無菌檢測市場規模、佔有率、成長分析（按產品/服務、按測試類型、按應用、按地區）- 產業預測，2024-2031 年

2022年全球無菌檢測市場規模約11億美元，預測期（2024-2031年）複合年成長率為10.5%，從2023年的12億美元成長到2031年的27億美元。美元。

在生技藥品、細胞和基因療法以及疫苗需求不斷成長的推動下，全球無菌檢測市場正在經歷顯著成長。隨著製藥和生物技術領域的不斷擴大，無菌檢測正成為確保產品安全性和有效性的重要品管措施。慢性疾病，特別是癌症和自體免疫疾病的增加，導致生物製藥的開發增加，這需要在製造過程中進行無菌測試。此外，FDA 和 EMA 等監管機構對藥品安全的日益關注正促使公司採用更嚴格的無菌檢測標準，尤其是注射劑。無菌測試程序自動化等技術進步有助於簡化業務、減少人為錯誤並加快測試流程，從而提高製造商的效率。北美由於其成熟的製藥基礎設施、強大的研發活動和有利的法律規範而在市場上佔據主導地位。然而，在政府加大醫療保健投資、生物製藥公司擴張以及醫療保健成本上升的推動下，亞太地區正在成為一個高成長地區。此外，為了降低成本和縮短交貨時間，越來越多的公司將檢驗流程外包給專業公司，合約測試機構（CTO）也越來越受歡迎。默克、查爾斯河實驗室和賽默飛世爾科技等市場主要企業正在投資研發並推出新產品以保持競爭力，進一步推動市場成長。

目錄

介紹

• 研究目的
• 定義
• 市場範圍

調查方法

• 資訊採購
• 二手資料來源和主要資料來源
• 市場規模預測
• 市場假設與限制

執行摘要

• 市場概況展望
• 供需趨勢分析
• 按細分市場的機會分析

市場動態及展望

• 市場動態
  • 促進因素
  • 機會
  • 抑制因素
  • 任務
• 波特的分析

主要市場考察

• 關鍵成功因素
• 競爭程度
• 主要投資機會
• 市場生態系統
• 供應鏈分析
• 專利分析
• 客戶和購買標準分析
• 貿易分析
• 監管分析

無菌檢測市場：依產品/服務分類

• 市場概況
• 試劑套件和試劑
• 服務
• 裝置

無菌測試市場：依測試類型

• 市場概況
• 薄膜過濾
• 直接接種
• 其他測試類型

無菌檢測市場：依應用分類

• 市場概況
• 製藥和生技藥品製造
• 醫療設備製造
• 其他用途

無菌測試市場：依最終用戶分類

• 市場概況
• 製藥公司
• 生技公司
• 其他最終用戶

無菌檢測市場規模：依地區分類

• 市場概況
• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 西班牙
  • 法國
  • 英國
  • 義大利
  • 其他歐洲國家地區
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 其他亞太地區
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲地區
• 中東和非洲 (MEA)
  • 海灣合作理事會國家
  • 南非
  • 其他中東/非洲地區

競爭格局

• 前5名企業對比
• 主要企業市場定位（2023年）
• 主要市場參與者所採取的策略
• 近期市集活動
• 主要企業市場佔有率（2023年）

主要企業簡介

• Merck Kgaa
• Charles River Laboratories
• Biomerieux Sa
• Sartorius Ag
• Wuxi Apptec
• Samsung Biologics
• Genscript
• Pacific Biolabs
• Nelson Laboratories, Llc
• Pace Analytical
• Tentamus
• Singota Solutions
• Lexamed
• Astell Scientific Ltd
• Himedia Laboratories
• Pall Corporation（Part Of Danaher Corporation）
• Boston Analytical
• Solvias Ag
• Bd

Global Sterility Testing Market size was valued at around 1.1 billion in 2022 and is expected to rise from USD 1.2 billion in 2023 to reach a value of USD 2.7 billion by 2031, at a CAGR of 10.5% over the forecast period (2024-2031).

The global sterility testing market is experiencing significant growth, driven by the increasing demand for biologics, cell and gene therapies, and vaccines. As the pharmaceutical and biotechnology sectors continue to expand, sterility testing is becoming a crucial quality control measure to ensure the safety and efficacy of products. The rise in chronic diseases, particularly cancer and autoimmune disorders, is leading to the increased development of biopharmaceutical products, which necessitate sterility testing during the manufacturing process. Furthermore, the growing focus on drug safety by regulatory authorities such as the FDA and EMA is pushing companies to adopt more stringent sterility testing standards, especially for injectable products. Technological advancements, such as automation in sterility testing procedures, are helping to streamline operations, reduce human errors, and speed up the testing process, making it more efficient for manufacturers. North America dominates the market due to its established pharmaceutical infrastructure, robust R&D activities, and favorable regulatory frameworks. However, Asia-Pacific is emerging as a high-growth region, fueled by increasing government investments in healthcare, expansion of biopharma companies, and rising healthcare expenditures. Contract testing organizations (CTOs) are also gaining traction as more companies outsource their sterility testing processes to specialized firms to reduce costs and improve turnaround times. Key players in the market, including Merck KGaA, Charles River Laboratories, and Thermo Fisher Scientific, are investing in R&D and launching new products to stay competitive, further propelling market growth.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Sterility Testing Market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Sterility Testing Market Segmental Analysis

Global Sterility Testing Market is segmented by Product & Services, Test Type, Application, End User, and region. Based on Product & Services, the market is segmented into Kits & Reagents, Services, Instruments. Based on Test type, the market is segmented into Membrane Filtration, Direct Inoculation, Other Tests. Based on Application, the market is segmented into Pharmaceuticals and Biologicals, Medical Devices, Other Applications. Based on End User, the market is segmented into Pharmaceutical Companies, Biotechnology Companies, and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & and Africa.

