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市場調查報告書

商品編碼

1896974

全球無菌檢測市場：依產品、檢測方法、應用、最終用戶及地區劃分－市場規模、產業動態、機會分析及預測（2026-2035 年）

Global Sterility Testing Market: By Products, Test, Application, End Users, Region - Market Size, Industry Dynamics, Opportunity Analysis and Forecast for 2026-2035

出版日期: 2025年12月26日 | 出版商:

Astute Analytica | 英文 210 Pages | 商品交期: 最快1-2個工作天內

價格

簡介目錄

無菌檢測市場持續強勁穩定成長，預計到 2025 年將達到約 13.3431 億美元。這一成長趨勢預計將在未來十年持續，到 2035 年將達到約 39.1335 億美元。這一顯著增長意味著 2026 年至 2035 年的複合年增長率 (CAGR) 為 11.36%。

推動市場擴張的主要因素之一是藥品生產監管環境的嚴格性。包括 FDA 和 EMA 在內的全球監管機構制定了嚴格的標準和指南，以確保無菌產品完全不含微生物污染。這些法規要求採用全面的無菌檢測方案，迫使製造商實施先進的檢測技術並維持嚴格的品質控制系統。

市場趨勢展望

全球無菌檢測市場的競爭格局正日益受到積極採用自動化和數位化技術以簡化檢測流程的公司的影響。這些技術進步使得無菌檢測流程更加快速、準確和高效，這對於滿足製藥和生物製藥行業嚴格的品質標準至關重要。

這一趨勢的一個顯著例證是，領先的合約研發生產機構 (CDMO) Recipharm 於 2025 年 10 月在其位於印度班加羅爾的工廠開設了一家新的注射劑研發和無菌檢測實驗室。此次擴建體現了該公司致力於透過引入先進技術和專業基礎設施來增強其服務能力，從而支援複雜的無菌產品研發。

大約在同一時間，即2025年10月30日，Avantron推出了其新一代無菌取樣平台和預製PUPSIT（產品單元滅菌前完整性測試）組件。這些創新技術旨在簡化生物製程驗證流程，並在生產過程中實現更明智的即時決策。同月，Sotera Health旗下子公司Nelson Labs推出了RapidCert。 Nelson Labs是醫療器材和製藥業領先的外包微生物和分析化學檢測服務提供者。這項新型快速生物指示劑（RBI）無菌檢測服務結合了傳統生物指示劑（BI）和快速微生物方法（RMM），可提供快速可靠的無菌檢測結果。

核心成長驅動因子

在製藥和生物製藥行業，無菌檢測是生產過程中每個階段都必須執行的重要流程，旨在最大限度地降低產品污染的風險。在研發、生產和包裝過程中保持產品無菌狀態對於確保病患安全和符合法規要求至關重要。這種全面的無菌檢測方法包括嚴格的監測和控制措施，以檢測和消除可能損害產品品質的微生物污染。由於藥品和生物製藥（尤其是生物製劑和無菌注射劑）的複雜性和敏感性，在整個生產過程中持續進行無菌檢測對於保護這些治療藥物的完整性至關重要。

新興機會

無菌檢測和顆粒檢測的日益融合是塑造無菌檢測市場的關鍵趨勢。這項發展主要源自於人們對藥品中異物顆粒污染風險的認識不斷提高。到2024年，約20%的產品召回將由外來物顆粒引起，這凸顯了全面品質保證措施的迫切需求，這些措施應同時解決微生物污染和顆粒物污染問題。因此，客戶現在正在尋求更精簡、更有效率的檢測解決方案，將這些必要的檢測整合到一個統一的服務中。

優化障礙

目前，無菌檢測市場面臨嚴重的人才短缺，這對市場成長和營運效率構成了重大挑戰。隨著業界向快速檢測方法和複雜生物製劑的開發方向發展，對具備驗證流程專業知識的微生物學家的需求激增。這些先進的檢測技術和複雜的產品需要專業人員不僅要對微生物學原理有深刻的理解，還要具備嚴格的驗證方案的實務經驗，以確保準確性和合規性。在創新技術不斷補充或取代傳統方法的環境下，這種專業技能對於維持最高的無菌保證標準至關重要。

產業價值鏈分析
- 原料供應商
- 製造商
- 經銷商
- 服務提供者
- 最終用戶
行業展望
- 研發支出（佔GDP的百分比）
- 2024年十大製藥公司研發預算
- 個案研究分析：
PESTLE分析
波特五力分析
- 供應商議價能力
- 買方議價能力
- 替代品威脅
- 新進入者威脅
- 競爭強度
市場成長與展望
- 市場收入估計與預測（2020-2035）
- 價格趨勢分析（按基材）
市場吸引力分析
- 依基材劃分
- 按地區劃分
可操作的洞見（分析師建議）

第四章：競爭格局概覽

市場集中度
公司市佔率分析（按價值，2025 年）
競爭格局分析與基準分析

第五章：全球無菌檢測市場分析

市場動態與趨勢
- 成長驅動因素
- 限制因素
- 機遇
- 主要趨勢
市場規模及預測（2020-2035 年）
- 按測試
  - 薄膜過濾
  - 直接轉移
  - 產品沖洗
- 依產品分類
  - 試劑盒
  - 服務
  - 設備
- 依應用程式分類
  - 醫療器材
  - 藥品
  - 其他
- 依最終使用者分類
  - 醫院和診所
  - 製藥公司
  - 研究實驗室
  - 其他
- 依地區分類

第六章：北美無菌檢測市場分析

第七章：歐洲無菌檢測市場分析

第八章：亞太地區無菌檢測市場分析

第九章：中東與非洲無菌檢測市場分析

第十章：南美洲無菌檢測市場分析

第十一章：公司簡介

賽默飛世爾科技公司 (Thermo Fisher Scientific Inc.)
查爾斯河實驗室國際公司 (Charles River Laboratories International, Inc.)
賽多利斯股份公司 (Sartorius AG)
SGS集團
生物梅里埃公司 (bioMerieux SA)
歐陸科技 (Eurofins Scientific)
阿爾卡米公司 (Alcami Corporation)
斯特里斯公司 (Steris plc)
佩斯分析公司 (Pace analytical)
納爾遜實驗室有限責任公司 (Nelson Laboratories, LLC) - 索特拉健康公司 (Sotera Health company)
維羅西有限公司 (Viroxy Sdn. Bhd.) Bhd
Pacific BioLabs, Inc.
藥明康德
Bioquell（藝康解決方案）
默克
其他主要參與者

第十二章附錄

簡介目錄

Product Code: AA1024945

The sterility testing market is witnessing robust and steady growth, with its valuation reaching approximately US$ 1,334.31 million in 2025. This upward trajectory is expected to continue throughout the coming decade, projecting the market to achieve a valuation of around US$ 3,913.35 million by 2035. This significant expansion corresponds to a compound annual growth rate (CAGR) of 11.36% during the forecast period from 2026 to 2035.

One of the primary drivers fueling this market expansion is the stringent regulatory environment governing pharmaceutical manufacturing. Regulatory agencies worldwide, including the FDA, EMA, and others, impose rigorous standards and guidelines to ensure that sterile products are free from microbial contamination. These regulations necessitate comprehensive sterility testing protocols, compelling manufacturers to adopt advanced testing technologies and maintain stringent quality control systems.

Noteworthy Market Developments

The competitive landscape of the global sterility testing market is increasingly shaped by companies that have successfully embraced automation and digitalization to enhance their testing workflows. These technological advancements enable faster, more accurate, and more efficient sterility testing processes, which are critical in meeting the demanding quality standards of the pharmaceutical and biopharmaceutical industries.

A notable example of this trend occurred in October 2025, when Recipharm, a leading contract development and manufacturing organization (CDMO), inaugurated its newly commissioned parenteral development and sterility testing laboratories at its Bengaluru facility in India. This expansion reflects Recipharm's commitment to enhancing its service capabilities by incorporating advanced technologies and specialized infrastructure to support complex sterile product development.

Around the same time, Avantoron introduced a next-generation sterile sampling platform alongside pre-engineered PUPSIT (Product Unit Pre-sterilization Integrity Test) assemblies on October 30, 2025. These innovations are aimed at streamlining bioprocessing qualification and enabling more informed, real-time decision-making during manufacturing. In the same month, Nelson Labs, a subsidiary of Sotera Health and a prominent provider of outsourced microbiological and analytical chemistry testing services for the medical device and pharmaceutical industries, launched RapidCert. This new rapid biological indicator (RBI) sterility service combines traditional biological indicators (BIs) with rapid microbiological methods (RMMs) to deliver expedited and reliable sterility testing results.

Core Growth Drivers

In the pharmaceutical and biopharmaceutical industries, sterility testing is an indispensable process conducted at every stage of manufacturing to minimize the risk of product contamination. Ensuring that products remain sterile throughout development, production, and packaging is critical for maintaining patient safety and regulatory compliance. This comprehensive approach to sterility testing involves rigorous monitoring and control measures designed to detect and eliminate any potential microbial contamination that could compromise product quality. Given the complexity and sensitivity of pharmaceutical and biopharmaceutical products, particularly biologics and sterile injectables, consistent sterility testing throughout the manufacturing pipeline is essential to safeguard the integrity of these therapies.

Emerging Opportunity Trends

A significant trend shaping the sterility testing market is the growing integration of sterility testing with particulate testing. This development is largely driven by the increasing awareness of the risks posed by foreign material contamination in pharmaceutical products. In 2024, approximately 20% of product recalls were attributed to the presence of foreign particles, highlighting the critical need for comprehensive quality assurance measures that address both microbial contamination and particulate matter. As a result, customers are now seeking more streamlined and efficient testing solutions that combine these essential inspections into a single, cohesive service offering.

Barriers to Optimization

The sterility testing market is currently grappling with a significant talent shortage, which poses a serious challenge to its growth and operational efficiency. As the industry increasingly shifts towards rapid testing methods and the development of complex biologics, the demand for microbiologists with specialized expertise in validation processes has surged. These advanced testing technologies and sophisticated products require professionals who not only have a deep understanding of microbiological principles but also possess hands-on experience with stringent validation protocols to ensure accuracy and compliance. This specialized skill set is essential to maintaining the highest standards of sterility assurance in an environment where traditional methods are being supplemented or replaced by innovative techniques.

Detailed Market Segmentation

Based on test type, the membrane filtration test currently holds a leading position in the sterility testing market, contributing over 46.1% of the total revenue. This prominent standing is largely due to its recognition as the pharmacopeial gold standard for sterility testing, especially when it comes to filterable pharmaceutical products. Membrane filtration is widely preferred in the industry because it allows for the effective separation and retention of microorganisms on a filter, enabling precise detection of potential contaminants. Its ability to handle large volumes of liquid samples makes it particularly suitable for products that require rinsing steps to eliminate antimicrobial agents that could otherwise interfere with the accuracy of sterility results.

Based on product type, sterility testing kits currently lead the sterility testing market, accounting for more than 49.0% of the total market share. This dominant position reflects the growing preference within the pharmaceutical and biopharmaceutical industries for consumable-based testing solutions. Sterility testing kits offer a convenient and standardized approach to detecting microbial contamination, making them integral to quality control processes. Their widespread adoption is fueled by the increasing emphasis on ensuring product safety while optimizing operational efficiency in manufacturing environments.

Based on end users, pharmaceutical companies occupy a leading position in the sterility testing market, commanding over 44.3% of the total market share. This dominance is driven by the critical role these companies play in ensuring the safety and efficacy of their products before they reach consumers. As the ultimate custodians of patient health, pharmaceutical manufacturers bear the responsibility for comprehensive quality assurance, which includes rigorous sterility testing of their products. Their commitment to maintaining high standards compels them to invest substantially in robust internal quality control systems to monitor and verify the sterility of every batch produced.

Based on application, sterility testing is predominantly utilized in the inspection of pharmaceutical products, representing a significant portion of the overall market. This application segment commands over 42.2% of the market share, highlighting its critical importance within the sterility testing landscape. The primary reason for this substantial share lies in the stringent regulatory requirements that mandate every batch of sterile pharmaceutical formulations to undergo comprehensive release testing before they can be distributed to patients.

Segment Breakdown

By Product

Kits
Services
Instruments

By Test

Membrane Filtration
Direct Transfer
Product Flush

By Application

Medical Devices
Pharmaceutical products
Other applications

By End User

Hospitals & Clinics
Pharmaceutical Companies
Research Laboratories
Others

By Region

North America
The U.S.
Canada
Mexico
Europe
Western Europe
The U.K.
Germany
France
Spain
Italy
Rest of Western Europe
Eastern Europe
Poland
Russia
Rest of Eastern Europe
Asia Pacific
China
India
Japan
Australia
ASEAN
South Korea
Rest of Asia Pacific
Middle East & Africa (MEA)
UAE
Turkey
Saudi Arabia
South Africa
Rest of MEA
South America
Argentina
Brazil
Rest of South America

Geography Breakdown

North America holds a commanding position in the global sterility testing market, controlling approximately 50.2% of the market share. This dominant stance is largely attributed to the region's aggressive upgrades in pharmaceutical infrastructure, which have significantly enhanced its capacity for sterility testing. The United States, in particular, plays a pivotal role due to the presence of numerous global pharmaceutical and biopharmaceutical companies, coupled with substantial funding from both government and private sectors dedicated to research and development.
The regulatory landscape in North America further strengthens its market dominance. Regulatory bodies in the region actively promote innovation while enforcing stringent quality and safety standards, which drives the demand for advanced sterility testing services. This regulatory environment ensures that pharmaceutical products meet rigorous sterility requirements, thereby safeguarding public health and boosting confidence in the market.

Leading Market Participants

Thermo Fisher Scientific Inc.
Charles River Laboratories International, Inc
Sartorius AG
SGS S.A.
bioMerieux SA
Eurofins Scientific
Alcami Corporation
Steris plc
Pace analytical
Nelson Laboratories, LLC - A Sotera Health company
Viroxy Sdn. Bhd
Pacific BioLabs, Inc.
WuXi AppTec
Bioquell (Ecolab Solution)
Merck
Other Prominent Players

Table of Content

Chapter 1. Executive Summary: Global Sterility Testing Market

Chapter 2. Research Methodology & Research Framework

2.1. Research Objective
2.2. Product Overview
2.3. Market Segmentation
2.4. Qualitative Research
- 2.4.1. Primary & Secondary Leather Types
2.5. Quantitative Research
- 2.5.1. Primary & Secondary Leather Types
2.6. Breakdown of Primary Research Respondents, By Region
2.7. Assumption for Study
2.8. Market Size Estimation
2.9. Data Triangulation

Chapter 3. Global Sterility Testing Market Overview

3.1. Industry Value Chain Analysis
- 3.1.1. Raw Material Provider
- 3.1.2. Manufacturer
- 3.1.3. Distributor
- 3.1.4. Service Provider
- 3.1.5. End User
3.2. Industry Outlook
- 3.2.1. Research and development expenditure (% of GDP)
- 3.2.2. Top 10 Pharma R&D Budgets in 2024
- 3.2.3. Case Study Analysis:
  - 3.2.3.1. Performance Survey and Comparison Between Rapid Sterility Testing Method and Pharmacopoeia Sterility Test
  - 3.2.3.2. Sterility Testing of Pharmaceuticals
3.3. PESTLE Analysis
3.4. Porter's Five Forces Analysis
- 3.4.1. Bargaining Power of Suppliers
- 3.4.2. Bargaining Power of Buyers
- 3.4.3. Threat of Substitutes
- 3.4.4. Threat of New Entrants
- 3.4.5. Degree of Competition
3.5. Market Growth and Outlook
- 3.5.1. Market Revenue Estimates and Forecast (US$ Mn), 2020-2035
- 3.5.2. Price Trend Analysis, By Base Material
3.6. Market Attractiveness Analysis
- 3.6.1. By Base Material
- 3.6.2. By Region
3.7. Actionable Insights (Analyst's Recommendations)

Chapter 4. Competition Dashboard

4.1. Market Concentration Rate
4.2. Company Market Share Analysis (Value %), 2025
4.3. Competitor Mapping & Benchmarking

Chapter 5. Global Sterility Testing Market Analysis

5.1. Market Dynamics and Trends
- 5.1.1. Growth Drivers
- 5.1.2. Restraints
- 5.1.3. Opportunity
- 5.1.4. Key Trends
5.2. Market Size and Forecast, 2020-2035 (US$ Mn)
- 5.2.1. By Test
  - 5.2.1.1. Key Insights
    - 5.2.1.1.1. Membrane Filtration
    - 5.2.1.1.2. Direct Transfer
    - 5.2.1.1.3. Product Flush
- 5.2.2. By Product Type
  - 5.2.2.1. Key Insights
    - 5.2.2.1.1. Instruments
    - 5.2.2.1.2. Kits & Reagents
    - 5.2.2.1.3. Services
- 5.2.3. By Application
  - 5.2.3.1. Key Insights
    - 5.2.3.1.1. Medical Devices
    - 5.2.3.1.2. Pharmaceutical Products
    - 5.2.3.1.3. Others
- 5.2.4. By End User
  - 5.2.4.1. Key Insights
    - 5.2.4.1.1. Hospitals & Clinics
    - 5.2.4.1.2. Pharmaceutical Companies
    - 5.2.4.1.3. Research Laboratories
    - 5.2.4.1.4. Others
- 5.2.5. By Region
  - 5.2.5.1. Key Insights
    - 5.2.5.1.1. North America
      - 5.2.5.1.1.1. The U.S.
      - 5.2.5.1.1.2. Canada
      - 5.2.5.1.1.3. Mexico
    - 5.2.5.1.2. Europe
      - 5.2.5.1.2.1. Western Europe
        
        5.2.5.1.2.1.1. The UK
        5.2.5.1.2.1.2. Germany
        5.2.5.1.2.1.3. France
        5.2.5.1.2.1.4. Italy
        5.2.5.1.2.1.5. Spain
        5.2.5.1.2.1.6. Rest of Western Europe
      - 5.2.5.1.2.2. Eastern Europe
        
        5.2.5.1.2.2.1. Poland
        5.2.5.1.2.2.2. Russia
        5.2.5.1.2.2.3. Rest of Eastern Europe
    - 5.2.5.1.3. Asia Pacific
      - 5.2.5.1.3.1. China
      - 5.2.5.1.3.2. India
      - 5.2.5.1.3.3. Japan
      - 5.2.5.1.3.4. South Korea
      - 5.2.5.1.3.5. Australia & New Zealand
      - 5.2.5.1.3.6. ASEAN
        
        5.2.5.1.3.6.1.1. Indonesia
        5.2.5.1.3.6.1.2. Malaysia
        5.2.5.1.3.6.1.3. Thailand
        5.2.5.1.3.6.1.4. Singapore
        5.2.5.1.3.6.1.5. Rest of ASEAN
      - 5.2.5.1.3.7. Rest of Asia Pacific
    - 5.2.5.1.4. Middle East & Africa
      - 5.2.5.1.4.1. UAE
      - 5.2.5.1.4.2. Saudi Arabia
      - 5.2.5.1.4.3. South Africa
      - 5.2.5.1.4.4. Rest of MEA
    - 5.2.5.1.5. South America
      - 5.2.5.1.5.1. Argentina
      - 5.2.5.1.5.2. Brazil
      - 5.2.5.1.5.3. Rest of South America

Chapter 6. North America Sterility Testing Market Analysis

6.1. Market Dynamics and Trends
- 6.1.1. Growth Drivers
- 6.1.2. Restraints
- 6.1.3. Opportunity
- 6.1.4. Key Trends
6.2. Market Size and Forecast, 2020-2035 (US$ Mn)
- 6.2.1. By Test
- 6.2.2. By Product Type
- 6.2.3. By Application
- 6.2.4. By End User
- 6.2.5. By Country

Chapter 7. Europe Sterility Testing Market Analysis

7.1. Market Dynamics and Trends
- 7.1.1. Growth Drivers
- 7.1.2. Restraints
- 7.1.3. Opportunity
- 7.1.4. Key Trends
7.2. Market Size and Forecast, 2020-2035 (US$ Mn)
- 7.2.1. By Test
- 7.2.2. By Product Type
- 7.2.3. By Application
- 7.2.4. By End User
- 7.2.5. By Country

Chapter 8. Asia Pacific Sterility Testing Market Analysis

8.1. Market Dynamics and Trends
- 8.1.1. Growth Drivers
- 8.1.2. Restraints
- 8.1.3. Opportunity
- 8.1.4. Key Trends
8.2. Market Size and Forecast, 2020-2035 (US$ Mn)
- 8.2.1. By Test
- 8.2.2. By Product Type
- 8.2.3. By Application
- 8.2.4. By End User
- 8.2.5. By Country

Chapter 9. Middle East & Africa Sterility Testing Market Analysis

9.1. Market Dynamics and Trends
- 9.1.1. Growth Drivers
- 9.1.2. Restraints
- 9.1.3. Opportunity
- 9.1.4. Key Trends
9.2. Market Size and Forecast, 2020-2035 (US$ Mn)
- 9.2.1. By Test
- 9.2.2. By Product Type
- 9.2.3. By Application
- 9.2.4. By End User
- 9.2.5. By Country

Chapter 10. South America Sterility Testing Market Analysis

10.1. Market Dynamics and Trends
- 10.1.1. Growth Drivers
- 10.1.2. Restraints
- 10.1.3. Opportunity
- 10.1.4. Key Trends
10.2. Market Size and Forecast, 2020-2035 (US$ Mn)
- 10.2.1. By Test
- 10.2.2. By Product Type
- 10.2.3. By Application
- 10.2.4. By End User
- 10.2.5. By Country