医薬品無菌性試験市場- 世界の産業規模、シェア、動向、機会、予測、タイプ別、製品タイプ別、試験タイプ別、地域別、競争別、2020-2030F

医薬品無菌性試験の世界市場は、2024年に12億9,000万米ドルと評価され、予測期間中のCAGRは10.43%で、2030年には23億4,000万米ドルに達すると予測されています。

医薬品無菌性試験は、医薬品が細菌、真菌、酵母、その他の潜在的に有害な汚染物質を含む生存可能な微生物から自由であることを保証するために製薬業界で使用される重要な品質管理プロセスです。無菌試験の主な目的は、医薬品が無菌であり、患者が安全に使用できることを確認することです。

市場促進要因

バイオテクノロジーの進歩

主な市場課題

複雑な生物学的製剤

主な市場動向

無菌処理の進歩

目次

第1章 概要

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 顧客の声

第5章 世界の医薬品無菌性試験市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • タイプ別（社内、アウトソーシング）
  • 製品タイプ別（キットおよび試薬、機器、サービス）
  • 試験の種類別（無菌試験、膜ろ過、直接接種、バイオバーデン試験、細菌エンドトキシン試験）
  • 地域別
  • 企業別（2024）
• 市場マップ

第6章 アジア太平洋地域の医薬品無菌性試験市場展望

• 市場規模・予測
• 市場シェア・予測
• アジア太平洋地域：国別分析
  • 中国
  • インド
  • オーストラリア
  • 日本
  • 韓国

第7章 欧州の医薬品無菌性試験市場展望

• 市場規模・予測
• 市場シェア・予測
• 国別
• 欧州：国別分析
  • フランス
  • ドイツ
  • スペイン
  • イタリア
  • 英国

第8章 北米の医薬品無菌性試験市場展望

• 市場規模・予測
• 市場シェア・予測
• 国別
• 北米：国別分析
  • 米国
  • メキシコ
  • カナダ

第9章 南米の医薬品無菌性試験市場展望

• 市場規模・予測
• 市場シェア・予測
• 南米：国別分析
  • ブラジル
  • アルゼンチン
  • コロンビア

第10章 中東・アフリカの医薬品無菌性試験市場展望

• 市場規模・予測
• 市場シェア・予測
• 中東・アフリカ：国別分析
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦

第11章 市場力学

• 促進要因
• 課題

第12章 市場動向と発展

• 最近の動向
• 製品上市
• 合併と買収

第13章 世界の医薬品無菌性試験市場：SWOT分析

第14章 ポーターのファイブフォース分析

• 業界内の競合
• 新規参入の可能性
• サプライヤーの力
• 顧客の力
• 代替品の脅威

第15章 PESTEL分析

第16章 競合情勢

• Pacific BioLabs Inc.
• STERIS
• Boston Analytical
• Nelson Laboratories, LLC
• Sartorius AG
• SOLVIAS AG
• Charles River Laboratories
• Thermo Fisher Scientific, Inc.
• Rapid Micro Biosystems, Inc.
• Almac Group

第17章 戦略的提言

第18章 調査会社について・免責事項

Global Pharmaceutical Sterility Testing Market was valued at USD 1.29 billion in 2024 and is expected to reach USD 2.34 billion by 2030 with a CAGR of 10.43% during the forecast period. Pharmaceutical sterility testing is a critical quality control process used in the pharmaceutical industry to ensure that a pharmaceutical product is free from viable microorganisms, including bacteria, fungi, yeast, and other potentially harmful contaminants. The primary objective of sterility testing is to verify that a pharmaceutical product is sterile and safe for patient use.

Key Market Drivers

Biotechnology Advancements

Biotechnology has introduced molecular biology methods, such as Polymerase Chain Reaction (PCR) and real-time PCR, for the detection of specific microbial DNA or RNA in samples. These techniques allow for rapid and highly specific identification of microorganisms, improving the speed and accuracy of sterility testing. Next-Generation Sequencing (NGS) technology has revolutionized microbial identification and genotypic characterization. It enables comprehensive microbial profiling and can detect a wide range of microorganisms in a single test. NGS can be applied to environmental monitoring and identifying contaminants in pharmaceutical products. Microarrays allow for the simultaneous detection of multiple microorganisms in a single test. They are especially valuable for environmental monitoring and identifying potential sources of contamination in pharmaceutical manufacturing facilities. Flow cytometry, coupled with fluorescent staining techniques, can rapidly assess microbial viability and cell count. This technology is useful for both in-process monitoring and the final product sterility testing. Biotechnology has enhanced traditional culture methods. Automated microbial detection systems, using technologies like bioluminescence or impedance, speed up the detection process and provide a real-time assessment of microbial growth. Biotechnology has enabled high-throughput sterility testing systems, which can process many samples simultaneously. This is particularly valuable for pharmaceutical manufacturers dealing with a high volume of products.

Microfluidic devices allow for miniaturized and automated sterility testing systems. They enable precise handling of small sample volumes and can reduce the time required for testing. Advances in bioinformatics and data analysis tools help in interpreting the vast amount of data generated by modern sterility testing methods. These tools facilitate microbial identification and genotypic characterization. Biotechnology has facilitated the development of portable and rapid sterility testing devices, which can be used in field applications and remote locations, enhancing access to sterility testing in resource-limited settings. Biotechnology has enabled the development of single-use sterility testing systems, reducing the risk of cross-contamination, and improving the efficiency of testing in pharmaceutical manufacturing. Biotechnology advancements have also contributed to the quality control and validation of sterility testing processes. This includes the development of reference materials, standards, and proficiency testing programs to ensure the accuracy and reliability of testing. Biotechnology-driven automation, including robotics, has enhanced the sterility testing process, reducing the potential for human error, and improving overall efficiency. This factor will help in the development of the Global Pharmaceutical Sterility Testing Market.

Key Market Challenges

Complex and Biologic Drug Products

Complex and biologic drug products, such as monoclonal antibodies and gene therapies, can be sensitive to traditional sterilization methods like heat or radiation. Sterility testing methods must be adapted to ensure that the product's efficacy is not compromised during the testing process. Cell-based therapies, such as stem cell treatments, are considered biologic drug products. Sterility testing for these therapies must address the presence of live cells, making traditional methods less suitable. Specialized techniques are required to detect potential contamination without harming the therapeutic cells. Some complex drug products have intricate formulations, often involving liposomes, nanoparticles, or emulsions. These complex formulations can interfere with traditional sterility testing methods, requiring the development of novel techniques to ensure accurate results. Biologic drug products, especially those derived from cell cultures, are at risk of viral contamination. Sterility testing for these products includes specific tests to detect the presence of viral contaminants. Some biologic drugs are administered in extremely low dosages. The sensitivity and accuracy of sterility testing methods become critical to detect any potential contamination in such small quantities.

Key Market Trends

Advancements in Aseptic Processing

Pharmaceutical manufacturers are increasingly adopting advanced barrier systems, including isolators and Restricted Access Barrier Systems (RABS). These systems create physical barriers that prevent external contaminants from entering the manufacturing process. These technologies improve sterility assurance during drug product filling and packaging. Single-use systems, such as disposable bags, tubing, and connectors, are being integrated into aseptic processing. They reduce the risk of cross-contamination and simplify the cleaning and sterilization processes, thereby enhancing sterility control. Automation and robotics play a vital role in aseptic processing by minimizing human intervention and reducing the potential for contamination. Automated filling, capping, and inspection systems enhance product sterility and consistency. Innovations in fill-finish technologies, such as pre-sterilized containers, nested syringes, and ready-to-use vials, are simplifying the aseptic filling process. These advancements reduce the handling of components and minimize the risk of contamination. Advanced microbial detection methods, including rapid microbial methods (RMM), are being integrated into aseptic processing to allow for real-time monitoring of microbial contamination. This enables proactive responses and corrective actions.

Key Market Players

• Pacific BioLabs Inc.
• STERIS
• Boston Analytical
• Nelson Laboratories, LLC
• Sartorius AG
• SOLVIAS AG
• Charles River Laboratories
• Thermo Fisher Scientific, Inc.
• Rapid Micro Biosystems, Inc.
• Almac Group

Report Scope:

In this report, the Global Pharmaceutical Sterility Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Pharmaceutical Sterility Testing Market, By Type:

• In-house
• Outsourcing

Pharmaceutical Sterility Testing Market, By Product Type:

• Kits and Reagents
• Instruments
• Service

Pharmaceutical Sterility Testing Market, By Test Type:

• Sterility Testing
• Membrane filtration
• Direct inoculation
• Bioburden Testing
• Bacterial Endotoxin Testing

Pharmaceutical Sterility Testing Market, By Region:

• North America
  • United States
  • Canada
  • Mexico
• Asia-Pacific
  • China
  • India
  • South Korea
  • Australia
  • Japan
• Europe
  • Germany
  • France
  • United Kingdom
  • Spain
  • Italy
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Pharmaceutical Sterility Testing Market.

Available Customizations:

Global Pharmaceutical Sterility Testing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Applications
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Pharmaceutical Sterility Testing Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Type (In-house, Outsourcing)
  • 5.2.2. By Product Type (Kits and Reagents, Instruments, Service)
  • 5.2.3. By Test Type (Sterility Testing, Membrane filtration, Direct inoculation, Bioburden Testing, Bacterial Endotoxin Testing)
  • 5.2.4. By Region
  • 5.2.5. By Company (2024)
• 5.3. Market Map

6. Asia Pacific Pharmaceutical Sterility Testing Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Type
  • 6.2.2. By Product Type
  • 6.2.3. By Test Type
  • 6.2.4. By Country
• 6.3. Asia Pacific: Country Analysis
  • 6.3.1. China Pharmaceutical Sterility Testing Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Type
      • 6.3.1.2.2. By Product Type
      • 6.3.1.2.3. By Test Type
  • 6.3.2. India Pharmaceutical Sterility Testing Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Type
      • 6.3.2.2.2. By Product Type
      • 6.3.2.2.3. By Test Type
  • 6.3.3. Australia Pharmaceutical Sterility Testing Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Type
      • 6.3.3.2.2. By Product Type
      • 6.3.3.2.3. By Test Type
  • 6.3.4. Japan Pharmaceutical Sterility Testing Market Outlook
    • 6.3.4.1. Market Size & Forecast
      • 6.3.4.1.1. By Value
    • 6.3.4.2. Market Share & Forecast
      • 6.3.4.2.1. By Type
      • 6.3.4.2.2. By Product Type
      • 6.3.4.2.3. By Test Type
  • 6.3.5. South Korea Pharmaceutical Sterility Testing Market Outlook
    • 6.3.5.1. Market Size & Forecast
      • 6.3.5.1.1. By Value
    • 6.3.5.2. Market Share & Forecast
      • 6.3.5.2.1. By Type
      • 6.3.5.2.2. By Product Type
      • 6.3.5.2.3. By Test Type

7. Europe Pharmaceutical Sterility Testing Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Type
  • 7.2.2. By Product Type
  • 7.2.3. By Test Type
• 7.2.4 By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. France Pharmaceutical Sterility Testing Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Type
      • 7.3.1.2.2. By Product Type
      • 7.3.1.2.3. By Test Type
  • 7.3.2. Germany Pharmaceutical Sterility Testing Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Type
      • 7.3.2.2.2. By Product Type
      • 7.3.2.2.3. By Test Type
  • 7.3.3. Spain Pharmaceutical Sterility Testing Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Type
      • 7.3.3.2.2. By Product Type
      • 7.3.3.2.3. By Test Type
  • 7.3.4. Italy Pharmaceutical Sterility Testing Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Type
      • 7.3.4.2.2. By Product Type
      • 7.3.4.2.3. By Test Type
  • 7.3.5. United Kingdom Pharmaceutical Sterility Testing Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Type
      • 7.3.5.2.2. By Product Type
      • 7.3.5.2.3. By Test Type

8. North America Pharmaceutical Sterility Testing Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Type
  • 8.2.2. By Product Type
  • 8.2.3. By Test Type
• 8.2.4 By Country
• 8.3. North America: Country Analysis
  • 8.3.1. United States Pharmaceutical Sterility Testing Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Type
      • 8.3.1.2.2. By Product Type
      • 8.3.1.2.3. By Test Type
  • 8.3.2. Mexico Pharmaceutical Sterility Testing Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Type
      • 8.3.2.2.2. By Product Type
      • 8.3.2.2.3. By Test Type
  • 8.3.3. Canada Pharmaceutical Sterility Testing Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Type
      • 8.3.3.2.2. By Product Type
      • 8.3.3.2.3. By Test Type

9. South America Pharmaceutical Sterility Testing Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Type
  • 9.2.2. By Product Type
  • 9.2.3. By Test Type
  • 9.2.4. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Pharmaceutical Sterility Testing Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Type
      • 9.3.1.2.2. By Product Type
      • 9.3.1.2.3. By Test Type
  • 9.3.2. Argentina Pharmaceutical Sterility Testing Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Type
      • 9.3.2.2.2. By Product Type
      • 9.3.2.2.3. By Test Type
  • 9.3.3. Colombia Pharmaceutical Sterility Testing Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Type
      • 9.3.3.2.2. By Product Type
      • 9.3.3.2.3. By Test Type

10. Middle East and Africa Pharmaceutical Sterility Testing Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Type
  • 10.2.2. By Product Type
  • 10.2.3. By Test Type
  • 10.2.4. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Pharmaceutical Sterility Testing Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Type
      • 10.3.1.2.2. By Product Type
      • 10.3.1.2.3. By Test Type
  • 10.3.2. Saudi Arabia Pharmaceutical Sterility Testing Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Type
      • 10.3.2.2.2. By Product Type
      • 10.3.2.2.3. By Test Type
  • 10.3.3. UAE Pharmaceutical Sterility Testing Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Type
      • 10.3.3.2.2. By Product Type
      • 10.3.3.2.3. By Test Type

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Recent Developments
• 12.2. Product Launches
• 12.3. Mergers & Acquisitions

13. Global Pharmaceutical Sterility Testing Market: SWOT Analysis

14. Porter's Five Forces Analysis

• 14.1. Competition in the Industry
• 14.2. Potential of New Entrants
• 14.3. Power of Suppliers
• 14.4. Power of Customers
• 14.5. Threat of Substitute Product

15. PESTLE Analysis

16. Competitive Landscape

• 16.1. Pacific BioLabs Inc.
  • 16.1.1. Business Overview
  • 16.1.2. Company Snapshot
  • 16.1.3. Products & Services
  • 16.1.4. Financials (As Reported)
  • 16.1.5. Recent Developments
  • 16.1.6. Key Personnel Details
  • 16.1.7. SWOT Analysis
• 16.2. STERIS
• 16.3. Boston Analytical
• 16.4. Nelson Laboratories, LLC
• 16.5. Sartorius AG
• 16.6. SOLVIAS AG
• 16.7. Charles River Laboratories
• 16.8. Thermo Fisher Scientific, Inc.
• 16.9. Rapid Micro Biosystems, Inc.
• 16.10. Almac Group

17. Strategic Recommendations

18. About Us & Disclaimer