Drivers of the Global Sterility Testing Market

One of the key drivers of the sterility testing market is the increasing demand for biologics and vaccines, driven by advancements in medical science and the ongoing threat of infectious diseases. Biologics, which include a wide range of products such as monoclonal antibodies, growth factors, and gene therapies, are highly sensitive to contamination due to their complex structure and manufacturing process. Vaccines, particularly during global pandemics like COVID-19, have underscored the importance of stringent sterility testing to ensure safety and efficacy. With the rise of personalized medicine and precision therapies, there is a growing emphasis on developing biologics tailored to specific patient populations, further boosting the need for robust sterility testing methods. This trend is expected to continue as new biopharmaceutical innovations emerge, supported by increasing investments in research and development. Manufacturers must comply with stringent regulatory guidelines that mandate thorough sterility testing, enhancing market growth.

Restraints in the Global Sterility Testing Market

Despite the positive market outlook, one of the major restraints in the sterility testing market is the high cost and time-intensive nature of these procedures. Sterility testing, especially for biologics and sterile injectable products, requires highly controlled environments, advanced equipment, and skilled personnel to ensure accurate results. The validation of testing methods, along with the need for multiple tests across different production batches, adds to the overall expense. Moreover, traditional sterility testing methods can take several days to yield results, which can slow down the production timeline, particularly in the case of urgent therapeutic products like vaccines. Small- and mid-sized pharmaceutical companies often find it challenging to balance the need for comprehensive sterility testing with cost constraints, potentially limiting their market participation. While automation and rapid microbial testing technologies offer solutions, the initial setup and operational costs of these technologies can be prohibitive for smaller market players.

Market Trends of the Global Sterility Testing Market

A notable trend in the global sterility testing market is the increasing adoption of rapid sterility testing technologies. Traditional sterility testing methods, such as membrane filtration and direct inoculation, are time-consuming, requiring up to 14 days to yield results. In contrast, rapid sterility testing methods, including ATP bioluminescence, nucleic acid amplification, and flow cytometry, can provide results in a matter of hours or days. These technologies not only speed up the quality control process but also enhance the sensitivity and accuracy of testing, reducing the risk of false negatives. As the pharmaceutical industry faces growing pressure to accelerate product development timelines, especially for critical therapies like vaccines, the demand for rapid testing solutions is rising. Moreover, regulatory bodies are beginning to recognize and approve these advanced methods, further encouraging their adoption. Companies that implement rapid sterility testing can streamline their production workflows, reduce storage costs associated with quarantine periods, and bring products to market faster, gaining a competitive edge.

Table of Contents

Introduction

• Objectives of the Study
• Definitions
• Market Scope

Research Methodology

• Information Procurement
• Secondary & Primary Data Sources
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Market Overview Outlook
• Supply Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Dynamics
  • Drivers
  • Opportunities
  • Restraints
  • Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of Substitute Products
  • Bargaining Power of Buyers
  • Threat of New Entrants
  • Bargaining Power of Suppliers

Key Market Insights

• Key Success Factor
• Degree of Competition
• Top Investment Pockets
• Ecosystem of the Market
• Supply Chain Analysis
• Patent Analysis
• Customer & Buying Criteria Analysis
• Trade Analysis
• Regulatory Analysis

Sterility Testing Market, By Product & Service

• Market Overview
• Kits & Reagents
• Services
• Instruments

Sterility Testing Market, By Test Type

• Market Overview
• Membrane Filtration
• Direct Inoculation
• Other Test Types

Sterility Testing Market, By Application

• Market Overview
• Pharmaceutical & Biologics Manufacturing
• Medical Device Manufacturing
• Other Applications

Sterility Testing Market, By End User

• Market Overview
• Pharmaceutical Companies
• Biotechnology Companies
• Other End Users

Sterility Testing Market Size by Region

• Market Overview
• North America
  • USA
  • Canada
• Europe
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America
  • Brazil
  • Rest of Latin America
• Middle East & Africa (MEA)
  • GCC Countries
  • South Africa
  • Rest of MEA

Competitive Landscape

• Top 5 Player Comparison
• Market Positioning of Key Players, 2023
• Strategies Adopted by Key Market Players
• Recent Activities in the Market
• Key Companies Market Share (%), 2023

Key Company Profiles

• Merck Kgaa
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Charles River Laboratories
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Biomerieux Sa
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sartorius Ag
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Wuxi Apptec
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Samsung Biologics
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Genscript
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pacific Biolabs
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Nelson Laboratories, Llc
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pace Analytical
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Tentamus
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Singota Solutions
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Lexamed
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Astell Scientific Ltd
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Himedia Laboratories
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pall Corporation (Part Of Danaher Corporation)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Boston Analytical
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Solvias Ag
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bd
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments