微生物附著量測試市場：按產品類型、按應用、按最終用戶、按地區

2024年微生物附著量測試市場規模為14億美元，預計2024年至2031年年複合成長率為9.2%，到2031年達到25.9億美元。

圖 1.2024年微生物附著量測試市場佔有率（%），依地區分類

微生物附著量測試是指對產品、原料、表面等上存在的微生物進行檢測和定量。微生物附著量測試可確保生產中使用的材料和設備符合適當的衛生標準，幫助監控藥品和保健產品的品質。它對於維持無菌及防止無菌設備、設備及成品污染有重要作用。由於嚴格的醫療設備測試法規、契約製造組織的滲透率不斷提高以及藥品製造外包的增加，微生物附著量測試市場不斷擴大。由於醫療設備和藥品與患者直接接觸，因此保持無菌條件並防止微生物生長非常重要。微生物附著量測試提供了一種品管措施，用於檢驗滅菌過程並檢測製造或運輸過程中可能引進的污染物。這些測試結果將有助於確定適當的保存期限並調查該產品批次的任何未來問題。

市場動態：

全球微生物附著量測試市場受到製藥和醫療設備製造中微生物附著量測試嚴格監管要求的推動。監管機構，例如食品藥物管理局（FDA）和歐洲藥品管理局（EMA）。 FDA 和歐洲藥品管理局 EMA 等監管機構要求在各個階段進行微生物附著量測試，以確保非無菌產品的安全性和有效性。製藥和醫療設備業的成長也推動了微生物附著量測試的需求。然而，與微生物附著量測試設備和服務相關的高成本限制了該市場的成長。快速自動化微生物附著量測試解決方案的出現提供了一個利潤豐厚的機會，因為它可以更快地獲得結果和更高的通量。在製造過程中採用連續監測系統進行微生物附著量測試為未來幾年提供了更多機會。

本研究的主要特點

• 本報告詳細分析了全球微生物附著量測試市場，並提供了以2023年為基準年的預測期（2024-2031）的市場規模和年複合成長率（CAGR%）。
• 揭示了各個細分市場的潛在商機，並為該市場說明了一系列有吸引力的投資提案。
• 提供了有關市場促進因素、限制因素、機會、新產品發布和核准、市場趨勢、區域前景、主要企業採取的競爭策略等的重要見解。
• 根據公司亮點、產品系列、主要亮點、財務表現和策略等參數，介紹了全球微生物附著量測試市場的主要企業。
• 本報告的見解使行銷人員和經營團隊負責人就未來的產品發布、類型升級、市場擴張和行銷策略做出明智的決策。
• 本研究報告針對該產業的各個相關人員，如投資者、供應商、產品製造商、經銷商、新進業者和財務分析師。

第1章 研究目的與前提

• 研究目標
• 先決條件
• 簡稱

第2章 市場概況

• 報告說明
• 市場定義和範圍
• 執行摘要
• Coherent Opportunity Map（COM）

第3章 市場動態、法規及趨勢分析

• 市場動態
• 影響分析
• 主要亮點
• 監管場景
• 產品發布/核准
• PEST分析
• 波特的分析
• 併購場景

第4章 冠狀病毒（COVID-19）大流行對微生物附著量測試市場的影響

• 新型冠狀病毒感染疾病（COVID-19）的流行病學
• 供需面分析
• 影響微生物附著量測試市場

第5章 微生物附著量測試市場，依產品，2019-2031

• 消耗品，2019-2031
• 設備，2019-2031

第6章 微生物附著量測試市場，依測試類型，2019-2031

• 有氧運動測試，2019-2031
• 厭氧計數測試，2019-2031
• 真菌/黴菌計數測試，2019-2031
• 孢子計數測試，2019-2031

第7章 微生物附著量測試市場，依應用分類，2019-2031

• 原料測試，2019-2031
• 醫療設備測試，2019-2031
• 進程內材料測試，2019-2031
• 滅菌檢驗測試，2019-2031
• 設備清洗檢驗，2019-2031

第8章 微生物附著量測試市場，依最終用途，2019-2031

• 製藥和生物技術公司，2019-2031
• 醫療設備製造商，2019-2031
• 契約製造組織，2019-2031
• 食品、飲料和農產品製造商，2019-2031
• 微生物檢測實驗室，2019-2031

第9章 2019-2031年微生物附著量測試市場，依地區

• 依地區
• 北美洲
• 美國
• 加拿大
• 歐洲
• 英國
• 德文
• 義大利
• 法國
• 西班牙
• 俄羅斯
• 歐洲其他地區
• 亞太地區
• 中國
• 印度
• 日本
• 澳洲
• 韓國
• ASEAN
• 其他亞太地區
• 中東、非洲
• GCC
• 以色列
• 其他中東地區
• 拉丁美洲
• 巴西
• 墨西哥
• 阿根廷

第10章 公司簡介-微生物附著量測試市場

• Charles River Laboratories International, Inc.
  • 公司簡介
  • 產品/服務組合
  • 財務績效
  • 最新動態/最新訊息
  • 策略概覽
• 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11章 參考文獻與調查方法

• 參考
• 調查方法

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