 - 2031( US$ Billion)
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2019 - 2031, ( US$ Billion)

9. Bioburden Testing Market, By Region, 2019 - 2031 ( US$ Billion)

• Introduction
  • Market Share Analysis, 2019 - 2031, ( US$ Billion)
  • Y-o-Y Growth Analysis, 2019 - 2031
  • Segment Trends
• By Region
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, 2019 - 2031, ( US$ Billion)
• North America
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, By Product, 2019 - 2031, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By Application, 2019 - 2031, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By End Use, 2019 - 2031, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By Country, 2019 - 2031, ( US$ Billion)
• U.S.
• Canada
• Europe
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, By Product, 2019 - 2031, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By Application, 2019 - 2031, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By End Use, 2019 - 2031, ( US$ Billion)
  • Market Size and Forecas and Y-o-Y Growth t, By Country, 2019 - 2031, ( US$ Billion)
• U.K
• German
• Italy
• France
• Spain
• Russia
• Rest Of Europe
• Asia Pacific
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, By Product, 2019 - 2031, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By Application, 2019 - 2031, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By End Use, 2019 - 2031, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By Country, 2019 - 2031, ( US$ Billion)
• China
• India
• Japan
• Australia
• South Korea
• Asean
• Rest Of Asia Pacific
• Middle East & Africa
  • Introduction
  • Market Size and Forecast, By Product and Y-o-Y Growth, 2019 - 2031, ( US$ Billion)
  • Market Size and Forecast, By Application and Y-o-Y Growth, 2019 - 2031, ( US$ Billion)
  • Market Size and Forecast, By End Use and Y-o-Y Growth, 2019 - 2031, ( US$ Billion)
  • Market Size and Forecast, By Country and Y-o-Y Growth, 2019 - 2031, ( US$ Billion)
• GCC
• Israel
• Rest Of Middle East
• Latin America
  • Introduction
  • Market Size and Forecast and Y-o-Y Growth, By Product, 2019 - 2031, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By Application, 2019 - 2031, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By End Use, 2019 - 2031, ( US$ Billion)
  • Market Size and Forecast and Y-o-Y Growth, By Country, 2019 - 2031, ( US$ Billion)
• Brazil
• Mexico
• Argentina

10. Company Profiles - Bioburden Testing Market

• Charles River Laboratories International, Inc.*
  • Company Overview
  • Product/Service Portfolio
  • Financial Performance
  • Recent Developments/Updates
  • Strategic Overview
• SGS SA
• Merck KGaA
• Becton
• Dickinson and Company
• Wuxi Apptec
• North American Science Associates Inc.
• Nelson Laboratories, LLC
• Biomerieux SA
• Thermo Fisher Scientific
• Pacific Biolabs

11. References and Research Methodology

• References
• Research Methodology
• About us and Sales Contact